UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): September 13, 2021

 

AzurRx BioPharma, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-37853

 

46-4993860

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

777 Yamato Road, Suite 502

Boca Raton, Florida

 

33431

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (561) 589-7020

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

AZRX

 

Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

 

Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

Item 1.01 Entry into a Material Definitive Agreement

 

On September 13, 2021, AzurRx BioPharma, Inc., a Delaware corporation (the “Company”), Alpha Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”), First Wave Bio, Inc., a Delaware corporation (“First Wave”), and Fortis Advisors LLC, a Delaware limited liability company, solely in its capacity as the representative of the stockholders and option holders of First Wave (the “Stockholders”), entered into an Agreement and Plan of Merger (the “Merger Agreement”). A copy of the Merger Agreement is filed as Exhibit 2.1 and is incorporated herein by reference.

   

Pursuant to the Merger Agreement, the Company will acquire First Wave through the merger of Merger Sub with and into First Wave (the “Merger”), with First Wave surviving the merger as the surviving entity (the “Surviving Corporation”). From and after the effective time of the Merger (the “Effective Time”), the separate corporate existence of Merger Sub will cease and the Surviving Corporation will continue its existence under the laws of the State of Delaware and become a wholly owned subsidiary of the Company. The Merger will close promptly on September 13, 2021 (the “Closing Date”) upon completing certain filings with the Secretary of State of the State of Delaware.

 

As a result of the Merger, each share of First Wave common stock, par value $0.0001 per share (“First Wave Common Stock”), options to purchase First Wave Common Stock (“First Wave Options”), First Wave restricted stock units, First Wave Series A Preferred Stock, par value $0.0001 per share, and First Wave Series B Preferred Stock, par value $0.0001 per share, outstanding immediately prior to the Effective Time will be converted into the right to receive the applicable share of an aggregate of approximately $22.0 million worth of consideration, consisting of (i) approximately $18.0 million in cash, approximately $3.0 million of which is due on the Closing Date (as adjusted for First Wave’s cash and cash equivalents and transaction expenses), $8.0 million of which is payable within 45 days of the Closing Date, and $7.0 million of which is payable by March 31, 2022, and (ii) 624,025 shares of common stock (the “Common Stock Consideration”) of the Company, par value $0.0001 per share (the “Common Stock”), based on a value of $4.0 million divided by $6.41 per share, as adjusted for the Company’s previously disclosed 10-for-1 reverse stock split (also effective on the Closing Date). Following the Merger, and after giving effect to the 10-for-1 reverse stock split, there will be an aggregate of approximately 9,965,174 shares of Common Stock outstanding.

   

Pursuant to the Merger Agreement, Stockholders will also be entitled to the applicable share of each Milestone Payment, if any, as defined in the Merger Agreement, in an aggregate amount of up to $207.0 million, contingent upon the achievement of specified development, regulatory and sales goals for the use of First Wave’s proprietary formulations of niclosamide in the treatment of COVID, Immune Checkpoint Inhibitor-Associated Colitis and ulcerative colitis, and Crohn’s disease, ulcerative proctitis and/or ulcerative proctosigmoiditis (“IBD”). All Milestone Payments will be payable in cash, provided that 25% of the Milestone Payments attributable to IBD will be payable, at the Company’s option,  in either cash or Common Stock. In addition, Stockholders are entitled to 10% of certain specified revenue received by the Company from any third party with a pre-existing niclosamide development program relating to COVID.

   

 

2

 

 

As a result of the Merger, as of the Closing Date, the License Agreement, dated December 31, 2020, previously entered into between the Company and First Wave will be acquired and will terminate. Under the License Agreement, First Wave had previously granted the Company a worldwide, exclusive right to develop, manufacture, and commercialize First Wave’s proprietary immediate release and enema formulations of niclosamide for the fields of treating ICI-AC and COVID-19 in humans. The Company’s development of those proprietary formulations for those fields will continue unabated following the Merger.

 

Common Stock Consideration and the shares of Common Stock, if any, issued as Milestone Payments, will be subject to customary registration rights, and the Company shall use commercially reasonable efforts to file a registration statement registering such shares of Common Stock promptly after December 31, 2021.

 

Following the Merger, the Company will change its corporate name to “First Wave BioPharma, Inc.”, and the Common Stock will trade on the Nasdaq Capital Market under the new ticker symbol “FWBI”, each of which is anticipated to be effective on or about September 23, 2021.

 

The foregoing description of the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Merger Agreement filed herewith as Exhibit 2.1 and incorporated herein by reference.

 

Item 1.02 Termination of a Material Definitive Agreement.

 

The information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 1.02.

    

Item 2.01 Completion of Acquisition or Disposition of Assets.

 

The information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 2.01.

 

Item 3.02 Unregistered Sales of Equity Securities.

 

The description of the shares of restricted Common Stock issued to Stockholders of First Wave in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02.

 

The Company will issue the shares of restricted Common Stock to the Stockholders in reliance on the exemption from registration provided for under Section 4(a)(2) of the Securities Act of 1933 and/or Section 506 of Regulation D promulgated thereunder. The Company will rely on this exemption from registration for private placements based in part on the representations made by the Stockholders, including the representations with respect to each Stockholder’s status as an “accredited investor,” as such term is defined in Rule 501(a) of the Securities Act, and the stockholders’ investment intent.

   

Item 7.01 Regulation FD Disclosure.

 

On September 13, 2021, the Company issued a press release announcing the Merger. as well as a conference call and live audio webcast to occur at 8:30 a.m. ET on that same day, to discuss the acquisition of First Wave by the Company. Details of the conference call and webcast are included in the press release. A copy of the press release is furnished as Exhibit 99.1 hereto.

   

In addition, on September 13, 2021, the Company updated its corporate presentation materials (the “Corporate Presentation”), which it anticipates to reference on the conference call and webcast and post to its corporate website. A copy of the Corporate Presentation is furnished as Exhibit 99.2 hereto.

   

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1 and Exhibit 99.2, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as shall be expressly set forth by a specific reference in such filing.

 

Item 8.01 Other Events.

 

The Company is filing updates to its business description and risk factors, for the purpose of supplementing and updating the disclosure contained in its Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the Securities and Exchange Commission on March 31, 2021. A copy of such update is filed as Exhibit 99.3 and incorporated herein by reference.

 

 

3

 

 

Item 9.01. Financial Statements and Exhibits.

 

(a) Financial Statements of Business Acquired

 

First Wave’s audited financial statements for the year ended December 31, 2020 and the notes related thereto are filed as Exhibit 99.4 and incorporated herein by reference.

 

First Wave’s unaudited interim financial statements for the three and six months ended June 30, 2021, and the notes related thereto, are filed as Exhibit 99.5 and incorporated herein by reference.

   

(b) Pro Forma Financial Information

 

The unaudited pro forma condensed combined statement of operations for the year ended December 31, 2020 and balance sheets and statement of operations as of and for the six months ended June 30, 2021, and the notes related thereto, are filed as Exhibit 99.6 and incorporated herein by reference.

   

(d)

Exhibit No.

 

Description

 

2.1*

 

Agreement and Plan of Merger, dated September 13, 2021, by and among the Company, Alpha Merger Sub, Inc., First Wave Bio, Inc. and Fortis Advisors LLC, as shareholders’ representative. †

 

23.1

 

Consent of Plante & Moran, PLLC, Independent Registered Public Accounting Firm.

 

99.1

 

Press Release, dated September 13, 2021.

 

99.2

 

Corporate Presentation

 

99.3

 

Description of Business and Risk Factor Update

 

99.4

 

The audited financial statements of First Wave Bio, Inc. for the year ended December 31, 2020, and the notes related thereto.

 

99.5

 

The unaudited interim financial statements of First Wave Bio, Inc. for the three and six months ended June 30, 2021, and the notes related thereto.

 

99.6

 

The unaudited pro forma condensed consolidated financial statements for the six months ended June 30, 2021 and for the year ended December 31, 2020, and the notes related thereto.

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

* Schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company hereby undertakes to furnish supplementally copies of any of the omitted schedules upon request by the SEC.

 

† Certain portions of this exhibit, that are not material and would likely cause competitive harm to the registrant if publicly disclosed, have been redacted pursuant to Item 601(b)(10) of Regulation S-K.

 

 

4

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

AzurRx BioPharma, Inc.

 

 

 

 

 

September 13, 2021

By:

/s/ Daniel Schneiderman

 

 

Name:

Daniel Schneiderman

 

 

Title:

Chief Financial Officer

 

 

 

5

 EXHIBIT 2.1

  

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL. THE REDACTED TERMS HAVE BEEN MARKED WITH THREE ASTERISKS [***]

 

AGREEMENT AND PLAN OF MERGER

 

AMONG

 

AZURRX BIOPHARMA, INC.,

 

ALPHA merger sub, inc.,

 

FIRST WAVE BIO, INC.

 

AND

 

FORTIS ADVISORS LLC, AS SHAREHOLDERS’ REPRESENTATIVE

 

DATED AS OF SEPTEMBER 13, 2021

    

 

 

 

TABLE OF CONTENTS

 

 

 

Page

 

ARTICLE 1 DEFINITIONS; INTERPRETATION

 

1

 

 

 

 

 

Section 1.1.

Definitions

 

1

 

Section 1.2.

Made Available

 

20

 

 

 

 

 

 

ARTICLE 2 THE MERGER

 

21

 

 

 

 

 

Section 2.1.

The Merger

 

21

 

Section 2.2.

Closing

 

21

 

Section 2.3.

Actions in Connection with the Closing

 

21

 

Section 2.4.

Effects of the Merger

 

22

 

Section 2.5.

Bylaws

 

22

 

Section 2.6.

Up-Front Payment

 

22

 

Section 2.8.

Company Stock Options

 

23

 

Section 2.9.

Stock Payment and Buyer Common Stock

 

23

 

Section 2.10.

Shareholders’ Representative

 

24

 

Section 2.11.

Close of Stock Transfer Books

 

27

 

Section 2.12.

Dissenting Shares

 

27

 

Section 2.13.

Restriction on Transfer

 

28

 

Section 2.14.

Milestone Payments

 

28

 

Section 2.15.

Additional Revenue

 

34

 

Section 2.16.

Expense Fund

 

34

 

Section 2.17.

Second Payment

 

35

 

Section 2.18.

Third Payment

 

35

 

Section 2.19.

Withholding Rights

 

35

 

 

 

 

 

 

ARTICLE 3 CLOSING DELIVERIES

 

36

 

 

 

 

 

Section 3.1.

Deliveries by the Company

 

36

 

 

 

 

 

 

ARTICLE 4 REPRESENTATIONS AND WARRANTIES OF THE COMPANY

 

37

 

 

 

 

 

Section 4.1.

Organization

 

37

 

Section 4.2.

Authority; Execution and Delivery; Enforceability

 

37

 

Section 4.3.

Non-Contravention and Approval

 

37

 

Section 4.4.

Capitalization; Shares and Stockholder Information

 

38

 

Section 4.5.

Financial Statements

 

39

 

Section 4.6.

No Undisclosed Liabilities

 

39

 

Section 4.7.

Absence of Changes

 

40

 

Section 4.8.

Real Property

 

40

 

Section 4.9.

Intellectual Property

 

40

 

Section 4.10.

Contracts

 

42

 

Section 4.11.

Taxes

 

43

 

Section 4.12.

Litigation

 

45

 

 

 

ii

 

  

Section 4.13.

Employment and Employee Benefit Matters

 

45

 

Section 4.14.

Compliance with Laws; Permits

 

47

 

Section 4.15.

Environmental Matters

 

48

 

Section 4.16.

Anti-Bribery

 

48

 

Section 4.17.

Regulatory Compliance

 

48

 

Section 4.18.

Insurance Policies

 

49

 

Section 4.19.

Bank Accounts

 

50

 

Section 4.20.

Powers of Attorney

 

50

 

Section 4.21.

Brokers and Finders

 

50

 

Section 4.22.

Clinical Operations; CMC

 

50

 

Section 4.23.

The Buyer Group’s Representations; Independent Investigation

 

50

 

Section 4.24.

Private Placement

 

51

 

 

 

 

 

 

ARTICLE 5 REPRESENTATIONS AND WARRANTIES OF THE BUYER GROUP

 

51

 

 

 

 

 

Section 5.1.

Organization

 

51

 

Section 5.2.

Authority; Execution and Delivery; Enforceability

 

52

 

Section 5.3.

Capitalization

 

52

 

Section 5.4.

Noncontravention and Approval

 

53

 

Section 5.5.

Litigation

 

53

 

Section 5.6.

Compliance with Laws; Regulatory Matters

 

53

 

Section 5.7.

SEC Documents

 

54

 

Section 5.8.

Stock Consideration

 

55

 

Section 5.9.

Regulatory Compliance

 

55

 

Section 5.10.

Data Privacy

 

55

 

Section 5.11.

Anti-Bribery

 

55

 

Section 5.12.

No Undisclosed Liabilities

 

55

 

Section 5.13.

Brokers and Finders

 

56

 

Section 5.14.

Availability of Funds

 

56

 

Section 5.15.

Company’s Representations; Independent Investigation

 

56

 

 

 

 

 

 

ARTICLE 6 COVENANTS

 

57

 

 

 

 

 

Section 6.1.

Tax Matters

 

57

 

Section 6.2.

Indemnification of Officers and Directors

 

58

 

Section 6.3.

Publicity

 

58

 

Section 6.4.

Consents

 

59

 

Section 6.5.

Shares of Buyer Common Stock; Shelf Registration

 

59

 

Section 6.6.

Nasdaq Listing

 

54

 

Section 6.7.

Further Assurance

 

65

 

Section 6.8.

Section 280G

 

65

 

Section 6.9.

Buyer Board

 

65

 

Section 6.10.

E-mails

 

65

 

Section 6.11.

R&W Insurance Policy

 

66

 

 

 

iii

 

  

ARTICLE 7 NON-SURVIVAL OF THE REPRESENTATIONS AND WARRANTIES

 

66

 

 

 

 

 

Section 7.1.

Non-Survival

 

66

 

 

 

 

 

 

ARTICLE 8 MISCELLANEOUS

 

66

 

 

 

 

 

Section 8.1.

Notices

 

66

 

Section 8.2.

Assignment

 

68

 

Section 8.3.

Captions

 

68

 

Section 8.4.

Consents and Approvals

 

68

 

Section 8.5.

Enforcement

 

68

 

Section 8.6.

Amendment and Waiver

 

69

 

Section 8.7.

Entire Agreement

 

69

 

Section 8.8.

No Third-Party Beneficiaries

 

70

 

Section 8.9.

Counterparts

 

70

 

Section 8.10.

Governing Law

 

70

 

Section 8.11.

Severability

 

70

 

Section 8.12.

Joint Drafting

 

70

 

Section 8.13.

No Recourse

 

71

 

Section 8.14.

Consent to Representation; Conflict of Interest

 

71

 

Section 8.15.

Transaction Costs

 

71

 

   

EXHIBITS:

 

EXHIBIT A:

WRITTEN CONSENT

EXHIBIT B:

COMPOUNDS

EXHIBIT C:

FORM OF SELLING HOLDER QUESTIONNAIRE

EXHIBIT D:

FORM OF CERTIFICATE OF MERGER

EXHIBIT E:

FORM OF SURVIVING COMPANY BYLAWS

EXHIBIT F:

FORM OF LETTER OF TRANSMITTAL

EXHIBIT G:

FORM OF OPTION CANCELLATION AGREEMENT

EXHIBIT H:

MILESTONES

EXHIBIT I:

PRESS RELEASE

 

 

SCHEDULES:

 

 

SCHEDULE I:

CONSIDERATION SCHEDULE

 

 

iv

 

 

AGREEMENT AND PLAN OF MERGER

 

This Agreement and Plan of Merger (this “Agreement”), dated as of September 13, 2021, is made by and among AZURRX BIOPHARMA, INC., a Delaware corporation (“Buyer”), ALPHA MERGER SUB, INC., a Delaware corporation (“Merger Sub”), FIRST WAVE BIO, INC., a Delaware corporation (the “Company”), and FORTIS ADVISORS LLC, a Delaware limited liability company, solely in its capacity as the Shareholders’ Representative (as defined below).

 

RECITALS

 

WHEREAS, upon the terms and subject to the conditions set forth herein, Buyer desires to acquire the Company through the merger of Merger Sub with and into the Company (the “Merger”);

 

WHEREAS, the board of directors of the Company has (i) approved and declared advisable this Agreement and the transactions contemplated by this Agreement, including the Merger, upon the terms and subject to the conditions set forth herein, (ii) determined that this Agreement and such transactions are fair to, and in the best interests of, the Company and its stockholders and (iii) resolved to recommend that the Company’s stockholders approve the adoption of this Agreement and the transactions contemplated hereby, including the Merger;

 

WHEREAS, each of the boards of directors of Buyer and Merger Sub has (i) approved and declared advisable this Agreement and the transactions contemplated by this Agreement, including the Merger, upon the terms and subject to the conditions set forth herein, and (ii) determined that this Agreement and such transactions are fair to, and in the best interests of, Buyer and Merger Sub, respectively, and the equity holders of Buyer and Merger Sub, respectively;

 

WHEREAS, Buyer, as the sole stockholder of Merger Sub, has approved this Agreement and the transactions contemplated by this Agreement, including the Merger; and

 

WHEREAS, concurrently with the execution and delivery of this Agreement, and as a condition and inducement to Buyer’s willingness to enter into this Agreement, certain Company Shareholders will execute a written consent approving this Agreement and the transactions contemplated herein, a form of which is attached hereto as Exhibit A (the “Written Consent”).

 

NOW, THEREFORE, in consideration of the foregoing and the respective representations, warranties, covenants and agreements set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

ARTICLE 1

DEFINITIONS; INTERPRETATION

 

Section 1.1. Definitions. As used herein, the following terms shall have the following meanings:

 

1934 Act” is defined in Section 5.7(a).

 

280G Approval” is defined in Section 6.8.

 

280G Benefit” is defined in Section 6.8.

 

280G Waiver” is defined in Section 6.8.

 

Action” means any claim, action, cause of action, complaint, demand, lawsuit, arbitration, hearing, audit, notice of violation, proceeding, litigation, or Governmental Entity audit of any nature, whether civil, criminal, administrative, regulatory, or otherwise, and whether at law or in equity.

 

Additional Revenue” is defined in Section 2.15.

 

Advisory Group” is defined in Section 2.10(c).

 

Affiliate” means, with respect to a Person, another Person that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, such Person; provided that for purposes of this definition, “control” means, with respect to a Person, the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of such Person, whether through the ownership of voting securities, by Contract, by board of director membership or representation, or otherwise. In addition to the foregoing, if the specified Person is an individual, the term “Affiliate” also includes (a) the individual’s spouse, (b) the members of the immediate family (including parents, siblings and children) of the individual or of the individual’s spouse and (c) any corporation, limited liability company, general or limited partnership, trust, association or other business or investment entity that directly or indirectly, through one or more intermediaries controls, is controlled by or is under common control with any of the foregoing individuals.

 

Agreement” is defined in the preamble of this Agreement.

 

Allocation Notice” is defined in Section 2.14(b)(ii).

 

Blackout Notice” is defined in Section 6.5(d).

 

Business Day” means a day other than Saturday, Sunday or any other day on which commercial banks located in New York City are authorized or obligated by applicable Laws to close.

 

Buyer” is defined in the preamble of this Agreement.

 

Buyer Business” means the business of Buyer as conducted on the date hereof.

 

Buyer Common Stock” means the voting common stock, par value $0.0001 per share, of Buyer.

 

Buyer Disclosure Schedule” is defined in Article 5.

 

 
-1-

 

 

Buyer Financial Statements” means the (a) audited balance sheet of Buyer as of December 31, 2019 and as of December 31, 2020 and the related audited statement of operations and statement of cash flows for each of the fiscal years then ended and (b) unaudited balance sheet of Buyer as of June 30, 2021 (the “Most Recent Buyer Balance Sheet“; and the date of the Most Recent Buyer Balance Sheet, the “Most Recent Buyer Balance Sheet Date“), and the unaudited statement of operations and statement of cash flows of Buyer for the six (6) months then ended.

 

Buyer Group” means Merger Sub, Buyer and Buyer’s Subsidiaries.

 

Buyer Material Adverse Effect” means a material adverse effect on the ability of Buyer or Merger Sub to perform its obligations under this Agreement and any event, change, occurrence or effect that has a material adverse effect on the financial condition or results of operations of Buyer, taken as a whole; provided, however, that none of the following, and no event, change, occurrence or effect arising out of or resulting from the following, shall constitute or be taken into account, individually or in the aggregate, in determining whether there has been or will be a “Buyer Material Adverse Effect”: (i) (1) Buyer’s or any of its Affiliates’ compliance with the terms and conditions of this Agreement, (2) the failure to take any action that Buyer or any of its Affiliates has requested the consent of the Company to take and with respect to which the Company did not grant its consent or (3) any other action by Buyer or any of its Affiliates (A) contemplated by this Agreement, (B) that the Company has expressly requested or (C) to which the Company has consented in writing; (ii) any event, change, occurrence, disruption of, or effect affecting the industry, industry sectors or any geographic markets in which Buyer operates generally or the United States or worldwide economy generally or the securities, syndicated loan, credit or other financial markets generally, including changes in interest or exchange rates; (iii) political or regulatory conditions, including the worsening of any existing conditions; (iv) any delay or failure of Buyer to obtain Consent from any Governmental Entity for the operation of the Buyer Business in any geographic area where the Buyer Business does not operate; (v) any natural or man-made disaster, pandemic, epidemic, disease outbreak (including COVID-19) or any acts of terrorism, sabotage, armed hostilities, military action or war (whether or not declared), or any escalation or worsening thereof, or any other force majeure event, whether or not caused by any person, or any national or international calamity or crisis; (vi) any failure of Buyer to meet any internal or published forecasts, projections, predictions, guidance, estimates, milestones or budgets (but the underlying reason for the failure to meet such forecasts, projections, predictions, guidance, estimates, milestones or budgets may be considered, except as otherwise provided in this definition); (vii) the negotiation or execution of this Agreement or the announcement or pendency or consummation of the Acquisition or a potential transaction involving Buyer, including any litigation or any loss of, threatened loss of, or impact on the relationship of Buyer with, any partners, suppliers, regulators, customers, distributors, licensors or licensees; (viii) any acts or omissions of the Company or any of its Affiliates; (ix) the initiation by any person other than Buyer or any of its Affiliates of Actions under Chapter 11 of the U.S. Bankruptcy Code or other similar Laws or any adverse developments related to such Actions; (x) any change or prospective change in Laws or GAAP, IFRS or any other applicable accounting standards in any jurisdiction outside of the United States or the enforcement thereof, (xi) any quarantine, “shelter in place,” “stay at home,” workforce reduction, social distancing, shut down, closure, sequester, safety or similar Law, directive, restrictions, guidelines, responses or recommendations of or promulgated by any Governmental Entity, including the Centers for Disease Control and Prevention and the World Health Organization, in each case, in connection with or in response to any health condition (including any epidemic, pandemic or disease outbreak, such as COVID-19) and any evolutions or mutations thereof or related or associated epidemics, pandemics or disease outbreaks (all of the foregoing, “Pandemic Measures”), including any change, effect, event or circumstance with respect to any health condition or Pandemic Measures or any escalation or worsening thereof (including any subsequent waves) or (xii) any determination by, delay of a determination by, the FDA or any other Governmental Entity, or any panel or advisory body empowered or appointed thereby, or any indication that any such entity, panel or body will make any determination or delay in making any determination, with respect to the approvability, labeling, contents of package insert, prescribing information, risk management profile, pre-approval inspection matters or requirements relating to the results of any pre-clinical or clinical testing, in each case or other matters, related to any of the Products; provided, however, that with respect to a matter described in any of clauses (ii), (iii), (v) and (x), such event, change, occurrence or effect may be taken into account in determining whether there has been a Buyer Material Adverse Effect only to the extent such event, change, occurrence or effect has a materially disproportionate adverse effect on the financial condition or results of operations of Buyer, taken as a whole, relative to other persons operating businesses similar to its business in the geographic areas in which Buyer operates (and only to the extent of such materially disproportionate adverse effect). Any determination of “Buyer Material Adverse Effect” shall exclude the effects of the matters disclosed in the Buyer Disclosure Schedule, or the Buyer Financial Statements.

 

 
-2-

 

 

Buyer Milestone Stock Price” means the average of the daily volume-weighted average sales price per share of the Capital Stock of Buyer on Nasdaq, as such daily volume-weighted average sales price per share is reported by Bloomberg L.P., calculated to four decimal places and determined without regard to after-hours trading or any other trading outside the regular trading session trading hours, for each of the five (5) consecutive trading days ending on and including the trading day immediately preceding the achievement of each applicable IBD Field related Milestone Event.

 

Buyer Stock Price” means $6.41. For the avoidance of doubt, the Buyer Stock Price takes into account the 10-for-1 reverse stock split that is effective as of 12:01 AM Eastern Time on September 13, 2021.

  

Buyer’s Knowledge”, “to the Knowledge of the Buyer” or variations thereof means the actual knowledge of each individual identified on Section 1.1(a) of the Buyer Disclosure Schedule.

 

Buyer’s SEC Documents” is defined in Section 5.7(a).

 

Capital Stock” means any capital stock or share capital of, other voting securities of, other equity interest in, or right to receive profits, losses or distributions of, any Person.

 

CARES Act” means the Coronavirus Aid, Relief and Economic Security Act (Pub. L. 116-136), (a) as amended by each of (i) the Paycheck Protection Program and Health Care Enhancement Act, (ii) the Paycheck Protection Program Flexibility Act of 2020, (iii) the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act, (iv) Title V of the American Rescue Plan Act of 2021 (“ARP Act”), and (v) the PPP Extension Act of 2021 and (b) as otherwise amended from time to time, and the regulations promulgated thereunder, as amended.

 

Cash and Cash Equivalents“ means in relation to the Company, the aggregate of all cash and all checks, money orders, marketable securities, short-term instruments and other Cash Equivalents, funds in demand deposits or similar accounts, in each case determined in accordance with GAAP, including all deposits and cash in transit, net of (i) outstanding checks, electronic payments, and overdrafts drawn on Company accounts and (ii) credit card receivables in transit to the bank.

 

 
-3-

 

 

Cash Equivalents” means marketable direct obligations or securities issued by, or guaranteed by, the United States government (or any agency thereof), any state, commonwealth, or territory of the United States (or any agency, political subdivision, or taxing authority thereof), certificates of deposit, time deposits, eurodollar time deposits or overnight bank deposits, commercial paper, securities backed by standby letters of credit issued by any commercial bank, money market, or similar funds, in each case, with maturities of one-year or less from the date of acquisition.

 

Certificate of Merger” is defined in Section 2.3(e).

 

Clinical Trials” means any tests and studies of pharmaceutical products in human subjects or that constitute observational clinical studies.

 

Closing” is defined in Section 2.2.

 

Closing Cash and Cash Equivalents” means Cash and Cash Equivalents as of immediately prior to the Closing.

 

Closing Date” means the date on which the Closing occurs.

 

Closing Indebtedness means Indebtedness as of immediately prior to the Closing.

 

Closing Transaction Expenses” means Transaction Expenses as of immediately prior to the Closing.

 

Closing Statement” is defined in Section 2.6.

 

Code” means the Internal Revenue Code of 1986, as amended, and any substitute or successor provisions.

 

Commercially Reasonable Efforts” is defined in Section 2.14(c).

 

Commercialization” means any and all activities directed to the preparation for sale of, the offering for sale of, or sale of the Products in the Field in the Territory, including activities related to marketing, promoting, distributing, importing and establishing pricing and reimbursement with respect to the Products, as well as interacting with Governmental Entities regarding any of the foregoing, but excluding Development and Manufacturing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” shall have a corresponding meaning.

 

 
-4-

 

 

Company Benefit Plan” means any “employee benefit plan” within the meaning of Section 3(3) of ERISA (whether or not subject to ERISA) and any plan, program, policy, agreement or arrangement (whether written or oral) providing for compensation, employment, individual consulting, bonuses, profit-sharing, stock option or other stock-related rights or other forms of incentive or deferred compensation, vacation benefits, insurance (including any self-insured arrangements), health or medical benefits, disability or sick leave benefits, supplemental unemployment benefits, severance benefits and postemployment or retirement benefits (including compensation, pension, health, medical or life insurance benefits) or other employee pension or welfare benefits (a) that is sponsored, maintained or contributed to by the Company or any of its ERISA Affiliates for the benefit of any employee or former employee of the Company or other individual service provider performing services for the Company or (b) with respect to which the Company or any of its ERISA Affiliates has or may have any Liability, whether actual or contingent.

 

Company” is defined in the preamble of this Agreement.

 

Company Business” means the business of the Company as conducted on the date hereof.

 

Company Capital Stock” means the Capital Stock of the Company.

 

Company Common Stock” means the common stock, par value $0.0001 per share, of the Company.

 

Company Contracts” is defined in Section 4.10(a).

 

Company Disclosure Schedule” is defined in Article 4.

 

Company Indemnitee” is defined in Section 6.2(a).

 

Company Intellectual Property” is defined in Section 4.9(d).

 

Company IP Revenue” means the sum of all payments plus the fair market value of all other consideration of any kind, received by Buyer or its Affiliates from (a) licensees and sublicensees, (b) royalties, (c) upfront payments, milestones and other payments and (d) enforcement recoveries net of any costs of documented out-of-pocket fees, costs and expenses of any related litigation, each of ((a)-(d)) solely to the extent (i) attributable to Owned Intellectual Property for use in the COVID Field and (ii) received from a Third Party with a pre-existing niclosamide development program in the COVID Field at the time of entry into an arrangement with such Third Party.

 

Company’s Knowledge”, “to the Knowledge of the Company” or variations thereof means the actual knowledge of each individual identified on Section 1.1(a) of the Company Disclosure Schedule.

 

 
-5-

 

 

Company Plan” means the First Wave Bio, Inc. 2019 Equity Incentive Plan.

 

Company Preferred Stock” means the Company Series A Preferred Stock and the Company Series B Preferred Stock.

 

Company Product” means any Product produced by the Company as of the date hereof.

 

 “Company Series A Preferred Stock” means the Series A preferred stock, par value $0.0001 per share, of the Company.

 

Company Series B Preferred Stock” means the Series B preferred stock, par value $0.0001 per share, of the Company.

 

Company Shareholder” means a holder of Company Capital Stock as of immediately prior to the Effective Time.

 

Company Stock Option” means an option to purchase or acquire shares of Company Common Stock pursuant to the Company Plan.

 

Compound” means the Company’s proprietary formulations of niclosamide as set forth in Exhibit B.

 

Consent” means any approval, consent, ratification, waiver or other authorization.

 

Constitutive Documents” means the Articles or Certificate of Incorporation and By-laws of a Person if such Person is a corporation, and analogous constitutive documents if such Person is another form of entity.

 

Contract” means, with respect to any Person, all contracts, leases, deeds, mortgages, licenses, instruments, notes, commitments, undertakings, indentures, joint ventures, and all other agreements, commitments, and arrangements, in each case, which are legally binding arrangements on such Person, whether written or oral.

 

Control” or “Controlled” means, with respect to any item of Know-How, material, Patent or other intellectual property right, possession of the right, directly or indirectly, and whether by ownership, license, covenant or otherwise, to grant a license, sublicense, covenant or other right to or under such item of Know-How, material, Patent or other intellectual property right as provided for herein without violating an agreement with a Third Party.

 

COVID-19” means the novel coronavirus disease, COVID-19 virus (SARS-COV-2 and related strains and sequences) or mutation (or antigenic shift) thereof or a public health emergency resulting therefrom or associated epidemics, pandemics or disease outbreaks.

 

COVID Field” means any treatment, prevention or diagnosis of any coronavirus-related disease, including but not limited to COVID-19.

 

 
-6-

 

 

Covington” is defined in Section 8.14.

 

Creator” is defined in Section 4.9(f).

 

D&O Tail Policy” has the meaning set forth in Section 6.2(c).

 

D&O Tail Premium” has the meaning set forth in Section 6.2(c).

 

Development” means, with respect to the Compound or the Products, any and all activities, whether before, on or after First Commercial Sale of the Products, directed to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, Manufacturing process development, Manufacturing scale-up, qualification and validation, quality assurance/quality control development, Clinical Trials, statistical analysis and report writing, the preparation and submission of drug approval applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful for, or otherwise requested, required or recommended by a Governmental Entity or other payor as a condition or in support of obtaining, maintaining or expanding approvals from Governmental Entities. When used as a verb, “Develop” means to engage in Development.

 

DGCL” means the General Corporation Law of the State of Delaware.

 

Dispute Resolution Procedure” means the procedure pursuant to which the items in dispute under Section 2.14(d) are referred by either Buyer or the Shareholders’ Representative for determination as promptly as practicable to a regional or national accounting firm mutually agreed upon by the Buyer and the Shareholder Representative (the “Independent Accounting Firm”), pursuant to an engagement letter in customary form which each of Buyer and the Shareholder Representative must execute. The Independent Accounting Firm, acting as an expert and not as an arbitrator, must make a written determination, with respect to such disputed items only (a “Determination”). The Determination must be based solely on (i) the initial written submission by Buyer and the Shareholders’ Representative of their respective positions on the matters in dispute, (ii) written answers by Buyer and the Shareholders’ Representative to written questions from the Independent Accounting Firm and (iii) any work papers, records, accounts or similar materials delivered to the Independent Accounting Firm by the Buyer or the Shareholders’ Representative in response to requests by the Independent Accounting Firm. Each of Buyer and the Shareholders’ Representative must use commercially reasonable efforts to make its submissions as promptly as practicable following submission to the Independent Accounting Firm of the disputed items (but in any event, such submissions must be made no later than ten (10) Business Days following the date on which the disputed items are submitted to the Independent Accounting Firm). Buyer and the Shareholders’ Representative must instruct the Independent Accounting Firm to deliver the Determination to Buyer and the Shareholders’ Representative no later than twenty (20) Business Days following the later of the dates on which Buyer and the Shareholders’ Representative make their submissions. In making its determination, the Independent Accounting Firm shall disregard any settlement proposal or negotiation materials exchanged between Buyer and the Shareholders’ Representative with respect to any disputed item referred to the Independent Accounting Firm (all of which such settlement proposals or negotiation materials shall be governed by Rule 408 of the Federal Rules of Evidence and any applicable similar state rule or precedent). The Independent Accounting Firm shall be authorized to address only the items in dispute and shall not assign a value greater than the greatest value for such item claimed by either Party or smaller than the smallest value for such item claimed by either Party. In the absence of fraud or manifest error, the Determination will be conclusive and binding upon Buyer and the Shareholders’ Representative and Buyer and the Shareholders’ Representative will act in accordance with the Determination. The determination of the Independent Accounting Firm shall not be deemed an award subject to review under the Federal Arbitration Act or any other Law. All fees and expenses of the Independent Accounting Firm incurred in connection with any dispute under Section 2.14(d) hereof will be borne proportionally (1) borne by Shareholders’ Representative in the proportion that the aggregate dollar amount of the disputed items submitted to the Independent Accounting Firm pursuant to Section 2.14(d) that are unsuccessfully disputed by Shareholders’ Representative (as finally determined by the Independent Accounting Firm) bears to the aggregate dollar amount of all disputed items submitted to the Independent Accounting Firm pursuant to Section 2.14(d) and (2) borne by Buyer in the proportion that the aggregate dollar amount of the disputed items submitted to the Independent Accounting Firm pursuant to Section 2.14(d) that are unsuccessfully disputed by Buyer (as finally determined by the Independent Accounting Firm) bears to the aggregate dollar amount of all disputed items submitted to the Independent Accounting Firm pursuant to Section 2.14(d).

 

 
-7-

 

 

Dissenting Shares” is defined in Section 2.12(a).

 

E-mail Accounts” means all existing e-mail accounts used by the Company prior to Closing, including those set forth on Section 1.1(b) of the Company Disclosure Schedules.

 

E-mails” means all e-mail correspondence to, from or including any officer, director, consultant, independent contractor or manager of the Company prior to the Closing.

 

Effective Time” is defined in Section 2.3(e).

 

Emergency Use Authorization” means an authorization to introduce a medicinal product into interstate commerce in the United States pursuant to Section 564 of the United States Federal Food, Drug, and Cosmetic Act.

 

Enforceability Exceptions” is defined in Section 4.2.

 

Environmental Laws” means all applicable Laws and Permits or binding agreements with any Governmental Entity: (a) relating to pollution (or the cleanup thereof) or the protection of, or payment for damages to, natural resources, endangered or threatened species, human health or safety (as it relates to human exposure to Hazardous Substances), or the environment (including ambient air, soil, surface water or groundwater, or subsurface strata); or (b) concerning the human exposure to, or the management, containment, handling, storage, recycling, reclamation, reuse, treatment, generation, discharge, transportation, processing, disposal or remediation of any Hazardous Substances. The term “Environmental Law” includes the following (including their implementing regulations and any state analogs): the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended by the Superfund Amendments and Reauthorization Act of 1986, 42 U.S.C. §§ 9601 et seq.; the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, as amended by the Hazardous and Solid Waste Amendments of 1984, 42 U.S.C. §§ 6901 et seq.; the Federal Water Pollution Control Act of 1972, as amended by the Clean Water Act of 1977, 33 U.S.C. §§ 1251 et seq.; the Toxic Substances Control Act of 1976, as amended, 15 U.S.C. §§ 2601 et seq.; the Emergency Planning and Community Right-to-Know Act of 1986, 42 U.S.C. §§ 11001 et seq.; the Clean Air Act of 1966, as amended by the Clean Air Act Amendments of 1990, 42 U.S.C. §§ 7401 et seq.; and the Occupational Safety and Health Act of 1970, as amended, 29 U.S.C. §§ 651 et seq.

 

 
-8-

 

 

ERISA” means the Employee Retirement Income Security Act of 1974.

 

ERISA Affiliate” means, with respect to an entity, any trade or business (whether or not incorporated) under common control with the Company and that, together with the Company, is treated as a single employer within the meaning of Section 414(b), (c), (m) or (o) of the Code or pursuant to Section 4001 of ERISA.

 

EU Big 4 means Germany, France, Spain and Italy.

 

Exercise Price” means with respect to any Company Stock Option the aggregate amount required to be paid by the holder thereof to exercise such Company Stock Option.

 

Expense Fund” is defined in Section 2.16.

 

Expense Fund Amount” is defined in Section 2.16.

 

Exploit” means to make, have made, import, use, sell or offer for sale, including to Develop, Commercialize, Manufacture, register, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, have distributed, promote, market or have sold or otherwise dispose of a product or a process, and “Exploitation” means the act of Exploiting a product or process.

 

FDA” means the United States Food & Drug Administration, or any successor agency thereto.

 

FDCA” means the United States Federal Food, Drug, and Cosmetic Act, as amended.

 

Field means the COVID Field, the IBD Field and the ICI-AC Field.

 

Financial Statements” is defined in Section 4.5.

 

First Commercial Sale” means, with respect to the U.S. or the E.U., as applicable, and a Product, the first sale of such Product for use or consumption by the general public (and excluding research or educational use, charitable or compassionate use, and indigent care) by a Party or its Affiliate or sublicensee to a Third Party in such country after all Permits required to sell such Product have been obtained in such country.

 

First Patient” means the first patient dosed in the applicable Clinical Trial.

 

 
-9-

 

 

Fraud” means intentional common law fraud under the laws of the State of Delaware with respect to the representations and warranties set forth in Article 4 or Article 5 of this Agreement. For the avoidance of doubt, “Fraud” does not include any claim for equitable fraud, promissory fraud, unfair dealings fraud, constructive fraud, or any torts based on negligence or recklessness

 

FWB Background IP” means any and all Know-How or Patents that are (a) related to the Compound in the Field in the Territory, (b) Controlled by the Company or its Affiliates as of the Effective Date or developed independent of this Agreement, and (c) necessary or reasonably useful to Exploit the existing Product in the Field in the Territory.

 

FWB Background Patents” means Patents within the FWB Background IP.

 

GAAP” is defined in Section 4.5.

 

Governmental Entity” means any federal, state, local, or foreign government or any court, administrative, or regulatory agency, department, instrumentality, body, or commission or other governmental authority or agency, domestic or foreign, including the U.S. Internal Revenue Service, the U.S. Department of Health and Human Services, the U.S. Food & Drug Administration, and any applicable state department of health.

 

Hazardous Substances” shall mean any pollutant, contaminant, hazardous substance or chemical, toxic, carcinogenic, infectious, radioactive, flammable, ignitable, reactive or corrosive substance, solid, chemical, or hazardous waste, special waste, petroleum or petroleum-derived substance or waste, asbestos or asbestos-containing material, polychlorinated biphenyls, contaminants of emerging concern (including per- and polyfluoroalkyl substances (“PFAS”) and 1,4- dioxane), natural gas (including natural gas liquids, liquefied natural gas or synthetic gas usable as fuel), or any constituent, raw material, product, or by-product of any such substance or waste, the management, use, handling, storage, treatment, or disposal of which is in any way governed by, subject to, or listed in any Environmental Law.

 

Holder of Registrable Securities” shall mean a holder of Registrable Securities as of or following the Closing Date.

 

IBD Field” means any treatment, prevention or diagnosis of ulcerative colitis, Crohn’s disease, ulcerative proctitis and/or ulcerative proctosigmoiditis.

 

ICI-ACmeans immune checkpoint inhibitor-associated colitis.

 

ICI-AC Field” means (the diagnosis, prevention or treatment of ICI-AC in humans).

 

 
-10-

 

 

Indebtedness” in relation to the Company, the aggregate amount owed without duplication in respect of (i) borrowed money, (ii) securitization, factoring or similar arrangements, (iii) interest rate swap, currency swap, forward currency or interest rate contracts or other hedging arrangements, (iv) all guaranties of obligations of others for borrowed money or any other indebtedness, (v) all obligations as an account party in respect of letters of credit, letters of guaranty, bankers’ acceptances, performance bonds, or similar items, in each case solely to the extent drawn or called prior to the Closing, (v) all liabilities arising from cash/book overdrafts, (vi) any accrued but unpaid liabilities of the Company for Taxes, attributable to the taxable period (or portions thereof) ending on or prior to the Closing Date; (vii) obligations evidenced by notes, bonds, debentures or other debt securities, (viii) obligations for the deferred purchase price of goods or services (other than trade payables and accruals incurred in the Ordinary Course of Business), (ix) all accrued and unpaid interest on any of the obligations referred to in the foregoing clauses (i) through (vii) and (x) obligations referred to in the foregoing clauses (i) through (ix) of other persons for the payment of which the Company is responsible as obligor, guarantor, surety or otherwise, including any guarantee of such obligations in relation to the Company.

 

Indebtedness Lenders” means the lenders or payees of the Indebtedness.

 

Indebtedness Payoff Letter” has the meaning set forth in Section 3.1(e).

 

Insurance Policies” is defined in Section 4.18.

 

Intellectual Property” means all (i) Patents, (ii) Trademarks, (iii) copyrights, including all copyright registrations and applications, (iv) domain name registrations and (v) trade secrets.

 

Invoiced Sales” is defined in the definition of “Net Sales”.

 

Judgment” means any judgment, order or decree of a Governmental Entity.

 

Know-How” means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, discoveries, compounds, compositions, formulations, processes, correspondence, computer programs, documents, apparatus, strategies, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results, regulatory documentation, information and submissions pertaining to, or made in association with, filings with any Governmental Entity or Patent Office, data in written, electronic, oral or other tangible or intangible form, and other material, including: biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, assays and biological methodology, and any inventions, improvements, discoveries, and developments included therein, in each case (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, but excluding in any event any published Patents.

 

Law” means all laws (statutory, common, or otherwise), constitutions, rules, codes, regulations, restrictions, ordinances, orders, directives, judgments, injunctions, writs, treaties, and decrees of, or issued by, all Governmental Entities.

 

Letter of Transmittal” is defined in Section 2.9(a).

 

 
-11-

 

 

Lien” means any charge, claim, community, or other marital property interest, condition, equitable interest, lien, license, assignment, option, pledge, security interest, mortgage, deed of trust, right of way, easement, encroachment, servitude, right of first offer or first refusal, buy/sell agreement, and any other restriction, encumbrance, or covenant with respect to, or condition governing the use, construction, voting (in the case of any security or equity interest), transfer, receipt of income, or exercise of, any other attribute of ownership or encumbrances of any nature or kind whatsoever.

 

LLC Act” means the Delaware Limited Liability Company Act.

 

Losses” is defined in Section 6.5(f).

 

Manufacture” and “Manufacturing” means any and all activities directed to the formulation development, production, manufacture, processing, filling, finishing, packaging, labeling, shipping, holding and disposing of the Compound or the Products, or any intermediate thereof, including stability testing, quality assurance, and quality control and interacting with Governmental Entities regarding any of the foregoing.

 

Material Adverse Effect” means any event, change, occurrence or effect that has a material adverse effect on the financial condition or results of operations of the Company, taken as a whole; provided, however, that none of the following, and no event, change, occurrence or effect arising out of or resulting from the following, shall constitute or be taken into account, individually or in the aggregate, in determining whether there has been or will be a “Material Adverse Effect”: (i) (1) the Company’s or any of its Affiliates’ compliance with the terms and conditions of this Agreement, (2) the failure to take any action that the Company or any of its Affiliates has requested the consent of Buyer to take and with respect to which Buyer did not grant its consent or (3) any other action by the Company or any of its Affiliates (A) contemplated by this Agreement, (B) that Buyer has expressly requested or (C) to which Buyer has consented in writing; (ii) any event, change, occurrence, disruption of, or effect affecting the industry, industry sectors or any geographic markets in which the Company operates generally or the United States or worldwide economy generally or the securities, syndicated loan, credit or other financial markets generally, including changes in interest or exchange rates; (iii) political or regulatory conditions, including the worsening of any existing conditions; (iv) any delay or failure of the Company to obtain Consent from any Governmental Entity for the operation of the Company Business in any geographic area where the Company Business does not operate; (v) any natural or man-made disaster, pandemic, epidemic, disease outbreak (including COVID-19) or any acts of terrorism, sabotage, armed hostilities, military action or war (whether or not declared), or any escalation or worsening thereof, or any other force majeure event, whether or not caused by any person, or any national or international calamity or crisis; (vi) any failure of the Company Business to meet any internal or published forecasts, projections, predictions, guidance, estimates, milestones or budgets (but the underlying reason for the failure to meet such forecasts, projections, predictions, guidance, estimates, milestones or budgets may be considered, except as otherwise provided in this definition); (vii) the negotiation or execution of this Agreement or the announcement or pendency or consummation of the Acquisition or a potential transaction involving the Company, including any litigation or any loss of, threatened loss of, or impact on the relationship of the Company with, any partners, suppliers, regulators, customers, distributors, licensors or licensees; (viii) any acts or omissions of Buyer or any of its Affiliates; (ix) the initiation by any person other than the Company or any of its Affiliates of Actions under Chapter 11 of the U.S. Bankruptcy Code or other similar Laws or any adverse developments related to such Actions; (x) any change or prospective change in Laws or GAAP, IFRS or any other applicable accounting standards in any jurisdiction outside of the United States or the enforcement thereof, (xi) any Pandemic Measures, including any change, effect, event or circumstance with respect to any health condition or Pandemic Measures or any escalation or worsening thereof (including any subsequent waves) or (xii) any determination by, delay of a determination by, the FDA or any other Governmental Entity, or any panel or advisory body empowered or appointed thereby, or any indication that any such entity, panel or body will make any determination or delay in making any determination, with respect to the approvability, labeling, contents of package insert, prescribing information, risk management profile, pre-approval inspection matters or requirements relating to the results of any pre-clinical or clinical testing, in each case or other matters, related to any of the Products; provided, however, that with respect to a matter described in any of clauses (ii), (iii), (v) and (x), such event, change, occurrence or effect may be taken into account in determining whether there has been a Material Adverse Effect only to the extent such event, change, occurrence or effect has a materially disproportionate adverse effect on the financial condition or results of operations of the Company, taken as a whole, relative to other persons operating businesses similar to the Company Business in the geographic areas in which the Company operates the Company Business (and only to the extent of such materially disproportionate adverse effect). Any determination of “Material Adverse Effect” shall exclude the effects of the matters disclosed in the Company Disclosure Schedule, or the Financial Statements.

 

 
-12-

 

 

Merger” is defined in the Recitals.

 

Merger Consideration” is defined in Section 2.7(a).

 

Merger Sub” is defined in the preamble of this Agreement.

 

 “Milestone Event” is defined in Section 2.14.

 

Milestone Payment” is defined in Section 2.14.

 

Milestone Payment Cash” is defined in Section 2.14.

 

Most Recent Balance Sheet” is defined in Section 4.5.

 

Most Recent Balance Sheet Date” is defined in Section 4.5.

 

Most Recent Buyer Balance Sheetis defined in the definition of Buyer Financial Statements.

 

Most Recent Buyer Balance Sheet Dateis defined in the definition of Buyer Financial Statements.

 

Nasdaq” means the Nasdaq Capital Market or any successor stock exchange operated by The Nasdaq Stock Market LLC or any successor thereto.

 

Ordinary Course of Business” means the ordinary course of business of the Company, consistent with past practice, including all reasonable and good faith actions or omissions by the Company in response to COVID-19, Pandemic Measures and applicable Law relating to COVID-19.

 

NDA” means a new drug application pursuant to Section 505(b) of the FDCA in conformance with applicable Law, or any foreign equivalent of any such application in any other country filed with a regulatory authority to obtain marketing approval for a pharmaceutical product.

 

 
-13-

 

 

Net Sales” means, with respect to any Product, the gross amounts invoiced for sales or other dispositions of such Product (the “Invoiced Sales”) by or on behalf of Buyer or its Affiliates or sublicensees to Third Parties, less the following deductions to the extent included in the gross invoiced sales price for such Product and determined in each case in accordance with GAAP or otherwise directly paid or incurred by Buyer or its Affiliates or sublicensees, as applicable, with respect to the sale or other disposition of such Product:

 

 

(a)

normal and customary trade and quantity discounts actually allowed and properly taken directly with respect to sales of such Product;

 

 

 

 

(b)

credits or allowances given or made for rejection or return of previously sold Products or for retroactive price reductions and billing errors;

 

 

 

 

(c)

rebates and chargeback payments granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), national, state/provincial, local, and other Government Authorities including, their agencies and purchasers and reimbursers, or to trade customers;

 

 

 

 

(d)

taxes, duties, or other governmental charges (including any non-recoverable value added or similar tax, but not including any recoverable value added or similar tax or any taxes based on or measured by income) directly levied on or measured by the billing amount for such Product, as adjusted for rebates and refunds;

 

 

 

 

(e)

amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;

 

 

 

 

(f)

the portion of administrative fees paid during the relevant time period to group purchasing organizations or pharmaceutical benefit managers relating to such Product;

 

 

 

 

(g)

gross sales offsets provided to specialty pharmacies, warehousing chains or distributors for their services provided; and

 

 

 

 

(h)

freight, insurance, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced.

 

 
-14-

 

  

Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of Buyer, its Affiliates, or sublicensees, which must be in accordance with GAAP. For purposes of determining Net Sales, a Product will be deemed to be sold when invoiced. A particular deduction may only be accounted for once in the calculation of Net Sales. Net Sales will exclude any samples of a Product transferred or disposed of at no cost, or cost below Buyer’s cost of goods for such Product, for promotional, development, or educational purposes.

 

In the event a Product is sold as part of a combination product in a country, the Parties will negotiate, reasonably and in good faith, an adjustment to Net Sales with respect to the combination product in such country to account for any value attributable to active ingredients included in the combination product other than the Compound.

 

For clarity, Net Sales will be calculated on an accrual basis, in a manner consistent with Buyer’s internal accounting policies, as consistently applied. To the extent any accrued amounts used in the calculation of Net Sales are estimates, such estimates shall be trued-up in accordance with Buyer’s internal accounting policies, consistently applied, and Net Sales and related payments under this Agreement shall be reconciled as appropriate.

 

Option Cancellation Agreement” is defined in Section 2.9(a).

 

Option Consideration” is defined in Section 2.8(a).

 

Owned Intellectual Property” means all Intellectual Property that is owned by the Company.

 

Pandemic Measures” is defined in the definition of “Buyer Material Adverse Effect”.

 

Party” means Buyer, Merger Sub, the Company and the Shareholders’ Representative.

 

Patent(s)” means (a) patents, including any utility or design patent, utility models or petty patents; (b) patent applications, including provisionals, non-provisionals, substitutions, divisionals, continuations, continuations in-part or renewals; (c) patents of addition, restorations, extensions, supplementary protection certificates, registration or confirmation patents, patents resulting from post-grant proceedings, re-issues, and re-examinations; (d) other patents or patent applications claiming priority directly or indirectly to: (i) any such specified patent or patent application specified in (a) through (c), or (ii) any patent or patent application from which a patent or patent application specified in (a) through (c) claims direct or indirect priority; (e) inventor’s certificates; (f) other rights issued from a Governmental Entity similar to any of the foregoing specified in (a) through (e); and (g) in each of (a) through (f), whether such patent, patent application or other right arises in the U.S. or any other jurisdiction in the world.

 

Paying Agent” means PNC Bank, National Association.

 

 
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Permit” means any permit, license, franchise, approval or authorization from any Governmental Entity.

 

Permitted Liens” means (i) such Liens as are set forth on Section 1.1(c) of the Company Disclosure Schedule, (ii) Liens for Taxes and other governmental charges that are not yet due, or that the taxpayer is contesting in good faith, in each case to the extent adequate reserves for such Taxes and other governmental charges have been established in accordance with GAAP, (iii) Liens disclosed in the Financial Statements or the notes thereto or securing liabilities reflected in the Financial Statements or the notes thereto or in the Closing Statement, (iv) restrictions under licenses, Permits or occupancy agreements to which the Company is a party, (v) rights or interests of a licensor or licensee (or sublicensor or sublicensee) or a party to a covenant not to sue or non-assertion or similar agreement evident from the face of a license (or sublicense or other agreement), (vi) Liens that will be released prior to or at the Closing and (vii) other imperfections of title, licenses or Liens, if any, that do not materially impair the continued use and operation of the assets to which they relate in the conduct of the Company Business.

 

Person” means an individual, corporation, company, partnership, limited liability company, joint venture, association, trust, business trust, Governmental Entity, unincorporated organization, a division or operating group of any of the foregoing or any other entity or organization.

 

Personal Information” means information (i) that identifies an individual or (ii) in combination with other information in the Company’s possession or under its control, identifies an individual.

 

 “Phase 2 Clinical Trial” means a study in humans involving a Product that is described as a phase 2 Clinical Trial in its protocol, or that otherwise would satisfy the requirements of 21 C.F.R. § 312.21(b) or foreign counterparts, as may be conducted anywhere in the world.

 

Phase 3 Clinical Trial” means a study in humans involving a Product that is described as a phase 3 Clinical Trial in its protocol or that otherwise would satisfy the requirements of 21 C.F.R. §312.21(c) or foreign counterparts, as may be conducted anywhere in the world.

 

Privacy and Security Laws” means all applicable federal, state, and local privacy, data security and data protection Laws concerning the processing of Personal Information.

 

Product” means any product that contains as an active ingredient (alone or with other active ingredients) a Compound, regardless of form, presentation, formulation and dosage form.

 

Prospectus” is defined in Section 6.5(b)).

 

R&W Insurance Policy” shall mean that certain insurance policy, to be issued by the R&W Insurer and to be bound as provided in Section 6.9.

 

 
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R&W Insurer” shall mean Ambridge Partners LLC.

 

R&W Policy Premium” means the fees, costs and expenses to be incurred by Buyer in connection with the R&W Insurance Policy.

 

Registrable Securities” means the shares of Buyer Common Stock issued in connection with the Closing pursuant to this Agreement as part of the Stock Consideration; provided, however, that shares of Buyer Common Stock shall cease to be Registrable Securities hereunder if and when (i) such Registrable Securities have been sold, transferred or otherwise disposed of pursuant to an effective registration statement registering such Registrable Securities (or the resale thereof) under the Securities Act, (ii) such Registrable Securities have been sold, transferred or otherwise disposed of pursuant to Rule 144 of the Securities Act (“Rule 144”) or (iii) with respect to the Registrable Securities held by a particular non-affiliate Company Shareholder, such Company Shareholder has held such Registrable Securities for at least one year and holds a number of Registrable Securities less than the number of shares of Buyer Common Stock issuable upon a conversion of Buyer Common Stock that can be sold by such Company Stockholder in a single 90-day period pursuant to Rule 144 (including Rule 144(e)).

 

Registration Statement” is defined in Section 6.5(b).

 

Registrational Trial means a study in humans involving a Product that is designed to meet the requirements (relating to safety and efficacy) for marketing approval, clearance, or authorization of a Product by any Governmental Entity, or is otherwise intended to be relied on by any such Governmental Entity for such marketing approval, clearance, or authorization. For clarity, all Phase 3 Clinical Trials are Registrational Trials, though a study does not have to be a Phase 3 Clinical Trial in order to be a Registrational Trial.

 

Release” shall mean any actual or threatened release, spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, abandonment, disposing or allowing to escape or migrate into or through the environment (including ambient air (indoor or outdoor), surface water, groundwater, land surface or subsurface strata).

 

Representative Losses” is defined in Section 2.10(c).

 

Representatives” means, with respect to a Person, such Person’s legal, financial, accounting and other advisors and representatives.

 

RSU Agreements” means those certain agreements set forth on Section 1.1(d) of the Company Disclosure Schedules.

 

RSU Holders” means those Persons set forth on Section 1.1(e) of the Company Disclosure Schedules.

 

 
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Schedule I” means a statement delivered to Buyer prior to the date hereof, with the following information:

 

(i) the name and email address of each Seller;

 

(ii) with respect to each Seller that is a Company Shareholder, the number of shares of Company Common Stock, Company Series A Preferred Stock and Company Series B Preferred Stock held by such Seller;

 

(iii) with respect to each Seller that is a Company Optionholder, the number of Company Stock Options held by such Seller and the Exercise Price for each such Company Stock Option; and

 

(iv) with the respect to each Seller, such Seller’s applicable portion of the Up-Front Payment, the Second Payment, the Third Payment, the Milestone Payments, if any, the Expense Fund, if and when distributed, the Stock Consideration and the Company IP Revenue, to which such Seller is entitled pursuant to this Agreement.

 

SEC” means the United States Securities and Exchange Commission.

 

Second Payment” means $8,000,000.

 

Securities Act” means the Securities Act of 1933.

 

Seller Group” is defined in Section 8.14.

 

Sellers” means the RSU Holders, Company Optionholders and Company Shareholders who are entitled to receive the Merger Consideration or Option Consideration in respect of the shares of Company Common Stock or Company Preferred Stock or Company Stock Options or to its RSU Agreements, as applicable, such Seller held prior to the Effective Time; provided, however, that neither Buyer nor any Subsidiary or Affiliate of Buyer shall be considered a Seller.

 

Selling Holder Questionnaire” means a selling holder questionnaire in the form attached hereto as Exhibit C.

 

Shareholders’ Representative” is defined in Section 2.10(a).

 

Shareholders’ Representative Engagement Agreement” is defined in Section 2.10(c).

 

Shareholders’ Representative Group” is defined in Section 2.10(c).

 

Standstill Period” means the period ending on December 31, 2021.

 

Stock Consideration” means the aggregate number of shares of Buyer Common Stock to be issued to each Seller in connection with the Merger, which shall equal 624,025. For the avoidance of doubt, the Stock Consideration takes into account the 10-for-1 reverse stock split that is effective as of 12:01 AM Eastern Time on September 13, 2021.

 

Subsidiary” means, with respect to any Person, (i) any corporation more than 50% of whose stock of any class or classes is owned by such Person directly or indirectly through one or more Subsidiaries of such Person and (ii) any partnership, association, joint venture or other entity in which such Person directly or indirectly through one or more Subsidiaries of such Person has more than a 50% equity interest.

 

 
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Successful Completion” means the completion of dosing and examination specified in the Clinical Trial protocol for purposes of collection of data for the primary endpoint(s) in a sufficient number of patients such that the pre-specified statistical analysis plan can be applied. For avoidance of doubt, Successful Completion includes Clinical Trials that complete per protocol but do not meet one or more primary endpoints, and Clinical Trials that are terminated earlier than contemplated by the applicable protocol due to clear demonstration of benefit.

 

Surviving Company” is defined in Section 2.1.

 

Tax” means (i) all forms of taxation imposed by any federal, state, provincial, local, foreign or other Taxing Authority, including income, franchise, property, sales, goods and services or harmonized sales taxes, use, excise, employment, unemployment, payroll, social security, estimated, value added, ad valorem, transfer, recapture, withholding, health and other taxes of any kind, including any interest, penalties and additions thereto, (ii) any liability for the payment of any amount of the type described in clause (i) as a result of being a member of an affiliated, consolidated, combined, unitary or aggregate group for any taxable period, and (iii) any liability for the payment of any amount of the type described in clauses (i) or (ii) as a result of being a transferee or successor to any Person or as a result of any express or implied obligation to indemnify any other Person, whether by Contract or applicable Law. For the avoidance of doubt, “Tax” or “Taxes” shall not include any anti-dumping, countervailing or other customs duties, tariffs or charges.

 

Tax Law” means all currently applicable Laws relating to or regulating the assessment, determination, reporting, withholding, collection or imposition of Taxes.

 

Tax Return” means any report, return, document, declaration or other information or filing required to be supplied to any Taxing Authority with respect to Taxes, including any amendment made with respect thereto.

 

Taxing Authority” means any Governmental Entity, any subdivision, agency, commission or authority thereof or any quasi-governmental body authorized to administer or collect Taxes.

 

Territory” means the world.

 

Third Party” means any Person other than the Company, Sellers, Merger Sub, Buyer, Shareholders’ Representative and their respective Affiliates and successors and permitted assigns.

 

Third Payment” means $7,000,000.

 

Trademark(s)” mean(s) any trademark, trade dress, service mark, trade name, logo or other business symbol that is an indicia of source or origin, whether or not registered, all registrations and applications therefor, and all goodwill associated therewith and symbolized thereby.

 

 
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Transaction Documents” means this Agreement and all the other agreements, certificates, instruments, and other documents to be executed or delivered pursuant to or in connection with this Agreement and the Transactions.

 

Transaction Expenses” means, without duplication (i) any sale, change-in-control, retention, or similar bonuses or payments to any current or former director, manager, officer, contractor, or consultant of the Company as a result of, triggered by, or otherwise in connection with the consummation of the transactions contemplated hereby, except with respect to the RSU Holders, (ii) any fees, costs, expenses and other amounts incurred or otherwise payable by the Company (on behalf of itself, Sellers or any of their respective Affiliates) arising from or incurred in connection with this Agreement, the transactions contemplated hereby, any alternatives thereto and the negotiation thereof, including legal, accounting, investment banking and other professional advisors’, independent contractors’ and agents’ fees and expenses, and any and all fees of the Paying Agent, in each case to the extent such fees, expenses and other amounts are unpaid immediately prior to the Closing, but expressly excluding any fees or expenses incurred by or at the express direction of Buyer or any of its Affiliates (including to the extent incurred by or at the express direction of Buyer or any of its Affiliates in connection with the transactions contemplated hereby or otherwise for the purpose of obtaining any Third Party consents), (iii) $50,000 of the R&W Policy Premium, and (iv) fifty percent (50%) of the D&O Tail Premium.

 

Transactions” means the Merger and the other transactions contemplated by this Agreement and the other Transaction Documents.

 

Treasury Regulations” means the United States Treasury Regulations promulgated under the Code.

 

U.S.” means the United States of America, its territories and possessions, including Puerto Rico.

 

Up-Front Payment” means (i) $3,035,026.88 in cash, plus (ii) the Closing Cash and Cash Equivalents, minus (iii) any Closing Indebtedness solely to the extent not discharged directly by the Company at the Closing pursuant to Section 2.3(d)(ii), (iv) minus the Transaction Expenses, minus (v) the Expense Fund Amount.

 

Update Report” is defined in Section 2.14(d).

 

Interpretation” The titles and headings to Sections herein and to the Exhibits and Schedules hereto are inserted for the convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement. This Agreement shall be construed without regard to any presumption or other rule requiring construction hereof against the party causing this Agreement to be drafted. The words “include”, “includes”, “included”, “including” and “such as” do not limit the preceding words or terms and shall be deemed to be followed by the words “without limitation”. All pronouns and any variations thereof refer to the masculine, feminine or neuter, singular or plural, as the context may require. All terms defined in this Agreement in their singular or plural forms, have correlative meanings when used herein in their plural or singular forms, respectively. All references herein to a Section, Article, Exhibit or Schedule are to a Section, Article, Exhibit or Schedule of or to this Agreement, unless otherwise indicated.

 

Section 1.2. Made Available. A document or information shall be deemed to have been “made available” if such document or information was in the electronic data room maintained by the Company in connection with the transactions contemplated by this Agreement no later than one (1) Business Day prior to the date hereof.

 

 
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ARTICLE 2

THE MERGER

 

Section 2.1. The Merger. Upon the terms and subject to the conditions set forth in this Agreement, at the Effective Time, Merger Sub shall be merged with and into the Company in accordance with the DGCL. Following the Merger, the separate corporate existence of Merger Sub shall cease and the Company shall continue as the surviving company (the “Surviving Company”) and a wholly owned Subsidiary of Buyer.

 

Section 2.2. Closing. The closing of the Merger (the “Closing”) shall take place remotely via the electronic exchange of documents, instruments and signature pages on the date hereof.

 

Section 2.3. Actions in Connection with the Closing.

 

(a) At the Closing, the Company shall deliver to Buyer and the Shareholders’ Representative a certificate, executed by its chief executive officer of the Company on behalf of the Company, certifying that Schedule I is complete and correct in all material respects.

 

(b) At the Closing, the Company shall deliver to Buyer each of the certificates, instruments and other documents referred to in Section 3.1.

 

(c) At the Closing, Buyer shall deliver or cause to be delivered (i) to Paying Agent (for the benefit of the Sellers), subject to the payment and exchange procedures set forth in Section 2.9 and Section 2.8, as applicable, the aggregate amount of cash set forth opposite each such Seller’s name on Schedule I (it being acknowledged and agreed for all purposes that the Company shall deliver to the Paying Agent at the Closing the Closing Cash and Cash Equivalents of the Company on behalf of Buyer in partial satisfaction of the foregoing obligation), (ii) to each Seller, the number of shares set forth opposite its name in the Schedule I; (iii) to the Shareholders’ Representative, the Expense Fund Amount and (iv) to each Person set forth on the Closing Statement under “Transaction Expenses,” an amount in cash equal to the Transaction Expenses set forth opposite such Person’s name.

 

(d) At the Closing, the Company shall deliver or cause to be delivered (i) to Paying Agent the Closing Cash and Cash Equivalents and (ii) to each holder of Closing Indebtedness set forth on the Closing Statement, an amount in cash equal to the Closing Indebtedness held by such person as set forth on the Closing Statement.

 

 
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(e) At the Closing, the Parties shall cause the Merger to be consummated by filing with the Secretary of State of the State of Delaware a certificate of merger (the “Certificate of Merger”) in substantially the form of Exhibit D attached hereto and executed in accordance with the relevant provisions of the DGCL. The Merger shall become effective at such date and time as the Certificate of Merger is filed with the Secretary of State of the State of Delaware or at such subsequent date and time as the Company and Merger Sub shall agree and specify in the Certificate of Merger. The date and time at which the Merger becomes effective is referred to in this Agreement as the “Effective Time”.

 

Section 2.4. Effects of the Merger. The Merger shall have the effect set forth in this Agreement and the applicable provisions of the DGCL.

 

Section 2.5. Bylaws. At the Effective Time, the Bylaws of the Surviving Company shall be amended and restated to be in the form attached hereto as Exhibit E.

 

Section 2.6. Up-Front Payment. Prior to the Closing, the Company shall deliver to Buyer (a) a statement (the “Closing Statement”), in form and substance reasonably satisfactory to Buyer, setting forth its good faith estimate of (i) the amount of the Closing Cash and Cash Equivalents, (ii) the amount of the Closing Indebtedness and (iii) the amount of the Closing Transaction Expenses, in each case, together with reasonably detailed supporting calculations and documentation for such estimates and, based thereon, its calculation of the Up-Front Payment, together with payment instructions for each of the payments to be made by Buyer at the Closing and (b) Schedule I.

 

Section 2.7. Conversion of Capital Stock.

 

(a) On the terms and subject to the conditions set forth in this Agreement, at the Effective Time, by virtue of the Merger and without any action on the part of Buyer, Company, Merger Sub or any Company Shareholder:

 

(i) each issued and outstanding share of common stock, par value $0.0001 per share, of Merger Sub shall be converted into and shall become one fully paid and nonassessable share of Company Common Stock upon the consummation of the Merger;

 

(ii) each share of Company Common Stock that is held by the Company as treasury stock or owned by the Company or owned by Buyer or any Subsidiary or Affiliate of Buyer shall be cancelled and retired and shall cease to exist and no consideration shall be delivered in exchange therefor;

 

(iii) subject to Section 2.9, each share of Company Common Stock and Company Preferred Stock, including shares of Company Series A Preferred Stock and Company Series B Preferred Stock, that is then outstanding (other than the Dissenting Shares) shall be converted into the right to receive the amounts as set forth on Schedule I opposite such Company Shareholder’s name in respect of such Company Shareholder’s applicable portion of the Up-Front Payment, the Second Payment, the Third Payment, the Milestone Payments, if any, the Expense Fund, if and when distributed, the Stock Consideration and the Company IP Revenue (collectively, the “Merger Consideration”).

 

 
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(b) The shares of Company Common Stock and Company Preferred Stock converted into the right to the Merger Consideration in accordance with this Section 2.7 shall no longer be outstanding and shall automatically be cancelled and retired and shall cease to exist.

 

Section 2.8. Company Stock Options.

 

(a) As of the Effective Time, each Company Optionholder shall cease to have any rights with respect thereto, and shall, in exchange therefor, have the right to receive the amounts as set forth on Schedule I opposite such Company Optionholder’s name in respect of such Company Optionholder’s applicable portion of the Up-Front Payment, the Second Payment, Third Payment, the Milestone Payments, if any, the Expense Fund, if and when distributed, the Stock Consideration and the Company IP Revenue (collectively, the “Option Consideration”);

 

(b) The board of directors of the Company shall take all action necessary under the Company Plan so that immediately prior to the Effective Time, each issued and outstanding Company Stock Option (whether or not vested or exercisable, or whether or not out-of-the-money) shall automatically be deemed exercisable or otherwise fully vested and all issued and outstanding Company Stock Options shall automatically be cancelled and retired and the Company Plan shall be terminated, in each case as of immediately prior to the Effective Time by virtue of the Merger.

 

Section 2.9. Stock Payment and Buyer Common Stock.

 

(a) As soon as practicable after the Effective Time, but no later than two (2) Business Days after the Effective Time, Buyer shall provide to (x) each Company Shareholder a letter of transmittal in substantially the form attached as Exhibit F hereto (a “Letter of Transmittal”), which shall include instructions for effecting the surrender of their Company Capital Stock in exchange for the Merger Consideration to be paid in accordance with Section 2.7(a) with respect to each of the shares of Company Capital Stock represented thereby and (y) each Company Optionholder an option cancellation agreement in substantially the form attached as Exhibit G hereto (a “Option Cancellation Agreement”), which shall include instructions for receiving the Option Consideration to be paid in accordance with Section 2.8(a) with respect to each Company Stock Option.

 

(b) After the Effective Time and no later than three (3) Business Days after delivery of a Letter of Transmittal duly executed and completed in accordance with the instructions thereto, a properly executed IRS Form W-9 or applicable IRS Form W-8, if applicable, from such holder in form and substance acceptable to Buyer, Paying Agent shall pay to the Company Shareholder (by check in accordance with the instructions set forth in the completed Letter of Transmittal), the aggregate amount of Up-Front Payment to which such holder is entitled pursuant to Section 2.7(a)(iii) with respect to the shares of Company Common Stock or Company Preferred Stock held by such Company Shareholder, which aggregate amount shall be rounded up to the nearest $0.01 and without any interest thereon, and the Buyer shall issue to such Company Shareholder the aggregate number of shares of Buyer Common Stock comprising the aggregate Stock Consideration to which such holder is entitled pursuant to Section 2.7(a)(iii) with respect to the shares of Company Common Stock or Company Preferred Stock held by such Company Shareholder, which aggregate number of shares of Buyer Common Stock shall be rounded up to the nearest whole share (no fractional shares of Buyer Common Stock shall be issued); provided, however, that Buyer shall substitute cash for shares of Buyer Common Stock (based on the Buyer Stock Price) in the event Buyer determines in its sole discretion that is has not received evidence reasonably satisfactory to it that a Company Shareholder is (or remains) an “accredited investor” as defined in Rule 501(a) under the Securities Act.

 

 
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(c) After the Effective Time and no later than three (3) Business Days after delivery of the Option Cancellation Agreement and a properly executed IRS Form W-9 or applicable IRS Form W-8, if applicable, from such holder in form and substance acceptable to Buyer, the Paying Agent shall pay to the Company Optionholder, the aggregate amount of Up-Front Payment to which such holder is entitled pursuant to Section 2.8(a) with respect to the Company Stock Options, which aggregate amount shall be rounded up to the nearest $0.01 and without any interest thereon, and Buyer shall issue to such Company Optionholder the aggregate number of shares of Buyer Common Stock comprising the aggregate Stock Consideration to which such Company Optionholder is entitled pursuant to Section 2.8(a) with respect to the Company Stock Options, which aggregate number of shares of Buyer Common Stock shall be rounded up to the nearest whole share (no fractional shares of Buyer Common Stock shall be issued); provided, however, that Buyer shall substitute cash for shares of Buyer Common Stock (based on the Buyer Stock Price) in the event Buyer determines in its sole discretion that is has not received evidence reasonably satisfactory to it that a Company Optionholder is (or remains) an “accredited investor” as defined in Rule 501(a) under the Securities Act.

 

(d) After the Effective Time and no later than three (3) Business Days after delivery of a properly executed IRS Form W-9 or applicable IRS Form W-8, if applicable, in form and substance acceptable to Buyer, the Paying Agent shall pay to all RSU Holders the aggregate amount of Up-Front Payment to which such holder is entitled to as set forth on Schedule I, and Buyer shall issue to such RSU Holder the aggregate number of shares of Buyer Common Stock comprising the aggregate Stock Consideration to which such RSU Holder is entitled to as set forth on Schedule I, which aggregate number of shares of Buyer Common Stock shall be rounded up to the nearest whole share (no fractional shares of Buyer Common Stock shall be issued); provided, however, that Buyer shall substitute cash for shares of Buyer Common Stock (based on the Buyer Stock Price) in the event Buyer determines in its sole discretion that is has not received evidence reasonably satisfactory to it that a RSU Holder is (or remains) an “accredited investor” as defined in Rule 501(a) under the Securities Act.

 

(e) All shares of Buyer Common Stock issued to the Sellers hereunder shall be uncertificated and shall be recorded in book entry form in Buyer’s electronic stock ledger.

 

(f) Subject to the terms and conditions of this Agreement, Buyer and the Surviving Company shall be permitted to rely, without further inquiry, on Schedule I in making any payments to the Sellers under this Agreement.

 

Section 2.10. Shareholders’ Representative.

 

(a) By approving the Merger or by delivering a duly executed Letter of Transmittal to Buyer in exchange for the Merger Consideration to be paid in accordance with Section 2.7(a) or by delivering a duly executed Option Cancellation Agreement to Buyer in exchange for the Option Consideration to be paid in accordance with Section 2.8(a), as applicable, each Seller irrevocably approves the constitution and appointment of, and hereby irrevocably constitutes and appoints Fortis Advisors LLC as the sole, exclusive, true and lawful agent, representative and attorney-in-fact of all Sellers and each of them (the “Shareholders’ Representative”) with respect to any and all matters relating to, arising out of, or in connection with, this Agreement, including for purposes of taking any action or omitting to take any action on behalf of the Sellers hereunder to:

 

 
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(i) act for the Sellers with regard to all matters pertaining to indemnification under this Agreement, including the power to defend, compromise, or settle any claims and to otherwise prosecute or pursue any litigation claims;

 

(ii) execute and deliver all amendments, waivers, Transaction Documents, certificates and documents that the Shareholders’ Representative deems necessary or appropriate in connection with the consummation of the transactions contemplated by this Agreement;

 

(iii) do or refrain from doing any further act or deed on behalf of the Sellers that the Shareholders’ Representative deems necessary or appropriate in its discretion relating to the subject matter of this Agreement or the Shareholders’ Representative Engagement Agreement as fully and completely as the Sellers could do if personally present;

 

(iv) give or receive notices to be given or received by the Sellers under this Agreement; and

 

(v) receive service of process in connection with any claims under this Agreement.

 

Notwithstanding the foregoing, the Shareholders’ Representative shall have no obligation to act on behalf of the Sellers, except as expressly provided herein and in the Shareholders’ Representative Engagement Agreement, and for purposes of clarity, there are no obligations of the Shareholders’ Representative in any ancillary agreement, schedule, exhibit or the Company Disclosure Schedule. All actions, notices, communications and determinations by or on behalf of the Sellers in connection with this Agreement shall be given or made by the Shareholders’ Representative and all such actions, notices, communications and determinations by the Shareholders’ Representative shall conclusively be deemed to have been authorized by, and shall be binding upon, any of and all Sellers and such Seller’s successors as if expressly confirmed and ratified in writing by such Seller, and no Seller shall have the right to object, dissent, protest or otherwise contest the same.

 

(b) Such appointment of the Shareholders’ Representative may be changed, and the Shareholders’ Representative may be replaced, by the number of Sellers who represented the majority of the right to vote immediately prior to the Merger. Notwithstanding the foregoing, the Shareholders’ Representative may resign at any time by providing written notice of intent to resign to Sellers, which resignation shall be effective upon the earlier of (i) 30 days following delivery of such written notice or (ii) the appointment of a successor by the number of Sellers who represented the majority of the right to vote immediately prior to the Merger. The immunities and rights to indemnification shall survive the resignation or removal of the Shareholders’ Representative or any member of the Advisory Group and the Closing or any termination of this Agreement a. No bond shall be required of the Shareholders’ Representative.

 

 
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(c) Certain Sellers have entered into an engagement agreement (the “Shareholders’ Representative Engagement Agreement”) with the Shareholders’ Representative to provide direction to the Shareholders’ Representative in connection with its services under this Agreement and the Shareholders’ Representative Engagement Agreement (such Sellers, including their individual representatives, collectively hereinafter referred to as the “Advisory Group”). Neither the Shareholders’ Representative nor its members, managers, directors, officers, contractors, agents and employees nor any member of the Advisory Group in its capacity as such (collectively, the “Shareholders’ Representative Group”) shall be liable for any act done or omitted hereunder or under the Shareholders’ Representative Engagement Agreement as Shareholders’ Representative while acting in good faith, even if such act or omission constitutes negligence on the part of such Shareholders’ Representative. The Shareholders’ Representative shall only have the duties expressly stated in this Agreement and shall have no other duty, express or implied. The Shareholders’ Representative may engage attorneys, accountants and other professionals and experts. The Shareholders’ Representative may in good faith rely conclusively upon information, reports, statements and opinions prepared or presented by such professionals, and any action taken by the Shareholders’ Representative based on such reliance shall be deemed conclusively to have been taken in good faith. Sellers shall indemnify and defend the Shareholders’ Representative Group and hold the Shareholders’ Representative Group harmless against any Loss, fee, judgment, claim, damage, liability, cost, expense (including costs incurred in connection with seeking recovery from insurers), fine or amounts paid in settlement incurred on the part of the Shareholders’ Representative (so long as the Shareholders’ Representative was acting in good faith in connection therewith) and arising out of or in connection with the acceptance or administration of the Shareholders’ Representative’s duties hereunder or under the Shareholders’ Representative Engagement Agreement including the reasonable fees and expenses of any legal counsel or other skilled professionals retained by the Shareholders’ Representative and fees incurred in connection with seeking recovery from insurers (collectively, the “Shareholders’ Representative Expenses”). Such Shareholders’ Representative Expenses may be recovered first, from the Expense Fund, second, directly from Sellers , and third, from any Milestone Payments at the time such amounts become payable to the Sellers. The Sellers acknowledge that the Shareholders’ Representative shall not be required to expend or risk its own funds or otherwise incur any financial liability in the exercise or performance of any of its powers, rights, duties or privileges or pursuant to this Agreement and the Shareholders’ Representative Engagement Agreement or the transactions contemplated hereby or thereby. Furthermore, the Shareholders’ Representative shall not be required to take any action unless the Shareholders’ Representative has been provided with funds, security or indemnities which, in its determination, are sufficient to protect the Shareholders’ Representative against the costs, expenses and liabilities which may be incurred by the Shareholders’ Representative in performing such actions.

 

(d) Buyer shall be entitled to rely on the authority of the Shareholders’ Representative (as evidenced by an instrument in writing signed by the Shareholders’ Representative) as the agent, representative and attorney-in-fact of the Sellers for all purposes under this Agreement and shall have no liability for any such reliance. No Seller may revoke the authority of the Shareholders’ Representative. By approving the Merger or by delivering a duly executed Letter of Transmittal to Buyer in exchange for the Merger Consideration to be paid in accordance with Section 2.7(a) or the Option Consideration to be paid in accordance with Section 2.8(a), each Seller hereby ratifies and confirms, and hereby agrees to ratify and confirm, any action taken by the Shareholders’ Representative in the exercise of the power-of-attorney granted to the Shareholders’ Representative pursuant to this Section 2.10. The powers, immunities and rights to indemnification granted to the Shareholders’ Representative Group hereunder are coupled with an interest and shall be irrevocable and shall survive the death, incapacity, bankruptcy, liquidation or incompetence of such Seller.

 

 
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(e) The Shareholders’ Representative shall be entitled to: (i) rely upon Schedule I, (ii) rely upon any signature believed by it to be genuine, and (iii) reasonably assume that a signatory has proper authorization to sign on behalf of the applicable Seller or other party.

 

Section 2.11. Close of Stock Transfer Books. At the Effective Time, the stock transfer books of the Company shall be closed and thereafter there shall be no further registration of transfers of shares of Company Capital Stock on the records of the Company. From and after the Effective Time, no shares of Company Capital Stock shall be deemed to be outstanding, and the holders of shares of Company Capital Stock immediately prior to the Effective Time shall cease to have any rights with respect to such shares, except as otherwise provided herein or by applicable Law.

 

Section 2.12. Dissenting Shares.

 

(a) Notwithstanding anything in this Agreement to the contrary, any shares of Company Capital Stock outstanding immediately prior to the Effective Time and held by a holder who has not voted in favor of the Merger, consented thereto in writing or otherwise contractually waived its rights to appraisal and who has exercised and perfected appraisal rights for such shares in accordance with Section 262 of the DGCL and has not effectively withdrawn or lost such appraisal rights (collectively, the “Dissenting Shares”) shall not be converted into or represent the right to consideration for Company Capital Stock set forth in Section 2.7, if any, and the holder or holders of such shares shall be entitled only to such rights as may be granted to such holder or holders in Section 262 of the DGCL.

 

(b) At the Effective Time, the Dissenting Shares shall no longer be outstanding and shall automatically be cancelled and shall cease to exist, and each holder of Dissenting Shares shall cease to have any rights with respect thereto, except the right to receive the appraised value of such shares in accordance with the provisions of Section 262 of the DGCL. Notwithstanding the provisions of Section 2.12(a), if any holder of Dissenting Shares shall effectively withdraw or lose (through failure to perfect or otherwise) such holder’s appraisal rights and dissenters rights under Section 262 of the DGCL, or a court of competent jurisdiction shall determine that such holder is not entitled to relief provided under Section 262 of the DGCL, then, as of the later of the Effective Time and the occurrence of such event, such holder’s shares of Company Capital Stock shall automatically be converted into and represent only the right to receive the consideration for Company Capital Stock set forth in Section 2.7, if any, without interest, following surrender of the certificate representing such shares in the manner provided in Section 2.9 or, in the case of a lost, stolen, mutilated, defaced or destroyed certificate, upon delivery of the documents, if required, described in Section 2.9. The Company shall give Buyer prompt notice of any written demands for appraisal, withdrawals of demands for appraisal and any other related instruments served pursuant to the DGCL and received by the Company, and Buyer shall have the right to participate in all negotiations and proceedings with respect to such demands. The Company shall not, except with the prior written consent of Buyer which shall be not unreasonably withheld, delayed or conditioned, voluntarily make any payment with respect to any demand for appraisal or settle or offer to settle any such demand.

 

 
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Section 2.13. Restriction on Transfer. After the Closing, no Seller may sell, exchange, transfer, assign or otherwise dispose of his, her or its right to receive any portion of the Merger Consideration or Option Consideration, as applicable, that becomes due and payable in accordance with this Agreement, other than a transfer (a) upon death by will or intestacy, (b) by instrument to an inter vivos or testamentary trust in which such right is to be passed to beneficiaries upon the death of the trustee, (c) pursuant to a court order, (d) if the Seller is a partnership or limited liability company, a distribution by the transferring partnership or limited liability company to its partners or members, as applicable, or (e) by operation of Law (including a consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity. The Shareholders’ Representative shall notify Buyer promptly in writing upon becoming aware of any such transfer, assignment or other disposition by a Seller. Any transfer, assignment or other disposition in violation of this Section 2.13 shall be null and void and shall not be recognized by Buyer or the Surviving Company.

 

Section 2.14. Milestone Payments.

 

(a) Within five (5) days following the first achievement of each of the milestone events described in the following table (each, “Milestone Event”), Buyer shall notify the Shareholders’ Representative in accordance with Section 8.1 that such Milestone Event has been achieved. Buyer shall, following the delivery of such notice and in any event within ninety (90) days following the achievement of a Milestone Event in either the COVID Field and ICI-AC Field and within forty-five (45) days following the achievement of a Milestone Event in the IBD Field, pay or cause to be paid in cash to the Paying Agent (for the benefit of the Sellers) the applicable milestone payment listed in the applicable row for such Milestone Event (“Milestone Payment”) in accordance with Section 2.14, provided however with respect to the IBD Field Milestone Event, the Buyer shall have the option in its sole and full discretion to pay up to 25% of each such applicable Milestone Payment in the form of Buyer Common Stock; in each such event, within five (5) Business Days following the achievement of an IBD Field Milestone Event, Buyer shall notify the Shareholders’ Representative in accordance with Section 8.1 that such IBD Field Milestone Event has been achieved, and the number of shares of Buyer Common Stock being issued and the Buyer Milestone Stock Price and shall issue the Buyer Common Stock to the Sellers in accordance with Schedule I within forty-five (45) days following the achievement of the applicable Milestone Event in the IBD Field.

 

 
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#

Milestone Event

 

Milestone Payment

COVID FIELD

 

1.

 

[***]

 

[***]

2.

 

[***]

 

[***]

3.

 

[***]

 

[***]

4.

 

[***]

 

[***]

5.

 

[***]

 

[***]

6.

 

[***]

 

[***]

ICI-AC FIELD

 

7.

 

[***]

 

[***]

8.

 

[***]

 

[***]

9.

 

[***]

 

[***]

10.

 

[***]

 

[***]

11.

 

[***]

 

[***]

12.

 

Upon First Commercial Sale in the US or EU(or EU Big 4 + UK) of a Product for the ICI-AC Field

 

[***]

IBD FIELD

 

13.

 

[***]

 

[***]

14.

 

[***]

 

[***]

15.

 

[***]

 

[***]

16.

 

[***]

 

[***]

17.

 

[***]

 

[***]

18.

 

[***]

 

[***]

19.

 

[***]

 

[***]

20.

 

[***]

 

[***]

21.

 

[***]

 

[***]

22.

 

[***]

 

[***]

23.

 

[***]

 

[***]

 

 
-29-

 

 

24.

 

[***]

 

[***]

25.

 

[***]

 

[***]

26.

 

[***]

 

[***]

27.

 

[***]

 

[***]

28.  

 

[***]

 

[***]

29.

  

[***]

 

[***]

30.  

 

[***]

 

[***]

Net Sales

 

31.

 

[***]

 

[***]

(b)

 

(i) Each of the Milestone Payments set forth above shall be payable only one (1) time upon first achievement of the associated Milestone Event.

 

(ii) For clarity, a single Product may be eligible to achieve Milestone Events in multiple Fields; provided, that the characteristics of such Product meet the applicable definitions set forth herein.

 

(iii) If any prior Milestone Event(s) in a given Field with respect to a Product has or have not yet been achieved and a later Milestone Event is achieved in Section 2.14(a), then all such prior Milestone Event(s) in such Field with respect to such Product shall be deemed to have been achieved concurrently with such later Milestone Event; ; provided, however, that notwithstanding anything to the contrary: (A) in the event that Milestone Event #3 in the COVID Field is achieved prior to the achievement of either Milestone Events #1 or Milestone Event #2 in the COVID Field, none of the Milestone Payments for such prior Milestone Events shall be payable unless and until the earlier of (1) the actual achievement of such Milestone Event, or (2) the achievement of Milestone Event #4 in the COVID Field, and in the case of (1), such prior Milestone Events shall be due and payable forty-five (45) days after the payment due date for Milestone Event #4 and (B) in the event Milestone Event #3 in the COVID Field is not achieved, then no payment for such Milestone Event shall be due whether or not a subsequent Milestone Event in the COVID Field is achieved (and, for clarity, the due date for the payment of Milestone #4 in the COVID Field shall remain unchanged).

  

(iv) For purposes of Milestone Events #13 – 18, Milestone Events #19 – 24 and Milestone Events #25 – 30, a Product is considered distinct from another Product or a different indication (so as to trigger the second set or third set of milestones, if applicable) if it has (a) a different indication, including a different label indication, (b) a different route of administration or (c) at least one different active ingredient in the IBD Field.  Two Products that differ solely  in the dosage strength or formulation will not count as a separate Product that triggers a separate Milestone Event in the IBD Field.

 

 
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(v) Exhibit H hereto contains example applications of this Section 2.14(a).

 

(c) Payment Procedures.

 

(i) Subject to this Section 2.14(b), (1) each of the Milestone Payments shall become payable upon the occurrence of the associated Milestone Event, irrespective of the order in which the Milestone Events are achieved relative to each other and (2) if multiple Milestone Events are achieved simultaneously, Buyer may aggregate the related Milestone Payments into a single Milestone Payment.

 

(ii) As promptly as practicable, and in any event no later than three (3) Business Days, after it receives any Milestone Notice, the Shareholders’ Representative shall deliver to Buyer and the Paying Agent an updated Schedule I together with a written notice (an “Allocation Notice”) that sets forth its calculations of the aggregate amount of cash to be paid to the Sellers with respect to the relevant Milestone Payment (the “Milestone Payment Cash”).

 

(iii) Following its receipt of an updated Schedule I and an Allocation Notice, and subject to the timely delivery of such updated Schedule I and Allocation Notice in accordance with Section 2.14(b)(ii) within the applicable time period for the payment of the relevant Milestone Payment specified in Section 2.14(a), Buyer shall pay or cause to be paid, by wire transfer of immediately available funds, the Milestone Payment Cash to the Paying Agent for the benefit of the Sellers and, solely with respect to the IBD Field Milestone Event, if the Buyer has elected to make a portion of such Milestone Payment in Buyer Common Stock, the Buyer shall issue to each Seller its portion of such Buyer Common Stock as set forth on Schedule I.

 

(iv) As promptly as practicable following the payments and deliveries described in Section 2.14(b)(iii), the Shareholders’ Representative shall instruct the Paying Agent to pay to each Seller such Seller’s portion of the applicable Milestone Payment (in accordance with the Schedule I by wire transfer of immediately available funds (or by check, as reasonably directed by such Seller). The right of any Seller to receive his, her or its applicable portion of a Milestone Payment pursuant to this Section 2.14(b) (A) shall not be evidenced by any form of certificate or instrument; (B) does not give such Seller dividend rights, voting rights, liquidation rights, preemptive rights or other equity or ownership rights of holders of Capital Stock of the Surviving Company following the Closing; (C) shall not accrue interest on any portion thereof; (D) does not represent any right other than the right to receive the consideration set forth in this Section 2.14 in accordance with Section 2.7 or Section 2.8, as applicable; and (E) shall not be assignable or transferable without Buyer’s written consent (not to be unreasonably withheld, delayed or conditioned) except by will, the applicable Laws of intestacy or other operation of applicable Law, and except as part of a distribution by such Seller to its stockholders, partners, members or other equityholders.

 

 
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(v) For purposes of calculating any Milestone Payment payable to Sellers, the amount of the applicable Milestone Payment shall be reduced by any amounts payable or due to the Shareholders’ Representative or to the Paying Agent that are payable in connection with such Milestone Payment (calculated without duplication of any such expenses previously paid or deducted in determining the Up-Front Payment or any prior Milestone Payment).

 

(vi) All amounts payable pursuant to this Section 2.14 shall, to the extent permitted by Law, shall be treated by the Parties for Tax purposes as adjustments to the Merger Consideration and Option Consideration.

 

(vii) The Parties agree that any Milestone Payments payable with respect to Company Stock Options will be treated and reported for all Tax purposes as being subject to a substantial risk of forfeiture within the meaning of Treasury Regulations Section 1.409A-1(b)(4) until such amounts become due payable under this Agreement, and shall be paid to holders of Company Stock Options entitled to such payments within the short-term deferral period within the meaning of Treasury Regulations Section 1.409A-1(b)(4).

 

(viii) Any Milestone Payments that are not timely paid to the Paying Agent in accordance with Section 2.14 shall be paid together with interest thereon at the rate of eight (8) percent per annum (but with interest accruing on a daily basis), from the date on which such Milestone Payment was originally due until the date of payment.

 

(d) Covenants. From the Closing Date and for so long as the Milestone Payments may become payable, Buyer covenants and agrees that it will, itself or through the Surviving Company, the Subsidiaries or another Affiliate of Buyer, (1) act in good faith and use Commercially Reasonable Efforts to (A) develop and commercialize worldwide with respect to at least one Product in each of the COVID Field, ICI-AC Field and the IBD Field, and (B) achieve the Milestone Events with respect to at least one Product in each of the COVID Field, the ICI-AC Field and the IBD Field and (2) not, and shall cause the Surviving Company, the Subsidiaries or another controlled Affiliate of Buyer to not, take any action, the primary intent of which is to avoid achievement of any Milestone Event or to obtain a reduction of the payment for a given Milestone Event. Subject to the foregoing, Sellers acknowledge and agree that Buyer, the Subsidiaries and all other Affiliates of Buyer (including the Surviving Company) shall, as of immediately after the Closing, (A) have sole discretion with regard to all matters of any nature relating to the control and operation of the Buyer, its Affiliates (including the Surviving Company) and the Subsidiaries, (B) have the unrestricted right to make use of all of the assets of the Surviving Company in any manner they deem commercially appropriate and have sole discretion regarding all decisions of any nature with respect to the Milestones (including all operational and tactical matters), (C) and be free to continue to offer, develop or acquire competing or substitute products with those of the Surviving Company. “Commercially Reasonable Efforts” shall mean, with respect to the efforts to be expended, or considerations to be undertaken, by Buyer with respect to the development and commercialization of a Product, the level of sustained and diligent efforts of, and using the level of resources commonly dedicated by, a similarly situated biopharmaceutical company in the development, manufacture, and commercialization of a pharmaceutical product of its own discovery, which is at a similar stage of research, development, and commercialization, is in a similar therapeutic and disease area, and is of similar market potential, taking into account such Product’s: (i) profile of efficacy and safety; (ii) regulatory status, including anticipated or approved labeling and anticipated or approved post-approval requirements; (iii) present and future market and commercial potential, including competitive market conditions, likelihood of success of commercialization, the cost and time of further development or commercialization and the reasonably expected and actual profitability and return on investment; and (iv) the reasonably expected and actual competitiveness of alternative products (including generic or biosimilar products) under development or sold in the marketplace, all of the foregoing (i) through (iv) as measured by the facts and circumstances at the time such efforts are due. Sellers acknowledge and agree for all purposes that (A) the Milestone Payments are subject to factors outside of the control of Buyer, its Affiliates (including the Surviving Company) and the Subsidiaries, and (B) there is no assurance that Sellers will receive any Milestone Payments. In the event that Buyer desires to no longer continue to conduct such activities with respect to a Product, then Commercially Reasonable Efforts will require Seller to use commercially reasonable efforts to outlicense or otherwise divest the Product at fair market value.

 

 
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(e) Duty to Notify; Information Rights.

 

(i) For so long as the Milestone Payments or the Company IP Revenue may become payable, Buyer shall deliver a status update to the Shareholders’ Representative on an annual basis (within sixty (60) days following the expiration of each quarter) (each such report, an “Update Report”). Such Update Reports shall include (1) description of Buyer’s Subsidiaries, its Affiliates’, or its or their licensees’ development and commercialization activities performed since the preceding Update Report (or the Closing Date with respect to the first Update Report), (2) the development and commercialization activities in process, (3) the future development and commercialization activities it expects to initiate during the following twelve (12) months, (4) a statement setting forth the amount of Invoiced Sales and Net Sales of each Product on a country-by-country basis during the preceding calendar quarter (including such amounts expressed in local currency and as converted to United States Dollars) and the Company IP Revenue and (5) any additional information reasonably required by the Shareholders’ Representative for the purpose of calculating the Milestone Payments and the Company IP Revenue. For clarity, the first Update Report shall be delivered no later than sixty (60) days following the expiration of the six (6)-month period following the Closing Date.

 

(ii) Buyer shall keep and maintain reasonably detailed books and records concerning Milestone Events and the Company IP Revenue, including complete and accurate financial books and records pertaining to the commercialization of Products hereunder and books and records of Invoiced Sales and Net Sales of Products, in reasonably sufficient detail to calculate and verify all amounts payable hereunder. Buyer shall and shall cause its Affiliates and its and their licensees to, for so long as the Milestone Payments may become payable, and for six (6) months thereafter; provided, that in the case of the financial books and records described in this Section 2.14(d)(ii), it shall retain such books and records until the later of (1) three (3) years after the end of the period to which such books and records pertain, (2) the expiration of the applicable tax statute of limitations (or any extensions thereof) and (3) for such period as may be required by Law. The Shareholders’ Representative shall have the right to examine and audit Buyer’s and its applicable Affiliates’ relevant books and records to verify the accuracy of the Update Reports delivered by Buyer pursuant to this Agreement. Any such audit shall be on at least five (5) days’ prior written notice. The Shareholders’ Representative’s right to perform an audit under this Section 2.14(d) shall be limited to not more than one (1) such audit in any calendar year (unless a previous audit during such calendar year revealed an error with respect to such period). The audit shall be performed at the Shareholders’ Representative’s sole expense by an independent certified public accounting firm of internationally recognized standing that is selected by Shareholders’ Representative and approved by Buyer (such approval not to be unreasonably withheld, conditioned or delayed). The accounting firm shall be required to enter into a reasonable and customary confidentiality agreement with Buyer to protect the confidentiality of its and its applicable Affiliates’ books and records. Buyer shall make the relevant books and records reasonably available during normal business hours for examination by the accounting firm. Upon completion of the audit, the accounting firm shall provide both Buyer and Shareholders’ Representative a written report disclosing whether or not the relevant Update Report(s) are correct, and the specific details concerning any discrepancies. In the event the accounting firm conducting an audit pursuant to this Section 2.14 concludes as a result of such audit that a Milestone Event was achieved, but the corresponding Milestone Payment was not paid to the Paying Agent, Buyer shall have thirty (30) Business Days to review such findings. If Buyer does not object to the accounting firm’s determinations in writing within such thirty (30) Business Day period, such Milestone Payment shall be paid to the Paying Agent in accordance with Section 2.14(b) within ten (10) Business Days of the date that the parties receive such accountant’s written report. If Buyer objects to the accounting firm’s determinations, Buyer and Shareholders’ Representative shall have fifteen (15) Business Days to negotiate in good faith to resolve any such objections. If Buyer and the Shareholders’ Representative are unable to resolve such differences within such fifteen (15) Business Day period, either Buyer or the Shareholders’ Representative may elect to resolve such dispute by way of the Dispute Resolution Procedure by promptly providing such other party written notice of such demand.

 

 
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(f) No Right of Setoff. Subject to Section 2.14(b)(v), Buyer may not deduct from, set off, holdback or otherwise reduce in any manner whatsoever any amount owed to Sellers hereunder against any amounts owed by Sellers to Buyer.

 

Section 2.15. Additional Revenue. From and after the date hereof until the sixth (6th) anniversary of the date of this Agreement, Buyer shall pay to Paying Agent (for the benefit of the Sellers) ten percent (10%) of its Company IP Revenue, set forth in the Update Report within five (5) Business Days following delivery of such Update Report, if the Shareholders’ Representative has not disputed such amounts in the Update Report.

 

Section 2.16. Expense Fund. Upon the Closing, Buyer shall wire to the Shareholders’ Representative $300,000 (the “Expense Fund Amount”). The Expense Fund Amount shall be held by the Shareholders’ Representative in a segregated client account and shall be used (i) for the purposes of paying directly or reimbursing the Shareholders’ Representative for any Shareholders’ Representative Expenses incurred pursuant to this Agreement, or (ii) as otherwise determined by the Shareholders’ Representative (the “Expense Fund”). The Shareholders’ Representative is not providing any investment supervision, recommendations or advice and shall have no responsibility or liability for any loss of principal of the Expense Fund other than as a result of its gross negligence or willful misconduct. The Shareholders’ Representative is not acting as a withholding agent or in any similar capacity in connection with the Expense Fund and has no tax reporting or income distribution obligations. The Sellers will not receive any interest on the Expense Fund and assign to the Shareholders’ Representative any such interest. Subject to Advisory Group approval, the Shareholders’ Representative may contribute funds to the Expense Fund from any consideration otherwise distributable to the Sellers. As soon as reasonably determined by the Shareholders’ Representative that the Expense Fund is no longer required to be withheld, the Shareholders’ Representative shall distribute the amounts remaining in the Expense Fund (if any) to the Paying Agent for further distribution to Sellers in accordance with each Seller’s applicable portion as set forth on Schedule I.

 

 
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Section 2.17. Second Payment. No later than forty-five (45) days following the Closing, Buyer shall deliver or cause to be delivered to Paying Agent (for the benefit of the Sellers), subject to the payment and exchange procedures set forth in Section 2.9 and Section 2.8, as applicable, the aggregate amount of cash equal to each Seller’s portion of the Second Payment, as set forth opposite its name in the Schedule I. To the extent Schedule I will need to be updated for the Second Payment, the Shareholders’ Representative shall deliver to Buyer an updated Schedule I that sets forth its calculations of the aggregate amount of cash to be paid to the Sellers with respect to the Second Payment.

 

Section 2.18. Third Payment. No later than March 31, 2022, Buyer shall deliver or cause to be delivered to Paying Agent (for the benefit of the Sellers), subject to the payment and exchange procedures set forth in Section 2.9 and Section 2.8, as applicable, the aggregate amount of cash equal to each Seller’s portion of the Third Payment, as set forth opposite its name in the Schedule I. To the extent Schedule I will need to be updated for the Third Payment, the Shareholders’ Representative shall deliver to Buyer an updated Schedule I that sets forth its calculations of the aggregate amount of cash to be paid to the Sellers with respect to the Third Payment.

 

Section 2.19. Withholding Rights. Notwithstanding anything herein to the contrary, Buyer, the Paying Agent, the Surviving Company, and any of their respective Affiliates, will be entitled to deduct and withhold from any consideration otherwise payable pursuant to this Agreement, such amounts as may be required to be deducted and withheld with respect to the making of such payment under applicable Law; provided, however, that the applicable withholding agent shall provide advance written notice of its intention to withhold any amounts otherwise payable pursuant to this Agreement and the Parties shall reasonably cooperate to reduce, minimize or eliminate any such withholding or deduction. To the extent that amounts are so deducted or withheld, such deducted or withheld amounts shall be timely remitted by the applicable withholding agent to the applicable Governmental Entity and will be treated for all purposes of this Agreement as having been paid hereunder.

 

 
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ARTICLE 3

CLOSING DELIVERIES

 

Section 3.1. Deliveries by the Company. At or prior to the Closing, the Company shall deliver, or cause to be delivered, to Buyer the following items, each in form and substance reasonably satisfactory to Buyer:

 

(a) Written Consent. A form of the Written Consent, with a fully executed copy of the Written Consent to follow promptly following execution of this Agreement;

 

(b) Certificate of Merger. The Certificate of Merger, duly executed by the Company;

 

(c) FIRPTA Certificate. A certificate from the Company pursuant to Treasury Regulations 1.897-2(h) (as described in Treasury Regulations 1.1445-2(c)(3)) stating that the Company is not, and within the five-year period ending on the Closing Date was not, a U.S. real property holding corporation as defined in Section 897 of the Code;

 

(d) Resignations and Releases. Copies of the resignations and releases, effective as of the Effective Time, of each director and officer of the Company;

 

(e) Payoff and Release Letters. Payoff and release letters, in customary form, with respect to the Indebtedness described in clause (i) of the definition thereof (each, a “Indebtedness Payoff Letter”), duly executed by the Company and the applicable Indebtedness Lenders;

 

(f) Secretary Certificate. A certificate duly executed by the secretary (or equivalent authorized officer) of the Company certifying that attached thereto are (i) a true, correct, and complete copy of the certificate of incorporation and all amendments thereto, of the Company, certified as of a recent date by the Secretary of State (or equivalent) of the jurisdiction in which the Company is organized, which copy shall not have been modified or rescinded and shall be in full force and effect as of the date thereof, (ii) a true, correct, and complete copy of the bylaws and all amendments thereto, of the Company, which copy shall not have been modified or rescinded and shall be in full force and effect as of the date thereof, (iii) a true, correct, and complete copy of a good standing certificate (or equivalent) for the Company obtained as of a recent date from the Secretary of State (or equivalent) of the jurisdiction in which the Company is organized and (iv) a true, correct, and complete copy of all resolutions adopted by the board of directors of the Company authorizing and approving the execution, delivery, and performance of this Agreement and the other Transaction Documents and the consummation of the Transactions, which resolutions shall not in any way have been modified or amended or rescinded and shall be in full force and effect as of the date thereof;

 

(g) Tail Policy. Evidence of procurement of the Tail Policy;

 

(h) Side Letter. Duly executed side letter with the Sellers set forth on Section 3.1(h) of the Company Disclosure Schedules; and

 

(i) such other documents or instruments as Buyer reasonably requests and are reasonably necessary to consummate the Transactions.

 

 
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ARTICLE 4

REPRESENTATIONS AND WARRANTIES OF THE COMPANY

 

The Company represents and warrants to Buyer as follows, with each such representation and warranty subject to such exceptions, if any, as are set forth in the disclosure schedule of the Company (the “Company Disclosure Schedule”). Disclosures in any section or subsection of the Company Disclosure Schedule are made generally and shall not only address the corresponding Section or subsection of this Agreement, but also other Sections or subsections of this Agreement to the extent that it is reasonably apparent on the face of such disclosure that such disclosure is applicable to such other Sections or subsections.

 

Section 4.1. Organization. The Company is a corporation duly formed, validly existing and in good standing under the Laws of the State of Delaware. The Company does not have any Subsidiaries. Section 4.1 of the Company Disclosure Schedule sets forth (i) the name of the Company, (ii) the jurisdiction of organization of the Company, (iii) all jurisdictions in which the Company is qualified to do business, (iv) the directors of the Company, and (v) the officers of the Company.

 

Section 4.2. Authority; Execution and Delivery; Enforceability. The Company has the requisite corporate power and authority to execute and deliver this Agreement and the other Transaction Documents to which it is a party, and to consummate the Transactions contemplated to be consummated by it pursuant to this Agreement. The Company is duly qualified and, where applicable, in good standing to do business as a foreign or extra-provincial entity in each jurisdiction in which such qualification is necessary for the conduct of the Company Business as currently conducted by the Company, except for such jurisdictions where the failure to be so qualified or, where applicable, in good standing, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has taken all corporate action required by its organizational documents to authorize the execution and delivery of this Agreement and the other Transaction Documents to which it is a party, and to authorize the consummation of the transactions contemplated to be consummated by it pursuant to this Agreement. The Company has duly executed and delivered this Agreement, and (assuming the due authorization, execution and delivery by each other Party of this Agreement) this Agreement constitutes its legal, valid and binding obligation, enforceable against the Company in accordance with its terms, subject, as to enforcement, to applicable bankruptcy, insolvency, moratorium, reorganization, fraudulent conveyance or similar Laws affecting the enforcement of creditors’ rights generally and to general equitable principles (whether considered in an Action in equity or at law) (the “Enforceability Exceptions”).

 

Section 4.3. Non-Contravention and Approval.

 

(a) The execution, delivery and performance by the Company of this Agreement and the other Transaction Documents to which it is a party do not, and the consummation by the Company of the transactions contemplated to be consummated by it pursuant to this Agreement will not, (i) conflict with or result in a violation or breach of, or default under, any provision of its organizational documents, (ii) subject to obtaining the Consents set forth on Section 4.3(a) of the Company Disclosure Schedule, result in any breach of, or constitute a default under, require notice pursuant to, or give rise to any right of termination or cancellation of, any Contract, (iii) subject to obtaining the Consents referred to in Section 4.3(b), violate any (1) Judgment or (2) Law, in either case ((1) or (2)), to which the Company is subject, or (iv) result in the creation or imposition of any Liens (other than Permitted Liens or Liens arising from any act of Buyer or its Affiliates) upon the Company Capital Stock or the properties or assets of the Company, except, in the case of clauses (ii), (iii) and (iv), for any such items that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect.

 

 
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(b) No Consent of any Governmental Entity is required to be obtained or made by the Company in connection with the execution, delivery and performance by the Company of this Agreement or the consummation of the Acquisition, other than (i) compliance with and filings, notifications and approvals, jointly determined by the Parties to be required for consummation of the Acquisition, under any applicable foreign antitrust, competition, or trade regulation Law, (ii) those that may be required solely by reason of Buyer’s or its Affiliates’ (as opposed to any Third Party’s) participation in the Acquisition and the other transactions contemplated by this Agreement, (iii) those set forth on Section 4.3(b) of the Company Disclosure Schedule and (iv) those the failure of which to obtain or make, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect.

 

Section 4.4. Capitalization; Shares and Stockholder Information.

 

(a) The Company has 14,165,053 authorized shares of Company Common Stock, of which 4,625,000 shares are issued and outstanding. The Company has 5,100,000 authorized shares of Company Series A Preferred Stock, of which 5,073,971 shares are issued and outstanding. The Company has 2,000,000 authorized shares of Company Series B Preferred Stock, of which 1,543,680 shares are issued and outstanding. The outstanding shares of Company Capital Stock have been duly authorized and validly issued and are fully paid and non-assessable. As of the date of this Agreement, there were 3,950,588 shares of Company Common Stock reserved for issuance under the Company Equity Plan. Except as set forth in the previous sentence, there are no outstanding options, warrants, convertible or exchangeable securities or other rights, subscriptions, claims of any character, agreements, arrangements or commitments relating to any shares of Capital Stock or other equity of the Company or obligating the Company or any of its Affiliates to issue or sell any shares of Capital Stock of, or any other interest in, the Company or obligating Seller or any of its Affiliates to issue or sell any shares of Capital Stock of, or any other equity interest in, the Company (other than this Agreement). Except as otherwise described in this Section 4.4(a), there is no authorized, issued, or outstanding capital stock or other equity of the Company. All of the shares of the Company were issued in compliance in all material respects with applicable Laws, were not issued in violation of any agreement, arrangement or commitment to which the Company is a party or is subject to or in violation of any purchase option, call, right of first refusal, right of first offer, preemptive, subscription, or similar rights of any Person, and are owned of record and beneficially by the Sellers set forth in Section 4.4(b) of the Company Disclosure Schedule, free and clear of all Liens (other than any restrictions under the Securities Act and applicable state securities Laws). The Company does not have outstanding or authorized any stock appreciation, phantom stock, profit participation or similar rights. Except as set forth on Section 4.4(a) of the Company Disclosure Schedule, there are no (i) voting trusts, voting agreements, proxies, security-holder agreements, buy-sell agreements, or other agreements that may affect the voting or transfer of any shares of the Company, (ii) Contracts between or among the Company, on the one hand, and any of its stockholders, members, or equityholders (or any Affiliate thereof), on the other hand, with respect to any shares of the Company, or (iii) outstanding registration rights (including piggyback registration rights), preemptive rights, rights of first offer, rights of first refusal, or other comparable obligations (contingent or otherwise) of the Company.

 

 
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(b) Section 4.4(b) of the Company Disclosure Schedule sets forth, (i) the number of shares of Company Capital Stock that each Seller holds and (ii) a list of each outstanding Company Stock Option, including the Company Optionholder thereof, date of grant, vesting schedule (including any acceleration provisions), the Exercise Price and the number of shares of Company Common Stock subject thereto.

 

(c) Upon consummation of the Transactions contemplated by this Agreement, the Buyer shall own all of the shares, free and clear of all Liens (other than any restrictions under the Securities Act and applicable state securities Laws or any Liens put in place as a result of actions taken by Buyer.

 

(d) Schedule I is complete and correct.

 

Section 4.5. Financial Statements. The following have been made available to Buyer: (a) the audited balance sheet of the Company as of December 31, 2019 and as of December 31, 2020 and the related audited statement of operations, stockholders’ equity and cash flows, together with all related notes and schedules thereto and statement of cash flows for each of the fiscal years then ended (collectively, the “Audited Financial Statements”) and (b) unaudited balance sheet of the Company as of June 30, 2021 (the “Most Recent Balance Sheet”; and the date of the Most Recent Balance Sheet, the “Most Recent Balance Sheet Date”), and the unaudited statements of operations and statement of cash flows of the Company for the six (6) months then ended (collectively (a) and (b), the “Financial Statements”). The Financial Statements (x) have been prepared based on the books and records of the Company, which, for the periods covered by the Financial Statements, have been maintained in all material respects accordance with United States generally accepted accounting principles (“GAAP”), and (y) fairly presents in all material respects the results of operations, cash flows, changes in stockholders’ equity and financial position of the Company for the respective fiscal periods or as of the respective dates therein set forth.

 

Section 4.6. No Undisclosed Liabilities. The Company does not have any liabilities required by GAAP to be reflected or reserved against in a balance sheet or the notes thereto, other than:

 

(a) liabilities provided for in the Financial Statements or the notes thereto;

 

(b) liabilities incurred in the Ordinary Course of Business since the Most Recent Balance Sheet Date;

 

 
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(c) liabilities set forth on Section 4.6 of the Company Disclosure Schedule; and

 

(d) liabilities incurred in connection with this Agreement and the transactions contemplated hereby.

 

Section 4.7. Absence of Changes. Other than any actions that are contemplated by this Agreement, from the Most Recent Balance Sheet Date, (a) except for matters relating to the transactions contemplated hereby, the Company Business has been conducted in the Ordinary Course of Business, other than actions or omissions taken reasonably and in good faith in response to COVID-19 and Pandemic Measures and (b) there has not been a Material Adverse Effect.

 

Section 4.8. Real Property. The Company does not own or lease any real property.

 

Section 4.9. Intellectual Property.

 

(a) Section 4.9 of the Company Disclosure Schedule sets forth a list of all of the following Owned Intellectual Property: (i) Patents, (ii) Trademark registrations and applications for Trademark registration; (iii) copyright registrations and applications for copyright registration; and (iv) domain name registrations.

 

(b) To the Knowledge of the Company, neither any Product, nor the use of any Product in the Field nor the conduct of the Company’s Business, infringes or misappropriates any Intellectual Property rights of any Person in the Territory. The Company solely owns and Controls the FWB Background Patents and the Owned Intellectual Property and has the right to grant licenses to the FWB Background Patents and the Owned Intellectual Property. The Company’s ownership of the FWB Background Patents and the Owned Intellectual Property is free and clear of any Liens other than Permitted Liens. To the Knowledge of the Company, except as set forth on Section 4.9(a) of the Company Disclosure Schedules each of the FWB Background Patents and any Patents included in the Owned Intellectual Property properly identifies each and every inventor of the claims thereof as determined in accordance with applicable Laws. All such inventors have assigned their entire right, title, and interest in and to such inventions to the Company and, except as set forth on Section 4.9(a) of the Company Disclosure Schedules, all such assignments have been duly recorded and are enforceable in accordance with applicable Law; and there are no claims or assertions in writing received by the Company regarding the inventorship of any FWB Background Patent or any Patent included in the Owned Intellectual Property alleging that additional or alternative inventors should be listed. All filing, application and renewal fees due thus far with respect to the FWB Background Patents and any Owned Intellectual Property have been duly paid, and the Company has taken all material steps required thus far for the maintenance and prosecution of the FWB Background Patents and any Owned Intellectual Property in accordance with applicable Law. The Company has not granted to any Third Party any license, option, covenant not to sue or other right under the FWB Background IP or any Owned Intellectual Property. Except as set forth on Section 4.9(b) of the Company Disclosure Schedules, to the Company’s Knowledge, there is no actual infringement or threatened infringement of any FWB Background Patent by any Person.

 

 
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(c) The Company has not received any written communication from, or written demand of, any claims or litigation that has been brought or threatened by any Person alleging that any FWB Background Patent or any registration or issued Patent included in the Owned Intellectual Property is invalid or unenforceable. The Company has not received any written communication from, or written demand of, any Third Party that the Development, Manufacture, use or Commercialization of the Products, or the conduct of the Company Business, infringed or misappropriated any Intellectual Property of such Third Party.

 

(d) The consummation of the transactions contemplated hereby will not result in the termination or alteration of the Company’s ownership of any Owned Intellectual Property or any license or other rights to Intellectual Property granted to Company pursuant to a Company Contract (collectively, “Company Intellectual Property”), and will not immediately following the Closing result in any licenses or Liens being granted under or imposed on any Company Intellectual Property.

 

(e) No Owned Intellectual Property (and, to the Knowledge of Company, no other Company Intellectual Property) is subject to any proceeding, order, judgment, settlement agreement, stipulation or right that restricts in any manner the use, transfer, or licensing thereof by Company, or which may affect the validity, use or enforceability of any such Company Intellectual Property.

 

(f) Company has secured from all consultants, advisors, employees and independent contractors who independently or jointly contributed to or participated in the conception, reduction to practice, creation or development of any Intellectual Property for Company (each an “Creator”), unencumbered and unrestricted exclusive ownership of all of the Creators’ Intellectual Property in such contribution that Company does not already own by operation of law and has obtained the waiver of all non-assignable rights. No Creator has retained any rights, licenses, claims or interest whatsoever with respect to any Intellectual Property developed by the Creator for Company. Without limiting the foregoing, Company has obtained written and enforceable proprietary information and invention disclosure and Intellectual Property assignments from all current and former Creators.

 

(g) Company has taken all commercially reasonable steps to protect and preserve the confidentiality of all trade secrets and other confidential or non-public information of Company or provided by any third party to Company (“Confidential Information”). All current and former employees (if any) and contractors of Company and third parties having access to Confidential Information have executed and delivered to Company a written legally binding agreement regarding the protection of the Confidential Information.

 

(h) No funding, facilities or resources of a university, college, other educational institution or research center or Governmental Entity has been used in the creation or development of any Company Intellectual Property or any other Intellectual Property that the Company uses or purports to own, and none of the Company Intellectual Property or any such other Intellectual Property is subject to any rights of any such university, college, other educational institution or research center or Governmental Entity.

 

 
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(i) The Company is in compliance in all material respects with applicable Privacy and Security Laws. The Company has taken commercially reasonable steps intended to protect Personal Information in its control and the material information technology systems of the Company used in the Company Business against unauthorized access or use. To the Knowledge of the Company, during the two (2)-year period immediately preceding the date of this Agreement, the Company has not experienced any material unauthorized access or use of Personal Information in its control requiring notice under Law applicable to the Company Business to consumers or applicable Governmental Entities.

 

(j) Neither the Sellers specified on Section 4. 9(j) of the Company Disclsoure Schedules nor any of such Sellers’ controlled Affiliates (nor, to the Knowledge of the Company, any Seller not specified on Section 4. 9(j) of the Company Disclosure Schedules or any controlled Affiliate of any such Seller) owns or controls any Intellectual Property or Know-How that (i) covers niclosamide or any formulations or uses thereof or any niclosamide product or niclosamide product candidate or (ii) is used in the Company Business or in the possession or control of Company as of the date hereof.

 

Section 4.10. Contracts.

 

(a) Section 4.10(a) of the Company Disclosure Schedule sets forth, as of the date of this Agreement, a complete and correct list of the Contracts to which the Company is a party and to which the Company still has outstanding obligations thereunder (such Contracts collectively, the “Company Contracts”); provided, that non-disclosure agreements pursuant to which the Company has outstanding obligations or rights thereunder shall not be required to be listed on Section 4.10(a) of the Company Disclosure Schedule but shall be deemed Company Contracts for purposes of this Agreement.

 

(b) The Company Contracts are valid, binding and in full force and effect with respect to the Company and, to the Knowledge of the Company, each other party thereto, subject, in each case as to enforcement, to the Enforceability Exceptions. As of the date of this Agreement, the Company is not in material breach of or material default under any Company Contract, and, to the Knowledge of the Company, no other party to any Company Contract is in material breach of or material default thereunder. As of the date of this Agreement, the Company has not given any written notice or received any written notice of any intention to terminate any Company Contract. To the Knowledge of the Company no event or circumstance has occurred that, with notice or lapse of time or both, would constitute an event of default under any Company Contract or result in a termination thereof or would cause or permit the acceleration or material modification of any right or obligation or the loss of any benefit thereunder. Complete and correct copies of all Company Contracts (including all modifications, amendments, and supplements thereto and waivers thereunder) have been made available to Buyer, except to the extent such Company Contracts have been redacted to (i) enable compliance with Laws, (ii) comply with confidentiality obligations owed to Third Parties or (iii) remove pricing information.

 

 
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Section 4.11. Taxes.

 

(a) All material Tax Returns required to have been filed by or on behalf of the Company have been timely filed, and such Tax Returns are complete and correct in all material respects. All material Taxes (whether or not shown to be due on such Tax Returns) have been paid in full by the due date thereof. As of the date of this Agreement, no claims have been asserted by a Taxing Authority in writing with respect to any such Taxes, and no examination or audit of any Tax Return of the Company by any Taxing Authority is currently in progress or, to the Knowledge of the Company, threatened or contemplated. As of the date of this Agreement, no material Liens for Taxes (other than Taxes not yet due and payable) with respect to the assets of the Company have been filed. There are no outstanding agreements or waivers extending the statutory period of limitations applicable to any material Tax Returns required to be filed by or with respect to the Company.

 

(b) All material Taxes which the Company was obligated to withhold from amounts owing to any employee, stockholder, creditor, supplier or third party have been withheld and paid or remitted to the appropriate Governmental Entity, and all Forms W-2, Forms 1099 and other documents required with respect to such withholding and remittances have been properly and timely filed and maintained in all material respects.

 

(c) No claim has been made by a Taxing Authority in a jurisdiction where the Company has not filed a Tax Return that of the Company is required to file a Tax Return in such jurisdiction.

 

(d) The Company is and always has been properly classified as a C corporation for U.S. federal income Tax purposes.

 

(e) The unpaid Taxes of the Company for taxable periods through the Most Recent Balance Sheet Date do not materially exceed the accruals and reserves for Taxes (excluding accruals and reserves for deferred Taxes established to reflect timing differences between book and Tax income) set forth on the Most Recent Balance Sheet.

 

(f) The Company will not be required to include any material item of income in, or exclude any material item of deduction from, taxable income for any taxable period (or portion thereof) ending after the Closing Date as a result of: (i) any change in method of accounting made prior to the Closing Date for a taxable period (or portion thereof) ending on or prior to the Closing Date, including the application of Section 481 or Section 263A of the Code (or any corresponding or similar provisions of state, local or foreign Tax Laws) to transactions, events or accounting methods employed prior to the Closing, (ii) any use of an improper method of accounting for a taxable period (or portion thereof) ending on or prior to the Closing Date; (iii) any “closing agreement,” as described in Section 7121 of the Code (or any corresponding or similar provision of state, local or foreign Tax Law) executed on or prior to the Closing Date, (iv) any “intercompany transaction” or any “excess loss account” (within the meaning of Treasury Regulations Sections 1.1502-13 and 1502-19, respectively) (or any corresponding or similar provisions of state, local or foreign Tax Law) occurring or arising with respect to any transaction on or prior to the Closing Date, (v) any installment sale, open transaction or other transaction made on or prior to the Closing Date, (vi) any deferred revenue or prepaid amount received or paid on or prior to the Closing Date, or (vii) any debt instrument held on or prior to the Closing Date that was acquired with “original issue discount” as defined in Section 1273(a) of the Code or subject to the rules set forth in Section 1276 of the Code.

 

 
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(g) [Reserved.]

 

(h) The Company has not (i) deferred any portion of any payroll, social security, unemployment, withholding or other Taxes pursuant to Section 2302 of the CARES Act or any other Law enacted or order issued on account of or in response to COVID-19 or (ii) claimed any Tax credits under Sections 7001 through 7005 of the Families First Coronavirus Response Act or Section 2301 of the CARES Act.

 

(i) The Company has not participated in any “listed transaction,” as defined in Section 6707A of the Code or Treasury Regulations Section 1.6011- 4.

 

(j) The Company is not a party to or bound by any Tax sharing, indemnity, allocation or similar Contract (other than any such Contract the primary purpose of which does not relate to Taxes), and the Company has no liability to another party under any such Contract.

 

(k) The Company is not now, nor has ever been, a member of a consolidated, combined, unitary or aggregate group of which the Company was not the ultimate parent corporation. The Company has no liability for the Taxes of any Person under Treasury Regulations Section 1.1502-6 (or any corresponding or similar provision of state, local or foreign Tax Law), as a transferee or successor, or by Contract.

 

(l) Within the past three (3) years, the Company has not constituted either a “distributing corporation” or a “controlled corporation” in a distribution of stock intended to qualify in whole or in part for Tax-free treatment under Section 355 of the Code (or so much of Section 356 of the Code as relates to Section 355 of the Code).

 

(m) The Company has not ever requested or received a ruling from any Taxing Authority or signed a closing or other agreement with any Taxing Authority.

 

(n) Except as set forth in Section 4.11(n) of the Company Disclosure Schedules, none of the assets of the Company include any Contract that constitutes a “partnership” for U.S. federal income tax purposes.

 

(o) The Company has received, from each current or former employee, non-employee director, consultant or other service provider who holds stock that is subject to a substantial risk of forfeiture as of the Closing Date, if any, a copy of the election(s) made under Section 83(b) of the Code with respect to all such shares of stock, and such elections were validly made and filed with the IRS in a timely fashion.

 

(p) The Company is not, nor has it been, a “United States real property holding corporation” within the meaning of Section 897(c)(2) of the Code during the applicable period specified in Section 897(c)(1)(A)(ii) of the Code.

 

 
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(q) The Company (i) has not, and has not ever had, a permanent establishment in any country other than the country in which it is organized and resident, (ii) has not engaged in a trade or business in any country other than the country in which it is organized and resident that subjected it to Tax in such country, and (iii) is not, and has not ever been, subject to Tax in a jurisdiction outside the country in which it is organized or resident.

 

Section 4.12. Litigation. There are no Actions, or the Company’s Knowledge, investigations, pending or, to the Knowledge of the Company, threatened against the Company and, to the Company’s Knowledge, no event has occurred or circumstances currently exist that would give rise to, or serve as a basis for, any such Action. There is no Action pending or threatened by the Company against any other Person, and there is no outstanding order and no unsatisfied judgments, penalties, or awards imposed, binding upon or against the Company that challenges or seeks to prevent, enjoin, or otherwise delay, or would reasonably be likely to have the effect of preventing, enjoining, delaying, making illegal, or otherwise interfering with, the Merger or the other Transactions and, to the Company’s Knowledge, no event has occurred or circumstances exist that would constitute or result in (with or without notice or lapse of time) a violation of any such existing order. To the Knowledge of the Company, there is no Action, or the Company’s Knowledge, an investigation, pending against any current or former director, manager, officer, employee, contractor, consultant, or agent of the Company with respect to which the Company has, or is reasonably likely to have, an indemnification obligation.

 

Section 4.13. Employment and Employee Benefit Matters.

 

(a) The Company has no employees and has never had any employees. Section 4.13(a) of the Disclosure Schedules contains a complete and correct list, as of the date of this Agreement, of all individual independent contractors currently providing services to the Company, including each such individual’s name, a description of services and date retained .

 

(b) The Company is, and has been for the past three (3) years in compliance in all material respects with all Laws regarding classification of individuals who perform services for the Company as independent contractors, and there is no Action, or the Company’s Knowledge, an investigation, pending or threatened that challenges such classifications.

 

(c) The Company is, and has been for the past three (3) years in compliance in all material respects with all applicable Laws pertaining to employment and employment practices, including all such Laws relating to the terms and conditions of employment, labor relations, collective bargaining, disability, health and safety, wages, hours and benefits, plant closings, layoffs, harassment, sexual harassment, nondiscrimination in employment, data protection and workers’ compensation and no such claims relating to alleged non-compliance with the foregoing are pending or, to the Knowledge of the Company, threatened. During the past three (3) years, there have been no Action, or the Company’s Knowledge, an investigation, pending or threatened involving any current, prospective or former employee or other service provider of the Company.

 

(d) There have not been (i) any allegations or formal or informal complaints made to or filed with the Company related to sexual harassment or sexual misconduct, (ii) any other Action, or the Company’s Knowledge, an investigation, initiated, filed or, to the Knowledge of the Company, threatened against the Company related to sexual harassment or sexual misconduct, or (iii) to the Knowledge of the Company, any other allegations, formal or informal complaints, or any other Actions, or the Company’s Knowledge, investigations, initiated, filed, or threatened against any Person other than the Company related to sexual harassment or sexual misconduct, in each case, by or against any current or former director, manager, officer, employee or independent contractor of the Company.

 

 
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(e) Neither the Company nor any of its ERISA Affiliates are or ever have been party to any collective bargaining agreement or union Contract with respect to any person, no collective bargaining agreement is currently being negotiated by the Company or any of its ERISA Affiliates, and, to the Knowledge of the Company, there has not been any organizational campaign, petition or other unionization activity seeking recognition of a collective bargaining unit relating to the Company or any of its ERISA Affiliates.

 

(f) Section 4.13(f) of the Company Disclosure Schedules contains a complete and correct list of each Company Benefit Plan. The Company does not have a written or unwritten commitment, whether legally binding or not, to establish any new, or modify any existing Company Benefit Plan. No Company Benefit Plan is an “employee benefit plan” within the meaning of Section 3(3) of ERISA and the Company has never sponsored or maintained an “employee benefit plan” within the meaning of Section 3(3) of ERISA.

 

(g) The Company has made available to the Buyer, complete and correct copies, (or to the extent no such copy exists, an accurate summary of all material terms thereof), of (i) all Company Benefit Plans and any related trust agreement, administrative service agreements, group insurance Contract or other funding instrument and any amendments related to such Company Benefit Plan; and (ii) any written communication with any Governmental Entity or material written communication with beneficiaries within the past three (3) years with respect to any Company Benefit Plan.

 

(h) All Company Benefit Plans (and related trusts and insurance Contracts) have been maintained, administered and operated, in compliance in all material respects with the terms of such Company Benefit Plan and the requirements prescribed by all Laws, including ERISA and the Code, applicable to such Company Benefit Plan and no event has occurred which would reasonably be likely to cause any such Company Benefit Plan to fail to comply with such requirements, and no written notice has been received from any Governmental Entity questioning or challenging such compliance.

 

(i) The Company has timely made all required contributions, premiums and payments with respect to any Company Benefit Plan as are required or due through the Closing Date under the terms of any such Company Benefit Plan, ERISA, the Code or any other applicable statutes, regulations, rulings, and other applicable Law.

 

(j) There are no Actions, or the Company’s Knowledge, investigations, (other than routine claims for benefits) pending or, to the Knowledge of the Company threatened, with respect to (or against the assets of) any Company Benefit Plan, nor, to the Knowledge of the Company are there any facts that would reasonably be expected to give rise to any such Actions or investigations.

 

 
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(k) Except as set forth in Section 4.13(k) of the Company Disclosure Schedules, the execution, delivery and performance of this Agreement and the consummation of the Merger will not (either alone or in conjunction with any other action by the Company prior to the Closing) (i) entitle any current or former employee, director, manager, officer, consultant, independent contractor, contingent worker or leased employee (or any dependents, spouses or beneficiaries thereof) of the Company to severance pay or any other similar payment or any other payment or benefit becoming due under any Company Benefit Plan, (ii) accelerate the time of payment or vesting or funding, or increase the amount of compensation due to such individual, (iii) increase any benefits under any Company Benefit Plan, (iv) result in the triggering or imposition of any restrictions or limitations on the ability to amend or terminate any Company Benefit Plan or (v) result in any breach or violation of, or default under any Company Benefit Plan.

 

(l) No amount, economic benefit or other entitlement that could be received (including in cash or property or vesting of property) as a result of the execution, delivery and performance of this Agreement or the consummation of the Merger (whether alone or in conjunction with any other event, including any termination of employment or service on or following the Closing) by any person who could be a “disqualified individual” (as defined in Section 280G(c) of the Code) with respect to the Company could give rise to any “parachute payment,” as defined under Section 280G(b)(2) of the Code and the regulations thereunder or trigger the excise tax under Section 4999 of the Code.

 

(m) Each Company Benefit Plan that is or has ever been a “nonqualified deferred compensation plan” within the meaning of Section 409A of the Code and associated Treasury Department guidance, if any, has been, since January 1, 2005, in operational compliance, and, since January 1, 2009, in documentary compliance, with Section 409A of the Code. The Company does not have any obligation to indemnify, reimburse, make whole or otherwise “gross-up” any Person for the interest or additional tax set forth under Section 409A, Section 280G, or Section 4999 of the Code, or otherwise.

 

(n) The Company has never sponsored or maintained a Company Benefit Plan. Neither the Company nor any ERISA Affiliate maintains, sponsors, participates in or contributes to (or has any obligation to contribute to), or has ever maintained, established, sponsored, participated in or contributed to (or had any obligation to contribute to), or has or is reasonably expected to have any direct or indirect liability with respect to any plan subject to Title IV of ERISA, including any “multiemployer plan,” as defined in Section 3(37) of ERISA.

 

Section 4.14. Compliance with Laws; Permits.

 

(a) The Company is in compliance in all material respects with all Laws applicable to the Company Business. The Company has not received any written notice from a Governmental Entity that alleges the conduct of the Company Business is not in compliance in all material respects with any Law applicable to the Company Business.

 

(b) Section 4.14(b) of the Company Disclosure Schedule sets forth a list of all material Permits held by the Company relating to any Compound or the Company Business. The Company holds all material permits, licenses, franchises, approvals or authorizations from any Governmental Entity (“Permits”) that are necessary to conduct the Company Business as presently being conducted. Except for breaches, violations, revocations, limitations, non-renewals and failures to be in full force and effect that would not be material, (i) such Permits are in full force and effect, (ii) the Company has not received any written notice of any violation in respect of any such Permit and (iii) no Action, or the Company’s Knowledge, an investigation, is pending or threatened in writing, to revoke or limit any such Permit.

 

 
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Section 4.15. Environmental Matters.

 

(a) The Company currently is and has been in compliance in all material respects with all Environmental Laws applicable to the Company Business.

 

(b) The Company has not received any notice or Action, or to the Company’s Knowledge, an investigation, against it alleging or relating to liability for any Release of Hazardous Substances or alleging any violation of any Environmental Laws, and, to the Company’s Knowledge, there are no facts or circumstances that would reasonably be expected to result in the imposition of such liability or a finding of such a violation.

 

(c) The Company has not retained or assumed, by contract or operation of Law, any material liabilities or obligations of third parties under Environmental Law.

 

Section 4.16. Anti-Bribery. The Company has not, (a) offered, made, paid or received any unlawful bribes to or from any person (including any customer or supplier) or Governmental Entity or (b) made or paid any contribution, directly or indirectly, to a domestic or foreign political party or candidate, in each case ((a) and (b)), in material violation of the Foreign Corrupt Practices Act or any other anti-corruption Law applicable to the Company Business.

 

Section 4.17. Regulatory Compliance.

 

(a) To the Company’s Knowledge, all Company Products that are subject to the jurisdiction of the FDA or a similar Governmental Entity have been and are currently being Developed or Manufactured in compliance in all material respects with all Laws applicable to the Company Business, including the FFDCA, the Public Health Service Act, and their applicable implementing regulations, and all comparable state and foreign Laws applicable to the Company Business in those jurisdictions outside the United States in which either (i) Clinical Trials involving a Company Product have been or are being conducted by the Company or (ii) any Company Product has been or is being Developed or Manufactured by or for the Company.

 

(b) The Company has not received any written notice that the FDA or any other Governmental Entity has initiated, or threatened to initiate, any action to suspend any Clinical Trial, impose a clinical hold, or suspend or terminate any IND or any comparable foreign regulatory application, in each case sponsored by the Company with respect to any Company Product.

 

 
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(c) To the Company’s Knowledge, all ongoing and completed non-clinical studies and Clinical Trials conducted by the Company, or by third-party vendors on the Company’s behalf, in the Field in the Territory, have been conducted in all material respects in accordance with applicable Good Clinical Practice regulations described in 21 CFR Parts 50, 54, 56 and 312 (including study protocols, informed consent obligations, and institutional review board approvals), and applicable Good Laboratory Practice regulations as described in 21 CFR Part 58 or comparable applicable foreign Laws. The Company has in its possession or subject to retrieval or control copies of all the material documentation in existence on or prior to the date hereof in each case which was required to be filed with the FDA or equivalent Governmental Entity as of the Effective Date for the development or registration of the Company Products. The Company has made available to Buyer complete and accurate copies of (i) all material filings with the FDA or equivalent Governmental Entity relating to the Company Products, (ii) all material correspondence with the FDA or equivalent Governmental Entity relating to the Company Products, and (iii) all material data, information, results, analyses, publications, and reports relating to the Company Products, including all Clinical Trial protocols, trial statistical analysis plans and published trial results.

 

(d) The Company has not received from any Governmental Entity any notices of adverse findings, warning or untitled letters, minutes of meetings or (ii) other correspondence concerning the Company Products, in each case, in which any Governmental Entity asserted in writing that the operations of the Company may not be in compliance with Laws applicable to the Company Business.

 

(e) The Company is in compliance in all material respects with applicable Privacy and Security Laws. The Company has taken commercially reasonable steps intended to protect Personal Information in its control and the material information technology systems of the Company used in the Company Business against unauthorized access or use. To the Knowledge of the Company, during the two (2)-year period immediately preceding the date of this Agreement, the Company has not experienced any material unauthorized access or use of Personal Information in its control requiring notice under Law applicable to the Company Business to consumers or applicable Governmental Entities.

 

(f) To the Knowledge of the Company, neither the Company nor any of its directors or officers, has committed any act, made any statement, or failed to make any statement, including with respect to any scientific data or information, that, at the time such act was committed or such statement was made or failed to be made, would reasonably provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of the Company, neither the Company nor any officer of the Company has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign Law applicable to the Company Business or (ii) exclusion under 42 U.S.C. Section 1320a–7 or any similar state or foreign Law applicable to the Company Business.

 

Section 4.18. Insurance Policies. Section 4.18 of the Company Disclosure Schedule sets forth a complete and correct list of (i) all current policies or binders of fire, liability, product liability, umbrella liability, real and personal property, workers’ compensation, vehicular, directors’ and officers’ liability, fiduciary liability, and other casualty and property insurance maintained by the Company (collectively, the “Insurance Policies”), specifying (A) the name of the insurer, (B) the policy number and (C) the policy period and (ii) all pending claims and the claims history of the Company during the past three (3) years including with respect to insurance obtained but not currently maintained. The Insurance Policies are in full force and effect. The Company has not received any written notice of cancellation of, premium increase (other than in the ordinary course of business) with respect to, or reduction of coverage under, any of the Insurance Policies. All Insurance Policies (i) are, to the Knowledge of the Company, valid and binding in accordance with their terms and (ii) have not been subject to any lapse in coverage. There are no claims pending under any such Insurance Policies as to which coverage has been questioned, denied, or disputed, or in respect of which there is an outstanding reservation of rights, in each case in writing, by the applicable carrier under such Insurance Policy. The Company is not in default under, or has otherwise failed to comply with, in any material respect, any provision contained in any Insurance Policy.

 

 
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Section 4.19. Bank Accounts. Section 4.19 of the Company Disclosure Schedule sets forth a complete and correct list of (i) all bank accounts, cash collection accounts, trust accounts, suspense or similar accounts, and safe deposit boxes of the Company, (ii) the name of each bank or financial institution in which the Company has any such account or safe deposit box, (iii) the title and last four digits of the account number of any such account or safe deposit box, and (iv) the names of the Persons authorized to draw on or who have access to each such account or safe deposit box.

 

Section 4.20. Powers of Attorney. Except as set forth in Section 4.20 of the Company Disclosure Schedule, there are no outstanding powers of attorney executed by or on behalf of the Company in favor of any Person.

 

Section 4.21. Brokers and Finders. There is no investment banker, broker, finder, financial advisor or other financial intermediary that has been retained by or is authorized to act on behalf of the Company or any of its Affiliates (including the Company) that is entitled to any fee or commission in connection with the Acquisition payable by Buyer or any of its Affiliates (including, following the Closing, the Company).

 

Section 4.22. Clinical Operations; CMC. All material documents, in the Company’s possession, which pertain to the Company’s clinical operations or to the Chemistry, Manufacturing and Controls (“CMC”) components of the Company Business have been made available to Buyer.

 

Section 4.23. The Buyer Group’s Representations; Independent Investigation.

 

(a) The Company acknowledges and agrees that, other than the representations and warranties of the Buyer Group specifically contained in Article 6, there are no representations or warranties of the Buyer Group or any other person either expressed, statutory or implied with respect to the Buyer Group, including with respect to any of the Buyer Group’s rights or assets, or the transactions contemplated hereby, individually or collectively. The Company, together with and on behalf of its respective Affiliates and Representatives, specifically disclaims that it or they are relying upon or have relied upon any such other representations or warranties that may have been made by any person, and the Company, together with and on behalf of its Affiliates and Representatives, acknowledges and agrees that they have specifically disclaimed and do hereby specifically disclaim any such other representation or warranty made by any person. Without limiting the generality of the foregoing, the Company acknowledges and agrees that none of the Buyer Group, its Affiliates or their respective Representatives makes any representations or warranties relating to (i) the maintenance, repair, condition, design, performance or marketability of any right or asset of the Buyer Group, including with respect to title, merchantability or fitness for a particular purpose, or, except as specifically contained in Article 6, validity, enforceability or non-infringement, (ii) the operation of the Buyer Group after the Closing or (iii) the probable success or profitability of the Buyer Group after the Closing.

 

 
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(b) The Company acknowledges and agrees that (i) the representations and warranties set forth in Section 5.10 are the sole and exclusive representations and warranties of the Buyer Group with respect to privacy data security matters and (ii) the representations and warranties set forth in Section 5.9 are the sole and exclusive representations and warranties of the Buyer Group with respect to regulatory compliance matters.

 

(c) Notwithstanding anything to the contrary herein or otherwise, nothing in this Section 4.23 shall be deemed to limit or modify in many manner whatsoever any rights or remedies available to Sellers based on Fraud.

 

Section 4.24. Private Placement. To the Company’s Knowledge, all Company Shareholders and Company Optionholders are “accredited investors” as defined in Rule 501(a) under the Securities Act.

 

ARTICLE 5

REPRESENTATIONS AND WARRANTIES OF THE BUYER GROUP

 

Buyer and Merger Sub represent and warrant to the Company as follows, with each such representation and warranty subject to such exceptions, if any, as are set forth in (x) the disclosure schedule of Buyer (the “Buyer Disclosure Schedule”) or (y) the (i) annual report of Buyer on Form 10-K for the year ended December 31, 2020 and (ii) quarterly reports of Buyer on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021. Disclosures in any section or paragraph of the Buyer Disclosure Schedule are made generally and shall not only address the corresponding Section or subsection of this Agreement, but also other Sections or subsections of this Agreement to the extent that it is reasonably apparent on the face of such disclosure that such disclosure is applicable to such other Sections or subsections.

 

Section 5.1. Organization. Each of Buyer and Merger Sub is a corporation duly organized, validly existing and in good standing under the Laws of its jurisdiction of incorporation. Merger Sub was formed solely for the purpose of engaging in the transactions contemplated by this Agreement and have not engaged in any business activities other than the execution and delivery of this Agreement, the performance of its obligations hereunder and matters ancillary thereto. Section 5.1 of the Buyer Disclosure Schedule sets forth a true and accurate list, with respect to each member of the Buyer Group, of (i) the name of such member, (ii) the jurisdiction of organization of such member, (iii) all jurisdictions in which such member is qualified to do business, (iv) the directors or managers of such member, and (v) the officers of such member.

 

 
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Section 5.2. Authority; Execution and Delivery; Enforceability. Each of Buyer, and Merger Sub has all requisite corporate power and authority to execute and deliver this Agreement and the other Transaction Document to which it is a party, to consummate the Merger and the other transactions contemplated to be consummated by it pursuant to this Agreement and pursuant to the other Transaction Documents to which it is a party. Each of Buyer and Merger Sub has taken all organizational action required by its organizational documents to authorize the execution and delivery of this Agreement and the other Transaction Document to which it is a party and to authorize the Merger and the consummation of the transactions contemplated to be consummated by it pursuant to this Agreement and pursuant to the other Transaction Document to which it is a party. Each of Buyer and Merger Sub has duly executed and delivered this Agreement and (assuming the due authorization, execution and delivery of this Agreement by each other Party) this Agreement constitutes its legal, valid and binding obligation, enforceable against such Party in accordance with its terms subject, as to enforcement, to the Enforceability Exceptions.

 

Section 5.3. Capitalization. The authorized Capital Stock of Buyer consists of 250,000,000 shares of Buyer Common Stock, 93,411,897 shares of which are issued and outstanding are issued and outstanding. All such outstanding shares of Buyer Common Stock have been duly authorized and validly issued, and are fully paid and nonassessable. Except as set forth on Section 5.3 of the Buyer Disclosure Schedules, there are no outstanding options, warrants, convertible or exchangeable securities or other rights, subscriptions, claims of any character, agreements, arrangements or commitments relating to any shares of Capital Stock or other equity of the Buyer or obligating the Buyer or any of its Affiliates to issue or sell any shares of Capital Stock of, or any other interest in, the Buyer or obligating any equityholders of the Buyer or any of their respective Affiliates to issue or sell any shares of Capital Stock of, or any other equity interest in, the Buyer (other than this Agreement). All of the Capital Stock of the Buyer were issued in compliance in all material respects with applicable Laws, were not issued in violation of any agreement, arrangement or commitment to which the Buyer is a party or is subject to or in violation of any purchase option, call, right of first refusal, right of first offer, preemptive, subscription, or similar rights of any Person. The Buyer does not have outstanding or authorized any stock appreciation, phantom stock, profit participation or similar rights. There are no (i) voting trusts, voting agreements, proxies, security-holder agreements, buy-sell agreements, or other agreements that may affect the voting or transfer of any Capital Stock of the Buyer, (ii) Contracts between or among the Company, on the one hand, and any of its stockholders, members, or equityholders (or any Affiliate thereof), on the other hand, with respect to any Capital Stock of the Buyer, or (iii) outstanding registration rights (including piggyback registration rights), preemptive rights, rights of first offer, rights of first refusal, or other comparable obligations (contingent or otherwise) of the Buyer. The rights and privileges of each class of Buyer’s Capital Stock are set forth in the certificate of incorporation of Buyer, as amended or restated from time to time. All the Buyer Common Stock to be issued in connection with the Merger Consideration or the Option Consideration will be, when issued on the terms and conditions of this Agreement, duly authorized, validly issued, fully paid and nonassessable and not subject to or issued in violation of any purchase option, call option, right of first refusal, preemptive right, subscription right or any similar right under any provision of the certificate of incorporation or bylaws of Buyer, as amended or restated from time to time, or any agreement to which Buyer is a party or is otherwise bound. Buyer has reserved out of its authorized Capital Stock a sufficient number of shares of Buyer Common Stock to issue such Buyer Common Stock at the Closing.

 

 
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Section 5.4. Noncontravention and Approval.

 

(a) The execution, delivery and performance by each of Buyer and Merger Sub of this Agreement and the other Transaction Document to which it is a party do not, and the consummation by Buyer and Merger Sub of the transactions contemplated to be consummated by it pursuant to this Agreement will not, (i) conflict with or result in a violation or breach of, or default under, any provision of its respective organizational documents, (ii) result in any breach of, or constitute a default under, require notice pursuant to, or give rise to any right of termination or cancellation of any Contract to which any of Buyer and Merger Sub is a party or by which any of its properties or assets is bound, (iii) violate any Judgment or Law to which any of Buyer, and Merger Sub or its respective properties or assets are subject, or (iv) result in the creation or imposition of any Lien upon any of the properties or assets of Buyer and Merger Sub, except, in the case of clauses (ii), (iii) and (iv), any such items that, individually or in the aggregate, would not reasonably be expected to have a Buyer Material Adverse Effect

 

(b) No Consent of, or registration, declaration or filing with, any Governmental Entity is required to be obtained or made by Buyer and Merger Sub in connection with the execution, delivery and performance of this Agreement or the consummation of the Acquisition, other than (i) compliance with and filings, notifications and approvals, jointly determined by the Parties to be required for consummation of the Acquisition, under any Foreign Merger Control Law and (ii) those the failure of which to obtain or make would not, individually or in the aggregate, reasonably be expected to have a Buyer Material Adverse Effect.

 

Section 5.5. Litigation. There are no Actions, or the Buyer’s Knowledge, investigations, pending or, to the Buyer’s Knowledge, threatened in writing against the Buyer Group or any of its respective Affiliates and the Buyer Group is not party to or subject to or in default under any unsatisfied Judgment and, to the Buyer’s Knowledge, no event has occurred or circumstances currently exist that would give rise to, or serve as a basis for, any such Action or investigation. There is no Action, or the Buyer’s Knowledge, an investigation, pending or threatened by the Buyer against any other Person, and there is no outstanding order and no unsatisfied judgments, penalties, or awards against the Buyer and, to the Buyer’s Knowledge, no event has occurred or circumstances exist that would constitute or result in (with or without notice or lapse of time) a violation of any such existing order. To the Knowledge of the Buyer, there is no Action, or the Buyer’s Knowledge, an investigation, pending against any current or former director, manager, officer, employee, contractor, consultant, or agent of the Buyer with respect to which the Buyer has, or is reasonably likely to have, an indemnification obligation.

 

Section 5.6. Compliance with Laws; Regulatory Matters.

 

(a) The Buyer Group and its respective controlled Affiliates are, and during the two (2)-year period immediately preceding the date of this Agreement have been, in compliance in all material respects with all applicable Laws.

 

 
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(b) During the three (3)-year period immediately preceding the date of this Agreement, none of the Buyer Group nor any of its respective Affiliates has received any written notice from any applicable Governmental Entity alleging or asserting material noncompliance with any applicable Law.

 

(c) None of the Buyer Group nor any of its respective Affiliates is subject to a deferred prosecution agreement, consent decree or settlement agreement with any Governmental Entity.

 

(d) To the Knowledge of Buyer, in the last five (5) years, (i) no allegations of sexual harassment or other sexual misconduct have been made against or made by any former or current officer, director, employee, contractor or agent of the Buyer Group and (ii) the Buyer Group has not entered into any settlement agreements related to allegations of sexual harassment or misconduct by any former or current officer, director, employee, contractor or agent of the Buyer Group. Buyer is not aware of any allegations relating to officers, directors, employees, contractors, or agents of the Buyer Group, that, if known to the public, would bring the Buyer Group into material disrepute.

 

(e) The Buyer Group holds all Permits that are necessary to conduct the Buyer Business as presently being conducted. Except for breaches, violations, revocations, limitations, non-renewals and failures to be in full force and effect that would not be material, (i) such Permits are in full force and effect, (ii) the Buyer Group has not received any written notice of any violation in respect of any such Permit and (iii) no Action, or the Buyer’s Knowledge, an investigation, is pending or threatened in writing, to revoke or limit any such Permit.

 

Section 5.7. SEC Documents.

 

(a) Buyer has filed or furnished all reports, schedules, forms, proxy statements, prospectuses, registration statements and other documents required to be filed or furnished by it with the SEC since January 1, 2020, and Buyer has made available to the Company (including through the SEC’s EDGAR database) complete and correct copies of all such documents (collectively, “Buyer’s SEC Documents”). As of their respective dates (or, if amended or supplemented, as of the date of the most recent amendment or supplement), each of Buyer’s SEC Documents complied in all material respects with the applicable requirements of the Securities Exchange Act of 1934, as amended (the “1934 Act”), the Securities Act and the Sarbanes-Oxley Act of 2002, and any rules and regulations promulgated thereunder, and none of Buyer’s SEC Documents, as of their respective dates, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading.

 

(b) Each of the consolidated financial statements (including, in each case, any notes thereto) contained in Buyer’s SEC Documents was prepared in accordance with GAAP throughout the periods indicated (except as may be indicated in the notes thereto and except that financial statements included with interim reports do not contain all notes to such financial statements) and each fairly presented in all material respects the consolidated financial position, results of operations and changes in stockholders’ equity and cash flows of Buyer and its consolidated subsidiaries as at the respective dates thereof and for the respective periods indicated therein (subject, in the case of unaudited statements, to normal year-end adjustments which are not expected, individually or in the aggregate, to be material).

 

 
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Section 5.8. Stock Consideration. The shares of Buyer Common Stock to be issued and delivered as Stock Consideration in accordance with this Agreement, when so issued and delivered, will be (a) duly authorized, validly issued, fully paid and nonassessable and not subject to preemptive, subscription or similar rights, and (b) issued pursuant to available and valid exemptions from the registration and qualification provisions of applicable federal and state securities Laws.

 

Section 5.9. Regulatory Compliance. To the Knowledge of Buyer, neither the Buyer Group nor any of its directors, officers, or employees has committed any act, made any statement, or failed to make any statement, including with respect to any scientific data or information, that, at the time such act was committed or such statement was made or failed to be made, would provide a basis for the FDA to invoke the FDA policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Buyer, neither the Buyer Group nor any officer or employee of the Buyer Group has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign applicable Law or (ii) exclusion under 42 U.S.C. Section 1320a–7 or any similar state or foreign applicable Law.

 

Section 5.10. Data Privacy. The Buyer Group is in compliance in all material respects with applicable Privacy and Security Laws. The Buyer Group has taken commercially reasonable steps intended to protect Personal Information in its control and the material information technology systems of the Buyer Group used in the Buyer Business against unauthorized access or use. To the Knowledge of Buyer, during the two (2)-year period immediately preceding the date of this Agreement, the Buyer Group has not experienced any material unauthorized access or use of Personal Information in its control requiring notice under applicable Law to consumers or applicable Governmental Entities.

 

Section 5.11. Anti-Bribery. The Buyer Group has not, (a) offered, made, paid or received any unlawful bribes to or from any person (including any customer or supplier) or Governmental Entity or (b) made or paid any contribution, directly or indirectly, to a domestic or foreign political party or candidate, in each case ((a) and (b)), in material violation of the Foreign Corrupt Practices Act or any other applicable anti-corruption Law.

 

Section 5.12. No Undisclosed Liabilities. The Buyer Group does not have any liabilities required by GAAP to be reflected or reserved against in a balance sheet or the notes thereto, other than:

 

(a) liabilities provided for in the Buyer Financial Statements or the notes thereto;

 

(b) liabilities set forth on Section 5.12 of the Buyer Disclosure Schedule;

 

 
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(c) liabilities incurred in the Ordinary Course of Business since the Most Recent Buyer Balance Sheet Date; and

 

(d) liabilities incurred in connection with this Agreement and the transactions contemplated hereby

 

Section 5.13. Brokers and Finders. There is no investment banker, broker, finder, financial advisor or other financial intermediary that has been retained by or is authorized to act on behalf of the Buyer Group or any of its Affiliates that is entitled to any fee or commission in connection with the Acquisition payable by Sellers, Shareholders’ Representative or any of their respective Affiliates.

 

Section 5.14. Availability of Funds. Buyer and Merger Sub will have at the Closing, cash available that is sufficient to enable it to consummate the Merger and the other transactions contemplated to occur at the Closing.

 

Section 5.15. Company’s Representations; Independent Investigation.

 

(a) Each of Buyer and Merger Sub acknowledges and agrees that, other than the representations and warranties of the Company specifically contained in Article 4, respectively, there are no representations or warranties of the Company or any other person either expressed, statutory or implied with respect to the Company, the Company Business, any Compound, any Product, the Company Common Stock and the Company Preferred Stock, including with respect to any of the Company’s rights or assets, or the transactions contemplated hereby, individually or collectively. Each of Buyer and Merger Sub, together with and on behalf of its respective Affiliates and Representatives, specifically disclaims that it or they are relying upon or have relied upon any such other representations or warranties that may have been made by any person, and Buyer and Merger Sub , together with and on behalf of their Affiliates and Representatives, acknowledges and agrees that the Company and Sellers and their respective Affiliates have specifically disclaimed and do hereby specifically disclaim any such other representation or warranty made by any person. Without limiting the generality of the foregoing, each of Buyer and Merger Sub acknowledges and agrees that except as specifically contained in Article 4, none of the Company, Sellers, their respective Affiliates or their respective Representatives makes any representations or warranties relating to (i) the maintenance, repair, condition, design, performance or marketability of any right or asset of the Company, including with respect to title, merchantability or fitness for a particular purpose, or, except as specifically contained in Article 4, validity, enforceability or non-infringement, (ii) the operation of the Company or the Company Business by Buyer after the Closing or (iii) the probable success or profitability of the Company, the Company Business, any Compound or any Product after the Closing.

 

(b) Each of Buyer and Merger Sub acknowledges and agrees that (i) the representations and warranties set forth in Section 4.9 are the sole and exclusive representations and warranties of the Company with respect to intellectual property matters; (ii) the representations and warranties set forth in Section 4.9(d) are the sole and exclusive representations and warranties of the Company with respect to privacy data security matters; (iii) the representations and warranties set forth in Section 4.11 are the sole and exclusive representations and warranties of the Company with respect to Tax matters; (iv) the representations and warranties set forth in Section 4.13 are the sole and exclusive representations and warranties of the Company with respect to employee matters and employee benefit plans; (v) the representations and warranties set forth in Section 4.15 are the sole and exclusive representations and warranties of the Company with respect to environmental matters and (vi) the representations and warranties set forth in Section 4.17 are the sole and exclusive representations and warranties of the Company with respect to regulatory compliance matters.

 

 
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(c) Notwithstanding anything to the contrary herein or otherwise, nothing in this Section 5.15 shall be deemed to limit or modify in many manner whatsoever any rights or remedies available to Buyer based on Fraud.

 

ARTICLE 6

COVENANTS

 

Section 6.1. Tax Matters.

 

(a) Buyer, on the one hand, and the Sellers, on the other hand, shall each be responsible for 50% of all transfer, documentary, sales, use, recordation, registration and other such Taxes incurred in connection with the consummation of the Merger (“Transfer Taxes”). All Transfer Taxes shall be paid to the relevant Taxing Authority when due by the Party that is legally responsible in the first instance under applicable Law for paying such Transfer Taxes, and such Party shall, at its own expense and with the reasonable cooperation of the other Party, timely file any Tax Return or other document required to be filed with respect to such Transfer Taxes. The other Party shall, not more than ten (10) days after receiving reasonably satisfactory evidence of the payment of such Transfer Taxes, remit payment in the amount of its share of such Transfer Taxes to the filing Party. Buyer and the Sellers will reasonably cooperate with each other to file such Tax Returns and lawfully minimize any such Transfer Taxes.

 

(b) Buyer, the Sellers, the Shareholders’ Representative and the Company shall cooperate fully, as and to the extent reasonably requested by the other Party, in connection with the filing of Tax Returns pursuant to this Agreement and any audit, administrative proceeding or judicial proceeding involving Taxes. Such cooperation shall include the retention and (upon the other Party’s request) the provision of records and information which are reasonably relevant to any such Tax Returns, audits, or administrative or judicial proceedings related to Taxes, including all records and information reasonably capable of being obtained or created, and making employees available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder through the applicable statute of limitations. Buyer, the Company, and the Shareholders’ Representative agree (A) to retain all books and records with respect to Tax matters pertinent to the Company relating to any taxable period beginning before the Closing Date until the expiration of the statute of limitations (including any extensions thereof) of the respective taxable periods, and to abide by all record retention Laws of, and agreements entered into with, any Governmental Entity; (B) to deliver or make available to Buyer, within 60 calendar days after the Closing Date, copies of all such books and records; and (C) to give the other Party reasonable written notice prior to transferring, destroying or discarding any such books and records and, if the other Party so requests, Buyer, the Company, and the Shareholders’ Representative, as the case may be, will allow the other Party to take possession or to prepare copies of such books and records at such other party’s expense.

 

 
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Section 6.2. Indemnification of Officers and Directors.

 

(a) Buyer and the Company agree that all rights to exculpation, indemnification and advancement of expenses for acts or omissions occurring at or prior to the Closing, whether asserted or claimed prior to, at or after the Closing, now existing in favor of the current or former directors or officers of the Company (each, a “Company Indemnitee”) as provided in the organizational documents of the Company or in any Contract with the Company as in effect on the date of this Agreement shall survive the Closing and shall continue in full force and effect.

 

(b) Buyer shall cause the Company to maintain in effect any and all exculpation, indemnification and advancement of expenses provisions currently existing in the organizational documents of the Company, or in any indemnification agreements of the Company with any of the Company Indemnitees, in each case in effect as of the date of this Agreement, for acts or omissions occurring at or prior to the Closing.

 

(c) Prior to the Effective Time, the Company shall purchase a prepaid “tail” liability insurance policy, for any claims-made Insurance Policies, with a policy period of no less than six (6) years from the Effective Time and which shall provide full prior acts coverage for alleged wrongful acts or omissions occurring at or prior to the Effective Time (the “D&O Tail Policy”). The D&O Tail Policy shall be effective as of the Effective Time and shall provide for policy limits, terms, conditions, retentions, and levels of coverage at least as favorable in the aggregate to the directors, managers, and officers covered under such insurance policies as the policy limits, terms, conditions, retentions, and levels of coverage in the existing policies of the Company. The aggregate amount necessary to purchase such D&O Tail Policy coverage shall be referred to as the “D&O Tail Premium.” Sellers shall bear 50% of the cost of the D&O Tail Premium as a Transaction Expense and the Buyer shall bear 50% of the cost of the D&O Tail Premium.

 

(d) During the term of the Tail Policy, none of the Buyer, the Surviving Company, nor any of their respective Affiliates shall take any action following the Closing to cause the Tail Policy to be cancelled or any provision therein to be amended or waived; provided, however, that none of the Buyer, the Surviving Corporation, or any of their respective Affiliates shall be obligated to pay any premiums or other amounts in respect of such D&O Tail Policy.

 

Section 6.3. Publicity. None of the Parties shall, and each Party shall use commercially reasonable efforts to cause its officers, directors, employees, advisors and other Representatives not to, issue a press release or public announcement or otherwise make any public disclosure concerning the subject matter of this Agreement or the transactions contemplated hereby without the prior written approval of Buyer and the Shareholders’ Representative; provided, that the Parties agree to issue the press release attached hereto as Exhibit I following the Closing.

 

 
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Section 6.4. Consents. Buyer agrees and acknowledges that none of Sellers, the Company or any of their respective Affiliates will have any liability whatsoever to Buyer (and Buyer will not be entitled to assert any claims), except as expressly set forth in Section 4.3, arising out of, or relating to, the failure to obtain any Consents that may have been or may be required in connection with the transactions contemplated by this Agreement or because of the default, acceleration or termination of any Contract to which the Company is a party as a result thereof. Buyer further agrees that no representation, warranty, covenant or agreement of the Company or Sellers contained herein will be breached or deemed breached as a result of the failure to obtain any such Consent or as a result of any such default, acceleration or termination or any action commenced or threatened by or on behalf of any person, except as expressly set forth in Section 4.3, arising out of, or relating to, the failure to obtain any such Consent or any such default, acceleration or termination.

 

Section 6.5. Shares of Buyer Common Stock; Shelf Registration.

 

(a) Restrictions on Buyer Common Stock. The Buyer Common Stock issued pursuant to the terms of this Agreement will be issued in a transaction exempt from registration under the Securities Act (by reason of Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated under the Securities Act) and therefore may not be re-offered or resold other than in conformity with the registration requirements of the Securities Act and such other applicable rules and regulations or pursuant to an exemption therefrom. The Buyer Common Stock to be issued pursuant to the terms of this Agreement will be “restricted securities” within the meaning of Rule 144 under the Securities Act and may not be offered, sold, pledged, assigned or otherwise transferred unless (A) a registration statement with respect thereto is effective under the Securities Act and any applicable state securities laws or (B) an exemption from such registration exists and either Buyer receives an opinion of counsel, which counsel and opinion are reasonably satisfactory to Buyer, that such securities may be offered, sold, pledged, assigned or transferred in the manner contemplated without an effective registration statement under the Securities Act or applicable state securities laws or Buyer agrees that such opinion is not necessary. Buyer will use commercially reasonable efforts, at its own cost, to cause its counsel to deliver any such opinions that may be required. The Buyer Common Stock issued hereunder shall, if certificated, bear an appropriate legend (or if held in book entry form, will be noted) with respect to such restrictions. Notwithstanding anything to the contrary set forth in this Agreement, Buyer shall substitute cash for shares of Buyer Common Stock (based on the Buyer Stock Price) in the event Buyer determines in its sole discretion that is has not received evidence reasonably satisfactory to it that a Company Shareholder is (or remains) an “accredited investor” as defined in Rule 501(a) under the Securities Act.

 

(b) Shelf Registration. Promptly (and in any event within fifteen (15) Business Days thereafter) following the expiration of the Standstill Period, Buyer shall file with the SEC, and use commercially reasonable efforts to cause to be declared effective as soon as reasonably practicable after filing, a shelf registration statement on Form S-3 (assuming Buyer remains eligible for the use of such form, otherwise on a Form S-1, including any amendments or supplements, the “Registration Statement”) and the prospectus (including any amendments or supplements, the “Prospectus”) forming part of the Registration Statement in compliance with Rule 415 under the Securities Act covering the resale on a continuous basis of all of the Registrable Securities pursuant to this Section 6.5; provided, that Buyer shall only be obligated to file the Registration Statement during an “open trading window” as determined by Buyer’s insider trading policies.

 

 
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(c) Holders of Registrable Securities. As a condition to its obligations under Section 6.5(b), Buyer may require each Holder of Registrable Securities as to which any registration is being effected to (i) furnish Buyer with such information regarding such Person that is necessary to satisfy the disclosure requirements relating to the registration and the distribution of such securities under the Securities Act and the rules and regulations promulgated thereunder as Buyer may from time to time reasonably request in writing, including a properly completed and executed Selling Holder Questionnaire, and (ii) promptly notify Buyer in writing of any changes in the information set forth in the applicable Registration Statement after it is prepared regarding the Holder of Registrable Securities. None of the information supplied (or to be supplied) by or on behalf of any of the Holders of Registrable Securities for inclusion or incorporation by reference in the applicable Registration Statement or Prospectus will, at the time the Registration Statement is declared effective under the Securities Act (or with respect to any post-effective amendments or supplements thereto, at the time such post-effective amendments or supplements become effective under the Securities Act), contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances under which they are made, not misleading.

 

(d) Blackout Periods. Buyer may, by two (2) days prior written notice to the Shareholders’ Representative (each such notice, a “Blackout Notice”), (i) delay the filing of the Registration Statement or a request for acceleration of the effective date or (ii) suspend the Registration Statement after effectiveness and require that the Holders of Registrable Securities immediately cease sales of shares pursuant to any Registration Statement in the event that (A) Buyer is engaged in any activity or transaction or preparations or negotiations for any activity or transaction that Buyer desires to keep confidential for business reasons, if Buyer determines in good faith that the public disclosure requirements imposed on Buyer under the Securities Act in connection with such Registration Statement would require at that time disclosure of such activity, transaction, preparations or negotiations and such disclosure could result in imminent and material harm to Buyer or (B) any other event occurs that makes any statement of a material fact made in such Registration Statement, including any document incorporated by reference therein, untrue or that requires the making of any additions or changes in such Registration Statement in order to make the statements therein not misleading. If Buyer suspends the Registration Statement and requires the Holders of Registrable Securities to cease sales of shares pursuant to this Section 6.5 (d), Buyer shall, as promptly as reasonably practicable following the termination of the circumstance which entitled Buyer to do so, take such actions as may be reasonably necessary to file or reinstate the effectiveness of such Registration Statement and give written notice to all Holders of Registrable Securities authorizing them to resume sales pursuant to such Registration Statement. If as a result thereof the Prospectus included in any Registration Statement has been amended to comply with the requirements of the Securities Act, Buyer shall enclose such revised Prospectus with the notice to the Shareholders’ Representative given pursuant to this Section 6.5, and the Holders of Registrable Securities shall make no offers or sales of shares pursuant to such Registration Statement other than by means of such revised Prospectus. Buyer need not specify the nature of the event giving rise to any delay or suspension in any notice to Holders of Registrable Securities.

 

 
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(e) Registration Expenses. All fees and expenses incident to the performance of or compliance with, this Section 6.5 by the Buyer shall be borne by the Buyer whether or not any Registrable Securities are sold pursuant to a Registration Statement. The fees and expenses referred to in the foregoing sentence shall include, without limitation, (i) all registration and filing fees (including, without limitation, fees and expenses of the Buyer’s counsel and independent registered public accountants) (A) with respect to filings made with the Commission, (B) with respect to filings required to be made with any trading market on which the Registrable Securities are then listed for trading, and (C) in compliance with applicable state securities or Blue Sky laws reasonably agreed to by the Buyer in writing (including, without limitation, fees and disbursements of counsel for the Buyer in connection with Blue Sky qualifications or exemptions of the Registrable Securities), (ii) printing expenses (including, without limitation, expenses of printing certificates for Registrable Securities), (iii) messenger, telephone and delivery expenses, (iv) fees and disbursements of counsel for the Buyer, (v) Securities Act liability insurance, if the Buyer so desires such insurance, and (vi) fees and expenses of all other Persons retained by the Buyer in connection with the consummation of the transactions contemplated by this Agreement. In addition, the Buyer shall be responsible for all of its internal expenses incurred in connection with the consummation of the transactions contemplated by this Section 6.5 (including, without limitation, all salaries and expenses of its officers and employees performing legal or accounting duties), the expense of any annual audit and the fees and expenses incurred in connection with the listing of the Registrable Securities on any securities exchange as required hereunder. In no event shall the Buyer be responsible for any broker or similar commissions of any Holder of Registrable Securities or any legal fees or other costs of the Holder of Registrable Securities.

 

(f) Indemnification.

 

(i) Indemnification by the Buyer. The Buyer shall, notwithstanding any termination of the rights under this Section 6.5, indemnify and hold harmless each Holder of Registrable Securities, the officers, directors, members, partners, agents, brokers (including brokers who offer and sell Registrable Securities as principal as a result of a pledge or any failure to perform under a margin call of Buyer Common Stock), investment advisors and employees (and any other Persons with a functionally equivalent role of a Person holding such titles, notwithstanding a lack of such title or any other title) of each of them, each Person who controls any such Holder of Registrable Securities (within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act) and the officers, directors, members, stockholders, partners, agents and employees (and any other Persons with a functionally equivalent role of a Person holding such titles, notwithstanding a lack of such title or any other title) of each such controlling Person, to the fullest extent permitted by applicable law, from and against any and all losses, claims, damages, liabilities, costs (including, without limitation, reasonable attorneys’ fees) and expenses (collectively, “Losses”), as incurred, arising out of or relating to (A) any untrue or alleged untrue statement of a material fact contained in a Registration Statement, any Prospectus or any form of prospectus or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading or (B) any violation or alleged violation by the Buyer of the Securities Act, the Exchange Act or any state securities law, or any rule or regulation thereunder, in connection with the performance of its obligations under this Section 6.5, except to the extent, but only to the extent, that such untrue statements or omissions are based solely upon information regarding such Holder of Registrable Securities furnished in writing to the Buyer by such Holder of Registrable Securities expressly for use therein, or to the extent that such information relates to such Holder of Registrable Securities or such Holder of Registrable Securities’ proposed method of distribution of Registrable Securities and was reviewed and expressly approved in writing by such Holder of Registrable Securities expressly for use in a Registration Statement, such Prospectus or in any amendment or supplement thereto. The Buyer shall notify the Holders of Registrable Securities promptly of the institution, threat or assertion of any Action or investigation arising from or in connection with the transactions contemplated by this Section 6.5 of which the Buyer is aware. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of such indemnified person and shall survive the transfer of any Registrable Securities by any of the Holders of Registrable Securities.

 

 
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(ii) Indemnification by Holders of Registrable Securities. Each Holder of Registrable Securities shall, severally and not jointly, indemnify and hold harmless the Buyer, its directors, officers, agents and employees, each Person who controls the Buyer (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act), and the directors, officers, agents or employees of such controlling Persons, to the fullest extent permitted by applicable law, from and against all Losses, as incurred, to the extent arising out of or based solely upon: any untrue or alleged untrue statement of a material fact contained in any Registration Statement, any Prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading to the extent, but only to the extent, that such untrue statement or omission is contained in any information so furnished in writing by such Holder of Registrable Securities to the Buyer expressly for inclusion in such Registration Statement or such Prospectus. In no event shall the liability of a selling Holder of Registrable Securities be greater in amount than the dollar amount of the proceeds (net of all expenses paid by such Holder of Registrable Securities in connection with any claim relating to this Section 6.5 and the amount of any damages such Holder of Registrable Securities has otherwise been required to pay by reason of such untrue statement or omission) received by such Holder of Registrable Securities upon the sale of the Registrable Securities included in the Registration Statement giving rise to such indemnification obligations.

 

Conduct of Indemnification Actions. If any Action or investigation shall be brought or asserted against any Person entitled to indemnity hereunder (an “Indemnified Party”), such Indemnified Party shall promptly notify the Person from whom indemnity is sought (the “Indemnifying Party”) in writing, and the Indemnifying Party shall have the right to assume the defense thereof, including the employment of counsel reasonably satisfactory to the Indemnified Party and the payment of all fees and expenses incurred in connection with defense thereof, provided that the failure of any Indemnified Party to give such notice shall not relieve the Indemnifying Party of its obligations or liabilities pursuant to this Section 6.5, except (and only) to the extent that it shall be finally determined by a court of competent jurisdiction (which determination is not subject to appeal or further review) that such failure shall have materially and adversely prejudiced the Indemnifying Party.

 

 
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An Indemnified Party shall have the right to employ separate counsel in any such Action or investigation and to participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of such Indemnified Party or Parties unless: (1) the Indemnifying Party has agreed in writing to pay such fees and expenses, (2) the Indemnifying Party shall have failed promptly to assume the defense of such Action or investigation and to employ counsel reasonably satisfactory to such Indemnified Party in any such Action or investigation, or (3) the named parties to any such Action or investigation (including any impleaded parties) include both such Indemnified Party and the Indemnifying Party, and counsel to the Indemnified Party shall reasonably believe that a material conflict of interest is likely to exist if the same counsel were to represent such Indemnified Party and the Indemnifying Party (in which case, if such Indemnified Party notifies the Indemnifying Party in writing that it elects to employ separate counsel at the expense of the Indemnifying Party, the Indemnifying Party shall not have the right to assume the defense thereof and the reasonable fees and expenses of no more than one separate counsel shall be at the expense of the Indemnifying Party). The Indemnifying Party shall not be liable for any settlement of any such Action or investigation effected without its written consent, which consent shall not be unreasonably withheld or delayed. No Indemnifying Party shall, without the prior written consent of the Indemnified Party, effect any settlement of any pending Action or investigation in respect of which any Indemnified Party is a party, unless such settlement includes an unconditional release of such Indemnified Party from all liability on claims that are the subject matter of such Action or investigation.

 

(iii) Subject to the terms of this Section 6.5, all reasonable fees and expenses of the Indemnified Party (including reasonable fees and expenses to the extent incurred in connection with investigating or preparing to defend such Action or investigation in a manner not inconsistent with this Section) shall be paid to the Indemnified Party, as incurred, within ten business days of written notice thereof to the Indemnifying Party, provided that the Indemnified Party shall promptly reimburse the Indemnifying Party for that portion of such fees and expenses applicable to such actions for which such Indemnified Party is finally determined by a court of competent jurisdiction (which determination is not subject to appeal or further review) not to be entitled to indemnification hereunder.

 

Contribution. If the indemnification under this Section 6.5 is unavailable to an Indemnified Party or insufficient to hold an Indemnified Party harmless for any Losses, then each Indemnifying Party shall contribute to the amount paid or payable by such Indemnified Party, in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party and Indemnified Party in connection with the actions, statements or omissions that resulted in such Losses as well as any other relevant equitable considerations. The relative fault of such Indemnifying Party and Indemnified Party shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact or omission or alleged omission of a material fact, has been taken or made by, or relates to information supplied by, such Indemnifying Party or Indemnified Party, and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such action, statement or omission. The amount paid or payable by a party as a result of any Losses shall be deemed to include, subject to the limitations set forth in this Section 6.5, any reasonable attorneys’ or other fees or expenses incurred by such party in connection with any Action or investigation to the extent such party would have been indemnified for such fees or expenses if the indemnification provided for in this Section 6.5 was available to such party in accordance with its terms.

 

 
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(iv) The parties hereto agree that it would not be just and equitable if contribution pursuant to this Section 6.5 were determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to in the immediately preceding paragraph. In no event shall the contribution obligation of a Holder of Registrable Securities be greater in amount than the dollar amount of the proceeds (net of all expenses paid by such Holder of Registrable Securities in connection with any claim relating to this Section 6.5 and the amount of any damages such Holder of Registrable Securities has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission) received by it upon the sale of the Registrable Securities giving rise to such contribution obligation. The indemnity and contribution agreements contained in this Section are in addition to any liability that the Indemnifying Parties may have to the Indemnified Parties.

 

(g) Piggy-Back Registrations. If, at any time while Registrable Securities are outstanding, there is not an effective Registration Statement covering all of the Registrable Securities and the Buyer shall determine to prepare and file with the Commission a registration statement relating to an offering for its own account or the account of others under the Securities Act of any of its equity securities, other than on Form S-4 or Form S-8 (each as promulgated under the Securities Act), or their then equivalents relating to equity securities to be issued solely in connection with any acquisition of any entity or business or equity securities issuable in connection with the Buyer’s stock option or other employee benefit plans, then the Buyer shall deliver to each Holder a written notice of such determination and, if within fifteen days after the date of the delivery of such notice, any such Holder shall so request in writing, the Buyer shall include in such registration statement all or any part of such Registrable Securities such Holder requests to be registered; provided, however, that the Buyer shall not be required to register any Registrable Securities pursuant to this Section 6.5(g) that are eligible for resale pursuant to Rule 144 (without volume restrictions or current public information requirements) promulgated by the Commission pursuant to the Securities Act or that are the subject of a then effective Registration Statement that is available for resales or other dispositions by such Holder.

 

Section 6.6. Nasdaq Listing. Buyer shall use commercially reasonable efforts to continue the listing and trading of its Buyer Common Stock on Nasdaq and, in accordance therewith, will use commercially reasonable efforts to comply in all material respects with Buyer’s reporting, filing and other obligations under the bylaws or rules of such market or exchange, as applicable.

 

 
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Section 6.7. Further Assurance. From time to time, as and when reasonably requested by any Party, the Parties shall execute and deliver, or cause to be executed and delivered, all such documents and instruments and shall take, or cause to be taken, all such further or other actions as a Party may reasonably deem necessary or desirable in order to carry out the intent and accomplish the purposes of this Agreement and, subject to the conditions of this Agreement, the consummation of the transactions contemplated hereunder.

 

Section 6.8. Section 280G. No later than two (2) Business Days prior to the Closing, the Company shall (a) make reasonable efforts to obtain from each Person, if any, who could receive or retain any payments and/or benefits that may be subject to an excise tax under Section 4999 of the Code or non-deductible under Section 280G of the Code in connection with the consummation of the transactions contemplated by this Agreement (without regard to Treasury Regulations Section 1.280G-1, Q&A 9), whether alone or together with any other event (a “280G Benefit”) (which determination shall be made by the Company and shall be subject to review and approval by Buyer, such approval not to be unreasonably withheld, conditioned or delayed), a duly executed waiver with respect to any payments and/or benefits, if any, that may separately or in the aggregate constitute “parachute payments” within the meaning of Section 280G(b)(2) of the Code and the regulations promulgated thereunder) (each a “280G Waiver”), and (b) to then submit to the stockholders of the Company, for approval in a manner reasonably satisfactory to the Buyer that complies with Section 280G(b)(5)(B) of the Code the 280G Benefits, such that, if approved by the stockholders of the Company, such payments and benefits shall not be deemed to be “parachute payments” under Section 280G(b)(2) of the Code and the regulations thereunder, and, if applicable, no less than one (1) Business Day prior to the Closing Date, the Company shall deliver to Buyer evidence reasonably satisfactory to Buyer (i) that approval of the stockholders the Company, was solicited in accordance with Section 280G and the regulations promulgated thereunder, and, if applicable, the requisite stockholder approval was obtained with respect to any payments and/or benefits that were subject to the stockholder approval (the “280G Approval”), or (ii) that the 280G Approval was not obtained and as a consequence that such “parachute payments” shall not be made or provided, pursuant to the applicable 280G Waivers which were executed by the affected individuals prior to the Closing Date. No less than two (2) Business Days prior to the date the Company, submit the 280G Benefits to the stockholders of the Company, the Company will provide to Buyer a draft of all documents and calculations of the parachute payments contemplated in this Section 6.8 and all relevant supporting documentation for its review. The Company will accept all reasonable comments that are made by Buyer or its representatives.

 

Section 6.9. Buyer Board. No later than the stockholder meeting scheduled for 2021, Buyer shall deliver evidence and resolutions reasonably acceptable to Sellers that (i) the board of directors of Buyer has been expanded to include, or a then current director has been removed and replaced by, a director appointed by the Sellers holding a majority of the shares of Buyer Common Stock issued pursuant to the Stock Consideration on an as-converted basis and (ii) the AzurRx Scientific Advisory Board has been expanded to include a member appointed by the Sellers holding a majority of the shares of Buyer Common Stock issued pursuant to the Stock Consideration on an as-converted basis.

 

Section 6.10. E-mails. Notwithstanding any other provision of this Agreement to the contrary, Buyer will not acquire or have access to the E-mails or the E-mail Accounts following Closing. Following the Closing, the Buyer and an information technology representative from the Sellers shall work together to effect the DNS record change for the website used by the Company prior to Closing and all e-mail services will continue to run inside the 365 environment used by the Company prior to Closing until 5:00 PM Eastern Time on Thursday September 16, 2021, at which time the domain will be transferred to Buyer and the E-mail Accounts will be terminated. Buyer and the Company shall not, and shall cause their respective Affiliates and Representatives not to, recreate or re-establish the E-mail Accounts listed on Section 1.1(b) of the Company Disclosure Schedules in their e-mail environment. For the avoidance of doubt, the E-mails and the E-mail Accounts shall not constitute assets or property of the Company.

 

 
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Section 6.11. R&W Insurance Policy. Buyer shall execute and enter into, and use commercially reasonable efforts to take all actions necessary to bind the R&W Insurance Policy substantially concurrently with the Closing on terms and in the form provided or made available to Sellers prior to the date hereof, which such policy shall, for the avoidance of doubt, specify that there is no right of, and that the insurer under the R&W Insurance Policy expressly waives any claims of, subrogation, contribution, or otherwise against any Seller or any of its Affiliates, except in the case of Fraud. From and after the binding of the R&W Insurance Policy containing the waivers by the insurer described above, Buyer shall provide the Shareholders’ Representative with a true and complete copy thereof and shall not amend, modify, or cancel the R&W Insurance Policy if such amendment, modification, or cancellation could reasonably be expected to adversely affect the rights of Sellers thereunder without the prior written consent of the Shareholders’ Representative.

 

ARTICLE 7

NON-SURVIVAL OF THE REPRESENTATIONS AND WARRANTIES

 

Section 7.1. Non-Survival. None of the representations and warranties and covenants and agreements to the extent to be performed prior to the Closing in this Agreement or in any certificate delivered pursuant to this Agreement shall survive the Closing. The Parties acknowledge and agree that no Party may bring an Action or otherwise assert any claim against any other Party claiming, based upon or arising out of any breach of any such representations, warranties or covenants and agreements to the extent to be performed prior to the Closing. The respective covenants and agreements of the Parties contained in or made pursuant to this Agreement (or in any document, certificate or instrument delivered pursuant to or in connection with this Agreement) that by their terms apply in whole or in part after the Closing shall survive the Closing in accordance with their respective terms. Notwithstanding the foregoing or anything to the contrary herein or otherwise, nothing in this Agreement shall limit or restrict any party’s right or ability to make any claim, or recover any amounts against any Party for Fraud and nothing in this Agreement shall limit the Buyer’s ability to pursue claims against the R&W Insurance Policy.

 

ARTICLE 8
MISCELLANEOUS

 

Section 8.1. Notices. All notices, requests, claims, demands, waivers and other communications under this Agreement shall be in writing and shall be sent by electronic mail, courier or express delivery service or personal delivery to the following addresses, or to such other addresses as shall be designated from time to time by a Party in accordance with this Section 8.1:

 

 
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(a) if to Buyer or Merger Sub, if after the Effective Time, to the Surviving Company:

 

AzurRx BioPharma, Inc.

777 Yamato Road

Suite 502

Boca Raton, FL 33431

Attention: Dan Schneiderman and Martin Krusin

E-Mail: dschneiderman@azurrx.com and mkrusin@azurrx.com

 

with copies (which shall not constitute notice) to:

 

Lowenstein Sandler LLP

One Lowenstein Drive

Roseland, New Jersey 07068

Attention: Michael Lerner, Sam E. Khan and James O’Grady

E-Mail: mlerner@lowenstein.com, skhan@lowenstein.com and

jogrady@lowenstein.com

 

(b) if to the Shareholders’ Representative:

 

Fortis Advisors LLC

12526 High Bluff Dr., Suite 280

San Diego, CA 92130

Attention: Jessica Mueller, Director, M&A

E-Mail: jmueller@fortisrep.com

 

with a copy (which shall not constitute notice) to:

 

Covington & Burling LLP

The New York Times Building

620 Eighth Avenue

New York, NY 10018-1405

Attention: Jack S. Bodner, Ellen Corenswet and Joseph C. Gangitano

E-Mail: jbodner@cov.com, ecorenswet@cov.com, jgangitano@cov.com

 

All notices, requests, claims, demands, waivers and other communications under this Agreement shall be deemed to have been duly given (i) when delivered by hand, if personally delivered, (ii) upon receipt when delivered by a courier or express delivery service (such date of receipt being evidenced by the courier’s or express delivery service’s records) or (iii) when sent, if sent by electronic mail during normal business hours of the recipient, and if not sent during normal business hours, then on the next Business Day.

 

 
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Section 8.2. Assignment. Neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned, in whole or in part, by operation of Law or otherwise by any of the Parties prior to the Effective Time without the prior written consent of the other Parties; provided, however, the Buyer and the Surviving Company may assign any or all of its rights and obligations hereunder to (i) one or more of its Affiliates, (ii) to any of its lenders as collateral security, or (iii) in connection with a sale of all or a portion of its or the Company equity interests or assets; provided, further, however, that, in the cases of each of the foregoing clauses (i), (ii) and (iii), no such assignment of obligations shall relieve the assigning Party from such obligations, and it shall be a condition to the effectiveness of such assignment that the assignee expressly assume such obligations. This Agreement shall be binding upon, inure to the benefit of and be enforceable by, the Parties hereto and their respective successors, heirs and assigns, and any reference to a Party shall also be a reference to the successors, heirs, and permitted assigns of such Party.

 

Section 8.3. Captions. The titles, headings, captions, and table of contents contained herein are inserted herein only as a matter of convenience and for reference and in no way define, limit, extend, or describe the scope of this Agreement or the intent or interpretation of any provision hereof.

 

Section 8.4. Consents and Approvals. For any matter under this Agreement requiring the consent or approval of any Party to be valid and binding on the Parties hereto, such consent or approval must be in writing and signed by the Party against which it is sought to be enforced.

 

Section 8.5. Enforcement.

 

(a) Any suit, action or other proceeding arising out of this Agreement or any transaction contemplated hereby shall be brought exclusively in a court of competent jurisdiction, federal or state, located in Delaware, and in no other jurisdiction. Each Party hereby consents to personal jurisdiction and venue in, and agrees to service of process issued or authorized by, such court.

 

(b) The Parties agree that irreparable damage would occur and that the Parties would not have any adequate remedy at law in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. Accordingly, notwithstanding anything in this Agreement to the contrary, in the event of a breach or threatened breach by the Company, on the one hand, and Buyer or Merger Sub, on the other hand, of any of their respective covenants or obligations set forth in this Agreement, Buyer or Merger Sub, on the one hand, and the Company, on the other hand, shall be entitled to an injunction or injunctions to prevent or restrain breaches or threatened breaches of this Agreement and to specifically enforce the terms and provisions of this Agreement to prevent breaches or threatened breaches of, or to enforce compliance with, the covenants and obligations of the other under this Agreement. The Parties agree not to assert that a remedy of specific enforcement is unenforceable, invalid, contrary to Law or inequitable for any reason, and not to assert that a remedy of monetary damages would provide an adequate remedy or that the Parties otherwise have an adequate remedy at law. The Parties acknowledge and agree that a Party seeking an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement in accordance with this Section 8.5(b) shall not be required to provide any bond or other security in connection with any such order or injunction.

 

 
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(c) In connection with the Parties’ rights under Section 8.5(a), EACH PARTY, TO THE EXTENT PERMITTED BY LAW, KNOWINGLY, VOLUNTARILY, AND INTENTIONALLY WAIVES ITS RIGHT TO A TRIAL BY JURY IN ANY ACTION OR OTHER LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT AND THE TRANSACTIONS IT CONTEMPLATES. THIS WAIVER APPLIES TO ANY ACTION OR LEGAL PROCEEDING, WHETHER SOUNDING IN CONTRACT, TORT, OR OTHERWISE. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (I) NO REPRESENTATIVE, AGENT, OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE SUCH WAIVER, (II) IT UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF SUCH WAIVER, (III) IT MAKES SUCH WAIVER VOLUNTARILY, AND (IV) IT HAS BEEN INDUCED TO ENTER THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVER AND CERTIFICATIONS CONTAINED IN THIS Section 8.5(c).

 

Section 8.6. Amendment and Waiver.

 

(a) No failure or delay on the part of any Party in exercising any right, power or remedy hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power or remedy preclude any other or further exercise thereof or the exercise of any other right, power or remedy. Except as expressly set forth in Article 7, the remedies provided for herein are cumulative and are not exclusive of any remedies that may be available to any Party at Law, in equity or otherwise.

 

(b) Except as otherwise specifically set forth in this Agreement, this Agreement may be amended by the Parties at any time, whether before or after the Shareholder Approval has been obtained; provided, however, that, after the Shareholder Approval has been obtained, there shall be made no amendment that by Law requires further approval by shareholders of either Party, without the further approval of such shareholders. This Agreement may not be amended except by an instrument in writing signed on behalf of each of the Parties.

 

(c) Except as otherwise specifically set forth in this Agreement, any amendment, supplement or modification of or to any provision of this Agreement and any waiver of any provision of this Agreement shall be effective (i) only if it is made or given in writing and signed by Buyer and the Company (or after the Effective Time, the Shareholders’ Representative) or, in the case of a waiver, by the party granting the waiver and (ii) only in the specific instance and for the specific purpose for which made or given.

 

Section 8.7. Entire Agreement. This Agreement, together with its schedules and exhibits and all Transaction Documents to be delivered in connection herewith and therewith, contain the entire agreement and understanding between the Parties with respect to the subject matter hereof and thereof and supersede all prior discussions, negotiations, commitments, agreements and understandings, both written and oral, relating to such subject matter. In the event of any inconsistency between the statements in the body of this Agreement, and those in the other Transaction Documents, the statements in the body of this Agreement will control.

 

 
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Section 8.8. No Third-Party Beneficiaries. Except as otherwise provided in this Agreement, including with respect to the Sellers as set forth in Article 2 and as set forth in Section 6.2 (Indemnification of Officers and Directors) and Section 6.5 (Shares of Buyer Common Stock, Shelf Registration), this Agreement is for the sole benefit of the Parties and their permitted successors and assigns and nothing herein expressed or implied shall give or be construed to give to any Person, other than the Parties and such successors and assigns, any legal or equitable rights hereunder. No covenant or other undertakings in this Agreement shall constitute an amendment to any Company Plan, program, policy or arrangement, and any covenant or undertaking that suggests that a Company Plan, program, policy or arrangement will be amended shall be effective only upon the adoption of a written amendment in accordance with the amendment procedures of such Company Plan, program, policy or arrangement.

 

Section 8.9. Counterparts. This Agreement may be executed in any number of counterparts and by the Parties in separate counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute one and the same agreement. This Agreement may be executed by facsimile, email, PDF, or other electronically transmitted signatures complying with the U.S. federal ESIGN Act of 2000 (e.g., www.docusign.com) and such signatures shall be deemed to bind each Party hereto as if they were the original signatures.

 

Section 8.10. Governing Law. This Agreement, and all claims or causes of action (whether in contract or tort) that may be based upon, arise out of, or relate to this Agreement, or the negotiation, execution, performance, validity, interpretation, construction, and enforcement of this Agreement (including any claim or cause of action based upon, arising out of, or related to any representation or warranty made in or in connection with this Agreement or as an inducement to enter into this Agreement) shall be governed by, and construed in accordance with, the substantive Laws of the State of Delaware, regardless of the Laws that might otherwise govern under applicable principles of conflicts of laws thereof; provided that matters involving the internal corporate affairs of Buyer, Merger Sub or the Company shall be governed by the Laws of the jurisdiction in which such corporation is organized and that the Laws of the State of Delaware shall apply as may be necessary to legally effect the Merger.

 

Section 8.11. Severability. Any term or provision of this Agreement that is invalid, illegal, or unenforceable in any situation in any jurisdiction shall not affect the validity, legality or enforceability of the remaining terms and provisions hereof or the validity, legality or enforceability of the offending term or provision in any other situation or in any other jurisdiction. Upon such determination that any term or other provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in a mutually acceptable manner in order that the Transactions be consummated as originally contemplated to the greatest extent possible.

 

Section 8.12. Joint Drafting. The Parties have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring either Party by virtue of the authorship of any of the provisions of this Agreement.

 

 
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Section 8.13. No Recourse. This Agreement may only be enforced against, and any claim or suit based upon, arising out of, or related to, this Agreement or the negotiation, execution or performance of this Agreement may only be brought against the named Parties to this Agreement and then only with respect to the specific obligations set forth herein with respect to the named Parties to this Agreement (in all cases, as limited by the applicable provisions of Article 7). No person who is not a named Party to this Agreement, including any past, present or future director, officer, employee, incorporator, member, partner, equityholder, Affiliate, agent, attorney or Representative of the Company or any Seller shall have or be subject to any liability or indemnification obligation (whether in contract, tort, equity or otherwise) arising from or in connection with any claim based on, in respect of, or by reason of, the Merger, including any alleged non-disclosure or misrepresentations made by any such persons, in each case, regardless of the legal theory under which such liability or obligation may be sought to be imposed, whether sounding in contract or tort, and whether at law or in equity, or otherwise; and, each Party waives and releases all such liabilities and obligations against any such persons.

 

Section 8.14. Consent to Representation; Conflict of Interest. If the Shareholders’ Representative so desires, acting on behalf of the Company Shareholders and without the need for any consent or waiver by Company, Buyer, Merger Sub or Covington & Burling LLP (“Covington”) shall be permitted to represent the Sellers after the Closing in connection with any matter, including anything related to the transactions contemplated by this Agreement, any other agreements referenced herein or any disagreement or dispute relating thereto. Without limiting the generality of the foregoing, after the Closing, Covington shall be permitted to represent the Sellers, any of their agents and Affiliates, or any one or more of them, in connection with any negotiation, transaction, or dispute (including any litigation, arbitration, or other adversary proceeding) with Buyer, the Surviving Company, or any of their agents or Affiliates under or relating to this Agreement, any transaction contemplated by this Agreement, and any related matter, such as claims or disputes arising under other agreements entered into in connection with this Agreement, including with respect to any indemnification claims. Company, Buyer or Merger Sub further agree that, as to all communications among Covington and the Shareholders’ Representative and the Sellers, and their respective Affiliates (individually and collectively, the “Seller Group”) and/or the Company that arise out of or primarily relate to the transactions contemplated by this Agreement, the attorney-client privilege and the exception of client confidence belongs solely to the Seller Group and may be controlled only by the Seller Group and shall not pass to or be claimed by Buyer and Company, because the interests of Buyer and its Affiliates were directly adverse to Company, the Sellers and the Shareholders’ Representative at the time such communications were made. This right to the attorney-client privilege shall exist even if such communications may exist on Company’s computer system or in documents in the Company’s possession. For the avoidance of doubt, with respect to communications among Covington and the Company that do not arise out of or are not primarily related to the transactions contemplated by this Agreement, the privilege will remain with the Company. Notwithstanding the foregoing, in the event that a dispute arises between Company, Buyer or Merger Sub, on the one hand, and a Person other than a party to this Agreement, on the other hand, after the Closing, the Surviving Company may assert the attorney-client privilege to prevent disclosure to such third-party of confidential communications by Covington to the Company; provided, however, that the Company may not waive such privilege without the prior written consent of the Shareholders’ Representative.

 

Section 8.15. Transaction Costs. Except as otherwise expressly provided herein, all costs and expenses, including fees and disbursements of counsel, financial advisors, and accountants, incurred in connection with this Agreement and the Transaction shall be paid by the Party incurring such costs and expenses, whether or not the Closing shall have occurred; provided, that the Company’s costs, fees and expenses incurred in connection with the preparation of its unaudited financial statements shall be paid by the Buyer; provided, further, that the Buyer shall pay for the R&W Premium in excess of $50,000.

 

[Signature page follows]

 

 
-71-

 

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be signed by their duly authorized representatives as of the date first written above.

 

  AZURRX BIOPHARMA, INC.
       
By: /s/ James Sapirstein

 

Name:

James Sapirstein  
  Title: President & CEO  
       

 

ALPHA MERGER SUB, INC.

 

 

 

 

 

 

By:

/s/ James Sapirstein

 

 

Name:

James Sapirstein

 

 

Title:

President & CEO

 

 

 

 

 

 

FIRST WAVE BIO, INC.

 

 

 

 

 

 

By:

/s/ Gary Glick

 

 

Name:

Gary D. Glick

 

 

Title:

CEO

 

 

 

 

 

 

SHAREHOLDERS’ REPRESENTATIVE:

 

 

 

 

 

 

FORTIS ADVISORS LLC

 

 

 

 

 

 

By:

/s/ Richard Fink

 

 

Name:

Richard Fink

 

 

Title:

Managing Director

 

 

 

 

EXHIBIT 23.1

 

CONSENT OF INDEPENDENT PUBLIC ACCOUNTING FIRM

 

We consent to the incorporation by reference in the Registration Statements on Form S-1 (File Nos. 333-235768 and 333-252087), Form S-8 (File No. 333-220781) and Form S-3 (File Nos. 333-226065, 333-231035, 333-231954, 333-240129, 333-252623 and 333-256476) of AzurRx BioPharma, Inc. of our report dated August 30, 2021 with respect to the balance sheets of First Wave Bio, Inc. as of December 31, 2020 and 2019 and the related statements of operations, stockholders’ equity (deficit), and cash flows, for the years then ended, which report appears in the Form 8-K of AzurRx BioPharma, Inc. dated September 13, 2021.

 

/s/ Plante & Moran, PLLC

 

Southfield, Michigan

Consent Date

 

EXHIBIT 99.1

 

AzurRx BioPharma Announces Acquisition of First Wave Bio and its Proprietary Niclosamide Formulations Targeting Multi-Billion Dollar Inflammatory Bowel Disease Indications

 

AzurRx BioPharma to be renamed “First Wave BioPharma” and trade under new NASDAQ ticker symbol, “FWBI”

 

Three IBD clinical indications, including ulcerative colitis and Crohn’s disease, added to GI therapeutic pipeline with multiple near-term inflection points

 

Conference call scheduled for today at 8:30 a.m. ET

 

BOCA RATON, Fla., September 13, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has entered a definitive agreement to acquire First Wave Bio, Inc. (“First Wave Bio”) in a stock and cash transaction valued at $229 million, including certain development, regulatory and sales milestones. First Wave Bio is a clinical-stage biotechnology company specializing in the development of novel, gut-targeted, small molecule therapies for auto-immune inflammatory bowel diseases (IBD) and other serious conditions.

 

In conjunction with the acquisition, AzurRx announced that it is changing its corporate name to “First Wave BioPharma, Inc.” As part of the plan, First Wave BioPharma will trade its common shares on Nasdaq under the new ticker symbol, “FWBI,” which is anticipated to be effective on or about Thursday, September 23, 2021. In addition, the Company will launch a new website with the following address: www.firstwavebio.com. AzurRx’s management team, including James Sapirstein, Chairman, President, and Chief Executive Officer, will continue to lead the renamed company.

 

“The acquisition of First Wave Bio, and the creation of First Wave BioPharma, Inc. is a transformative event that significantly expands our GI development pipeline and positions our company for new growth opportunities in the inflammatory bowel disease therapeutic space,” stated Mr. Sapirstein. “Our portfolio now includes new indications for several IBDs that represent multi-billion dollar commercial market opportunities. In the U.S. last year, it is estimated that there were more than 850,000 ulcerative colitis diagnoses and 625,000 Crohn’s disease diagnoses, and these patient populations and markets are expected to grow substantially over the next decade. We believe that our proprietary formulations of niclosamide, with their novel anti-inflammatory mechanism of action, non-systemic absorption, and safety benefits, will enable us to address significant unmet clinical needs for IBD patients, especially in the mild-to-moderate disease categories. With our expanded pipeline and new IBD indications, we expect strong growth and increased shareholder value.”

 

Per the definitive agreement, AzurRx will wholly own all rights to First Wave Bio’s proprietary formulations of niclosamide, a small molecule drug which features anti-viral and anti-inflammatory properties that are designed to address multiple GI conditions. Further, AzurRx will have sole ownership of First Wave Bio’s robust intellectual property (IP) portfolio, which covers method of use and delivery of these formulations as treatments for various auto-immune, inflammatory and viral conditions.

 

In January 2021, AzurRx in-licensed from First Wave Bio the exclusive global rights to develop two niclosamide therapeutic indications – for COVID-19-related GI infections, and for immune checkpoint inhibitor-associated colitis and diarrhea (ICI-AC) in advanced stage cancer patients. Following the acquisition of First Wave Bio, AzurRx’s internal development pipeline will include three new clinical IBD indications in ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), ulcerative colitis (UC), and Crohn’s disease (CD).

 

 

 

 

James Pennington, M.D., Chief Medical Officer of AzurRx, commented, “There is a wealth of clinical data that supports the antiviral and anti-inflammatory capabilities of niclosamide. More recently, data generated by First Wave Bio in ulcerative proctitis supported the broader potential for niclosamide in multiple inflammatory bowel diseases where we believe our niclosamide formulations could offer significant advantages over other currently available treatments including steroids, 5-ASAs, and biologics – especially in the mild-to-moderate disease stage. Specifically, our niclosamide formulations are orally delivered, are targeted specifically to the areas of the GI tract where the disease-causing inflammation occurs, and avoid the risk of steroid-related immunosuppressant complications. Additionally, the manufacturing process for our niclosamide products can be scaled up to supply large populations quickly.”

 

Mr. Sapirstein commented, “I’m excited about our expanded pipeline as we move into the IBD therapeutic space. We will now be advancing a pipeline that spans six indications and includes several clinical-stage programs. These programs are all built around our two proprietary technologies -- niclosamide, and adrulipase (MS1819), which we are continuing to develop as a treatment for exocrine pancreatic insufficiency (EPI), a life-threatening digestive disorder seen in patients with cystic fibrosis and chronic pancreatitis. With multiple clinical trials advancing and others to soon initiate, along with a strong portfolio of long-lasting patents protecting niclosamide’s use for COVID-19 GI infections, ICI-AC and the IBDs, the next several years should be rich in milestones as we continue to advance our development programs, generate data, and bring new assets into the clinic.”

 

Gary D. Glick, CEO and Founder of First Wave Bio, added, “This is an exciting day. We believe the acquisition of First Wave Bio by AzurRx will unlock the value of our proprietary niclosamide formulations targeting IBD. We are confident that the AzurRx team will successfully advance these programs along their respective clinical and regulatory pathways.”

 

Pursuant to the terms of the definitive agreement, the transaction is being effected via a reverse triangular merger, and is anticipated to close imminently this morning upon receipt of evidence from the Secretary of State of the State of Delaware of the completion of certain filings relating to the merger. For a more detailed description of the terms of the First Wave Bio acquisition and the related definitive merger agreement, please see the Company’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission on September 13, 2021.

 

H.C. Wainwright & Co. acted as advisor to AzurRx in connection with the acquisition.

 

Conference Call Information:

AzurRx BioPharma (or FirstWave BioPharma) will host a conference call and live audio webcast today, September 13, 2021, at 8:30 a.m. ET, to discuss the acquisition of First Wave Bio and provide a strategic outlook for the new company, First Wave BioPharma, Inc. Interested participants and investors may access the conference call by using the following call credentials:

 

 

·

(833) 607-1647 (U.S.)

 

·

(914) 987-7760 (international)

 

·

Conference ID: 3989154

  

 

 

 

An audio webcast of the conference call will be accessible via the Investors section of the AzurRx BioPharma website (www.azurrx.com) and the First Wave BioPharma website (www.firstwavebio.com). An archive of the webcast will remain available for 90 days, beginning at approximately 10:30 a.m. ET on September 13, 2021.

 

About Niclosamide

Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used by millions of patients for several clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties.

 

About First Wave Bio, Inc.

First Wave Bio was founded to improve the lives of people living with IBD. Recent discoveries in immune cell metabolism have opened up the possibility of selectively targeting disease-causing immune cells to treat inflammatory diseases without unwanted side effects such as broad immunosuppression. First Wave Bio has developed a suite of MetaWave product candidates, gut-restricted small molecules that target the metabolism of disease-causing Th17 cells. The company’s first clinical MetaWave program, FW-424, has shown benefits for patients with mild-to-moderate ulcerative colitis in a Phase 1b/2a trial. First Wave is advancing FW-424 through additional clinical studies in patients with mild-to-moderate IBD. Given FW-424’s novel mechanisms of action and established safety profile, First Wave Bio believes that it has the potential to replace the current standard-of-care and improve the lives of patients at all stages of IBD.

 

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ: AZRX) (to be renamed “First Wave BioPharma, Inc.” with its common stock trading under new ticker symbol “FWBI” effective on or about September 23, 2021), is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. AzurRx is currently advancing a therapeutic development pipeline populated with multiple clinical stage programs built around its two proprietary technologies – niclosamide, an oral small molecule drug with anti-viral and anti-inflammatory properties, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients.  Our niclosamide portfolio is led by three clinical programs: FW-COV, for COVID-19 gastrointestinal infections; FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced stage oncology patients; and FW-UP, for ulcerative proctitis (UP) in patients with inflammatory bowel disease (IBD). Our next two IBD niclosamide programs, FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease), are planned for future pipeline development. AzurRx is also advancing adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis and chronic pancreatitis. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit www.firstwavebio.com or www.azurrx.com.

 

 

 

   

Forward-Looking Statement

This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

  

For more information:

AzurRx BioPharma, Inc.

777 Yamato Road, Suite 502

Boca Raton, FL 33431

Phone: (561) 589-7020

info@azurrx.com

 

Media contact:

Tiberend Strategic Advisors, Inc.

Johanna Bennett / David Schemelia / Ingrid Mezo

(212) 375-2665 / (609) 468-9325 / (646) 604-5150

jbennett@tiberend.com / dschemelia@tiberend.com / imezo@tiberend.com

 

 

 

EXHIBIT 99.2 

 

 

CORPORATE PRESENTATION (NASDAQ:AZRX) September 2021

 
 

 

 

 

Certain statements in this presentation constitute “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Any statements that refer to expectations or other characterizations of future events, circumstances or results are forward-looking statements. Such forward-looking statements include projections. Such projections were not prepared in accordance with public guidelines of the American Institute of Certified Public Accountants regarding projections and forecasts, nor have such projections been audited, examined or otherwise reviewed by independent auditors of the company. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company and its clinical trials to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The views expressed are those of management and are based on currently available information. Estimates and projections contained herein have been prepared by management and involve significant elements of subjective judgment and analysis and are based on certain assumptions. No representation nor warranty, expressed or implied, is made as to the accuracy or completeness of the information contained in this document, and nothing contained herein is, or shall be relied upon, as a promise or representation, whether as to the past or the future. The projections are not intended to follow generally accepted accounting principles. Neither our accountants nor our legal counsel have compiled, audited, prepared, or contributed to the projections or the underlying assumptions. None of these parties express an opinion with respect to the projections. You are cautioned not to place undue reliance on these forward-looking statements. Except for ongoing obligations of the company to disclose material information under the federal securities laws, the company does not undertake any obligation to release any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events. Company Disclaimer

 
 

 

 

 

Overview First Wave BioPharma is a clinical stage biotechnology company currently focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, with two assets and six clinical indications spanning inflammatory bowel diseases (IBD), COVID viral infections, oncology therapy induced colitis, and pancreatic digestive disorders. Niclosamide: Re-purposed small molecule drug with potent anti-viral and anti-inflammatory properties, proprietary micronized formulation COVID-19 GI infections (Phase 2 launched 1H 2021) Immune Checkpoint Inhibitor-Associated Colitis (Phase 1b/2a in 2H 2021) IBD: Ulcerative Proctitis (Phase 2 in 2H 2021) IBD: Ulcerative Colitis (Phase 1b/2a) IBD: Crohn’s Disease (Phase 2a) Adrulipase: Recombinant lipase biologic for the treatment of Exocrine Pancreatic Insufficiency (EPI) 6. EPI in Cystic Fibrosis (CF); new enteric formulation (Phase 2b in 1H 2022) Assets leverage the Company’s core competencies and expertise in developing targeted, safe, non-systemic oral GI therapies Pipeline of gut-targeted GI therapies address significant unmet medical needs in billion-dollar markets

 
 

 

 

 

Recent Developments: AzurRx BioPharma Acquires First Wave Bio First Wave BioPharma (“First Wave Bio” or “First Wave”) created through the merger of AzurRx BioPharma and First Wave Bio Total Consideration: Up to $229MM - $22MM Upfront Payment: $18MM Cash in Tranched Payments and $4MM Stock - Up to $207MM in Clinical, Regulatory and Commercial Milestone Payments Company acquires FirstWave’s robust Niclosamide IP portfolio and proprietary micronized formulations COVID-GI Infections Immune Checkpoint Inhibitor-Associated Colitis Inflammatory Bowel Diseases (IBD) Oral tablet and topical delivery mechanisms Pipeline Expansion into the Multi-Billion Dollar Mild-to-Moderate IBD Market - Ulcerative Proctitis - Ulcerative Colitis Crohn’s Disease NASDAQ “FWBI” Ticker to replace “AZRX” on Thursday, Sept. 23rd

 
 

 

 

 

First Wave BioPharma Management Team Combined Experience in Developing and Launching more than 25 Drugs Loreal McDonald General Counsel Image

 
 

 

 

 

First Wave Bio Pipeline: Five Clinical Stage Programs in 2021

 
 

 

 

 

First Wave BioPharma Clinical Pipeline Six Programs - 3 New IBD Indications NICLOSAMIDE Phase 2 Phase 1b/2a Phase 2 Phase 1 Phase 2a Phase 2 Phase 2b ADRULIPASE Phase 2b Phase 2b Phase 2

 
 

 

 

 

Expanding the GI Portfolio into IBD Multi-Billion Dollar Opportunities with Mild-to-Moderate Patients Sources: EPI: The CorStar Group 2019. Cystic Fibrosis Foundation 2020. National Pancreas Foundation 2020. COVID: Acute COVID: (35) Gut Journal: Vol 69, Issue 6: 2020; (36) Gut Journal: Vol 69, Issue 6: 2020; (37) JAMA Network: Vol 3, Issue 6: 2020; (38) Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; (40) Cheung Gastroenterology: Vol 159, Issue 1: 2020. Long COVID: Davis, Hannah E, Assaf, Gina S, et al. “Characterizing Long COVID in an International Cohort: 7 Months of Symptoms and Their Impact”. medRxiv. https://www.medrxiv.org/content/10.1101/2020.12.24.20248802v3 Dec. 27, 2020.; New York Times. (9/5/21) https://www.nytimes.com/interactive/2021/world/covid-cases.html ; https://www.businesswire.com/news/home/20210210005504/en/Global-Anti-Viral-Drug-Therapy-Market-2020-to-2030---Opportunities-and-Strategies-with-COVID-19-Implications-and-Growth---ResearchAndMarkets.com ICI-AC: Wang DY, Ye F, Zhao S, et al. Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: a systematic review and meta-analysis. Oncoimmunology 2017; 10: e1344805; Immune Checkpoint Inhibitors Market, ResearchAndMarkets.com, 2020. UP-UC: GlobalData Ulcerative Colitis Global Drug Forecast and Market Analysis to 2026: US Adults. 2018 CD: GlobalData Crohn's Disease Global Drug Forecast and Market Analysis to 2029: US. 2020

 
 

 

 

 

NICLOSAMIDE: COVID-19 GI Infections Immune Checkpoint Inhibitor - Associated Colitis IBD: Ulcerative Proctitis IBD: Ulcerative Colitis IBD: Crohn’s Disease

 
 

 

 

 

History and Safety Profile of Niclosamide FDA approved (1982) small molecule anthelmintic drug used for intestinal tapeworm infections Clean safety history Ideal profile for GI-targeted agent Low oral bio-availability with minimal systemic exposure Niclosamide inhibits pro-inflammatory pathways Non-steroidal anti-inflammatory option Opportunities for combinations with standard of care for multiple indications without systemic immunosuppression

 
 

 

 

 

Proprietary Micronized Formulations: Potentially Transformative Efficacy Micronized niclosamide – a transformative treatment for multiple GI indications: Reduced particle size (~7 ) compared to regular non-micronized (~60 ) niclosamide Smaller particles have greater surface to solvent (GI fluids) ratio Improved dissolution: broader distribution and higher local GI concentrations Not systemically absorbed Preclinical studies confirm higher GI concentrations (~200x) with micronized niclosamide Micronized formulation, similar to non-micronized niclosamide, is not systemically absorbed (animal studies) Historically clean safety profile Avoids steroid-related complications; non-immunosuppressant

 
 

 

 

 

FW-COV: Treating COVID-19 GI Infections

 
 

 

 

 

COVID-19: The Medical Problem of our time Urgent Need for Treatment of Acute and Long COVID-19 GI Infections Gastrointestinal Infections with COVID-19: Symptoms include severe diarrhea, vomiting, and abdominal pain Possible reservoir for recurrence and/or fecal spread ACE2, entry receptor for COVID-19, is highly expressed on GI cells No treatment for COVID diarrhea currently available Urgent need to reduce hospital burden of patients and potential hospital spread The Potential Solution: A targeted drug to destroy COVID-19 in the gut that is fast-acting and can be administered in an out-patient setting 18% of patients experienced GI symptoms 48% of patients’ stool samples were virus RNA positive Sources: Acute COVID: (35) Gut Journal: Vol 69, Issue 6: 2020; (36) Gut Journal: Vol 69, Issue 6: 2020; (37) JAMA Network: Vol 3, Issue 6: 2020; (38) Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; (40) Cheung Gastroenterology: Vol 159, Issue 1: 2020. Long COVID: Davis, Hannah E, Assaf, Gina S, et al. “Characterizing Long COVID in an International Cohort: 7 Months of Symptoms and Their Impact”. medRxiv. https://www.medrxiv.org/content/10.1101/2020.12.24.20248802v3 Dec. 27, 2020. ~10% of COVID patients after 6 months Acute COVID Long COVID ~60% of these patients report GI symptoms - diarrhea

 
 

 

 

 

Acute and Long COVID GI Infections: A Significant Unmet Clinical Need Unreported COVID Cases Could be up to 3x Higher1 in the U.S. Alone Sources: 1 Crist, Carolyn. “Study: COVID Cases have Been ‘Severely Undercounted’. WebMD. Feb.10,2021 2 New York Times. (9/5/21) https://www.nytimes.com/interactive/2021/world/covid-cases.html 3 (35) Gut Journal: Vol 69, Issue 6: 2020; (36) Gut Journal: Vol 69, Issue 6: 2020; (37) JAMA Network: Vol 3, Issue 6: 2020; (38) Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; (40) Cheung Gastroenterology: Vol 159, Issue 1: 2020. 4 Davis, Hannah E, Assaf, Gina S, et all. “Characterizing Long COVID in an International Cohort: 7 Months of Symptoms and Their Impact”. medRxiv. https://www.medrxiv.org/content/10.1101/2020.12.24.20248802v3 Dec. 27, 2020. Note: AzurRx Management’s Calculations in Blue

 
 

 

 

 

Micronized Niclosamide: The Potential Key to Killing COVID-19 in the GI Tract Advantages of Micronized Niclosamide for Treatment of COVID-19 Diarrhea: Niclosamide: Best activity against COVID-19 in Institut Pasteur Korea screen Mechanism of Action: Induces ‘autophagy’ in COVID-infected cells, reduces COVID propagation Local GI niclosamide concentration now reaches levels needed to kill COVID-19 (confirmed in animal study) Animal study shows micronization does not lead to systemic absorption Low COGS and scalable manufacturing are attractive

 
 

 

 

 

COVID GI Infection: Reservoir Trial Phase 2 Reservoir trial initiated in April 2021 Data Monitoring Committee (DMC) approved initiation of Part 2 150 patient efficacy study in U.S., Ukraine and India in Sept. 2021 Topline data anticipated in Q1 2022 Potential Emergency Use Authorization (EUA)

 
 

 

 

 

FW-ICI-AC: Immune Checkpoint Inhibitor-Associated Colitis

 
 

 

 

 

Use of ICIs Lead to Recurrent Diarrhea and Colitis Treating with Systemic Immunosuppressants Reduces Progression Free Survival Unmet Clinical Need for a Non-Steroidal Treatment Option Unmet Clinical Need for Treatment for Grade 1 Diarrhea Unmet Clinical Need for an Outpatient Therapy - current treatments involve hospital-based infusions of biologics or IV-steroids Immune Checkpoint Inhibitor-Associated Colitis “Patients on ICI therapy who develop diarrhea require prompt evaluation to assess disease activity and risk of progression. Treatment should be started promptly, as the colitis can quickly progress in severity and potential death. A low threshold for hospitalization should be used for patients with grade 3 or 4 diarrhea.” Emanuelle Bellaguarda, MD and Stephen Hanauer, MD. Am J Gastroenterology 2020;115:202–210

 
 

 

 

 

Immune Checkpoint Inhibitor-Associated Colitis is Progressive Throughout the Duration of Checkpoint Therapy Source: ASCO 2018 Guideline Management of ICI-Associated Colitis

 
 

 

 

 

Diarrhea and Colitis are Common ICI-associated Adverse Events 2018 (Wang) and 2019 (Som) Data Source: Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418 Percentage ranges of all grade immune-related common adverse events by checkpoint inhibitor class CTLA-4: Cytotoxic T-lymphocyte-associated antigen 4: PD-1: Programmed cell death protein 1; PD-L1: Programmed death-ligand 1; ALT: Alanine aminotransferase Source: “Time to onset of colitis is within weeks. Patients with ICPI-induced diarrhea or colitis have improved survival outcomes.” Wang et al., J Immunother Cancer. 2018; 6: 37.

 
 

 

 

 

The Potential Solution: A gut targeted drug to treat the colitis with little or no systemic bioavailability that could counteract the activity of the ICI Niclosamide has the potential to prevent GI disease damage and stop disease progression to colitis in patients on ICIs by attacking the cell populations in the colon that cause this problem Agent can induce (with fast onset of action) and maintain long term remission GI-targeted Reduces systemic immune suppression Reduces off-target adverse effects Functions through clinically validated mechanisms Mitigates pathogenic lamina propria T cells Decreases the production of pro-inflammatory cytokines Enables Outpatient Treatment - may reduce hospital admissions for ICI-induced diarrhea Breakthrough Designation Potential - increases the therapeutic window for checkpoint inhibitors and the population of patients who benefit from checkpoint inhibitors.

 
 

 

 

 

Phase 1b-2a ICI-AC: Passport Trial Number of subjects/sites: Stage 1: 12 patients (safety) Stage 2: 90 patients (safety and efficacy) Timeline: IND submitted August 31 ~18 Months Enrollment

 
 

 

 

 

IBD Opportunity

 
 

 

 

 

Inflammatory Bowel Disease (IBD) Affects 3 million people in the U.S.1 Two major types of IBD Ulcerative colitis (UC) Ulcerative Proctitis-Sigmoiditis (subgroup of ulcerative colitis) Crohn’s Disease (CD) UC is 3 times more prevalent than CD Similarities between UC and CD Immunopathology Clinical signs and symptoms (abdominal pain, diarrhea, fever, anemia, weight loss) Equal distribution between males and females Differences between UC and CD UC limited to colon; CD patchy through-out colon and small intestine UC more responsive to medical treatment CD requires surgery more often 1 https://www.cdc.gov/ibd/data-statistics.htm

 
 

 

 

 

IBD Patient Diagnosed Prevalence and ICI-AC Eligibility (2020-2032) Source: (23) GlobalData Ulcerative Colitis Global Drug Forecast and Market Analysis to 2026: US Adults. 2018. GlobalData Men and Women >= 18 years old patient forecasts from 2020-2029 were projected out to 2032 using a 3 year moving average. Source: (25) GlobalData Crohn's Disease Global Drug Forecast and Market Analysis to 2029: US. 2020.

 
 

 

 

 

Treatments for IBD Ulcerative Colitis Mild disease: sulfasalazines; 5-ASAs (mesalamine) Moderate: steroids (budesonide; prednisone); azathioprine; 6-mercaptopurine; methotrexate Severe: Anti-TNF; Entyvio; Xeljanz; Stelara Crohn’s Disease Mild/Moderate: steroids Moderate/Severe: Anti-TNF; Entyvio; Stelara; Tysabri

 
 

 

 

 

Many Patients with Mild-to-Moderate UC Have Inadequate Response to First Line Therapy * Am. J. Gastroenterol. 2012;107:167, Gastroenterology 2019;156:769 DIAGNOSIS Doctors diagnose patient with mild-to-moderate UC TREAT Treat patient with 5-ASA (oral, rectal, or both together) in the hope of inducing and maintaining remission FAIL Remission fails to occur in patients all too often NEXT STEPS Patient with moderate-to-severe UC is treated with corticosteroids, anti-TNF therapy, or other agents—all of which have significant systemic side effects SURGERY Patients who fail to respond to corticosteroids, anti-TNF’s, or other agents —or who become dependent on corticosteroids—may require colectomy (a major surgical procedure) to treat the disease ~58% fail remission with oral 5-ASA* ~50% fail remission with rectal 5-ASA* Mild-to-Moderate UC Moderate-to-Severe UC

 
 

 

 

 

Role for Niclosamide in IBD Pharmacology ideal for local bowel disease; not absorbed from GI tract Mechanism of action is to impair oxidative phosphorylation; i.e. how cells make energy. Pathogenic Th17 cells have overly active oxidative phosphorylation; niclosamide down regulates this over active cell. In vitro (cells from bowel wall of IBD patients); and in vivo (animal models of IBD) experiments demonstrate niclosamide provides beneficial effects. Preliminary data from human study of niclosamide in ulcerative proctitis show promising results Initial clinical trials of niclosamide in IBD will target mild or moderate non-responders to conventional therapy. Goal is to prevent advanced disease requiring more toxic immunosuppressive agents.

 
 

 

 

 

UP-UPS: Clinical remission efficacy with topical rectal niclosamide formulation superior to budesonide in Low Dose Phase 1b/2a Trial Clinical remission efficacy of 59% compares favorably to steroids as 2nd line therapy in mild-to-moderate Ulcerative Colitis (UC) Remission rate for budesonide in Ulcerative Proctitis (UP)/Ulcerative Proctosigmoiditis (UPS) is 38-44% Steroid use lowers patients’ ability to fight infections and leads to complications including bleeding, nausea, heartburn, and headaches Treatment-emergent adverse event (TEAE) reported in 35% (6/17 subjects) All but 1 TEAE was mild No serious or drug-related TEAEs First Ever Proof of Principle for Treatment of IBD with Niclosamide

 
 

 

 

 

Ulcerative Proctitis ICI-Associated Colitis Ulcerative Proctosigmoiditis Pancolitis Rationale for using Oral and/or Topical Niclosamide to Treat ICI-AC, Ulcerative Proctitis and Ulcerative Colitis (Pancolitis) Rectal Enema Oral Capsule, Rectal Enema, or Both Oral Capsule

 
 

 

 

 

Ulcerative Colitis: The launch of new novel medications for the treatment UC is the primary driver in the expected increase in sales Market Projections: Ulcerative Colitis Sales by Severity (in dollars) 23 (Estimated sales of ulcerative colitis medications for American adults by severity year over year) Source: (23) GlobalData Ulcerative Colitis Global Drug Forecast and Market Analysis to 2026: US Adults. 2018. Mild to Moderate Prevalence is 84% of all UC Patients; 86% of UC Market Size

 
 

 

 

 

CD sales expected to increase by nearly 50% according to market projections Market Projections: Crohn’s Disease Sales by Severity (in dollars) 25 (Estimated sales of Crohn’s Disease medications for American adults by severity year over year) Source: (25) GlobalData Crohn's Disease Global Drug Forecast and Market Analysis to 2029: US. 2020. Mild to Moderate Prevalence is 76% of all CD Patients; 58% of UC Market Size

 
 

 

 

 

ADRULIPASE: Exocrine Pancreatic Insufficiency in Cystic Fibrosis & Chronic Pancreatitis

 
 

 

 

 

Recombinant lipase for treatment of Exocrine Pancreatic Insufficiency (EPI) Targeting patients with Cystic Fibrosis (CF) and Chronic Pancreatitis (CP) Addressing established global market (>$2 billion) (1) Recombinant alternative to porcine pancreatic enzyme replacement therapy (PERT) Clear unmet medical need Demonstrated safety and efficacy profile in two Phase 2 clinical trials in two indications Pursuing parallel monotherapy and combination therapy clinical pathways Topline Phase 2b CF monotherapy data announced in Q1 2021 Topline Interim Phase 2 CF combination (MS1819 + PERT) therapy data announced in Q3 2021; final Clinical Study Reports in Q4 2021 New enteric granule formulation being developed, Phase 2b trial in 1H 2022 (1) The CorStar Group 2019. Symphony Health 2019. ADRULIPASE: MS1819 Clinical Program

 
 

 

 

 

Sources: The CorStar Group 2019. Cystic Fibrosis Foundation 2020. National Pancreas Foundation 2020. Exocrine Pancreatic Insufficiency (EPI) A chronic nutritional deficiency – the pancreas is damaged and does not produce the digestive enzymes needed to break up food in the GI tract so that nutrients can be absorbed

 
 

 

 

 

Large Established U.S. Market Of ~$1.6 Billion(1) All lipase products are pig derived and are less active at the pH in humans resulting in a large pill burden $ in millions 1,094 980 633 455 1,222 844 CAGR ~17% 1,391 1,503 1,608 Sources: Global Market Size: Symphony Health 2019. The CorStar Group (2019). U.S. Market Size: Creon 2013-2020 AbbVie 10-K’s, 2021 Mgmt. Estimate; Zenpep, Allergan 2014-2020 10-Ks, 2021 Mgmt. Estimate; Vivus and Pertzye.

 
 

 

 

 

Sources: Results from the Company’s clinical trials, internal studies and management estimates. Adrulipase: Fulfilling an Unmet Medical Need Differentiated mechanism of action No dose-limiting safety issues to date on ~100 patients

 
 

 

 

 

Lessons Learned From the MS1819 Program and Next Steps Four Phase 2 Studies to Date: Phase 2 CP Phase 2a CF Monotherapy (OPTION) Phase 2b CF Monotherapy (OPTION 2) Phase 2 CF Combination Therapy (MS1819 + PERT) Product has evidence of lipase activity Product shows dose-response in chronic pancreatitis Combination therapy with commercial PERT shows clinically meaningful improvement for less controlled patients with Severe EPI in cystic fibrosis Safety is excellent at all doses studied Despite lack of protease, CNAs are consistently >80% Current powder formulation in immediate release or enteric capsules is not sufficient to obtain consistent CFAs >80% Formulation with good gastric dispersion plus gastric acid protection logical next step Next Steps: Enteric Microgranule Formulation Development Phase 2b FW-EPI Monotherapy Trial 1H 2022

 
 

 

 

 

Intellectual Property Investment Highlights

 
 

 

 

 

Robust IP Portfolio (2021-2041) Key Patents Secure for the next 15-20 years NICLOSAMIDE U.S. Patent 8,334,130 Clinical Exclusivity Novel Biologics (EMA – 10 years)* ADRULIPASE Hatch-Waxman PTE (up to 5 years)* U.S. Patent 10,292,951 U.S. Patent 10,980,756   U.S. 16/842,695 Europe/ROW PCT/FR2006/001352 Clinical Exclusivity Novel Biologics (FDA - 12 years)* U.S. Patent 10,772,854 U.S. Patent 10,744,103 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 * Anticipated

 
 

 

 

 

Overview First Wave BioPharma is a clinical stage biotechnology company currently focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, with two assets and six clinical indications spanning inflammatory bowel diseases (IBD), COVID viral infections, oncology therapy induced colitis, and pancreatic digestive disorders. Niclosamide: Re-purposed small molecule drug with potent anti-viral and anti-inflammatory properties, proprietary micronized formulation COVID-19 GI infections (Phase 2 launched 1H 2021) Immune Checkpoint Inhibitor-Associated Colitis (Phase 1b/2a in 2H 2021) IBD: Ulcerative Proctitis (Phase 2 in 2H 2021) IBD: Ulcerative Colitis (Phase 1b/2a) IBD: Crohn’s Disease (Phase 2a) Adrulipase: Recombinant lipase biologic for the treatment of Exocrine Pancreatic Insufficiency (EPI) 6. EPI in Cystic Fibrosis; new enteric formulation (Phase 2b in 1H 2022) Assets leverage the Company’s core competencies and expertise in developing targeted, safe, non-systemic oral GI therapies Pipeline of gut-targeted GI therapies address significant unmet medical needs in billion-dollar markets

 
 

 

EXHIBIT 99.3

 

Business Update

 

As a result of the Merger, the Company provided the following business update:

 

Overview

 

We are engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases. Non-systemic therapies are non-absorbable drugs that act locally, i.e. in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation.

 

We are currently focused on developing our pipeline of gut-restricted GI clinical drug candidates, including niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic adrulipase (formerly MS1819), a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients.

 

Our niclosamide programs leverage proprietary oral and topical formulations to address multiple GI conditions, including inflammatory bowel diseases (“IBD”) indications and viral diseases. We are currently advancing three separate clinical programs of our niclosamide formulations, including FW-COV for Severe Acute Respiratory Syndrome Coronavirus 2 (“COVID-19”) GI infections, FW-ICI-AC for Immune Checkpoint Inhibitor-associated colitis (“ICI-AC”) and diarrhea in advanced stage oncology patients, and FW-UP for ulcerative proctitis (“UP”) and ulcerative proctosigmoiditis (“UPS”). We are further developing two pre investigational new drug (“IND”) programs of our niclosamide therapies for additional IBD indications, including FW-UC for ulcerative colitis (“UC”) and FW-CD for Crohn’s disease (“CD”).

 

Our adrulipase programs are focused on the development of an oral, non-systemic, biologic capsule for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis (“CF”) and chronic pancreatitis (“CP”). Our goal is to provide CF and CP patients with a safe and effective therapy to control EPI that is non-animal derived and offers the potential to dramatically reduce their daily pill burden.

 

We are developing our drug candidates for a host of GI diseases where there are significant unmet clinical needs and limited therapeutic options, resulting in painful, life threatening and discomforting consequences for patients. Our mission is to help protect the health and restore quality of life for the millions of people afflicted by these GI diseases.

 

Each drug candidate and clinical program is described below.

 

Niclosamide

 

Niclosamide, a pro-inflammatory pathway inhibitor, is a prescription small molecule drug that has been safely used on millions of patients. Niclosamide is listed as an essential medicine by the World Health Organization (WHO). In the U.S., niclosamide was approved by the United States Food and Drug Administration (“FDA”) in 1982 for the treatment of intestinal tapeworm infections. Niclosamide’s activity as an antihelminthic results from direct action in the intestinal lumen where it disrupts parasitic metabolic function called oxidative phosphorylation, killing parasites. Niclosamide has been commercially available worldwide for more than 50 years as 500mg single-dose tablets intended for use in pediatric and adult populations, at a dose rate of 2g per adult or child over six years of age. No safety issues have ever been identified. In addition to its antihelminthic activity, niclosamide has novel anti-inflammatory and anti-viral properties.

 

We believe niclosamide, and more specifically our proprietary and patent-pending micronized niclosamide formulation, has the potential to be an ideal therapeutic to treat multiple GI indications due to the following favorable properties: (i) it has a reduced particle size (D(90) between 5 and 9 µM) as compared to regular non-micronized niclosamide (approximately D(90) ≥ 60µM) with greater surface to solvent ratio, (ii) low oral bio-availability with minimal systemic absorption / exposure, (iii) improved dissolution with broader distribution allowing for higher local GI concentrations (up to approximately 200 times based on preclinical study results), and (iv) it exhibits anti-inflammatory effects while avoiding steroid-related complications and adverse events.

 

 

 

 

FW-COV Program for COVID-19 GI infections

 

We are developing FW-COV, a small molecule micronized niclosamide in an oral immediate release tablet formulation as treatment for SARS-CoV-2 intestinal infection. The formulation to be used has been milled (micronized) to allow superior dissolution in the gut fluids. This in turn allows local niclosamide concentrations to reach anti-viral levels. Thus, FW-COV has the potential to benefit COVID-19 patients by decreasing viral load in the GI tract, treating infection symptoms and preventing transmission of the virus through fecal spread. Evidence of niclosamide’s antiviral properties is sufficient to expect a clinical pharmacodynamic response against viral replication and clinical benefit, justifying the proposed clinical study in COVID-19 patients and favorable benefit-risk assessment.

 

An IND for FW-COV micronized niclosamide for COVID-19 GI infections was cleared by the FDA in September 2020. In April 2021, we initiated our Phase 2 RESERVOIR clinical trial for the treatment of COVID-19 related GI infections. The Phase 2 RESERVOIR clinical trial is a two-part, two-arm, randomized, placebo-controlled study examining the safety and efficacy of micronized oral niclosamide tablets in patients with COVID-19 GI infection. The two primary objectives of the RESERVOIR trial are to confirm the safety of niclosamide in the treatment of patients with COVID-19 GI infection and to demonstrate efficacy in clearing the SARS-CoV-2 virus from the GI tract.

 

Part 1 of the trial studied 9 patients with COVID-19 and had diarrhea. Patients were randomized (2:1 niclosamide:placebo), treated for 14 days and observed closely for any signs of safety issues. In September 2021, we announced positive results from an independent Data Monitoring Committee review of the interim safety data, which approved initiating patient enrollment in Part 2.

 

Part 2 of the trial will study approximately 150 patients in the U.S., Ukraine and India with mild or moderate COVID-19. Patients will be randomized to either niclosamide, 400 mg tablets, three times a day, or placebo tablets three times a day. After 14 days of treatment, patients will be taken off study drugs and remain on study observation for up to 6 months.

 

The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six months. These long-term observation data could indicate that niclosamide treatment has the potential to improve ‘long haul’ COVID-19 symptoms. Topline data from the RESERVOIR trial is expected in the first half of 2022.

 

FW-ICI-AC Program for Immune Checkpoint Inhibitor-associated Colitis (ICI-AC)

 

Immune checkpoint inhibitors (“ICIs”) are monoclonal antibodies that target down-regulators of the anti-cancer immune response and have revolutionized the treatment of a variety of malignancies. The global market for ICIs in in 2019 was estimated to be over $22 billion and growing rapidly. Approximately 44% of patients with advanced cancer tumors, or about 260,000 patients, are eligible to receive ICIs.

 

However, many immune-related adverse events, especially diarrhea and colitis, limit the use of ICIs. While Grade 1 colitis (less than four stools per day) is treated symptomatically as outpatients, about 30% or more of patients with Grade 1 colitis progress to Grade 2 or worse. Those patients must be taken off the ICI being used for the treatment of their cancer. Also, they receive aggressive immunosuppressive therapies, further aggravating their underlying cancer.

 

The incidence of immune-mediated colitis (“IMC”) ranges from 1% to 25% depending on the type of ICI and whether they are used in combination. Approximately 30% of ICI patients develop diarrhea, which can progress to colitis. The onset of diarrhea in ICI-AC patients occurs within six to seven weeks and progressively worsens, and the progression to colitis is rapid and unpredictable. For example, in patients taking ipilimumab (Yervoy), between 25% and 30% of patients developed diarrhea and approximately 8% to 12% developed colitis. Moreover, the trend is towards the use of combination ICI therapies (e.g. Yervoy and Opdivo) which may lead to a concomitant increase in both diarrhea and colitis.

 

Administration of corticosteroids, or treatment with certain immunosuppressive biologics, while withholding ICI therapy are recommended for Grade 2 or more severe ICI-AC. The impact of this colitis complication and the withholding of treatment may reduce the goal of progression free cancer survival. An oral, non-absorbed treatment, such as niclosamide, for Grade 1 or Grade 2 colitis (diarrhea) may prevent progression of ICI-AC. We believe there currently is no approved treatment for Grade 1 colitis.

 

 

 

  

FW-ICI-AC is a niclosamide-based small molecule anti-inflammatory inhibitor therapy which we intend to use for the treatment of immune checkpoint inhibitor-associated colitis and diarrhea in advanced stage cancer patients.  FW-ICI-AC will be supplied in two formulations, as an oral immediate-release tablet and as a topical rectal enema. The standard care for treating IBD, such as UC and CD, are corticosteroids and aminosalicylic acids or 5-ASAs, which can cause problems when used for checkpoint inhibitor patients due to their immunosuppressant effects.  FW-ICI-AC has the potential to safely treat Grade 1 ICI colitis and diarrhea and prevent its progression to more serious and potentially fatal later stages. The overall goal of early niclosamide treatment is to enable oncology patients to remain on their ICI treatment without interruption.

 

In September 2021, we submitted an IND application to the FDA to commence our Phase 1b/2a PASSPORT ICI-AC clinical trial using both an oral immediate-release tablet and a topical rectal enema formulations of niclosamide for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with ICIs. We plan to initiate the 1b/2a PASSPORT ICI-AC trial in the U.S. following FDA clearance of the IND application as early as the fourth quarter of 2021.

 

The primary objective of our planned Phase 1b/2a PASSPORT trial of niclosamide is to determine the safety, and potential efficacy of niclosamide in treatment of ICI-AC. The trial will be in two parts. Part 1 will study 12 patients with ICI-AC using oral niclosamide or oral plus niclosamide enemas, treated for two weeks. If deemed safe, Part 2 will study 90 patients in three arms (30 patients per arm), treated for two weeks. One arm will receive oral niclosamide three times daily, another arm will receive placebo three times daily. These two arms will be blinded. The third arm will employ oral niclosamide, three times daily, plus niclosamide enemas, twice daily. The primary efficacy endpoint for Part 2 will be time needed to resolve the diarrhea. Important secondary endpoints will be sparing of steroids, prevention of progression of disease and recurrence of diarrhea.

 

FW-UP Program for Ulcerative Proctitis (UP) and Ulcerative Proctosigmoiditis (UPS)

 

UP and UPS are two types of UC, a chronic inflammatory bowel disease consisting of fine ulcerations in the inner mucosal lining of the large intestine that do not penetrate the bowel muscle wall. UPS causes inflammation in the colon and rectum, while UP is confined only to the rectum. Symptoms include weight loss, fatigue, abdominal pain and cramps, rectal pain and bleeding, and diarrhea, although constipation can also develop as the body struggles to maintain normal bowel function. UP and UPS affect approximately 200,000 patients in the U.S. annually.

 

UP and UPS can occur at any point throughout life, with a high occurrence in young children and then again around 40-50 years of age. Progression of this disease to ulcerative colitis, extending farther up the bowel to involve the sigmoid colon, occurs in about 30-50% of patients. UP and UPS allow convenient clinical management and observation by local sigmoidoscopy Although there is a range of treatments to help ease symptoms and induce remission, there is no cure.

 

We are developing FW-UP, a niclosamide-based, small molecule anti-inflammatory inhibitor therapy in enema formulation for the treatment of UP and UPS. FW-UP is currently being investigated in a three stage Phase 1b/2a clinical trial in Europe to study the safety and potential efficacy of niclosamide in patients with UP and UPS.

 

Stage 1 of the trial studied 17 subjects with UP who had failed first line therapy with 5-ASAs, and were treated for six weeks with low dose FW-UP niclosamide rectal enemas twice a day. Preliminary results demonstrated that FW-UP niclosamide enemas were well tolerated, with a durable therapeutic effect. The efficacy endpoint was to achieve a clinical remission, defined as a Modified Mayo Score of 2 or less. A clinical remission rate of 59% was achieved which is higher than currently approved second line therapy with budesonide (38% to 44%).

 

Stage 2 of the trial is designed to study a higher dose of niclosamide enema twice daily for six-weeks. Initially, four subjects have been enrolled open label to ensure tolerability of the higher dose, which was well tolerated. Stage 2 will include approximately 28 more subjects in a placebo-controlled study, which we expect to begin enrollment in the first half of 2022. Upon completion of Stage 2, we will assess overall dose response, efficacy and tolerability.

 

Stage 3 of the trial will be an adaptively designed stage based upon the results obtained from Stage 2.

 

 

 

 

Adrulipase Program for Exocrine Pancreatic Insufficiency (EPI)

 

Adrulipase, a recombinant lipase enzyme for the treatment of EPI associated with CF and CP, is supplied as an oral capsule. Adrulipase is derived from the yeast Yarrowia lipolytica and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the adrulipase lipase does not contain any animal products.

 

EPI is a condition characterized by deficiency of exocrine pancreatic enzymes, primarily lipase, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency of these enzymes can be responsible for greasy diarrhea, fecal urge, abdominal pain and weight loss. We believe that there are two principal therapeutic indications for EPI compensation by adrulipase: (i) children and adults affected by CF, and (ii) adult patients with CP. There are more than 30,000 patients with EPI caused by CF according to the Cystic Fibrosis Foundation and there are approximately 90,000 patients in the U.S. with EPI caused by CP according to the National Pancreas Foundation. The digestive standard of care for both CF and CP patients with EPI are commercially available porcine pancreatic enzyme replacement (“PERT”) pills.

 

We have determined to initially pursue the indication for adults in CF.

 

Completed Phase 2 OPTION Bridging Dose Monotherapy Study

 

In October 2018, the FDA cleared our IND application for adrulipase in patients with EPI due to CF. In connection with the FDA’s clearance of the IND, we initiated a multi-center Phase 2 bridging dose safety study in the fourth quarter of 2018 in the U.S. and Europe (the “OPTION Bridging Dose Study”). We targeted enrollment of 30 to 35 patients, ages 18 or older, and in September 2019, we announced positive results from the OPTION Bridging Dose Study on 32 patients.

 

Results showed that the primary efficacy endpoint of coefficient of fat absorption (“CFA”) was comparable to the CFA in a prior Phase 2a study in patients with CP, while using the same dosage of adrulipase. The dosage used in the OPTION Bridging Dose Study was 2.2 grams per day, which was determined in agreement with the FDA as a bridging dose from the highest safe dose used in the Phase 2a CP dose escalation study. Although the OPTION Bridging Dose Study was not powered for statistical significance, we believe the data demonstrated meaningful efficacy results, with approximately 50% of the patients showing CFA high enough to reach non-inferiority with standard PERTs. Additionally, the coefficient of nitrogen absorption (“CNA”) was comparable between the adrulipase and PERT arms, 93% vs. 97%, respectively, in the OPTION Bridging Dose Study. This important finding confirms that protease supplementation is not likely to be required with adrulipase treatment.

 

Ongoing Phase 2b OPTION 2 Monotherapy Trial

 

In October 2019, the Cystic Fibrosis Foundation Data Safety Monitoring Board (the “CFF DSMB”) completed its review of our final results of the OPTION Bridging Dose Study. It found no safety concerns for adrulipase, and supported our plan to proceed to a higher 4.4 gram dose of adrulipase with enteric (delayed release) capsules in multi-center dose escalation Phase 2b clinical trial (the “OPTION 2 Trial”). In December 2019, we submitted the clinical trial protocol for the OPTION 2 Trial to the existing IND at the FDA. The clinical trial protocol was reviewed by the FDA with no comments. In April 2020, we received approval to conduct the OPTION 2 Trial in Therapeutics Development Network clinical sites in the U.S. as well as Institutional Review Board (“IRB”) approval to commence the OPTION 2 Trial.

 

The OPTION 2 Trial was designed to investigate the safety, tolerability and efficacy of adrulipase (2.2 gram and 4.4 gram doses in enteric capsules) in a head-to-head manner versus the current standard of care, PERT pills. The OPTION 2 Trial was an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. Enrollment included a total of 26 CF patients 18 years or older. Adrulipase was administered in enteric capsules to provide gastric protection and test for optimal delivery of enzyme to the duodenum. Patients were initially randomized into two cohorts: to either the adrulipase arm, where they received a 2.2 gram daily oral dose of adrulipase for three weeks; or to the PERT arm, where they received their pre-study dose of PERT pills for three weeks. After three weeks, stools were collected for analysis of CFA. Patients were then crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools were again collected for analysis of CFA. A parallel group of patients were randomized and studied in the same fashion, using a 4.4 gram daily dose of adrulipase. All patients were followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients were assessed using descriptive methods for efficacy, comparing CFA between adrulipase and PERT arms, and for safety.

 

 

 

 

In November 2020, we announced that we would submit protocol amendment request to the FDA for the OPTION 2 Trial to add a study arm utilizing immediate release adrulipase capsules. In January 2021, we announced that we had initiated the additional study arm. This extension phase tested patients 18 years or older, who had already completed the cross-over phase, with immediate release capsules at higher 4.4 and 6.6 gram doses relative to the 2.2 gram capsules previously used in the OPTION Bridging Dose Study. The purpose of the additional study arm was to allow us to compare data from the existing crossover arm using enteric (delayed release) capsules with data from the new extension arm, to help us identify the optimal dose and delivery method for adrulipase.

 

In March 2021, we announced topline data results from the OPTION 2 Trial. The data demonstrated adrulipase to be safe and well-tolerated. In addition, we believe the data from the OPTION 2 Trial also demonstrates meaningful drug activity, as was also the case with our OPTION Bridging Dose Study and a prior Phase 2a study in patients with CP, and also with the interim data in our ongoing Combination Trial (as defined and discussed in further detail below). However, patients in the OPTION 2 Trial did not consistently meet the primary efficacy endpoint. Some patients were able to achieve CFA at levels beyond what is required to demonstrate non-inferiority with PERT therapies, but the majority did not. As such, we did not meet our primary endpoint for the trial.

 

We expect to receive the final clinical study report for the OPTION 2 Trial in the fourth quarter of 2021.

 

We believe that the underlying cause of the adrulipase’s uneven efficacy performance in the OPTION 2 Trial lies with the enteric capsule formulation. While we believe the enteric capsule protected the lipase from breaking down in the stomach acid, the trial data suggests the enteric capsule may dissolve too slowly in the small intestine to release the lipase enzyme in time to aid with proper digestion and nutrient absorption.

 

As a result, we have announced plans to develop a new formulation for adrulipase, employing a capsule filled with acid-resistant granules, or microbeads, similar to what is used in CREON®, ZENPEP® and other PERT therapies. These beads will be placed into immediate release capsules that are intended to dissolve in the stomach, dispersing the beads, which should then pass through to the small intestine and break down, releasing the lipase enzyme so that it thoroughly mixes with food as it is being digested.

 

We are currently working with contract manufacturers to develop this new formulation. If successfully developed, we plan to initiate a further Phase 2 bridging study in the first half of 2022 to evaluate the new formulation’s efficacy, without substantially delaying our development efforts in other areas.

 

Ongoing Phase 2 Combination Therapy Trial

 

In addition to the CF monotherapy studies, we launched a Phase 2 multi-center clinical trial (the “Combination Trial”) in Europe (Hungary and Turkey) to investigate the safety, tolerability and efficacy of escalating doses of adrulipase, in combination with PERT, in order to increase CFA levels and relieve abdominal symptoms in CF patients who suffer from severe EPI and continue to experience clinical symptoms of fat malabsorption despite taking the maximum daily dose of PERTs.

 

Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, approximately 25-30% of CF patients do not achieve normal absorption of fat with PERTs. Achieving an optimal nutritional status, including normal fat absorption levels, in CF patients is important for maintaining better pulmonary function, physical performance and prolonging survival. Furthermore, a decline of body mass index around the age of 18 years predicts a substantial drop in lung function. We believe a combination therapy of PERT and adrulipase has the potential to: (i) correct macronutrient and micronutrient maldigestion; (ii) eliminate abdominal symptoms attributable to maldigestion; and (iii) sustain optimal nutritional status in CF patients with severe EPI.

 

 

 

 

The Combination Trial enrolled 20 patients, 12 years of age or older, with severe EPI, with CFA levels less than 80%, at clinical sites in Hungary and Turkey. We dosed the first patients in the Combination Trial in Hungary in October 2019. Patients enrolled in the study received escalating doses of 700mg, 1200mg, and 2240mg of adrulipase daily for 15 days per dosing level, in addition to their standard PERT dose. Baseline CFA was established by measuring CFA levels while on standard of care therapy only, before beginning combination therapy. The primary efficacy endpoint of the trial is improvement in CFA; secondary endpoints of the study are improvements in the stool weight, stool consistency, number of bowel movements, the incidence of steatorrhea, and increase of body weight.

 

We announced positive interim data on the first five patients in the Combination Trial in August 2020. The primary efficacy endpoint was met, with CFAs greater than 80% for all patients across all visits. For secondary efficacy endpoints, we observed that stool weight decreased, the number of stools per day decreased, steatorrhea improved, and body weight increased. Additionally, no serious adverse events were reported. In October 2020, we opened a total of five clinical sites in Turkey and dosed the first patients in November 2020.

 

In May 2021, we announced positive interim data from the first 18 out of 20 patients in our Phase 2 Combination Trial evaluating adrulipase in combination with PERT, the current standard of care, for the treatment of severe EPI in CF patients.

 

In August 2021, we announced positive full topline results from all 20 patients enrolled in the Combination Trial. Data collected from the 20 patients indicated that adrulipase in combination with PERT led to clinically meaningful improvements in the primary efficacy endpoint, the CFA, with an average gain of more than six percentage points from baseline. According to the clinical literature, a five-point improvement in CFA is considered clinically significant.

 

We expect to receive the final clinical study report for the Combination Trial in the fourth quarter of 2021.

 

Product Programs

 

Our current therapeutic product pipeline consists of four clinical-stage programs and two pre-IND programs, each of which are described below.

 

Niclosamide

 

Niclosamide, a pro-inflammatory pathway inhibitor, is a prescription small molecule drug that has been safely used on millions of patients. Niclosamide is listed as an essential medicine by the World Health Organization (WHO). In the U.S., niclosamide was approved by the FDA in 1982 for the treatment of intestinal tapeworm infections. Niclosamide’s activity as an antihelminthic result from direct action in the intestinal lumen where it disrupts parasite oxidative metabolism, killing parasites. Niclosamide has been commercially available worldwide for more than 50 years as 500mg tablets intended for use in pediatric and adult populations, at a dose of 2g per adult or child over six years of age per day. No safety issues have ever been identified. In addition to its antihelminthic activity, niclosamide has novel anti-inflammatory and anti-viral properties.

 

We believe niclosamide, and more specifically the patented and proprietary micronized niclosamide formulation developed by First Wave, has the potential to be an ideal therapeutic to treat multiple GI indications due to the following favorable properties: (i) it has a reduced particle size ((D(90) between 5 and 9 µM) as compared to regular non-micronized niclosamide (approximately D(90) ≥ 60µM) with greater surface to solvent ratio, (ii) low oral bio-availability with minimal systemic absorption / exposure, (iii) improved dissolution with broader distribution allowing for higher local GI concentrations (up to approximately 200 times based on preclinical study results), and (iv) it exhibits anti-inflammatory effects while avoiding steroid-related complications and adverse events.

 

Scientific Background

 

Recent discoveries in immune cell metabolism suggest that it is possible to selectively target disease-causing immune cells to treat inflammatory diseases without unwanted side effects such as broad immunosuppression. Research indicates that IBD, including ulcerative colitis, ulcerative proctitis/proctosigmoiditis and Crohn’s disease, is driven by pathogenic Th17 cells, which release a cascade of local cytokines that in turn cause inflammation in bowel wall tissues.

 

 

 

 

Th17 cells rely on a cellular process called oxidative phosphorylation to survive. Niclosamide is known to disrupt the oxidative phosphorylation in the mitochondria of pathogenic Th17 cells in a manner that selectively induces apoptosis of pathogenic Th17 cells, overcoming their inherent resistance to cell death. This effect is mild enough that it does not interfere with normal cells. By killing Th17 cells, niclosamide may reduce inflammation and calm the gut, selectively killing pathogenic, inflammatory cells while leaving healthy cells untouched.

 

Numerous cell culture studies using cells obtained by biopsy of inflamed bowel tissues from IBD patients, and also in animal models of IBD, have demonstrated beneficial effects of niclosamide.

 

Our suite of proprietary, gut-restricted niclosamide product candidates are designed to target the metabolism of disease-causing Th17 cells to potentially halt or delay the progression of disease, stop flare-ups, and address patient needs at all stages of IBD, from mild to severe, and for cancer patients with ICI-AC.

 

Inflammatory Bowel Disease (IBD) Background

 

IBD is an umbrella term used to describe disorders that involve chronic inflammation of the digestive track. IBD affects approximately 3 million people in the U.S. annually. IBD is divided into two main classes of gastrointestinal inflammatory diseases: (i) ulcerative colitis (UC), including ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), and (ii) Crohn’s Disease (CD). There are similarities between UC and CD, such as immunopathology, and equal distribution between males and females. However, there are also notable differences. UC is generally limited to the colon, while CD may occur anywhere in the small or large intestine. UC usually affects continuous mucosal surfaces, while CD is patchier, with areas of normal bowel mucosa separating the inflammatory patches. Importantly, CD often involves deep bowel tissues and can lead to fistulas into the abdominal cavity or out to the skin surface. CD requires surgical intervention more often than UC. While medical treatments for UC and CD are generally similar, CD is much less responsive.

 

FW-COV Program for COVID-19 GI infections

 

The COVID-19 pandemic is a global public health emergency caused by the SARS-CoV-2 virus. An increasing volume of convergent evidence indicates that GI infection and fecal-oral transmission of SARS-CoV-2 are important factors in the clinical presentation, virology and epidemiology of COVID-19. There is currently no etiological treatment for COVID-19 GI effects. We believe our FW-COV micronized niclosamide formulation will be the only one being tested in clinical trials for a COVID-19 GI indication. Given the potentially critical role of COVID-19 GI infections we believe there is a clear unmet therapeutic need.

 

Drug repurposing and/or repositioning aimed at identifying new therapeutic applications for existing clinically approved drugs is a critical strategy to accelerate drug discovery for the COVID-19 pandemic. Multiple companies and laboratories have identified and validated niclosamide to have potent antiviral activity against SARS-CoV-2.

 

A study published in July 2020 in Antimicrobial Agents and Chemotherapy, an American Society for Microbiology journal (Jeon et. Al, 2020) examined a small set (n=49) of FDA-approved drugs that were selected based on either having known activity against SARS-CoV or being recommended by infectious disease experts for activity against the SARS-CoV-2 virus. Results from this study indicated that niclosamide was the most potent of all agents tested in a Vero cell cytopathic assay with an IC50 value of 0.28 µM. For comparison, in terms of potency, niclosamide out-performed reference compounds chloroquine, lopinavir, and remdesivir with IC50 values of 7.28, 9.12, and 11.41 µM, respectively. IC50 is a quantitative measure that indicates how much of a particular inhibitory substance (e.g. a drug) is needed to inhibit, in vitro, a given biological process or biological component by fifty percent. Thus, niclosamide is approximately 40-fold more potent in vitro than VEKLURY® (remdesivir), an antiviral drug marketed by Gilead Sciences Inc. that received FDA approval in October 2020 for use in adult and pediatric patients for the treatment of COVID-19 requiring hospitalization.

 

Following oral administration, niclosamide is poorly absorbed, which results in a majority of the administered dose remaining in the GI tract. We believe this basic property of niclosamide, when combined with micronized niclosamide in the drug product to accelerate dissolution, allows this drug product to achieve pharmacologically effective concentrations of niclosamide in the GI tract while having almost no bioavailability, potentially enhancing efficacy and safety. We believe these properties make our micronized niclosamide formulation an ideal and differentiated therapeutic for treating COVID-19 infections and GI symptoms.

 

 

 

 

There are multiple other late-stage clinical trials evaluating the standard (non-micronized) formulation of niclosamide in COVID-19. We believe this further indicates that available data on niclosamide’s antiviral properties against SARS-CoV-2 is considered by others to be sufficient to proceed with clinical testing.

 

Evidence of niclosamide’s antiviral properties is sufficient to expect a clinical pharmacodynamic response against viral replication and clinical benefit, justifying the proposed clinical study in COVID-19 patients and favorable benefit -risk assessment.

 

In April 2021, we initiated our Phase 2 RESERVOIR clinical trial for the treatment of COVID-19 related GI infections. The Phase 2 RESERVOIR clinical trial is a two-part, two-arm, randomized, placebo-controlled study examining the safety and efficacy of micronized oral niclosamide tablets in patients with COVID-19 GI infection. The two primary objectives of the RESERVOIR trial will be to confirm the safety of niclosamide in the treatment of patients with COVID-19 GI infection and to demonstrate efficacy in clearing the SARS-CoV-2 virus from the GI tract.

 

Part 1 of the trial studied 9 patients with COVID-19 and GI positive stool or rectal swabs for SARS-CoV-2. Patients were treated for 14 days and observed closely for any signs of safety issues. In September 2021, we announced positive results from an independent Data Monitoring Committee review of the interim safety data, which approved initiating patient enrollment in Part 2.

 

Part 2 of the trial will study approximately 150 patients in the U.S., Ukraine and India in outpatient care setting with COVID-19 and PCR positive stool or rectal swabs for SARS-CoV-2. Patients will be randomized to either niclosamide, 400 mg tablets, three times a day, or placebo tablets three times a day. After 14 days of treatment, patients will be taken off study drugs and remain on study observation for up to 6 months (long-term observation).

 

The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS-CoV-2 virus clearance (stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm. The long-term observation data could indicate that niclosamide treatment has the potential to improve ‘long haul’ COVID-19 symptoms. Topline data from the RESERVOIR trial is expected in the first half of 2022.

 

FW-ICI-AC for Immune Checkpoint Inhibitor Colitis (ICI-AC)

 

Immune checkpoint inhibitors (“ICIs”) are monoclonal antibodies that target down-regulators of the anti-cancer immune response and have gained increasing popularity and have revolutionized the treatment of a variety of malignancies. However, many immune-related adverse events, especially diarrhea and colitis, limit their use. A 2019 study titled, “Immune checkpoint inhibitor-induced colitis: A comprehensive review,” published in World Journal of Clinical Cases (Sol et.al, 2019) estimated the incidence of IMC ranges from 1% to 25% depending on the type of ICI and whether they are used in combination. A 2017 study titled “Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: a systematic review and meta-analysis” published in Oncoimmunology (Wang et.al, 2017) estimated that approximately 44%, or 260,000 patients with advanced and metastatic tumors were eligible to receive ICIs. Further, approximately 30% of ICI patients develop diarrhea, which can progress to colitis. The onset of diarrhea in ICI-AC patients occurs within six to seven weeks and progressively worsens, and the progression to colitis is rapid and unpredictable.

 

In patients taking Yervoy® (ipilimumab) marketed by Bristol Myers Squibb, between 25% to 30% developed diarrhea and approximately 8% to 12% developed colitis, as reported in a peer-reviewed article, “Immune-checkpoint inhibitor-induced diarrhea and colitis in patients with advanced malignancies: retrospective review at MD Anderson” published in the Journal for ImmunoTherapy of Cancer (Wang et. al,, 2018). Moreover, there is a treatment trend towards the use of combination ICI therapies (for example combining Yervoy® and Opdivo®), which is believed to lead to a concomitant increase in both diarrhea and colitis.

 

 

 

 

We believe there currently is no approved treatment for Grade 1 colitis. The recommended treatment for Grade 2 or more severe colitis is administration of corticosteroids, or treatment with certain immunosuppressive biologics, while withholding ICI therapy (National Cancer Institute, 2020). The impact of this colitis complication and treatment may reduce the goal of progression free cancer survival. We believe there is an unmet medical need and an oral, non-absorbed therapeutic, such as our FW-ICI-AC niclosamide, for Grade-1 colitis (diarrhea) may prevent progression to Grade 2 or more severe disease.

 

In September 2021, we submitted an IND application to the FDA to commence our Phase 1b/2a PASSPORT ICI-AC clinical trial using both an oral immediate-release tablet and a topical rectal enema formulations of niclosamide for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with ICIs. We plan to initiate the 1b/2a PASSPORT ICI-AC trial in the U.S. following FDA clearance of the IND application as early as the second half of 2021.

 

The primary objective of our planned Phase 1b/2a PASSPORT trial of niclosamide is to determine the safety, and potential efficacy of niclosamide in treatment of ICI-AC. The trial will be in two parts. Part 1 will study 12 patients with ICI-AC using oral niclosamide or oral plus niclosamide enemas, treated for two weeks. If deemed safe, Part 2 will study 90 patients in three arms (30 patients per arm), treated for two weeks. One arm will receive oral niclosamide three times daily, another arm will receive placebo three times daily. These two arms will be blinded. The third arm will employ oral niclosamide, three times daily, plus niclosamide enemas, twice daily. The primary efficacy endpoint for Part 2 will be time needed to resolve the diarrhea. Important secondary endpoints will be sparing of steroids, prevention of progression of disease and recurrence of diarrhea.

 

FW-UC for Ulcerative Colitis (UC)

 

UC is an IBD that causes inflammation and ulcers (sores) in the digestive tract. UC generally affects the innermost lining of the large intestine (colon). UC affects approximately 830,000 patients in the U.S. annually and approximately 84% or 700,000 have mild to moderate disease.The immunopathology of UC is complex and is generally considered to be caused by a dysregulated immune system. There is evidence that a hereditary trait is involved. While the cause is not known, most researchers now feel that invasive bacteria or virus in the bowel wall sets off an abnormal response by local T lymphocytes. Normally, a subgroup of lymphocytes called Th17 cells protect the bowel wall from microbial invaders. However, in patients with UC, these Th17 cells become pathogenic and release a cascade of local cytokines, which in turn cause inflammation in bowel wall tissues. This persistent inflammation causes tissue damage, and clinical symptoms. Clinical symptoms include abdominal pain, diarrhea, which is sometimes bloody, intermittent fever, anemia, and weight loss, and symptoms usually develop over time, rather than suddenly.

 

Severity of UC is generally classified as mild, moderate or severe. Mild disease is treated by sulfasalazine and 5-ASA’s, most commonly mesalamine. These may be given orally or rectally and are modestly potent anti-inflammatory agents. While inexpensive and well tolerated, only about 50% of UC patients will maintain a clinical response to these agents. Non-responders or relapsers will progress to moderate or even severe disease.

 

Patients failing on 5-ASA’s are usually placed onto steroid therapy, such as budesonide or prednisone, risking the well-known side effects of steroids. Failing, or not tolerating steroids leads to treatment with much more potent and expensive immunosuppressive agents such as anti-TNFs, or newer agents such as Entyvio or Xeljanz. We believe there is a clear unmet medical need for a well-tolerated, effective therapeutic for patients who fail first line treatment with 5-ASAs.

 

Our initial clinical trial in UC involves patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), which is currently in a Phase 1b/2a clinical trial.

 

We intend to commence the clinical development of FW-UC, an oral immediate-release tablet in a Phase 1 clinical trial for subjects with UC as early as the second half of 2022, subject to successful results from Stage 2 of the FW-UP Phase 1b/2a clinical trial.

 

FW-UP for Ulcerative Proctitis (UP) and Ulcerative Proctosigmoiditis (UPS)

 

UP and UPS, are two types of UC, a chronic inflammatory bowel disease consisting of fine ulcerations in the inner mucosal lining of the large intestine that do not penetrate the bowel muscle wall. UPS causes inflammation in the colon and rectum, while UP is confined only to the rectum. Symptoms include weight loss, fatigue, abdominal pain and cramps, rectal pain and bleeding, and diarrhea, although constipation can also develop as the body struggles to maintain normal bowel function. UP and UPS affect approximately 200,000 patients in the U.S. annually.

 

 

 

 

UP and UPS can occur at any point throughout life, with a high occurrence in young children and then again around 40-50 years of age. Progression of this disease to ulcerative colitis, extending farther up the bowel to involve the sigmoid colon, occurs in about 30-50% of patients. UP and UPS allow convenient clinical management and observation by local sigmoidoscopy. Although there is a range of treatments to help ease symptoms and induce remission, there is no cure.

 

We are developing FW-UP, a niclosamide-based, small molecule anti-inflammatory inhibitor therapy in enema formulation for the treatment of UP and UPS. FW-UP is currently being investigated in a three-stage Phase 1b/2a clinical trial study in Europe to study the safety and potential efficacy of niclosamide in patients with UP and UPS. The limited local disease in rectum and rectosigmoid areas allow for convenient topical therapy.

 

Stage 1 of the trial studied 17 subjects with UP who had failed first line therapy with 5-ASAs, and were treated for six weeks with low dose FW-UP niclosamide rectal enemas twice a day. Preliminary results demonstrated that FW-UP niclosamide enemas were well tolerated, with a durable therapeutic effect. The efficacy endpoint was to achieve a clinical remission, defined as a Modified Mayo Score of 2 or less. A clinical remission rate of 59% was achieved which is higher than currently approved second line therapy with budesonide (38% to 44%).

 

Stage 2 of the trial is designed to study a higher dose of niclosamide enema twice daily for six-weeks. Initially, four subjects have been enrolled open label to ensure tolerability of the higher dose, which was well tolerated. Stage 2 will include approximately 28 more subjects in a placebo-controlled study, which we expect to begin enrollment in the first half of 2022. Upon completion of Stage 2, we will assess overall dose response, efficacy and tolerability.

 

Stage 3 of the trial will be an adaptively designed stage based upon the results obtained from Stage 2.

 

FW-CD for Crohn’s Disease (CD)

 

While the immunopathology of CD resembles that of UC, the location of disease, the response to treatment and the overall morbidity are different, as CD is more difficult to manage. Patient response to standard therapy is more variable than in UC, thus making clinical management more challenging. In UC, a reasonably clear course of disease from mild to moderate severity can be predicted based upon response to first line treatment. In CD, first line treatment often includes more immunosuppressive agents, such as steroids, immunomodulators, and anti-TNF agents as compared to the 5-ASAs used for first line in UC.

 

CD affects approximately 660,000 patients in the U.S. annually and approximately 76% or 500,000 have mild to moderate disease. We believe FW-CD, an oral niclosamide-based small molecule anti-inflammatory inhibitor therapy can be an important therapeutic in the treatment of mild to moderate CD, with the goal of reducing steroid and immunomodulators treatments.

 

We intend to commence clinical development of FW-CD in a Phase 2a clinical trial as early as 2024, subject to the successful completion of a FW-UC Phase 1 clinical trial.

 

Adrulipase

 

Adrulipase is the active pharmaceutical ingredient (“API”), derived from Yarrowia lipolytica, an aerobic yeast naturally found in various foods such as cheese and olive oil that is widely used as a biocatalyst in several industrial processes. Adrulipase is a secreted lipase naturally produced by Yarrowia lipolytica, known as LIP2, that we are developing through recombinant DNA technology for the treatment of EPI associated with CF and CP. Lipases are enzymes that help with the digestion of lipids and fat.

 

We previously held the exclusive right to commercialize adrulipase in the U.S., Canada, South America (excluding Brazil), Asia (excluding China and Japan), Australia, New Zealand and Israel pursuant to a sublicense from Laboratories Mayoly Spindler SAS (“Mayoly”) under the JDLA (as defined below), which also granted us joint commercialization rights for Brazil, Italy, China and Japan. In March 2019, we purchased all rights, title and interest in and to adrulipase from Mayoly pursuant to the Mayoly APA (as defined below), providedhowever, Mayoly retained exclusive commercial rights in France and Russia.

 

 

 

 

Background

 

The pancreas is both an endocrine gland that produces several important hormones, including insulin, glucagon, and pancreatic polypeptide, as well as a digestive organ that secretes pancreatic juice containing digestive enzymes that assist the absorption of nutrients and digestion in the small intestine.

 

The targeted indication of adrulipase is the compensation of EPI, which is observed when the exocrine functions of the pancreas are below 10% of normal. The symptomatology of EPI is essentially due to the deficiency of pancreatic lipase, an enzyme that hydrolyses triglycerides into monoglycerides and free fatty acids. The pancreatic lipase enzymatic activity is hardly compensated by extra-pancreatic mechanisms, because gastric lipase has nearly no lipolytic activity in the pH range of the intestine. On the other hand, when they are impaired, the pancreatic amylase and protease (enzymes that break up carbohydrates (starches) and proteins, respectively) activities can be compensated by the salivary amylase, the intestinal glycosidase, the gastric pepsin, and the intestinal peptidases, all of which are components of the gastric juice secreted by the stomach walls. Lipid maldigestion due to lipase deficiency is responsible for weight loss, steatorrhea featured by greasy diarrhea, and fat-soluble vitamin deficiencies (i.e. A, D, E and K vitamins).

 

CP, the most common cause of EPI, is a long-standing inflammation of the pancreas that alters its normal structure and functions. In the U.S., its prevalence rate is of 42 cases per 100,000 inhabitants, resulting in approximately 132,000 cases. Approximately 60% of patients affected with CP display EPI, resulting in approximately 90,000 patients requiring substitution therapy in the U.S. In Western societies, CP is caused by chronic alcoholic consumption in approximately 55-80% of cases. Other relatively frequent etiologies include the genetic form of the disease that is inherited as an autosomal dominant condition with variable penetrance, pancreatic trauma and idiopathic causes.

 

CF, another dominant etiology of EPI, is a severe genetic disease associated with chronic morbidity and life-span decrease of most affected individuals. In most Caucasian populations, CF prevalence is of 7-8 cases per 100,000 inhabitants, but is less common in other populations, resulting in more than 30,000 affected individuals in the U.S. and more than 70,000 affected individuals worldwide. CF is inherited as monogenic autosomal recessive disease due to the defect at a single gene locus that encodes the Cystic Fibrosis Transmembrane Regulator protein, or CFTR, a regulated chloride channel. Mutation of both alleles of this chloride channel gene results in the production of thick mucus, which causes a multisystem disease of the upper and lower respiratory tracts, digestive system, and the reproductive tract. The progressive destruction of the pancreas results in EPI that is responsible for malnutrition and contributes to significant morbidity and mortality. About 80-90% of patients with CF develop EPI, resulting in approximately 25,000-27,000 patients in the U.S. that require substitution therapy.

 

Current treatments for EPI stemming from CP and CF rely on porcine (pig derived) pancreatic enzyme replacement therapies (PERTs), which have been on the market since the late 1800s. PERTs are typically comprised of three digestive enzymes; lipases, proteases, and amylases. The PERT market is well established with estimated sales of approximately $1.4 billion in 2019 in the U.S. and has been growing for the past five years at a compound annual growth rate of approximately 20%. In spite of their long-term use, however, PERTs suffer from poor stability, formulation problems, possible transmission of conventional and non-conventional infectious agents due to their animal origins, and possible adverse events at high doses in patients with CF and limited effectiveness.

 

History of the Program

 

In 1998, Mayoly, a European pharmaceutical company focusing primarily on gastroenterology disorders, launched a program for the discovery and characterization of novel lipases of non-animal origin that could be used in replacement therapy for EPI. The program was conducted in collaboration with INRA TRANSFERT, a subsidiary of the French academic laboratory, Institut National de la Recherche Agronomique, or National Institute for Agricultural Research (“INRA”). In 2000, Mayoly and INRA discovered that the yeast Yarrowia lipolytica secreted a lipase named LIP2. During the ensuing years, Mayoly investigated the in vitro enzymatic activities of LIP2 in collaboration with the Laboratory of Enzymology at Interfaces and Physiology of Lipolysis, a French public-funded research laboratory at the French National Scientific Research Centre laboratory (“CNRS”), which focuses on the physiology and molecular aspects of lipid digestion.

 

 

 

 

Pre-Clinical Program

 

The efficacy of adrulipase has been investigated in normal minipigs, which are generally considered as a relevant model for digestive drug development when considering their physiological similarities with humans and their omnivore diet. Experimental pancreatitis was induced by pancreatic duct ligation, resulting in severe EPI with baseline CFA around 60% post-ligature. CFA is a measurement obtained by quantifying the amount of fat ingested orally over a defined time period and subtracting the amount eliminated in the stool to ascertain the amount of fat absorbed by the body. Pigs were treated with either adrulipase or enteric-coated PERTs, both administered as a single-daily dose.

 

At doses ranging from 10.5 to 211 mg, adrulipase increased the CFA by +25 to +29% in comparison to baseline (p<0.05 at all doses), whereas the 2.5 mg dose had milder activity. Similar efficacy was observed in pigs receiving 100,000 U lipase of enteric-coated porcine pancreatic extract. These findings demonstrate the in vivo activity of adrulipase in a relevant in vivo model at a level similar to the PERTs at dosages of 10.5mg or greater.

 

To date, two non-clinical toxicology studies have been conducted. Both show that adrulipase lipase is clinically well tolerated at levels up to 1000mg/kg in rats and 250 mg/kg in minipigs up to 13 weeks. Adrulipase is therefore considered non-toxic in both rodent and non-rodent species up to a maximum feasible dose of 1,000 mg/kg/day in the rats over six months of administration.

 

Clinical Program

 

We believe that there are two principal therapeutic indications for EPI compensation by adrulipase: (i) children and adults affected by CF, and (ii) adult patients with CP. We have determined to initially pursue the indication for adults first in CF.

 

During 2010 and 2011, a phase 1/2a clinical trial of adrulipase was conducted in conjunction with Mayoly in a single center in France. The study was an exploratory study mainly designed to investigate the safety of adrulipase and was a randomized, double blind, placebo controlled, parallel clinical trial in 12 patients affected with CP or pancreatectomy and severe EPI. The primary efficacy endpoint of the study was defined as the relative change in steatorrhea (an established surrogate biomarker of EPI correction) in comparison to baseline. The study found that adrulipase was well tolerated with no serious adverse events. Only two adverse events were observed: constipation (two patients out of eight with adrulipase) and hypoglycemia (two patients out of eight with adrulipase, and one patient out of four with placebo). A non-statistically significant difference of the primary endpoint, possibly due to the small group size, was found between the two groups both in intention-to-treat, a group that included three patients who received the in-patient facility study diet but did not fulfill the protocol’s inclusion criteria, and per-protocol analysis. This study was not designed, nor did it aim, to demonstrate statistically significant changes of CFA or steatorrhea under adrulipase.

 

We received regulatory approval in Australia and New Zealand in 2016, with the addition of a 2018 regulatory approval in France, to conduct a Phase 2 multi-center dose escalation study of adrulipase in CP and pancreatectomy. The primary endpoint of this study was to evaluate the safety of escalating doses of adrulipase in 11 CP patients. The secondary endpoint was to investigate the efficacy of adrulipase in these patients by analysis of the CFA and its change from baseline. In September 2018, we announced that in pre-planned analyses, both the study’s primary and secondary endpoints were reached with a statistically significant (p=0.002) improvement in the CFA of 21.8%, in a per protocol analysis, with the highest evaluated dose of 2,240 mg/day of adrulipase. Statistical significance of the trial results is typically based on widely used, conventional statistical methods that establishes the p-value of the results. A p-value of 0.05 or less is required to demonstrate statistical significance. As such, these CFA levels are considered to be statistically significant.

 

In October 2018, the FDA cleared our IND application for adrulipase in patients with EPI due to CF. In December 2018, we initiated the Phase 2 OPTION Bridging Dose Study to investigate adrulipase in CF patients with EPI and in February 2019, we dosed the first patients. The Phase 2 OPTION Bridging Dose Study investigated the safety, tolerability and efficacy of adrulipase in a head-to-head comparison against the current PERT standard of care. The OPTION Bridging Dose Study employed a six-week non-inferiority CFA primary efficacy endpoint comparing adrulipase to PERTs.

 

 

 

 

In September 2019, we announced positive results from the OPTION Bridging Dose Study. Results showed that the primary efficacy endpoint of CFA was comparable to the CFA in a prior Phase 2 study in patients with CP, while using the same dosage of adrulipase. The dosage used in the OPTION Bridging Dose Study was 2.2 grams per day, which was determined in agreement with the FDA as a bridging dose from the highest safe dose used in the Phase 2 CP dose escalation study. Although the study was not powered for statistical significance, the data demonstrated meaningful efficacy results, with approximately 50% of the patients showing CFAs high enough to reach non-inferiority with standard PERTs. Additionally, the CNA was comparable between the adrulipase and PERT arms, 93% vs. 97%, respectively, in the OPTION Bridging Dose Study. This important finding confirms that protease supplementation is not likely to be required with adrulipase treatment. A total of 32 patients, ages 18 or older, completed the OPTION Bridging Dose Study.

 

In October 2019, the CFF DSMB completed its review of our final results of the OPTION Bridging Dose Study and found no safety concerns for adrulipase and supported our plan to proceed to the Phase 2b OPTION 2 Trial. In December 2019, we submitted the clinical trial protocol to the existing IND at the FDA, which has been reviewed by the FDA with no comments. In April 2020, we received approval to conduct the OPTION 2 Trial in Therapeutics Development Network clinical sites in the U.S. as well as IRB approval to commence the OPTION 2 Trial.

 

The OPTION 2 Trial was designed to investigate the safety, tolerability and efficacy of adrulipase (2.2 gram and 4.4 gram doses in enteric capsules) in a head-to-head manner versus the current standard of care, PERT pills. The OPTION 2 Trial was an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. Enrollment included a total of 26 CF patients 18 years or older.  Adrulipase was administered in enteric capsules to provide gastric protection and test for optimal delivery of enzyme to the duodenum.  Patients were first randomized into two cohorts: to either the adrulipase arm, where they received a 2.2 gram daily oral dose of adrulipase for three weeks; or to the PERT arm, where they received their pre-study dose of PERT pills for three weeks. After three weeks, stools were collected for analysis of CFA. Patients were then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools were again be collected for analysis of CFA. A parallel group of patients were randomized and studied in the same fashion, using a 4.4 gram daily dose of adrulipase. All patients were followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients were assessed using descriptive methods for efficacy, comparing CFA between adrulipase and PERT arms, and for safety.

 

In January 2021, we announced an additional study arm in OPTION 2 Trial using an immediate release adrulipase capsules in order to identify the optimal dose and delivery method of adrulipase. This extension phase tested patients 18 years or older, who have already completed the crossover phase, at higher doses relative to the previously conducted OPTION Bridging Dose Study, this allowed us to compare data from the existing crossover arm using enteric (delayed release) capsules with data from the new extension arm, and ultimately select the optimal delivery method for a pivotal Phase 3 clinical trial.

 

In March 2021, we announced topline data results from the OPTION 2 Trial. The data demonstrated adrulipase to be safe and well-tolerated. In addition, we believe the data from the OPTION 2 Trial also demonstrates meaningful drug activity, as was also the case with our OPTION Bridging Dose Study and a prior Phase 2a study in patients with CP, and also with the interim data in our ongoing Combination Trial. However, patients in the OPTION 2 Trial did not consistently meet the primary efficacy endpoint. Some patients were able to achieve CFA at levels beyond what is required to demonstrate non-inferiority with PERT therapies, but the majority did not. As such, we did not meet our primary endpoint for the trial.

 

We believe that the underlying cause of the adrulipase’s uneven efficacy performance in the OPTION 2 Trial lies with the enteric capsule formulation. While we believe the enteric coating protects the capsule from breaking down in the stomach acid, the trial data suggests it may dissolve too slowly in the small intestine to release the lipase enzyme in time to aid with proper digestion and nutrient absorption.

 

As a result, we have announced plans to develop a new formulation for adrulipase, employing a capsule filled with acid-resistant granules, or microbeads, similar to what is used in CREON®, ZENPEP® and other PERT therapies. These beads will be placed into immediate release capsules that are intended to dissolve in the stomach, dispersing the beads, which should then pass through to the small intestine and break down, releasing the lipase enzyme so that it thoroughly mixes with food as it is being digested.

 

 

 

  

We are currently working with contract manufacturers to develop this new formulation. If successfully developed, we plan to initiate a further Phase 2 bridging study in the first half of 2022 to evaluate the new formulation’s efficacy, without substantially delaying our development efforts in other areas.

 

We launched the Phase 2 Combination Trial in Hungary in July 2019 to investigate adrulipase in combination with PERT, for CF patients who suffer from severe EPI, but continue to experience clinical symptoms of fat malabsorption despite taking the maximum daily dose of PERTs. The Combination Trial was designed to investigate the safety, tolerability and efficacy of escalating doses of adrulipase (700 mg, 1120 mg and 2240 mg per day, respectively), in conjunction with a stable dose of PERTs, in order to increase CFA and relieve abdominal symptoms. In October 2020, we opened a total of five clinical sites in Turkey and dosed the first patients in November 2020. In March 2021, we reached targeted enrollment of 18 patents.

 

In August 2021, we announced positive full topline results from all 20 patients enrolled in the Combination Trial. Data collected from the 20 patients indicated that adrulipase in combination with PERT led to clinically meaningful improvements in the primary efficacy endpoint, the CFA, with an average gain of more than six percentage points from baseline. According to the clinical literature, a five-point improvement in CFA is considered clinically significant.

 

We believe a combination therapy of PERT and adrulipase has the potential to: (i) correct macronutrient and micronutrient maldigestion; (ii) eliminate abdominal symptoms attributable to maldigestion; and (iii) sustain optimal nutritional status on a normal diet in CF patients with severe EPI.

 

Intellectual Property

 

Our goal is to obtain, maintain and enforce patent protection for our drug candidates, formulations, processes, methods and any other proprietary technologies, preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the United States and in other countries. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our current drug candidates and any future drug candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the United States and abroad. However, patent protection may not afford us with complete protection against competitors who seek to circumvent our patents.

 

We also depend upon the skills, knowledge, experience and know-how of our management and research and development personnel, as well as that of our advisors, consultants and other contractors. To help protect our proprietary know-how, which is not patentable, and for inventions for which patents may be difficult to enforce, we currently rely and will in the future rely on trade secret protection and confidentiality agreements to protect our interests. To this end, we require all of our employees, consultants, advisors and other contractors to enter into confidentiality agreements that prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.

 

Niclosamide

 

Our FW-ICI-AC, FW-UP, FW-UC and FW-CD niclosamide programs are protected by patent filings that include the following:

 

US10,912,746; US10,905,666; US10,292,951; US10,772,854; US10,744,103; US10,799,468; US10,849,867; and related continuation applications as well as corresponding worldwide patent filings all entitled “Methods and Compositions for Treating Conditions Associated with an Abnormal Inflammatory Process.” The expiration date of the issued patents is September 1, 2036; and

 

A PCT International application filed in 2021 directed to methods for treating conditions characterized by an abnormal inflammatory response such as an autoimmune disorder, colitis, autoimmune colitis, an inflammatory bowel disease, Crohn’s disease and ulcerative colitis. Any national designated patent application from this filing upon issuance will have an expected expiration in 2041.

 

 

 

 

Our FW-COV niclosamide programs are protected by patent filings that include the following:

 

US10,980,756 and corresponding PCT International and foreign patent applications directed to the use of niclosamide for the treatment of COVID-19 gastrointestinal infections. The expiration of the issued patent is March 31, 2040.

 

Adrulipase

 

The adrulipase program is protected by the following issued patents that we have licensed under the Mayoly Agreement:

 

PCT/FR2006/001352 patent family (including the patent EP2035556 and patent US8,334,130 and US8,834,867) “Method for producing lipase, transformed Yarrowia lipolytica cell capable of producing said lipase and their uses” describes a method for producing Yarrowia lipolytica acid-resistant recombinant lipase utilizing a culture medium without any products of animal origin or non-characterized mixtures such as tryptone, peptone or lactoserum, in addition to its uses. The European patents expire June 15, 2026, U.S. patent 8,334,130 expires September 11, 2028, and U.S. patent 8,834,867 expires September 15, 2026.

 

In addition, a PCT International application was filed in 2021 directed to our proprietary formulation of FW-EPI. Any national designated patent application from this filing upon issuance will have an expected expiration in 2041.

 

Manufacturing

 

We currently outsource all manufacturing, and we intend to use our collaborators and contract development and manufacturing organizations (CDMOs) for the foreseeable future. However, certain members of our team have broad experience in manufacturing, which we believe may provide a competitive advantage.

 

Niclosamide

 

Niclosamide API is obtained by chemical synthesis and is currently manufactured by Olon SpA at a facility in Murcia, Spain. Niclosamide drug product is currently manufactured at a contract facility located in Milan, Italy owned by Monteresearch and at a contract facility located in Tianjin, China owned by Asymchem. We believe there are multiple alternative contract manufacturers capable of producing the product we need for clinical trials; however, there is no guarantee that the processes are easily reproducible and transferrable.

 

Adrulipase

 

Adrulipase API is obtained by fermentation in bioreactors using our engineered and proprietary Yarrowia lipolytica strain. The proprietary yeast cell line from which the API is derived is kept at a storage facility maintained by Charles River. Adrulipase drug substance is currently manufactured at a contract facility located in Capua, Italy owned by Olon SpA. Adrulipase drug product is currently manufactured at a contract facilities located in Reims, France and Craigavon, United Kingdom owned by Delpharm and Almac Pharma Services. We believe there are multiple alternative contract manufacturers capable of producing the product we need for clinical trials. We are in the process of establishing alternative manufacturers and manufacturing sites for the product; however, there is no guarantee that the processes are easily reproducible and transferrable. In December 2020, we entered into a master service agreement with Asymchem to initiate the transfer of the manufacturing process for API, drug substance and drug product.

 

 

 

 

Competition

 

The pharmaceutical and biotechnology industries are characterized by rapidly evolving technology and intense competition. Many companies of all sizes, including major pharmaceutical companies and specialized biotechnology companies, are engaged in the development and commercialization of therapeutic agents designed for the treatment of the same diseases and disorders that we target. Many of our competitors have substantially greater financial and other resources, larger research and development staff and more experience in the regulatory approval process. Moreover, potential competitors have or may have patents or other rights that conflict with patents covering our technologies.

 

Niclosamide

 

With respect to FW-COV, our oral micronized formulation of niclosamide for COVID-19 GI infections, if approved, will compete with currently approved antivirals, including VEKLURY® (remdesivir) marketed by Gilead Sciences, Inc. and vaccines, including those marketed by Pfizer Inc. and BioNTech SE, Moderna, Inc. Johnson & Johnson and AstraZeneca plc. There are also several therapeutic and vaccine candidates in various stages of development that may obtain regulatory approval for the treatment or prevention of COVID-19 infections. Additionally, there are currently ongoing clinical studies using niclosamide by ANA Therapeutics (acquired by NeuroBo Pharmaceuticals, Inc.), Daewoong Pharmaceuticals Co Ltd, and Union Therapeutics A/S, among others at various stages of development. We believe our approach to target COVID-19 GI infections is differentiated. We believe our ability to compete in this market, if we are successful in developing and obtaining regulatory approval to market FW-1022, will depend on our ability (or that of future corporate partners) to convince patients, their physicians, healthcare agencies and payors and the medical community of the benefits of using FW-COV to treat patients with COVID-19 infections with GI symptoms.

 

With respect to FW-ICI-AC, our oral micronized formulation and niclosamide for ICI-AC, if approved, will compete with both oral and intravenous administered steroids as well as hospital-based infusions of biologics, including infliximab and vedolizumab. We believe our ability to compete in this market, if we are successful in developing and obtaining regulatory approval to market FW- ICI-AC, will depend on our ability (or that of future corporate partners) to convince patients, their physicians, healthcare agencies and payors and the medical community of the benefits of using a non-steroidal, non-biologic therapeutic option for the treatment of ICI-AC.

 

With respect to FW-UP and FW-UC, our topical formulation of niclosamide for UP, if approved, will compete with sulfasalazines and 5-ASAs, for the treatment of mild disease, steroids, including budesonide and prednisone, azathioprine, 6-mercaptopurine, and methotrexate for the treatment of moderate disease, and Anti-TNFs, Entyvio (vedolizumab), Xeljanz (Tofacitinib); Stelara (Ustekinumab) for the treatment of severe disease. We believe our ability to compete in this market, if we are successful in developing and obtaining regulatory approval to market FW- UP and FW-UC, will depend on our ability (or that of future corporate partners) to convince patients, their physicians, healthcare agencies and payors and the medical community of the benefits of using a non-steroidal, non-biologic therapeutic option to prevent the advancement disease requiring more toxic immunosuppressive therapeutic option for the treatment of mild and moderate UP and UC.

 

Adrulipase

 

With respect to adrulipase, we will compete with PERTs (pancrelipase), a well-established market that is currently dominated by a few large pharmaceutical companies, including CREON® marketed by AbbVie Inc., ZENPEP® sold to Nestlé S.A. by Allergan plc. in January 2020, PANCREAZE® marketed by VIVUS, Inc. and PERTZYE® marketed by Chiesi Farmaceutici S.p.A. There are currently six PERT products that have been approved by the FDA for sale in the U.S. We believe our ability to compete in this market, if we are successful in developing and obtaining regulatory approval to market adrulipase, will depend on our ability (or that of a future corporate partner) to convince patients, their physicians, healthcare payors and the medical community of the benefits of using a non-animal-based product to treat EPI, as well as by addressing other shortcomings associated with PERTs, including a large pill burden.

 

 

 

 

Risk Factors

 

Risks Related to the Merger

 

The Company may not realize the anticipated benefits of the Merger

 

The success of the Merger will depend, in part, on the Company’s ability to realize the anticipated benefits of acquiring First Wave Bio, Inc. The Company’s ability to realize these anticipated benefits is subject to certain risks, including, among others:

 

 

·

The Company’s ability to successfully integrate First Wave Bio, Inc.’s business;

 

 

 

 

·

The risk that First Wave Bio, Inc.’s business will not perform as expected;

 

 

 

 

·

The extent to which the parties will be able to realize expected synergies, including those from the consolidation of clinical, research and manufacturing functions;

 

 

 

 

·

The possibility that the aggregate consideration being paid for First Wave Bio, Inc. is greater than the value that the Company will derive from the Merger;

 

 

 

 

·

The reduction of cash available for operations and other uses;

 

 

 

 

·

The assumption of known and unknown liabilities of First Wave Bio, Inc.; and

 

 

 

 

·

The possibility of costly litigation challenging the Merger.

 

Integrating the Company’s and First Wave Bio, Inc.’s businesses may be more difficult, time-consuming or costly than expected

 

The Company and First Wave Bio, Inc. have operated independently, and there can be no assurances that their businesses can be integrated successfully. It is possible that the integration process could result in the loss of key employees, the disruption of either company’s or both companies’ ongoing businesses or unexpected integration issues, such as higher than expected integration costs and an overall post-completion integration process that takes longer than originally anticipated. Specifically, issues that must be addressed in integrating the operations of the Company and First Wave Bio, Inc. in order to realize the anticipated benefits of the Merger so the business performs as expected include, among others:

 

 

combining the companies’ separate operational, financial, reporting and corporate functions;

 

 

integrating the companies’ technologies, products and services;

 

 

 

 

identifying and eliminating redundant and underperforming operations and assets;

 

 

harmonizing the companies’ operating practices, internal controls and other policies, procedures and processes;

 

 

 

 

addressing possible differences in corporate cultures and management philosophies;

 

 

 

 

maintaining employee morale and retaining key management and other employees;

 

 

 

 

attracting and recruiting prospective employees;

 

 

 

 

consolidating the companies’ corporate, administrative and information technology infrastructure;

 

 

 

 

managing the movement of certain businesses and positions to different locations;

 

 

 

 

maintaining existing agreements with vendors and avoiding delays in entering into new agreements with prospective vendors;

 

 

 

 

coordinating geographically dispersed organizations; and

 

 

 

 

effecting potential actions that may be required in connection with obtaining regulatory approvals.

 

 

 

 

In addition, at times, the attention of certain members of each company’s management and each company’s resources may be focused on the integration of the businesses of the two companies and diverted from day-to-day business operations, which may disrupt each company’s ongoing business and, consequently, the business of the Company.

 

Third parties may terminate or alter existing contracts or relationships with AzurRx or First Wave Bio, Inc.

 

Each of AzurRx and First Wave Bio, Inc. has contracts with vendors and other business partners which may require AzurRx or First Wave Bio, Inc., as applicable, to obtain consents from these other parties in connection with the Merger. If these consents cannot be obtained, the counterparties to these contracts and other third parties with which AzurRx and/or First Wave Bio, Inc. currently have relationships may have the ability to terminate, reduce the scope of or otherwise materially adversely alter their relationships with either party following the Merger. The pursuit of such rights may result in us suffering a loss of potential future revenue, incurring liabilities in connection with a breach of such agreements or losing rights that are material to our business. Any such disruptions could limit our ability to achieve the anticipated benefits of the Merger.

 

AzurRx may have difficulty attracting, motivating and retaining executives and other key employees in light of the Merger.

 

Our success after the Merger will depend in part on AzurRx’s ability to retain key executives and other employees. Uncertainty about the effect of the Merger on AzurRx’s employees may have an adverse effect on the company and consequently, the combined business. This uncertainty may impair our ability to attract, retain and motivate key personnel.

 

Furthermore, if any of our key employees depart or are at risk of departing, including because of issues relating to the uncertainty and difficulty of integration, financial security or a desire not to become employees of the combined business, we may have to incur significant costs in retaining such individuals or in identifying, hiring and retaining replacements for departing employees and may lose significant expertise and talent, and our ability to realize the anticipated benefits of the Merger may be materially and adversely affected. No assurance can be given that we will be able to attract or retain key employees to the same extent that we have been able to attract or retain employees in the past.

 

The Merger Agreement requires us to make significant developmental milestone and other payments which will require additional financing.

 

Under the Merger Agreement, we must pay to First Wave significant milestone payments of up to $207 million specified development, regulatory and net sales (as defined in the Merger Agreement) milestones. In order to make the various milestone payments that are required, we will need to raise additional funds.

 

AzurRx and First Wave Bio will incur significant transaction and Merger-related transition costs in connection with the Merger.

 

AzurRx and First Wave expect that they will incur significant, non-recurring costs in connection with consummating the Merger and integrating the operations of the two companies post-closing. AzurRx may incur additional costs to retain key employees. AzurRx and/or First Wave will also incur significant fees and expenses relating to financing arrangements and legal services (including any costs that would be incurred in defending against any potential class action lawsuits and derivative lawsuits in connection with the Merger if any such proceedings are brought), accounting and other fees and costs, associated with consummating the Merger. Some of these costs are payable regardless of whether the Merger is completed. Though AzurRx and First Wave continue to assess the magnitude of these costs, additional unanticipated costs may be incurred in the Merger and the integration of the businesses of AzurRx and First Wave.

 

 

 

 

The unaudited pro forma financial information included in this filing is preliminary and our actual financial position or results of operations after the First Wave Acquisition may differ materially.

 

The unaudited pro forma financial information in this filing is presented for illustrative purposes only and is not necessarily indicative of what our actual financial position or results of operations would have been had the Merger been completed on the dates indicated. The unaudited pro forma financial information reflects adjustments, which are based upon estimates and assumptions, to allocate the purchase price to tangible and identifiable intangible assets acquired and liabilities assumed, based on their estimated acquisition-date fair values. The purchase price allocation reflected in the unaudited pro forma financial statements is preliminary, and a final determination of the fair value of assets acquired and liabilities assumed will be based on the actual net tangible and intangible assets and liabilities of First Wave that existed as of the date of the completion of the Merger. Accordingly, the final purchase accounting adjustments may differ materially from the pro forma information reflected in this Current Report on Form 8-K.

 

AzurRx may be the target of securities class action and derivative lawsuits which could result in substantial costs and may delay or prevent the First Wave Acquisition from being completed.

 

Securities class action lawsuits and derivative lawsuits are often brought against public companies that have entered into acquisition agreements. Even if the lawsuits are without merit, defending against these claims can result in substantial costs and divert management time and resources. An adverse judgment could result in monetary damages, which could have a negative impact on AzurRx’s liquidity and financial condition. Additionally, if a plaintiff is successful in obtaining an injunction prohibiting completion of the Merger, then that injunction may delay or prevent the Merger from being completed, which may adversely affect AzurRx’s business, financial position and results of operations. As of the date of this Current Report on Form 8-K, no such lawsuits have been filed in connection with the Merger and we cannot predict whether any will be filed.

 

The lack of a public market for First Wave shares makes it difficult to determine the fair market value of the First Wave shares, and AzurRx may pay more than the fair market value of the First Wave shares.

 

First Wave Bio, Inc. is privately held and its share capital is not traded in any public market. The lack of a public market makes it extremely difficult to determine First Wave’s fair market value. Because the amount of AzurRx’s equity issued to the First Wave Shareholders was determined based on negotiations between the parties, it is possible that AzurRx may pay more than the aggregate fair market value for First Wave.

 

The market price for shares of AzurRx Common Stock may decline as a result of the Merger, including as a result of some AzurRx stockholders adjusting their portfolios.

 

The market value of AzurRx Common Stock at the time of consummation of the Merger may vary significantly from the price of AzurRx Common Stock on the date the Merger Agreement was executed. The market price of AzurRx Common Stock may decline if, among other things, the costs related to the Merger are greater than expected, AzurRx does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial or industry analysts or the effect of the Merger on AzurRx’s financial position, results of operations or cash flows is not consistent with the expectations of financial or industry analysts.

 

In addition, sales of AzurRx Common Stock by AzurRx’s stockholders after the completion of the Merger may cause the market price of AzurRx Common Stock to decrease. Based on the number of shares of AzurRx Common Stock outstanding as of September 10, 2021, approximately 9,965,174 shares of AzurRx Common Stock are issued and outstanding immediately after the closing of the Merger. Many AzurRx stockholders and former First Wave Shareholders may decide not to hold the shares of AzurRx Common Stock that they received in the Merger. Such sales of AzurRx Common Stock could have the effect of depressing the market price for AzurRx Common Stock and may take place once a registration statement registering such shares is filed and declared effective with the SEC, which the Company must use commercially reasonable efforts to effect promptly following December 31, 2021.

 

Any of these events may make it more difficult for AzurRx to sell equity or equity-related securities, dilute your ownership interest in AzurRx and have an adverse impact on the price of AzurRx Common Stock.

 

 

 

 

Risks Related to Our Common Stock

 

The Reverse Stock Split may not result in a proportional increase in the per share price of our common stock.

 

On September 13, 2021, we completed a one-for-ten reverse stock split of our shares of common stock (the “Reverse Stock Split”) and proportionate reduction in the number of authorized shares of common stock from 250,000,000 to 25,000,000. The Reverse Stock Split was effected in accordance with the authorization adopted by our stockholders at a special meeting held on February 24, 2021 and was announced on September 10, 2021. Among other reasons, our Board of Directors determined to effect the Reverse Stock Split because it is a potentially effective means to increase the per share market price of our common stock and thus enable us to regain compliance with the $1.00 per share minimum closing price required to maintain continued listing of our common stock on Nasdaq under Nasdaq Listing Rule 5550(a)(2), or the minimum bid price requirement. However, there can be no assurance that the market price of our common stock following the Reverse Stock Split will remain at the level required for continuing compliance with the minimum bid price requirement, and there are a number of risks and potential disadvantages associated with a reverse stock split. The effect of the Reverse Stock Split on the market price for our common stock cannot be accurately predicted. It is not uncommon for the market price of a company’s common stock to decline in the period following a reverse stock split. If the market price of our common stock declines during the period following the Reverse Stock Split, the percentage decline may be greater than would occur in the absence of the Reverse Stock Split. The market price of our common stock may also be affected by other factors which may be unrelated to the Reverse Stock Split or the number of shares outstanding.

 

Moreover, because some investors may view the Reverse Stock Split negatively, we cannot assure you that the Reverse Stock Split will not adversely impact the market price of our common stock. Accordingly, our total market capitalization after the Reverse Stock Split may be lower than the market capitalization before the Reverse Stock Split.

 

The Reverse Stock Split may decrease the liquidity of the shares of our common stock.

 

The liquidity of the shares of our common stock may be affected adversely by the Reverse Stock Split given the reduced number of shares that will be outstanding following the Reverse Stock Split, especially if the market price of our common stock does not increase as a result of the Reverse Stock Split. In addition, the Reverse Stock Split may increase the number of stockholders who own odd lots (less than 100 shares) of our common stock, creating the potential for such shareholders to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.

 

Following the Reverse Stock Split, the resulting market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.

 

Although we believe that a higher market price of our common stock may help generate greater or broader investor interest, there can be no assurance that the Reverse Stock Split will result in a share price that will attract new investors, including institutional investors. In addition, there can be no assurance that the market price of our common stock will satisfy the investing requirements of those investors. As a result, the trading liquidity of our common stock may not necessarily improve.

 

 

 

EXHIBIT 99.4

 

First Wave Bio, Inc.

 

Financial Report

December 31, 2020

 

 

 

 

First Wave Bio, Inc.

 Contents

   

 

Independent Auditor’s Report

 

1

 

Financial Statements

 

 

 

Balance Sheet

 

2

 

Statement of Operations

 

3

 

Statement of Stockholders’ Equity (Deficit)

 

4

 

Statement of Cash Flows

 

5

 

Notes to Financial Statements

 

6-11

 

 

 

 

 

Independent Auditor’s Report

 

To the Board of Directors

First Wave Bio, Inc.

 

We have audited the accompanying financial statements of First Wave Bio, Inc. (the "Company"), which comprise the balance sheet as of December 31, 2020 and 2019 and the related statements of operations, stockholders’ equity (deficit), and cash flows for the years then ended, and the related notes to the financial statements.

 

Management’s Responsibility for the Financial Statements

 

Management is responsible for the preparation and fair presentation of these financial statements in accordance with accounting principles generally accepted in the United States of America; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error.

 

Auditor’s Responsibility

 

Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free from material misstatement.

 

An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entity’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.

 

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

 

Opinion

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of First Wave Bio, Inc. as of December 31, 2020 and 2019 and the results of its operations and its cash flows for the years then ended in accordance with accounting principles generally accepted in the United States of America.

 

 

/s/ Plante & Moran, PLLC

 

     

August 30, 2021

 

 
1

 

 

First Wave Bio, Inc.

 

Balance Sheet

 

December 31, 2020 and 2019

 

 

 

2020

 

 

2019

 

Assets

Current Assets

 

 

 

 

 

 

Cash

 

$ 350,978

 

 

$ 36,059

 

Accounts receivable

 

 

13,278,568

 

 

 

-

 

Prepaid expenses and other current assets

 

 

25,102

 

 

 

4,041

 

Total current assets

 

 

13,654,648

 

 

 

40,100

 

Intangible Asset ‑ Net (Note 3)

 

 

236,250

 

 

 

251,250

 

Total assets

 

$ 13,890,898

 

 

$ 291,350

 

 

Liabilities and Stockholders’ Equity (Deficit)

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$ 1,607,070

 

 

$ 1,128,402

 

Convertible debt (Note 4)

 

 

3,862,500

 

 

 

12,500

 

Accrued and other current liabilities

 

 

87,659

 

 

 

165,314

 

Total liabilities

 

 

5,557,229

 

 

 

1,306,216

 

Stockholders’ Equity (Deficit)

 

 

8,333,669

 

 

 

(1,014,866 )

Total liabilities and stockholders’ equity (deficit)

 

$ 13,890,898

 

 

$ 291,350

 

 

See notes to financial statements.

 

 
2

 

 

First Wave Bio, Inc.

Statement of Operations

 

Years Ended December 31, 2020 and 2019

 

 

 

2020

 

 

2019

 

Net Revenue

 

$ 13,250,000

 

 

$ -

 

Operating Expenses

 

 

 

 

 

 

 

 

Amortization

 

 

15,000

 

 

 

15,000

 

General and administrative expenses

 

 

4,094,625

 

 

 

2,227,058

 

Total operating expenses

 

 

4,109,625

 

 

 

2,242,058

 

Operating Income (Loss)

 

 

9,140,375

 

 

 

(2,242,058 )

Nonoperating (Expense) Income

 

 

 

 

 

 

 

 

Foreign exchange loss

 

 

(40,030 )

 

 

(19,996 )

Litigation settlement (Note 9)

 

 

-

 

 

 

707,200

 

Interest expense

 

 

(78,893 )

 

 

(28,789 )

Other income

 

 

16,800

 

 

 

-

 

Total nonoperating (expense) income

 

 

(102,123 )

 

 

658,415

 

Income (Loss) ‑ Before income taxes

 

 

9,038,252

 

 

 

(1,583,643 )

Income Tax Expense (Note 6)

 

 

2,520

 

 

 

-

 

Net Income (Loss)

 

$ 9,035,732

 

 

$ (1,583,643 )

 

See notes to financial statements.

 

 
3

 

 

First Wave Bio, Inc.

Statement of Stockholders’ Equity (Deficit)

 

Years Ended December 31, 2020 and 2019

 

 

 

Common Stock

 

 

Preferred Stock

 

 

Additional

Paid‑in Capital

 

 

Accumulated

Deficit

 

 

Total

 

Balance ‑ January 1, 2019

 

$ 200

 

 

$ 558

 

 

$ 6,088,115

 

 

$ (8,452,483 )

 

$ (2,363,610 )

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,583,643 )

 

 

(1,583,643 )

Issuance of Series B preferred stock (Note 7)

 

 

-

 

 

 

104

 

 

 

2,395,283

 

 

 

-

 

 

 

2,395,387

 

Conversion of debt to equity

 

 

-

 

 

 

-

 

 

 

537,000

 

 

 

-

 

 

 

537,000

 

Balance ‑ December 31, 2019

 

 

200

 

 

 

662

 

 

 

9,020,398

 

 

 

(10,036,126 )

 

 

(1,014,866 )

Net income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

9,035,732

 

 

 

9,035,732

 

Stock option expense

 

 

-

 

 

 

-

 

 

 

312,803

 

 

 

-

 

 

 

312,803

 

Balance ‑ December 31, 2020

 

$ 200

 

 

$ 662

 

 

$ 9,333,201

 

 

$ (1,000,394 )

 

$ 8,333,669

 

 

See notes to financial statements.

 

 
4

 

 

First Wave Bio, Inc.

Statement of Cash Flows

 

Years Ended December 31, 2020 and 2019

 

 

 

2020

 

 

2019

 

Cash Flows from Operating Activities

 

 

 

 

 

 

Net income (loss)

 

$ 9,035,732

 

 

$ (1,583,643 )

Adjustments to reconcile net income (loss) to net cash from operating activities:

 

 

 

 

 

 

 

 

Amortization of intangible assets

 

 

15,000

 

 

 

15,000

 

Stock option expense

 

 

312,803

 

 

 

-

 

Changes in operating assets and liabilities that (used) provided cash:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(13,278,388 )

 

 

-

 

Prepaid expenses and other assets

 

 

(21,241 )

 

 

(1,594 )

Accounts payable

 

 

478,668

 

 

 

131,355

 

Accrued and other liabilities

 

 

(77,655 )

 

 

72,341

 

Net cash used in operating activities

 

 

(3,535,081 )

 

 

(1,366,541 )

Cash Flows from Financing Activities

 

 

 

 

 

 

 

 

Proceeds from convertible debt

 

 

3,850,000

 

 

 

-

 

Payments on debt

 

 

-

 

 

 

(537,602 )

Proceeds from issuance of Series B preferred stock

 

 

-

 

 

 

1,678,489

 

Net cash provided by financing activities

 

 

3,850,000

 

 

 

1,140,887

 

Net Increase (Decrease) in Cash

 

 

314,919

 

 

 

(225,654 )

Cash ‑ Beginning of year

 

 

36,059

 

 

 

261,713

 

Cash ‑ End of year

 

$ 350,978

 

 

$ 36,059

 

Significant Noncash Transactions

 

 

 

 

 

 

 

 

Series B preferred stock issued in exchange for notes payable

 

$ -

 

 

$ 716,898

 

Debt forgiveness

 

 

-

 

 

 

537,000

 

 

See notes to financial statements.

 

 
5

 

  

First Wave Bio, Inc.

 

Notes to Financial Statements

 

December 31, 2020 and 2019

 

Note 1 - Nature of Business

 

First Wave Bio, Inc. (the "Company") is engaged in the research and development of proprietary medical solutions to address the lack of effective and safe treatments for inflammatory bowel disease. The Company’s products are also being evaluated and developed for alternative applications, such as treatment for COVID‑19 patients.

 

Note 2 - Significant Accounting Policies

 

Basis of Presentation

 

The financial statements of the Company have been prepared on the basis of generally accepted accounting principles (GAAP). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect amounts reported in the financial statements. Actual results could differ from those estimates.

 

Credit Risk and Major Customer

 

Sales of products to a single customer account for 100 percent of the Company’s revenue in 2020. The Company executed a licensing agreement contract in 2020 to provide the customer with exclusive use of certain patents in defined territories. Loss of this contract could result in a loss of revenue, which could adversely affect future operations.

 

Trade Accounts Receivable

 

Accounts receivable are stated at net invoice amounts. Based on management’s review of outstanding receivable balances and historical collection information, management’s best estimate is that all balances will be collected. Accordingly, the Company has not established an allowance for doubtful accounts. Accounts receivable as of December 31, 2020 include $3,000,000 of noncash consideration that is expected to be paid in the form of stock.

 

Intangible Asset

 

The intangible asset consists of a license agreement for certain technologies from a business owned by a company founder and is being amortized using the straight‑line method. The license agreement is recorded at cost and is amortized over 20 years, the life of the agreement.

 

Revenue Recognition

 

Revenue and Cost Recognition

 

The Company has developed medical technologies to address certain medical conditions or diseases. The Company has only one revenue stream, which is to license its proprietary technology to other biotechnology or pharmaceutical companies. Only one licensing agreement existed during 2020. The Company has entered into an agreement with a pharmaceutical company (the "Customer") to provide the customer with exclusive development, manufacturing, and commercialization rights to the Company’s proprietary product. The Company had no revenue during the year ended December 31, 2019.

 

Timing of Satisfaction

 

In exchange for providing certain rights to the Customer, in 2020, the Company received compensation, including an upfront payment of cash and noncash consideration totaling $13,250,000. The revenue was recognized at a point in time upon execution of the agreement in 2020, as it was at that point that the customer obtained control of the licensed intellectual property. The noncash consideration was in the form of stock, and the revenue recorded represented the fair market value of the stock at the time the stock was granted. This advance payment is payable in 2021 based on the payment terms outlined in the licensing agreement.

 

 
6

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

December 31, 2020 and 2019

Note 2 - Significant Accounting Policies (Continued)

 

The license agreement provides for royalty revenue payable to the Company quarterly, based on the Customer’s net sales of the product for such calendar quarter. The timing of revenue will coincide with the period in which the Customer’s sales were earned. No royalty revenue was recorded in 2020.

 

The license agreement also provides for milestone‑based payments, based on the Customer meeting certain clinical trial or regulatory approval milestones. The milestones represent variable consideration. Due to uncertainty around meeting these milestones, the variable consideration related to milestones has been restrained to $0 in determining the transaction price. No milestone payments were recorded as revenue during 2020.

 

Determining the Transaction Price

 

The transaction price of the license agreement is the amount of consideration to which the Company expects to be entitled in exchange for providing exclusive rights to the customer. At contract inception, the Company has a legally enforceable right to payment related to the advance payment of $13,250,000. The transaction price related to the royalty agreement is variable based on the Customer’s sales. The transaction price will be determined once the Customer’s sales are known. The transaction price relating to the milestone payments is also variable because the timing of those payments is determined based on the Customer meeting certain clinical trial or regulatory approval milestones. Due to uncertainty around meeting these milestones, the variable consideration related to milestones has been restrained to $0 in determining the transaction price.

 

Significant Payment Terms

 

Each component of the license agreement is subject to differing payment terms. The cash component of the advance is payable in two tranches, with tranche one being due within 10 days of the execution of the agreement and tranche two due within six months of the execution of the agreement. Payments in connection with the royalty revenue are payable within 90 days after the end of each calendar quarter. In the event a milestone is triggered related to milestone‑based revenue, payment is due within 45 days of the milestone being met.

 

Research and Development

 

Research and development expenditures of approximately $1,840,000 and $1,302,000$0 in 2020 and 2019, respectively, were charged to expense as incurred.

 

Foreign Currency Translation

 

Certain liabilities of the Company are denominated in a foreign currency and are translated into U.S. dollars at the rate of exchange in effect at the close of the period. Expenses are translated at an average rate of exchange for the period. The aggregate effect of translating the financial statements is included in the statement of operations.

 

Income Taxes

 

A current tax liability or asset is recognized for the estimated taxes payable or refundable on tax returns for the year. Deferred tax liabilities or assets are recognized for the estimated future tax effects of temporary differences between financial reporting and tax accounting.

 

Use of Estimates

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

 

 
7

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

December 31, 2020 and 2019

Note 2 - Significant Accounting Policies (Continued)

 

Subsequent Events

 

The financial statements and related disclosures include evaluation of events up through and including August 30, 2021, which is the date the financial statements were available to be issued.

 

Note 3 - Acquired Intangible Asset

 

The intangible asset of the Company at December 31, 2020 and 2019 is summarized as follows:

 

 

 

2020

 

 

2019

 

 

 

Gross

Carrying Amount

 

 

Accumulated Amortization

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortized intangible asset ‑ License agreement

 

$ 300,000

 

 

$ 63,750

 

 

$ 300,000

 

 

$ 48,750

 

 

Amortization expense for the intangible asset totaled $15,000$0 for the years ended December 31, 2020 and 2019.

 

Estimated amortization expense for the years ending December 31 is as follows:

 

Years Ending

 

Amount

 

 

 

 

 

2021

 

$ 15,000

 

2022

 

 

15,000

 

2023

 

 

15,000

 

2024

 

 

15,000

 

2025

 

 

15,000

 

Thereafter

 

 

161,250

 

Total

 

$ 236,250

 

 

Note 4 - Long‑term Debt

 

During 2019, a note payable to a shareholder in the amount of $652,459 was converted from debt to equity, in which $115,459 was converted to Series B preferred stock, as discussed in Note 7, and the remaining $537,000 was treated as a capital contribution. Additionally, this is considered a noncash transaction, as disclosed in the statement of cash flows.

 

During 2020, the Company issued convertible promissory notes to various investors totaling $3,862,500. The notes bear interest at 3.0 percent, are unsecured, and mature on April 2, 2021 or upon a qualifying event if such an event occurs prior to this date. If a qualifying event does not occur, the notes are repayable in cash. Those events include an equity transaction resulting in proceeds in excess of $3,000,000 or a change in control of the Company. The notes contain a conversion feature that gives the debtholder the option to convert the notes to company stock upon a change in control of the majority of the Company’s stock. In the event of an equity transaction that exceeds $3,000,000 in proceeds, the notes automatically convert to stock at the lesser of (a) a per share priced based on a $25,000,000 valuation or (b) 80.0 percent of the lowest per share price in which the equity transaction occurred. In the event of a change in control, the notes convert to stock at the per share price based on a $25,000,000 valuation. At December 31, 2020, accrued interest of $80,007 has been recorded on the balance sheet.

 

Prior to 2020, the Company had issued convertible notes with stock warrants that allowed the debtholders to purchase the Company’s common stock. In total, 2,028,971 preferred stock warrants were issued, all of which were unexercised and expired in 2020. The Company estimated the value of the warrants using a Black‑Scholes valuation model, which resulted in an insignificant value.

 

Interest expense for 2020 and 2019 was $78,893 and $28,789, respectively.

 

 
8

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

December 31, 2020 and 2019

Note 5 - Related Party Transactions

 

The Company incurred expenses for various consulting services that were provided by stockholders of the Company totaling $268,275 and $125,652 during 2020 and 2019, respectively. Of that amount, $241,666 and $12,931 was included in accounts payable at December 31, 2020 and 2019, respectively.

 

Note 6 - Income Taxes

 

The components of the income tax provision included in the statement of operations are all attributable to continuing operations and are detailed as follows:

 

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

Current income tax expense

 

$ 2,520

 

 

$ -

 

Deferred income tax expense (recovery)

 

 

2,280,877

 

 

 

(407,421 )

Change in valuation reserve

 

 

(2,280,877 )

 

 

407,421

 

Total income tax expense

 

$ 2,520

 

 

$ -

 

 

A reconciliation of the provision for income taxes to income taxes computed by applying the statutory United States federal rate to income before taxes is as follows:

 

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

Income tax expense (recovery), computed at 21 percent of pretax income

 

$ 1,898,033

 

 

$ (332,565 )

State income tax expense at effective state tax rate

 

 

419,293

 

 

 

(75,026 )

Effect of nondeductible expenses

 

 

(40,404 )

 

 

170

 

Change in valuation allowance

 

 

(2,280,877 )

 

 

407,421

 

Adjustments of prior year estimates and other

 

 

6,475

 

 

 

-

 

Total provision for income taxes

 

$ 2,520

 

 

$ -

 

 

The income tax provision differs from the expense that would result from applying statutory rates to income before income taxes as a result of the utilization of net operating loss (NOL) carryforwards. The Company utilized all of its remaining NOL carryforward in 2020.

 

The details of the net deferred tax asset (liability) are as follows:

 

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

Total deferred tax liabilities

 

$ (5,899 )

 

$ -

 

Total deferred tax assets

 

 

34,557

 

 

 

2,309,535

 

Valuation allowance recognized for deferred tax assets

 

 

(28,658 )

 

 

(2,309,535 )

Total

 

$ -

 

 

$ -

 

 

Deferred tax liabilities result principally from differences in the value of intangible assets for financial reporting purposes and tax purposes. Deferred tax assets are a result of unused research and development credits. Realization of deferred tax assets is dependent on generating sufficient taxable income prior to the expiration of credit carryforwards. The Company has income tax credits for tax purposes of approximately $35,000, which expire between 2035 to 2037. Due to uncertainty, a valuation allowance of approximately $29,000 and $2,310,000 has been recognized as of December 31, 2020 and 2019, respectively.

 

 
9

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

December 31, 2020 and 2019

 

Note 7 - Capital Stock

 

The Company has authorized shares totaling 21,265,053, which consist of 14,165,053 shares of common stock and 7,100,000 shares of preferred stock. Both classes of stock have a par value of $0.0001 per share. Of the preferred stock, 5,100,000 shares have been designated as Series A and 2,000,000 shares as Series B.

 

During 2019, the Company issued 1,015,680 of Series B preferred stock totaling $2,395,283. Of that amount, $716,898 was issued in exchange for the extinguishment of certain notes payable. This amount is considered a noncash financing activity.

 

Series A and Series B preferred stock (Series Preferred) contain certain rights and preferences, including the following:

 

Dividend Rights

 

When determined and declared by the board of directors, Series Preferred stock holders are entitled to dividends equal to its common stock equivalent.

 

Voting Rights

 

Preferred stock holders have the rights to one vote for each share of common stock equivalent. Voting rights for preferred stock holders are equal to the voting rights and powers of common stock holders.

 

Liquidation Rights

 

Upon liquidation, dissolution, or winding‑up of the Company, the Series Preferred stock holders will be entitled to receive, in preference to any other class of the Company’s stock, an amount equal to the greater of (a) their respective original issue price per share plus all declared and unpaid dividends or (b) such amount per share as would have been payable had all shares of preferred stock been converted to common stock. The distribution preference is first to Series B preferred stock holders, second to Series A preferred stock holders, and last to common stock holders.

 

Conversion Rights

 

Any shares of Series Preferred stock may, at the option of the holder, be converted into fully paid nonassessable shares of common stock. The number of shares of common stock received shall be calculated by dividing the original issue price by the conversion price in effect at the time of the conversion. The Series A conversion price is initially equal to $1.00, and the Series B conversion price is initially equal to $2.50. These conversion prices are subject to adjustment from time to time.

 

The number of issued and outstanding shares of capital stock at December 31, 2020 and 2019 is as follows:

 

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

Common

 

 

4,625,000

 

 

 

4,625,000

 

Series A preferred

 

 

5,073,971

 

 

 

5,073,971

 

Series B preferred

 

 

1,543,680

 

 

 

1,543,680

 

Total

 

 

11,242,651

 

 

 

11,242,651

 

 

Subsequent to year end, the Company granted 147,000 shares of common stock to a vendor. Those shares vest upon the closing of a change in control or sale transaction. None of the shares have vested as of the report date. Additionally, the Company granted a phantom equity award to a shareholder of the Company, which shall be paid upon the closing of a change in control, or sale transaction, in an amount equal to the cash that would have been payable to the shareholder in such transaction if the shareholder held options to purchase 84,387 shares of common stock of the Company with an exercise price of $0.15 per share.

 

 
10

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

December 31, 2020 and 2019

 

Note 8 - Stock Options

 

The Company’s Equity Incentive Plan (the "Plan"), which is board of directors approved, permits the grant of stock options to certain service providers and directors of the board. During 2020, 2,919,878 shares of common stock options were issued. Option awards are generally granted with an exercise price equal to the market price of the Company’s stock at the date of grant; those option awards generally vest over 4 years and expire 10 years from the issuance date. Certain option awards provide for accelerated vesting if there is a change in control (as defined in the Plan).

 

The fair value of each option award is estimated on the date of grant using a Black‑Scholes option valuation model that uses the weighted‑average assumptions noted in the following table. Expected volatilities are based on historical volatility of comparable companies that are publicly held. The risk‑free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.

 

When calculating the amount of annual compensation expense, the Company has elected not to estimate forfeitures and instead accounts for forfeitures as they occur. The compensation expense during 2020 for share‑based awards is recognized ratably over the requisite vesting period of the award.

 

Volatility

 

 

100.00 %

Expected term (in years)

 

 

3

 

Risk‑free rate

 

 

0.29 %

 

During 2020, the Company granted 2,919,878 shares of stock options, of which 2,139,294 shares were vested as of December 31, 2020. Of the stock options granted, 2,362,853 of the shares carry a four‑year vesting provision, in which two years of service were credited upon issuance; 253,161 of the shares carry a four‑year vesting provision, with no years of service credited upon issuance; and the remaining 303,864 shares issued carried a two‑month vesting provision and were 100 percent vested as of December 31, 2020. The grant‑date fair value of options granted during 2020 was approximately $0.15. The Company recorded stock option expense of $312,803 during 2020. As of December 31, 2020, there is approximately $114,000 of unrecognized compensation expense related to the unvested options. The cost is expected to be recognized over the next two years.

 

Note 9 - Litigation

 

During 2019, the Company reached a favorable settlement agreement regarding a pending legal matter. As a result, the Company received settlement proceeds totaling $707,200 in 2019, which has been recorded in Statement of Operations as litigation settlement.

 

 

11

 

 

EXHIBIT 99.5

   

First Wave Bio, Inc.

Balance Sheet

 

 

 

June 30,

2021

 

 

December 31,

2020

 

Assets

 

Current Assets

 

 

 

 

 

 

Cash

 

$ 4,656,445

 

 

$ 350,978

 

Accounts receivable

 

 

1,250,000

 

 

 

13,278,568

 

Prepaid expenses and other current assets

 

 

52,920

 

 

 

25,102

 

Total current assets

 

 

5,959,365

 

 

 

13,654,648

 

Intangible Asset ‑ Net (Note 3)

 

 

228,750

 

 

 

236,250

 

Other Assets ‑ Investment in common stock

 

 

2,729,893

 

 

 

-

 

Total assets

 

$ 8,918,008

 

 

$ 13,890,898

 

Liabilities and Stockholders’ Equity

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$ 266,519

 

 

$ 1,607,070

 

Convertible debt (Note 4)

 

 

2,000,000

 

 

 

3,862,500

 

Accrued and other current liabilities

 

 

203,601

 

 

 

87,659

 

Total liabilities

 

 

2,470,120

 

 

 

5,557,229

 

Stockholders’ Equity

 

 

6,447,888

 

 

 

8,333,669

 

Total liabilities and stockholders’ equity

 

$ 8,918,008

 

 

$ 13,890,898

 

 

See notes to financial statements.

 

 
1

 

 

First Wave Bio, Inc.

Statement of Operations

 

 

 

Six‑month Period Ended June 30, 2021

 

 

Three‑month Period Ended June 30, 2021

 

 

Six‑month Period Ended June 30, 2020

 

 

Three‑month Period Ended June 30, 2020

 

Net Revenue

 

$ -

 

 

$ -

 

 

$ -

 

 

$ -

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization

 

 

7,500

 

 

 

3,750

 

 

 

7,500

 

 

 

3,750

 

General and administrative expenses

 

 

1,585,146

 

 

 

844,760

 

 

 

1,675,136

 

 

 

1,043,588

 

Operating Loss

 

 

(1,592,646 )

 

 

(848,510 )

 

 

(1,682,636 )

 

 

(1,047,338 )

Nonoperating (Expense) Income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign exchange loss

 

 

(30,732 )

 

 

(10,505 )

 

 

(7,188 )

 

 

(6,396 )

Unrealized loss on investment in common stock

 

 

(299,313 )

 

 

(1,731,152 )

 

 

-

 

 

 

-

 

Other income

 

 

29,206

 

 

 

-

 

 

 

16,800

 

 

 

-

 

Interest expense

 

 

(40,108 )

 

 

(15,164 )

 

 

(19,101 )

 

 

(20,215 )

Total nonoperating expense

 

 

(340,947 )

 

 

(1,756,821 )

 

 

(9,489 )

 

 

(26,611 )

Net Loss

 

$ (1,933,593 )

 

$ (2,605,331 )

 

$ (1,692,125 )

 

$ (1,073,949 )

 

See notes to financial statements.

 

 
2

 

 

First Wave Bio, Inc.

Statement of Stockholders’ Equity

 

 

 

Six‑month Period Ended June 30, 2020

 

 

Common Stock

 

 

Preferred Stock

 

 

Additional Paid‑in Capital

 

 

Retained Earnings

 

 

Total

 

Balance ‑ January 1, 2020

 

$ 200

 

 

$ 662

 

 

$ 9,020,398

 

 

$ (10,036,126 )

 

$ (1,014,866 )

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,692,125 )

 

 

(1,692,125 )

Stock option expense

 

 

-

 

 

 

-

 

 

 

264,990

 

 

 

-

 

 

 

264,990

 

Balance ‑ June 30, 2020

 

$ 200

 

 

$ 662

 

 

$ 9,285,388

 

 

$ (11,728,251 )

 

$ (2,442,001 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six‑month Period Ended June 30, 2021

 

 

Common Stock

 

 

Preferred Stock

 

 

Additional Paid‑in Capital

 

 

Accumulated Deficit

 

 

Total

 

Balance ‑ January 1, 2021

 

$ 200

 

 

$ 662

 

 

$ 9,333,201

 

 

$ (1,000,394 )

 

$ 8,333,669

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,933,593 )

 

 

(1,933,593 )

Stock option expense

 

 

-

 

 

 

-

 

 

 

47,812

 

 

 

-

 

 

 

47,812

 

Balance ‑ June 30, 2021

 

$ 200

 

 

$ 662

 

 

$ 9,381,013

 

 

$ (2,933,987 )

 

$ 6,447,888

 

 

See notes to financial statements.

 

 
3

 

 

First Wave Bio, Inc.

 

Statement of Cash Flows

 

 

 

Six‑month Period Ended June 30, 2021

 

 

Six‑month Period Ended June 30, 2020

 

Cash Flows from Operating Activities

 

 

 

 

 

 

Net loss

 

$ (1,933,593 )

 

$ (1,692,125 )

Adjustments to reconcile net loss to net cash from operating activities:

 

 

 

 

 

 

 

 

Amortization of intangible assets

 

 

7,500

 

 

 

7,500

 

Stock option expense

 

 

47,812

 

 

 

264,990

 

Changes in operating assets and liabilities that provided (used) cash:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

9,028,568

 

 

 

-

 

Prepaid expenses and other assets

 

 

242,289

 

 

 

(32,382 )

Accounts payable

 

 

(1,340,551 )

 

 

(130,303 )

Accrued and other liabilities

 

 

115,942

 

 

 

(37,271 )

Net cash provided by (used in) operating activities

 

 

6,167,967

 

 

 

(1,619,591 )

Cash Flows from Financing Activities

 

 

 

 

 

 

 

 

Proceeds from convertible debt

 

 

-

 

 

 

3,850,000

 

Payments on convertible debt

 

 

(1,862,500 )

 

 

-

 

Net cash (used in) provided by financing activities

 

 

(1,862,500 )

 

 

3,850,000

 

Net Increase in Cash

 

 

4,305,467

 

 

 

2,230,409

 

Cash ‑ Beginning of period

 

 

350,978

 

 

 

36,059

 

Cash ‑ End of period

 

$ 4,656,445

 

 

$ 2,266,468

 

Significant Noncash Transactions ‑ AzurRx stock issued in exchange for accounts receivable

 

$ 3,000,000

 

 

$ -

 

 

See notes to financial statements.

 

 
4

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

June 30, 2021 and December 31, 2020

 

Note 1 - Nature of Business

 

First Wave Bio, Inc. (the “Company”) is engaged in the research and development of proprietary medical solutions to address the lack of effective and safe treatments for inflammatory bowel disease. The Company’s products are also being evaluated and developed for alternative applications, such as treatment for COVID‑19 patients.

 

Note 2 - Significant Accounting Policies

 

Basis of Presentation

 

The accompanying unaudited condensed financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and Rule 10‑01 of Regulation S‑X. The unaudited condensed financial statements, including the condensed notes thereto, are unaudited and exclude some of the disclosures required in audited financial statements. The condensed balance sheet as of December 31, 2020 has been derived from our audited financial statements as of that date but does not include all of the information and footnotes required by GAAP for complete financial statements.

 

In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments and eliminations, consisting only of normal recurring adjustments, necessary for a fair presentation in conformity with GAAP. The accompanying unaudited condensed financial statements should be read in conjunction with the audited financial statements for the period ended December 31, 2020.

 

Credit Risk and Major Customer

 

Sales of products to AzurRx Biopharma, Inc. (AzurRx) account for 100 percent of the Company’s revenue. The Company executed a licensing agreement contract in 2020 to provide AzurRx with exclusive use of certain patents in defined territories. Loss of this contract could result in a loss of revenue, which could adversely affect future operations.

 

Trade Accounts Receivable

 

Accounts receivable are stated at net invoice amounts. Based on management’s review of outstanding receivable balances and historical collection information, management’s best estimate is that all balances will be collected. Accordingly, the Company has not established an allowance for doubtful accounts. Accounts receivable as of December 31, 2020 include $3,000,000 of noncash consideration that was paid in the form of stock.

 

Investments

 

Investments in AzurRx common stock are reported at fair value, with unrealized gains and losses included in earnings. As of June 30, 2021, $2,729,893 of AzurRx common stock is reported at its fair value in the balance sheet. During the six‑month and three‑month periods ended June 30, 2021, the Company recorded unrealized losses of $299,313 and $1,731,152, respectively, on AzurRx common stock in the statement of operations.

 

Fair Value Measurements

 

Accounting standards require certain assets and liabilities be reported at fair value in the financial statements and provide a framework for establishing that fair value. The framework for determining fair value is based on a hierarchy that prioritizes the inputs and valuation techniques used to measure fair value.

Fair values determined by Level 1 inputs use quoted prices in active markets for identical assets that the Company has the ability to access.

   

 
5

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

June 30, 2021 and December 31, 2020

 

Note 2 - Significant Accounting Policies (Continued)

 

Fair values determined by Level 2 inputs use other inputs that are observable, either directly or indirectly. These Level 2 inputs include quoted prices for similar assets in active markets and other inputs, such as interest rates and yield curves, that are observable at commonly quoted intervals.

 

Level 3 inputs are unobservable inputs, including inputs that are available in situations where there is little, if any, market activity for the related asset. These Level 3 fair value measurements are based primarily on management’s own estimates using pricing models, discounted cash flow methodologies, or similar techniques taking into account the characteristics of the asset.

 

In instances where inputs used to measure fair value fall into different levels in the above fair value hierarchy, fair value measurements in their entirety are categorized based on the lowest level input that is significant to the valuation. The Company’s assessment of the significance of particular inputs to these fair value measurements requires judgment and considers factors specific to each asset.

 

The Company measures its investment in AzurRx common stock at fair value on a recurring basis. The fair value of the common stock is based on Level 1 inputs, as described above.

 

Intangible Asset

 

The intangible asset consists of a license agreement for certain technologies from a business owned by a company founder and is being amortized using the straight‑line method. The license agreement is recorded at cost and is amortized over 20 years, the life of the agreement.

 

Revenue Recognition

 

Revenue and Cost Recognition

 

The Company has developed medical technologies to address certain medical conditions or diseases. The Company has only one revenue stream, which is to license its proprietary technology to other biotechnology or pharmaceutical companies. Only one licensing agreement existed during 2020 with AzurRx. The Company has entered into an agreement with AzurRx, a bio pharmaceutical company, to provide AzurRx with exclusive development, manufacturing, and commercialization rights to the Company’s proprietary product.

 

Timing of Satisfaction

 

In exchange for providing certain rights to AzurRx, the Company received compensation, including an upfront payment of cash and noncash consideration totaling $13,250,000. The revenue was recognized at a point in time upon execution of the agreement in December 2020, as it was at that point that AzurRx obtained control of the licensed intellectual property. The noncash consideration was in the form of convertible preferred stock with an aggregate stated value of $3,000,000, and the revenue recorded represented the fair market value of the stock at the time the preferred stock was granted. The preferred stock accrued dividends at the rate of 8 percent per annum payable quarterly in cash or in kind until converted. The preferred stock shall convert automatically to AzurRx common stock on a 1:1 basis immediately following the close of business on the date on which AzurRx obtains stockholder approval for issuance of common stock. The advance payment was payable in 2021 based on the payment terms outlined in the licensing agreement.

 

The license agreement provides for royalty revenue payable to the Company quarterly, based on AzurRx’s net sales of the product for such calendar quarter. The timing of revenue will coincide with the period in which AzurRx’s sales were earned. No royalty revenue was recorded for the six‑month periods ended June 30, 2021 and 2020.

    

 
6

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

June 30, 2021 and December 31, 2020

Note 2 - Significant Accounting Policies (Continued)

 

The license agreement also provides for milestone‑based payments, based on AzurRx meeting certain clinical trial or regulatory approval milestones. The milestones represent variable consideration. Due to uncertainty around meeting these milestones, the variable consideration related to milestones has been restrained to $0 in determining the transaction price. No milestone payments were recorded as revenue for the six‑month periods ended June 30, 2021 and 2020.

 

Determining the Transaction Price

 

The transaction price of the license agreement is the amount of consideration to which the Company expects to be entitled in exchange for providing exclusive rights to AzurRx. At contract inception, the Company has a legally enforceable right to payment related to the advance payment of $13,250,000. The transaction price related to the royalty agreement is variable based on AzurRx’s sales. The transaction price will be determined once AzurRx’s sales are known. The transaction price relating to the milestone payments is also variable because the timing of those payments is determined based on AzurRx meeting certain clinical trial or regulatory approval milestones. Due to uncertainty around meeting these milestones, the variable consideration related to milestones has been restrained to $0 in determining the transaction price.

 

Significant Payment Terms

 

Each component of the license agreement is subject to differing payment terms. The cash component of the advance is payable in two tranches, with tranche one being due within 10 days of the execution of the agreement and tranche two due within six months of the execution of the agreement. Payments in connection with the royalty revenue are payable within 90 days after the end of each calendar quarter. In the event a milestone is triggered related to milestone‑based revenue, payment is due within 45 days of the milestone being met.

 

Research and Development

 

Research and development expenditures of approximately $831,000 and $730,000 for the six‑month periods ended June 30, 2021 and 2020, respectively, were charged to expense as incurred.

 

Foreign Currency Translation

 

Certain liabilities of the Company are denominated in a foreign currency and are translated into U.S. dollars at the rate of exchange in effect at the close of the period. Expenses are translated at an average rate of exchange for the period. The aggregate effect of translating the financial statements is included in the statement of operations.

 

Income Taxes

 

A current tax liability or asset is recognized for the estimated taxes payable or refundable on tax returns for the year. Deferred tax liabilities or assets are recognized for the estimated future tax effects of temporary differences between financial reporting and tax accounting.

 

Use of Estimates

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

 

Subsequent Events

 

The financial statements and related disclosures include evaluation of events up through and including August 30, 2021, which is the date the financial statements were available to be issued.

    

 
7

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

June 30, 2021 and December 31, 2020

 

Note 3 - Acquired Intangible Asset

 

The intangible asset of the Company at June 30, 2021 and December 31, 2020 is summarized as follows:

 

 

 

2021

 

 

2020

 

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortized intangible asset ‑ License agreement

 

$ 300,000

 

 

$ 71,250

 

 

$ 300,000

 

 

$ 63,750

 

 

Amortization expense for the intangible asset totaled $7,500$0 for the six‑month periods ended June 30, 2021 and 2020.

 

Estimated amortization expense for the years ending June 30 is as follows:

 

Years Ending

 

Amount

 

 

 

 

 

2022

 

$ 15,000

 

2023

 

 

15,000

 

2024

 

 

15,000

 

2025

 

 

15,000

 

2026

 

 

15,000

 

Thereafter

 

 

153,750

 

Total

 

$ 228,750

 

 

Note 4 - Long‑term Debt

 

During 2020, the Company issued convertible promissory notes to various investors totaling $3,862,500. The notes bear interest at 3.0 percent, are unsecured, and mature on April 2, 2021 or upon a qualifying event if such an event occurs prior to this date. If a qualifying event does not occur, the notes are repayable in cash. Those events include an equity transaction resulting in proceeds in excess of $3,000,000 or a change in control of the Company. The notes contain a conversion feature that gives the debtholder the option to convert the notes to company stock upon a change in control of the majority of the Company’s stock. In the event of an equity transaction that exceeds $3,000,000 in proceeds, the notes automatically convert to stock at the lesser of (a) a per share priced based on a $25,000,000 valuation or (b) 80.0 percent of the lowest per share price in which the equity transaction occurred. In the event of a change in control, the notes convert to stock at the per share price based on a $25,000,000 valuation. For the six‑month period ended June 30, 2021, the Company repaid $1,862,500 of promissory notes. The remaining $2,000,000 convertible promissory notes were extended with no set maturity date and bear interest at 3.0 percent. At June 30, 2021 and December 31, 2020, accrued interest of $74,630 and $80,007, respectively, has been recorded on the accompanying balance sheet.

 

Prior to 2020, the Company had issued convertible notes with warrants that allowed the debtholders to purchase the Company’s common stock. In total, 2,028,971 preferred stock warrants were issued, all of which were unexercised and expired in 2020. The Company estimated the value of the warrants using a Black‑Scholes valuation model, which resulted in an insignificant value.

 

Interest expense for the six‑month periods ended June 30, 2021 and 2020 was $40,108 and $19,101 respectively.

 

Note 5 - Related Party Transactions

 

During the periods ended June 30, 2021 and 2020, the Company incurred expenses for various consulting services that were provided by stockholders of the Company totaling $318,426 and $10,104, respectively. At June 30, 2021 and December 31, 2020, $3,035 and $241,666, respectively, of that amount was included in accounts payable.

   

 
8

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

June 30, 2021 and December 31, 2020

 

Note 6 - Income Taxes

 

The components of the income tax provision included in the statement of operations for the six‑month periods ended June 30, 2021 and 2020 are all attributable to continuing operations and are detailed as follows:

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Current income tax recovery (expense)

 

$ -

 

 

$ -

 

Deferred income tax expense

 

 

(579,203 )

 

 

(460,223 )

Change in valuation reserve

 

 

579,203

 

 

 

460,223

 

Total income tax recovery (expense)

 

$ -

 

 

$ -

 

 

A reconciliation of the provision for income taxes to income taxes computed by applying the statutory United States federal rate to income before taxes for the six‑month periods ended June 30, 2021 and 2020 is as follows:

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Income tax expense, computed at 21 percent of pretax income

 

$ (406,055 )

 

$ (355,346 )

State income tax expense at effective state tax rate

 

 

(89,751 )

 

 

(76,848 )

Effect of nondeductible expenses

 

 

8,423

 

 

 

14,878

 

Change in valuation allowance

 

 

579,203

 

 

 

460,223

 

Adjustments of prior year estimates and other

 

 

(91,820 )

 

 

(42,907 )

Total provision for income taxes

 

$ -

 

 

$ -

 

 

The income tax provision differs from the expense that would result from applying statutory rates to income before income taxes as a result of the utilization of net operating loss (NOL) carryforwards. The Company utilized all of its remaining NOL carryforward as of December 31, 2020.

 

The details of the net deferred tax asset (liability) as of June 30, 2021 and December 31, 2020 are as follows:

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Total deferred tax liabilities

 

$ (649 )

 

$ (5,899 )

Total deferred tax assets

 

 

608,509

 

 

 

34,557

 

Valuation allowance recognized for deferred tax assets

 

 

(607,860 )

 

 

(28,658 )

Total

 

$ -

 

 

$ -

 

 

Deferred tax liabilities result principally from differences in the value of intangible assets for financial reporting purposes and tax purposes. Deferred tax assets are a result of loss carryforwards, IRC Section 163(j) business limitation, and unused research and development credits. Realization of deferred tax assets is dependent on generating sufficient taxable income prior to the expiration of loss and credit carryforwards. The Company has loss carryforwards and income tax credits for tax purposes of approximately $1,617,000, of which $30,000 expires between 2035 to 2037. Due to uncertainty, a valuation allowance of approximately $608,000 and $29,000 has been recognized as of June 30, 2021 and December 31, 2020, respectively.

 

Note 7 - Capital Stock

 

The Company has authorized shares totaling 21,265,053, which consist of 14,165,053 shares of common stock and 7,100,000 shares of preferred stock. Both classes of stock have a par value of $0.0001 per share. Of the preferred stock, 5,100,000 shares have been designated as Series A and 2,000,000 shares as Series B.

    

 
9

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

June 30, 2021 and December 31, 2020

 

Note 7 - Capital Stock (Continued)

 

Series A and Series B preferred stock (Series Preferred) contain certain rights and preferences, including the following:

 

Dividend Rights

 

When determined and declared by the board of directors, Series Preferred stock holders are entitled to dividends equal to its common stock equivalent.

 

Voting Rights

 

Preferred stock holders have the rights to one vote for each share of common stock equivalent. Voting rights for preferred stock holders are equal to the voting rights and powers of common stock holders.

 

Liquidation Rights

 

Upon liquidation, dissolution, or winding‑up of the Company, the Series Preferred stock holders will be entitled to receive, in preference to any other class of the Company’s stock, an amount equal to the greater of (a) their respective original issue price per share plus all declared and unpaid dividends or (b) such amount per share as would have been payable had all shares of preferred stock been converted to common stock. The distribution preference is first to Series B preferred stock holders, second to Series A preferred stock holders, and last to common stock holders.

 

Conversion Rights

 

Any shares of Series Preferred stock may, at the option of the holder, be converted into fully paid nonassessable shares of common stock. The number of shares of common stock received shall be calculated by dividing the original issue price by the conversion price in effect at the time of the conversion. The Series A conversion price is initially equal to $1.00, and the Series B conversion price is initially equal to $2.50. These conversion prices are subject to adjustment from time to time.

 

The number of issued and outstanding shares of capital stock at June 30, 2021 and 2020 is as follows:

 

 

 

2021

 

 

2020

 

 

 

Number of Shares

 

 

Number of Shares

 

 

 

 

 

 

 

 

Common

 

 

4,625,000

 

 

 

4,625,000

 

Series A preferred

 

 

5,073,971

 

 

 

5,073,971

 

Series B preferred

 

 

1,543,680

 

 

 

1,543,680

 

Total

 

 

11,242,651

 

 

 

11,242,651

 

 

During 2021, the Company granted 147,000 shares of common stock to a vendor. Those shares vest upon the closing of a change in control or sale transaction. None of the shares have vested as of June 30, 2021. Additionally, the Company granted a phantom equity award to a shareholder, which shall be paid upon the closing of a change in control, or sale transaction, in an amount equal to the cash that would have been payable to the shareholder in such transaction if the shareholder held options to purchase 84,387 shares of common stock of the Company with an exercise price of $0.15 per share.

 

Note 8 - Stock Options

 

The Company’s Equity Incentive Plan (the “Plan”), which is board of directors approved, permits the grant of stock options to certain service providers and directors of the board. During 2020, 2,919,878 shares of common stock options were issued. Option awards are generally granted with an exercise price equal to the market price of the Company’s stock at the date of grant; those option awards generally vest over 4 years and expire 10 years from the issuance date. Certain option awards provide for accelerated vesting if there is a change in control (as defined in the Plan).

    

 
10

 

 

First Wave Bio, Inc.

 

Notes to Financial Statements

 

June 30, 2021 and December 31, 2020

 

Note 8 - Stock Options (Continued)

 

The fair value of each option award is estimated on the date of grant using a Black‑Scholes option valuation model that uses the weighted‑average assumptions noted in the following table. Expected volatilities are based on historical volatility of comparable companies that are publicly held. The risk‑free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.

 

When calculating the amount of annual compensation expense, the Company has elected not to estimate forfeitures and instead accounts for forfeitures as they occur. The compensation expense during 2021 and 2020 for share‑based awards is recognized ratably over the requisite vesting period of the award.

 

Volatility

 

 

100.00 %

Expected term (in years)

 

 

3

 

Risk‑free rate

 

 

0.29 %

 

During 2020, the Company granted 2,919,878 shares of stock options, of which 2,466,296 and 1,812,292 shares were vested as of June 30, 2021 and 2020, respectively. Of the stock options granted, 2,362,853 shares carry a four‑year vesting provision, in which two years of service were credited upon issuance; 253,161 shares carry a four‑year vesting provision, with no years of service credited upon issuance; and the remaining 303,864 shares issued carried a two‑month vesting provision and were 100 percent vested as of June 30, 2021. The grant‑date fair value of options granted was approximately $0.15. The Company recorded stock option expense of $47,812 and $264,990 during the six‑month periods ended June 30, 2021 and 2020, respectively. As of June 30, 2021, there is approximately $66,322 of unrecognized compensation expense related to the unvested options. The cost is expected to be recognized over the next two years.

  

 
11

 

EXHIBIT 99.6

  

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

 

The following unaudited pro forma condensed combined financial information was prepared using the acquisition method of accounting under United States generally accepted accounting principles (“U.S. GAAP”), and gives effect to the transaction between AzurRx Biopharma, Inc. (“AzurRx” or the “Company”), Alpha Merger Sub, Inc. (“Merger Sub”), and Alpha First Wave Bio, LLC and First Wave Bio, Inc. (“First Wave Bio”) to be accounted for as an asset acquisition for accounting purposes. The transaction was accounted for as an asset acquisition in accordance with FASB ASC 805-50 and FASB ASC 350 as the majority of the fair value of the assets acquired was concentrated in a group of similar assets, and the acquired assets did not have outputs or employees.

 

The following unaudited pro forma condensed combined financial statements are based on AzurRx’s historical financial statements and First Wave Bio’s historical financial statements, as adjusted, to give effect to AzurRx’s asset acquisition of First Wave Bio. The unaudited pro forma condensed combined statements of operations for the six months ended June 30, 2021 and the year ended December 31, 2020 give effect to these transactions as if they had occurred on January 1, 2020. The unaudited pro forma condensed combined balance sheet as of June 30, 2021 gives effect to these transactions as if they had occurred on June 30, 2021.

 

The unaudited pro forma condensed combined financial information is based on the assumptions and adjustments that are described in the accompanying notes.

 

The unaudited pro forma condensed combined financial information does not give effect to the potential impact of current financial conditions, regulatory matters, operating efficiencies or other savings or expenses that may be associated with the integration of the two companies. The unaudited pro forma condensed combined financial information is preliminary and has been prepared for illustrative purposes only and is not necessarily indicative of the financial position or results of operations in future periods or the results that actually would have been realized had AzurRx and First Wave Bio been a combined company during the specified periods. The actual results reported in periods following the transaction may differ significantly from those reflected in the pro forma financial information presented herein for a number of reasons, including, but not limited to, differences between the assumptions used to prepare this pro forma financial information.

 

The assumptions and estimates underlying the unaudited adjustments to the pro forma condensed combined financial statements are described in the accompanying notes, which should be read together with the pro forma condensed combined financial statements.

 

The unaudited pro forma condensed combined financial statements should be read together with AzurRx’s historical financial statements, which are included in AzurRx’s latest annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 31, 2021 and the June 30, 2021 results included in AzurRx’s report on Form 10-Q filed with the SEC on August 16, 2021, and First Wave Bio’s historical information included herein.

 

Except as otherwise indicated, all share and per share information in the following unaudited pro forma condensed combined financial information gives effect to the reverse stock split of AzurRx’s outstanding common stock, which was effected at a ratio of 1-for-10 as of 12:01 a.m. Eastern Time on Monday, September 13, 2021 (the “Reverse Stock Split”). Unless otherwise indicated, preliminary estimates of share and per share information in the following unaudited pro forma condensed combined financial information, after giving effect to the Reverse Stock Split, are subject to revision upon final settlement of the Reverse Stock Split by the Depository Trust and Clearing Corporation and AzurRx’s transfer agent, Colonial Stock Transfer Company, Inc., following the effective date thereof.

 

 
1

 

 

Pro Forma Condensed Combined Balance Sheet as of June 30, 2021

(in thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

Transaction

 

 

 

 

Pro Forma

 

 

 

AzurRx

 

 

First Wave Bio

 

 

Adjustments

 

 

Note 3

 

Combined

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$ 8,074

 

 

$ 4,656

 

 

$ (2,471 )

 

(b)

 

$ 6,324

 

 

 

 

 

 

 

 

 

 

 

 

(3,935 )

 

(c)

 

 

 

 

Accounts receivable

 

 

-

 

 

 

1,250

 

 

 

(1,250 )

 

(g)

 

 

-

 

Prepaid expense and other current assets

 

 

541

 

 

 

53

 

 

 

-

 

 

 

 

 

594

 

Total current assets

 

 

8,615

 

 

 

5,959

 

 

 

(7,656 )

 

 

 

 

6,918

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Property, equipment, and leasehold improvements, net

 

 

89

 

 

 

-

 

 

 

-

 

 

 

 

 

89

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangible assets

 

 

-

 

 

 

229

 

 

 

(229 )

 

(c)

 

 

-

 

Investment in common stock

 

 

-

 

 

 

2,730

 

 

 

(2,730 )

 

(g)

 

 

-

 

Patents, net

 

 

2,616

 

 

 

-

 

 

 

-

 

 

 

 

 

2,616

 

Goodwill

 

 

1,991

 

 

 

-

 

 

 

-

 

 

 

 

 

1,991

 

Operating lease right-of-use assets

 

 

396

 

 

 

-

 

 

 

-

 

 

 

 

 

396

 

Deposits

 

 

70

 

 

 

-

 

 

 

-

 

 

 

 

 

70

 

Total other assets

 

 

5,073

 

 

 

2,959

 

 

 

(2,959 )

 

 

 

 

5,073

 

Total assets

 

$ 13,777

 

 

$ 8,918

 

 

$ (10,615 )

 

 

 

$ 12,080

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$ 4,644

 

 

$ 471

 

 

$ (471 )

 

(b)

 

$ 20,894

 

 

 

 

 

 

 

 

 

 

 

 

15,000

 

 

(c)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,250

 

 

(d)

 

 

 

 

Payable related to license agreement

 

 

1,250

 

 

 

-

 

 

 

(1,250 )

 

(g)

 

 

-

 

Accrued dividends payable

 

 

231

 

 

 

-

 

 

 

-

 

 

 

 

 

231

 

Note payable

 

 

139

 

 

 

-

 

 

 

-

 

 

 

 

 

139

 

Convertible debt

 

 

-

 

 

 

2,000

 

 

 

(2,000 )

 

(b)

 

 

-

 

Other current liabilities

 

 

190

 

 

 

-

 

 

 

-

 

 

 

 

 

190

 

Total current liabilities

 

 

6,454

 

 

 

2,471

 

 

 

12,529

 

 

 

 

 

21,454

 

Other current liabilities

 

 

286

 

 

 

-

 

 

 

-

 

 

 

 

 

286

 

Total liabilities

 

 

6,740

 

 

 

2,471

 

 

 

12,529

 

 

 

 

 

21,740

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders' equity (deficit)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock, $0.0001 par value per share

 

 

7

 

 

 

-

 

 

 

-

 

 

(a)

 

 

7

 

Series B preferred stock, $0.0001 par value per share

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

-

 

Series C preferred stock, $0.0001 par value per share

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

-

 

Additional paid-in-capital

 

 

120,586

 

 

 

9,381

 

 

 

-

 

 

(a)

 

 

121,856

 

 

 

 

 

 

 

 

 

 

 

 

(9,381 )

 

(c)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,000

 

 

(c)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,730 )

 

 

 

 

 

 

Accumulated deficit

 

 

(112,331 )

 

 

(2,934 )

 

 

2,934

 

 

(c)

 

 

(134,278 )

 

 

 

 

 

 

 

 

 

 

 

(20,372 )

 

(c)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(325 )

 

(c)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,250 )

 

(d)

 

 

 

 

Accumulated other comprehensive loss

 

 

(1,225 )

 

 

-

 

 

 

-

 

 

 

 

 

(1,225 )
Total stockholders' equity (deficit)

 

 

7,037

 

 

 

6,447

 

 

 

(27,124 )

 

 

 

 

(13,640 )
Total liabilities and stockholders' equity

 

$ 13,777

 

 

$ 8,918

 

 

$ (10,615 )

 

 

 

$ 12,080

 

   

 
2

 

 

Pro Forma Condensed Combined Statement of Operations — Six Months Ended June 30, 2021

(in thousands, except share and per share amounts)

 

 

 

 

 

 

 

 

 

Transaction

 

 

 

 

Pro Forma

 

 

 

AzurRx

 

 

First Wave Bio

 

 

Adjustments

 

 

Note 3

 

Combined

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

8,164

 

 

 

-

 

 

 

-

 

 

 

 

 

8,164

 

Research and development - licensed acquired

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

-

 

General and administrative

 

 

9,327

 

 

 

1,593

 

 

 

-

 

 

 

 

 

10,920

 

Total operating expenses

 

 

17,491

 

 

 

1,593

 

 

 

-

 

 

 

 

 

19,084

 

Loss from operations

 

 

(17,491 )

 

 

(1,593 )

 

 

-

 

 

 

 

 

(19,084 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(8 )

 

 

(40 )

 

 

40

 

 

(e)

 

 

(8 )
Other income

 

 

2

 

 

 

29

 

 

 

-

 

 

 

 

 

31

 

Foreign exchange loss

 

 

-

 

 

 

(31 )

 

 

-

 

 

 

 

 

(31 )
Unrealized loss on investment in common stock

 

 

-

 

 

 

(299 )

 

 

299

 

 

(g)

 

 

-

 

Change in fair value of liability

 

 

532

 

 

 

-

 

 

 

-

 

 

 

 

 

532

 

Total other (income)/expense

 

 

526

 

 

 

(341 )

 

 

339

 

 

 

 

 

524

 

Net loss

 

$ (16,965 )

 

$ (1,934 )

 

$ 339

 

 

 

 

$ (18,560 )
Deemed dividend on preferred stock issuances

 

 

(4,507 )

 

 

-

 

 

 

-

 

 

 

 

 

(4,507 )
Deemed dividend on preferred stock exchanges

 

 

(21,008 )

 

 

-

 

 

 

-

 

 

 

 

 

(21,008 )
Preferred stock dividends

 

 

(231 )

 

 

-

 

 

 

-

 

 

 

 

 

(231 )
Net loss applicable to common shareholders

 

$ (42,711 )

 

$ (1,934 )

 

$ 339

 

 

 

 

$ (44,306 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$ (6.39 )

 

 

 

 

 

 

 

 

 

 

 

$ (2.54 )
Weighted average number of shares

 

 

6,679,918

 

 

 

 

 

 

 

624,025

 

 

(f)

 

 

7,303,943

 

 

 
3

 

 

Pro Forma Condensed Combined Statement of Operations — Year Ended December 31, 2020

(in thousands, except share and per share amounts)

 

 

 

 

 

 

 

 

 

Transaction

 

 

 

 

Pro Forma

 

 

 

AzurRx

 

 

First Wave Bio

 

 

Adjustments

 

 

Note 3

 

Combined

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenues

 

$ -

 

 

$ 13,250

 

 

$ (13,250 )

 

(g)

 

$ -

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

5,888

 

 

 

-

 

 

 

-

 

 

 

 

 

5,888

 

Research and development - license acquired

 

 

13,250

 

 

 

-

 

 

 

20,372

 

 

(c)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,250 )

 

(g)

 

 

20,372

 

General and administrative

 

 

7,295

 

 

 

4,110

 

 

 

325

 

 

(c)

 

 

12,980

 

 

 

 

 

 

 

 

 

 

 

 

1,250

 

 

(d)

 

 

 

 

Total operating expenses

 

 

26,433

 

 

 

4,110

 

 

 

8,697

 

 

 

 

 

39,240

 

Loss from operations

 

 

(26,433 )

 

 

9,140

 

 

 

(21,947 )

 

 

 

 

(39,240 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(5,840 )

 

 

(79 )

 

 

79

 

 

(e)

 

 

(5,840 )
Interest income

 

 

1

 

 

 

-

 

 

 

-

 

 

 

 

 

1

 

Foreign exchange loss

 

 

-

 

 

 

(40 )

 

 

-

 

 

 

 

 

(40 )
Other

 

 

-

 

 

 

17

 

 

 

-

 

 

 

 

 

17

 

Gain on settlement

 

 

211

 

 

 

-

 

 

 

-

 

 

 

 

 

211

 

Loss on debt extinguishment

 

 

(610 )

 

 

-

 

 

 

-

 

 

 

 

 

(610 )
Total other (income)/expense

 

 

(6,238 )

 

 

(102 )

 

 

79

 

 

 

 

 

(6,261 )
Loss before income taxes

 

 

(32,671 )

 

 

9,038

 

 

 

(21,868 )

 

 

 

 

(45,501 )
Income tax expense

 

 

-

 

 

 

2

 

 

 

-

 

 

 

 

 

2

 

Net loss

 

$ (32,671 )

 

$ 9,036

 

 

$ (21,868 )

 

 

 

$ (45,503 )
Deemed dividend on preferred stock

 

 

(8,155 )

 

 

-

 

 

 

-

 

 

 

 

 

(8,155 )
Preferred stock dividends

 

 

(906 )

 

 

-

 

 

 

-

 

 

 

 

 

(906 )
Net loss applicable to common shareholders

 

$ (41,732 )

 

$ 9,036

 

 

$ (21,868 )

 

 

 

$ (54,564 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss applicable to common shareholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$ (11.49 )

 

 

 

 

 

 

 

 

 

 

 

$ (13.12 )
Weighted average number of shares

 

 

2,843,629

 

 

 

 

 

 

 

624,025

 

 

(f)

 

 

3,467,654

 

 

 
4

 

 

Notes to the Unaudited Pro Forma Condensed

 

Basis of Presentation

 

The unaudited pro forma condensed combined financial information has been prepared in accordance with Article 11, as amended by SEC Final Rule Release No. 33-10786, Amendments to Financial Disclosures About Acquired and Disposed Businesses. In accordance with Release No. 33-10786, the unaudited condensed combined pro forma balance sheet and statements of operations reflect transaction accounting adjustments, as well as other adjustments deemed to be directly related to the transaction, irrespective of whether or not such adjustment is deemed to be recurring.

 

The unaudited pro forma condensed combined financial information was prepared in accordance with U.S. GAAP and pursuant to the rules and regulations of SEC Regulation S-X and presents the pro forma financial position and results of operations of the combined companies based upon the historical data of AzurRx and First Wave Bio.

 

For the purposes of the unaudited pro forma combined financial information, the accounting policies of AzurRx and First Wave Bio are aligned with no differences. Accordingly, no effect has been provided for the pro forma adjustments described in Note 3, “Pro forma adjustments.”

 

The attached proforma gives effect to the 10-for-1 reverse stock split that was also effective on the Closing Date.

 

Description of Transaction

 

On September 13, 2021, AzurRx, Alpha Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of AzurRx (“Merger Sub”), First Wave Bio, and Fortis Advisors LLC, a Delaware limited liability company, solely in its capacity as the representative of the stockholders and option holders of First Wave Bio (the “Stockholders”) entered into an Agreement and Plan of Merger (the “Merger Agreement”). Pursuant to the Merger Agreement, the Company acquired First Wave Bio through the merger of Merger Sub with and into First Wave Bio (the “Merger”), with First Wave Bio surviving the merger as the surviving entity (the “Surviving Corporation”). The Merger closed on September 13, 2021 (the “Closing Date”). From and after the effective time of the Merger (the “Effective Time”), the separate corporate existence of Merger Sub ceased and the Surviving Corporation continued its existence under the laws of the State of Delaware and became a wholly owned subsidiary of the Company.

 

As a result of the Merger, each share of First Wave Bio common stock, par value $0.0001 per share (“First Wave Bio Common Stock”), options to purchase First Wave Common Stock (“First Wave Bio Options”), First Wave Bio restricted stock units, First Wave Bio Series A Preferred Stock, par value $0.0001 per share, and First Wave Bio Series B Preferred Stock, par value $0.0001 per share, outstanding immediately prior to the Effective Time will be converted into the right to receive the applicable pro rata share of an aggregate of approximately $22.0 million worth of consideration, consisting of (i) approximately $18.0 million in cash, approximately $3.0 million of which is due on the Closing Date (as adjusted for First Wave Bio’s cash and cash equivalents, outstanding indebtedness, transaction expenses and the aggregate exercise price of First Wave Bio Options outstanding immediately prior to the Closing Date), $8.0 million of which is payable within 45 days of the Closing Date, and $7.0 million of which is payable by March 31, 2022, and (ii) 624,025 shares of common stock (the “Common Stock Consideration”) of the Company, par value $0.0001 per share (the “Common Stock”), based on a value of $4.0 million divided by $6.41 per share, as adjusted for the Company’s previously disclosed 10-for-1 reverse stock split that was also effective on the Closing Date.

 

Pursuant to the Merger Agreement, Stockholders are also entitled to the applicable pro rata share of each Milestone Payment, if any, as defined in the Merger Agreement, in an aggregate amount of up to $207.0 million, contingent upon the achievement of specified development, regulatory and sales goals for the use of First Wave Bio’s proprietary formulations of niclosamide in the treatment of COVID, Immune Checkpoint Inhibitor-Associated Colitis and ulcerative colitis, and Crohn’s disease, ulcerative proctitis and/or ulcerative proctosigmoiditis (“IBD”). All Milestone Payments will be payable in cash, provided that 25% of the Milestone Payments attributable to IBD will be payable, at the Company’s option, in Common Stock. In addition, Stockholders are entitled to 10% of certain specified revenue received by the Company from any third party with a pre-existing niclosamide development program relating to COVID.

 

 
5

 

 

As a result of the Merger, as of the Closing Date, the License Agreement, dated December 31, 2020, previously entered into between the Company and First Wave Bio will terminate. Under the License Agreement, First Wave Bio granted the Company a worldwide, exclusive right to develop, manufacture, and commercialize First Wave Bio’s proprietary immediate release and enema formulations of niclosamide for the fields of treating ICI-AC and COVID-19 in humans.

 

Common Stock Consideration and the shares of Common Stock, if any, issued as Milestone Payments, are subject to customary registration rights, and the Company shall use commercially reasonable efforts to file a registration statement registering such shares of Common Stock promptly after December 31, 2021.

 

Accounting for the Transaction

 

AzurRx has concluded that the transaction will be accounted for as an asset acquisition in accordance with FASB ASC 805-50 and FASB ASC 350 as the majority of the fair value of the assets acquired was concentrated in a group of similar assets, and the acquired assets did not have outputs or employees. The assets acquired had not yet received regulatory approval, the $20.0 million purchase price for First Wave Bio’s intangible assets will be expensed in the Company’s statement of operations on the consummation of the transaction. In addition, the potential milestone payments are not yet considered probable, and no milestone payments have been accrued in this pro forma financial statement at June 30, 2021.

 

Note 2 — Preliminary purchase price allocation

 

The following is the preliminary estimate of the fair value assets acquired and the liabilities assumed by AzurRx in the merger, reconciled to the purchase price transferred (in thousands):

 

Cash and cash equivalents

 

$ 2,185

 

Prepaid expense and other current assets

 

 

53

 

Research and development - license acquired

 

 

20,372

 

Legal expenses

 

 

325

 

Total consideration

 

$ 22,935

 

 

 
6

 

 

Note 3 — Pro forma adjustments

 

The pro forma adjustments are based on our preliminary estimates and assumptions that are subject to change. The following adjustments have been reflected in the unaudited pro forma condensed combined financial information:

  

 

(a)

Represents the issuance of 624,025 shares of AzurRx and its effect on the common stock (par value of $0.0001 per share) and additional paid in capital accounts (in thousands). The 624,025 shares of common stock  priced at $6.41 equals the $4.0 million in common stock consideration.

 

 

 

Common

 

 

Additional

 

 

 

Shares

 

 

Paid in Capital

 

 

 

 

 

 

 

 

Issuance of 624,025 shares

 

$ -

 

 

$ -

 

 

 

(b)

Represents the pay-off of all of First Wave Bio’s liabilities.

 

Accounts payable and accrued expenses

 

$ 471

 

Convertible debt

 

 

2,000

 

Pay-off of all liabilities

 

$ 2,471

 

 

 

(c)

Represents the elimination of the historical equity of First Wave Bio’s equity and the initial allocation of excess purchase price to research and development expense – license acquired and legal expenses to general and administrative expenses, as follows (in thousands):

 

Total consideration

 

$ 22,935 (**)
Additional paid-in-capital

 

 

(9,381 )
Accumulated deficit

 

 

2,934

 

Elimination of AzuRx common stock

 

 

2,730

 

Elimination of payable/receivable for license

 

 

1,250

 

Write-off of intangibles

 

 

229

 

Legal expenses

 

 

(325 )
Research and development expense

 

$ 20,372

 

______________

(**)

Consideration of $22.9 million represents 1) the upfront cash payment of $3.9 million ($3.0 million payment with contractual adjustments), 2) common stock consideration of $4.0 million, 3) second cash payment of $8.0 million (payable with 45 days after closing) and 4) third cash payment of $7.0 million (payable by March 31, 2022).

 

 

(d)

Reflects an adjustment of approximately $1.25 million for the estimated transaction costs for both AzurRx and First Wave Bio, such as adviser fees, legal and accounting expenses that were not incurred as of June 30, 2021.

 

 

 

 

(e)

Represents the elimination of convertible debt interest on First Wave Bio.

 

 

 

 

(f)

Represents the increase in the weighted average shares due to the issuance of an estimated 624,025 shares of common stock in connection with the Merger.

 

 
7

 

 

 

(g)

Represents the elimination of:

 

 

·

$1.250 million license payable/receivable between AzurRx and First Wave Bio as of June 30, 2021;

 

 

 

 

·

$13.25 million related to the fair value of the license (recorded as research and development - license acquired by AzurRx and revenue by First Wave Bio) during the year ended December 31, 2021; and

 

 

 

 

·

the elimination of AzurRx common stock as of June 30, 2021 and related unrealized loss of $0.3 million recorded during he six months ended June 30, 2021.

 

 
8