UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): February 26, 2021

 

 

SATSUMA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39041   81-3039831

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification Number)

400 Oyster Point Boulevard, Suite 221

South San Francisco, CA 94080

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 410-3200

 

 

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 (see General Instructions A.2. below):

 

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    STSA    The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 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 February 26, 2021, Satsuma Pharmaceuticals, Inc. (“Satsuma” or the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain purchasers identified on Exhibit A thereto (the “Purchasers”), pursuant to which the Company offered to the Purchasers, in an unregistered offering, shares of common stock, par value $0.0001 per share (the “Common Stock”) for aggregate gross proceeds to the Company of approximately $80.0 million (the “Private Placement”). Pursuant to the Purchase Agreement, the Company has agreed to sell and issue to the Purchasers an aggregate of 14,084,507 shares of its Common Stock (the “Shares”) at a per share purchase price of $5.68, the closing price of its Common Stock on the Nasdaq Global Market on February 26, 2021. The Private Placement is being made in accordance with applicable Nasdaq rules and is priced at the “Minimum Price” (as defined in the Nasdaq rules). The closing of the Private Placement is expected to occur on March 3, 2021 (the “Closing”). Following the Closing of the Private Placement, the Company will have 31,521,485 shares of Common Stock outstanding.

Pursuant to the Purchase Agreement at the Closing, the Registration Rights Agreement that the Company and the Purchasers entered into in connection with the Private Placement will become effective. Pursuant to the Registration Rights Agreement, the Company has agreed to file a resale registration statement with the Securities and Exchange Commission as soon as practicable, and in all events within 45 days after the Closing, to register the resale of the Shares issued at the Closing.

The foregoing summaries of the Private Placement, the Shares to be issued in connection therewith, the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the definitive transaction documents. A copy of the Purchase Agreement and the Registration Rights Agreement are attached hereto as Exhibits 10.1 and 10.2, respectively, and are incorporated herein by reference.

 

Item 3.02

Unregistered Sales of Equity Securities.

To the extent required by Item 3.02 of Form 8-K, the information regarding the Common Stock set forth under Item 1.01 of this Form 8-K is incorporated by reference in this Item 3.02. The Company issued the Common Stock in reliance on the exemption from registration provided for under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Rule 506 of Regulation D thereunder. The Company relied on this exemption from registration for private placements based in part on the representations made by the Purchasers, including the representations with respect to each Purchaser’s status as an accredited investor, as such term is defined in Rule 501(a) of the Securities Act, and each Purchaser’s investment intent. The offer and sale of the Shares have not been registered under the Securities Act.

 

Item 8.01

Other Events.

On March 1, 2021, Satsuma issued a press release regarding its updated STS101 development plan (dihydroergotamine (DHE) nasal) powder as an acute treatment for migraine. In addition, the Company intends to host a conference call on Monday, March 1, 2021 at 8:00 a.m. Eastern Time to discuss the updated development plan. A copy of the press release and the presentation materials are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

(d)    Exhibits

 

Exhibit

No.

  

Description

10.1    Securities Purchase Agreement, dated February 26, 2021
10.2    Registration Rights Agreement to be effective on March 3, 2021
99.1    Press Release dated March 1, 2021
99.2    Company presentation dated March 1, 2021


SIGNATURES

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

 

    SATSUMA PHARMACEUTICALS, INC.
Date: March 1, 2021     By:  

/s/ Thomas O’Neil

     

Thomas O’Neil

Chief Financial Officer

Exhibit 10.1

SECURITIES PURCHASE AGREEMENT

This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is made and entered into as of February 26, 2021 by and among Satsuma Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and the Investors identified on Exhibit A attached hereto (each an “Investor” and collectively the “Investors”).

RECITALS

A. The Company and the Investors are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by the provisions of Section 4(a)(2) of the 1933 Act (as defined below), and Rule 506 of Regulation D (“Regulation D”) as promulgated by the SEC (as defined below) under the 1933 Act;

B. The Investors wish to purchase from the Company, and the Company wishes to sell and issue to the Investors, upon the terms and subject to the conditions stated in this Agreement, an aggregate of 14,084,507 shares (the “Shares”) of the Company’s Common Stock, par value $0.0001 per share (the “Common Stock”); and

C. Contemporaneously with the sale of the Shares, the parties hereto will execute and deliver a Registration Rights Agreement, in the form attached hereto as Exhibit B (the “Registration Rights Agreement”), pursuant to which the Company will agree to provide certain registration rights in respect of the Shares under the 1933 Act and applicable state securities laws.

In consideration of the mutual promises made herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

1. Definitions. For the purposes of this Agreement, the following terms shall have the meanings set forth below:

Affiliate” means, with respect to any Person, any other Person which directly or indirectly through one or more intermediaries Controls, is controlled by, or is under common Control with such Person.

Business Day” means a day, other than a Saturday or Sunday, on which banks in New York City are open for the general transaction of business.

Closing” has the meaning set forth in Section 3.1.

Closing Date” has the meaning set forth in Section 3.1.

Common Stock” has the meaning set forth in the recitals to this Agreement.

Company Covered Person” means, with respect to the Company as an “issuer” for purposes of Rule 506 promulgated under the 1933 Act, any Person listed in the first paragraph of Rule 506(d)(1).

 


Company’s Knowledge” means the actual knowledge of the executive officers (as defined in Rule 405 under the 1933 Act) of the Company.

Control” (including the terms “controlling,” “controlled by” or “under common control with”) means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.

Disqualification Event” has the meaning set forth in Section 4.31.

EDGAR system” has the meaning set forth in Section 4.9.

Effective Date” has the meaning set forth in Section 7.4(b).

Environmental Laws” has the meaning set forth in Section 4.15.

GAAP” has the meaning set forth in Section 4.17.

Intellectual Property” has the meaning set forth in Section 4.14.

Losses” has the meaning set forth in Section 8.2.

Material Adverse Effect” means a material adverse effect on (i) the assets, liabilities, results of operations, financial condition or business of the Company taken as a whole, (ii) the legality or enforceability of any of the Transaction Documents or (iii) the ability of the Company to perform its obligations under the Transaction Documents, except that for purposes of Section 6.1(i) of this Agreement, in no event shall a change in the market price of the Common Stock alone constitute a “Material Adverse Effect”.

Material Contract” means any contract, instrument or other agreement to which the Company is a party or by which it is bound that has been filed or was required to have been filed as an exhibit to the SEC Filings pursuant to Item 601(b)(4) or Item 601(b)(10) of Regulation S-K.

Nasdaq” means the Nasdaq Global Market.

Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

Placement Agent” means SVB Leerink LLC.

Press Release” has the meaning set forth in Section 9.7.

Principal Trading Market” means the Trading Market on which the Common Stock is primarily listed on and quoted for trading, which, as of the date of this Agreement and the Closing Date, shall be the Nasdaq Global Market.

Registration Rights Agreement” has the meaning set forth in the recitals to this Agreement.

 

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Regulation D” has the meaning set forth in the recitals to this Agreement.

Regulatory Authorities” has the meaning set forth in Section 4.28.

Required Investors” has the meaning set forth in the Registration Rights Agreement.

SEC” means the U.S. Securities and Exchange Commission.

SEC Filings” has the meaning set forth in Section 4.8.

Shares” has the meaning set forth in the recitals to this Agreement.

Short Sales” means all “short sales” as defined in Rule 200 of Regulation SHO under the 1934 Act (but shall not be deemed to include the location and/or reservation of borrowable shares of Common Stock).

Trading Day” means (i) a day on which the Common Stock is listed or quoted and traded on its Principal Trading Market (other than the OTC Bulletin Board), or (ii) if the Common Stock is not listed on a Trading Market (other than the OTC Bulletin Board), a day on which the Common Stock is traded in the over-the-counter market, as reported by the OTC Bulletin Board, or (iii) if the Common Stock is not quoted on any Trading Market, a day on which the Common Stock is quoted in the over-the-counter market as reported in the “pink sheets” by OTC Markets Group Inc. (or any similar organization or agency succeeding to its functions of reporting prices); provided, that in the event that the Common Stock is not listed or quoted as set forth in (i), (ii) or (iii) hereof, then Trading Day shall mean a Business Day.

Trading Market” means whichever of the New York Stock Exchange, the NYSE American, the Nasdaq Global Select Market, the Nasdaq Global Market, the Nasdaq Capital Market or the OTC Bulletin Board on which the Common Stock is listed or quoted for trading on the date in question.

Transfer Agent” has the meaning set forth in Section 7.4(a).

Transaction Documents” means this Agreement and the Registration Rights Agreement.

1933 Act” means the Securities Act of 1933, as amended, or any successor statute, and the rules and regulations promulgated thereunder.

1934 Act” means the Securities Exchange Act of 1934, as amended, or any successor statute, and the rules and regulations promulgated thereunder.

2. Purchase and Sale of the Shares. On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company will issue and sell, and each Investor will purchase, severally and not jointly, the number of Shares set forth opposite the name of such Investor under the heading “Number of Shares to be Purchased” on Exhibit A attached hereto. The purchase price per Share shall be $5.68.

 

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3. Closing.

3.1. Upon the satisfaction of the conditions set forth in Section 6, the completion of the purchase and sale of the Shares (the “Closing”) shall occur remotely via exchange of documents and signatures at a time (the “Closing Date”) to be agreed to by the Company and the Investors but (i) in no event earlier than the second Business Day after the date hereof and (ii) in no event later than the fifth Trading Day after the date hereof, and of which the Investors will be notified in advance by the Placement Agent.

3.2. On the Closing Date, each Investor shall deliver or cause to be delivered to the Company, via wire transfer of immediately available funds pursuant to the wire instructions delivered to such Investor by the Company on or prior to the Closing Date, an amount equal to the purchase price to be paid by the Investor for the Shares to be acquired by it as set forth opposite the name of such Investor under the heading “Aggregate Purchase Price of Shares” on Exhibit A attached hereto.

3.3. At or before the Closing, the Company shall deliver or cause to be delivered to each Investor a number of Shares, registered in the name of the Investor (or its nominee in accordance with its delivery instructions), equal to the number of Shares set forth opposite the name of such Investor under the heading “Number of Shares to be Purchased” on Exhibit A attached hereto. The Shares shall be delivered via a book-entry record through the Company’s transfer agent. Unless the Company and an Investor otherwise mutually agree with respect to such Investor’s Shares, at Closing settlement shall occur on a “delivery versus payment” basis.

4. Representations and Warranties of the Company. The Company hereby represents and warrants to the Investors that, except (a) as described in the Company’s SEC Filings (as defined below) and (b) as set forth on the disclosure schedule delivered herewith (which is arranged in numbered and lettered sections corresponding to the numbered and lettered sections contained in this Section 4) (the “Disclosure Schedule”), each of which qualify these representations and warranties in their entirety:

4.1. Organization, Good Standing and Qualification. The Company is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has all requisite corporate power and authority to carry on its business as now conducted and to own or lease its properties and to enter into and perform its obligations under the Transaction Documents. The Company is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction in which the conduct of its business or its ownership or leasing of property makes such qualification or leasing necessary unless the failure to so qualify has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

4.2. Authorization. The Company has the requisite corporate power and authority and has taken all requisite corporate action necessary for, and no further action on the part of the Company, its officers, directors and stockholders is necessary for, (i) the authorization, execution and delivery of the Transaction Documents, (ii) the authorization of the performance of all obligations of the Company hereunder or thereunder, and (iii) the authorization, issuance (or reservation for issuance) and delivery of the Shares. The Transaction Documents have been duly executed and delivered by the Company and constitute the legal, valid and binding obligations of the Company, enforceable against the Company in accordance with their terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability, relating to or affecting creditors’ rights generally and to general equitable principles.

 

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4.3. Capitalization. The Company is authorized under its Certificate of Incorporation to issue 300,000,000 shares of Common Stock and 10,000,000 shares of Preferred Stock, par value $0.0001 per share. The Company’s disclosure of its issued and outstanding capital stock in its most recent SEC Filing containing such disclosure was accurate in all material respects as of the date indicated in such SEC Filing. All of the issued and outstanding shares of the Company’s capital stock have been duly authorized and validly issued and are fully paid and nonassessable; none of such shares were issued in violation of any preemptive rights; and such shares were issued in compliance in all material respects with applicable state and federal securities law and any rights of third parties. No Person is entitled to preemptive or similar statutory or contractual rights with respect to the issuance by the Company of any securities of the Company, including, without limitation, the Shares. Except for stock options granted under Company stock-based compensation plans described in the SEC Filings, there are no outstanding warrants, options, convertible securities or other rights, agreements or arrangements of any character under which the Company is or may be obligated to issue any equity securities of any kind, except as contemplated by this Agreement. There are no voting agreements, buy-sell agreements, option or right of first purchase agreements or other similar agreements among the Company and any of the securityholders of the Company relating to the securities of the Company held by them. Except as provided in the Registration Rights Agreement, and except as provided in that certain Amended and Restated Investors’ Rights Agreement, dated as of April 23, 2019, by and among the Company and certain investors signatory thereto, no Person has the right to (i) require the Company to register any securities of the Company under the 1933 Act, whether on a demand basis or in connection with the registration of securities of the Company for its own account or for the account of any other Person, or (ii) prohibit the Company from filing a registration statement under the 1933 Act.

The issuance and sale of the Shares hereunder will not obligate the Company to issue shares of Common Stock or other securities to any other Person (other than the Investors) and will not result in the adjustment of the exercise, conversion, exchange or reset price of any outstanding security.

The Company does not have outstanding stockholder purchase rights or “poison pill” or any similar arrangement in effect giving any Person the right to purchase any equity interest in the Company upon the occurrence of certain events.

4.4. Valid Issuance. The Shares have been duly and validly authorized and, when issued and paid for pursuant to this Agreement, will be validly issued, fully paid and nonassessable, and shall be free and clear of all encumbrances and restrictions (other than those created by the Investors), except for restrictions on transfer set forth in the Transaction Documents or imposed by applicable securities laws.

 

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4.5. Consents. Subject to the accuracy of the representations and warranties of each Investor set forth in Section 5 hereof, the execution, delivery and performance by the Company of the Transaction Documents and the offer, issuance and sale of the Shares require no consent of, action by or in respect of, or filing with, any Person, governmental body, agency, or official other than (a) filings that have been made pursuant to applicable state securities laws, (b) post-sale filings pursuant to applicable state and federal securities laws, (c) filings pursuant to the rules and regulations of Nasdaq and (d) filing of the registration statement required to be filed by the Registration Rights Agreement, each of which the Company has filed or undertakes to file within the applicable time. Subject to the accuracy of the representations and warranties of each Investor set forth in Section 5 hereof, the Company has taken all action necessary to exempt (i) the issuance and sale of the Shares and (ii) the other transactions contemplated by the Transaction Documents from the provisions of any stockholder rights plan or other “poison pill” arrangement, any anti-takeover, business combination or control share law or statute binding on the Company or to which the Company or any of its assets and properties is subject that is or could reasonably be expected to become applicable to the Investors as a result of the transactions contemplated hereby, including without limitation, the issuance of the Shares and the ownership, disposition or voting of the Shares by the Investors or the exercise of any right granted to the Investors pursuant to this Agreement or the other Transaction Documents.

4.6. Use of Proceeds. The net proceeds of the sale of the Shares hereunder shall be used by the Company for working capital and general corporate purposes.

4.7. No Material Adverse Change. Since September 30, 2020, except as identified and described in the SEC Filings filed at least one Trading Day prior to the date hereof, there has not been:

(i) any change in the consolidated assets, liabilities, financial condition or operating results of the Company from that reflected in the financial statements included in the Company’s Quarterly Report on Form 10-Q for the nine month period ended September 30, 2020 except for changes in the ordinary course of business which have not had and would not reasonably be expected to have a Material Adverse Effect, individually or in the aggregate;

(ii) any declaration or payment by the Company of any dividend, or any authorization or payment by the Company of any distribution, on any of the capital stock of the Company, or any redemption or repurchase by the Company of any securities of the Company;

(iii) any material damage, destruction or loss, whether or not covered by insurance, to any assets or properties of the Company;

(iv) any waiver, not in the ordinary course of business, by the Company of a material right or of a material debt owed to it;

(v) any satisfaction or discharge of any lien, claim or encumbrance or payment of any obligation by the Company, except in the ordinary course of business and which is not material to the assets, properties, financial condition, operating results or business of the Company (as such business is presently conducted);

 

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(vi) any change or amendment to the Company’s Certificate of Incorporation or Bylaws, or material change to any material contract or arrangement by which the Company is bound or to which any of its assets or properties is subject;

(vii) any material labor difficulties or, to the Company’s Knowledge, labor union organizing activities with respect to employees of the Company;

(viii) any material transaction entered into by the Company other than in the ordinary course of business;

(ix) the loss of the services of any key employee, or material change in the composition or duties of the senior management of the Company; or

(x) any other event or condition of any character that has had or would reasonably be expected to have a Material Adverse Effect.

4.8. SEC Filings. The Company has timely filed all reports, schedules, forms, statements and other documents required to be filed by the Company under the 1933 Act and the 1934 Act, including pursuant to Section 13(a) or 15(d) thereof, since the Company’s initial public offering (or such shorter period as the Company was required by law or regulation to file such material) (collectively, the “SEC Filings”). The SEC Filings do not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading. At the time of filing thereof, the SEC Filings complied in all material respects with the requirements of the 1933 Act or the 1934 Act, as applicable, and the rules and regulations of the SEC thereunder.

4.9. No Conflict, Breach, Violation or Default. The execution, delivery and performance of the Transaction Documents by the Company and the issuance and sale of the Shares in accordance with the provisions thereof will not, except (solely in the case of clauses (i)(b) and (ii)) for such violations, conflicts or defaults as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, (i) conflict with or result in a breach or violation of (a) any of the terms and provisions of, or constitute a default under, the Company’s Certificate of Incorporation or the Company’s Bylaws, both as in effect on the date hereof (true and complete copies of which have been made available to the Investors through the Electronic Data Gathering, Analysis, and Retrieval system (the “EDGAR system”)), or (b) assuming the accuracy of the representations and warranties in Section 5, any applicable statute, rule, regulation or order of any governmental agency or body or any court, domestic or foreign, having jurisdiction over the Company, or any of their assets or properties, or (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any lien, encumbrance or other adverse claim upon any of the properties or assets of the Company or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any Material Contract. This Section does not relate to matters with respect to tax status, which are the subject of Section 4.10, employee relations and labor matters, which are the subject of Section 4.13, or environmental laws, which are the subject of Section 4.15.

 

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4.10. Tax Matters. The Company has timely prepared and filed all material tax returns required to have been filed by them with all appropriate governmental agencies and timely paid all material taxes shown thereon or otherwise owed by them. There are no material unpaid assessments against the Company nor, to the Company’s Knowledge, any audits by any federal, state or local taxing authority. All material taxes that the Company is required to withhold or to collect for payment have been duly withheld and collected and paid to the proper governmental entity or third party when due. There are no tax liens pending or, to the Company’s Knowledge, threatened against the Company or any of its assets or property. With the exception of agreements or other arrangements that are not primarily related to taxes entered into in the ordinary course of business, there are no outstanding tax sharing agreements or other such arrangements between the Company and any other corporation or entity.

4.11. Title to Properties. The Company has good and marketable title to all real properties and all other properties and assets owned by them, in each case free from liens, encumbrances and defects, except such as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect; and the Company holds any leased real or personal property under valid and enforceable leases with no exceptions, except such as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

4.12. Certificates, Authorities and Permits. The Company possesses adequate certificates, authorities or permits issued by appropriate governmental agencies or bodies necessary to conduct the business now operated by it, except where failure to so possess would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. The Company has not received any written, and to the Company’s Knowledge, oral, notice of proceedings relating to the revocation or modification of any such certificate, authority or permit that would reasonably be expected to have a Material Adverse Effect, individually or in the aggregate, on the Company.

4.13. Labor Matters.

(a) The Company is not party to or bound by any collective bargaining agreements or other agreements with labor organizations. The Company has not violated in any material respect any laws, regulations, orders or contract terms affecting the collective bargaining rights of employees or labor organizations, or any laws, regulations or orders affecting employment discrimination, equal opportunity employment, or employees’ health, safety, welfare, wages and hours.

(b) No material labor dispute with the employees of the Company, or with the employees of any principal supplier, manufacturer, customer or contractor of the Company, exists or, to the Company’s Knowledge, is threatened or imminent.

4.14. Intellectual Property. The Company owns, possesses, licenses or has other rights to use, all patents, patent applications, trade and service marks, trade and service mark registrations, trade names, copyrights, licenses, inventions, trade secrets, technology, know-how and other intellectual property (collectively, the “Intellectual Property”) necessary for the conduct of the Company’s business in all material respects as now conducted or as proposed in the SEC Filings to be conducted; and (a) there are no rights of third parties to any such Intellectual Property,

 

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including no liens, security interests or other encumbrances; (b) to the Company’s Knowledge, there is no material infringement by third parties of any such Intellectual Property; (c) there is no pending or, to the Company’s Knowledge, threatened action, suit, proceeding or claim by others challenging the Company’s rights in or to any such Intellectual Property; (d) such Intellectual Property that is described in the SEC Filings has not been adjudged by a court of competent jurisdiction invalid or unenforceable, in whole or in part; (e) there is no pending or, to the Company’s Knowledge, threatened action, suit, proceeding or claim by others challenging the validity or scope of any such Intellectual Property that is owned or licensed by the Company, including interferences, oppositions, reexaminations or government proceedings; (f) there is no pending or, to the Company’s Knowledge, threatened action, suit, proceeding or claim by others that the Company infringes, misappropriates, or otherwise violates any patent, trademark, copyright, trade secret or other proprietary rights of others; and (g) to the Company’s Knowledge, each Company employee involved with the development of Intellectual Property has entered into an invention assignment agreement with the Company.

4.15. Environmental Matters. The Company is not in violation of any statute, rule, regulation, decision or order of any governmental agency or body or any court, domestic or foreign, relating to the use, disposal or release of hazardous or toxic substances or relating to the protection or restoration of the environment or human exposure to hazardous or toxic substances (collectively, “Environmental Laws”), has not released any hazardous substances regulated by Environmental Law onto any real property that it owns or operates and has not received any written notice or claim it is liable for any off-site disposal or contamination pursuant to any Environmental Laws, which violation, release, notice, claim, or liability would reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, and to the Company’s Knowledge, there is no pending or threatened investigation that would reasonably be expected to lead to such a claim.

4.16. Legal Proceedings. There are no legal, governmental or regulatory investigations, actions, suits or proceedings pending to which the Company is or may reasonably be expected to become a party or to which any property of the Company is or may reasonably be expected to become the subject that, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect.

4.17. Financial Statements. The financial statements included in each SEC Filing comply in all material respects with applicable accounting requirements and the rules and regulations of the SEC with respect thereto as in effect at the time of filing (or to the extent corrected by a subsequent restatement) and present fairly, in all material respects, the consolidated financial position of the Company as of the dates shown and its consolidated results of operations and cash flows for the periods shown, subject in the case of unaudited financial statements to normal, immaterial year-end audit adjustments, and such consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles applied on a consistent basis during the periods involved (“GAAP”) (except as may be disclosed therein or in the notes thereto, and except that the unaudited financial statements may not contain all footnotes required by GAAP, and, in the case of quarterly financial statements, except as permitted by Form 10-Q under the 1934 Act). Except as set forth in the financial statements of the Company included in the SEC Filings filed prior to the date hereof, the Company has not incurred any liabilities, contingent or otherwise, except those incurred in the ordinary course of business, consistent (as to amount and nature) with past practices since the date of such financial statements, none of which, individually or in the aggregate, have had or would reasonably be expected to have a Material Adverse Effect.

 

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4.18. Insurance Coverage. The Company maintains in full force and effect insurance coverage that is customary for comparably situated companies for the business being conducted and properties owned or leased by the Company, and the Company reasonably believes such insurance coverage to be adequate against all liabilities, claims and risks against which it is customary for comparably situated companies to insure.

4.19. Compliance with Nasdaq Continued Listing Requirements. The Company is in compliance with applicable Nasdaq continued listing requirements. There are no proceedings pending or, to the Company’s Knowledge, threatened against the Company relating to the continued listing of the Common Stock on Nasdaq and the Company has not received any notice of, nor to the Company’s Knowledge is there any reasonable basis for, the delisting of the Common Stock from Nasdaq.

4.20. Brokers and Finders. Other than the Placement Agent, no Person will have, as a result of the transactions contemplated by the Transaction Documents, any valid right, interest or claim against or upon the Company or an Investor for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Company. No Investor shall have any obligation with respect to any fees, or with respect to any claims made by or on behalf of other Persons for fees, in each case of the type contemplated by this Section 4.20 that may be due in connection with the transactions contemplated by this Agreement or the Transaction Documents.

4.21. No Directed Selling Efforts or General Solicitation. Neither the Company nor any Person acting on its behalf has conducted any general solicitation or general advertising (as those terms are used in Regulation D) in connection with the offer or sale of any of the Shares.

4.22. No Integrated Offering. Neither the Company nor any Person acting on its behalf has, directly or indirectly, made any offers or sales of any Company security or solicited any offers to buy any Company security, under circumstances that would adversely affect reliance by the Company on Section 4(a)(2) and Regulation D for the exemption from registration for the transactions contemplated hereby or would require registration of the Shares under the 1933 Act.

4.23. Private Placement. Assuming the accuracy of the representations and warranties of the Investors set forth in Section 5, the offer and sale of the Shares to the Investors as contemplated hereby is exempt from the registration requirements of the 1933 Act. The issuance and sale of the Shares does not contravene the rules and regulations of Nasdaq.

4.24. Transactions with Affiliates. None of the executive officers or directors of the Company and, to the Company’s Knowledge, none of the employees of the Company is presently a party to any transaction with the Company (other than as holders of stock options, warrants and/or restricted stock, and for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring payments to or from any officer, director or such employee or, to the Company’s Knowledge, any entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee or partner.

 

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4.25. Internal Controls. The Company has established and maintains disclosure controls and procedures (as defined in Rules 13a-15 and 15d-15 under the 1934 Act), which are designed to ensure that material information relating to the Company, is made known to the Company’s principal executive officer and its principal financial officer by others within those entities. Since the end of the Company’s most recent audited fiscal year, there have been no material weaknesses in the Company’s internal control over financial reporting (whether or not remediated) and no change in the Company’s internal control over financial reporting that has materially affected, or would reasonably be expected to materially affect, the Company’s internal control over financial reporting. The Company is not aware of any change in its internal controls over financial reporting that has occurred during its most recent fiscal quarter that has materially affected, or would reasonably be expected to materially affect, the Company’s internal control over financial reporting.

4.26. Disclosures. Neither the Company nor any Person acting on its behalf has provided the Investors or their agents or counsel with any information that constitutes material nonpublic information concerning the Company, other than with respect to the transactions contemplated hereby and such information that will be disclosed in the Press Release or the 8-K Filing (each as defined below). The Company understands and confirms that the Investors will rely on the foregoing representations in effecting transactions in securities of the Company.

4.27. Required Filings. Except for the transactions contemplated by this Agreement, including the acquisition of the Shares contemplated hereby, no event or circumstance has occurred or information exists with respect to the Company or its business, properties, operations or financial condition, which, under applicable law, rule or regulation, requires public disclosure or announcement by the Company but which has not been so publicly announced or disclosed (assuming for this purpose that the SEC Filings are being incorporated by reference into an effective registration statement filed by the Company under the 1933 Act).

4.28. Investment Company. The Company is not required to be registered as, and immediately following the Closing will not be required to register as, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.

4.29. Tests and Preclinical and Clinical Trials. All clinical and pre-clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described or referred to in the SEC Filings were and, if still pending, are being conducted, in all material respects, in compliance with the experimental protocols established for such trials, with accepted medical and scientific standards, and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and Good Clinical Practice and Good Laboratory Practice requirements. The descriptions of the clinical and pre-clinical trials, including the results thereof, contained in the SEC Filing are accurate and complete in all material respects and fairly present the data derived from such trials in all material respects; and the

 

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Company is not aware of any other clinical or pre-clinical trials, the results of which reasonably call into question the results described in the SEC Filings. The Company has not received any notices or correspondence from the Regulatory Authorities or institutional review boards or comparable authorities requiring the termination, suspension, material modification or clinical hold of any clinical or pre-clinical trials conducted by or on behalf of the Company, and to the Company’s Knowledge, there are no reasonable grounds for the same.

4.30. Manipulation of Price. The Company has not taken, and, to the Company’s Knowledge, no Person acting on its behalf has taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the Shares.

4.31. Anti-Bribery and Anti-Money Laundering Laws. The Company, and any of its respective officers, directors, supervisors, managers, agents, or employees are and have at all times been in compliance with and its participation in the offering will not violate: (A) anti-bribery laws, including but not limited to, any applicable law, rule, or regulation of any locality, including but not limited to any law, rule, or regulation promulgated to implement the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions, signed December 17, 1997, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.K. Bribery Act 2010, or any other law, rule or regulation of similar purposes and scope or (B) anti-money laundering laws, including, but not limited to, applicable federal, state, international, foreign or other laws, regulations or government guidance regarding anti-money laundering, including, without limitation, Title 18 US. Code sections 1956 and 1957, the Patriot Act, the Bank Secrecy Act, and international anti-money laundering principles or procedures by an intergovernmental group or organization, such as the Financial Action Task Force on Money Laundering, of which the United States is a member and with which designation the United States representative to the group or organization continues to concur, all as amended, and any Executive order, directive, or regulation pursuant to the authority of any of the foregoing, or any orders or licenses issued thereunder.

4.32. No Bad Actors. No “bad actor” disqualifying event described in Rule 506(d)(1)(i)-(viii) of the 1933 Act (a “Disqualification Event”) is applicable to the Company or, to the Company’s Knowledge, any Company Covered Person, except (i) for a Disqualification Event as to which Rule 506(d)(2)(ii–iv) or (d)(3) is applicable and (ii) no such representation is made with respect to the Placement Agent, or any of their respective general partners, managing members, directors, executive officers or other officers.

4.33. No Additional Agreements. The Company has no other agreements or understandings (including, without limitation, side letters) with any Investor to purchase Shares on terms more favorable to such Investor than as set forth herein.

4.34. Shell Company Status. The Company is not, and has never been, an issuer identified in Rule 144(i)(1).

 

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4.35. Compliance. The Company is not (i) in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company under), nor has the Company received notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other agreement or instrument to which it is a party or by which it or any of its properties is bound (whether or not such default or violation has been waived) or (ii) in violation of any judgment, decree or order of any court, arbitrator or governmental body, except in each case as could not have or reasonably be expected to result in a Material Adverse Effect.

5. Representations and Warranties of the Investors. Each of the Investors hereby severally, and not jointly, represents and warrants to the Company that:

5.1. Organization and Existence. Such Investor is a duly incorporated or organized and validly existing corporation, limited partnership, limited liability company or other legal entity, has all requisite corporate, partnership or limited liability company power and authority to enter into and consummate the transactions contemplated by the Transaction Documents and to carry out its obligations hereunder and thereunder, and to invest in the Shares pursuant to this Agreement, and is in good standing under the laws of the jurisdiction of its incorporation or organization.

5.2. Authorization. The execution, delivery and performance by such Investor of the Transaction Documents to which such Investor is a party have been duly authorized and each has been duly executed and when delivered will constitute the valid and legally binding obligation of such Investor, enforceable against such Investor in accordance with their respective terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability, relating to or affecting creditors’ rights generally, and general principles of equity.

5.3. Purchase Entirely for Own Account. The Shares to be received by such Investor hereunder will be acquired for such Investor’s own account, not as nominee or agent, for the purpose of investment and not with a view to the resale or distribution of any part thereof in violation of the 1933 Act, and such Investor has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the 1933 Act without prejudice, however, to such Investor’s right at all times to sell or otherwise dispose of all or any part of such Shares in compliance with applicable federal and state securities laws. The Shares are being purchased by such Investor in the ordinary course of its business. Nothing contained herein shall be deemed a representation or warranty by such Investor to hold the Shares for any period of time. Such Investor is not a broker-dealer registered with the SEC under the 1934 Act or an entity engaged in a business that would require it to be so registered.

5.4. Investment Experience. Such Investor acknowledges that it can bear the economic risk and complete loss of its investment in the Shares and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment contemplated hereby.

5.5. Disclosure of Information. Such Investor has had an opportunity to receive, review and understand all information related to the Company requested by it and to ask questions of and receive answers from the Company regarding the Company, its business and the terms and conditions of the offering of the Shares, and has conducted and completed its own independent due diligence. Such Investor acknowledges that copies of the SEC Filings are available on the

 

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EDGAR system. Based on the information such Investor has deemed appropriate, and without reliance upon the Placement Agent, it has independently (or together with its investment adviser) made its own analysis and decision to enter into the Transaction Documents. Such Investor is relying exclusively on its own investment analysis and due diligence (and/or that of its investment adviser) (including professional advice it deems appropriate) with respect to the execution, delivery and performance of the Transaction Documents, the Shares and the business, condition (financial and otherwise), management, operations, properties and prospects of the Company, including but not limited to all business, legal, regulatory, accounting, credit and tax matters. Such Investor has not relied on any information or advice furnished by or on behalf of the Placement Agent in connection with the transactions contemplated hereby. Neither such inquiries nor any other due diligence investigation conducted by such Investor (or its investment adviser) shall modify, limit or otherwise affect such Investor’s right to rely on the Company’s representations and warranties contained in this Agreement.

5.6. Restricted Securities. Such Investor understands that the Shares are characterized as “restricted securities” under the U.S. federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the 1933 Act only in certain limited circumstances.

5.7. Legends. It is understood that, except as provided below, certificates or book-entry records evidencing the Shares may bear the following or any similar legend:

(a) “The securities represented hereby have not been registered with the Securities and Exchange Commission or the securities commission of any state in reliance upon an exemption from registration under the Securities Act of 1933, as amended, and, accordingly, may not be transferred unless (i) such securities have been registered for sale pursuant to the Securities Act of 1933, as amended, (ii) such securities may be sold pursuant to Rule 144, (iii) the Company has received an opinion of counsel reasonably satisfactory to it that such transfer may lawfully be made without registration under the Securities Act of 1933, as amended, or (iv) the securities are transferred without consideration to an affiliate of such holder or a custodial nominee (which for the avoidance of doubt shall require neither consent nor the delivery of an opinion).”

(b) If required by the authorities of any state in connection with the issuance of sale of the Shares, the legend required by such state authority.

5.8. Accredited Investor. Such Investor is an “accredited investor” within the meaning of Rule 501(a) of Regulation D. To the extent requested by the Company, such Investor will execute and deliver to the Company a questionnaire (to the extent delivered, such Investor represents and warrants is true, correct and complete in all material respects) certifying that it is an “accredited investor”, including that such Investor: (a) is a sophisticated institutional investor with sufficient knowledge and experience in investing in private equity transactions to properly evaluate the risks and merits of its purchase of the Shares; and (b) has determined based on its own independent review and such professional advice as it deems appropriate that its purchase of the Shares and participation in the transactions contemplated by the Transaction Documents (i) are fully consistent with its financial needs, objectives and condition, (ii) comply and are fully consistent with all investment policies, guidelines and other restrictions applicable to such

 

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Investor, (iii) have been duly authorized and approved by all necessary action, (iv) do not and will not violate or constitute a default under such Investor’s charter, bylaws or other constituent document or under any law, rule, regulation, agreement or other obligation by which such Investor is bound and (v) are a fit, proper and suitable investment for such Investor, notwithstanding the substantial risks inherent in investing in or holding the Shares.

5.9. Placement Agent. Such Investor hereby acknowledges and agrees that (a) the Placement Agent is acting solely as placement agent in connection with the execution, delivery and performance of the Transaction Documents and is not acting as an underwriter or in any other capacity and is not and shall not be construed as a fiduciary for such Investor, the Company or any other person or entity in connection with the execution, delivery and performance of the Transaction Documents, (b) the Placement Agent has not made and will not make any representation or warranty, whether express or implied, of any kind or character, and has not provided any advice or recommendation in connection with the execution, delivery and performance of the Transaction Documents, (c) the Placement Agent will not have any responsibility with respect to (i) any representations, warranties or agreements made by any person or entity under or in connection with the execution, delivery and performance of the Transaction Documents, or the execution, legality, validity or enforceability (with respect to any person) thereof, or (ii) the business, affairs, financial condition, operations, properties or prospects of, or any other matter concerning the Company, and (d) the Placement Agent will not have any liability or obligation (including without limitation, for or with respect to any losses, claims, damages, obligations, penalties, judgments, awards, liabilities, costs, expenses or disbursements incurred by such Investor, the Company or any other person or entity), whether in contract, tort or otherwise, to such Investor, or to any person claiming through it, in respect of the execution, delivery and performance of the Transaction Documents.

5.10. No General Solicitation. Such Investor did not learn of the investment in the Shares as a result of any general or public solicitation or general advertising, or publicly disseminated advertisements or sales literature, including (a) any advertisement, article, notice or other communication published in any newspaper, magazine, website, or similar media, or broadcast over television or radio, or (b) any seminar or meeting to which such Investor was invited by any of the foregoing means of communications.

5.11. Brokers and Finders. No Person will have, as a result of the transactions contemplated by the Transaction Documents, any valid right, interest or claim against or upon the Company or an Investor for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of such Investor.

5.12. Short Sales and Confidentiality Prior to the Date Hereof. Other than consummating the transactions contemplated hereunder, such Investor has not, nor has any Person acting on behalf of or pursuant to any understanding with such Investor, directly or indirectly executed any purchases or sales, including Short Sales, of the securities of the Company during the period commencing as of the time that such Investor was first contacted by the Company, the Placement Agent or any other Person regarding the transactions contemplated hereby and ending immediately prior to 8:30 a.m. (New York City time) on Business Day following the date hereof. Notwithstanding the foregoing, in the case of an Investor that is a multi-managed investment vehicle whereby separate portfolio managers or desks manage separate portions of such

 

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Investor’s assets, the representation set forth above shall only apply with respect to the portion of assets managed by the portfolio manager or desk that made the investment decision to purchase the Shares covered by this Agreement (the “Investing Portfolio Manager”) and the portfolio managers or desks who have direct knowledge of the investment decisions made by the Investing Portfolio Manager. Other than to other Persons party to this Agreement and other than to such Person’s outside attorney, accountant, auditor, investment advisor, or other Representatives (as defined in the confidentiality agreement between the Company and such Investor) only to the extent necessary to permit evaluation of the investment, and the performance of the necessary or required tax, accounting, financial, legal, or administrative tasks and services and other than as may be required by law, such Investor has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction). Notwithstanding the foregoing, for avoidance of doubt, nothing contained herein shall constitute a representation or warranty, or preclude any actions, with respect to the identification of the availability of, or securing of, available shares to borrow in order to effect Short Sales or similar transactions in the future.

5.13. No Government Recommendation or Approval. Such Investor understands that no United States federal or state agency, or similar agency of any other country, has reviewed, approved, passed upon, or made any recommendation or endorsement of the Company or the purchase of the Shares.

5.14. No Intent to Effect a Change of Control. Such Investor has no present intent to effect a “change of control” of the Company as such term is understood under the rules promulgated pursuant to Section 13(d) of the 1934 Act.

5.15. Residency. Such Investor’s office in which its investment decision with respect to the Shares was made is located at the address immediately below such Investor’s name on its signature page hereto.

5.16. No Conflicts. The execution, delivery and performance by such Investor of the Transaction Documents and the consummation by such Investor of the transactions contemplated hereby and thereby will not (i) result in a violation of the organizational documents of such Investor or (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, indenture or instrument to which such Investor is a party, or (iii) result in a violation of any law, rule, regulation, order, judgment or decree (including federal and state securities laws) applicable to such Investor, except in the case of clauses (ii) and (iii) above, for such conflicts, defaults, rights or violations which would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on the ability of such Investor to perform its obligations hereunder.

6. Conditions to Closing.

6.1. Conditions to the Investors’ Obligations. The obligation of each Investor to purchase Shares at the Closing is subject to the fulfillment to such Investor’s satisfaction, on or prior to the Closing Date, of the following conditions, any of which may be waived by such Investor (as to itself only):

 

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(a) The representations and warranties made by the Company in Section 4 hereof shall be true and correct in all material respects, except for those representation and warranties qualified by materiality or Material Adverse Effect, which shall be true and correct in all respects as of the date hereof and as of the Closing Date, as though made on and as of such date, except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date. The Company shall have performed in all material respects all obligations and covenants herein required to be performed by it on or prior to the Closing Date.

(b) The Company shall have obtained any and all consents, permits, approvals, registrations and waivers necessary for the consummation of the purchase and sale of the Shares and the consummation of the other transactions contemplated by the Transaction Documents, all of which shall be in full force and effect.

(c) The Company shall have executed and delivered the Registration Rights Agreement.

(d) The Company shall have filed with Nasdaq a Notification Form: Listing of Additional Shares for the listing of the Shares.

(e) No judgment, writ, order, injunction, award or decree of or by any court, or judge, justice or magistrate, including any bankruptcy court or judge, or any order of or by any governmental authority, shall have been issued, and no action or proceeding shall have been instituted by any governmental authority, enjoining or preventing the consummation of the transactions contemplated hereby or in the other Transaction Documents.

(f) The Company shall have delivered a Certificate, executed on behalf of the Company by its Chief Executive Officer or its Chief Financial Officer, dated as of the Closing Date, certifying to the fulfillment of the conditions specified in subsections (a), (b), (d), (e) and (j) of this Section 6.1.

(g) The Company shall have delivered a Certificate, executed on behalf of the Company by its Secretary, dated as of the Closing Date, certifying the resolutions adopted by the Board of Directors of the Company approving the transactions contemplated by this Agreement, the other Transaction Documents and the issuance of the Shares, certifying the current versions of the Certificate of Incorporation and Bylaws of the Company and certifying as to the signatures and authority of persons signing the Transaction Documents and related documents on behalf of the Company.

(h) The Investors shall have received an opinion from Latham & Watkins LLP, the Company’s counsel, dated as of the Closing Date, in form and substance reasonably acceptable to the Investors and addressing such legal matters as the Investors may reasonably request.

(i) There shall have been no Material Adverse Effect with respect to the Company since the date hereof.

 

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(j) No stop order or suspension of trading shall have been imposed by Nasdaq, the SEC or any other governmental or regulatory body with respect to public trading in the Common Stock.

6.2. Conditions to Obligations of the Company. The Company’s obligation to sell and issue the Shares at the Closing (as to an Investor) is subject to the fulfillment to the satisfaction of the Company on or prior to the Closing Date of the following conditions, any of which may be waived by the Company:

(a) The representations and warranties made by such Investor in Section 5 hereof shall be true and correct in all material respects as of the date hereof, and shall be true and correct as of the Closing Date with the same force and effect as if they had been made on and as of such date, except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date. . The Investors shall have performed in all material respects all obligations and covenants herein required to be performed by such Investor on or prior to the Closing Date.

(b) The Investor shall have executed and delivered the Registration Rights Agreement and, to the extent requested by the Company, such Investor’s questionnaire.

(c) The Investor shall have paid in full its purchase price to the Company.

6.3. Termination of Obligations to Effect Closing; Effects.

(a) The obligations of the Company, on the one hand, and the Investors, on the other hand, to effect the Closing shall terminate as follows:

(i) Upon the mutual written consent of the Company and Investors that agreed to purchase a majority of the Shares to be issued and sold pursuant to this Agreement;

(ii) By the Company if any of the conditions set forth in Section 6.2 shall have become incapable of fulfillment, and shall not have been waived by the Company;

(iii) By an Investor (with respect to itself only) if any of the conditions set forth in Section 6.1 shall have become incapable of fulfillment, and shall not have been waived by the Investor; or

(iv) By either the Company or any Investor (with respect to itself only) if the Closing has not occurred on or prior to the fifth Trading Day following the date of this Agreement;

provided, however, that, except in the case of clause (i) above, the party seeking to terminate its obligation to effect the Closing shall not then be in breach of any of its representations, warranties, covenants or agreements contained in this Agreement or the other Transaction Documents if such breach has resulted in the circumstances giving rise to such party’s seeking to terminate its obligation to effect the Closing.

 

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(b) In the event of termination by the Company or any Investor of its obligations to effect the Closing pursuant to this Section 6.3, written notice thereof shall be given to the other Investors by the Company and the other Investors shall have the right to terminate their obligations to effect the Closing upon written notice to the Company and the other Investors. Nothing in this Section 6.3 shall be deemed to release any party from any liability for any breach by such party of the terms and provisions of this Agreement or the other Transaction Documents or to impair the right of any party to compel specific performance by any other party of its obligations under this Agreement or the other Transaction Documents.

7. Covenants and Agreements of the Company.

7.1. No Conflicting Agreements. The Company will not take any action, enter into any agreement or make any commitment that would conflict or interfere in any material respect with the Company’s obligations to the Investors under the Transaction Documents.

7.2. Nasdaq Listing. The Company will use reasonable best efforts to continue the listing and trading of its Common Stock on Nasdaq or other Trading Market and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Company’s reporting, filing and other obligations under the bylaws or rules of such market or exchange, as applicable.

7.3. Termination of Covenants. The provisions of Sections 7.1 and 7.2 shall terminate and be of no further force and effect on the date on which the Company’s obligations under the Registration Rights Agreement to register or maintain the effectiveness of any registration covering the Registrable Securities (as such term is defined in the Registration Rights Agreement) shall terminate.

7.4. Removal of Legends.

(a) In connection with any sale, assignment, transfer or other disposition of the Shares by an Investor pursuant to Rule 144 or pursuant to any other exemption under the 1933 Act such that the purchaser acquires freely tradable shares and upon compliance by the Investor with the requirements of this Agreement, if requested by the Investor, the Company shall request the transfer agent for the Common Stock (the “Transfer Agent”) to remove any restrictive legends related to the book entry account holding such Shares and make a new, unlegended entry for such book entry shares sold or disposed of without restrictive legends within two (2) Trading Days of any such request therefor from such Investor, provided that the Company has timely received from the Investor customary representations and other documentation reasonably acceptable to the Company in connection therewith.

(b) Subject to receipt from the Investor by the Company and the Transfer Agent of customary representations and other documentation reasonably acceptable to the Company and the Transfer Agent in connection therewith, upon the earliest of such time as the Shares (i) are subject to an effective registration statement wherein the Investor is named as a selling shareholder, (ii) have been sold or transferred pursuant to an effective registration statement, (iii) have been sold pursuant to Rule 144, or (iv) are eligible for resale under Rule 144(b)(1) or any successor provision (such earliest date, the “Effective Date”), the Company shall

 

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promptly, in accordance with the provisions of this Section 7.4(b) and, in any event within two (2) Trading Days of any request therefor from an Investor accompanied by such customary and reasonably acceptable documentation referred to above (including, in the case of an delegending request pursuant to clause (i) of this sentence, an acknowledgement letter as to the Investor’s continued obligations under the 1933 Act), (A) deliver to the Transfer Agent irrevocable instructions that the Transfer Agent shall make a new, unlegended entry for such book entry Shares, (B) cause its counsel to deliver to the Transfer Agent one or more opinions to the effect that the removal of such legends in such circumstances may be effected under the 1933 Act if required by the Transfer Agent to effect the removal of the legend in accordance with the provisions of this Agreement and (C) to the extent requested by an Investor cause its transfer agent to issue such Shares without such legends to the holders thereof by electronic delivery at the applicable balance account at the Depository Trust Company upon surrender of any stock certificates evidencing such Shares. The Company agrees that following the Effective Date or at such time as such legend is no longer required under this Section 7.4, it will, within two (2) Trading Days of the delivery by an Investor to the Company or the Transfer Agent of a certificate representing shares issued with a restrictive legend and receipt from the Investor by the Company and the Transfer Agent of customary representations and other documentation reasonably acceptable to the Company and the Transfer Agent in connection therewith, deliver or cause to be delivered to such Investor a certificate representing such Shares (or uncertificated interest therein) that is free from all restrictive and other legends. Shares subject to legend removal hereunder may be transmitted by the Transfer Agent to the Investor by crediting the account of the Investor’s prime broker with the DTC System as directed by such Investor. The Company shall be responsible for the fees of its Transfer Agent and all DTC fees associated with such issuance.

(c) Each Investor, severally and not jointly with the other Investors, agrees with the Company (i) that such Investor will sell any Shares only pursuant to either the registration requirements of the 1933 Act, including any applicable prospectus delivery requirements, or an exemption therefrom, (ii) that if Shares are sold pursuant to a registration statement, they will be sold in compliance with the plan of distribution set forth therein and (iii) that if, after the effective date of the registration statement covering the resale of the Shares, such registration statement ceases to be effective and the Company has provided notice to such Investor to that effect, such Investor will sell Shares only in compliance with an exemption from the registration requirements of the 1933 Act.

7.5. Fees. The Company shall be responsible for the payment of any placement agent’s fees, financial advisory fees, or broker’s commissions (other than for Persons engaged by any Investor) relating to or arising out of the transactions contemplated hereby, including, without limitation, any fees or commissions payable to the Placement Agent.

7.6. Short Sales and Confidentiality After the Date Hereof. Each Investor covenants that neither it nor any Affiliates acting on its behalf or pursuant to any understanding with it will trade in the securities of the Company and will not execute any Short Sales during the period from the date hereof until the earlier of such time as (i) both (a) the transactions contemplated by this Agreement are first publicly announced and (b) all material information set forth in the Disclosure Schedule, if any, have been publicly disclosed by the Company (which, for the avoidance of doubt, shall occur simultaneously) or (ii) this Agreement is terminated in full. Notwithstanding the foregoing, in the case of an Investor that is a multi-managed investment

 

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vehicle whereby separate portfolio managers or desks manage separate portions of such Investor’s assets, the representation set forth above shall only apply with respect to the portion of assets managed by the portfolio manager or desk that made the investment decision to purchase the Shares covered by this Agreement (the “Investing Portfolio Manager”) and the portfolio managers or desks who have direct knowledge of the investment decisions made by the Investing Portfolio Manager. Each Investor covenants that until such time (i) as all material terms of the sale of the Shares to the Investors pursuant to this Agreement are publicly disclosed by the Company, such Investor and its Affiliates will maintain the confidentiality of the existence and terms of this Agreement and (ii) as all material information set forth in the Disclosure Schedule, if any, are publicly disclosed by the Company, such Investor and its Affiliates will maintain the confidentiality of all information included on the Disclosure Schedule, other than, in each case, to such Person’s outside attorney, accountant, auditor, investment advisor, or other Representatives only to the extent necessary to permit evaluation of the investment, and the performance of the necessary or required tax, accounting, financial, legal, or administrative tasks and services and other than as may be required by law.

8. Survival and Indemnification.

8.1. Survival. The representations, warranties, covenants and agreements contained in this Agreement shall survive the Closing of the transactions contemplated by this Agreement for the applicable statute of limitations.

8.2. Indemnification. The Company agrees to indemnify and hold harmless each Investor and its Affiliates, and their respective directors, officers, trustees, members, managers, employees, investment advisers and agents, from and against any and all losses, claims, damages, liabilities and expenses (including without limitation reasonable and documented attorney fees and disbursements and other documented out-of-pocket expenses reasonably incurred in connection with investigating, preparing or defending any action, claim or proceeding, pending or threatened and the costs of enforcement thereof) (collectively, “Losses”) to which such Person may become subject as a result of any breach of representation, warranty, covenant or agreement made by or to be performed on the part of the Company under the Transaction Documents, and will reimburse any such Person for all such amounts as they are incurred by such Person solely to the extent such amounts have been finally judicially determined not to have resulted from such Person’s fraud or willful misconduct.

8.3. Conduct of Indemnification Proceedings. Any person entitled to indemnification hereunder shall (i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any person entitled to indemnification hereunder shall have the right to employ separate counsel and to participate in the defense of such claim, but the fees and expenses of such counsel shall be at the expense of such person unless (a) the indemnifying party has agreed in writing to pay such fees or expenses, (b) the indemnifying party shall have failed to assume the defense of such claim and employ counsel reasonably satisfactory to such person or (c) in the reasonable judgment of any such person, based upon written advice of its counsel, a conflict of interest exists between such person and the indemnifying party with respect to such claims (in which case, if the person notifies the indemnifying party in writing that such person elects to

 

21


employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of such claim on behalf of such person); and provided, further, that the failure of any indemnified party to give written notice as provided herein shall not relieve the indemnifying party of its obligations hereunder, except to the extent that such failure to give notice shall materially adversely affect the indemnifying party in the defense of any such claim or litigation. It is understood that the indemnifying party shall not, in connection with any proceeding in the same jurisdiction, be liable for fees or expenses of more than one separate firm of attorneys at any time for all such indemnified parties. No indemnifying party will, except with the consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement that does not include as an unconditional term thereof the giving by the claimant or plaintiff to such indemnified party of a release from all liability in respect of such claim or litigation. No indemnified party will, except with the consent of the indemnifying party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement.

9. Miscellaneous.

9.1. Successors and Assigns. This Agreement may not be assigned by a party hereto without the prior written consent of the Company or each of the Investors, as applicable, provided, however, that an Investor may assign its rights and delegate its duties hereunder in whole or in part to an Affiliate or to a third party acquiring some or all of its Shares in a transaction complying with applicable securities laws without the prior written consent of the Company or the other Investors, provided such assignee agrees in writing to be bound by the provisions hereof that apply to Investors. The provisions of this Agreement shall inure to the benefit of and be binding upon the respective permitted successors and assigns of the parties. Without limiting the generality of the foregoing, in the event that the Company is a party to a merger, consolidation, share exchange or similar business combination transaction in which the Common Stock is converted into the equity securities of another Person, from and after the effective time of such transaction, such Person shall, by virtue of such transaction, be deemed to have assumed the obligations of the Company hereunder, the term “Company” shall be deemed to refer to such Person and the term “Shares” shall be deemed to refer to the securities received by the Investors in connection with such transaction. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective permitted successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

9.2. Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or any electronic signatures complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

9.3. Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

 

22


9.4. Notices. Unless otherwise provided, any notice required or permitted under this Agreement shall be given in writing and shall be deemed effectively given as hereinafter described (i) if given by personal delivery, then such notice shall be deemed given upon such delivery, (ii) if given by e-mail, then such notice shall be deemed given upon receipt of confirmation of receipt of an e-mail transmission, (iii) if given by mail, then such notice shall be deemed given upon the earlier of (A) receipt of such notice by the recipient or (B) three days after such notice is deposited in first class mail, postage prepaid, and (iv) if given by an internationally recognized overnight air courier, then such notice shall be deemed given one Business Day after delivery to such carrier. All notices shall be addressed to the party to be notified at the address as follows, or at such other address as such party may designate by ten days’ advance written notice to the other party:

If to the Company:

Satsuma Pharmaceuticals, Inc.

400 Oyster Point Boulevard, Suite 221

South San Francisco, CA 94080

Attention: Tom O’Neil, Chief Financial Officer

Email: tom@satsumax.com

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

Latham & Watkins LLP

Attention: Brian J. Cuneo

140 Scott Drive

Menlo Park, CA 94025

Email: Brian.Cuneo@lw.com

If to the Investors:

Only to the addresses set forth on the signature pages hereto.

9.5. Expenses. The parties hereto shall pay their own costs and expenses in connection herewith regardless of whether the transactions contemplated hereby are consummated; it being understood that each of the Company and each Investor has relied on the advice of its own respective counsel.

9.6. Amendments and Waivers. No amendment or waiver of any provision of this Agreement will be effective with respect to any party unless made in writing and signed by a duly authorized representative of such party.

9.7. Publicity. Except as set forth below, no public release or announcement concerning the transactions contemplated hereby shall be issued by any Investors without the prior consent of the Company, except as such release or announcement may be required by law or the applicable rules or regulations of any securities exchange or securities market, in which case such Investor shall allow the Company reasonable time to comment on such release or announcement in advance of such issuance. Notwithstanding the foregoing, each Investor may identify the

 

23


Company and the value of such Investor’s security holdings in the Company in accordance with applicable investment reporting and disclosure regulations or internal policies without prior notice to or consent from the Company (including, for the avoidance of doubt, filings pursuant to Sections 13 and 16 of the 1934 Act). The Company shall not include the name of any Investor or any Affiliate or investment adviser of such Investor in any press release or public announcement (which, for the avoidance of doubt, shall not include any SEC Filing to the extent such disclosure is required by SEC rules and regulations) without the prior written consent of such Investor. By 8:30 a.m. (New York City time) on the Business Day following the date this Agreement is executed, the Company shall issue one or more press releases disclosing all material terms of the transactions contemplated by this Agreement and any other material nonpublic information that the Company may have provided any Investor at any time prior to the filing of such press releases (the “Press Releases”). From and after the issuance of the Press Releases, no Investor shall be in possession of any material nonpublic information received from the Company, or any of its officers, directors, employees or agents (including the Placement Agent). No later than 5:30 p.m. (New York City time) on the second Business Day following the date this Agreement is executed, the Company will file a Current Report on Form 8-K (the “8-K Filing”) attaching or disclosing the details of the press release(s) described in the foregoing sentence as well as copies of the Transaction Documents. In addition, the Company will make such other filings and notices in the manner and time required by the SEC or Nasdaq. The Company shall not, and shall cause each of its officers, directors, employees and agents not to, provide any Investor with any material nonpublic information regarding the Company from and after the filing of the Press Releases without the express prior written consent of such Investor.

9.8. Severability. Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof but shall be interpreted as if it were written so as to be enforceable to the maximum extent permitted by applicable law, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. To the extent permitted by applicable law, the parties hereby waive any provision of law which renders any provision hereof prohibited or unenforceable in any respect.

9.9. Benefit of Agreement. The Placement Agent is an intended third-party beneficiary of the representations and warranties of the Company and of each Investor set forth in Section 4 and Section 5, respectively, of this Agreement.

9.10. Entire Agreement. This Agreement, including the signature pages, Exhibits, the other Transaction Documents and the confidentiality agreement between the Company and each Investor constitute the entire agreement among the parties hereof with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, both oral and written, between the parties with respect to the subject matter hereof and thereof.

9.11. Further Assurances. The parties shall execute and deliver all such further instruments and documents and take all such other actions as may reasonably be required to carry out the transactions contemplated hereby and to evidence the fulfillment of the agreements herein contained.

 

24


9.12. Governing Law. This Agreement shall be governed by, and construed in accordance with, the laws of the State of New York. Service of process in connection with any such suit, action or proceeding may be served on each party hereto anywhere in the world by the same methods as are specified for the giving of notices under this Agreement.

9.13. Independent Nature of Investors’ Obligations and Rights. The obligations of each Investor under any Transaction Document are several and not joint with the obligations of any other Investor, and no Investor shall be responsible in any way for the performance of the obligations of any other Investor under any Transaction Document. The decision of each Investor to purchase Shares pursuant to the Transaction Documents has been made by such Investor independently of any other Investor. Nothing contained herein or in any Transaction Document, and no action taken by any Investor pursuant thereto, shall be deemed to constitute the Investors as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Investors are in any way acting in concert or as a group with respect to such obligations or the transactions contemplated by the Transaction Documents. Each Investor acknowledges that no other Investor has acted as agent for such Investor in connection with making its investment hereunder and that no Investor will be acting as agent of such Investor in connection with monitoring its investment in the Shares or enforcing its rights under the Transaction Documents. Each Investor shall be entitled to independently protect and enforce its rights, including, without limitation, the rights arising out of this Agreement or out of the other Transaction Documents, and it shall not be necessary for any other Investor to be joined as an additional party in any proceeding for such purpose. The Company acknowledges that each of the Investors has been provided with the same Transaction Documents for the purpose of closing a transaction with multiple Investors and not because it was required or requested to do so by any Investor. It is expressly understood and agreed that each provision contained in this Agreement is between the Company and an Investor, solely, and not between the Company and the Investors collectively and not between and among the Investors.

9.14. Exculpation of the Placement Agent. Each party hereto agrees for the express benefit of the Placements Agent and its affiliates and representatives that:

(i) none of the Placement Agent, its affiliates or any of its representatives (1) has any duties or obligations other than those specifically set forth herein or in the engagement letter, dated as of February 24, 2021 (the “Engagement Letter”), between the Company and the Placement Agent; (2) shall be liable for any improper payment made in accordance with the information provided by the Company; (3) makes any representation or warranty, or has any responsibilities as to the validity, accuracy, value or genuineness of any information, certificates or documentation delivered by or on behalf of the Company pursuant to this Agreement or the Transaction Documents or in connection with any of the transactions contemplated hereby and thereby; or (4) shall be liable (x) for any action taken, suffered or omitted by any of them in good faith and reasonably believed to be authorized or within the discretion or rights or powers conferred upon it by this Agreement or any Transaction Document or (y) for anything which any of them may do or refrain from doing in connection with this Agreement or any Transaction Document, except in each case for such party’s own gross negligence, willful misconduct or bad faith.

 

25


(ii) The Placement Agent, its affiliates and its representatives shall be entitled to (1) rely on, and shall be protected in acting upon, any certificate, instrument, notice, letter or any other document or security delivered to any of them by or on behalf of the Company, and (2) be indemnified by the Company for acting as the Placement Agent hereunder pursuant to the indemnification provisions set forth in the Engagement Letter.

[remainder of page intentionally left blank]

 

26


IN WITNESS WHEREOF, the parties have executed this Agreement or caused their duly authorized officers to execute this Agreement as of the date first above written.

 

COMPANY:     SATSUMA PHARMACEUTICALS, INC.
    By:  

/s/ John Kollins

      Name: John Kollins
      Title: President and Chief Executive Officer


INVESTOR: Lumira Ventures III, L.P.    
    By:  

/s/ Vasco Larcina

     

Name: Vasco Larcina

Title: CFO

    By:  

/s/ Benjamin Rovinski

     

Name: Benjamin Rovinski

Title: Sr. VP


INVESTOR: Lumira Ventures III (International), L.P.  
    By:  

/s/ Vasco Larcina

     

Name: Vasco Larcina

Title: CFO

    By:  

/s/ Benjamin Rovinski

     

Name: Benjamin Rovinski

Title: Sr. VP

 

29


INVESTOR: Point72 Associates, LLC
    By:  

/s/ Vincent Tortorella

     

Name: Vincent Tortorella

Title: Authorized Person

 

30


INVESTOR: Shin Nippon Biomedical Laboratories, Ltd.  
    By:  

/s/ Ryoichi Nagata, MD, PhD

     

Name: Ryoichi Nagata, MD, PhD

Title: President & CEO

 

31


INVESTOR: Vivo Opportunity Fund, L.P.  
    By:  

/s/ Gaurav Aggarwal

     

Name: Gaurav Aggarwal

Title: Managing Member of Vivo

Opportunity, LLC, General Partner

 

32


INVESTOR: BEMAP Master Fund Ltd  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

33


INVESTOR: DS Liquid Div RVA Mon LLC  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

34


INVESTOR: Bespoke Alpha MAC MIM LP  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

35


INVESTOR: SFL SPV I LLC  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

36


INVESTOR: Monashee Pure Alpha SPV I LP  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

37


INVESTOR: Monashee Solitario Fund LP  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

38


INVESTOR: Ikarian Capital, LLC  
    By:  

/s/ Chart Westcott

     

Name: Chart Westcott

Title: COO of Ikarian Capital, LLC, Investment Adviser

 

39


INVESTOR: Commodore Capital Master LP  
    By:  

/s/ R. Egen Atkinson, MD

     

Name: R. Egen Atkinson, MD

Title: Authorized Signatory

 

40


INVESTOR: Samlyn Onshore Fund, LP  
    By:  

/s/ Michael Barry

     

Name: Michael Barry

Title: Authorized Signatory

 

41


INVESTOR: Samlyn Offshore Master Fund, Ltd.  
    By:  

/s/ Michael Barry

     

Name: Michael Barry

Title: Authorized Signatory

 

42


INVESTOR: Samlyn Net Neutral Master Fund, Ltd.  
    By:  

/s/ Michael Barry

     

Name: Michael Barry

Title: Authorized Signatory

 

43


INVESTOR: Samlyn Long Alpha Master Fund, Ltd.  
    By:  

/s/ Michael Barry

     

Name: Michael Barry

Title: Authorized Signatory

 

44


INVESTOR: Growth Equity Opportunities 17, L.P.  
    By:  

/s/ Louis S. Citron

     

Name: Louis S. Citron

Title: Chief Legal Officer

 

45


INVESTOR:  

RA CAPITAL HEALTHCARE FUND, L.P.

By: RA Capital Healthcare Fund GP, LLC

Its: General Partner

    By:  

/s/ Rajeev Shah

     

Name: Rajeev Shah

Title: Manager

 

46


INVESTOR: North Sound Trading, LP  
    By:  

/s/ Brian Miller

     

Name: Brian Miller

Title: President of the General Partner

 

47


INVESTOR: Maven Investment Partners US Limited-NY Branch  
    By:  

/s/ Jose R. Castillo

     

Name: Jose R. Castillo

Title: Director

 

48


INVESTOR: Ghost Tree Capital Group, LP  
    By:  

/s/ Matthew Diaz

     

Name: Matthew Diaz

Title: COO/CFO

 

49


INVESTOR:  

Logos GLOBAL MASTER FUND LP

By: Logos GP LLC

Its General Partner

    By:  

/s/ Arsani William

     

Name: Arsani William

Title: Managing Partner

 

50


INVESTOR:  

ASPIRE CAPITAL FUND, LLC

By: Aspire Capital Partners, LLC

By: SGM Holdings Corp.

    By:  

/s/ Steven G. Martin

     

Name: Steven G. Martin

Title: President

 

51


INVESTOR:  

Citadel Multi-Strategy Equities Master Fund Ltd.

By: Citadel Advisors LLC, its portfolio manager

    By:  

/s/ Shellane Mulcahy

     

Name: Shellane Mulcahy

Title: Authorized Signatory

 

52


EXHIBIT A

Schedule of Investors

 

Investor Name

   Number of Shares to be
Purchased
    Aggregate Purchase Price of Shares  

Lumira Ventures III, L.P.

     340,773     $ 1,935,590.64  

Lumira Ventures III (International), L.P.

     11,339     $ 64,405.52  

Point72 Associates, LLC

     528,169     $ 2,999,999.92  

Shin Nippon Biomedical Laboratories, LTD

     1,232,394     $ 6,999,997.92  

Vivo Opportunity Fund, L.P.

     1,232,394     $ 6,999,997.92  

BEMAP Master Fund Ltd

     45,005     $ 255,628.40  

DS Liquid Div RVA MON LLC

     53,748     $ 305,288.64  

Bespoke Alpha MAC MIM LP

     6,530     $ 37,090.40  

SFL SPV I LLC

     7,803     $ 44,321.04  

Monashee Pure Alpha SPV I LP

     27,992     $ 158,994.56  

Monashee Solitario Fund LP

     34,979     $ 198,680.72  

Ikarian Healthcare Master Fund, LP

     [176,057   [$ 1,000,003.76

Boothbay Absolute Return Strategies, LP

     [         [    

Boothbay Diversified Alpha Master Fund, LP

     [         [    

Commodore Capital Master LP

     1,575,000     $ 8,946,000.00  

Samlyn Onshore Fund, LP

     215,595     $ 1,224,579.60  

Samlyn Offshore Master Fund, Ltd

     540,879     $ 3,072,192.72  

Samlyn Net Neutral Master Fund, Ltd

     434,262     $ 2,466,608.16  

Samlyn Long Alpha Master Fund, Ltd

     41,658     $ 236,617.44  

Growth Equity Opportunities 17, L.P.

     2,992,958     $ 17,000,001.44  

RA Capital Healthcare Fund, L.P.

     1,232,394     $ 6,999,997.92  

North Sound Trading, LP

     361,620     $ 2,054,001.60  

 

53


Investor Name

   Number of Shares to be
Purchased
     Aggregate Purchase Price of Shares  

Maven Investment Partners US Limited-NY Branch

     88,029      $ 500,004.72  

Ghost Tree Master Fund, LP

     123,381      $ 700,804.08  

NR 1 SP, a Segregated Portfolio of North Rock SPC

     143,110      $ 812,864.80  

NR 2, a Segregated Portfolio of North Rock SPC

     143,361      $ 814,290.48  

Schonfeld EXT Master Fund, LP

     203,344      $ 1,154,993.92  

Squarepoint Diversified Partners Fund Limited

     91,029      $ 517,044.72  

Aspire Capital Fund, LLC

     792,254      $ 4,500,002.72  

Citadel Multi-Strategy Equities Master Fund Ltd.

     880,281      $ 4,999,996.08  

Logos Global Master Fund LP

     528,169      $ 2,999,999.92  

TOTAL

     14,084,507      $ 79,999,999.76  

 

54


EXHIBIT B

Form of Registration Rights Agreement

[Attached as Exhibit 10.2 to Current Report on Form 8-k]

 

55


DISCLOSURE SCHEDULE

 

56

Exhibit 10.2

REGISTRATION RIGHTS AGREEMENT

This REGISTRATION RIGHTS AGREEMENT (this “Agreement”) is made and entered into as of March 3, 2021 by and among Satsuma Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and the “Investors” named in that certain Securities Purchase Agreement by and among the Company and the Investors, dated as of February 26, 2021 (the “Purchase Agreement”). Capitalized terms used herein have the respective meanings ascribed thereto in the Purchase Agreement unless otherwise defined herein.

The parties hereby agree as follows:

1. Definitions.

As used in this Agreement, the following terms shall have the following meanings:

Agreement” has the meaning set forth in the first paragraph.

Allowed Delay” has the meaning set forth in Section 2(c)(ii).

Availability Date” has the meaning set forth in Section 3(i).

Company” has the meaning set forth in the first paragraph.

Cut Back Shares” has the meaning set forth in Section 2(d).

Effectiveness Period” has the meaning set forth in Section 3(a).

Filing Deadline” has the meaning set forth in Section 2(a)(i).

Inspectors” has the meaning set forth in Section 4.

Investors” means the Investors identified in the Purchase Agreement and any Affiliate or permitted transferee of any Investor who is a subsequent holder of Registrable Securities.

Prospectus” means (i) the prospectus included in any Registration Statement, as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by such Registration Statement and by all other amendments and supplements to the prospectus, including post-effective amendments and all material incorporated by reference in such prospectus, and (ii) any “free writing prospectus” as defined in Rule 405 under the 1933 Act.

Purchase Agreement” has the meaning set forth in the first paragraph.

Qualification Date” has the meaning set forth in Section 2(a)(ii).

Qualification Deadline” has the meaning set forth in Section 2(a)(ii).

Records” has the meaning set forth in Section 4.


Register,” “registered” and “registration” refer to a registration made by preparing and filing a Registration Statement or similar document in compliance with the 1933 Act, and the declaration or ordering of effectiveness of such Registration Statement or document.

Registrable Securities” means (i) the Shares and (ii) any other securities issued or issuable with respect to or in exchange for Shares, whether by merger, charter amendment or otherwise; provided, that a security shall cease to be a Registrable Security upon (A) sale pursuant to a Registration Statement or Rule 144 under the 1933 Act, or (B) such security becoming eligible for sale without restriction by the Investor holding such security pursuant to Rule 144, including without any manner of sale or volume limitations, and without the requirement to be in compliance with Rule 144(c)(1) (or any successor thereto) promulgated under the 1933 Act.

Registration Statement” means any registration statement of the Company under the 1933 Act that covers the resale of any of the Registrable Securities pursuant to the provisions of this Agreement, amendments and supplements to such Registration Statement, including post-effective amendments, all exhibits and all material incorporated by reference in such Registration Statement.

Required Investors” means the Investors holding a majority of the Registrable Securities outstanding from time to time.

Restriction Termination Date” has the meaning set forth in Section 2(d).

SEC” means the U.S. Securities and Exchange Commission.

SEC Restrictions” has the meaning set forth in Section 2(d).

Shelf Registration Statement” has the meaning set forth in Section 2(a)(ii).

2. Registration.

(a) Registration Statements.

(i) Promptly following the Closing Date but no later than forty-five (45) days after the Closing Date (the “Filing Deadline”), the Company shall prepare and file with the SEC one Registration Statement covering the resale of all of the Registrable Securities. Subject to any SEC comments, such Registration Statement shall include the plan of distribution attached hereto as Exhibit A; provided, however, that no Investor shall be named as an “underwriter” in such Registration Statement without the Investor’s prior written consent. Such Registration Statement also shall cover, to the extent allowable under the 1933 Act and the rules promulgated thereunder (including Rule 416), such indeterminate number of additional shares of Common Stock resulting from stock splits, stock dividends or similar transactions with respect to the Registrable Securities. Such Registration Statement shall not include any shares of Common Stock or other securities for the account of any other holder without the prior written consent of the Required Investors. Such Registration Statement (and each amendment or supplement thereto, and each request for acceleration of effectiveness thereof) shall be provided in accordance with Section 3(c) to the Investors prior to its filing or other submission.


(ii) The Registration Statement referred to in Section 2(a)(i) shall be on Form S-3. In the event that Form S-3 is not available for the registration of the resale of Registrable Securities hereunder, the Company shall (i) register the resale of the Registrable Securities on such other form as is available to the Company and (ii) so long as Registrable Securities remain outstanding, promptly following the date (the “Qualification Date”) upon which the Company becomes eligible to use a registration statement on Form S-3 to register the Registrable Securities for resale, but in no event more than forty-five (45) days after the Qualification Date (the “Qualification Deadline”), the Company shall file a registration statement on Form S-3 covering the Registrable Securities (or a post-effective amendment on Form S-3 to a registration statement on Form S-1) (a “Shelf Registration Statement”) and shall use commercially reasonable efforts to cause such Shelf Registration Statement to be declared effective as promptly as practicable thereafter; provided that the Company shall maintain the effectiveness of the Registration Statement then in effect until such time as a Shelf Registration Statement covering the Registrable Securities has been declared effective by the SEC.

(b) Expenses. The Company will pay all expenses associated with each Registration Statement, including filing and printing fees, the Company’s counsel and accounting fees and expenses, costs associated with clearing the Registrable Securities for sale under applicable state securities laws and listing fees, but excluding discounts, commissions, fees of underwriters, selling brokers, dealer managers or similar securities industry professionals with respect to the Registrable Securities being sold.

(c) Effectiveness.

(i) The Company shall use commercially reasonable efforts to have each Registration Statement declared effective as soon as practicable after such Registration Statement has been filed with the SEC. By 5:30 p.m. (Eastern time) on the second Business Day following the date on which the Registration Statement is declared effective by the SEC, the Company shall file with the SEC, in accordance with Rule 424 under the 1933 Act, the final prospectus to be used in connection with sales pursuant to such Registration Statement. The Company shall notify the Investors by e-mail as promptly as practicable, and in any event, within twenty-four (24) hours, after any Registration Statement is declared effective and shall simultaneously provide the Investors with copies of any related Prospectus to be used in connection with the sale or other disposition of the securities covered thereby.

(ii) For not more than thirty (30) consecutive days or for a total of not more than sixty (60) days in any twelve (12) month period, the Company may suspend the use of any Prospectus included in any Registration Statement contemplated by this Section in the event that the Company determines in good faith that such suspension is necessary to (A) delay the disclosure of material nonpublic information concerning the Company, the disclosure of which at the time is not, in the good faith opinion of the Company, in the best interests of the Company or (B) amend or supplement the affected Registration Statement or the related Prospectus so that such Registration Statement or Prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the case of the Prospectus in light of the circumstances under which they were made, not misleading; provided, however, in no event shall holders of Registrable Securities be suspended from selling Registrable Securities pursuant to the Registration Statement for a period


that exceeds 30 consecutive calendar days or 60 total calendar days in any 360-day period (any such suspension contemplated by this Section 2(c), an “Allowed Delay”); provided, that the Company shall promptly (a) notify each Investor in writing of the commencement of an Allowed Delay, but shall not (without the prior written consent of an Investor) disclose to such Investor any material nonpublic information giving rise to an Allowed Delay, (b) advise the Investors in writing to cease all sales under such Registration Statement until the end of the Allowed Delay and (c) use commercially reasonable efforts to terminate an Allowed Delay as promptly as practicable. Upon disclosure of such information or the termination of the condition described above, the Company shall provide prompt notice to holders whose Registrable Securities are included in the Registration Statement, and shall promptly terminate any suspension of sales it has put into effect and shall take such other reasonable actions to permit registered sales of Registrable Securities as contemplated hereby.

(d) Rule 415; Cutback. If at any time the SEC takes the position that the offering of some or all of the Registrable Securities in a Registration Statement is not eligible to be made on a delayed or continuous basis under the provisions of Rule 415 under the 1933 Act or requires any Investor to be named as an “underwriter,” the Company shall use commercially reasonable efforts to advocate before the SEC its reasonable position that the offering contemplated by such Registration Statement is a valid secondary offering and not an offering “by or on behalf of the issuer” as defined in Rule 415 and that none of the Investors is an “underwriter.” The Investors shall have the right to select one legal counsel to review and oversee any registration or matters pursuant to this Section 2(d), including participation in any meetings or discussions with the SEC regarding the SEC’s position and to comment on any written submission made to the SEC with respect thereto, which counsel shall be designated by the holders of a majority of the Registrable Securities. In the event that, despite the Company’s commercially reasonable efforts and compliance with the terms of this Section 2(d), the SEC does not alter its position, the Company shall (i) remove from such Registration Statement such portion of the Registrable Securities (the “Cut Back Shares”) and/or (ii) agree to such restrictions and limitations on the registration and resale of the Registrable Securities as the SEC may require to assure the Company’s compliance with the requirements of Rule 415 (collectively, the “SEC Restrictions”); provided, however, that the Company shall not agree to name any Investor as an “underwriter” in such Registration Statement without the prior written consent of such Investor. Any cut-back imposed on the Investors pursuant to this Section 2(d) shall be allocated among the Investors on a pro rata basis and shall be applied first to any of the Registrable Securities of such Investor as such Investor shall designate, unless the SEC Restrictions otherwise require or provide or the Investors otherwise agree. From and after such date as the Company is able to effect the registration of such Cut Back Shares in accordance with any SEC Restrictions applicable to such Cut Back Shares (such date, the “Restriction Termination Date”), all of the provisions of this Section 2 (including the Company’s obligations with respect to the filing of a Registration Statement and its obligations to use commercially reasonable efforts to have such Registration Statement declared effective within the time periods set forth herein) shall again be applicable to such Cut Back Shares; provided, however, that (i) the Filing Deadline and/or the Qualification Deadline, as applicable, for such Registration Statement including such Cut Back Shares shall be ten (10) Business Days after such Restriction Termination Date, and (ii) the Company shall use commercially reasonable efforts to obtain effectiveness with respect to such Cut Back Shares as soon as practicable after the Restriction Termination Date.


3. Company Obligations. The Company will use commercially reasonable efforts to effect the registration of the Registrable Securities in accordance with the terms hereof, and pursuant thereto the Company will, as expeditiously as possible:

(a) use commercially reasonable efforts to cause such Registration Statement to become effective and to remain continuously effective for a period that will terminate upon the earlier of (i) the date on which all Registrable Securities covered by such Registration Statement, as amended from time to time, have been sold, and (ii) the date on which all Shares cease to be Registrable Securities (the “Effectiveness Period”) and advise the Investors promptly in writing when the Effectiveness Period has expired;

(b) prepare and file with the SEC such amendments and post-effective amendments to such Registration Statement and the related Prospectus as may be necessary to keep such Registration Statement effective for the Effectiveness Period and to comply with the provisions of the 1933 Act and the 1934 Act with respect to the distribution of all of the Registrable Securities covered thereby;

(c) provide copies to and permit each Investor to review each Registration Statement and all amendments and supplements thereto no fewer than two (2) days prior to their filing with the SEC and to furnish reasonable comments thereon;

(d) furnish to each Investor whose Registrable Securities are included in any Registration Statement (i) promptly after the same is prepared and filed with the SEC, if requested by the Investor, one (1) copy of any Registration Statement and any amendment thereto, each preliminary prospectus and Prospectus and each amendment or supplement thereto, and each letter written by or on behalf of the Company to the SEC or the staff of the SEC, and each item of correspondence from the SEC or the staff of the SEC, in each case relating to such Registration Statement (other than any portion thereof which contains information for which the Company has sought confidential treatment), and (ii) such number of copies of a Prospectus, including a preliminary prospectus, and all amendments and supplements thereto and such other documents as each Investor may reasonably request in order to facilitate the disposition of the Registrable Securities owned by such Investor that are covered by such Registration Statement;

(e) use reasonable best efforts to (i) prevent the issuance of any stop order or other suspension of effectiveness and, (ii) if such order is issued, obtain the withdrawal of any such order at the earliest practical moment;

(f) prior to any public offering of Registrable Securities, use commercially reasonable efforts to register or qualify or cooperate with the Investors and their counsel in connection with the registration or qualification of such Registrable Securities for the offer and sale under the securities or blue sky laws of such jurisdictions requested by the Investors and do any and all other commercially reasonable acts or things necessary or advisable to enable the distribution in such jurisdictions of the Registrable Securities covered by the Registration Statement; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (i) qualify to do business in any jurisdiction where it would not otherwise be required to qualify but for this Section 3(f), (ii) subject itself to general taxation in any jurisdiction where it would not otherwise be so subject but for this Section 3(f), or (iii) file a general consent to service of process in any such jurisdiction;


(g) use commercially reasonable efforts to cause all Registrable Securities covered by a Registration Statement to be listed on each securities exchange, interdealer quotation system or other market on which similar securities issued by the Company are then listed;

(h) promptly notify the Investors, at any time prior to the end of the Effectiveness Period, upon discovery that, or upon the happening of any event as a result of which, the Prospectus includes an untrue statement of a material fact or omits to state any material fact required to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing (provided that such notice shall not, without the prior written consent of an Investor, disclose to such Investor any material nonpublic information regarding the Company), and promptly prepare, file with the SEC and furnish to such holder a supplement to or an amendment of such Prospectus as may be necessary so that such Prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing;

(i) otherwise use commercially reasonable efforts to comply with all applicable rules and regulations of the SEC under the 1933 Act and the 1934 Act, including, without limitation, Rule 172 under the 1933 Act, file any final Prospectus, including any supplement or amendment thereof, with the SEC pursuant to Rule 424 under the 1933 Act, promptly inform the Investors in writing if, at any time during the Effectiveness Period, the Company does not satisfy the conditions specified in Rule 172 and, as a result thereof, the Investors are required to deliver a Prospectus in connection with any disposition of Registrable Securities and take such other actions as may be reasonably necessary to facilitate the registration of the Registrable Securities hereunder; and make available to its security holders, as soon as reasonably practicable, but not later than the Availability Date (as defined below), an earnings statement covering a period of at least twelve (12) months, beginning after the effective date of each Registration Statement, which earnings statement shall satisfy the provisions of Section 11(a) of the 1933 Act, including Rule 158 promulgated thereunder (for the purpose of this subsection 3(i), “Availability Date” means the 45th day following the end of the fourth fiscal quarter that includes the effective date of such Registration Statement, except that, if such fourth fiscal quarter is the last quarter of the Company’s fiscal year, “Availability Date” means the 90th day after the end of such fourth fiscal quarter);

(j) if requested by an Investor, the Company shall (i) as soon as practicable, incorporate in a prospectus supplement or post-effective amendment such information as an Investor reasonably requests to be included therein relating to the sale and distribution of Registrable Securities, including, without limitation, information with respect to the number of Registrable Securities being offered or sold, the purchase price being paid therefor and any other terms of the offering of the Registrable Securities to be sold in such offering; (ii) as soon as practicable, make all required filings of such prospectus supplement or post-effective amendment after being notified of the matters to be incorporated in such prospectus supplement or post-effective amendment; and (iii) as soon as practicable, supplement or make amendments to any Registration Statement if reasonably requested by an Investor holding any Registrable Securities;


(k) within two (2) Business Days after a Registration Statement which covers Registrable Securities is ordered effective by the SEC, the Company shall deliver to the transfer agent for such Registrable Securities (with copies to the Investors whose Registrable Securities are included in such Registration Statement) confirmation that such Registration Statement has been declared effective by the SEC; and

(l) with a view to making available to the Investors the benefits of Rule 144 (or its successor rule) and any other rule or regulation of the SEC that may at any time permit the Investors to sell shares of Common Stock to the public without registration, the Company covenants and agrees to: (i) make and keep adequate current public information available, as those terms are understood and defined in Rule 144, until the earlier of (A) six months after such date as all of the Registrable Securities may be sold without restriction (including the current public information requirement) by the holders thereof pursuant to Rule 144 or any other rule of similar effect or (B) such date as all of the Registrable Securities shall have been resold; (ii) file with the SEC in a timely manner all reports and other documents required of the Company under the 1934 Act; and (iii) furnish to each Investor upon request, as long as such Investor owns any Registrable Securities, (A) a written statement by the Company that it has complied with the reporting requirements of the 1934 Act, (B) a copy of the Company’s most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, and (C) such other information as may be reasonably requested in order to avail such Investor of any rule or regulation of the SEC that permits the selling of any such Registrable Securities without registration.

4. Due Diligence Review; Information. The Company shall, upon reasonable prior notice, make available, during normal business hours, for inspection and review by the Investors, and advisors to and representatives of the Investors (who may or may not be affiliated with the Investors and who are reasonably acceptable to the Company) (collectively, the “Inspectors”), all pertinent financial and other records, and all other corporate documents and properties of the Company (collectively, the “Records”), as may be reasonably necessary for the purpose of such review, and cause the Company’s officers, directors and employees, within a reasonable time period, to supply all such information reasonably requested by the Inspectors (including, without limitation, in response to all questions and other inquiries reasonably made or submitted by any of them), prior to and from time to time after the filing and effectiveness of such Registration Statement for the sole purpose of enabling the Investors and their accountants and attorneys to conduct initial and ongoing due diligence with respect to the Company and the accuracy of such Registration Statement; provided, however, that each Inspector shall have agreed in writing to hold in strict confidence and to not make any disclosure (except to such Investor) or use of any Record or other information which the Company determines in good faith to be confidential, and of which determination the Inspectors are so notified, unless (a) the disclosure of such Records is necessary to avoid or correct a misstatement or omission in any Registration Statement or is otherwise required under the 1933 Act, (b) the release of such Records is ordered pursuant to a final, non-appealable subpoena or order from a court or government body of competent jurisdiction, or (c) the information in such Records has been made generally available to the public other than by disclosure in violation of this Section 4 or any other Transaction Document.


Notwithstanding the foregoing, the Company shall not disclose material nonpublic information to the Investors, or to advisors to or representatives of the Investors, unless prior to disclosure of such information the Company identifies such information as being material nonpublic information and provides the Investors, such advisors and such representatives with the opportunity to accept or refuse to accept such material nonpublic information for review and any Investor wishing to obtain such information enters into an appropriate confidentiality and non-use agreement with the Company with respect thereto.

5. Obligations of the Investors.

(a) Each Investor shall furnish in writing to the Company such information regarding itself, the Registrable Securities held by it and the intended method of disposition of the Registrable Securities held by it, as shall be reasonably required to effect the registration of such Registrable Securities, and shall execute such documents in connection with such registration as the Company may reasonably request. At least seven (7) Business Days prior to the first anticipated filing date of any Registration Statement, the Company shall notify each Investor of the information the Company requires from such Investor if such Investor elects to have any of the Registrable Securities included in such Registration Statement. An Investor shall provide such information to the Company at least three (3) Business Days prior to the first anticipated filing date of such Registration Statement if such Investor elects to have any of the Registrable Securities included in such Registration Statement.

(b) Each Investor, by its acceptance of the Registrable Securities, agrees to cooperate with the Company as reasonably requested by the Company in connection with the preparation and filing of a Registration Statement hereunder, unless such Investor has notified the Company in writing of its election to exclude all of its Registrable Securities from such Registration Statement.

(c) Each Investor agrees that, upon receipt of any notice from the Company of either (i) the commencement of an Allowed Delay pursuant to Section 2(c)(ii) or (ii) the happening of an event pursuant to Section 3(h) hereof, such Investor will immediately discontinue disposition of Registrable Securities pursuant to any Registration Statement covering such Registrable Securities (but not, for the avoidance of doubt, pursuant to Rule 144 if sales pursuant to Rule 144 are then permitted),, until the Investor is advised by the Company that such dispositions may again be made.

(d) Each Investor covenants and agrees that it will comply with the prospectus delivery requirements of the 1933 Act as applicable to it or an exemption therefrom in connection with sales of Registrable Securities pursuant to any Registration Statement.

6. Indemnification.

(a) Indemnification by the Company. The Company will indemnify and hold harmless each Investor and its officers, directors, members, employees and agents, and each other person, if any, who controls such Investor within the meaning of the 1933 Act, against any losses, claims, damages or liabilities, joint or several, to which they may become subject under the 1933 Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) and expenses (and expense (including reasonable and documented attorney’s fees), arise out of or are based upon (i) any untrue statement or alleged untrue statement or omission or alleged omission of any material fact contained in any Registration Statement, any preliminary Prospectus or final


Prospectus, or any amendment or supplement thereof or (ii) any violation by the Company or its agents of any applicable federal, state and self-regulatory organization laws, rules and regulations, including but not limited to, any rule or regulation promulgated under the 1933 Act applicable to the Company or its agents and relating to action or inaction required of the Company in connection with such registration, and will reimburse such Investor, and each such officer, director, member, employee, agent and each such controlling person for any legal or other documented, out-of-pocket expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage or liability (or action in respect thereof); provided, however, that the Company will not be liable in any such case if and to the extent that any such loss, claim, damage or liability arises out of or is based upon (i) an untrue statement or alleged untrue statement or omission or alleged omission so made in conformity with information furnished by such Investor or any such controlling person in writing specifically for use in such Registration Statement or Prospectus, (ii) the use by an Investor of an outdated or defective Prospectus after the Company has notified such Investor in writing that such Prospectus is outdated or defective; (iii) an Investor’s failure to send or give a copy of the Prospectus or supplement (as then amended or supplemented), if required (and not exempted) to the Persons asserting an untrue statement or omission or alleged untrue statement or omission at or prior to the written confirmation of the sale of Registrable Securities (if the Company has made such Prospectus or supplement (as then amended or supplemented) then available to the Investor as provided for in this Agreement); or (iv) an Investor’s bad faith, gross negligence, recklessness, fraud or willful misconduct.

(b) Indemnification by the Investors. Each Investor agrees, severally but not jointly, to indemnify and hold harmless, to the fullest extent permitted by law, the Company, its directors, officers, employees, stockholders and each person who controls the Company (within the meaning of the 1933 Act) against any losses, claims, damages, liabilities and expense (including reasonable attorney fees) resulting from any untrue statement of a material fact or any omission of a material fact required to be stated in any Registration Statement or Prospectus or preliminary Prospectus or amendment or supplement thereto or necessary to make the statements therein not misleading, to the extent, but only to the extent that such untrue statement or omission is contained in any information furnished in writing by such Investor to the Company specifically for inclusion in such Registration Statement or Prospectus or amendment or supplement thereto. Except to the extent that any such losses, claims, damages, liabilities or expenses are finally judicially determined to have resulted from an Investor’s bad faith, gross negligence, recklessness, fraud or willful misconduct, in no event shall the liability of an Investor be greater in amount than the dollar amount of the proceeds (net of all expense paid by such Investor in connection with any claim relating to this Section 6 and the amount of any damages such Investor has otherwise been required to pay by reason of such untrue statement or omission) received by such Investor upon the sale of the Registrable Securities included in such Registration Statement giving rise to such indemnification obligation.

(c) Conduct of Indemnification Proceedings. Any person entitled to indemnification hereunder shall (i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any person entitled to indemnification hereunder shall have the right to employ separate counsel and to participate in the defense of such claim, but the fees and expenses of such counsel shall be at the expense of such person unless (a) the indemnifying party has agreed in


writing to pay such fees or expenses, (b) the indemnifying party shall have failed to assume the defense of such claim and employ counsel reasonably satisfactory to such person or (c) in the reasonable judgment of any such person, based upon written advice of its counsel, a conflict of interest exists between such person and the indemnifying party with respect to such claims (in which case, if the person notifies the indemnifying party in writing that such person elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of such claim on behalf of such person); and provided, further, that the failure of any indemnified party to give written notice as provided herein shall not relieve the indemnifying party of its obligations hereunder, except to the extent that such failure to give notice shall materially adversely affect the indemnifying party in the defense of any such claim or litigation. It is understood that the indemnifying party shall not, in connection with any proceeding in the same jurisdiction, be liable for fees or expenses of more than one separate firm of attorneys at any time for all such indemnified parties. No indemnifying party will, except with the consent of the indemnified party, which shall not be unreasonably withheld or conditioned, consent to entry of any judgment or enter into any settlement that does not include as an unconditional term thereof the giving by the claimant or plaintiff to such indemnified party of a release from all liability in respect of such claim or litigation.

(d) Contribution. If for any reason the indemnification provided for in the preceding paragraphs (a) and (b) is unavailable to an indemnified party or insufficient to hold it harmless, other than as expressly specified therein, then the indemnifying party shall contribute to the amount paid or payable by the indemnified party as a result of such loss, claim, damage or liability in such proportion as is appropriate to reflect the relative fault of the indemnified party and the indemnifying party, as well as any other relevant equitable considerations. No person guilty of fraudulent misrepresentation within the meaning of Section 11(f) of the 1933 Act shall be entitled to contribution from any person not guilty of such fraudulent misrepresentation. Except to the extent that any such losses, claims, damages or liabilities are finally judicially determined to have resulted from a holder of Registrable Securities’ bad faith, gross negligence, recklessness, fraud or willful misconduct, in no event shall the contribution obligation of such holder be greater in amount than the dollar amount of the proceeds (net of all expenses paid by such holder in connection with any claim relating to this Section 6 and the amount of any damages such holder 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.

7. Miscellaneous.

(a) Effective Date. This Agreement shall be effective as of the Closing, and if the Closing has not occurred on or prior to fifth Trading Day following the date of the Purchase Agreement, unless otherwise mutually agreed, then this Agreement shall be null and void.

(b) Amendments and Waivers. This Agreement may be amended only by a writing signed by the Company and the Required Investors; provided that no such amendment shall be effective to the extent that it applies to less than all of the Investors or holders of Registrable Securities. The Company may take any action herein prohibited, or omit to perform any act herein required to be performed by it, only if the Company shall have obtained the written consent to such amendment, action or omission to act of the Required Investors.


(c) Notices. All notices and other communications provided for or permitted hereunder shall be made as set forth in Section 9.4 of the Purchase Agreement.

(d) Assignments and Transfers by Investors. The provisions of this Agreement shall be binding upon and inure to the benefit of the Investors and their respective successors and assigns. An Investor may transfer or assign, in whole or from time to time in part, to one or more persons its rights hereunder in connection with the transfer of Registrable Securities by such Investor to such person, provided that such Investor complies with all laws applicable thereto, and the provisions of the Purchase Agreement, and provides written notice of assignment to the Company promptly after such assignment is effected, and such person agrees in writing to be bound by all of the provisions contained herein.

(e) Assignments and Transfers by the Company. This Agreement may not be assigned by the Company (whether by operation of law or otherwise) without the prior written consent of the Required Investors, provided, however, that in the event that the Company is a party to a merger, consolidation, share exchange or similar business combination transaction in which the Common Stock is converted into the equity securities of another Person, from and after the effective time of such transaction, such Person shall, by virtue of such transaction, be deemed to have assumed the obligations of the Company hereunder, the term “Company” shall be deemed to refer to such Person and the term “Registrable Securities” shall be deemed to include the securities received by the Investors in connection with such transaction unless such securities are otherwise freely tradable by the Investors after giving effect to such transaction.

(f) Benefits of the Agreement. The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective permitted successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

(g) Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or any electronic signatures complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

(h) Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

(i) Severability. Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof but shall be interpreted as if it were written so as to be enforceable to the maximum extent permitted by applicable law, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. To the extent permitted by applicable law, the parties hereby waive any provision of law which renders any provisions hereof prohibited or unenforceable in any respect.


(j) Further Assurances. The parties shall execute and deliver all such further instruments and documents and take all such other actions as may reasonably be required to carry out the transactions contemplated hereby and to evidence the fulfillment of the agreements herein contained.

(k) Entire Agreement. This Agreement is intended by the parties as a final expression of their agreement and intended to be a complete and exclusive statement of the agreement and understanding of the parties hereto in respect of the subject matter contained herein. This Agreement supersedes all prior agreements and understandings between the parties with respect to such subject matter.

(l) Governing Law. This Agreement shall be governed by, and construed in accordance with, the laws of the State of New York. Service of process in connection with any such suit, action or proceeding may be served on each party hereto anywhere in the world by the same methods as are specified for the giving of notices under this Agreement.

(m) Cumulative Remedies. The remedies provided herein are cumulative and not exclusive of any remedies provided by law.

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IN WITNESS WHEREOF, the parties have executed this Agreement or caused their duly authorized officers to execute this Agreement as of the date first above written.

 

COMPANY:     SATSUMA PHARMACEUTICALS, INC.
    By:  

/s/ John Kollins

      Name: John Kollins
      Title: President and Chief Executive Officer


INVESTOR: Lumira Ventures III, L.P.    
    By:  

/s/ Vasco Larcina

     

Name: Vasco Larcina

Title: CFO

    By:  

/s/ Benjamin Rovinski

     

Name: Benjamin Rovinski

Title: Sr. VP


INVESTOR: Lumira Ventures III (International), L.P.  
    By:  

/s/ Vasco Larcina

     

Name: Vasco Larcina

Title: CFO

    By:  

/s/ Benjamin Rovinski

     

Name: Benjamin Rovinski

Title: Sr. VP

 

15


INVESTOR: Point72 Associates, LLC    
    By:  

/s/ Vincent Tortorella

     

Name: Vincent Tortorella

Title: Authorized Person

 

16


INVESTOR: Shin Nippon Biomedical Laboratories, Ltd.  
    By:  

/s/ Ryoichi Nagata, MD, PhD

     

Name: Ryoichi Nagata, MD, PhD

Title: President & CEO

 

17


INVESTOR: Vivo Opportunity Fund, L.P.  
    By:  

/s/ Gaurav Aggarwal

     

Name: Gaurav Aggarwal

Title: Managing Member of Vivo Opportunity, LLC, General Partner

 

18


INVESTOR: BEMAP Master Fund Ltd  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

19


INVESTOR: DS Liquid Div RVA Mon LLC  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

20


INVESTOR: Bespoke Alpha MAC MIM LP  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

21


INVESTOR: SFL SPV I LLC  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

22


INVESTOR: Monashee Pure Alpha SPV I LP  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

23


INVESTOR: Monashee Solitario Fund LP  
    By:  

/s/ Jeff Muller

     

Name: Jeff Muller

Title: CCO

 

24


INVESTOR: Ikarian Capital, LLC  
    By:  

/s/ Chart Westcott

     

Name: Chart Westcott

Title: COO of Ikarian Capital, LLC, Investment Adviser

 

25


INVESTOR: Commodore Capital Master LP  
    By:  

/s/ R. Egen Atkinson, MD

     

Name: R. Egen Atkinson, MD

Title: Authorized Signatory

 

26


INVESTOR: Samlyn Onshore Fund, LP

 
   

By:

 

/s/ Michael Barry

     

Name: Michael Barry

Title: Authorized Signatory

 

27


INVESTOR: Samlyn Offshore Master Fund, Ltd.

 
   

By:

 

/s/ Michael Barry

     

Name: Michael Barry

Title: Authorized Signatory

 

28


INVESTOR: Samlyn Net Neutral Master Fund, Ltd.

 
   

By:

 

/s/ Michael Barry

     

Name: Michael Barry

Title: Authorized Signatory

 

29


INVESTOR: Samlyn Long Alpha Master Fund, Ltd.  
    By:  

/s/ Michael Barry

     

Name: Michael Barry

Title: Authorized Signatory

 

30


INVESTOR: Growth Equity Opportunities 17, L.P.  
    By:  

/s/ Louis S. Citron

     

Name: Louis S. Citron

Title: Chief Legal Officer

 

31


INVESTOR:    

RA CAPITAL HEALTHCARE FUND, L.P.

By: RA Capital Healthcare Fund GP, LLC

Its: General Partner

    By:  

/s/ Rajeev Shah

     

Name: Rajeev Shah

Title: Manager

 

32


INVESTOR: North Sound Trading, LP  
    By:  

/s/ Brian Miller

     

Name: Brian Miller

Title: President of the General Partner

 

33


INVESTOR: Maven Investment Partners US Limited-NY Branch  
    By:  

/s/ Jose R. Castillo

     

Name: Jose R. Castillo

Title: Director

 

34


INVESTOR: Ghost Tree Capital Group, LP  
    By:  

/s/ Matthew Diaz

     

Name: Matthew Diaz

Title: COO/CFO

 

35


INVESTOR:    

Logos GLOBAL MASTER FUND LP

By: Logos GP LLC

Its General Partner

    By:  

/s/ Arsani William

     

Name: Arsani William

Title: Managing Partner

 

36


INVESTOR:    

ASPIRE CAPITAL FUND, LLC

By: Aspire Capital Partners, LLC

By: SGM Holdings Corp.

    By:  

/s/ Steven G. Martin

     

Name: Steven G. Martin

Title: President

 

37


INVESTOR:    

Citadel Multi-Strategy Equities Master Fund Ltd.

By: Citadel Advisors LLC, its portfolio manager

    By:  

/s/ Shellane Mulcahy

     

Name: Shellane Mulcahy

Title: Authorized Signatory

 

38


Plan of Distribution

The selling stockholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.

The selling stockholders may use any one or more of the following methods when disposing of shares or interests therein:

– ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

– block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction;

– purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

– an exchange distribution in accordance with the rules of the applicable exchange;

– privately negotiated transactions;

– in settlement of short sales;

– through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

– broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share;

– a combination of any such methods of sale; and

– any other method permitted by applicable law.

The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from time to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act of 1933, as amended (the “Securities Act”), amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.


In connection with the sale of our common stock or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the common stock in the course of hedging the positions they assume. The selling stockholders may also sell shares of our common stock short and deliver these securities to close out their short positions, or loan or pledge the common stock to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

The aggregate proceeds to the selling stockholders from the sale of the common stock offered by them will be the purchase price of the common stock less discounts or commissions, if any. Each of the selling stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of common stock to be made directly or through agents. We will not receive any of the proceeds from this offering.

The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act of 1933, provided that they meet the criteria and conform to the requirements of that rule.

The selling stockholders and any underwriters, broker-dealers or agents that participate in the sale of the common stock or interests therein may be “underwriters” within the meaning of Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are “underwriters” within the meaning of Section 2(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.

To the extent required, the shares of our common stock to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agents, dealer or underwriter, and any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.

In order to comply with the securities laws of some states, if applicable, the common stock may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the common stock may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.


We have advised the selling stockholders that the anti-manipulation rules of Regulation M under the Securities Exchange Act of 1934, as amended, may apply to sales of shares in the market and to the activities of the selling stockholders and their affiliates. In addition, to the extent applicable, we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the selling stockholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling stockholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.

We have agreed to indemnify the selling stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the registration of the shares offered by this prospectus.

We have agreed with the selling stockholders to use commercially reasonable efforts to cause the registration statement of which this prospectus constitutes a part effective and to remain continuously effective until the earlier of (1) such time as all of the shares covered by this prospectus have been disposed of pursuant to and in accordance with such registration statement or (2) the date on which all of the shares may be sold without restriction pursuant to Rule 144 of the Securities Act.

Exhibit 99.1

 

LOGO

PRESS RELEASE

Satsuma Pharmaceuticals Announces Updated STS101 Development Plan

-New STS101 Phase 3 efficacy trial planned to begin mid-2021 with topline results expected second half of 2022-

-Proceeds from $80 million private placement and existing cash expected to fund operations into second half of 2023-

-Conference call this morning at 8:00 AM ET; dial in details are listed below-

South San Francisco, CA, March 1, 2021Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) a clinical-stage biopharmaceutical company, today announced an update to the development plan for STS101 (dihydroergotamine (DHE) nasal powder), an investigational acute treatment for migraine. The updated STS101 development plan includes a new Phase 3 efficacy trial, which the Company anticipates initiating in mid-2021, with topline results expected in the second half of 2022. The new Phase 3 trial takes into account findings from the EMERGE pivotal study in which STS101 showed numerical differences in favor of STS101 5.2 mg and 3.9 mg versus placebo but did not achieve statistical significance versus placebo on the co-primary endpoints of freedom from pain and most bothersome symptom at two hours post-administration. In addition, the Company plans to explore dose strengths greater than 5.2 mg by conducting a Phase 1 trial in the second quarter of 2021 to evaluate the pharmacokinetics, safety, and tolerability of STS101 5.2 mg and two higher dose strengths. The Company plans to select the STS101 dose strength to utilize in its next Phase 3 efficacy trial based on the results of this Phase 1 trial.

Satsuma also announced today that it has entered into a securities purchase agreement with existing and new investors for an $80 million private placement financing. The Company believes that net proceeds from the private placement financing, together with its existing cash, cash equivalents and short-term investments of $68.2 million as of December 31, 2020, will be sufficient to fund company operations into the second half of 2023.

The Company is holding a conference call this morning to discuss its updated STS101 development plan, as well as preliminary results to date from the ongoing open-label ASCEND long-term safety trial of STS101 5.2 mg, and a synopsis of key EMERGE trial findings.

“We continue to have strong conviction that STS101 has the potential to be an important and differentiated acute treatment option that can address the unmet needs of many people with migraine. After conducting a comprehensive, multi-functional review of our STS101 program, including EMERGE trial findings and preliminary results to date from our ongoing ASCEND open-label, long-term safety trial, we believe there is a compelling rationale for continuing development of STS101 and undertaking a second Phase 3 efficacy trial,” said John Kollins, President & Chief Executive Officer of Satsuma. “We are pleased to have strong support for our updated STS101 development plan from our expert clinical advisors and leading specialist healthcare investors.”

 

1


LOGO

 

EMERGE Phase 3 efficacy trial results

On September 10, 2020, the Company announced topline results from the EMERGE Phase 3 efficacy trial of STS101. As detailed in the table below, although topline data showed numerical differences in favor of STS101 3.9 mg and 5.2 mg versus placebo on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia and nausea) at two hours post-administration, these differences did not achieve statistical significance for either dose strength.

 

EMERGE Co-primary Endpoints1:

   3.9 mg     5.2 mg     Placebo  

Patients

     n=354       n=353       n=358  

Freedom from Pain at 2 hours

N

% responders

Difference vs Placebo

p-value

    

69/354

19.5

4.7

0.10

 

% 

 

   

68/353

19.3

4.5

0.11

 

% 

 

   

53/358

14.8

—  

—  

 

% 

 

 

Freedom from Most Bothersome Symptom at 2 hours

N

% responders

Difference vs Placebo

p-value

    

133/340

39.1

5.4

0.14

 

% 

 

   

139/343

40.5

6.8

0.06

 

% 

 

   

119/353

33.7

—  

—  

 

% 

 

 

Both dose strengths of STS101 did, however, demonstrate significant effects (nominal p-value < 0.05) on both freedom from pain and most bothersome symptom endpoints by three hours post-dose and later time points. Consistent with the safety and tolerability results to date observed in other STS101 clinical trials, including the ongoing ASCEND open-label, long-term safety trial, both STS101 dose strengths were well-tolerated in the EMERGE trial, with low adverse event rates and no drug-related serious adverse events reported.

Based on its analyses, the Company believes it has identified, and is taking steps to address in the new Phase 3 efficacy trial, the key reasons that STS101 did not achieve statistical significance versus placebo on the co-primary endpoints in the EMERGE trial.

ASCEND Phase 3 open-label, long-term safety trial preliminary results to date

As of February 23, 2021, the Company has enrolled more than 275 subjects in its ongoing ASCEND open-label, long-term safety trial who have treated a total of more than 2,200 migraine attacks with STS101 5.2 mg. STS101 5.2 mg has been been well-tolerated to date in the ASCEND trial, with low adverse event rates and no drug-related serious adverse events reported. In addition, the Company believes that, based on the preliminary results from the ASCEND open-label, long-term safety trial, STS101 5.2 mg demonstrates anti-migraine activity at the two-hour time point.

 

1 

Per the EMERGE trial Statistical Analysis Plan, subjects who did not report efficacy data for the 2-hour post-treatment time point were imputed to be non-responders, irrespective of response status as of the last time point prior to 2 hours when efficacy data was reported.

 

2


LOGO

 

Anticipated STS101 development milestones

 

Second Quarter 2021    – Complete Phase 1 safety and pharmacokinetic study with STS101 5.2 mg and two higher dose strengths
Mid-2021    – Initiate second STS101 Phase 3 efficacy trial
Second Half 2022    – Read out topline results from second Phase 3 efficacy trial
Fourth Quarter 2022    – File STS101 NDA

Conference Call and Webcast Details The Company’s management team will host a conference call and webcast this morning, Monday, March 1, at 8:00am ET / 5:00am PT.

The call is accessible via the below teleconference numbers and the Conference ID#: 13716986# USA/Canada: +1 (877) 705-6003 International Dial-In Number: +1 (201) 493-6725

The webcast can be followed live online via the link:http://public.viavid.com/index.php?id=143740

About Satsuma Pharmaceuticals and STS101

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product candidate for the acute treatment of migraine. Its product candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, which is designed to be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. DHE products have long been recommended as a first-line therapeutic option for the acute treatment of migraine and have significant advantages over other therapeutics for many patients. However, broad use has been limited by invasive and burdensome administration and/or sub-optimal clinical performance of available injectable and liquid nasal spray products. STS101 is specifically designed to deliver the clinical advantages of DHE while overcoming these shortcomings.

Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.

 

3


LOGO

 

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101, the potential results of the ASCEND trial, the potential for STS-101 to be an important and differentiated acute treatment option, and the expected cash runway of the Company. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; and the risk that the COVID-19 worldwide pandemic may negatively impact the Company’s business, operations, clinical trials or ability to raise capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR AND CORPORATE CONTACTS:

Corey Davis, PhD

LifeSci Advisors, LLC

cdavis@lifesciadvisors.com

Tom O’Neil, Chief Financial Officer

Satsuma Pharmaceuticals, Inc.

tom@satsumarx.com

 

4

SLIDE 0

Corporate and STS101 (DHE nasal powder for migraine) program update Conference call March 1, 2021 NASDAQ: STSA Exhibit 99.2


SLIDE 1

Important Notice This Presentation contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the potential continued development of STS101; the Company’s expectations regarding the completion of its analysis of the EMERGE trial data and announcement of its updated business plans by early 2021; Company’s expectations regarding the potential safety and efficacy of STS101; the Company’s clinical and regulatory development plans; the Company’s expectations with regard to the ASCEND trial; the Company’s expectations regarding the potential market size and size of the potential patient populations for STS101, if approved for commercial use; the Company’s commercialization, marketing and manufacturing plans and expectations; the pricing and reimbursement of STS101, if approved; the implementation of the Company’s business model and strategic plans for its business and STS101; the scope of protection the Company is able to establish and maintain for intellectual property rights covering STS101, including the projected terms of patent protection; estimates of the Company’s expenses, future revenue, capital requirements, its need for additional financing and its ability to obtain additional capital; the Company’s future financial performance; and developments and projections relating to the Company’s competitors and the Company’s industry, including competing therapies and procedures. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the Company’s ability to select suitable dosing regimens; the results of preclinical and clinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to raise additional capital; and the risk that costs of clinical trials and preclinical activities will exceed expectations. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. This Presentation discusses STS101, a product candidate that is under clinical study, and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied. Disclaimer


SLIDE 2

DHE’s anti-migraine effects are differentiated and well-established However, route of administration and/or performance of available dosage forms have limited DHE use Summary STS101 (DHE nasal powder) 12/31/20 cash: $68.2M Position & next steps Approved in 1997 Large and growing market with high unmet needs Developing innovative and differentiated treatment Acute treatment of migraine Updated plan features new Ph3 efficacy trial Key factors informing our updated plan EMERGE trial results and findings from our analyses Preliminary results to date from ASCEND Ph3 open-label safety trial KOL feedback and support Expected long product life with branded product price point Automated, commercial-scale manufacturing established 39M patients in U.S. alone, with many underdiagnosed, undertreated, poorly served with existing treatments Acute market has continued to grow (by ~14%) since recent introductions of new preventive and acute treatments Gepant launches validate market opportunity and high unmet need; net sales currently annualizing at >$700M/year STS101 $80M private placement financing announced 3/1/21 Current cash and financing proceeds fund operations into 2H 2023 and through key milestones: Readout of second STS101 Ph3 efficacy trial in 2H 2022 Completion of STS101 ASCEND long-term safety trial in 2H 2022 Filing of NDA Q4 2022 Well-capitalized Team with strong track record of execution Significant value creation opportunity Proprietary, advanced formulation and delivery device technologies Product of >15 years of R&D Broad and long-lived IP estate, with 10 issued U.S. patents with expiration dates as late as end of 2039


SLIDE 3

Presentation overview EMERGE Phase 3 efficacy trial results Why EMERGE missed on co-primary endpoints and how we can apply what we’ve learned to make our next STS101 Ph3 trial successful STS101 under-delivery Early data entry for co-primary endpoints Very high proportions of subjects and treated attacks with characteristics associated with poor treatment outcomes High placebo response rate given severity of treated attacks Potential opportunity to maximize efficacy in next Ph3 trial with dose strength > 5.2 mg Preliminary results to date from ASCEND open-label, long-term safety trial (STS101 5.2 mg) Go-forward STS101 development plan


SLIDE 4

Phase 3 EMERGE design & enrollment summary 28-day electronic headache diary Randomize STS101 5.2 mg DHE STS101 3.9 mg DHE Placebo Confirm patients had ≥ 2 and ≤ 8 migraine attacks during 28-day screening period (consistent with self-reported attack frequency during 3 months prior to initial screening visit) Screening period Treatment of single migraine attack within 56 days of randomization (n = 400) (n = 399) (n = 402) Designed per published FDA guidance for developing acute treatment of migraine drugs (Feb 2018) EMERGE design (n = 1,201) n = 353 n = 354 n = 358 mITT 1,065 Total mITT Co-primary endpoints assessed 2 hours post-treatment in mITT population: % Free from Pain % Free from Most-Bothersome Symptom (from among photophobia, phonophobia or nausea) Trial timeline Trial conducted June 2019 - July 2020 (>1200 subjects randomized in < 1yr, including during COVID pandemic) Topline results reported September 2020 Enrollment & disposition 1,201 subjects randomized 1,093 in safety population* 1,065 in mITT population** * All subjects who took study medication **All subjects with qualifying migraine attack (i.e., Moderate or Severe pain severity at baseline) who took study medication and entered efficacy data for at least one time point ≤ 2hrs


SLIDE 5

Demographics 3.9 mg STS101 5.2 mg STS101 Placebo Age (mean) 40.5 40.5 40.1 Gender (% Female) 87.3 87.3 87.4 Race (% White) 81.4 79.6 84.1 Use of preventive medications (%) 15.0 14.4 13.1 Headache Impact Test (HIT-6) score (mean) 64.5 65.5 64.4 HIT-6 score ≥60, indicating severe impact (%) 82.5 88.1 83.8 HIT-6 score ≥70 indicating very severe impact (%) 17.2 23.5 17.1 Source:STS101-002 Topline Data September 2020; mITT Population EMERGE treatment groups were well balanced for age, gender, race, and use of preventive medications A higher % of subjects in the 5.2 mg STS101 group had HIT-6 scores indicating “severe” or “very severe” impact


SLIDE 6

Characteristics of treated attacks (reported at time of treatment) Treated attacks had high rates of characteristics associated with poor treatment outcome Severe symptomology suggests many subjects treated attacks late in the migraine cycle Source:STS101-002 Topline Data September 2020; mITT Population 3.9 mg STS101 (%) 5.2 mg STS101 (%) Placebo (%) Pain severity (moderate/severe) 52.5/47.5 49.3/50.7 53.6/46.4 Nausea 73.2 73.4 71.8 Photophobia 93.5 95.8 95 Phonophobia 88.1 90.7 88.8 Allodynia1 67.8 64.6 63.7 Moderate or Severe Functional Impairment2 85.9 83.9 86.3 Allodynia was considered present if subject had 2 positive responses in 6 question allodynia questionnaire immediately before study drug administration (Ashkenazi 2007; Tepper 2011) Moderate: Unable to perform certain activities of daily living; Severe: Unable to perform most activities of daily living or requiring bedrest


SLIDE 7

STS101 narrowly missed on co-primary efficacy endpoints1 3.9mg 5.2mg Difference vs Placebo 4.7% 4.5% p-value 0.10 0.11 3.9mg 5.2mg Difference vs Placebo 5.4% 6.8% p-value 0.14 0.06 1. Per SAP, any subject with missing data at 2hrs imputed to be nonresponder, irrespective of responder status at the last earlier time point when data was entered 68/353 69/354 53/358 119/353 139/343 133/340


SLIDE 8

Freedom from Pain over time Source: STS101-002 Topline Data September 2020; mITT Population * denotes p<0.05 vs placebo * * * * * * * * * STS101 5.2 mg was numerically superior to Placebo at all time points and to STS101 3.9 mg at 9 of 12 time points Difference vs Placebo was significant at 3 hours (p<0.05) and all time points thereafter through 24 hours Subjects with missing data at a time point imputed as nonresponders


SLIDE 9

Freedom from MBS over time Source: STS101-002 Topline Data September 2020; mITT Population Both STS101 dose strengths were significant (p<0.05) versus placebo by 3 hours and through 12 hours * * * * * * * * * * denotes p<0.05 vs placebo Subjects with missing data at a time point imputed as nonresponders


SLIDE 10

STS101 showed favorable safety & tolerability profile No Serious Adverse Events No cardiovascular-related Adverse Events No nausea signal Most frequent nasal adverse event (discomfort) occurred in < 6% Adverse Events 3.9 mg STS101 5.2 mg STS101 Placebo Safety Population (n) 363 367 363 At least 1 treatment emergent AE (n/%) 57 (15.7) 57 (15.5) 33 (9.1) Most frequent AEs (%) Nasal discomfort 5.5 5.7 1.9 Dysgeusia 4.1 4.9 1.4 Rhinorrhea 2.5 1.4 1.1 Nasal congestion 1.4 2.2 0.8 Nausea 1.1 1.1  0.6


SLIDE 11

EMERGE trial summary High % of treated attacks had characteristics associated with poor treatment outcome Both STS101 dose strengths demonstrated anti-migraine activity, but narrowly missed achieving statistical significance on co-primary endpoints at 2 hours Statistically significant effect by 3 hours and thereafter STS101 5.2 mg was numerically superior to placebo at all time points (15 min – 48 hrs) Significant effect (p<0.05) on multiple secondary efficacy endpoints Favorable safety and tolerability profile Absolute response rates in EMERGE in context: Were generally in-line, particularly at later time points, with rates reported in other similarly-designed large Ph3 trials in which subjects had high rates of characteristics associated with poor treatment outcome (e.g., MAP0004 FREEDOM, AXS-07 MOMENTUM)


SLIDE 12

Findings from our EMERGE trial analyses and how we are addressing them Interlinked reasons for EMERGE miss Strategy for addressing in next STS101 Ph3 trial In addition, given safety/tolerability profile observed in EMERGE and to date in ASCEND, a dose strength greater than 5.2 mg should be feasible and could maximize efficacy. We are conducting a Ph1 PK study to evaluate 5.2 mg and two higher dose strengths. STS101 under-delivery Improve patient training and instructions for use Improve STS101 delivery device with minor changes Very high proportions of subjects and treated attacks with characteristics associated with poor treatment outcomes Adjust screening procedures / inclusion criteria Instruct subjects to treat qualifying migraines as soon as pain intensity reaches “moderate” Early data entry for co-primary endpoints Adjust time windows for eDiary data entry to align with nominal time points High placebo response rate given severity of treated attacks Increase trial size and statistical power Site and subject training to minimize expectation bias and increase standardization of reported outcomes 2-arm study will reduce expectation of receiving active vs EMERGE (3-arms: 2 active + placebo)


SLIDE 13

STS101 designed for intuitive administration – a full dose within seconds Fold Off tab 1 Insert In nostril 2 squeeze to deliver (Repeat 3x) 3


SLIDE 14

STS101 under-delivery in EMERGE EMERGE subjects delivered, on average, ~70% of label dose* Reasons: 1. Learning curve effect First use of STS101 (or placebo) by EMERGE subjects was in the treated attack for which efficacy was evaluated Tentativeness with first use → slow pump squeeze 2. STS101 devices used in EMERGE If first pump squeeze was slow, full dose was not delivered AND remaining dose in device was not available for delivery with subsequent two pump squeezes * Estimate based on post-trial analysis of amount drug remaining in 689 returned STS101 devices used by EMERGE subjects Calculated % Emitted Dose STS101 (5.2 mg) EMERGE (5.2 mg) N 346 Mean 73% Median 81% SD 24% Similar calculated % Emitted Dose (ED) results observed in EMERGE for STS101 3.9 mg


SLIDE 15

STS101 under-delivery in EMERGE EMERGE subjects delivered, on average, ~70% of label dose* Reasons: 1. Learning curve effect First use of STS101 (or placebo) by EMERGE subjects was in the treated attack for which efficacy was evaluated Tentativeness with first use → slow pump squeeze 2. STS101 devices used in EMERGE If first pump squeeze was slow, full dose was not delivered AND remaining dose in device was not available for delivery with subsequent two pump squeezes Placebo %ED ≤ 70% %ED > 70% Placebo %ED ≤ 70% %ED > 70% Pain Free MBS Free STS101 5.2 mg * p=0.03 vs Placebo * Estimate based on post-trial analysis of amount drug remaining in 689 returned STS101 devices used by EMERGE subjects Higher % Emitted Dose generally associated with higher response rates across various endpoints


SLIDE 16

Ensuring adequate delivery of drug in our next STS101 Ph3 trial Issues in EMERGE 1. Learning curve effect 2. STS101 devices used in EMERGE Site staff and subject training Subjects practice improved self-administration procedure during screening visits (using STS101 devices filled with inactive powder)—i.e., before treatment of actual migraine attack Developing improved training with input from human factors expert Minor improvements to STS101 device to increase robustness and tolerance for suboptimal administration technique Minor device changes Pumps with thin walls for easier squeezing Added simple check valve Increased delivery with first squeeze, even if slow / tentative Ensure full dose is available for delivery Improvements


SLIDE 17

Improvements to increase % Emitted Dose Thinner pump wall for easier squeezing (all STS101 devices in ASCEND) Initial training improvements (ASCEND results don’t reflect full effect of initial training improvements, as implementation initiated several months after study start) Data may reflect some learning curve effects, i.e., administration technique improving with successive uses Further % Emitted Dose improvements likely Devices incorporating check valve Further training improvements Pain Free response rates at 2h in ASCEND have increased over time as some, but not all, improvements have been implemented Initial data from ongoing open-label ASCEND long-term safety study indicate improvements effectively increase % Emitted Dose EMERGE (5.2 mg) ASCEND (5.2 mg) Change N 346 768 Mean 73% 83% +10% Median 81% 89% +8% SD 24% 17% -7% % Emitted Dose in EMERGE and initial ASCEND data set


SLIDE 18

Findings from our EMERGE trial analyses and how we are addressing them Interlinked reasons for EMERGE miss Strategy for addressing in next STS101 Ph3 trial In addition, given safety/tolerability profile observed in EMERGE and to date in ASCEND, a dose strength greater than 5.2 mg should be feasible and could maximize efficacy. We are conducting a Ph1 PK study to evaluate 5.2 mg and two higher dosage strengths. STS101 under-delivery Improve patient training and instructions for use Improve STS101 delivery device with minor changes Very high proportions of subjects and treated attacks with characteristics associated with poor treatment outcomes Adjust screening procedures / inclusion criteria Instruct subjects to treat qualifying migraines as soon as pain intensity reaches “moderate” Early data entry for co-primary endpoints Adjust time windows for eDiary data entry to align with nominal time points High placebo response rate given severity of treated attacks Increase trial size and statistical power Site and subject training to minimize expectation bias and increase standardization of reported outcomes 2-arm study will reduce expectation of receiving active vs EMERGE (3-arms: 2 active + placebo)


SLIDE 19

Adjusting time window and timing of subject prompts for eDiary data entry should increase effect size in our next STS101 Ph3 trial EMERGE 2h nominal time point in eDiary opened for data entry at 1h:45m (with alarm) and closed at 2h:15m Nearly all subjects entered data at or just after 1h:45m Response rate curves and are steepest from 0-3h Interpolation analysis indicates ~30% increase in effect size with 15-minute time window shift


SLIDE 20

Findings from our EMERGE trial analyses and how we are addressing them Interlinked reasons for EMERGE miss Strategy for addressing in next STS101 Ph3 trial In addition, given safety/tolerability profile observed in EMERGE and to date in ASCEND, a dose strength greater than 5.2 mg should be feasible and could maximize efficacy. We are conducting a Ph1 PK study to evaluate 5.2 mg and two higher dosage strengths. STS101 under-delivery Improve patient training and instructions for use Improve STS101 delivery device with minor changes Very high proportions of subjects and treated attacks with characteristics associated with poor treatment outcomes Adjust screening procedures / inclusion criteria Instruct subjects to treat qualifying migraines as soon as pain intensity reaches “moderate” Early data entry for co-primary endpoints Adjust time windows for eDiary data entry to align with nominal time points High placebo response rate given severity of treated attacks Increase trial size and statistical power Site and subject training to minimize expectation bias and increase standardization of reported outcomes 2-arm study will reduce expectation of receiving active vs EMERGE (3-arms: 2 active + placebo)


SLIDE 21

Impact of migraine pain intensity in treated attacks, and how we plan to reduce the proportion of attacks with SEVERE pain intensity Migraine attacks are more difficult to treat when pre-treatment pain intensity has progressed to SEVERE, and baseline pain severity is the key predictor of pain-freedom at 2 hours In EMERGE, STS101 placebo-adjusted response rates for co-primary endpoints at 2 hours were substantially greater for attacks with MODERATE versus SEVERE baseline pain, approximately 8-10% versus 1-5%, respectively EMERGE and other studies utilizing an eDiary during screening to prospectively confirm migraine and headache frequency immediately prior to randomization consistently have higher proportions of subjects with SEVERE pain in treated attacks In our next Ph3 trial, not relying on the eDiary for the above purpose should reduce the proportion of treated attacks with SEVERE baseline pain Sources: Diener et al., Neurology 2004; Diener et al., Cephalalgia 2007; Lombard et al., Headache 2020; STS101-002 Topline Data September 2020; mITT Population; Aurora et al., Headache 2011; Spierings et al., Cephalalgia 2017; Dodick et al., NEJM 2019; Lipton et al., JAMA 2019; Kuca et al., Neurology 2018; Goadsby et al., Brain 2019; Lipton et al., AHS 2018; Lipton et al., NEJM 2019; Croop et al., Lancet 2019


SLIDE 22

Findings from our EMERGE trial analyses and how we are addressing them Interlinked reasons for EMERGE miss Strategy for addressing in next STS101 Ph3 trial In addition, given safety/tolerability profile observed in EMERGE and to date in ASCEND, a dose strength greater than 5.2 mg should be feasible and could maximize efficacy. We are conducting a Ph1 PK study to evaluate 5.2 mg and two higher dosage strengths. STS101 under-delivery Improve patient training and instructions for use Improve STS101 delivery device with minor changes Very high proportions of subjects and treated attacks with characteristics associated with poor treatment outcomes Adjust screening procedures / inclusion criteria Instruct subjects to treat qualifying migraines as soon as pain intensity reaches “moderate” Early data entry for co-primary endpoints Adjust time windows for eDiary data entry to align with nominal time points High placebo response rate given severity of treated attacks Increase trial size and statistical power Site and subject training to minimize expectation bias and increase standardization of reported outcomes 2-arm study will reduce expectation of receiving active vs EMERGE (3-arms: 2 active + placebo)


SLIDE 23

Minimizing and mitigating placebo response rate in our next STS101 Ph3 trial Expectation bias Odds of receiving active treatment How investigator & site personnel introduce study & study medication Nasal administration of powder formulation (nose feel) Non-oral treatments that engender sensation (e.g., injectable and nasal) may report higher placebo response rates Sources: de Craen et al, J Neurol 1999; Macedo et al., Eu J Clin Pharm 2006; Evans et al. Cephalalgia 2020; Treister et al., Pain 2019; Viana et al., Cephalalgia 2015; Gibbons et al., J Exp Soc Psychol 1979; Ashina, et al., Cephalalgia 2021 Factors influencing placebo response rates Strategy for addressing in next STS101 Ph3 Study with single active arm reduces odds of receiving active treatment Implement Placebo Response Reduction training:* Neutralize site staff and subject expectations Standardize data reporting and reduce variability Subjects to use STS101 device to administer inactive powder during screening and randomization visits so that they experience “nose feel” prior to treating actual migraine attack Increasing trial size to ~700 per arm will mitigate effect of higher placebo response rate by increasing statistical power *Successfully implemented in migraine and back pain studies, achieving 30-50% reductions in placebo response rates AND


SLIDE 24

DHE (mg) Cmax (ng/mL) Time to C ≥ 2.5 ng/mL (minutes) IM/SC DHE 2.9-3.51,5,6 5-151,5,6 STS101 7.8 mg (projected values) 2.67 <157 MAP0004 2.52 102 Sources: 1STS101-001 Data; 2Kellerman et al., J Aerosol Med Pulm Drug Del 2013; 3Winner et al., Headache 1996; 4Aurora et al., Headache 2011; 5Schran et al., Curr Ther Res 1994; 6FDA approval package for SC DHE 1998; 7STS101-001 Dose Extrapolation Report, Nov 6, 2020 We plan to conduct a PK study (preliminary results expected in April 2021) Study will evaluate IM DHE, Migranal, & three STS101 dose strengths (5.2 mg & 2 higher dose strengths) STS101 7.8 mg PK projected to be similar to MAP0004 and IM DHE Final dose for next STS101 Ph3 trial to be selected based on PK study results Potential for maximizing efficacy with higher STS101 dose in our next Ph3 trial Values in table are geometric means MAP0004


SLIDE 25

Potential impact of changes on pain freedom at 2hrs in our next Ph3 trial Estimated Response Rates STS101 Placebo 23-28% 12-15% Values are hypothetical, based on our internal modeling and may not predict clinical trial results In addition, larger sample size of ~700/arm increases power to detect effect with statistical significance +4% Active Arm Response Deliver full dose +1.5 to 2% Active Arm Response Collect data at 2-hr time point -1 to 2% Placebo Response +1 to 2 % Active Arm Response Increase % of attacks with MODERATE pain intensity Placebo Response Reduction Training


SLIDE 26

ASCEND open-label, long-term safety trial results to date


SLIDE 27

Preliminary ASCEND results summary Last 4 weeks Total to date Attacks treated (by 279 subjects) 639 2,240 % Pain Free @ 2 hrs 37% 30% % Pain Free @ 4 hrs 60% 56% % Pain Free @ 24 hrs 86% 82% % Pain Relief @ 2 hrs 82% 72% Response rates are based on treated attacks for which subjects have reported efficacy data at indicated time point; i.e., no imputation for missing data For some subjects, 4h & 24h response rates may be affected by second dose; second dose taken after 2h in ~17% of treated attacks Pain severity at time of treatment across all treated attacks: 48% severe; 45% moderate; 7% mild Dropout rate to date: ~20% As of Feb 23, 2021


SLIDE 28

Preliminary results from ongoing ASCEND study No STS101 related Serious Adverse Events No cardiovascular-related Adverse Events Adverse Events 5.2 mg STS101 Safety Population (n) 283 Most frequent AEs % of subjects reporting AE at least once Dysgeusia 15.1 Nasal discomfort 14.1 Rhinorrhea 7.3 Nasal congestion 5.2 Nausea 4.7 As of Jan 19, 2021


SLIDE 29

Updated STS101 development plan


SLIDE 30

Next steps $68.2M cash, equivalents, and marketable securities as of 12/31/2020 Current cash and financing proceeds fund operations into 2H 2023 and through key milestones Anticipated STS101 development milestones Q2 2021 Complete Phase 1 safety and pharmacokinetic study with STS101 5.2 mg and two higher dose strengths Mid-2021 Initiate second STS101 Phase 3 efficacy trial 2H 2022 Read out topline results from second Phase 3 efficacy trial 2H 2022 Complete ASCEND STS101 long-term safety trial Q4 2022 File STS101 NDA


SLIDE 31

Supplemental slides


SLIDE 32

Some terminology Term Meaning / comment Baseline Time immediately before subject administered study medication 2 hours Post-treatment timepoint when co-primary endpoints were assessed Note: In EMERGE, eDiary prompted subjects to record efficacy beginning at 1h:45m post-treatment and continued to accept entries for “2 hour” timepoint through 2h:15m post-treatment. Most EMERGE subjects entered efficacy data in eDiary for “2 hour” timepoint at ~1h:45m Pain Severity Severity of pain reported by subjects per a 4-point scale: No pain (“0”) Mild pain (“1”) Moderate pain (“2”) Severe pain (“3”) Modified Intent to Treat (mITT) population Population in which primary efficacy analysis is conducted and includes qualifying migraine attack (i.e., migraine with Moderate or Severe Baseline Pain Severity), who took study medication, and entered efficacy data for at least one time point ≤ 2 hrs Freedom from Pain Pain Severity of “No pain” at the timepoint of interest Most Bothersome Symptom (MBS) The symptom present at Baseline in the treated attack that was most bothersome to the subject. Selected from among photophobia, phonophobia or nausea. Categorical variable (present / absent). Freedom from MBS Absence of MBS at the timepoint of interest Pain Relief A change in Pain Severity from Moderate or Severe at Baseline to Mild Pain or No Pain at the timepoint of interest. Secondary efficacy endpoint commonly utilized in acute treatment of migraine trials. “Pain Relief” is a lower efficacy hurdle than “Freedom from Pain”. As is standard in acute treatment of migraine trials, EMERGE subjects were instructed to treat a migraine attack with Moderate or Severe Baseline Pain Severity. Only subjects who did so are included in the efficacy analysis.


SLIDE 33

Some dose response trends observed as function of % emitted dose Higher calculated % emitted dose (ED) generally results in higher response rates across various endpoints 3.5 mg* 1.8 mg* 2.4 mg* 4.6 mg* * calculated mean emitted dose within subgroup 3.9 mg 5.2 mg ≤70% ED >70% ED Placebo ≤70% ED >70% ED


SLIDE 34

Large body of migraine literature points to pain severity at baseline as the key predictor of response at 2 hours “Treatment and pretreatment pain severity were conclusively the most important predictors of clinical outcome by several orders of magnitude compared with other significant predictors. These data are consistent with other analyses showing migraine pain may be more difficult to treat when it has progressed to severe pain.”


SLIDE 35

We can increase % of treated attacks with moderate pain at baseline by utilizing “Historical self-reporting only” screening approach to confirm monthly migraine attacks and headache days Trial Historical self-reporting by subject FOLLOWED BY Prospective validation with eDiary during 28-day screening period Historical self-reporting only MAP0004 ADAM zolmitriptan STS101 Mean Ubrogepant Lasmiditan Rimegepant Mean Pain intensity at baseline FREEDOM EMERGE ACHIEVE I ACHIEVE II SAMURAI SPARTAN 301 302 303 Moderate 54% 49% 52% 52% 63% 59% 71% 70% 71% 66% 71% 67% Severe 46% 51% 48% 48% 37% 41% 29% 30% 29% 34% 29% 33% Studies with “Historical self-reporting only” consistently have higher proportions of subjects with moderate pain in treated attacks EMERGE screening procedure Screening procedure to be utilized in our next STS101 Ph3 trial Sources: STS101-002 Topline Data September 2020; mITT Population; Aurora et al., Headache 2011; Spierings et al., Cephalalgia 2017; Dodick et al., NEJM 2019; Lipton et al., JAMA 2019; Kuca et al., Neurology 2018; Goadsby et al., Brain 2019; Lipton et al., AHS 2018; Lipton et al., NEJM 2019; Croop et al., Lancet 2019


SLIDE 36

PD / efficacy measure: Pain Relief@2hr response rate data reported in 9 DHE trials 6 Migranal trials (including 4 trials listed in Migranal label, Boureau & Touchon) 2 MAP0004 trials (Ph2 & Ph3) 1 SC DHE (Winner) PK values Migranal values from STS101-001 Ph1 PK trial MAP0004 values reported by Kellerman et al. MAP0004 meta-analysis paper SC DHE assumed to have same PK as IM DHE in STS101-001 trial given that they are reported to be bioequivalent For DHE (and STS101), we believe Cmax is dose-dependent and the best PK predictor of efficacy at 2hrs MAP0004 PK parameter R2 (goodness of fit) Cmax 0.55 AUC0-30min 0.51 AUC0-60 min 0.40 Time plasma concentration > 1 ng/mL 0.32 AUC0-2hrs 0.24


SLIDE 37

Actual EMERGE 5.2 mg %PR2h (50.8%) Est. mean Cmax in EMERGE (~1.4 ng/mL) based on observed %ED Projected EMERGE 5.2 mg %PR2h if mean Cmax had been as observed in Ph1 PK trial (~2 ng/mL) PD / efficacy measure: Pain Relief@2hr response rate data reported in 9 DHE trials 6 Migranal trials (including 4 trials listed in Migranal label, Boureau & Touchon) 2 MAP0004 trials (Ph2 & Ph3) 1 SC DHE (Winner) PK values Migranal values from STS101-001 Ph1 PK trial MAP0004 values reported by Kellerman et al. MAP0004 meta-analysis paper SC DHE assumed to have same PK as IM DHE in STS101-001 trial given that they are reported to be bioequivalent STS101 under-delivery in EMERGE: lower-than-expected Cmax (estimated based on % emitted dose) and 2hr efficacy were consistent with PK/PD model MAP0004


SLIDE 38

Cmax and early AUC drive DHE efficacy at 2 hrs DHE (mg) Cmax (ng/mL) Tmax (minutes) AUC0-30m (ng*hr/mL) % Patients with Pain Relief at 2hrs IM/SC DHE (1 mg) 2.9-3.51,5,6 15-301,5,6 1.31 733 MAP0004 (1 mg) 2.52 102 0.72 594 Sources: 1STS101-001 Data; 2Kellerman et al., J Aerosol Med Pulm Drug Del 2013; 3Winner et al., Headache 1996; 4Aurora et al., Headache 2011; 5Schran et al., Curr Ther Res 1994; 6FDA approval package for SC DHE 1998 DHE is maximally effective at 2 hours with high early AUC when plasma concentration of 2.5 ng/mL achieved within 10-30 min   Values in table are geometric means


SLIDE 39

Placebo response rate in EMERGE was higher than expected given the high % of subjects with severe pain at baseline EMERGE actual EMERGE predicted Sources: Diener et al., Neurology 2004; Aurora et al., Headache 2011; Tepper et al., Mayo Clinic Proc 2011; Dodick et al, New Engl J Med 2019; Lipton et al., JAMA 2019; Axsome Therapeutics Conference Call December 30, 2019; Kuca et al., Neurology 2018; Goadsby et al., Brain 2019 Placebo response rates in Ph3 migraine trials tend to decrease as % of subjects with severe pain at baseline in treated attacks increases


SLIDE 40

Pain Freedom at 2h endpoint – sensitivity analysis & modeling EMERGE results (5.2 mg STS101) How much any single parameter would need to change to achieve p<0.05 With eDiary data entry shifted from 1:47 to 2:00 EMERGE results (5.2 mg STS101) How much any single parameter would need to change to achieve p<0.05 Calculated EMERGE results How much any single parameter would need to change to achieve p<0.05 Moderate/Severe (%) 49/51 65/35 49/51 50/50 N per arm (mITT) ~355 538 ~355 365 PF at 2h placebo response rate 14.8% 13.7% 16.6% 1 14.5% 2 PF at 2hr response rate 19.3% 20.4% 22.5% 1 19.3%+ 2 p-value 0.1137 ~0.004 (cumulative effect of all changes) 0.051 ~0.03 (cumulative effect of all changes) Values are hypothetical based on our internal modeling and not intended to predict clinical trial results 2. values at 1h:47m 1. based on interpolation analysis


SLIDE 41

Powering our next STS101 Ph3 trial and potential outcomes per our modeling EMERGE Next STS101 Ph3 trial Conservative 7.5% effect size Next STS101 Ph3 trial Nominal upside 12.2% effect size Moderate/Severe (%) 49/51 55/45 60/40 N per arm (mITT) ~355 650 650 PF at 2h placebo response rate 14.8% 15.0% 13.8% PF at 2hr response rate 19.3% 22.5% 25% p-value 0.1137 0.0005 0.0000003 Our next Ph3 trial will be powered to detect 7.5% effect size for both Pain Free (2h) and MBS Free (2h) co-primary endpoints with >95% and 80% power, respectively N=1400; (700/arm with ~650/arm in mITT population) How our strategy could play out Values are hypothetical based on our internal modeling and not intended to predict clinical trial results