false 0001659617 0001659617 2024-08-15 2024-08-15
 
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): August 15, 2024
 
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MOLECULIN BIOTECH, INC.
(Exact Name of Registrant as Specified in its Charter)
 
Delaware
001-37758
47-4671997
(State or Other Jurisdiction of Incorporation
or Organization)
(Commission File No.)
(I.R.S. Employer Identification No.)
 
5300 Memorial Drive, Suite 950, Houston, TX 77007
(Address of principal executive offices and zip code)
 
(713) 300-5160
(Registrant’s telephone number, including area code)
(Former name or former address, if changed from last report)
 
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction 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-14(c))
 
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. ☐
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
Trading Symbol (s)
Name of each exchange on which registered
Common Stock, par value $.001 per share
MBRX
The NASDAQ Stock Market LLC
 
 
 
 
Item 1.01 Entry into a Material Definitive Agreement.
 
On August 15, 2024, Moleculin Biotech, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”) for the sale by the Company of (i) 283,000 shares (the “Shares”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”) and 2,183,368 pre-funded warrants to purchase shares of Common Stock in lieu thereof (the “Pre-Funded Warrants”); (ii) Series A Warrants to purchase up to an aggregate of 2,466,368 shares of Common Stock (the “Series A Warrants”); and (iii) Series B Warrants to purchase up to an aggregate of 2,466,368 shares of Common Stock (the “Series B Warrants”, and together with the Series A Warrants, the “Common Warrants)) (the “Offering”). The Common Warrants and Pre-Funded Warrants are collectively referred to herein as the (“Warrants”). The combined purchase price for the securities was $2.23 per Share of Common Stock (or Pre-Funded Warrant in lieu thereof) and accompanying Common Warrants. H.C. Wainwright & Co. (“Wainwright”) acted as the exclusive placement agent for the Offering pursuant to an Engagement Agreement, dated June 8, 2024 (the “Engagement Agreement”). The closing of the Offering is expected to occur on August 19, 2024 (the “Closing Date”).
 
Each Pre-Funded Warrant is exercisable for one share of Common Stock at an exercise price of $0.001 per share (as adjusted from time to time in accordance with the terms thereof). The Pre-Funded Warrants are exercisable immediately and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full, subject to the Beneficial Ownership Limitation described below.
 
Each Common Warrant has an exercise price of $2.23 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the Common Warrants (the “Warrant Stockholder Approval”). The Company agreed to seek Warrant Stockholder Approval no later than 90 days after the consummation of Offering. If the Company does not obtain Warrant Stockholder Approval at the first stockholder meeting for such purpose after this Offering, the Company agreed to call a stockholder meeting every 90 days thereafter until the earlier of the date it obtains Warrant Stockholder Approval or the date the Common Warrants are no longer outstanding. The exercise price of the Common Warrants is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders.
 
The Series A Warrants expire on the earlier of (i) two years from the initial exercise date, or (ii) 60 days from the Company’s public announcement that it has achieved the Series A Milestone Event (defined below). The Series B warrants expire on the earlier of (i) five years from the initial exercise date, or (ii) six months from the Company’s public announcement that it has achieved the Series B Milestone Event (defined below). As used herein, “Series A Milestone Event” means the Company releases interim data for the first subject group from the MIRACLE trial whereby the complete remission rate for either doses of the Company’s study drug is greater than placebo; and “Series B Milestone Event” means the Company releases final topline data from the MIRACLE trial and documented a statistically significant improvement in the primary efficacy endpoint.
 
The Warrants may only be exercised on a cashless basis if there is no registration statement registering, or the prospectus contained therein is not available for, the issuance of shares of Common Stock underlying the Pre-Funded Warrants and Common Warrants to the holder. The holder of a Warrant may not exercise any such warrants to the extent that such exercise would result in the number of shares of Common Stock beneficially owned by such holder and its affiliates exceeding 4.99% or 9.99% (at the election of the holder) of the total number of shares of Common Stock outstanding immediately after giving effect to the exercise, which percentage may be increased or decreased at the holder’s election not to exceed 9.99% (the “Beneficial Ownership Limitation”). In the event of certain fundamental transactions, the holder of the Common Warrants will have the right to receive the Black Scholes value of its Common Warrants calculated pursuant to a formula set forth in the Common Warrants, payable either in cash or in the same type or form of consideration that is being offered and being paid to the holders of Common Stock.
 
The gross proceeds from the Offering, before deducting the placement agent's fees and other offering expenses payable by the Company, are expected to be approximately $5.5 million and up to an additional approximately $11.0 million in gross proceeds if the Warrants are fully exercised for cash. The Company intends to use the net proceeds from the Offering to advance Annamycin and the Company’s other two drug portfolios through clinical development, advancing the remainder of the existing portfolio through preclinical studies and into INDs or their equivalent, sponsoring research at MD Anderson and HPI, and for working capital.
 
The Company has agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of, any shares of Common Stock or any securities convertible into or exercisable or exchangeable for shares of Common Stock or file any registration statement or prospectus, or any amendment or supplement thereto for 90 days after the Closing Date, subject to certain exceptions. In addition, the Company has agreed not to effect or enter into an agreement to effect any issuance of Common Stock or any securities convertible into or exercisable or exchangeable for shares of Common Stock involving a variable rate transaction (as defined in the Purchase Agreement) until the one-year anniversary of the Closing Date, subject to certain exceptions.
 
On August 15, 2024, the Company entered into a warrant amendment agreement (the “Warrant Amendment”) pursuant to which the Company agreed that effective upon closing of the Offering, and subject to the Warrant Stockholder Approval, to amend certain existing warrants to purchase up to an aggregate of 895,834 shares of Common Stock at an exercise price of $9.60 per share and a termination date of February 14, 2029, so that the amended warrants will have a reduced exercise price of $2.23 per share effective upon the closing of the Offering, will be exercisable beginning on the effective date of Warrant Stockholder Approval of the issuance of the shares upon exercise of the warrants and will expire five years from the date of Warrant Stockholder Approval. If the Warrant Stockholder Approval is not received, on or before the one-year anniversary of the date of the Warrant Amendment, the Warrant Amendment will be null and void and the provisions of the existing warrants in effect prior to the date of the Warrant Amendment will remain in effect.
 
 
 
 
The Offering of the Shares and Warrants was made pursuant to a Registration Statement on Form S-1 (File No. 333-280951) (the “Registration Statement”), which was filed by the Company with the Securities and Exchange Commission on July 22, 2024 and declared effective on August 15, 2024. The Offering of the Shares and Warrants was made only by means of a prospectus forming a part of the Registration Statement.
 
Pursuant to the Engagement Agreement, the Company agreed to pay Wainwright a fee equal to 7% of the aggregate gross proceeds received by the Company from the sale of the securities in the Offering. The Company also agreed to (i) pay Wainwright a non-accountable expense allowance of $50,000, (ii) reimburse Wainwright for legal fees and expenses in an amount up to $100,000, and (iii) reimburse Wainwright for clearing fees in an amount of $15,950.
 
Pursuant to the Engagement Agreement, the Company will also issue to Wainwright or its designees warrants (the “Placement Agent Warrants”) to purchase up to 123,318 shares of Common Stock (which represents 5% of the aggregate number of shares of Common Stock to be issued in the Offering and issuable upon the exercise of the Pre-Funded Warrants to be issued in the Offering) with an exercise price of $2.7875 per share (representing 125% of the public offering price per share) and that terminate five years from the date of the commencement of sales in the Offering.
 
The representations, warranties and covenants contained in the Purchase Agreement and Engagement Agreement were made solely for the benefit of the parties to the Purchase Agreement and Engagement Agreement. In addition, such representations, warranties and covenants: (i) are intended as a way of allocating the risk between the parties to such agreements and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Purchase Agreement and Engagement Agreement are filed with this report only to provide investors with information regarding the terms of transaction, and not to provide investors with any other factual information regarding the Company. Information concerning the subject matter of the representations and warranties may change after the date of the Purchase Agreement or Engagement Agreement, which subsequent information may or may not be fully reflected in public disclosures.
 
The forms of the Purchase Agreement, the Engagement Agreement, the Series A Warrant, the Series B Warrant, the Pre-Funded Warrant, the Placement Agent Warrant, and the Warrant Amendment are filed as Exhibits 1.1, 4.1, 4.2, 4.3, 4.4, 10.1 and 10.2, respectively, to this Current Report on Form 8-K. The foregoing summaries of the terms of these documents are subject to, and qualified in their entirety by, such documents, which are incorporated herein by reference.
 
Item 7.01.         Regulation FD Disclosure
 
On August 16, 2024, the Company issued a press release regarding the transactions described above under Item 1.01 of this Current Report on Form 8-K. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
 
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (“Exchange Act”), nor shall it be incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (“Securities Act”), unless specifically identified therein as being incorporated by reference.
 
Item 9.01.         Financial Statements and Exhibits
 
(d)         Exhibits
 
Exhibit No.
  
Exhibit Description
1.1
  
4.1
  
4.2
  
4.3
  
4.4
  
10.1
  
10.2
  
99.1
  
104
  
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 
 
 
SIGNATURE
 
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: August 16, 2024
MOLECULIN BIOTECH, INC.
   
 
By: /s/ Jonathan P. Foster
Jonathan P. Foster
Chief Financial Officer
 
 
 

 

Exhibit 10.2

 

August __, 2024

 

Holder of Warrants to Purchase Common Stock set forth on Exhibit A attached hereto

 

Re: Amendment to Existing Warrants

 

Dear Holder:

 

Reference is hereby made to the offering on Form S-1 (File No. 333-280951) on or about the date hereof (the “Offering”) by Moleculin Biotech, Inc. (the “Company”) of its common stock, par value $0.001 per share (“Common Stock”), and/or other securities of the Company (collectively, the “Securities”).

 

This letter confirms that, in consideration for the Holder’s participation in the Offering and purchase of Securities in the Offering (the “Purchase Commitment”), the Company hereby amends, effective as of the closing of the Offering, the Common Stock purchase warrants set forth on Exhibit A hereto (the “Existing Warrants”) by (i) reducing the Exercise Price (as defined therein) of the Existing Warrants to $____ per share, (ii) amending the Existing Warrants so that they will not be exercisable commencing on the date hereof and until the Stockholder Approval Date (as defined in the Securities Purchase Agreement dated as of August __, 2024, by and between the Company and each purchaser signatory thereto), and (iii) amending the expiration date of the Existing Warrants to five (5) years following the Stockholder Approval Date (the “Warrant Amendment”). The Warrant Amendment shall be effective upon the closing the Offering and the satisfaction of the other terms and conditions referenced below.

 

The Warrant Amendment is subject to the Shareholder Approval, the consummation of the Offering and the Holder’s satisfaction of the Purchase Commitment. In the event that (i) the Shareholder Approval is not obtained on or before the one-year anniversary of the date hereof, (ii) the Offering is not consummated, or (iii) the Holder does not satisfy the Purchase Commitment, the Warrant Amendment shall be null and void and the provisions of the Existing Warrants in effect prior to the date hereof shall remain in effect.

 

Except as expressly set forth herein, the terms and provisions of the Existing Warrants shall remain in full force and effect after the execution of this letter and shall not be in any way changed, modified or superseded except by the terms set forth herein.

 

From and after the effectiveness of the Warrant Amendment, the Company agrees to promptly deliver to the Holder, upon request, amended Existing Warrants that reflect the Warrant Amendments in exchange for the surrender for cancellation of the Holder’s Existing Warrants to be amended as provided herein. For any registered Existing Warrants or if the Common Stock underlying the Existing Warrants are registered for resale on a registration statement, the Company shall file a prospectus supplement to the applicable registration statement in connection with the amendments hereunder by the closing of the Offering and upon on the Shareholder Approval Date, if necessary.

 

 

[Signature Page Follows]

IN WITNESS WHEREOF, the parties hereto have caused this agreement to be duly executed by their respective authorized signatories as of the date first indicated above.

 

 

 

MOLECULIN BIOTECH, INC.

 

 

By: _____________________

Name:

Title:

 

 

 

Name of Holder: ________________________________________________________

 

Signature of Authorized Signatory of Holder: __________________________________

 

Name of Authorized Signatory: ____________________________________________________

 

EXHIBIT A

EXISTING WARRANTS

 

 

Exhibit 99.1

 

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Moleculin Announces Pricing of up to $16.5 Million Public Offering

 

$5.5 million financing upfront with up to an additional $11.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants

 

HOUSTON, August 16, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the pricing of a public offering of an aggregate of 2,466,368 shares of its common stock (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 2,466,368 shares of common stock and Series B warrants to purchase up to 2,466,368 shares of common stock, at a combined public offering price of $2.23 per share (or per common stock equivalent in lieu thereof) and accompanying warrants.

 

The Series A warrants have an exercise price of $2.23, are exercisable immediately upon Shareholder Approval (as defined below) and will expire upon the earlier of (i) the 2 year anniversary of the date of Stockholder Approval (as defined below) and (ii) the 60th day following the date the Company releases interim data for the first subject group from the MIRACLE trial whereby the complete remission rate for either doses of the Company’s study drug is greater than placebo. The Series B warrants have an exercise price of $2.23, are exercisable immediately upon Shareholder Approval (as defined below) and will expire upon the earlier of (i) the 5 year anniversary of the date of Stockholder Approval (as defined below) and (ii) the 6 month anniversary following the date the Company releases final topline data from the MIRACLE trial and documented a statistically significant improvement in the primary efficacy endpoint. Pursuant to Nasdaq Listing Rule 5635(d), the exercise of the Series A warrants and Series B warrants is subject to shareholder approval (the “Shareholder Approval”). The closing of the offering is expected to occur on or about August 19, 2024, subject to the satisfaction of customary closing conditions.

 

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

 

The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses payable by the Company, are expected to be approximately $5.5 million and up to an additional approximately $11.0 million in gross proceeds if the warrants are fully exercised for cash. The Company intends to use the net proceeds from this offering to advance Annamycin and its other two drug portfolios through clinical development, advance the remainder of the Company’s existing portfolio through preclinical studies and into INDs or their equivalent, sponsor research at MD Anderson and HPI, and for working capital.

 

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-280951), which was declared effective by the Securities and Exchange Commission (the “SEC”) on August 15, 2024. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

 

 
 

 

The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 895,834 shares of common stock that were previously issued in December 2023 and have an exercise price of $9.60 per share such that the amended warrants will have a reduced exercise price of $2.23 per share effective upon the closing of the offering, will be exercisable beginning on the effective date of Stockholder Approval of the issuance of the shares upon exercise of the warrants and will expire five years from the date of Stockholder Approval.

 

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

 

The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

 

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of viruses, as well as certain cancer indications. 

 

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These forward-looking statements, include, but are not limited to, statements regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering, the anticipated use of proceeds therefrom and the receipt of Stockholder Approval. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Investor Contact:

 

JTC Team, LLC

Jenene Thomas

(833) 475-8247

MBRX@jtcir.com