Basic Stats
| LEI | 549300IB1TLJZCHEO353 |
| CIK | 1659617 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Moleculin Biotech, Inc.
SEC Filings (Chronological Order)
This page provides a complete, chronological list of SEC Filings, excluding ownership filings which we provide elsewhere.
| September 5, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. |
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| August 29, 2025 |
Moleculin Announces Exercise of Warrants for $6.0 Million Gross Proceeds Exhibit 99.1 Moleculin Announces Exercise of Warrants for $6.0 Million Gross Proceeds HOUSTON, August 28, 2025 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has entered into agreements with certain holders of its exist |
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| August 29, 2025 |
Exhibit 10.1 MOLECULIN BIOTECH, INC. August 27, 2025 Holder of Common Stock Purchase Warrants Re: Inducement Offer to Exercise Common Stock Purchase Warrants Dear Holder: Moleculin Biotech, Inc. (the “Company”) is pleased to offer to you (“Holder”, “you” or similar terminology) the opportunity to receive new warrants to purchase shares of the Company’s common stock, par value $0.001 per share (the |
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| August 29, 2025 |
SERIES F COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE 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 (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR |
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| August 29, 2025 |
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 28, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| August 27, 2025 |
Exhibit 99.1 Moleculin Issues New Positive AML Overall Survival Data: Median Overall Survival (OS) of 15 months for subjects with complete remission (n=8) Median OS of 2nd Line efficacy evaluable population of 12 months (n=9) Median OS of Intent to Treat population (1L-7L) of 9 months (n=22) OS demonstrated by Annamycin in the MB-106 trial is significantly above industry expectations for relapsed |
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| August 27, 2025 |
Exhibit 3.1 State of Delaware Secretary of State Division of Corporations Delivered 02:10 PM 08/21/2025 FILED 02:10 PM 08/21/2025 SR 20253747621 - FileNumber 5793265 CERTIFICATE OF AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF MOLECULIN BIOTECH, INC. Moleculin Biotech, Inc., a corporation organized and existing under the laws of the State of Delaware (the "Corporation") for |
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| August 27, 2025 |
-12-31 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 21, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Or |
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| August 18, 2025 |
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 18, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| August 18, 2025 |
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 18, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| August 18, 2025 |
Exhibit 99.1 |
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| August 13, 2025 |
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 13, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| August 13, 2025 |
Exhibit 99.1 Moleculin Reports Second Quarter 2025 Financial Results and Highlights - Continues recruitment and opens US and EU sites for the Phase 2B/3 MIRACLE trial - 20+ additional clinical sites in Europe and the US expected to begin recruitment by the end of Q3 - Anticipated data readout of MIRACLE Part A targeted before end of 2025 HOUSTON, August 13, 2025 - Moleculin Biotech, Inc., (Nasdaq: |
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| August 12, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37758 MOL |
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| August 6, 2025 |
Exhibit 99.1 Moleculin Biotech, Inc. Unveils Promising Preclinical Data of Annamycin in Liver Cancer Treatment Presented data highlights the potential of Annamycin for treating broad range of human cancers, including high-need oncology indications Annamycin currently in late-stage clinical development in combination with cytarabine for the treatment of AML; Anticipated preliminary data readout in |
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| August 6, 2025 |
Liposomal Annamycin (L-ANN) Efficacy against primary and Metastatic Liver Cancers poster Exhibit 99.2 |
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| August 6, 2025 |
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 6, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| August 1, 2025 |
Investor Presentation dated July 2025 Exhibit 99.1 |
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| August 1, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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 1, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| July 30, 2025 |
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): July 30, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| July 30, 2025 |
Exhibit 99.1 Moleculin Receives Notice of Intent to Grant New European Patent for Annamycin – New patent enhances market position in Europe HOUSTON, July 30, 2025 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has recei |
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| July 17, 2025 |
Exhibit 99.1 Moleculin Engages Industry Veteran Adriano Treve to Explore Accelerated Strategic Partnerships 40+ year career at Roche founded on dedication to bringing new innovative medicines to patients and making them accessible HOUSTON, July 17, 2025 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candi |
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| July 17, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): July 17, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| July 11, 2025 |
Moleculin Biotech, Inc. Up to $6,500,000 Common Stock Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-280064 Prospectus Supplement (to Prospectus dated July 1, 2024) Moleculin Biotech, Inc. Up to $6,500,000 Common Stock On July 11, 2025, we entered into a certain At The Market Offering Agreement (“ATM Agreement”) with Roth Capital Partners, LLC as sales agent (“Roth”) relating to the sale of shares of our common stock, par val |
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| July 11, 2025 |
Exhibit 1.1 AT THE MARKET OFFERING AGREEMENT July 11, 2025 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Moleculin Biotech, Inc., a corporation organized under the laws of Delaware (the “Company”), confirms its agreement (this “Agreement”) with Roth Capital Partners, LLC (the “Manager”) as follows: 1. Definitions. The terms that follow, |
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| July 11, 2025 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits 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): July 11, 2025 MOLECULIN BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-37758 47-4671997 (State or other jurisdiction of incorporation) (Commission F |
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| July 9, 2025 |
Exhibit 99.1 Moleculin Expands Phase 3 MIRACLE Clinical Trial into the Country of Georgia, Enrollment Update and Future Plans Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for Phase 2B/3 MIRACLE trial Recent EU approval from the European Medicines Agency (EMA) boosts trial profile Enrollment in Part A of MIRACLE reaches seven subjects trea |
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| July 9, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): July 9, 2025 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 |
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| July 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| July 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Defin |
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| June 27, 2025 |
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): June 27, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| June 27, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| June 23, 2025 |
Moleculin Announces $5.9 Million Public Offering Exhibit 99.1 Moleculin Announces $5.9 Million Public Offering HOUSTON, June 20, 2025 (GLOBE NEWSWIRE) - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-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 consisting of 16,080,000 shares of common stock (or p |
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| June 23, 2025 |
Table of Contents Filed Pursuant to Rule 424(b)(4) Registration No. 333-287727 Moleculin Biotech, Inc. 9,972,026 Shares of Common Stock and 29,916,078 Accompanying Series E Warrants to Purchase up to 29,916,078 Shares of Common Stock 6,107,974 Pre-Funded Warrants to Purchase up to 6,107,974 Shares of Common Stock and 18,323,922 Accompanying Series E Warrants to Purchase up to 18,323,922 Shares of |
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| June 23, 2025 |
Placement Agency Agreement between Moleculin Biotech, Inc. and Roth Capital Partners, LLC Exhibit 1.1 PLACEMENT AGENCY AGREEMENT June 20, 2025 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of $5,950,000.00 of registered securities of the Company, |
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| June 23, 2025 |
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): June 20, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| June 23, 2025 |
Exhibit 4.1 SERIES E COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Issue Date: June 23, 2025 THIS SERIES E COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Stockholde |
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| June 23, 2025 |
Form of Securities Purchase Agreement Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of June 20, 2025, between Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions |
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| June 18, 2025 |
Exhibit 99.1 Moleculin Receives Positive FDA Feedback on Pediatric Study Plan for Annamycin in Children with R/R AML Annamycin aims to eliminate cardiotoxicity associated with anthracyclines used to treat about 60% of all children with cancer FDA recommends inclusion of patients as young as 6 months – younger than Moleculin had proposed – to be allowed in the pediatric clinical study Enrollment an |
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| June 18, 2025 |
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): June 18, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| June 16, 2025 |
As filed with the U.S. Securities and Exchange Commission on June 16, 2025. Table of Contents As filed with the U.S. Securities and Exchange Commission on June 16, 2025. Registration No. 333-287727 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or other ju |
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| June 11, 2025 |
Form of Securities Purchase Agreement Exhibit 10.35 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of [], 2025, between Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set |
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| June 11, 2025 |
As filed with the U.S. Securities and Exchange Commission on June 11, 2025. Table of Contents As filed with the U.S. Securities and Exchange Commission on June 11, 2025. Registration No. 333-287727 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or other ju |
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| June 11, 2025 |
Exhibit 4.12 SERIES E COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Issue Date: [], 2025 THIS SERIES E COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Stockholder Ap |
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| June 6, 2025 |
As filed with the U.S. Securities and Exchange Commission on June 6, 2025. Table of Contents As filed with the U.S. Securities and Exchange Commission on June 6, 2025. Registration No. 333-287727 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or other jur |
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| June 6, 2025 |
Exhibit 4.12 SERIES E COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Issue Date: [], 2025 THIS SERIES E COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Stockholder Ap |
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| June 6, 2025 |
Form of Securities Purchase Agreement Exhibit 10.35 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of [], 2025, between Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set |
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| June 6, 2025 |
Exhibit 107 Calculation of Filing Fee Table Form S-1 (Form Type) Moleculin Biotech, Inc. |
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| June 5, 2025 |
Virtual KOL Event Presentation dated June 5, 2025 Exhibit 99.1 |
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| June 5, 2025 |
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): June 5, 2025 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 |
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| June 4, 2025 |
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): June 4, 2025 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 |
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| June 4, 2025 |
Exhibit 99.1 Moleculin Reports Positive Topline Efficacy Results from U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB-107) Annamycin delivering better performance 7th line than would be expected even in 2nd line for monotherapy Responders (Stable Disease or Partial Response) after 2 cycles of Annamycin showed improvement in OS and Pr |
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| June 2, 2025 |
Exhibit 1.1 PLACEMENT AGENCY AGREEMENT [], 2025 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of $[] of registered securities of the Company, including, but |
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| June 2, 2025 |
As filed with the U.S. Securities and Exchange Commission on June 2, 2025. Table of Contents As filed with the U.S. Securities and Exchange Commission on June 2, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or other jurisdiction of (Primary Sta |
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| June 2, 2025 |
Exhibit 4.12 SERIES E COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Issue Date: [], 2025 THIS SERIES E COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the [Stockholder A |
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| June 2, 2025 |
Exhibit 107 Calculation of Filing Fee Table Form S-1 (Form Type) Moleculin Biotech, Inc. |
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| June 2, 2025 |
Exhibit 4.13 PREFUNDED COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Initial Exercise Date: [], 2025 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the |
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| June 2, 2025 |
Form of Securities Purchase Agreement Exhibit 10.35 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of [], 2025, between Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set |
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| May 23, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. |
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| May 23, 2025 |
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing 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): May 23, 2025 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 |
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| May 23, 2025 |
Table of Contents As confidentially submitted to the U.S. Securities and Exchange Commission on May 23, 2025. This draft registration statement has not been filed publicly with the U.S. Securities and Exchange Commission and all information contained herein remains strictly confidential. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRA |
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| May 14, 2025 |
Exhibit 99.1 Moleculin Reports First Quarter 2025 Financial Results and Provides Corporate Update Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin (naxtarubicin) for the treatment of R/R AML Regulatory and site selection progress to date supports interim data readout expected in the second half of 2025 Recently received European Medicines Agency ( |
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| May 14, 2025 |
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): May 14, 2025 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 |
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| May 13, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37758 MO |
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| May 12, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): May 12, 2025 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 |
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| May 12, 2025 |
Exhibit 99.1 Moleculin Receives European Medicines Agency Approval to Expand Phase 3 MIRACLE Clinical Trial Adds nine additional countries to the Company’s ongoing pivotal Phase 3 trial; Authorization granted in all EU countries requested Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin for the treatment of R/R AML; Interim data readout expected i |
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| May 9, 2025 |
Submission of Matters to a Vote of Security Holders 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): May 9, 2025 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) |
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| May 7, 2025 |
Exhibit 99.1 Moleculin to Report First Quarter 2025 Financial Results on May 13, 2025 and Host Conference Call and Webcast HOUSTON, May 7, 2025 - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced that it will report its financial results f |
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| May 7, 2025 |
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): May 7, 2025 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) |
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| May 6, 2025 |
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): May 6, 2025 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) |
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| May 6, 2025 |
Exhibit 99.1 Moleculin Announces World Health Organization Approval of “naxtarubicin” as International Non-Proprietary Name for Annamycin Annamycin has the potential to be safer and more effective than current prescribed anthracyclines to treat serious, hard-to-treat cancers Ongoing pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin for the treatment of acute myelo |
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| May 5, 2025 |
Exhibit 99.1 Moleculin Bolsters Annamycin Intellectual Property Portfolio with Granting of Two New U.S. Patents Company continues to expand global IP coverage and claims to major markets, now extending to June 2040 HOUSTON, May 5, 2025 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting ha |
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| May 5, 2025 |
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): May 5, 2025 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) |
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| April 30, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K/A (Amendment No. 2) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF For the transition period from to Commission File Number: 001-37758 Moleculin Biotech, |
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| April 29, 2025 |
Exhibit 99.2 |
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| April 29, 2025 |
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): April 29, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| April 29, 2025 |
Exhibit 99.1 Moleculin Announces New Pre-Clinical Data for Annamycin Demonstrating Market Expansion Potential Including Treatment for Pancreatic Cancer Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 Annamycin is potentially a highly versatile drug capable of working synergistically with numerous mechanistically different FDA approved anticancer first line |
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| April 25, 2025 |
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): April 25, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| April 21, 2025 |
InvestorPresentation dated April 2025 Exhibit 99.1 |
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| April 21, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): April 21, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| April 18, 2025 |
-12-31FY2024 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. |
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| April 17, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): April 17, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| April 17, 2025 |
Exhibit 99.1 Moleculin Announces Acceptance of Abstract to be Presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 HOUSTON, April 17, 2025 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced that an abstract |
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| April 9, 2025 |
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): April 9, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| April 4, 2025 |
Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 April 4, 2025 Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 April 4, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Alan Campbell Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-286276 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin |
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| April 1, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): April 1, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| April 1, 2025 |
Exhibit 99.1 Moleculin Doses First Patient in Pivotal, Adaptive Phase 3 MIRACLE Trial – Initial data readout on track for second half of 2025 HOUSTON, April 1, 2025 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the first patient has |
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| March 31, 2025 |
As filed with the Securities and Exchange Commission on March 31, 2025. Table of Contents As filed with the Securities and Exchange Commission on March 31, 2025. |
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| March 31, 2025 |
Exhibit 107 Calculation of Filing Fee Tables FORM S-1 (Form Type) Moleculin Biotech, Inc. |
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| March 24, 2025 |
Investor Presentation dated March 2025 Exhibit 99.1 |
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| March 24, 2025 |
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): March 24, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| March 24, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): March 24, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| March 24, 2025 |
Exhibit 99.1 Moleculin Reports Full Year 2024 Financial Results and Provides Corporate Update –Continued progress in pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) toward first subject treated, on track to take place in the first quarter of 2025 –Multiple subjects currently being screened in first MIRACLE site activated – Initial data readout of the Phase 3 MIRACLE trial expected i |
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| March 21, 2025 |
Moleculin Biotech, Inc. Insider Trading Policy Exhibit 19 Moleculin Biotech, Inc. INSIDER TRADING POLICY (adopted October 2, 2019) Purpose This Insider Trading Policy (the “Policy”) provides guidelines with respect to transactions in Moleculin Biotech, Inc. (the “Company”) securities and the handling of confidential information about the Company and the companies with which the Company does business. The Company’s board of directors has adopte |
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| March 21, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF For the transition period from to Commission File Number: 001-37758 Moleculin Bi |
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| March 13, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. |
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| March 6, 2025 |
Exhibit 99.1 Moleculin Announces Additional Annamycin Patent Allowances to Enhance Global Exclusivity New patents will extend coverage to major markets outside the U.S., expanding upon existing U.S. claims Affirms expectations for an initial data readout of the phase 3 MIRACLE trial for the second half of 2025 HOUSTON, March 6, 2025 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin |
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| March 6, 2025 |
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): March 6, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| March 3, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. |
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| February 26, 2025 |
Exhibit 10.2 PLACEMENT AGENCY AGREEMENT February 25, 2025 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of $3,500,002 of registered and unregistered securit |
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| February 26, 2025 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-280064 Prospectus Supplement (to Prospectus dated July 1, 2024) 1,150,000 Shares of Common Stock Pre-Funded Warrants to Purchase up to 2,121,029 Shares of Common Stock We are offering 1,150,000 shares of our common stock (the “Shares”) to institutional investors pursuant to this prospectus supplement and the accompanying prospectus, and a secur |
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| February 26, 2025 |
Exhibit 4.1 PREFUNDED COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Initial Exercise Date: February 26, 2025 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or af |
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| February 26, 2025 |
Entry into a Material Definitive Agreement 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 25, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| February 26, 2025 |
Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE 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 (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR |
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| February 26, 2025 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of February 25, 2025, between Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditi |
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| February 26, 2025 |
Exhibit 99.1 Moleculin Announces Pricing of $3.5 Million Registered Direct Offering and Concurrent Private Placement Priced At The Market Under Nasdaq Rules HOUSTON, February 25, 2025 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today a |
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| February 24, 2025 |
Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 February 24, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-283820 (“Registration Statement”) Ladies and Gentlemen: Please be advised that the Company hereby requests withdrawal of the |
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| February 13, 2025 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits 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 13, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| February 13, 2025 |
Exhibit 99.1 Moleculin Receives Positive FDA Guidance for Acceleration of its Registration-Enabling MIRACLE Trial for R/R Acute Myeloid Leukemia (AML) Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) in the first quarter of 2025 HOUSTON, February 13, 2025 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “ |
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| February 13, 2025 |
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 13, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| February 13, 2025 |
Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE 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 (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR |
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| February 13, 2025 |
Exhibit 10.1 MOLECULIN BIOTECH, INC. February 13, 2025 Holder of Common Stock Purchase Warrants Re: Inducement Offer to Exercise Common Stock Purchase Warrants Dear Holder: Moleculin Biotech, Inc. (the “Company”) is pleased to offer to you (“Holder”, “you” or similar terminology) (i) the opportunity to receive new warrants to purchase shares of the Company’s common stock, par value $0.001 per shar |
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| February 11, 2025 |
Form of Securities Purchase Agreement Exhibit 10.34 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of [], 2025, between Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set |
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| February 11, 2025 |
Exhibit 99.1 Moleculin Receives First Country Approval in Europe to Begin Recruiting for the MIRACLE Phase 3 R/R Acute Myeloid Leukemia (AML) Pivotal Trial First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) in the firs |
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| February 11, 2025 |
As filed with the Securities and Exchange Commission on February 11, 2025. As filed with the Securities and Exchange Commission on February 11, 2025. Registration No. 333-283820 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or other jurisdiction of (Prim |
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| February 11, 2025 |
Exhibit 107 Calculation of Filing Fee Tables FORM S-1 (Form Type) Moleculin Biotech, Inc. |
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| February 11, 2025 |
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 11, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| February 10, 2025 |
Exhibit 4.15 PREFUNDED COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Initial Exercise Date: [], 2025 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the |
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| February 10, 2025 |
Form of Waiver agreement dated February 9, 2025 Exhibit 10.35 WAIVER THIS WAIVER (this “Waiver”) is entered into by and among Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and the purchaser signatory hereto (the “Purchaser”). Reference is hereby made to that certain Securities Purchase Agreement, dated as of August 15, 2024, by and between the Company and the Purchaser (the “Purchase Agreement”). Capitalized terms used herein |
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| February 10, 2025 |
Form of Securities Purchase Agreement Exhibit 10.34 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of [], 2025, between Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set |
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| February 10, 2025 |
Exhibit 1.1 PLACEMENT AGENCY AGREEMENT [], 2025 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of $[] of registered securities of the Company, including, but |
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| February 10, 2025 |
Entry into a Material Definitive Agreement 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 9, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiza |
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| February 10, 2025 |
As filed with the Securities and Exchange Commission on February 10, 2025. As filed with the Securities and Exchange Commission on February 10, 2025. Registration No. 333-283820 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or other jurisdiction of (Prim |
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| February 10, 2025 |
Exhibit 4.14 SERIES D COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Issue Date: [], 2025 THIS SERIES D COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Stockholder Ap |
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| February 10, 2025 |
Exhibit 4.13 SERIES C COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Issue Date: [], 2025 THIS SERIES C COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the Stockholder Ap |
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| February 10, 2025 |
Exhibit 107 Calculation of Filing Fee Tables FORM S-1 (Form Type) Moleculin Biotech, Inc. |
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| January 29, 2025 |
As filed with the Securities and Exchange Commission on January 29, 2025. As filed with the Securities and Exchange Commission on January 29, 2025. Registration No. 333-283820 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or other jurisdiction of (Prima |
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| January 29, 2025 |
Exhibit 4.13 SERIES C COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Issue Date: [], 2025 THIS SERIES C COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the [Stockholder A |
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| January 29, 2025 |
Exhibit 4.14 SERIES D COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Issue Date: [], 2025 THIS SERIES D COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the [Stockholder A |
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| January 29, 2025 |
Exhibit 4.15 PREFUNDED COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: [] Initial Exercise Date: [], 2025 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the |
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| January 29, 2025 |
Exhibit 1.1 PLACEMENT AGENCY AGREEMENT [], 2025 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of $[] of registered securities of the Company, including, but |
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| January 29, 2025 |
Exhibit 107 Calculation of Filing Fee Tables FORM S-1 (Form Type) Moleculin Biotech, Inc. |
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| January 29, 2025 |
Form of Securities Purchase Agreement Exhibit 10.34 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of [], 2025, between Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set |
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| January 27, 2025 |
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): January 27, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiza |
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| January 27, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): January 27, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiza |
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| January 27, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K/A CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): January 27, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organi |
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| January 27, 2025 |
Virtual Investor What This Means featuring Moleculin Bio Exhibit 99.1 Virtual Investor What This Means featuring Moleculin Bio Participants: ● Wally Klemp, Chairman and Chief Executive Officer Moleculin Bio (Nasdaq: MBRX) Jenene Introduction: ● Welcome back to another Virtual Investor What This Means segment. My name is Jenene Thomas, CEO of JTC IR. Today we are featuring Moleculin Biotech! I am pleased to be joined by Walter Klemp, Chairman and Chief E |
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| January 27, 2025 |
Exhibit 99.1 Moleculin Participates in Virtual Investor “What This Means” Segment – Walter Klemp, CEO of Moleculin, provides an update on the Company’s Phase 3 pivotal trial of Annamycin for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (the “MIRACLE” trial) – Watch the “What This Means" segment here HOUSTON, January 27, 2025 /PRNewswire/ - Molec |
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| January 8, 2025 |
Exhibit 99.1 Moleculin Highlights Development Progress of Annamycin, Phase 2 Data Outperforms Billion-Dollar Assets in AML, Phase 3 Data Readouts in 2025 & 2026 – Received US Institutional Review Board (IRB) approval for pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) and engaged leading contract research organization (CRO); On track to begin dosing of Annamycin in combination with |
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| January 8, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): January 8, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| January 8, 2025 |
Investor Presentation dated January 2025 Exhibit 99.1 |
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| January 8, 2025 |
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): January 8, 2025 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| December 18, 2024 |
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): December 18, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| December 18, 2024 |
Investor Presentation dated December 2024 Exhibit 99.1 |
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| December 13, 2024 |
Exhibit 107 Calculation of Filing Fee Tables FORM S-1 (Form Type) Moleculin Biotech, Inc. |
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| December 13, 2024 |
As filed with the Securities and Exchange Commission on December 13, 2024. Table of Contents As filed with the Securities and Exchange Commission on December 13, 2024. |
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| December 11, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): December 11, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| December 11, 2024 |
Exhibit 99.1 Moleculin Announces Online Publication of Preclinical Data Demonstrating Significant Activity of Annamycin in Venetoclax Resistant AML Model Abstract published as part of the American Society of Hematology (ASH) Annual Meeting Study shows Annamycin effectively targets both Cytarabine (Ara-C) and Venetoclax resistant acute myeloid leukemia (AML) cell lines from heavily pretreated relap |
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| December 3, 2024 |
As filed with the Securities and Exchange Commission on December 3, 2024. Table of Contents As filed with the Securities and Exchange Commission on December 3, 2024. |
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| November 18, 2024 |
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): November 18, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| November 18, 2024 |
InvestorPresentation dated November 2024 Exhibit 99.1 |
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| November 18, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): November 18, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| November 18, 2024 |
Exhibit 99.1 New Findings Show Moleculin’s Annamycin Overcomes Resistance to Venetoclax in AML Preclinical data accepted for online publication at ASH Annual Meeting reveal significant activity of Annamycin in Venetoclax resistant AML model New preliminary clinical results show Annamycin plus Ara-C achieved 60% CR/CRi in subjects who were relapsed from or refractory to Venetoclax regimens; more th |
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| November 14, 2024 |
Exhibit 99.1 Moleculin Accelerates Planned Unblinded Data Readout for MIRACLE Phase 3 R/R Acute Myeloid Leukemia (AML) Pivotal Trial to H2 2025 Amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” t |
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| November 14, 2024 |
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): November 14, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| November 14, 2024 |
MBRX / Moleculin Biotech, Inc. / ARMISTICE CAPITAL, LLC Passive Investment SC 13G/A 1 armistice-mbrx093024a1.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* Moleculin Biotech, Inc. (Name of Issuer) Common Stock, par value $.001 per share (Title of Class of Securities) 60855D309 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Chec |
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| November 14, 2024 |
InvestorPresentation dated November 2024 Exhibit 99.1 |
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| November 14, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): November 14, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| November 12, 2024 |
Exhibit 99.1 Moleculin Receives Institutional Review Board Approval for MIRACLE Phase 3 Pivotal Trial of Annamycin in Combination with Cytarabine for the Treatment of R/R Acute Myeloid Leukemia (AML) Company on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) in the first quarter of 2025 Trial designed for possible accelerated approval of Annamycin |
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| November 12, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): November 11, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| November 12, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): November 12, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| November 12, 2024 |
InvestorPresentation dated November 2024 Exhibit 99.1 |
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| November 12, 2024 |
Exhibit 99.1 Moleculin Reports Third Quarter 2024 Financial Results and Provides Corporate Update - On track to start dosing in pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025 - Median durability of CRc in MB-106 Annamycin+ Cytarabine AML clinical trial cont |
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| November 12, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): November 12, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| November 8, 2024 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-3775 |
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| November 5, 2024 |
Exhibit 99.1 Moleculin to Report Third Quarter 2024 Financial Results on November 8, 2024 and Host Conference Call and Webcast HOUSTON, Nov. 5, 2024 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that it will report its financial resul |
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| November 5, 2024 |
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): November 5, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiza |
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| October 25, 2024 |
Forms of award agreements under Moleculin Biotech, Inc. 2024 Stock Plan. Exhibit 99.2 THIS DOCUMENT CONSTITUTES PART OF THE SECTION 10(a) PROSPECTUS COVERING SECURITIES THAT HAVE BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933. Moleculin Biotech, Inc. 2024 Stock Plan Incentive Stock Option Agreement The employee identified below has been selected to be a Participant in the Moleculin Biotech, Inc. 2024 Stock Plan(the “2024 Plan”) and has been granted an Incentive Stock |
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| October 25, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Moleculin Biotech, Inc. |
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| October 25, 2024 |
Moleculin Biotech, Inc. 2024 Stock Plan Exhibit 99.1 MOLECULIN BIOTECH, INC. 2024 STOCK PLAN Section 1. Establishment and Purpose. 1.1 The Board of Directors of Moleculin Biotech, Inc. (the “Company”) established the Moleculin Biotech, Inc. 2024 Stock Plan (the “Plan”), subject to approval by the Company’s stockholders at the Company’s annual meeting on October 24, 2024. 1.2 The purpose of the Plan is to attract and retain outstanding i |
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| October 25, 2024 |
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): October 24, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiza |
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| October 25, 2024 |
Exhibit 10.1 MOLECULIN BIOTECH, INC. 2024 STOCK PLAN Section 1. Establishment and Purpose. 1.1 The Board of Directors of Moleculin Biotech, Inc. (the “Company”) established the Moleculin Biotech, Inc. 2024 Stock Plan (the “Plan”), subject to approval by the Company’s stockholders at the Company’s annual meeting on October 24, 2024. 1.2 The purpose of the Plan is to attract and retain outstanding i |
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| October 25, 2024 |
As filed with the Securities and Exchange Commission on October 25, 2024 As filed with the Securities and Exchange Commission on October 25, 2024 Registration No. |
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| October 17, 2024 |
Virtual Acute Myeloid Leukemia KOL Day Presentation Exhibit 99.3 |
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| October 17, 2024 |
Exhibit 99.1 Transcript from Moleculin’s Recent Virtual Acute Myeloid Leukemia KOL Event Now Available Access the transcript here HOUSTON, October 17, 2024 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the transcript from |
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| October 17, 2024 |
Moleculin Biotech Virtual Acute Myeloid Leukemia KOL Event October 14, 2024 Exhibit 99.2 Moleculin Biotech Virtual Acute Myeloid Leukemia KOL Event October 14, 2024 Presenters Walter Klemp, Chief Executive Officer John Paul Waymack, Senior Chief Medical Officer Jenene Thomas, Investor Relations Michael Andreef, Key Opinion Leader, Professor at University of Texas, MD Anderson Cancer Center Giovanni Martinelli, Key Opinion Leader, University of Bologna Mohamad Cherry, Key |
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| October 17, 2024 |
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): October 17, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiza |
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| October 7, 2024 |
Exhibit 99.1 Moleculin to Host Virtual Acute Myeloid Leukemia KOL Event on October 14, 2024 Live webcast discussion featuring internationally renowned Acute Myeloid Leukemia (AML) Key Opinion Leaders Ongoing progress of pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed |
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| October 7, 2024 |
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): October 7, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| October 2, 2024 |
Investor Presentation dated October 2024 Exhibit 99.1 |
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| October 2, 2024 |
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): October 2, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| September 23, 2024 |
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): September 23, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organi |
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| September 23, 2024 |
Exhibit 99.1 Moleculin Announces Positive In Vivo Efficacy Data of Annamycin in Orthotopic and Experimental Lung Metastatic Models of Sarcoma Data recently presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer Treatment with Annamycin results in statistically significant inhibition of tumor growth and extension of survival in orthotopi |
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| September 16, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): September 16, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organi |
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| September 16, 2024 |
Exhibit 99.1 Moleculin Participates in Virtual Investor “What this Means” Segment Wally Klemp, CEO of Moleculin, discusses the Company’s recent update on the Phase 2 clinical trial of STAT3 inhibitor in combination with radiation for the treatment of glioblastoma Watch the "What This Means" video here HOUSTON, September 16, 2024 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” o |
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| September 16, 2024 |
Investor Presentation dated September 2024 EX-99.1 2 ex723789.htm EXHIBIT 99.1 Exhibit 99.1 |
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| September 16, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): September 16, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organi |
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| September 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| September 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Defin |
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| September 9, 2024 |
Exhibit 99.1 Moleculin Announces First Patients Treated in Phase 2 Clinical Trial of STAT3 Inhibitor in Combination with Radiation for the Treatment of Glioblastoma – Investigator-initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin – Funding for study provided by NIH and BrainUp® – Trial combines WP1066 and radiation, which demonstrated both signific |
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| September 9, 2024 |
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): September 9, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organiz |
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| September 3, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| August 19, 2024 |
Prospectus Supplement Filed Pursuant to Rule 424(b)(3) (To the Prospectus dated February 12, 2024) Registration No. |
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| August 19, 2024 |
Moleculin Announces Closing of up to $16.5 Million Public Offering Exhibit 99.1 Moleculin Announces Closing 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 19, 2024 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a Phase 3 clinical stage pharmaceutical compa |
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| August 19, 2024 |
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 19, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| August 16, 2024 |
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 |
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| August 16, 2024 |
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 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| August 16, 2024 |
Exhibit 99.1 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 compa |
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| August 16, 2024 |
Table of Contents Prospectus Filed pursuant to Rule 424(b)(4) Registration No. 333-280951 Moleculin Biotech, Inc. 283,000 Shares of Common Stock, 283,000 Accompanying Series A Common Warrants to Purchase up to 283,000 Shares of Common Stock and 283,000 Accompanying Series B Common Warrants to Purchase up to 283,000 Shares of Common Stock 2,183,368 Pre-Funded Warrants to Purchase Up to 2,183,368 Sh |
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| August 15, 2024 |
Exhibit 4.12 PLACEMENT AGENT COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: Initial Exercise Date: , 2024 THIS PLACEMENT AGENT COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after t |
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| August 15, 2024 |
August 15, 2024 VIA FACSIMILE AND EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 (Registration No. 333-280951) - Concurrence in Acceleration Request Ladies and Gentlemen: H.C. Wainwright & Co., LLC (“Wainwright”), solely acting as placement agent on a best-efforts basis in an offering p |
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| August 15, 2024 |
As filed with the Securities and Exchange Commission on August 15, 2024. Table of Contents As filed with the Securities and Exchange Commission on August 15, 2024. |
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| August 15, 2024 |
As filed with the Securities and Exchange Commission on August 14, 2024. Table of Contents As filed with the Securities and Exchange Commission on August 14, 2024. |
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| August 15, 2024 |
Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 August 15, 2024 Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 August 15, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Jessica Dickerson Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-280951 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Mole |
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| August 15, 2024 |
Exhibit 10.32 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of , 2024, between Moleculin Biotech, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set fo |
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| August 15, 2024 |
Exhibit 1.1 June 8, 2024 STRICTLY CONFIDENTIAL Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 Attn: Jonathan P. Foster, Executive Vice President and Chief Financial Officer Dear Mr. Foster: This letter agreement (this “Agreement”) constitutes the agreement between Moleculin Biotech, Inc. (the “Company”) and H.C. Wainwright & Co., LLC (“Wainwright”), that Wainwright shall |
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| August 15, 2024 |
EXHIBIT 4.9 PREFUNDED COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: Initial Exercise Date: , 2024 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date here |
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| August 15, 2024 |
Exhibit 4.10 EXHIBIT A-2 SERIES A COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: Issue Date: , 2024 THIS SERIES A COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the [Stockhold |
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| August 15, 2024 |
Exhibit 4.11 EXHIBIT A-3 SERIES B COMMON STOCK PURCHASE WARRANT MOLECULIN BIOTECH, INC. Warrant Shares: Issue Date: , 2024 THIS SERIES B COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the [Stockhold |
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| August 15, 2024 |
Exhibit 107 Calculation of Filing Fee Tables FORM S-1 (Form Type) Moleculin Biotech, Inc. |
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| August 14, 2024 |
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 14, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizat |
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| August 14, 2024 |
Exhibit 99.1 Moleculin Reports Second Quarter 2024 Financial Results and Provides Corporate Update - Positive outcome from End of Phase 1B/2 Meeting with FDA - Company proceeding with a pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML - Webcast replay of the Company’s r |
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| August 13, 2024 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37758 MOL |
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| August 6, 2024 |
Investor Clinical Update Transcript August 6, 2024 Exhibit 99.1 Investor Clinical Update Transcript August 6, 2024 Operator Hello, and welcome to the Moleculin Biotech Corporate Update webcast. As a brief reminder, all participants are currently in a listen-only mode. Note that this webcast is being recorded at the Company's request and a replay will be made available on the Company's website following the end of the event. I will now turn the cal |
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| August 6, 2024 |
Investor Presentation dated August 2024 Exhibit 99.2 |
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| August 6, 2024 |
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 6, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| August 5, 2024 |
Exhibit 99.1 Moleculin to Host Webcast Presentation to Discuss Recently Announced Plans for MIRACLE Phase 3 Pivotal Trial Tuesday, August 6, 2024 at 8:30 AM ET HOUSTON, August 5, 2024 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruse |
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| August 5, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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 5, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| August 1, 2024 |
Investor Presentation dated August 2024 Exhibit 99.1 |
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| August 1, 2024 |
Exhibit 99.1 Moleculin Announces Plans for MIRACLE Phase 3 Pivotal Trial Based on an encouraging discussion in the End of Phase 1B/2 Meeting with FDA the Company plans to: Proceed with a pivotal, adaptive Phase 3 clinical trial (the “MIRACLE” trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML; Run such futur |
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| August 1, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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 1, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| August 1, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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 1, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| July 30, 2024 |
As filed with the Securities and Exchange Commission on July 30, 2024. Table of Contents As filed with the Securities and Exchange Commission on July 30, 2024. |
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| July 22, 2024 |
As filed with the Securities and Exchange Commission on July 22, 2024. S-1 1 mbrx20240624s1.htm Table of Contents As filed with the Securities and Exchange Commission on July 22, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or other jurisdi |
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| July 22, 2024 |
Exhibit 107 Calculation of Filing Fee Tables FORM S-1 (Form Type) Moleculin Biotech, Inc. |
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| July 10, 2024 |
Moleculin Completes End of Phase 2 Meeting with FDA for Annamycin in AML Exhibit 99.1 Moleculin Completes End of Phase 2 Meeting with FDA for Annamycin in AML HOUSTON, July 10, 2024 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the completion of its End of Phase 2 (EOP2) meeting with the U |
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| July 10, 2024 |
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): July 10, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| June 27, 2024 |
Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 June 27, 2024 Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 June 27, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Chris Edwards Re: Moleculin Biotech, Inc. Registration Statement on Form S-3 Registration No. 333-280064 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin |
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| June 18, 2024 |
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): June 18, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| June 18, 2024 |
InvestorPresentation dated June 2024 Exhibit 99.1 |
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| June 14, 2024 |
Exhibit 99.1 Moleculin Announces Additional Positive Preliminary Interim Data from AML Clinical Trial – 89% of CRc’s were subjects with “poor prognosis” cytogenetics and/or mutations – Current median durability of response (mDOR) of CRc’s = 6 months and increasing (n=9) – In 2nd line subjects (n=10) Annamycin in combination with Cytarabine (AnnAraC) achieved an estimated median overall survival (m |
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| June 14, 2024 |
Exhibit 99.2 |
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| June 14, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): June 14, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizatio |
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| June 7, 2024 |
Form of Unsubordinated Indenture* Exhibit 4.1 MOLECULIN BIOTECH, INC. TO AS TRUSTEE INDENTURE DATED AS OF , 20 SENIOR DEBT SECURITIES TABLE OF CONTENTS Page ARTICLE 1 DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION 1 SECTION 1.1 DEFINITIONS 1 SECTION 1.2 COMPLIANCE CERTIFICATES AND OPINIONS 8 SECTION 1.3 FORM OF DOCUMENTS DELIVERED TO TRUSTEE 8 SECTION 1.4 ACTS OF HOLDERS; RECORD DATES 9 SECTION 1.5 NOTICES, ETC., TO TRUST |
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| June 7, 2024 |
As filed with the Securities and Exchange Commission on June 7, 2024 Table of Contents As filed with the Securities and Exchange Commission on June 7, 2024 Registration No. |
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| June 7, 2024 |
Form of Subordinated Indenture* Exhibit 4.2 MOLECULIN BIOTECH, INC. TO AS TRUSTEE INDENTURE DATED AS OF , 20 SUBORDINATED DEBT SECURITIES TABLE OF CONTENTS Page ARTICLE 1 DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION 1 SECTION 1.1 DEFINITIONS 1 SECTION 1.2 COMPLIANCE CERTIFICATES AND OPINIONS 9 SECTION 1.3 FORM OF DOCUMENTS DELIVERED TO TRUSTEE 10 SECTION 1.4 ACTS OF HOLDERS; RECORD DATES 10 SECTION 1.5 NOTICES, ETC., |
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| June 7, 2024 |
Calculation of Filing Fee Tables* Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Moleculin Biotech, Inc. |
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| May 16, 2024 |
Exhibit 99.1 Moleculin Abstract Accepted for Poster Presentation at the European Hematology Association (EHA) 2024 Hybrid Congress HOUSTON, May 16, 2024 /PRNewswire/ - Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced its abstract has b |
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| May 16, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): May 16, 2024 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 |
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| May 15, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): May 15, 2024 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 |
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| May 15, 2024 |
Exhibit 99.1 Moleculin Announces Commencement of NIH-Funded Phase 2 Clinical Trial of STAT3 Inhibitor for the Treatment of Glioblastoma (NU 21C06) – Investigator-Initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin – Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune “memory” in glioblastoma animal |
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| May 14, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): May 14, 2024 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 |
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| May 14, 2024 |
InvestorPresentation dated May 2024 Exhibit 99.1 |
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| May 13, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K/A CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): May 13, 2024 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37758 47-4671997 (State or Other Jurisdiction of Incorporation or Organizati |
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| May 13, 2024 |
Moleculin Reports First Quarter 2024 Financial Results and Provides Corporate Update Exhibit 99.1 Moleculin Reports First Quarter 2024 Financial Results and Provides Corporate Update – Recently announced interim data from ongoing MB-106 study demonstrating Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1st and 2nd line AML subjects (N=13) – Also announced MB-106 reaches 20 subjects enrolled – Company to host conference call and webcast toda |
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| May 13, 2024 |
Moleculin Reports First Quarter 2024 Financial Results and Provides Corporate Update Exhibit 99.1 Moleculin Reports First Quarter 2024 Financial Results and Provides Corporate Update – Recently announced interim data from ongoing MB-106 study demonstrating Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1st and 2nd line AML subjects (N=13) – Also announced MB-106 reaches 20 subjects enrolled – Company to host conference call and webcast toda |
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| May 13, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): May 13, 2024 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 |
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| May 10, 2024 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37758 MO |
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| May 9, 2024 |
Exhibit 99.1 Moleculin Announces U.S. Patent Issue Notification for Lipid-Based Delivery Technology for Annamycin Patent, once issued, will provide composition protection through 2040, with potential for additional term extension Annamycin is advancing towards pivotal AML study in 2024 and may qualify for an accelerated approval pathway HOUSTON, May 9, 2024 /PRNewswire/ - Moleculin Biotech, Inc., |
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| May 9, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): May 9, 2024 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) |
