Moleculin Announces Notice of Grant of U.S. Patent for Lipid-Based Delivery Technology for Annamycin

The patent, once issued, will provide protection for the composition until 2040, with potential for further extension

Annamycin advances to pivotal AML study in 2024 and could benefit from accelerated approval

HOUSTON, May 9, 2024 /PRNewswire/ — Molecule Biotech, Inc.(Nasdaq: MBRX) (Moleculin or the Company), a clinical-stage pharmaceutical company with a broad pipeline of drug candidates targeting difficult-to-treat tumors and viruses, today announced that it has received a problem notification from the from the United States Patent and Trademark Office. Office (USPTO) for United States Patent Number 11,980,634 entitled “Liposomal annamycin reconstitution method” (the “634 patent”) which will be issued on May 14, 2024 to the molecule and University of Texas System Board of Regents.

Once issued, the patent will provide claims to liposomal annamycin suspension compositions with a base patent term currently extending to June 2040, subject to extension to accommodate time required to meet regulatory requirements for FDA approval. Moleculin’s new candidate for the treatment of acute myelogenous leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets) uses a unique lipid-based delivery technology. In addition to the expected ‘634 patent and the recently issued ‘118 patent, Moleculin has additional patent applications related to annamycin pending in the United States and major jurisdictions around the world.

Walter KlempCEO and Chairman of Moleculin, said: “We remain committed to establishing a strong patent portfolio for Annamycin and advancing its development. In addition to our recently announced patented composition of matter for Annamycin, we believe we are well positioned for a potential partnership. discussions we plan to have in the near future. The issuance of this patent further highlights the importance and proprietary nature of the innovation that makes this next-generation anthracycline possible and reinforces our confidence in its potential to treat a number of high-value indications in which there remains unmet medical needs.

Annamycin is the company’s next-generation anthracycline that was designed to be noncardiotoxic (unlike currently prescribed anthracyclines) and was found to be noncardiotoxic in all 82 subjects treated in several studies in the United States. and in America. Europe. Additionally, Annamycin recently showed in Moleculin’s European clinical study for the treatment of AML using Annamycin in combination with Cytarabine (MB-106) a preliminary composite complete response (CRc) rate of 60%. in 2nd line subjects (N = 10) and an overall interim CRc rate of 39% in all subjects (N = 18), regardless of the number of prior therapies, in the European trial. The sustainability of CRcs is growing. One topic passed the one-year mark with a complete and lasting response. Recruitment in MB-106 is complete for 2nd line subjects while recruitment for 1st and 3rd line subjects continues. Annamycin is currently in development for the treatment of AML and STS lung diseases, and the company believes the drug could potentially treat other indications.

Disclosure
MD Anderson has an institutional conflict of interest with Moleculin, and this relationship is managed in accordance with an MD Anderson Institutional Conflict of Interest Management and Monitoring Plan.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical-stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for difficult-to-treat tumors and viruses. Annamycin, the company’s lead program, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little or no cardiotoxicity. Annamycin is currently in development for the treatment of lung metastases from relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS).

Additionally, the Company is developing WP1066, an immune/transcription modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers, and WP1220, an analogue of WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122, for the potential treatment of viruses, as well as cancer indications , including brain tumors, pancreatic cancer and other cancers.

For more information about the Company, please visit www.moleculin.com and log on to TwitterLinkedIn and Facebook.

Forward-looking statements

Certain of the statements contained in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements contained in this press release include, but are not limited to, the anticipated issuance of the patent discussed above. Although Moleculin believes that the expectations reflected in these forward-looking statements are reasonable as of the date they are made, the expectations may prove to be materially different from the results expressed or implied by these forward-looking statements. Moleculin has attempted to identify forward-looking statements using terminology such as “believes”, “estimates”, “anticipates”, “expects”, “plans”, “projects”, “intends” “, “potential”, “may”, “could”, “could”, “will”, “should”, “approximately” or other words that reflect the uncertainty of future events or results to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in Section 1A. “Risk Factors” in our most recently filed Form 10-K with the Securities and Exchange Commission (SEC) and as updated from time to time in our Forms 10-Q and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor contact:

JTC Team, LLC

Jénène Thomas
(833) 475-8247
[email protected]

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SOURCE Moleculin Biotech, Inc.