Moleculin Expands Global IP Portfolio with New Australian Patent for Annamycin

Rhea-AI Summary

Moleculin (Nasdaq: MBRX) announced that IP Australia granted Patent No. 2024203598 titled "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE", covering preliposomal Annamycin lyophilizates with improved stability and high purity.

The patent has a base term currently extending until June 2040, subject to extension to account for regulatory approval time, and expands the company's global IP portfolio alongside an expected Canadian patent and previously issued U.S. and allowed European patents. Annamycin (naxtarubicin) has FDA Fast Track Status and Orphan Drug Designation for relapsed/refractory AML and Orphan Drug Designation for STS lung mets; EMA orphan status for relapsed/refractory AML is also noted.

Positive

• Australian patent granted (Patent No. 2024203598) for preliposomal Annamycin
• Patent term to June 2040, with possible extension for regulatory approval time
• Global patent family includes issued U.S., allowed European, and expected Canadian patents
• Annamycin designations: FDA Fast Track and multiple Orphan Drug Designations

Negative

• Patent term is base to June 2040 and depends on extension timing for regulatory approval
• Additional applications pending in U.S., Europe and other major jurisdictions (protection not complete)

Insights

IP & Oncology Strategist

Australian patent grant strengthens global IP around Annamycin, extending protection into at least June 2040.

Moleculin now holds Australian Patent No. 2024203598 covering the "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE," which claims improved stability and high purity for preliposomal Annamycin lyophilizates. Stronger formulation patents can raise barriers to entry by protecting manufacturing methods and product quality attributes tied to this delivery form.

Value depends on regulatory and patent timelines. The patent term currently extends to June 2040 and may lengthen to reflect regulatory approval delays. The family already includes a U.S. patent, an allowed European patent, and an expected Canadian patent, with additional applications pending, so enforceable territorial coverage will determine commercial leverage.

Watch for regulatory milestones and granted patents in other jurisdictions over the next 12–36 months, plus any patent term extensions tied to approval. Also monitor whether claims are maintained during prosecution or challenged, and the timing of FDA/EMA approvals for Annamycin.

HOUSTON, Oct. 29, 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 cancers and viral infections, today announced that the Australian Patent Office (IP Australia) has granted Patent No. 2024203598 titled, “PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE,” with claims covering certain preliposomal Annamycin lyophilizates with improved stability and high purity, with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. This patent further expands the Company’s intellectual property portfolio globally.

Walter Klemp, Chairman and CEO of Moleculin, commented, “As we continue our mission to provide patients with Annamycin, a potentially transformative therapeutic candidate for hard-to-treat tumors, we remain focused on building our global patent protection to strengthen our competitive moat in oncology and bolster our position as a leader in the space. I am proud of our team’s diligent work in securing patent protection across key markets, and adding this Australian patent to our growing global IP portfolio underscores our commitment and belief in the potential of Annamycin. We remain encouraged by the data demonstrated by Annamycin to date and look forward to its continued advancement.”

Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Additional preclinical studies performed at a world-renowned cancer center indicate Annamycin may be a potential treatment for many other types of cancers. The new chemical entity uses a unique lipid-based delivery technology and has shown the potential to be used in a wide range of cancers. In addition to the newly granted Australian patent, this patent family relating to the preparation of preliposomal Annamycin includes an expected Canadian patent and previously issued U.S. and allowed European patents. Moleculin also has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.

About Moleculin Biotech, Inc.

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

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

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

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

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:

JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com 

FAQ

What did Moleculin (MBRX) announce on October 29, 2025 about Annamycin patents?

IP Australia granted Patent No. 2024203598 for preliposomal Annamycin lyophilizates, expanding Moleculin's global IP portfolio.

How long is the newly granted Australian patent for Annamycin valid for MBRX?

The patent has a base term currently extending until June 2040, subject to extension for regulatory approval time.

Does Moleculin (MBRX) have other Annamycin patents besides Australia?

Yes; the patent family includes an expected Canadian patent and previously issued U.S. and allowed European patents, with additional applications pending worldwide.

What regulatory designations does Annamycin (MBRX) hold that may aid commercialization?

Annamycin has FDA Fast Track Status and multiple Orphan Drug Designations for relapsed/refractory AML and STS lung mets, plus EMA orphan designation for relapsed/refractory AML.

What specific invention does Patent No. 2024203598 cover for MBRX's Annamycin?

The patent covers certain preliposomal Annamycin lyophilizates with improved stability and high purity.