Moleculin receives Canadian patent allowance for cancer drug Annamycin

HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a clinical-stage biotech company with a current market capitalization of $15.6 million, announced Thursday that the Canadian Intellectual Property Office has issued a notice of allowance for a patent application covering methods of making its cancer drug candidate Annamycin. According to InvestingPro data, the company maintains a favorable cash position relative to its debt, though it faces challenges with rapid cash burn.

The patent, expected to be issued in the coming months, will protect methods of producing a preliposomal Annamycin lyophilizate with improved stability and high purity. The base patent term extends until June 2040, subject to potential extension based on regulatory approval timelines. With the company’s next earnings report due on November 12, 2025, investors following this development can access comprehensive analysis through InvestingPro’s detailed research reports, which provide deeper insights into the company’s financial health and growth prospects.

Annamycin, also known by its non-proprietary name naxtarubicin, is being developed as what the company describes as potentially the first non-cardiotoxic anthracycline to receive approval. The drug candidate is currently in development for treating acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases.

The drug has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML treatment, along with Orphan Drug Designation for treating soft tissue sarcoma lung metastases. The European Medicines Agency has also granted Orphan Drug Designation for the treatment of relapsed or refractory AML.

"We remain committed to bolstering our global intellectual property portfolio for Annamycin," said Walter Klemp, Chairman and CEO of Moleculin. "This Canadian patent further strengthens our current IP portfolio which includes claims to methods of making our preliposomal Annamycin, in yet another key territory."

Moleculin has begun the MIRACLE Trial, described as a pivotal Phase 3 study evaluating Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia.

The company stated in its press release that it has additional patent applications related to Annamycin pending in the U.S., Europe, and other major jurisdictions worldwide. While analyst price targets range from $4 to $12, significantly above the current trading price, InvestingPro analysis reveals the company faces financial challenges, with an overall Financial Health Score rated as ’WEAK’. Investors can access 13 additional exclusive ProTips and detailed metrics through InvestingPro’s comprehensive research platform.

In other recent news, Moleculin Biotech has made significant advancements in its clinical trials and strategic operations. The company is expanding its Phase 2B/3 clinical trial, known as MIRACLE, for the treatment of acute myeloid leukemia (AML) across multiple countries, aiming to recruit 45 patients by the fourth quarter. This trial involves the drug Annamycin in combination with cytarabine, with 13 subjects already enrolled and 10 receiving treatment. Moleculin has also enrolled its first two patients in the European Union for this pivotal trial, with active recruitment sites in the United States, Spain, Ukraine, Georgia, and Romania.

Additionally, Moleculin received a Notice of Intent to Grant for a European patent application covering its cancer drug candidate Annamycin, ensuring protection for its preparation methods until 2040. In another strategic move, the company appointed Adriano Treve, a former Roche executive, as a Strategic Advisor to bolster its partnerships. H.C. Wainwright has reiterated its Buy rating for Moleculin Biotech, maintaining a $4.00 price target, following updates on the company’s patient recruitment and site activation for its ongoing trials. These developments reflect Moleculin’s continued efforts in advancing its treatment options for challenging diseases.

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