Moleculin reports Annamycin cancer drug synergy at AACR meeting

Published 29/04/2025, 13:42
Moleculin reports Annamycin cancer drug synergy at AACR meeting

HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a late-stage pharmaceutical company currently valued at $13.8 million, disclosed findings from a study at the American Association for Cancer Research (AACR) Annual Meeting on Monday, demonstrating that its drug candidate Annamycin works synergistically with various FDA-approved anticancer therapies. According to InvestingPro data, while the company maintains more cash than debt on its balance sheet, it faces significant challenges with rapid cash burn and volatile stock performance. The study’s results suggest that Annamycin could be an effective addition to treatment regimens for a range of cancers, including leukemia, sarcoma, and pancreatic cancer.

The research presented at the AACR meeting in Chicago on April 28, 2025, involved testing both non-liposomal and liposomal forms of Annamycin in combination with other anticancer agents. The combinations that showed the most promise in vitro were then tested in vivo using established models of leukemia and solid tumors. This approach aligns with current trends in cancer treatment, which often involve drug combinations.

Annamycin, a next-generation anthracycline, is designed to avoid the multidrug resistance and cardiotoxicity that limit the use of current anthracyclines. Moleculin’s CEO, Walter Klemp, expressed optimism about the expanding potential markets for Annamycin, citing its ability to generate synergistic results with commonly used drugs. The company is preparing for future investigator-initiated trials, potentially focusing on pancreatic cancer or advanced soft tissue sarcomas.

The study’s implications could broaden Annamycin’s clinical applications and enhance its attractiveness to potential partners. Moleculin is already advancing Annamycin through clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. With analyst price targets ranging from $4 to $20, significantly above the current trading price, market expectations suggest potential upside if clinical trials succeed. InvestingPro subscribers can access 12 additional key insights about MBRX’s financial health and market position, along with comprehensive research reports that provide deep-dive analysis of the company’s prospects. The MIRACLE Trial, a pivotal Phase 3 adaptive design trial, is evaluating Annamycin in combination with cytarabine for AML treatment.

Moleculin’s broader pipeline includes WP1066, an immune/transcription modulator, and a suite of antimetabolites like WP1122, targeting viruses and various cancers.

The company’s progress is based on the premise that Annamycin will continue to demonstrate clinical efficacy in line with the promising preclinical results. However, as with all clinical-stage pharmaceutical companies, Moleculin faces the challenges of securing adequate financing and navigating regulatory pathways. Financial metrics from InvestingPro indicate the company reported negative EBITDA of $26.5 million in the last twelve months, with analysts not anticipating profitability this year. The stock has experienced significant volatility, declining over 80% in the past year, though current analysis suggests the stock may be undervalued based on InvestingPro’s Fair Value calculations.

This article is based on a press release statement from Moleculin Biotech, Inc. and does not include any additional analysis or commentary. The forward-looking statements from the company involve risks and uncertainties, and actual results may differ materially from those projected.

In other recent news, Moleculin Biotech has been making significant strides in its clinical trial efforts and financial management. The company announced its fourth-quarter financials for 2024, emphasizing its focus on the pivotal Phase 3 trial, MIRACLE, which will evaluate Anamycin for treating acute myeloid leukemia (AML). Moleculin Biotech has reduced its operating expenses by $3 million in 2024 and maintains a cash balance of $13 million, expected to last until the third quarter of 2025. H.C. Wainwright has reaffirmed its Buy rating for Moleculin Biotech, with a price target of $8.00, citing confidence in the MIRACLE study and the company’s progress in clinical site selection.

The company is poised to open clinical sites in Europe and the Middle East, with additional sites planned for the United States. Moleculin Biotech plans to treat the first subject in the first quarter of 2025, with data unblinding expected by the end of the year. The company is targeting approximately 70 clinical locations, with 25 sites already selected. Additionally, Moleculin Biotech’s Special Meeting of Stockholders was adjourned due to a lack of quorum, rescheduled to allow more shareholder participation. These developments highlight the company’s ongoing efforts to advance its clinical trials and manage its financial resources effectively.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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