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HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a late-stage pharmaceutical company with a market capitalization of $11.87 million, announced positive results from its U.S. Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases (STS lung mets). According to InvestingPro data, while the company maintains more cash than debt on its balance sheet, it faces challenges with cash burn rates and profitability. The trial’s findings suggest improved overall survival (OS) and progression-free survival (PFS) rates for patients, potentially offering a new treatment avenue for thousands diagnosed with STS annually.
The trial, known as MB-107, was conducted across multiple centers as an open-label, single-arm monotherapy study. It aimed to establish the maximum tolerable dose and recommended Phase 2 dose while assessing the safety and efficacy of Annamycin. Despite the positive trial results, the company’s stock has experienced significant volatility, with InvestingPro analysis showing a beta of 1.57 and a 81.45% decline over the past year. The Clinical Benefit Rate (CBR) was reported at 59.4%, with 18 subjects achieving stable disease and one subject experiencing a partial response.
Notably, subjects who received optimized doses of Annamycin demonstrated a median PFS of approximately four months and an OS of roughly twenty months. These figures are particularly significant when compared to typical results for second-line monotherapies in STS, which range from eight to twelve months. The study also indicated that subjects with fewer prior therapies had even higher OS/PFS rates.
The absence of cardiotoxicity in subjects, a common issue with similar drugs, further underscores the potential of Annamycin as a safer treatment alternative. Moleculin’s Chairman and CEO, Walter Klemp, expressed optimism about the future evaluations of Annamycin based on these results.
Moleculin’s Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, as well as Orphan Drug Designation for the treatment of STS.
The company plans to discuss the MB-107 data in an on-demand webcast with Key Opinion Leaders on Thursday, June 5, 2025. This webcast will be available on the Moleculin website and accessible for 90 days.
Soft tissue sarcoma, from which approximately 13,500 individuals are diagnosed annually, is expected to see a market opportunity grow to $2.6 billion by 2030. The promising results from the Annamycin trial could play a significant role in addressing this market, offering a new treatment option for a disease with limited effective therapies. Analyst price targets for MBRX range from $4 to $20, suggesting significant potential upside from current levels. For deeper insights into MBRX’s financial health and growth prospects, including 12 additional ProTips and comprehensive valuation metrics, visit InvestingPro.
The information in this article is based on a press release statement from Moleculin Biotech, Inc.
In other recent news, Moleculin Biotech Inc. highlighted several developments in its Q1 2025 earnings call. The company did not disclose specific earnings per share or revenue figures but shared updates on its cash position and strategic initiatives. Moleculin reported ending the first quarter with $8 million in cash, which is expected to fund operations into Q3 2025. The company is advancing its flagship drug, Anamycin, with the initiation of the Phase 3 MIRACLE trial and the expansion of clinical trial sites to 38 locations globally. Moleculin also received European Medicines Agency approval for Anamycin in nine EU countries, marking significant progress in its regulatory efforts.
Additionally, Moleculin Biotech received a non-compliance notice from the Nasdaq Stock Market for not meeting the minimum stockholders’ equity requirement for continued listing. The company has 45 days to submit a plan to regain compliance, which, if accepted, could grant an extension of up to 180 days to demonstrate compliance. On the analyst front, Roth Capital and Maxim Group analysts engaged with Moleculin’s management during the earnings call, discussing the company’s ongoing trials and future expectations. Moleculin’s strategic focus remains on developing non-cardiotoxic cancer treatments, with its innovative drug Anamycin positioned as a potential breakthrough in oncology.
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