MBRX stock touches 52-week low at $1.46 amid sharp yearly decline

Moleculin Biotech Inc (NASDAQ:MBRX) stock has reached a 52-week low, trading at $1.46, down 85% from its 52-week high of $10.35. According to InvestingPro analysis, the company maintains a favorable cash position, holding more cash than debt on its balance sheet, though it faces significant challenges marked by a substantial decrease in its stock value. Over the past year, MBRX has experienced a precipitous drop, with a 1-year change showing a decline of -79.76%. This downturn reflects investor concerns and broader market trends that have impacted the biotech sector, leading to a cautious approach towards stocks like MBRX that are perceived as higher risk amidst uncertain market conditions. InvestingPro subscribers have access to 14 additional key insights and a comprehensive Pro Research Report, offering detailed analysis of MBRX’s financial health, valuation metrics, and growth prospects.

In other recent news, Moleculin Biotech, a late-stage pharmaceutical company, has made significant strides in its clinical trials and financial position. The company has received Institutional Review Board approval for a pivotal Phase 3 trial of its drug candidate Annamycin, set to begin enrollment in the first quarter of 2025. This drug, aimed at treating relapsed or refractory acute myeloid leukemia, has been granted Fast Track Status and Orphan Drug Designation by the FDA and EMA.

Furthermore, Moleculin Biotech has announced an amendment to its Phase 3 "MIRACLE" study of Annamycin, which will expedite the unblinding of preliminary primary efficacy data and safety/tolerability for the first 45 subjects in the trial. The company ended the quarter with $9.4 million in cash, anticipated to fund operations until Q1 2025. The company also plans a rolling New Drug Application submission by late 2028.

In the ongoing Phase 3 MIRACLE trial for Annamycin, recruitment efforts are in progress at 60 sites, with 17 additional sites targeted globally. Moleculin Biotech expects crucial data readouts from this trial by mid-2026. These recent developments represent critical steps in Moleculin Biotech’s ongoing efforts to advance Annamycin through the clinical trial process.

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