Moleculin reports progress in Annamycin AML trial

HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a clinical-stage pharmaceutical company, has announced the completion of its End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding its clinical trial for Annamycin, a drug candidate for the treatment of acute myeloid leukemia (AML).

The EOP2 meeting is a significant regulatory milestone, where the company discussed safety and efficacy results from its MB-106 clinical trial. This trial investigates Annamycin in combination with Cytarabine, also known as Ara-C, in treating AML patients. The meeting's outcomes are expected to be reported by the end of Q3 2024, as per the company's statement today.

In the latest clinical update, as of June 14, 2024, 22 subjects were enrolled in the trial, with 20 having completed efficacy evaluations. Notably, 45% of these subjects achieved a composite complete remission (CRc), which includes complete remission (CR) and complete remission with incomplete recovery of peripheral blood counts (CRi).

For subjects treated with AnnAraC as second-line therapy, the CR rate was 50%, and the CRc rate was 60%. The median duration of remission (mDOR) for subjects achieving CRc is approximately 7 months and may continue to increase.

Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, and similar designations for the treatment of soft tissue sarcoma. The European Medicines Agency (EMA) has also granted Orphan Drug Designation for Annamycin in AML treatment.

Moleculin's portfolio includes other drug candidates like WP1066, an immune/transcription modulator, and WP1122, an antimetabolite for potential treatment of viruses and certain cancers.

In other recent news, Moleculin Biotech, Inc. has reported significant advancements in the development of its drug Annamycin. Preliminary results from the ongoing clinical trial for Annamycin indicate a composite complete remission rate of 45% in subjects with acute myeloid leukemia (AML).

The drug, currently in Phase 1B/2 trial, has shown promising results, with nine out of 20 subjects achieving complete remission.

In a recent earnings call, Moleculin highlighted the progress of Annamycin, revealing a 60% complete remission rate in second-line AML patients. The company has secured a patent for Annamycin, ensuring market exclusivity until at least 2040.

Moleculin is preparing for a pivotal trial expected to commence by the end of 2024 or early 2025. The company is also planning an End of Phase 2 meeting with the FDA.

InvestingPro Insights

In light of Moleculin Biotech's recent developments with its Annamycin drug candidate, investors and stakeholders may be keen on understanding the company's financial health and market performance. According to InvestingPro data, Moleculin Biotech holds a market capitalization of $7.52 million, which reflects the market's valuation of the company as of the first quarter of 2024. This is particularly relevant as the company navigates through critical phases of drug development and regulatory milestones.

Annamycin's progress is indeed a pivotal aspect of Moleculin's operations, but InvestingPro Tips suggest that the company's financial metrics warrant attention. Moleculin Biotech's price/book ratio, as of the last twelve months ending Q1 2024, stands at 0.35, potentially indicating that the stock is undervalued relative to its assets. Moreover, the company's stock price has taken a significant hit, with a one-week total price return of -10.41% and a one-month return of -24.55%, reflecting recent market sentiments.

InvestingPro Tips also highlight that Moleculin Biotech holds more cash than debt on its balance sheet and that the stock is currently in oversold territory according to the Relative Strength Index (RSI). This could be of interest to investors looking for potential entry points, especially considering the stock is trading near its 52-week low. For those interested in deeper analysis, there are additional tips available on InvestingPro, and users can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.

While Moleculin Biotech navigates its clinical trials and seeks regulatory approvals, investors can stay informed about the company's financial health and stock performance by accessing a total of 16 InvestingPro Tips, which provide a broader perspective on the potential risks and opportunities associated with MBRX shares.

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