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HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a clinical-stage biotech company currently trading at $0.38 per share, has enrolled its first two patients in the European Union for its pivotal Phase 2B/3 trial of Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (AML), the company announced Monday. According to InvestingPro analysis, the stock appears undervalued despite falling 84% over the past year.
The trial, known as MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation), has active recruitment sites in the United States, Spain, Ukraine, Georgia, and Romania, with additional sites expected to open by the end of September. InvestingPro data shows the company maintains a healthy balance sheet with more cash than debt, though it’s currently burning through cash reserves rapidly.
One of the two enrolled patients at the Spanish site has already received treatment. The company aims to recruit 45 subjects for the initial part of the trial by the end of 2025, allowing for preliminary data unblinding.
"For our first site in Spain to have opened up with two subjects enrolled indicates the unmet need in treating second line R/R AML," said Walter Klemp, Chairman and CEO of Moleculin.
The MIRACLE study employs an adaptive design with patients randomized to receive high-dose cytarabine combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin. The protocol allows for unblinding of preliminary efficacy and safety data at 45 subjects and again at the conclusion of Part A (75-90 subjects).
The company expects to reach the first unblinding milestone in the second half of 2025, with the second unblinding anticipated in the first half of 2026.
Annamycin, also known as naxtarubicin, has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML, as well as Orphan Drug Designation from both the FDA and European Medicines Agency for various indications.
According to the press release statement, the trial is registered on clinicaltrials.gov under identifier NCT06788756 and on euclinicaltrials.eu under reference 2024-518359-47-00. With a market capitalization of just $13.78 million and analyst price targets ranging from $4 to $12, investors seeking deeper insights can access comprehensive financial analysis and 14 additional ProTips through InvestingPro’s detailed research report.
In other recent news, Moleculin Biotech, Inc. has announced several key developments. The company received a Notice of Intent to Grant for a European patent covering its cancer drug candidate Annamycin, which will extend patent protection until 2040, subject to regulatory approvals. Additionally, Moleculin has entered a $6.5 million At The Market equity offering agreement with Roth Capital Partners, allowing for the sale of shares from time to time. The company has also priced a public offering expected to raise approximately $5.9 million, involving shares of common stock and Series E warrants.
Further, Moleculin received approval from Georgia’s Regulation Agency for Medical and Pharmaceutical Activities for its Phase 2B/3 MIRACLE trial, which tests Annamycin in combination with cytarabine for acute myeloid leukemia. This approval follows authorization from the European Medicines Agency, broadening the trial’s reach. In a strategic move, Moleculin appointed Adriano Treve, a former Roche executive, as a Strategic Advisor for partnerships. These developments reflect Moleculin’s ongoing efforts to advance its drug pipeline and expand its market presence.
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