Moleculin Biotech, Inc.

Moleculin Biotech announced positive results from an independent market landscape assessment for its lead drug, Annamycin, in relapsed/refractory acute myeloid leukemia (R/R AML). The assessment revealed strong physician interest, with oncologists reporting a high likelihood to prescribe (6 out of 7) due to Annamycin's complete remission rates, transplant-bridging potential, biomarker-agnostic use, and reduced cardiotoxicity. Payers also showed strong support, recognizing Annamycin's potential to address a significant unmet need in the R/R AML treatment landscape.

Moleculin Biotech announced positive results from an independent market landscape assessment for Annamycin in relapsed/refractory acute myeloid leukemia (R/R AML). Oncologists reported a high likelihood-to-prescribe score of 6 out of 7, citing deep remissions, potential to bridge to transplant, biomarker-agnostic use, and reduced cardiotoxicity. Payers also showed strong support, viewing Annamycin as a meaningful value proposition due to its efficacy, safety, and broad applicability.

Moleculin Biotech, Inc. announced that the 45th subject has been enrolled in its pivotal Phase 2B/3 MIRACLE trial, evaluating Annamycin in combination with cytarabine (AnnAraC) for relapsed or refractory acute myeloid leukemia (R/R AML). This milestone triggers the final phase of preparation for the trial's interim 45-subject data unblinding, which is expected in mid-2026. The company views this as a potentially defining inflection point for Annamycin's development, believing the pathway towards potential approval for AML is substantially de-risked.

Moleculin Biotech, Inc. announced new data at the 2026 ASCO Annual Meeting, demonstrating that its lead drug candidate, Annamycin, exhibited no detectable cardiotoxicity. This was observed across five clinical trials, even at cumulative exposure levels significantly exceeding conventional anthracycline limits. The findings, independently reviewed by Cleveland Clinic, reinforce Annamycin's differentiated cardiac safety profile. The company also highlighted previously reported efficacy data from its Phase 1b/2 AML study, including a 50% complete remission rate, and confirmed that unblinding for the pivotal Phase 2b/3 MIRACLE trial is on track for June 2026.

Moleculin Biotech announced new data at ASCO 2026, reinforcing the differentiated cardiac safety profile of its lead drug candidate, Annamycin. A pooled analysis across five clinical trials demonstrated no detectable cardiotoxicity, even at cumulative exposure levels substantially exceeding traditional anthracycline dose limitations. This data was independently reviewed by Cleveland Clinic cardiology specialists, providing external validation. The company believes this strengthens the rationale for its ongoing pivotal Phase 2b/3 MIRACLE trial for relapsed or refractory AML, with unblinding from the first 45 patients expected in June 2026.

Moleculin Biotech, Inc. announced the release of its updated corporate presentation. The presentation, dated May 2026, is now available on the company's website and has been furnished to the SEC as Exhibit 99.1 to a Form 8-K. This filing serves to make the presentation publicly accessible under Regulation FD.

Moleculin Biotech reported its first quarter 2026 financial results and provided a clinical update on its pivotal MIRACLE trial for relapsed/refractory AML. The company announced encouraging early blinded results from the MIRACLE trial, showing a 40% composite complete remission rate at both the 30 and 45 subject marks, with the first interim unblinding expected in June 2026. Financially, Moleculin reported a net loss of $(12.8) million for the quarter and secured approximately $8.3 million in gross proceeds from financing transactions, extending its cash runway into Q3 2026.

Moleculin Biotech reported encouraging early blinded results from its pivotal MIRACLE Phase 2B/3 trial for Annamycin in relapsed/refractory AML, showing a 40% composite complete remission rate. The first interim unblinding of data for 45 subjects is expected in June 2026, with enrollment continuing towards 90 subjects in Q3 2026. For Q1 2026, the company reported a net loss of $12.8 million, R&D expenses of $5.4 million, and cash and equivalents of $10.3 million, stating current resources will support operations into Q3 2026.

Moleculin Biotech reported a net loss of $(12.8) million for Q1 2026, significantly wider than the $(5.9) million loss in Q1 2025. The company's cash on hand of $10.3 million is deemed insufficient to fund operations for at least one year, raising substantial doubt about its ability to continue as a going concern. During the quarter, the company generated $8.3 million gross proceeds from warrant inducement agreements and also implemented a 1-for-25 reverse stock split in December 2025.

Moleculin Biotech announced it is nearing the first unblinding of data from its pivotal Phase 2B/3 MIRACLE trial for Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML), expected before June 30, 2026. Preliminary blinded data for the first 45 subjects show a composite complete remission rate (CRc) exceeding 40% and a complete remission (CR) rate of approximately 30%. These results significantly outperform historical CR rates of 17-18% for cytarabine alone, suggesting a substantial advancement in AML treatment. The company continues to recruit for Part A, with 56 subjects enrolled towards a target of 90 in Q3 2026.