Houston-based Moleculin Biotech, Inc. (Nasdaq: MBRX) announced the pricing of a USD 9.3 million best-efforts public offering on July 31, 2026, with proceeds directed toward continued clinical development of Annamycin (naxtarubicin), its lead anthracycline candidate, at a pivotal stage in the MIRACLE trial for relapsed or refractory acute myeloid leukemia (R/R AML).
The offering comprises shares of common stock or pre-funded warrants with a five-year term that if fully exercised would generate up to approximately USD 27.8 million in additional gross proceeds. Roth Capital Partners acted as exclusive placement agent. The offering was expected to close on August 3, 2026.
Moleculin stated it intends to use net proceeds to advance Annamycin through clinical development and for working capital. The offering represents the company's latest in a series of financings over the past two years, which have included registered direct offerings, warrant exercises, and an at-the-market facility, all consistently arranged through Roth Capital Partners.
Annamycin is a liposomal anthracycline designed to circumvent multidrug resistance mechanisms and avoid the cardiotoxicity associated with conventional anthracyclines such as daunorubicin. It is currently being evaluated in the MIRACLE trial (MB-108), a pivotal, adaptive-design Phase II/III study assessing Annamycin in combination with cytarabine (AnnAraC) versus high-dose cytarabine alone in adult patients with R/R AML. As of July 2026, 74 of the 90 patients required for Part A of the trial had been enrolled, with final Part A treatment completion targeted for September 2026 and comprehensive unblinded Part A results expected between December 2026 and February 2027.
The capital raise follows a first unblinded interim analysis reported on June 30, 2026, in which both Annamycin dose arms outperformed the control arm on the primary endpoint of complete remission (CR) on a full intent-to-treat basis across the first 45 patients: the 190 mg/m² arm reported a 43% CR rate, the 230 mg/m² arm reported 36%, and the high-dose cytarabine control arm reported 12%. A July 31, 2026 update also reported a 37% composite complete remission rate in venetoclax-failed patients, a difficult-to-treat subgroup with limited salvage options. Moleculin said the company and the FDA and the European Medicines Agency (EMA) have engaged on the development pathway following the completed Phase Ib/II study (MB-106), which the company said substantially de-risks the regulatory path toward a potential approval.
Beyond AML, Annamycin is also in development for soft tissue sarcoma lung metastases. Moleculin's broader pipeline includes WP1066, a p-STAT3 and oncogenic transcription factor inhibitor that crosses the blood-brain barrier, currently in a Phase II investigator-initiated trial at Northwestern University for newly diagnosed adult glioblastoma, and a completed Phase I pediatric brain tumor study at Emory University that the company said warranted advancement to Phase II. WP1122, an antimetabolite prodrug of 2-deoxy-D-glucose targeting glioblastoma and pathogenic viruses, holds FDA Fast Track Designation for glioblastoma and has cleared an investigational new drug application, though no sponsored Phase I trial has been initiated as of mid-2026, with Moleculin evaluating collaboration opportunities for its development.
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