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Moleculin Biotech, Inc. reports developments as a clinical-stage pharmaceutical company advancing drug candidates for hard-to-treat tumors and viruses. Its lead program is Annamycin, also known as naxtarubicin, a next-generation anthracycline designed to avoid cardiotoxicity and multidrug resistance, with development focused on relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases.
Recurring news covers Annamycin clinical and preclinical data, the MIRACLE study of Annamycin in combination with cytarabine, oncology conference presentations, intellectual-property protection for liposomal Annamycin, and corporate financial updates. Additional pipeline coverage includes WP1066, an immune/transcription modulator targeting p-STAT3 and other oncogenic transcription factors, and WP1122, an antimetabolite program for pathogenic viruses and cancer indications.
Moleculin (Nasdaq: MBRX) entered a research and material transfer agreement dated December 8, 2025 with CIC biomaGUNE to support investigator-initiated preclinical studies of Annamycin in glioblastoma multiforme (GBM).
The collaboration will evaluate intra-arterial delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin versus Doxil and Free-doxorubicin in mouse GBM models. Moleculin will supply Annamycin and CIC biomaGUNE will conduct the planned studies under Principal Investigator Jesús Ruiz-Cabello.
Annamycin holds FDA Fast Track status and multiple Orphan Drug designations (FDA and EMA) and has shown prior clinical activity in AML and soft tissue sarcomas per the announcement.
Moleculin (NASDAQ: MBRX) announced that Walter Klemp, Chairman and CEO, will participate in the Virtual Investor Closing Bell Series on Tuesday, December 2, 2025 at 4:00 PM ET.
Mr. Klemp will provide a corporate overview and business outlook, followed by a live Q&A. A live video webcast will be available on the Events page under Investors at moleculin.com. A replay will be posted two hours after the live event and remain accessible for 90 days.
Moleculin (Nasdaq: MBRX) filed an amendment to its certificate of incorporation to effect a 1-for-25 reverse stock split of its common stock, effective 12:01 am ET on December 1, 2025. The company said shares will open for trading on Nasdaq on December 1, 2025 on a post-split basis under the existing ticker MBRX but with a new CUSIP 60855D 408. Every 25 pre-split shares will be consolidated into one share, with no change to the $0.001 par value. Fractional shares will not be issued; holders entitled to fractions will receive a cash payment in lieu. Outstanding shares are expected to fall from approximately 51.7 million to approximately 2.1 million, while authorized shares remain 500 million.
Moleculin (Nasdaq: MBRX) reported that 60% of the target subjects for the first planned interim unblinding of its pivotal Phase 2B/3 MIRACLE trial have consented, toward a 45-subject early-unblinding target. The company expects to complete treatment of the first 45 subjects in Q1 2026 with initial unblinded efficacy and safety data thereafter, and a second unblinding expected in H1 2026.
The MIRACLE design combines Part A (2B) and Part B (3) for primary efficacy assessment; the first unblinding will include 30 subjects receiving Annamycin plus HiDAC and 15 subjects receiving HiDAC plus placebo. Annamycin holds FDA Fast Track status, Orphan Drug designations (FDA and EMA), and composition-of-matter patent protection through 2040 with potential extension to 2045.
Moleculin (Nasdaq: MBRX) announced a grant-funded research and material transfer agreement with the University of North Carolina at Chapel Hill dated Nov 12, 2025 to support investigator-initiated preclinical studies evaluating Annamycin for pancreatic cancer.
Moleculin will supply Annamycin while UNC investigators will test liposomal and free formulations versus Doxil and free doxorubicin in PDAC GEMM models to assess tumor delivery when combined with novel agents and modalities. The company noted Annamycin's regulatory designations and its ongoing pivotal Phase 2B/3 MIRACLE trial (NCT06788756) in relapsed/refractory AML.
Moleculin (Nasdaq: MBRX) will present at the 14th Annual Acute Leukemia Meeting in Madrid on October 30-31, 2025. Dr. Paul Waymack, senior chief medical officer, will speak on Thursday, October 30 at 2:35 PM CEST about L-Annamycin (naxtarubicin) and the ongoing pivotal Phase 2B/3 “MIRACLE” trial.
The MIRACLE study is a multi-center, randomized, double-blind, placebo-controlled, adaptive design trial evaluating Annamycin combined with cytarabine (AnnAraC) in adult patients with relapsed or refractory acute myeloid leukemia (R/R AML). It is a global approval trial with sites in the US, Europe and the Middle East (clinicaltrials.gov NCT06788756; euclinicaltrials.eu 2024-518359-47-00). Annamycin currently holds FDA Fast Track status and Orphan Drug designations from FDA and EMA for R/R AML.
Moleculin (Nasdaq: MBRX) announced that IP Australia granted Patent No. 2024203598 titled "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE", covering preliposomal Annamycin lyophilizates with improved stability and high purity.
The patent has a base term currently extending until June 2040, subject to extension to account for regulatory approval time, and expands the company's global IP portfolio alongside an expected Canadian patent and previously issued U.S. and allowed European patents. Annamycin (naxtarubicin) has FDA Fast Track Status and Orphan Drug Designation for relapsed/refractory AML and Orphan Drug Designation for STS lung mets; EMA orphan status for relapsed/refractory AML is also noted.
Moleculin (NASDAQ:MBRX) is collaborating with Atlantic Health on an investigator-initiated Phase 1B/2 single-arm study testing Annamycin for third-line (3L) advanced pancreatic cancer, announced Oct 23, 2025. Moleculin will supply drug material and maintain the IND; Atlantic Health will conduct and fund the study. Moleculin estimates incremental trial costs of approximately $1 million from 2026 into 2030 for drug supply and outside lab testing. Preclinical data show pancreatic uptake, activity vs pancreatic tumors and liver metastases, and topoisomerase II as a validated target. Annamycin has FDA Fast Track and multiple Orphan Drug designations.
Moleculin Biotech (Nasdaq: MBRX) has received a notice of allowance from the Canadian Intellectual Property Office for a patent covering their novel drug candidate Annamycin. The patent, extending until June 2040, will protect methods of making preliposomal Annamycin lyophilizate with improved stability and high purity.
Annamycin is positioned to become the first non-cardiotoxic anthracycline for approval, targeting acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases. The drug has received Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications.
Moleculin Biotech (Nasdaq: MBRX) reported significant progress in its Phase 3 "MIRACLE" clinical trial for Annamycin in combination with cytarabine (AnnAraC) for treating acute myeloid leukemia (AML). The company has recruited 13 subjects (10 already dosed) and expects to reach 20 subjects by September 2025.
The trial is expanding globally across multiple European countries and the US, with plans to increase from 12 to 20 active sites in September, and over 30 sites by year-end. The company aims to recruit the 45th subject in Q4 2025 for initial data unblinding, with Part A completion expected in H1 2026.
The MIRACLE study employs an adaptive design with 75-90 subjects in Part A and approximately 220 additional subjects in Part B. Annamycin currently holds Fast Track Status and Orphan Drug Designation from both FDA and EMA.