Moleculin Biotech (MBRX) Company Report

Moleculin Biotech, Inc. (MBRX) announced a 1-for-25 reverse stock split of its common stock.
The reverse stock split will become effective at 12:01 a.m. Eastern Time on December 1, 2025, with post-split trading commencing the same day under a new CUSIP number 60855D 408.
As a result, the number of outstanding common shares will be reduced from approximately 51.6 million to approximately 2.07 million, while the authorized shares will remain at 500 million.
No fractional shares will be issued; instead, stockholders will receive a cash payment.

Nov 28, 2025, 6:16 PM

Moleculin Biotech Updates on MIRACLE AML Trial Enrollment

MBRX

New Projects/Investments

Guidance Update

Moleculin Biotech (MBRX) announced that 60% of the target 45 subjects for the first interim unblinding of its pivotal Phase 2B/3 "MIRACLE" study have consented for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML).
The company expects to complete treatment for these 45 subjects in Q1 2026, with initial unblinded data to be released thereafter.
The MIRACLE study is evaluating Annamycin in combination with cytarabine, and Annamycin holds Fast Track Status and Orphan Drug Designation from the FDA and Orphan Drug Designation from the EMA for R/R AML.
Walter Klemp, Chairman and CEO, noted strong recruitment momentum and that blinded response activity is tracking within the expected range.

Nov 13, 2025, 1:36 PM

Moleculin Biotech, Inc. Announces Grant-Funded Research for Annamycin in Pancreatic Cancer

MBRX

New Projects/Investments

On November 12, 2025, Moleculin Biotech, Inc. (MBRX) announced a research and material transfer agreement with the University of North Carolina at Chapel Hill (UNC).
This agreement initiates preclinical research to evaluate Annamycin for the treatment of pancreatic cancer, with UNC conducting the studies as part of funded grants.
The company views this as a critical strategic opportunity to expand Annamycin's potential clinical applications into an indication with significant unmet need and market potential.
Annamycin currently holds Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, and Orphan Drug Designation for STS lung mets.

Nov 12, 2025, 2:02 PM

Moleculin Biotech secures new Australian patent for Annamycin

MBRX

New Projects/Investments

Product Launch

Moleculin Biotech, Inc. announced that the Australian Patent Office (IP Australia) has granted Patent No. 2024203598 titled, "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE".
This patent covers preliposomal Annamycin lyophilizates with improved stability and high purity, with a base patent term extending until June 2040, subject to extension for regulatory approval time.
The new patent further expands the Company's global intellectual property portfolio for Annamycin, a novel drug candidate for hard-to-treat cancers such as acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases.
Annamycin has Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, and Orphan Drug Designation for STS lung mets.

Oct 29, 2025, 12:35 PM

Moleculin Biotech Announces Australian Patent Grant for Annamycin

MBRX

New Projects/Investments

Legal Proceedings

Moleculin Biotech, Inc. (Nasdaq: MBRX) has been granted Australian Patent No. 2024203598 for "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE".
This patent, which extends until June 2040, covers preliposomal Annamycin lyophilizates with improved stability and high purity, strengthening the company's global intellectual property portfolio.
Annamycin is a novel drug candidate positioned as a non-cardiotoxic anthracycline for treating acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases.
The drug candidate has Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, and Orphan Drug Designation for STS lung mets from the FDA and for relapsed or refractory AML from the EMA.
Moleculin is currently developing Annamycin in the MIRACLE Trial (MB-108), a pivotal Phase 3 study for relapsed or refractory AML.

Oct 29, 2025, 12:35 PM

Moleculin Biotech Announces Positive AML Clinical Trial Results and Share Authorization Increase

MBRX

New Projects/Investments

Proxy Vote Outcomes

Moleculin Biotech, Inc. announced the completion of its Phase 1B/2 (MB-106) clinical trial for Annamycin in acute myeloid leukemia (AML), reporting a median overall survival of 15 months for complete remissions and 12 months for the 2nd line efficacy evaluable population, which significantly exceeds industry expectations of 4-6 months for relapsed AML patients.
The company highlighted no clinically significant cardiotoxicity in the MB-106 trial and that 50% of subjects achieving complete remission proceeded to a curative bone marrow transplant.
Moleculin is progressing its pivotal Phase 3 MIRACLE trial for Annamycin in relapsed or refractory AML, aiming to recruit the first 45 enrolled patients before the end of 2025 for safety and efficacy unblinding.
Stockholders approved an increase in the authorized common stock from 100,000,000 shares to 500,000,000 shares, which became effective on August 21, 2025.