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Moleculin Biotech (MBRX)

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Earnings summaries and quarterly performance for Moleculin Biotech.

Recent press releases and 8-K filings for MBRX.

Moleculin Biotech Reports Independent Assessment of Annamycin Cardiotoxicity
MBRX
New Projects/Investments
  • Moleculin Biotech, Inc. announced an independent assessment confirmed no cardiotoxicity of Annamycin in 90 subjects across five clinical trials for acute myeloid leukemia (AML) and soft tissue sarcoma (STS).
  • The assessment included 65 subjects treated above the FDA's lifetime maximum cumulative anthracycline exposure of 550 mg/m2, with one subject exceeding 6500 mg/m2.
  • Annamycin is a next-generation anthracycline designed to avoid multidrug resistance and lack the cardiotoxicity common with currently prescribed anthracyclines, with the potential to be the first non-cardiotoxic anthracycline.
  • The company is advancing Annamycin in a pivotal, adaptive design Phase 3 trial (MIRACLE Trial) for relapsed or refractory acute myeloid leukemia.
Jan 13, 2026, 1:55 PM
Moleculin Biotech's Annamycin Shows No Cardiotoxicity in 90 Subjects
MBRX
New Projects/Investments
  • Moleculin Biotech announced a new independent assessment confirming no evidence of cardiotoxicity for its drug Annamycin.
  • The assessment covered a total of 90 subjects across five clinical trials for acute myeloid leukemia (AML) and soft tissue sarcoma (STS).
  • Notably, 65 of the 90 subjects received Annamycin doses exceeding the FDA’s lifetime maximum for other anthracyclines, with one subject receiving over 6500 mg/m2, yet still showed no cardiotoxicity.
  • The company believes Annamycin has the potential to be the first non-cardiotoxic anthracycline, offering a significant advantage over current cardiotoxic treatments for cancer.
Jan 13, 2026, 1:55 PM
Moleculin Biotech Amends Warrants and Regains Nasdaq Equity Compliance
MBRX
Accounting Changes
Delisting/Listing Issues
Convertible Preferred Issuance
  • On December 21, 2025, Moleculin Biotech, Inc. entered into warrant amendment agreements for its Series E, F, and G warrants, reducing their exercise price to $3.90 per share.
  • These amendments also removed certain provisions for exercise price adjustments and modified the Black Scholes Value definition for Series E and F warrants.
  • The company received a Nasdaq delist determination letter on November 20, 2025, due to non-compliance with the $2.5 million minimum stockholders' equity requirement, but has appealed the decision.
  • To address the listing deficiency, Moleculin Biotech completed a warrant inducement transaction raising $6.8 million and an at-the-market offering raising $1.1 million.
  • As a result of these actions, including the reclassification of certain warrant liabilities to equity, the company's stockholders' equity increased from a $26.9 million deficit on September 30, 2025, to in excess of $10.0 million as of December 22, 2025.
Dec 22, 2025, 1:55 PM
Moleculin Biotech Announces Positive Phase 1 Clinical Trial Results for WP1066
MBRX
New Projects/Investments
  • Moleculin Biotech (MBRX) announced positive results from a Phase 1 clinical trial evaluating WP1066 for the treatment of pediatric recurrent malignant brain tumors.
  • The trial, which was the first to test WP1066 in children, found no significant toxicity and established a maximum feasible dose.
  • WP1066 demonstrated encouraging signals of activity, including a partial tumor response in a diffuse intrinsic pontine glioma (DIPG) patient and clear anti-tumor immune changes.
  • These results are expected to form the foundation for a Phase 2 trial concept.
Dec 17, 2025, 1:31 PM
Moleculin Biotech, Inc. Announces Positive Phase 1 Clinical Trial Results for WP1066
MBRX
New Projects/Investments
  • Moleculin Biotech, Inc. announced positive results from its Phase 1 clinical trial evaluating WP1066 for the treatment of pediatric recurrent malignant brain tumors on December 17, 2025.
  • The trial, conducted at the Aflac Cancer and Blood Disorders Center, found WP1066 to be safe and effective, inducing anti-tumor immune responses, and warrants a Phase 2 trial.
  • The study treated 10 children and evaluated compassionate use in three others, demonstrating no significant toxicity and the suppression of STAT3 expression.
Dec 17, 2025, 1:30 PM
Moleculin Biotech Announces Warrant Exercise and Expected Proceeds
MBRX
  • Moleculin Biotech, Inc. has entered into agreements for the immediate exercise of existing warrants, which are expected to generate approximately $6.5 million in aggregate gross proceeds.
  • The exercised warrants include 727,969 shares originally issued in February 2025 at an exercise price of $6.63 per share and 316,360 shares originally issued in August 2025 at an exercise price of $6.3219 per share.
  • In consideration for the immediate exercise, the company will issue new unregistered warrants to purchase up to 2,610,823 shares of common stock at an exercise price of $6.63 per share, exercisable upon shareholder approval.
  • The transaction is anticipated to close on or about December 11, 2025, with the net proceeds intended for working capital and general corporate purposes.
Dec 10, 2025, 1:30 PM
Moleculin Biotech Updates on MIRACLE Phase 2B/3 AML Trial Progress
MBRX
New Projects/Investments
Guidance Update
  • Moleculin Biotech, Inc. announced an increase to 78% of the target 45 subjects for the first planned interim unblinding of data having consented to its pivotal Phase 2B/3 "MIRACLE" study of Annamycin for Acute Myeloid Leukemia (AML), up from 60% in November.
  • The company expects to complete treatment of the first 45 subjects in the MIRACLE trial in the first quarter of 2026, with the first unblinding of data anticipated shortly thereafter.
  • Blinded response activity in the trial is tracking within the expected range, and the full Part A of the MIRACLE trial, involving up to 90 patients, is projected to be completed within the first half of 2026.
  • Annamycin, the drug being studied, holds Fast Track Status and Orphan Drug Designation from the FDA and EMA for the treatment of relapsed or refractory acute myeloid leukemia.
Dec 9, 2025, 1:16 PM
Moleculin Biotech, Inc. Announces 1-for-25 Reverse Stock Split
MBRX
Delisting/Listing Issues
Proxy Vote Outcomes
  • 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

Quarterly earnings call transcripts for Moleculin Biotech.