Moleculin Announces Acceptance of Annamycin Data for Presentation at the 2026 American Society of Hematology (ASH) Annual Meeting

Complete remission rates in the two Annamycin arms were 43% and 36%, compared with 12% in the placebo arm.

Rhea-AI Summary

Moleculin Biotech (Nasdaq: MBRX) announced acceptance of interim Annamycin trial data for presentation at the ASH Annual Meeting, December 12–15, 2026.

The pivotal MB-108 Phase 2/3 trial evaluates Annamycin with cytarabine in patients with relapsed or refractory acute myeloid leukemia, a blood cancer. Among the first 45 randomized patients evaluated, complete remission rates were 43% and 36% in the two Annamycin arms, versus 12% with placebo. No signs, symptoms or echocardiographic findings suggestive of heart toxicity were observed through the data cutoff. The independent Data Monitoring Committee recommended continuing without amendment, retaining all three arms. Moleculin expects the second interim analysis in early 2027, when cardiac safety data will undergo independent review.

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointComplete remission rates were 43% and 36% in Annamycin arms versus 12% with placebo among 45 randomized patients evaluated.
• Minor pointNo findings suggestive of heart toxicity were observed through the data cutoff.
• Minor pointIndependent Data Monitoring Committee recommended continuation without amendment, maintaining all three treatment arms.
• Minor point. Forward-looking: it has not happened yet and may not happen.Second interim analysis is expected in early 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Successful MB-108 results could support a New Drug Application submission under the company's FDA agreement.

Negative

• Minor pointAll cardiac safety data await independent expert and Data Monitoring Committee review at the second interim analysis.

Key Figures

Patients evaluated: 45 patients Complete remission rate: 43% Complete remission rate: 36% +2 more

Patients evaluated

45 patients

First randomized patients evaluated in the interim analysis

Complete remission rate

43%

Annamycin treatment arm

Complete remission rate

36%

Second Annamycin treatment arm

Complete remission rate

12%

Placebo arm

Second interim analysis

Early 2027

Expected timing

Historical Context

1 past event · Latest: Oct 30

1 event

1. Oct 30

   Trial dosing completion

   24h Move

   -9.4%

   Completed Part A dosing in the same MIRACLE trial ahead of a comprehensive data readout.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

echocardiographic, cardiotoxicity, placebo-controlled, relapsed or refractory

4 terms

echocardiographic medical

"no signs, symptoms or echocardiographic findings suggestive of cardiotoxicity"

Relating to echocardiography, which is a medical test that uses ultrasound (sound waves) to create moving pictures of the heart’s structure and function. Echocardiographic measurements show how well the heart pumps, the motion of its valves and walls, and any fluid or abnormal masses; investors see the term in clinical or regulatory reports because these objective imaging results can affect a drug or device’s safety and effectiveness profile.

cardiotoxicity medical

"findings suggestive of cardiotoxicity were observed through the data cutoff"

Cardiotoxicity is damage to the heart caused by a drug, chemical or medical treatment that can weaken heart function, disrupt heartbeat or cause inflammation. It matters to investors because evidence of cardiotoxicity can halt or delay product approvals, trigger costly additional testing, recalls or legal risk, and reduce future revenue potential—similar to how rust in an engine can undermine a machine’s reliability and resale value.

placebo-controlled medical

"randomized, double-blind, placebo-controlled Phase 2/3 trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

relapsed or refractory medical

"in patients with relapsed or refractory (R/R) acute myeloid leukemia"

"Relapsed or refractory" describes a situation where a disease, such as an illness or condition, returns after treatment or does not respond to initial treatment efforts. For investors, this indicates ongoing challenges or setbacks in managing the disease, which can affect the success of related treatments or therapies and impact the potential value of associated companies or products. Understanding this helps gauge the stability and future prospects of medical developments or healthcare investments.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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First interim results from pivotal Phase 2/3 trial highlight encouraging remission rates in patients with relapsed or refractory AML

HOUSTON, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. (Nasdaq: MBRX) (“Moleculin” or the “Company”) today announced that an abstract highlighting data from its lead drug candidate, Annamycin, has been accepted for presentation at the 2026 American Society of Hematology (ASH) Annual Meeting, taking place December 12-15, 2026 in New Orleans, Louisiana.

The abstract, titled “A Pivotal Phase 2/3 Study of Naxtarubicin as Second Line Therapy in Patients with AML,” presents results from the first prespecified interim analysis of the Company's pivotal MB-108 Phase 2/3 trial evaluating Annamycin in combination with cytarabine (Ara-C) in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).

Among the first 45 randomized patients evaluated, complete remission rates were 43% and 36% in the two Annamycin treatment arms, respectively, compared to 12% in the placebo arm. Consistent with findings across Annamycin's clinical development program to date, no signs, symptoms or echocardiographic findings suggestive of cardiotoxicity were observed through the data cutoff. All cardiac safety data will undergo independent expert and independent Data Monitoring Committee review at the second interim analysis. Following its review, the independent Data Monitoring Committee recommended that the study continue without amendment, with all three treatment arms maintained.

“We are encouraged by these initial findings from our pivotal Phase 2/3 trial, particularly the remission rates observed in the Annamycin treatment arms. The independent Data Monitoring Committee's recommendation to continue the study without modification represents an important milestone for the program. We look forward to sharing these findings with the broader hematology community at ASH as we continue advancing Annamycin's development for patients facing this challenging disease,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

The MIRACLE Trial (MB-108) is designed to confirm the efficacy and safety findings observed in the Company's completed MB-106 Phase 1/2 trial and, if successful, could support a New Drug Application submission, consistent with the Company's agreement with the U.S. Food and Drug Administration. As previously announced, the second interim analysis is expected in early 2027.

Presentation Details

• Meeting: 68th American Society of Hematology (ASH) Annual Meeting
• Abstract Title: A pivotal Phase 2/3 study of naxtarubicin as second line therapy in patients with AML
• Presentation Type: Poster
• Presenting Author: Oksana Karnabeda, MD, PhD, Arensia Exploratory Medicine, LLC
• Location: Ernest N. Morial Convention Center – Hall F (Poster Hall), 900 Convention Center Blvd, New Orleans, LA 70130
  

The abstract will be available through the ASH Annual Meeting website.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), has shown to be an efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company is conducting the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design, multi-center, randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating Annamycin in combination with cytarabine (also referred to as “Ara-C”), together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway toward a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential efficacy and safety of Annamycin, the timing and results of the second interim analysis of the MB-108 trial, the potential for the MB-108 trial to support a New Drug Application submission, and the Company’s ability to secure additional financing to conduct its clinical trials. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the completion of the clinical trials described in this press release assumes the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Moleculin's first interim Annamycin analysis show?

Among the first 45 randomized patients evaluated, complete remission rates were 43% and 36% in the two Annamycin treatment arms, compared with 12% in the placebo arm. The pivotal Phase 2/3 MB-108 trial evaluates Annamycin combined with cytarabine in relapsed or refractory acute myeloid leukemia.

Could Moleculin's MB-108 trial support an Annamycin approval application?

A successful MB-108 trial could support a New Drug Application submission, consistent with Moleculin's agreement with the U.S. Food and Drug Administration. The trial is designed to confirm the efficacy and safety findings from the completed MB-106 Phase 1/2 trial.