Press Releases April 7, 2026

Moleculin Releases Next CEO Corner Segment Highlighting Annamycin’s Non-Cardiotoxic Profile

Moleculin highlights Annamycin's non-cardiotoxic profile in CEO Corner, advancing Phase 3 trial for AML treatment

By Leila Farooq MBRX
Moleculin Releases Next CEO Corner Segment Highlighting Annamycin’s Non-Cardiotoxic Profile
MBRX

Moleculin Biotech released a CEO Corner segment focusing on the differentiated safety profile of its lead drug candidate, Annamycin, designed to avoid cardiotoxicity common with traditional anthracyclines. The company is conducting a pivotal Phase 3 MIRACLE trial for relapsed or refractory acute myeloid leukemia (AML), positioning Annamycin as a promising oncology option. This non-cardiotoxic feature could expand treatment options and offers regulatory and commercial benefits.

Key Points

  • Annamycin is designed to avoid cardiotoxicity, a major limitation of existing anthracyclines like doxorubicin.
  • Moleculin has initiated the Phase 3 MIRACLE trial evaluating Annamycin plus cytarabine for relapsed/refractory AML.
  • The differentiated safety profile may allow use in patients with cardiac risks and broaden therapeutic application.
  • Sectors impacted include biotechnology, pharmaceuticals, oncology therapeutics, and healthcare providers offering cancer treatments.

Access the Moleculin CEO Corner here

HOUSTON, April 07, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer.

In this segment, Mr. Klemp highlights the differentiated safety profile of Annamycin, emphasizing its lack of cardiotoxicity which is a significant limitation associated with traditional anthracyclines such as doxorubicin. Annamycin was specifically designed to avoid cardiac damage, and has demonstrated this advantage across preclinical and clinical studies. This non-cardiotoxic profile could expand treatment options for patients with relapsed or refractory acute myeloid leukemia (AML) and advanced solid tumors, particularly those previously treated with anthracyclines or with existing cardiac risk factors. Mr. Klemp also notes the potential benefits for physicians in enabling more flexible treatment strategies, as well as the favorable regulatory and commercial implications of a differentiated safety profile. As the Company advances its MIRACLE Study, he underscores that Annamycin’s unique design may position it as a promising new option in oncology, with the potential to reshape the use of anthracyclines in modern cancer care.

Access the CEO Corner on the Company’s website here.

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), is a highly 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 has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) and, 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 towards 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, statements regarding the continued recruitment, treatment, and receipt of the unblinded data for the first 45 subjects of the MIRACLE clinical trial as described. 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 milestones described in this press release assume 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
[email protected]


Risks

  • Moleculin requires significant additional financing to complete clinical trials, with no commitments currently in place.
  • Future clinical data might not confirm initial safety and efficacy, particularly regarding cardiotoxicity claims.
  • Regulatory approvals depend on successful trial outcomes and feedback, introducing uncertainty to the development pathway.

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