Press Releases August 27, 2026 09:01 AM

Moleculin CEO, Walter Klemp, Participates in the Virtual Investor “Why Now” On-Demand Conference

Moleculin CEO Highlights Clinical Progress and Upcoming Key Catalyst for Annamycin in AML at Virtual Investor Conference

By Derek Hwang
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MBRX

Moleculin Biotech's CEO Walter Klemp presented promising interim results from the pivotal Phase 2/3 MIRACLE trial of Annamycin for relapsed or refractory acute myeloid leukemia (AML). The presentation emphasized the drug's differentiated clinical profile, ongoing enrollment, expanding commercial potential, and an upcoming interim analysis of 90 patients poised as a significant value catalyst toward potential drug registration. The company also highlighted its immuno-oncology pipeline and multiple indications under development.

Moleculin CEO, Walter Klemp, Participates in the Virtual Investor “Why Now” On-Demand Conference
MBRX
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Key Points

  • Interim Phase 2/3 trial results for Annamycin in AML show encouraging trends, supporting progression toward registration.
  • The MIRACLE trial continues enrollment, with a key 90-patient interim analysis expected soon, potentially impacting valuation.
  • Moleculin's pipeline includes immune/transcription modulators and antimetabolites targeting various cancers and viruses.
  • Sectors impacted include biotechnology, pharmaceuticals, oncology, and healthcare markets.

- Video webcast now available here

HOUSTON, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that it participated in the Virtual Investor “Why Now” on-demand conference.

During the presentation, Walter Klemp, Chairman and Chief Executive Officer of Moleculin, highlighted the Company's clinical progress and long-term opportunity, discussing encouraging interim results from the pivotal Phase 2/3 MIRACLE trial evaluating Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML). The presentation also emphasized Annamycin's differentiated clinical profile, continued enrollment progress, expanding commercial opportunity, and the upcoming 90-patient interim analysis as a key value-driving catalyst supporting the Company's path toward potential registration.

The video webcast is now accessible for on-demand viewing here.

JTC Team and Virtual Investor Co. are paid consultants to Moleculin Biotech, Inc. JTC Team and Virtual Investor Co. are investor relations and corporate communications firms. Any content included in this release shall not be construed as an offer to purchase securities of Moleculin Biotech, Inc. Interested parties are responsible for conducting their own due diligence and are encouraged to review the Company's website and the SEC website for the latest information and filings on the Company.

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, multi-center, randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) 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, the potential efficacy and safety of Annamycin and AnnAraC in R/R AML and the expectation that interim efficacy trends observed in a limited patient population will be confirmed in the full study population (the interim results presented are based on a small sample size (n=45), have not achieved statistical significance, and may not be predictive of results from the completed trial). 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

  • Interim results are based on a small sample size (n=45) and have not achieved statistical significance, which may not predict final outcomes.
  • Moleculin requires significant additional financing for trials, with no commitments currently secured, posing funding risk.
  • Regulatory approvals remain uncertain and dependent on future FDA and international feedback and filings, introducing developmental and commercial risk.

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