Press Releases June 4, 2026 08:31 AM

Moleculin CEO, Walter Klemp, Highlights 45 Subject Enrollment Milestone in Recent Virtual Investor “What This Means” Segment

Moleculin CEO Highlights 45-Subject Enrollment in Pivotal Phase 2B/3 Trial for AML Treatment

By Jordan Park MBRX

Moleculin Biotech's CEO, Walter Klemp, emphasized the enrollment milestone of 45 subjects in the Phase 2B/3 MIRACLE trial evaluating Annamycin combined with cytarabine for relapsed or refractory acute myeloid leukemia (R/R AML). The upcoming interim unblinding in mid-2026 may serve as a critical inflection point for the company, advancing the potential approval pathway for its lead candidate Annamycin. The company also develops other therapeutic candidates targeting tumors and viruses.

Moleculin CEO, Walter Klemp, Highlights 45 Subject Enrollment Milestone in Recent Virtual Investor “What This Means” Segment
MBRX

Key Points

  • The MIRACLE trial has enrolled its 45th subject, triggering preparation for interim data unblinding expected mid-2026.
  • Annamycin is a next-generation anthracycline designed to combat multidrug resistance and avoid cardiotoxicity, targeting R/R AML and soft tissue sarcoma lung metastases.
  • Moleculin's pipeline includes WP1066 and antimetabolites like WP1122 targeting brain tumors, pancreatic cancer, and pathogenic viruses, impacting oncology and biotech sectors.

- Access the segment here

HOUSTON, June 04, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin, participated in a Virtual Investor “What This Means” segment.

As part of the segment, Mr. Klemp discussed the Company’s recent news announcing that the 45th subject has been enrolled in its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adult subjects with relapsed or refractory acute myeloid leukemia (R/R AML). Mr. Klemp gave insight into how this milestone triggers the final phase of preparation for the trial’s interim 45 subject data unblinding, which remains on track for mid-2026 and represents a potentially defining inflection point for the Company.

The segment is now available for on-demand viewing 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 next-generation 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”) 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 expected timing and results of the 45-subject interim data unblinding in the MIRACLE trial, the anticipated clinical milestones set forth above, and the potential efficacy and safety of Annamycin and AnnAraC in R/R AML and other indications. 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

  • Trial outcomes and interim data may differ, impacting the drug’s development and regulatory approval prospects, affecting biotech investments.
  • Significant additional financing is required for ongoing trials, with no current commitments, presenting financial risk for development continuity.
  • Regulatory feedback and long-term follow-up data may alter the development pathway, introducing uncertainty about timing and eventual commercialization.

More from Press Releases

Algoma Steel Releases 2025 Sustainability Report Jun 4, 2026 SOLV Energy Announces Full Exercise and Closing of Underwriters’ Option to Purchase Additional Shares of Class A Common Stock Jun 4, 2026 NRx Pharmaceuticals, Inc. Announces Closing of $22.3 Million Public Offering of Common Stock and Including Exercise of the Underwriters’ Option Jun 4, 2026 DLH Announces Filing of New Shelf Registration Statement Jun 4, 2026 FutureCorp Space Acquisition 1 Announces Pricing of $200,000,000 Initial Public Offering Jun 4, 2026