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

Key Takeaway: Moleculin Biotech's CEO, Walter Klemp, announced the enrollment of the 45th subject in the pivotal Phase 2B/3 MIRACLE trial for Annamycin combined with cytarabine, targeting relapsed or refractory acute myeloid leukemia. This milestone signals the upcoming interim data unblinding, expected in mid-2026, which could be crucial for the company's future. The company also highlighted the need for additional financing to continue its clinical trials.
Price reaction · baseline $2.46 (2026-06-03 close) · hit pre-market · 1 other MBRX headline(s) in the window, move may be shared
day 0 close · peak
+2%

Market Sentiment Analysis

POSITIVE FACTORS

  • Moleculin achieved a significant milestone with 45 subjects enrolled.
  • The interim data unblinding is on track for mid-2026.
  • The trial represents a potential inflection point for the company.

CONCERNS & RISKS

  • The company requires significant additional financing for clinical trials.
  • There are inherent risks and uncertainties in the forward-looking statements.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+44%
120-day peak, hindsight
Typical move
10.3%
average across 4 past catalysts
Cash runway
~2 mo
High dilution risk
Lead asset
WP1066
Phase 2 · Glioblastoma, IDH-Wildtype

Full Press Release Details

– 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 ( M olecul i n R /R AML A nnAraC Cl inical E valuation) 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.

Frequently Asked Questions

What is the MIRACLE trial?

The MIRACLE trial is a pivotal Phase 2B/3 study evaluating Annamycin combined with cytarabine for treating relapsed or refractory acute myeloid leukemia.

What milestone did Moleculin achieve recently?

Moleculin announced the enrollment of its 45th subject in the MIRACLE trial.

When is the interim data unblinding expected?

The interim data unblinding is expected to occur in mid-2026.

What is Annamycin used for?

Annamycin is being developed for the treatment of relapsed or refractory acute myeloid leukemia and soft tissue sarcoma.

What financial challenges does Moleculin face?

Moleculin requires significant additional financing to conduct its clinical trials.

Last updated: Jun 4, 2026