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Moleculin CEO, Walter Klemp, Highlights Positive Preliminary MIRACLE Trial Results in Virtual Investor "What This Means" Segment

Key Takeaway: Moleculin Biotech's CEO Walter Klemp discussed the promising preliminary results from the first 45 patients in the Phase 2/3 MIRACLE trial for Annamycin, aimed at treating relapsed or refractory acute myeloid leukemia. The early data suggests potential efficacy and commercial opportunities, although the results are based on a limited sample size and have not yet reached statistical significance. The company is optimistic about the drug's future, pending further trials and necessary financing.
Price reaction · baseline $2.64 (2026-07-02 close) · hit pre-market · clean, no other MBRX news in the window
day 0 close
-9.1%
day 1 · peak
-12.1%
day 3
-7.6%

Market Sentiment Analysis

POSITIVE FACTORS

  • Positive preliminary efficacy results from the MIRACLE trial.
  • Potential commercial opportunity for Annamycin in treating R/R AML.
  • Early efficacy trends observed across treatment arms.

CONCERNS & RISKS

  • Interim results are based on a small sample size (n=45).
  • Results have not achieved statistical significance.
  • Company requires significant additional financing for clinical trials.

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 segmenthere
HOUSTON, July 06, 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 aVirtual Investor “What This Means” segment.
For the segment, Chairman and CEO Wally Klemp discusses the positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML). During the conversation, Mr. Klemp provides his perspective on the significance of the early efficacy trends observed across both Annamycin treatment arms, summarizes the key data, and discusses the commercial opportunity, including insights from the Company's recent market research assessing the potential addressable market for Annamycin if approved.
The segment is now available for on-demand viewinghere.

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 (MoleculinR/R AMLAnnAraCClinicalEvaluation) 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 visitwww.moleculin.comand connect onX,LinkedInandFacebook.

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, LLCJenene Thomas(908) 824-0775MBRX@jtcir.com

Frequently Asked Questions

What are the preliminary results of the MIRACLE trial?

The preliminary results indicate positive efficacy trends from the first 45 patients.

What is Annamycin used to treat?

Annamycin is being developed for relapsed or refractory acute myeloid leukemia.

What challenges does Moleculin face for the trial?

Moleculin requires significant additional financing to conduct its clinical trials.

What is the sample size of the MIRACLE trial's preliminary results?

The preliminary results are based on a small sample size of 45 patients.

What is the significance of the MIRACLE trial?

It evaluates Annamycin's efficacy and commercial potential in treating R/R AML.

Last updated: Jul 6, 2026