Moleculin Releases Next CEO Corner Segment Highlighting Recent Progress in Annamycin MIRACLE Trial
The full 90-patient Part A data readout is anticipated in the first quarter of 2027, with Part B expansion discussed as a next step.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Moleculin Biotech (MBRX) reported completed Part A enrollment in its Phase 2/3 MIRACLE trial in a new CEO Corner segment. The trial evaluates Annamycin plus high-dose cytarabine in patients receiving second-line treatment for acute myeloid leukemia that has returned or resisted treatment. Moleculin anticipates the full 90-patient Part A data readout in the first quarter of 2027.
Chairman and CEO Walter Klemp discussed interim efficacy results, which the company characterized as encouraging, and next steps toward the pivotal Part B expansion. MIRACLE uses an adaptive, randomized, double-blind, placebo-controlled design across multiple centers. The discussion also covered Annamycin’s potential to address treatment resistance and cardiac safety concerns associated with conventional anthracycline cancer drugs.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointPart A enrollment completed in the Phase 2/3 MIRACLE trial evaluating Annamycin plus high-dose cytarabine.
- Moderate pointInterim efficacy results were characterized by Moleculin as encouraging.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Full 90-patient Part A readout is anticipated by Moleculin in the first quarter of 2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.Pivotal Part B expansion remains a planned next step discussed by the CEO.
Negative
- None.
Key Figures
- Part A data readout population
- 90 patients
- Full MIRACLE trial Part A readout
- Anticipated data readout
- First quarter of 2027
- MIRACLE trial Part A
Historical Context
-
Part A enrollment closed at 89 subjects; the Q1 2027 readout remained planned.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
aml medical
anthracyclines medical
cardiotoxicity medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Access the Moleculin CEO Corner here
HOUSTON, Oct. 20, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. (Nasdaq: MBRX) (“Moleculin” or the “Company”) today announced that it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer.
In this episode of CEO Corner, Moleculin Biotech Chairman and CEO Walter Klemp discusses the progress of the Company’s Phase 2/3 MIRACLE trial evaluating Annamycin in combination with high-dose cytarabine (HiDAC) for patients with second-line relapsed or refractory acute myeloid leukemia (AML). The discussion highlights the completion of enrollment in Part A, encouraging interim efficacy results, Annamycin’s potential to address treatment resistance and cardiac safety concerns associated with conventional anthracyclines, and the anticipated full 90-patient Part A data readout in the first quarter of 2027. Mr. Klemp also outlines the next steps toward the pivotal Part B expansion and the broader potential for Annamycin across AML and other cancers treated with anthracyclines.
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), has shown to be an 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 is conducting 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 (also referred to as “Ara-C”), together referred to as AnnAraC, 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 toward 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, expected timing of the comprehensive Part A data readout in Q1 2027, the anticipated composition of the Part A population including the expected approximate 50/50 split between fit and unfit subjects, the potential for Part A data to support dose selection for Part B, and the expectation that interim efficacy trends observed in a limited patient population will be confirmed in the full study population. 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
MBRX@jtcir.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When does Moleculin expect the MIRACLE Part A trial results?
Moleculin anticipates the full 90-patient Part A data readout in the first quarter of 2027. Enrollment in Part A has been completed.
What treatment is Moleculin evaluating in the MIRACLE trial?
MIRACLE evaluates Annamycin combined with high-dose cytarabine for patients receiving second-line treatment for relapsed or refractory acute myeloid leukemia. These patients have leukemia that has returned or resisted treatment.