Moleculin Biotech completes dosing; data expected Q1 2027
Moleculin expects absolute remission rates for the control and Annamycin arms to be lower than historical studies that allowed multiple treatment cycles.
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 Filing Summary
Moleculin Biotech, Inc. completed dosing in Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine for adults with relapsed or refractory acute myeloid leukemia. The randomized, double-blind Part A includes 90 patients and compares two Annamycin doses plus cytarabine with cytarabine and placebo, with each arm receiving one cycle. The company remains on track to report comprehensive Part A data in Q1 2027; the analysis is expected to support selection of an Annamycin dose for Part B.
Moleculin expects the final Part A population to include an approximately 50/50 split between patients who failed intensive 7+3 chemotherapy and those who failed venetoclax-based regimens, compared with approximately 70/30, respectively, among the first 45 subjects. The company also cited the continued absence of cardiotoxicity in blinded interim data.
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 point. Forward-looking: it has not happened yet and may not happen.MIRACLE Part A dosing completed for 90 patients; data readout remains on track for Q1 2027.
Negative
- None.
Filing Explained
Moleculin says significant additional financing is needed, but discloses no commitments supporting its planned first-quarter 2027 readout.
Moleculin says dosing in Part A is complete, but its planned first-quarter 2027 data readout assumes significant additional financing is secured on time; it reports no commitments for that funding.
Part A is a randomized, double-blind comparison of two Annamycin doses plus cytarabine against cytarabine plus placebo, with all arms receiving one treatment cycle.
The company expects absolute remission rates in both the Annamycin and control arms to be lower than results in cited historical studies that allowed multiple cycles, and says the concurrent randomized control is the most meaningful comparison.
As of
Sources and calculations
- Moleculin Biotech Form 8-K and Exhibit 99.1 (2026-10-30)
- Moleculin Biotech second-quarter 2026 fundamentals (2026-06-30)
- Available liquidity against the last reported quarterly operating outflow, in days at that rate $7,262,000 / ($6,657,000 / 91) = 99.3 days
8-K Event Classification
Key Figures
Key Terms
relapsed or refractory acute myeloid leukemia medical
randomized, double-blind medical
cardiotoxicity medical
venetoclax-based regimens medical
7+3 chemotherapy medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When will MBRX report MIRACLE Part A data?
How does MBRX's MIRACLE Part A compare the treatment arms?
AI-generated analysis. How Rhea-AI works. Not financial advice.
(State or Other Jurisdiction of Incorporation or Organization) | (Commission File No.) | (I.R.S. Employer Identification No.) |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c)) |
Title of each class | Trading Symbol (s) | Name of each exchange on which registered |
The |
Item 7.01 | Regulation FD Disclosure |
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
Exhibit No. | Description |
99.1 | Press Release dated October 30, 2026 |
104 | Cover page Interactive Data File (formatted as Inline XBRL document) |
MOLECULIN BIOTECH, INC. | |||
Date: | October 30, 2026 | ||
By: | /s/ Jonathan P. Foster | ||
Jonathan P. Foster | |||
Exhibit 99.1
Moleculin Completes Dosing Patients in Part A of Pivotal MIRACLE Trial; Comprehensive Data Readout on Track for Q1 2027
Milestone underscores execution of pivotal Phase 2/3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML)
Fully treated, randomized, double-blind n=90 Part A population sets up Annamycin dose selection for Part B, with balanced representation of AML patients who failed 7+3 chemotherapy and venetoclax-based regimens
HOUSTON, October 30, 2026 /GlobeNewswire/ -- Moleculin Biotech, Inc. (Nasdaq: MBRX) (“Moleculin” or the “Company”) today announced that dosing has been completed in Part A of its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML). The Company remains on track to report comprehensive Part A data in the first quarter of 2027.
Reaching this treatment milestone represents continued execution in the MIRACLE trial as the Company advances toward a comprehensive analysis of the full 90-patient Part A population. The planned Q1 2027 data readout is expected to provide important insights into the potential of AnnAraC across clinically distinct R/R AML patient populations and support selection of the optimal Annamycin dose for advancement into Part B of the trial.
The expanded Part A dataset is expected to provide further insight into AnnAraC in patients who have relapsed from or are refractory to different first-line AML treatment approaches, including intensive 7+3 chemotherapy and venetoclax-based regimens. The Company expects the final Part A population to reflect an approximately 50/50 split between these treatment groups, compared with an approximately 70/30 split, respectively, among the first 45 subjects. This broader representation is expected to help characterize AnnAraC’s potential across patient populations with differing treatment histories and clinical challenges.
“Reaching the completion of dosing in Part A represents another important step toward our planned Q1 2027 comprehensive n=90 data readout,” said Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Combined with the continued absence of cardiotoxicity in blinded interim data, we believe our Q1 2027 readout positions us to select our Part B dose and to define Annamycin's potential role across today's R/R AML landscape.”
About the MIRACLE Trial
MIRACLE is a pivotal Phase 2/3 study of Annamycin in combination with cytarabine for the treatment of adult subjects with AML who are refractory to, or have relapsed (R/R) after, induction therapy. Part A of the trial is a randomized, double-blind portion of the study that compares two different doses of Annamycin plus cytarabine to a control arm of cytarabine plus placebo, all with just one cycle of therapy.
Importantly, as specified by the MIRACLE protocol, remission rates for all three arms, including the control arm, reflect outcomes measured after only a single cycle of therapy. The most commonly cited historical benchmarks in this setting, including the MIRROS and CLASSIC I studies, as well as Moleculin’s own MB-106 study, permitted multiple cycles of treatment. The Company therefore expects absolute remission rates for both the control and Annamycin arms to be lower than those reported in such multi-cycle datasets and believes the most meaningful comparison is the performance of the Annamycin arms relative to the concurrent, randomized control arm evaluated on the same single-cycle basis.
The comprehensive Part A analysis is expected to evaluate efficacy and safety across the complete randomized population and support selection of the optimal Annamycin dose for advancement into Part B of MIRACLE.
For additional information on the MIRACLE trial, please visit ClinicalTrials.gov and reference Identifier NCT06788756.
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, the continued absence of cardiotoxicity based on blinded interim data, 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 patients who failed intensive 7+3 chemotherapy and those who failed venetoclax-based regimens, the potential for Part A data to support dose selection for Part B, and the potential for Part A data to support dose selection for Part B. 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