Moleculin Biotech, Inc.

Moleculin Completes Dosing Patients in Part A of Pivotal MIRACLE Trial; Comprehensive Data Readout on Track for Q1 2027

Moleculin Biotech completed dosing of all 90 patients in Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) in relapsed/refractory acute myeloid leukemia. The company remains on track for a comprehensive Part A data readout in Q1 2027, which will support selection of the Annamycin dose for Part B of the trial. The final Part A population is expected to split roughly 50/50 between patients who failed 7+3 chemotherapy and those who failed venetoclax-based regimens, versus a 70/30 split in the first 45 subjects. Management also cited the continued absence of cardiotoxicity in blinded interim data.

•2d ago

Moleculin Releases Next CEO Corner Segment Highlighting Recent Progress in Annamycin MIRACLE Trial

Moleculin released a new CEO Corner video in which Chairman and CEO Walter Klemp discusses progress in the Phase 2/3 MIRACLE trial of Annamycin plus high-dose cytarabine in second-line relapsed or refractory AML. The segment reiterates that Part A enrollment is complete, interim efficacy results are encouraging, and the full 90-patient Part A data readout is anticipated in Q1 2027, with the pivotal Part B expansion to follow. No new clinical data or figures were disclosed; this is investor-communication content that keeps the Q1 2027 readout on the calendar as the near-term catalyst. The company also flags it will require significant additional financing for which it has no commitments.

•12d ago

Moleculin Biotech Completes Enrollment in Part A of Phase 2/3 R/R AML MIRACLE Trial, Keeping Program on Track for Q1 2027 Data Readout

Moleculin Biotech completed and closed enrollment in Part A of its pivotal Phase 2/3 MIRACLE trial, with 89 subjects enrolled evaluating Annamycin plus cytarabine (AnnAraC) in relapsed/refractory AML. The company remains on track for a comprehensive Part A data readout in Q1 2027, which will also support dose selection for Part B of the trial. Management estimates the Part A population at roughly a 50/50 split between 'fit' and 'unfit' subjects — a more challenging mix than the first 45 subjects — and reports continued absence of cardiotoxicity in blinded data. The company discloses it will require significant additional financing, for which it has no commitments, to conduct its clinical trials as planned.

•1mo ago

Moleculin Announces Publication of Peer-Reviewed Cardiac Safety Analysis of Annamycin in Frontiers in Cardiovascular Medicine

Moleculin announced peer-reviewed publication in Frontiers in Cardiovascular Medicine of a pooled cardiac safety analysis of Annamycin covering 90 patients across five clinical trials in AML and metastatic soft tissue sarcoma. The analysis, independently evaluated by a Cleveland Clinic cardio-oncology lab, found no clinical or subclinical cardiotoxicity, with mean LVEF unchanged (60.6% baseline vs 60.0% post-treatment, p=0.84) even at a median cumulative dose of 660 mg/m² — above conventional anthracycline lifetime limits. The findings support continued development of Annamycin in the pivotal Phase 2/3 MIRACLE trial for relapsed/refractory AML, where a safer anthracycline profile could differentiate the asset, though the publication restates previously presented data.

•1mo ago

Annamycin Turns “Cold” Pancreatic Tumors “Hot” in New Preclinical Data Presented at AACR

Moleculin Biotech presented new preclinical data at the AACR Conference on Pancreatic Cancer showing Annamycin's antitumor activity is partially mediated by CD8+ T cells. The findings suggest Annamycin may convert immunologically 'cold' pancreatic tumors to a 'hot,' immune-responsive state, potentially supporting combination approaches and complementing the WP1066 immune-modulating program. Importantly, these are preclinical-only results; Annamycin's lead clinical program remains the pivotal MIRACLE Phase 2/3 trial of AnnAraC in relapsed/refractory AML, and the company notes it is not developing Annamycin for pancreatic cancer currently.

•1mo ago

Moleculin Biotech Secures Mexican Patent Protecting Lung-Targeted Liposomal Annamycin Through 2040

Moleculin Biotech was granted Mexican Patent No. 436849 protecting its lung-targeted liposomal Annamycin formulation, with exclusivity running until November 23, 2040. Annamycin remains in the pivotal Phase 2/3 MIRACLE trial combined with cytarabine for relapsed or refractory acute myeloid leukemia. The patent is an incremental IP milestone with no immediate financial or clinical impact, though the company notes it will require significant additional financing for which it has no commitments.

•1mo ago

Moleculin to Showcase New Annamycin Data at AACR Conference on Pancreatic Cancer and Two European Scientific Meetings

Moleculin Biotech's lead drug candidate Annamycin (naxtarubicin) will be featured in three scientific presentations in September 2026, including the AACR Conference on Pancreatic Cancer in San Diego and two meetings in Wroclaw, Poland. The talks, led by UT MD Anderson's Waldemar Priebe and Morristown Medical Center's Angela Alistar, examine Annamycin's tissue-concentrating properties (organotropism), its topoisomerase II mechanism, and CD8+ T cell-mediated antitumor activity in pancreatic cancer — a potential second indication beyond AML. The AACR abstract remains under embargo until September 25, 2026, when it publishes as a supplement to Cancer Research; Moleculin says it will report the findings at that time. The presentations run alongside the pivotal Phase 2/3 MIRACLE trial of AnnAraC in relapsed/refractory AML, which remains the company's primary focus; the release cautions interim results were based on only 45 patients without statistical significance and that Moleculin will require significant additional financing for which it has no commitments.

•1mo ago

Moleculin CEO, Walter Klemp, Participates in the Virtual Investor “Why Now” On-Demand Conference

Moleculin Biotech CEO Walter Klemp presented at the Virtual Investor 'Why Now' conference, highlighting the clinical progress of the pivotal Phase 2/3 MIRACLE trial evaluating Annamycin for relapsed or refractory AML. Management emphasized encouraging interim results and identified the upcoming 90-patient interim analysis as a key catalyst for potential registration. The presentation also provided an overview of the company's pipeline, including WP1066 for brain tumors and WP1122 for viral indications.

•2mo ago

Moleculin Biotech Reports Second Quarter 2026 Financial Results and Highlights Continued Advancement of Pivotal MIRACLE Trial

Moleculin reported a Q2 net loss of $7.6 million, or $(1.40) per share, with cash and equivalents of $7.3 million as of June 30. The company raised $9.3 million in financing after the quarter-end, extending its expected cash runway into the first quarter of 2027 to support ongoing operations. Interim data from the pivotal MIRACLE trial showed Annamycin achieved complete remission rates of 43% and 36%, versus 12% for the control arm, with enrollment on track to reach 90 patients by September 2026.

•2mo ago

Moleculin’s MIRACLE R/R AML Trial Reports Positive Interim Data with 37% Blinded CRc in Venetoclax-Failed Patients

Moleculin Biotech reported updated interim blinded results from the Phase 2/3 MIRACLE trial of Annamycin in relapsed/refractory AML, showing a composite complete remission (CRc) rate of 37% across 62 evaluable patients. The CRc rate remained consistent at 37% in a subgroup of 30 patients who had failed prior venetoclax therapy, roughly triple the historical salvage remission rate of approximately 13% for this population. Enrollment has reached 74 of 90 subjects, with final Part A treatment expected in September 2026 and comprehensive unblinded results anticipated between December 2026 and February 2027.

•3mo ago

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

CEO Walter Klemp discussed positive preliminary unblinded efficacy results from the first 45 patients in Part A of the pivotal Phase 2/3 MIRACLE trial for Annamycin in R/R AML during a Virtual Investor segment. The company cautioned that the interim results are based on a small sample size and have not yet achieved statistical significance, requiring confirmation in the full study population. Annamycin is an anthracycline designed to avoid multidrug resistance and lack the cardiotoxicity of current treatments, currently being evaluated in combination with cytarabine (AnnAraC).

•3mo ago

Moleculin Reports Positive Phase 2/3 MIRACLE Interim Results, With Annamycin Complete Remission Rates 3-fold Greater than Control

Moleculin reported positive interim data from the Phase 2/3 MIRACLE trial, showing Annamycin achieved Complete Remission (CR) rates of 36% and 43% versus 12% for the control arm in relapsed or refractory AML patients. Composite Complete Remission (CRc) rates reached 50% and 57% for the two Annamycin doses compared to 29% for control in this intent-to-treat population of 45 subjects. The Independent Data Monitoring Committee recommended continuing the trial, citing strong numeric trends despite the lack of statistical significance at this interim stage.

•4mo ago

Independent Market Research Finds Strong Physician Intent to Prescribe Moleculin's Annamycin in Relapsed/Refractory AML

Moleculin Biotech announced results from an independent market assessment showing strong physician interest in its lead asset Annamycin for relapsed/refractory AML. Oncologists reported an average likelihood-to-prescribe score of 6 out of 7, citing deep remissions, transplant-bridging potential, and reduced cardiotoxicity as key drivers. Payers also indicated strong support for Annamycin’s value proposition, driven by its efficacy, safety profile, and broad applicability to patients without actionable mutations. The company is currently conducting the pivotal MIRACLE Phase 2b/3 trial (MB-108) evaluating Annamycin in combination with cytarabine.

•4mo ago

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

Moleculin Biotech announced that its pivotal MIRACLE trial for Annamycin in relapsed/refractory AML has enrolled its 45th subject. This milestone triggers the final phase of preparation for the interim data unblinding, which remains on track for mid-2026. CEO Walter Klemp highlighted this as a potentially defining inflection point for the company, noting the trial's adaptive design and prior de-risking from Phase 1B/2 data.

•4mo ago

Moleculin Presents ASCO 2026 Data Demonstrating No Detectable Cardiotoxicity with Annamycin Despite Exposure Levels Far Exceeding Conventional Anthracycline Limits

Moleculin presented pooled cardiac safety data for Annamycin at ASCO 2026, showing no detectable cardiotoxicity in 90 patients across five completed trials. The analysis covered cumulative doses up to 2,970 mg/m², far exceeding conventional anthracycline limits, with independent validation from Cleveland Clinic cardiology specialists. The company highlighted prior Phase 1b/2 efficacy in AML, including a 50% complete remission rate, and noted that unblinding of the first 45 patients in the pivotal MIRACLE Phase 2b/3 trial is on track for June 2026.

•5mo ago

Moleculin Highlights Abstract Accepted for Poster Presentation at the 2026 ASCO Annual Meeting Highlighting Cardiac Safety Data for Annamycin

Moleculin Biotech announced that an abstract featuring pooled cardiac safety data for its lead drug candidate Annamycin has been accepted for poster presentation at the 2026 ASCO Annual Meeting. The analysis of 90 patients showed no statistically significant change in left ventricular ejection fraction (LVEF) from baseline, with a mean difference of -0.12% (p=0.84), despite median cumulative doses exceeding conventional anthracycline limits. No correlation was observed between cumulative dose or patient age and changes in LVEF, supporting the drug's differentiated safety profile and strengthening the rationale for the ongoing pivotal Phase 2b/3 MIRACLE trial in AML.

•5mo ago

Moleculin’s Annamycin Extends Survival by More Than 60% in Metastatic Pancreatic Cancer Preclinical Models - Data Presented at AACR 2026

Moleculin presented preclinical data at AACR 2026 showing its lead drug Annamycin extended median survival by more than 60% in metastatic pancreatic cancer models (29 days vs 18 days, p=0.0003). The data demonstrated significant tumor growth inhibition across multiple PDAC models (p<0.001) and higher tumor accumulation than doxorubicin (p<0.0001), while maintaining absence of cardiotoxicity. Annamycin remains in a pivotal Phase 2B/3 "MIRACLE" trial for AML, with these new findings supporting potential expansion into solid tumors.

•6mo ago