Moleculin Biotech Inc (MBRX) News & EventsMBRXMoleculin Biotech Inc

Moleculin Biotech Announces 1-for-20 Reverse Stock Split

Moleculin Biotech announced that it filed an amendment to its amended and restated certificate of incorporation with the Secretary of State of the State of Delaware to effect a 1-for-20 reverse stock split of its common stock. The reverse stock split will take effect at 12:01 am on October 20 and the company's common stock will open for trading on The Nasdaq Capital Market on October 20 on a post-split basis.

Moleculin Biotech Publishes Cardiac Safety Analysis of Annamycin

Moleculin Biotech announced the publication of a peer-reviewed analysis of the cardiac safety of Annamycin in Frontiers in Cardiovascular Medicine. The publication, titled "Cardiac safety of L-Annamycin: a pooled analysis of five clinical trials," reports cardiac safety findings from 90 patients treated across five clinical trials in acute myeloid leukemia, AML, and metastatic soft tissue sarcoma, STS. Key findings from the pooled analysis include: No significant change in cardiac function: Mean LVEF was 60.6% at baseline compared with 60.0% following treatment, with no statistically significant difference. No relationship between cumulative dose and change in LVEF: The analysis found no association between cumulative Annamycin exposure and changes in LVEF. No relationship between age and change in LVEF: Patient age was not associated with changes in LVEF. No treatment-related cardiotoxicity identified: Serial ECGs, cardiac biomarkers including troponin I/T, and global longitudinal strain assessments showed no evidence of treatment-related cardiotoxicity. High cumulative exposure: Patients received a median cumulative Annamycin dose of 660 mg/m2, with findings observed despite cumulative exposures exceeding conventional anthracycline lifetime limits.

Moleculin Biotech Announces Preliminary Results from MIRACLE Trial

Moleculin Biotech announced preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the company's pivotal Phase 2/3 MIRACLE trial, analyzed on a full intent-to-treat basis with no patient exclusions. Both Annamycin treatment arms demonstrated favorable efficacy trends compared with the control arm in patients with relapsed or refractory acute myeloid leukemia. The interim analysis demonstrated a clear efficacy advantage for both Annamycin treatment arms, 190 mg/m plus HiDAC and 230 mg/m plus HiDAC, over the HiDAC control arm. CR reached 43% and 36% in the respective Annamycin cohorts, compared with 12% for control, while CRc reached 50% and 57%, respectively, versus 29% for the control arm. The n=45 population contained 75.6% over 60 years of age, 55.6% 7+3 and 31.1% venetoclax regimens for first line therapies. Importantly, the remission rates for all three arms, including the control arm, reflect outcomes measured after only a single cycle of therapy, as specified by the MIRACLE protocol. 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 expected absolute remission rates for both the control and Annamycin arms in this single-cycle interim analysis 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.