Moleculin Biotec Stock Price, News & Analysis

Moleculin Biotech (Nasdaq: MBRX) has announced plans for its MIRACLE Phase 3 pivotal trial following a positive End of Phase 1B/2 meeting with the FDA. The trial will evaluate Annamycin in combination with cytarabine (AnnAraC) for treating relapsed or refractory acute myeloid leukemia (R/R AML). Key points include:

1) The trial will be global, including US sites.
2) It will use an adaptive design with CR (complete remission) at day 30 as the primary endpoint.
3) The study will allow dosing above the lifetime maximum allowable anthracycline dose.
4) The trial design offers potential for accelerated approval.
5) Initial focus on 2nd line R/R AML treatment, followed by 3rd line R/R AML.

Moleculin aims to begin contracting trial sites in 2H 2024, with the first subject treated in Q1 2025. The company expects to submit an NDA for accelerated approval in 2H 2028.

Moleculin Biotech has completed its End of Phase 2 (EOP2) meeting with the FDA for its Phase 1B/2 clinical trial of Annamycin combined with Cytarabine for treating AML (MB-106). The meeting focused on reviewing clinical data and planning the next steps, with official outcomes expected by Q3 2024. Interim results show that out of 22 enrolled subjects, 45% achieved a composite complete remission (CRc) and 40% had a complete remission (CR). For second-line treatments, 50% achieved CR and 60% achieved CRc. Annamycin holds Fast Track Status and Orphan Drug Designations for relapsed or refractory AML in the U.S. and EMA.

Moleculin Biotech reported additional positive interim data from its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (AnnAraC) for acute myeloid leukemia (AML). The trial enrolled 22 subjects, with 20 completing efficacy evaluations. The results showed a composite complete remission (CRc) in 45% of subjects, a median durability of response (mDOR) of 6 months and increasing, and no cardiotoxicity. In a 2nd line setting, AnnAraC achieved a median overall survival (mOS) of 6 months and 50% complete remissions (CR). The data was presented at the European Hematology Association (EHA) 2024 Hybrid Congress and showcased promising efficacy outcomes, especially for poor prognosis patients.

Moleculin Biotech (Nasdaq: MBRX) announced its participation in the Virtual Investor Pitch Conference on June 18, 2024, at 3:00 PM ET. Walter Klemp, Chairman and CEO, will present an elevator pitch and discuss the company's upcoming milestones. Investors can submit questions during the live video webcast, available on Moleculin's website. A replay will be accessible for 90 days post-event.

Moleculin Biotech (Nasdaq: MBRX) announced its participation in the Virtual Investor Lunch Break: The Moleculin Opportunity event scheduled for June 12, 2024, at 12:00 PM ET. Walter Klemp, Chairman and CEO, will provide a corporate overview and business outlook. The event includes a live Q&A session where attendees can submit questions. A live webcast will be available on Moleculin's website, with a replay accessible for 90 days.

Moleculin Biotech (Nasdaq: MBRX) announced that its abstract has been accepted for a poster presentation at the European Hematology Association (EHA) 2024 Hybrid Congress. The event will take place from June 13-16, 2024, in Madrid, Spain, and virtually.

The presentation will focus on the study titled 'Liposomal Annamycin (L-ANN) in Combination with Cytarabine for Treatment of Patients with Acute Myeloid Leukemia (AML) Refractory to or Relapsed After Induction Therapy (MB-106 Study).'

The presenting author will be Dr. Wolfram C. M. Dempke, European Chief Medical Officer of Moleculin.

Moleculin Biotech has announced the start of a Phase 2 clinical trial evaluating WP1066 in combination with radiation therapy for glioblastoma, in collaboration with Northwestern University.

The trial, funded by the NIH and BrainUp, is aimed at improving treatment options for glioblastoma, which has a median survival rate of 15 months.

WP1066 has shown promise in animal models, demonstrating both therapeutic responses and immune 'memory' effects. This trial will focus on progression-free survival and tumor microenvironment analysis.

Moleculin's WP1066 is designed to activate immune responses and inhibit important oncogenic transcription factors involved in tumor survival and proliferation. The company has also received Orphan Drug Designation for WP1066 for brain tumors and Rare Pediatric Disease designation for other pediatric indications.

Moleculin Biotech, Inc., reported strong financial results for the first quarter of 2024. The company achieved a 62% CRc rate in 1st and 2nd line AML subjects with Annamycin in combination with Cytarabine. The MB-106 trial reached 20 subjects with a CRc rate of 45% in 1st – 7th line. The company also highlighted the positive interim data for Annamycin and announced the formation of the Annamycin Scientific Advisory Board. Financially, R&D expenses decreased due to clinical trials activity levels, while cash and cash equivalents stood at $16.8 million as of March 31, 2024.

Moleculin Biotech, Inc. announced the receipt of a U.S. Patent for Lipid-Based Delivery Technology for Annamycin, extending through 2040 with potential for further extensions. The drug Annamycin is moving towards a pivotal AML study in 2024, possibly qualifying for accelerated approval. The Company aims to establish a strong patent estate for Annamycin and drive its development forward, with promising results in clinical trials.