Moleculin Biotech, Inc., a clinical stage pharmaceutical company, has reported its financial results for the first quarter of 2024, alongside providing updates on its corporate and clinical trial progress. The company highlighted interim data from the ongoing MB-106 study, which shows that Annamycin in combination with Cytarabine (AnnAraC) achieves a CRc rate of 62% (54% CR) in first and second line AML subjects (N=13). Additionally, the MB-106 trial has reached 20 subjects enrolled, with a CRc of 45% in 1st – 7th line patients and a median durability at 4.9 months and climbing.
Recent Highlights:
- Patent Estate Bolstering: Received U.S. patents for methods related to Annamycin, extending patent protection until mid-2040.
- Virtual AML Clinical Day: Showcased positive interim data for Annamycin from its AML clinical development program.
- Orphan Drug Designation: Granted by the European Medicines Agency for Annamycin in AML treatment, adding to existing US designations.
- AACR Annual Meeting Presentation: Presented data demonstrating Annamycin's high anti-cancer activity and non-cardiotoxic properties.
Ongoing AML Clinical Trial Summary:
The company is conducting a Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine for AML treatment. Preliminary results show a CRc rate of 45% and an overall remission rate (ORR) of 55% for all subjects (N=20). Notably, 1st and 2nd line patients achieved a CRc rate of 67% and 60%, respectively, with an ORR of 67% and 70%.
Expected Milestones for Annamycin AML Development Program:
- H1 2024: Complete MB-106 Phase 1B/2 clinical trial and hold End of Phase 2 Meeting with FDA.
- H1 2025: Initiate pivotal trial.
- H2 2026: Conclude pivotal trial and receive feedback from the FDA EOP2 Meeting.
- 2027: Potential NDA submission.
Summary of Financial Results for the First Quarter 2024:
- Research and Development (R&D) Expense: $4.3 million, a decrease from $5.7 million in the previous year.
- General and Administrative Expense: $2.4 million, down from $2.6 million.
- Cash and Cash Equivalents: $16.8 million as of March 31, 2024, deemed sufficient to meet operating requirements into the fourth quarter of 2024.
Moleculin Biotech, Inc. continues to advance its portfolio of drug candidates targeting hard-to-treat tumors and viruses, with a focus on addressing significant unmet needs in cancer treatment.
