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Mar 31, 2024
Moleculin Q1 2024 Earnings Report
Reported financial results for the quarter ended March 31, 2024.
Key Takeaways
Moleculin Biotech reported its financial results for Q1 2024, with a focus on the clinical development program for Annamycin, particularly its application in AML treatment. The company highlighted positive interim data from the MB-106 trial, progress in patent estate, and the formation of an Annamycin Scientific Advisory Board. They believe their cash is sufficient to meet its projected operating requirements into the fourth quarter of 2024.
MB-106 trial reached 20 subjects with a CRc of 45% across all lines of therapy.
1st and 2nd line AML patients in the MB-106 trial achieved a CRc rate of 62% and a CR rate of 54%.
Annamycin Scientific Advisory Board was formed with the inaugural appointment of Dr. Martin Tallman.
EMA granted Orphan Drug Designation to Annamycin for AML treatment, complementing existing US designations.
Forward Guidance
Moleculin expects to complete the MB-106 Phase 1B/2 clinical trial and hold an End of Phase 2 Meeting with the FDA in H1 2024. They anticipate initiating a pivotal trial in H1 2025, receiving feedback from the FDA EOP2 Meeting in H2 2026, concluding the pivotal trial in H2 2026, and potentially submitting an NDA in 2027.
Positive Outlook
- Complete MB-106 Phase 1B/2 clinical trial in H1 2024.
- Hold MB-106 End of Phase 2 Meeting with FDA in H1 2024.
- Initiate pivotal trial in H1 2025.
- Receive feedback from the FDA EOP2 Meeting in H2 2026.
- Conclude pivotal trial in H2 2026.
Challenges Ahead
- Potential delays in clinical trials.
- Uncertainties in regulatory feedback and approval processes.
- Risks associated with drug development and commercialization.
- Dependence on successful trial outcomes and data.
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