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Sep 30, 2024
Moleculin Q3 2024 Earnings Report
Reported financial results for the third quarter of 2024.
Key Takeaways
Moleculin Biotech reported its Q3 2024 financial results, highlighting the ramp-up for the upcoming MIRACLE trial and positive interactions with potential clinical trial sites. The company's focus remains on advancing Annamycin in combination with Cytarabine to a Phase 3 pivotal trial for the treatment of AML patients.
On track to start dosing in the pivotal, adaptive Phase 3 MIRACLE trial in Q1 2025 for possible accelerated approval of Annamycin.
Median durability of CRc in the MB-106 Annamycin+ Cytarabine AML clinical trial continues to climb, now past 8 months.
A virtual AML KOL event underscored how Annamycin could significantly change the AML treatment landscape.
Closed a $5.5 million financing upfront with up to an additional $11.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants.
Forward Guidance
Moleculin anticipates several milestones for its Annamycin AML development program, including contracting with MIRACLE trial sites and IRB approval in Q4 2024, first subject treated in the MIRACLE trial in Q1 2025, and recruitment and overall efficacy rate update in Q4 2025.
Positive Outlook
- Contracting with MIRACLE trial sites and IRB approval in Q4 2024
- First subject treated in MIRACLE trial in Q1 2025
- Recruitment and overall efficacy rate update (n=45) in Q4 2025
- Interim efficacy and safety data (n=90) unblinded and Optimum Dose set for MIRACLE trial in 2H 2026
- Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE in 2028 2H
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