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Jun 30, 2024
Moleculin Q2 2024 Earnings Report
Reported financial results for the quarter ended June 30, 2024, and provided a corporate update, highlighting a positive outcome from the End of Phase 1B/2 Meeting with the FDA and plans to proceed with a pivotal Phase 3 clinical trial for Annamycin.
Key Takeaways
Moleculin Biotech reported its financial results for the second quarter of 2024, emphasizing a positive outcome from their meeting with the FDA regarding Annamycin and their progress towards a pivotal Phase 3 clinical trial. They believe they have de-risked the path to potential approval.
Positive outcome from End of Phase 1B/2 Meeting with FDA.
Company proceeding with a pivotal, adaptive Phase 3 clinical trial for Annamycin in combination with cytarabine for the treatment of R/R AML.
Recruitment began in an Investigator-initiated Phase 2 study evaluating WP1066 in combination with radiation therapy for the treatment of adults with glioblastoma.
Existing cash and cash equivalents as of June 30, 2024 will be sufficient to fund planned operations into the fourth quarter of 2024.
Forward Guidance
Moleculin Biotech anticipates several milestones in the development of Annamycin, including contracting with MIRACLE trial sites, treating the first subject in the MIRACLE trial, providing a recruitment update, unblinding interim data, beginning enrollment of 3rd line subjects in MIRACLE2, ending enrollment of 2nd line subjects, presenting final data for 2nd line subjects in MIRACLE, and beginning submission of a new drug application.
Positive Outlook
- Begin contracting with MIRACLE trial sites in 2H 2024.
- First subject treated in MIRACLE trial in Q1 2025.
- Recruitment update (n=40) in Q4 2025.
- Interim data (n=75) unblinded and Optimum Dose set for MIRACLE trial in Mid 2026.
- Begin submission of a new drug application (NDA) the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE in 2H 2028.
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