Moleculin Reports Second Quarter 2024 Financial Results and Provides Corporate Update

Core Insights - Moleculin Biotech, Inc. has received positive feedback from the FDA regarding its End of Phase 1B/2 meeting, allowing the company to proceed with the pivotal Phase 3 clinical trial (MIRACLE trial) for Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML) [1][3] Clinical Development - The MIRACLE trial will be a global study, including sites in the US, and aims to evaluate Annamycin combined with cytarabine for R/R AML patients [3] - Recent data from the Phase 1B/2 trial showed that 41% of subjects achieved a composite complete remission (CRc), with 36% achieving complete remission (CR) [3] - The trial design includes an adaptive approach where the first 75 subjects will be randomized to receive different doses of Annamycin, followed by an unblinding to select the optimum dose for the remaining subjects [3] Financial Results - For Q2 2024, the company reported R&D expenses of $4.1 million, up from $3.9 million in Q2 2023, primarily due to increased sponsored research costs [4] - General and administrative expenses decreased to $2.1 million from $2.5 million year-over-year, attributed to lower regulatory and legal fees [4] - As of June 30, 2024, the company had cash and cash equivalents of $10.8 million, which is expected to fund operations into Q4 2024, with plans to raise an additional $12 million through equity issuance [4] Upcoming Milestones - Key milestones for the Annamycin AML development program include beginning site contracting for the MIRACLE trial in 2H 2024 and treating the first subject in Q1 2025 [3] - Interim data is expected to be unblinded in mid-2026, with a new drug application submission anticipated in 2H 2028 for accelerated approval based on primary endpoint of CR [3] Company Overview - Moleculin Biotech, Inc. is focused on developing therapeutic candidates for hard-to-treat tumors and viruses, with Annamycin as its lead program targeting R/R AML and soft tissue sarcoma [5] - The company is also developing WP1066, an immune/transcription modulator for various cancers, and a portfolio of antimetabolites for potential viral treatments [5]