Altimmune(US:ALT)2025-11-06 14:30Financial Data and Key Metrics Changes - Total cash as of September 30 was $211 million, representing a 60% increase from the beginning of the year [11] - R&D expenses for Q3 2025 were $15 million, down from $19.8 million in Q3 2024, primarily due to the timing of CRO development costs [12] - Net loss for Q3 2025 was $19 million or $0.21 per share, compared to a net loss of $22.8 million or $0.32 per share in Q3 2024 [13] Business Line Data and Key Metrics Changes - Direct costs related to Pemvidutide development in Q3 2025 included $9.2 million, with $3.7 million for the IMPACT phase 2b trial, $3.4 million for AUD and ALD startup costs, and $1.3 million for CMC [12] Market Data and Key Metrics Changes - Market research indicated that 70%-80% of surveyed physicians expressed a high likelihood to prescribe Pemvidutide based on its product profile [7] - Positive feedback from payers suggested broad coverage expectations across the EU for Pemvidutide [8] Company Strategy and Development Direction - The company is preparing for a scheduled end-of-phase two meeting with the FDA to review the proposed phase three MASH program [2][15] - Pemvidutide is positioned as a promising therapeutic candidate for MASH, AUD, and ALD, leveraging its dual mechanism of action [3][5] - The company aims to design a flexible phase three trial to adapt to potential regulatory changes regarding endpoints [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the 24-week data supporting the upcoming discussions with the FDA [18][19] - The company anticipates continued weight loss and improvements in NITs at the 48-week mark, reinforcing the efficacy of Pemvidutide [20][35] Other Important Information - The company has raised $127 million through various capital sourcing options to support key development milestones [11] - A $400 million shelf registration and a new $200 million ATM facility were filed to enhance financial flexibility [12] Q&A Session Summary Question: Upcoming 48-week data from the phase two IMPACT trial - Management indicated that the end-of-phase two meeting with the FDA was based on the 24-week data, and the 48-week data would be submitted later [18][19] Question: Probability of using NITs or AI-based histological reading - Management noted ongoing discussions and increasing interest in NITs, with flexibility built into the phase three design to adapt to regulatory changes [25] Question: Advantages of AI-based biopsy reading - AI provides a more comprehensive evaluation of fibrosis with less variability compared to traditional histology, which is subject to human error [25][26] Question: Clinically meaningful endpoint for the RECLAIM trial - The primary endpoint for the RECLAIM trial is the number of heavy drinking days per week, with a focus on assessing changes from baseline [28][31] Question: Competitive positioning against Retatrutide - Management believes Pemvidutide's dual mechanism of action provides a competitive advantage in the MASH space compared to Retatrutide [64][65] Question: Progress on the oral formulation of Pemvidutide - The company is advancing its oral formulation program and plans to share more data as it progresses [70]