Altimmune, Inc. Q2 FY2025 earnings call

• NASH Program Advancement: Presented 24 - week top - line data from the IMPACT trial where pembigutide achieved statistical significance in NASH resolution and multiple efficacy measures, including noninvasive markers of inflammation and fibrosis, liver fat reduction, and weight loss. • Phase II Trials in AUD and ALD: RECLAIM and RESTORE trials in AUD and ALD respectively are underway. • Board Change: Jerry Durso was appointed Chairman of the Board, bringing commercial and corporate development experience, including building a successful liver franchise. • Clinical Development Update: At 24 weeks, pemvigutide showed class - leading effects in CT1 imaging, a weight loss of over 6%, and excellent safety with only a single adverse event - related discontinuation across the two pempidutide treatment arms versus two in the placebo group without dose titration. • Financial Strengthening: Cash and cash equivalents were $183.1 million, strengthening the balance sheet.

In the second quarter of 2025, R&D expenses were $17.2 million, G&A expenses were $5.7 million. The net loss was $22.1 million (or $0.27 per share). Cash and cash equivalents stood at $183.1 million, a significant increase from the start of the year. R&D expenses included $11.2 million in direct costs related to pembidutide development, with $5.5 million for the IMPACT Phase 2B trial, $2.6 million for AUD and ALD startup Phase two costs, and $1 million for pempadutide oral formulation preclinical development.

• Report the forty - eight - week impact data and prepare for the end - of - Phase II meeting with the FDA. • Continue enrolling the Phase II trials in AUD and ALD.

• Forward - looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. • Refer to the company's filings with the SEC for a full review of risk factors affecting future results and operations.

Q: Related to the NASH development plan, after digesting the data, how to leverage other improvements at week 24 and how does the FDA view new measures, and could endpoints be included in Phase III?

A: Scott Harris said there's more emphasis on noninvasive tests and the FDA is warm to them, PathAI analyses are accepted in Europe and FDA is reviewing the proposal; Vipin Garg noted confidence in hitting the fibrosis endpoint in Phase III despite 24 - week results.

Q: On the AUD/ALD trial, why is only 2.4 mg being tested?

A: Scott Harris said for the Phase II trial, it's appropriate to test one dose, and they'll re - examine other doses in the Phase III program.

Q: On the end - of - Phase II meeting, what will be discussed with the FDA and when will there be an update?

A: Scott Harris said details can't be provided yet, but expect a rich conversation and an update after the meeting.

Q: Measures on alcohol consumption in the IMPACT study and timing for ALD/ARD readouts?

A: Scott Harris said they're analyzing the data, are confident in hitting the endpoints, and will meet the FDA after the Phase II results.

Q: With the new chairman appointment, how will the corporate strategy evolve regarding Phase III and commercialization?

A: Vipin Garg said Jerry's appointment adds an advantage for Phase III and commercialization.

Q: How do T1 responses compare to other programs?

A: Scott Harris said the results show class - leading superiority.

Q: Phase III program dosing strategy, endpoints, and commercial potential?

A: Scott Harris talked about the attractiveness of the 2.4 mg dose, dual endpoints in Phase III; Vipin Garg emphasized the safety database and combining mechanisms for commercial advantage.

Q: Lilly's trial and its impact on Altimmune's Phase III?

A: Scott Harris and Vipin Garg said it creates an opportunity for noninvasive tests and will be discussed with the FDA.

Q: Merck's data and Altimmune's 48 - week data?

A: Scott Harris said Altimmune's 48 - week data would be as good or better, supported by noninvasive test results.

Q: R&D spend cadence for AUD and ALD studies?

A: Greg Weaver said AUD and ALD phase II trials are baked into the budget and are modest in size.

Q: Oral program technology and positioning?

A: Scott Roberts and Vipin Garg discussed gastric absorption enhancement, cost - of - goods aspects, and life cycle management for the oral program.