Altimmune, Inc. Q3 FY2024 earnings call

• Phase 2b IMPACT trial of pemvidutide in MASH is fully enrolled, top-line efficacy data expected in Q2 2025. Successful readout could lead to end of Phase 2 meeting with FDA in Q4 2025 for MASH. • Alignment with FDA on comprehensive Phase 3 registration program for obesity, with four Velocity trials outlined. Pemvidutide has potential to fill gaps in obesity comorbidity treatment. • Plan to expand R&D investments into up to three additional indications leveraging pemvidutide's attributes, with IND submission for first indication by end 2024 and Phase 2 trial in H1 2025. • Financials: Cash, cash equivalents, and short-term investments at $139.4M; R&D expenses $19.8M; G&A $5M; net loss $22.8M.

No detailed segment performance with revenue contributions provided. Altimmune ended Q3 2024 with approximately $139.4 million in cash, cash equivalents, and short-term investments. R&D expenses were $19.8 million, G&A expenses were $5 million. Net loss was $22.8 million.

• Top-line efficacy data from Phase 2b IMPACT trial in MASH expected in Q2 2025. • If positive, expect to start Phase 3 program in MASH by end of 2025. • Plan to submit IND for first additional indication by end of 2024, with Phase 2 trial in H1 2025. • Four Velocity Phase 3 trials in obesity to enroll ~5,000 subjects over 60 weeks.

• Forward-looking statements subject to risks and uncertainties; actual results may differ from forward-looking statements. Refer to SEC filings for full risk factors. No specific operational failures discussed in detail during call.

Q: How important was the alignment with FDA in terms of strategic discussion and partnership, and about study sequencing and additional indications?

A: Vipin Garg stated alignment is a significant milestone, strategy is to seek partnership around obesity while advancing MASH and other indications. Study sequencing ideally parallel, details of additional indications to be disclosed after regulatory alignment.

Q: How thinking about ESSENCE trial and competitiveness for incretins in MASH?

A: Scott Harris mentioned ESSENCE trial had modest effects as expected, pemvidutide has class-leading liver fat reduction and direct effect on fibrosis, expected to be first incretin-based agent to show statistical significance at 24-weeks.

Q: Thoughts on cardiac safety and timing of additional indications?

A: Scott Harris stated no cardiac safety class effect with pemvidutide, FDA confirmed no safety signals. Additional indications' trials to launch in H1 2025, more info in next year.

Q: How selecting additional indications and trial sizes?

A: Scott Harris said indications based on targets benefiting from glucagon, Phase 2 proof-of-concept studies to launch in H1 2025 after IND.

Q: Thoughts on strategic partnerships and evolving conversations?

A: Ray Jordt mentioned strategic partner discussions continue as companies figure out their own initiatives, focus on generating data and advancing programs to create value.