Altimmune, Inc. Q4 FY2024 earnings call

• 2024 was a year of progress with the Phase 2b IMPACT trial of pemvidutide in NASH nearing top-line data in Q2 2025, targeting NASH resolution and fibrosis improvement at 24 weeks. Pending results, the company plans to request an end-of-Phase 2 meeting with the FDA by year-end 2025 to align on a registrational Phase 3 program in NASH starting early 2026.
• In Q4 2024, the company submitted INDs for pemvidutide in two additional indications, which were cleared by the FDA, positioning the start of Phase 2 efficacy trials in mid-2025.
• An upcoming virtual R&D Day on March 13 will disclose details of the two additional indications and provide an overview of new opportunities, featuring key opinion leaders in MASH, obesity, and the additional indications.
• Teri Lawver and Jerry Durso were added to the Board of Directors, bringing decades of pharmaceutical industry experience relevant to Altimmune's development of pemvidutide.
• Chief Medical Officer Scott Harris plans to retire in Feb 2026 but will remain with the company through the IMPACT data readout and the end-of-Phase 2 FDA meeting for MASH.

No detailed financial performance by product segments provided in the transcript.

• Top-line data from the IMPACT trial is expected in Q2 2025.
• The company intends to request an end-of-Phase 2 meeting with the FDA by the end of 2025, with the goal of initiating a Phase 3 program in NASH in early 2026.
• Phase 2 efficacy trials for the two additional indications are scheduled to start in mid-2025.
• The R&D Day on March 13 will provide detailed plans for the Phase 2 programs in the additional indications.

• Forward-looking statements made during the call are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, as per Altimmune's filings with the SEC. These risks include factors that could affect the company's future results and operations, as outlined in its regulatory filings.

Q: Unidentified Analyst on new indications: Will announce details at R&D Day and start Phase 2 trials midyear?

A: Vipin Garg says the company will provide a comprehensive picture of the two indications at the R&D Day, including plans for the start of the Phase 2 programs.

Q: Yasmeen Rahimi on Phase III design and cirrhosis: A: Scott Harris talks about the use of MRI-PDFF and the view that cirrhosis is an extension of F3 fibrosis, with a high likelihood of success in the cirrhosis population.

Q: Annabel Samimy on IMPACT trial success and market evolution: A: Scott Harris discusses the competitive edge of pemvidutide over incretins and FGF21s, and mentions plans to release secondary endpoints with the top-line readout.

Q: Liisa Bayko on prioritization and oral form: A: Scot Roberts talks about progress on the oral formulation of pemvidutide, noting focus on new indications at the R&D Day and excitement about progress on oral bioavailability.

Q: Unidentified Analyst on additional indications Phase 2: A: Scott Harris says the two Phase 2 studies will be proof-of-concept, with expectation of proof-of-concept data in 2026 and evaluation of up to three additional indications.

Q: William Wood on IMPACT endpoints and new indications: A: Scott Harris and Vipin Garg discuss the endpoints of the IMPACT trial, including MASH resolution and fibrosis improvement, and the focus on obesity as a comorbidity across new indications.

Q: Jonathan Wolleben on MASH trial placebo control and real-world adherence: A: Scott Harris talks about the triple reader model and low adverse event discontinuation rates in the IMPACT trial, indicating competitive compliance.

Q: Patrick Trucchio on MASH trial placebo control, Phase 3 timing, and development sequence: A: Scott Harris discusses the 3-reader model to control placebo effect, expectation of Phase 3 start in Q1 2026, and parallel development of additional trials while initiating the Phase 3 program for MASH