Altimmune (ALT) investor relations material

Strategic focus and clinical progress

• Transitioned to a late-stage development company with a primary focus on liver diseases, especially MASH, using the balanced glucagon/GLP-1 agonist pemvidutide.

• Phase III PERFORMA trial for MASH is actively enrolling, following positive phase II data and strengthened financials to support execution.

• Positive phase II results in alcohol use disorder (AUD) highlight pemvidutide's potential across multiple liver-related indications.

• Emphasis on differentiation through dual action on liver and metabolic pathways, aiming for better adherence and patient outcomes.

• Ongoing efforts to expand into additional indications, including alcohol-related liver disease (ALD), with phase II trials fully enrolled.

Clinical trial design and differentiation

• PERFORMA phase III uses biopsy endpoints and innovative AI-assisted biopsy reading to reduce variability and facilitate enrollment.

• Study includes two cohorts and tests both 1.8 mg and 2.4 mg doses, with simple titration and strong tolerability.

• Focus on classic efficacy markers, adherence rates, and muscle mass preservation, with MRI used for body composition analysis.

• Data readout for PERFORMA expected in 2029, with accelerated approval data at 52 weeks.

• Differentiation from competitors highlighted by lower discontinuation rates and balanced dual agonism.

Market opportunity and regulatory strategy

• Addressing high unmet needs in MASH, AUD, and ALD, with a U.S. target population of 12 million for moderate to severe AUD and 6 million for ALD.

• Planning phase III for AUD, targeting both typical AUD and those with overlapping ALD, with regulatory engagement underway.

• RESTORE phase II ALD trial uses FibroScan as a primary endpoint, with 12-month data readout planned.

• Regulatory strategy includes end-of-phase II meetings with FDA and European agencies for both MASH and AUD.

• Strong financial position with $519 million in cash, supporting operations through MASH readout in 2029; additional funding options considered for AUD phase III.