Altimmune (ALT) Piper Sandler 37th Annual Healthcare Conference summary

Leadership transition and strategic direction

• Smooth transition to new leadership, with Jerry Durso taking over as CEO at the start of next year and Vipin Garg remaining as an advisor for the first half of the year.

• Jerry brings commercial expertise to guide the company through phase III and potential commercialization.

• Focus remains on maximizing the value and differentiation of pemvidutide, with further strategic updates expected after the leadership transition.

• Recent hires in commercial and medical leadership signal a shift toward market readiness.

Clinical development and regulatory milestones

• Two major catalysts expected by year-end: an in-person end of phase II FDA meeting and 48-week NIT-based data readout.

• Phase III trial design aims for flexibility, allowing adaptation to either AI-based biopsy reading or NIT-based endpoints, depending on FDA guidance.

• 24-week data showed strong MASH resolution, fibrosis improvement, and significant weight loss, with expectations to maintain or improve these at 48 weeks.

• Plan to propose two dose levels for phase III, leveraging data from the 48-week readout.

Scientific and operational insights

• AI-based biopsy reading offers greater objectivity and sensitivity, removing human bias and potentially improving trial outcomes.

• NITs (including liver stiffness and ELF) are central to future endpoints, with scientific consensus growing around their use.

• Ease of patient enrollment and study execution expected to improve if NITs replace biopsies.

• Tolerability and sustained patient adherence are highlighted as key differentiators, with no dose titration required for pemvidutide.