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Altimmune (ALT) investor relations material
Altimmune Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Leadership transition and strategic direction
Smooth transition to new leadership, with Jerry Durso taking over as CEO at the start of the year and Vipin Garg remaining as an advisor for the first half of next year.
Jerry brings commercial expertise, aiming to guide the company through phase III and commercialization.
Focus remains on maximizing the value and differentiation of pemvidutide, with a clear intent to build and develop the program rather than seek a sale.
Recent hires in commercial and medical leadership signal a shift toward market readiness and payer engagement.
The company is evolving from a development-focused to a commercially oriented organization.
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 pivot to AI-based or NIT-based endpoints depending on regulatory direction.
24-week data showed strong MASH resolution, liver defatting, fibrosis improvement, and high-quality weight loss.
48-week data will focus on maintaining benefits in NITs, further improvement in fibrosis-related NITs, continued weight loss, and strong tolerability.
Plan to propose two dose levels for phase III, with no need for dose titration, enhancing tolerability.
Scientific and market insights
AI-based biopsy reading and NITs offer more objective, sensitive, and less invasive endpoints, potentially improving trial efficiency and patient enrollment.
Scientific community and regulatory agencies are increasingly aligned on the use of NITs for liver disease trials.
Pemvidutide’s benefits extend to AUD and ALD, with rapid trial enrollment due to its potential for liver health improvement and weight loss.
AUD trial’s primary endpoint is reduction in heavy drinking days, with additional biomarker and liver health assessments.
The company is preparing for a commercial launch by focusing on payer needs, value proposition, and evolving market dynamics.
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