Altimmune (ALT) investor relations material

Strategic focus and clinical progress

• Focused on liver diseases, particularly with the lead candidate pemvidutide, a balanced glucagon-GLP agonist, now in late-stage development.

• 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) and ongoing phase II in alcohol-related liver disease (ALD) support a broader liver disease franchise.

• Emphasis on differentiating pemvidutide through its dual mechanism, targeting both metabolic and direct liver effects.

• Anticipates robust progress in trial enrollment and execution over the coming year.

Clinical trial design and differentiation

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

• Two dosing cohorts and a simple titration scheme aim to improve patient adherence and tolerability.

• The 2.4 mg dose, not previously tested in phase II, is included to assess higher efficacy.

• MRI will be used to assess muscle preservation, with a focus on quality weight loss.

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

Competitive landscape and scientific rationale

• Pemvidutide's balanced dual agonism is positioned as more tolerable and adherent compared to other agents like survodutide, which had higher discontinuation rates.

• Retatrutide is highlighted as a different molecule, with much higher affinity for GIP and less for glucagon, while pemvidutide maintains high affinity for both GLP-1 and glucagon.

• The importance of muscle preservation and quality weight loss is emphasized as a differentiator.

• The mechanism of glucagon in AUD is not fully understood, but early data suggest potential benefits.