Altimmune disclosed that an AI‑based analysis of liver biopsies from its IMPACT Phase 2b trial demonstrated a 31 % reduction in total fibrosis area at 24 weeks for patients receiving 1.8 mg of pemvidutide, compared with an 8 % reduction in the placebo group. Early fibrosis fell 34 % versus 9 % in placebo, and advanced fibrosis fell 27 % versus 11 % in placebo, confirming the drug’s anti‑fibrotic activity across all fibrosis stages.
The analysis was performed with the Liver Explore platform, an AI tool that quantifies fibrosis area and correlates the results with non‑invasive biomarkers. The quantitative data provide a more objective assessment than traditional histology, strengthening the evidence base for pemvidutide’s liver‑directed efficacy and offering a potential regulatory advantage in the MASH approval pathway.
Clinically, the findings reinforce pemvidutide’s ability to achieve MASH resolution and fibrosis improvement, milestones that are central to the drug’s development plan. The objective, AI‑derived data may support regulatory submissions and could influence the company’s upcoming End‑of‑Phase 2 meeting with the FDA, while also bolstering investor confidence as the program moves toward Phase 3.
Financially, Altimmune reported a net loss of $19.01 million for Q3 2025, a narrowing from $22.85 million in Q3 2024, and sales of $0.005 million—unchanged from the prior year. R&D expenses fell to $15.0 million from $19.8 million, while G&A rose to $5.9 million from $5.0 million. Cash reserves reached $210.8 million at September 30, a 60 % increase from December 31 2024, providing a solid runway for continued clinical development.
Management highlighted the significance of the data. CEO Vipin K. Garg said the company is “approaching a major inflection point for the pemvidutide MASH program,” and Chief Medical Officer Dr. Christophe Arbet‑Engels noted that the AI analysis confirms the drug’s anti‑fibrotic effect, supporting the MASH resolution data from the trial.
The market reacted positively to the combined financial improvement and the robust clinical data. Analysts emphasized the narrowed loss, increased cash, and the objective evidence of fibrosis reduction, viewing the AI analysis as a key element that could accelerate regulatory progress and strengthen the company’s competitive position in the growing MASH market.
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