Altimmune (ALT) Q1 2025 earnings summary

Executive summary

• Top-line data from the IMPACT Phase 2b MASH trial of pemvidutide is expected in Q2 2025, aiming for statistical significance in MASH endpoints and clinically meaningful weight loss, with potential best-in-class results.

• Phase 2 trials for pemvidutide in Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD) are planned to begin in Q2 and Q3 2025, targeting significant unmet needs.

• Pemvidutide is positioned as a foundational treatment for multiple fibrotic liver diseases, leveraging both liver-directed and weight loss effects.

• No product sales revenue to date; operations funded through equity and debt offerings.

Financial highlights

• Ended Q1 2025 with $150 million in cash, cash equivalents, and short-term investments, up from $132 million at year-end 2024.

• Raised $35 million via ATM facility in Q1 2025 and an additional $16.3 million since April 1.

• R&D expenses were $15.8 million, down from $21.5 million year-over-year, mainly due to lower clinical trial and manufacturing costs.

• G&A expenses rose to $6 million from $5.3 million, driven by higher stock compensation and professional fees.

• Net loss for Q1 2025 was $19.6 million ($0.26/share), improved from $24.4 million ($0.34/share) in Q1 2024.

Outlook and guidance

• IMPACT Phase 2b MASH trial data readout is expected in Q2 2025, with 48-week data as a catalyst later in the year.

• Preparing for a phase 3 MASH trial, with an end-of-phase 2 FDA meeting planned for Q4 2025 and potential registration program initiation in early 2026.

• Phase 2 trials for AUD and ALD to begin in Q2 and Q3 2025, respectively, following FDA clearance of IND applications.

• Cash runway extends to Q3 2026, with potential for an additional year if all Hercules facility tranches are drawn.

• Management believes current cash resources are sufficient to fund operations for at least twelve months from the financial statement issuance date.