Altimmune reports Q3 EPS (21c), consensus (27c)

Reports Q3 revenue $5,000, consensus $560,000. “We have made a number of important advancements in the second half of 2025 and are approaching a major inflection point for the pemvidutide MASH program. Later this quarter we expect two milestones that will set the stage for 2026 and beyond, including our scheduled, in-person End-of-Phase 2 Meeting with the FDA which was granted to the Company based upon the strength of our 24-week IMPACT trial data. In addition, the 48-week data from the IMPACT trial is expected before year end and we look forward to assessing the longer treatment duration of pemvidutide in this MASH patient population,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune (ALT). “At the End-of-Phase 2 meeting, we will seek alignment with the FDA on the proposed design of our Phase 3 MASH trial. One of the attributes of the design is the flexibility to adapt the trial pending the outcome of emerging regulatory discussions around approvable MASH endpoints, which could include the potential adoption of non-invasive tests and AI-based biopsy readings. Beyond MASH, we recently announced completion of patient recruitment and randomization in the RECLAIM trial of pemvidutide in alcohol use disorder, ahead of our expected enrollment timeline. Our ability to enroll this trial so quickly is a clear indication of the unmet need in AUD, a condition affecting millions of patients with currently approved therapies providing limited benefit. In addition to the clinical and regulatory progress, we are continuing to build the organization for our next phase of growth with several strategic additions to our management team, including the recent appointments of Dr. Christophe Arbet-Engels as Chief Medical Officer, Linda Richardson as Chief Commercial Officer and Robin Abrams as Chief Legal Officer. Christophe, Linda and Robin bring a wealth of expertise to our leadership team. They have already made significant contributions to our clinical, regulatory and organizational strategy and we are excited to continue benefiting from their deep experience.”