Altimmune (NASDAQ:ALT) executives highlighted clinical progress across multiple pemvidutide programs and discussed the company’s financing priorities during a Barclays fireside chat, with management pointing to upcoming catalysts in 2026 and a planned Phase 3 start in metabolic dysfunction-associated steatohepatitis (MASH) this year.
Clinical momentum: MASH Phase 2 readouts and expanding Phase 2 pipeline
Chief Executive Officer Jerry Durso said the company made “significant progress” on the clinical side in 2025, led by two MASH Phase 2 readouts that provided data at 24 weeks (released in June) and 48 weeks (released in December). Durso said the 48-week dataset helped the company better understand pemvidutide’s potential profile in MASH and informed Phase 3 planning, adding that management believes pemvidutide could be “significantly differentiated” in the MASH space.
- Alcohol use disorder (AUD): The company enrolled the trial in late 2025 “ahead of schedule” and is guiding to a Q3 top-line readout.
- Alcohol-associated liver disease (ALD): The trial launched last year and is enrolling, with the company expecting enrollment to complete this year. The study includes readouts at 24 and 48 weeks.
Management on differentiation: mechanism, tolerability, and body composition
Chief Medical Officer Christophe Arbet-Engels described pemvidutide as a “unique one-to-one ratio” of glucagon and GLP-1, arguing the balance is important because glucagon may have a direct impact on the liver while GLP-1 addresses the metabolic context in which liver disease develops.
Arbet-Engels emphasized three areas he believes could differentiate pemvidutide:
- Liver activity: He said data showed effects on fibrosis and MASH resolution, with “very early MASH resolution at 24 weeks.”
- Tolerability and persistence on therapy: He said more patients stayed on treatment at active doses than on placebo in the Phase 2, and that the discontinuation rate was lower than placebo. He contrasted this with what he described as higher discontinuation rates reported for some other agents.
- Lean mass preservation: He said pemvidutide’s weight loss was associated with lean mass preservation, which he suggested could matter in MASH and potential combination settings where minimizing bone and lean mass loss may be important.
MASH data discussion: 24-week histology and 48-week NITs
Durso reviewed the Phase 2 MASH endpoints, noting that the 24-week timepoint included the primary endpoint and captured histology, while the 48-week readout included non-invasive tests (NITs) plus safety. He said the trial showed MASH resolution at 24 weeks, but did not reach statistical significance on the fibrosis endpoint. Durso characterized 24 weeks as an “aggressive and optimistic timeframe” for this mechanism, and said the 48-week data provided signals consistent with an effect taking longer to play out.
Arbet-Engels added that the 24-week biopsy readout was “a little confusing” because placebo performance was elevated. He said that beyond biopsy results, other measures “were all pointing to the same direction,” including AI-based analysis (LiverExplore), statistically significant NITs, and molecular data that he said supported an anti-fibrotic impact. He said the company had a “very positive” end-of-Phase 2 meeting with the FDA. Regarding the 48-week results, he said they showed “added value,” a “clear dose response,” and a “very strong anti-fibrotic effect.”
Phase 3 trial approach and use of AIM-MASH AI Assist
Management described the Phase 3 MASH design as “fairly standard” but highlighted several features. The study will include three arms: placebo, 1.8 mg, and 2.4 mg. Arbet-Engels said the company is powering the study on the 1.8 mg dose, while also evaluating 2.4 mg, which it believes is feasible due to tolerability and a “very simple” one- or two-step titration.
The trial includes two cohorts (F2 and F3 biopsy-proven patients). Arbet-Engels said the first cohort is intended to support Subpart H efficacy, while an NIT-assessed F2/F3 cohort will complement safety assessment under Subpart H. Both cohorts would continue toward longer-term clinical outcomes and final approval.
A major element discussed was the planned use of AIM-MASH AI Assist in Phase 3, which management said would be the first pivotal Phase 3 MASH study to use the tool. Arbet-Engels explained that AIM-MASH digitizes biopsy slides and prompts pathologists to specific features to help score disease activity and fibrosis more consistently. He said it is still a consensus process in which pathologists remain responsible for final scoring, with a third pathologist used if there is disagreement. Management expressed hope the tool could reduce variability and potentially lower placebo response by making reads more objective, while noting the study was powered conservatively without assuming benefit from these measures.
On timelines, Arbet-Engels said biopsy-based trials typically enroll over 18 to 24 months and that Altimmune is aiming for the lower end of that range, citing site relationships from Phase 2, trial structure, and tolerability as factors supporting enrollment.
AUD program: endpoints, objective measures, and potential path forward
For AUD, Arbet-Engels said approved drugs have been assessed using endpoints including “zero drinking days” and “heavy drinking days,” defining heavy drinking days as five drinks for men and four for women. He said Altimmune’s study uses the weekly average of heavy drinking days as its primary endpoint and also captures an endpoint the FDA is considering based on WHO risk levels.
He noted patient-reported outcomes can be affected by trial participation itself, and said the study is 90% powered with conservative assumptions that enrollment in a study could reduce drinking even in the control group. To add an objective measure, he said the trial includes phosphatidylethanol (PEth), a blood test intended to reflect alcohol consumption over recent weeks, measured at baseline and at the end of the study up to six months.
Management said the FDA indicated that a single trial might be sufficient, given the safety database expected from MASH and previous studies. Durso also discussed the size of the AUD population, citing estimates of roughly 12 million people in certain categories, while noting that few patients currently receive drug therapy and that the market for new entrants would need to be built.
Balance sheet priorities and leadership changes
Chief Financial Officer Greg Weaver said bolstering the balance sheet has been the company’s “highest priority” as it approaches Phase 3, and that Altimmune used “various tools” including a combination of debt and equity. He added the company is “active and open” to discussions with strategic partners, with the goal of having sufficient capital allocation to advance the Phase 3 trial.
Durso also pointed to leadership changes as the company transitions toward late-stage development, noting he joined the board last year and moved into the CEO role at the start of the year, alongside other additions to the leadership team.
About Altimmune (NASDAQ:ALT)
Altimmune, Inc is a clinical-stage biopharmaceutical company headquartered in Gaithersburg, Maryland, dedicated to the development of vaccines and immunotherapeutics. The company leverages proprietary technology platforms to create intranasal vaccine candidates and novel therapies targeting liver diseases and metabolic disorders. Altimmune’s approach emphasizes the stimulation of both systemic and mucosal immune responses to address unmet medical needs in infectious and chronic conditions.
Among its lead programs, NasoVAX is an investigational intranasal influenza vaccine designed to provide broad, long-lasting protection through a single, non-invasive dose.
