Altimmune NASDAQ: ALT executives used the company’s year-end 2025 results call to outline preparations for a pivotal Phase 3 program for pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH), while also providing updates on ongoing Phase 2 studies in alcohol use disorder (AUD) and alcohol-related liver disease (ALD) and reviewing year-end liquidity.
Management frames pemvidutide’s positioning in liver disease
Chief Executive Officer Jerry Durso, who joined Altimmune as CEO in January, said the company is now “exclusively focused on liver disease,” emphasizing what he described as ongoing unmet need in conditions such as MASH. Durso highlighted pemvidutide’s “balanced one-to-one agonism of glucagon and GLP-1” as a potential differentiator, arguing the glucagon component may drive reductions in liver fat, inflammation, and fibrotic activity while GLP-1 contributes to weight loss and appetite suppression.
Durso also pointed to Altimmune’s proprietary “uPort” structure, which he said slows absorption and is believed to improve tolerability, potentially supporting adherence in chronic treatment settings. He said the company plans to incorporate a “one or two-step titration scheme” in Phase 3, contrasting it with more complex titration regimens used by some other injectable therapies.
Durso added that pemvidutide recently received FDA Breakthrough Therapy designation in MASH, which he said the company views as recognition of preliminary evidence suggesting potential substantial improvement on a clinically significant endpoint.
Phase 2 MASH data informs Phase 3 dose selection
Chief Medical Officer Dr. Christophe Arbet-Engels reviewed 48-week data from the Phase 2 IMPACT program in MASH, describing evidence of anti-fibrotic effect at week 48 following “early MASH resolution” observed at week 24. He said the dataset showed a dose response supporting a Phase 3 focus on a 1.8 mg dose, while also evaluating a 2.4 mg dose that could provide additional benefits on weight loss and “most importantly, liver efficacy.”
Arbet-Engels said the company observed improvements from baseline and from week 24 to week 48 in non-invasive markers including ELF and liver stiffness, with results at 1.8 mg described as “particularly clinically relevant” and “comparable to or greater than” results observed with an approved MASH product. He also cited statistically significant improvements in liver fat content and other liver health measures such as ALT and cT1 imaging, again highlighting the 1.8 mg arm.
On tolerability, Arbet-Engels said the low discontinuation rates seen at 48 weeks were maintained, attributing this to a favorable safety profile with limited gastrointestinal adverse events despite the absence of titration in Phase 2. He said most GI events occurred in the first one to two months of treatment, informing the simplified titration plan for Phase 3.
Pivotal Phase 3 design: biopsy cohort plus NIT cohort
Arbet-Engels said minutes received in January from the company’s end-of-Phase 2 meeting with the FDA confirmed alignment on key design aspects for a single pivotal Phase 3 study enrolling patients with moderate to advanced fibrosis. Participants in active arms will start at 1.2 mg and titrate in one or two steps to 1.8 mg or 2.4 mg.
Key design elements discussed on the call included:
- Biopsy-confirmed cohort: 990 patients with F2 or F3 MASH, split evenly among placebo, 1.8 mg, and 2.4 mg (330 per arm).
- Primary endpoints at 52 weeks: either MASH resolution without worsening of fibrosis or fibrosis improvement without worsening of MASH, with MASH Assist used to aid histologic assessment.
- Accelerated approval path: management said the 52-week endpoint is intended to support potential accelerated approval, with five-year clinical outcomes data on liver-related events required for final approval.
- NIT cohort: approximately 800 additional patients with non-invasive test (NIT)-assessed F2/F3 MASH to measure changes in NITs over the same treatment period and support safety and long-term outcomes evaluation.
- Total enrollment: approximately 1,800 patients globally, with sites planned across North and South America, Europe, and Asia.
In Q&A, Arbet-Engels said the program’s “path for approval” is a single trial from accelerated approval through final outcomes, and management indicated FDA’s newer “single pivotal framework” did not change Altimmune’s approach. He also said the study is powered “more than 90%” for the two primary endpoints, with alpha for accelerated approval described as 0.1 and the remainder allocated to clinical outcomes.
On NITs as potential registrational endpoints, Durso said the FDA viewed that discussion as “premature” at the end-of-Phase 2 meeting, which is why the company is pursuing biopsy-driven endpoints while still collecting NIT data. Arbet-Engels added the company structured the trial to maintain flexibility if the agency’s position evolves.
Management also discussed ongoing work on pathology logistics, including using a consensus approach and working with PathAI’s MASH Assist to reduce variability. Arbet-Engels said the company was still finalizing details such as the pathologist panel structure and quality control processes, describing these as among the remaining operational elements being optimized as the protocol is finalized.
Other clinical programs: AUD readout expected in Q3
Beyond MASH, Altimmune reiterated expectations for its Phase 2 AUD study (RECLAIM) and Phase 2 ALD study (RESTORE). Arbet-Engels said RECLAIM completed enrollment in the fourth quarter of 2025 and the company remains on track to report top-line data in the third quarter of 2026. The trial includes patient-reported alcohol consumption measures and an objective blood-based biomarker associated with alcohol intake, along with weight and safety endpoints.
For RESTORE in ALD, Arbet-Engels said enrollment is continuing and the company expects to complete enrollment later in 2026, noting the ALD population is more difficult to enroll than AUD.
Financial results and cash runway
Chief Financial Officer Greg Weaver reported fourth-quarter 2025 R&D expense of $18.4 million versus $19.8 million in the prior-year quarter, citing the conclusion of the Phase 2b trial in late 2025. He said Q4 R&D included $12.8 million of direct pemvidutide development costs, including $3.1 million for the IMPACT Phase 2b trial, $7.4 million for Phase 2 trials in AUD and ALD, and $1.2 million in CMC-related expenses.
Fourth-quarter 2025 G&A expense rose to $10.5 million from $5.1 million a year earlier, driven in part by a one-time non-cash and cash stock compensation and payroll charge related to an executive transition totaling $2.6 million, as well as higher professional fees and compensation-related costs. Net loss for Q4 2025 was $27.4 million, or $0.27 per share, compared with a net loss of $23.2 million, or $0.33 per share, in Q4 2024.
Weaver said full-year 2025 cash operating expenses were approximately $67.5 million, excluding $16.0 million in non-cash stock compensation, and he expects cash use to increase in 2026 as the company approaches the launch of the Phase 3 MASH trial.
Altimmune reported $274 million in cash at year-end 2025. Weaver said the company recorded net proceeds of approximately $208 million during 2025, including $174 million in net equity capital and $35 million in funding from a Hercules tranche loan facility. He also noted a $75 million registered direct offering announced in January with Alyeska Investment Group and $8 million raised via the company’s at-the-market facility in January, resulting in a pro forma cash position of approximately $340 million. Weaver said the company forecasts its current cash position provides operating runway into 2028 based on current expectations for the Phase 3 MASH plan and the Phase 2 AUD and ALD studies.
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.
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