Altimmune (NASDAQ:ALT) said it has strengthened its balance sheet and is preparing to begin a global Phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis, or MASH, in the second half of 2026, as the company reported first-quarter financial results and provided updates across its liver disease pipeline.
President and Chief Executive Officer Jerome Durso said the company has made progress since the start of the year in building its team, advancing pemvidutide and securing additional capital. In April, Altimmune completed an oversubscribed public offering that generated $225 million in gross proceeds. Together with existing funds, the company had approximately $535 million in cash as of April 30, which Durso said is expected to fund operations through the Phase 3 MASH 52-week data readout expected in 2029.
“We’re entering a new phase for the company with the right team in place and a very strong balance sheet,” Durso said. “We’re now focused on execution and believe we’re well-positioned to successfully execute our strategy.”
Phase 3 MASH Trial Set to Begin in Second Half
Altimmune’s lead program is pemvidutide, a balanced 1-to-1 glucagon and GLP-1 dual agonist being developed for MASH and other liver conditions. Durso said the company has finalized the protocol for its global Phase 3 MASH trial, called PERFORMA, and submitted it to the U.S. Food and Drug Administration as part of the standard process. He also said Altimmune completed the scientific advice process in Europe and that the final protocol is aligned with feedback from the European Medicines Agency.
Chief Medical Officer Dr. Christophe Arbet-Engels said startup activities for PERFORMA are progressing as planned, including work with a contract research organization, global vendors, laboratories and clinical supply chains. He said the company expects to begin screening and enrolling patients in the second half of the year.
Arbet-Engels said the company has alignment with both the FDA and EMA on the Phase 3 trial design. He described PERFORMA as an event-driven study, with a 52-week biopsy-based interim analysis intended to support accelerated approval. The company expects the 52-week data readout in 2029.
The Phase 3 program will evaluate 1.8 mg and 2.4 mg doses of pemvidutide. Arbet-Engels said the 1.8 mg dose is the company’s “anchor dose” based on Phase 2 data, while the 2.4 mg dose is being included because it showed additional weight loss in a prior obesity study and may offer added liver efficacy. He said the study is powered conservatively using the effect size observed with the 1.8 mg dose.
Company Highlights Tolerability and Weight Loss Profile
Durso and other executives emphasized what they described as pemvidutide’s potentially differentiated profile in MASH, including tolerability, efficacy and “quality weight loss.” Durso said recent market research conducted by the company indicated that prescribing decisions in MASH may be influenced by a favorable tolerability profile that does not sacrifice efficacy, along with quality weight loss.
Chief Commercial Officer Linda M. Richardson said pemvidutide’s potential target product profile includes early metabolic benefits, improvements in inflammation and fibrosis, weight loss that may help preserve lean muscle mass, and a simple titration schedule. She said that in the Phase 2 IMPACT trial, both the 1.2 mg and 1.8 mg doses were efficacious and well-tolerated, with fewer adverse event-related discontinuations in the pemvidutide arms than in the placebo group.
Richardson contrasted pemvidutide’s planned titration approach with some GLP-1-based therapies, which she said have been associated with gastrointestinal side effects and discontinuations in clinical trials and real-world use. She said the Phase 3 design starts at an active 1.2 mg dose and escalates to either 1.8 mg or 2.4 mg after one or two four-week titration steps.
Richardson also said the company plans to evaluate lean muscle mass preservation in the Phase 3 MASH program, noting that MASH patients are often diagnosed in an age range where muscle loss becomes more clinically relevant.
Additional Pemvidutide Data Expected in 2026
Arbet-Engels said the 48-week results from the Phase 2 IMPACT trial will be presented orally by Dr. Mazen Noureddin at the EASL conference in Barcelona later this month. He said the abstract was selected as a “best of EASL” abstract. Altimmune also plans to present three posters at the conference covering cardiovascular risk factors, weight loss, noninvasive tests and qFibrosis.
During the question-and-answer session, Arbet-Engels said the EASL presentations will include additional qFibrosis evidence related to early anti-fibrotic effects at 24 weeks, as well as analyses related to weight loss, lipids and cardiovascular risk. He said qFibrosis is distinct from the AIM-MASH AI Assist tool that Altimmune plans to incorporate into the Phase 3 biopsy read process.
Arbet-Engels said Altimmune expects top-line data next quarter from the Phase 2 RECLAIM trial of pemvidutide in alcohol use disorder, or AUD. The study is evaluating the 2.4 mg dose in 100 subjects with moderate to severe AUD over 24 weeks. The primary endpoint is change from baseline in heavy drinking days, defined as five or more drinks for men and four or more drinks for women in a 24-hour period.
Key secondary endpoints include zero heavy drinking days, a two-level reduction in the World Health Organization risk drinking level, changes in alcohol consumption, and changes in body weight and BMI. The company is also measuring phosphatidylethanol, or PEth, as an exploratory blood-based biomarker of alcohol consumption.
Durso said that after the AUD data readout, Altimmune will assess the full data set and hold regulatory discussions before deciding whether to advance the indication. If the company sees value in moving forward, he said Altimmune would prefer to explore non-dilutive funding options for the program.
Altimmune is also studying pemvidutide in alcohol-associated liver disease, or ALD. The company now expects to complete enrollment in the RESTORE trial in the third quarter of 2026.
First-Quarter Financial Results
Chief Financial Officer Greg Weaver said Altimmune reported $332 million in cash as of March 31 and $535 million on a pro forma basis as of April 30, after the public offering. He said this cash position is expected to provide operating runway through the Phase 3 MASH 52-week data readout.
- Research and development expense: $16.2 million in the first quarter of 2026, compared with $15.8 million in the prior-year period.
- General and administrative expense: $8.1 million, compared with $6.0 million in the first quarter of 2025.
- Net loss: $22.6 million, or $0.18 per share, compared with a net loss of $19.6 million, or $0.26 per share, in the year-earlier quarter.
Weaver said the increase in research and development spending was driven primarily by ongoing AUD and ALD trials, as well as startup costs for the Phase 3 MASH trial, partially offset by lower expenses tied to completion of the Phase 2 IMPACT trial. He said the increase in general and administrative expense was primarily due to severance costs and professional fees.
In closing remarks, Durso said Altimmune has made “significant progress” as it evolves into a late-stage company and remains focused on advancing pemvidutide and creating long-term shareholder value.
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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