Altimmune NASDAQ: ALT executives said the company is preparing to begin enrolling patients in the second half of the year for a Phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis, or MASH, while also awaiting data from related alcohol-associated liver disease programs.
Speaking at the Jefferies 2026 Global Healthcare Conference, Chief Executive Officer Jerry Durso said Altimmune is in the startup phase of its Phase 3 MASH program and expects patient enrollment to begin later this year. He also pointed to recently presented data at the European Association for the Study of the Liver, or EASL, meeting as strengthening the company’s view of pemvidutide’s potential differentiation in MASH.
“It is an exciting year for Altimmune,” Durso said, adding that the company is continuing to build its understanding of what pemvidutide could bring to the MASH population as the market becomes more competitive.
Company Highlights EASL Data and Fibrosis Analyses
Altimmune’s chief medical officer, Christophe, said the company had a significant presence at EASL and received a “best of EASL” abstract designation for an oral presentation on 48-week data. He said Altimmune also presented data on cardiovascular risk, non-invasive testing and qFibrosis, a second harmonic generation-based analysis of biopsy samples.
Christophe said several methods of evaluating fibrosis were directionally consistent, including biological markers such as PRO-C3 and CTX, PathAI’s LiverExplore approach and qFibrosis.
“All these different approaches were consistently showing that anti-fibrotic effect of pemvidutide,” he said.
He noted that standard histological reading of biopsies can vary among pathologists, especially at 24 weeks, and said Altimmune designed its Phase 3 trial with a 52-week biopsy-based interim analysis partly to address that variability. He said the company’s 48-week Phase 2 data showed a “very strong anti-fibrotic effect.”
Phase 3 Trial to Use Biopsy and Non-Invasive Tools
Christophe said Altimmune has regulatory alignment with the U.S. Food and Drug Administration and European regulators on the Phase 3 protocol. He said the trial will use MASH assist, an artificial intelligence-supported tool that helps pathologists read digital biopsy images, while pathologists retain final judgment.
Altimmune also plans to include qFibrosis as a secondary endpoint in the Phase 3 trial. Christophe emphasized that qFibrosis is not an approved primary endpoint, but said it could complement biopsy-based primary endpoint assessments.
The Phase 3 study will include patients with F2 and F3 fibrosis. Christophe said Cohort 1 will include about 990 biopsy-proven F2 and F3 patients and will support the accelerated approval efficacy assessment. A second cohort will be based more heavily on non-invasive tests, or NITs, while also contributing to the safety database needed for accelerated approval.
Durso said Altimmune will collect non-invasive test data for all patients, which could position the company to respond if regulators eventually allow NIT-based endpoints in MASH.
“We would need the agency to move their position,” Durso said.
Executives Emphasize Differentiation in MASH Market
Asked about pemvidutide’s potential positioning if approved, Durso said differentiation will be central as more MASH therapies enter the market. He said pemvidutide’s dual mechanism, combining weight loss effects with direct liver activity, could be important for selected patient segments.
Durso said GLP-1 monotherapies may become a common first-line option by the time pemvidutide could reach the market, but he argued that durability of treatment and tolerability could be key differentiators. He said in Altimmune’s Phase 2 trial, discontinuation on the 1.8 mg dose was lower than placebo.
He also pointed to potential use in patients at risk of sarcopenia and said pemvidutide may fit in the “middle of the treatment cascade,” while other approaches could be used in different patient groups.
Durso said the EASL meeting reinforced the company’s view that the balance between glucagon and GLP-1 activity matters. He said Altimmune believes pemvidutide’s balanced ratio and its EuPort domain may contribute to a differentiated tolerability and efficacy profile.
Balance Sheet Supports MASH Readout Timeline
Chief Financial Officer Greg Weaver said Altimmune has raised capital through two equity offerings this year, including $75 million in January and a more recent $225 million offering. He said the company’s balance sheet is now “north of $500 million.”
Weaver said that funding is expected to cover the company’s runway through delivery of MASH results in 2029, while also supporting Phase 2 trials in alcohol use disorder, or AUD, and alcohol-associated liver disease, or ALD.
“Going forward, we would focus on non-dilutive options as our preferred go-forward plan,” Weaver said, noting possible strategic investments, debt facility use or an at-the-market program as additional sources of flexibility.
AUD and ALD Data Remain Upcoming Catalysts
Durso said the company is also looking forward to data from its AUD and ALD programs, calling them an expansion of pemvidutide’s potential into areas of high unmet need. He said AUD data are expected in the third quarter, with ALD enrollment expected to be completed in the third quarter as well.
Christophe said pemvidutide may be relevant in AUD and ALD because its GLP-1 activity could address reward and alcohol cravings, while its glucagon activity may address liver-related effects. He said the AUD study will evaluate heavy drinking days, and the company powered the trial around a one-day difference between pemvidutide and placebo.
He said the study will also use blood markers, including phosphatidylethanol, or PEth, and will evaluate other endpoints such as days of no drinking and World Health Organization drinking level changes.
Durso said Altimmune expects to issue a traditional topline data release for the AUD study in the third quarter. If the data are positive, he said the company would seek interaction with regulators and update its plans.
“The company stays extremely focused,” Durso said. “We are in an era of execution.”
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.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.
Before you consider Altimmune, you'll want to hear this.
MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Altimmune wasn't on the list.
While Altimmune currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys.
View The Five Stocks Here
Click the link to see MarketBeat's guide to investing in 5G and which 5G stocks show the most promise.
Get This Free Report
