What Altimmune (ALT) Said on Its Q3 Earnings Call

Key Points

• Altimmune has activated more than 70 U.S. sites for its phase III PERFORMA trial of pemvidutide in MASH, with screening and dosing underway and a 52-week data readout expected in 2029.
• The company will seek FDA feedback in December on a phase III program for alcohol use disorder. It plans to propose risk drinking levels as the primary endpoint, but trial timing and design depend on regulatory feedback and funding.
• Altimmune ended the quarter with $480 million in cash, equivalents and investments, which it expects to fund operations through the MASH trial readout. Its quarterly net loss widened to $31.6 million as research and development spending rose.

Altimmune NASDAQ: ALT is ramping up a late-stage trial of its experimental drug pemvidutide for a serious liver disease and preparing for a December meeting with the U.S. Food and Drug Administration on a potential phase III program in alcohol use disorder.

On its third-quarter earnings call Nov. 12, management said the company had activated more than 70 U.S. sites for the phase III PERFORMA trial in metabolic dysfunction-associated steatohepatitis, or MASH. Patients are being screened and dosed, with a 52-week data readout expected in 2029.

The company also reported a wider quarterly net loss as research and development spending rose. It ended the quarter with $480 million in cash, equivalents and investments, which it expects to fund operations through the PERFORMA readout.

MASH Trial Progress

Chairman and CEO Jerry Durso said PERFORMA’s early progress was encouraging and that site activation was tracking to plan. Altimmune has previously discussed an enrollment period of 18 to 24 months. It did not disclose how many patients had been randomized.

Chief Medical Officer Christophe Arbet-Engels said most planned U.S. sites were active and recruiting, while sites outside the U.S. were expected to come online in the coming months. Roughly one-third of the study’s eventual sites are expected to be in the U.S., Durso said.

Management also discussed new noninvasive test analyses from the phase IIb IMPACT trial, presented at The Liver Meeting. Arbet-Engels said the analyses showed improvements across measures of liver fat, inflammation and fibrosis compared with placebo. Altimmune said the trial’s 48-week efficacy and safety results were published in The Lancet.

PERFORMA is testing a 2.4-milligram dose of pemvidutide alongside the 1.8-milligram dose studied in phase II. Arbet-Engels cautioned that data presented for another drug in the same class came from a separate study, not a head-to-head comparison with pemvidutide.

Alcohol Use Disorder Plans

Altimmune is seeking FDA feedback in December on the design and regulatory path for a phase III alcohol use disorder, or AUD, program. Durso said meeting minutes typically arrive within 30 days and the company would communicate appropriately afterward. He also expects dialogue with the European Medicines Agency in the first quarter.

In the phase II RECLAIM trial, pemvidutide produced statistically significant improvements in the primary measure of heavy drinking days and in key secondary measures, including World Health Organization risk drinking levels and the achievement of no heavy drinking days, Arbet-Engels said. An objective blood-based measure of alcohol consumption corroborated the self-reported reductions, he added.

Altimmune plans to propose risk drinking level as the primary endpoint for its phase III AUD study, with no heavy drinking days as a key secondary endpoint. The proposed design would test 1.8-milligram and 2.4-milligram doses, assess primary efficacy at 26 weeks and continue for up to a year to collect additional data. The final design remains subject to regulatory discussions.

Arbet-Engels said the company plans to include patients with advanced liver impairment and a group with a body mass index below 25. RECLAIM had limited enrollment to patients with a BMI above 25. He said responses were consistent across BMI groups, while the company continued to analyze the data.

Durso declined to give a start date for the phase III AUD trial, saying regulatory feedback and funding would help determine the next steps.

Financial Results and Funding

Third-quarter research and development expenses increased to $27 million from $15 million a year earlier, primarily reflecting the start of the phase III MASH trial and the ongoing phase II study in alcohol-associated liver disease, or ALD, Chief Financial Officer Greg Weaver said. General and administrative expenses rose to $8.7 million from $5.9 million.

The net loss widened to $31.6 million, or 15 cents per share, from $19 million, or 21 cents per share, a year earlier.

Weaver said Altimmune prefers non-dilutive funding for the phase III AUD program, including potential royalty debt or a strategic partnership. Durso said the company was open to approaches that could advance pemvidutide, but did not provide further partnership details.

Altimmune also expects top-line results in the second half of 2027 from RESTORE, a 48-week phase II trial in 121 patients with ALD. Arbet-Engels said he could not predict the size of the treatment effect in that patient population.

About Altimmune (NASDAQ:ALT)

Altimmune, Inc. is a clinical-stage biopharmaceutical company developing peptide-based treatments for obesity and liver diseases. The company is headquartered in Gaithersburg, Maryland. Its lead candidate, pemvidutide, is an investigational medicine that activates GLP-1 and glucagon receptors. Altimmune has studied the drug for obesity and metabolic dysfunction-associated steatohepatitis (MASH), a serious form of fatty liver disease. Altimmune's work focuses on advancing treatments through clinical development; pemvidutide is not an approved medicine.

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