On August 12, 2026 Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.
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"We have achieved several important milestones as we continue to successfully execute our strategy, including the initiation of the PERFORMA Phase 3 MASH trial and positive topline data from the RECLAIM Phase 2 AUD trial. The team remains focused on advancing our differentiated pemvidutide franchise in both MASH and AUD, each an area of unmet need with substantial future sales potential," said Jerry Durso, Chief Executive Officer and Chairman of the Board of Altimmune. "We are also pleased to announce completion of enrollment in the RESTORE Phase 2 ALD trial. Our momentum positions Altimmune to deliver on our goals of bringing pemvidutide to patients with serious liver diseases and creating value for shareholders."
Key Highlights and Anticipated Milestones
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Pemvidutide was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) based on 24-week data from the IMPACT Phase 2b trial
In August 2026, the Company announced the initiation of the global PERFORMA Phase 3 MASH trial, with 52-week data readout anticipated in 2029
The PERFORMA trial is a Phase 3, Global, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects with MASH
Alcohol Use Disorder (AUD)
In July 2026, the Company reported positive topline results from the RECLAIM Phase 2 trial of pemvidutide in AUD
The RECLAIM trial evaluated the safety and efficacy of pemvidutide versus placebo in 100 patients with AUD over a 24-week treatment period
Pemvidutide achieved a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial
Important secondary endpoints were also met, including a 2-level reduction in WHO-risk drinking levels and zero heavy drinking days, both recognized by the FDA as registrational endpoints
A generally favorable safety and tolerability profile was observed in the trial
The Company plans to request an End-of-Phase 2 meeting with the FDA and engage with the European regulatory agencies to discuss a path forward in AUD
The FDA granted Fast Track designation to pemvidutide for the treatment of AUD
Alcohol-associated Liver Disease (ALD)
In July 2026, the Company completed patient enrollment in the RESTORE Phase 2 trial of pemvidutide in ALD
The RESTORE trial is a 48-week study evaluating the safety and efficacy of pemvidutide versus placebo in approximately 120 patients with liver disease due to excessive alcohol consumption
The trial enrolled patients with ALD and a history of chronic and heavy drinking at baseline
To support future regulatory discussions, the Company has amended the trial protocol to more fully evaluate the liver benefits pemvidutide may provide after one year of treatment in the ALD population
The primary endpoint, change from baseline in Liver Stiffness Measurement (LSM), will now be assessed hierarchically at Week 48 and then at Week 24
The secondary endpoints include changes in Enhanced Liver Fibrosis (ELF) score, alcohol consumption and body weight
The Company expects to report topline data in the second half of 2027
Corporate Updates
In April 2026, the Company completed an oversubscribed public offering of common stock, pre-funded warrants, and stock warrants, resulting in gross proceeds of $225.0 million
In June 2026, the Company announced plans to relocate its corporate headquarters to Morristown, New Jersey later in 2026
Financial Results for the Three Months Ended June 30, 2026
Altimmune reported cash, cash equivalents and investments totaling $519 million as of June 30, 2026
Research and development (R&D) expenses were $18.7 million for the three months ended June 30, 2026, compared to $17.2 million in the same period in 2025, with the increase driven primarily by the ongoing ALD trial as well as the startup costs for the PERFORMA Phase 3 trial in MASH, partially offset by the decrease in expenses related to completion of the IMPACT Phase 2b trial in MASH, which was ongoing in 2025. R&D expenses for the quarter ended June 30, 2026, included $11.6 million in direct costs related to pemvidutide development activities
General and administrative (G&A) expenses were $7.6 million for the three months ended June 30, 2026, compared to $5.7 million in the same period in 2025. The increase was driven primarily by an increase in professional services and compensation expenses in the second quarter of 2026
Interest income was $4.5 million for the three months ended June 30, 2026
Net loss for the three months ended June 30, 2026, was $22.8 million, or $0.12 net loss per share, compared to a net loss of $22.1 million, or $0.27 net loss per share, in the same period in 2025
Conference Call Information:
Date: August 12, 2026
Time: 8:30 a.m. Eastern Time
Webcast: To listen, the conference call will be webcast live on Altimmune’s Investor Relations (IR) website at View Source
Dial-in: To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call.
Following the conclusion of the call, the webcast will be available for replay on the IR page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.
About Pemvidutide
Pemvidutide is an investigational novel peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity that has an effect on reducing liver fat, inflammation, and fibrosis, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss and are involved in pathways related to craving and reward.
The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced topline 48-week data from the IMPACT Phase 2b trial in MASH. In July 2026, the PERFORMA Phase 3 trial, a global, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH was initiated. In July 2026, the Company announced positive topline results from the RECLAIM Phase 2 trial in AUD. In July 2026, the Company completed enrollment of the RESTORE Phase 2 trial in ALD.
(Press release, Altimmune, AUG 12, 2026, View Source [SID1234670022])