On March 5, 2026 Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update.
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"In pemvidutide, we have a unique and differentiated compound with the potential to address critical unmet needs of patients with serious liver diseases such as MASH. We are committed to taking the necessary steps to realize its value for all of our stakeholders and have significantly progressed our efforts to strengthen our financial and operational foundation," said Jerry Durso, President and Chief Executive Officer of Altimmune. "We remain focused on ensuring that we have the means and the capabilities to successfully execute Phase 3 development in MASH and capture the significant opportunities ahead of us. We have a number of important inflection points in 2026, most notably the upcoming initiation of our Phase 3 trial of pemvidutide in MASH, for which we are actively finalizing the study plan. Finally, we look forward to the topline data from our RECLAIM Phase 2 trial of pemvidutide in AUD, which we expect to release in the third quarter."
Recent Highlights and Anticipated Milestones
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Positive 48-week data from IMPACT Phase 2b trial reported in December 2025
Statistically significant improvements observed in key non-invasive markers of fibrosis and inflammation, such as Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), with continued reductions from 24-week timepoint
These markers are strongly associated with MASH histologic changes
These results build upon the statistically significant MASH resolution and positive trends in fibrosis improvement observed at 24 weeks
Additional weight loss from 24 to 48 weeks at the 1.8 mg dose with no evidence of plateauing
Greater adherence to treatment in pemvidutide arms, as shown by lower discontinuation rate than placebo group
Adherence likely attributable to favorable safety and tolerability profile of pemvidutide
Breakthrough Therapy Designation granted by FDA
Breakthrough Therapy Designation was granted based on 24-week data from IMPACT trial
This designation is awarded to therapies designed to treat serious or life- threatening conditions that have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies on a clinically significant endpoint
Successful End-of-Phase 2 Meeting with FDA
Alignment on Phase 3 registrational trial design confirmed following receipt of meeting minutes
Global Phase 3 trial expected to evaluate multiple pemvidutide doses over a 52-week treatment period with biopsy-based endpoints to support potential accelerated approval
Company has submitted request for scientific advice to European regulators
Alcohol Use Disorder (AUD)
Topline data from RECLAIM Phase 2 trial of pemvidutide in AUD expected in third quarter 2026
The RECLAIM trial is evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with AUD over a 24-week treatment period
Enrollment was completed in November 2025, several months ahead of schedule, signaling significant interest from patients and providers in potential new AUD therapies
Alcohol-associated Liver Disease (ALD)
RESTORE Phase 2 trial of pemvidutide in ALD continuing to enroll
The RESTORE trial is a 48-week study evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with ALD
Corporate Updates
Appointed Jerry Durso as Chief Executive Officer
Mr. Durso, who joined the Company’s Board of Directors in February 2025 and was appointed Chairman in August 2025, is an accomplished life sciences executive with more than 30 years of leadership experience in corporate and commercial strategy, business development and operations. His accomplishments include the development of a successful rare liver disease franchise at Intercept Pharmaceuticals, where he served as Chief Executive Officer until its acquisition by Alfasigma. Previously, he oversaw multiple blockbuster franchises during more than 20 years in senior leadership positions at Sanofi
Strengthened balance sheet
In January 2026, the Company completed a registered direct offering of common stock and pre-funded warrants with Alyeska Investment Group, resulting in gross proceeds of $75.0 million, and raised an additional $8.0 million via the At-the-Market (ATM) facility
Financial Results for the Three Months Ended December 31, 2025
Altimmune reported cash, cash equivalents and short-term investments totaling $274 million as of December 31, 2025, an increase of approximately 107% as compared to $132 million at December 31, 2024
As of February 28, 2026, the Company had approximately $340 million of cash and cash equivalents, reflecting the proceeds from the $75 million registered direct offering and $8 million from the sale of stock under the Company’s ATM facility
Research and development (R&D) expenses were $18.4 million for the three months ended December 31, 2025, compared to $19.8 million in the same period in 2024, with the decrease related to fluctuations in timing of Clinical Research Organization (CRO) related costs. R&D expenses for the quarter ended December 31, 2025, included $12.8 million in direct costs related to pemvidutide development activities
General and administrative (G&A) expenses were $10.5 million and $5.1 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily attributable to additional professional fees and compensation expenses, including a one-time stock compensation and payroll-related expense of approximately $2.6 million in the fourth quarter of 2025
Interest income was $2.4 million for the three months ended December 31, 2025
Net loss for the three months ended December 31, 2025, was $27.4 million, or $0.27 net loss per share, compared to a net loss of $23.2 million, or $0.33 net loss per share, in the same period in 2024
Financial Results for the Year Ended December 31, 2025
R&D expenses were $66.4 million for the year ended December 31, 2025, compared to $82.2 million in the same period in 2024, with the decrease primarily related to the timing of CRO development costs. The R&D expenses for the year ended December 31, 2025, included $42.4 million in direct costs related to pemvidutide development activities
G&A expenses were $28.1 million and $21.0 million for the 12 months ended December 31, 2025, and 2024, respectively. The G&A increase was primarily attributable to a one-time executive transition cost, as well as increases in professional fees and stock compensation and other labor-related expenses
Interest income was $7.5 million for the year ended December 31, 2025, compared to $8.1 million in the same period in 2024
Net loss for the three months ended December 31, 2025 was $88.1 million, or $1.00 net loss per share, compared to a net loss of $95.1 million, or $1.34 net loss per share, in the same period in 2024
Conference Call Information:
Date: March 5, 2026
Time: 8:30 a.m. Eastern Time
Webcast: To listen, the conference call will be webcast live on Altimmune’s Investor Relations 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 Investor Relations (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 a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, 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, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss.
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 48-week data from the IMPACT Phase 2b trial in MASH. The Phase 2 RECLAIM trial in AUD and RESTORE trial in ALD were initiated in May 2025 and July 2025, respectively, and are currently ongoing.
(Press release, Altimmune, MAR 5, 2026, View Source [SID1234663308])