Altimmune, Inc.

Altimmune, Inc. announced the initiation of patient enrollment in its global PERFORMA Phase 3 trial for pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This advancement into late-stage development follows positive results from the IMPACT Phase 2b study and incorporates feedback from the U.S. FDA and European regulatory agencies. The trial aims to evaluate pemvidutide's efficacy and safety, with a 52-week data readout expected in 2029, and is designed to support both accelerated and final regulatory approval.

Altimmune, Inc. announced positive topline results from its RECLAIM Phase 2 trial evaluating pemvidutide 2.4 mg for moderate to severe alcohol use disorder (AUD). The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days per week versus placebo. Key secondary endpoints, including a two-level reduction in WHO Risk Drinking Level and zero heavy drinking days (both FDA registrational endpoints), were also met. The company observed a generally favorable safety and tolerability profile and plans to request an End-of-Phase 2 meeting with the FDA.

Altimmune, Inc. announced its plan to relocate its corporate headquarters from Gaithersburg, Maryland, to Morristown, New Jersey, later this year. The move is strategically aimed at leveraging New Jersey's robust biopharmaceutical industry presence to attract top-tier talent and support the company's growth as a late-stage development company. The company has secured a 5-year lease for the new headquarters, with annual rent payments of approximately $300,000, and expects to achieve long-term cost efficiencies from the relocation.

Altimmune announced new 48-week data from its IMPACT Phase 2b trial for pemvidutide, showing significant reductions in elevated lipids and improvements in multiple cardiometabolic risk factors in MASH patients. The data, presented at EASL 2026, highlighted reductions in triglycerides, total cholesterol, weight, waist circumference, and blood pressure. The safety profile was maintained, with a generally favorable tolerability profile. The company plans to initiate the PERFORMA Phase 3 trial later this year to further evaluate pemvidutide's efficacy and safety in MASH patients.

Altimmune, Inc. announced that its management will participate in two upcoming investor conferences in June 2026. The company will present at the 2026 Jefferies Global Healthcare Conference on June 4 and the Goldman Sachs 47th Annual Global Healthcare Conference on June 10. Webcasts of the fireside chats will be accessible via the company's website.

Altimmune, Inc. reported a net loss of $(22.6) million for the first quarter of 2026, an increase from $(19.6) million in Q1 2025, driven by higher operating expenses. Subsequent to the quarter, the company completed an April 2026 Offering, raising approximately $211.2 million in net proceeds and potentially an additional $225 million from warrant exercises. The company also increased its authorized common stock from 200 million to 400 million shares to support future capital needs.

Altimmune reported a net loss of $22.6 million, or $0.18 per share, for the first quarter ended March 31, 2026. The company significantly strengthened its balance sheet, holding $535 million in cash, cash equivalents, and short-term investments as of April 30, 2026, following recent public offerings. Key clinical milestones include the planned initiation of the PERFORMA Phase 3 MASH trial in the second half of 2026 for pemvidutide, which has Breakthrough Therapy Designation, and anticipated topline data from the RECLAIM Phase 2 AUD trial in Q3 2026. Enrollment completion for the RESTORE Phase 2 ALD trial is also expected in Q3 2026.

Altimmune, Inc. announced that analyses of data from its IMPACT Phase 2b clinical trial for pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) will be presented at the European Association for the Study of the Liver (EASL) Congress 2026. The company's abstract on 48-week results was selected as "Best of EASL 2026" and will be featured in an oral presentation. Additionally, new 24-week findings, including digital pathology analysis of liver fibrosis regression and cardiovascular measures, will be presented in poster sessions.

Altimmune, Inc. announced it will report its first quarter 2026 financial results on Wednesday, May 13, 2026. The company's management will host a conference call at 8:30 a.m. ET on the same day to discuss the results and provide a business update. The conference call will be webcast live on Altimmune's Investor Relations website, with a replay available for three months.

Altimmune, Inc. completed a public offering, raising approximately $211.2 million in net proceeds. The offering included 64,250,000 shares of common stock and 10,750,000 pre-funded warrants, each accompanied by common stock warrants. The company plans to use the funds to advance the clinical development of pemvidutide, including its global pivotal Phase 3 trial for MASH, and for general corporate purposes.