Altimmune Reports Q1 2024 Financials and Business Update

Altimmune, Inc., a clinical-stage biopharmaceutical company listed on Nasdaq as ALT, has disclosed its financial results for the first quarter ending March 31, 2024, and shared a business update. The company remains focused on advancing its therapeutic candidate, pemvidutide, aimed at treating obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH).

In the burgeoning field of obesity therapeutics, the emphasis is shifting towards treatments that not only induce weight loss but also improve the quality of weight lost and address obesity-related comorbidities. Altimmune's lead candidate, pemvidutide, has shown promising results in clinical trials, achieving substantial weight loss, preserving lean mass, and significantly reducing serum lipids and liver fat. These outcomes could potentially differentiate pemvidutide in a competitive market. The company is preparing for an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), expected in the late third quarter of 2024. This meeting is anticipated to provide clarity regarding the Phase 3 registration program for pemvidutide in obesity.

In March 2024, Altimmune released additional data from its Phase 2 MOMENTUM trial for obesity. The results demonstrated significant weight loss with exceptional preservation of lean mass, where 74.5% of the weight loss in pemvidutide-treated subjects came from body fat and only 25.5% was lean mass. Moreover, the analysis showed a preferential reduction of visceral fat over subcutaneous fat in those treated with pemvidutide. Detailed analyses from the MOMENTUM study and other new data are scheduled for presentation at scientific meetings later in the year.

The company continues to advance the enrollment in the IMPACT Phase 2b trial of pemvidutide in MASH. This trial, which is biopsy-driven, is expected to enroll approximately 190 subjects, including those with and without diabetes. Participants will be randomized to receive one of two doses of pemvidutide or a placebo. The primary efficacy measures are the resolution of MASH or improvement in fibrosis, with top line results anticipated in the first quarter of 2025. Notably, this trial will provide the earliest readout for any incretin-based therapy in MASH at 24 weeks of treatment.

Financially, as of March 31, 2024, Altimmune reported cash, cash equivalents, and short-term investments totaling $182.1 million. Research and development expenses for the quarter were $21.5 million, up from $17.2 million in the same period in 2023. This increase includes $13.5 million in direct costs related to the development of pemvidutide and $1 million for the winddown of the HepTcell program. General and administrative expenses also rose to $5.3 million from $4.5 million in the previous year, primarily due to increased stock compensation and labor-related expenses. Interest income increased to $2.4 million from $1.7 million a year earlier, primarily from higher returns on cash equivalents and short-term investments. The net loss for the quarter was $24.4 million, translating to a net loss per share of $0.34, compared to a net loss of $20.1 million or $0.40 per share in the same period in 2023.

Pemvidutide is an investigational peptide-based GLP-1/glucagon dual receptor agonist targeting obesity and MASH. By activating both GLP-1 and glucagon receptors, it aims to replicate the complementary effects of diet and exercise on weight loss, with GLP-1 reducing appetite and glucagon enhancing energy expenditure and hepatic fat metabolism. Clinical trials have shown that once-weekly pemvidutide administration results in significant weight loss, reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure, while maintaining a favorable safety profile. The U.S. FDA has granted Fast Track designation to pemvidutide for treating MASH.

Altimmune continues to push forward with its innovative peptide-based therapeutics, with pemvidutide leading the charge. The ongoing trials and forthcoming regulatory meetings are critical milestones that the company is poised to navigate as it advances its clinical and business objectives.