Altimmune Reports Q2 2024 Financial Results and Business Update

Altimmune, Inc., a clinical-stage biopharmaceutical firm, has recently shared its financial results for the second quarter ending June 30, 2024, along with notable updates regarding their ongoing projects. The company, listed on Nasdaq under the ticker ALT, is making significant strides in the development of its lead candidate, pemvidutide, particularly in the fields of obesity and metabolic dysfunction-associated steatohepatitis (MASH).

Dr. Vipin K. Garg, President and CEO of Altimmune, highlighted the second quarter's advancements. The company showcased compelling evidence supporting pemvidutide’s potential at major medical conferences. Specifically, data presented at the European Association for the Study of the Liver (EASL) meeting emphasized pemvidutide’s potential in modifying disease progression in MASH. Additionally, presentations at the American Diabetes Association (ADA) Scientific Sessions demonstrated significant weight reduction and serum lipid improvements in patients treated with pemvidutide. These findings bolster Altimmune’s confidence in pemvidutide’s differentiated profile and its potential utility in various metabolic disorders, including obesity and MASH.

Key developments during the second quarter include promising data from the Phase 2 MOMENTUM trial for obesity. Subjects treated with pemvidutide for 48 weeks exhibited substantial weight loss, with some achieving a reduction of up to 15.6%. Moreover, the treatment demonstrated superior preservation of lean mass compared to other incretin agents, with 78.1% of the weight loss attributed to fat rather than lean mass. Additionally, significant reductions in triglycerides, total cholesterol, and LDL cholesterol were observed in patients with elevated lipid levels. An end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) is anticipated in late Q3 2024, where Altimmune seeks to finalize the Phase 3 trial design and endpoints.

For MASH, Altimmune presented data at the EASL International Liver Congress™ 2024, which supported pemvidutide’s potential in modifying the disease. Analysis from the Phase 1 trial showed promising outcomes, with higher proportions of subjects achieving significant responses in FibroScan-aspartate aminotransferase (FAST) score, MRI-PDFF, and alanine aminotransferase (ALT) when compared to placebo. A computational model predicted that pemvidutide’s dual GLP-1/glucagon agonism would yield more potent effects on MASH resolution and fibrosis improvement than GLP-1 therapy alone. Additionally, lipidomic profiling indicated significant reductions in cardiovascular disease-associated serum lipids, reinforcing the therapeutic potential of pemvidutide in MASH and associated cardiovascular comorbidities.

Altimmune also published data in the Journal of Hepatology from a previously reported 12-week clinical trial of pemvidutide in MASLD. This Phase 1 trial involving 94 subjects demonstrated substantial reductions in liver fat content (LFC), with up to 68.5% relative reduction, compared to 4.4% in the placebo group. Significant improvements in body weight and liver inflammation markers were also observed. Importantly, the study showed a low adverse event discontinuation rate of 2.9%.

The company is advancing the IMPACT Phase 2b trial, aiming to enroll around 190 subjects, with and without type 2 diabetes, to further investigate pemvidutide’s efficacy in MASH. The primary endpoints will assess MASH resolution or fibrosis improvement at 24 weeks.

Financially, Altimmune reported cash, cash equivalents, and short-term investments totaling $164.9 million as of June 30, 2024. Research and development expenses rose to $21.2 million, primarily due to ongoing development activities for pemvidutide. General and administrative expenses were $5.6 million, mainly attributed to increased stock compensation expenses. For the quarter, the company reported a net loss of $24.6 million, or $0.35 per share.

In summary, Altimmune is making significant progress with pemvidutide in both obesity and MASH, backed by robust clinical data and ongoing trials, positioning the company well for future advancements in these therapeutic areas.