Altimmune Announces First Quarter 2024 Financial Results and Provides a Business Update

GAITHERSBURG, Md., May 09, 2024 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024, and provided a business update.

“As the obesity therapeutics space evolves, increasing attention is being placed on agents that are able to drive weight loss while addressing the quality of that weight loss and the comorbidities of obesity. With significant weight loss, preservation of lean mass and reductions in serum lipids and liver fat achieved in our clinical trials, we believe that pemvidutide could differentiate itself from other therapies in this competitive market. With these promising data, we are preparing for our End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which is expected to occur late in the third quarter. This meeting is expected to provide further clarity regarding the Phase 3 pemvidutide obesity registrational program, and we look forward to our upcoming interactions with the Agency,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “Further, we continue to advance IMPACT, our Phase 2b trial of pemvidutide in MASH, with top line results expected in the first quarter of 2025.”

Recent Highlights and Anticipated Milestones:

  • In March 2024, Altimmune reported additional data from the Phase 2 MOMENTUM trial of pemvidutide in obesity, demonstrating significant weight loss with class-leading preservation of lean mass
    • Body composition analysis from MOMENTUM showed 74.5% of weight loss came from body fat and only 25.5% of weight loss came from lean mass in pemvidutide-treated subjects.
    • This analysis demonstrated a preferential reduction of visceral over subcutaneous fat in the pemvidutide group.
    • Analyses of the MOMENTUM body composition and other new data to be presented at scientific meetings later this year.
  • Preparations underway for an End-of-Phase 2 meeting with FDA
    • The Company plans to present a comprehensive data package, including data from the MOMENTUM Phase 2 trial of pemvidutide in obesity.
    • The meeting is currently expected to take place in late Q3 2024.
  • The Company has continued to advance enrollment in IMPACT, a biopsy-driven Phase 2b trial of pemvidutide in MASH
    • The Company expects to enroll approximately 190 subjects with and without diabetes, randomized to receive one of two doses of pemvidutide or placebo.
    • The primary efficacy measures of the trial are MASH resolution or fibrosis improvement with topline data expected in Q1 2025.
    • The primary efficacy readout will be at 24 weeks of treatment, which is the earliest time point for any incretin-based therapy in MASH.

Financial Results for the Three Months Ended March 31, 2024

  • Altimmune had cash, cash equivalents and short-term investments totaling $182.1 million at March 31, 2024.
  • Research and development expenses were $21.5 million for the three months ended March 31, 2024, compared to $17.2 million in the same period in 2023. The expenses for the quarter ended March 31, 2024 included $13.5 million in direct costs related to development activities for pemvidutide and $1.0 million in direct costs related to winddown and closing of our HepTcell program as announced on March 27, 2024.
  • General and administrative expenses were $5.3 million for the three months ended March 31, 2024, compared to $4.5 million in the same period in 2023. The increase was primarily due to a $0.6 million increase in stock compensation and other labor related expenses.
  • Interest income for the three months ended March 31, 2024 was $2.4 million as compared to $1.7 million in the same period in 2023, primarily due to an increase in interest income earned on cash equivalents and short-term investments.
  • Net loss for the three months ended March 31, 2024 was $24.4 million, or $0.34 net loss per share, compared to a net loss of $20.1 million, or $0.40 net loss per share, in the same period in 2023.

About Pemvidutide

Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, leading to rapid reductions in levels of liver fat and serum lipids. In clinical trials, once-weekly pemvidutide has shown compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure with a clean safety profile to date. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide has recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the IMPACT Phase 2b MASH trial.

About Altimmune

Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit