Altimmune, Inc. (NASDAQ: ALT) is a clinical-stage biopharmaceutical company that has emerged as a promising player in the treatment of obesity and non-alcoholic steatohepatitis (NASH). The company's lead product candidate, pemvidutide, is a novel GLP-1/glucagon dual receptor agonist that has demonstrated impressive results in clinical trials, positioning it as a potential best-in-class therapy for these prevalent and challenging metabolic disorders.
Business Overview
Altimmune is focused on developing innovative peptide-based therapeutics, with a particular emphasis on obesity and NASH. The company's pipeline is anchored by pemvidutide, which is being evaluated for the treatment of both conditions. Pemvidutide's unique mechanism of action, which targets the GLP-1 and glucagon receptors, is designed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure.In the obesity indication, Altimmune recently reported positive results from the Phase 2 MOMENTUM trial, which demonstrated that pemvidutide achieved significant and sustained weight loss, with up to 74.5% of the weight loss coming from body fat. These results, along with robust reductions in liver fat and serum lipids, position pemvidutide as a potential best-in-class therapy for individuals with obesity and associated metabolic comorbidities.
Turning to NASH, Altimmune is currently enrolling patients in the Phase 2b IMPACT trial, which is evaluating the safety and efficacy of pemvidutide in subjects with NASH. The company believes that pemvidutide's ability to directly target the liver, in addition to its weight loss effects, could make it a compelling treatment option for this patient population. Altimmune has received Fast Track designation from the FDA for the investigation of pemvidutide in NASH, underscoring the significant unmet need in this area.
Financials
Altimmune's financial performance has been marked by significant investment in the development of its pipeline, particularly pemvidutide. For the full year 2023, the company reported annual revenue of $426,000 and a net loss of $88,447,000. The company's annual operating cash flow and free cash flow were -$76,005,000 and -$76,052,000, respectively.In the first quarter of 2024, Altimmune reported revenue of negligible amounts, consistent with the prior-year period, as the company continues to close out a government contract. Research and development expenses increased to $21.5 million in Q1 2024, compared to $17.2 million in Q1 2023, primarily due to the ramp-up of the IMPACT trial in NASH and ongoing activities for the MOMENTUM trial in obesity. General and administrative expenses also rose to $5.3 million in Q1 2024, up from $4.5 million in the same period last year, driven by an increase in stock-based compensation and other labor-related expenses.
The company ended the first quarter of 2024 with approximately $182.1 million in cash, cash equivalents, and short-term investments, which it believes will fund operations into the first half of 2026, fully covering the IMPACT trial in NASH and the planned Phase 3 program in obesity.
Competitive Landscape and Differentiation
Altimmune's pemvidutide faces competition from other GLP-1-based therapies, such as semaglutide and tirzepatide, which have also demonstrated impressive weight loss and metabolic benefits. However, Altimmune believes that pemvidutide's unique dual agonist mechanism, targeting both the GLP-1 and glucagon receptors, provides a key point of differentiation.The company's data has shown that pemvidutide can achieve significant weight loss while preserving lean muscle mass, a critical factor that may differentiate it from other therapies. Additionally, pemvidutide has demonstrated robust reductions in liver fat and serum lipids, which could make it a particularly attractive option for patients with obesity and associated metabolic comorbidities, such as NASH.
Altimmune is also exploring the development of an oral formulation of pemvidutide, which could provide patients with additional flexibility and convenience in administration, potentially further enhancing the product's competitiveness.
Regulatory Milestones and Partnering Efforts
Altimmune is preparing for a pivotal end-of-Phase 2 meeting with the FDA for the obesity indication, which the company expects to be a value-driving event. During this meeting, the company plans to discuss the optimal design of its Phase 3 program, including the selection of patient populations, endpoints, and treatment durations that will best highlight pemvidutide's differentiated profile.In parallel, Altimmune continues to actively pursue partnership opportunities for pemvidutide. The company believes that finding the right partner, with the ability to maximize the near- and long-term value of the program, is a key priority. Altimmune's management has stated that they are committed to securing a partner before initiating the Phase 3 program in obesity.
Risks and Challenges
As with any clinical-stage biopharmaceutical company, Altimmune faces several risks, including the potential for delays or failures in its clinical trials, regulatory hurdles, and competition from other therapies. The company's reliance on the success of pemvidutide also represents a concentration risk, as the failure or underperformance of this lead candidate could have a significant impact on Altimmune's overall prospects.However, Altimmune also has several potential catalysts on the horizon. The upcoming end-of-Phase 2 meeting with the FDA for the obesity indication, as well as the anticipated readout of the IMPACT trial in NASH in the first quarter of 2025, could provide important validation and guidance for the company's development plans. Additionally, the potential for an oral formulation of pemvidutide could further enhance the product's commercial potential.