Business Overview and History
Altimmune, Inc. is a clinical-stage biopharmaceutical company that has made significant strides in developing innovative peptide-based therapeutics, with a particular focus on addressing obesity and metabolic disorders. The company's lead product candidate, pemvidutide, has demonstrated impressive results in clinical trials, positioning Altimmune as a promising player in the burgeoning metabolic disease market.
Altimmune was founded in 2010 and is headquartered in Gaithersburg, Maryland. Since its inception, the company has focused on developing treatments for various diseases and disorders, as well as vaccines. In the early years, Altimmune devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and raising capital. The company has financed its operations through the issuance of common and preferred stock, long-term debt, and proceeds from research grants and government contracts.
One of Altimmune's early product candidates was Flunisyn, a T-cell vaccine for the treatment of influenza, based on the company's Densigen platform. In 2015, the company suspended the development of Flunisyn after clinical trials showed mixed results. In 2017, Altimmune merged with PharmAthene, Inc., acquiring additional stock-based compensation instruments to incentivize employees and attract talent.
Throughout its history, Altimmune has faced various challenges, including clinical holds imposed by regulatory authorities and difficulties in manufacturing clinical materials. Despite these obstacles, the company has continued to advance its research and development efforts. In 2019, Altimmune made a strategic pivot by acquiring Spitfire Pharma and shifting its core focus toward the development of peptide-based therapeutics for metabolic diseases, particularly pemvidutide.
Under the leadership of CEO Vipin K. Garg, Ph.D., Altimmune has made significant progress in advancing pemvidutide, a novel GLP-1/glucagon dual receptor agonist. Pemvidutide is currently in late-stage clinical development for the treatment of obesity and metabolic associated steatohepatitis (MASH), a severe form of non-alcoholic fatty liver disease (NAFLD).
Financials
As of December 31, 2024, Altimmune reported a strong cash, cash equivalents, and short-term investments position of $131.9 million, providing the company with sufficient runway to continue its clinical development activities. The company's financial performance has been marked by significant research and development (R&D) investments, with R&D expenses totaling $82.2 million in 2024, up from $65.8 million in 2023. This reflects the company's focus on advancing its pipeline, particularly the development of pemvidutide.
Altimmune's net loss for the year ended December 31, 2024, was $95.1 million, compared to a net loss of $88.4 million in the prior year. The company's operating cash flow and free cash flow for 2024 were both negative $79.8 million, as the company continued to invest heavily in its clinical programs.
For the most recent fiscal year (2024), Altimmune reported: - Revenue: $20,000 - Net Income: -$95.06 million - Operating Cash Flow: -$79.85 million - Free Cash Flow: -$79.85 million
In the most recent quarter (Q4 2024), the company reported: - Revenue: $5,000 - Net Income: -$23.18 million - Operating Cash Flow: Not available - Free Cash Flow: Not available
It's important to note that Altimmune has not generated meaningful revenue from product sales, as its product candidates are still in clinical development. The company has primarily financed its operations through equity offerings.
Liquidity
Despite the significant net losses, Altimmune's balance sheet remains relatively strong, with a current ratio of 13.11 and a quick ratio of 13.11 as of December 31, 2024, indicating a solid liquidity position. The company's debt-to-equity ratio is also low at 0.014, suggesting a conservative capital structure.
Altimmune's liquidity position as of December 31, 2024: - Cash and Short-term Investments: $131.9 million - Debt/Equity Ratio: 0.014 - Current Ratio: 13.11 - Quick Ratio: 13.11
The company believes its current cash resources are sufficient to fund operations for at least a twelve-month period from the issuance date of the December 31, 2024 financial statements. Furthermore, management expects the current cash position of $132 million to fund operations well into the second half of 2026, which includes the key catalyst of the Phase 2b NASH readout next quarter and the funding of the Phase 2 trials for additional indications.
Pemvidutide: Altimmune's Promising Lead Candidate
The key driver of Altimmune's growth potential is its lead product candidate, pemvidutide. Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist that is currently in late-stage clinical development for the treatment of obesity and MASH.
Pemvidutide's unique mechanism of action, which combines the weight loss effects of GLP-1 agonism with the liver-directed benefits of glucagon agonism, has positioned it as a potentially differentiated therapy in the rapidly evolving metabolic disease landscape. Altimmune believes pemvidutide's mechanism of action can 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, which is believed to lead to rapid reductions in levels of liver fat and serum lipids.
In the company's 48-week MOMENTUM Phase 2 obesity trial, subjects receiving pemvidutide achieved mean weight loss of 10.3%, 11.2%, and 15.6% at the 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively, compared to 2.2% for placebo. Pemvidutide also resulted in robust reductions in serum lipids and improvements in blood pressure without imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate.
Importantly, pemvidutide has also shown promising results in the treatment of MASH. In a separate 12-week Phase 1b trial in subjects with overweight or obesity and MASLD, pemvidutide reduced liver fat content relative to baseline by up to 68.5% and decreased total cholesterol and triglycerides by up to 12.2% and 44.6%, respectively, after 12 weeks of treatment.
Upcoming Catalysts and Regulatory Milestones
Altimmune is poised for several key catalysts in the near future. The company recently completed enrollment in the 48-week Phase 2b biopsy-driven IMPACT trial, which is evaluating pemvidutide in subjects with MASH. Top-line data from this study are expected in the second quarter of 2025, and positive results could position pemvidutide as the first incretin-based agent to demonstrate both significant fibrosis improvement and meaningful weight loss in a 24-week treatment period.
The key metric for success in the IMPACT trial will be the ability to achieve statistical significance on the fibrosis improvement endpoint at 24 weeks. Altimmune believes the IMPACT trial is sufficiently powered to achieve this goal, given the larger treatment arms compared to previous successful FGF21 trials and the greater liver fat reduction observed with pemvidutide.
Additionally, Altimmune has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for pemvidutide in the treatment of obesity. The company has aligned with the FDA on the design of a Phase 3 registrational program, which is expected to commence in early 2026. This represents a crucial milestone as Altimmune works to advance pemvidutide towards potential regulatory approval. The planned Phase 3 program will include four trials evaluating pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg over 60 weeks of treatment.
Furthermore, the company has recently filed Investigational New Drug (IND) applications for pemvidutide in two additional undisclosed indications, which have been cleared by the FDA. Altimmune plans to initiate Phase 2 efficacy trials for these new indications in the middle of 2025, further diversifying its pipeline and exploring the versatility of pemvidutide.
Altimmune also plans to request an end-of-Phase 2 meeting with the FDA to align on a registrational Phase 3 program in NASH, which they expect to occur before the end of 2025.
Risks and Challenges
As with any clinical-stage biopharmaceutical company, Altimmune faces a range of risks and challenges that investors should be aware of. The success of the company's operations is heavily dependent on the continued development and regulatory approval of pemvidutide. Any setbacks or delays in the clinical trials or regulatory review process could have a significant impact on the company's valuation and future prospects.
Additionally, Altimmune operates in a highly competitive landscape, with several other companies developing therapies for obesity and metabolic disorders. The company's ability to differentiate pemvidutide and maintain a competitive edge will be crucial to its long-term success.
Altimmune also faces the typical risks associated with drug development, including the potential for adverse events, manufacturing challenges, and the need to attract and retain key talent. Successful commercialization of any approved product will also depend on the company's ability to effectively market and distribute the therapy.
Conclusion
Altimmune is a clinical-stage biopharmaceutical company that has positioned itself as a promising player in the rapidly evolving metabolic disease space. The company's lead candidate, pemvidutide, has demonstrated impressive results in clinical trials, particularly in the treatment of obesity and MASH. With several key catalysts on the horizon, including the anticipated Phase 2b IMPACT data readout and the initiation of Phase 2 trials in new indications, Altimmune is poised to capitalize on the growing demand for effective therapies in the metabolic disease market.
While the company faces the typical risks associated with drug development, Altimmune's strong financial position, experienced management team, and promising pipeline suggest that it is well-equipped to navigate the challenges and deliver value for its shareholders. As the company continues to advance its clinical programs and diversify its portfolio, Altimmune's story is one that deserves close attention from investors in the biotechnology sector.