Business Overview and History

Altimmune, a clinical-stage biopharmaceutical company, has established itself as a leader in the development of innovative peptide-based therapeutics targeting obesity and metabolic disorders. With a strong pipeline and a focus on leveraging the unique properties of balanced GLP-1/glucagon dual agonism, Altimmune is poised to make significant strides in addressing the growing global epidemic of obesity and its associated comorbidities.

Altimmune, Inc. was incorporated under the laws of the State of Delaware and founded in 2017, with its headquarters established in Gaithersburg, Maryland. Since its inception, the company has focused on business planning, research and development, recruiting management and technical staff, and raising capital. Altimmune has primarily financed its operations through the issuance of common and preferred stock, long-term debt, and proceeds from research grants and government contracts.

A significant milestone in Altimmune's history occurred in 2019 when the company acquired Spitfire Pharma, Inc., a privately held, preclinical pharmaceutical company. This acquisition brought with it the development rights for novel peptide products, including pemvidutide, which would become Altimmune's lead candidate for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). As part of the acquisition agreement, Altimmune is obligated to make payments of up to $80 million upon achieving specified worldwide net sales targets for products developed using the acquired technology.

Pemvidutide, formerly known as ALT-801, is a unique investigational agent that leverages the balanced activation of GLP-1 (Glucagon-Like Peptide-1) and glucagon receptors. This dual agonism approach has demonstrated promising results in addressing the multi-faceted nature of obesity and its related conditions, such as metabolic dysfunction-associated steatohepatitis (MASH), previously termed non-alcoholic steatohepatitis (NASH).

In recent years, Altimmune has made significant progress in advancing pemvidutide through its clinical development program. The company has completed several successful Phase 1 and Phase 2 trials, evaluating the safety, tolerability, and efficacy of the drug candidate in both obesity and MASH indications.

Notably, the company's MOMENTUM Phase 2 trial in obesity, which enrolled 391 subjects, demonstrated impressive weight loss results, with the highest dose of pemvidutide (2.4 mg) achieving a mean weight loss of 16.5% at 48 weeks. Importantly, the trial also showed that a significant portion of the weight loss was derived from adipose tissue, with a preferential reduction in visceral adipose tissue, which is associated with increased cardiovascular risk.

In the MASH space, Altimmune is currently conducting the IMPACT Phase 2b trial, which is evaluating the effects of pemvidutide on liver fat, MASH resolution, and fibrosis improvement. The trial, which completed enrollment in September 2024, is expected to report top-line efficacy data in the second quarter of 2025.

Despite its progress, Altimmune has faced several challenges in recent years. In 2023, the company had to wind down and complete the in-life portion of a Phase 2 clinical trial for its HepTcell product candidate after the overall response was deemed insufficient to warrant further advancement. Additionally, Altimmune has incurred significant losses, with net losses of $84.7 million in 2022 and $88.4 million in 2023. It's important to note that the company has not generated any revenues from product sales to date, and there is no assurance of future revenues from product sales.

Financial Performance and Liquidity

As a clinical-stage biopharmaceutical company, Altimmune has not yet generated significant revenue from product sales. The company's financial performance has been primarily driven by research and development (R&D) activities, as well as funding from government grants and partnerships.

For the nine months ended September 30, 2024, Altimmune reported total revenue of $15,000, compared to $389,000 in the same period of the previous year. The decrease in revenue was primarily due to the completion of one of the company's remaining government contracts.

Research and development expenses for the nine-month period ending September 30, 2024, were $62.45 million, up from $48.89 million in the same period of 2023. This increase was largely attributed to the ramp-up of the IMPACT Phase 2b trial in MASH and the initiation of additional nonclinical studies.

General and administrative (G&A) expenses for the nine-month period ending September 30, 2024, were $15.88 million, up from $13.80 million in the same period of 2023. The increase in G&A expenses was primarily due to a $2.1 million increase in stock-based compensation and other labor-related expenses.

For the most recent fiscal year (2023), Altimmune reported revenue of $426,000, a net loss of $88,447,000, operating cash flow of -$75,810,000, and free cash flow of -$75,857,000. The most recent quarter (Q3 2024) showed revenue of $5,000, a net loss of $22,845,000, operating cash flow of -$27,118,000, and free cash flow of -$27,118,000. The decrease in revenue was due to the completion of a government grant contract in the prior year quarter, while the increase in net loss and negative cash flows was primarily due to higher R&D and G&A expenses related to the advancement of the pemvidutide program.

As of September 30, 2024, Altimmune had $139.4 million in cash, cash equivalents, and short-term investments, which the company believes will be sufficient to fund operations well into the first half of 2026. This cash position provides the company with the necessary runway to advance its lead program, pemvidutide, through key clinical milestones, including the expected readout of top-line data from the IMPACT Phase 2b trial in the second quarter of 2025.

Altimmune's liquidity position remains strong, with a debt-to-equity ratio of 0, a current ratio of 16.87, and a quick ratio of 16.87. The company currently operates solely in the United States.

Regulatory Milestones and Strategic Partnerships

In November 2024, Altimmune announced the successful completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for pemvidutide in the treatment of obesity. The company and the agency aligned on the design of a comprehensive Phase 3 registrational program, which will leverage the unique attributes of pemvidutide, including its balanced GLP-1/glucagon dual agonism.

The planned Phase 3 program, dubbed the "Velocity" trials, will consist of four pivotal studies evaluating pemvidutide's effects on body weight, serum lipids, liver fat, and body composition, with a focus on preserving lean mass. The trials are expected to enroll a total of approximately 5,000 subjects, similar to past registrational programs in obesity.

Altimmune has also announced plans to expand the development of pemvidutide beyond obesity and MASH, with the intention of submitting Investigational New Drug (IND) applications for up to three additional indications by the end of 2024. These new indications are designed to further capitalize on pemvidutide's unique profile as a balanced GLP-1/glucagon dual agonist, potentially addressing other metabolic disorders and comorbidities associated with obesity. The company expects to initiate a Phase 2 clinical trial for the first of these additional indications in the first half of 2025.

The successful completion of the obesity End-of-Phase 2 meeting and the company's plans to explore additional indications for pemvidutide have further strengthened Altimmune's position in ongoing strategic partnership discussions. The company continues to seek a partnership centered around the obesity program while maintaining the flexibility to advance the MASH and other indications independently or through additional collaborations.

Competitive Landscape and Risks

The obesity and metabolic disease treatment landscape is highly competitive, with several major pharmaceutical companies and emerging biotechnology firms vying for a share of the market. Altimmune faces competition from established GLP-1 agonists, as well as newer entrants, such as dual agonists targeting GLP-1 and glucagon or other novel mechanisms of action.

One key risk for Altimmune is the potential for safety concerns or unfavorable clinical trial results, which could delay or prevent the advancement of pemvidutide through the development process. Additionally, the company's reliance on government grants and strategic partnerships for funding introduces uncertainty, as the availability and terms of such arrangements may fluctuate.

Altimmune also faces the challenge of navigating the regulatory landscape and securing necessary approvals for its product candidates. The successful completion of the obesity End-of-Phase 2 meeting with the FDA represents a significant milestone, but the company must continue to work closely with regulatory authorities to ensure the smooth progression of its clinical programs.

In May 2024, a class action complaint was filed against Altimmune and three of its executive officers alleging violations of securities laws. A similar shareholder derivative complaint was also filed. Altimmune intends to vigorously defend against these lawsuits, which represent an additional risk and potential distraction for the company's management.

Conclusion

Altimmune's focus on developing innovative peptide-based therapeutics, exemplified by its lead candidate pemvidutide, positions the company as a potential leader in addressing the growing global epidemic of obesity and associated metabolic disorders. The company's balanced GLP-1/glucagon dual agonism approach, combined with its progress in clinical trials and regulatory milestones, suggests that Altimmune may be well-equipped to navigate the competitive landscape and deliver meaningful solutions for patients.

As Altimmune continues to advance its pipeline and explore new indications for pemvidutide, investors will closely monitor the company's ability to execute on its strategic priorities, secure necessary funding, and demonstrate the long-term clinical and commercial potential of its differentiated approach. The completion of enrollment in the IMPACT Phase 2b trial for MASH and the alignment with the FDA on the Phase 3 program for obesity represent significant steps forward, with key data readouts and potential regulatory milestones on the horizon.

With a strong cash position expected to fund operations into the first half of 2026, Altimmune appears well-positioned to continue its clinical development programs and pursue its strategic objectives. However, the company will need to navigate the challenges of clinical development, regulatory approval, and potential competition in the rapidly evolving obesity and metabolic disease treatment landscape.