Altimmune, Inc.

Altimmune, Inc. is a late clinical-stage biopharmaceutical company developing novel therapies for serious liver diseases. The company's lead product candidate, pemvidutide, is a balanced 1:1 glucagon/GLP-1 dual receptor agonist in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The biopharmaceutical industry is intensely competitive and characterized by rapid technological progress, with competition based on product efficacy, safety, reliability, availability, price and patent position. Large and established companies such as Eli Lilly, Roche, Novo Nordisk, Pfizer, AstraZeneca, Amgen, Boehringer Ingelheim and Merck compete in the same general therapeutic areas as the company's product programs.

The company faces substantial competition for pemvidutide in MASH from companies such as Madrigal Pharmaceuticals, Aligos and Viking Therapeutics (developing orally administered THR-β-selective agonists); Novo Nordisk, Roche, and GSK (developing FGF-21 analogs); Novo Nordisk (developing a GLP-1 agonist); Merck/Hanmi Pharmaceutical and Boehringer Ingelheim (developing GLP-1/glucagon dual agonists); Eli Lilly (developing a GIP/GLP-1 dual agonist and a GLP-1 GIP/glucagon triple agonist); Roche (developing a GLP-1/GIP dual agonist); AstraZeneca (developing a GLP-1/glucagon and amylin combination); Inventiva (developing a pan-PPAR agonist); Sagimet (developing a fatty acid synthetase inhibitor); Apollo Therapeutics Group Limited/HEC Pharma (developing a GLP-1/FGF-21 dual agonist); and Pfizer, Roche, Gilead, AstraZeneca, and Eli Lilly (developing small molecule GLP-1 agonists). In ALD, competitors include GSK developing GSK4532990, an RNAi targeting HSD17B13, and Novo Nordisk developing NNC0194-0499 (FGF-21), cagrilintide and semaglutide. In AUD, competitors include Alkermes' vivitrol, generic products such as naltrexone, acamprosate and disulfiram, and Eli Lilly developing mazdutide and brenipatide. The company believes pemvidutide is the only glucagon/GLP-1 dual receptor agonist with a balanced 1:1 potency at glucagon and the GLP-1 receptors.

The company has not generated any revenue from the sale of any products to date. Its revenues in previous years consisted primarily of government and foundation grants and contracts. The company's business model is centered on developing and commercializing novel therapies for serious liver diseases, with a strategy that includes initiating a registrational Phase 3 development program in MASH, continuing development of other liver-related indications such as AUD and ALD, building capabilities to support development and commercialization of pemvidutide, researching alternative formulations, and assessing strategic partnerships and licensing opportunities.

The company's lead product candidate, pemvidutide, is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity in clinical development for the treatment of MASH, AUD and ALD. As of December 31, 2025, over 700 patients have been exposed to pemvidutide in 8 completed studies and 2 ongoing studies. Pemvidutide has received Breakthrough Therapy Designation for MASH from the FDA based on data obtained from the IMPACT trial at 24 weeks. The IMPACT Phase 2b trial enrolled 212 subjects with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes randomized 1:2:2 to receive weekly subcutaneous doses of pemvidutide at 1.2 mg, 1.8 mg or placebo. In an ITT analysis at 24 weeks, the proportions of subjects achieving MASH resolution without worsening of fibrosis were 58.2% ¹ and 52.1% ² for pemvidutide 1.2 mg and 1.8 mg, respectively versus 19.9% ³ for placebo (p<0.0001 both doses). The effects on fibrosis improvement without worsening of MASH in an ITT analysis were 32.6% ⁴ and 35.7% ⁵ for pemvidutide 1.2 mg and 1.8 mg, respectively compared with 27.9% ⁶ for placebo (differences not statistically significant). At 48 weeks, pemvidutide-treated participants achieved statistically significant reductions in non-invasive markers of fibrosis, including ELF and LSM; ELF: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -0.49 ⁷ and -0.58 ⁸ respectively, vs. +0.16 ⁹ in placebo-treated patients (p<0.0001, both doses); LSM: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -3.04 ¹⁰ (p<0.05) and -3.97 ¹¹ (p<0.001), respectively, vs. -0.03 ¹² in placebo-treated participants. Participants receiving pemvidutide 1.2 mg and 1.8 mg achieved weight loss of 4.5% ¹³ and 7.5% ¹⁴, respectively, vs. 0.2% ¹⁵ of placebo-treated participants (p<0.0001, both doses), with no plateauing at 48 weeks with the 1.8 mg dose. Adverse events leading to treatment discontinuation occurred in 0% ¹⁶ and 1.2% ¹⁷ of patients treated with pemvidutide 1.2 mg and 1.8 mg, respectively, vs. 3.5% ¹⁸ of participants on placebo. For AUD, the RECLAIM Phase 2 trial targets enrollment of approximately 100 subjects ¹⁹ randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks. For ALD, the RESTORE Phase 2 trial enrolls approximately 100 patients ²⁰ across 34 sites ²¹ in the United States, randomized 1:1 to receive either 2.4mg pemvidutide or placebo weekly for 48 weeks.

On March 13, 2025, the company announced it is pursuing AUD and ALD as additional indications for pemvidutide. On May 19, 2025, the company announced the enrollment of the first subject in the RECLAIM Phase 2 trial for AUD. On August 19, 2025, the FDA granted Fast Track designation to pemvidutide for the treatment of AUD. On November 3, 2025, the company announced the completion of enrollment in the RECLAIM Phase 2 trial. On July 9, 2025, the company announced the enrollment of the first patient in the RESTORE Phase 2 trial for ALD. On June 26, 2025, the company released 24-week topline efficacy results from the IMPACT Phase 2b trial of pemvidutide in MASH. On December 11, 2025, the company held an End-of-Phase 2 meeting with the FDA to discuss parameters for a registrational Phase 3 trial of pemvidutide for MASH. On December 19, 2025, the company announced positive 48-week topline results from the IMPACT Phase 2b trial. On May 13, 2025, the company entered into a Loan and Security Agreement with Hercules Capital, Inc. for up to $100.0 million ²² in aggregate principal amount of term loans. On November 5, 2025, the company amended the Loan Agreement to increase the aggregate principal amount to up to $125.0 million ²³. The first Term Loan tranche was drawn down on the Closing Date in an aggregate principal amount of $15.0 million ²⁴. The second Term Loan tranche was drawn down on the Amendment Closing in an aggregate principal amount of $20.0 million ²⁵. On November 6, 2025, the company entered into an Equity Distribution Agreement with Leerink Partners LLC for an at-the-market offerings program under which it may offer and sell shares of common stock having an aggregate offering price of up to $200.0 million ²⁶. Since inception through December 31, 2025, the company raised approximately $25.4 million ²⁷ in net proceeds from the November 2025 Agreement, with $174.2 million ²⁸ remaining available. On February 27, 2025, the company entered into an Equity Distribution Agreement with Leerink Partners LLC, Piper Sandler & Co. and Stifel, Nicolaus & Company, Incorporated for an at-the-market offerings program under which it offered and sold shares of common stock having an aggregate offering price of up to $150.0 million ²⁹. Since inception through termination, the company raised approximately $118.3 million ³⁰ in net proceeds from the February 2025 Agreement. On January 27, 2026, the company entered into a securities purchase agreement for a registered direct offering for the purchase and sale of 12,397,920 ³¹ shares of its common stock and 4,647,534 ³² pre-funded warrants for net proceeds of approximately $70.4 million ³³.

The company has incurred significant losses since its inception and has not yet generated revenues from product sales. Net loss was $88.1 million ³⁴ and $95.1 million ³⁵ for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, the company had an accumulated deficit of $649.5 million ³⁶. Total revenues were $41,000 ³⁷ for the year ended December 31, 2025 compared to $20,000 ³⁸ for the year ended December 31, 2024. Research and development expenses were $66.4 million ³⁹ for the year ended December 31, 2025 compared to $82.2 million ⁴⁰ for the year ended December 31, 2024. General and administrative expenses were $28.1 million ⁴¹ for the year ended December 31, 2025 compared to $21.0 million ⁴² for the year ended December 31, 2024. Loss from operations was $94.5 million ⁴³ for the year ended December 31, 2025 compared to $103.2 million ⁴⁴ for the year ended December 31, 2024. Net cash used in operating activities was $67.5 million ⁴⁵ for the year ended December 31, 2025 compared to $79.8 million ⁴⁶ for the year ended December 31, 2024. As of December 31, 2025, the company had $273.5 million ⁴⁷ of cash, cash equivalents, restricted cash and short-term investments.

Management states that based on the clinical data obtained from the IMPACT trial and FDA feedback, the company is currently preparing to initiate a pivotal, 52-week, Phase 3 clinical trial in MASH in 2026. The company is on track to complete the 24-week treatment period and announce topline results for the RECLAIM Phase 2 trial in AUD in 2026.

The company's primary growth vector is the initiation of a registrational Phase 3 development program in MASH. The registrational program is expected to assess clinical data in support of key differentiators including rapid and statistically significant improvements in markers of liver inflammation and fibrosis, statistically significant responses in both MASH resolution and fibrosis stage, statistically significant weight loss, statistically significant improvements in lean mass and/or function compared to placebo, and an excellent tolerability profile with low rates of discontinuation from therapy. The company is also pursuing AUD and ALD as additional indications for pemvidutide. For AUD, the RECLAIM Phase 2 trial targets enrollment of approximately 100 subjects ⁴⁸ randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks. For ALD, the RESTORE Phase 2 trial enrolls approximately 100 patients ⁴⁹ across 34 sites ⁵⁰ in the United States, randomized 1:1 to receive either 2.4mg pemvidutide or placebo weekly for 48 weeks. The company may also pursue additional indications for pemvidutide that leverage its differentiated clinical profile.

The company expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. The company anticipates that expenses will increase significantly if and as it continues development work for clinical programs, initiates additional preclinical studies or clinical trials, manufactures material for clinical trials and potential commercial sale, seeks regulatory approvals, establishes a sales and marketing infrastructure, seeks to discover and develop additional product candidates, acquires or in-licenses other product candidates and technologies, makes royalty or milestone payments, forms strategic partnerships, maintains and expands its intellectual property portfolio, attracts and retains skilled personnel, and creates additional infrastructure to support operations.The company does not have any manufacturing facilities and currently relies, and expects to continue to rely, on third parties for the manufacture of its product candidates for preclinical studies and clinical trials, as well as for commercial manufacture if product candidates receive marketing approval. The company intends to identify and qualify additional contract manufacturers to provide commercial scale manufacturing prior to submission of an NDA or BLA to the FDA. As of December 31, 2025, the company had 57 ⁵¹ full-time employees, 16 ⁵² of whom hold M.D. or Ph.D. degrees and 23 ⁵³ of whom hold other advanced degrees. As of December 31, 2025, 56 ⁵⁴ employees are located in the United States and 1 ⁵⁵ employee is located in the United Kingdom.

The company expects to continue to expend substantial resources for the foreseeable future developing its product candidates, including costs associated with research and development, maintaining its intellectual property estate, potentially acquiring new technologies, obtaining regulatory approvals and manufacturing products, forming partnerships and strategic alliances, as well as marketing and selling products approved for sale. The company's future capital requirements depend on many factors including the progress, results and costs of clinical trials for its leading product candidate, the scope and costs of preclinical development and clinical trials for other product candidates, the amount of funding from non-dilutive sources, the number and development requirements of other product candidates, the timing and costs of obtaining regulatory approvals, the ability to contract with third-party manufacturing facilities, the cost and timing of future commercialization activities, revenue from commercial sales, the ability to establish strategic partnerships, and the costs involved in preparing, filing and prosecuting patent applications. The company may also seek additional capital due to favorable market conditions or strategic considerations. As of December 31, 2025, the company had $273.5 million ⁵⁶ of cash, cash equivalents, restricted cash and short-term investments. Based on its current operating plan, management believes that existing cash will be sufficient to fund projected operating expenses and capital expenditure requirements for at least a twelve-month period from the issuance date of the December 31, 2025 financial statements. The company does not expect that these funds will be sufficient to enable it to complete the clinical trials needed to seek marketing approval or commercialize any of its product candidates. On November 13, 2025, the company filed a shelf registration statement on Form S-3, which was declared effective on December 5, 2025, allowing the company to offer and sell up to $400.0 million ⁵⁷ of its common stock, preferred stock, debt securities, warrants, rights and units. On February 27, 2025, the company filed a shelf registration statement on Form S-3, which was declared effective on March 13, 2025, allowing the company to offer and sell up to $400.0 million ⁵⁸ of its common stock, preferred stock, debt securities, warrants, rights and units. The Term Loan, as amended, provides up to $125.0 million ⁵⁹ of debt financing and has interest-only payments until December 1, 2027, which will be extended to June 1, 2028, or December 1, 2028, if certain conditions are met. The Term Loan will mature on January 1, 2029 ⁶⁰.

The company faces structural headwinds including that it has incurred significant losses since its founding and anticipates continuing to incur significant losses for the foreseeable future and may never achieve or maintain profitability. The company has not generated any revenues from the sale of any products to date and does not expect to generate any product revenues in the foreseeable future. The company's profitability depends on its ability to develop and commercialize its current and future product candidates. The company is currently in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by current regulatory activities and economic policies, ongoing military conflicts and geopolitical instability, and inflation and interest rates. International trade disputes, including threatened or implemented tariffs by the Trump administration and threatened or implemented tariffs by foreign countries in retaliation, could adversely impact the company's business, including by adversely impacting supply chains and increasing costs or delaying delivery of key inventories and supplies. The company's ability to raise capital may be limited by applicable laws and regulations, including SEC rules that if its public float is less than $75.0 million ⁶¹, the aggregate market value of securities sold under its Form S-3 in any 12-month period is limited to an aggregate of one-third of its public float. The company's ability to timely raise sufficient additional capital also may be limited by Nasdaq's stockholder approval requirements for transactions involving the issuance of its common stock or securities convertible into its common stock.

The company is heavily dependent on the success of its leading product candidate, pemvidutide, and if it is ultimately unable to develop, obtain regulatory approval for or commercialize pemvidutide, its business will be substantially harmed. The company has incurred significant losses since its founding, with a net loss of $88.1 million ⁶² for the year ended December 31, 2025 and an accumulated deficit of $649.5 million ⁶³ as of December 31, 2025, and it may never achieve or maintain profitability. The company will require substantial additional financing to achieve its goals; as of December 31, 2025, it had $273.5 million ⁶⁴ in cash, cash equivalents, restricted cash and short-term investments, but management does not expect these funds to be sufficient to complete the clinical trials needed to seek marketing approval or commercialize any product candidates. The company faces substantial competition from large and established companies such as Eli Lilly, Roche, Novo Nordisk, Pfizer, AstraZeneca, Amgen, Boehringer Ingelheim and Merck, as well as numerous smaller companies, in the same therapeutic areas as its product programs. The company's ability to raise capital may be limited by SEC rules; if its public float is less than $75.0 million ⁶⁵, the aggregate market value of securities sold under its Form S-3 in any 12-month period is limited to an aggregate of one-third of its public float.

Management's message emphasizes the company's goal to become a leading biopharmaceutical company offering innovative treatments for serious liver diseases. Key strategic priorities emphasized for the period ahead include initiating the registrational Phase 3 development program in MASH that, provided safety and efficacy are established, provides for an accelerated approval based on data obtained after one year of treatment; continuing development of other liver-related indications such as AUD and ALD that may benefit from the dual activity of glucagon and GLP-1a; continuing to build and develop experience and capabilities to support the development and commercialization of pemvidutide; researching and developing alternative formulations, doses, and presentations of pemvidutide for the benefit of patients; and assessing strategic partnerships and licensing opportunities to help accelerate the development of pemvidutide and achieve goals. Management states that based on the clinical data obtained from the IMPACT trial and FDA feedback, the company is currently preparing to initiate a pivotal, 52-week, Phase 3 clinical trial in MASH in 2026. Management also states that the company is on track to complete the 24-week treatment period and announce topline results for the RECLAIM Phase 2 trial in AUD in 2026.