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Altimmune, Inc. (Nasdaq: ALT) is a clinical-stage biopharmaceutical company dedicated to developing next-generation immunotherapeutics and vaccines addressing critical public health and biodefense needs. Leveraging the unique properties of its proprietary platform technologies, Altimmune is adept at swiftly designing product candidates targeting a range of diseases, including respiratory conditions, chronic infections, and cancer.
Altimmune's advanced Densigen™ T-cell platform technology is specifically designed to guide the immune system's response against complex disease targets by focusing on multiple antigens simultaneously. Another key platform, RespirVec™, uses needle-free intranasal delivery for faster and broader immunity against pathogens compared to traditional vaccines.
The company is also heavily involved in addressing obesity and liver diseases through its innovative peptide therapeutics. The lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist under development for obesity and non-alcoholic steatohepatitis (NASH). Pemvidutide has shown promising results in clinical trials, achieving significant weight loss and liver fat reduction. It has received Fast Track designation from the U.S. FDA for treating NASH, highlighting its potential to meet significant unmet medical needs.
Altimmune's pipeline also includes HepTcell™, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B. However, the company has recently decided to cease further development on HepTcell based on Phase 2 trial findings.
Financially, Altimmune maintains a robust cash position, enabling it to advance its clinical programs. Recent financial results indicate a focused investment in research and development, ensuring continued progress in its pipeline.
Significant recent achievements include:
- Positive top-line results from the 48-week MOMENTUM Phase 2 obesity trial of pemvidutide.
- Ongoing Phase 2b IMPACT trial of pemvidutide in MASH with top-line results expected in Q1 2025.
- Strong financial position with substantial cash reserves to support ongoing and future research activities.
Altimmune is poised at the forefront of developing transformative therapies for serious health conditions, potentially delivering significant advancements in patient care.
Altimmune (Nasdaq: ALT) presented new data from its 12-week Phase 1b trial of pemvidutide in MASLD patients at The Liver Meeting®. The study demonstrated that weekly subcutaneous doses of pemvidutide significantly reduced inflammatory lipids and showed promising effects on cardiovascular health markers. In the trial of 94 subjects, pemvidutide reduced liver fat content by up to 68.5%, total cholesterol by 12.2%, and triglycerides by 44.6% after 12 weeks. The company is currently conducting the Phase 2b IMPACT trial in MASH patients, with results expected in Q2 2025.
Altimmune (ALT) announced key developments in Q3 2024, including completion of enrollment in the Phase 2b IMPACT trial of pemvidutide for MASH, with top-line data expected in Q2 2025. The company successfully completed its End-of-Phase 2 FDA meeting for pemvidutide's obesity program, planning four Phase 3 trials. At EASD, they presented promising data showing pemvidutide's lean mass preservation and visceral fat reduction. The company plans to submit INDs for up to three additional pemvidutide indications starting Q4 2024.
Financial results showed $139.4 million in cash and investments, R&D expenses of $19.8 million, and a net loss of $22.8 million ($0.32 per share) for Q3 2024.
Altimmune (Nasdaq: ALT) has appointed Greg Weaver as Chief Financial Officer, effective immediately. Weaver brings over 25 years of finance experience in life sciences companies and will lead the company's finance, accounting, and investor relations functions. His previous role was CFO at Cognito Therapeutics, and he notably led a $225 million IPO at atai Life Sciences. Throughout his career, Weaver has managed various capital market transactions and served as CFO at multiple biotech companies, including Sirna Therapeutics and ILEX Oncology. The appointment comes at a important time as Altimmune advances its lead program, pemvidutide, which targets metabolic disorders through liver-targeting mechanisms.
Altimmune (Nasdaq: ALT) announced equity awards granted to incoming Chief Financial Officer Gregory Weaver, effective November 11, 2024. The compensation package includes options to purchase 225,000 shares of common stock and 75,000 restricted stock units (RSUs). Based on November 8 closing price, approximately 172,920 options would be issued as inducement awards, with the remainder as incentive stock options. The options and RSUs will vest over four years, with 25% vesting after the first year and the remainder vesting gradually, subject to continued employment.
Altimmune (Nasdaq: ALT) announced successful completion of End-of-Phase 2 Meeting with FDA for pemvidutide in obesity treatment. The company received agreement on Phase 3 registrational program design, which will include four Phase 3 trials (VELOCITY-1,2,3,4) enrolling approximately 5,000 subjects over 60-week periods. The trials will evaluate pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg, focusing on different patient populations including those with elevated LDL cholesterol, elevated liver fat, and elderly with sarcopenia. The program aims to leverage pemvidutide's balanced GLP-1/glucagon dual agonism benefits.
Altimmune (Nasdaq: ALT) has announced its participation in two upcoming investor conferences. The company will attend the Guggenheim Inaugural Healthcare Innovation Conference in Boston on November 11, 2024, featuring a fireside chat at 11:30 a.m. Eastern Time. Additionally, they will participate in the UBS Global Healthcare Conference in Rancho Palos Verdes on November 13, 2024, with a fireside chat scheduled for 9:30 a.m. Pacific Time and availability for one-on-one meetings. Both sessions will be accessible via webcast through the Events section of Altimmune's website.
Altimmune (Nasdaq: ALT) announced it will release its third quarter 2024 financial results on Tuesday, November 12, 2024. The clinical-stage biopharmaceutical company will host a conference call at 8:30 am E.T. on the same day to discuss the financial results and provide a business update. The conference call will be webcast live on Altimmune's Investor Relations website, with a replay available for up to three months after the call.
Altimmune (Nasdaq: ALT) announced new data on the lipidomic profile of subjects treated with pemvidutide will be presented at The Liver Meeting® 2024 of the American Association for the Study of Liver Diseases (AASLD) in San Diego, CA, November 15-19, 2024. The data shows reductions in multiple classes of atherogenic and cardio-inflammatory lipids from a 12-week Phase 1b randomized, placebo-controlled study in subjects with metabolic dysfunction-associated steatotic liver disease (MASLD).
The presentation, titled "Effect of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Plasma Lipidomic Profiles in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)," will be given by Dr. Sarah K. Browne on Friday, November 15, 2024, at 1:00 pm PST. Altimmune has also completed enrollment in a Phase 2b efficacy trial of pemvidutide in patients with biopsy-confirmed F2/F3 MASH, with topline data expected in Q2 2025.
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, has announced its participation in the H.C. Wainwright 8th Annual MASH Virtual Conference. The company's Chief Executive Officer, Vipin Garg, Ph.D., and Chief Medical Officer, Scott Harris, M.D., will take part in a fireside chat during the event.
The presentation is scheduled for Monday, October 7, 2024, at 11:30 a.m. EDT. Interested parties can access the webcast of the session by visiting the Events section of the Altimmune website. This participation provides an opportunity for the company to share insights and updates with investors and industry professionals in a virtual setting.
Altimmune (Nasdaq: ALT) has completed enrollment in its Phase 2b IMPACT trial, evaluating pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH). The trial includes approximately 190 subjects, with top-line efficacy data expected in Q2 2025. An End-of-Phase 2 Meeting with the FDA for the obesity program is scheduled for early November 2024.
The company plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications starting in Q4 2024. Altimmune aims to expand pemvidutide's differentiation in the metabolic disease space and enhance its long-term value proposition. The IMPACT trial is notable as the first incretin-based study to evaluate a biopsy-driven fibrosis endpoint at 24 weeks.
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