Core Insights - Altimmune, Inc. is hosting a virtual R&D Day on March 13, 2025, featuring presentations from Key Opinion Leaders (KOLs) in obesity, MASH, and two additional indications for pemvidutide [1][2] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing next-generation peptide-based therapeutics, specifically pemvidutide, a GLP-1/glucagon dual receptor agonist targeting obesity, MASH, and other indications [4] Event Details - The R&D Day will cover the scientific rationale for pemvidutide, clinical data generated to date, and future development plans, including topline data from the Phase 2b trial in MASH expected in Q2 2025 [2]

Core Insights - Altimmune, Inc. will host a virtual R&D Day on March 13, 2025, at 12:00 pm Eastern Time [1] - The event will feature presentations from Key Opinion Leaders (KOLs) discussing the scientific rationale and clinical data for pemvidutide, along with future development plans [2] - Pemvidutide is being developed as a dual receptor agonist for obesity, MASH, and other indications [4] Event Details - The virtual R&D Day will be accessible via the Altimmune website and a dedicated event link [3] - The upcoming topline data readout from the Phase 2b trial in MASH is expected in the second quarter of 2025 [2] Company Overview - Altimmune is focused on next-generation peptide-based therapeutics and is currently in late clinical stages of development [4] - Pemvidutide targets GLP-1 and glucagon receptors, indicating a novel approach to treating obesity and related conditions [4]

Group 1 - Altimmune, Inc. is a late clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics [2] - The company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist aimed at treating obesity and MASH [2] - Management will participate in a fireside chat at the Leerink Global Healthcare Conference on March 10, 2025, at 3:40 p.m. EST, which will be webcast [1] Group 2 - The conference details can be accessed through the Events section of the Altimmune website [1] - Contact information for the company's Chief Financial Officer and investor relations is provided for further inquiries [2]

Group 1 - The group caters to both novice and experienced biotech investors, providing insights on catalysts, buy and sell ratings, and product sales forecasts for major pharmaceutical companies [1] - It offers integrated financial statements, discounted cash flow analysis, and market-by-market analysis to aid investment decisions [1] - Edmund Ingham, a biotech consultant with over 5 years of experience, leads the investing group Haggerston BioHealth and has compiled detailed reports on more than 1,000 companies [1]

Financial Performance - Altimmune reported a revenue of $20,000 for the year ended December 31, 2024, a decrease of 95% compared to $426,000 in 2023[492]. - The net loss for the year ended December 31, 2024, was $95,059,000, an increase of 7% from a net loss of $88,447,000 in 2023[492]. - Revenues for the year ended December 31, 2024, decreased to $20, down 95.3% from $426 in 2023[541]. - Net loss for 2024 was $95.1 million, compared to a net loss of $88.4 million in 2023, representing an increase of 7.5%[541]. - The net loss before income tax benefit for the year ended December 31, 2024 was $95.059 million, compared to $88.447 million for 2023[628]. Research and Development - Research and development expenses increased by 25% to $82,226,000 in 2024 from $65,799,000 in 2023, primarily driven by the ramp-up of the IMPACT Phase 2b trial[494]. - The development of the product candidate pemvidutide saw a 49% increase in expenses, totaling $53,274,000 in 2024 compared to $35,768,000 in 2023[494]. - The Phase 3 registrational program for pemvidutide is expected to enroll approximately 5,000 subjects across four trials, evaluating doses of 1.2 mg, 1.8 mg, and 2.4 mg[474]. - Pemvidutide demonstrated a reduction in liver fat content by up to 68.5% and decreased total cholesterol and triglycerides by up to 12.2% and 44.6%, respectively, in a Phase 1b trial[475]. - The Phase 2b trial for pemvidutide in MASH is expected to provide top-line data in the second quarter of 2025[476]. - The company discontinued the development of HepTcell after the Phase 2 trial was deemed insufficient for further advancement[482]. Cash Flow and Liquidity - As of December 31, 2024, the company had $131.9 million in cash, cash equivalents, restricted cash, and short-term investments, which is deemed sufficient to fund operations for at least the next twelve months[501]. - Cash and cash equivalents decreased to $36.9 million as of December 31, 2024, from $135.2 million at the end of 2023, a decline of 72.7%[539]. - Net cash used in operating activities was $79.8 million in 2024, an increase of $4.0 million from $75.8 million in 2023, primarily due to a $16.8 million increase in net loss[506]. - Net cash used in investing activities was $28.4 million in 2024, compared to a net cash provided of $13.7 million in 2023, largely due to $115.7 million in purchases of short-term investments[507]. - Net cash provided by financing activities was $10.0 million in 2024, a significant decrease from $86.1 million in 2023, primarily from the issuance of common stock[508]. Equity and Financing - The company raised approximately $96.6 million in net proceeds from at-the-market offerings since inception through December 31, 2024[504]. - The company plans to continue pursuing additional equity or debt financing to address long-term capital needs, including planned clinical trials[511]. - Proceeds from issuance of common stock in at-the-market offerings, net, were $10.0 million in 2024, down from $86.6 million in 2023[543]. - 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[545]. - The Company has U.S. federal net operating loss carryforwards of approximately $186.6 million as of December 31, 2024[631]. Assets and Liabilities - Total assets decreased to $139.3 million in 2024, down 33.8% from $210.6 million in 2023[539]. - Total liabilities decreased slightly to $15.8 million in 2024, compared to $16.5 million in 2023[539]. - Stockholders' equity decreased to $123.5 million in 2024, down 36.4% from $194.1 million in 2023[539]. - Total accrued research and development expenses were $6.4 million as of December 31, 2024, with prepaid expenses and other current assets at $2.2 million[534]. - Noncurrent liabilities rose to $5.330 million in 2024 from $4.398 million in 2023, primarily due to an increase in long-term lease obligations[599]. Stock-Based Compensation - Total stock-based compensation expense for the year ended December 31, 2024 was $14.393 million, compared to $10.640 million for 2023[626]. - The total intrinsic value of stock options exercised in 2024 was $1.1 million, compared to $0.2 million in 2023[616]. - As of December 31, 2024, there was $17.5 million of unrecognized compensation cost related to stock options, expected to be recognized over a weighted-average period of 2.5 years[618]. - The Company granted 559,600 shares of Restricted Stock Units (RSUs) with a weighted-average grant date fair value of $9.05 per share during the year ended December 31, 2023[619]. - As of December 31, 2024, total unrecognized compensation expense related to RSUs was $5.4 million, expected to be recognized over approximately 2.5 years[620]. Legal and Regulatory Matters - A class action complaint was filed against the Company on May 6, 2024, alleging violations of the Securities Exchange Act of 1934[645]. - There are ongoing shareholder derivative complaints against the Company's executive officers and board members, alleging breaches of fiduciary duty and other claims[646]. - The derivative actions were consolidated and later dismissed without prejudice on February 3, 2025[646]. - The Company is involved in various contracts and disputes, but none are currently expected to result in material loss[647]. Company Overview - Altimmune, Inc. is a clinical stage biopharmaceutical company focused on developing treatments for obesity and metabolic diseases, with its lead product candidate pemvidutide currently in clinical development[545]. - The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH[648]. - The Company has not generated any revenue from the sale of any products to date[648]. - The Chief Executive Officer is the chief operating decision maker, assessing performance based on net (loss) income[649].

Financial Data and Key Metrics Changes - Total cash and investments at year-end 2024 were reported at $132 million, expected to fund operations into the second half of 2026 [29] - R&D expenses for Q4 2024 were $19.8 million, up from $16.9 million in Q4 2023, with a full-year R&D expense of $82.2 million compared to $65.8 million in 2023 [30][32] - G&A expenses increased to $5.1 million in Q4 2024 from $4.3 million in Q4 2023, with a full-year G&A expense of $21 million compared to $18.1 million in 2023 [31][32] - Net loss for Q4 2024 was $23.2 million, an improvement from a net loss of $31.6 million in Q4 2023, while the full-year net loss was $95 million compared to $88 million in 2023 [31][32] Business Line Data and Key Metrics Changes - The company is focused on pemvidutide, with significant progress in the MASH (Metabolic Associated Steatotic Liver Disease) program, including the completion of enrollment in the Phase 2b IMPACT trial [9][10] - The upcoming Phase 2 trials for two additional indications are expected to start in mid-2025, following the clearance of INDs by the FDA [11][12] Market Data and Key Metrics Changes - The company anticipates that pemvidutide will be the first incretin-based agent to achieve fibrosis improvement at 24 weeks, positioning it favorably in the MASH treatment landscape [10][20] - The market for MASH is evolving, with increasing competition from agents like semaglutide and FGF21s, but pemvidutide's dual action on weight loss and liver health is expected to differentiate it [56][62] Company Strategy and Development Direction - The company plans to initiate a Phase 3 program in MASH in early 2026, contingent on positive data from the IMPACT trial [10][11] - The strategy includes leveraging the unique mechanism of action of pemvidutide to expand into additional indications while maintaining a primary focus on MASH [70][71] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming milestones in 2025, including the Phase 2b readout in MASH and the initiation of Phase 2 trials for new indications [35][36] - The leadership transition is planned with the upcoming retirement of the Chief Medical Officer, ensuring continuity through key milestones [15][17] Other Important Information - A virtual R&D Day is scheduled for March 13, 2025, where the company will disclose additional indications and provide a detailed overview of future plans [12][35] - The company has added experienced members to its Board of Directors, enhancing its expertise in the pharmaceutical industry [13][14] Q&A Session Summary Question: Will details about the new indications be announced at the R&D Day? - Management confirmed that comprehensive information about the two new indications will be provided at the R&D Day, including plans for starting Phase 2 programs [38][39] Question: What are the expectations for the IMPACT trial regarding competitive success? - Management indicated that achieving statistical significance at 24 weeks would differentiate pemvidutide from other agents, as it would be the only incretin to attempt such a readout [54][59] Question: How does the company plan to address real-world adherence and discontinuation rates? - Management expressed confidence in competitive compliance and low discontinuation rates based on previous trial data, anticipating similar results in the IMPACT trial [111][112] Question: What is the strategy for prioritizing the development of pemvidutide across multiple indications? - The company plans to focus on MASH while pursuing additional indications, leveraging the dual mechanism of action of pemvidutide to validate its efficacy [70][71]

Investigational New Drug (IND) applications in two additional indications have received FDA clearance, with Phase 2 trials to commence mid-2025 Company to hold virtual R&D Day on March 13, 2025. Program will include KOL presentations on pemvidutide development in obesity, MASH and additional indications Two pharmaceutical industry veterans added to Company Board of Directors Cash, cash equivalents and short-term investments of $131.9 million on December 31, 2024 Exhibit 99.1 Altimmune Announces Fourth Quart ...

Top-line data from Phase 2b IMPACT trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) to be reported in Q2 2025 Investigational New Drug (IND) applications in two additional indications have received FDA clearance, with Phase 2 trials to commence mid-2025 Company to hold virtual R&D Day on March 13, 2025. Program will include KOL presentations on pemvidutide development in obesity, MASH and additional indications Two pharmaceutical industry veterans added to Company Board of Dir ...

Ms. Lawver, former Chief Commercial Officer of Dexcom and Global Vice President at Johnson & Johnson responsible for billion-dollar Immunology and Cardiovascular & Metabolism Portfolios over her 20-year career Mr. Durso led biopharmaceutical company focused on liver disease as former CEO of Intercept Pharmaceuticals, previously oversaw multiple blockbuster franchises including cardiovascular and diabetes during 22-year tenure at Sanofi GAITHERSBURG, Md., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Na ...

GAITHERSBURG, Md., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company, today announced that it will report its fourth quarter and full year 2024 financial results on Thursday, February 27, 2025. Altimmune management will host a conference call at 8:30 am E.T. on February 27 to discuss financial results and provide a business update. The conference call will be webcast live on Altimmune's Investor Relations website at https://ir.altimmune.com/investors. ...