Altimmune(ALT) - 2024 Q2 - Quarterly Results

Executive Summary & Business Update Altimmune provided a comprehensive business update, detailing recent progress and anticipated milestones for its pemvidutide programs in obesity and MASH, alongside an overview of the company and its lead therapeutic Recent Highlights and Anticipated Milestones Altimmune provided a business update highlighting recent progress and anticipated milestones for its pemvidutide programs in obesity and MASH, supported by new data presentations at major medical meetings; the company is advancing its clinical trials and engaging with regulatory bodies Obesity Program (Pemvidutide) Pemvidutide demonstrated significant weight loss and favorable body composition in the Phase 2 MOMENTUM trial, with robust reductions in key lipid markers and an End-of-Phase 2 FDA meeting planned - At 48 weeks of treatment in the Phase 2 MOMENTUM obesity trial, subjects receiving pemvidutide achieved weight loss of up to 15.6%, with weight loss continuing at the end of treatment[4] - A full analysis of body composition data showed class-leading lean mass preservation among incretin agents, with only 21.9% of weight loss attributable to lean mass and 78.1% attributable to fat[4] - Treatment with pemvidutide resulted in robust reductions of triglycerides (55.8%), total cholesterol (20.0%), and LDL cholesterol (17.4%) in subjects with elevated baseline lipids on the 2.4mg dose[4] - An End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) is expected in late Q3 2024 to discuss Phase 3 trial design and study endpoints[4] Metabolic Dysfunction-Associated Steatohepatitis (MASH) Program (Pemvidutide) Pemvidutide showed disease-modifying potential in MASH with significant liver fat reduction and high response rates, advancing its biopsy-driven Phase 2b IMPACT trial with topline data expected in Q1 2025 - Data presented at EASL International Liver Congress™ 2024 supported pemvidutide's disease-modifying potential in MASH, with higher proportions of subjects achieving FAST score, MRI-PDFF, and ALT responses compared to placebo in a Phase 1 trial[5] - A 12-week clinical trial of pemvidutide in MASLD, published in the Journal of Hepatology, showed up to 68.5% relative reduction in Liver Fat Content (LFC) and up to 55.6% of subjects achieving LFC normalization[6] - The adverse event discontinuation rate was only 2.9% in subjects receiving pemvidutide, with no severe or serious adverse events reported[7] - The biopsy-driven Phase 2b IMPACT trial of pemvidutide in MASH is advancing, with enrollment progressing and topline data expected in Q1 2025; the trial's primary efficacy measures are MASH resolution or fibrosis improvement at Week 24[2][7] About Pemvidutide Pemvidutide is an investigational, peptide-based GLP-1/glucagon dual receptor agonist under development for obesity and MASH, demonstrating compelling clinical benefits and granted Fast Track designation by the U.S. FDA for MASH - Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH[11] - It has demonstrated compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure in clinical trials[11] - The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH[11] About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics, primarily pemvidutide, for obesity and MASH - Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics[12] - The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH[12] Financial Results for the Three Months Ended June 30, 2024 Altimmune reported its financial results for Q2 2024, highlighting a net loss increase driven by higher R&D expenses, and provided an update on its cash position and balance sheet Key Financial Highlights Altimmune reported a net loss of $24.6 million for the second quarter of 2024, an increase from $16.1 million in the same period of 2023, primarily due to higher research and development expenses; the company held $164.9 million in cash, cash equivalents, and short-term investments as of June 30, 2024 Key Financial Highlights (Three Months Ended June 30) | Financial Metric (in millions) | 2024 | 2023 | Change (YoY) | | :----------------------------- | :--- | :--- | :----------- | | Cash, cash equivalents & short-term investments (as of June 30) | $164.9 | N/A | N/A | | Research and development expenses | $21.2 | $13.3 | +$7.9 | | General and administrative expenses | $5.6 | $4.8 | +$0.8 | | Interest income | $2.2 | $1.8 | +$0.4 | | Net loss | $(24.6) | $(16.1) | $(8.5) | | Net loss per share | $(0.35) | $(0.32) | $(0.03) | - Research and development expenses for Q2 2024 included $13.8 million in direct costs related to pemvidutide development and $1.0 million for winding down the HepTcell program[8] - The increase in general and administrative expenses was primarily due to a $1.0 million increase in stock compensation expense caused by modifications of stock awards[8] Consolidated Balance Sheets As of June 30, 2024, Altimmune's total assets decreased to $173.3 million from $210.6 million at December 31, 2023, primarily driven by a reduction in cash and cash equivalents, partially offset by an increase in short-term investments; total liabilities increased, while total stockholders' equity decreased Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2024 (Unaudited) | December 31, 2023 | Change | | :----------------- | :------------------------ | :---------------- | :----- | | Cash and cash equivalents | $57,128 | $135,117 | $(77,989) | | Short-term investments | $107,780 | $62,698 | $45,082 | | Total current assets | $171,186 | $209,626 | $(38,440) | | Total assets | $173,346 | $210,640 | $(37,294) | | Total current liabilities | $15,155 | $12,143 | $3,012 | | Total liabilities | $20,815 | $16,541 | $4,274 | | Total stockholders' equity | $152,531 | $194,099 | $(41,568) | Consolidated Statements of Operations and Comprehensive Loss For the three months ended June 30, 2024, Altimmune reported a net loss of $24.6 million, an increase from $16.1 million in the prior year period, primarily due to a significant rise in operating expenses, particularly research and development, which outpaced a modest increase in interest income Consolidated Statements of Operations Highlights (in thousands) | Statement of Operations Item | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Change | | :--------------------------- | :------------------------------- | :------------------------------- | :----- | | Revenues | $5 | $6 | $(1) | | Research and development | $21,155 | $13,253 | $7,902 | | General and administrative | $5,595 | $4,760 | $835 | | Total operating expenses | $26,750 | $18,013 | $8,737 | | Loss from operations | $(26,745) | $(18,007) | $(8,738) | | Interest income | $2,182 | $1,835 | $347 | | Net loss | $(24,640) | $(16,061) | $(8,579) | | Net loss per share, basic and diluted | $(0.35) | $(0.32) | $(0.03) | - Weighted-average common shares outstanding increased to 70,924,371 for the three months ended June 30, 2024, from 50,691,558 in the same period of 2023[19] Additional Information This section provides details on the Q2 2024 conference call, important forward-looking statements, and key company contact information Conference Call Information Altimmune hosted a conference call and webcast on August 8, 2024, to discuss its second quarter 2024 financial results and business update; replay information is available on the company's investor relations website - A conference call and webcast were held on Thursday, August 8, 2024, at 8:30 am Eastern Time[9] - The webcast will be available for replay on Altimmune's Investor Relations website at **https://ir.altimmune.com/investors**[10](index=10&type=chunk) Forward-Looking Statement This press release contains forward-looking statements regarding future financial and business performance, clinical milestones, and regulatory approvals, which are subject to various assumptions, risks, and uncertainties - Statements regarding future financial or business performance, clinical asset milestones, and prospects for regulatory approval or commercialization are forward-looking statements[13] - These statements are subject to numerous assumptions, risks, and uncertainties, including delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment challenges, and the success of future clinical trials[13] Company Contacts Contact information is provided for Altimmune's President and CEO, investor relations, and media relations - Contact details are available for Vipin Garg (President and CEO), Investor Relations (Lee Roth and Julia Weilman at Burns McClellan), and Media Contact (Danielle Cantey at Inizio Evoke, Biotech)[14]