Altimmune(US:ALT)2025-11-06 21:10Financial Performance - Revenues for the three months ended September 30, 2025, were $5, unchanged from the same period in 2024[90] - The net loss for the three months ended September 30, 2025, was $19.01 million, a decrease of $3.83 million, or 17%, from a net loss of $22.85 million in 2024[90] - Revenues for the nine months ended September 30, 2025, remained unchanged at $15,000 compared to the same period in 2024[98] - Net loss for the nine months ended September 30, 2025, was $60.7 million, a decrease of $11.1 million, or 16%, from a net loss of $71.9 million in 2024[98] Expenses - Research and development expenses decreased by $4.8 million, or 24%, to $14.96 million for the three months ended September 30, 2025, compared to $19.80 million in 2024[93] - General and administrative expenses increased by $0.9 million, or 19%, to $5.90 million for the three months ended September 30, 2025, compared to $4.97 million in 2024[95] - Research and development expenses decreased by $14.4 million, or 23%, to $48.0 million for the nine months ended September 30, 2025, from $62.4 million in 2024[100] - General and administrative expenses increased by $1.7 million, or 11%, to $17.6 million for the nine months ended September 30, 2025[102] Other Income and Cash Flow - Total other income (expense), net decreased by $0.1 million, or 4%, for the three months ended September 30, 2025, compared to the same period in 2024[96] - Total other income (expense), net decreased by $2.2 million, or 35%, to $4.2 million for the nine months ended September 30, 2025[103] - Net cash used in operating activities was $48.1 million for the nine months ended September 30, 2025, compared to $61.6 million in 2024, reflecting a decrease of $13.5 million[116] - Net cash provided by financing activities was $125.7 million during the nine months ended September 30, 2025, primarily from the issuance of common stock[118] Financial Position - Cash, cash equivalents, restricted cash, and short-term investments totaled $210.8 million as of September 30, 2025[105] - The accumulated deficit as of September 30, 2025, was $622.1 million, indicating significant losses since operations commenced[106] - The company plans to continue pursuing additional equity or debt financing to address long-term capital needs for clinical trials[119] Clinical Trials and Designations - In a Phase 2b trial for MASH, 58% and 52% of subjects achieved MASH resolution with pemvidutide doses of 1.2 mg and 1.8 mg, respectively, compared to 20% for placebo (p<0.0001) at 24 weeks[77] - Mean weight loss in pemvidutide-treated subjects was 4.8% and 5.8% at the 1.2 mg and 1.8 mg doses, respectively, versus 0.5% in the placebo group (p<0.001) at 24 weeks[79] - The U.S. FDA granted Fast Track designation to pemvidutide for the treatment of alcohol use disorder (AUD) on August 19, 2025[83] - The RECLAIM Phase 2 trial for AUD has enrolled approximately 100 subjects, with topline results expected in 2026[84] - The RESTORE Phase 2 trial for alcohol-associated liver disease (ALD) is enrolling approximately 100 patients, with a primary endpoint of liver stiffness measurement change at Week 24[85] Accounting and Reporting - Management's Discussion and Analysis is based on unaudited consolidated financial statements prepared in accordance with U.S. GAAP[121] - There have been no changes in critical accounting policies and significant judgments since the Annual Report for the year ended December 31, 2024[122] - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[123]