Invivyd Reports Third Quarter 2025 Financial Results and Recent Business Highlights

Core Insights - Invivyd, Inc. reported strong financial results for Q3 2025, with a net product revenue of $13.1 million, reflecting a 41% year-over-year growth and an 11% quarter-over-quarter growth [5][10] - The company is preparing for pivotal studies and a potential commercial launch of VYD2311, an antibody alternative to COVID vaccination, following recent IND clearance and FDA alignment [2][4] - Invivyd's cash position improved significantly, ending Q3 2025 with $85 million in cash and cash equivalents, bolstered by a public offering and ATM facility [5][10] Recent Business Highlights - The company is focused on the urgent need for antibody protection against COVID-19 and is also exploring additional pathogens beyond COVID [2][3] - The REVOLUTION clinical program for VYD2311 includes two pivotal trials: DECLARATION and LIBERTY, expected to begin around year-end 2025, with top-line data anticipated by mid-2026 [5][6][7] Clinical & Regulatory Developments - Invivyd received U.S. IND clearance for VYD2311, which is designed to prevent COVID-19, and is preparing for the initiation of the DECLARATION and LIBERTY clinical trials [5][6] - The DECLARATION trial will evaluate the safety and efficacy of VYD2311 in preventing symptomatic COVID-19, while the LIBERTY trial will assess its interaction with mRNA-based COVID vaccines [6][7] Commercial Execution - The uptake of PEMGARDA (pemivibart) continues to grow among healthcare providers, supported by Invivyd's sales force [6] - Positive in vitro neutralization data for PEMGARDA and VYD2311 against the XFG variant of SARS-CoV-2 was announced, indicating no significant change in neutralization activity [6][8] Corporate and Financial Updates - The company reported a net loss of $10.5 million for Q3 2025, a significant reduction from a net loss of $60.7 million in Q3 2024 [10][27] - Research and development expenses decreased to $8 million in Q3 2025 from $57.9 million in the same period of 2024, primarily due to reduced clinical trial costs [10][27] Pipeline Expansion - Invivyd is initiating discovery efforts to expand its pipeline beyond SARS-CoV-2, targeting potential pathogens such as respiratory syncytial virus (RSV) and measles [8][9]