Invivyd Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Recent Business Highlights and DECLARATION Clinical Trial Updates

Core Insights - Invivyd, Inc. reported strong financial results for Q4 and full year 2025, with significant revenue growth and reduced operating expenses, highlighting the potential commercialization of VYD2311 and ongoing clinical trials [2][4][12]. Financial Performance - Q4 2025 net product revenue from PEMGARDA reached $17.2 million, a 25% increase year-over-year and a 31% increase quarter-over-quarter [4][12]. - Full year 2025 net product revenue totaled $53.4 million, compared to $25.4 million in 2024 [12]. - Cash and cash equivalents at year-end 2025 were $226.7 million, bolstered by over $200 million raised in financing during the second half of 2025 [4][12]. - Research and Development (R&D) expenses decreased to $38.3 million in 2025 from $137.3 million in 2024, primarily due to lower contract research costs [12]. - Selling, General & Administrative (SG&A) expenses increased to $66.9 million in 2025 from $63.4 million in 2024, attributed to higher personnel-related costs [12]. - The net loss for 2025 was $52.5 million, significantly reduced from $169.9 million in 2024, with a net loss per share of $0.30 compared to $1.43 in the previous year [12][36]. Clinical and Regulatory Developments - The DECLARATION Phase 3 pivotal clinical trial for VYD2311 has achieved full enrollment, with top-line data expected in mid-2026 [4][5]. - The FDA granted Fast Track designation for VYD2311 in December 2025, facilitating expedited development and review processes [5][7]. - The Independent Data Monitoring Committee (IDMC) recommended allowing pregnant and breastfeeding women to enroll in the DECLARATION trial after reviewing unblinded safety data [5]. - The LIBERTY Phase 3 clinical trial will assess the safety and immunologic profile of VYD2311 compared to mRNA COVID vaccines, with specific monitoring for adverse events of interest [5][7]. Pipeline Expansion - Invivyd is advancing its pipeline with VBY329, a monoclonal antibody candidate for the prevention of Respiratory Syncytial Virus (RSV) in children, expected to enter IND readiness in the second half of 2026 [7][12]. - The company is also planning a Phase 2 clinical trial for VYD2311 in individuals with Long COVID or COVID vaccine injury, anticipated to start by mid-2026 [7]. Corporate Updates - Michael Mina, M.D., Ph.D., has been appointed as Chief Medical Officer, indicating a strategic move to enhance clinical leadership [12]. - Invivyd is launching a national multimedia educational campaign in partnership with Lindsey Vonn to raise public awareness about the role of antibodies in disease prevention [12].