Group 1 - Invivyd, Inc. reported preliminary fourth-quarter 2025 net product revenue of $17.2 million from PEMGARDA, reflecting a 25% year-over-year growth and a 31% increase from the previous quarter [1][2] - The company ended 2025 with $226.7 million in cash and equivalents, supported by financing completed in the second half of the year, and has a current ratio of 2.47, indicating strong liquidity for operations and pipeline advancement [1][3] - Invivyd has launched the DECLARATION Phase 3 pivotal trial for VYD2311, a monoclonal antibody for COVID-19 prevention, which received FDA Fast Track designation in December 2025, with top-line results expected by mid-2026 [2][3] Group 2 - The company is expanding its pipeline beyond COVID-19, with VBY329, an RSV antibody candidate expected to reach IND readiness in late 2026, and a measles antibody program in preclinical development with candidate selection planned for early 2026 [3][4] - PEMGARDA has a gross margin of 93.3%, highlighting its commercial potential in the market [2]

Core Insights - Invivyd, Inc. reported strong revenue growth for its monoclonal antibody PEMGARDA® (pemivibart), with preliminary Q4 2025 net product revenue of $17.2 million, reflecting a 25% year-over-year increase and a 31% quarter-over-quarter increase [4][8] - The company is preparing for the potential commercial launch of VYD2311, a vaccine-alternative for COVID-19, which has received Fast Track designation from the FDA [2][5] - 2026 is anticipated to be a pivotal year for Invivyd as it aims to establish a new standard of care for COVID prophylaxis and expand its pipeline of monoclonal antibodies [2][4] Business Highlights - Preliminary Q4 2025 revenue for PEMGARDA® reached $17.2 million, marking a 25% increase from Q4 2024 and a 31% increase from Q3 2025 [4] - The company ended 2025 with cash and cash equivalents of $226.7 million, bolstered by over $200 million raised in financing during the second half of 2025 [4][8] - The DECLARATION Phase 3 clinical trial for VYD2311 has been initiated, with top-line data expected in mid-2026 [5][8] Clinical & Regulatory Developments - The DECLARATION trial is a Phase 3, randomized, placebo-controlled study to evaluate VYD2311's efficacy and safety in preventing COVID-19, with a total expected enrollment of 1770 participants [5][17] - VYD2311 has been granted Fast Track designation by the FDA, which may expedite its development and review process [5][8] - The trial aims to assess both a single dose and monthly dosing of VYD2311 compared to placebo [5][17] Pipeline Expansion - Invivyd is expanding its pipeline with the nomination of VBY329, a potential best-in-class monoclonal antibody for preventing Respiratory Syncytial Virus (RSV) in infants and children [6][18] - The company is also targeting a preclinical measles mAb candidate selection in the first half of 2026 [6][8] - VBY329 is expected to advance toward IND readiness in the second half of 2026, with the pediatric RSV prophylaxis market projected to grow to $3-$4 billion by 2030 [6][8] Corporate and Financial Updates - The company has a strong balance sheet with sufficient cash to support ongoing clinical trials and commercial preparations for VYD2311 [4][8] - Total shares of common stock outstanding as of December 31, 2025, were 281,987,033, excluding pre-funded warrants [4][8] - Invivyd's financial position is expected to support continued research and development efforts across its pipeline programs [4][8]

Group 1 - Invivyd Inc. has selected VBY329 as a monoclonal antibody candidate for the prevention of Respiratory Syncytial Virus (RSV) in neonates, infants, and children [1] - VBY329 has demonstrated 1.5-fold greater antiviral potency than clesrovimab in in vitro testing, and the company aims for IND readiness in the second half of 2026 [2][4] - The RSV prophylaxis market for babies and children under 24 months is identified as a rapidly growing pharmaceutical market, providing significant opportunities for the company [3] Group 2 - D. Boral Capital downgraded Invivyd to a Hold from a Buy, reflecting concerns about the pipeline and balance sheet expectations [4] - Invivyd utilizes a proprietary technology platform to create medicines that are more potent and resistant to virus evolution than the human immune system [5]

Core Viewpoint - Invivyd, Inc. has identified a potentially best-in-class monoclonal antibody candidate, VBY329, for the prevention of Respiratory Syncytial Virus (RSV) in neonates, infants, and children, leveraging its proprietary antibody discovery technology [1][5][6] Group 1: Product Development - VBY329 demonstrates in vitro properties that indicate higher potency and improved resistance compared to existing treatments like nirsevimab and clesrovimab, with an antiviral potency 1.5-fold greater than nirsevimab and 1.2-fold greater than clesrovimab [2][6] - The antibody candidate shows up to approximately 500-fold enhanced neutralization activity against RSV F protein variants resistant to nirsevimab, indicating a strong resistance profile [6] - Invivyd aims to achieve IND readiness for VBY329 in the second half of 2026, with plans to present in vitro data at a future medical congress [3][6] Group 2: Market Potential - The market for RSV prophylaxis among children under 24 months is projected to grow significantly, with expectations of reaching $3-$4 billion in annual revenues globally by 2030 [3][6] - Monoclonal antibodies have been a critical treatment option for vulnerable populations for nearly 30 years, suggesting a robust market opportunity for VBY329 [3] Group 3: Company Overview - Invivyd, Inc. is focused on developing innovative monoclonal antibodies for serious viral infectious diseases, with a unique integrated technology platform for antibody assessment and development [7] - The company has previously received emergency use authorization from the U.S. FDA for another monoclonal antibody, highlighting its capability in the biopharmaceutical sector [7]