PEMGARDA® (pemivibart)
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Invivyd Reports Preliminary Fourth Quarter 2025 Revenue and Recent Business Highlights
Globenewswire· 2026-01-08 12:01
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]
Adagio(IVVD) - 2025 Q3 - Earnings Call Presentation
2025-11-06 13:30
Invivyd Q3 Earnings Call & Business Update November 6, 2025 © 2025 Invivyd, Inc. All trademarks used in this presentation are the property of their respective owners. 1 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," ...
Invivyd (NasdaqGM:IVVD) Earnings Call Presentation
2025-10-30 12:30
COVID Landscape and Vaccine Challenges - COVID vaccines may face durability issues due to the nature of coronavirus immunity[9, 10] - A CDC survey in June-July 2024 indicated that 20% of adults avoided COVID vaccines due to concerns about serious/unknown side effects[13] - Americans have avoided COVID vaccines due to safety fears and mistrust[12] Invivyd's Antibody Approach - Invivyd is developing best-in-class antibody protection and treatment of viral threats[5] - Invivyd's monoclonal antibodies can be engineered for consistent high activity, unlike vaccines[19] - Pemivibart's target epitope has remained relatively unchanged over the past 3 years[22, 23] - VYD2311 is a minimally evolved molecular engineered antibody designed to improve performance[24] REVOLUTION Clinical Program - VYD2311 Phase 1/2 study showed attractive safety at high doses, up to 4500 mg IV[35, 38] - The DECLARATION Phase 3 clinical trial will evaluate prevention of symptomatic COVID at three months[45] - The company aims for a 70%-90% reduction in symptomatic COVID with a 250 mg single dose IM of VYD2311 versus placebo over 3 months[47] Commercial Landscape - Approximately 342 million of the US population is 12+[74] - In the 24-25 flu season, 147 million flu vaccine doses were administered[75] - 36% was the 2023-2024 vaccine dose, ≥7 days 18 and over vaccine efficacy (VE) reduction in hospitalization estimate from CDC[73]
Adagio(IVVD) - 2025 Q2 - Earnings Call Presentation
2025-08-20 12:30
COVID-19 Landscape and Strategy - COVID-19 is the leading cause of hospitalizations and death from respiratory viruses in the U S, with 460,000 hospitalizations and 45,200 deaths between October 1, 2023, and June 15, 2024[7] - The company believes COVID-19 vaccines do not provide sufficient protection, with vaccine effectiveness against hospitalization for immunocompromised adults at a maximum of approximately 36% within 7-59 days of the 2023-2024 vaccine dose[19] - Monoclonal antibodies have demonstrated a significant reduction in the risk of symptomatic COVID-19, with pemivibart showing an 84-94% reduction in risk in ordinary Americans[22] - The company aims to provide Americans with a choice for COVID-19 protection through VYD2311, a monoclonal antibody with high efficacy and long duration of protection, contrasting with the reactogenic and modestly effective COVID-19 vaccines[48, 49] Pipeline and Development - Pemgarda has received emergency use authorization (EUA) from the U S FDA in March 2024 for pre-exposure prophylaxis of COVID-19 in certain immunocompromised persons[29] - VYD2311 is designed to be a high potency, long half-life monoclonal antibody for COVID-19, with an observed IM half-life of 76 days in the first-in-human trial[39, 40] - The company is planning a Phase 2/3 clinical trial for VYD2311 for the prevention of COVID-19, supported by a single, randomized, double-blind, placebo-controlled trial[29] - The company is in the discovery phase for RSV prevention and early discovery for measles and influenza prevention[29] Financials - Q2 2025 Pemgarda net product revenue was $11 8 million[66] - The company ended Q2 2025 with approximately $34 9 million in cash and cash equivalents[66]
Scientist Dr. Akiko Iwasaki Joins SPEAR Study Group to Investigate Monoclonal Antibodies for Long COVID and COVID-19 Post-Vaccination Syndrome
Globenewswire· 2025-07-23 11:01
Core Insights - Invivyd, Inc. has announced the addition of Dr. Akiko Iwasaki to the SPEAR Study Group, which focuses on the biology and clinical implications of persistent SARS-CoV-2 spike antigen [1][2] - The SPEAR Study Group aims to assess the safety and exploratory efficacy of monoclonal antibodies in individuals suffering from Long COVID and COVID-19 Post-Vaccination Syndrome (PVS) [3][4] Company Developments - Dr. Iwasaki is recognized for her research on viral pathogenesis and post-viral chronic conditions, including Long COVID, and leads several studies related to these areas [2] - The SPEAR Study Group was established in response to reports suggesting symptom improvement in Long COVID patients following administration of PEMGARDA, a monoclonal antibody authorized for emergency use [3][4] - Invivyd is utilizing monoclonal antibody technology to provide therapeutic options for individuals affected by Long COVID and PVS [3][4] Product Information - PEMGARDA (pemivibart) is an investigational monoclonal antibody with demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants [5][6] - VYD2311 is a novel monoclonal antibody candidate being developed to address the urgent need for new COVID-19 prophylactic and therapeutic options [11][12] - Both PEMGARDA and VYD2311 are engineered to target the SARS-CoV-2 spike protein, aiming to inhibit virus attachment to human cells [5][12]