WALTHAM, Mass., Aug. 22, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced the closing of its previously announced underwritten public offering of 89,234,480 shares of its common stock, which includes the exercise in full by the underwriter of its option to purchase an additional 14,423,076 shares of common stock, at a public offering price of $0.52 per share and pre-funded warrants to purchase 21,342,442 shares of its common stock at a public offering price of $0.5199 per pre- ...

Core Points - Invivyd, Inc. announced a public offering of 74,811,404 shares of common stock at $0.52 per share, along with pre-funded warrants for 21,342,442 shares at $0.5199 each, aiming for gross proceeds of approximately $50 million [1][3] - The offering is expected to close on or about August 22, 2025, subject to customary closing conditions [1] - Cantor is acting as the sole book-running manager for the offering [2] Use of Proceeds - The net proceeds will be utilized for trial protocol development and advancement of the VYD2311 clinical program, research and development for pipeline programs including RSV and measles, and efforts related to monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome [3] Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on protection against serious viral infectious diseases, starting with SARS-CoV-2, and has a proprietary technology platform for developing antibodies [7]

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]

Core Insights - Invivyd, Inc. announced positive in vitro neutralization data for PEMGARDA (pemivibart) against the XFG variant of SARS-CoV-2, indicating no significant change in neutralization activity [1][2][3] - The company anticipates continued clinical activity for pemivibart as the targeted epitopes remain structurally intact across various SARS-CoV-2 variants [2][3] - Invivyd is advancing its next-generation monoclonal antibody candidate, VYD2311, which has shown similar neutralization results with higher potency [3][12] Company Developments - PEMGARDA is authorized by the FDA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients, demonstrating consistent in vitro neutralizing activity over several years [1][4][7] - The company plans to provide updated data on PEMGARDA's neutralizing activity to the FDA, which will be included in the PEMGARDA Fact Sheet for Healthcare Providers [4][5] - VYD2311 is designed to offer a more patient-friendly administration route and aims to address the urgent need for new COVID-19 prophylactic and therapeutic options [12][13] Industry Context - COVID-19 activity is reportedly on the rise in the U.S., with high levels of viral activity detected in wastewater across 12 states, and infections growing in 34 states [2][3] - The CDC's data indicates that the XFG variant is contributing to a growing wave of COVID-19 cases in America, reinforcing the need for effective treatments like PEMGARDA and VYD2311 [5][6] - The stability of the epitopes targeted by Invivyd's monoclonal antibodies across SARS-CoV-2 evolution highlights the company's robust molecular design strategy [3][4]

Core Insights - Invivyd, Inc. is entering a transformative phase with a focus on VYD2311 as a promising alternative to COVID-19 vaccination, supported by recent clinical trial data [2][5][7] - The company reported a significant year-over-year increase in net product revenue for PEMGARDA, reaching $11.8 million in Q2 2025, representing a 413% growth [5][9] - Despite not meeting the near-term profitability target for the first half of 2025, Invivyd remains optimistic about achieving profitability with the upcoming respiratory virus season [5][9] Recent Business Highlights - The company is actively designing clinical and go-to-market strategies for VYD2311, which has shown an attractive safety profile and pharmacokinetics in Phase 1/2 trials [2][5] - Invivyd anticipates identifying a best-in-class RSV candidate in Q3 2025 and a preclinical measles candidate by the end of 2025 [2][5] Clinical & Regulatory Developments - Invivyd has aligned with the U.S. FDA on a rapid pathway to full approval for VYD2311, which aims to protect American adults and adolescents from COVID-19 [5][7] - The VYD2311 candidate demonstrated a 76-day observed half-life for intramuscular administration, indicating potential for long-term protection [5][6] Commercial Execution - PEMGARDA's uptake is increasing among healthcare providers for immunocompromised patients, supported by Invivyd's sales force and expanded field presence [6][10] - The product has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-Cell Lymphomas [6] Financial Results - For Q2 2025, Invivyd reported a net loss of $14.7 million, a decrease from $47.2 million in Q2 2024, with a net loss per share of $0.12 [9][28] - Research and development expenses were $9.6 million for the quarter, down from $30.3 million in the same period of 2024, primarily due to reduced clinical trial costs [9][28] Pipeline Expansion - The company is exploring pipeline expansion beyond SARS-CoV-2, including potential targets like RSV and measles [11][19] - Invivyd has formed the SPEAR Study Group to assess monoclonal antibody therapy effects for Long COVID and COVID-19 Post-Vaccination Syndrome [11][19]

Core Viewpoint - Invivyd, Inc. has received guidance from the U.S. FDA on a rapid pathway for Biologics License Application (BLA) approval for its monoclonal antibody candidate VYD2311, aimed at preventing COVID-19, which could provide an alternative to vaccines for the American population [1][2][3] Group 1: FDA Guidance and Clinical Trials - The FDA advised that a single Phase 2/3 randomized, double-blind, placebo-controlled trial could support a BLA submission for VYD2311, focusing on symptomatic COVID-19 events [1][3] - Invivyd plans to study two doses of VYD2311 to evaluate differences in protection levels and safety, aiming to provide more options for COVID-19 protection [2][4] - The primary endpoint for the trial is RT-PCR-confirmed symptomatic COVID-19, with a measurement timepoint expected at 12 weeks, and a potential longer duration of 24 weeks [3][4] Group 2: Product Profile and Market Position - VYD2311 is designed to be a low-dose, intramuscular, scalable, and cost-effective option for adults and adolescents, with potential expansion to pediatric populations [4][5] - The antibody is engineered to neutralize contemporary virus lineages and is based on a common molecular lineage with other successful Invivyd antibodies [2][8] - Invivyd's analysis suggests that VYD2311 may provide robust, long-term protection from symptomatic COVID-19 due to its high potency and long half-life of approximately 76 days [4][5] Group 3: Strategic Importance and Future Plans - The company emphasizes the importance of providing a non-vaccine choice for COVID-19 prevention amidst declining public trust in vaccines [2][3] - Invivyd has quantities of VYD2311 available for clinical supply and potential commercial launch, indicating readiness for market introduction if approved [6][8] - The company aims to finalize a pivotal clinical trial design with the FDA and is committed to advancing innovative solutions for COVID-19 prevention [6][3]

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]

Core Insights - Invivyd, Inc. announced full Phase 1/2 clinical data for VYD2311, a next-generation monoclonal antibody (mAb) candidate aimed at preventing and treating COVID-19 [1] - VYD2311 is structurally 99%+ identical to previous antibodies and is designed to enhance potency and resistance against SARS-CoV-2 variants [2][10] - The Phase 1/2 study demonstrated that VYD2311 was well tolerated with mild to moderate adverse events and a long half-life, suggesting potential for long-term protection [4][5] Company Overview - Invivyd, Inc. is focused on developing innovative monoclonal antibodies to combat serious viral infectious diseases, starting with SARS-CoV-2 [18] - The company utilizes a proprietary technology platform to create antibodies that can adapt to viral evolution [18] Clinical Trial Details - The Phase 1/2 study involved 40 subjects and tested various routes of administration (IV, IM, SC) and doses to maximize flexibility for future registrational pathways [3] - VYD2311 showed a half-life ranging from 61 days (IV) to 76 days (IM), significantly longer than pemivibart's 49 days [5] Safety and Efficacy - All adverse events reported were mild to moderate, with no serious adverse events linked to the study drug [4] - The modeling analysis indicated that VYD2311 could provide robust protection against symptomatic COVID-19, potentially surpassing vaccine efficacy [8][10] Regulatory Plans - Invivyd plans to engage with the FDA in early Q3 2025 to discuss registration pathways for VYD2311 and subsequent COVID-19 mAbs [6][8] - The company aims to provide non-vaccine mediated protection for vulnerable populations, including the elderly and immunocompromised individuals [8][10]

Core Insights - Invivyd, Inc. announced the publication of results from its CANOPY Phase 3 clinical trial of pemivibart, demonstrating its safety and efficacy for the prevention of symptomatic COVID-19 in a contemporary U.S. population facing immune-evasive Omicron variants [1][4][6] Group 1: Clinical Trial Overview - The CANOPY Phase 3 clinical trial randomized 788 adult participants across 18 sites, focusing on immunocompromised individuals and those at risk due to regular face-to-face interactions [2][8] - The trial met all primary and exploratory endpoints during a significant COVID-19 transmission period in the U.S. from September 2023 to September 2024 [2][8] - Pemivibart showed an 84% relative risk reduction in symptomatic COVID-19 compared to placebo over six months [4][6] Group 2: Safety and Tolerability - Pemivibart was generally well-tolerated, with most adverse events classified as mild to moderate [3][6] - The most common treatment-emergent adverse events included infusion-related reactions, with a low incidence of anaphylactic reactions (0.6%) [3][12] - The safety profile aligns with previous clinical trials for COVID-19 monoclonal antibodies [3][6] Group 3: Regulatory and Future Implications - The trial's results support the emergency use authorization (EUA) of PEMGARDA (pemivibart) for pre-exposure prophylaxis in certain immunocompromised patients [2][10] - The publication aims to educate clinicians on the potential of monoclonal antibodies in combating COVID-19, particularly for immunocompromised individuals [5][7] - Invivyd plans to leverage data from the CANOPY trial to expedite the approval of novel antibodies like VYD2311 [7][18]

Core Insights - Invivyd, Inc. commends the FDA for addressing uncertainties regarding COVID-19 vaccine booster efficacy and providing a pathway to resolve these issues [1][4] - The FDA has encouraged manufacturers to conduct randomized, placebo-controlled trials to evaluate the efficacy of COVID-19 vaccines, particularly in individuals who have had COVID-19 within the past year [2][4] - Invivyd's CANOPY Phase 3 clinical trial of pemivibart demonstrated an 84% reduction in the risk of symptomatic COVID-19 compared to placebo, highlighting the potential of monoclonal antibodies as a viable alternative to vaccines [2][3][4] FDA's Actions and Recommendations - The FDA has identified gaps in the understanding of COVID-19 vaccine booster efficacy and has called for trials to include healthy adults and those who have had COVID-19 recently [2][4] - The FDA considers a 30% reduction in symptomatic COVID-19 as "meaningful" protection, while Invivyd's pemivibart showed an 84% reduction, suggesting a significantly higher level of efficacy [3][4] Invivyd's Clinical Trials and Products - The CANOPY Phase 3 trial included a randomized cohort of individuals at risk of acquiring SARS-CoV-2, with a follow-up period of six months to assess the durability of the vaccine's efficacy [2][14] - Invivyd plans to advance next-generation monoclonal antibodies to improve scalability and efficacy, with an update on investigational mAb VYD2311 expected soon [4][6][15] Monoclonal Antibodies as a Treatment Option - The FDA has acknowledged the uncertainty surrounding the benefits of repeat COVID-19 vaccine boosters, positioning monoclonal antibody therapies like pemivibart as a critical alternative [4][5] - Invivyd emphasizes the importance of monoclonal antibodies for high-risk populations, particularly children, due to the limitations of vaccination strategies [5][6] Future Developments - Invivyd is set to engage with the FDA on expedited pathways for developing scalable COVID-19 prevention and treatment options, addressing the ongoing health crisis posed by COVID-19 [4][6][17] - The company is focused on delivering high-quality protection against COVID-19, with a commitment to advancing innovative antibody candidates [17]