IVVD

Mr. Elia has served as Chairman of Invivyd’s Board of Directors since June of 2022; has architected Invivyd’s scientific and corporate strategy Ajay Royan, Founder of Mithril Capital and a founding, long-term investor in Invivyd, appointed Lead Independent Director Ian Sheffield appointed to Invivyd’s Board of Directors as an independent director DECLARATION and LIBERTY studies of VYD2311 approaching completion with further updates expected within weeks NEW HAVEN, Conn., Sept. 01, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the company has appointed Marc Elia, current Chairman of the Invivyd Board of Directors, as Chief Executive Officer (CEO) of the company. He will serve as Chairman and CEO of Invivyd going forward. “Invivyd is transforming the way people are protected from serious viral infectious disease and requires a leader who has an expansive vision for how to improve public health and the ability to persuade others to bring the vision to life. That leader is Marc Elia,” said Ajay Royan, Lead Independent Director of Invivyd. “Marc has been a significant contributor to Invivyd since joining the Board and becoming Chairman. I’m eager to see the success he will bring to the company and to humanity as the Chief Executive Officer.” “Invivyd and its antibody technologies have the potential to revolutionize COVID prevention, and infectious disease medicine more broadly,” commented Marc Elia, Chairman and CEO of Invivyd. “Invivyd has been purpose-built to offer Americans and the world a new way to stay well by reliably accessing high quality, targeted, monoclonal antibody immune support that can provide protection from disease beyond the limits of vaccinology. Our current status quo involves too many Americans left to be sick too often, and many Americans, including myself, have struggled with the effects of Long COVID for years. Now more than ever we need companies that can bring forward medicines that advance our society past a need to repeatedly get sick from viruses we can prevent and treat with monoclonal antibodies. It’s an honor to lead the charge at Invivyd.” Joining the Invivyd Board of Directors as a new independent director is Ian Sheffield, founder and Managing Partner of North Country Holdings, a private investment firm. Mr. Sheffield has more than 20 years of experience as a healthcare investor and medical technology executive, previously holding senior roles at Ashler Capital (Citadel), Bridger Capital, Great Point Partners, and Versant Ventures. Invivyd continues to expect top-line data from the VYD2311 program around the end of Q3 2026. At that time, Invivyd plans to either unblind the DECLARATION study in its entirety and submit a Biologics License Application (BLA) towards traditional product approval, or partially unblind the study (leaving clinical events blinded) and submit a BLA towards Accelerated Approval on the basis of antiviral activity and safety, with greater statistical power expected to be achieved in a post-approval confirmatory clinical cohort. Preparing such options for filing pathway will substantially reduce the risk that play of chance related to the statistical powering in DECLARATION intrudes into the near-term availability of VYD2311, a highly active anti-COVID-19 monoclonal antibody that is functionally identical to prior Invivyd antibodies adintrevimab and pemivibart. The company has been in discussions with FDA about potential paths forward and believes that either route can provide a near-term pathway to make VYD2311 available for millions of Americans, subject to FDA review and approval. Invivyd will provide further updates in the coming weeks as previously guided. About VYD2311 VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration. VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. About DECLARATIONDECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without risk factors for progression to severe COVID-19 at three months. Participants will receive either a single dose or monthly doses of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is approximately 2,400 participants. About LIBERTYLIBERTY is a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311, an mRNA COVID vaccine, and co-administered VYD2311 with an mRNA COVID vaccine. Total enrollment of the trial is approximately 210 participants. About Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more. Trademarks are the property of their respective owners. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” “future,” and “target” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the anticipated contributions of the company’s Chief Executive Officer; plans related to the company’s research and development activities, and the timing and potential results thereof; expectations regarding the company’s clinical trial designs, event accumulation and progress, regulatory pathway, product profile, indication, patient populations, and administration paradigm for VYD2311; the company’s plans to provide future updates and the timing thereof; expectations regarding the public health landscape and potential benefits of mAbs; the potential of Invivyd and its antibody technologies to revolutionize COVID prevention, and infectious disease medicine more broadly; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; the company’s business strategies and objectives; the company’s future prospects; and other statements that are not historical fact. The company may not actually achieve the plans, intentions, or expectations disclosed in the company’s forward-looking statements, and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress, and results of the company’s discovery, preclinical, and clinical development activities; uncertainties regarding clinical trial event accumulation rates and statistical powering; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; whether or not any preclinical candidate identified by the company is determined to be suitable for clinical development; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory approval process, and available development and regulatory pathways; the company’s ability to generate the data needed to support a potential BLA submission for VYD2311; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitope that VYD2311 targets remains structurally intact and the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the ability to maintain a continued acceptable safety, tolerability, and efficacy profile of any product candidate following regulatory authorization or approval; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies may adversely impact the development or commercial success of the company’s product candidates; changes in expected or existing competition; the company’s reliance on third parties; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, each as filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. Contacts: Media Relations(781) [email protected] Investor Relations(781) [email protected]

Achieved Q2 2026 PEMGARDA® (pemivibart) net product revenue of $14.3 million, representing 21% growth versus Q2 2025 net product revenue of $11.8 million Completed rapid enrollment in VYD2311 DECLARATION clinical trial expansion cohort and LIBERTY clinical trial, driven by strong subject demand DECLARATION pivotal clinical trial enrollment is complete; the ongoing study is approaching its planned analysis, and in lieu of a Q2 2026 quarterly earnings call, Invivyd plans to hold an investor call post study completion LIBERTY study fully dosed with top-line data anticipated in late Q3 2026 Strong balance sheet with Q2 2026 ending cash and cash equivalents of $160.1 million anticipated to provide runway through DECLARATION pivotal data readout and support potential commercial launch readiness for VYD2311 NEW HAVEN, Conn., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the second quarter ended June 30, 2026, and recent business highlights. “With our VYD2311 DECLARATION and LIBERTY clinical trials planned to wrap up in the coming weeks, we are looking forward to the next steps for vulnerable Americans,” said Marc Elia, Chairman of the Board of Invivyd. “The public health need for antibody-based protection with attractive safety is enormous, and we are confident that many public health leaders and policy makers in the United States understand the importance of having non-vaccine options available for the American public health.” “We are pleased with continued growth of PEMGARDA, especially in the face of understandably diminished COVID vaccine utilization,” commented Bill Duke, Chief Financial Officer of Invivyd. “We are pleased with our strong cash position as we approach planned top-line data for our VYD2311 pivotal program later this quarter. We have continued to diligently manage expenses, albeit during a period of critical heavy clinical investment in our pivotal VYD2311 program, which we expect to complete shortly as we move toward potential launch of VYD2311, if approved.” Second Quarter 2026 and Recent Company Highlights PEMGARDA® Commercial Performance & Regulatory Update PEMGARDA net product revenue was $14.3 million for the quarter ended June 30, 2026, compared to $11.8 million in for the quarter ended June 30, 2025. Growth of 21% was driven by increased patient demand. In July 2026, Invivyd announced receipt of twelve months’ advanced notice of emergency use authorization (EUA) termination for PEMGARDA and that the company is in dialogue with the U.S. Food and Drug Administration (FDA) about appropriate next steps. Research & Development (R&D) Highlights COVID-19 Invivyd continued to advance its REVOLUTION program, which is Invivyd’s development program for VYD2311 that is designed to elaborate the profile of monoclonal antibody-mediated prophylaxis from COVID-19 and the potential medical benefits to vulnerable Americans: Measles In April 2026, Invivyd announced advancement of a measles monoclonal antibody candidate, VMS063. VMS063 is a novel, highly potent, broadly in vitro neutralizing, high resistance barrier, half-life-extended, potentially first- and best-in-class monoclonal antibody candidate for the treatment and prevention of measles. Invivyd has begun Investigational New Drug (IND)-enablement and regulatory outreach to advance VMS063 toward IND readiness in 2H 2026. Respiratory Syncytial Virus (RSV) Invivyd expects to advance VBY329, a novel, potential best-in-class monoclonal antibody candidate being developed to prevent RSV among neonates, infants, and children, for development in pediatric RSV prophylaxis, a blockbuster pharmaceutical market in 2024, expected to grow to $3-$4 billion in annual revenues globally by 2030. Invivyd expects to advance VBY329 toward IND readiness in 2H 2026. Corporate Updates In April 2026, Marc Elia spoke at the POLITICO Health Care Summit. During the session, Mr. Elia framed the evolving landscape of viral disease prevention, including the role of monoclonal antibodies in keeping Americans healthy moving forward. In April 2026, Invivyd launched “Antibodies for Any Body” in partnership with world ski champion Lindsey Vonn to inspire actions that support immune health. Publications & Other R&D Updates In May 2026, Invivyd published a preprint “Safety first: should the high tolerability of intramuscular anti-spike COVID-19 monoclonal antibody change our expectations of vaccine safety?” Linked here. The analysis supports the strong early tolerability profile of intramuscular-administered adintrevimab, a low-dose investigational monoclonal antibody for the prevention of COVID-19 that is the parent antibody to pemivibart and VYD2311. In May 2026, Invivyd reported positive, continued, in vitro neutralization data for PEMGARDA (pemivibart) and for VYD2311, the company’s vaccine alternative monoclonal antibody candidate for the prevention of COVID-19, against SARS-CoV-2 variant BA.3.2.2 (“Cicada”). Positive in vitro neutralization data for pemivibart against SARS-CoV-2 virus circulating in the U.S. over the past four years affirm Invivyd’s unique technology and reflect consistently stable target epitopes. Second Quarter 2026 Financial Results Revenue: Reported Q2 2026 PEMGARDA net product revenue of $14.3 million, compared to $11.8 million in Q2 2025, representing a 21% increase. Cash Position: Cash and cash equivalents were $160.1 million as of June 30, 2026. Cash and cash equivalents are anticipated to provide runway through DECLARATION pivotal data readout and support potential commercial launch readiness for VYD2311. R&D Expenses: R&D expenses were $29.4 million for the quarter ended June 30, 2026, compared to $9.6 million for the comparable period in 2025. This increase is primarily attributable to higher contract research costs associated with the DECLARATION and LIBERTY clinical trials for VYD2311. Selling, General & Administrative (SG&A) Expenses: SG&A expenses were $29.5 million for the quarter ended June 30, 2026, compared to $16.6 million for the comparable period in 2025. This increase is primarily attributable to an increase in personnel, communications and commercial-related costs. Net Loss and Net Loss per Share: Net loss was $44.4 million for the quarter ended June 30, 2026, compared to $14.7 million for the comparable period in 2025. Basic and diluted net loss per share was $0.14 for the quarter ended June 30, 2026, compared to $0.12 for the comparable period in 2025. About PEMGARDAPEMGARDA® (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, LP.8.1 and XFG. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells. PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. PEMGARDA is not authorized for use for the treatment of COVID-19, Long COVID, or COVID-19 Post-Vaccination Syndrome, or for post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination. Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse reactions included systemic infusion-related reactions and hypersensitivity reactions, local infusion site reactions, and infusion site infiltration or extravasation. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning. To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies. The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization revoked sooner. On June 30, 2026, the U.S. Department of Health and Human Services (HHS) announced notice of the termination of the declaration, effective June 29, 2027. About VYD2311 VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration. VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. About DECLARATIONDECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without risk factors for progression to severe COVID-19 at three months. Participants will receive either a single dose or monthly doses of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is approximately 2,400 participants. About LIBERTYLIBERTY is a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311, an mRNA COVID vaccine, and co-administered VYD2311 with an mRNA COVID vaccine. Total enrollment of the trial is approximately 210 participants. About Antibodies for Any BodyAntibodies for Any Body is a national education campaign designed to elevate public understanding of the immune system and explain the role antibodies play in keeping the body healthy. Visit AntibodiesforAnyBody.com to access information and resources and take the Antibodies for Any Body Wellness Assessment to learn more about your health. About VMS063VMS063 is a monoclonal antibody candidate engineered via Invivyd’s proprietary antibody discovery platform to target a highly conserved protein of a measles virus. The antibody has shown sub-nanomolar potencies across all variants tested in vitro to date. About VBY329VBY329 is a novel, potential best-in-class monoclonal antibody (mAb) candidate being developed to prevent Respiratory Syncytial Virus (RSV) among neonates, infants, and children. About SPEAR Study GroupInvivyd and leading researchers formed the SPEAR (Spike Protein Elimination and Recovery) Study Group to assess the effects of monoclonal antibody (mAb) therapy for Long COVID and COVID-19 Post-Vaccination Syndrome. About Invivyd  Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more. Trademarks are the property of their respective owners. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” “future,” and “target” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, plans related to the company’s research and development activities, and the timing and potential results thereof; expectations regarding the company’s clinical trial designs, event accumulation and progress, regulatory pathway, product profile, indication, and administration paradigm for VYD2311, including the company’s REVOLUTION clinical program and the timing of expenditures and results related thereto, as well as preparations for the potential commercial launch of VYD2311, if approved; the company’s plans to hold a future investor call; expectations regarding the public health landscape and potential advantages of mAbs; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; expectations regarding the future termination of the EUA granted by the FDA for PEMGARDA and the transition period; the company’s plans and expectations with respect to its other product candidates, including VMS063 and VBY329; the company’s business strategies and objectives; the company’s expectations regarding the sufficiency of its current cash and cash equivalents; the potential market size and opportunity for the company’s product candidates; the company’s future prospects; and other statements that are not historical fact. The company may not actually achieve the plans, intentions, or expectations disclosed in the company’s forward-looking statements, and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: uncertainties regarding the company’s expectations, projections, and estimates regarding future costs and expenses, future revenue, capital requirements, and the availability of and the need for additional financing; uncertainties regarding market acceptance, payor coverage, and reimbursement, or future revenue generated by any authorized or approved product; uncertainties regarding the impact of the future termination of the EUA granted by the FDA for PEMGARDA on the business of the company; uncertainties related to the transition period for PEMGARDA; the ability to maintain a continued acceptable safety, tolerability, and efficacy profile of any product candidate following regulatory authorization or approval; the success of the company’s in-house sales force, and the company’s ability to maintain and expand sales, marketing, and distribution capabilities to successfully commercialize any authorized or approved product; changes in expected or existing competition; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; whether or not any preclinical candidate identified by the company is determined to be suitable for clinical development; the timing, progress, and results of the company’s discovery, preclinical, and clinical development activities; clinical trial event accumulation rates; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; the company’s ability to generate the data needed to support a potential BLA submission for VYD2311; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitopes that pemivibart and VYD2311 target remain structurally intact and the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies may adversely impact the development or commercial success of the company’s product candidates; the company’s reliance on third parties; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. Contacts: Media Relations(781) [email protected] Investor Relations(781) [email protected] (1) Includes an allowance for doubtful accounts of $199 and $323 as of June 30, 2026 and December 31, 2025, respectively. (2) Includes related-party amounts of $576 and $703 as of June 30, 2026 and December 31, 2025, respectively. (1) Includes related-party amounts of $571 and $1,121 for the three and six months ended June 30, 2026, respectively, and $472 and $924 for the three and six months ended June 30, 2025, respectively.(2) Includes related-party amounts of $1,129 and $2,255 for the three and six months ended June 30, 2026, respectively, and $1,140 and $2,268 for the three and six months ended June 30, 2025, respectively.

Interested in Invivyd, Inc.? Here are five stocks we like better. VYD2311 remains on track: Invivyd said its pivotal DECLARATION study is progressing on schedule, with recruitment into the expanded cohort moving faster than expected before a temporary slowdown. The company also highlighted a monitoring change from two hours to 30 minutes after a safety review, which it views as a potentially positive sign. PEMGARDA posted year-over-year growth: The company said PEMGARDA revenue rose 22% from the first quarter of 2025, helped by persistent COVID-19 demand and less seasonal weakness than typical respiratory products. Management is preparing to leverage much of PEMGARDA’s commercial infrastructure if VYD2311 is approved. Clinical spending increased, but cash remains strong: First-quarter expenses were lifted by heavy investment in the VYD2311 trial and commercialization prep, though Invivyd said its cash position is “very strong” after raising additional funds in April. The company expects spending to normalize as the pivotal study winds down. Invivyd (NASDAQ:IVVD) said its first quarter of 2026 was marked by continued progress in its pivotal COVID-19 antibody program, year-over-year growth for PEMGARDA and elevated clinical spending tied to its VYD2311 development efforts. On the company’s earnings call, Chairman Marc Elia said Invivyd’s pivotal DECLARATION study for VYD2311 remains on schedule after the company triggered an upsizing of the study in early April. Elia said recruitment into the expanded cohort moved “well faster” than internal expectations, prompting Invivyd to slow enrollment temporarily during a lull in COVID-19 and broader respiratory disease activity in order to extend patient exposure into what the company expects could be a normal summer COVID wave. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “We’ve resumed full speed recruitment and believe we will finish up imminently, keeping the program on time with our previous estimates,” Elia said. Chief Medical Officer Dr. Michael Mina said the Independent Data Monitoring Committee recently recommended reducing post-dose monitoring in the DECLARATION study from two hours to 30 minutes after reviewing unblinded VYD2311 safety data. Mina said the study has been modified accordingly, and the company views the change as a potentially encouraging sign for safety and tolerability after administration. → MP Materials Is Quietly Building a Rare Earth Powerhouse During the question-and-answer session, analysts asked whether the 30-minute monitoring period could ultimately appear in VYD2311’s label if approved. Elia said it was too early to know and emphasized that the change reflects the evolution of the clinical program rather than a final commercial or regulatory position. Mina added that Invivyd anticipates an intramuscular monoclonal antibody could eventually resemble common post-vaccination waiting practices as physicians become more comfortable with the product profile. Mina also said Invivyd aims to open and begin recruiting the LIBERTY study shortly. That study is intended to evaluate the safety and immunology of combining a COVID-19 vaccine with a monoclonal antibody and to prospectively compare the safety and tolerability of monoclonal antibody approaches against mRNA vaccination. → Micron Investors Face a High-Stakes Moment After the Latest Rally A central theme of the call was Invivyd’s view that monoclonal antibodies may offer an advantage over vaccines in terms of systemic reactogenicity, or short-term symptoms such as fever, chills, headache and fatigue after immunization. Mina discussed a recent manuscript analyzing adintrevimab, an earlier investigational Invivyd antibody that completed a placebo-controlled pivotal prevention study. Mina said the company compared symptom categories from the adintrevimab EVADE study with symptoms reported in Sanofi’s COMPARE Phase IV study of protein-based and mRNA-based COVID-19 vaccines. He cautioned that there were “real methodological differences” between the studies and said the LIBERTY study will be needed for a direct comparison. Even so, Mina said the results support Invivyd’s view that monoclonal antibodies do not rely on immune education in the same way as vaccines and therefore may avoid much of the inflammatory response tied to vaccination. He argued that post-immunization symptoms can affect willingness to receive future immunizations and therefore may have public health implications. Elia said the company is not positioning the analysis as an anti-vaccine argument, but rather as part of a broader discussion about risk, benefit and tolerability. In response to an analyst question, Elia said Invivyd selected the VYD2311 dose with the expectation that corresponding antiviral titers would “conceptually generate” a 70% to 90% protective benefit against symptomatic disease, while stressing that the clinical trial will determine the actual outcome. Chief Commercial Officer Tim Lee said PEMGARDA grew 22% compared with the first quarter of 2025. He noted that the first quarter is typically weaker for pharmaceuticals, infectious disease and preventive medicine, but said PEMGARDA has not shown the same degree of seasonal decline expected for a seasonal respiratory vaccine. Lee attributed that relative stability to the continuing presence of SARS-CoV-2, including periodic waves and the potential for a summer surge. He said vulnerable populations and care teams appear to be making decisions that reflect COVID-19 as an ongoing threat. Lee said Invivyd is preparing for a potential transition to VYD2311, if approved, which he described as an “entirely new kind of COVID antibody.” While the distribution model would differ from PEMGARDA, Lee said much of the commercial infrastructure built for PEMGARDA could be leveraged and expanded for VYD2311. The company also said it is increasing use of new channels for healthcare provider education, including leading artificial intelligence platforms, and expanding direct-to-consumer efforts to build disease and brand awareness. Lee said those consumer efforts remain in the early stages but could be scaled if VYD2311 is approved. Chief Scientific Officer Dr. Robert Allen said Invivyd continues to see “attractive neutralization data” for its medicines against relevant SARS-CoV-2 variants, including formal confirmation of neutralization against Omicron BA.3.2. Allen said the company has no current expectation of future activity concerns based on the variant landscape it sees today. Beyond COVID-19, Allen said Invivyd has disclosed early programs targeting measles and RSV, and is expanding discovery work across other vaccine-preventable viruses including mumps and rubella, as well as Borrelia burgdorferi, the bacterium associated with Lyme disease. Allen said the company views monoclonal antibody technology as underutilized in infectious disease prevention and treatment. Invivyd said first-quarter results included meaningful clinical spending to support the DECLARATION trial, describing the investment as substantial compared with ordinary clinical and SG&A spending. The company said it also made targeted investments to prepare for potential VYD2311 commercialization, if approved, while noting some of those investments could also support PEMGARDA. The company characterized its cash position as “very strong,” citing additional cash raised in April through its at-the-market offering facility from long-term investors. Invivyd said it expects continued PEMGARDA growth and a return to more normalized research and development spending as the pivotal VYD2311 trial winds down over coming quarters. Elia closed the call by saying the company believes several important milestones are approaching “within months,” while emphasizing that regulatory outcomes and clinical data remain ahead. Invivyd, Inc, a commercial-stage biopharmaceutical company, focuses on the discovery, development, and commercialization of antibody-based solutions for infectious diseases in the United States. The company developed INVYMAB, a platform that combines viral surveillance and predictive modeling with advanced antibody engineering. Its pipeline includes PEMGRADA (pemivibart) injection, a half-life extended investigational monoclonal antibody (mAb) for the prevention of COVID-19 in adults and adolescents; VYD2311, an mAb candidate which is in preclinical studies for the prevention or treatment for COVID-19; and adintrvimab, that is in phase 3 clinical trials for the prevention or treatment of COVID-19. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Invivyd Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Image source: The Motley Fool. May 14, 2026 at 8:30 a.m. ET Chairman of the Board — Marc Elia Chief Medical Officer — Dr. Michael Mina Chief Scientific Officer — Dr. Robert Allen Chief Commercial Officer — Tim Lee Chief Financial Officer — William Duke Need a quote from a Motley Fool analyst? Email [email protected] Marc Eiia, Chairman of Invivyd's Board of Directors. He is joined by Dr. Michael Mina, Chief Medical Officer; Dr. Robert Allen, Chief Scientific Officer; Tim Lee, Chief Commercial Officer; and Bill Duke, Chief Financial Officer. During today's discussion, we will be making forward-looking statements concerning, among other things, our corporate and commercial strategy, our research and development activities, our regulatory plans, certain financial expectations, our future prospects and other statements that are not historical facts. These forward-looking statements are covered within the meaning of the Private Securities Litigation Reform Act and are subject to various risks, assumptions and uncertainties that may change over time and cause our actual results to differ materially from those expressed or implied today. These forward-looking statements speak only as of the date of this call, and Invivyd assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd's business can be found in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K, which are also available on our website. I will now turn the call over to Marc. Marc Elia: Thanks, Katie. Good morning, and thank you all for joining us. It's an exciting time for Invivyd and an exciting time for the future of infectious disease medicine. The first quarter of 2026 and the current quarter have been very busy here, and we'll use this time today to remind you of our news and put it into the broader context of our mission. I'll start by recapping some recent events. First, our pivotal program continues at high speed. As you may remember, we triggered our DECLARATION study upsizing in early April, and the recruitment speed into this additional upsized cohort occurred well faster than our internal expectations. Given the lull in COVID-19 and overall respiratory disease burden in April, we actually slowed recruitment to stretch our upsized patient exposures into what we would expect to be a normal summer COVID wave. We've resumed full speed recruitment and believe we will finish up imminently, keeping the program on time with our previous estimates. Next, we have substantially increased our government affairs activity of late, and I'll share some general observations about what we are seeing and hearing in Washington, D.C. The overall landscape from the Invivyd point of view is highly positive, but we are very focused on making sure policymakers are aware of the potential of our medicines and so have no intention of slowing down our work. We recently published a manuscript, a preprint we call safety first that we think is perhaps more profound than it may seem at first glance. Our colleague, Dr. Michael Mina, will walk through some of the implications of our work in more detail in a moment and describe how the analysis we are performing bear on potential overall American wellness. Finally, we're happy to announce that as we expected, we formally confirmed virus neutralization of our medicines against Omicron BA.3.2, a COVID virus variant that may reveal more about overall evolutionary trends than posing any particular and clinical challenge. Dr. Robert Allen, our CSO, will describe those findings in a bit more detail. So where does all this leave us in the big picture? We are seeing continued growth in our monoclonal antibody revenues, while COVID vaccine utilization and revenue declined. We see overwhelming demand for our antibody study at the recruitment level, while recently, we read another company in the field abandoned a major vaccine study for lack of demand. We think this means we're on to something good. Beyond the centerpiece of our company in COVID-19 prevention and treatment, we recently disclosed our early discovery pipeline in the presentation given by Dr. Allen at the World Vaccine Congress. You can find the link on our website, and you will note that beyond the measles antibody program we've already described, there are several vaccine preventable pathogens on the slide, including mumps and rubella, the other components of the MMR pediatric vaccine, as well as Lyme disease and several other burdensome pathogens that may benefit from immune supplementation or treatment via monoclonal antibodies that can operate beyond the limits of vaccinology. We believe that in Invivyd, we've created the premier industrial platform for the discovery, development and commercialization of monoclonal antibodies for burdensome viruses with major associated public health benefit and potential shareholder value creation. Going forward, we think investors and the broader medical community will be pleased with the scope of our technical capability and the unique role our molecules can play in improving health outcomes by adding to or synergizing with vaccination. On government affairs, we've taken the opportunity to introduce Invivyd in our work to portions of the new administration and key advisers and influencers in that space. Without going into too much detail, we're happy to share some impressions that may surprise investors. First, our observation has been that a great many people within and the leadership of the MAHA movement often demonstrate a superior technical understanding of basic and translational immunology than we commonly encounter. Second and perhaps less surprising, these same people often have a much more clear and detailed understanding of both the randomized and observational data around COVID-19 vaccinology than much of the medical establishment. It actually appears that the data on COVID-19 vaccines presented by the CDC over the last 5 years has been taken up and understood more clearly by elements of the MAHA movement than even the traditional infectious disease medicine establishment. That was unexpected and welcome news to us. More and consistent with the wide range of various sources on this slide, we have observed consistent, direct and clear support for the concept of monoclonal antibody immune supplementation, not just from the medical establishment, but also from this new segment in modern medicine. Whether you are President Trump opining on the value of monoclonals or Tony Fauci or even Joe Rogan, it doesn't appear to matter what political or scientific perspective one holds. The concept of supplementing human immunity by adding the power of monoclonal antibodies appears to be regarded as a universal positive. Some investors of ours have raised concern that "vaccine skeptical" or hesitant communities may not appreciate monoclonal antibodies. I'll take this opportunity again to disagree. Our clear experience is that to the contrary, people who describe themselves as vaccine skeptical are telling a precise truth. They're not medicine skeptical and they're not confused to assume they are as to risk missing the point and inflaming the overall debate. Finally, and consistent with now years of experience, we have actually shared these impressions with multiple media outlets have authored multiple op eds about the shared common ground across this polarized modern infectious disease medicine complex, but have enjoyed almost no traction or uptake. The apparent fighting about vaccines and health playing out in the media will continue so long as the public continues to click on ads and find conflict more interesting than resolution. Meanwhile, we're excited to continue to work for a better way forward, and we're thrilled with the level of understanding of and appreciation for our work we've encountered. By working in COVID and infectious disease generally, we have a duty to the public, and that begins with educating our leadership on the scientific and medical landscape to the best of our abilities. We expect that to continue. We're also beginning to educate the public at scale on the role antibodies play in basic human immunology. The last few years have, of course, created all manner of misunderstanding and misapprehension in the public, thanks to the strange circuitous relationship the public has enjoyed with vaccinology. We think a better future starts with simple, basic immunology education that can be found on Pages 1 through 3 of any immunology textbook. But who better to inform the public on these issues than Lindsay Vonn, who is, we can assure all of you, the real deal genuine article and perhaps the single most inspiring human being many of us are likely to encounter. It is clear from our personal experiences at Invivyd that you don't want to race against her, you don't want to tell her that she cannot or should not do something. On the flip side, you actually might want to dare her that she can't possibly do scientific education for the American public. She appears to be undertaking this challenge with real vigor. We've partnered with Lindsay on our antibodies for anybody campaign and are very pleased with the attention garnered in our initial rollout. As we move forward as a company, it's essential that we keep our eye on the basics that investors may take for granted, but on which most consumers and many health care providers are not actually all that clear. Accurately identifying the role of antibodies in human immune physiology for the general public will be an important contributor to the value of our work long term. I'll now turn the call over to Dr. Michael Mina, our Chief Medical Officer. Michael Mina: Thanks, Marc. As most of you know, the pivotal program for VYD2311 is well underway. A quick update on our ongoing DECLARATION study. We're pleased that the Independent Data Monitoring Committee, or IDMC, recently recommended that post-dose subject monitoring be reduced from 2 hours to 30 minutes after review of unblinded 2311 safety data. We've modified the DECLARATION study accordingly and believe this update may reflect an encouraging indicator of product safety and tolerability post administration. In addition to DECLARATION, we aim to have the LIBERTY study open and recruiting shortly to assess the safety and immunology of COVID-19 vaccine combined with monoclonal antibody and to assess in a direct prospective fashion, the safety and tolerability of monoclonal antibody approaches to immunization against COVID-19 mRNA vaccination. This comparison should go a long way to providing a direct view on what we believe is the first advantage of an antibody approaches infectious disease prevention, high safety and tolerability. Our view is that symptomatic vaccine reactogenicity is a major driver of people's willingness to get vaccinated and agree with data from CDC and recent statements from Sanofi indicating the same. On that point, I was pleased to recently work with other Invivyd authors and Dr. David Putrino of the Icahn School of Medicine on a recent manuscript that evaluated adintrevimab, an old investigational antibody from Invivyd that completed a placebo-controlled pivotal study for the prevention of symptomatic COVID-19 similar to the DECLARATION study. More adintrevimab is highly similar to 2311, different by only a handful of amino acids in the variable region and was administered intramuscularly at a similar dose to 2311. Upon seeing results from Sanofi's COMPARE Phase IV study comparing protein-based COVID vaccine against mRNA-based COVID vaccine, which demonstrated a statistically significant difference on early systemic reactogenicity symptoms such as headache, fever, chills and fatigue over the first 7 days post vaccination. We undertook an analysis of the same symptoms from the adintrevimab EVADE study over the same duration. The results of our analysis are presented on the slide as they can be found in our manuscript. There are real methodological differences in how these symptom data were collected in the COMPARE study versus the EVADE study, and so we will have to wait for liberty for an apple-to-apples direct evaluation. Nonetheless, the comparative results are striking. We see as we'd expect that while COVID-19 vaccination relies on immune education and reeducation with its associated inflammatory response, monoclonal antibodies do not. As an epidemiologist and physician, there are implications to these data that go beyond a competitive or comparative profile and get the issues we must grapple with at the level of public health. If it's true that people's experiences with immunization directly influences their willingness to get immunized in the future, then systemic reactogenicity is itself an important consideration in public health. A vaccine that generates an 80% to 90% probability of 3 to 3.5 symptom days actually represents a meaningful portion of the symptom burden of an actual breakthrough COVID-19 infection. And so it's not surprising that we see declining vaccine utilization and therefore, declining protection from a virus and SARS-CoV-2 that is still inflicting a substantial medical burden on humanity. We can calculate the cost to society and symptom days per million immunizations given. Logically, if a person starts with a high probability of a few days of real burdensome systemic symptoms from the vaccine itself, then the vaccine will have to be very protective against symptomatic disease for quite a while to generate a net benefit in overall symptomatic patient days. Recent COVID vaccine efficacy data does not make a particularly compelling case on that dimension with estimated protection from symptomatic disease peaking at approximately 50% for a relatively short duration. By contrast, 2311 data look like adintrevimab safety data and do not start patients with a meaningful symptomatic burden. A monoclonal can be essentially minimally protective on the order of 10% to 15% protected with symptomatic disease while still generating a net benefit in symptoms. We'd expect any monoclonal antibody we generate to have much more meaningful protection, but the point remains the more reactogenic the vaccine, the higher the public expectation will be for consequent strong and durable protection. The results of our modeling are presented here on Slide 11, and we expect to make this point with more refined modeling and present it to relevant policymakers and regulators as much as we can in the coming months. The big picture is clear, and I want to be clear that this is not some form of anti-vax statement, but rather the reality of the data. Our major concern at Invivyd is protecting people and doing so in a way that allows vulnerable populations to stay safe and well because low-dose intramuscular COVID antibodies appear to confer very low levels of systemic reactogenicity. We believe that intramuscular monoclonal antibodies can address these experiential problems and can exert meaningful population level benefits at scale. Obviously, we'll look to our DECLARATION of LIBERTY studies to provide high-quality prospective and controlled data on these safety and tolerability issues near term. I'll now turn the call over to Dr. Robert Allen, our Chief Scientific Officer. Robert Allen: Thanks, Michael. And we can turn to Slide 15 very quickly. And as we expected, we continue to see attractive neutralization data for our medicines against relevant SARS-CoV-2 variants. This is consistent with our hypothesis and the industrial process for druggable targets like the SARS-CoV-2 spike protein. More, we continue to believe that our medicines engage important territory on the RBD. And as usual, we have no expectation of future activity concern based on the virus variant landscape we see today. On Slide 16, beyond COVID, in our early pipeline, we have disclosed what we view as potential best-in-class antibodies to treat and prevent critical virus threats in measles and RSV. As Marc noted, we are expanding our early discovery across a host of viruses, including vaccine preventable viruses such as mumps and rubella and key threats to chronic health in America such as Lyme disease or Borrelia burgdorferi. We see monoclonal antibody technology as underutilized across infectious disease medicine, both for prevention and treatment in many diseases and are looking forward to using our technology to open up new cases, new use cases that meaningfully improve our ability to keep people well in the face of both established and emerging viral threats. Now, I'll turn the call over to Tim Lee, our Chief Commercial Officer, to discuss our commercial progress. Timothy Lee: Thanks, Robbie. We were pleased that PEMGARDA once again grew year-over-year, now at 22% over 1Q in 2025. Traditionally, the first quarter is a bit weaker in the pharmaceutical industry and indeed in infectious diseases and preventive medicine, one traditionally sees a major seasonal drop-off from the third and fourth quarters to the first and second. Interestingly, we are not seeing nearly so much of that same seasonal change as you would expect from a seasonal respiratory vaccine. We attribute our relatively more stable P&L to the fact that SARS-CoV-2 has periodic waves, including the anticipated coming summer surge. And even at low levels is a ubiquitous and ever-present threat. Vulnerable populations and their care teams appear to be making more rational decisions that reflect the nature of this viral threat. Elsewhere, our leading indicators are showing good ongoing growth, and we are preparing for and looking forward to transitioning forward into an entirely new kind of COVID antibody. And we believe that can be game changing in the form of VYD2311, if approved. Although the distribution model will be entirely different, we are pleased that much of what we have built for PEMGARDA already is going to be leveraged and expanded for VYD2311. Turning to Slide 19. We're also increasing our exposure to new mechanisms by which health care providers access information about medicine, including the leading AI platforms. These tools promise to dramatically increase the efficiency by which companies like Invivyd as well as much bigger companies can disseminate appropriate information about our medicines to health care providers. Our expectation is to continue to think differently about how we design and deploy our resources. Our expectation is that these tools will help us to differentiate from more traditional pharmaceutical companies who historically have relied solely on feet on the street, and we'll be focused and nimble with our sales force as well as the resources we bring to market. So far, our early efforts with AI tools appear to be encouraging, and we will meter our investments in these tools appropriately over the coming quarters with our PEMGARDA business. Turning to Slide 20. Finally, we have increased our direct-to-consumer efforts, which although still in its infancy, are beginning to generate greater disease and brand awareness. This is another efficient channel that we'll expect to ramp up if VYD2311 is approved. And with that, I'll ask Bill to cover the financials. William Duke: Thanks, Tim. Turning to Slide 22. The first quarter of 2026 included meaningful clinical spend to support our DECLARATION clinical trial. This is a very substantial investment compared to our ordinary clinical and SG&A spending, but one we feel has extraordinary commercial potential. Our cash position remains very strong, especially considering the additional cash raised in April from long-term investors who wish to increase their position through our at-the-market offering facility. We are looking forward to continued PEMGARDA growth and as the pivotal trial for VYD2311 winds up over the coming quarters, a return to more normalized R&D spending. Turning to Slide 23. You can see the effects of VYD2311 spend on our overall burn via this chart that provides a bridge from Q4 '25 to Q1 2026. You will note that we have also made targeted investments to prepare for VYD2311 commercialization, if approved, although it is reasonable to expect that some of these investments in personnel and commercial infrastructure could benefit our current PEMGARDA business as well. With that, we are happy to take your questions. Operator? Operator: And our first question coming from the line of Josh Schimmer with Cantor Fitzgerald. Joshua Schimmer: First, for the 30-minute post-administration monitoring time for 2311, do you anticipate that would be ultimately included in the label? And if so, how might that impact adoption? And then second, the last I checked in terms of the wastewater monitoring for COVID, it's still at a mid-year. But do you, from your vantage point, see any indications of the new summer wave starting to emerge yet? Marc Elia: So I think just to go in order, hey, good morning, Josh, by the way. So on the 30-minute monitoring, I think it's a little premature. Now when we go out into the field, and you will all, I'm sure, remember from the pandemic, different medical interventions administered in different settings will carry with them some obligation typically, right? And particularly, if I recall back in 2021, I wondered the hallways of Walgreens for about 12 to 15 minutes before a pharmacist told me I could leave. So I think to us, what you're really looking at is the evolution of a clinical program only at this point. And it's -- I think as we go through FDA and then out into the field, we would hope that something that has a profile that we would expect to be relatively modestly burdensome barring the administrative out, I think let's see. I certainly don't think of it as something a variable that we are concerned about in terms of adoption and uptake bigger picture. But I'll just invite anyone else from Invivyd to have a view or? Michael Mina: Yes. Josh, it's Michael Mina. Certainly, what the wave ones are saying that's going to be based on the studies and our discussions. But we have -- we anticipate from what we know, in particular from a base that we're going to see high tolerability, low reactogenicity. And overall, we would anticipate that as we move into the future with an IM monoclonal that practice is going to start to look more like the way that people currently wait following a vaccine, which will probably -- as people get more comfortable, physicians get more comfortable, we would expect that concerns that would lead somebody to stick around for 2 hours would certainly fall by the wayside. Marc Elia: As I reflect, I would also just add, remember, early on in the -- people would often wonder what would be the biophysical relationships between, say, adintrevimab, pemivibart and then 2311. And we would have always reminded folks that when we deal in part, we are dealing in extraordinarily high doses of monoclonal antibody delivered via IV infusion. And so as we moved into the DECLARATION program, I think people were perhaps justifiably wondering, would there be meaningful per-administrative issue like, for example, hypersensitivity and allergic reaction that is common at some low rate with protein-based therapeutics and monoclonal antibodies. And again, going back to my remark about the evolution of a study, I think, again, we don't know what the IDMC is looking at, but it is to a large degree to us make sure and we would expect that there will be very little to talk about on this front as we get through the final data. But of course, there's one way to find out, and so shall we all in time. On the wastewater I think, again, I'll ask Robbie in a minute if he has anything to add. But I think what we essentially know boils down not in terms of variant perception from what most people can see, although different wastewater services and sites have different levels of latency, okay? So all of us depending on what source we're looking at, are looking some number of days in arrears. I think there is something reassuring to the simple arithmetic of exponential growth. COVID and is a little unique among the more classically seasonal respiratory diseases. COVID, it appears to us since now 6 years to either be declining or to be rising. And it certainly appears to have radically slowed its level of decline, albeit now down to low levels. Typically, that would portend a relatively predictable rise. And the critical thing from an Invivyd standpoint is to make sure that we have the maximum number of patient exposures out there when that rise occurs. And so again, maybe a little bit of inside baseball from a practitioner standpoint, I think it's, in some ways, unfortunate the DECLARATION started up about 2 weeks, 2 weeks only later than in hindsight, could have been ideal relative to a December, January wave. And is that a big problem or a big issue? No, certainly not. But it does go to how finally we try to map these things and tune these things to the benefit of event rate accumulation. So look, all I think I'm saying is at a certain point, we start to get conviction that a turn is either upon us and not yet detected or imminent to a point where a forward 3-month lens feels like a very attractive place to place our patient exposures. And it can't be a guarantee. It's just the experience of 6 or so years of watching this stuff. We're all going to, like we say, find out together, unfortunately, on this point, but I think we feel pretty good about our setup going into this summer and then the ramp-up of the study. Operator: And our next question coming from the line of Patrick Trucchio with H.C. Wainwright. Patrick Trucchio: Congrats on the progress. Just a couple of follow-ups on DECLARATION. The first is, I think you mentioned that even low efficacy antibody, monoclonal antibody could generate symptomatic benefit, but we're expecting much stronger protection. So I'm wondering, though, what point estimate or lower confidence down would you consider clinically meaningful, commercially viable and supportive of a BLA? And then separately, how should we think about the single dose versus multi-dose arms? How is the, I guess, the statistical hierarchy structured and commercial read-through that we should see between the single dose and monthly dose arms? Marc Elia: Okay. Thanks for that. Let me start, and then I know some others are going to weigh in. Okay. So on your first question, in some ways, you posed the considerations in what I think are a really interesting and important order, okay? And I'm going to go backwards in effect. In terms of what would be required for BLA, recognize that, that's a determination made by a small group of people who work for the federal government, and they make the rules and we all follow them. So we will all end up being in receipt of whatever it is, the U.S. FDA deems a positive risk benefit for the American public. We certainly, of course, expect a much better VE. We're certainly, of course, providing antiviral titers that we would imagine would carry much higher VE. But then I'll get to your other points. What is commercially viable? Well, today, there's $3 billion or so in U.S. revenue of something that would appear to not have a particularly impressive nor particularly durable VE. So your mileage may vary on that point. And in terms of what is clinically meaningful, I think actually, whether or not you mean it, of course, you are getting at the heart of the analysis we're providing here, which is the goal of clinical medicine and infectious practice is to keep people ground. And so I think the point we're trying to demonstrate here is just that it's -- we're all operating against a very high proposed bar of overall profile when we deploy these maps. We're looking for very, very high protection at a very, very low symptomatic penalty or tolerability penalty. That's our goal. But if you asked us what was clinically meaningful and you were talking to, let's say, a vulnerable person, and here, I'll just use myself as a fun example because I happen to be here and I'm speaking. I would be thrilled if I could routinely access something that is very low penalty modulated my risk of symptomatic disease. The reason I say that is because symptomatic disease is going to define, yes, my day-to-day experience. But typically, one would imagine that it is also a predicate for derivative follow-on benefits, right, such that if I don't get sick, it's probably unlikely I'm going to go to the hospital. If I don't get sick or go to the hospital, it's probably unlikely I'm going to die. So again, I would just point out, you actually did [Technical Difficulty] like all of these waterfalls of consideration that suggest to us, and we're very comfortable doing this, we are operating with the aim of delivering a very, very exciting new medicine that proposes to ask very little of patients or subjects in terms of tolerability and return something really, really meaningful, which would be relatively very high protection over a very long term. We think that is awesome. All we mean to point out is that indeed, let's say we were in a dialogue over time or in some point in the future with a group of people who have been designated in our social contract to decide whether or not these are useful objects. Remember what DECLARATION is first designed to do, I think we would argue, establish safety and tolerability relative to placebo. I say that because we all know the calculation of protection in VE is going to be dependent to some extent on infectious disease attack rate in the study, so on and so forth. That is a probabilistic thing. Again, as we've disclosed previously, we feel like we're in great shape and looking forward to completing the study. But it's critical people not lose sight of the fact that if we are able to generate a highly active anti-SARS-CoV-2 antibody that is scalable and highly safe, it's a really good thing for society through viewed through any one of those lenses you proposed. Now in terms of the single and multi-dose, I'll just remind everybody, we first embarked on a multi-dose cohort principally because the FDA asked us to demonstrate multi-dose safety, which is a perfectly reasonable request we're happy to provide. The reason we picked the increment of 1 month was to afford future subjects of these medicines the maximum reasonable flexibility in their dosing regimen, right, such that if somebody wished to take a medicine like this monthly, I suppose if we're so fortunate as to demonstrate safety and efficacy, and we're so fortunate to earn a BLA, they could do that on the basis of that multi-dose arm and DECLARATION. Now the only reason we didn't pick, for example, an increment of 1 day is because if one were to take VYD2311 monthly, given the antiviral potency we see now, that human being would be carrying around a fairly extraordinary quantity of antiviral power, not to suggest more couldn't be a tiny bit better. But there's a limit, I think, to how much somebody is going to end up wanting to sort of gigamap themselves on the way to maximum potential protection. It's not to say we couldn't have done a day. It's just that we picked a month because that felt like a reasonable quantum that affords some flexibility. In terms of expectation, what you're asking is really about the probabilities of study conduct in this regard, right? Meaning if we could run DECLARATION 10,000 times like a Monte Carlo simulation of outcomes, you would, of course, imagine you'd see some level of potentially low breakthrough infection in the single-dose arm and then some much lower level of breakthrough infection in the multi-dose arm, consistent with the modeling we provided in our correlative protection analysis that was -- that went into the literature just a couple of months ago. So the math ought to math as it were, as you go through these things. But of course, this is a clinical trial. It has its own contours, and we're all going to find out what the answer is together. I only lit we can't run it 10,000 times because I think we would all feel very, very comforted about by the mean outcome and then the tails. Nonetheless, as we're doing it in sort of real time and operational space, we still feel great about our progress and what we think we're going to demonstrate. Anyone else want to add to that or refine? Michael Mina: I'd just say getting to one of your first questions, it really comes down to risk versus benefit. And certainly, we know that COVID causes significant symptoms, and we expect the tolerability and the symptom profile of our mAb to be very, very low. And similarly, what Sanofi's COMPARE study recently showed, and I discussed it, but to be very clear, it showed effects of upwards of 90% of individuals or more with an mRNA vaccine or over 80% with a protein-based vaccine, directly getting 3 or so days of symptoms as a result of that vaccine. So that's a real effect on the benefit versus detriment scale of getting a biologic that's currently on the market. And we expect our overall safety and tolerability profile to be substantially better is our expectation. And so as we look at risk benefit, the point of what I said earlier is that we anticipate it will be significantly better than 15% efficacy. But even if something as extraordinarily low as a 15% efficacy, we still expect our medicine to provide a positive benefit/risk ratio. And I think that's really where we're going to be focusing a lot of our discussions as we move into the future. Marc Elia: And I can't help myself just because I've worked on the buy side for sufficiently long to know that I want to remind everyone the dose justification we selected for VYD2311 and the corresponding antiviral titers would conceptually generate a 70% to 90% protected benefit on symptomatic disease. So just because we're spending time contemplating it what happens at much lower levels, don't mistake that for a second as something we expect. We don't. We expect something much higher, and that's how we've dosed the medicine. I just think -- I think we think this is a really, really important concept for a whole lot of people, not just our investing partners, our capital partners, but also our counterparties across both infectious disease medicine, general medicine and policymakers to really think through. This is a really important moment, not just for our company, but hopefully, for the future of this and potentially other diseases as we start to really understand the unique merits of an emerging modality that hasn't been deployed at particular scale. So we aim to do that, and we think it's really, really important to double underline and educate what we see as a really substantial benefit set that's available here to the public if we're so lucky to have the good luck we hope and earn a BLA. Does that all make sense? I know that was a lot. Operator: And our next question coming from the line of Tom Shrader with BTIG. Thomas Shrader: Congratulations on a nice quarter. A couple of quickies on safety, and then I have a monitoring question. But the surveillance time, what is that for a vaccine now? Has that gone away? My memory is you're supposed to -- you were supposed to sit for a while in that case, too, so maybe 30 minutes isn't differentiating. And then I apologize if you said this, but the AEs you see, do you describe them blinded? Have you seen anaphylaxis? And again, you mentioned it, I apologize. And then I have a monitoring follow-up. Marc Elia: Okay. So on post-vaccine dose monitoring, I will say, I don't believe any of us in the room understand the current labeling off the top of our heads. I remember -- the practice of medicine, of course, out there runs very different depending upon which provider someone runs into, in what context and what that subject is or is not, right? So I'm going to defer because, frankly, I suspect that what was very clear, very clear in 2021, you will take this vaccine and then you will wander around or sit quietly for 15 minutes. I don't know the extent to which that is actually cued to out in clinical practice today anymore. So stay tuned. But again, I think we would imagine that if we're successful in our work, we would be given equivalent consideration, if not superior, right? Let's just see how the profile of the medicine plays out. In terms of monitoring our blinded pooled safety data, I'm just going to decline to answer that question mainly because while it's a fun thing to contemplate, we are, of course, running a ongoing pivotal study. And I think doing exercises such as you're suggesting raises the potential for type 1 error that we really don't need in our lives at this point. So I think all we see is that going back to adintrevimab, which is, again, a highly structurally related antibody delivered at an approximately equivalent dose, there was not much to write home about. And you'll see that in our analysis of the AVADE study. And as we have DECLARATION unfold in real time, we can only make the loose inference that a change in monitoring time may well reflect some measure of comfort that the IDMC would also have. But we don't know that. It's just a supposition we can make on the basis of the representation. So I apologize. I just don't want to get too into sort of fun but dangerous looks at ongoing studies that we're not doing. Thomas Shrader: That's a fair point and a good reminder to keep the trial clean. On the monitoring front, where is that these days? Is it as robust as it was years ago? Do you have good surveillance? And I'm curious, given you have essentially instant protection, you could, in fact, be used to respond to outbreaks. And the question is, does the infrastructure exist that you should -- maybe the antibody is appropriate for highly at-risk people all the time, but maybe the bar drops if you realize that suddenly there's an outbreak in an area. So where is the surveillance now relative to where it was? And what kind of data do you get? Marc Elia: So Tom, thank you for that. And I'm going to apologize in advance because you've asked a question I love so much, you're going to have to sit a little longer than usual because I'm just too excited to answer it. The monitoring is more than sufficient for the purposes you're describing. So just to answer the question plainly, of course, there's less sequencing going on out there in the world than there was in 2021. But if you ever sit with us at Invivyd and you look through some of the analytics that Robbie and his team routinely study, back in 2021, you could identify clinical and wastewater variants at such comically low frequency. I'm not sure that the sample and the sequencer wasn't the only variant that existed like that on earth at the time, meaning it was an extraordinary resolution, wildly unnecessary, right? Akin to counting the individual fleeves on one dog, it was stunning. We don't have that today, but what you still have very clearly is you can roughly know when and where COVID is and is not. And by the way, you can do it with flu, you can do it with RSV. There are now a whole host of services, again, mainly the focus on the fecal shedding and the wastewater, which is a perfectly wonderful way to measure the overall sort of location and timing of the burden. And the reason I love your question so much is, of course, we named our program REVOLUTION. We named our studies, DECLARATION and LIBERTY because I think the kind of data you're describing is the kind of data that can actually rationalize prophylaxis, meaning, why would I go get a COVID vaccine, let's say, that may only confer short-term protection if I don't reasonably anticipate a meaningful burden of COVID anytime soon. Say if I'm on the down slope of a recent wave and appear to be approaching in nature, well, it wouldn't be particularly rational for me as a consumer to take on the side effect and tolerability burden at that time if what I'm exchanging it for is a pretty low probability of earning a benefit back in protecting me from disease, right? And look, some of those habits are well worn. Some of them are sort of cemented by typical public health guidance of, hey, it's fall, go get your vaccine suite. Well, it turns out that might not be the best way to skin the cat, so to speak, in 2026 when we do have access to all these data. And if you look at that chart, which I will concede is not the most intuitive concept in the world in our earnings slides, you will notice that part of the point of that is to note, if you want to go through a tolerability event, you really want to protect your way back out of future sickness. So in a future that a monoclonal antibody at scale can unlock, it would be our vision and hope that it's used rationally, meaning that individuals in concert with their care teams, in concert, we hope with the federal complex and using big data can actually start to allocate prophylactic medicine across space and time in a way that resembles the underlying community attack rate, right? So that is a really substantial shift in infectious disease medicine prophylaxis thinking, but I think it would be welcome. And again, I apologize that was too long. And I'm saying all this in front of an epidemiologist physician who specializes in infectious disease prophylaxis. So once again, Dr. Mina, surely, you can clean that up. Michael Mina: Well, I just wanted to mention there was a question about the duration that somebody might be anticipated to have to sit around. Currently, on the vaccine labels, there's no longer any suggestion or specificity given to the clinicians around waiting time after administration of the vaccines, and we are expecting that will fall in a similar category on in our labels. Robert Allen: Regarding [indiscernible], I don't have too much more to offer than what Marc already mentioned. Marc Elia: Well, anyway, spread the word, Robbie. I think you're thinking in the right way. And I think what you're talking about could be a meaningful step change for the overall burden of disease in our society if we can pull this off. Operator: And there are no further questions in the queue at this time. I'll now turn the call back over to Mr. Marc Elia for any closing comments. Marc Elia: Thanks, operator. Thank you all for joining us this morning. I hope it's clear that we believe we are on to some pretty important and big things, and these event sets are coming your way within months. So stay tuned, and thanks so much for joining us today. We're going to look forward to your questions throughout the rest of the day. Bye-bye. Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Before you buy stock in Invivyd, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Invivyd wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $472,205!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,384,459!* Now, it’s worth noting Stock Advisor’s total average return is 999% — a market-crushing outperformance compared to 208% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 14, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Invivyd (IVVD) Q1 2026 Earnings Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Monoclonal Antibody Revenue Growth: Continued growth in monoclonal antibody revenues. PEMGARDA Revenue Growth: 22% year-over-year increase over Q1 2025. Clinical Spend: Significant investment in the DECLARATION clinical trial. Cash Position: Strong cash position bolstered by additional cash raised in April. R&D Spending: Expected return to more normalized R&D spending as VYD2311 trial concludes. Warning! GuruFocus has detected 4 Warning Signs with IVVD. Is IVVD fairly valued? Test your thesis with our free DCF calculator. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Invivyd Inc (NASDAQ:IVVD) has accelerated recruitment for its pivotal program, exceeding internal expectations. The company has increased its government affairs activity, receiving positive feedback from policymakers. Invivyd Inc (NASDAQ:IVVD) confirmed virus neutralization of its medicines against the Omicron BA.3.2 variant. The company reported continued growth in monoclonal antibody revenues, contrasting with declining COVID-19 vaccine revenues. Invivyd Inc (NASDAQ:IVVD) is expanding its early discovery pipeline to include antibodies for measles, mumps, rubella, Lyme disease, and other pathogens. The company had to slow recruitment due to a lull in COVID-19 and respiratory disease burden. There is uncertainty about the inclusion of the 30-minute post-administration monitoring time for VYD2311 in the product label. The company faces challenges in educating the public and policymakers about the benefits of monoclonal antibodies. Invivyd Inc (NASDAQ:IVVD) is experiencing high clinical spending, impacting its financials. There is a risk of declining vaccine utilization due to public perception of vaccine reactogenicity. Q: For the 30-minute post-administration monitoring time for VYD2311, do you anticipate that would be ultimately included in the label? And if so, how might that impact adoption? Also, do you see any indications of a new or summer COVID wave starting to emerge yet? A: Marc Elia, Independent Chairman of the Board, explained that it's premature to determine if the 30-minute monitoring will be included in the label. He noted that the evolution of the clinical program is ongoing, and they hope the profile will be modestly burdensome. Michael Mina, Chief Medical Officer, added that they anticipate high tolerability and low reactogenicity, expecting practices to align more with current vaccine waiting times. Regarding the COVID wave, Elia mentioned that while COVID appears to be declining, they are prepared for a potential rise and aim to maximize patient exposures during such events. Q: What point estimate or lower confidence bound would you consider clinically meaningful, commercially viable, and supportive of a BLA for the DECLARATION study? How should we think about the single-dose versus multi-dose arms? A: Marc Elia stated that the determination for a BLA is made by the FDA, and they expect much better vaccine efficacy (VE) than current standards. He emphasized that the goal is to deliver high protection with low tolerability penalties. The multi-dose cohort was primarily to demonstrate safety, with a one-month increment chosen for flexibility. The expectation is that the multi-dose arm will show lower breakthrough infection rates, consistent with their modeling. Q: What is the current surveillance time for vaccines, and have you seen any anaphylaxis or adverse events (AEs) in your studies? A: Marc Elia noted that the current practice of post-vaccine monitoring varies, and they expect equivalent or superior consideration for their product. He declined to discuss blinded pooled safety data to avoid type 1 error but mentioned that previous studies with similar antibodies showed minimal issues. Michael Mina added that current vaccine labels no longer specify waiting times, and they expect similar labeling for their product. Q: How robust is the current monitoring infrastructure, and could your antibodies be used to respond to outbreaks? A: Marc Elia explained that while sequencing has decreased since 2021, the current monitoring is sufficient to identify COVID presence. He emphasized the potential for rational prophylaxis, using data to allocate medicine based on community attack rates. Michael Mina added that current vaccine labels do not specify waiting times, and they expect similar labeling for their product. Q: What are your expectations for the DECLARATION study's efficacy and safety profile? A: Michael Mina highlighted that they expect the tolerability and symptom profile of their monoclonal antibody to be significantly better than current vaccines. He noted that even with low efficacy, their product would provide a positive benefit-risk ratio. Marc Elia reiterated that they expect much higher efficacy and emphasized the importance of understanding the unique merits of their emerging modality. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Achieved Q1 2026 PEMGARDA® (pemivibart) net product revenue of $13.7 million, representing 22% growth versus Q1 2025 net product revenue of $11.3 million Invivyd in vitro data showed continued neutralizing activity of pemivibart and VYD2311 against SARS-CoV-2 variant BA.3.2.2 (“Cicada”), confirming anticipated activity DECLARATION trial Independent Data Monitoring Committee (IDMC) ad hoc review of unblinded VYD2311 safety data resulted in IDMC recommendation for reduction of post-dose monitoring time from two hours to thirty minutes Operating expense increase quarter-over-quarter primarily attributable to DECLARATION pivotal program costs for VYD2311 for which top-line data is anticipated in Q3 2026 Strong balance sheet with Q1 2026 ending cash and cash equivalents of $184.2 million; additional ~$20 million in gross proceeds from usage of at-the-market (ATM) offering facility in April 2026 Invivyd to host conference call today at 8:30AM ET NEW HAVEN, Conn., May 14, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the first quarter ended March 31, 2026, and recent business highlights. “Invivyd is moving forward as fast as possible to bring Americans a solution to the major current problem in infectious disease prevention,” said Marc Elia, Chairman of the Board of Invivyd. “Our VYD2311 REVOLUTION clinical program is proceeding on track, with the LIBERTY head-to-head safety and combination study of VYD2311 versus mRNA COVID vaccine planned to begin shortly. Related, we were pleased to recently publish a preprint focused on the side effect profile of a past Invivyd low-dose monoclonal antibody for COVID-19 prevention versus COVID vaccines that builds on recently presented randomized data demonstrating high degrees of systemic side effects following COVID vaccination, in strong contrast to our investigational COVID-19 monoclonal antibody approach. Further, and as we expected, we have confirmed in vitro neutralization activity of Omicron BA.3.2.2 variant virus with our antibodies. As a variant that appears to escape vaccine-induced neutralization, we note once again that our monoclonal antibodies have the potential to allow America to break the unsatisfactory annual cycle of trying to play catch-up with poorly tolerated, variant-specific vaccine boosts. Millions of vulnerable Americans deserve a better way to stay well, and we are working hard to bring a new option forward.” “PEMGARDA revenue continues to grow even as vaccine uptake appears to wane, and we are managing expenses diligently outside of our non-recurring pivotal clinical trial expenditures,” commented Bill Duke, Chief Financial Officer of Invivyd. “We look forward to continued commercial execution, as well as managing our overall expenses responsibly as we anticipate the end of major clinical spending on VYD2311 later this summer. Meanwhile, we are pleased with our continued balance sheet strength and are well into launch planning for VYD2311.” Recent Business Highlights Clinical & Regulatory Developments Invivyd reports positive, continued, in vitro neutralization data for PEMGARDA® (pemivibart) and for VYD2311, the company’s vaccine alternative monoclonal antibody candidate for the prevention of COVID-19, against SARS-CoV-2 variant BA.3.2.2 (“Cicada”). Invivyd announces that the Independent Data Monitoring Committee (IDMC), responsible for monitoring the safety in the DECLARATION trial, recently completed an ad hoc review of unblinded safety data for VYD2311 in the DECLARATION trial that resulted in the IDMC recommendation for reduction of post-dose monitoring time from two hours to 30 minutes. In April 2026, Invivyd announced that the IDMC completed its prespecified review of unblinded safety data at an early timepoint, as defined in the protocol, for VYD2311 in the DECLARATION trial and returned the following recommendations: Pregnant and breastfeeding women are now eligible to participate in the study and may enroll. Women of childbearing age are no longer required to use contraception. Further pre-existing protocol-specified safety visits and evaluations at Day 8, Day 38, and Day 68 are no longer required. During March and April 2026, Invivyd provided updates on its REVOLUTION program, which is Invivyd’s development program for VYD2311 that is designed to elaborate the profile of monoclonal antibody-mediated prophylaxis from COVID-19 and the potential medical benefits to vulnerable Americans: DECLARATION: Following trial initiation in late 2025, the DECLARATION pivotal clinical trial recruitment progressed rapidly with full initial enrollment achieved in March 2026. In April 2026, Invivyd announced that confirmed, pooled, blinded COVID-19 events in the ongoing DECLARATION clinical trial accumulated to date (~ 50% of study progress) could already provide sufficient statistical power to support the high end of anticipated VYD2311 efficacy. Invivyd conducted a pre-specified blinded sample size re-estimation analysis when 1,500 of 1,818 enrolled patients reached Day 45 of 90 total days (April 6th), designed to add robustness given future event rate variability; upsizing was triggered and increases confidence in overall study statistical power. DECLARATION upsizing provides ~500 additional subjects and will likely shift study result timing modestly, by approximately two months, from original “mid-year” guidance to Q3 2026. DRUMMER: Invivyd agreed with the U.S. Food and Drug Administration (FDA) on an initial pediatric study plan to support Biologics License Application (BLA) filing. The plan includes a single clinical trial (“DRUMMER”) which will assess the immunogenicity and safety of VYD2311 in children 0 – 11 years of age, with efficacy extrapolation from DECLARATION. LIBERTY: In February 2026, Invivyd announced it received and was aligned with advice from the FDA on the LIBERTY Phase 3 clinical trial, which will assess the safety and immunologic profile of VYD2311 versus commercially available mRNA COVID vaccines. The FDA, providing feedback jointly from CDER and CBER, requested specific monitoring of adverse events of special interest relevant to mRNA COVID vaccines, citing the known risk of myocarditis/pericarditis in the young adult population following mRNA COVID vaccination; no similar requests have been made for other Invivyd clinical trials without an mRNA COVID vaccine arm. In January 2026, Invivyd and the SPEAR (Spike Protein Elimination and Recovery) Study Group announced the plan to initiate a Phase 2 clinical trial evaluating VYD2311 in individuals with Long COVID or COVID vaccine injury. The Phase 2 clinical trial is expected to be initiated mid-2026. Publications & Presentations In May 2026, Invivyd published a preprint “Safety first: should the high tolerability of intramuscular anti-spike COVID-19 monoclonal antibody change our expectations of vaccine safety?” Linked here. The analysis supports the strong early tolerability profile of intramuscular-administered adintrevimab, a low-dose investigational monoclonal antibody for the prevention of COVID-19 that is the parent antibody to pemivibart and VYD2311. A post-hoc evaluation of the EVADE trial , a Phase 2/3 double-blind, randomized, placebo-controlled study of adintrevimab, assessed the rates of systemic side effects (e.g., headache, chills, fever, fatigue, myalgia, diarrhea, nausea, and vomiting) associated with adintrevimab and observed only 2% of participants in the adintrevimab group and 1% in the placebo group reported at least one systemic treatment-emergent adverse event within the first seven days post-dose. Recent data from Sanofi’s COMPARE study -- a head-to-head Phase 4 study that compared tolerability of Sanofi’s NUVAXOVID to Moderna’s mNEXSPIKE – observed very high rates of systemic adverse events (Grades 1/2/3)* within seven days post-booster vaccine dose (84% and 92% of participants), and meaningful impacts on daily activity. To further investigate the risk-benefit of these modalities, the LIBERTY clinical trial will evaluate the comparative safety, tolerability, and pharmacokinetics of VYD2311 versus mRNA COVID-19 vaccination. *Invivyd’s May 11, 2026 press release titled “Invivyd and Collaborators Author New Manuscript Evaluating Early Tolerability of COVID Monoclonal Antibody and Comparing Results to COVID Vaccination” has been updated on its website for a scrivener’s error and now reflects systemic adverse events as Grades 1/2/3. In March 2026, Invivyd announced Chief Scientific Officer, Robert Allen, Ph.D., presented as part of the “Antibodies for Infectious Disease Workshop” at the World Vaccine Congress Washington. Dr. Allen’s presentation, titled “Developing mAb Therapies that Keep Pace with Rapidly Evolving Viral Threats,” conveyed the ability of monoclonal antibodies to address virus variation. The key challenges that have impacted broad utilization of monoclonal antibodies to date are scalability, access, economics, and the ability to address virus variation. Dr. Allen’s presentation focused on how to address virus variation. Dr. Allen’s slides can be seen here, and describe Invivyd’s early discovery pipeline. The World Vaccine Congress is a series of conferences and exhibitions that have grown over 25 years to become the largest vaccine meetings of their kind across the globe. The event format allows for whole-sector topics with hundreds of speakers and covers the complete vaccine value chain, enabling thousands of attendees from science, government, and manufacturers to come together to create ground-breaking progress. More information can be found at https://www.terrapinn.com/conference/world-vaccine-congress-washington/index.stm Pipeline Expansion In April 2026, Invivyd announced advancement of a measles monoclonal antibody candidate, VMS063. VMS063 is a novel, highly potent, broadly in vitro neutralizing, high resistance barrier, half-life-extended, potentially first- and best-in-class monoclonal antibody candidate for the treatment and prevention of measles. Invivyd has begun Investigational New Drug (IND)-enablement and regulatory outreach to support rapid VMS063 development; goal is expedited development with target IND readiness in late 2026. Invivyd expects to advance VBY329 toward IND readiness in 2H 2026 for development in pediatric RSV prophylaxis, a blockbuster pharmaceutical market in 2024, expected to grow to $3-$4 billion in annual revenues globally by 2030. Corporate Updates In April 2026, Marc Elia spoke at the POLITICO Health Care Summit. During the session, Mr. Elia framed the evolving landscape of viral disease prevention, including the role of monoclonal antibodies in keeping Americans healthy moving forward. In April 2026, Invivyd launched “Antibodies for Any Body” in partnership with world ski champion Lindsey Vonn to inspire actions that support immune health. The national education campaign aims to educate Americans about antibodies and their role in immune health. Campaign centerpiece, AntibodiesforAnyBody.com, offers an interactive immune health wellness assessment to empower people to better understand the relationship between their daily habits and immune health and wellness. First Quarter 2026 Financial Results Revenue: Reported Q1 2026 net product revenue of PEMGARDA of $13.7 million, compared to $11.3 million in Q1 2025, representing a 22% increase. Cash Position: Cash and cash equivalents were $184.2 million as of March 31, 2026. In April 2026, Invivyd raised an additional ~$20 million in gross proceeds from the sale of common stock pursuant to its at-the-market (ATM) offering facility. Cash and cash equivalents are anticipated to provide runway through DECLARATION pivotal data readout and support potential commercial launch of VYD2311. Research & Development (R&D) Expenses: R&D expenses were $30.7 million for the quarter ended March 31, 2026, compared to $10.6 million for the comparable period in 2025. This increase is primarily attributable to higher contract research costs associated with the DECLARATION clinical trial for VYD2311. Selling, General & Administrative (SG&A) Expenses: SG&A expenses were $25.1 million for the quarter ended March 31, 2026, compared to $16.8 million for the comparable period in 2025. This increase is primarily attributable to an increase in personnel-related costs and commercial and marketing-related costs. Net Loss and Net Loss per Share: Net loss was $41.4 million for the quarter ended March 31, 2026, compared to $16.3 million for the comparable period in 2025. Basic and diluted net loss per share was $0.13 for the quarter ended March 31, 2026, compared to $0.14 for the comparable period in 2025. Total shares of common stock outstanding as of March 31, 2026 were 282,803,863, excluding pre-funded warrants totaling 27,342,442 which were included in shares outstanding utilized to calculate net loss per share. Conference Call & Webcast Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. About PEMGARDA PEMGARDA® (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, LP.8.1 and XFG. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells. PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. PEMGARDA is not authorized for use for the treatment of COVID-19, Long COVID, or COVID-19 Post-Vaccination Syndrome, or for post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination. Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse reactions included systemic infusion-related reactions and hypersensitivity reactions, local infusion site reactions, and infusion site infiltration or extravasation. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning. To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies. About VYD2311 VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration. VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. About DECLARATION DECLARATION (NCT07298434) is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without risk factors for progression to severe COVID-19, at three months. Participants will receive either a single dose or a monthly dose of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is expected to be approximately 2,301 participants. About LIBERTY LIBERTY is a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311, an mRNA COVID vaccine, and co-administered VYD2311 with an mRNA COVID vaccine. Total enrollment of the trial is expected to be about 210 participants. About Antibodies for Any Body Antibodies for Any Body is a national education campaign designed to elevate public understanding of the immune system and explain the role antibodies play in keeping the body healthy. Visit AntibodiesforAnyBody.com to access information and resources and take the Antibodies for Any Body Wellness Assessment to learn more about your health. About VMS063 VMS063 is a monoclonal antibody candidate engineered via Invivyd’s proprietary antibody discovery platform to target a highly conserved protein of a measles virus. The antibody has shown sub-nanomolar potencies across all variants tested in vitro to date. About VBY329 VBY329 is a novel, potential best-in-class monoclonal antibody (mAb) candidate being developed to prevent Respiratory Syncytial Virus (RSV) among neonates, infants, and children. About SPEAR Study Group Invivyd and leading researchers formed the SPEAR (Spike Protein Elimination and Recovery) Study Group to assess the effects of monoclonal antibody (mAb) therapy for Long COVID and COVID-19 Post-Vaccination Syndrome. About Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more. Trademarks are the property of their respective owners. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” “future,” and “target” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, plans related to the company’s research and development activities, and the timing and potential results thereof; expectations regarding the company’s clinical trial designs, enrollment, event accumulation and progress, regulatory pathway, product profile, indication, and administration paradigm for VYD2311, including the company’s REVOLUTION clinical program and the timing of expenditures and results related thereto, as well as preparations for the potential commercial launch of VYD2311, if approved; expectations regarding the COVID landscape and potential advantages of mAbs; the company’s plans and expectations with respect to the commercialization of PEMGARDA; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; the company’s plans and expectations with respect to its other product candidates, including VMS063 and VBY329; the company’s business strategies and objectives; the company’s expectations regarding the sufficiency of its current cash and cash equivalents; the potential market size and opportunity for the company’s product candidates; the company’s future prospects; and other statements that are not historical fact. The company may not actually achieve the plans, intentions, or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: uncertainties regarding the company’s expectations, projections, and estimates regarding future costs and expenses, future revenue, capital requirements, and the availability of and the need for additional financing; uncertainties regarding market acceptance, payor coverage, and reimbursement, or future revenue generated by any authorized or approved product; how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether such EUA is revised or revoked by the FDA; the ability to maintain a continued acceptable safety, tolerability, and efficacy profile of any product candidate following regulatory authorization or approval; the success of the company’s in-house sales force, and the company’s ability to maintain and expand sales, marketing, and distribution capabilities to successfully commercialize any authorized or approved product; changes in expected or existing competition; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; whether or not any preclinical candidate identified by the company is determined to be suitable for clinical development; the timing, progress and results of the company’s discovery, preclinical, and clinical development activities; clinical trial site activation, enrollment, and event accumulation rates; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; the company’s ability to generate the data needed to support a potential BLA submission for VYD2311; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitopes that pemivibart and VYD2311 target remain structurally intact and the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies to prevent or treat COVID-19 or other infectious diseases may adversely impact the development or commercial success of the company’s product candidates; the company’s reliance on third parties; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. Contacts: Media Relations (781) 208-0160 [email protected] Investor Relations (781) 208-1747 [email protected] (1) Includes an allowance for doubtful accounts of $274 and $323 as of March 31, 2026 and December 31, 2025, respectively. (2) Includes related-party amounts of $625 and $0 as of March 31, 2026 and December 31, 2025, respectively. (3) Includes related-party amounts of $551 and $703 as of March 31, 2026 and December 31, 2025, respectively. (1) Includes related-party amounts of $550 and $452 for the three months ended March 31, 2026 and 2025, respectively. (2) Includes related-party amounts of $1,127 and $1,128 for the three months ended March 31, 2026 and 2025, respectively.

Invivyd authors evaluated early side effects of prior low-dose investigational monoclonal antibody adintrevimab from the EVADE study, demonstrating minimal tolerability issues Results allow for comparison to contemporary COVID-19 mRNA and protein vaccine tolerability, as well as epidemiologic extrapolation of systemic symptom days experienced via each approach Upcoming LIBERTY trial head-to-head study comparing safety and tolerability between VYD2311 and mRNA vaccine will build on these results in a rigorous, prospective fashion NEW HAVEN, Conn., May 11, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that a preprint of original research regarding COVID monoclonal antibody and vaccine systemic reactogenicity is now available on MedRxiv and is titled “Safety first: should the high tolerability of intramuscular anti-spike COVID-19 monoclonal antibody change our expectations of vaccine safety?” Linked here. On April 18, 2026, at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Munich, Germany, Sanofi presented results from its COMPARE Phase 4 study, which characterized early systemic side effects of protein-based COVID-19 vaccine in comparison to mRNA-based COVID-19 vaccine. The results showed a statistically significant advantage in favor of protein-based vaccine in reactogenicity, defined as Grade 2/3 side effects occurring within seven days of vaccination, with protein vaccine resulting in a probability of experiencing at least one systemic reaction at 83.6% versus mRNA vaccine at 91.6%, with symptoms lasting 3.1 and 3.5 days, respectively. Invivyd previously conducted the EVADE trial, a Phase 2/3 double-blind, randomized, placebo-controlled study of adintrevimab, a low-dose investigational monoclonal antibody for the prevention of COVID-19 that is the parent antibody to pemivibart and VYD2311. In new research announced today, safety and tolerability data from adintrevimab in EVADE were re-analyzed post-hoc to assess comparable systemic adverse events (AEs) within the same seven days post-dosing evaluated in COMPARE. While limited by cross-trial comparison and methodologic differences, the data demonstrate a large gap in early tolerability between vaccine and monoclonal antibody COVID immunizations: These results allow for epidemiologic extrapolation and calculation of the total symptom days immunization subjects would undergo under different combinations of immunization efficacy and COVID-19 community attack rate (Figure 1 of the new manuscript). Calculating total symptom days that include both vaccine symptomatic reactogenicity as well as the burden of symptomatic disease from breakthrough infection demonstrates the net symptomatic burden experienced by immunized subjects. Such analysis directly highlights the public health challenge of encouraging the public to stay well via vaccination by asking the public to feel sick via vaccination. Dr. Michael Mina, Chief Medical Officer of Invivyd and senior author on the manuscript commented, “Our re-evaluation of the EVADE data for adintrevimab, a low-dose investigational monoclonal antibody highly similar to VYD2311, allows us to compare antibody versus vaccine immunization approaches on a metric that has contributed to meaningful reduction in COVID-19 vaccine utilization: the degree to which people feel sick after immunization. As we would expect from a monoclonal antibody that doesn’t engage the immune system, adintrevimab presents a minimal overall symptomatic burden and a de minimis difference from placebo. In this comparison, the difference between low-dose antibody and COVID vaccine is night and day. Further, the COMPARE study of two vaccine approaches highlights the challenge of trying to convince a population to protect itself from symptomatic COVID-19 when the protective vaccine itself gives most immunized subjects 3 to 3.5 days feeling of being sick, in return for apparent modest, short-term protection from being sick from COVID-19.” “Vulnerable populations deserve next-generation tools to protect themselves from ubiquitous pathogens like SARS-CoV-2 with the least possible burden. Invivyd’s goal is to provide optimal protection for as many people as possible, and that starts with safety and tolerability. We are executing our pivotal program as rapidly as possible and hope that data, especially anticipated controlled data from our upcoming LIBERTY study, provide policy makers and regulators, and then, if approved, healthcare professionals and Americans, with the conviction to move forward into a new era of protection from COVID,” said Marc Elia, Chairman of Invivyd’s Board of Directors. Invivyd anticipates near-term start of the LIBERTY study, which will evaluate mRNA vaccination and low-dose investigational monoclonal antibody candidate VYD2311 on systemic symptoms in a head-to-head single controlled study. About Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more. About VYD2311 VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration. VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. About LIBERTY LIBERTY is a Phase 3, randomized, double-blind study to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311, an mRNA COVID vaccine, and co-administered VYD2311 with an mRNA COVID vaccine. Total enrollment of the trial is expected to be about 210 participants. Trademarks are the property of their respective owners. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” “future,” and “target” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, beliefs regarding the potential advantages of monoclonal antibody immunization versus vaccine immunization; predictions based on epidemiologic extrapolation of systemic symptom days experienced post-dosing between vaccine and monoclonal antibody approaches to COVID immunization; the potential of next-generation tools to offer protection from pathogens like SARS-CoV-2 with the least possible burden, and the company’s goal to provide optimal protection for as many people as possible; plans related to the company’s research and development activities; expectations regarding the company’s pivotal program, including the company’s clinical trial designs, and the expected timing and results thereof; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; expectations regarding the COVID landscape; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; and other statements that are not historical fact. The company may not actually achieve the plans, intentions, or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress, and results of the company’s discovery, preclinical, and clinical development activities; clinical trial site activation, enrollment, and event accumulation rates; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; how long the EUA granted by the U.S. FDA for pemivibart will remain in effect and whether such EUA is revised or revoked by the U.S. FDA; the ability to maintain a continued acceptable safety, tolerability, and efficacy profile of any product candidate following regulatory authorization or approval; changes in expected or existing competition; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; the company’s ability to generate the data needed to support a potential Biologics License Application submission for VYD2311; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitopes that pemivibart and VYD2311 target remain structurally intact and the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies to prevent or treat COVID-19 or other infectious diseases may adversely impact the development or commercial success of the company’s product candidates; the company’s reliance on third parties; macroeconomic and political uncertainties; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. Contacts: Media Relations (781) 208-0160 [email protected] Investor Relations (781) 208-1747 [email protected]

This article first appeared on GuruFocus. PEMGARDA Net Revenues: Increased 31% over Q3 2025 and 25% over Q4 2024. Full Year 2025 Net Revenues: Totaled $53.4 million. Cash and Cash Equivalents: Ended the year with $226.7 million. Capital Raised: Over $200 million in the second half of 2025. Release Date: March 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Invivyd Inc (NASDAQ:IVVD) has successfully recruited an esteemed physician scientist, Michael Mina, as their new Chief Medical Officer, which could enhance their clinical and strategic capabilities. The company reported a 31% increase in PEMGARDA net revenues in Q4 2025 compared to Q3 2025, indicating strong commercial performance. Invivyd Inc (NASDAQ:IVVD) has a well-capitalized position with $226.7 million in cash and cash equivalents, providing financial stability for future developments. The DECLARATION clinical trial for VYD2311 has reached its target enrollment, demonstrating efficient recruitment and progress in their clinical pipeline. The company is actively expanding its commercial footprint with over 15,000 contracted GPO sites, enhancing its market reach and potential for growth. The DECLARATION trial may require resizing to ensure statistical power, which could potentially delay results and increase costs. There is uncertainty regarding the attack rate in the DECLARATION study, which could impact the efficacy assessment of VYD2311. The company faces competition in the RSV antibody market, which is already established with existing products like nirsevimab. The potential need for trial resizing in the DECLARATION program indicates challenges in predicting COVID-19 event rates, which could affect study outcomes. The company's focus on monoclonal antibodies as an alternative to vaccines may face regulatory and market acceptance challenges, given the established presence of COVID-19 vaccines. Warning! GuruFocus has detected 4 Warning Signs with IVVD. Is IVVD fairly valued? Test your thesis with our free DCF calculator. Q: Can you elaborate on the potential trial resizing decision in the DECLARATION program and the criteria that would trigger it? Also, are you collecting secondary endpoints like viral load or symptom duration? A: Marc Elia, Independent Chairman of the Board, explained that the resizing decision is based on a pre-specified algorithm considering expected vaccine efficacy (VE) and event accumulation. The upsizing target could be about 30% of the study, depending on recruitment speed and COVID wave timing. Secondary endpoints like healthcare interactions are being recorded, but the study isn't powered for low-frequency events like hospitalization. Q: Could you provide more details on the envisioned use case for the measles antibody program? A: Marc Elia mentioned potential use cases such as outbreak prophylaxis and pediatric bridge therapy. The antibody could be used for treating active disease or as a bridge to enhance vaccine efficacy in children. Robert Allen, Chief Scientific Officer, added that the program is designed to address treatment and post-exposure prophylaxis needs. Q: How effective has the strategy been to target hot spot areas for the DECLARATION study? Also, how is myocarditis being monitored in the LIBERTY study? A: Marc Elia stated that the study is designed to place sites in areas with community COVID attack rates, using clinical and wastewater sequencing data. Myocarditis monitoring is primarily a yes/no exercise due to the small study size, with further exploration possible if events occur. Q: Can you provide details on the RSV antibody program and its competitive edge? A: Marc Elia and Robert Allen highlighted that the RSV antibody is designed to address evolutionary drift and known liabilities of existing antibodies. The program aims to compete in a growing market by updating antibodies to match the current viral environment. Q: What are the financial highlights for Invivyd in Q4 2025? A: William Duke, CFO, reported that PEMGARDA net revenues grew by 31% over Q3 2025 and 25% over Q4 2024, totaling $53.4 million for 2025. Invivyd ended the year with $226.7 million in cash, well-capitalized for future developments. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Achieved Q4 2025 PEMGARDA® (pemivibart) net product revenue of $17.2 million, representing 25% growth year-over-year and 31% growth quarter-over-quarter 2025 year-end cash and cash equivalents of $226.7 million after raising over $200 million from financing transactions in 2H 2025 Announced initiation of DECLARATION Phase 3 pivotal clinical trial of vaccine-alternative antibody VYD2311 to prevent COVID, with top-line data expected mid-2026; Fast Track designation for VYD2311 granted by FDA in December 2025 DECLARATION trial on track with full enrollment achieved DECLARATION trial Independent Data Monitoring Committee (IDMC) prespecified review of unblinded VYD2311 safety data resulted in IDMC recommendation to allow enrollment of pregnant and breastfeeding women in the DECLARATION trial DECLARATION trial blinded, pooled early COVID event accumulation appears on track; any potential re-sizing decision to depend on trial progress but could occur in approximately April Distinguished scientist and physician Michael Mina, M.D., Ph.D., appointed Chief Medical Officer Management to host conference call today at 8:30AM ET NEW HAVEN, Conn., March 05, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the fourth quarter and full year ended December 31, 2025, and recent business highlights. “With potential commercialization of VYD2311 on the horizon, we are encouraged by continued commercial execution and appeal for monoclonal antibody prophylaxis demonstrated by revenue of PEMGARDA® (pemivibart) more than doubling year over year, while operating expenses were reduced by nearly half,” noted Bill Duke, Chief Financial Officer of Invivyd. “While we are pleased with Invivyd’s ability to exhibit financial discipline, we are most excited about the positive momentum behind VYD2311 and that our recent capital raises enable us to invest in the ongoing DECLARATION pivotal clinical trial and potential commercialization, if approved, in addition to our other pipeline programs.” “2026 is off to a busy start as we execute our pivotal VYD2311 program, expand our pipeline of monoclonal antibodies, and educate key stakeholders about the role monoclonal antibodies can and should play in the prevention of critical infectious diseases, beginning with COVID,” commented Marc Elia, Chairman of the Invivyd Board of Directors. “We are pleased with the progress we’ve made and remain focused on creating medical value for patients and shareholders with molecules that can complement, provide alternative to, or synergize with vaccination across multiple pathogens. We look forward to sharing additional updates throughout the year.” Recent Business Highlights Clinical & Regulatory Developments Following trial initiation in late 2025, the DECLARATION pivotal clinical trial recruitment has progressed rapidly with full enrollment achieved. The Independent Data Monitoring Committee (IDMC), responsible for monitoring safety in the DECLARATION trial, recently completed its prespecified review of unblinded safety data at an early timepoint, as defined in the protocol, for VYD2311 in the DECLARATION trial and returned the following recommendations: Pregnant and breastfeeding women are now eligible to participate in the study and may enroll. Women of childbearing age are no longer required to use contraception. Further pre-existing protocol-specified safety visits and evaluations at Day 8, Day 38, and Day 68 are no longer required. Early blinded, pooled COVID events in the DECLARATION trial are beginning to accumulate and suggest overall trial progress is on track; any potential trial up-sizing decision to support statistical power will be based on overall progress and COVID event rate using prespecified criteria, and could be decided upon in approximately April. In February 2026, Invivyd announced it received and was aligned with advice from the U.S. Food and Drug Administration (FDA) on the LIBERTY Phase 3 clinical trial, which will assess the safety and immunologic profile of VYD2311, the company’s vaccine-alternative monoclonal antibody investigational candidate for the prevention of COVID-19, versus commercially available mRNA COVID vaccines. LIBERTY is part of the company’s broader REVOLUTION clinical program designed to elaborate the profile of monoclonal antibody-mediated prophylaxis from COVID-19 and the potential medical benefits to vulnerable Americans. The LIBERTY clinical trial will evaluate comparative safety and immunology of VYD2311 versus mRNA COVID vaccine, as well as explore the safety and immunology of co-administered VYD2311 and mRNA COVID vaccine. The FDA, providing feedback jointly from CDER and CBER, requested specific monitoring of adverse events of special interest relevant to mRNA COVID vaccines, citing the known risk of myocarditis/pericarditis in the young adult population following mRNA COVID vaccination; no similar requests have been made for other Invivyd clinical trials without an mRNA COVID vaccine arm. In January 2026, Invivyd and the SPEAR (Spike Protein Elimination and Recovery) Study Group announced the plan to initiate a Phase 2 clinical trial evaluating VYD2311 in individuals with Long COVID or COVID vaccine injury. The Phase 2 clinical trial is expected to be initiated by mid-2026. In December 2025, Invivyd announced the initiation of its DECLARATION clinical trial. DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of COVID versus placebo, at three months, from a single intramuscular (IM) dose. A second arm will evaluate monthly IM doses versus placebo to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk persons seek periodic extra protection from COVID. The primary endpoint of DECLARATION is the reduction of PCR-confirmed symptomatic COVID incidence versus placebo; total expected enrollment of 1770 people across all three arms. DECLARATION is part of Invivyd’s REVOLUTION clinical program aimed at establishing monoclonal antibody prophylaxis for prevention of COVID; top-line data are expected mid-2026. In the Phase 1/2 clinical trial, IM administered VYD2311, at 4 times the planned dose in DECLARATION, was well tolerated, with all adverse events (AEs) considered mild to moderate in severity with no serious or severe AEs reported; all AEs, including headache and injection site pain, were deemed unrelated to study drug. In December 2025, Invivyd announced that the FDA granted Fast Track designation for VYD2311. Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If relevant criteria are met, programs with Fast Track designation can become eligible for priority review and rolling Biologics License Application (BLA) submission, which can reduce the timelines associated with regulatory action. VYD2311 was granted Fast Track designation by the FDA for the prevention of COVID in individuals with underlying risk factors for severe COVID. Pipeline Expansion In November 2025, Invivyd announced selection of a potential best-in-class Respiratory Syncytial Virus (RSV) antibody candidate VBY329. VBY329 is designed for the prevention of RSV infections in newborns, infants, and children, and results from Invivyd’s proprietary antibody discovery platform. VBY329 meets Invivyd’s target profile of higher potency and improved barrier to resistance compared to standard of care RSV medicines, as assessed in vitro. Invivyd expects to advance VBY329 toward IND readiness in 2H 2026 for development in pediatric RSV prophylaxis, a blockbuster pharmaceutical market in 2024, expected to grow to $3-$4 billion in annual revenues globally by 2030. Invivyd has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2 and RSV, and anticipates providing an update on selection of a preclinical measles monoclonal antibody candidate in the first half of 2026. Corporate Updates As announced earlier today, distinguished scientist and physician Michael Mina, M.D., Ph.D., appointed Chief Medical Officer In January 2026, Invivyd announced its partnership with renowned ski champion Lindsey Vonn to elevate public understanding of antibodies, one of the most important parts of the immune system, and their role in preventing disease. A national multimedia educational campaign is planned to launch in early Spring 2026. Fourth Quarter and Full-Year 2025 Financial Results Revenue: Reported full year 2025 net product revenue of PEMGARDA of $53.4 million, compared to $25.4 million in 2024, with PEMGARDA net revenues commencing in Q2 2024. Reported $17.2 million of net product revenue of PEMGARDA in Q4 2025, representing a 25% increase over Q4 2024 net product revenue of $13.8 million and a 31% increase over Q3 2025 net product revenue of $13.1 million. Cash Position: Cash and cash equivalents were $226.7 million as of December 31, 2025. In the second half of 2025, Invivyd secured over $200 million of capital. Invivyd’s current cash and cash equivalents are anticipated to be sufficient to support the DECLARATION pivotal clinical trial, commercial preparedness for the potential launch of VYD2311, continued research and development related to its pipeline programs such as RSV and measles, continued advancement of the SPEAR Study Group efforts related to assessing the effects of monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and other general corporate purposes. Research & Development (R&D) Expenses: R&D expenses were $38.3 million for the year ended December 31, 2025, compared to $137.3 million for the comparable period in 2024. This decrease is primarily attributable to lower contract research costs associated with the Phase 3 CANOPY clinical trial for pemivibart, and a decrease in VYD2311 and pemivibart manufacturing costs. Selling, General & Administrative (SG&A) Expenses: SG&A expenses were $66.9 million for the year ended December 31, 2025, compared to $63.4 million for the comparable period in 2024. This increase is primarily attributable to an increase in personnel-related costs. Net Loss and Net Loss per Share: Net loss was $52.5 million for the year ended December 31, 2025, compared to $169.9 million for the comparable period in 2024. Basic and diluted net loss per share was $0.30 for the year ended December 31, 2025, compared to $1.43 for the comparable period in 2024. Total shares of common stock outstanding as of December 31, 2025 were 281,987,033, excluding pre-funded warrants totaling 27,342,442 which were included in shares outstanding utilized to calculate net loss per share. Conference Call & Webcast Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. About PEMGARDA PEMGARDA® (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, LP.8.1 and XFG. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells. PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. PEMGARDA is not authorized for use for the treatment of COVID-19, Long COVID, or COVID-19 Post-Vaccination Syndrome, or for post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination. Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse reactions included systemic infusion-related reactions and hypersensitivity reactions, local infusion site reactions, and infusion site infiltration or extravasation. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning. To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies. About VYD2311 VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration. VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. About DECLARATION DECLARATION (NCT07298434) is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without risk factors for progression to severe COVID-19, at three months. Participants will receive either a single dose or a monthly dose of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is expected to be 1770 participants. About LIBERTY LIBERTY is a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311, an mRNA COVID vaccine, and co-administered VYD2311 with an mRNA COVID vaccine. Total enrollment of the trial is expected to be about 210 participants. About VBY329 VBY329 is a novel, potential best-in-class monoclonal antibody (mAb) candidate being developed to prevent Respiratory Syncytial Virus (RSV) among neonates, infants, and children. About SPEAR Study Group Invivyd and leading researchers formed the SPEAR (Spike Protein Elimination and Recovery) Study Group to assess the effects of monoclonal antibody (mAb) therapy for Long COVID and COVID-19 Post-Vaccination Syndrome. About Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more. Trademarks are the property of their respective owners. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” “future,” and “target” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, plans related to the company’s research and development activities, and the timing and potential results thereof; expectations regarding the company’s clinical trial designs, enrollment, event accumulation and progress, regulatory pathway, product profile, indication, and administration paradigm for VYD2311, including the company’s REVOLUTION clinical program and the timing of results related thereto, as well as preparations for the potential commercial launch of VYD2311, if approved; the potential benefits of Fast Track designation; expectations regarding the COVID landscape; the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised persons; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; pipeline expansion beyond SARS-CoV-2, including potential targets such as RSV and measles, and expected announcements related thereto; the potential of VBY329 as a novel, potential best-in-class RSV mAb candidate; expectations regarding the company’s partnership with Lindsey Vonn and plans for an educational campaign to elevate public understanding of antibodies and their role in disease protection, including the timing thereof; the company’s business strategies and objectives, and ability to execute on them, including with respect to the sufficiency of its current cash and cash equivalents; expectations about the market size and opportunity for the company’s product candidates; the company’s expectation to create medical and shareholder value; the company’s future prospects; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: uncertainties regarding the company’s expectations, projections and estimates regarding future costs and expenses, future revenue, capital requirements, and the availability of and the need for additional financing; uncertainties regarding market acceptance, payor coverage and reimbursement, or future revenue generated by any authorized or approved product; how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether such EUA is revised or revoked by the FDA; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; the success of the company’s in-house sales force, and the company’s ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize any authorized or approved product; changes in expected or existing competition; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; whether or not any preclinical candidate identified by the company is determined to be suitable for clinical development; the timing, progress and results of the company’s discovery, preclinical and clinical development activities; clinical trial site activation, enrollment and event accumulation rates; any potential clinical trial up-sizing decision and the timing thereof; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; the company’s ability to generate the data needed to support a potential BLA submission for VYD2311; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitopes that pemivibart and VYD2311 target remain structurally intact and the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies to prevent or treat COVID-19 or other infectious diseases may adversely impact the development or commercial success of the company’s product candidates; the company’s reliance on third parties; whether the anticipated benefits of the company’s partnership with Lindsey Vonn are realized; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. Contacts: Media Relations (781) 208-0160 [email protected] Investor Relations (781) 208-1747 [email protected] (1) Includes an allowance for doubtful accounts of $323 and $0 for the years ended December 31, 2025 and 2024, respectively. (2) Includes related-party amounts of $703 and $1,274 for the years ended December 31, 2025 and 2024, respectively. (1) Includes related-party amounts of $2,137 and $1,027 for the years ended December 31, 2025 and 2024, respectively. (2) Includes related-party amounts of $4,557 and $4,546 for the years ended December 31, 2025 and 2024, respectively.