Regulatory Approvals - Invivyd, Inc. received emergency use authorization (EUA) from the FDA for PEMGARDA on March 22, 2024, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents [156]. - The company received Emergency Use Authorization (EUA) from the FDA for PEMGARDA on March 22, 2024 [181]. Financial Performance - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, with an accumulated deficit of $918.3 million as of the same date [165]. - Product revenue, net was $11.3 million for the three months ended March 31, 2025, compared to $0 for the same period in 2024, reflecting sales from the launch of PEMGARDA [191]. - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, a decrease from a net loss of $43.5 million in the same period of 2024 [206][207]. - Other income decreased to $0.6 million for the three months ended March 31, 2025, from $2.6 million in 2024, primarily due to interest earned on invested cash balances [197]. - The company incurred a net cash used in operating activities of $21.1 million for the three months ended March 31, 2025, compared to $50.2 million for the same period in 2024, indicating a 58.1% improvement [205][207]. - The company reported a net decrease in cash and cash equivalents of $21.3 million for the three months ended March 31, 2025, compared to a decrease of $11.3 million in the same period of 2024 [205]. Research and Development - The ongoing Phase 1 clinical trial of VYD2311 is evaluating safety, tolerability, pharmacokinetics, and immunogenicity, with positive clinical data reported for both safety and pharmacokinetics [157]. - The company aims to develop monoclonal antibodies (mAbs) for serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications [158]. - The company expects research and development expenses to increase as it advances VYD2311 through clinical development and seeks regulatory approval for its product candidates [177]. - Research and development expenses decreased by $20.5 million to $10.6 million for the three months ended March 31, 2025, from $31.2 million in 2024 [196]. - Acquired in-process research and development expenses consist primarily of costs related to acquiring rights to Adimab's antibodies for COVID-19 and SARS [182]. Commercialization and Expenses - Invivyd, Inc. has incurred significant commercialization expenses related to product manufacturing, marketing, sales, and distribution of PEMGARDA [166]. - The company anticipates ongoing expenses related to the commercialization of PEMGARDA and the development of other product candidates, which may lead to continued operating losses [198]. - Selling, general and administrative expenses increased by $1.8 million to $16.8 million for the three months ended March 31, 2025, compared to $14.9 million in 2024 [196]. - Cost of product revenue was $0.8 million for the three months ended March 31, 2025, with no cost recorded for the same period in 2024 [192]. - The company has committed to noncancelable purchase obligations of $27.4 million related to commercial drug substance and drug product manufacturing, expected to be paid in 2025 [214]. Funding and Liquidity - Invivyd, Inc. has financed operations primarily with net proceeds of $464.7 million from preferred stock sales and $327.5 million from its IPO [164]. - The company expects to require additional funding to support ongoing operations and growth strategy, with substantial doubt about its ability to continue as a going concern without securing additional funds [169]. - The company entered into a Loan Agreement providing for a senior secured term loan facility of up to $30 million, with terms including a repayment period starting March 1, 2029 [203][204]. - The company raised $39.3 million from the sale of 9,000,000 shares of common stock at an average price of $4.50 per share under a Sales Agreement in February 2024 [202]. - The company expects to finance operations through a combination of revenue contributions, equity offerings, and debt financing, indicating a focus on maintaining liquidity [213]. - The company has substantial doubt about its ability to continue as a going concern, as it may not have sufficient cash to fund operations beyond one year from the issuance of its financial statements [212]. Inventory and Manufacturing - The company has capitalized inventory costs since March 2024, which would have resulted in reported margins approaching 80% if pre-EUA manufacturing costs had been capitalized [193]. - The company is actively monitoring SARS-CoV-2 variants and reported continued neutralizing activity of PEMGARDA against variants KP.3.1.1 and LB.1 [161]. - The company has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles [162]. Accounting and Compliance - The JOBS Act allows emerging growth companies to delay the adoption of new accounting standards until they apply to private companies [220]. - Companies are exempt from compliance with the auditor attestation requirement for internal control over financial reporting [221]. - Reduced disclosure obligations regarding executive compensation are available for smaller reporting companies [221]. - Exemptions from non-binding advisory votes on executive compensation and stockholder approval of golden parachute payments are provided [221]. - Companies are not required to disclose quantitative and qualitative information about market risk as they qualify as smaller reporting companies [222].

Commercial Performance & Strategy - Invivyd's Q1 2025 net product revenue for PEMGARDA was $11.3 million[82] - HCP interactions increased by 37% from 8,608 on January 1 to 11,669 on April 30[12] - The number of accounts called on increased by 37% from 4,566 on January 1 to 6,242 on April 30[12] - Accounts ordering PEMGARDA increased by 20% from 534 on January 1 to 642 on April 30[12] - PEMGARDA is priced lower than nearly all FDA-approved monoclonal antibodies launched in the past 5 years, ranking 59 out of 63 mAb drugs based on annual pricing[24] Research & Development - VYD2311 is designed to target a highly conserved epitope on SARS-CoV-2, with >15x improved neutralization potency relative to VYD222 (PEMGARDA)[47, 51] - The in-life phase of the Phase 1 clinical trial for VYD2311 has been completed, with data read-out anticipated later in Q2 2025[50] - Invivyd is conducting discovery programs for RSV and measles, with progress updates expected by the end of 2025[5, 41, 45] Financial Status - Operating expenses decreased to $27.4 million in Q1 2025 from $32.3 million in Q4 2024[82] - The company ended Q1 2025 with approximately $48.1 million in cash and cash equivalents[82] - A $30 million loan facility was secured in April 2025[5, 82]

Exhibit 99.1 Invivyd Reports First Quarter 2025 Financial Results and Recent Business Highlights WALTHAM, Mass., May 15, 2025 – Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the quarter ended March 31, 2025, and provided recent business highlights. "To drive long-term topline growth, we made a strategic decision to internalize our sales force at the beginning of 2025," said Bill Duke, Chief Financial Officer of Invivyd. "Although this shift created a short-term headwind, we're now seein ...

Core Insights - Invivyd, Inc. reported financial results for Q1 2025, highlighting a strategic shift to internalize its sales force, which initially created challenges but is now showing signs of growth and momentum [2][6][7]. Financial Results - For Q1 2025, Invivyd reported net product revenue of $11.3 million from PEMGARDA™, a decrease from $13.8 million in Q4 2024, with no revenue reported in Q1 2024 [7][15]. - The company recorded a net loss of $16.3 million for Q1 2025, an improvement from a net loss of $43.5 million in the same period of 2024, resulting in a net loss per share of $0.14 compared to $0.38 in Q1 2024 [15][28]. Cash Position and Funding - As of March 31, 2025, Invivyd had cash and cash equivalents of $48.1 million and secured a $30 million non-dilutive term loan facility to support its operations and potential growth [4][15]. Business Highlights - The company is targeting near-term profitability by the end of the first half of 2025, supported by anticipated growth in net product revenue and a reduction in operating expenses [2][7]. - PEMGARDA's uptake is increasing among healthcare providers for immunocompromised patients, aided by the internalized sales force [8]. Pipeline Developments - VYD2311 Phase 1 clinical trial data read-out is expected later in Q2 2025, with ongoing evaluations for pipeline expansion beyond SARS-CoV-2, including potential targets like respiratory syncytial virus (RSV) and measles [5][8][19]. - The FDA declined Invivyd's request to expand the EUA for PEMGARDA to treat mild-to-moderate COVID-19, but the reasoning may provide a near-term pathway for VYD2311 [8]. Regulatory and Safety Updates - Since the EUA of PEMGARDA in March 2024, no documented cases of anaphylaxis have been reported across thousands of doses administered [7][8]. - In vitro data indicate sustained neutralizing activity of PEMGARDA against dominant SARS-CoV-2 variants, which represent over 75% of circulating variants in the U.S. [8].

Core Viewpoint - Invivyd, Inc. has submitted a Citizen Petition to the FDA advocating for a shift in the development approach for COVID-19 vaccines and monoclonal antibodies to restore public trust and enhance the effectiveness of preventive measures against COVID-19 and other viral diseases [1][6]. Group 1: Changes in Immunity and Virus Evolution - The immunological landscape in the U.S. has changed significantly since 2020, with most Americans now having some level of immunologic memory due to vaccinations or infections [2]. - The SARS-CoV-2 virus has evolved from the original Wuhan strain to more immune-evasive Omicron variants, leading to reduced vaccine efficacy against these newer strains [3]. Group 2: Vaccine Efficacy and Clinical Trials - There is a better understanding of the rapid waning of vaccine efficacy, necessitating long-term clinical evaluations rather than short-term studies [4]. - Invivyd's petition calls for new clinical trials to assess COVID-19 vaccines in a modern U.S. population, including seropositive individuals, and against contemporary Omicron variants, with efficacy measured over six months or longer [6]. Group 3: Monoclonal Antibodies and Regulatory Recommendations - Invivyd emphasizes the importance of developing non-vaccine solutions, such as monoclonal antibodies, to provide high-quality alternatives for the American population [6]. - The petition recommends that the FDA consider serum virus neutralizing antibody (sVNA) titers as a basis for Biologics License Application (BLA) approval, which would benefit patients and healthcare providers [7]. Group 4: Company Overview - Invivyd, Inc. is focused on delivering protection against serious viral infectious diseases, starting with SARS-CoV-2, and has received emergency use authorization for a monoclonal antibody from the FDA [8].

Core Viewpoint - Invivyd, Inc. will participate in the H.C. Wainwright 3rd Annual BioConnect Investor Conference, indicating active engagement with investors and stakeholders in the biopharmaceutical sector [1][2]. Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [3]. - The company utilizes a proprietary integrated technology platform that is unique in the industry, aimed at assessing, monitoring, developing, and adapting to create best-in-class antibodies [3]. - In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody in its pipeline, highlighting its innovative approach and regulatory progress [3]. Investor Engagement - Management will host investor meetings at the conference, suggesting a proactive approach to investor relations and communication [2]. - A live webcast of the fireside chat will be available on the company's investor website, ensuring transparency and accessibility for investors [2].

Core Viewpoint - Invivyd, Inc. has initiated a discovery program for a measles monoclonal antibody (mAb) in response to inquiries from healthcare providers, as there are currently no approved therapies for measles or post-exposure prophylaxis [1][6] Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, utilizing a proprietary integrated technology platform for developing best-in-class antibodies [7] Industry Context - There are no antiviral treatments for measles, with current options being limited to high-dose Vitamin A and human donor-derived pooled plasma immune globulin (IVIG), both of which have significant limitations [2] - Standard measles vaccines are effective but face challenges in post-exposure prophylaxis and are underutilized due to access issues and personal beliefs [3] - The resurgence of measles outbreaks globally, including in the U.S., poses a significant public health risk, with over 20 million unvaccinated Americans [5][6] Health Implications - Acute measles infection can lead to severe complications, including hospitalization in one in four cases and death in one in every 1,000 cases [4] - The decline in vaccination rates has serious health consequences, potentially leading to the reestablishment of previously eradicated pathogens like measles [3][5] Development Goals - Invivyd aims to identify a preclinical measles mAb candidate by 2025 and plans to provide updates on progress by the end of the year [6] - The company is focused on developing a safe, convenient, and highly effective mAb against measles that can be easily integrated into clinical practice [7]

Core Viewpoint - Invivyd, Inc. will host a conference call on May 15, 2025, to discuss its Q1 2025 financial results and recent business highlights [1]. Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [3]. - The company utilizes a proprietary integrated technology platform that is unique in the industry for assessing, monitoring, developing, and adapting to create best-in-class antibodies [3]. - In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody in its pipeline of innovative antibody candidates [3].

Core Viewpoint - Invivyd, Inc. has secured a $30 million term loan facility with Silicon Valley Bank to support its development pipeline, particularly focusing on the monoclonal antibody candidate VYD2311 for COVID-19 [1][2] Group 1: Financial Developments - The $30 million term loan facility allows for future capital drawdown contingent on meeting specific conditions and milestones [1] - The financing is non-dilutive, providing balance sheet flexibility for the company to concentrate on enhancing per-share value [2] Group 2: Product Development - VYD2311 is a novel monoclonal antibody candidate aimed at addressing the urgent need for new COVID-19 prophylactic and therapeutic options [2] - The candidate is designed to deliver clinically meaningful titer levels through a more patient-friendly intramuscular administration route [2] - VYD2311 utilizes Invivyd's proprietary technology platform and is optimized for neutralizing contemporary virus lineages [3] Group 3: Related Products - PEMGARDA (pemivibart) is another investigational monoclonal antibody developed from adintrevimab, showing in vitro neutralizing activity against major SARS-CoV-2 variants [4][5] - PEMGARDA has received emergency use authorization for pre-exposure prophylaxis in certain immunocompromised patients [5][6] - The product is not authorized for treatment or post-exposure prophylaxis of COVID-19 and should not replace vaccination [6][10] Group 4: Regulatory Context - The emergency use of PEMGARDA is authorized only during the COVID-19 pandemic under specific conditions, including variant susceptibility [10] - The company has received emergency use authorization from the U.S. FDA for a monoclonal antibody in its pipeline [11]

WALTHAM, Mass., March 26, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) is pleased to announce the appointment of Ajay Royan to its Board of Directors. Mr. Royan is a venture capitalist focused on transformational companies that have solved critical problems in healthcare, technology, and energy. Mr. Royan’s investment firm, Mithril, is a significant long-term holder of Invivyd stock, and Mr. Royan led the 2022 shareholder action that focused Invivyd on its mission to deliver protection from serious ...