Invivyd, Inc.

Previous wording

our expectations related to VYD2311, our next generation monoclonal antibody (“mAb”) candidate for COVID-19, and the potential of VYD2311 to offer the ability to deliver clinically meaningful titer levels through more system- and patient-friendly means;

Current wording

our expectations related to VYD2311, our next generation monoclonal antibody (“mAb”) candidate for COVID-19, the REVOLUTION clinical program for VYD2311 and the potential of VYD2311 to offer the ability to deliver clinically meaningful titer levels through more healthcare system- and patient-friendly means;

Previous wording

the anticipated timing, design, progress and results of preclinical studies and clinical trials of our product candidates, including expectations regarding the DECLARATION and LIBERTY clinical trials that are part of our broader REVOLUTION clinical program, and including statements regarding initiation or completion of studies or trials and related preparatory work, the period during which results of any studies or trials will become available, and potential regulatory submissions;

Current wording

the anticipated timing, design, progress and results of preclinical studies and clinical trials of our product candidates, including statements regarding initiation or completion of studies or trials and related preparatory work, the period during which results of any studies or trials will become available, and potential regulatory submissions;

Previous wording

our devotion to delivering protection from serious viral infectious diseases, and our aim to develop mAbs that could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications;

Current wording

our devotion to delivering protection from serious viral infectious diseases, and our commitment to developing a robust pipeline of product candidates that could be used in prevention or treatment of serious viral infectious diseases, starting with COVID-19 and expanding into other high-need indications, such as respiratory syncytial virus (“RSV”) and measles;

Previous wording

our ability to identify and develop future product candidates;

Current wording

our ability to identify and develop new product candidates that exert continuous pharmaceutical activity in the face of viral evolution;

Previous wording

our expectations regarding the SPEAR Study Group, including its anticipated focus, goals and plans;

Current wording

our expectations regarding the SPEAR (Spike Protein Elimination and Recovery) Study Group, including its anticipated focus, goals and plans;

Previous wording

Invivyd, Inc. is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. PEMGARDA® (pemivibart) is our first monoclonal antibody (“mAb”) to receive regulatory authorization and was designed to keep pace with SARS-CoV-2 viral evolution.

Current wording

Invivyd, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of monoclonal antibody (“mAb”) therapies for the prevention and treatment of serious viral infectious diseases. We are devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2, the virus that causes COVID-19. PEMGARDA® (pemivibart) is our first mAb to receive regulatory authorization and was designed to exert continuous pharmaceutical activity in the face of viral evolution.

Previous wording

Globally, COVID-19 has caused millions of deaths and lasting health problems in many survivors and remains a significant global health concern, particularly for immunocompromised individuals. Isolation and mental health impacts, absenteeism from work, and educational losses for children have been profound consequences of this crisis. COVID-19 persists and continues to impact patients, notably those who are immunocompromised, and combating this disease will require a variety of effective and safe prevention and treatment options for years to come. By leveraging our capabilities, which we have developed through our experience with adintrevimab and pemivibart and over five years in the COVID-19 space, we aim to develop mAbs that could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications.

Current wording

Globally, COVID-19 has caused millions of deaths and lasting health problems in many survivors and remains a significant global health concern, particularly for immunocompromised individuals. COVID-19 persists and continues to impact patients, notably those who are immunocompromised, and combating this disease will require for years to come a variety of prevention and treatment options with demonstrated efficacy and safety. By leveraging our capabilities, which we have developed through our experience with adintrevimab and pemivibart and over five years in the COVID-19 space, we aim to develop mAbs that could be used in prevention or treatment of serious viral infectious diseases, starting with COVID-19 and expanding into other high-need indications, such as respiratory syncytial virus (“RSV”) and measles.

Previous wording

On March 22, 2024, we received emergency use authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) for PEMGARDA injection, for intravenous use, a half-life extended investigational mAb, 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.

Current wording

On March 22, 2024, we received emergency use authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) for PEMGARDA injection, for intravenous (“IV”) use, a half-life extended investigational mAb, 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.

Previous wording

PEMGARDA has not been approved but has been authorized for emergency use by the FDA under an EUA, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg). 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 (“FDCA”), 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.

Current wording

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 (“FDCA”), 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.

Previous wording

In January 2024, we nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate, and in September 2024, we announced dosing of the first participants in a Phase 1/2 clinical trial of VYD2311. VYD2311 is a mAb with high in vitro neutralization potency shown against prominent SARS-CoV-2 variants tested to date. The Phase 1/2 randomized, blinded, placebo-controlled clinical trial evaluated escalating dosing as well as safety, tolerability, pharmacokinetics and immunogenicity of VYD2311 in healthy trial participants. The Phase 1/2 clinical trial was conducted in Australia and evaluated multiple dose levels of VYD2311 through various routes of administration, including exploration of intramuscular (“IM”) administration and subcutaneous administration, which are designed to be more system- and patient-friendly than intravenous administration. In June 2025, we announced positive full Phase 1/2 clinical data for VYD2311 for both safety and pharmacokinetics. In August 2025, we announced alignment with advice from the FDA on a compact and, therefore, rapid pathway to potential BLA approval for VYD2311 for the prevention of COVID-19. As part of Type C meeting feedback, the FDA advised that a single, randomized, placebo-controlled trial evaluating mAb efficacy in prevention of RT-PCR-confirmed symptomatic COVID-19 disease events could support a BLA submission for VYD2311 for the prevention of COVID-19 in a broad population of Americans (12 years of age and older, weighing at least 40kg), including immunocompromised people, subject to agreement on safety database size and pending full protocol review. In October 2025, we announced that the FDA cleared our Investigational New Drug (“IND”) application for VYD2311 and provided feedback to advance our REVOLUTION clinical program, which is our development program for VYD2311. The REVOLUTION clinical program will include two clinical trials, DECLARATION and LIBERTY. The DECLARATION clinical trial is our BLA-enabling, Phase 3 randomized, triple-blind, placebo-controlled pivotal clinical trial to evaluate the efficacy and safety of VYD2311 for the prevention of symptomatic COVID at three months, with either a single dose or monthly doses of VYD2311, each administered via IM injection, compared to placebo. The LIBERTY clinical trial is designed as a Phase 3, randomized, pooled-vaccine, double-blind clinical trial to evaluate head-to-head safety and tolerability and co-administration interaction of VYD2311 with approved mRNA-based COVID vaccines in adults, subject to final alignment with the FDA. The DECLARATION and LIBERTY clinical trials are expected to begin around year-end 2025, with top-line data anticipated mid-2026. Additional studies in the REVOLUTION clinical program may be contemplated for conduct post-approval of VYD2311, if a BLA is granted by the FDA, to further elaborate the profile of antibody prevention of COVID. Like pemivibart, VYD2311 was engineered from adintrevimab, our inv…

Excerpt shortened here; the source contains the full paragraph.

Current wording

In January 2024, we nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate. VYD2311 is a mAb with high in vitro neutralization potency shown against prominent SARS-CoV-2 variants tested to date. In September 2024, we announced dosing of the first participants in a Phase 1/2 clinical trial of VYD2311. The Phase 1/2 randomized, blinded, placebo-controlled clinical trial evaluated escalating dosing as well as safety, tolerability, pharmacokinetics and immunogenicity of VYD2311 in healthy trial participants. The Phase 1/2 clinical trial was conducted in Australia and evaluated multiple dose levels of VYD2311 through various routes of administration, including exploration of intramuscular (“IM”) administration and subcutaneous administration, which are designed to be more healthcare system- and patient-friendly than IV administration. In June 2025, we announced positive full Phase 1/2 clinical data for VYD2311 for both safety and pharmacokinetics. Like pemivibart, VYD2311 was engineered from adintrevimab, our investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19.

Previous wording

In July 2025, we announced that we had formed the SPEAR (Spike Protein Elimination and Recovery) Study Group with leading investigators to structure and guide anticipated clinical trials evaluating the effects of broadly neutralizing anti-SARS-CoV-2 spike protein mAb therapy in people suffering from Long COVID or Post-Vaccination Syndrome (“PVS”). The SPEAR Study Group intends to launch multi-center translational clinical research on Long COVID and PVS using next-generation antibodies like our investigational mAb candidate VYD2311.

Current wording

In July 2025, we announced that we had formed the SPEAR (Spike Protein Elimination and Recovery) Study Group with leading investigators to structure and guide anticipated clinical trials evaluating the effects of broadly neutralizing anti-SARS-CoV-2 spike protein mAb therapy in people suffering from Long COVID or Post-Vaccination Syndrome (“PVS”). The SPEAR Study Group intends to launch multi-center translational clinical research on Long COVID and PVS using next-generation antibodies like our investigational mAb candidate VYD2311. In January 2026, we and the SPEAR Study Group announced plans 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.

Previous wording

We engage in active SARS-CoV-2 variant monitoring of antiviral activity as part of our ongoing industrial virology effort, which leverages a consistent, high-quality, independent, third-party pseudoviral system that routinely tests authentic Invivyd-produced molecules and is supported by structure-based analytics. In September 2024, we announced continued neutralizing activity of PEMGARDA against SARS-CoV-2 variants KP.3.1.1 and LB.1, announced attractive neutralization potency of VYD2311 against the same contemporary viruses, and provided an update to ongoing structural analysis showing no meaningful mutational change in the pemivibart binding site since the Omicron shift late in 2021. In January 2025, March 2025 and August 2025, we announced continued neutralizing activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2 variants XEC, LP.8.1 and XFG, respectively.

Current wording

We engage in active SARS-CoV-2 variant monitoring of antiviral activity as part of our ongoing industrial virology effort, which leverages a consistent, high-quality, independent, third-party pseudoviral system that routinely tests authentic Invivyd-produced molecules and is supported by structure-based analytics. In September 2024, we announced continued neutralizing activity of PEMGARDA against SARS-CoV-2 variants KP.3.1.1 and LB.1 and attractive neutralization potency of VYD2311, our next generation mAb candidate for COVID-19, against the same contemporary viruses, and we also provided an update to ongoing structural analysis showing no meaningful mutational change in the pemivibart binding site since the Omicron shift late in 2021. In January 2025, March 2025 and August 2025, we announced continued neutralizing activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2 variants XEC, LP.8.1 and XFG, respectively. In May 2026, we announced that in vitro neutralization data showed continued neutralizing activity of PEMGARDA and VYD2311 against emerging SARS-CoV-2 variant BA.3.2.2 (“Cicada”).

Previous wording

We rely on partnerships, external consultants and contract research organizations (“CROs”) to conduct discovery, nonclinical, preclinical, clinical and commercial activities. Additionally, we rely on contract testing laboratories and a contract development and manufacturing organization (“CDMO”), WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”), to execute our chemistry, manufacturing and controls development, testing and clinical and commercial manufacturing activities. Further, in 2022, we secured dedicated laboratory space and expanded our research team in order to enable internal discovery and development of our mAb candidates, while continuing to leverage our existing partnership with Adimab, LLC (“Adimab”). We are focused on antibody discovery and use of Adimab’s platform technology, while building our internal capabilities. In addition, we expect to continue to rely on third parties for clinical trials and the manufacture and testing of our product candidates, as well as to perform ongoing research and development and other services on our behalf.

Current wording

We rely on partnerships, external consultants and contract research organizations (“CROs”) to conduct discovery, nonclinical, preclinical, clinical and commercial activities. Additionally, we rely on contract testing laboratories and contract development and manufacturing organizations (“CDMOs”) to execute our chemistry, manufacturing and controls development, testing and clinical and commercial manufacturing activities. In 2022, we secured dedicated laboratory space and expanded our research team in order to enable internal discovery and development of our mAb candidates, while continuing to leverage our existing partnership with Adimab, LLC (“Adimab”), including Adimab’s platform technology. In addition, we expect to continue to rely on third parties for clinical trials and the manufacture and testing of our product candidates, as well as to perform ongoing research and development and other services on our behalf.

Previous wording

Since our inception and through September 30, 2025, we have financed our operations primarily through the sale and issuance of preferred and common stock, including net proceeds of $464.7 million from sales of our preferred stock, net proceeds of $327.5 million from our initial public offering (“IPO”), net proceeds of $43.8 million from sales of our common stock under the Sales Agreement (as defined below) and net proceeds of $53.5 million from sales of our common stock and pre-funded warrants under the Underwriting Agreement (as defined below). We have also funded our operations from sales of PEMGARDA. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and commercialization of one or more of our product candidates, as they become authorized or approved.

Current wording

Since our inception and through March 31, 2026, we have financed our operations primarily through the sale and issuance of preferred and common stock, including net proceeds of $464.7 million from sales of our preferred stock, net proceeds of $327.5 million from sales of our common stock from our initial public offering (“IPO”), net proceeds of $72.7 million from sales of our common stock under the Sales Agreement (as defined below) and net proceeds of $181.6 million from sales of our common stock and pre-funded warrants under the Underwriting Agreements (as defined below). We have also funded our operations from sales of PEMGARDA. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and commercialization of one or more of our product candidates, as they become authorized or approved.

Previous wording

Since our inception, we have incurred significant losses, including a net loss of $41.4 million for the nine months ended September 30, 2025. As of September 30, 2025, we had an accumulated deficit of $943.4 million. We may continue to incur significant expenses and recognize losses in the foreseeable future as we expand and progress our research and development activities, manufacturing activities and commercialization efforts. In addition, our losses from operations may fluctuate significantly from period to period depending on the timing of our clinical trials and our expenditures on other research and development activities, manufacturing activities, and commercialization efforts. Our expenses could increase substantially in connection with our ongoing activities, as we:

Current wording

Since our inception, we have incurred significant losses, including a net loss of $41.4 million for the three months ended March 31, 2026. As of March 31, 2026, we had an accumulated deficit of $995.9 million. We may continue to incur significant expenses and recognize losses in the foreseeable future as we expand and progress our research and development activities, manufacturing activities and commercialization efforts. In addition, our losses from operations may fluctuate significantly from period to period depending on the timing of our clinical trials and our expenditures on other research and development activities, manufacturing activities, and commercialization efforts. Our expenses could increase substantially in connection with our ongoing activities, as we:

Previous wording

initiate and conduct clinical trials of our product candidates;

Current wording

initiate and conduct clinical trials of our product candidates, including advancement of our REVOLUTION clinical program;

Previous wording

advance our preclinical and discovery programs, including development and screening of additional antibodies, as well as ongoing SARS-CoV-2 variant monitoring and testing;

Current wording

advance our preclinical and discovery programs, such as RSV and measles, including development and screening of additional antibodies, as well as engage in ongoing SARS-CoV-2 variant monitoring and testing;

Previous wording

Based on current operating plans and excluding any contribution from future revenues or future external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance date of the condensed consolidated financial statements in this Quarterly Report on Form 10-Q, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See the section entitled “Liquidity and Capital Resources” for more information.

Current wording

Based on current operating plans and excluding future external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance date of the condensed consolidated financial statements in this Quarterly Report on Form 10-Q, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See the section entitled “Liquidity and Capital Resources” for more information.

Previous wording

In March 2024, we received EUA from the FDA for PEMGARDA. Product revenue, net consists of product revenue earned on the sales of PEMGARDA in the U.S. Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances, trade discounts and distributor fees, government chargebacks, product returns and other incentives such as co-pay assistance programs.

Current wording

In March 2024, we received EUA from the FDA for PEMGARDA. Product revenue, net consists of product revenue earned on the sales of PEMGARDA in the U.S. Product revenues are recognized net of variable consideration, including discounts and allowances, trade discounts and distributor fees, chargebacks, product returns and other incentives such as co-pay assistance programs.

Previous wording

Our primary focus since inception has been the development of antibodies against COVID-19. We have also initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles. Our research and development costs consist primarily of external costs, such as fees paid to a CDMO, CROs and consultants in connection with our nonclinical studies, preclinical studies, clinical trials and product manufacturing. To date, external research and development costs for any individual product candidate have been tracked commencing upon product candidate nomination. We do not allocate employee-related costs, costs associated with our discovery efforts and other internal or indirect costs to specific research and development programs or product candidates because these resources are used and these costs are deployed across multiple programs under development and, as such, are not separately classified.

Current wording

Our primary focus since inception has been the development of antibodies against COVID-19. We have also initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including the selection of a preclinical mAb candidate for the prevention of RSV, the selection of a preclinical mAb candidate for the prevention of measles and the advancement of early discovery programs targeting other potential targets. Our research and development costs consist primarily of external costs, such as fees paid to CDMOs, CROs and consultants in connection with our nonclinical studies, preclinical studies, clinical trials and product candidate manufacturing. To date, external research and development costs for any individual product candidate have been tracked commencing upon product candidate nomination. We do not allocate employee-related costs, costs associated with our discovery efforts and other internal or indirect costs to specific research and development programs or product candidates because these resources are used and these costs are deployed across multiple programs under development and, as such, are not separately classified.

Previous wording

the costs associated with the development of any additional development programs and product candidates we identify in-house or acquire through collaborations;

Current wording

the costs associated with the development of any additional development programs and product candidates we identify in-house or obtain through collaborations, licenses or acquisitions;

Previous wording

Through September 30, 2025, we have operated as a hybrid company. We have not incurred material operating expenses for the rent, maintenance and insurance of facilities, or for the depreciation of fixed assets.

Current wording

Through March 31, 2026, we have operated as a hybrid company with employees working at our corporate headquarters and remotely. We have not incurred material operating expenses for the rent, maintenance and insurance of facilities, or for the depreciation of fixed assets.

Previous wording

Other income, net consists of interest income earned from our cash, cash equivalents and marketable securities and the net amortization or accretion of premiums and discounts related to our marketable securities. We expect our interest income to vary each reporting period depending on our average bank deposits, money market funds and investment balances during the period and market interest rates.

Current wording

Other income, net consists of interest income earned from our cash and cash equivalents. We expect our interest income to vary each reporting period depending on our average bank deposits, money market funds and investment balances during the period and market interest rates.

Previous wording

Product revenue, net was $13.1 million and $9.3 million for the three months ended September 30, 2025 and 2024, respectively. The $3.8 million increase is the result of increased product sales following the launch of PEMGARDA.

Current wording

Product revenue, net was $13.7 million and $11.3 million for the three months ended March 31, 2026 and 2025, respectively. The $2.4 million increase is the result of increased product sales of PEMGARDA due to an increase in product demand.

Previous wording

Cost of product revenue was $1.1 million and $0.8 million for the three months ended September 30, 2025 and 2024, respectively. The $0.3 million increase is the result of increased PEMGARDA product sales following launch and certain period costs.

Current wording

Cost of product revenue was $1.0 million and $0.8 million for the three months ended March 31, 2026 and 2025, respectively. The $0.2 million increase is the result of increased PEMGARDA sales and certain period costs.

Previous wording

Research and development expenses were $8.0 million for the three months ended September 30, 2025, compared to $57.9 million for the three months ended September 30, 2024. The $49.8 million decrease in research and development expenses was primarily due to the following:

Current wording

Research and development expenses were $30.7 million for the three months ended March 31, 2026, compared to $10.6 million for the three months ended March 31, 2025. The $20.1 million increase in research and development expenses was primarily due to the following:

Previous wording

Decrease in direct costs related to our pemivibart program resulted from decrease of $12.5 million in contract costs for commercial manufacturing, $11.4 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.8 million in nonclinical costs, and $0.6 million in other external costs;

Current wording

Decrease in direct costs related to our pemivibart program resulted from a decrease of $0.6 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.5 million in nonclinical expenses and $0.1 million in contract costs for commercial manufacturing;

Previous wording

Decrease in direct costs related to our VYD2311 program resulted from decrease of $59.5 million in contract costs for clinical and commercial manufacturing, $1.7 million in nonclinical expense, and $0.3 million in clinical trial expense, partially offset by increase of $0.1 million in external discovery-related and other costs;

Current wording

Increase in direct costs related to our VYD2311 program resulted from an increase of $21.5 million in contract research costs for our Phase 3 DECLARATION clinical trial and $0.4 million in external discovery-related and other costs, partially offset by a decrease of $0.3 million in contract costs for commercial manufacturing and $0.3 million in nonclinical expenses;

Previous wording

Selling, general and administrative expenses were $15.0 million for the three months ended September 30, 2025, compared to $13.0 million for the three months ended September 30, 2024. The $2.0 million increase in selling, general and administrative expenses was primarily due to the following:

Current wording

Selling, general and administrative expenses were $25.1 million for the three months ended March 31, 2026, compared to $16.8 million for the three months ended March 31, 2025. The $8.3 million increase in selling, general and administrative expenses was primarily due to the following:

Previous wording

Increase in personnel related costs primarily related to a $2.2 million increase in headcount-related costs and $0.4 million in stock-based compensation expense;

Current wording

Increase in personnel related costs resulted from an increase in headcount-related costs;

Previous wording

Decrease in professional and consultant fees resulted from decrease of $1.0 million related to sales and marketing costs and $0.2 million in insurance cost, partially offset by increase of $0.1 million in professional service fees; and

Current wording

Increase in professional and consultant fees resulted from an increase of $3.4 million in professional service fees and $1.7 million related to sales and marketing costs, partially offset by a decrease of $0.1 million in insurance costs; and

Previous wording

Increase in other costs primarily resulted from increase of $1.6 million in travel costs and $0.2 million in software licensing costs.

Current wording

Increase in other costs primarily resulted from an increase of $0.7 million in employee related travel expense, $0.3 million in conference related costs and $0.2 million in technology related costs.

Previous wording

Other income was $0.6 million and $1.6 million for the three months ended September 30, 2025 and 2024, respectively, in each case consisting primarily of interest earned on our invested cash balances.

Current wording

Other income, net was $1.7 million and $0.6 million for the three months ended March 31, 2026 and 2025, respectively, consisting primarily of interest earned on our invested cash balances. The $1.1 million increase in other income, net was primarily due to an increase in cash invested.

Previous wording

Through September 30, 2025, we have incurred significant operating losses and negative cash flows from operations. Although we received an EUA from the FDA for PEMGARDA in March 2024, we may continue to incur significant expenses and potential operating losses for the foreseeable future as we continue to commercialize PEMGARDA and advance the development of VYD2311 and our other product candidates. As of September 30, 2025, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, with aggregate net proceeds from our IPO in August 2021 of $327.5 million, with aggregate net proceeds after deducting issuance costs of $43.8 million from sales of our common stock under the Sales Agreement (as defined below), and with net proceeds after deducting underwriting discounts and commissions and offering expenses of $53.5 million from sales of our common stock and pre-funded warrants under the Underwriting Agreement (as defined below). After receiving EUA in March 2024, we have also funded our operations from sales of PEMGARDA.

Current wording

Through March 31, 2026, we have incurred significant operating losses and negative cash flows from operations. Although we received an EUA from the FDA for PEMGARDA in March 2024, we may continue to incur significant expenses and potential operating losses for the foreseeable future as we continue to commercialize PEMGARDA and advance the development of VYD2311, VBY329, VMS063 and our other product candidates. As of March 31, 2026, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, $327.5 million from sales of our common stock from our IPO in August 2021, $72.7 million from sales of our common stock under the Sales Agreement (as defined below), and $181.6 million from sales of our common stock and pre-funded warrants under the Underwriting Agreements (as defined below). After receiving EUA in March 2024, we have also funded our operations from sales of PEMGARDA.

Previous wording

As of September 30, 2025, we had cash and cash equivalents of $85.0 million. In October 2025, we sold 18,655,402 shares of our common stock under the Sales Agreement at an average price of $1.60 per share for $28.9 million in proceeds net of commissions.

Current wording

As of March 31, 2026, we had cash and cash equivalents of $184.2 million. In April 2026, we sold 11,803,589 shares of our common stock under the Sales Agreement at an average price of $1.70 per share for $19.4 million in proceeds net of commissions.

Previous wording

In October 2025, we filed a new shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus, for the offer and sale of up to $350 million of our securities (the “2025 Shelf Registration Statement”).

Current wording

In September 2022, we filed a shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus, which was declared effective by the SEC on October 5, 2022, for the offer and sale of up to $400 million of our securities (the “2022 Shelf Registration Statement”). The 2022 Shelf Registration Statement expired upon the effectiveness of the 2025 Shelf Registration Statement (as defined below).

Previous wording

In September 2022, we filed a shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus, which was declared effective by the SEC on October 5, 2022, for the offer and sale of up to $400 million of our securities (the “2022 Shelf Registration Statement”). As of September 30, 2025, $267.5 million of our securities remained available for offer and sale under the 2022 Shelf Registration Statement.

Current wording

In October 2025, we filed a new shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus, which was declared effective by the SEC on December 23, 2025, for the offer and sale of up to $350 million of our securities (the “2025 Shelf Registration Statement”). As of March 31, 2026, excluding the $75 million allocated to the 2025 ATM Prospectus Supplement (as defined below), $275 million of our securities remained available for offer and sale under the 2025 Shelf Registration Statement.

Previous wording

In December 2023, we entered into a Controlled Equity Offering SMSales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”) and filed with the SEC a prospectus supplement to the 2022 Shelf Registration Statement (the “2023 ATM Prospectus Supplement”), pursuant to which we may, at our option, offer and sell shares of our common stock, with a sales value of up to $75.0 million, from time to time, through Cantor, acting as sales agent, in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended. Cantor is entitled to a commission of 3% of the gross proceeds from any sales of such shares.

Current wording

In December 2023, we entered into a Controlled Equity Offering SMSales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”) and filed with the SEC a prospectus supplement to the 2022 Shelf Registration Statement (the “2023 ATM Prospectus Supplement”), pursuant to which we could, at our option, offer and sell shares of our common stock, with a sales value of up to $75.0 million, from time to time, through Cantor, acting as sales agent, in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”). Cantor was entitled to a commission of 3% of the gross proceeds from any sales of such shares. In 2024, we sold 9,000,000 shares of our common stock under the Sales Agreement and 2023 ATM Prospectus Supplement at an average price of $4.50 per share for $39.3 million in proceeds net of commissions. In 2025, we sold 23,055,402 shares of our common stock under the Sales Agreement and 2023 ATM Prospectus Supplement at an average price of $1.49 per share for $33.4 million in proceeds net of commissions. Upon the effectiveness of the 2025 Shelf Registration Statement, all offers and sales under the 2023 ATM Prospectus Supplement were deemed terminated.

Previous wording

In October 2025, in connection with the filing of the 2025 Shelf Registration Statement, we filed with the SEC a new prospectus supplement, pursuant to which we may, at our option, after the 2025 Registration Statement is declared effective by the SEC, offer and sell shares of our common stock, with a sales value of up to $75.0 million, from time to time, through Cantor, acting as sales agent, in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended. Cantor is entitled to a commission of 3% of the gross proceeds from any sales of such shares.

Current wording

In October 2025, in connection with the filing of the 2025 Shelf Registration Statement, we filed with the SEC a new prospectus supplement (the “2025 ATM Prospectus Supplement”), pursuant to which we may, at our option, offer and sell shares of our common stock, with a sales value of up to $75.0 million, from time to time, through Cantor, acting as sales agent, in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act. Cantor is entitled to a commission of 3% of the gross proceeds from any sales of such shares. The 2025 Shelf Registration Statement was declared effective by the SEC on December 23, 2025. As of March 31, 2026, $75.0 million remained available for sale under the 2025 ATM Prospectus Supplement.

Previous wording

In August 2025, we completed an underwritten public offering pursuant to an underwriting agreement (the “Underwriting Agreement”) with Cantor, as representative of the underwriters named therein, pursuant to which we issued and sold an aggregate of 89,234,480 shares of our common stock at a price of $0.52 per share, and pre-funded warrants to purchase up to an aggregate of 21,342,442 shares of common stock at a price of $0.5199 per pre-funded warrant. The price of $0.5199 per pre-funded warrant represented the $0.52 per share purchase price for the common stock less the exercise price of $0.0001 per pre-funded warrant. The pre-funded warrants are exercisable at any time after their original issuance and will not expire. We received total net proceeds of approximately $53.5 million, after deducting underwriting discounts and commissions and offering expenses.

Current wording

In August 2025, we completed an underwritten public offering pursuant to an underwriting agreement (the “August Underwriting Agreement”) with Cantor, as representative of the underwriters named therein, pursuant to which we issued and sold an aggregate of 89,234,480 shares of our common stock at a price of $0.52 per share, and pre-funded warrants to purchase up to an aggregate of 21,342,442 shares of common stock at a price of $0.5199 per pre-funded warrant. The price of $0.5199 per pre-funded warrant represented the $0.52 per share purchase price for the common stock less the exercise price of $0.0001 per pre-funded warrant. The pre-funded warrants are exercisable at any time after their original issuance and will not expire. We received total net proceeds of approximately $53.5 million, after deducting underwriting discounts and commissions and offering expenses.