What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-14 compared with 2025-11-06 · 155 added, 186 removed, 250 unchanged (58% of the section changed)

12 unchanged sentences

Food and Drug Administration (“FDA”) in March 2024, including our expectations about the potential market opportunity;

• the design of PEMGARDA to keep pace with SARS-CoV-2 viral evolution;

• 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;

• our expectations regarding availability of a rapid pathway to potential Biologics License Application (“BLA”) approval for VYD2311 for the prevention of COVID-19 and the compact pivotal clinical trial that could substantiate it;

• 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;

• 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;

• our discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles;

• our goal of establishing streamlined development pathways to efficiently introduce new mAb candidates targeting SARS-CoV-2;

• 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;

• 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;

• 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;

• our expectations regarding the regulatory pathway for our product candidates, including the anticipated timing of any submission of filings for regulatory authorization or approval of, and our ability to obtain and maintain regulatory authorizations or approvals for, our product candidates;

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• our expectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of our product candidates, if authorized or approved for commercial use;

• our expectation of continued reliance 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;

• our manufacturing capabilities and strategy, and our expectations regarding supply and demand of our product candidates;

• our ability to successfully commercialize our product candidates, if authorized or approved, including our distribution capabilities and strategy;

• our ability to identify and develop future product candidates;

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

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

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

• our estimates of our expenses, ongoing losses, future potential revenue, capital requirements and our need for or ability to obtain additional funding;

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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.

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.

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.

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.

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.

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.

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.

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 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.

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.

In August 2025, we announced alignment with advice from the FDA on a compact and, therefore, rapid pathway to potential Biologics License Application (“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.

The REVOLUTION clinical program includes three clinical trials, DECLARATION, LIBERTY and DRUMMER.

In December 2025, we initiated DECLARATION, which is a Phase 3 randomized, triple-blind, placebo-controlled clinical trial to evaluate VYD2311 safety and efficacy in prevention of symptomatic, RT-PCR-confirmed COVID-19 at three months, with either a single dose or monthly doses of VYD2311, each administered via IM injection, compared to placebo.

In April 2026, we announced that we conducted a prospectively designed, conservative, algorithmic sample size re-estimation pooled, blinded analysis for the DECLARATION clinical trial aimed at ensuring adequate COVID-19 clinical events and associated statistical power given the variability of COVID-19 attack rates.

As of the sample-size re-estimation analysis, conducted when the first 1,500 (of 1,818 total) subjects reached Day 45, clinical events accrued to date could support statistical powering for the high end of anticipated VYD2311 efficacy levels with approximately half of the base DECLARATION clinical trial still to go.

The sample size re-estimation was designed conservatively with the aim of accomplishing strong statistical power to accommodate a range of potential VYD2311 efficacy results and COVID events in the trial, and upsizing was triggered.

The DECLARATION upsizing includes approximately 500 additional subjects, in addition to 1,818 total randomized subjects in the initial trial population.

DECLARATION is designed to support potential BLA submission.

Depending on recruitment rates following the trial upsizing, top-line data from DECLARATION are expected in the third quarter of 2026.

In February 2026, we announced alignment with the FDA on LIBERTY, which is designed as a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of (1) VYD2311, (2) an mRNA COVID vaccine, and (3) co-administered VYD2311 with an mRNA COVID vaccine.

Additionally, we have agreed with the FDA on an initial Pediatric Study Plan for an efficient safety and immunobridging clinical trial to support potential BLA for VYD2311 in children aged 0-11 years.

This DRUMMER pediatric clinical trial will be actioned only if the pivotal DECLARATION clinical trial is successful.

The FDA has granted “Fast Track” designation for VYD2311 for the prevention of COVID-19 in individuals with underlying risk factors for progression to severe disease.

Fast Track designation is a process designed to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need, including eligibility for priority review and rolling review of BLA submissions, if specified criteria are met.

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.

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.

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).

§ 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

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.

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 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.

Since our inception, we have devoted substantially all of our resources to organizing and staffing, building an intellectual property portfolio, business planning, conducting research and development, establishing and executing arrangements with third parties for the manufacture of our product candidates, and raising capital.

Our recent focus has been and will continue to be supporting the commercialization of PEMGARDA, advancing VYD2311 as our next generation mAb candidate for COVID-19, and establishing streamlined development pathways that could enable us to efficiently introduce new mAb candidates targeting SARS-CoV-2, leveraging previously generated safety and efficacy data from our clinical trials of adintrevimab and/or pemivibart.

We have also initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles.

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”).

In addition to our COVID-19 programs, in November 2025, we announced the selection of VBY329, a potential best-in-class mAb candidate being developed for the prevention of RSV infections in neonates, infants and children.

We expect to advance VBY329 toward IND readiness in the second half of 2026.

Also, in April 2026, we announced the discovery and

advancement of VMS063, a novel, highly potent, half-life-extended, high resistance barrier measles mAb candidate.

We have begun IND-enablement and regulatory outreach to support rapid VMS063 development, with the goal of expedited development with target IND readiness in late 2026.

Through our proprietary technology platform, we continue to investigate additional mAbs for protection and treatment of other important infectious diseases.

We are also committed to advancing national education and awareness about antibodies and their role in immune health.

In April 2026, we launched Antibodies for Any Body, a national education campaign designed to elevate public understanding of antibodies, one of the most important parts of the immune system, and their role in protecting against disease.

The campaign was launched in collaboration with renowned ski champion Lindsey Vonn, whose career has been defined by training with intention, overcoming challenges, and taking control of her health and wellness.

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.

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.

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).

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.

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.

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.

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.

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• continue to commercialize PEMGARDA;

• advance the development of VYD2311;

• initiate and conduct clinical trials of our product candidates;

• advance the development of VYD2311 and prepare for its potential commercial launch, if approved, as well as advance development of our other product candidates, such as VBY329 and VMS063;

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

• develop product candidates in any new indications or patient populations;

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

• 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;

• seek regulatory authorization or approval for any product candidates that successfully complete clinical trials;

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If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

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.

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.

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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.

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.

Cost of Product Revenue

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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.

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.

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• successful enrollment and timely completion of clinical trials, including our ability to generate positive data from any such clinical trials;

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

• 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;

• the prevalence, nature and severity of adverse events experienced with any product candidates;

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We also expect to incur additional intellectual property-related expenses as we file additional patent applications to protect innovations arising from our research and development activities.

Through September 30, 2025, we have operated as a hybrid company.

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.

Other Income, Net

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.

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.

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We continue to monitor the manner in which countries will enact legislation to implement the Pillar Two framework proposed by the Organisation for Economic Co-operation and Development, which proposes a 15% global corporate minimum tax.

As of September 30, 2025, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years.

As of March 31, 2026, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years.

While we do not expect these rules to have a material impact on our effective tax rate, we continue to monitor these initiatives on a global basis.

Results of Operations

Comparison of the three months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:

Three Months Ended September 30,

Comparison of the three months ended March 31, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31,

(in thousands)

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Product Revenue, Net

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.

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.

Cost of Product Revenue

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.

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.

We began capitalizing our inventory costs in March 2024, in connection with EUA from the FDA and based upon our expectation that these costs would be recoverable through commercialization of PEMGARDA.

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Research and Development Expenses

Three Months Ended September 30,

Three Months Ended March 31,

(in thousands)

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Pemivibart (1)

Early-stage programs

Unallocated research and development expenses:

Personnel related (including stock-based compensation)

Personnel related costs (including stock-based compensation)

External discovery-related and other costs

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(2) In March 2024, we announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19.

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:

• Decrease in direct costs related to our pemivibart program resulted from decrease of $2.8 million in contract research costs for our Phase 3 CANOPY clinical trial, $1.1 million in contract development and manufacturing expenses, $0.2 million in nonclinical expenses, and $0.2 million in other external costs;

• Decrease in direct costs related to our VYD2311 program resulted from decrease of $43.6 million in contract costs for commercial manufacturing, $0.7 million in contract research costs for our Phase 1/2 clinical trial, and $0.5 million in nonclinical expense;

• The direct costs related to our adintrevimab program remained relatively consistent between periods;

• Decrease in personnel related costs resulted from decrease of $0.3 million in headcount-related costs;

• Decrease in external discovery-related and other costs resulted from decrease of $0.3 million in contract development and manufacturing costs related to our pipeline candidates.

(3) In November 2025, we announced the nomination of VBY329 as an RSV mAb candidate for preclinical development.

(4) In April 2026, we announced the nomination of VMS063 as a measles mAb candidate for clinical development.

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:

• 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;

• 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;

• Increase in direct costs related to our VBY329 program resulted from the nomination of VBY329 as an RSV mAb candidate in the fourth quarter of 2025, with costs resulting from nonclinical expenses;

• Increase in direct costs for our VMS063 program resulted from the nomination of VMS063 as a measles mAb candidate in the second quarter of 2026, with costs resulting from external discovery-related and other costs;

• Decrease in direct costs related to our early-stage programs resulted from a decrease of external discovery-related and other costs;

• Decrease in personnel related costs resulted from a decrease of headcount-related costs;

• Decrease in external discovery-related and other costs resulted from a decrease of $0.3 million in contract manufacturing costs and $0.1 million in nonclinical costs, partially offset by an increase of $0.2 million in clinical trial expenses and $0.1 million in other external costs.

Selling, General and Administrative Expenses

Three Months Ended September 30,

Three Months Ended March 31,

(in thousands)

Personnel related (including stock-based compensation)

Personnel related costs (including stock-based compensation)

Professional and consultant fees

Total selling, general and administrative expenses

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.

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:

• 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;

• 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;

• Increase in other costs primarily resulted from an increase of travel costs of $0.6 million.

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.

Comparison of the nine months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

Nine Months Ended September 30,

(in thousands)

Product revenue, net

Total revenue

Operating costs and expenses:

Cost of product revenue

Research and development

Selling, general and administrative

Total operating costs and expenses

Loss from operations

Other income:

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

• 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;

• 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.

Other Income, net

Total other income, net

The following discussion presents the components of our expenses for the periods presented:

Product Revenue, Net

Product revenue, net was $36.2 million and $11.6 million for the nine months ended September 30, 2025 and 2024, respectively.

The $24.6 million increase is the result of increased product sales following the launch of PEMGARDA in April 2024.

Cost of Product Revenue

Cost of product revenue was $2.6 million and $0.9 million for the nine months ended September 30, 2025 and 2024, respectively.

The $1.7 million increase is the result of increased PEMGARDA product sales following launch and certain period costs.

Prior to the capitalization of our inventory costs, such costs were recorded as research and development expenses in the period incurred.

Had our pre-EUA manufacturing costs been capitalized, our reported margins would approach 80%.

Research and Development Expenses

Nine Months Ended September 30,

(in thousands)

Direct, external research and development expenses by program:

Pemivibart (1)

Unallocated research and development expenses:

Personnel related (including stock-based compensation)

External discovery-related and other costs

Total research and development expenses

(1) In March 2023, we announced the nomination of VYD222 (pemivibart) as a novel mAb therapeutic option for COVID-19.

(2) In March 2024, we announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19.

Research and development expenses were $28.3 million for the nine months ended September 30, 2025, compared to $119.3 million for the nine months ended September 30, 2024.

The $91.0 million decrease in research and development expenses was primarily due to the following:

• 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;

• 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;

• The direct costs related to our adintrevimab program remained relatively consistent between periods;

• Decrease in personnel related costs resulted from decrease of $3.4 million in headcount-related costs;

• Decrease in external discovery-related and other costs resulted from $0.9 million in contract development and manufacturing expense related to our pipeline candidates.

Selling, General and Administrative Expenses

Nine Months Ended September 30,

(in thousands)

Personnel-related costs

Professional and consultant fees

Total selling, general and administrative expenses

Selling, general and administrative expenses were $48.4 million for the nine months ended September 30, 2025, compared to $49.0 million for the nine months ended September 30, 2024.

The $0.6 million decrease in selling, general and administrative expenses was primarily due to the following:

• Decrease in personnel related costs resulted from decrease of $6.6 million in stock-based compensation expense, partially offset by increase of $4.5 million in headcount-related costs.

The decrease in stock-based compensation expense was primarily due to stock-based compensation expense recognized in 2024 associated with the accelerated vesting of a portion of the outstanding stock options granted to our former Chief Executive Officer, in accordance with the terms of his employment agreement;

• Decrease in professional and consultant fees resulted from decrease of $0.4 million in sales and marketing costs and $0.4 million in insurance costs, partially offset by increase of $0.5 million in professional service fees;

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

Other income was $1.6 million and $6.2 million for the nine months ended September 30, 2025 and 2024, respectively, in each case consisting primarily of interest earned on our invested cash balances.

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.

Liquidity and Capital Resources

Sources of Liquidity

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).

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.

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.

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.

Shelf Registration Statements

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.

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”).

As of the date of this Quarterly Report on Form 10-Q, the 2025 Shelf Registration Statement has not yet been declared effective by the SEC.

However, we are permitted to continue to offer and sell, subject to applicable SEC requirements, unsold securities remaining on the 2022 Shelf Registration Statement until the 2025 Shelf Registration Statement has been declared effective (or April 3, 2026, if sooner).

The 2022 Shelf Registration Statement expired upon the effectiveness of the 2025 Shelf Registration Statement (as defined below).

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.

Sales Agreement

In December 2023, we entered into a Controlled Equity Offering SM Sales 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.

In February 2024, we sold 9,000,000 shares of our common stock under the Sales Agreement at an average price of $4.50 per share for $39.3 million in net proceeds after deducting issuance costs.

In August 2025, we sold 4,400,000 shares of our

common stock under the Sales Agreement at an average price of $1.05 per share for $4.5 million in proceeds net of commissions.

As of September 30, 2025, $29.9 million remained available for sale under the 2023 ATM Prospectus Supplement.

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.

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.

In December 2023, we entered into a Controlled Equity Offering SM Sales 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.

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.

Underwriting Agreement

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 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.

Underwriting Agreements

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.

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We received total net proceeds of approximately $53.5 million, after deducting underwriting discounts and commissions and offering expenses.

In November 2025, we completed an underwritten public offering pursuant to an underwriting agreement (the “November Underwriting Agreement” and together with the August Underwriting Agreement, the “Underwriting Agreements”) with Cantor, as representative of the underwriters named therein, pursuant to which we issued and sold an aggregate of 44,000,000 shares of our common stock at a price of $2.50 per share, and pre-funded warrants to purchase up to an aggregate of 6,000,000 shares of common stock at a price of $2.4999 per pre-funded warrant (the “November 2025 Underwritten Public Offering”).

The price of $2.4999 per pre-funded warrant represented the $2.50 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

We received total net proceeds of approximately $117.2 million, after deducting underwriting discounts and commissions and offering expenses.

In December 2025, and in connection with the November 2025 Underwritten Public Offering, Cantor exercised the option pursuant to the November Underwriting Agreement to purchase 4,675,000 additional shares of common stock at the public offering price of $2.50, less underwriting discounts and commissions.

In connection with such exercise, we received total net proceeds of approximately $10.9 million, after deducting underwriting discounts and commissions and offering expenses payable by us.

Loan Agreement

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The proceeds of the Term Facility may be used for working capital and general business purposes.

As of September 30, 2025, we had not satisfied the net product revenue milestone required to be eligible to access proceeds from the Term Facility.

As of March 31, 2026, we had not satisfied certain financial covenants and conditions, including the net product revenue milestone required to be eligible to access proceeds from the Term Facility.

Accordingly, as of March 31, 2026, no amounts have been drawn down under the Loan Agreement.

The loans under the Term Facility are due and payable on March 1, 2029 and bear interest that is payable monthly, commencing with the month in which any loans are funded under the Term Facility, in arrears at a per annum rate, subject to increase during an Event of Default (as defined in the Loan Agreement), equal to the greater of (x) the Wall Street Journal prime rate minus 0.25%, subject to a 9.00% cap, and (y) 6.00%.

Commencing on April 1, 2027, which date may be extended to April 1, 2028 upon the achievement of certain net product revenue milestones (the “Interest-Only Period Extension”), we are required to repay the principal of the Term Facility in 24 consecutive equal monthly installments or, in the case of the Interest-Only Period Extension, 12 consecutive equal monthly installments.

Commencing on April 1, 2027, which date may be extended to April 1, 2028 upon the achievement of certain net product revenue milestones (the “Interest-Only Period Extension”), we will be required to repay the principal of the Term Facility in 24 consecutive equal monthly installments or, in the case of the Interest-Only Period Extension, 12 consecutive equal monthly installments.

At maturity, or if earlier prepaid, we will also be required to pay a final payment fee equal to 4.50% of the aggregate principal amount of the loans advanced under the Term Facility.

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The following table summarizes our sources and uses of cash for each of the periods presented:

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

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Net cash used in investing activities

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

Net cash (used in) provided by financing activities

Effect of exchange rate changes on cash and cash equivalents

Net decrease in cash and cash equivalents

Operating Activities

During the nine months ended September 30, 2025, operating activities used $42.7 million of cash, primarily due to our net loss of $41.4 million and changes in our operating assets and liabilities of $12.3 million, partially offset by non-cash charges

of $11.0 million.

The changes in our operating assets and liabilities primarily consisted of a $24.9 million decrease in accrued expenses, and a $1.0 million decrease in operating lease liabilities, partially offset by a $7.5 million increase in accounts payable, a $5.4 million decrease in prepaid expenses and other current assets, and a $0.7 million decrease in accounts receivable.

The change in accrued expenses was primarily due to the timing of vendor invoicing and payments.

During the nine months ended September 30, 2024, operating activities used $132.9 million of cash, primarily due to our net loss of $151.5 million, partially offset by non-cash charges of $18.3 million and changes in our operating assets and liabilities of $0.3 million.

The changes in our operating assets and liabilities primarily consisted of a $16.0 million increase in accrued expenses, a $15.3 million decrease in prepaid expenses and other current assets, and a $9.7 million increase in accounts payable, partially offset by a $23.4 million increase in inventory, a $8.1 million increase in accounts receivables, a $7.3 million increase in other non-current assets, a $1.2 million decrease in operating lease liabilities and a $0.7 million decrease in other non-current liabilities.

The increase in accrued expenses was primarily due to the timing of vendor invoicing and payments.

The decrease in prepaid expenses and other current assets was primarily due to the utilization of WuXi Biologics manufacturing prepayments.

During the three months ended March 31, 2026, operating activities used $41.7 million of cash, primarily due to our net loss of $41.4 million and changes in our operating assets and liabilities of $3.6 million, partially offset by non-cash charges of $3.3 million.

The changes in our operating assets and liabilities primarily consisted of a $11.6 million decrease in accounts payable, a $2.1 million increase in prepaid expenses and other current assets, a $1.0 million increase in other non-current assets, and a $0.3 million decrease in operating lease liabilities, partially offset by a $9.2 million increase in accrued expenses and a $2.2 million decrease in accounts receivable.

The change in accounts payable and accrued expenses was primarily due to the timing of vendor invoicing and payments.

During the three months ended March 31, 2025, operating activities used $21.1 million of cash, primarily due to our net loss of $16.3 million, and changes in our operating assets and liabilities of $8.4 million, partially offset by non-cash charges of $3.6 million.

The changes in our operating assets and liabilities primarily consisted of a $10.0 million decrease in accrued expenses, a $1.6 million decrease in accounts payable, and a $0.4 million decrease in operating lease liabilities, partially offset

by a $2.3 million decrease in accounts receivable and a $1.3 million decrease in prepaid expenses and other current assets.

The decrease in accrued expenses was primarily due to the timing of vendor invoicing and payments.

Investing Activities

Net cash used in investing activities during the nine months ended September 30, 2025 consisted primarily of $0.2 million in purchases of property and equipment.

Net cash used in investing activities during the nine months ended September 30, 2024 consisted of $0.1 million in purchases of property and equipment.

Net cash used in investing activities during the three months ended March 31, 2026 consisted of $0.7 million in purchases of property and equipment.

Net cash used in investing activities during the three months ended March 31, 2025 consisted of $0.1 million in purchases of property and equipment.

Financing Activities

Net cash provided by financing activities during the nine months ended September 30, 2025 consisted of $54.0 million from the issuance of common stock and pre-funded warrants sold under the Underwriting Agreement, $4.5 million from the issuance of common stock under the Sales Agreement, $0.2 million from the issuance of common stock under the employee stock purchase plan, and $0.1 million from exercises of stock options, partially offset by $0.2 million in payments for offering costs related to the Underwriting Agreement and $0.1 million in payments for offering costs related to the Sales Agreement.

Net cash provided by financing activities during the nine months ended September 30, 2024 consisted of $39.3 million from the issuance of common stock under the Sales Agreement, $0.3 million from exercises of stock options, and $0.2 million from the issuance of common stock under the employee stock purchase plan, partially offset by $0.5 million in payments for offering costs related to the Sales Agreement.

Net cash used in financing activities during the three months ended March 31, 2026 consisted of $0.2 million in payments for offering costs related to the Underwriting Agreement and $0.1 million in payments for offering costs related to the Sales Agreement, partially offset by $0.1 million from the issuance of common stock under our employee stock purchase plan, and $0.1 million from exercises of stock options.

Net cash provided by financing activities during the three months ended March 31, 2025 consisted of $0.1 million from the exercises of stock options and the issuance of common stock under our employee stock purchase plan, offset by $0.1 million in payments for offering costs related to the Sales Agreement.

Funding Requirements

Our expenses are expected to increase in connection with our ongoing activities, particularly as we advance the REVOLUTION clinical program for VYD2311, the nonclinical and preclinical studies and the clinical trials of our other product candidates, our ongoing and planned commercialization efforts, and any associated manufacturing activities in connection with our clinical development and commercialization activities.

Our expenses are expected to increase in connection with our ongoing activities, particularly as we advance the REVOLUTION clinical program, our nonclinical and preclinical studies, and the clinical trials of our other product candidates, our ongoing and planned commercialization efforts, and any associated manufacturing activities in connection with our clinical development and commercialization activities.

Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including:

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• the costs, timing and outcome of regulatory review of our product candidates;

• our headcount growth and associated costs as we expand our research and development capabilities and maintain and expand a commercial infrastructure for product candidates for which we obtain regulatory authorization or approval;

• the timing and costs of securing sufficient manufacturing capacity for clinical and commercial supply of our product candidates, or the raw material components thereof, as needed in the future;

• our headcount growth and associated costs as we expand our research and development capabilities and build and maintain a commercial infrastructure for product candidates for which we obtain regulatory authorization or approval;

• the timing and costs of securing sufficient manufacturing capacity for clinical and commercial supply of our product candidates, or the raw material components thereof;

• the costs and timing of commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive regulatory authorization or approval;

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In accordance with Accounting Standards Update 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we are required to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern from the issuance date of our condensed consolidated financial statements.

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 of these condensed consolidated financial statements, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern.

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 of these condensed consolidated financial statements, 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.

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Contractual Obligations and Commitments

Through September 30, 2025, we committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Services Agreement with WuXi Biologics, which was entered into in December 2020, amended and restated in August 2021 and further amended and restated in September 2023 (as amended and restated, the “Commercial Manufacturing Agreement”).

As of September 30, 2025, the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $25.6 million, which was included in accounts payable and accrued expenses.

The remaining balance is expected to be paid in 2025.

Through September 30, 2025, we committed to noncancelable purchase obligations related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.

September 30, 2025, the total remaining contractually binding purchase obligations due to WuXi Biologics was $3.5 million, which was included in accounts payable and accrued expenses.

The remaining balance is expected to be paid in 2025.

We lease certain office and laboratory space classified as operating leases.

See Note 9 of our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for further detail on our lease obligations and the timing of expected future payments.

In addition, we enter into agreements with third parties in the ordinary course of business for various products and services, including those related to research, preclinical and clinical operations, manufacturing and support, supply chain, and distribution.

These contracts do not contain any material minimum purchase commitments.

Certain of these agreements provide for termination rights subject to the payment of termination fees and/or wind-down costs.

Under such agreements, we are contractually obligated to make certain payments to vendors upon early termination, primarily to reimburse them for their unrecoverable outlays incurred prior to cancellation as well as any amounts owed by us prior to early termination.

The actual amounts we could pay in the future to the vendors under such agreements may differ from the purchase order amounts due to cancellation provisions.

The termination fees were not probable of payment as of March 31, 2026.

Critical Accounting Policies and Significant Judgments and Estimates

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Emerging Growth Company Status

We are an “emerging growth company,” as defined in the JOBS Act, and may remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering.

However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.235 billion or we issue more than $1.0 billion of non-convertible debt in the previous three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.

We are an “emerging growth company,” as defined in the JOBS Act, and will remain an emerging growth company until December 31, 2026.

For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis