IVVD 10-K & 10-Q changes, risk factors and insider trading

We have incurred significant losses since our inception and are highly dependent on the commercial success of PEMGARDAour only authorized product, PEMGARDA, for the foreseeable future.future, until VYD2311 or any other product candidate is authorized or approved and successfully commercialized, if ever. We may not achieve or maintain profitability.

advance the development of VYD2311 and prepare for its potential commercial launch, if approved;

initiate and conduct clinical trials of our product candidatescandidates, including our REVOLUTION clinical program for VYD2311;

advance our preclinical and discovery programs, such as RSV and measles, including development and screening of additional antibodies;

Our ability to execute our current business strategy and become and remain profitable is heavily dependent on the commercial success of PEMGARDA for the foreseeable future and our ability to develop and commercialize other product candidates that generate significant revenue. This will require us to be successful in a range of challenging activities on a timeline that keeps pace with viral evolution, including completing preclinical testing and clinical trials of our product candidates, validating manufacturing processes, obtaining regulatory authorization or approval, and manufacturing, distributing, marketing, and selling any products for which we obtain regulatory authorization or approval, as well as discovering and developing additional product candidates. We will remain highly dependent on the commercial success of our only authorized product, PEMGARDA, for the foreseeable future, until VYD2311 or any other product candidate is authorized or approved and successfully commercialized, if ever.

We are a biopharmaceutical company with a limited operating history. We commenced operations in June 2020, and our operations to date have been largely focused on 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 capital raising. 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. To date, we have received regulatory authorization for only one product candidate, PEMGARDA, which received an EUA from the FDA in March 2024 for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients. It is uncertain as to if or when we may be successful in expanding the authorized use of PEMGARDA, if ever. Our operations to date have been largely focused on organizing and staffing, building an intellectual property portfolio, business planning, conducting research and development, regulatory activities, establishing and executing arrangements for third-party manufacturing of our product candidates, commercializing PEMGARDA, and capital raising. 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 preparing for the potential commercial launch of VYD2311, if approved. Furthermore, while we continue to advance our BLA-enabling clinical program for VYD2311, it is uncertain as to if or when we may submit such BLA for VYD2311 or an application for regulatory authorization or approval for any other product candidate, and we may not be successful in receiving any such additional regulatory authorization or approval. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating or commercial history. In addition, as a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors.

We will require additional funding through a combination of contribution from revenues, equity offerings, government or private-party grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements to support our continuing operations and pursue our growth strategy. If we are unable to secure and access additional funding when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

Our operations have consumed substantial amounts of cash since inception, and, although we received an EUA from the FDA for PEMGARDA in March 2024, we may continue to incur significant expenses and operating losses as we continue to advance VYD2311 as our next generation mAb candidate for COVID-19 and otherwise develop our product candidate pipeline. Aside from any revenue generated from sales of PEMGARDA, additional revenue, if any, will be derived from sales of products that may not be commercially available for a number of years, if at all. Furthermore, even if we obtain regulatory authorization to expand the authorized use of PEMGARDA or if we obtain regulatory approval of VYD2311 or regulatory authorization or approval for another product candidate that we develop or otherwise acquire, we may incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. Accordingly, until such time, if ever, as we can generate substantial revenue from PEMGARDA or sales of any future authorized or approved product, we expect to finance our operations through a combination of equity offerings, government or private-party grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements.

the rate of progress in the development of our product candidates, such as VYD2311 and VBY329;

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;

We mayexpect to require additional capital to achieve our business objectives. In December 2023, we entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which we may, at our option, offer and sell up to an aggregate amount of $75.0 million of our common stock, through Cantor, acting as sales agent. To date, we have sold 9,000,000 shares of our common stock from time to time through Cantor in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the SalesSecurities Agreement, resulting in net proceedsAct of $39.3 million.1933. Funds additional to the proceeds we may raise under the Sales Agreement may not be available on a timely basis, on favorable terms or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Further, our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, including tariff uncertainty, higher inflation rates, changes in interest rates and the recent disruptions to and volatility in the credit and financial markets in the U.S. and worldwide. If we are unable to secure additional funding when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

Until such time, if ever, as we can generate substantial revenue from sales of authorized or approved products, such as PEMGARDA, we expect to finance our operations through a combination of equity offerings, government or private-party grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements. WeAside from our milestone-based Term Facility (as defined below), we do not currently have any other committed external source of funds. To the extent that we raise additional capital through the sale of equity, including pursuant to our existing Sales Agreement with Cantor, or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan.

Newly emerging and future SARS-CoV-2 variants could reduce the activity and effectiveness of mAbs as afor potential prevention of or treatment for symptomatic COVID-19, which may significantly and adversely affect our ability to complete our clinical trials and to obtain and maintain authorization or approval of,of and commercialize our product candidates.

Our primary focus since inception has been the development of antibodies against COVID-19. Multiple variants of the virus that causes COVID-19 have been documented in the U.S. and globally, and newly emerging and future SARS-CoV-2 variants could reduce the activity and effectiveness of mAbs as afor potential prevention of or treatment for symptomatic COVID-19, which may significantly and adversely affect our ability to complete our clinical trials and to obtain and maintain authorization or approval of,of and commercialize our product candidates. For example, although preclinical studies showed that our investigational mAb adintrevimab had the potential to broadly neutralize SARS-CoV-2 and the previously predominantly circulating variants, including Alpha, Beta, Delta, and Gamma, in vitro analyses to evaluate neutralizing activity of adintrevimab against the Omicron variant and its sublineages generated data showing reduced neutralizing activity of adintrevimab against the Omicron BA.1 and BA.1.1 sublineages compared to a reference strain and a lack of neutralizing activity against Omicron BA.2. As a result, we paused enrollment in adintrevimab’s Phase 2/3 trials in January 2022, which were subsequently closed, and we paused submission of an EUA request. While we intend to continue to monitor the evolution of SARS-CoV-2 and the in vitro activity of adintrevimab against predominant variants in the U.S. to identify a potential opportunity for an EUA request, we cannot be certain that adintrevimab will neutralize future variants and that we will submit an EUA for adintrevimab or whether an EUA will be granted if we do submit such request.

PEMGARDA, which received an EUA from the FDA in March 2024, is an engineered version of adintrevimab, which we modified to improve binding to the Omicron variant and its sublineages. 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%. To date, PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XECXEC, LP.8.1 and LP.8.1.XFG. However, newly emerging and future SARS-CoV-2 variants could reduce the neutralizing activity and effectiveness of PEMGARDA. If this were to occur, the FDA may revise or revoke the EUA for PEMGARDA, which would adversely affect our commercial prospects, and our ability to generate revenues from PEMGARDA may be limited or lost.

As the SARS-CoV-2 virus evolves over time, we anticipate leveraging our integrated technology platform to periodically introducingintroduce new mAb candidates. InOur platform is designed to produce new mAb candidates that provide broad in vitro neutralization against past and current VOCs and their sublineages and that exert continuous pharmaceutical activity in the face of viral evolution. For example, in January 2024, we nominated VYD2311, a mAb optimized for neutralization potency against SARS-CoV-2 lineages such as BA.2.86 and JN.1, as a drug candidate. BasedHowever, on in vitro analyses, we believe such modifications may be able to enhance neutralization potency against current and future novel variants, but such efforts may not be successful against newly emerging or future variants, in order to support regulatory authorization or approval of VYD2311. Additionally, it is possible that in vivo analyses may not be consistent with in vitro analyses. Newnew SARS-CoV-2 variants could be less susceptible to such modifications and their mechanisms of action, or the results shown in preclinical studies may not be replicated in clinical trials. Additionally, it is possible that even if a product candidate showed in vitro neutralizing activity against the predominant SARS-CoV-2 variant at the initiation of a clinical trial, the predominant circulating variant may evolve and neutralizing activity of the candidate become reduced or negligible during the course of a clinical trial or at the time of our planned submission for regulatory authorization or approval. Further, we may not be able to address reductions in neutralization potency with adjustments to the dose or dosing frequency.frequency, Thisand wouldour current and future product candidates may not be durable enough to increase the probability of providing a longer period of protection than other antibody solutions or be high-functioning and long-lasting with a high barrier to viral escape. These risks may significantly and adversely affect our ability to complete our clinical trials,trials and obtain and maintain authorization or approval of and commercialize VYD2311 or any futureother product candidates. In addition, if our planned dosing of a product candidate were to be increased in response to reduction in neutralizing activity against dominant circulating SARS-CoV-2 variants or for other reasons, it could impact drug supply and pricing, which could adversely affect our commercial prospects. Even if we obtain authorization or approval, such authorization or approval may be revised or revoked based on changes in circulating variants that reduce the neutralizing activity or effectiveness of our product candidates.

To date, we have received regulatory authorization for only one product candidate, PEMGARDA. If we are unable to successfully develop, receive and maintain an EUA or regulatory approval for and commercialize our product candidates for the indications we seek, or successfully develop any other product candidates, or experience significant delays in doing so, our business will be substantially harmed.

To date, we have received regulatory authorization for only one product candidate, PEMGARDA, which has not been approved, but has been authorized for emergency use by the FDA under an EUA only for pre-exposure prophylaxis of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg). We currently have no other products approved or authorized for sale. In July 2024, we submitted a request to the FDA to expand the existing EUA for PEMGARDA to cover treatment of mild-to-moderate COVID-19 in certain immunocompromised patients, which request was denied by the FDA in February 2025. While we have submitted a response requesting that the FDA reconsider our EUA amendment request for treatment, we cannot be certain if or when the FDA may do so, or the outcome of any further engagement with the FDA regarding such request. Adintrevimab is an investigational mAb that we previously advanced into global Phase 2/3 trials for the prevention and treatment of COVID-19. We reported preliminary safety and efficacy data (pre-Omicron) for both trials in March 2022. However, based on feedback from the FDA regarding adintrevimab’s lack of neutralizing activity against the Omicron BA.2 variant, we paused the submission of an EUA request and we have closed such trials. Although we intend to monitor the evolution of SARS-CoV-2 and the in vitro activity of adintrevimab against predominant variants in the U.S. to identify a potential opportunity for an EUA request for adintrevimab in the event of a susceptible variant, we cannot be certain that adintrevimab will neutralize future variants and that we will submit an EUA for adintrevimab or whether an EUA will be granted if we do submit such request. In January 2024, we nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate, and in FebruaryOctober 2025, we announced completionthat the FDA cleared our IND application for VYD2311 and provided feedback to advance our REVOLUTION clinical program, which is our development program for VYD2311 comprising two clinical trials, DECLARATION and LIBERTY. In December 2025, we initiated DECLARATION, and in February 2026, we announced alignment with the FDA on LIBERTY, each as further described in Part I, Item 1 “Business” of recruitmentthis inAnnual ourReport Phaseon 1Form clinical10-K. trial of VYD2311, as well as positive clinical data for both safety and pharmacokinetics; however,However, we cannot be certain of the current or future development, regulatory or commercialization timelines of such product candidate.VYD2311. Our ability to generate revenue from VYD2311 or any of our futureother product candidates will depend heavily on successfully completing development, obtaining regulatory authorization or approval, obtaining manufacturing supply, capacity and expertise, and eventually commercializing oursuch product candidates.

our ability to successfully work with the FDA or other regulatory authorities to establish streamlined development pathways that would allow us to efficiently periodically introduce new mAb candidates targeting SARS-CoV-2, including willingness of regulators to utilize a correlate of protection (surrogate of clinical efficacy) to understand and quantify the relationship between COVID-19 mAbs and estimated clinical protection for related mAbs derived from the same platform without requiring clinical assessment of every individual SARS-CoV-2 variant;

our ability to align with the FDA or other regulatory authorities as to the design or implementation of our clinical trials, includingand theour useeligibility offor aexpedited correlateregulatory ofreview protectionand (surrogateapproval ofapproaches clinicalthat efficacy)we inmay anpursue immunobridgingfor approachour toproduct a pivotal clinical trialcandidates;

our ability to align with the FDA or other regulatory authorities on the data required to support the regulatory authorization or approvals that we seek for our product candidates, particularly in light of the FDA’s discretion with respect to EUAs in the U.S. in making its determination about whether, based on the totality of scientific evidence available, the known and potential benefits of a product candidate outweigh the known and potential riskscandidates;

If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize PEMGARDA or any other product candidates thatfor which we developreceive regulatory authorization or otherwise may acquire,approval, which would materiallysubstantially harm our business. If we do not maintain regulatory authorization for PEMGARDA or receive and maintain regulatory authorization or approval for VYD2311 or any futureother product candidates we develop or otherwise may acquire, we may not be able to continue our operations.

Because our COVID-19 product candidates represent novel approaches to the prevention and/or treatment of a relatively new disease, there are many uncertainties regarding the development, market acceptance, third-party reimbursement coverage,coverage and commercial potential of our COVID-19 product candidates. We may not be successful in aligning with regulators on an expedited and replicable pathway to SARS-CoV-2 mAb authorization or approval.

COVID-19 is a relatively new disease, and the prevention and treatment of this disease is evolving. Another party may be successful in producing a more efficacious prophylaxis or treatment for COVID-19, which may make it more difficult for us to obtain funding or lead to decreased demand for our product candidates. Other small and large companies may be developing therapies for the prevention and/or treatment of COVID-19, including antibodies, vaccines, antivirals,antivirals and other products. Some of these are being marketed and others are further along in the development and commercialization process than we are and several of these companies have access to larger pools of capital, including government funding, and broader infrastructure that may make them more successful at developing, manufacturing or commercializing their products for the prevention and/or treatment of COVID-19. The success or failure of other companies, or perceived success or failure, may impact our ability to obtain future funding or to successfully commercialize our product candidates for COVID-19 prevention and/or treatment.

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.SARS-CoV-2, the virus that causes COVID-19. PEMGARDA™® (pemivibart) is our first monoclonal antibody (“mAb”) to receive regulatory authorization and was designed to keepexert pacecontinuous withpharmaceutical SARS-CoV-2activity 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. 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 for years to come a variety of effective and safe prevention and treatment options forwith yearsdemonstrated toefficacy come.and safety. By leveraging our capabilities, which we have developed through our experience with adintrevimab and pemivibart and nearlyover 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 potentially expanding into other high-need indications.indications, such as respiratory syncytial virus (“RSV”) and measles.

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.

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,LB.1 and attractive neutralization potency of VYD2311VYD2311, 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 MarchAugust 2025, we announced continued neutralizing activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2 variants XECXEC, LP.8.1 and LP.8.1,XFG, respectively.

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, inIn 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 ofincluding Adimab’s platform technology, while building our internal capabilities.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,inception and through December 31, 2025, we have financed our operations primarily withthrough the sale and issuance of preferred and common stock, including net proceeds of $464.7 million from sales of our preferred stock, with net proceeds of $327.5 million from our initial public offering (“IPO”), and with net proceeds of $39.3$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). After receiving EUA in March 2024, weWe 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.

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

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;

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.

costs of outside consultants and advisors, including their fees and any stock-based compensation;

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 and the advancement of early discovery programs targeting other potential targets such as 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 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.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher and more variable development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Our research and development expenses will increase as we continue advancing VYD2311 through clinical development, particularly as we advance the REVOLUTION clinical trial program, pursue EUA or regulatory approval of our product candidates, and continue to discover and develop additional product candidates.

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

Other income, net consists of interest income earned from our cash,cash and cash equivalents and marketable securities and the net amortization or accretion of premiums and discounts related to our marketable securities.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.

Product revenue, net was $53.4 million and $25.4 million for the yearyears ended December 31, 2024.2025 Thereand was2024, no product revenue, net for the year ended December 31, 2023.respectively. The $25.4$28.0 million increase is primarily the result of increased product sales in 20242025 following the launch of PEMGARDA.PEMGARDA in the second quarter of 2024.

Cost of product revenue was $3.7 million and $1.6 million for the yearyears ended December 31, 2024.2025 Thereand was2024, no cost of product revenue for the year ended December 31, 2023.respectively. The $1.6$2.1 million increase is the result of sales related to PEMGARDA due to an increase in product sales following launchdemand and certain period costs.

The decreaseDecrease in direct costs related to our pemivibart program resulted from $60.2decrease millionof in contract costs for commercial manufacturing, $5.0$13.7 million in contract research costs for our Phase 3 CANOPY clinical trial, and$12.8 $0.2million in contract costs for commercial manufacturing, $1.4 million in nonclinical expenses,costs partiallyand offset by an increase of $0.5$0.7 million in other external expensescosts;

The increaseIncrease in direct costs related tofor our VYD2311VBY329 program resulted from the nomination of ourVBY329 VYD2311as productan RSV mAb candidate in the firstfourth quarter of 20242025, andwith consistedcosts primarilyresulting offrom contract$0.4 manufacturingmillion in external discovery costs, as well as $0.2 million in nonclinical expenses and contract research costs for our Phase 1 clinical trialexpense;

The decreaseDecrease in personnel related costs resulted from $6.6decrease of $6.5 million in headcount-related costs and capitalization of $2.2 million of certain inventory costs which were recorded as research and development costs prior to the EUA of PEMGARDA; and The decreaseDecrease in external discovery-related and other costs resulted from $8.2decrease million in contract manufacturing costs related to our pipeline candidates and $3.7 million in other non-clinical expenses, partially offset by aof $1.2 million increase in other external costs and $0.2$0.4 million in nonclinical costs, partially offset by an increase of $0.5 million in contract manufacturing and $0.1 million in clinical trial expenses.

There was no IPR&D expense recognized for the yearyears ended December 31, 2025 and 2024.

The increaseIncrease in personnel relatedpersonnel-related costs was primarily due to an increase in headcount-related costs,costs includingof an$7.5 increasemillion, partially offset by a decrease in stock-based compensation expense of $2.4$6.2 millionmillion. thatThe 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;

The increaseDecrease in professional and consultant fees wasresulted primarilyfrom duedecrease toof an $11.6$0.6 million increasein relatedsales toand themarketing commercializationcosts ofand PEMGARDA,$0.5 million in insurance costs, partially offset by decreasesincrease of $1.0 million in professional services fees; and Increase in other costs primarily resulted from increase of $0.9 million in conference related costs and $0.7$1.2 million in director and officer insurance premiums and professional service fees, respectively; and The increase in other costs was primarilyemployee related totravel software license costs and related amortization.expense.

Other income was $3.1 million and $7.0 million for the yearyears ended December 31, 2025 and 2024, respectively, consisting primarily of interest earned on our invested cash balances.

Through December 31, 2024,2025, 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, VBY329, and our other product candidates. ToAs date,of December 31, 2025, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, with$327.5 aggregate net proceedsmillion from our IPO in August 20212021, of $327.5 million, and with net proceeds of $39.3$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.

Net cash used in investing activities during the yearyears ended December 31, 2025 and 2024 consisted of $0.2 million and $0.1 millionmillion, respectively, in purchases of property and equipment.

Information regarding risks and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of the 2025 Form 10-K. As of the date of this Quarterly Report on Form 10-Q, there have been no material changes from the risk factors set forth in the 2025 Form 10-K.10-K, other than as described below.

our devotion to delivering protection from serious viral infectious diseases, including our intent to pursue permanent, high quality medical protection from COVID-19 infection for immune-compromised and other vulnerable Americans, 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 measles and respiratory syncytial virus (“RSV”) and measles;

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 fivesix 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 measles and 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 (“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. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies.

The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360bbb-3(b)(1), unless the declarationauthorization is terminated or authorization revoked sooner. PEMGARDAOn isJune authorized30, for2026, useHHS onlyprovided whenadvance notice of the combined national frequencytermination of variantsthe withdeclaration, substantiallywhich reducedwill susceptibilitytake toeffect after a twelve-month transition period ending on June 29, 2027. Consequently, the EUA for PEMGARDA is less than or equalset to 90%, basedterminate on availableJune information29, including2027. variantConsistent susceptibilitywith EUA transition processes, we are in dialogue with the FDA about appropriate next steps for PEMGARDA. We intend to PEMGARDApursue permanent, high quality medical protection from COVID-19 infection for immune-compromised and nationalother variantvulnerable frequencies.Americans.

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 includesincluded approximately 500 additional subjects, in addition to 1,818 total randomized subjects in the initial trial population. In June 2026, we announced completion of enrollment in the upsized DECLARATION clinical trial. Total enrollment of the trial is approximately 2,400 participants. DECLARATION is designed to support potential BLA submission. Depending on recruitment rates following the trial upsizing, top-lineTop-line data from DECLARATION are expectedplanned later 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. In June 2026, we announced initiation and completion of enrollment in LIBERTY. Total enrollment of the trial is approximately 210 participants. The LIBERTY clinical trial is fully dosed, with top-line data anticipated later in the third quarter of 2026.

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 submission 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.

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, withand theexpect goalto ofadvance expeditedVMS063 development with targettoward IND readiness in latethe second half of 2026. Through our proprietary technology platform, we continue to investigate additional mAbs for protection and treatment of other important infectious diseases.

Since our inception and through MarchJune 31,30, 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$92.1 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$85.8 million for the threesix months ended MarchJune 31,30, 2026. As of MarchJune 31,30, 2026, we had an accumulated deficit of $995.9$1,040.3 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:

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

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

Because of the numerous risks and uncertainties associated with pharmaceutical product development and emergence of SARS-CoV-2 variants, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. We may never obtain regulatory authorization or approval for any of our product candidates other than PEMGARDA.the EUA for PEMGARDA, which is set to terminate on June 29, 2027. Even with product sales, we may not become profitable. 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.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher and more variable development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Our research and development expenses will increase as we continue advancing VYD2311 through clinical development, particularly as we advance the REVOLUTION clinical program, pursue EUA or regulatory approval of our product candidates, and continue to discover and develop additional product candidates.

our ability to obtain and maintain patent, trademark and trade secret protection and regulatory exclusivity for our product candidates, if and when approved, and otherwise protectingprotect our rights in our intellectual property portfolio;

timely receipt of regulatory authorizations or approvals from applicable regulatory authoritiesauthorities, including our eligibility for any expedited regulatory review and approval approaches that we may pursue for our product candidates;

Our selling, general and administrative expenses will increase in the future as our business expands and we increase our headcount to support the expected growth in our research and development activities and the commercialization of any authorized or approved product candidates, such as PEMGARDA.PEMGARDA while it remains authorized. We also anticipate increased expenses associated with operating as a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services, director and officer insurance premiums, and investor and public relations costs. 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 MarchJune 31,30, 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.

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 MarchJune 31,30, 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.

Comparison of the three months ended MarchJune 31,30, 2026 and 2025

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025:

Product revenue, net was $13.7$14.3 million and $11.3$11.8 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The $2.4$2.5 million increase is the result of increased product sales of PEMGARDA due to an increase in product demand.

Cost of product revenue was $1.0$1.3 million and $0.8$0.7 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The $0.2$0.6 million increase is the result of increased PEMGARDA sales and certain period costs.

(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 clinicalpreclinical development.

Research and development expenses were $30.7$29.4 million for the three months ended MarchJune 31,30, 2026, compared to $10.6$9.6 million for the three months ended MarchJune 31,30, 2025. The $20.1$19.8 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$0.4 million in contract research costs for ourmanufacturing, Phase 3 CANOPY clinical trial, $0.5$0.1 million in nonclinical expenses and $0.1 million in contractexternal discovery-related and other costs for commercial manufacturing;

Increase in direct costs related to our VYD2311 program resulted from an increase of $21.5$18.5 million in contract research costs for our Phase 3 DECLARATION and LIBERTY clinical trialtrials, and $0.4$0.5 million in external discovery-related and other costs, partially offset by a decrease ofand $0.3 million in contract costs for commercial manufacturing and $0.3 million in nonclinical expenses;

Increase in direct costs forrelated to our VMS063VBY329 program resulted from the nomination of VMS063VBY329 as aan measlesRSV mAb candidate in the secondfourth quarter of 2026,2025, withand costsconsist resultingprimarily fromof external discovery-related and other costs;

DecreaseIncrease in direct costspersonnel related to our early-stage programscosts resulted from aan decreaseincrease ofin externalheadcount-related costs; and External discovery-related and other costs; remained relatively consistent between periods.

Selling, general and administrative expenses were $25.1$29.5 million for the three months ended MarchJune 31,30, 2026, compared to $16.8$16.6 million for the three months ended MarchJune 31,30, 2025. The $8.3$12.9 million increase in selling, general and administrative expenses was primarily due to the following:

Increase in professional and consultant fees primarily resulted from an increase of $3.4$4.2 million in professional service fees and $1.7$3.5 million related to sales and marketing costs, partially offset by a decrease of $0.1 million in insurance costs; and Increase in other costs primarily resulted from an increase of $0.7$0.5 million in employee related travel expense, $0.3$0.2 million in conferencesoftware relatedlicensing costs and $0.2 million in technologyrent related costs.expense.

Other income, net was $1.7$1.4 million and $0.6$0.4 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively, consisting primarily of interest earned on our invested cash balances. The $1.1$1.0 million increase in other income, net was primarily due to an increase in cash invested.