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Invivyd, Inc.

Invivyd, Inc.IVVD決算レポート

Nasdaq · ヘルスケア · 生物製品（診断物質を含まない）

Invivyd, Inc. is a clinical-stage biopharmaceutical company focused on developing broadly neutralizing antibody therapies to prevent and treat serious viral infectious diseases. Its core research and development pipeline targets high-burden respiratory pathogens including respiratory syncytial virus, catering to unmet medical needs of global patient groups.

What changed in Invivyd, Inc.'s 10-K — 2024 vs 2025

Top changes in Invivyd, Inc.'s 2025 10-K

752 paragraphs added · 726 removed · 564 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

201 edited+52 added−42 removed279 unchanged
On February 4, 2020, the Secretary of HHS determined pursuant to his authority under Section 564 of the FDCA that COVID-19 represented a public health emergency with significant potential to affect national security or the health and security of U.S. citizens living abroad.
On February 4, 2020, the Secretary of HHS determined pursuant to his authority under Section 564 of the FDCA that COVID-19 represented a public health emergency with significant potential to affect national security or the health and security of U.S. citizens living abroad.
Although the Biden Administration allowed the COVID-19 public health emergency declared by HHS under Section 319 of the PHS Act to expire on May 11, 2023, this did not impact the FDA’s ability to authorize COVID-19 drugs and biological products for emergency use pursuant to the relevant declaration under Section 564 of the FDCA.
Although the Biden Administration allowed the COVID-19 public health emergency declared by HHS under Section 319 of the PHS Act to expire on May 11, 2023, this did not impact the FDA’s ability to authorize COVID-19 drugs and biological products for emergency use pursuant to the relevant declaration under Section 564 of the FDCA.
In all cases, again, the clinical studies are conducted in accordance with cGCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
In all cases, again, clinical studies are conducted in accordance with cGCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
Failure to comply with the requirements of GDPR may result in fines of up to 20,000,000 Euros or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties; 31 • The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to payments, ownership and investment interests, or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals. • In the European Union, interactions between pharmaceutical companies and physicians are also governed by strict laws, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct.
Failure to comply with the requirements of GDPR may result in fines of up to 20,000,000 Euros or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties; • The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to payments, ownership and investment interests, or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals. • In the European Union, interactions between pharmaceutical companies and physicians are also governed by strict laws, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct.
Additionally, we may be subject to state laws that require pharmaceutical companies to comply with the federal government’s and/or pharmaceutical industry’s voluntary compliance guidelines and state laws that require drug and biologics manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, as well as state and foreign laws governing the privacy and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA.
Additionally, we may be subject to state laws that require pharmaceutical companies to comply with the federal government’s and/or pharmaceutical industry’s voluntary compliance guidelines and state laws that require drug and biologics manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, as well as state and foreign laws governing the privacy and security of health information, many of which differ 33 from each other in significant ways and often are not preempted by HIPAA.
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.
Such products are generally eligible for accelerated assessment and may also benefit from different types of fast-track approvals, such as a conditional marketing authorization or a marketing authorization under 27 exceptional circumstances granted on the basis of less comprehensive clinical data than normally required (respectively in the likelihood that the sponsor will provide such data within an agreed timeframe or when comprehensive data cannot be obtained even after authorization).
Such products are generally eligible for accelerated assessment and may also benefit from different types of fast-track approvals, such as a conditional marketing authorization or a marketing authorization under exceptional circumstances granted on the basis of less comprehensive clinical data than normally required (respectively in the likelihood that the sponsor will provide such data within an agreed timeframe or when comprehensive data cannot be obtained even after authorization).
Penalties for a False Claims Act violation may include three times the actual damages sustained by the government, plus significant civil penalties for each separate false or fraudulent claim, and the potential for exclusion from participation in federal healthcare programs. • In the European Union, the advertising and promotion of products are subject to laws governing promotion of medicinal products, interactions with physicians, misleading and comparative advertising and unfair commercial practices.
Penalties for a False Claims Act violation may include three times the actual damages sustained by the government, plus significant civil penalties for each separate false or fraudulent claim, and the potential for exclusion from participation in federal healthcare programs. 32 • In the European Union, the advertising and promotion of medicinal products are subject to laws governing promotion of medicinal products, interactions with physicians, misleading and comparative advertising and unfair commercial practices.
Importantly, all therapeutic mAbs targeting SARS-CoV-2 previously authorized, prior to the EUA for PEMGARDA, have had their authorizations revoked in the U.S. due to loss of activity as new variants emerged. Current Approaches for Prevention and Treatment of COVID-19 and Their Limitations In response to the COVID-19 pandemic, multiple therapeutics have been discovered, developed and authorized at an unprecedented speed.
Importantly, all therapeutic mAbs targeting SARS-CoV-2 previously authorized, prior to the EUA for PEMGARDA, have had their authorizations revoked in the U.S. due to loss of activity as new variants emerged. 8 Current Approaches for Prevention and Treatment of COVID-19 and Their Limitations In response to the COVID-19 pandemic, multiple therapeutics have been discovered, developed and authorized at an unprecedented speed.
PEMGARDA was engineered from adintrevimab, our investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC and LP.8.1.
PEMGARDA was engineered from adintrevimab, our investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, LP.8.1 and XFG.
We are obligated to pay Adimab an annual fee of single digit millions on each of the first four anniversaries of the Adimab Platform Transfer Agreement Effective Date, which allows us to receive material improvements to the platform technology, including materially improved antibody optimization libraries, updates that provide new functionality to the platform, and software upgrades, from Adimab through June 2027.
We are obligated to pay Adimab an annual fee of single digit millions on each of the first four anniversaries of the Adimab Platform Transfer Agreement Effective Date, which allows us to receive material improvements to the platform 16 technology, including materially improved antibody optimization libraries, updates that provide new functionality to the platform, and software upgrades, from Adimab through June 2027.
In addition to infectious disease, our leaders’ combined experience spans a broad set of therapeutic areas, such as oncology, organ transplant, rare disease, orphan disease and immunology which provides a diverse perspective and skill set that serve our patient communities. Based on our team’s collective track record, we executed on the clinical, regulatory, and manufacturing plan for PEMGARDA.
In addition to infectious disease, our leaders’ combined experience spans a broad set of therapeutic areas, such as oncology, organ transplant, rare disease, orphan disease and immunology, which provides a diverse perspective and skill set to serve our patient communities. Based on our team’s collective track record, we executed on the clinical, regulatory, and manufacturing plan for PEMGARDA.
The FDA, therefore, 8 may continue to issue new EUAs going forward when criteria for issuance are met. Such authority arises from the determinations and declarations issued pursuant to Section 564 of the FDCA, including the EUA declaration on March 27, 2020, which remains in effect unless or until the Secretary of HHS terminates such declaration.
The FDA therefore may continue to issue new EUAs going forward when criteria for issuance are met. Such authority arises from the determinations and declarations issued pursuant to Section 564 of the FDCA, including the EUA declaration on March 27, 2020, which remains in effect unless or until the Secretary of HHS terminates such declaration.
The royalty term will expire for each product on a country-by-country 14 basis upon the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of any patent claiming composition of matter or method of making or using any antibody identified or optimized under the Adimab Collaboration Agreement in such country.
The royalty term will expire for each product on a country-by-country basis upon the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of any patent claiming composition of matter or method of making or using any antibody identified or optimized under the Adimab Collaboration Agreement in such country.
The overall ten-year period will be extended to a maximum of 11 years if, during the first eight years of those 10 years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
The overall ten-year period will be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
See “Risk Factors—Risks Related to Our Intellectual Property.” We actively seek to protect our proprietary technology, inventions and other intellectual property that is commercially important to the development of our business by a variety of means, such as seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties.
See “Risk Factors—Risks Related to Our Intellectual Property.” 18 We actively seek to protect our proprietary technology, inventions and other intellectual property that is commercially important to the development of our business by a variety of means, such as seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties.
Under the Adimab Collaboration Agreement, we have an exclusive option, on a program-by-program basis, to obtain licenses and assignments to commercialize selected products containing or comprising antibodies directed against the applicable target, which option may be exercised upon the payment of a specified option fee for each program.
Under the Adimab Collaboration Agreement, 15 we have an exclusive option, on a program-by-program basis, to obtain licenses and assignments to commercialize selected products containing or comprising antibodies directed against the applicable target, which option may be exercised upon the payment of a specified option fee for each program.
Under the platform transfer agreement, we were granted the right under certain intellectual property of Adimab to practice certain elements of Adimab’s platform technology, including B-cell cloning using Adimab’s proprietary yeast cell lines and other antibody optimization libraries, trade secrets, protocols and software of Adimab, to discover, engineer and optimize antibodies.
Under the Adimab Platform Transfer Agreement, we were granted the right 14 under certain intellectual property of Adimab to practice certain elements of Adimab’s platform technology, including B-cell cloning using Adimab’s proprietary yeast cell lines and other antibody optimization libraries, trade secrets, protocols and software of Adimab, to discover, engineer and optimize antibodies.
Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events should occur.
Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events occur.
A complete response letter usually describes all of the specific deficiencies in the BLA identified by the FDA. 21 The complete response letter may require additional clinical data and/or one or more additional pivotal Phase 3 clinical trials, and/or other significant and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing.
A complete response letter usually describes all of the specific deficiencies in the BLA identified by the FDA. The complete response letter may require additional clinical data and/or one or more additional pivotal Phase 3 clinical trials, and/or other significant and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing.
As a condition for approval, the FDA may also require additional trials or nonclinical testing as a Phase 4 commitment. Product approvals may be withdrawn for non-compliance with regulatory requirements if problems occur following launch, or if the FDA determines that the product is no longer safe or effective.
As a condition for approval, the FDA may also 23 require additional trials or nonclinical testing as a Phase 4 commitment. Product approvals may be withdrawn for non-compliance with regulatory requirements if problems occur following launch, or if the FDA determines that the product is no longer safe or effective.
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.
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 (“CMC”) development, testing and clinical and commercial manufacturing activities.
Systems need to be put in place to record and evaluate adverse events reported by healthcare providers and patients and to 23 assess product complaints. An increase in severity or new adverse events can result in labeling changes or product recalls. Defects in manufacturing of commercial products can result in product recalls. Sales and Marketing.
Systems need to be put in place to record and evaluate adverse events reported by healthcare providers and patients and to assess product complaints. An increase in severity or new adverse events can result in labeling changes or product recalls. Defects in manufacturing of commercial products can result in product recalls. Sales and Marketing.
The ACA is intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency 32 requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical manufacturers and impose additional health policy reforms.
The ACA is intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical manufacturers and impose additional health policy reforms.
The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information 24 contained in personal health records. Enforcement by the FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or enforcement actions.
The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records. Enforcement by the FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or enforcement actions.
Once a CTA is approved in accordance with the applicable requirements, clinical trial development may proceed. The requirements and processes governing the conduct of clinical trials are overall harmonized at the European Union level. In all cases, the clinical studies are conducted in accordance with cGCP, applicable regulatory requirements and applicable ethical principles.
Once a CTA is approved in accordance with the applicable requirements, clinical trial development may proceed. The requirements and processes governing the conduct of clinical trials are overall harmonized at the European Union level. In all cases, the clinical trials are conducted in accordance with cGCP, applicable regulatory requirements and applicable ethical principles.
Per the PEMGARDA Fact Sheet for Healthcare Providers, medical conditions or treatments that may result in moderate-to-severe immune compromise and an inadequate immune response to COVID-19 vaccination include: • Active treatment for solid tumor and hematologic malignancies • Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia) • Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy) • Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome) • Advanced or untreated HIV infection (people with HIV and CD4 cell counts 3 , history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer 10 chemotherapeutic agents classified as severely immunosuppressive, and biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents) PEMGARDA is not authorized for use for treatment of COVID-19, or for post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.
Per the PEMGARDA Fact Sheet for Healthcare Providers, medical conditions or treatments that may result in moderate-to-severe immune compromise and an inadequate immune response to COVID-19 vaccination include: • Active treatment for solid tumor and hematologic malignancies • Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia) • Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy) • Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome) • Advanced or untreated HIV infection (people with HIV and CD4 cell counts 3 , history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, and biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents) PEMGARDA is not authorized for the treatment of COVID-19, Long COVID, or PVS, or for post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.
In the European Union, marketing authorization for a medicinal product can be obtained through a centralized procedure, mutual recognition procedure, decentralized procedure, or the national procedure of an individual European Union Member State. A marketing authorization, irrespective of its route to authorization, may be granted only to an applicant established in the European Union.
In the European Union, marketing authorization for a medicinal product can be obtained through a centralized 28 procedure, mutual recognition procedure, decentralized procedure, or the national procedure of an individual European Union Member State. A marketing authorization, irrespective of its route to authorization, may be granted only to an applicant established in the European Union.
Following this determination, on March 27, 2020, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, subject to the terms of any authorization issued by the FDA.
Following this determination, on March 27, 2020, the Secretary of HHS declared that 24 circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, subject to the terms of any authorization issued by the FDA.
On the PHP Effective Date, we and PHP entered into the first work order under the PHP MSA (the “PHP Work Order”), pursuant to which PHP agreed to 15 advise and counsel us regarding clinical development and regulatory matters with respect to our product candidates.
On the PHP Effective Date, we and PHP entered into the first work order under the PHP MSA (the “PHP Work Order”), pursuant to which PHP agreed to advise and counsel us regarding clinical development and regulatory matters with respect to our product candidates.
The key competitive factors affecting the success of PEMGARDA and our other product candidates, if 16 authorized or approved, are likely to be their efficacy, safety, convenience, price and the availability of reimbursement from government and other third-party payors.
The key competitive factors affecting the success of PEMGARDA and our other product candidates, if authorized or approved, are likely to be their efficacy, safety, convenience, price and the availability of reimbursement from government and other third-party payors.
The product development and approval processes require substantial time and effort, and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.
The product 22 development and approval processes require substantial time and effort, and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.
Failure to comply with applicable U.S. requirements at any time during the product development process, authorization or approval process or after authorization or approval may subject an applicant or manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity.
Failure to comply with applicable U.S. requirements at any time during the product development process, authorization or approval process or after authorization or approval may subject an applicant or 25 manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity.
Biosimilarity to an approved reference product requires that there be no differences in conditions of use, route of administration, dosage form and strength and no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency.
Biosimilarity to an approved reference product requires that there be no differences in conditions of use, route of administration, dosage form and strength and no clinically meaningful differences between the biological product and the reference product in terms of safety, purity 27 and potency.
The governments of the European Union Member States influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers.
The governments of the European Union Member States influence the price of pharmaceutical products through their 31 pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers.
We consider our relationship with our employees to be strong. Our human capital resources objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants, and ensuring we have a diverse and inclusive team.
We consider our relationship with our employees to be strong. 35 Our human capital resources objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants, and ensuring we have a diverse and inclusive team.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use received EUA from the FDA in March 2024 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.
PEMGARDA (pemivibart) injection (4500 mg), for IV use received EUA from the FDA in March 2024 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.
Each clinical trial must be conducted under a protocol which details, among other things, the study objectives and parameters for monitoring safety and the efficacy criteria, if any, to be evaluated.
Each clinical trial must be conducted under a protocol which details, among other things, the study objectives and parameters for 20 monitoring safety and the efficacy criteria, if any, to be evaluated.
After the EUA is no longer valid, the product is no longer considered to be 22 legally marketed and one of the FDA’s non-emergency premarket pathways would be necessary to resume or continue distribution of the subject product.
After the EUA is no longer valid, the product is no longer considered to be legally marketed and one of the FDA’s non-emergency premarket pathways would be necessary to resume or continue distribution of the subject product.
Further, any failure to comply with applicable laws and regulations could have a material negative impact on our ability to successfully develop and commercialize product candidates, and therefore on our financial performance.
Further, any failure to comply with applicable laws and regulations could have a material negative impact on our ability to successfully develop and commercialize product candidates and our financial performance.
Furthermore, the SARS-CoV-2 RBD is a well validated target and mechanism of action for mAbs with robust safety and efficacy data generated across the class.
Furthermore, the SARS-CoV-2 RBD is a well validated target and mechanism of action for mAbs with robust safety and efficacy 9 data generated across the class.
Our Strategy Our strategy is to discover, develop and commercialize differentiated product candidates that could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications. In order to achieve this goal, our strategy involves execution of the following key elements: • Continued execution of PEMGARDA commercial launch in the U.S.
Our Strategy Our strategy is to discover, develop and commercialize differentiated 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. In order to achieve this goal, our strategy involves execution of the following key elements: • Continued execution of PEMGARDA commercial launch in the U.S.
The current FDA performance goals provide that the FDA should review and act on 90% of standard new molecular entity New Drug Applications and original BLAs within 10 months after the 60-day filing date. The FDA may miss or extend these goal actions dates under certain circumstances, including if there is a major amendment to the application.
The current FDA performance goals provide that the FDA should review and act on 90% of standard new molecular entity New Drug Applications and original BLAs within ten months after the 60-day filing date. The FDA may miss or extend these goal actions dates under certain circumstances, including if there is a major amendment to the application.
Such scrutiny has resulted in several recent congressional inquiries, executive orders and proposed and enacted federal and state legislation and regulation designed to, among other things, bring more transparency to drug pricing, review 33 the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare and reform government program reimbursement methodologies for pharmaceutical products.
Such scrutiny has resulted in several recent congressional inquiries, executive orders and proposed and enacted federal and state legislation and regulation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare and Medicaid and reform government program reimbursement methodologies for pharmaceutical products.
The conduct of the nonclinical tests must comply with federal regulations and requirements, including cGLP and the Animal Welfare Act, which are enforced by the Department of Agriculture.
The conduct of the nonclinical tests must comply with applicable federal regulations and requirements, including cGLP and the Animal Welfare Act, which are enforced by the Department of Agriculture.
The protocol is submitted to the FDA as part of the IND and reviewed by the agency; • submission to the FDA of a Biologics License Application (“BLA”) for marketing approval that includes substantive evidence of safety, purity, potency, and efficacy from results of nonclinical testing and clinical trials; • satisfactory completion of a potential FDA pre-licensure inspection prior to BLA approval of the manufacturing facility or facilities where the biological product candidate is produced to assess compliance with cGMP to assure that the facilities, methods and controls are adequate to preserve the biological product candidate’s identity, strength, quality and purity; • potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the BLA; • potential FDA advisory committee meeting to elicit expert input on critical issues, including a vote by external committee members; and • FDA review and approval, or licensure, of the BLA and payment of associated user fees, when applicable.
The protocol is submitted to the FDA as part of the IND and reviewed by the agency; • submission to the FDA of a BLA for marketing approval that includes substantive evidence of safety, purity, potency, and efficacy from results of nonclinical testing and clinical trials; • satisfactory completion of a potential FDA pre-licensure inspection prior to BLA approval of the manufacturing facility or facilities where the biological product candidate is produced to assess compliance with cGMP to assure that the facilities, methods and controls are adequate to preserve the biological product candidate’s identity, strength, quality and purity; • potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the BLA; • potential FDA advisory committee meeting to elicit expert input on critical issues, including a vote by external committee members; and • FDA review and approval, or licensure, of the BLA and payment of associated user fees, when applicable.
Vaccines for pre-exposure prophylaxis of COVID-19 have not demonstrated adequate efficacy against symptomatic disease or more significant outcomes in the immunocompromised population. This vulnerable population that is unlikely to mount an adequate response to vaccination has been left with no therapeutic options for prevention of COVID-19 outside of pemivibart.
Vaccines for pre-exposure prophylaxis of COVID-19 have not demonstrated adequate efficacy against symptomatic disease or more significant outcomes in the immunocompromised population. This vulnerable population that is unlikely to mount an adequate response to vaccination has been left with no therapeutic options for prevention of COVID-19 outside of PEMGARDA.
In addition, we may obtain health information from third parties, including research institutions from which we obtain clinical trial data, that are subject to privacy and security requirements under the federal Health Insurance Portability and Accountability Act, as amended by the Health Information Technology for Economic and Clinical Health Act, and the regulations promulgated thereunder (collectively, “HIPAA”).
In addition, we may obtain health information from third parties, including research institutions from which we obtain clinical trial data, that are subject to privacy and security requirements under the federal Health Insurance Portability and Accountability Act, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the regulations promulgated thereunder (collectively, “HIPAA”).
Further, each clinical trial must be reviewed and approved by an independent IRB at or servicing each institution at which the clinical 19 trial will be conducted.
Further, each clinical trial must be reviewed and approved by an independent IRB at or servicing each institution at which the clinical trial will be conducted.
HIPAA imposes privacy and security obligations on covered entity health care providers, health plans, and health care clearinghouses, as well as their “business associates” – certain persons or entities that create, receive, maintain, or transmit protected health information in connection with providing a specified service or performing a function for or on behalf of a covered entity.
HIPAA imposes privacy and security obligations on covered entity health care providers, health plans, and health care clearinghouses, as well as their “business associates” (i.e., certain persons or entities that create, receive, maintain, or transmit protected health information in connection with providing a specified service or performing a function for or on behalf of a covered entity).
The IRA also prohibits Medicare Part D plans from imposing cost-sharing for certain vaccines that are recommended by the Advisory Committee on Immunization Practices. Congress continues to examine various policy proposals that may result in pressure on the prices of prescription drugs in the government health benefit programs.
The IRA also prohibited Medicare Part D plans from imposing cost-sharing for certain vaccines that are recommended by the Advisory Committee on Immunization Practices. Congress continues to examine various policy proposals that may result in pressure on the prices of prescription drugs in the government health benefit programs.
The FDA may refer applications for novel products or products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.
The FDA may refer applications for novel products or products that present difficult questions of safety or efficacy to an advisory committee, which is typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.
A priority review means that the goal for the FDA’s review of an application is six months from the 60-day filing date rather than the standard goal of 10 months from the 60-day filing date under current PDUFA performance goals. Products that receive fast-track designation are eligible to receive a priority review if the relevant criteria are met.
A priority review means that the goal for the FDA’s review of an application is six months from the 60-day filing date rather than the standard goal of ten months from the 60-day filing date under current PDUFA performance goals. Products that receive Fast Track designation are eligible to receive a priority review if the relevant criteria are met.
Failure to timely pay a Part B or Part D inflation rebate for a product subject to these programs is subject to a civil monetary penalty.
Failure to timely pay a Part B or Part D inflation rebate for a product 34 subject to these programs is subject to a civil monetary penalty.
We expect to leverage this experience to support our anticipated follow-on programs. Background on COVID-19 and SARS-CoV-2 Variants COVID-19, the disease caused by SARS-CoV-2 and its variants, gave rise to a global pandemic in 2020. SARS-CoV-2 continues to cause infections and disease. COVID-19 remains a significant global health problem.
We expect to leverage this experience to support our anticipated follow-on programs, including VYD2311. Background on COVID-19 and SARS-CoV-2 Variants COVID-19, the disease caused by SARS-CoV-2 and its variants, gave rise to a global pandemic in 2020. SARS-CoV-2 continues to cause infections and disease. COVID-19 remains a significant global health problem.
The IRA further makes several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs, and a change in manufacturer liability under the program for an applicable drug that could negatively affect the profitability of our product candidates.
The IRA further made several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs, and a change in manufacturer liability under the program for an applicable drug that could negatively affect the profitability of our product candidates.
Under the Prescription Drug User Fee Act, as amended (the “PDUFA”), each BLA may be accompanied by a significant user fee. Under federal law, the submission of most applications is subject to an application user fee. The sponsor of an approved application is also subject to an annual program fee.
Under the Prescription Drug User Fee Act, as amended (the “PDUFA”), each BLA may be accompanied by significant user fees. Under federal law, the submission of most applications is subject to an application user fee. The sponsor of an approved application is also subject to an annual program fee.
Adimab Platform Transfer Agreement In September 2022 (the “Adimab Platform Transfer Agreement Effective Date”), we entered into a Platform Transfer Agreement with Adimab (the “Adimab Platform Transfer Agreement”), under which we were granted the right under certain intellectual property of Adimab to practice certain elements of Adimab’s platform technology, including B-cell cloning using Adimab’s proprietary yeast cell lines and other antibody optimization libraries, trade secrets, protocols and software of Adimab, to discover, engineer and optimize antibodies.
Adimab Platform Transfer Agreement In September 2022 (the “Adimab Platform Transfer Agreement Effective Date”), we entered into the Adimab Platform Transfer Agreement under which we were granted the right under certain intellectual property of Adimab to practice certain elements of Adimab’s platform technology, including B-cell cloning using Adimab’s proprietary yeast cell lines and other antibody optimization libraries, trade secrets, protocols and software of Adimab, to discover, engineer and optimize antibodies.
The American Rescue Plan Act of 2021 eliminated the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s AMP, for single-source and innovator multiple-source drugs, as of January 1, 2024.
The American Rescue Plan Act of 2021 eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s AMP, for single-source and innovator multiple-source drugs, as of January 1, 2024.
During the additional two-year period of market exclusivity, a generic or biosimilar marketing authorization can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar product can be marketed until the expiration of the market exclusivity.
During the additional two-year period of market exclusivity, a generic or biosimilar marketing authorization can be submitted and authorized, and the innovator’s data may be referenced, but no generic or biosimilar product can be marketed 29 until the expiration of the market exclusivity.
On April 26, 2023, the European Commission published its proposal to revise the European Union pharmaceutical legislation, consisting of a new Directive and a new Regulation, which would revise and replace the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicinal products for pediatric use and on orphan medicinal products (Regulation 1901/2006 and Regulation 141/2000/EC, respectively).
On April 26, 2023, the European Commission published its proposal to revise the European Union pharmaceutical legislation (the “EU Pharma Package”), consisting of a new Directive and a new Regulation, which would revise and replace the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicinal products for pediatric use and on orphan medicinal products (Regulation 1901/2006 and Regulation 141/2000, respectively).
Unlike the centralized authorization procedure, the decentralized marketing authorization procedure requires a separate application to, and leads to separate approval by, the authorities of each European Union Member State in which the product is to be marketed.
Unlike the centralized authorization procedure, the decentralized marketing authorization procedure requires a separate application to, and leads to separate authorizations by, the authorities of each European Union Member State in which the product is to be marketed.
Medicines authorized with the results of studies from a PIP included in the product information are eligible for an extension of their supplementary protection certificate by six months, even when the results of the studies are negative. Scientific advice and protocol assistance at the EMA are free of charge for questions relating to the development of pediatric medicines.
Medicinal products authorized with the results of studies from a PIP included in the product information are eligible for an extension of their supplementary protection certificate by six months, even when the results of the studies are negative. Scientific advice and protocol assistance at the EMA are free of charge for questions relating to the development of pediatric medicinal products.
The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products, which is prohibited in the European Union, is governed by the national anti-bribery laws of the European Union Member States, as described below. Violation of these laws could result in substantial fines and imprisonment.
The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products, which is prohibited in the European Union, is governed by the national anti-bribery laws of the European Union Member States. Violation of these laws could result in substantial fines and imprisonment.
As the SARS-CoV-2 virus evolves over time, we anticipate periodically introducing new mAb candidates, an approach that could be analogous to the periodic updates made to influenza and COVID-19 vaccines. Beyond PEMGARDA and VYD2311, we have additional anti-SARS-CoV-2 mAb candidates in discovery and pre-clinical characterization.
As the SARS-CoV-2 virus evolves over time, we anticipate periodically introducing new mAb candidates, an approach that could be analogous to the periodic updates made to influenza and COVID-19 vaccines. Beyond PEMGARDA and VYD2311, we have additional anti-SARS-CoV-2 mAb candidates in discovery and preclinical characterization.
Key elements that we believe differentiate our approach include: • Recognition of the importance of broadly neutralizing antibodies with a reduced risk of viral escape: From the outset of our COVID-19 program, we chose to identify and engineer mAbs with a high potential to resist SARS-CoV-2 variant escape.
Key elements that we believe differentiate our approach include: • Recognition of the importance of broadly neutralizing antibodies with a reduced risk of viral escape: From the outset of our COVID-19 program, we have chosen to identify and engineer mAbs with a high potential to resist SARS-CoV-2 variant escape.
Where applicable, we specifically engineer our antibodies, for example to extend their half-lives or modify their Fc-mediated innate immune effector function. • Expedited path to the clinic and market: In order to deliver new mAb products in a rapid and timely manner to patients at risk, we believe that new, expedited approaches and pathways are needed across nonclinical, clinical and CMC development.
Where applicable, we specifically engineer our antibodies, such as to extend their half-lives or modify their Fc-mediated innate immune effector function. • Expedited path to the clinic and market: In order to deliver new mAb products in a rapid and timely manner to patients at risk, we believe that new, expedited approaches and pathways are needed across nonclinical, clinical and CMC development.
The IRA, among other things, establishes a Medicare Part B inflation rebate scheme, under which, generally speaking, manufacturers will owe rebates if a reportable average sales price of an eligible Part B rebatable drug, not including certain vaccines, increases faster than the pace of inflation.
The IRA, among other things, established a Medicare Part B inflation rebate scheme, under which, generally speaking, manufacturers owe rebates if a reportable average sales price of an eligible Part B rebatable drug, not including certain vaccines, increases faster than the pace of inflation.
Development Process The process required by the FDA before a biological product candidate may be marketed in the U.S. generally involves the following: • completion of nonclinical laboratory tests and animal studies according to current Good Laboratory Practices (“cGLP”) and applicable requirements for the humane use of laboratory animals or other applicable regulations; • manufacture and preparation of clinical trial material in accordance with applicable current Good Manufacturing Practices (“cGMP”); 18 • submission to the FDA of an Investigational New Drug Application (“IND”), which contains, among other data and information, nonclinical testing results and provides a basis for the FDA to conclude that there is an adequate basis for testing the investigational product in humans.
Development Process The process required by the FDA before a biological product candidate may be marketed in the U.S. generally involves the following: • completion of nonclinical laboratory tests and animal studies according to current Good Laboratory Practices (“cGLP”) and applicable requirements for the humane use of laboratory animals or other applicable regulations; • manufacture and preparation of clinical trial material in accordance with applicable current Good Manufacturing Practices (“cGMP”); • submission to the FDA of an IND, which contains, among other data and information, nonclinical testing results and provides a basis for the FDA to conclude that there is an adequate basis for testing the investigational product in humans.
We have devoted significant resources to the manufacture of PEMGARDA and VYD2311, and we believe we have secured sufficient supply to meet demand for PEMGARDA and anticipated initial demand for VYD2311, if authorized or approved.
We have devoted significant resources to the manufacture of PEMGARDA and VYD2311, and we believe we have secured sufficient supply to meet demand for PEMGARDA and anticipated initial demand for VYD2311, if approved.
Review and Approval Processes After the completion of clinical trials of a biological product candidate, FDA approval of a BLA must be obtained before commercial marketing of the product. The BLA must include results of product development, laboratory and animal studies, clinical trials, information on the manufacture and composition of the product, proposed labeling and other relevant information.
Review and Approval Processes After the completion of clinical trials of a biological product candidate, FDA approval of a BLA must be obtained before commercial marketing of the product. The BLA must include results of product development, nonclinical studies, clinical trials, information on the manufacture and composition of the product, proposed labeling and other relevant information.
Since July 2020, we are party to an assignment and license agreement with Adimab under which Adimab assigned to us its rights to all existing coronavirus antibodies controlled by it and their derivatives, including adintrevimab.
Since July 2020, we are party to an assignment and license agreement with Adimab (the “Adimab Assignment Agreement”) under which Adimab assigned to us its rights to all existing coronavirus antibodies controlled by it and their derivatives, including adintrevimab.
This route is optional for certain other products, including medicinal products that are of significant therapeutic, scientific or technical innovation, or whose authorization would be in the interest of public or animal health at European Union level.
This route is optional for certain other products, including medicinal products that are of significant therapeutic, scientific or technical innovation, or whose authorization would be in the interest of patients’ health at European Union level.
Any U.S. non-provisional patent applications or foreign patent applications timely filed based upon 17 these patent applications, if issued, are expected to expire in 2043, without taking into account any possible patent term adjustment or extension.
These patent applications and any additional U.S. non-provisional patent applications or foreign patent applications timely filed based upon these patent applications, if issued, are expected to expire in 2043, without taking into account any possible patent term adjustment or extension.
The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing.
The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA may be filed under protest or resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing.
At this time none of these products, other than PEMGARDA, are authorized for use in prevention or treatment of COVID-19 in the U.S. due to loss of activity as new variants emerged.
At this time, none of these products are authorized for the treatment of COVID-19 in the U.S. and, other than PEMGARDA, none are authorized for prevention in the U.S., due to loss of activity as new variants emerged.
While reserving all rights under the Adimab Assignment Agreement and the applicable law, through December 31, 2024, we made aggregate royalty payments of $0.5 million. Unless earlier terminated, the Adimab Assignment Agreement remains in effect until the expiration of the last-to-expire Royalty Term for any and all Products.
While reserving all rights under the Adimab Assignment Agreement and the applicable law, through December 31, 2025, we made aggregate royalty payments of $2.5 million. Unless earlier terminated, the Adimab Assignment Agreement remains in effect until the expiration of the last-to-expire Royalty Term for any and all Products.
VYD2311 leverages the same antibody backbone as pemivibart, our investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, our investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.
VYD2311 leverages the same antibody backbone as pemivibart, our investigational mAb granted EUA in the U.S. for the pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients, and adintrevimab, our investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.
Through December 31, 2024, we had made aggregate payments of $7.0 million to Adimab under the Adimab Platform Transfer Agreement. Population Health Partners In November 2022 (the “PHP Effective Date”), we entered into a Master Services Agreement with Population Health Partners, L.P.
Through December 31, 2025, we had made aggregate payments of $9.0 million to Adimab under the Adimab Platform Transfer Agreement. Population Health Partners In November 2022 (the “PHP Effective Date”), we entered into a Master Services Agreement with Population Health Partners, L.P.
The IRA also creates a drug price negotiation program under which the prices for Medicare units of certain FDA approved or licensed high Medicare spend drugs and biologics without generic or biosimilar competition will be capped by reference to, among other things, a specified non-federal AMP, starting in 2026.
The IRA also created a drug price negotiation program under which the prices for Medicare units of certain FDA approved or licensed high Medicare spend drugs and biologics without generic or biosimilar competition will be capped by reference to, among other things, a specified non-federal AMP.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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As such, our current mission is focused on antibody-based therapies that protect vulnerable people from the consequences of viral threats, beginning with SARS-CoV-2, and we have committed a significant portion of our financial and personnel resources to the manufacturing and commercialization of PEMGARDA, which received an EUA from the FDA in March 2024, and the development of VYD2311, our next generation mAb candidate for COVID-19.
As such, our current mission is focused on antibody-based therapies that protect vulnerable people from the consequences of viral threats, beginning with SARS-CoV-2, and we have committed a significant portion of our financial and personnel resources to the manufacturing and commercialization of PEMGARDA, which received an EUA from the FDA in March 2024, and the manufacturing and development of VYD2311, our next generation mAb candidate for COVID-19.
For example, PEMGARDA has been authorized with a boxed warning for anaphylaxis, which could impede our ability to successfully market and commercialize PEMGARDA and our ability to compete successfully against our competitors.
For example, PEMGARDA has been authorized with a boxed warning for anaphylaxis, which could impede our ability to successfully market and commercialize PEMGARDA and our ability to compete successfully against our competitors.
The timing and amount of our funding requirements will depend on many factors, including: • the revenue received from sales of PEMGARDA and any other product candidates for which we receive future regulatory authorization or approval; • the rate of progress in the development of our product candidates, such as VYD2311; • the scope, progress, results and costs of discovery, nonclinical studies, preclinical development, laboratory testing and clinical trials for our product candidates and associated development programs; • the extent to which we develop, in-license or acquire other product candidates, intellectual property and/or technologies; • the scope, progress, results and costs of manufacturing and validation activities associated with our current product candidates and with the development and manufacturing of our future product candidates as we advance them through preclinical and clinical development; • the number and development requirements of product candidates that we may pursue; • 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 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; • the costs necessary to obtain regulatory authorizations or approvals, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where authorization or approval is obtained; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; • the continuation of our existing licensing and collaboration arrangements and entry into new collaborations and licensing arrangements, if at all; • the costs we incur in maintaining business operations; • the need to implement additional internal systems and infrastructure; • the effect of competing technological, product and market developments; • the costs of operating as a public company; and • the impact of any business interruptions to our operations or to those of our third-party contractors resulting from any public health crisis.
The timing and amount of our funding requirements will depend on many factors, including: • the revenue received from sales of PEMGARDA and any other product candidates for which we receive future regulatory authorization or approval; • the rate of progress in the development of our product candidates, such as VYD2311 and VBY329; • the scope, progress, results and costs of discovery, nonclinical studies, preclinical development, laboratory testing and clinical trials for our product candidates and associated development programs; • the extent to which we develop, in-license or acquire other product candidates, intellectual property and/or technologies; • the scope, progress, results and costs of manufacturing and validation activities associated with our current product candidates and with the development and manufacturing of our future product candidates as we advance them through preclinical and clinical development; • the number and development requirements of product candidates that we may pursue; • 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 build and maintain a commercial infrastructure; • 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; • the costs necessary to obtain regulatory authorizations or approvals, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where authorization or approval is obtained; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; • the continuation of our existing licensing and collaboration arrangements and entry into new collaborations and licensing arrangements, if at all; • the costs we incur in maintaining business operations; • the need to implement additional internal systems and infrastructure; • the effect of competing technological, product and market developments; • the costs of operating as a public company; and • the impact of any business interruptions to our operations or to those of our third-party contractors resulting from any public health crisis.
The following examples are illustrative: • others may be able to make products that are similar to or otherwise competitive with our product candidates but that are not covered by the claims of any of our patents, should they issue; • an in-license necessary for the manufacture, use, sale, offer for sale or importation of one or more of our product candidates may be terminated by the licensor; • we or our collaborators might not have been the first to make the inventions covered by our future issued patents or our pending patent applications; • we or our collaborators might not have been the first to file patent applications covering certain of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing, misappropriating or otherwise violating our intellectual property rights; • it is possible that our pending patent applications will not lead to issued patents; • issued patents that we own or in-license may be held invalid or unenforceable as a result of legal challenges by our competitors; • issued patents that we own or in-license may not provide coverage for all aspects of our product candidates in all countries; • our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • we may not develop additional proprietary technologies that are patentable; and • the patents of others may have an adverse effect on our business.
The following examples are illustrative: • others may be able to make products that are similar to or otherwise competitive with our product candidates but that are not covered by the claims of any of our patents, should they issue; • an in-license necessary for the manufacture, use, sale, offer for sale or importation of one or more of our product candidates may be terminated by the licensor; • we or our collaborators might not have been the first to make the inventions covered by our future issued patents or our pending patent applications; • we or our collaborators might not have been the first to file patent applications covering certain of our inventions; 88 • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing, misappropriating or otherwise violating our intellectual property rights; • it is possible that our pending patent applications will not lead to issued patents; • issued patents that we own or in-license may be held invalid or unenforceable as a result of legal challenges by our competitors; • issued patents that we own or in-license may not provide coverage for all aspects of our product candidates in all countries; • our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; • we may not develop additional proprietary technologies that are patentable; and • the patents of others may have an adverse effect on our business.
Such delay, failure or inability to manufacture or test can result from: • a failure in the manufacturing process itself, for example by an error in manufacturing process, operator or human error, equipment failure, raw material or reagent failure, failure in any step of the manufacturing process, failure to maintain a cGMP environment or failure in quality systems applicable to manufacture (whether by us or our third-party contract development and manufacturing organization), sterility failures, testing failure or contamination during processing; • a lack of reliability or reproducibility in the manufacturing process itself leading to variability in process execution or in product quality, which may lead to regulatory authorities placing a hold on a clinical trial or commercial supply and distribution or requesting further information on the process, which could in turn result in delays to the clinical trials or commercial supply and distributions; • inability to obtain manufacturing or testing slots within desired timeframes or to have enough manufacturing slots to manufacture our product candidates to meet clinical or commercial requirements and demands; • unfavorable FDA or foreign or state regulatory inspection of the manufacturing or testing site; • inability to procure raw materials and reagents due to global supply chain shortages or otherwise; • loss, depletion or performance degradation of the cell line starting material; and • loss of or close-down of any manufacturing facility used in the manufacture of our product candidates, or the inability to find alternative manufacturing capability in a timely fashion.
Such delay, failure or inability to manufacture or test can result from: • a failure in the manufacturing process itself, for example by an error in manufacturing process, operator or human error, equipment failure, raw material or reagent failure, failure in any step of the manufacturing process, failure to maintain a cGMP environment or failure in quality systems applicable to manufacture (whether by us or our third-party contract development and manufacturing organization), sterility failures, testing failure or contamination during processing; • a lack of reliability or reproducibility in the manufacturing process itself leading to variability in process execution or in product quality, which may lead to regulatory authorities placing a hold on a clinical trial or commercial supply and distribution or requesting further information on the process, which could in turn result in delays to the clinical trials or commercial supply and distributions; • inability to obtain manufacturing or testing slots within desired timeframes or to have enough manufacturing slots to manufacture our product candidates to meet clinical or commercial requirements and demands; • unfavorable FDA or foreign or state regulatory inspection of the manufacturing or testing site; 58 • inability to procure raw materials and reagents due to global supply chain shortages or otherwise; • loss, depletion or performance degradation of the cell line starting material; and • loss of or close-down of any manufacturing facility used in the manufacture of our product candidates, or the inability to find alternative manufacturing capability in a timely fashion.
Therefore, our ability to compete successfully will depend largely on our ability to: • develop and commercialize drugs that are differentiated from products in the market; • demonstrate through our clinical trials that our product candidates are differentiated from existing and future therapies; • attract qualified scientific, product development and commercial personnel; • obtain patent or other proprietary protection for our medicines; • obtain and maintain required regulatory authorizations or approvals; • obtain placement in COVID-19 prevention and treatment guidelines from organizations such as the CDC, the WHO and the Infectious Diseases Society of America (the “IDSA”); • obtain coverage and adequate reimbursement from, and negotiate competitive pricing with, third-party payors; • manufacture sufficient supply to meet market demand; and • successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines.
Therefore, our ability to compete successfully will depend largely on our ability to: • develop and commercialize drugs that are differentiated from products in the market; • demonstrate through our clinical trials that our product candidates are differentiated from existing and future therapies; • attract qualified scientific, product development and commercial personnel; • obtain patent or other proprietary protection for our medicines; • obtain and maintain required regulatory authorizations or approvals; 65 • obtain placement in COVID-19 prevention and treatment guidelines from organizations such as the CDC, the WHO and the Infectious Diseases Society of America (the “IDSA”); • obtain coverage and adequate reimbursement from, and negotiate competitive pricing with, third-party payors; • manufacture sufficient supply to meet market demand; and • successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines.
To the extent that virologic activity data in the public domain generated by academic or other third-party labs not related to us creates doubt regarding the neutralization activity of pemivibart or our other product candidates, it could adversely impact our regulatory authorization and market acceptance by HCPs or patients, particularly if such publicly available neutralization 59 findings are referenced by the FDA in relation to the regulatory authorization of any product candidate of ours, which would adversely affect our commercial prospects and ability to generate revenues, even if such data is preliminary, non-peer-reviewed, and/or generated with molecules that are not authentic Invivyd molecules, and even if such data is ultimately shown to be inconsistent with neutralization data generated through our industrial-grade virology efforts.
To the extent that virologic activity data in the public domain generated by academic or other third-party labs not related to us creates doubt regarding the neutralization activity of pemivibart or our other product candidates, it could adversely impact our regulatory authorization and market acceptance by HCPs or patients, particularly if such publicly available neutralization findings are referenced by the FDA in relation to the regulatory authorization of any product candidate of ours, which would adversely affect our commercial prospects and ability to generate revenues, even if such data is preliminary, non-peer-reviewed, and/or generated with molecules that are not authentic Invivyd molecules, and even if such data is ultimately shown to be inconsistent with neutralization data generated through our industrial-grade virology efforts.
For example, following receipt of EUA from the FDA in March 2024 for PEMGARDA™ (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg), we were informed in mid-July 2024 by our third-party authentic virus neutralization assay (“AVNA”) vendor that a possible contamination event may have impacted the AVNA potency value generated by such vendor for pemivibart against JN.1, which was the dominant circulating SARS-CoV-2 variant in the U.S. between January 2024 and April 2024.
For example, following receipt of EUA from the FDA in March 2024 for PEMGARDA (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and 72 adolescent individuals (12 years of age and older weighing at least 40 kg), we were informed in mid-July 2024 by our third-party authentic virus neutralization assay (“AVNA”) vendor that a possible contamination event may have impacted the AVNA potency value generated by such vendor for pemivibart against JN.1, which was the dominant circulating SARS-CoV-2 variant in the U.S. between January 2024 and April 2024.
In addition, the government may assert that a claim, including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act; 85 • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and their implementing regulations, also imposes obligations, including mandatory contractual terms, on “covered entities,” certain healthcare providers, health plans, healthcare clearinghouses, and their respective “business associates,” certain persons or entities that create, receive, maintain or transmit protected health information for or on behalf of a covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of protected health information.
In addition, the government may assert that a claim, including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and their implementing regulations, also imposes obligations, including mandatory contractual terms, on “covered entities,” certain healthcare providers, health plans, healthcare clearinghouses, and their respective “business associates,” certain persons or entities that create, receive, maintain or transmit protected health information for or on behalf of a covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of protected health information.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant penalties, including, without limitation, civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in federal and state funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, diminished profits and future earnings, reputational harm and the curtailment or restructuring of our operations, any of which could harm our business.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant penalties, including, without limitation, civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in federal and state funded healthcare programs, such as Medicare and Medicaid, 90 additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, diminished profits and future earnings, reputational harm and the curtailment or restructuring of our operations, any of which could harm our business.
Patient enrollment is affected by other factors, including: • the eligibility and exclusion criteria for the trial in question; • the size of the patient population and process for identifying patients; • the severity and difficulty of diagnosing the disease under investigation; • the impact infection prevalence may have on enrollment, as well as the emergence and evolution of SARS-CoV-2 variants, which may impact the prevalent variant of infection for patients at one or more clinical trial sites and adversely impact enrollment potential; • our ability to recruit clinical trial investigators with the appropriate competencies and experience; • the design of the trial protocol, including but not limited to the use of a placebo control or active comparator; • the perceived risks and benefits of the product candidate in the trial, including relating to mAb and/or vaccine approaches; • the availability of competing commercially available therapies and other competing therapeutic candidates’ clinical trials for the disease or condition under investigation; • the willingness of patients to be enrolled in our clinical trials; • the ability to obtain and maintain subject consents; • the efforts to facilitate timely enrollment in clinical trials; • potential disruptions caused by a public health crisis, such as the COVID-19 pandemic, including difficulties in initiating clinical sites, enrolling and retaining participants, diversion of healthcare resources away from clinical 49 trials, vaccine mandate policies, travel or quarantine policies that may be implemented, our ability to import and export clinical trial supplies, raw materials and commercial supply and other factors; • the patient referral practices of physicians; • the ability to monitor patients adequately during and after treatment; • the risk that subjects enrolled in our clinical trials will drop out of the trials before completion; and • the proximity and availability of clinical trial sites for prospective patients.
Patient enrollment is affected by other factors, including: • the eligibility and exclusion criteria for the trial in question; • the size of the patient population and process for identifying patients; • the severity and difficulty of diagnosing the disease under investigation; • the impact infection prevalence may have on enrollment, as well as the emergence and evolution of SARS-CoV-2 variants, which may impact the prevalent variant of infection for patients at one or more clinical trial sites and adversely impact enrollment potential; • our ability to recruit clinical trial investigators with the appropriate competencies and experience; • the design of the trial protocol, including but not limited to the use of a placebo control or active comparator; • the perceived risks and benefits of the product candidate in the trial, including relating to mAb and/or vaccine approaches; • the availability of competing commercially available therapies and other competing therapeutic candidates’ clinical trials for the disease or condition under investigation; 54 • the willingness of patients to be enrolled in our clinical trials; • the ability to obtain and maintain subject consents; • the efforts to facilitate timely enrollment in clinical trials; • potential disruptions caused by a public health crisis, such as the COVID-19 pandemic, including difficulties in initiating clinical sites, enrolling and retaining participants, diversion of healthcare resources away from clinical trials, vaccine mandate policies, travel or quarantine policies that may be implemented, our ability to import and export clinical trial supplies, raw materials and commercial supply and other factors; • the patient referral practices of physicians; • the ability to monitor patients adequately during and after treatment; • the risk that subjects enrolled in our clinical trials will drop out of the trials before completion; and • the proximity and availability of clinical trial sites for prospective patients.
For example, following our review of data generated in external in vitro analyses examining the neutralizing activity of adintrevimab against the Omicron SARS-CoV-2 BA.1 variant in both authentic and pseudovirus assays, in January 2022 we paused enrollment of new patients in both our EVADE (evaluating adintrevimab for the prevention of COVID-19) and STAMP (evaluating adintrevimab for the treatment of COVID-19) clinical trials to assess dosing strategy and revise our trial protocols in light of the global spread of the Omicron variant and its sublineages; we reported preliminary safety and efficacy data from both trials in March 2022, but as a result of the lack of neutralizing activity against the Omicron BA.2 variant, we paused the submission of an EUA request, and we have closed such trials.
For example, following our review of data generated in external in vitro analyses examining the neutralizing activity of adintrevimab against the Omicron SARS-CoV-2 BA.1 variant in both authentic and pseudovirus assays, in January 2022 we paused enrollment of new patients in both our EVADE (evaluating adintrevimab for the prevention of COVID-19) and STAMP (evaluating adintrevimab for the treatment of COVID-19) clinical trials to assess dosing strategy and revise our trial protocols in light of the global spread of the Omicron variant and its sublineages; we reported preliminary safety and efficacy data from both trials in March 2022, but as a result of the lack of neutralizing activity against the Omicron BA.2 variant, we paused the submission of an EUA request, and we closed such trials.
The Adimab Collaboration Agreement additionally contains obligations that require us to make payments in the event certain milestone events are achieved and royalty payments on net sales of subject products, in accordance with the Adimab Collaboration Agreement, on a product-by-product and country-by-country basis, for a period ending on the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of any patent claiming composition of matter or method of making or using any antibody identified or optimized under the Adimab Collaboration Agreement in such country.
The Adimab Collaboration Agreement additionally contains obligations that require us to make payments in the event certain milestone events are achieved and royalty payments on net sales of subject products, in accordance with the Adimab 79 Collaboration Agreement, on a product-by-product and country-by-country basis, for a period ending on the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of any patent claiming composition of matter or method of making or using any antibody identified or optimized under the Adimab Collaboration Agreement in such country.
In addition, regulatory authorities may, at any time, audit or inspect us or any of our contract manufacturing, testing, and storage facilities involved with the preparation of our product candidates or our other potential products or the associated quality systems for compliance with the regulations applicable to the activities being conducted, and they could put a hold on one or more of our clinical trials (or could delay regulatory authorization or 54 approval) if the facilities or quality systems of our or third-party contractors do not pass such audit or inspections.
In addition, regulatory authorities may, at any time, audit or inspect us or any of our contract manufacturing, testing, and storage facilities involved with the preparation of our product candidates or our other potential products or the associated quality systems for compliance with the regulations applicable to the activities being conducted, and they could put a hold on one or more of our clinical trials (or could delay regulatory authorization or approval) if the facilities or quality systems of our or third-party contractors do not pass such audit or inspections.
We cannot ensure that our data protection efforts and our investment in information technology, or the efforts or investments of our CDMO, CROs, consultants or other third parties with which we work, will prevent cybersecurity incidents that cause loss, destruction, unavailability, alteration, dissemination of, or damage or unauthorized access to, our data, including personal data, assets and other data processed or maintained on our behalf, that could have a material adverse effect upon our reputation, business, operations or financial condition.
We cannot ensure that our data protection efforts and our investment in information technology (“IT”), or the efforts or investments of our CDMO, CROs, consultants or other third parties with which we work, will prevent cybersecurity incidents that cause loss, destruction, unavailability, alteration, dissemination of, or damage or unauthorized access to, our data, including personal data, assets and other data processed or maintained on our behalf, that could have a material adverse effect upon our reputation, business, operations or financial condition.
The ACA, among other things contains a number of provisions of particular import to the pharmaceutical and biotechnology industries, including, but not limited to, those governing enrollment in federal healthcare programs, a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, and annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs.
The ACA, among other things contains a number of provisions of particular import to the pharmaceutical and biotechnology industries, including, but not limited to, those governing enrollment 92 in federal healthcare programs, a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, and annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs.
Adverse events in our or others’ clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the authorization or approval of our product candidates, stricter labeling requirements 48 for those product candidates that are authorized or approved or a decrease in demand for any such product candidates, all of which would have a negative impact on our business and operations.
Adverse events in our or others’ clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the authorization or approval of our product candidates, stricter labeling requirements for those product candidates that are authorized or approved or a decrease in demand for any such product candidates, all of which would have a negative impact on our business and operations.
If any such event were to occur in countries in which we operate, it could lead to the loss, destruction, alteration, prevention of access to, disclosure, dissemination of, or damage or unauthorized access to, our data (including trade secrets or other confidential information, intellectual property, 64 proprietary business information and personal data) or data that is processed or maintained on our behalf, and cause interruptions in our operations, resulting in a material disruption of our product development programs.
If any such event were to occur in countries in which we operate, it could lead to the loss, destruction, alteration, prevention of access to, disclosure, dissemination of, or damage or unauthorized access to, our data (including trade secrets or other confidential information, intellectual property, proprietary business information and personal data) or data that is processed or maintained on our behalf, and cause interruptions in our operations, resulting in a material disruption of our product development programs.
On March 22, 2024, we received an EUA from the FDA for PEMGARDA 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 56 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.
On March 22, 2024, we received an EUA from the FDA for PEMGARDA 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.
If WuXi Biologics or any of the other third parties that we engage to supply any materials or manufacture products for our 69 preclinical tests and clinical trials should cease to continue to do so for any reason, we could experience delays in advancing these tests and trials while we identify and qualify replacement suppliers or manufacturers and we may be unable to obtain replacement supplies on terms that are favorable to us, or at all.
If WuXi Biologics or any of the other third parties that we engage to supply any materials or manufacture products for our preclinical tests and clinical trials should cease to continue to do so for any reason, we could experience delays in advancing these tests and trials while we identify and qualify replacement suppliers or manufacturers and we may be unable to obtain replacement supplies on terms that are favorable to us, or at all.
If we are unable to prevent material disclosure of the non-patented intellectual property related to our technologies to third parties, and there is no guarantee that we will have any such enforceable trade secret protection, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations and financial condition.
If we are unable to prevent material disclosure of the non-patented intellectual property related to our technologies 78 to third parties, and there is no guarantee that we will have any such enforceable trade secret protection, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations and financial condition.
The ability of the FDA to review and approve new products or review other regulatory submissions can be affected by a variety of factors, including government budget and funding levels, a reduction in the FDA’s workforce and its ability to hire and retain key personnel and accept the payment of user fees, shifting policy priorities as a result of changes in the U.S. presidential administration and political appointees tasked to oversee the agency, and statutory, regulatory and policy changes.
The ability of the FDA to review and approve new products or review other regulatory submissions can be affected by a variety of factors, including government budget and funding levels, a reduction in the FDA’s workforce and its ability to hire and retain key personnel and accept the payment of user fees, shifting policy priorities as a result of the current U.S. presidential administration and political appointees tasked to oversee the agency, and statutory, regulatory and policy changes.
While we believe that we have secured sufficient supply to meet demand for PEMGARDA and anticipated initial demand for VYD2311, if authorized or approved, the loss of this CDMO, a disruption in production at this CDMO or the inability of this CDMO to timely manufacture sufficient quantities on acceptable pricing terms to meet our needs, and our failure to find alternative manufacturing capability in a timely fashion, would impair our ability to develop and commercialize our product candidates.
While we believe that we have secured sufficient supply to meet demand for PEMGARDA and anticipated initial demand for VYD2311, if approved, the loss of this CDMO, a disruption in production at this CDMO or the inability of this CDMO to timely manufacture sufficient quantities on acceptable pricing terms to meet our needs, and our failure to find alternative manufacturing capability in a timely fashion, would impair our ability to develop and commercialize our product candidates.
As product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and product characteristics. Such changes carry the risk that they will not achieve our intended objectives.
As product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and 60 formulation, are altered along the way in an effort to optimize processes and product characteristics. Such changes carry the risk that they will not achieve our intended objectives.
If we, or a regulatory authority, discover previously unknown problems with a drug, such as adverse events of unanticipated severity or frequency, or problems with the facility where the drug is manufactured or if a regulatory authority disagrees with the promotion, marketing or labeling of that drug, a regulatory authority may impose restrictions relative to that drug, the manufacturing facility or us, including requesting a recall or requiring variation, suspension or withdrawal of marketing authorization, or suspension of manufacturing, or imposition of financial penalties or other enforcement measures.
If we, or a regulatory authority, discover previously unknown problems with a drug, such as adverse events of unanticipated severity or frequency, or problems with the facility where the drug is manufactured or if a regulatory authority disagrees with the promotion, marketing or labeling of that drug, a regulatory authority may impose restrictions relative to that drug, the 91 manufacturing facility or us, including requesting a recall or requiring variation, suspension or withdrawal of marketing authorization, or suspension of manufacturing, or imposition of financial penalties or other enforcement measures.
In pursuing, and eventually obtaining, an EUA for PEMGARDA in the U.S., we aligned with the FDA on a primary efficacy analysis for our CANOPY Phase 3 pivotal clinical trial that used a correlate of protection (surrogate of clinical efficacy) in an immunobridging approach comparing data obtained in the CANOPY clinical trial to certain historical data from our previous Phase 2/3 clinical trial of adintrevimab for the prevention of COVID-19 (EVADE).
In pursuing, and eventually obtaining, an EUA for PEMGARDA (pemivibart) in the U.S., we aligned with the FDA on a primary efficacy analysis for our CANOPY Phase 3 pivotal clinical trial that used a correlate of protection (surrogate of clinical efficacy) in an immunobridging approach comparing data obtained in the CANOPY clinical trial to certain historical data from our previous Phase 2/3 clinical trial of adintrevimab for the prevention of COVID-19 (EVADE).
If we cannot demonstrate that any adverse events were not caused by the drug, the FDA or foreign regulatory authorities could order us to cease further 47 development of, or deny approval of, our product candidates for any or all targeted indications, or require that we conduct additional animal or human studies regarding the safety and efficacy of our product candidates that we have not planned or anticipated.
If we cannot demonstrate that any adverse events were not caused by the drug, the FDA or foreign regulatory authorities could order us to cease further development of, or deny approval of, our product candidates for any or all targeted indications, or require that we conduct additional animal or human studies regarding the safety and efficacy of our product candidates that we have not planned or anticipated.
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.
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 38 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.
Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory authorization or approval process for our product candidates. 68 We also are required to register certain clinical trials and post the results of certain completed clinical trials on a government-sponsored database, such as ClinicalTrials.gov, within specified timeframes.
Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory authorization or approval process for our product candidates. We also are required to register certain clinical trials and post the results of certain completed clinical trials on a government-sponsored database, such as ClinicalTrials.gov, within specified timeframes.
A weak or declining economy or political disruption, including any international trade disputes, or changes in laws or policies governing the terms of international trade, and in particular increased trade restrictions, tariffs or taxes on imports from 97 countries where we manufacture products, such as China, could strain our manufacturer or suppliers, possibly resulting in supply disruption or increased manufacturing and distribution costs.
A weak or declining economy or political disruption, including any international trade disputes, or changes in laws or policies governing the terms of international trade, and in particular increased trade restrictions, tariffs or taxes on imports from countries where we manufacture products, such as China, could strain our manufacturer or suppliers, possibly resulting in supply disruption or increased manufacturing and distribution costs.
If competitors are able to obtain marketing approval for biosimilars referencing our candidates, if approved, our products may become subject to competition from such biosimilars, with the attendant competitive pressure and potential adverse consequences. 63 Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
If competitors are able to obtain marketing approval for biosimilars referencing our candidates, if approved, our products may become subject to competition from such biosimilars, with the attendant competitive pressure and potential adverse consequences. Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
However, the clinical utility of these products has varied over time due to the emergence of SARS-CoV-2 variants demonstrating partial or full resistance to neutralization and at this time none of these products, other than PEMGARDA, are authorized for use in prevention or treatment of COVID-19 in the U.S. due to loss of activity as new variants emerged.
However, the clinical utility of these products has varied over time due to the emergence of SARS-CoV-2 variants demonstrating partial or full resistance to neutralization and at this time none of these products are authorized for the treatment of COVID-19 and, other than PEMGARDA, none of these products are authorized for prevention of COVID-19 in the U.S., due to loss of activity as new variants emerged.
If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which could significantly impact our ability to timely develop, obtain regulatory authorization or approval for or market our product candidates, if authorized or approved.
If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which could significantly impact our ability to timely develop, obtain regulatory authorization or approval for or 73 market our product candidates, if authorized or approved.
If we materially breach the Adimab Assignment Agreement, the Adimab Collaboration Agreement or the Adimab Platform Transfer Agreement, our licenses under the Adimab Assignment Agreement, the Adimab Collaboration Agreement and the Adimab Platform Transfer Agreement can 75 be terminated, we can be required to return to Adimab the assigned patent rights and any patents or patent applications that claim priority to such patents, our rights to develop and commercialize our product candidates will be adversely affected, and we could be found liable for substantial monetary damages.
If we materially breach the Adimab Assignment Agreement, the Adimab Collaboration Agreement or the Adimab Platform Transfer Agreement, our licenses under the Adimab Assignment Agreement, the Adimab Collaboration Agreement and the Adimab Platform Transfer Agreement can be terminated, we can be required to return to Adimab the assigned patent rights and any patents or patent applications that claim priority to such patents, our rights to develop and commercialize our product candidates will be adversely affected, and we could be found liable for substantial monetary damages.
We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our or our CDMO’s, CROs’, contractors’, consultants’ or collaborators’ cybersecurity.
We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. 68 Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our or our CDMO’s, CROs’, contractors’, consultants’ or collaborators’ cybersecurity.
In addition, the GDPR generally restricts the transfers of personal data from the EEA, including the European Union, United Kingdom and Switzerland, to other jurisdictions that the European Commission/United Kingdom Secretary of State, as applicable, does not recognize as having “adequate” data protection laws unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data.
In addition, the GDPR generally restricts the transfers of personal data from the EEA, including the European Union and the United Kingdom, to other jurisdictions that the European Commission/United Kingdom Secretary of State, as applicable, does not recognize as having “adequate” data protection laws unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data.
Enforcing a claim that a third party illegally obtained and is using our trade secrets, like patent litigation, is expensive and time-consuming, and the outcome is unpredictable. Further, the laws of some foreign countries do not protect proprietary 73 rights to the same extent or in the same manner as the laws of the U.S.
Enforcing a claim that a third party illegally obtained and is using our trade secrets, like patent litigation, is expensive and time-consuming, and the outcome is unpredictable. Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the U.S.
As a result, our revenue from applicable products could be reduced, which could have a material adverse effect on our business. 74 We are a party to an assignment and license agreement, a collaboration agreement and a platform transfer agreement with Adimab, pursuant to which we are obligated to make payments upon achievement of milestone events and royalties.
As a result, our revenue from applicable products could be reduced, which could have a material adverse effect on our business. We are a party to an assignment and license agreement, a collaboration agreement and a platform transfer agreement with Adimab, pursuant to which we are obligated to make payments upon achievement of milestone events and royalties.
As a result, we may not be able to prevent competitors from developing and commercializing competitive products in territories included in all of our licenses. Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and licensed patents, and the enforcement or defense of our licensed patents or future owned patents.
As a result, we may not be able to prevent competitors from developing and commercializing competitive products in territories included in all of our licenses. 81 Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and licensed patents, and the enforcement or defense of our licensed patents or future owned patents.
While we believe that we have secured sufficient supply to meet demand for PEMGARDA and anticipated initial demand for VYD2311, if authorized or approved, any delay, failure or inability to manufacture or test on a timely basis in the future could impact the timelines for our future clinical trials or our commercialization plans.
While we believe that we have secured sufficient supply to meet demand for PEMGARDA and anticipated initial demand for VYD2311, if approved, any delay, failure or inability to manufacture or test on a timely basis in the future could impact the timelines for our future clinical trials or our commercialization plans.
In the U.S., numerous federal and state laws and regulations could apply to our operations or the operations of our partners, including state data breach notification laws, state health information privacy laws 65 and federal and state consumer protection laws and regulations, including Section 5 of the FTC Act and the FTC Health Breach Notification Rule, that govern the collection, use, disclosure and protection of health-related and other personal information.
In the U.S., numerous federal and state laws and regulations could apply to our operations or the operations of our partners, including state data breach notification laws, state health information privacy laws and federal and state consumer protection laws and regulations, including Section 5 of the FTC Act and the FTC Health Breach Notification Rule, that govern the collection, use, disclosure and protection of health-related and other personal information.
If we are unable to do so, we may have to curtail the development of such product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or 71 marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.
If we are unable to do so, we may have to curtail the development of such product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.
Several pharmaceutical and other healthcare companies have been investigated and have reached substantial financial settlements with the federal government under the civil False Claims Act for a variety of alleged misconduct, including, for example, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product.
Pharmaceutical and other healthcare companies have been investigated and have reached substantial financial settlements with the federal government under the civil False Claims Act for a variety of alleged misconduct, including, for example, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product.
The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our drugs. It is also possible that additional governmental action will be taken in response to the COVID-19 pandemic.
The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate 93 revenue, attain profitability, or commercialize our drugs. It is also possible that additional governmental action will be taken in response to the COVID-19 pandemic.
We may fail to demonstrate with substantial evidence from adequate and well-controlled trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that our product candidates are safe and effective for their intended uses or otherwise meet requirements for an EUA.
We may fail to demonstrate with substantial evidence from adequate and well-controlled trials, and to the 52 satisfaction of the FDA or comparable foreign regulatory authorities, that our product candidates are safe and effective for their intended uses or otherwise meet requirements for an EUA.
In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid, is unenforceable or is not infringed, or may refuse to stop the other party in such infringement proceeding from using the technology at issue on the grounds that our patents do not cover the technology in question.
In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid, is unenforceable or is not 82 infringed, or may refuse to stop the other party in such infringement proceeding from using the technology at issue on the grounds that our patents do not cover the technology in question.
On February 4, 2020, the Secretary of HHS determined pursuant to his authority under Section 564 of the FDCA that COVID-19 represented a public health emergency with significant potential to affect national security or the health and security of U.S. citizens living abroad.
On February 4, 2020, the Secretary of HHS determined pursuant to his authority under Section 564 of the FDCA that COVID-19 represented a public health emergency with significant potential to affect national security or the health and security 49 of U.S. citizens living abroad.
For example, in many countries in the European Union, procedures to obtain price 62 approvals, coverage and reimbursement can take considerable time after the receipt of marketing authorization. Many European countries periodically review their reimbursement of medicinal products, which could have an adverse impact on reimbursement status.
For example, in many countries in the European Union, procedures to obtain price approvals, coverage and reimbursement can take considerable time after the receipt of marketing authorization. Many European countries periodically review their reimbursement of medicinal products, which could have an adverse impact on reimbursement status.
Such proceedings could result in revocation of or amendment to our future patents in such a way that they no longer cover our product candidates 78 or prevent third parties from competing with our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
Such proceedings could result in revocation of or amendment to our future patents in such a way that they no longer cover our product candidates or prevent third parties from competing with our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
Our determination of the expiration date of any patent in the U.S. or abroad that we consider relevant may be 79 incorrect, which may negatively impact our ability to develop and market our product candidates. Our failure to identify and correctly interpret relevant third-party patents may negatively impact our ability to develop and market our products.
Our determination of the expiration date of any patent in the U.S. or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our product candidates. Our failure to identify and correctly interpret relevant third-party patents may negatively impact our ability to develop and market our products.
We expect to rely on trademarks as one means to distinguish our product candidates, if approved for marketing, from the drugs of our competitors. We also expect to rely on trademarks to protect our company name. Once we select new trademarks 83 and apply to register them, our trademark applications may not be approved.
We expect to rely on trademarks as one means to distinguish our product candidates, if approved for marketing, from the drugs of our competitors. We also expect to rely on trademarks to protect our company name. Once we select new trademarks and apply to register them, our trademark applications may not be approved.
Executive officers may terminate employment with us at any time, 89 and the ability to attract a key executive to replace that position and the ability to retain additional key executives are critical to our success. We do not maintain “key person” insurance for any of our executives or employees.
Executive officers may terminate employment with us at any time, and the ability to attract a key executive to replace that position and the ability to retain additional key executives are critical to our success. We do not maintain “key person” insurance for any of our executives or employees.
We could experience manufacturing problems, may be unable to access desired future manufacturing capacity within desired timeframes, or may be unable to access raw materials due to global supply chain shortages or otherwise, that result in delays in the development or commercialization of our product candidates or otherwise harm our business.
We could experience manufacturing problems, may be unable to access desired future manufacturing capacity within desired timeframes, or may be unable to access raw 57 materials due to global supply chain shortages or otherwise, that result in delays in the development, supply, or commercialization of our product candidates or otherwise harm our business.
Accordingly, even if we determine to pursue a BLA and we believe that one of our product candidates meets the criteria 50 for accelerated approval, fast track designation or breakthrough therapy designation, the FDA may disagree and instead determine not to grant such designation.
Accordingly, even if we determine to pursue a BLA and we believe that one of our product candidates meets the criteria for accelerated approval, Fast Track designation or breakthrough therapy designation, the FDA may disagree and instead determine not to grant such designation.
Many of these companies 60 have also been successful in securing government funding to support research and development and/or manufacturing of their product candidates as well as government contracts to purchase their supply orders. Additional vaccines and therapeutics are in development by other pharmaceutical and biopharmaceutical companies.
Many of these companies have also been successful in securing government funding to support research and development and/or manufacturing of their product candidates as well as government contracts to purchase their supply orders. Additional vaccines and therapeutics are in development by other pharmaceutical and biopharmaceutical companies.
There is additional uncertainty as it is not known what actions, including the imposition of potential sanctions or tariffs, may be taken by the new U.S. presidential administration. Additionally, the biopharmaceutical industry in particular in China is strictly regulated by the Chinese government.
There is additional uncertainty as it is not known what actions, including the imposition of potential sanctions or tariffs, may be taken by the U.S. presidential administration. Additionally, the biopharmaceutical industry in particular in China is strictly regulated by the Chinese government.
If the breadth or strength of protection provided by the patent and patent applications we hold, obtain or pursue with respect to our product candidates and technologies is challenged, or if they fail to provide meaningful exclusivity for our product candidates and technologies, it could threaten our ability to commercialize our product candidates and technologies.
If the breadth or strength of protection provided by the patent and patent applications we hold, obtain or pursue with respect to our product candidates and technologies is challenged, or if they fail to provide meaningful exclusivity 77 for our product candidates and technologies, it could threaten our ability to commercialize our product candidates and technologies.
Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could have a negative impact on our ability to commercialize our product candidates.
Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which 84 could have a negative impact on our ability to commercialize our product candidates.
Furthermore, even if we obtain regulatory authorization to expand the authorized use of PEMGARDA or if we obtain 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.
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.
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 harmed.
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.
The evolution and of the disease and the continued emergence of VoCs, and the availability, administration and acceptance of vaccines, mAbs, antiviral agents and other therapies may affect the design and enrollment of our clinical trials, the potential regulatory authorization or approval of our product candidates and the commercialization of our product candidates, if authorized or approved.
The evolution and impact of the disease and the continued emergence of VoCs, and the availability, administration and acceptance of vaccines, mAbs, antiviral agents and other therapies may affect the design and enrollment of our clinical trials, the potential regulatory authorization or approval of our product candidates and the commercialization of our product candidates, if authorized or approved.
Manufacturing and testing our product candidates and commercialization of any authorized or approved products requires many specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial biologics production.
Manufacturing and testing our product candidates and commercialization of any authorized or approved products requires many specialty materials and equipment, some of which are manufactured or supplied by small companies with limited 59 resources and experience to support commercial biologics production.
The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.
The FTC also has the power to enforce the Health 70 Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.
If we do not successfully develop and commercialize product candidates based upon our approach, 51 we will not be able to obtain product revenue in future periods, which would result in significant harm to our financial position and adversely affect our stock price.
If we do not successfully develop and commercialize product candidates based upon our approach, we will not be able to obtain product revenue in future periods, which would result in significant harm to our financial position and adversely affect our stock price.
Many of these laws differ from each other in significant ways and thus complicate compliance efforts; • HIPAA, which created additional federal criminal statutes which prohibit, among other things, a person from knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services, including those by private payors.
Many of these laws differ from each other in significant ways and thus complicate compliance efforts; • HIPAA also created federal criminal statutes which prohibit, among other things, a person from knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services, including those by private payors.
Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an 67 amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended, which could seriously harm our business.
Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended, which could seriously harm our business.
For example, 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.
For example, in July 2024, we submitted a request to the FDA to expand the existing EUA for PEMGARDA to 61 cover treatment of mild-to-moderate COVID-19 in certain immunocompromised patients, which request was denied by the FDA in February 2025.
The landscape of laws regulating personal data is constantly evolving, and compliance with these laws requires a flexible privacy framework and substantial resources. Accordingly compliance efforts will likely be an increasing and substantial cost in the future.
The landscape of laws regulating personal data is constantly evolving, and compliance with these laws requires a flexible privacy framework and substantial resources. Accordingly compliance efforts will likely be an increasing and 71 substantial cost in the future.
For example, we will be required to immediately report any serious and 86 unexpected adverse events and certain quality or production problems with our authorized or approved products to regulatory authorities along with other periodic reports.
For example, we will be required to immediately report any serious and unexpected adverse events and certain quality or production problems with our authorized or approved products to regulatory authorities along with other periodic reports.
We do not have any product candidates authorized or approved for sale in any jurisdiction other than PEMGARDA in the U.S. under an EUA, including in international markets, and we do not have experience in obtaining regulatory authorization or approval in international markets.
We do not have any product candidates authorized or approved for sale in any jurisdiction other than PEMGARDA in the U.S. under an EUA, and we do not have experience in obtaining regulatory authorization or approval in international markets.
The stock market in general, and the Nasdaq Global Market and biotechnology companies in particular, have experienced extreme price and volume fluctuations, including as a result of the COVID-19 pandemic, the ongoing conflict between Russia and Ukraine, increases in inflation rates, disruptions to global supply chain or other macroeconomic factors, that have often been unrelated or disproportionate to the prospects of the issuer and which have resulted in decreased stock prices for many companies notwithstanding the lack of a fundamental change in their underlying business models or prospects.
The stock market in general, and the Nasdaq Global Market and biotechnology companies in particular, have experienced extreme price and volume fluctuations, including as a result of the COVID-19 pandemic, the ongoing conflict between Russia and Ukraine, increases in inflation rates, disruptions to global supply chain, tariff uncertainty or other macroeconomic factors, that have often been unrelated or disproportionate to the prospects of the issuer and which have resulted in decreased stock prices for many companies notwithstanding the lack of a fundamental change in their underlying business models or prospects.
There is no certainty that all of our employees, agents, suppliers, manufacturer, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of 96 these laws.
There is no certainty that all of our employees, agents, suppliers, manufacturer, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws.
The FDA may issue an EUA during a public health emergency declared under the FDCA if the agency determines that the known and potential benefits of a product outweigh the known and potential risks and if other regulatory criteria are met.
The FDA may issue an EUA during a public health emergency declared under the FDCA if the FDA determines that the known and potential benefits of a product outweigh the known and potential risks and if other regulatory criteria are met.
Government entities, such as the CDC, the WHO and non-government professional societies, such as the IDSA, may produce treatment and/or prevention guidelines for the prevention and treatment of COVID-19, including guidance regarding the use of mAbs in these indications.
Government entities, such as the CDC, the WHO and non-government professional societies, such as the IDSA, may produce treatment and/or prevention guidelines for the prevention and treatment of COVID-19, including guidance 66 regarding the use of mAbs in these indications.
Delisting from Nasdaq may adversely affect our ability to raise additional financing through the public or private sale of equity securities, significantly affect the ability of investors to trade our securities, or negatively affect the 92 value and liquidity of our common stock.
Delisting from Nasdaq may adversely affect our ability to raise additional financing through the public or private sale of equity securities, significantly affect the ability of investors to trade our securities, or negatively affect the value and liquidity of our common stock.
Even 53 though we aim to have backup supplies of raw materials, cell lines and reagents whenever possible, we cannot be certain they will be sufficient if our primary sources are unavailable.
Even though we aim to have backup supplies of raw materials, cell lines and reagents whenever possible, we cannot be certain they will be sufficient if our primary sources are unavailable.
We currently depend on sole-source third-party suppliers and a single contract manufacturer for materials and services that are necessary for the conduct of preclinical studies, manufacture and testing of our product candidates for clinical trials and commercial supply, and the loss of these third-party suppliers or contract manufacturer or their inability to supply us with sufficient quantities of adequate materials or services, or to do so at acceptable quality levels, acceptable pricing terms, and on a timely basis, could harm our business.
We currently depend on sole-source third-party suppliers and a single contract manufacturer for materials and services that are necessary for the conduct of preclinical studies, manufacture and testing of our COVID-19 product candidates for clinical trials and commercial supply, and the loss of these third-party suppliers or contract manufacturer or their inability to supply us with sufficient quantities of adequate materials or services, or to do so at acceptable quality levels, acceptable pricing terms, and on a timely basis, could harm our business.
We cannot offer any assurances about which of our patent applications will issue, the breadth of any resulting patent or whether any of the issued patents will be found invalid and unenforceable or will be threatened by third 72 parties.
We cannot offer any assurances about which of our patent applications will issue, the breadth of any resulting patent or whether any of the issued patents will be found invalid and unenforceable or will be threatened by third parties.
Preclinical tests and Phase 1 and Phase 2 clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to understand the side effects of product candidates at various doses and schedules.
Preclinical tests and Phase 1 and Phase 2 clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to 51 understand the side effects of product candidates at various doses and schedules.
The multitude and complexity of our information systems may furthermore make them susceptible to service interruption, cybersecurity incidents, disruption of data integrity, inadvertent errors that expose our data or systems, malicious intrusion, or cyberattacks.
The multitude and complexity of our information systems may make them susceptible to service interruption, cybersecurity incidents, disruption of data integrity, inadvertent errors that expose our data or systems, malicious intrusion, or cyberattacks.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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The Audit Committee reviews and discusses with management and the Company’s auditors, as appropriate, our risks relating to data privacy, technology, and information security, including cybersecurity and back-up of information systems. The Audit Committee also confers with management and our auditors, as appropriate, regarding the adequacy and effectiveness of our policies and the internal controls regarding information security.
The Audit Committee reviews and discusses with management and our auditors, as appropriate, our risks relating to data privacy, technology, and information security, including cybersecurity and back-up of information systems. The Audit Committee also confers with management and our auditors, as appropriate, regarding the adequacy and effectiveness of our policies and the internal controls regarding information security.
Our Head of IT leverages over 20 years of experience in various cybersecurity functions. As part of our overall risk mitigation strategy, we maintain an Enterprise Risk Register to identify, prioritize and track system risks, including cybersecurity risks.
Our Head of IT leverages over ten years of experience in various cybersecurity functions. As part of our overall risk mitigation strategy, we maintain an Enterprise Risk Register to identify, prioritize and track system risks, including cybersecurity risks.
National Institute of Standards and Technology. We have adopted an IT Security Management Policy (“IT Policy”) to establish the requirements for securing and managing our IT assets and data, as well as an Incident Response Policy designed to coordinate the activities for preparing for, identifying, responding to, and recovering from cybersecurity threats.
We have adopted an IT Security Management Policy (“IT Policy”) to establish the requirements for securing and managing our IT assets and data, as well as an Incident Response Policy designed to coordinate the activities for preparing for, identifying, responding to, and recovering from cybersecurity threats.
As of December 31, 2024, we are not aware of any cybersecurity threats, including as a result of any previous cybersecurity incidents, that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition. However, evolving cybersecurity threats make it increasingly challenging to anticipate, detect, and defend against cybersecurity threats and incidents.
As of December 31, 2025 , we are not aware of any cybersecurity threats, including as a result of any previous cybersecurity incidents, that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition.
Item 1C. Cyber security. Risk Management and Strategy We have established policies and processes for assessing, identifying, and managing the risks from foreseeable cybersecurity threats and for detecting and responding to any cybersecurity incidents. These policies and processes are built into our information technology (“IT”) function and are designed to align with the NIST Cybersecurity Framework, published by the U.S.
Item 1C. Cyber security. Risk Management and Strategy We have established policies and processes for assessing, identifying, and managing the risks from foreseeable cybersecurity threats and for detecting and responding to any cybersecurity incidents.
Added
These policies and processes are built into our IT function and are designed to align with key principles of the NIST Cybersecurity Framework, published by the U.S. National Institute of Standards and Technology.
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We also use a number of means to assess cyber risks related to our third-party service providers, including conducting due diligence in connection with onboarding new vendors and periodic ongoing due diligence with key third-party vendors.
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We also seek to collect and assess cybersecurity audit reports and other supporting documentation when available and include appropriate security terms in our contracts where applicable as part of our oversight of third party providers.
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However, evolving cybersecurity threats make it increasingly challenging to anticipate, detect, and defend against cybersecurity threats and incidents.

Item 2. Properties

Properties — owned and leased real estate

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We lease this space under a lease agreement that is scheduled to expire on April 30, 2025. Additionally, we lease laboratory and office space in Newton, Massachusetts for research and development purposes. We lease this space under a lease agreement that is scheduled to expire on November 30, 2025.
Additionally, we lease laboratory and office space in Newton, Massachusetts for research and development purposes. We lease this space under a lease agreement that is scheduled to expire in December 2027.
Item 2. Pr operties. We operate as a hybrid company with employees working at our principal office in Waltham, Massachusetts, our laboratory in Newton, Massachusetts and remotely. 99 Our principal office is located at 1601 Trapelo Road, Suite 178, Waltham, MA, 02451, where we lease 9,600 square feet of office space for general and administrative purposes.
Item 2. Pr operties. We operate as a hybrid company with employees working at our principal office in New Haven, Connecticut, our laboratory in Newton, Massachusetts and remotely. 103 Our principal office is located at 209 Church Street, New Haven, Connecticut 06510, where we lease office space for general and administrative purposes.
Added
We lease this space under a lease agreement that is scheduled to expire in May 2026. In January 2026, we entered into an agreement to lease office space in New Haven, Connecticut for general and administrative purposes.
Added
The term of the lease will commence after the later of (i) the date on which landlord improvements to the premises are deemed to be substantially completed, or (ii) the delivery of the lender consent package. The lease has an initial term of one hundred twenty-nine months, measured from the lease commencement date.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Significant judgment is required to determine both probability and estimated exposure amount. Legal fees and other costs associated with such proceedings are expensed as incurred. As of December 31, 2024, we were not a party to any material legal proceedings. Item 4. Mine Safety Disclosures. Not applicable. 100 PART II
Significant judgment is required to determine both probability and estimated exposure amount. Legal fees and other costs associated with such proceedings are expensed as incurred. As of December 31, 2025, we were not a party to any material legal proceedings. Item 4. Mine Safety Disclosures. Not applicable. 104 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Purchases of Equity Securities by the Issuer and Affiliated Purchasers We did not repurchase any of our equity securities during the quarter ended December 31, 2024. Item 6. [ R eserved] 101
Purchases of Equity Securities by the Issuer and Affiliated Purchasers We did not repurchase any of our equity securities during the quarter ended December 31, 2025. Item 6. [ R eserved] 105
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is listed on the Nasdaq Global Market under the symbol “IVVD”. Holders of Record As of March 11, 2025, there were 8 holders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is listed on the Nasdaq Global Market under the symbol “IVVD”. Holders of Record As of March 1, 2026, there were 7 holders of record of our common stock.
Securities Authorized for Issuance under Equity Compensation Plans Information regarding securities authorized for issuance under equity compensation plans is incorporated by reference into the information in Part III, Item 12 of this Annual Report on Form 10-K.
Securities Authorized for Issuance under Equity Compensation Plans Information regarding securities authorized for issuance under equity compensation plans is incorporated by reference into the information in Part III, Item 12 of this Annual Report on Form 10-K. Recent Sales of Unregistered Securities We did not issue any unregistered equity securities during the twelve months ended December 31, 2025.
Removed
Recent Sales of Unregistered Securities Other than as previously disclosed on our Current Reports on Form 8-K or Quarterly Reports on Form 10-Q, we did not issue any unregistered equity securities during the twelve months ended December 31, 2024.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Our research and development costs consist primarily of external costs, such as fees paid to a CDMO, CROs and consultants in connection with our nonclinical studies, preclinical studies, clinical trials and product manufacturing. To date, external research and development costs for any individual product candidate have been tracked commencing upon product candidate nomination.
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.
Financing Activities Net cash provided by financing activities during the year ended December 31, 2024 consisted of $39.3 million from the issuance of common stock under the Sales Agreement, $0.4 million from exercises of stock options, and $0.2 million from issuances of common stock under our employee stock purchase plan, partially offset by $0.6 million in payments for offering costs related to the Sales Agreement.
Net cash provided by financing activities during the year ended December 31, 2024 consisted of $39.3 million from the issuance of common stock under the Sales Agreement, $0.4 million from exercises of stock options, and $0.2 million from issuances of common stock under our employee stock purchase plan, partially offset by $0.6 million in payments for offering costs related to the Sales Agreement.
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.
In September 2022, we entered into the Adimab Platform Transfer Agreement with Adimab, under which we were granted the right under certain intellectual property of Adimab to practice certain elements of Adimab’s platform technology, 113 including B-cell cloning using Adimab’s proprietary yeast cell lines and other antibody optimization libraries, trade secrets, protocols and software of Adimab, to discover, engineer and optimize antibodies.
In September 2022, we entered into the Adimab Platform Transfer Agreement with Adimab, under which we were granted the right under certain intellectual property of Adimab to practice certain elements of Adimab’s platform technology, including B-cell cloning using Adimab’s proprietary yeast cell lines and other antibody optimization libraries, trade secrets, protocols and software of Adimab, to discover, engineer and optimize antibodies.
This process involves estimating the level of service performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments.
This process involves estimating the level of service performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; 121 however, some require advance payments.
The co-pay assistance program assists certain commercially insured patients by reducing each participating patient’s financial responsibility for the purchase price, up to a specified dollar amount of assistance. 115 Accrued Research and Development Expenses As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses.
The co-pay assistance program assists certain commercially insured patients by reducing each participating patient’s financial responsibility for the purchase price, up to a specified dollar amount of assistance. Accrued Research and Development Expenses As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses.
Such costs consist of: • personnel-related expenses, including salaries, bonuses, benefits, third-party fees and other compensation-related costs, including stock-based compensation expense, for employees engaged in research and development functions; • expenses incurred under agreements with third parties, such as collaborators, consultants, contractors and CROs, that conduct the discovery, nonclinical and preclinical studies and clinical trials of our product candidates and research programs; 104 • costs of procuring manufactured product candidates for use in nonclinical studies, preclinical studies, clinical trials and for commercial supply, prior to receiving authorization or approval, from a third-party CDMO; • costs of outside consultants and advisors, including their fees and stock-based compensation; • laboratory-related expenses, which include equipment, laboratory supplies, rent expense, depreciation expense, and other operating costs; • payments made under third-party licensing agreements; and • other expenses incurred as a result of research and development activities.
Such costs consist of: • personnel-related expenses, including salaries, bonuses, benefits, third-party fees and other compensation-related costs, including stock-based compensation expense, for employees engaged in research and development functions; • expenses incurred under agreements with third parties, such as collaborators, consultants, contractors and CROs, that conduct the discovery, nonclinical and preclinical studies and clinical trials of our product candidates and research programs; • costs of procuring manufactured product candidates for use in nonclinical studies, preclinical studies, clinical trials and for commercial supply, prior to receiving authorization or approval, from a third-party CDMO; • costs of outside consultants and advisors, including their fees and any stock-based compensation; • laboratory-related expenses, which include equipment, laboratory supplies, rent expense, depreciation expense, and other operating costs; • payments made under third-party licensing agreements; and • other expenses incurred as a result of research and development activities.
At contract inception, we assess the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each 114 promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
At contract inception, we assess the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Under ASC 606, an entity recognizes revenue when or as performance obligations are satisfied by transferring control of promised goods or services to the customer, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services.
Under ASC 606, an entity recognizes revenue when or as performance obligations are satisfied by transferring control of 120 promised goods or services to the customer, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services.
This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of: • the timing and progress of preclinical and clinical development activities; • the number and scope of preclinical and clinical programs we decide to pursue; • filing acceptable IND applications with the FDA or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates; • sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials, manufacture the product candidates and complete associated regulatory activities; • our ability to establish and maintain agreements with third-party manufacturers for clinical supply for our clinical trials and successfully develop, obtain regulatory authorization or approval for our product candidates; • 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 prevalence, nature and severity of adverse events experienced with any product candidates; • the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder; • 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 protecting our rights in our intellectual property portfolio; 105 • our ability to maintain compliance with regulatory requirements, including current Good Clinical Practices, current Good Laboratory Practices and cGMPs, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products; • timely receipt of regulatory authorizations or approvals from applicable regulatory authorities; • potential significant and changing government regulation, regulatory guidance and requirements and evolving treatment guidelines; and • the impact of any business interruptions to our operations or those of third parties with which we work, including as a result of any public health crisis.
This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of: • the timing and progress of preclinical and clinical development activities; 109 • the number and scope of preclinical and clinical programs we decide to pursue; • filing acceptable IND applications with the FDA or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates; • sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials, manufacture the product candidates and complete associated regulatory activities; • our ability to establish and maintain agreements with third-party manufacturers for clinical supply for our clinical trials and successfully develop, obtain regulatory authorization or approval for our product candidates; • 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 obtain through collaborations, licenses or acquisitions; • the prevalence, nature and severity of adverse events experienced with any product candidates; • the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder; • 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 protecting our rights in our intellectual property portfolio; • our ability to maintain compliance with regulatory requirements, including current Good Clinical Practices, current Good Laboratory Practices and cGMPs, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products; • timely receipt of regulatory authorizations or approvals from applicable regulatory authorities; • potential significant and changing government regulation, regulatory guidance and requirements and evolving treatment guidelines; and • the impact of any business interruptions to our operations or those of third parties with which we work, including as a result of any public health crisis.
Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including: • the revenue received from sales of PEMGARDA and any other product candidates for which we receive future regulatory authorization or approval; • the rate of progress in the development of our product candidates, such as VYD2311; • the scope, progress, results and costs of discovery, nonclinical studies, preclinical development, laboratory testing and clinical trials for our product candidates and associated development programs; • the extent to which we develop, in-license or acquire other product candidates, intellectual property and/or technologies; • the scope, progress, results and costs of manufacturing and validation activities associated with our current product candidates with the development and manufacturing of our future product candidates as we advance them through preclinical and clinical development; • the number and development requirements of product candidates that we may pursue; • 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 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; • the costs necessary to obtain regulatory authorizations or approvals, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where authorization or approval is obtained; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; • the continuation of our existing licensing and collaboration arrangements and entry into new collaborations and licensing arrangements, if at all; • the costs we incur in maintaining business operations; • the need to implement additional internal systems and infrastructure; • the effect of competing technological, product and market developments; • the costs of operating as a public company; and • the impact of any business interruptions to our operations or to those of our third-party contractors resulting from any public health crisis.
Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including: • the revenue received from sales of PEMGARDA and any other product candidates for which we receive future regulatory authorization or approval; • the scope, progress, results and costs of discovery, nonclinical studies, preclinical development, laboratory testing and clinical trials for our product candidates and associated development programs, including our REVOLUTION clinical program; • the extent to which we develop, in-license or acquire other product candidates, intellectual property and/or technologies; • the scope, progress, results and costs of manufacturing and validation activities associated with our current product candidates with the development and manufacturing of our future product candidates as we advance them through preclinical and clinical development; • the number and development requirements of product candidates that we may pursue; • 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 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; • the costs necessary to obtain regulatory authorizations or approvals, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where authorization or approval is obtained; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; • the continuation of our existing licensing and collaboration arrangements and entry into new collaborations and licensing arrangements, if at all; • the costs we incur in maintaining business operations; • the need to implement additional internal systems and infrastructure; • the effect of competing technological, product and market developments; • the costs of operating as a public company; and • the impact of any business interruptions to our operations or to those of our third-party contractors resulting from any public health crisis.
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.
For so long 122 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.
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 December 31, 2024, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years.
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 December 31, 2025, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years.
Therefore, we estimate our expected stock volatility based on the historical volatility of a publicly traded set of peer companies and we expect to continue to do so until such time that we have adequate historical data regarding the volatility of our own traded stock price. We have primarily issued awards with service-based vesting conditions through December 31, 2024.
Therefore, we estimate our expected stock volatility based on the historical volatility of a publicly traded set of peer companies and we expect to continue to do so until such time that we have adequate historical data regarding the volatility of our own traded stock price. We have primarily issued awards with service-based vesting conditions through December 31, 2025.
To the extent that we raise 111 additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a common stockholder.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interest will be diluted, 117 and the terms of such securities may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a common stockholder.
Product Returns We offer a right of return for purchased units of PEMGARDA for damage, defect, recall, and/or product expiry, provided the product expiry is within a specified period as set forth in the Company’s return goods policy. We estimate the amount of product sales that will be returned using quantitative and qualitative considerations.
Product Returns We offer a right of return for purchased units of PEMGARDA for damage, defect, recall, and/or product expiry, provided the product expiry is within a specified period as set forth in our return goods policy. We estimate the amount of product sales that will be returned using quantitative and qualitative considerations.
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 our other product candidates.
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.
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.
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 December 31, 2026.
Operating Lease Commitments In September 2021, we entered into a five-year noncancelable facilities lease agreement for approximately 9,600 square feet of office space in Waltham, Massachusetts, which provides for monthly rental payments, including base rent charges of $0.4 million per year, subject to periodic rent increases, and our proportionate share of operating expenses.
Operating Lease Commitments In September 2021, we entered into a five-year facilities lease agreement for approximately 9,600 square feet of office space in Waltham, Massachusetts, which provided for monthly rental payments, including base rent charges of $0.4 million per year, subject to periodic rent increases, and our proportionate share of operating expenses.
On a quarterly basis, we update our estimates, if necessary, and record any material adjustments in the period they are identified. Trade Discounts and Distributor Fees We provide customary discounts on PEMGARDA sales for prompt payment, the terms of which are explicitly stated in our contracts.
On a quarterly basis, we update our estimates, if necessary, and record any material adjustments in the period they are identified. Trade Discounts, Group Purchase Organization and Distributor Fees We provide customary discounts on PEMGARDA sales for prompt payment, the terms of which are explicitly stated in our contracts.
During the year ended December 31, 2024, we expensed $1.0 million of royalties, while reserving all rights under the Adimab Assignment Agreement and the applicable law. Further, we are obligated to pay Adimab royalties of a specified percentage in the range of 45% to 55% of any compulsory sublicense consideration received by us in lieu of certain royalty payments.
During the year ended December 31, 2025, we expensed $2.1 million of royalties, while reserving all rights under the Adimab Assignment Agreement and the applicable law. Further, we are obligated to pay Adimab royalties of a specified percentage in the range of 45% to 55% of any compulsory sublicense consideration received by us in lieu of certain royalty payments.
Liquidity and Capital Resources Sources of Liquidity Through December 31, 2024, we have incurred significant operating losses and negative cash flows from operations.
Liquidity and Capital Resources Sources of Liquidity Through December 31, 2025, we have incurred significant operating losses and negative cash flows from operations.
Our expenses could increase substantially in connection with our ongoing activities, as we: • continue to commercialize PEMGARDA; • advance the development of VYD2311; • initiate and conduct clinical trials of our product candidates; • 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; • seek regulatory authorization or approval for any product candidates that successfully complete clinical trials; • pursue coverage and reimbursement for our product candidates, if authorized or approved; • acquire or in-license other product candidates, intellectual property and/or technologies; • further develop and validate our commercial-scale current Good Manufacturing Practices (“cGMP”) manufacturing process and manufacture material under cGMP at our contracted manufacturing facilities for clinical trials and commercial sales; • maintain, expand, enforce, defend and protect our intellectual property portfolio; • comply with regulatory requirements established by the applicable regulatory authorities; • maintain and expand a sales, marketing and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory authorization or approval; 103 • hire and retain personnel, including research, clinical, development, manufacturing, quality control, quality assurance, regulatory, scientific and other personnel; and • incur additional legal, accounting and other expenses in operating as a public company.
Our expenses could increase substantially in connection with our ongoing activities, as we: • continue to commercialize PEMGARDA; 107 • 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; • 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, 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; • pursue coverage and reimbursement for our product candidates, if authorized or approved; • acquire or in-license other product candidates, intellectual property and/or technologies; • further develop and validate our commercial-scale current Good Manufacturing Practices (“cGMP”) manufacturing process and manufacture material under cGMP at our contracted manufacturing facilities for clinical trials and commercial sales; • maintain, expand, enforce, defend and protect our intellectual property portfolio; • comply with regulatory requirements established by the applicable regulatory authorities; • maintain and expand a sales, marketing and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory authorization or approval; • hire and retain personnel, including research, clinical, development, manufacturing, quality control, quality assurance, regulatory, scientific and other personnel; and • incur additional legal, accounting and other expenses in operating as a public company.
Such fees are not for a distinct good or service and, accordingly, are recorded as a reduction of revenue, as well as a reduction to accounts receivable (trade discounts) or as a component of accrued expenses (distributor fees). Government Chargebacks We are subject to discount obligations under our contract with the U.S. Department of Veterans Affairs.
Such fees are not for a distinct good or service and, accordingly, are recorded as a reduction of revenue, as well as a reduction to accounts receivable (trade discounts) or as a component of accrued expenses (distributor and GPO fees). Chargebacks We are subject to discount obligations under our contract with the U.S.
For each option exercised by us to commercialize a specific research program, we are obligated to pay Adimab an exercise fee of $1.0 million. During the year ended December 31, 2024, we were not obligated to pay any option exercise fee, a drug delivery fee, or optimization completion fee.
For each option exercised by us to commercialize a specific research program, we are obligated to pay Adimab an exercise fee of $1.0 million. During the years ended December 31, 2025 and 2024, we were not obligated to pay any option exercise fee, a drug delivery fee, or optimization 119 completion fee.
After the initial public offering, the fair value of our common stock is based on the quoted market price of our common stock. Due to the proximity to the IPO, we continue to lack company-specific historical and implied volatility information.
The fair value of our common stock is based on the quoted market price of our common stock. Due to the proximity to the IPO, we continue to lack company-specific historical and implied volatility information.
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 against the same contemporary viruses, and 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 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.
After receiving EUA in March 2024, 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.
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.
The amount and timing of such royalty payments are not known. For additional information, see Note 7 to our annual consolidated financial statements appearing at the end of this Annual Report on Form 10-K. In July 2020, we entered into the Adimab Assignment Agreement with Adimab, with respect to discovery and optimization of coronavirus-specific antibodies, including COVID-19 and SARS.
For additional information, see Note 7 to our annual consolidated financial statements appearing at the end of this Annual Report on Form 10-K. In July 2020, we entered into the Adimab Assignment Agreement with Adimab, with respect to discovery and optimization of coronavirus-specific antibodies, including COVID-19 and SARS.
Acquired In-Process Research and Development ("IPR&D") Expenses There was no IPR&D expense recognized for the year ended December 31, 2024.
Acquired In-Process Research and Development ( “ IPR&D ” ) Expenses There was no IPR&D expense recognized for the years ended December 31, 2025 and 2024.
Future minimum lease payments under the noncancelable leases as of December 31, 2024 were as follows (in thousands): Year Ending December 31, Operating Lease 2025 1,335 Total lease payments 1,335 Present value adjustment (31 ) Present value of operating lease liability $ 1,304 112 Other Commitments Under a separate cell line license agreement with WuXi Biologics, we are obligated to pay royalties of less than 1.0% to WuXi Biologics based on our net sales of any products covered by the license.
Future minimum lease payments under the noncancelable leases as of December 31, 2025 were as follows (in thousands): Year Ending December 31, Operating Lease 2026 $ 1,320 2027 $ 1,320 Total lease payments 2,640 Present value adjustment (146 ) Present value of operating lease liability $ 2,494 Other Commitments Under a separate cell line license agreement with WuXi Biologics, we are obligated to pay royalties of less than 1.0% to WuXi Biologics based on our net sales of any products covered by the license.
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 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 2024, the Newton, MA Lease was further amended to extend the lease through November 2025, with an option to further extend the lease for an additional twenty-five months or continue the lease on a month-to-month basis after completion of the term ending in November 2025.
In August 2024 and May 2025, the Newton, MA Lease was further amended to extend the lease through December 2027, with an option to further extend the lease for an additional twenty-four months or continue the lease on a month-to-month basis after completion of the term ending in December 2027.
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.
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.
The Commercial Manufacturing Agreement outlines the terms and conditions under which WuXi Biologics manufactures drug substance and drug product for commercial use. During the year ended December 31, 2024, we committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.
The Commercial Manufacturing Agreement outlines the terms and conditions under which WuXi Biologics manufactures drug substance and drug product for commercial use. Through December 31, 2025, we committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.
Our research and development expenses will increase as we continue advancing VYD2311 through clinical development, pursue EUA or regulatory approval of our product candidates, and continue to discover and develop additional product candidates.
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 next potential milestone under the Adimab Assignment Agreement is a low single-digit million-dollar regulatory milestone. In addition, we are obligated to pay Adimab royalties of a mid-single-digit percentage based on our net sales of products under the agreement, beginning upon the first commercial sale of a product in accordance with the terms of the Adimab Assignment Agreement.
In addition, we are obligated to pay Adimab royalties of a mid-single-digit percentage based on our net sales of products under the agreement, beginning upon the first commercial sale of a product in accordance with the terms of the Adimab Assignment Agreement.
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.
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.
Investing Activities Net cash used in investing activities during the year ended December 31, 2024 consisted of $0.1 million in purchases of property and equipment.
Investing Activities Net cash used in investing activities during the years ended December 31, 2025 and 2024 consisted of $0.2 million and $0.1 million, respectively, in purchases of property and equipment.
Contractual Obligations and Commitments Clinical and Manufacturing Commitments In December 2020, we entered into a Commercial Manufacturing Services Agreement with WuXi Biologics, which was amended and restated in August 2021 and further amended and restated in September 2023 (as amended and restated, the “Commercial Manufacturing Agreement”).
In December 2020, we entered into a Commercial Manufacturing Services Agreement with WuXi Biologics, which was amended and restated in August 2021, further amended and restated in September 2023 and amended in March 2026 (as amended and restated and subsequently amended, the “Commercial Manufacturing 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”), 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.
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 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”).
By leveraging our capabilities, which we have developed through our experience with adintrevimab and pemivibart and nearly 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.
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.
Funding Requirements Our expenses could increase in connection with our ongoing activities, particularly as we advance the nonclinical and preclinical studies and the clinical trials of our product candidates, including any associated manufacturing activities, and 110 commercialization efforts.
Funding Requirements Our expenses could 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 116 and commercialization activities.
The $1.6 million increase is the result of PEMGARDA product sales following launch and certain period costs. 107 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.
The $2.1 million increase is the result of sales related to PEMGARDA due to an increase in product demand 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.
Further, in 2022, we secured dedicated laboratory space and expanded our research team in order to enable internal discovery and development of our mAb candidates, while continuing to leverage our existing partnership with Adimab, LLC (“Adimab”). We are focused on antibody discovery and use of Adimab’s platform technology, while building our internal capabilities.
In 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.
We also pay fees to specialty distributors for sales order management, data, and distribution services, the terms of which are also explicitly stated in our contracts.
We also pay fees to specialty distributors for sales order management, data, and distribution services, as well as fees to group purchasing organizations (“GPO”) for administrative services, the terms of which are also explicitly stated in our contracts.
Through December 31, 2024, 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. As of December 31, 2024, the total remaining contractually binding purchase obligations due to WuXi Biologics was $11.6 million, which is expected to be paid in 2025.
Through December 31, 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. As of December 31, 2025, the total remaining contractually binding purchase obligations due to WuXi Biologics was $3.5 million, which was included in accrued expenses.
The Phase 1 clinical trial is being conducted in Australia and is evaluating multiple dose levels of VYD2311 through various routes of administration, including exploration of intramuscular administration and subcutaneous administration, which are designed to be more system- and patient-friendly than intravenous administration.
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.
The maximum aggregate amount of milestone payments payable under the agreement for any and all products under the agreement is $24.6 million, of which a total of $11.1 million has been achieved and paid as of December 31, 2024.
The maximum aggregate amount of milestone payments payable under the agreement for any and all products under the agreement is $24.6 million, of which a total of $11.1 million has been achieved and paid as of December 31, 2025. The next potential milestone under the Adimab Assignment Agreement is a low single-digit million-dollar regulatory milestone.
Since our inception, we have incurred significant losses, including a net loss of $169.9 million for the year ended December 31, 2024. As of December 31, 2024, we had an accumulated deficit of $902.0 million.
Since our inception, we have incurred significant losses, including a net loss of $52.5 million for the year ended December 31, 2025. As of December 31, 2025, we had an accumulated deficit of $954.5 million.
During the year ended December 31, 2023, operating activities used $173.2 million of cash, primarily due to our net loss of $198.6 million, partially offset by non-cash charges of $19.6 million and changes in our operating assets and liabilities of $5.8 million.
During the year ended December 31, 2024, operating activities used $170.5 million of cash, primarily due to our net loss of $169.9 million and changes in our operating assets and liabilities of $23.5 million, partially offset by non-cash charges of $22.9 million.
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.
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.
This lease agreement is scheduled to expire on April 30, 2025. In June 2022, we entered into a two-year noncancelable agreement for dedicated laboratory and office space in Newton, Massachusetts (the “Newton, MA Lease”), which was amended in September 2022.
We exercised our option to terminate and this lease agreement expired in accordance with its terms on May 31, 2025. In June 2022, we entered into a two-year noncancelable agreement for dedicated laboratory and office space in Newton, Massachusetts (the “Newton, MA Lease”), which was amended in September 2022.
To date, 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, and with net proceeds of $39.3 million from sales of our common stock under the Sales Agreement (as defined below).
As of December 31, 2025, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, $327.5 million 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).
As of December 31, 2024, $27.5 million of the $27.6 million total remaining purchase obligation, related to the contractually binding commercial drug substance and drug product batches was included in accounts payable and accrued expenses, which is expected to be paid in 2025.
As of December 31, 2025, the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $10.6 million, which was included in accounts payable and accrued expenses. The remaining contractually binding purchase obligation was paid in January 2026.
The changes in our operating assets and liabilities primarily consisted of a $19.2 million increase in accrued expenses, a $6.5 million increase in accounts payable, and a $0.7 million increase in non-current liabilities, partially offset by a $18.9 million increase in prepaid expenses and other current assets, and a $1.6 million decrease in operating lease liabilities.
The changes in our operating assets and liabilities primarily consisted of a $30.8 million decrease in accrued expenses, a $3.3 million increase in accounts receivable, a $1.2 million decrease in operating lease liabilities, and a $0.4 million increase in inventory, partially offset by a $12.9 million decrease in prepaid expenses and a $3.2 million increase in accounts payable.
Net cash provided by financing activities during the year ended December 31, 2023 consisted of $1.0 million from exercises of stock options and $0.2 million from issuances of common stock under our employee stock purchase plan, partially offset by $0.1 million in payments for offering costs.
Financing Activities Net cash provided by financing activities during the year ended December 31, 2025 consisted of $182.5 million from the issuance of common stock and pre-funded warrants sold under the Underwriting Agreements, $33.4 million from the issuance of common stock under the Sales Agreement, $0.4 million from exercises of stock options, and $0.2 million from issuances of common stock under our employee stock purchase plan, partially offset by $0.6 million in payments for offering costs related to the Underwriting Agreements and $0.3 million in payments for offering costs related to the Sales Agreement.
Since our inception, we have financed our operations primarily with 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 million from sales of our common stock under the Sales Agreement (as defined below).
Since our inception and through December 31, 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 $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).
The increases in accounts payable and accrued expenses were primarily due to the timing of vendor invoicing and payments. The increase in prepaid expenses and other current assets was primarily due to prepayments and deposits to WuXi Biologics for commercial manufacturing.
The decrease 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 credits.
These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses.
Department of Veterans Affairs and GPOs where pricing on PEMGARDA is extended below wholesaler list price to participating entities and GPO members. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses.
Revenue is recognized when or as performance obligations are satisfied by transferring control of promised goods to a customer, generally upon delivery, based on an amount that reflects the consideration to which we expected to be entitled. To date, we have applied for mandatory distribution licenses that some states require for us to sell our product throughout the U.S.
Revenue is recognized when or as performance obligations are satisfied by transferring control of promised goods to a customer, generally upon delivery, based on an amount that reflects the consideration to which we expected to be entitled. Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances.
After receiving EUA in March 2024, we have also funded our operations from sales of PEMGARDA.
After receiving EUA in March 2024, we have also funded our operations from sales of PEMGARDA. As of December 31, 2025, we had cash and cash equivalents of $226.7 million.
The $21.4 million decrease in research and development expenses was primarily due to the following: • The decrease in direct costs related to our pemivibart program resulted from $60.2 million in contract costs for commercial manufacturing, $5.0 million in contract research costs for our Phase 3 CANOPY clinical trial, and $0.2 million in nonclinical expenses, partially offset by an increase of $0.5 million in other external expenses; • The increase in direct costs related to our VYD2311 program resulted from the nomination of our VYD2311 product candidate in the first quarter of 2024 and consisted primarily of contract manufacturing costs, nonclinical expenses and contract research costs for our Phase 1 clinical trial; • The decrease in direct costs related to our adintrevimab program of $3.3 million resulted from the nomination of our pemivibart product candidate in the first quarter of 2023; • The decrease in personnel related costs resulted from $6.6 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 decrease in external discovery-related and other costs resulted from $8.2 million in contract manufacturing costs related to our pipeline candidates and $3.7 million in other non-clinical expenses, partially offset by a $1.2 million increase in other external costs and $0.2 million in clinical trial expenses.
The $99.0 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 $13.7 million in contract research costs for our Phase 3 CANOPY clinical trial, $12.8 million in contract costs for commercial manufacturing, $1.4 million in nonclinical costs and $0.7 million in other external costs; • Decrease in direct costs related to our VYD2311 program resulted from decrease of $62.1 million in contract costs for clinical and commercial manufacturing and $1.8 million in nonclinical expenses, partially offset by increase of $0.6 million in clinical trial costs and $0.4 million in external discovery-related and other costs; • Increase in direct costs for our VBY329 program resulted from the nomination of VBY329 as an RSV mAb candidate in the fourth quarter of 2025, with costs resulting from $0.4 million in external discovery costs, as well as $0.2 million in nonclinical expense; • Decrease in direct costs related to our early-stage programs resulted from decrease of $0.9 million in contract development and manufacturing costs, partially offset by an increase of $0.3 million in external discovery-related and other costs; • Decrease in personnel related costs resulted from decrease of $6.5 million in headcount-related costs; and • Decrease in external discovery-related and other costs resulted from decrease of $1.2 million in other external costs and $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.
Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations and cash flows is disclosed in Note 2 to our consolidated financial statements appearing at the end of this Annual Report on Form 10-K. 116 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.
Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations and cash flows is disclosed in Note 2 to our consolidated financial statements appearing at the end of this Annual Report on Form 10-K.
VYD2311 is a mAb with high in vitro neutralization potency shown against prominent SARS-CoV-2 variants tested to date. The ongoing Phase 1 randomized, blinded, placebo-controlled clinical trial is evaluating escalating dosing as well as safety, tolerability, pharmacokinetics and immunogenicity of VYD2311 in healthy trial participants.
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.
Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries, bonuses, benefits, third-party fees and other compensation-related costs, including stock-based compensation, for our personnel and external contractors involved in our executive, finance, legal, business development and other administrative functions, as well as our commercial function.
We will recognize additional IPR&D expenses in the future if and when it is deemed probable that we will make contingent milestone payments to Adimab under the terms of the agreement by which we acquired the IPR&D assets. 110 Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries, bonuses, benefits, third-party fees and other compensation-related costs, including stock-based compensation, for our personnel and external contractors involved in our executive, finance, legal, business development and other administrative functions, as well as our commercial function.
Payments due upon cancellation consist only of payments for services provided and expenses incurred up to the date of cancellation, including non-cancelable obligations of our service providers and, in some cases, wind-down costs. The exact amounts of such obligations are dependent on the timing of termination and the terms of the associated agreement.
These contracts do not contain any minimum purchase commitments and provide for termination by us upon prior written notice. Payments due upon cancellation consist only of payments for services provided and expenses incurred up to the date of cancellation, including non-cancelable obligations of our service providers and, in some cases, wind-down costs.
We have not incurred material operating expenses for the rent, maintenance and insurance of facilities, or for the depreciation of fixed assets. 106 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.
Through December 31, 2025, 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 and cash equivalents.
There was no product revenue, net for the year ended December 31, 2023. The $25.4 million increase is the result of product sales in 2024 following the launch of PEMGARDA. Cost of Product Revenue Cost of product revenue was $1.6 million for the year ended December 31, 2024.
The $28.0 million increase is primarily the result of increased product sales in 2025 following the launch of PEMGARDA in the second quarter of 2024. Cost of Product Revenue Cost of product revenue was $3.7 million and $1.6 million for the years ended December 31, 2025 and 2024, respectively.
However, if we use WuXi Biologics to manufacture all of our commercial supplies, no royalties would be owed by us to WuXi Biologics for net sales of licensed products. We have an option to buy out our royalty obligations by making a one-time payment in the low eight-figures to WuXi Biologics.
However, if we use WuXi Biologics to manufacture all of our commercial supplies for a product under the cell line license agreement, no royalties would be owed by us to WuXi Biologics for net sales of such a licensed product.
For additional information, see Note 7 to our annual consolidated financial statements appearing at the end of this Annual Report on Form 10-K. In November 2022, we entered into the PHP MSA.
For additional information, see Note 7 to our annual consolidated financial statements appearing at the end of this Annual Report on Form 10-K. We enter into other contracts in the normal course of business with other third parties for preclinical research studies and testing, clinical trials, manufacturing and other services.
Research and Development Expenses Year Ended December 31, Year Ended December 31, (in thousands) 2024 2023 Change Direct, external research and development expenses by program: Pemivibart (1) $ 31,757 $ 96,695 $ (64,938 ) VYD2311 (2) 67,505 1,425 66,080 Adintrevimab 582 3,857 (3,275 ) Unallocated research and development expenses: Personnel related (including stock-based compensation) 21,274 30,074 (8,800 ) External discovery-related and other costs 16,136 26,607 (10,471 ) Total research and development expenses $ 137,254 $ 158,658 $ (21,404 ) (1) In March 2023, we announced the nomination of VYD222 (pemivibart) as a novel mAb therapeutic option for COVID-19.
Research and Development Expenses Year Ended December 31, Year Ended December 31, (in thousands) 2025 2024 Change Direct, external research and development expenses by program: Pemivibart (1) $ 3,140 $ 31,757 $ (28,617 ) VYD2311 (2) 4,597 67,505 (62,908 ) VBY329 (3) 615 — 615 Early-stage programs 428 974 (546 ) Unallocated research and development expenses: Personnel related (including stock-based compensation) 14,783 21,274 (6,491 ) External discovery-related and other costs (4) 14,745 15,744 (999 ) Total research and development expenses $ 38,308 $ 137,254 $ (98,946 ) (1) In March 2023, we announced the nomination of VYD222 (pemivibart) as a novel mAb therapeutic option for COVID-19.
The $14.3 million increase in selling, general and administrative expenses was primarily due to the following: • The increase in personnel related costs was primarily due to an increase in headcount-related costs, including an increase in stock-based compensation expense of $2.4 million that was primarily due to 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 increase in professional and consultant fees was primarily due to an $11.6 million increase related to the commercialization of PEMGARDA, partially offset by decreases of $0.9 million and $0.7 million in director and officer insurance premiums and professional service fees, respectively; and • The increase in other costs was primarily related to software license costs and related amortization.
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 $0.6 million in sales and marketing costs and $0.5 million in insurance costs, partially offset by increase 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 $1.2 million in other employee related travel expense. 113 Other Income Other income was $3.1 million and $7.0 million for the years ended December 31, 2025 and 2024, respectively, consisting primarily of interest earned on our invested cash balances.
Product revenue, net consists of product revenue earned on the sales of PEMGARDA in the U.S. Cost of Product Revenue Cost of product revenue includes PEMGARDA manufacturing costs, labor and overhead costs, and stability study costs. PEMGARDA manufacturing costs include manufacturing materials, third-party manufacturing costs, packaging costs, shipping costs, and royalties.
Cost of Product Revenue 108 Cost of product revenue includes PEMGARDA manufacturing costs, labor and overhead costs, and stability study costs. PEMGARDA manufacturing costs include manufacturing materials, third-party manufacturing costs, packaging costs, shipping costs, and royalties. Research and Development Expenses The nature of our business and primary focus of our activities generates a significant amount of research and development costs.
(2) In March 2024, we announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19. Research and development expenses were $137.3 million for the year ended December 31, 2024, compared to $158.7 million for the year ended December 31, 2023.
(2) In March 2024, we announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19. 112 (3) In November 2025, we announced the nomination of VBY329 as an RSV mAb candidate for preclinical development.
As of December 31, 2024, we had cash and cash equivalents of $69.3 million. 109 Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: Year Ended December 31, Year Ended December 31, (in thousands) 2024 2023 Net cash used in operating activities $ (170,491 ) $ (173,164 ) Net cash (used in) provided by investing activities (140 ) 280,684 Net cash provided by financing activities 39,331 1,045 Effect of exchange rate changes on cash and cash equivalents 8 — Net (decrease) increase in cash and cash equivalents $ (131,292 ) $ 108,565 Operating Activities During the year ended December 31, 2024, operating activities used $170.5 million of cash, primarily due to our net loss of $169.9 million and changes in our operating assets and liabilities of $23.5 million, partially offset by non-cash charges of $22.9 million.
The Loan Agreement provides for an unused term loan commitment fee equal to 1.00% of the Term Facility upon the earliest to occur of (a) July 1, 2027, (b) the occurrence of an Event of Default under the Loan Agreement and (c) the termination of the Loan Agreement; provided, that such fee will be waived by the Lender in the event that we have requested and the Lender has funded any loans under the Term Facility prior to such date. 115 Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: Year Ended December 31, Year Ended December 31, (in thousands) 2025 2024 Net cash used in operating activities $ (58,135 ) $ (170,491 ) Net cash used in investing activities (155 ) (140 ) Net cash provided by financing activities 215,630 39,331 Effect of exchange rate changes on cash and cash equivalents — 8 Net increase (decrease) in cash and cash equivalents $ 157,340 $ (131,292 ) Operating Activities During the year ended December 31, 2025, operating activities used $58.1 million of cash, primarily due to our net loss of $52.5 million and changes in our operating assets and liabilities of $19.6 million, partially offset by non-cash charges of $14.0 million.
In January 2025 and March 102 2025, we announced continued neutralizing activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2 variants XEC and LP.8.1, respectively.
In January 2025, March 2025 and August 2025, we announced continued neutralizing activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2 variants XEC, LP.8.1 and XFG, respectively. In 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.
Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023: Year Ended December 31, Year Ended December 31, (in thousands) 2024 2023 Change Revenue: Product revenue, net $ 25,384 $ — $ 25,384 Total revenue 25,384 — 25,384 Operating costs and expenses: Cost of product revenue 1,618 — 1,618 Research and development 137,254 158,658 (21,404 ) Acquired in-process research and development — 4,975 (4,975 ) Selling, general and administrative 63,388 49,125 14,263 Total operating costs and expenses 202,260 212,758 (10,498 ) Loss from operations (176,876 ) (212,758 ) 35,882 Other income: Other income, net 6,951 14,115 (7,164 ) Total other income, net 6,951 14,115 (7,164 ) Net loss $ (169,925 ) $ (198,643 ) $ 28,718 The following discussion presents the components of our expenses for the periods presented: Product Revenue, Net Product revenue, net was $25.4 million for the year ended December 31, 2024.
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. 111 Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024: Year Ended December 31, Year Ended December 31, (in thousands) 2025 2024 Change Revenue: Product revenue, net $ 53,426 $ 25,384 $ 28,042 Total revenue 53,426 25,384 28,042 Operating costs and expenses: Cost of product revenue $ 3,747 $ 1,618 $ 2,129 Research and development 38,308 137,254 (98,946 ) Selling, general and administrative 66,931 63,388 3,543 Total operating costs and expenses 108,986 202,260 (93,274 ) Loss from operations (55,560 ) (176,876 ) 121,316 Other income: Other income, net 3,071 6,951 (3,880 ) Total other income, net 3,071 6,951 (3,880 ) Net loss $ (52,489 ) $ (169,925 ) $ 117,436 The following discussion presents the components of our expenses for the periods presented: Product Revenue, Net Product revenue, net was $53.4 million and $25.4 million for the years ended December 31, 2025 and 2024, respectively.
Overview 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. On March 22, 2024, we received emergency use authorization (“EUA”) from the U.S.
Overview Invivyd, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of monoclonal antibody (“mAb”) therapies for the prevention and treatment of serious viral infectious diseases. We are devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2, the virus that causes COVID-19.
IPR&D expenses of $5.0 million for the year ended December 31, 2023 consisted of $3.6 million incurred related to milestones under the Adimab Assignment Agreement and $1.4 million incurred related to an option exercise fee, a drug discovery fee and an optimization completion fee under the Adimab Collaboration Agreement. 108 Selling, General and Administrative Expenses Year Ended December 31, Year Ended December 31, (in thousands) 2024 2023 Change Personnel related (including stock-based compensation) $ 29,909 $ 27,323 $ 2,586 Professional and consultant fees 29,773 19,833 9,940 Other 3,706 1,969 1,737 Total selling, general and administrative expenses $ 63,388 $ 49,125 $ 14,263 Selling, general and administrative expenses were $63.4 million for the year ended December 31, 2024, compared to $49.1 million for the year ended December 31, 2023.
Selling, General and Administrative Expenses Year Ended December 31, Year Ended December 31, (in thousands) 2025 2024 Change Personnel-related costs $ 31,256 $ 29,909 $ 1,347 Professional and consultant fees 29,698 29,773 (75 ) Other 5,977 3,706 2,271 Total selling, general and administrative expenses $ 66,931 $ 63,388 $ 3,543 Selling, general and administrative expenses were $66.9 million for the year ended December 31, 2025, compared to $63.4 million for the year ended December 31, 2024.

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