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What changed in Invivyd, Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of Invivyd, Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+730 added−683 removedSource: 10-K (2025-03-20) vs 10-K (2024-03-28)

Top changes in Invivyd, Inc.'s 2024 10-K

730 paragraphs added · 683 removed · 527 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

141 edited+59 added−31 removed322 unchanged
Biggest changeIn the traditional commercial 8 model, customers purchase the product directly from wholesalers and/or distributors and the product is shipped to the various sites of care, including provider institutions and clinics that bill health insurance plans for the product.
Biggest changeDistribution Strategy Unlike previous EUAs for COVID-19, where products were available via an Advance Purchase Agreement with the U.S. federal government, PEMGARDA follows a traditional commercial distribution model in which end customers purchase the product directly from third-party specialty distributors and the product is shipped to the various sites of care, including provider institutions, infusion centers and clinics that bill health insurance plans for the product. 12 We entered into a third-party logistics distribution agreement (the “3PL Agreement”) to engage a logistics distribution agent (the “3PL Agent”) to distribute our product to our end customers.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the FDCA, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the FDCA, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner.
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.
A Pediatric Investigation Plan (“PIP”) in the European Union is aimed at ensuring that the necessary data are obtained to support the authorization of a medicine for children, through studies in children.
A Pediatric Investigation Plan (“PIP”) in the European Union is aimed at ensuring that the necessary data are obtained to support the authorization of medicine for children, through studies in children.
Violations of the rules governing the promotion of medicinal products in the European Union could be penalized by administrative measures, fines and imprisonment; • HIPAA created additional federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or making any false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, impose obligations on certain types of individuals and entities regarding the electronic exchange of information in common healthcare transactions, as well as standards relating to the privacy and security of individually identifiable health information.
Violations of the rules governing the promotion of medicinal products in the European Union could be penalized by administrative measures, fines and imprisonment; • HIPAA created additional federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or making any false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services, including those by private payors; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, impose obligations on certain types of individuals and entities regarding the electronic exchange of information in common healthcare transactions, as well as standards relating to the privacy and security of individually identifiable health information.
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 application for 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”); 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.
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 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 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.
Food and Drug Administration (“FDA”) for PEMGARDA™ (pemivibart) 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 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 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 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).
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; 29 • 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; 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.
To support the EUA for PEMGARDA, an 10 immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum neutralization titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA.
To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum neutralization titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA.
Although we generally require all of our employees to assign their 16 inventions to us, and require all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed with all third parties who may have helped to develop our intellectual property or who had access to our proprietary information, or that our agreements will not be breached.
Although we generally require all of our employees to assign their inventions to us, and require all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed with all third parties who may have helped to develop our intellectual property or who had access to our proprietary information, or that our agreements will not be breached.
These laws may differ from 22 each other in significant ways, thus complicating compliance efforts. Federal regulators, state attorneys general, and plaintiffs’ attorneys have been and will likely continue to be active in this space. Activities outside of the U.S. implicate local and national data protection standards, impose additional compliance requirements and generate additional risks of enforcement for non-compliance.
These laws may differ from each other in significant ways, thus complicating compliance efforts. Federal regulators, state attorneys general, and plaintiffs’ attorneys have been and will likely continue to be active in this space. Activities outside of the U.S. implicate local and national data protection standards, impose additional compliance requirements and generate additional risks of enforcement for non-compliance.
We expect that changes or additions to the ACA, IRA or their implementing regulations or guidance, changes to the Medicare and Medicaid programs, changes regarding the federal government’s authority to directly negotiate drug prices and changes stemming from other 31 healthcare reform measures, especially with regard to healthcare access or financing or other legislation in individual states, could have a material adverse effect on the healthcare industry and our business.
We expect that changes or additions to the ACA, IRA or their implementing regulations or guidance, changes to the Medicare and Medicaid programs, changes regarding the federal government’s authority to directly negotiate drug prices and changes stemming from other healthcare reform measures, especially with regard to healthcare access or financing or other legislation in individual states, could have a material adverse effect on the healthcare industry and our business.
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 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 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.
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 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.
If ongoing regulatory requirements are not met, safety problems occur after a product reaches market, or additional data change the FDA’s view of the risk-benefit profile of the product, the 21 FDA may take actions to change the conditions under which the product is marketed, such as requiring labeling modifications, restricting distribution, or even withdrawing authorization or approval.
If ongoing regulatory requirements are not met, safety problems occur after a product reaches market, or additional data change the FDA’s view of the risk-benefit profile of the product, the FDA may take actions to change the conditions under which the product is marketed, such as requiring labeling modifications, restricting distribution, or even withdrawing authorization or approval.
Expedited Review and Approval Programs The FDA has various programs, including fast track designation, priority review, accelerated approval and breakthrough therapy designation, that are intended to expedite the process for the development and FDA review of certain biological product candidates that are intended for the treatment of serious or life-threatening diseases or conditions and demonstrate the potential to address unmet medical needs.
Expedited Review and Approval Programs The FDA has various approaches, including fast track designation, priority review, accelerated approval and breakthrough therapy designation, that are intended to expedite the process for the development and/or FDA review of certain biological product candidates that are intended for the treatment of serious or life-threatening diseases or conditions and demonstrate the potential to address unmet medical needs.
This means that medicinal products that are tested and released in the United Kingdom must be retested and re-released when entering the European Union market for commercial use. As it relates to marketing authorizations, Great Britain has introduced a separate regulatory submission process, approval process and a separate national marketing authorization.
This means that medicinal products that are tested and released in the United Kingdom must be retested and re-released when entering the European Union market for commercial use. As it relates to marketing 28 authorizations, Great Britain has introduced a separate regulatory submission process, approval process and a separate national marketing authorization.
However, as of January 1, 2024, Great Britain implemented the international recognition procedure (the “IRP”) which provides for an expedited authorization procedure for applicants that have already received an authorization for the same product from one of MHRA’s specified reference regulators (each, an “RR”). A positive opinion from the CHMP is considered for this purpose as an “RR” authorization”.
However, as of January 1, 2024, Great Britain implemented the international recognition procedure (the “IRP”) which provides for an expedited authorization procedure for applicants that have already received an authorization for the same product from one of MHRA’s specified reference regulators (each, an “RR”). A positive opinion from the CHMP is considered for this purpose as an “RR” authorization.
The FDA and the sponsor must reach agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based 20 on data collected from nonclinical studies, early phase clinical trials, and/or other clinical development programs.
The FDA and the sponsor must reach agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from nonclinical studies, early phase clinical trials, and/or other clinical development programs.
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 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act, and the regulations promulgated thereunder.
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”).
Manufacturing Strategy We do not currently own or operate any manufacturing facilities and have invested significant resources to develop commercial-scale manufacturing in partnership with our contract manufacturer partner, WuXi Biologics, with whom we have been working since our inception. We have contracted with WuXi Biologics for the manufacturing of commercial-scale PEMGARDA and VYD2311.
Manufacturing Strategy We do not currently own or operate any manufacturing facilities, and we have invested significant resources to develop commercial-scale manufacturing in partnership with our sole contract manufacturer partner, WuXi Biologics, with whom we have been working since our inception. We have contracted with WuXi Biologics for the manufacturing of commercial-scale PEMGARDA and VYD2311.
In the European Union, for example, the Clinical Trials Regulation (Regulation (EU) No 536/2014) (the “Current CTR”) came into effect on January 31, 2022, and is directly applicable in all the European Union Member States, repealing the previous 24 Clinical Trials Directive (Directive 2001/20/EC) (the “Previous CTD”) which previously regulated clinical trials in the European Union.
In the European Union, for example, the Clinical Trials Regulation (Regulation (EU) No 536/2014) (the “Current CTR”) came into effect on January 31, 2022, and is directly applicable in all the European Union Member States, repealing the previous Clinical Trials Directive (Directive 2001/20/EC) (the “Previous CTD”) which previously regulated clinical trials in the European Union.
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.
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.
By coupling ongoing variant surveillance and prediction of viral evolution with our discovery and engineering capabilities, our innovation engine has generated a pipeline of therapeutic candidates which could be used in prevention or treatment of serious viral diseases, starting with SARS-CoV-2.
By coupling ongoing variant surveillance and prediction of viral evolution with our discovery and engineering capabilities, our innovation engine has generated a pipeline of therapeutic candidates which could be used in prevention or treatment of serious viral diseases, 7 starting with SARS-CoV-2.
The application also needs to be published and submitted in an electronic format that can be processed through the FDA’s electronic 19 systems. If the electronic submission is not compatible with the FDA’s systems, the BLA can be refused for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA.
The application also needs to be published and submitted in an electronic format that can be processed through the FDA’s electronic systems. If the electronic submission is not compatible with the FDA’s systems, the BLA can be refused for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA.
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.
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.
PEMGARDA and VYD2311 are produced using an industry standard mAb manufacturing process including a recombinant Chinese Hamster Ovary (“CHO”) commercial cell line, fed-batch suspension cell culture and a chromatography column-based purification process. The drug product manufacture uses an industry standard sterile liquid drug product manufacturing process.
PEMGARDA and VYD2311 are produced using an industry standard mAb manufacturing process including a recombinant Chinese Hamster Ovary commercial cell line, fed-batch suspension cell culture and a chromatography column-based purification process. The drug product manufacture uses an industry standard sterile liquid drug product manufacturing process.
If a European Union Member State cannot approve the assessment report and related materials due to concerns 25 relating to a potential serious risk to public health, disputed elements may be referred to the European Commission, whose decision is binding on all European Union Member States.
If a European Union Member State cannot approve the assessment report and related materials due to concerns relating to a potential serious risk to public health, disputed elements may be referred to the European Commission, whose decision is binding on all European Union Member States.
The TCA also encourages, although it does not oblige, the parties to consult one 26 another on proposals to introduce significant changes to technical regulations or inspection procedures. Among the areas of absence of mutual recognition are batch testing and batch release.
The TCA also encourages, although it does not oblige, the parties to consult one another on proposals to introduce significant changes to technical regulations or inspection procedures. Among the areas of absence of mutual recognition are batch testing and batch release.
In addition, biological products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments.
Biological products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments.
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 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.
Our pending Patent Cooperation Treaty 15 (“PCT”) patent applications are not eligible to become issued patents until, among other things, we file a national stage patent application within 30 months in the countries in which we seek patent protection.
Our pending Patent Cooperation Treaty (“PCT”) patent applications are not eligible to become issued patents until, among other things, we file a national stage patent application within 30 months in the countries in which we seek patent protection.
The principal decisions about reimbursement for new medicines are typically made on the federal level by the Centers for Medicare & Medicaid Services (“CMS”), an agency within HHS that administers the Medicare program, and, on the state level, by state Medicaid programs.
The principal decisions about reimbursement for new medicines are typically made on the federal level by the Centers for Medicare & Medicaid Services (“CMS”), an agency within HHS that administers the Medicare and Medicaid programs, and, on the state level, by state Medicaid programs.
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.
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.
Individual European Union Member States will continue to be responsible for drawing conclusions on the overall value of new health technology for their healthcare system, and pricing and reimbursement decisions. 28 Healthcare Laws and Regulations Sales of our product candidates, if authorized or approved, or any other future product candidate will be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments in which we might conduct our business.
Individual European Union Member States will continue to be responsible for drawing conclusions on the overall value of new health technology for their healthcare system, and pricing and reimbursement decisions. 30 Healthcare Laws and Regulations Sales of our product candidates, if authorized or approved, or any other future product candidate will be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments in which we might conduct our business.
Our product candidates can be tuned to improve potency, breadth of neutralization, as well as format, 7 including half-life extending and other fragment crystallizable (“Fc”) region modifications.
Our product candidates can be tuned to improve potency, breadth of neutralization, as well as format, including half-life extending and other fragment crystallizable (“Fc”) region modifications.
Upon any termination of the agreement prior to its expiration, all licenses and rights granted pursuant to the 12 arrangement will automatically terminate and revert to the granting party and all other rights and obligations of the parties will terminate.
Upon any termination of the agreement prior to its expiration, all licenses and rights granted pursuant to the arrangement will automatically terminate and revert to the granting party and all other rights and obligations of the parties will terminate.
We may also need to provide discounts to purchasers, private health plans or government healthcare programs. Our product candidates may nonetheless not be considered medically 27 necessary or cost-effective.
We may also need to provide discounts to purchasers, private health plans or government healthcare programs. Our product candidates may nonetheless not be considered medically necessary or cost-effective.
We are leveraging and applying our experience with adintrevimab, which demonstrated clinically meaningful results and a robust safety package, and PEMGARDA, to new therapeutic candidates. We seek to streamline nonclinical toxicology studies where possible, with the intention of reducing dependence on animal studies, which we believe is well in line with the FDA’s position.
We are leveraging and applying our experience with adintrevimab, which demonstrated clinically meaningful results and a robust safety package, and PEMGARDA to new therapeutic candidates, including VYD2311. We seek to streamline nonclinical toxicology studies where possible, with the intention of reducing dependence on animal studies, which we believe is well in line with the FDA’s position.
Foreign contract manufacturing organizations, including WuXi Biologics, may be subject to U.S. legislation, including the proposed BIOSECURE Act, investigations, sanctions, trade restrictions, and other foreign regulatory requirements, which could increase the cost or reduce the supply of material available to us, delay or impact clinical trials, or delay procurement of 11 commercial supply.
Foreign contract manufacturing organizations, including WuXi Biologics, may be subject to U.S. legislation, including the proposed BIOSECURE Act, investigations, sanctions, trade restrictions, tariffs, and other foreign regulatory requirements, which could increase the cost or reduce the supply of material available to us, delay or impact clinical trials, or delay procurement of commercial supply.
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.
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.
The Current CTR harmonizes the assessment and supervision processes for clinical trials throughout the CTIS, which contains a centralized European Union portal and database.
The Current CTR harmonizes the assessment and supervision processes for clinical trials throughout 26 the CTIS, which contains a centralized European Union portal and database.
Numerous federal and state laws, including state security breach notification laws, state health information privacy laws, and federal and state consumer protection and privacy laws, (including, for example, Section 5 of the Federal Trade Commission Act of 1914 (“FTC Act”), and the California Consumer Privacy Act (“CCPA”), as amended by the California Privacy Rights Act (“CPRA”)) govern the collection, use and disclosure of personal information.
Numerous federal and state laws, including state security breach notification laws, state health information privacy laws, and federal and state consumer protection and privacy laws, (including, for example, Section 5 of the Federal Trade Commission Act of 1914 (“FTC Act”), the FTC Health Breach Notification Rule, and the California Consumer Privacy Act (“CCPA”), as amended by the California Privacy Rights Act (“CPRA”)) govern the collection, use and disclosure of personal information.
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 30 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 32 requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical manufacturers and impose additional health policy reforms.
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; 17 • 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 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.
Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. To support the commercialization of PEMGARDA, we have directly hired key leaders for our sales, marketing, market access, and medical affairs teams who have extensive experience commercializing products within the infectious diseases space.
Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. To support the commercialization of PEMGARDA, we have directly hired key leaders for our sales, marketing, market access, and medical affairs teams who have extensive experience commercializing products within the infectious and rare diseases spaces.
The IRA also creates a drug price negotiation program under which the prices for Medicare units of certain 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 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.
We believe that our hybrid working approach is adequate to meet our ongoing needs, and that, if we require additional physical facilities, we will be able to obtain additional facilities on commercially reasonable terms. 32
We believe that our hybrid working approach is adequate to meet our ongoing needs, and that, if we require additional physical facilities, we will be able to obtain additional facilities on commercially reasonable terms. 34
Further, in 2022, we secured dedicated laboratory space and expanded our research team in order to enable internal discovery and 5 development of our mAb candidates, while continuing to leverage our existing partnership with Adimab. We are focused on antibody discovery and use of Adimab’s platform technology, while building our internal capabilities.
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.
Any U.S. non-provisional patent applications timely filed based upon these U.S. provisional patent applications, if issued, are expected to expire in 2043, without taking into account any possible patent term adjustment or extension. Trademarks Certain features of our business and product candidates are protected by trademarks.
Any U.S. non-provisional patent applications or foreign patent applications timely filed based upon these U.S. provisional patent applications, if issued, are expected to expire in 2044, without taking into account any possible patent term adjustment or extension. Trademarks Certain features of our business and product candidates are protected by trademarks.
The HTA Regulation will apply to all European Union Member States beginning on January 12, 2025. The HTA Regulation provides that European Union Member States will be able to use common HTA tools, methodologies, and procedures across the European Union.
The HTA Regulation applies to all European Union Member States beginning on January 12, 2025. The HTA Regulation provides that European Union Member States will be able to use common HTA tools, methodologies, and procedures across the European Union.
For so long as we were paying such quarterly fee (or earlier if (i) we experience a change of control after the third anniversary of the Adimab Collaboration Agreement or (ii) Adimab owns less than a specified percentage of our equity), Adimab and its affiliates agreed not to assist or direct certain third parties to discover or optimize antibodies intended to bind to coronaviruses or influenza viruses.
For so long as we were paying such quarterly fee (or earlier if (i) we experienced a change of control after the third anniversary of the Adimab Collaboration Agreement or (ii) Adimab owned less than a specified percentage of our equity), Adimab and its affiliates agreed not to assist or direct certain third parties to discover or optimize antibodies intended to bind to coronaviruses or influenza viruses.
Moreover, under the Food and Drug Administration Safety and Innovation Act enacted in 2012, a sponsor can request designation of a product candidate as a “breakthrough therapy.” A breakthrough therapy is defined as a drug or biological product that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening 23 disease or condition and preliminary clinical evidence indicates that the drug or biological product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Under the Food and Drug Administration Safety and Innovation Act enacted in 2012, a sponsor can request designation of a product candidate as a “breakthrough therapy.” A product may receive a breakthrough therapy designation if it is a drug or biological product that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug or biological product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
The healthcare laws and regulations that may affect our ability to operate include the following: • The federal Anti-Kickback Statute makes it illegal for any person or entity to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that is in exchange for or to induce or reward the referral of business, including the purchase, order, lease, or arranging for or recommending purchasing, leasing, or ordering any good, facility, item or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid.
The healthcare laws and regulations that may affect our ability to operate include the following: • The federal Anti-Kickback Statute makes it illegal for any person or entity to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that is in exchange for or to induce or reward the referral of an individual or the purchase, order, lease, or arranging for or recommending purchasing, leasing, or ordering any item or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid.
Additionally, the variability associated with cell-based EC 50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges.
Additionally, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges.
The legislation also extended Medicaid drug rebates, previously due only on fee-for-service Medicaid utilization, to include the utilization of Medicaid managed care organizations as well and created an alternative rebate formula for certain new formulations of certain existing products that is intended to increase the amount of rebates due on those drugs.
The legislation also extended Medicaid drug rebates for manufacturers participating in the Medicaid Drug Rebate Program, previously due only on fee-for-service Medicaid utilization, to include the utilization of Medicaid managed care organizations as well and created an alternative rebate formula for certain new formulations of certain existing products that is intended to increase the amount of rebates due on those drugs.
We plan to concentrate initially on the healthcare practitioners and institutions who care for the estimated 485,000 highest risk moderately to severely immunocompromised adults and adolescents through a highly focused field sales organization which can potentially expand over time to reach additional healthcare practitioners and institutions who care for other groups of moderately to severely immunocompromised adults and adolescents.
We have concentrated initially on the healthcare practitioners and institutions who care for the estimated 485,000 highest risk moderately to severely immunocompromised adults and adolescents through a highly focused field sales organization which can potentially expand over time to reach additional healthcare practitioners and institutions who care for other groups of moderately to severely immunocompromised adults and adolescents.
The maximum aggregate amount of milestone payments payable under the agreement for any and all Products is $24.6 million. Through December 31, 2023, we had made aggregate milestone payments of $11.1 million to Adimab under the Adimab Assignment Agreement.
The maximum aggregate amount of milestone payments payable under the agreement for any and all Products is $24.6 million. Through December 31, 2024, we had made aggregate 13 milestone payments of $11.1 million to Adimab under the Adimab Assignment Agreement.
Applications have been filed inside and outside of the United States, and while many are still pending, a number of registrations have been issued in Australia, China, European Union, Japan, New Zealand, Norway, Switzerland, and United Kingdom.
Applications have been filed inside and outside of the U.S., and while many are still pending, a number of registrations have been issued in the U.S., Australia, China, European Union, Japan, New Zealand, Norway, Switzerland, and United Kingdom.
Violations of this law may be punishable by up to ten years in prison, criminal fines, damages, administrative civil money penalties, and the potential for exclusion from participation in federal healthcare programs.
Violations of this law may be punishable by up to ten years in prison, criminal fines, damages, administrative civil money penalties, and exclusion from participation in federal healthcare programs.
We plan to concentrate initially on the healthcare practitioners and institutions who care for the highest risk immunocompromised adults and adolescents through a highly focused field sales organization, which can potentially expand over time to reach the additional healthcare practitioners and institutions who care for other groups of moderately to severely immunocompromised adults and adolescents.
We have concentrated initially on the healthcare practitioners and institutions who care for the highest risk immunocompromised adults and adolescents through a highly focused field sales organization, which can potentially expand over time to reach the additional healthcare practitioners and institutions who care for other groups of moderately to severely immunocompromised adults and adolescents.
We expect that these data will enable the continued application of surrogate endpoints in future development programs, an approach that was leveraged in our CANOPY clinical trial of VYD222 with the use of calculated serum neutralizing antibody titers as a correlate of protection.
We expect that these data will enable the continued application of surrogate endpoints in future development programs, an approach that was leveraged in our Phase 3 CANOPY clinical trial of pemivibart with the use of calculated serum neutralizing antibody titers as a correlate of protection.
Emergency Use Authorization Environment in the U.S. Under Section 564 of the FDCA, the FDA Commissioner has the authority to authorize the emergency use of an unapproved medical product or an unapproved use of an approved medical product for certain emergency circumstances after the Secretary of the U.S.
Under Section 564 of the FDCA, the FDA Commissioner has the authority to authorize the emergency use of an unapproved medical product or an unapproved use of an approved medical product for certain emergency circumstances after the Secretary of the U.S.
Through December 31, 2023, we had made aggregate payments of $5.0 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, 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.
Among other things, the ACA expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum Medicaid rebate for both branded and generic drugs and biologics, expanded the 340B program, and revised the definition of average manufacturer price (“AMP”), which could increase the amount of Medicaid drug rebates manufacturers are required to pay to states.
Among other things, the ACA expanded rebate liability for manufacturers that participate in the Medicaid Drug Rebate Program by increasing the minimum Medicaid rebate for both branded and generic drugs and biologics, expanded the 340B program, and revised the definition of average manufacturer price (“AMP”), which could increase the amount of Medicaid drug rebates manufacturers are required to pay to states.
Addressable Patient Populations Pre-Exposure Prophylaxis Based on our market research and internal analysis, we believe that there are more than 9 million immunocompromised people, with varying degrees of immune compromise, in the U.S. alone who may not adequately respond to COVID-19 vaccination, increasing their risk for severe COVID-19.
Based on our market research and internal analysis, we believe that there are more than 9 million immunocompromised people, with varying degrees of immune compromise, in the U.S. alone who may not adequately respond to COVID-19 vaccination, increasing their risk for severe COVID-19.
In order to provide solutions to vulnerable people as new variants emerge, we seek to leverage evolving regulatory paradigms, which may rely on surrogate endpoints, to expedite drug development. Our company has been designed to identify and develop high-quality, long-lasting antibodies with a high barrier to viral escape on a perpetual basis.
In order to provide solutions to vulnerable people as new variants emerge, we seek to leverage evolving regulatory paradigms, which may rely on surrogate endpoints, to expedite drug development. Our company has been designed to identify and develop high-quality, long-lasting antibodies with a high barrier to viral escape in a manner that keeps pace with viral evolution.
Patents As of March 12, 2024, we own one patent family for which we have three issued U.S. patents (U.S. 11,192,940, issued December 7, 2021; U.S. 11,220,536, issued January 11, 2022; and U.S. 11,414,479, issued August 16, 2022), one pending U.S. non-provisional patent application, and foreign patent applications in Argentina, Brazil, Canada, China, Europe, Japan, Mexico, and Taiwan.
Patents As of March 1, 2025, we own one patent family for which we have three issued U.S. patents (U.S. 11,192,940, issued December 7, 2021; U.S. 11,220,536, issued January 11, 2022; and U.S. 11,414,479, issued August 16, 2022), one pending U.S. non-provisional patent application, and foreign patent applications in Argentina, Canada, China, Europe, and Mexico.
However, we expect competition from multiple sources, including major pharmaceutical, specialty pharmaceutical and existing or emerging biotechnology companies, academic research institutions, governmental agencies and public and private research institutions worldwide.
However, competition may come from multiple sources, including major pharmaceutical, specialty pharmaceutical and existing or emerging biotechnology companies, academic research institutions, governmental agencies and public and private research institutions worldwide.
As of March 12, 2024, we have filed trademark applications for marks including INVIVYD, PEMGARDA and INVYMAB, as well as logos and certain stylized versions of these word marks.
As of March 1, 2025, we have filed trademark applications for marks including INVIVYD, PEMGARDA and INVYMAB, as well as logos and certain stylized versions of these word marks.
While COVID-19 prevention is our current focus, and PEMGARDA is not authorized for use for treatment of COVID-19 or for post-exposure prophylaxis of COVID-19, we believe there could be opportunities to further explore the development of mAbs for the treatment of COVID-19.
While PEMGARDA is not authorized for use for treatment of COVID-19 or for post-exposure prophylaxis of COVID-19, we believe there could be opportunities to further explore the development of mAbs for the treatment of COVID-19.
The IRA also establishes a Medicare Part D inflation rebate scheme, under which, generally speaking, manufacturers will owe rebates if the AMP of a Part D drug increases faster than the pace of inflation.
The IRA also establishes a Medicare Part D inflation rebate scheme, under which, generally speaking, manufacturers will owe rebates if a reported annualized AMP of an eligible Part D rebatable drug increases faster than the pace of inflation.
While we are currently focused on commercializing PEMGARDA in the U.S. with the commercial organization we have built, we continue to explore potential opportunities to expand our ability to serve vulnerable people through partnerships and collaborations. • Ensuring supply of drug product for PEMGARDA and future clinical product candidates.
We are currently focused on commercializing PEMGARDA in the U.S. with the commercial organization we have built, however we continue to explore potential opportunities to expand our ability to serve vulnerable people outside the U.S. through discussions with regulatory authorities as well as through potential partnerships and collaborations. • Ensuring supply of drug product for PEMGARDA and future clinical product candidates.
We continue to evaluate access to capacity at WuXi Biologics and other CDMOs so we can aim to meet potential future demand for PEMGARDA and future clinical product candidates. • Establishing streamlined development pathways that would allow us to fully leverage our INVYMAB platform approach to efficiently introduce new or engineered mAb candidates targeting SARS-CoV-2.
We continue to evaluate access to capacity at WuXi Biologics and other CDMOs so we can aim to meet potential future demand for PEMGARDA, VYD2311 and future clinical product candidates. • Establishing streamlined development pathways that would allow us to efficiently introduce new mAb candidates targeting SARS-CoV-2.
With respect to privacy, the FTC also sets expectations for failing to honor the privacy promises made to individuals about how the company handles consumers’ personal information; such failure may also constitute unfair or deceptive acts or practices in violation of the FTC Act. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.
With respect to privacy, the FTC also sets expectations for failing to honor the privacy promises made to individuals about how the company handles consumers’ personal information; such failure may also constitute unfair or deceptive acts or practices in violation of the FTC Act.
We have a hybrid workforce, with approximately 51% of our employees based in Massachusetts, 11% based in California, 7% based in New Jersey, 5% based in North Carolina, and the remaining 26% in various additional states. None of our employees are represented by labor unions or covered by collective bargaining agreements.
We have a hybrid workforce, with approximately 40% of our employees based in Massachusetts, 6% based in California, 6% based in New Jersey, 4% based in North Carolina, and the remaining 44% in various additional states. None of our employees are represented by labor unions or covered by collective bargaining agreements.
Drug and biological products designated as breakthrough therapies are also eligible for accelerated approval. The FDA must take certain actions, such as holding timely meetings and providing advice, intended to expedite the development and review of an application for approval of a breakthrough therapy.
Drug and biological products designated as breakthrough therapies may also be eligible for Fast Track benefits (including priority review) and use of the accelerated approval pathway. The FDA must take certain actions, such as holding timely meetings and providing advice, intended to expedite the development and review of an application for approval of a breakthrough therapy.
We also seek to streamline our manufacturing approach, leveraging platform processes and historical data to ensure product quality for future product candidates. We will be actively engaging with regulatory authorities to seek concurrence on these proposals as we advance our product candidates. We are employing similar strategies for other antigenically variable viruses, such as influenza.
We also seek to streamline our manufacturing approach, leveraging platform processes and historical data to ensure product quality for future product candidates. We will be actively engaging with regulatory authorities to seek concurrence on these proposals as we advance our product candidates.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThe success of PEMGARDA or any other product candidates that we develop or otherwise may acquire will depend on many factors, including: • the status of new or emerging SARS-CoV-2 variants and whether such SARS-CoV-2 variants reduce the neutralizing activity and effectiveness of PEMGARDA or any other mAb candidates we may develop, and whether we are successful in timely identifying new mAb candidates that mitigate the risk of reduced neutralizing activity and effectiveness against future SARS-CoV-2 variants; • the continuing need for therapies for the prevention and treatment of COVID-19, including as a result of the development of COVID-19 into an endemic disease or the inability of other available therapies to effectively address COVID-19; • the timing and progress of our discovery, nonclinical, and clinical development activities; • the number and scope of nonclinical and clinical programs we decide to pursue; 37 • our ability to successfully work with the FDA or other regulatory authorities to establish streamlined development pathways that would allow us to fully leverage our INVYMAB platform approach to efficiently introduce new or engineered mAb candidates targeting SARS-CoV-2; • 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; • our ability to reach agreement with the FDA or other regulatory authorities as to the design or implementation of our clinical trials, including the use of a correlate of protection (surrogate of clinical efficacy) in an immunobridging approach to a pivotal clinical trial; • the sufficiency of our financial and other resources to complete the necessary nonclinical studies and clinical trials, manufacture the product candidates and complete associated regulatory activities; • our ability to establish and maintain agreements with third-party manufacturers and suppliers for clinical supply for our clinical trials and commercial manufacturing and successfully develop, obtain regulatory authorization or approval for, and then successfully commercialize 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 discovery and development of any additional development programs and product candidates we identify in-house or acquire through collaborations; • timely receipt of authorizations or approvals from applicable regulatory authorities, and the scope and duration of any emergency use authorization received, such as the EUA for PEMGARDA; • developing and expanding sales, marketing and distribution capabilities and commercializing products, if authorized or approved, whether alone or in collaboration with others; • our ability to secure and maintain required state licenses for distribution of our products, if authorized or approved, or other distribution disruptions; • acceptance of the benefits and use of our products, including method of administration, if authorized or approved, by patients, the medical community and third-party payors, for their authorized or approved indications; • the prevalence and severity of adverse events experienced with our product candidates; • the availability, perceived advantages, cost, safety and efficacy of alternative therapies for any product candidate that we develop; • the availability and sufficiency of government funding for the purchase and/or reimbursement of products for the diagnosis, prevention and treatment of COVID-19; • our ability to obtain and maintain third-party coverage and adequate reimbursement for our product candidates, if authorized or approved, and the extent to which patients will be willing to pay out-of-pocket for such products, in the absence of such coverage or reimbursement for all or part of the cost; • 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 approved, and otherwise protecting our rights in our intellectual property portfolio; • our ability to maintain compliance with regulatory requirements, cGCP, cGLP, and cGMP, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products; • potential significant and changing government regulation, regulatory guidance and requirements and evolving treatment guidelines; • our ability to maintain a continued acceptable safety, tolerability and efficacy profile of products following any authorization or approval; 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. 38 If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize PEMGARDA or any other product candidates that we develop or otherwise may acquire, which would materially harm our business.
Biggest changeThe success of PEMGARDA, VYD2311 or any other product candidates that we develop or otherwise may acquire will depend on many factors, including: • the status of new or emerging SARS-CoV-2 variants and whether such SARS-CoV-2 variants reduce the neutralizing activity and effectiveness of PEMGARDA, VYD2311 or any other mAb candidates we may develop, and whether we are successful in timely identifying new mAb candidates that mitigate the risk of reduced neutralizing activity and effectiveness against future SARS-CoV-2 variants; • the continuing need for therapies for the prevention and treatment of COVID-19, including as a result of the development of COVID-19 into an endemic disease, and the existence of any other available therapies that effectively prevent or treat COVID-19 in the populations targeted by our product candidates; • the timing and progress of our discovery, nonclinical, and clinical development activities; • the number and scope of nonclinical and clinical programs we decide to pursue; • our ability to successfully work with the FDA or other regulatory authorities to establish streamlined development pathways that would allow us to efficiently periodically introduce new mAb candidates targeting SARS-CoV-2; • 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; • our ability to align with the FDA or other regulatory authorities as to the design or implementation of our clinical trials, including the use of a correlate of protection (surrogate of clinical efficacy) in an immunobridging approach to a pivotal clinical trial; • our ability to align with the FDA or other regulatory authorities on the data required to support the regulatory authorization or approvals that we seek for our product candidates, particularly in light of the FDA’s discretion with respect to EUAs in the U.S. in making its determination about whether, based on the totality of scientific evidence available, the known and potential benefits of a product candidate outweigh the known and potential risks; 38 • the sufficiency of our financial and other resources to complete the necessary nonclinical studies and clinical trials, manufacture our product candidates and complete associated regulatory activities; • our ability to establish and maintain agreements for clinical and commercial supply of our product candidates, and to successfully develop, obtain regulatory authorization or approval for, and commercialize 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 discovery and development of any additional product candidates we identify in-house or acquire through collaborations; • timely receipt of regulatory authorizations or approvals, and the scope and duration of any emergency use authorization received, such as the EUA for PEMGARDA; • developing and expanding sales, marketing and distribution capabilities and commercializing products, if authorized or approved, whether alone or in collaboration with others; • our ability to secure and maintain required state licenses for distribution of our products, if authorized or approved, or other distribution disruptions; • acceptance of the benefits and use of our products, including method of administration, if authorized or approved, by patients, the medical community and third-party payors, for their authorized or approved indications; • the prevalence and severity of adverse events experienced with our product candidates; • the availability, perceived advantages, cost, safety and efficacy of alternative therapies for any product candidate that we develop; • our ability to obtain and maintain third-party coverage and adequate reimbursement for our product candidates, if authorized or approved, and the extent to which patients are willing to pay out-of-pocket for such products, in the absence of such coverage or reimbursement; • 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 approved, and otherwise protecting our rights in our intellectual property portfolio; • our ability to maintain compliance with regulatory requirements, cGCP, cGLP, and cGMP, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products; • potential significant and changing government regulation, regulatory guidance and requirements and evolving treatment guidelines; • our ability to maintain a continued acceptable safety, tolerability and efficacy profile of products following any authorization or approval; 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.
To date, we have received regulatory authorization for only one product candidate, PEMGARDA, which has not been approved, but has been authorized for emergency use by the FDA under an EUA, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg).
To date, we have received regulatory authorization for only one product candidate, PEMGARDA, which has not been approved, but has been authorized for emergency use by the FDA under an EUA only for pre-exposure prophylaxis of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg).
Moreover, results acceptable to support authorization or approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory authorization or approval in that other jurisdiction.
Moreover, results acceptable to support authorization or approval in one jurisdiction may be deemed inadequate by another regulatory authority to support authorization or approval in that other jurisdiction.
Although we received an EUA from the FDA for PEMGARDA, there is no guarantee that we will apply for an EUA for adintrevimab, VYD2311 or any other product candidates, or other similar authorization or, if we do apply, that we will be able to obtain an EUA or such similar authorization.
Although we received an EUA from the FDA for PEMGARDA, there is no guarantee that we will apply for an EUA or similar authorization for adintrevimab, VYD2311 or any other product candidates or, if we do apply, that we will be able to obtain an EUA or such similar authorization.
If our product candidates are authorized or approved by the FDA or comparable foreign regulatory authorities, we may only promote or market our products for their specifically approved indications.
If our product candidates are authorized or approved by the FDA or comparable foreign regulatory authorities, we may only promote or market our products for their specifically authorized or approved indications.
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.
If our product candidates, to the extent authorized or approved, fail to be added to these guidelines, or if they receive poor positioning within these guidelines, payors and other customers may be less inclined to add any such product candidate to their formularies, significantly reducing demand for such product candidate, if approved.
If our product candidates, to the extent authorized or approved, fail to be added to these guidelines, or if they receive poor positioning within these guidelines, payors and other customers may be less inclined to add any such product candidate to their formularies, significantly reducing demand for such product candidate, if authorized or approved.
For example, the ongoing conflict between Russia and Ukraine has led to an increase in cyberattacks on the Ukraine, including its government, companies, institutions and people, as well on the financial and communications infrastructure of other countries, companies and individuals therein.
For example, the ongoing conflict between Russia and Ukraine has led to an increase in cyberattacks on Ukraine, including its government, companies, institutions and people, as well on the financial and communications infrastructure of other countries, companies and individuals therein.
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 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act, and the regulations promulgated thereunder.
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 (“HIPAA”).
The GDPR imposes substantial fines for breaches and violations (for the most serious breaches of up to the greater of €20 million or 4% of annual global turnover) and confers the right for data subjects to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR.
The GDPR imposes substantial fines for breaches and violations (for the most serious violations of up to the greater of €20 million or 4% of annual global turnover) and confers the right for data subjects to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR.
Risks Related to Employee Matters and Managing Our Growth Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel. We are highly dependent on the management, scientific, clinical, manufacturing, commercial, financial, legal and business development expertise of our executive officers.
Risks Related to Employee Matters and Managing Our Growth Our future success depends on our ability to attract and retain key executives and to attract, retain and motivate qualified personnel. We are highly dependent on the management, scientific, clinical, manufacturing, commercial, financial, legal and business development expertise of our executive officers.
Our current and future collaborations and licenses could subject us to a number of risks, including: • we may be required to undertake the expenditure of substantial operational, financial and management resources; • we may be required to comply with various development, diligence, commercialization and other obligations and meet development timelines, or exercise commercially reasonable efforts to develop and commercialize licensed products, in order to maintain the licenses (for example, under the Adimab Assignment Agreement, we are required to use commercially reasonable efforts to achieve specified development and regulatory milestones for products in certain major markets and to commercialize a product in any country in which we obtain marketing approval); • we may be required to issue equity securities that would dilute our stockholders’ percentage ownership of our company; • we may be required to assume substantial actual or contingent liabilities; • we may not be able to control the amount and timing of resources that our strategic collaborators devote to the development or commercialization of our product candidates; • we may not have the right to control the preparation, filing, prosecution and maintenance of patents and patent applications covering the technology that we license, and we cannot always be certain that these patents and patent applications will be prepared, filed, prosecuted and maintained in a manner consistent with the best interests of our business (for example, we have no rights to control the preparation, filing, prosecution or maintenance of the patents licensed to us under Adimab’s antibody discovery and optimization platform technology under the Adimab Assignment Agreement); 74 • strategic collaborators may select indications or design clinical trials in a way that may be less successful than if we were doing so; • strategic collaborators may delay clinical trials, provide insufficient funding, terminate a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new version of a product candidate for clinical testing; • strategic collaborators may not pursue further development and commercialization of products resulting from the strategic collaboration arrangement or may elect to discontinue research and development programs; • strategic collaborators may not commit adequate resources to the marketing and distribution of our product candidates, limiting our potential revenue from these products; • disputes may arise between us and our strategic collaborators that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management’s attention and consumes resources; • strategic collaborators may experience financial difficulties; • strategic collaborators may not properly maintain, enforce or defend our intellectual property rights or may use our proprietary information in a manner that could jeopardize or invalidate our proprietary information or expose us to potential litigation; • business combinations or significant changes in a strategic collaborator’s business strategy may adversely affect a strategic collaborator’s willingness or ability to complete its obligations under any arrangement; • strategic collaborators could decide to move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and • strategic collaborators could terminate the arrangement or allow it to expire, which would delay the development and may increase the cost of developing our product candidates.
Our current and future collaborations and licenses could subject us to a number of risks, including: • we may be required to undertake the expenditure of substantial operational, financial and management resources; • we may be required to comply with various development, diligence, commercialization and other obligations and meet development timelines, or exercise commercially reasonable efforts to develop and commercialize licensed products, in order to maintain the licenses (for example, under the Adimab Assignment Agreement, we are required to use commercially reasonable efforts to achieve specified development and regulatory milestones for products in certain major markets and to commercialize a product in any country in which we obtain marketing approval); • we may be required to issue equity securities that would dilute our stockholders’ percentage ownership of our company; • we may be required to assume substantial actual or contingent liabilities; • we may not be able to control the amount and timing of resources that our strategic collaborators devote to the development or commercialization of our product candidates; • we may not have the right to control the preparation, filing, prosecution and maintenance of patents and patent applications covering the technology that we license, and we cannot always be certain that these patents and patent applications will be prepared, filed, prosecuted and maintained in a manner consistent with the best interests of our business (for example, we have no rights to control the preparation, filing, prosecution or maintenance of the patents licensed to us under Adimab’s antibody discovery and optimization platform technology under the Adimab Assignment Agreement); 76 • strategic collaborators may select indications or design clinical trials in a way that may be less successful than if we were doing so; • strategic collaborators may delay clinical trials, provide insufficient funding, terminate a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new version of a product candidate for clinical testing; • strategic collaborators may not pursue further development and commercialization of products resulting from the strategic collaboration arrangement or may elect to discontinue research and development programs; • strategic collaborators may not commit adequate resources to the marketing and distribution of our product candidates, limiting our potential revenue from these products; • disputes may arise between us and our strategic collaborators that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management’s attention and consumes resources; • strategic collaborators may experience financial difficulties; • strategic collaborators may not properly maintain, enforce or defend our intellectual property rights or may use our proprietary information in a manner that could jeopardize or invalidate our proprietary information or expose us to potential litigation; • business combinations or significant changes in a strategic collaborator’s business strategy may adversely affect a strategic collaborator’s willingness or ability to complete its obligations under any arrangement; • strategic collaborators could decide to move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and • strategic collaborators could terminate the arrangement or allow it to expire, which would delay the development and may increase the cost of developing our product candidates.
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.
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.
We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K, and will remain a smaller reporting company so long as either of the following conditions are true – (i) the market value of our common stock held by non-affiliates is less than $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual revenues are less than $100 million 92 during the most recently completed fiscal year and the market value of our common stock held by non-affiliates is less than $700 million as of the end of that year’s second fiscal quarter.
We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K, and will remain a smaller reporting company so long as either of the following conditions are true – (i) the market value of our common stock held by non-affiliates is less than $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual revenues are less than $100 million during the most recently completed fiscal year and the market value of our common stock held by non-affiliates is less than $700 million as of the end of that year’s second fiscal quarter.
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.
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 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 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.
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.
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.
In addition, according to our EUA, printed matter, advertising, and promotional materials relating to the emergency use of PEMGARDA must provide accurate descriptions of safety results and efficacy results on a clinical 55 endpoint(s) or surrogate endpoint(s) from the clinical trial(s) summarized in the authorized labeling, including any limitations of the clinical trial data as described in the authorized labeling, and contain certain clear and conspicuous statements regarding the emergency use authorization.
In addition, according to our EUA, printed matter, advertising, and promotional materials relating to the emergency use of PEMGARDA must provide accurate descriptions of safety results and efficacy results on a clinical endpoint(s) or surrogate endpoint(s) from the clinical trial(s) summarized in the authorized labeling, including any limitations of the clinical trial data as described in the authorized labeling, and contain certain clear and conspicuous statements regarding the emergency use authorization.
To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of an authorization or approval, we may be required to expend significant resources, which may not be available to us, to conduct additional preclinical studies or trials for our product candidates either prior to or post-authorization or approval, or they may object to elements of our clinical development program, requiring their alteration.
To the extent that the 41 results of our trials are not satisfactory to the FDA or foreign regulatory authorities for support of an authorization or approval, we may be required to expend significant resources, which may not be available to us, to conduct additional preclinical studies or trials for our product candidates either prior to or post-authorization or approval, or they may object to elements of our clinical development program, requiring their alteration.
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.
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.
A lack of valid transfer mechanisms for GDPR-covered data could increase exposure to enforcement actions as described above and may affect our business operations and require commercial cost (including potentially limiting our ability 64 to collaborate/work with certain third parties and/or requiring an increase in our data processing capabilities in the European Union and United Kingdom).
A lack of valid transfer mechanisms for GDPR-covered data could increase exposure to enforcement actions as described above and may affect our business operations and require commercial cost (including potentially limiting our ability to collaborate/work with certain third parties and/or requiring an increase in our data processing capabilities in the European Union and United Kingdom).
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.
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.
With the GDPR, CCPA and other state laws, regulations and other obligations relating to privacy and data protection imposing new and relatively burdensome obligations, and with the substantial uncertainty over the interpretation and application of these and other obligations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices and may incur significant costs and expenses in an effort to do so.
With the GDPR, CCPA and other laws, regulations and other obligations relating to privacy and data protection imposing new and relatively burdensome obligations, and with the substantial uncertainty over the interpretation and application of these and other obligations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices and may incur significant costs and expenses in an effort to do so.
Pursuant to the Adimab Assignment Agreement, Adimab additionally granted us a non-exclusive, worldwide, royalty-bearing sublicensable license to certain of its platform patents and technology for the development, manufacture and commercialization of the CoV Antibodies and pharmaceutical products containing or comprising one or more 72 CoV Antibodies for all indications and uses, with the exception of certain diagnostic uses and use as a research reagent.
Pursuant to the Adimab Assignment Agreement, Adimab additionally granted us a non-exclusive, worldwide, royalty-bearing sublicensable license to certain of its platform patents and technology for the development, manufacture and commercialization of the CoV Antibodies and pharmaceutical products containing or comprising one or more CoV Antibodies for all indications and uses, with the exception of certain diagnostic uses and use as a research reagent.
Any regulatory approvals that we receive for a product candidate may also be subject to a REMS, limitations on the approved indicated uses for which the drug may be marketed or to the conditions of 84 approval, or requirements that we conduct potentially costly post-marketing testing and surveillance studies, including Phase 4 trials and surveillance to monitor the quality, safety and efficacy of the drug.
Any regulatory approvals that we receive for a product candidate may also be subject to a REMS, limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or requirements that we conduct potentially costly post-marketing testing and surveillance studies, including Phase 4 trials and surveillance to monitor the quality, safety and efficacy of the drug.
Further, increasing efforts by third-party payors in the U.S. and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates, if approved.
Further, increasing efforts by third-party payors in the U.S. and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for 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 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 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.
The American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals, and increased the statute of 86 limitations period for the government to recover overpayments to providers from three to five years. Additionally, the American Rescue Plan Act of 2021 eliminated the statutory Medicaid drug rebate cap, effective January 1, 2024.
The American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Additionally, the American Rescue Plan Act of 2021 eliminated the statutory Medicaid drug rebate cap, effective January 1, 2024.
In such instance, we would expect to vigorously assert 93 the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.
In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.
In the European Union, biosimilars can only be authorized once the period of data exclusivity on our candidate, as ‘reference’ biological medicinal product, has 61 expired. In general, this means that the biological reference medicine must have been authorized for at least eight years before another company can apply for approval of a similar biological product.
In the European Union, biosimilars can only be authorized once the period of data exclusivity on our candidate, as ‘reference’ biological medicinal product, has expired. In general, this means that the biological reference medicine must have been authorized for at least eight years before another company can apply for approval of a similar biological product.
Any actual or alleged failure to comply with promotion requirements may result in fines, warning letters, injunctions, or civil or criminal penalties. Our mAb product candidates may face significant competition from vaccines, antiviral agents and other therapeutics, including mAbs, for COVID-19 that are currently available or in development.
Any actual or alleged failure to comply with promotion requirements may result in fines, warning letters, injunctions, or civil or criminal penalties. Our mAb product candidates, including PEMGARDA, may face significant competition from vaccines, antiviral agents and other therapeutics, including mAbs, for COVID-19 that are currently available or in development.
It is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or 88 regulations.
It is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
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.
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.
If the Adimab Assignment Agreement, the Adimab Collaboration Agreement or the Adimab Platform Transfer Agreement is terminated as a result of our breach or otherwise, our business and prospects will be materially and adversely affected. 73 Our rights to develop and commercialize our product candidates are subject, in part, to the terms and conditions of licenses granted to us by others.
If the Adimab Assignment Agreement, the Adimab Collaboration Agreement or the Adimab Platform Transfer Agreement is terminated as a result of our breach or otherwise, our business and prospects will be materially and adversely affected. Our rights to develop and commercialize our product candidates are subject, in part, to the terms and conditions of licenses granted to us by others.
Since our product candidates represent novel approaches to treating various conditions, it may be difficult, in any event, to accurately estimate the potential revenues from these product candidates. Accordingly, we may spend significant capital trying to obtain authorization or approval for product candidates that have an uncertain commercial market.
Since our product candidates represent novel approaches to treating various conditions, it may be difficult, in any event, to accurately estimate the potential revenues from these product candidates. Accordingly, we may spend significant capital trying to obtain regulatory authorization or approval for product candidates that have an uncertain commercial market.
In considering the market potential for our product candidates, our projections of the number of immunocompromised people in the U.S. who may not adequately respond to COVID-19 vaccination and the estimated U.S. total addressable market for our mAb candidates for the pre-exposure prophylaxis of COVID-19 are estimates based on 57 Invivyd-sponsored market research and our internal analysis.
In considering the market potential for our product candidates, our projections of the number of immunocompromised people in the U.S. who may not adequately respond to COVID-19 vaccination and the estimated U.S. total addressable market for our mAb candidates for the pre-exposure prophylaxis of COVID-19 are estimates based on Invivyd-sponsored market research and our internal analysis.
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, 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.
Further, we may not be able to address reductions in neutralization potency with adjustments to the dose or dosing frequency. This would significantly and adversely affect our ability to complete our clinical trials, obtain and maintain authorization or approval of and commercialize VYD2311 or any future product candidates.
Further, we may not be able to address reductions in neutralization potency with adjustments to the dose or dosing frequency. This would significantly and adversely affect our ability to complete our clinical trials, obtain and 37 maintain authorization or approval of and commercialize VYD2311 or any future product candidates.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk as we sell any products that have been authorized or approved, such as PEMGARDA, which received an EUA from the FDA in March 2024.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and face an even greater risk as we sell any products that have been authorized or approved, such as PEMGARDA, which received an EUA from the FDA in March 2024.
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. The EUA request for PEMGARDA was issued under this declaration.
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. The EUA for PEMGARDA was issued under this declaration.
There could be other disruptions, delays or uncertainties in our development activities as a result of any public health outbreak, pandemic or epidemic, such as the COVID-19 pandemic. Public health outbreaks, pandemics or epidemics, such as the COVID-19 pandemic, which caused a broad impact globally, may also materially affect us economically.
There could be other disruptions, delays or uncertainties in our development activities as a result of any future public health outbreak, pandemic or epidemic. Public health outbreaks, pandemics or epidemics, such as the COVID-19 pandemic, which caused a broad impact globally, may also materially affect us economically.
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.
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.
Further, even if we obtain authorization or approval for a product candidate for one indication that may have potential for new or additional indications, we may determine that those additional indications are not worth pursuing for strategic reasons, including new legislation that may impact our ability to commercialize such compounds for such indications, if approved.
Further, even if we obtain authorization or approval for a product candidate for one indication that may have potential for new or additional indications, we may determine that those additional indications are not worth pursuing for strategic reasons, including new legislation that may impact our ability to commercialize such compounds for such indications, if authorized or approved.
A new manufacturer or manufacturing site would have to be educated on, or develop substantially equivalent processes for, production of our product candidates, and it may be difficult or impossible to transfer certain elements of our manufacturing process to a 54 new manufacturer or for us to find a replacement manufacturer on acceptable terms quickly, or at all.
A new manufacturer or manufacturing site would have to be educated on, or develop substantially equivalent processes for, production of our product candidates, and it may be difficult or impossible to transfer certain elements of our manufacturing process to a new manufacturer or for us to find a replacement manufacturer on acceptable terms quickly, or at all.
Since patent applications in the U.S. and most other countries are confidential for a period of time after filing, we cannot be 70 certain that we or our future licensors were the first to file any patent application related to our product candidates and technologies.
Since patent applications in the U.S. and most other countries are confidential for a period of time after filing, we cannot be certain that we or our future licensors were the first to file any patent application related to our product candidates and technologies.
These laws will impact, among other things, our clinical research, proposed sales, marketing and educational programs, and other interactions with healthcare professionals. In addition, we may be subject to patient privacy laws by both the federal government and the states in which we conduct or may conduct our business.
These laws will impact, among other things, our clinical research, proposed sales, marketing and educational programs, and other interactions with healthcare professionals and patients. In addition, we may be subject to patient privacy laws by both the federal government and the states in which we conduct or may conduct our business.
If we are unable to secure additional funding when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy. Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
If we are unable to secure additional funding when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy. 36 Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Even if our future clinical trials are completed as planned, we cannot be certain that their results will support the safety and effectiveness of our product candidates 40 for their targeted indications or support continued clinical development of such product candidates. Our current or future clinical trial results may not be successful.
Even if our future clinical trials are completed as planned, we cannot be certain that their results will support the safety and effectiveness of our product candidates for their targeted indications or support continued clinical development of such product candidates. Our current or future clinical trial results may not be successful.
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.
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.
European Union Member States’ legislation may also restrict or impose 58 limitations on the ability to advertise products directly to the general public. In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of products to the general public and may impose limitations on promotional activities with healthcare professionals.
European Union Member States’ legislation may also restrict or impose limitations on the ability to advertise products directly to the general public. In addition, voluntary European Union and national Codes of Conduct provide guidelines on the advertising and promotion of products to the general public and may impose limitations on promotional activities with healthcare professionals.
We could experience manufacturing problems, may be unable to access desired 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 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.
If we are unable to build and maintain sales, marketing and distribution capabilities for PEMGARDA or any other product candidate that may receive regulatory authorization or approval, we may not be successful in commercializing PEMGARDA or such other product candidates if and when they are authorized or approved.
If we are unable to continue to build and maintain sales, marketing and distribution capabilities for PEMGARDA or any other product candidate that may receive regulatory authorization or approval, we may not be successful in commercializing PEMGARDA or such other product candidates if and when they are authorized or approved.
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.
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.
The risk of a cybersecurity incident, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication 62 of attempted attacks and intrusions from around the world have increased.
The risk of a cybersecurity incident, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.
Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the 65 use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.
Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.
In addition, if we are not able to 67 obtain adequate supplies of our products or product candidates or the substances used to manufacture them, it will be more difficult for us to develop our product candidates, commercialize our products and compete effectively.
In addition, if we are not able to obtain adequate supplies of our products or product candidates or the substances used to manufacture them, it will be more difficult for us to develop our product candidates, commercialize our products and compete effectively.
In addition, the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. If the FDA’s policies and guidance change unexpectedly and/or materially or if we misinterpret them, potential sales of PEMGARDA could be adversely impacted.
In addition, the PEMGARDA Fact Sheet for Healthcare Providers (“HCPs”) includes a boxed warning for anaphylaxis. If the FDA’s policies and guidance change unexpectedly and/or materially or if we misinterpret them, potential sales of PEMGARDA could be adversely impacted.
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.
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.
The FCPA generally prohibits offering, promising, giving or 95 authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain or retain business.
The FCPA generally prohibits offering, promising, giving or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain or retain business.
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.
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.
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.
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.
Because the use of engineered mAbs is a relatively new and expanding area of novel therapeutic interventions, there are many uncertainties related to development, marketing, reimbursement and the commercial potential for our product candidates.
Because the use of mAbs is a relatively new and expanding area of novel therapeutic interventions, there are many uncertainties related to development, marketing, reimbursement and the commercial potential for our product candidates.
The landscape of laws regulating personal data is constantly evolving, and compliance with these laws requires a flexible privacy framework and substantial resources, and 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 substantial cost in the future.
For example, a widespread outbreak, pandemic or epidemic could result 50 in significant disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity.
For example, a widespread outbreak, pandemic or epidemic could result in significant disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity.
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.
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.
In the U.S., there are numerous federal and state privacy and data security laws and regulations governing the collection, use, disclosure and protection of personal information, including federal 63 and state health information privacy laws, federal and state security breach notification laws and federal and state consumer protection laws.
In the U.S., there are numerous federal and state privacy and data security laws and regulations governing the collection, use, disclosure and protection of personal information, including federal and state health information privacy laws, federal and state security breach notification laws and federal and state consumer protection laws.
Depending on our development progress, we may experience growth in the number of our employees and the scope of our operations, particularly in the areas of research and discovery, clinical product development, regulatory affairs, manufacturing and sales, marketing and distribution.
Depending on our development progress, we may experience growth in the number of our employees and the scope of our operations, particularly in the areas of research and discovery, clinical product development, regulatory affairs, and sales, marketing and distribution.
Any such event could also compel us to comply with federal and state breach notification laws, and foreign law equivalents, subject us to mandatory corrective action and otherwise subject us to substantial liability under laws, rules, regulations and standards that protect the privacy and security of personal data, which could result in significant legal and financial exposure and reputational damages that could potentially have an adverse effect on our business.
Any such event could also compel us to comply with federal and state breach notification laws, and foreign law equivalents, subject us to investigations or mandatory corrective action and otherwise subject us to substantial liability under laws, rules, regulations and standards that protect the privacy and security of personal data, which could result in significant legal and financial exposure and reputational damages that could potentially have an adverse effect on our business.
We may experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, or we may pause, delay or terminate enrollment of our clinical trials, which could in turn delay or prevent our receipt of necessary regulatory approvals.
We may experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, or we may pause, delay or terminate enrollment of our clinical trials, which could in turn delay or prevent our receipt of necessary regulatory authorizations or approvals.
Moreover, even security measures that are deemed appropriate, reasonable, and/or in accordance with applicable legal requirements may not be able to protect the information we maintain.
Moreover, even security measures that are deemed appropriate, reasonable, and/or in accordance with applicable legal standards or requirements may not be able to protect the information we maintain.
Our expenses could increase substantially as we: • commercialize PEMGARDA; • initiate and conduct clinical trials of our product candidates; • develop product candidates in new indications or patient populations; • advance our preclinical and discovery programs, including development and screening of additional antibodies; • seek regulatory authorization or approval for any product candidates that successfully complete clinical trials; • pursue regulatory authorizations or approvals and coverage and reimbursement for our product candidates, if authorized or approved; • acquire or in-license other product candidates, intellectual property and/or technologies; • validate our commercial-scale cGMP manufacturing processes, and manufacture material under cGMP at our contracted manufacturing facilities for clinical trials and potential commercial sales; • maintain, expand, enforce, defend and protect our intellectual property portfolio; • comply with regulatory requirements established by the applicable regulatory authorities; 33 • 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.
Our expenses could increase substantially as we: • continue to commercialize PEMGARDA; • advance the development of VYD2311; • initiate and conduct clinical trials of our product candidates; • develop product candidates in new indications or patient populations; • advance our preclinical and discovery programs, including development and screening of additional antibodies; • seek regulatory authorization or approval for any product candidates that successfully complete clinical trials; • pursue regulatory authorizations or approvals and coverage and reimbursement for our product candidates, if authorized or approved; • acquire or in-license other product candidates, intellectual property and/or technologies; • validate our commercial-scale cGMP manufacturing processes, and manufacture material under cGMP at our contracted manufacturing facilities for clinical trials and potential commercial sales; • maintain, expand, enforce, defend and protect our intellectual property portfolio; • comply with regulatory requirements established by the applicable regulatory authorities; 34 • 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.
Should any of these events occur, they could significantly harm our business, results of operations and prospects. 82 Risks Related to Legal and Regulatory Compliance Matters We received an EUA for PEMGARDA, which the FDA would be required to revoke if HHS determines that emergency use is no longer warranted, which would adversely impact our ability to market PEMGARDA in the United States.
Should any of these events occur, they could significantly harm our business, results of operations and prospects. 84 Risks Related to Legal and Regulatory Compliance Matters We received an EUA for PEMGARDA, which the FDA would be required to revoke if HHS determines that emergency use is no longer warranted, which would adversely impact our ability to market PEMGARDA in the United States.
The government may deem companies to have “caused” the submission of false or fraudulent claims by, for example, because of the companies’ marketing of products for unapproved, and thus non-reimbursable, uses.
The government may deem companies to have “caused” the submission of false or fraudulent claims by, for example, the companies’ marketing of products for unapproved, and thus non-reimbursable, uses.
Even if we obtain any regulatory authorization or approval for our product candidates, such as PEMGARDA, which received an EUA from the FDA in March 2024, they will be subject to ongoing regulatory requirements applicable to manufacturing, labeling, packaging, storage, advertising, promoting, sampling, record-keeping and submission of safety and other post-market information, among other things.
If and when we obtain any regulatory authorization or approval for our product candidates, such as PEMGARDA, which received an EUA from the FDA in March 2024, they will be subject to ongoing regulatory requirements applicable to manufacturing, labeling, packaging, storage, advertising, promoting, sampling, record-keeping and submission of safety and other post-market information, among other things.
It is also quite common that depending on the country, the scope of patent protection may vary for the same product candidate or technology. 80 While we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our product candidates.
It is also quite common that depending on the country, the scope of patent protection may vary for the same product candidate or technology. 82 While we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our product candidates.
Our business could be negatively impacted by our allocation of significant resources to a global health threat that is unpredictable and could change, dissipate or stabilize, which could limit or eliminate demand for PEMGARDA or any new or engineered mAb candidates that we anticipate periodically introducing in the future as the SARS-CoV-2 virus evolves over time.
Our business could be negatively impacted by our allocation of significant resources to a global health threat that is unpredictable and could change, dissipate or stabilize, which could limit or eliminate demand for PEMGARDA, VYD2311 or any new mAb candidates that we anticipate periodically introducing in the future as the SARS-CoV-2 virus evolves over time.
Any such delays could negatively impact our business, financial condition, results of operations and prospects. 45 Interim, top-line, initial and preliminary results from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
Any such delays could negatively impact our business, financial condition, results of operations and prospects. 46 Interim, top-line, initial and preliminary results from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
Some side effects may not be appropriately recognized or managed by the treating medical staff, such as anaphylaxis that has been seen in the class 46 of mAbs of which ADG20 and PEMGARDA are a part, and toxicities resulting from mAb therapy targeting an exogenous target, as with our product candidates, which can be nonspecific.
Some side effects may not be appropriately recognized or managed by the treating medical staff, such as anaphylaxis that has been seen in the class of mAbs of which ADG20 (adintrevimab) and PEMGARDA are a part, and toxicities resulting from mAb therapy targeting an exogenous target, as with our product candidates, which can be nonspecific.
To date, we have sold 9,000,000 shares of our common stock under the Sales Agreement, resulting in net 35 proceeds of $39.3 million.
To date, we have sold 9,000,000 shares of our common stock under the Sales Agreement, resulting in net proceeds of $39.3 million.
Risks Related to the Development of our Product Candidates Newly emerging and future SARS-CoV-2 variants could reduce the activity and effectiveness of antibodies as a potential prevention of or treatment for symptomatic COVID-19, which may significantly and adversely affect our ability to complete our clinical trials and to obtain and maintain authorization or approval of, and commercialize our product candidates.
Risks Related to the Development of our Product Candidates Newly emerging and future SARS-CoV-2 variants could reduce the activity and effectiveness of mAbs as a potential prevention of or treatment for symptomatic COVID-19, which may significantly and adversely affect our ability to complete our clinical trials and to obtain and maintain authorization or approval of, and commercialize our product candidates.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeAs of the date of this report, 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.
Biggest changeAs 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.
Our Head of IT meets regularly with our Chief Operating Officer to discuss our cybersecurity threat landscape, address open gaps and issues, and evaluate solutions to cover any identified gaps. Our Head of IT, in collaboration with members of senior management, reports relevant cybersecurity matters to our Audit Committee. For discussion of cybersecurity risks, please see Item 1A, “Risk Factors.”
Our Head of IT meets regularly with our Chief Financial Officer to discuss our cybersecurity threat landscape, address opportunities for improvement and issues, and evaluate solutions to cover identified gaps. Our Head of IT, in collaboration with members of senior management, reports significant cybersecurity matters to our Audit Committee , consistent with the Incident Response Policy.
However, evolving cybersecurity threats make it increasingly challenging to anticipate, detect, and defend against cybersecurity threats and incidents. Governance While our Board of Directors has overall responsibility for risk oversight, the Audit Committee of our Board of Directors (the “Audit Committee”) is responsible for overseeing our cybersecurity risk management and strategy.
For discussion of cybersecurity risks, please see Item 1A, “Risk Factors.” Governance While our Board of Directors has overall responsibility for risk oversight, the Audit Committee of our Board of Directors (the “Audit Committee”) is responsible for overseeing our cybersecurity risk management and strategy.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Pr operties. 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. We lease this space under a lease agreement that terminates on September 30, 2026.
Biggest changeItem 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.
Additionally, we lease laboratory and office space in Newton, Massachusetts for research and development purposes. We lease this space under a lease agreement that terminates on November 30, 2024. We believe that our facilities are sufficient to meet our current needs. 98
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.
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We believe that our facilities are sufficient to meet our current needs, and that, if we require additional physical facilities, we will be able to obtain additional facilities on commercially reasonable terms.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Item 3. Legal Proceedings. On January 31, 2023, a securities class action lawsuit captioned Brill v. Invivyd, Inc., et. al., Case No. 1:23-CV-10254-LTS, was filed against us and certain of our former officers in the U.S. District Court for the District of Massachusetts.
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Item 3. Legal Proceedings. From time to time, we may become involved in legal proceedings or other litigation relating to claims arising in the ordinary course of business. We accrue liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated.
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The complaint alleges violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder on the basis of purportedly materially false and misleading statements and omissions concerning ADG20’s effectiveness against the Omicron variant of COVID-19. The complaint seeks, among other things, unspecified damages, attorneys’ fees, expert fees, and other costs.
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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
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The court appointed lead plaintiffs for the action on June 28, 2023. On August 23, 2023, the lead plaintiffs filed an amended complaint that makes allegations similar to those in the original complaint and asserts the same claims against the same defendants as the original complaint.
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On October 19, 2023, the parties filed a joint stipulation to advise the court that the lead plaintiffs intended to seek leave to file a second amended complaint, and on November 22, 2023, the lead plaintiffs filed a second amended complaint that makes allegations similar to those in the prior complaints and asserts the same claims against the same defendants as the prior complaints.
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On January 12, 2024, the defendants filed a motion to dismiss the second amended complaint in its entirety. The lead plaintiffs filed an opposition to the motion to dismiss on February 26, 2024, and the defendants filed a reply in further support of their motion to dismiss on March 27, 2024.
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We believe that we have strong defenses, and we intend to vigorously defend against this action. The lawsuit is in early stages, and, at this time, no assessment can be made as to the likely outcome or whether the outcome will be material to us. Item 4. Mine Safety Disclosures. Not applicable. 99 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 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 12, 2024, there were 11 holders of record of our common stock.
Biggest changeItem 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.
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, 2023.
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.
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Use of Proceeds On August 5, 2021, our Registration Statement on Form S-1, as amended (File No. 333-257975), was declared effective in connection with our initial public offering, pursuant to which we sold an aggregate of 20,930,000 shares of our common stock, including the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $17.00 per share.
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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
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Morgan Stanley & Co. LLC, Jefferies LLC, Stifel, Nicolaus & Company, Incorporated and Guggenheim Securities, LLC acted as joint book-running managers. The initial public offering closed on August 10, 2021.
Removed
The aggregate net proceeds received by the Company from the initial public offering were approximately $327.5 million, after deducting underwriting discounts and commissions of $24.9 million and offering expenses payable by the Company of $3.4 million.
Removed
In connection with our initial public offering, no payments were made by us to directors, officers or persons owning ten percent or more of our common stock or to their associates or to our affiliates.
Removed
Other than the reallocation of proceeds to fund clinical development, manufacturing supply and initial commercialization costs from ADG20 to other product candidates, there has been no material change in the planned use of proceeds from our initial public offering as described in our prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on August 6, 2021. 100 Purchases of Equity Securities by the Issuer and Affiliated Purchasers Period Total Number of Shares (or Units) Purchased Average Price Paid per Share (or Unit) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs October 1, 2023 to October 31, 2023 31,765 (1) $ 0.002 — — November 1, 2023 to November 30, 2023 — — — — December 1, 2023 to December 31, 2023 — — — — Total 31,765 $ 0.002 — — (1) We repurchased shares of our common stock that were previously issued upon the early exercise of employee stock options in connection with the exercise of our repurchase right upon cessation of service of certain of our employees and directors.

Item 7. Management's Discussion & Analysis

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

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Biggest changeThe costs were primarily related to contract manufacturing costs. 107 • In the first quarter of 2023, we prioritized the clinical development of VYD222 instead of NVD200 and therefore, there was no comparable spend for NVD200 during the year ended December 31, 2023. • The decrease in personnel-related costs of $7.1 million was primarily due to a reduction in headcount, including a decrease in stock-based compensation expense of $6.6 million, partially offset by an increase in our bonus compensation in 2023. • The increase in external discovery-related and other costs of $10.3 million was primarily due to an increase in contract manufacturing costs related to our pipeline candidates of $8.6 million and an increase in other external costs of $2.3 million primarily due to services performed by PHP under the PHP Work Order, partially offset by a decrease in nonclinical and clinical trial costs of $0.6 million.
Biggest changeThe $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.
Other Income, Net Other income, net for the year ended December 31, 2023 was $14.1 million, consisting primarily of $7.3 million of interest earned on our invested cash balances and $6.8 million of net accretion of discounts related to our marketable securities.
Other income was $14.1 million for the year ended December 31, 2023, consisting primarily of $7.3 million of interest earned on our invested cash balances and $6.8 million of net accretion of discounts related to our marketable securities.
Investing Activities Net cash provided by investing activities during the year ended December 31, 2023 consisted of $372.5 million in maturities of marketable securities, offset by $91.2 million in purchases of marketable securities and $0.6 million in purchases of property and equipment.
Net cash provided by investing activities during the year ended December 31, 2023 consisted of $372.5 million in maturities of marketable securities, offset by $91.2 million in purchases of marketable securities and $0.6 million in purchases of property and equipment.
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; • 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; • 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.
Food and Drug Administration (“FDA”) for PEMGARDA™ (pemivibart) 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 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, 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, 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.
To the extent that we raise 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 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 date, there have not been any material adjustments to our prior estimates of accrued research and development expenses. Stock-Based Compensation 114 We grant stock-based awards to employees, directors and non-employees in the form of stock options to purchase shares of our common stock.
To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses. Stock-Based Compensation We grant stock-based awards to employees, directors and non-employees in the form of stock options to purchase shares of our common stock.
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 commercialization efforts.
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.
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.
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.
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, 2023.
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.
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; • 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 need and ability to hire and retain additional research, clinical, development, scientific and manufacturing personnel; • 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 110 • 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 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.
In March 2023, we achieved the first specified milestone for the second product candidate under the agreement upon dosing of the first subject in a Phase 1 clinical trial evaluating VYD222, which obligated us to make a $0.4 million milestone payment to Adimab, which was paid in May 2023.
In March 2023, we achieved the first specified milestone for the second product candidate under the agreement upon dosing of the first subject in a Phase 1 clinical trial evaluating pemivibart, which obligated us to make a $0.4 million milestone payment to Adimab, which was paid in May 2023.
In September 2023, we achieved specified milestones for the second product candidate under the agreement upon dosing of the first subject in a pivotal clinical trial evaluating VYD222, which obligated us to make a $3.2 million milestone payment to Adimab, which was paid in October 2023.
In September 2023, we achieved specified milestones for the second product candidate under the agreement upon dosing of the first subject in a pivotal clinical trial evaluating pemivibart, which obligated us to make a $3.2 million milestone payment to Adimab, which was paid in October 2023.
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, 2023.
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 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, 2023, 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. 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.
Research and development expenses represent costs incurred by us for: • the nonclinical and preclinical development of our product candidates, including our discovery efforts; • the procurement of our product candidates from a third-party manufacturer; and • the global clinical development of our product candidates 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 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; 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.
In addition, our losses from operations may fluctuate significantly from period to period depending on the timing of our clinical trials and our expenditures on other research and development activities, including any associated manufacturing activities, and commercialization efforts.
In addition, our losses from operations may fluctuate significantly from period to period depending on the timing of our clinical trials and our expenditures on other research and development activities, manufacturing activities, and commercialization efforts.
Our expenses could increase substantially in connection with our ongoing activities, as we: • initiate and conduct clinical trials of our product candidates; • develop product candidates in new indications or patient populations; • advance our preclinical and discovery programs, including development and screening of additional antibodies; • seek regulatory authorization or approval for any product candidates that successfully complete clinical trials; • pursue regulatory authorizations or approvals and 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 potential 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.
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.
As such, excluding any contribution from revenues or external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance of these consolidated financial statements, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern.
Based on current operating plans and excluding any contribution from future revenues or external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance of these consolidated financial statements, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern.
The preparation of consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated 113 financial statements, as well as the reported expenses incurred during the reporting periods.
The preparation of consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses incurred during the reporting periods.
While the COVID-19 public health emergency declared by HHS under the Public Health Service Act expired on May 11, 2023, this does not impact the FDA’s ability to authorize COVID-19 drugs and biological products for emergency use. On March 22, 2024, we received EUA from the FDA for PEMGARDA.
While the COVID-19 public health emergency declared by HHS under the Public Health Service Act expired on May 11, 2023, this does 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. On March 22, 2024, we received EUA from the FDA for PEMGARDA.
If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
Even with product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
As of December 31, 2023, the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $33.9 million, which is expected to be paid in 2024.
As of December 31, 2024, the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $27.6 million, which is expected to be paid in 2025.
As such, excluding any contribution from revenues or external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance of our consolidated financial statements appearing at the end of this Annual Report on Form 10-K, and therefore, we have 103 concluded that there is substantial doubt about our ability to continue as a going concern.
Based on current operating plans and excluding any contribution from future revenues or external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance date of the consolidated financial statements in this Annual Report on Form 10-K, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern.
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”) to execute our chemistry, manufacturing and controls development, testing and 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 development, testing and clinical and commercial manufacturing activities.
Future minimum lease payments under the noncancelable leases as of December 31, 2023 were as follows (in thousands): Year Ending December 31, Operating Lease 2024 1,521 2025 430 2026 328 2027 — Total lease payments 2,279 Present value adjustment (114 ) Present value of operating lease liability $ 2,165 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, 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.
Although we received an EUA from the FDA for PEMGARDA in March 2024, to date, we have not yet generated any revenue from product sales and we may continue to incur significant expenses and potential operating losses for the foreseeable future as we 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 our other product candidates.
Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends.
Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan.
The changes in our operating assets and liabilities primarily consisted of a $34.9 million decrease in accrued expenses, a $4.3 million decrease in accounts payable, and a $0.5 million decrease in operating lease liabilities, partially offset by a $20.4 million decrease in prepaid expenses and other current assets and a $3.1 million decrease in other non-current assets.
The changes in our operating assets and liabilities primarily consisted of a $24.9 million increase in inventory, a $10.9 million increase in accounts receivable, a $1.7 million decrease in operating lease liabilities, and a $0.7 million decrease in other non-current liabilities, partially offset by a $9.0 million increase in accrued expenses, a $3.2 million decrease in prepaid expenses, a $2.4 million increase in accounts payable, and a $0.1 million decrease in other non-current assets.
Our focus in recent months has been and will continue to be supporting the commercialization of PEMGARDA and establishing streamlined development pathways that could enable us to efficiently introduce new or engineered mAb candidates targeting SARS-CoV-2, leveraging our INVYMAB platform approach and previously generated safety and efficacy data from our clinical trials of adintrevimab and/or pemivibart.
Our recent focus has been and will continue to be supporting the commercialization of PEMGARDA, advancing VYD2311 as our next generation mAb candidate for COVID-19, and establishing streamlined development pathways that could enable us to efficiently introduce new mAb candidates targeting SARS-CoV-2, leveraging previously generated safety and efficacy data from our clinical trials of adintrevimab and/or pemivibart.
As of December 31, 2023, $24.1 million 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 2024.
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.
Because of the numerous risks and uncertainties associated with pharmaceutical product development and emergence of SARS-CoV-2 variants of concern (“VoCs”), we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability.
Because of the numerous risks and uncertainties associated with pharmaceutical product development and emergence of SARS-CoV-2 variants, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. We may never obtain regulatory authorization or approval for any of our product candidates other than PEMGARDA.
Net cash provided by financing activities during the year ended December 31, 2022 primarily consisted of $0.2 million from exercises of stock options and $0.3 million from issuances of common stock under the Company’s employee stock purchase plan.
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.
Income Taxes Since our inception, we have not recorded any income tax expense or realized benefits for the net losses we have incurred or for the research and development tax credits generated in each period as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized. 106 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.
Income Taxes Since our inception, we have not recorded any income tax expense or realized benefits for the net losses we have incurred or for the research and development tax credits generated in each period as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized.
We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See the section entitled “Liquidity and Capital Resources” for more information. Components of Our Results of Operations Revenue Through December 31, 2023, we had not generated any revenue from product sales or any other sources.
We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See the section entitled “Liquidity and Capital Resources” for more information. Components of Our Results of Operations Product Revenue, Net In March 2024, we received EUA from the FDA for PEMGARDA.
Isolation and mental health impacts, absenteeism from work, and educational losses for children have been profound consequences of this crisis. COVID-19 persists and continues to impact patients, notably those who are immunocompromised, and combating this disease will require a variety of effective and safe prevention and treatment options for years to come.
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.
During the year ended December 31, 2022, operating activities used $220.0 million of cash, primarily due to our net loss of $241.3 million and changes in our operating assets and liabilities of $16.1 million, partially offset by non-cash charges of $37.5 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.
In December 2023, pursuant to the terms of the Adimab Collaboration Agreement, we elected to decrease the scope of Adimab’s exclusivity obligations to cover only coronaviruses and obtained a corresponding 112 decrease in the quarterly fee.
In December 2023, pursuant to the terms of the Adimab Collaboration Agreement, we elected to decrease the scope of Adimab’s exclusivity obligations to cover only coronaviruses and obtained a corresponding decrease in the quarterly fee. Effective January 2024, we are obligated to pay Adimab a quarterly fee of $0.6 million, a decrease from the previous quarterly fee of $1.3 million.
We have implemented a go-to-market strategy, including building our own commercial organization and outsourcing to contract sales and marketing organizations. On March 22, 2024, we received EUA from the FDA for PEMGARDA, and as such, we will continue to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.
On March 22, 2024, we received EUA from the FDA for PEMGARDA, and as such, we will continue to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.
As of December 31, 2023, we had an accumulated deficit of $732.1 million. We may continue to incur significant expenses and recognize losses in the foreseeable future as we expand and progress our research and development activities, as well as the associated manufacturing activities and commercialization efforts.
We may continue to incur significant expenses and recognize losses in the foreseeable future as we expand and progress our research and development activities, manufacturing activities and commercialization efforts.
To date, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, and with aggregate net proceeds from our IPO in August 2021 of $327.5 million. As of December 31, 2023, we had cash and cash equivalents of $200.6 million.
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).
We entered into a separate two-year noncancelable agreement for new dedicated laboratory and office space on the same campus as the Newton, MA Lease. We took occupancy of the new dedicated laboratory and office space in December 2022. The monthly rental payments under the amended agreement include base rent charges of $1.3 million per year.
Pursuant to the amended Newton, MA Lease, we entered into a two-year noncancelable agreement for new dedicated laboratory and office space in Newton, Massachusetts, on the same campus as, and in lieu of, the space leased under the original lease. We took occupancy of the new dedicated laboratory and office space in December 2022.
Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: Year Ended December 31, (in thousands) 2023 2022 Net cash used in operating activities $ (173,164 ) $ (219,987 ) Net cash provided by (used in) investing activities 280,684 (230,667 ) Net cash provided by financing activities 1,045 506 Net increase (decrease) in cash and cash equivalents $ 108,565 $ (450,148 ) Operating Activities 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.
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.
Until such time as we can generate significant product revenue, if ever, we expect to finance our operations through a combination of equity offerings, government or private-party funding or grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements.
We expect to finance our operations through a combination of contribution from revenues, equity offerings, government or private-party grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements to support our continuing operations and pursue our growth strategy.
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.
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.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564 of the FDCA, unless the declaration is terminated or authorization revoked sooner. 105 Acquired In-Process Research and Development Expenses Acquired in-process research and development (“IPR&D”) expenses consist primarily of costs of contingent milestone payments incurred to acquire rights to Adimab’s antibodies relating to COVID-19 and SARS and related intellectual property and a license to certain of Adimab’s platform patents and technology (the “IPR&D assets”) for use in the research and development of our product candidates.
Acquired In-Process Research and Development Expenses Acquired in-process research and development (“IPR&D”) expenses consist primarily of costs of contingent milestone payments incurred to acquire rights to Adimab’s antibodies relating to COVID-19 and SARS and related intellectual property and a license to certain of Adimab’s platform patents and technology (the “IPR&D assets”) for use in the research and development of our product candidates.
Our research and development expenses will increase as we continue to advance PEMGARDA and as we expect to advance VYD2311 through clinical development, pursue 104 EUA or regulatory approval of our product candidates, continue to discover and develop additional product candidates and incur expenses associated with hiring additional personnel to support our research and development efforts, including the associated manufacturing activities.
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.
The decreases in accounts payable and accrued expenses were primarily due to the timing of vendor invoicing and payments. The decreases in prepaids expenses and other current assets and in other non-current assets were primarily due to our utilization of WuXi Biologics manufacturing deposits.
The increase in accrued expenses was primarily due to the timing of vendor invoicing and payments. The decrease in prepaid expenses and other current assets was primarily due to the utilization of WuXi Biologics manufacturing prepayments.
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.
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.
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.
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.
As of December 31, 2023, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years. While we do not expect these rules to have a material impact on our effective tax rate, we continue to monitor these initiatives on a global basis.
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.
Until such time, if ever, as we can generate significant product revenue, we expect to finance our operations through a combination of equity offerings, government or private-party funding or grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements.
As a result, we will require additional funding through a combination of contribution from revenues, equity offerings, government or private-party grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements to support our continuing operations and pursue our growth strategy.
Since our inception, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock and with net proceeds of $327.5 million from our initial public offering (“IPO”). Through December 31, 2023, we had not generated any revenue from any sources, including product sales.
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).
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. The amount and timing of such milestone and royalty payments are not known.
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 first quarter of 2024, we committed to additional noncancelable purchase obligations of $24.7 million related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.
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.
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. We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time.
We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time. At each end period, we corroborate the accuracy of these estimates with the service providers and make adjustments, if necessary.
Our ability to generate product revenue sufficient 102 to achieve profitability will depend heavily on the successful development and commercialization of one or more of our product candidates, as they become authorized or approved. Since our inception, we have incurred significant losses, including a net loss of $198.6 million for the year ended December 31, 2023.
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.
By leveraging our capabilities, which we have developed through our experience with adintrevimab and pemivibart and nearly four years in the COVID-19 space, we aim to develop a continuous repertoire of SARS-CoV-2 neutralizing mAbs to keep pace with viral evolution.
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.
Net cash used in investing activities during the year ended December 31, 2022 consisted of $298.0 million in purchases of marketable securities and $1.7 million in purchases of property and equipment, offset by $69.0 million in maturities of marketable securities. 109 Financing Activities Net cash provided by financing activities during the year ended December 31, 2023 primarily consisted of $1.0 million from exercises of stock options and $0.2 million from issuances of common stock under the Company’s employee stock purchase plan.
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.
Acquired In-Process Research and Development Expenses Acquired 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.
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.
Research and development expenses were $158.7 million for the year ended December 31, 2023, compared to $179.2 million for the year ended December 31, 2022.
(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.
The $2.1 million increase in selling, general and administrative expenses was primarily due to the following: • The increase in personnel-related costs of $6.2 million was primarily due to our bonus compensation in 2023 and the reversal of stock-based compensation expense related to the forfeiture of stock options in conjunction with the resignation of our former Chief Executive Officer and President during the year ended December 31, 2022. • The decrease in professional and consultant fees of $4.1 million was primarily due to a $3.9 million decrease in expenses related to corporate governance matters and a $1.7 million decrease in director and officer insurance premiums, offset by a $1.5 million increase in commercial costs. • Other costs remained relatively consistent between periods.
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.
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. 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.
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.
In June 2022, and subsequently amended in September 2022, we entered into a lease agreement for dedicated laboratory and office space in Newton, Massachusetts for research and development purposes. Through December 31, 2023, we have operated as a hybrid company with employees working at our corporate headquarters and remotely.
Through December 31, 2024, we have operated as a hybrid company with employees working at our corporate headquarters and remotely.
The monthly rental payments under the lease, which include base rent charges of $0.4 million per year, are subject to periodic rent increases through September 2026. In addition to base rent, monthly rental payments include our proportionate share of operating expenses.
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.
Results of Operations Comparison of the Years Ended December 31, 2023 and 2022 The following table summarizes our results of operations for the years ended December 31, 2023 and 2022: Year Ended December 31, (in thousands) 2023 2022 Operating expenses: Research and development $ 158,658 $ 179,214 Acquired in-process research and development 4,975 4,400 Selling, general and administrative 49,125 47,044 Warrant expense — 17,373 Total operating expenses 212,758 248,031 Loss from operations (212,758 ) (248,031 ) Other income: Other income, net 14,115 6,714 Total other income, net 14,115 6,714 Net loss $ (198,643 ) $ (241,317 ) Research and Development Expenses Year Ended December 31, (in thousands) 2023 2022 Direct, external research and development expenses by program: VYD222 (1) $ 96,695 $ — Adintrevimab 3,857 106,024 VYD2311 (2) 1,425 — NVD200 (3) — 19,665 Unallocated research and development expenses: Personnel related (including stock-based compensation) 30,074 37,181 External discovery-related and other costs 26,607 16,344 Total research and development expenses $ 158,658 $ 179,214 (1) In March 2023, we announced the nomination of VYD222 as a novel mAb therapeutic option for COVID-19.
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.
Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. PEMGARDA is our first mAb in a planned series of innovative mAb candidates designed to keep pace with SARS-CoV-2 viral evolution.
Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. In January 2024, we nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate, and in September 2024, we announced dosing of the first participants in a Phase 1 clinical trial of VYD2311.
In addition to developing candidates for COVID-19, we expect to apply our INVYMAB platform approach to produce lead molecules for other viral diseases, such as influenza. Globally, COVID-19 has caused millions of deaths and lasting health problems in many survivors and remains a significant global health concern, particularly for immunocompromised individuals.
Globally, COVID-19 has caused millions of deaths and lasting health problems in many survivors and remains a significant global health concern, particularly for immunocompromised individuals. Isolation and mental health impacts, absenteeism from work, and educational losses for children have been profound consequences of this crisis.
The lease terms provide for one five-year extension term with base rent calculated on the then-market rate. 111 In June 2022, we entered into a two-year noncancelable agreement for dedicated laboratory and office space in Newton, Massachusetts (the “Newton, MA Lease”). The monthly rental payments under the agreement include base rent charges of $0.7 million per year.
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 expect to generate revenue from sales of PEMGARDA, which received EUA from the FDA in March 2024.
After receiving EUA in March 2024, we have also funded our operations from sales of PEMGARDA.
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Overview Invivyd, Inc. is a commercial-stage company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (“mAbs”) to keep pace with evolving viral threats.
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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.
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On March 22, 2024, we received emergency use authorization (“EUA”) from the U.S.
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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.
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As the SARS-CoV-2 virus evolves over time, we anticipate leveraging our INVYMAB platform approach to periodically introduce new or engineered mAb candidates, an approach that would be analogous to the periodic updates made to influenza and COVID-19 vaccines.
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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.
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In January 2024, we nominated VYD2311, a mAb optimized for neutralization potency against recent SARS-CoV-2 lineages such as BA.2.86 and JN.1, as a drug candidate, and we expect it will be the next pipeline program to advance into clinical development.
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In February 2025, we announced completion of recruitment in our Phase 1 clinical trial of VYD2311, as well as positive clinical data for both safety and pharmacokinetics. We expect additional data readouts from the Phase 1 clinical trial and VYD2311 program throughout 2025.
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We have engaged WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”), a CDMO, for the development and manufacture of our product candidates for clinical and commercial use.

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Other IVVD 10-K year-over-year comparisons