Invivyd (IVVD) risk factors, FY2025 10-K

Risks Related to our Financial Position and Capital Needs

1. 01Our financial condition raises substantial doubt regarding our ability to continue as a going concern67% rewritten
2. 02incur additional legal, accounting and other expenses in operating as a public company28% rewritten
3. 03We have a limited operating history and limited experience with commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability70% rewritten
4. 04our operations through a combination of equity offerings, government or private-party grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangementsNew
5. 05the impact of any business interruptions to our operations or to those of our third-party contractors resulting from any public health crisis35% rewritten
6. 06Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
7. 07Our failure to comply with the covenants or other terms of our Loan Agreement, including as a result of events beyond our control, could result in a default under the Loan Agreement that could materially and adversely affect the ongoing viability of our businessNew
8. 08certain specified insolvency and bankruptcy-related eventsNew
9. 09For our Loan Agreement, we must satisfy certain conditions to be eligible to draw down the Term LoansNew
10. 10Our Loan Agreement contains restrictions that limit our flexibility in operating our businessNew
11. 11enter into certain transactions with our affiliatesNew
12. 12To service our indebtedness, as applicable, we will require a significant amount of cash and our ability to generate cash depends on many factors beyond our controlNew

Risks Related to the Development of our Product Candidates

1. 13the 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 crisis96% rewritten
2. 14reimbursement coverage and commercial potential of our COVID-19 product candidates. We may not be successful in aligning with regulators on an expedited and replicable pathway to SARS-CoV-2 mAb authorization or approvalNew
3. 15or 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 alterationNew
4. 16We have and may experience delays in beginning or conducting clinical trials or numerous unforeseen events before, during or as a result of clinical trials that could delay or prevent our ability to complete clinical trials, receive regulatory authorization or approval or commercialize our product candidates
5. 17any future collaborators that conduct clinical trials may face any of the above issues and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us
6. 18have regulatory authorities withdraw or suspend their authorization or approval of the product or impose restrictions on its distribution after obtaining authorization or approval53% rewritten
7. 19We may not succeed in obtaining the regulatory approval necessary to sell our product candidatesNew
8. 20application and provided feedback to advance our REVOLUTION clinical program for VYD2311 and, in December 2025, we announced initiation of our DECLARATION pivotal clinical trial. However, we cannot be certain that VYD2311 will receive the BLA that we are pursuing in the U.SNew
9. 21the approval policies or regulations of the FDA or comparable foreign authorities may significantly change in a manner rendering our clinical data insufficient for approval100% rewritten
10. 22Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. Our product candidates may not have favorable results in later clinical trials, if any, or receive regulatory authorization or approval
11. 23Interim, 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 data49% rewritten
12. 24satisfaction of the FDA or comparable foreign regulatory authorities, that our product candidates are safe and effective for their intended uses or otherwise meet requirements for an EUANew
13. 25our reputation and physician or patient acceptance of our products may suffer
14. 26Lack of awareness or negative public opinion of mAb therapies and increased regulatory scrutiny of mAb therapies to prevent or treat COVID-19 or other infectious diseases may adversely impact the development or commercial success of our product candidates
15. 27We 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
16. 28the proximity and availability of clinical trial sites for prospective patients
17. 29We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
18. 30We have conducted and may in the future conduct clinical trials for our product candidates outside the U.S., and the FDA and similar foreign regulatory authorities may not accept data from such trials conducted in locations outside of their jurisdiction
19. 31We may not be successful in our efforts to build a pipeline of additional product candidates through internal efforts or through partnerships for discovery of novel antibody product candidates
20. 32Our business and operations may be adversely affected by public health outbreaks, pandemics or epidemics, such as the COVID-19 pandemic
21. 33Our product candidates may be negatively impacted by future development or regulatory difficulties81% rewritten

Risks Related to the Manufacturing of our Product Candidates

1. 34materials due to global supply chain shortages or otherwise, that result in delays in the development, supply, or commercialization of our product candidates or otherwise harm our businessNew
2. 35The manufacture of mAbs and other protein-based therapies are technically complex and necessitate substantial expertise and capital investment. Production difficulties caused by unforeseen events may delay the availability of material for our clinical trials or commercialization efforts
3. 36loss of or close-down of any manufacturing facility used in the manufacture of our product candidates, or the inability to find alternative manufacturing capability in a timely fashion
4. 37Any contamination or interruption in our manufacturing process, shortages of raw materials or failure of our suppliers of reagents to deliver necessary components could result in delays in our clinical development or commercialization schedules
5. 38Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay

Risks Related to the Commercialization of Our Product Candidates

1. 39If the FDA revokes or terminates our EUA for PEMGARDA, we will be required to stop commercial distribution of PEMGARDA immediately unless we can obtain FDA approval for PEMGARDA under a traditional regulatory pathway, which may be lengthy and expensive, which could harm our future business prospects
2. 40Our product candidates may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, due to the product profile, reimbursement dynamics or other reasons
3. 41The commercial success of our product candidates, if authorized or approved, is dependent upon market acceptance by physicians, HCPs and patients, which will be informed, in part, by cost, convenience, route of administration, safety and efficacy, including efficacy against emerging SARS-CoV-2 variants over time
4. 42If we do not establish sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates
5. 43The affected populations for our product candidates, including PEMGARDA, may be smaller than we or third parties currently project, which may affect the addressable markets for our product candidates58% rewritten
6. 44data and statistical information used in this Annual Report on Form 10-K, and in our other filings with the SEC, including estimates derived from them, may differ from information and estimates made by our competitors or from current or future studies conducted by independent sourcesNew
7. 45Off-label use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, and/or subject us to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any product22% rewritten
8. 46Our mAb product candidates, including PEMGARDA, may face significant competition from vaccines, antiviral agents and other therapeutics for COVID-19 that are currently available or in development
9. 47successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines
10. 48The success of PEMGARDA and our product candidates depends significantly on coverage and adequate reimbursement or the willingness of patients to pay for these therapies
11. 49Any product candidates for which we determine to seek approval as biological products may face biosimilar competition sooner than anticipated
12. 50Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
13. 51the inability to commercialize any products that we may develop
14. 52Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our or our CDMO’s, CROs’, contractors’, consultants’ or collaborators’ cybersecurity20% rewritten
15. 53We are subject to a variety of privacy and data security laws, rules, regulations, policies, industry standards and contractual obligations, and our failure to comply with them could harm our business72% rewritten
16. 54Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actionsNew
17. 55If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could seriously harm our business

Risks Related to Our Dependence on Third Parties

1. 56We rely on third parties to manufacture, test, label, package, store and distribute clinical and commercial supplies of our product candidates
2. 57We currently rely on third parties for manufacturing, testing, labeling, packaging, storing and distributing our product candidates. We do not own or operate any facilities for product manufacturing, testing, labeling, packaging, or storage35% rewritten
3. 58disruptions to operations of a third-party manufacturer or suppliers by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier
4. 59We may seek collaborations with third parties for the discovery, development or commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates
5. 60collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates
6. 61The third parties upon whom we depend may be adversely affected by earthquakes, wildfires or other natural and manmade disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster

Risks Related to Our Intellectual Property

1. 62for our product candidates and technologies, it could threaten our ability to commercialize our product candidates and technologies. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection, if approved, would be reducedNew
2. 63If we are unable to protect the confidentiality of trade secrets, our business and competitive position would be harmed
3. 64Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will be effective94% rewritten
4. 65to third parties, and there is no guarantee that we will have any such enforceable trade secret protection, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations and financial conditionNew
5. 66strategic 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
6. 67Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and licensed patents, and the enforcement or defense of our licensed patents or future owned patents
7. 68We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products
8. 69We may be unsuccessful in licensing or acquiring intellectual property from third parties that may be required to develop and commercialize our product candidates
9. 70Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain
10. 71We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties
11. 72We may be subject to claims challenging the inventorship or ownership of our future patents and other intellectual property
12. 73Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed
13. 74We may enjoy only limited geographical protection with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world
14. 75Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
15. 76Any trademarks we have obtained or may obtain may be infringed or otherwise violated, or successfully challenged, resulting in harm to our business
16. 77Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to Legal and Regulatory Compliance Matters

1. 78We 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
2. 79If and when we obtain regulatory authorization or approval for a product candidate, such products will remain subject to ongoing regulatory oversight, which may result in significant additional expense
3. 80manufacturing facility or us, including requesting a recall or requiring variation, suspension or withdrawal of marketing authorization, or suspension of manufacturing, or imposition of financial penalties or other enforcement measuresNew
4. 81refuse to allow us to enter into supply contracts, including government contracts52% rewritten
5. 82In order to market any products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacyNew
6. 83Healthcare legislative or regulatory reform measures may have a negative impact on our business and results of operations85% rewritten
7. 84in federal healthcare programs, a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, and annual fees based on pharmaceutical companies’ share of sales to federal healthcare programsNew
8. 85revenue, attain profitability, or commercialize our drugs. It is also possible that additional governmental action will be taken in response to the COVID-19 pandemicNew
9. 86additional recordkeeping

Risks Related to Employee Matters and Managing Our Growth

1. 87Our future success depends on our ability to attract and retain key executives and to attract, retain and motivate qualified personnel94% rewritten
2. 88We may expand our clinical development and regulatory capabilities and have implemented sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
3. 89Our employees, independent contractors, consultants, collaborators, principal investigators, CROs, CDMO, suppliers and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements

Risks Related to Ownership of Our Common Stock and Our Status as a Public Company

1. 90The trading price of the shares of our common stock has been and may continue to be volatile, and purchasers of our common stock could incur substantial losses22% rewritten
2. 91other events or factors, many of which are beyond our control
3. 92There can be no assurance that we will continue to be able to comply with the continued listing standards of Nasdaq60% rewritten
4. 93Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result
5. 94stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings
6. 95We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors
7. 96an exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on the financial statements
8. 97We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
9. 98Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment
10. 99any action asserting a claim against us that is governed by the internal-affairs doctrine
11. 100Our ability to use net operating losses to offset future taxable income may be subject to certain limitations76% rewritten
12. 101is variation in how states are responding. In addition, for state income tax purposes, there may be periods during which the use of NOLs is suspended or otherwise limitedNew
13. 102We maintain our cash at financial institutions, often in balances that exceed federally insured limits
14. 103Our business activities are subject to the FCPA and similar anti-bribery and anti-corruption laws. We could face liability and other serious consequences for violations
15. 104Unfavorable global economic conditions and geopolitical events, including as a result of trade tensions between the U.S. and China, could adversely affect our business, financial condition or results of operations, including conduct of our clinical trials and our manufacturing activities