Invivyd (IVVD) risk factors, FY2024 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 concern
2. 02We have incurred significant losses since our inception and are highly dependent on the commercial success of PEMGARDA for the foreseeable future. We may not achieve or maintain profitability
3. 03incur additional legal, accounting and other expenses in operating as a public company
4. 04We 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 viability
5. 05In addition, as a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors
6. 06the impact of any business interruptions to our operations or to those of our third-party contractors resulting from any public health crisis
7. 07Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates

Risks Related to the Development of our Product Candidates

1. 08the 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
2. 09We 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
3. 10any 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
4. 11have regulatory authorities withdraw or suspend their authorization or approval of the product or impose restrictions on its distribution after obtaining authorization or approval
5. 12the approval policies or regulations of the FDA or comparable foreign authorities may significantly change in a manner rendering our clinical data insufficient for approval
6. 13Success 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
7. 14Interim, 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
8. 15our reputation and physician or patient acceptance of our products may suffer
9. 16Lack of awareness or negative public opinion of mAb therapies and increased regulatory scrutiny of mAb therapies to prevent or treat COVID-19 may adversely impact the development or commercial success of our product candidates
10. 17We 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
11. 18the proximity and availability of clinical trial sites for prospective patients
12. 19We 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
13. 20We 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
14. 21We 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
15. 22Our business and operations may be adversely affected by public health outbreaks, pandemics or epidemics, such as the COVID-19 pandemic
16. 23Our product candidates may be negatively impacted by future development or regulatory difficulties

Risks Related to the Manufacturing of our Product Candidates

1. 24The 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
2. 25loss 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
3. 26Any 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
4. 27Changes 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. 28If 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. 29Our 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. 30The 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. 31If 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. 32The 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 candidates
6. 33Off-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 product
7. 34Our 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
8. 35successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines
9. 36The success of PEMGARDA and our product candidates depends significantly on coverage and adequate reimbursement or the willingness of patients to pay for these therapies
10. 37Any product candidates for which we determine to seek approval as biological products may face biosimilar competition sooner than anticipated
11. 38Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
12. 39the inability to commercialize any products that we may develop
13. 40Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our or our CDMO’s, CROs’, contractors’, consultants’ or collaborators’ cybersecurity
14. 41We 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 business
15. 42If 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. 43We rely on third parties to manufacture, test, label, package, store and distribute clinical and commercial supplies of our product candidates
2. 44We 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 storage
3. 45disruptions 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. 46We 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. 47collaborations 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. 48The 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. 49If we are unable to protect the confidentiality of trade secrets, our business and competitive position would be harmed
2. 50Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will be effective
3. 51strategic 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
4. 52Patent 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
5. 53We 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
6. 54We may be unsuccessful in licensing or acquiring intellectual property from third parties that may be required to develop and commercialize our product candidates
7. 55Third 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
8. 56We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties
9. 57We may be subject to claims challenging the inventorship or ownership of our future patents and other intellectual property
10. 58Reliance 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
11. 59We 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
12. 60Obtaining 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
13. 61Any trademarks we have obtained or may obtain may be infringed or otherwise violated, or successfully challenged, resulting in harm to our business
14. 62Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to Legal and Regulatory Compliance Matters

1. 63We 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. 64If 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. 65refuse to allow us to enter into supply contracts, including government contracts
4. 66Despite obtaining authorization under an EUA for PEMGARDA in the U.S., we may never obtain authorization or approval for or commercialize PEMGARDA or any other product candidate in any other jurisdiction, which would limit our ability to realize any of their full market potential
5. 67Healthcare legislative or regulatory reform measures may have a negative impact on our business and results of operations
6. 68additional recordkeeping

Risks Related to Employee Matters and Managing Our Growth

1. 69Our future success depends on our ability to attract and retain key executives and to attract, retain and motivate qualified personnel
2. 70and the ability to attract a key executive to replace that position and the ability to retain additional key executives are critical to our success. We do not maintain “key person” insurance for any of our executives or employees
3. 71Adimab owns a significant percentage of our common stock, will be able to exert significant influence over matters subject to stockholder approval and may have interests that conflict with those of our other stockholders
4. 72We 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
5. 73Our 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. 74The 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 losses
2. 75other events or factors, many of which are beyond our control
3. 76There can be no assurance that we will continue to be able to comply with the continued listing standards of Nasdaq
4. 77value and liquidity of our common stock. Delisting also could have other negative results, including the potential loss of employee confidence, the loss of institutional investors or interest in potential business development opportunities
5. 78If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline
6. 79A significant portion of our total outstanding shares are available for immediate resale. This could cause the market price of our common stock to drop significantly, even if our business is doing well
7. 80Provisions 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
8. 81stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings
9. 82Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions
10. 83We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors
11. 84an 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
12. 85We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
13. 86Because 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
14. 87any action asserting a claim against us that is governed by the internal-affairs doctrine
15. 88Our ability to use net operating losses to offset future taxable income may be subject to certain limitations
16. 89We maintain our cash at financial institutions, often in balances that exceed federally insured limits
17. 90Our 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
18. 91Unfavorable 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