Vera Therapeutics (VERA) risk factors, FY2024 10-K

Risks related to our financial position and need for additional capital

1. 01We have completed a limited number of clinical trials for our lead product candidate, atacicept, and have no products approved for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability
2. 02add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts
3. 03We have incurred net losses since inception, and we expect to continue to incur net losses for the foreseeable future. In addition, we may be unable to continue as a going concern over the long-term
4. 04We have never generated revenue from product sales and may never be profitable
5. 05attracting, developing and retaining qualified personnel
6. 06The terms of our loan agreement place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business

Risks related to the discovery, development and commercialization of our product candidates

1. 07Even if our clinical trials are completed as planned, we cannot be certain that their results will support our proposed indications
2. 08authorities for commercialization. If we are unable to bring our product candidates to market, our ability to create long-term shareholder value will be limited
3. 09Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and jeopardize or delay our ability to obtain regulatory approval and commence product sales
4. 10third-party contractors not performing data collection or analysis in a timely or accurate manner; or
5. 11In addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval
6. 12competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating
7. 13We 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
8. 14We may develop atacicept, MAU868, VT-109, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks
9. 15Interim, initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more participant data become available and are subject to audit and verification procedures that could result in material changes in the final data
10. 16We face significant competition, which may result in others discovering, developing or commercializing products before or more successfully than us
11. 17Changes in methods of manufacturing or formulation of our product candidates may result in additional costs or delays

Risks related to regulatory approval and other legal compliance matters

1. 18the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
2. 19This lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in our failing to obtain regulatory approval to market our product candidates, which would significantly harm our business, financial condition, results of operations and prospects
3. 20Even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success
4. 21the approval of other new therapies for the same indications
5. 22Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage, such inability could significantly harm our business, financial condition, results of operations and prospects
6. 23Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval in other jurisdictions
7. 24reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our product is also subject to approval
8. 25Even if any product candidate we develop receives regulatory approval, it could be subject to significant post-marketing regulatory requirements and will be subject to continued regulatory oversight
9. 26The occurrence of any event or penalty described above may inhibit our ability to commercialize atacicept, MAU868, VT-109, or any product candidate we may develop in the future, and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity
10. 27We are currently seeking orphan drug designation for atacicept for the treatment of IgAN, but even if designated we may not ultimately realize the potential benefits of orphan drug designation
11. 28Even though MAU868 has Fast Track designation from FDA for the prevention of BK viremia in renal transplant and hematopoietic stem cell transplant, it may not lead to a faster development or regulatory review or approval process, and will not increase the likelihood that MAU868 will receive marketing approval
12. 29transplant recipients, we may not experience a faster development process, review or approval compared to conventional FDA procedures. In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program
13. 30Biosimilars to our product candidates may provide competition sooner than anticipated
14. 31still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty
15. 32Any product candidate we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations
16. 33neither experimental nor investigational
17. 34We may face difficulties from changes to current regulations and future legislation
18. 35delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements
19. 36additional recordkeeping
20. 37analogous state and foreign laws and regulations, such as state and foreign anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers
21. 38individual EU Member States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment
22. 39groups. Regulators in the United States are also increasingly scrutinizing certain personal data transfers and have imposed, and may in the future impose, certain personal data transfer or localization requirements
23. 40If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could significantly harm our business, financial condition, results of operations or prospects

Risks related to employee matters, managing our growth and other risks related to our business

1. 41Unfavorable geopolitical and global economic conditions could adversely affect our business, financial condition and results of operations
2. 42Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees and key consultants
3. 43what we have to offer. If we are unable to continue to attract and retain high-quality personnel, the rate and success at which we can discover, develop and commercialize atacicept, MAU868, VT-109, or any other product candidate will be limited and the potential for successfully growing our business will be harmed
4. 44We have never commercialized a product candidate before and may lack the necessary expertise, personnel, and resources to successfully commercialize any products on our own or together with suitable collaborators
5. 45In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth
6. 46improving our operational, financial and management controls, reporting systems and procedures
7. 47We or the third parties upon whom we depend may be adversely affected by earthquakes, fires or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
8. 48Comprehensive tax reform legislation could adversely affect our business and financial condition
9. 49Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
10. 50A variety of risks associated with marketing our current or any future product candidate we may develop internationally could significantly harm our business, financial condition, results of operations and prospects

Risks related to our intellectual property

1. 51Our success depends on our ability to protect our intellectual property and our proprietary technologies
2. 52licensees or collaborators are unable to obtain or maintain patent protection with respect to atacicept, MAU868, VT-109, and our other products, proprietary technologies and their uses, our business, financial condition, results of operations and prospects could be significantly harmed
3. 53countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates
4. 54If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates
5. 55We may be required to make significant payments under our license agreements related to atacicept, MAU868, and VT-109
6. 56If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected
7. 57The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad
8. 58was identified during examination of a patent application so that, even if a patent issues, it may be susceptible to challenge that it is not valid over art that was not considered during its examination
9. 59Intellectual property rights do not necessarily address all potential threats to our competitive advantage
10. 60Should any of these events occur, it could significantly harm our business, financial condition, results of operations and prospects
11. 61require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining access to the same technology
12. 62While we may have in-licensed patents that cover atacicept, MAU868, and VT-109, it is possible that third parties may have blocking patents that prevent us from marketing, manufacturing or commercializing our patented products and practicing our in-licensed patented technology
13. 63We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court
14. 64Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline
15. 65Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party
16. 66Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our patents
17. 67We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
18. 68Patent terms may be inadequate to protect our competitive position on atacicept, MAU868, VT-109, or any future product candidates we may develop for an adequate amount of time
19. 69Any of the foregoing could significantly harm our business, financial condition, results of operations and prospects
20. 70We will not be able to protect our intellectual property rights throughout the world
21. 71Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment, and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
22. 72If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business, financial condition, results of operations and prospects could be significantly harmed
23. 73If we are unable to protect the confidentiality of our trade secrets, our business, financial condition, results of operations, prospects and competitive position would be significantly harmed
24. 74We may be subject to claims that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets
25. 75Our rights to develop and commercialize our technology and product candidates may be subject, in part, to the terms and conditions of licenses granted to us by others
26. 76If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business
27. 77the priority of invention of patented technology

Risks related to our dependence on third parties

1. 78the misappropriation of our proprietary information, including our trade secrets and know-how
2. 79If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks
3. 80our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs
4. 81We may enter into collaborations with third parties for the development and commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of atacicept, MAU868, or VT-109
5. 82If we decide to establish collaborations in the future, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans

Risks related to ownership of our Class A common stock

1. 83The price of our common stock may be volatile, and you could lose all or part of your investment
2. 84sales of our securities by us, our insiders or our other stockholders; and
3. 85Our business could be negatively affected as a result of actions of activist stockholders, and such activism could impact the trading value of our securities
4. 86significant fluctuations in our stock price based upon temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our business
5. 87Our principal stockholders and management own a significant percentage of our outstanding voting stock and will be able to exert significant control over matters subject to stockholder approval
6. 88Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall
7. 89As of December 31, 2024, there were 63,559,858 shares of common stock outstanding and held of record by 17 stockholders. The number of record holders of our common stock does not include DTC participants or beneficial owners holding shares through nominee names
8. 90Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to atacicept, MAU868, VT-109, or future product candidates we may develop on unfavorable terms to us
9. 91We no longer qualify as an “emerging growth company” or a “smaller reporting company” and, as a result, we will no longer be able to avail ourselves of certain reduced disclosure requirements applicable to emerging growth companies and/or smaller reporting companies
10. 92We do not currently intend to pay dividends on our common stock and, consequently, your ability to achieve a return on your investment will depend on appreciation of the value of our common stock
11. 93Provisions in our amended and restated certificate of incorporation and amended and restated bylaws and Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
12. 94require the approval of the holders of at least 66 2/3% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our amended and restated certificate of incorporations or amended and restated bylaws
13. 95This choice of forum provision would not apply to claims or causes of action brought to enforce a duty or liability created by the Securities Act, the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction
14. 96In the ordinary course of business, we and our third-party partners (such as contract research organizations and clinical trial sites) process sensitive information
15. 97Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
16. 98Future changes in financial accounting standards or practices may cause adverse and unexpected revenue fluctuations and adversely affect our reported results of operations
17. 99The requirements of being a public company may strain our resources, result in more litigation and divert management’s attention
18. 100We may be subject to securities litigation, which is expensive and could divert management attention
19. 101If securities or industry analysts do not publish research or reports, or if they publish adverse or misleading research or reports, regarding us, our business or our market, our stock price and trading volume could decline