Humacyte (HUMA) risk factors, FY2024 10-K

Risks Related to the Development of Symvess and Commercialization of Our Product Candidates

1. 01Symvess and our product candidates, if approved, 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
2. 02Our progress in early stage clinical trials may not guarantee success in late stage clinical trials, and our progress in trials for one product candidate or the FDA’s approval of Symvess may not be indicative of progress in trials for another product candidate
3. 03Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
4. 04If SAEs occur at an unacceptable rate or other unacceptable side effects are identified in our ATEVs we may need to delay, abandon or limit development and marketing of our product candidates
5. 05We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals
6. 06Lack of experience by investigators and surgeons with our ATEVs can lead to incorrect implantation or follow-up procedures which could harm the results of our clinical trials and market acceptance of Symvess and our product candidates
7. 07We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates
8. 08We face and will continue to face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do, which may adversely affect our ability to successfully market or commercialize Symvess or our product candidates
9. 09than the products that we develop. Our competitors also may obtain FDA or other marketing approval for their products more rapidly than we may obtain the same approval for ours, which could provide them with further competitive advantage
10. 10Our distribution agreement with Fresenius Medical Care imposes obligations on us that may restrict our ability to operate our business in ways we believe to be in our long-term best interest
11. 11Product liability lawsuits against us could cause us to incur substantial liabilities that may not be covered by our limited product liability insurance and may limit the development, approval and commercialization of Symvess and any product candidates that we develop in the future

Risks Related to Manufacturing Symvess and Our Product Candidates

1. 12Manufacturing facilities are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals

Risks Related to Our Reliance on Third Parties

1. 13We rely on third parties to conduct and support our clinical trials, and those third parties may not perform satisfactorily, including by failing to adhere to regulatory requirements or our stated protocols or to meet deadlines for the completion of such trials
2. 14failure to conduct a trial in accordance with its protocol, applicable regulations, GCPs, and generally accepted research standards

Risks Related to Our Financial Position and Need for Additional Funding

1. 15We have never generated product revenue and have incurred significant losses to date. We expect to continue to incur losses for the foreseeable future and may never generate product revenue or be profitable
2. 16Our ability to use our net operating loss and tax credit carryforwards to offset future taxable income may be subject to certain limitations
3. 17We expect to need to raise additional funding, which may not be available on acceptable terms, or at all, and any failure to obtain capital when needed may force us to delay, limit or terminate our product development or commercialization efforts
4. 18Pursuant to the terms of the Purchase Agreement, we may be limited in our ability to incur future debt
5. 19To date, we have obtained marketing approval for, and begun commercializing, only one product, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability

Risks Related to Government Regulation

1. 20Even though we received marketing approval for Symvess, we continue to be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to significant penalties if we fail to comply with applicable regulatory requirements
2. 21We may not obtain marketing approval from the FDA for any of our product candidates even if we successfully complete our clinical trials, which failure would materially harm our business, prospects, operating results and financial condition
3. 22Even though we obtained approval for Symvess from the FDA, we may never obtain approval for our ATEVs outside of the United States, where the regulatory process is also complex and subject to significant uncertainty. Failure to do so would limit our market opportunities and adversely affect our business
4. 23Even if we seek “rolling review” or priority review, the review time for BLAs for our product candidates may be longer and more expensive than for other products because of the novelty and complexity of our product candidates, which would delay our ability to begin commercialization and earn product revenues
5. 24We may in the future seek orphan drug designation for the use of our ATEVs to treat congenital pediatric heart defects. We may be unable to obtain such designation or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced
6. 25Healthcare reform measures could hinder or prevent commercial success of Symvess or our product candidates
7. 26We cannot predict how further developments of or changes to these laws and regulations will affect our business
8. 27If we fail to comply with healthcare regulations, we could face substantial penalties and our business, prospects, operating results and financial condition could be adversely affected
9. 28Our business and operations, including our development programs, could be materially disrupted in the event of system failures, security breaches, violations of data protection laws or data loss or damage by us or third parties on which we rely, including our CROs or other contractors or consultants
10. 29If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines and penalties or incur costs that could harm our business
11. 30Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation and adverse publicity and could negatively affect our operating results and business
12. 31We or the third parties upon which we depend may be adversely affected by natural 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. 32Our ability to successfully commercialize Symvess or our product candidates, if approved, may be impaired if we are unable to obtain and maintain effective intellectual property rights for our proprietary scientific technology platform, Symvess and our product candidates
2. 33The patent protection we obtain for Symvess or our product candidates may not be sufficient enough to provide us with any competitive advantage or our owned or licensed patents may be challenged
3. 34Pending and future patent applications may not result in patents being issued that protect our business, in whole or in part, or which effectively prevent others from commercializing competitive products
4. 35We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful
5. 36Third 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 and could harm our business, prospects, operating results and financial condition
6. 37If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business
7. 38We may not be successful in obtaining necessary intellectual property rights to product candidates for our development pipeline through acquisitions and in-licenses
8. 39We may be unable to protect the confidentiality of our trade secrets, particularly in light of our reliance on third parties, which increases the possibility that such trade secrets will be disclosed or misappropriated, thus harming our business and competitive position
9. 40Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets
10. 41Patent terms may be inadequate to protect our competitive position on Symvess or our product candidates for an adequate amount of time
11. 42We may not be able to protect our intellectual property rights throughout the world
12. 43If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected
13. 44Intellectual property rights do not necessarily address all potential threats

Risks Related to Business Matters and Our Ability to Manage Growth

1. 45Our future success depends on our ability to retain our key employees, consultants and advisors and to attract, retain and motivate qualified personnel
2. 46We expect to increase the size of our workforce in the future, and we may encounter difficulties in managing this growth, which could harm our operations

Risks Related to Ownership of Our Securities

1. 47The price of our common stock may be volatile
2. 48Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock
3. 49We may issue additional shares of common stock or other equity securities without stockholder approval, which would dilute your ownership interests and may depress the market price of our common stock
4. 50common stock or other equity securities of equal or senior rank in the future in connection with, among other things, future acquisitions or repayment of outstanding indebtedness, without stockholder approval, in a number of circumstances
5. 51Because 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
6. 52The Public Warrants may not be in the money in the future, and they may expire worthless, and the terms of the Public Warrants may be amended in a manner adverse to a holder if holders of at least 50% of the then outstanding Public Warrants approve of such amendment
7. 53We may redeem your unexpired Public Warrants prior to their exercise at a time that is disadvantageous to you, thereby making your Public Warrants worth less than they would be if you held and exercised them at a later time
8. 54The value received upon exercise of the Public Warrants (i) may be less than the value the holders would have received if they had exercised their Public Warrants at a later time where the underlying share price is higher and (ii) may not compensate the holders for the value of the Public Warrants
9. 55We have derivative securities that are accounted for as assets and liabilities and the changes in value of such derivative securities could have a material effect on our financial results
10. 56Our business could be adversely impacted by inflation
11. 57We are and may continue to be subject to legal and other proceedings that could cause us to incur significant expenses, divert our management’s attention, and materially harm our business, financial condition, and operating results
12. 58Changes in U.S. government policies under the Trump administration, including increased tariffs and reductions in federal research funding, could adversely affect our business
13. 59We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on our financial condition, results of operations and stock price, which could cause you to lose some or all of your investment
14. 60The obligations associated with being a public company involve significant expenses and will require significant resources and management attention, which may divert from our business operations
15. 61If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock
16. 62Anti-takeover provisions in our Second Amended and Restated Certificate of Incorporation and under Delaware law could make an acquisition of the Company, which may be beneficial to our stockholders, more difficult, and may prevent attempts by our stockholders to replace or remove our current management