FibroBiologics (FBLG) risk factors, FY2024 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01There is substantial doubt about our ability to continue as a going concern
2. 02We have a limited operating history and none of our current product candidates have been approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability
3. 03We have incurred significant net losses since inception, expect to continue to incur significant net losses for the foreseeable future, and may never achieve or maintain profitability
4. 04We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts
5. 05Raising additional capital may cause dilution to our existing stockholders, restrict our operations, require us to relinquish rights to our product candidates on unfavorable terms to us and could cause our stock price to fall

Risks Related to Development, Regulatory Approval and Commercialization

1. 06We may encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
2. 07The outcome of preclinical studies or early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, the EMA, or other comparable foreign regulatory authorities
3. 08The successful development of biopharmaceutical products is highly uncertain
4. 09The length of time necessary to complete clinical trials and submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product candidate to the next and from one country or jurisdiction to the next and may be difficult to predict
5. 10Interim, 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
6. 11Even 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
7. 12Our refrigerated product candidates require specific distribution, storage, handling, and administration at the clinical sites
8. 13We may be unable to obtain U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize our product candidates
9. 14Any delay or failure in seeking or obtaining required approvals would have a material and adverse effect on our ability to generate revenue from the particular product candidate for which we are developing and seeking approval
10. 15We may develop our current and future product candidates in combination with other therapies, which exposes us to additional risks, and certain of our product candidates are regulated as combination products
11. 16Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated
12. 17We 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. 18Our present and potential future international operations may expose us to business, political, operational, and financial risks associated with doing business outside of the United States
14. 19Any of these factors could harm our contemplated clinical trial in Australia, as well as any future international operations and, consequently, our business, financial condition, prospects, and results of operations
15. 20We are subject to export and import controls, economic sanctions, and anti-corruption laws and regulations of the United States and other jurisdictions. We can face criminal liability and other serious consequences for violations of these laws and regulations, which can harm our business

Risks Related to Our Business

1. 21Our company has limited experience in designing clinical trials and may experience delays or unexpected difficulties in obtaining regulatory approval for our current and future product candidates
2. 22The sizes of the markets for our product candidates are estimates, and these markets may be smaller than estimated
3. 23Our long-term prospects may depend in part upon discovering, developing, and commercializing additional product candidates, which may fail in development or suffer delays that adversely affect their commercial viability
4. 24We have never commercialized a fibroblast cell-based therapy product candidate before and may lack the necessary expertise, personnel, and resources to successfully commercialize any product candidates, if approved, on our own or together with suitable collaborators
5. 25We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer, or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted

Risks Relating to Our Dependence on Third Parties

1. 26If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
2. 27If we decide to establish additional collaborations but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans
3. 28Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations

Risks Related to Manufacturing

1. 29The production of our cell banks and product candidates by a contract development manufacturing organization may fail and result in delays, additional costs, or technical failure
2. 30Changes in the methods of product candidate manufacturing or formulation may result in additional costs or delay
3. 31If we or our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages
4. 32We rely on third parties for our manufacturing process and may, in the future, depend on third-party manufacturers for our product candidates, and this increases the risk related to the timely and sufficient production of our product candidates
5. 33Any contamination or interruption in our manufacturing processes, shortages of raw materials, or failure of our suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules

Risks Related to Legal and Regulatory Compliance Matters

1. 34We, our collaborators, and our service providers are, or may become, subject to evolving global data protection laws and regulations, which may require us to incur substantial compliance costs, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations
2. 35Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inability could have an adverse effect on our business and financial condition
3. 36Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations, which could make it difficult for us to sell them profitably
4. 37We face potential liability related to the privacy of health information we obtain from clinical trials sponsored by us
5. 38If 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 have a material adverse effect on our business
6. 39The FDA, the EMA, and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction
7. 40Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions
8. 41Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight
9. 42The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity
10. 43The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
11. 44We may face difficulties from changes to current regulations and future legislation

Risks Related to Our Intellectual Property

1. 45Our success depends on our ability to protect our intellectual property and our proprietary technologies
2. 46We do not currently have rights to any composition of matter patents or patent applications covering our CybroCell product candidate and we cannot be certain that any of our pending patent applications or our future patent applications will result in issued patent claims covering such aspects of our product candidate
3. 47If the scope of any patent protection we have is not sufficiently broad, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected
4. 48We 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 product candidates
5. 49Intellectual property rights do not necessarily address all potential threats to our competitive advantage
6. 50Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts
7. 51We 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
8. 52Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline
9. 53Derivation or interference 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
10. 54Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
11. 55Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
12. 56We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
13. 57Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
14. 58If we do not obtain patent term extension for our product candidates, our business may be materially harmed
15. 59We may not be able to protect our intellectual property rights throughout the world
16. 60Obtaining 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
17. 61If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
18. 62We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties
19. 63If 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 may be adversely affected

Risks Related to Employee Matters and Managing our Growth

1. 64Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees
2. 65In 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
3. 66If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval

Risks Related to Ownership of Our Common Stock

1. 67Failure to maintain compliance with the applicable Nasdaq continued listing requirements could result in our common stock being delisted, which could limit stockholders’ ability to trade our common stock
2. 68An active trading market may not be sustained and the market price of shares of our common stock may be volatile
3. 69Our board of directors and stockholders approved the creation and issuance of an aggregate of 2,500 shares of Series C Preferred Stock, all of which were issued to Pete O’Heeron, our founder and Chief Executive Officer, in conjunction with our direct listing
4. 70We are a “controlled company” within the meaning of the Nasdaq Stock Market Rules because our insiders beneficially own more than 50% of the voting power of our outstanding voting securities
5. 71Future issuances of our common stock pursuant to our 2022 Stock Plan could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
6. 72Because we have no current plans to pay cash dividends on our common stock, you may not receive any return on investment unless you sell your common stock for a price greater than that which you paid for it
7. 73We are an emerging growth company and a smaller reporting company, and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors
8. 74Provisions of our amended and restated certificate of incorporation and amended and restated bylaws may delay or prevent a take-over that may be in the best interests of our stockholders
9. 75The foregoing provision would not preclude stockholders that assert claims under the Exchange Act from bringing such claims in federal court, to the extent that the Exchange Act confers exclusive federal jurisdiction over such claims, subject to applicable law
10. 76Reports 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
11. 77Our operations are vulnerable to interruption by fire, severe weather conditions, power loss, telecommunications failure, terrorist activity and other events beyond our control, which could harm our business
12. 78Unfavorable global economic and geopolitical conditions could adversely affect our business, financial condition, stock price, and results of operations
13. 79Fluctuations in foreign currency exchange rates could negatively impact our results of operations and result in changes in our foreign currency translation adjustments
14. 80We, or the third parties upon whom we depend, may be adversely affected by natural disasters, public health crises or other business interruptions and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
15. 81Changes in tax law could adversely affect our business and financial condition
16. 82We may become involved in securities class action litigation that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages