Bone Biologics (BBLG) risk factors, FY2024 10-K

Other

1. 01○ The results of our clinical trials may not support our product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily predictive of future results
2. 02○ Our employees may engage in misconduct or other improper activities, which could cause significant liability for us and harm our reputation
3. 03○ We must comply with our obligations under license agreements or risk losing rights that are important to our business
4. 04○ If we are unable to protect our intellectual property rights, our competitors may develop and market products with similar features that may reduce demand for our potential products
5. 05○ Healthcare legislative measures aimed at reducing healthcare costs may negatively impact our business
6. 06○ Our ability to use net operating losses to offset future taxable income may be subject to limitations
7. 07○ The application of privacy provisions of HIPAA is uncertain
8. 08○ If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares

Risks Relating to Our Financial Position and Capital Needs

1. 09Our limited operating history makes it difficult to evaluate our current business and future prospects
2. 10Our long-term capital requirements are subject to numerous risks
3. 11Our recurring operating losses have raised substantial doubt regarding our ability to continue as a going concern
4. 12We have no significant operating history and since inception to December 31, 2024 have incurred accumulated losses of approximately $85.0 million. We will continue to incur significant expenses for development activities for our lead product candidate NELL-1/DBM
5. 13We face a number of risks associated with the incurrence of substantial debt which could adversely affect our financial condition

Risks Related to the Development and Regulatory Approval of our Product Candidates

1. 14Our product candidates are at an early stage of development and may not be successfully developed or commercialized
2. 15Any product candidates advanced into clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals to commercialize such product candidates
3. 16Any product candidate we advance into clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent their regulatory approval or commercialization or limit their commercial potential
4. 17Delays in the commencement of clinical trials could result in increased costs and delay our ability to pursue regulatory approval
5. 18Suspensions or delays in the completion of clinical testing could result in increased costs to us and delay or prevent our ability to complete development of that product or generate product revenues
6. 19We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications for which there may be a greater likelihood of success
7. 20We may find it difficult to enroll patients in our clinical trials which could delay or prevent the start of clinical trials for our product candidate
8. 21The results of preclinical studies are not necessarily predictive of future results. Our product candidates that may advance into clinical trials may not have favorable results in later clinical trials or receive regulatory approval
9. 22Risks associated with operating in foreign countries could materially adversely affect our product development
10. 23Failure to obtain regulatory approval in international jurisdictions would prevent our product candidate from being marketed abroad
11. 24Even if our lead product candidate received regulatory approval, it may still face future development and regulatory difficulties
12. 25The occurrence of any event or penalty described above may inhibit our ability to successfully commercialize our product and generate revenues
13. 26The results of our clinical trials may not support our product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily predictive of future results

Risks Related to Our Dependence on Third Parties

1. 27We may fail to retain or recruit necessary personnel, and we may be unable to secure the services of consultants
2. 28We rely on third parties to supply our raw materials, and if certain manufacturing-related services do not timely supply these products and services, it may delay or impair our ability to develop, manufacture and market our products
3. 29We depend on third parties, including researchers, who are not under our control
4. 30Business interruptions could adversely affect future operations, revenues, and financial conditions, and may increase our costs and expenses
5. 31Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation

Risks Related to our Intellectual Property

1. 32We rely on patents and patent applications and various regulatory exclusivities to protect some of our product candidates, and our ability to compete may be limited or eliminated if we are not able to protect our products
2. 33We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, as well as costs associated with lawsuits
3. 34We cannot guarantee that our technologies will not conflict with the rights of others. In some foreign jurisdictions, we could become involved in opposition proceedings, either by opposing the validity of others’ foreign patents or by persons opposing the validity of our foreign patents
4. 35We cannot be certain we will be able to obtain patent protection to protect our product candidates and technology
5. 36If we fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose rights that are important to our business
6. 37If disputes over the 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
7. 38We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts, stop us from commercializing or increase the costs of commercializing our product candidates, and force us to pay damages
8. 39We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets
9. 40The terms of our patents may not be sufficient to effectively protect our product candidates and business
10. 41Our intellectual property may not be sufficient to protect our products from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal
11. 42If we are not able to protect and control our unpatented trade secrets, know-how and other technological innovation, we may suffer competitive harm
12. 43We may incur substantial costs enforcing our patents, defending against third-party patents, invalidating third-party patents or licensing third-party intellectual property, as a result of litigation or other proceedings relating to patent and other intellectual property rights
13. 44If we are unable to protect our intellectual property rights, our competitors may develop and market products with similar features that may reduce demand for our potential products
14. 45We will be able to protect our intellectual property rights in patents and trade secrets from unauthorized use by third parties only to the extent that such intellectual property rights are covered by valid and enforceable patents or are effectively maintained as trade secrets

Risks Relating to Commercializing of our Lead Product Candidate and Future Product Candidates

1. 46Our commercial success and ability to generate revenue depends upon attaining significant market acceptance of our lead product candidate and future product candidates, if approved, among physicians, patients, healthcare payors and treatment centers
2. 47Even if we are able to commercialize our lead product candidate or any future product candidates, the products may not receive coverage and adequate reimbursement from third-party payors in the U.S. and in other countries in which we seek to commercialize our products, which could harm our business
3. 48Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations

Risks Related to Our Business Operations

1. 49We operate in a highly competitive environment
2. 50Our future success is dependent, in part, on the performance and continued service of our officers and directors
3. 51Competitors could develop and/or gain FDA approval of our products for a different indication
4. 52We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
5. 53The impact of public health crises is difficult to predict and could materially and adversely affect our business and results of operations
6. 54Significant disruptions of information technology systems, computer system failures or breaches of information security could adversely affect our business
7. 55We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth
8. 56Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
9. 57Our ability to use net operating losses to offset future taxable income may be subject to limitations

Risks Related to Healthcare Compliance Regulations

1. 58The application of privacy provisions of HIPAA is uncertain

Risks Related to Owning our Common Stock

1. 59The price of our common stock and public warrants may fluctuate substantially
2. 60Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall
3. 61There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq, a failure of which could result in a delisting of our common stock and certain warrants
4. 62We do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares
5. 63The right of our President and Chief Executive Officer and Chief Financial Officer to participate in future financings of ours could impair our ability to raise capital
6. 64If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares
7. 65As of December 31, 2024, management assessed the effectiveness of our internal controls over financial reporting, and based on that evaluation, they concluded that our internal controls and procedures were effective
8. 66We may be at risk of securities class action litigation
9. 67Market and economic conditions may negatively impact our business, financial condition and share price
10. 68If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline
11. 69Our Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline
12. 70Provisions of our warrants could discourage an acquisition of us by a third party
13. 71Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters