BioRestorative Therapies (BRTX) risk factors, FY2025 10-K

Risks Related to Our Common Stock

1. 01Risks Associated with Our Nasdaq Listing
2. 44There is no assurance that an active trading market for our common stock will be sustained
3. 45We have incurred, and will continue to incur, increased costs as a result of being an SEC reporting company
4. 46Material weaknesses in our internal control over financial reporting have caused and may cause us to fail to timely and accurately report our financial results or result in a material misstatement of our consolidated financial statements
5. 47Our stock price may fluctuate significantly and be highly volatile and this may make it difficult for a securityholder to resell our securities at the volume, prices and times the securityholder finds attractive
6. 48There may be significant future issuances or resales of our common stock which may materially and adversely dilute stockholders’ ownership interest and affect the market price of our securities71% rewritten
7. 49In addition, in February 2024, in connection with certain warrant exercises, we issued warrants for the purchase of an aggregate of 2,513,686 shares of common stock. We have registered the resale of the shares of common stock underlying such warrantsNew
8. 50We also have an effective registration statement on Form S-1 with regard to the resale of up to 508,592 shares of our common stock issuable upon the exercise of warrantsNew
9. 51Our common stock is classified as a “penny stock;” the restrictions of the penny stock regulations of the SEC may result in less liquidity for our common stockNew
10. 52Anti-takeover provisions and the regulations to which we may be subject may make it more difficult for a third party to acquire control of us, even if the change in control would be beneficial to our securityholders30% rewritten
11. 53We cannot assure you that we will be able to comply with the minimum bid price requirement of Nasdaq 29% rewritten
12. 54The market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve
13. 55Our failure to meet the continued listing standards of Nasdaq could result in a delisting of our common stockNew

Risks Related to Our Business Generally

1. 02We will need to obtain a significant amount of financing to complete our clinical trials and implement our business plan
2. 03Our business strategy is high risk
3. 04We will need to enter into agreements in order to implement our business strategy
4. 05We depend on our executive officers and on our ability to attract and retain additional qualified personnel20% rewritten
5. 06In the event that we are unable to utilize our current premises and need to relocate, we will be required to comply with regulatory requirements as to the operation of our laboratory, which could have had a material adverse effect on the conduct of our clinical trials and on our businessNew

Risks Related to Our Cell Therapy Product Development Efforts

1. 07We may experience delays and other difficulties in enrolling a sufficient number of patients in our clinical trials which could delay or prevent the receipt of necessary regulatory approvals
2. 08We may have other delays in completing our clinical trials and we may not complete them at all
3. 09The development of our cell therapy product candidates is subject to uncertainty because autologous cell therapy is inherently variable
4. 10Any disruption to our access to the media (including cell culture media) and reagents we are using in the clinical development of our cell therapy product candidates could adversely affect our ability to perform clinical trials and seek future regulatory submissions
5. 11Products that appear promising in research and development may be delayed or may fail to reach later stages of clinical development
6. 12Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization
7. 13Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize a product candidate, and the approval may be for a narrower indication than we seek
8. 14We may never obtain FDA approval for any of our product candidates in the United States and, even if we do, we may never obtain approval for or commercialize any of our product candidates in any foreign jurisdiction, which would limit our ability to realize our full market potential
9. 15We presently lack manufacturing capabilities to produce our product candidates at commercial scale quantities and do not have an alternate manufacturing supply at this time, which could negatively impact our ability to meet any future demand for the products
10. 16The commercial potential and profitability of our products are unknown and subject to significant risk and uncertainty
11. 17We may have difficulties in sourcing brown adipose (fat) tissue
12. 18If safety problems are encountered by us or others developing new stem cell-based therapies, our stem cell initiatives could be materially and adversely affected
13. 19We are vulnerable to competition and technological change, and also to physicians’ inertia
14. 20We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements
15. 21We have limited experience in the development and marketing of cell therapies and may be unsuccessful in our efforts to establish a profitable business
16. 22Our cell therapy business is based on novel technologies that are inherently expensive, risky and may not be understood by or accepted in the marketplace, which could adversely affect our future value
17. 23Our cell therapy product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated45% rewritten
18. 24The FDA’s regulation of regenerative medicine products remains unpredictable and we are not certain what impact this will have on the potential approval of our products
19. 25We may be subject to significant product liability claims and litigation, including potential exposure from the use of our product candidates in human subjects, and our insurance may be inadequate to cover claims that may arise
20. 26Whether or not we are ultimately successful in any product liability litigation that may arise, such litigation could consume substantial amounts of our financial and managerial resources, result in decreased demand for our products and injure our reputation
21. 27Our internal computer systems, or those that are expected to be used by our clinical investigators, clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of development programs for our product candidates
22. 28To operate and sell in international markets carries great risk
23. 29Our inability to obtain reimbursement for our products and services from private and governmental insurers could negatively impact demand for our products and services
24. 30Our activity as a contract manufacturer of biologic-based cosmetics could result in FDA enforcement for reasons outside of our control, which could disrupt the development of our own product candidates or harm our reputation53% rewritten

Risks Related to Our Intellectual Property

1. 31We may not be able to protect our proprietary rights
2. 32We may not be able to protect our intellectual property in countries outside of the United States
3. 33Changes to United States patent law may have a material adverse effect on our intellectual property rights
4. 34In certain countries, patent holders may be required to grant compulsory licenses, which would likely have a significant and detrimental effect on any future revenues in such country

Risks Related to Government Regulation

1. 35Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory oversight
2. 36We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties
3. 37Our current and future employees, consultants and advisors and our future principal investigators, medical institutions and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
4. 38The failure to receive regulatory approvals for our cell therapy product candidates would likely have a material and adverse effect on our business and prospects
5. 39If we are unable to conduct clinical studies in accordance with regulations and accepted standards, we may be delayed in receiving, or may never receive, regulatory approvals of our product candidates from the FDA and other regulatory authorities
6. 40Health care companies have been the subjects of federal and state investigations, and we could become subject to investigations in the future
7. 41Similarly, the trend toward managed health care and bundled pricing for health care services in the United States, could significantly influence the purchase of healthcare products and services, resulting in lower prices and reduced demand for our therapeutic products under development
8. 42Unintended consequences of healthcare reform in the United States may adversely affect our business
9. 43Competitor companies or hospitals in the EU may be able to take advantage of EU rules permitting sales of unlicensed medicines for individual patients to sell competing products without a marketing authorization