Bio Green Med Solution (BGMS) risk factors, FY2024 10-K

Other

1. 01Risks Associated with Development and Commercialization of Our Drug Candidates
2. 02If we experience delays or difficulties in the enrollment of research subjects in clinical trials, those clinical trials could take longer than expected to complete and our receipt of necessary regulatory approvals could be delayed or prevented
3. 03encounter difficulties in enrollment. If we experience delays in our clinical trials, the timeline for obtaining regulatory approval of our product candidate will most likely be delayed
4. 04The outcome of preclinical testing and 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 or comparable foreign regulatory authorities
5. 05We are making use of biomarkers, which are not scientifically validated, and our reliance on biomarker data may thus cause us to direct our resources inefficiently
6. 06Our product candidate may cause undesirable side effects that could delay or prevent their marketing approval, limit their commercial potential, or result in significant negative consequences following marketing approval, if marketing approval is obtained
7. 07Any of these events could prevent us from achieving or maintaining market acceptance of plogo and could substantially increase the costs of its commercializing, if approved, and significantly impact our ability to successfully commercialize plogo and generate revenues
8. 08As we evolve from a company primarily involved in discovery and development to one also involved in the commercialization of drugs and devices, we may encounter difficulties in managing our growth and expanding our operations successfully
9. 09Our applications for regulatory approval could be delayed or denied due to problems with studies conducted before we licensed the rights to some of our product candidates
10. 10Even if we obtain regulatory approval for a product candidate, we will remain subject to ongoing regulatory requirements
11. 11Obtaining and maintaining marketing approval of our current and future product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our current and future therapeutic product candidates in other jurisdictions
12. 12Even if we successfully complete the clinical trials for Plogo, the product candidate may fail for other reasons
13. 13We face intense competition and our competitors may develop drugs that are less expensive, safer, or more effective than our drug candidates
14. 14Our future product candidates, if any, for which we obtain approval may face competition sooner than anticipated
15. 15The commercial success of our drug candidates depends upon their market acceptance among physicians, patients, healthcare providers and payors and the medical community
16. 16other third-party payors; and
17. 17The failure to attract and retain skilled personnel and key relationships could impair our drug development and commercialization efforts
18. 18We may be exposed to product liability claims that cause us to incur substantial liabilities and we may be required to limit commercialization of our drugs that may damage our reputation and we may not be able to obtain adequate insurance
19. 19If a supplier upon whom we rely fails to produce on a timely basis the finished goods in the volumes that we require or fails to meet quality standards and maintain necessary licensure from regulatory authorities, we may be unable to meet demand for our products, potentially resulting in lost revenues
20. 20The commercialization of our products will be substantially dependent on our ability to develop effective sales and marketing capabilities
21. 21We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product candidate and may have to limit its commercialization
22. 22Healthcare legislative reform measures may have a material adverse effect on our business, financial condition or results of operations
23. 23We 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
24. 24Defending against claims relating to improper handling, storage or disposal of hazardous chemical, radioactive or biological materials could be time consuming and expensive
25. 25Our business and operations would suffer in the event of system failures

Risks Related to Our Business and Financial Condition

1. 26Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price
2. 27Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code and may be subject to further limitation as a result of the transactions completed in connection with our initial public offering
3. 28Our employees, independent contractors, principal investigators, contract research organizations, consultants or vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
4. 29If we are unable to compete successfully in our marketplace, it will harm our business
5. 30We are at an early stage of development as a company and we do not have, and may never have, any products that generate significant revenues
6. 31If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
7. 32We effected a 15:1 reverse stock split of our common stock on December 18, 2023 (the “Reverse Stock Split”), which enabled us to regain compliance with Nasdaq’s minimum bid price requirements
8. 33To the extent we elect to fund the development of a drug candidate or the commercialization of a drug at our expense, we will need substantial additional funding
9. 34Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities
10. 35Funding constraints may negatively impact our research and development, forcing us to delay our efforts to develop Plogo, which may prevent us from commercializing our product candidate as quickly as possible
11. 36We are exposed to risks related to foreign currency exchange rates

Risks Related to our Reliance on Third Parties

1. 37We rely, and expect to continue to rely, on third parties to conduct some aspects of our product formulation, research, preclinical, and clinical studies, and those third parties may not perform satisfactorily, including by failing to meet deadlines for the completion of such formulation, research or testing
2. 38We rely on third-party supply and manufacturing partners for drug supplies for our late-stage clinical activities and may do the same for any commercial supplies of our product candidate
3. 39An important element of our strategy for developing, manufacturing and commercializing our drug candidates is entering into strategic alliances with pharmaceutical companies, research institutions or other industry participants to advance our programs and enable us to maintain our financial and operational capacity
4. 40To the extent we are able to enter into strategic transactions, we will be exposed to risks related to those collaborations and alliances

Risks Related to our Intellectual Property

1. 41If we fail to enforce adequately or defend our intellectual property rights, our business may be harmed
2. 42Our commercial success depends in large part on obtaining and maintaining patent and trade secret protection for our drug candidates, the methods used to manufacture those drug candidates and the methods for treating patients using those drug candidates
3. 43If we do not obtain protection under the Hatch-Waxman Act and similar legislation outside of the United States by extending the patent terms and obtaining data exclusivity for our product candidate, our business may be materially harmed
4. 44We may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets of former employers
5. 45Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete
6. 46Intellectual property rights of third parties may increase our costs or delay or prevent us from being able to commercialize our drug candidates
7. 47We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights
8. 48Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
9. 49The patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position

Risks Related to Securities Regulations and Investment in Our Securities

1. 50Failure to achieve and maintain internal controls in accordance with Sections 302 and 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price
2. 51We incur increased costs and management resources as a result of being a public company, and we may fail to comply with public company obligations
3. 52An active trading market for our common stock has not developed and it may have a volatile public trading price, thus, purchasers of our common stock could incur substantial losses
4. 53Fluctuations in our operating losses could adversely affect the price of our common stock
5. 54If securities or industry analysts do not publish research or reports about us, if they change their recommendations regarding our stock adversely or if our operating results do not meet their expectations, our stock price and trading volume could decline
6. 55Anti-takeover provisions in our charter documents and provisions of Delaware law may make an acquisition more difficult and could result in the entrenchment of management
7. 56As at December 31, 2024, we had 135,273 shares of 6% Convertible Exchangeable Preferred Stock and 264 shares of Series A Preferred Stock issued and outstanding
8. 57In the event of an acquisition of our common stock, we cannot assure our common stockholders that we will be able to negotiate terms that would provide for a price equivalent to, or more favorable than, the price at which our shares of common stock may be trading at such time
9. 58Our certificate of incorporation and bylaws and certain provisions of Delaware law may delay or prevent a change in our management and make it more difficult for a third-party to acquire us
10. 59We may have limited ability to pay cash dividends on our preferred stock, and there is no assurance that future quarterly dividends will be declared
11. 60Our common and preferred stock may experience extreme price and volume fluctuations, which could lead to costly securities-related litigation, including securities class action litigation or securities-related investigations, which could make an investment in us less appealing
12. 61The future sale of our common and convertible preferred stock and future issuances of our common stock upon conversion of our preferred stock could negatively affect our stock price and cause dilution to existing holders of our common stock
13. 62If we exchange the convertible preferred stock for debentures, the exchange will be taxable, but we will not provide any cash to pay any tax liability that any convertible preferred stockholder may incur
14. 63If we automatically convert the convertible preferred stock, there is a substantial risk of fluctuation in the price of our common stock from the date we elect to automatically convert to the conversion date
15. 64We do not intend to pay cash dividends on our common stock in the foreseeable future
16. 65The number of shares of common stock which are registered, including the shares to be issued upon exercise of our outstanding warrants, is significant in relation to our currently outstanding common stock and could cause downward pressure on the market price for our common stock
17. 66If persons engage in short sales of our common stock, including sales of shares to be issued upon exercise of our outstanding warrants, the price of our common stock may decline
18. 67We are exposed to risks related to the marketable securities we may purchase
19. 68Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful stockholder claims against us and may reduce the amount of money available to us