MIRA Pharmaceuticals (MIRA) risk factors, FY2024 10-K

Risks Related to Our Intellectual Property

1. 01If third parties claim that our intellectual property, products, processes, or anything else used by us infringes upon their intellectual property, our operating profits could be adversely affected
2. 47We may not be able to adequately protect our product candidates or our proprietary technology in the marketplace
3. 48We have no patent protection for MIRA-55, which could adversely impact MIRA-55’s potential competitive position

Risks Relating to Our Business and Our Industry

1. 02Results of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results
2. 13Our future viability will largely depend on the positive development of Ketamir-2 and MIRA-55, and any future product candidates, which development will require significant capital resources and years of clinical development effort
3. 14We are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized
4. 15Impact of global tensions may increase uncertainty of our future operations
5. 16We have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future
6. 17Should we later determine if it is in our best interest to develop a sales force, we may be unable to effectively train and equip our sales force, therefore our ability to successfully commercialize our products may be harmed
7. 18Our management and personnel, systems, and facilities currently in place may not be adequate to support our business plan and future growth. As a result, we may need to further expand certain areas of our organization
8. 19Our product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate revenue from new products
9. 20If the price for any future approved products decreases or if government and other third-party payers do not provide coverage and adequate reimbursement levels, our revenue and prospects for profitability will suffer
10. 21We expect to face intense competition, often from companies with greater resources and experience than we have
11. 22Product shipment delays could have a material adverse effect on our business, results of operations and financial condition
12. 23Business interruptions could delay us in the process of developing our product candidates and could disrupt our product sales
13. 24If product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the commercialization of Ketamir-2 and MIRA-55 and our product candidates
14. 25Counterfeit versions of our products could harm our business
15. 26We depend upon our key personnel and our ability to attract and retain employees
16. 27Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
17. 28Our proprietary information, or that of our suppliers and business partners, may be lost or we may suffer security breaches
18. 29Failure of our information technology systems, including cybersecurity attacks or other data security incidents, could significantly disrupt the operation of our business
19. 30Security breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessing critical information or expose us to liability, which could adversely affect our business and our reputation
20. 31Legislative or regulatory reform of the health care system in the U.S. may affect our ability to profitably sell our products, if approved
21. 32We expect additional federal and state legislative proposals for health care reform, which could limit the prices that can be charged for the products we develop and may limit our commercial opportunity
22. 33Unfavorable global economic and geopolitical conditions could adversely affect our business, financial condition, stock price, and results of operations
23. 34We may acquire other companies which could divert our management’s attention, result in additional dilution to our shareholders and otherwise disrupt our operations and harm our operating results

Risks Related to Our Reliance Upon Third Parties

1. 03We rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates
2. 44Our existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates
3. 45We depend on a limited number of suppliers for materials and components required to manufacture our product candidates. The loss of these suppliers, or their failure to supply us on a timely basis, could cause delays in our current and future capacity and adversely affect our business
4. 46We maintain our cash at financial institutions, at times in balances that exceed federally insured limits. The failure of financial institutions could adversely affect our ability to pay operational expenses or make other payments

Risks Related to Our Operations and Financial Condition

1. 04We are an early development-stage company with no revenues. As such, our losses from operations and negative cash flows as of December 31, 2024 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings
2. 05The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going concern
3. 06We may not be successful in the integration of our potential acquisition of SKNY
4. 07Because we have a limited operating history, you may not be able to accurately evaluate our operations
5. 08We have significant and increasing liquidity needs and will require additional funding
6. 09Operating results may vary significantly in future periods
7. 10We have yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all
8. 11Conflicts of interest may arise between us and MIRALOGX
9. 12Certain of our executive officers will not be employed by us on a full-time basis

Risks Related to Development and Regulatory Approval of Our Product Candidates

1. 35Clinical trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination. The results of clinical trials are open to differing interpretations
2. 36Clinical trials of synthetic cannabinoid drug candidates and ketamine analogs are novel with very limited or non-existing history; we face a significant risk that the trials will not result in commercially viable drugs and treatments
3. 37We are subject to extensive regulation by U.S. federal and state governments in each of the markets where we have product candidates progressing through the approval process
4. 38We are subject to federal and state healthcare laws and regulations and implementation of or changes to such healthcare laws and regulations could adversely affect our business and results of operations
5. 39We plan to conduct clinical trials at sites outside the United States. The FDA may not accept data from trials conducted in such locations, and the conduct of trials outside the United States could subject us to additional delays and expense
6. 40The regulatory approval processes with the FDA are lengthy and inherently unpredictable
7. 41There is a high rate of failure for drug candidates proceeding through clinical trials
8. 42If we are found in violation of federal or state “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended from participation in federal or state health care programs, which may adversely affect our business, financial condition, and results of operations
9. 43Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our product candidates, limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already marketed

Risks Relating to the Ownership of our Common Stock

1. 49Because of the speculative nature of investment risk, you may lose your entire investment
2. 50Certain of our founding stockholders, plus our existing officers and directors, control a substantial interest in us and thus may influence certain actions requiring stockholder vote
3. 51Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock
4. 52The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members
5. 53We are an “emerging growth company,” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies could make shares of our common stock less attractive to investors
6. 54Investors could find our shares less attractive if we choose to rely on these exemptions. If some investors find shares less attractive as a result of any choice to reduce future disclosure, there may be a less active trading market for our shares and our share price may be more volatile
7. 55If we fail to maintain compliance with Nasdaq Listing Rules, our shares may be delisted from Nasdaq, which would result in a limited trading market for our shares and make obtaining future debt or equity financing more difficult for the us
8. 56If our shares were to be delisted from Nasdaq, they may become subject to the SEC’s “penny stock” rules
9. 57Our status as a Florida corporation and the anti-takeover provisions of the Florida Business Corporation Act, which we sometimes refer to as the FBCA, may discourage, delay or prevent a change in control even if a change in control would be beneficial to our shareholders
10. 58Both the control share acquisition statute and the affiliated transactions statute may have the effect of discouraging or preventing certain change of control or takeover transactions involving us
11. 59Securities or industry analysts may not regularly publish reports on us, which could cause the price of our securities or trading volumes to decline
12. 60We will likely conduct further offerings of our equity securities in the future, in which case your proportionate interest may become diluted
13. 61We may issue shares of preferred stock in the future, which could make it difficult for another company to acquire us or could otherwise adversely affect holders of our common stock, which could depress the price of our common stock
14. 62We have never declared or paid any cash dividends or distributions on our capital stock. We currently intend to retain our future earnings, if any, to support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock in the foreseeable future