Rocket One (RKTO) risk factors, FY2024 10-K

Risks Related to Our Financial Position, Financial Reporting Matters and Need for Capital

1. 01We have generated no revenue from commercial sales to date and our future profitability is uncertain
2. 02If we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment
3. 03Even if we can raise additional funding, we may be required to do so on terms that are dilutive to you
4. 04The Restatement of our financial statements may affect shareholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations

Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

1. 05We are dependent upon the clinical success of our licensed products and technologies. If we are unable to generate revenues from our licensed products and technologies, our ability to create shareholder value may be limited
2. 06The marketing approval process of the FDA is lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for the product candidates we intend to develop, our business may be substantially harmed
3. 07We may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities
4. 08If we are not able to obtain any required regulatory approvals for our product candidates, we will not be able to commercialize our product candidates and our ability to generate revenue will be limited
5. 09We may not be able to obtain or maintain ODD or exclusivity for our product candidates
6. 10Modifications to our products may require new drug approvals
7. 11Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit
8. 12Additional delays to the completion of clinical studies may result from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or required by the occurrences in the given trial
9. 13There can be no assurance that the data generated from our clinical trials using modified protocols will be acceptable to FDA
10. 14We rely on and intend to rely on third-parties to conduct our clinical trials and to assist us with pre-clinical development. If these third-parties do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products
11. 15Each of these risks could delay our clinical trials, as well as the approval, if any, of our product candidates by the FDA, or the commercialization of our product candidates, or could result in higher costs, or could deprive us of potential product revenue
12. 16The future results of our current or future clinical trials may not support our product candidate claims or may result in the discovery of unexpected adverse side effects
13. 17Even if our product candidates are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA regulations or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market
14. 18Our revenue stream will depend upon third-party reimbursement
15. 19Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain for such product candidates
16. 20We are dependent on third parties for manufacturing and marketing of our proposed product candidates. If we are not able to secure favorable arrangements with such third parties, our business and financial condition could be harmed
17. 21We may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates
18. 22Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from its sales, if any, may be limited
19. 23Our products will face significant competition, and if they are unable to compete successfully, our business will suffer
20. 24Adverse events involving our products may lead the FDA or other regulatory agencies to delay or deny clearance for our products or result in product recalls that could harm our reputation, business and financial results
21. 25If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected
22. 26Furthermore, to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws
23. 27In the event that we need to change our CMOs, our pre-clinical studies, clinical trials or the commercialization of our product candidates could be delayed, adversely affected or terminated, or such a change may result in significantly higher costs
24. 28Healthcare Reform in the United States
25. 29Our business may be adversely affected by cybersecurity threats, information systems interruptions and/or threats to our physical buildings

Risks Related to Our Intellectual Property Rights

1. 30We rely upon licenses granted to us by various licensors, and if such licensors do not adequately defend such licenses, our business may be harmed
2. 31Our business depends upon us securing and protecting critical intellectual property
3. 32Patent positions in our industry are highly uncertain and involve complex legal and factual questions
4. 33If we are found to be infringing on patents or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue the development or sale of our products, and/or pay damages
5. 34Our ability to protect and enforce any patents we may obtain does not guarantee that we will secure the right to commercialize such patents
6. 35We rely on confidentiality agreements to protect our trade secrets. If these agreements are breached by our employees or other parties, our trade secrets may become known to our competitors

Risks Related to the Company

1. 36We have expanded and may continue to expand our business through the acquisition of rights to new drug candidates that could disrupt our business, harm our financial condition and may also dilute current shareholders’ ownership interests in our Company
2. 37Any international operations we undertake may subject us to risks inherent with operations outside of the United States
3. 38We may not be successful in hiring and retaining key employees, including executive officers
4. 39Managing our growth as we expand operations may strain our resources
5. 40If a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial damage awards that could materially harm our business
6. 41Our business may be adversely affected by public health crises, such as pandemics and epidemics, which may have a material adverse effect on our business
7. 42Significant disruptions of information technology systems or breaches of data security could adversely affect our business

Risks Related to Our Common Stock

1. 43The price of our common stock may fluctuate substantially
2. 44We may acquire other companies or technologies which could divert our management’s attention, result in dilution to our shareholders and otherwise disrupt our operations and adversely affect our operating results
3. 45Unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may have serious adverse consequences on our business, financial condition and stock price
4. 46Future sales and issuances of our securities could result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall
5. 47We 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
6. 48We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
7. 49We may be at risk of securities class action litigation
8. 50Our Articles of Incorporation, as amended (“Articles of Incorporation”), our Amended and Restated Bylaws, and Nevada law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline
9. 51Our Amended and Restated Bylaws provide that the Eighth Judicial District Court of Clark County, Nevada will be the sole and exclusive forum for certain disputes which could limit shareholders’ ability to obtain a favorable judicial forum for disputes with us or its directors, officers, employees or agents
10. 52If 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. 53Financial reporting obligations of being a public company in the United States are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters
12. 54The restatement of our prior quarterly financial statements may affect investor confidence and raise reputational issues and may subject us to additional risks and uncertainties, including increased professional costs and the increased possibility of legal proceedings and regulatory inquiries
13. 55Failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock. If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud