Citius Oncology (CTOR) risk factors, FY2024 10-K

Other

1. 01An investment in our securities involves a high degree of risk. You should carefully consider the risks described below before making an investment decision

Risks Related to the Company’s Business and Our Industry

1. 02We currently have only one approved product and we are heavily dependent on the planned launch and commercial success of LYMPHIR
2. 03We require substantial additional funding in the near future to support our operations, complete the commercialization of LYMPHIR, which may not be available on acceptable terms, or at all
3. 04We have a history of net losses and expect to incur losses for the foreseeable future. We may never generate revenues or, if we are able to generate revenues, achieve profitability
4. 05Our ongoing exploration of alternative strategic paths may not result in entering into or completing transactions, when necessary, and the process of reviewing alternative strategic paths or their conclusion could adversely affect our stock price
5. 06We have one approved product and have an unproven business strategy and may never achieve commercialization of LYMPHIR or any future product candidates or achieve or maintain profitability
6. 07We have a limited operating history upon which to evaluate our ability to successfully commercialize LYMPHIR and any future product candidate
7. 08We are and may be required to make milestone payments to the licensor and former licensee of the LYMPHIR intellectual property in connection with our development and commercialization of LYMPHIR, which could adversely affect the profitability of LYMPHIR
8. 09A material breach or default under any of our license agreements, including failure to make timely payments when due, gives the licensor party to such agreement the right to terminate the license agreement, which termination would materially harm our business
9. 10We rely exclusively on third parties to formulate and manufacture our product candidates. Our failure to abide by our contractual obligations with these third parties, including timely payment, could result in a delay or the loss of necessary third-party support
10. 11We face significant risks in our development efforts of LYMPHIR and any future product candidate
11. 12LYMPHIR may not gain market acceptance among physicians, patients, healthcare payers or the medical community and may not generate significant revenue
12. 13We will not be able to create a market for LYMPHIR or any future product candidate if we fail to establish marketing, sales, and distribution capabilities
13. 14The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
14. 15The markets in which we operate are highly competitive and we might be unable to compete successfully against new entrants or established companies
15. 16Our ability to generate product revenues will be diminished if LYMPHIR, or any of our future product candidates that may be approved, sells for inadequate prices or patients are unable to obtain adequate levels of reimbursement
16. 17We are actively engaged with the Center for Medicare and Medicaid Services (“CMS”) in order to obtain the necessary coverage to facilitate reimbursement for LYMPHIR. However, we can offer no assurance as any reimbursement coverage
17. 18Healthcare reform measures could hinder or prevent LYMPHIR’s commercial success, or any of our future product candidates that may be approved
18. 19Any termination, or breach by, or conflict with our strategic partners could harm our business
19. 20We rely on the significant experience and specialized expertise of the executive management and other key personnel and the loss of any of the executive management or key personnel or our inability to successfully hire their successors could harm our business
20. 21If we are unable to retain or hire additional qualified personnel, our ability to grow our business might be harmed
21. 22We expect to need to increase the size of our organization to further develop our product candidates, and we may experience difficulties in managing growth
22. 23We are subject to information technology and cyber-security threats which could have an adverse effect on our business and results of operations
23. 24The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and our current and any future product candidates may not have favorable results in later studies or trials
24. 25We may be required to demonstrate through large, long-term outcome trials that our future product candidates, if any, are safe and effective for use in a broad population prior to obtaining regulatory approval. This would increase the duration and cost of any such trial

Risks Related to the Company’s Regulatory and Legal Environment

1. 26Following the regulatory approval of LYMPHIR, we remain subject to ongoing regulatory obligations and restrictions, which may result in significant expense and limit our ability to commercialize LYMPHIR and any future approved products
2. 27We could be forced to pay substantial damage awards if product liability claims that may be brought against us are successful
3. 28We might not obtain the necessary U.S. or foreign regulatory approvals to commercialize any future product candidates

Risks Related to the Company’s Intellectual Property

1. 29Our business depends on protecting our intellectual property
2. 30We rely on trade secret protections through confidentiality agreements with our employees and other parties, and the breach of these agreements could adversely affect our business and prospects
3. 31If we infringe the rights of third parties we might have to forego developing and/or selling any approved products, pay damages, or defend against litigation
4. 32If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition and our business, financial condition and results of operations may be adversely affected

Risks Related to the Company’s Common Stock

1. 33The market price of our Common Stock is highly volatile, and you may lose some or all of your investment
2. 34Future sales of a substantial number of shares of our Common Stock may cause the price of our Common Stock to decline
3. 35You may experience dilution of your ownership interests because of the future issuance of additional shares of Common Stock or securities convertible into Common Stock
4. 36Substantial sales of our Common Stock may occur in connection with the potential distribution of shares by Citius Pharma, which could cause our stock price to decline
5. 37If we fail to meet the Nasdaq continued listing requirements, it could result in a suspension or delisting of the Common Stock
6. 38If our Common Stock were delisted and determined to be a “penny stock,” a broker-dealer may find it more difficult to trade the Common Stock and an investor may find it more difficult to acquire or dispose of the Common Stock in the secondary market
7. 39The Certificate of Incorporation of Company allows for our Board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of the Common Stock
8. 40We have not paid cash dividends in the past and we do not expect to pay cash dividends in the foreseeable future. Any return on investment may be limited to the capital appreciation, if any, of the Common Stock
9. 41Our operating results may fluctuate significantly
10. 42If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse opinion regarding our Common Stock, our stock price and trading volume could decline
11. 43Volatility in our share price could subject us to securities litigation
12. 44Provisions in our Certificate of Incorporation, Bylaws and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management
13. 45We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our shares less attractive to investors
14. 46If our estimates or judgments relating to our critical accounting policies prove to be incorrect or financial reporting standards or interpretations change, the Company’s results of operations could be adversely affected
15. 47Conflicts of interest may arise from our relationship with Citius Pharma
16. 48Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with Citius Pharma
17. 49Citius Pharma currently performs or supports many of our important corporate functions, which would be difficult to replace if Citius Pharma were to cease providing
18. 50In addition, we owe Citius Pharma for fees for each of the services set forth in the A&R Shared Services Agreement and we reimburse Citius Pharma for all reasonable out-of-pocket costs and expenses that it incurs in connection with providing the services
19. 51Our financial statements may not necessarily be indicative of the conditions that would have existed if we had been operated as an unaffiliated company of Citius Pharma
20. 52We are controlled by Citius Pharma, whose interests may differ from those of public stockholders