UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒** ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**
For the Fiscal Year Ended September 30,2024:
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number 001-41534
Citius Oncology, Inc.
(Exact name of Registrant as specified in its Charter)
| Delaware | 99-4362660 |
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| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
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11 Commerce Drive, First Floor, Cranford, NJ 07016
(Address of principal executive offices) (Zip Code)
(908) 967-6677
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered |
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| Common Stock, par value $0.0001 per share | CTOR | The NASDAQ Capital Market |
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Securities registered pursuant to section 12(g) of the Act:
(Title of Class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. ☐ Yes ☒No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒Yes ☐ No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,”
“accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
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| Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
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| Emerging growth company | ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒No
The aggregate market value of the voting and non-voting common equity held by non-affiliates of TenX Keane Acquisition, a Cayman Islands exempted company, our predecessor, computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter (March 28, 2024) was approximately $47,700,000 million.
Affiliates for the purpose of this item refers to the issuer’s executive officers and directors and/or any persons or firms (excluding those brokerage firms and/or clearing houses and/or depository companies holding issuer’s securities as record holders only for their respective clients’ beneficial interest) owning 10% or more of the issuer’s common stock, both of record and beneficially.
Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date:
71,552,402 shares as of December 18, 2024, all of one class of common stock, $0.0001 par value.
DOCUMENTS INCORPORATED BY REFERENCE
Information for Part III of this Form 10-K will either (i) be incorporated by reference to portions of the registrant’s Definitive Proxy Statement for its 2025 Annual Meeting of Stockholders, or (ii) if the Definitive Proxy is not filed with the Securities and Exchange Commission within 120 days after the registrant’s fiscal year end of September 30,2024, it will be provided by amendment to this Form 10-K.
Citius Oncology, Inc.
FORM 10-K
September 30, 2024
TABLE OF CONTENTS
| Page |
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| PART I |
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| Item 1. | Business | 1 |
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| Item 1A. | Risk Factors | 17 |
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| Item 1B. | Unresolved Staff Comments | 45 |
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| Item 1C. | Cybersecurity | 45 |
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| Item 2. | Properties | 45 |
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| Item 3. | Legal Proceedings | 45 |
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| Item 4. | Mine Safety Disclosures | 45 |
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| PART II |
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| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 46 |
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| Item 6. | [Reserved] | 46 |
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| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 46 |
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| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 50 |
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| Item 8. | Financial Statements and Supplementary Data | 50 |
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| Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 50 |
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| Item 9A. | Controls and Procedures | 51 |
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| Item 9B. | Other Information | 51 |
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| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 51 |
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| PART III |
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| Item 10. | Directors, Executive Officers and Corporate Governance | 52 |
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| Item 11. | Executive Compensation | 52 |
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| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 52 |
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| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 52 |
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| Item 14. | Principal Accountant Fees and Services | 52 |
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| PART IV |
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| Item 15. | Exhibits and Financial Statement Schedules | 53 |
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| Signatures | 55 | |
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NOTES
In this annual report on Form 10-K, and unless the context otherwise requires, the “Company,” “Citius Oncology” “we,” “us” and “our” refer to Citius Oncology, Inc. and its wholly-owned subsidiary Citius Oncology Sub Inc., “Citius Oncology Sub”, taken as a whole.
LYMPHIRTM (denileukin diftitox) is our registered trademark. All other trade names, trademarks and service marks appearing in this annual report are the property of their respective owners. We have assumed that the reader understands that all such terms are source-indicating. Accordingly, such terms, when first mentioned in this report, appear with the trade name, trademark or service mark notice and then throughout the remainder of this report without trade name, trademark or service mark notices for convenience only and should not be construed as being used in a descriptive or generic sense.
FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, plans, strategies, predictions, or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in this report, including the risks described under Item 1A - “Risk Factors,” and Item 7 - “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this report and in other documents which we file with the Securities and Exchange Commission (“SEC”). In addition, such statements could be affected by risks and uncertainties related to:
| ● | the ability of the Company to recognize the anticipated benefits of the Merger (as defined herein), which may not be realized fully, if at all, or may take longer to realize than expected; |
| ● | the Company’s need for substantial additional funds and its ability to raise those funds; |
| ● | our ongoing evaluations of strategic alternatives; |
| ● | the ability of the Company to commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and services; |
| ● | the ability of LYMPHIR or any of our future product candidates to impact the quality of life of our target patient populations; |
| ● | the estimated markets for LYMPHIR or any of our future product candidates and the acceptance thereof by any market; |
| ● | our ability to procure cGMP commercial-scale supply; |
| ● | our dependence on third-party suppliers; |
| ● | risks arising from changes in the fields in which LYMPHIR and any of our future product candidates, if approved, may compete; |
| ● | risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; |
| ● | the ability of the Company to maintain compliance with the continued listing requirements the Nasdaq Stock Market LLC (“Nasdaq”); |
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| ● | ability to obtain, perform under and maintain financing and strategic agreements and relationships; |
| ● | the Company’s operating results and financial performance; |
| ● | uncertainties relating to preclinical and clinical testing, approval and commercialization of any future product candidates by the Company; |
| ● | the Company’s ability to manage and grow our business and execution of our business and growth strategies; |
| ● | the competitive environment in the life sciences and biotechnology industry; |
| ● | failure to maintain, protect and defend the Company’s intellectual property rights; |
| ● | changes in government laws and regulations, including laws governing intellectual property, and the enforcement thereof affecting the Company’s business; |
| ● | changes in general economic conditions, geopolitical risk, including as a result of any pandemic or international conflict, including in the Middle East and between Russia and Ukraine; |
| ● | the effect of the transactions on the Company’s business relationships, operating results, and businesses generally; |
| ● | volatility in the price of the Company’s securities due to a variety of factors, including the Company’s inability to implement their business plans or meet or exceed our financial projections; |
| ● | the outcome of any litigation related to or arising out of the Business Combination, or any adverse developments therein or delays or costs resulting therefrom; and |
| ● | other risks and uncertainties set forth under the section entitled “Risk Factors.” |
Any forward-looking statements speak only as of the date on which they are made, and, except as may be required under applicable securities laws, we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the filing date of this report.
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SUMMARY OF RISK FACTORS
An investment in our securities involves a high degree of risk. You should carefully consider the risks summarized in Item 1A, “Risk Factors” included in this report. These risks include, but are not limited to, the following:
| ● | We have one approved product that we have not yet commercialized and have an unproven business strategy and may never achieve commercialization of LYMPHIR or any future product candidates or achieve or maintain profitability. |
| ● | We require substantial additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed on acceptable terms, or at all, or execute on alternative strategic paths, could force us to delay, limit, reduce or terminate our commercialization efforts and business operations. |
| ● | We have a history of net losses and expects to incur losses for the foreseeable future. We may never generate revenues or, if we are able to generate revenues, achieve profitability. |
| ● | We are 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. |
| ● | Any material breach or default under our license agreements, including the failure to make timely payment when due, gives the licensor party to such agreement the right to terminate the license agreement, which termination would materially harm our business. |
| ● | We 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. |
| ● | LYMPHIR may not gain market acceptance among physicians, patients, healthcare payers or the medical community and may not generate significant revenue. |
| ● | We 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. |
| ● | We have a limited operating history upon which to evaluate our ability to successfully commercialize LYMPHIR and any future product candidate. |
| ● | The markets in which we operate are highly competitive and we might be unable to compete successfully against new entrants or established companies. |
| ● | Our ability to generate product revenues will be diminished if LYMPHIR sells for inadequate prices or patients are unable to obtain adequate levels of reimbursement. |
| ● | Healthcare reform measures could hinder or prevent LYMPHIR’s, or any of our future product candidates that may be approved, commercial success. |
| ● | Any termination, or breach by, or conflict with our strategic partners could harm our business. |
| ● | We rely on the significant experience and specialized expertise of our executive management and other key personnel and the loss of any of our executive management or key personnel or our inability to successfully hire their successors could harm our business. |
| ● | If we are unable to retain or hire additional qualified personnel, our ability to grow our business might be harmed. |
| ● | The U.S. Food and Drug Administration (the “FDA”) and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. |
| ● | Even with 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. |
| ● | We expect to need to increase the size of our organization to further develop our product candidates, and we may experience difficulties in managing growth. |
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| ● | We could be forced to pay substantial damage awards if product liability claims that may be brought against us is successful. |
| ● | We might not obtain the necessary U.S. or foreign regulatory approvals to commercialize any future product candidates. |
| ● | Our business depends on protecting our intellectual property. |
| ● | If 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. |
| ● | If 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. |
| ● | The market price of our common stock, $0.0001 par value (the “Common Stock”), is highly volatile, and you may lose some or all of your investment. |
| ● | You may experience dilution of your ownership interests because of the future issuance of additional shares of Common Stock or securities convertible into Common Stock. |
| ● | If we fail to meet Nasdaq’s continued listing requirements, it could result in a suspension or delisting of the Common Stock. |
| ● | If 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. |
| ● | The Certificate of Incorporation of the Company allows for our board of directors (the “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. |
| ● | We 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 Common Stock. |
| ● | Our operating results may fluctuate significantly. |
| ● | We are a controlled company within the meaning of the Nasdaq continued listing requirements and, as a result, may rely on exemptions from certain corporate governance requirements. |
| ● | Volatility in the Company’s share price could subject us to securities litigation. |
| ● | Provisions 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. |
| ● | If 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. |
| ● | Conflicts of interest may arise from our relationship with Citius Pharmaceuticals, Inc. (“Citius Pharma”). |
| ● | Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with Citius Pharma. |
| ● | Citius Pharma currently performs or supports many of our important corporate functions, which would be difficult to replace if Citius Pharma were to cease providing. |
| ● | Our 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. |
| ● | Our Certificate of Incorporation provides for an exclusive forum provision. |
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