CITIUS ONCOLOGY, INC. Files 2024 Annual Report

TL;DR

Citius Oncology filed its 2024 10-K. All systems go.

AI Summary

CITIUS ONCOLOGY, INC. filed its annual report for the fiscal year ended September 30, 2024. The company, formerly known as TenX Keane Acquisition until March 15, 2021, is incorporated in Delaware and operates in the Pharmaceutical Preparations sector. Its principal executive offices are located at 11 Commerce Drive, Cranford, NJ.

Why It Matters

This filing provides a comprehensive overview of Citius Oncology's financial performance and business operations for the past fiscal year, crucial for investors and stakeholders to assess the company's health and future prospects.

Risk Assessment

Risk Level: low — This is a standard annual report filing, providing factual information about the company's operations and financials.

Key Numbers

• 001-41534 — SEC File Number (Identifies the company's filings with the SEC.)
• 0930 — Fiscal Year End (Indicates the end of the company's reporting period.)

Key Players & Entities

• CITIUS ONCOLOGY, INC. (company) — Registrant
• TenX Keane Acquisition (company) — Former company name
• 20240930 (date) — Fiscal year end
• 20241227 (date) — Filing date
• 11 Commerce Drive, Cranford, NJ (location) — Principal executive offices

FAQ

Key Financial Figures

• $0.0001 — ich Registered Common Stock, par value $0.0001 per share CTOR The NASDAQ Capital Marke
• $400 m — market for LYMPHIR, estimated to exceed $400 million, that is underserved by existing

Filing Documents

• ea0225372-10k_citius.htm (10-K) — 855KB
• ea022537201ex4-2_citius.htm (EX-4.2) — 27KB
• ea022537201ex10-3_citius.htm (EX-10.3) — 138KB
• ea022537201ex19-1_citius.htm (EX-19.1) — 61KB
• ea022537201ex31-1_citius.htm (EX-31.1) — 9KB
• ea022537201ex31-2_citius.htm (EX-31.2) — 10KB
• ea022537201ex32-1_citius.htm (EX-32.1) — 4KB
• 0001213900-24-113150.txt ( ) — 3810KB
• tenk-20240930.xsd (EX-101.SCH) — 28KB
• tenk-20240930_cal.xml (EX-101.CAL) — 21KB
• tenk-20240930_def.xml (EX-101.DEF) — 143KB
• tenk-20240930_lab.xml (EX-101.LAB) — 278KB
• tenk-20240930_pre.xml (EX-101.PRE) — 153KB
• ea0225372-10k_citius_htm.xml (XML) — 215KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 17 Item 1B. Unresolved Staff Comments 45 Item 1C. Cybersecurity 45 Item 2.

Properties

Properties 45 Item 3.

Legal Proceedings

Legal Proceedings 45 Item 4. Mine Safety Disclosures 45 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 46 Item 6. [Reserved] 46 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 46 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 50 Item 8.

Financial Statements and

Financial Statements and Supplementary Data 50 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 50 Item 9A.

Controls and Procedures

Controls and Procedures 51 Item 9B. Other Information 51 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 51 PART III Item 10. Directors, Executive Officers and Corporate Governance 52 Item 11.

Executive Compensation

Executive Compensation 52 Item 12.

Security Ownership of Certain

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 52 Item 13. Certain Relationships and Related Transactions, and Director Independence 52 Item 14. Principal Accountant Fees and Services 52 PART IV Item 15. Exhibits and Financial 53 Item 16. Form 10-K Summary 54

Signatures

Signatures 55 i 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. LYMPHIR TM (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

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains "forward-looking plans, strategies, predictions, or any other statements relating to our future activities or other future events or conditions. These 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 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 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 comme

Business

Item 1. Business Business Overview The Company, headquartered in Cranford, New Jersey, is a biopharmaceutical company focused on developing and commercializing innovative targeted oncology therapies. The Company's strategy centers on achieving a market leading position by advancing innovative therapies with reduced development and clinical risks, and competitive advantages supported by intellectual property and regulatory exclusivity protection. This includes new formulations of previously approved drugs with substantial existing safety and efficacy data or expanded indications for approved therapies. The Company's lead product candidate is LYMPHIR TM , an engineered IL-2 diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent CTCL, a rare form of non-Hodgkin lymphoma. LYMPHIR was approved by the FDA in August 2024. The Company believes there is an attractive and growing market for LYMPHIR, estimated to exceed $400 million, that is underserved by existing treatments. See below for more detailed information on LYMPHIR. In the future, the Company intends to commercialize our products independently in the U.S., and partner to market products outside of the U.S. The Company is in the process of establishing a small, targeted oncology sales force, initially for LYMPHIR, focused on key geographies and stakeholders, primarily major cancer centers. This commercialization strategy is anticipated to result in a combination of direct sales revenue, and royalty income, as well as incremental operating expenses and greater working capital requirements. Citius Oncology and the Business Combination On August 23, 2021, Citius Pharmaceuticals, Inc. ("Citius Pharma"), formed Citius Acquisition Corp. ("SpinCo") as a wholly-owned subsidiary in conjunction with the acquisition of LYMPHIR, but SpinCo did not begin operations until April 2022, when Citius Pharma transferred the assets related to LYMPHIR to SpinCo, including the related licens

View Full Filing

View this 10-K filing on SEC EDGAR