As filed with the Securities and Exchange Commission on July 14, 2025

Registration Statement No. 333-_______

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT UNDER

THE SECURITIES ACT OF 1933

CITIUS ONCOLOGY, INC.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation or organization)

8731

(Primary Standard Industrial Classification Code Number)

99-4362660

(I.R.S. Employer

Identification Number)

11 Commerce Drive, First Floor

Cranford, New Jersey 07016

Telephone: (908) 967-6677

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Leonard Mazur

Chief Executive Officer

11 Commerce Drive, First Floor

Cranford, New Jersey 07016

Telephone: (908) 967-6677

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Lorna A. Knick, Esq.

Alexander M. Donaldson, Esq.

Christopher P. Agoranos, Esq.

Wyrick Robbins Yates & Ponton LLP

4101 Lake Boone Trail, Suite 300

Raleigh, North Carolina 27607

Telephone: (919) 781-4000

Mark E. Crone, Esq.

Cassi Olson, Esq.

The Crone Law Group P.C.

420 Lexington Avenue, Suite 2446

New York, NY 10170

Telephone: +1 646-861-7891

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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	☐	Non-accelerated filer	☒	Accelerated filer	☐
Smaller reporting company	☒	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 7(a)(2)(B) of the Securities Act. ☐

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the U.S. Securities and Exchange Commission is effective. The preliminary prospectus is not an offer to sell these securities and does not constitute the solicitation of offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED JULY 14, 2025

PRELIMINARY PROSPECTUS

Citius Oncology, Inc.

Up to $15 million of Shares of Common Stock

Up to $15 million of Pre-Funded Warrants to Purchase up to $15 million of Shares of Common Stock

Up to $15 million of Warrants to Purchase $15 million of Shares of Common Stock

Up to $15 million of Shares of Common Stock underlying the Warrants and Pre-Funded Warrants

Up to $750,000 of Shares of Common Stock Underlying the Placement Agent’s Warrants

We are offering up to $15 million of shares of common stock, par value $0.0001 per share (the “Common Stock”), and accompanying warrants to purchase up to $15 million of shares of Common Stock (the “Warrants”), at an assumed combined offering price of $[____] per share of Common Stock and accompanying Warrant (assuming a public offering price equal to the closing price of our Common Stock of $[____] per share as reported by the Nasdaq Capital Market (“Nasdaq”) on July [__], 2025).

Each Warrant will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the Warrants (the “Warrant Stockholder Approval”), provided however, if the Pricing Conditions (as defined below) are met, the Warrant Stockholder Approval will not be required and the Warrants will be exercisable upon issuance (the “Initial Exercise Date”). The Warrants will expire five years from the Initial Exercise

The shares of Common Stock and Warrants will be issued separately and will be immediately separable upon issuance but will be purchased together in this offering. This prospectus also relates to the shares of common stock issuable upon exercise of the common warrants sold in this offering. As used herein “Pricing Conditions” means that the combined public offering price per share and accompanying common warrant is such that the Warrant Stockholder Approval is not required under the rules of The Nasdaq Stock Market LLC (“Nasdaq”) because either (i) the offering is an at-the-market offering under the rules of Nasdaq (the “Nasdaq Rules”) and such price equals or exceeds the sum of (a) the applicable “Minimum Price” per share under Nasdaq Rule 5635(d) plus (b) $0.125 per whole share of common stock underlying the common warrants or (ii) the offering is a discounted offering where the pricing and discount (including attributing a value of $0.125 per whole share underlying the common warrants) meet the pricing requirements under the Nasdaq Rules.

We are also offering to those purchasers, if any, whose purchase of the Common Stock in this offering would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or at the election of the purchaser, 9.99%) of our outstanding Common Stock immediately following the consummation of this offering, the opportunity to purchase, if they so choose, pre-funded warrants in lieu of the Common Stock that would otherwise result in ownership in excess of 4.99% (or 9.99%, as applicable) of our outstanding Common Stock (the “Pre-Funded Warrants”). The purchase price for each Pre-Funded Warrant will equal the per share public offering price for the Common Stock in this offering less the $0.0001 per share exercise price of each such Pre-Funded Warrant. Each Pre-Funded Warrant will be exercisable upon issuance and will not expire prior to exercise. For each Pre-Funded Warrant we sell, the number of shares of Common Stock we are offering will be decreased on a one-for-one basis. This prospectus also relates to the shares of Common Stock that are issuable from time to time upon exercise of the Pre-Funded Warrants.

Our Common Stock is traded on Nasdaq under the symbol “CTOR”. There is no established trading market for the Warrants and Pre-Funded Warrants being sold in this offering and we do not expect a market to develop. In addition, we do not intend to list the Warrants and Pre-Funded Warrants on Nasdaq or any other nationally recognized trading system. Without an active trading market, the liquidity of the Warrants and Pre-Funded Warrants will be limited.

The public offering price for our securities in this offering will be determined at the time of pricing, and may be at a discount to the then-current market price. The assumed combined public offering price used throughout this prospectus may not be indicative of the final offering price. The final public offering price will be determined through negotiation between us and investors based upon a number of factors, including our history and our prospects, the industry in which we operate, our past and present operating results, the previous experience of our executive officers and the general condition of the securities markets at the time of this offering.

We have engaged Maxim Group LLC as our exclusive placement agent (“Maxim” or the “placement agent”) to use its reasonable best efforts to solicit offers to purchase our securities in this offering. The placement agent has no obligation to purchase any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. Because there is no minimum offering amount required as a condition to closing in this offering the actual public offering amount, placement agent’s fee, and proceeds to us, if any, are not presently determinable and may be substantially less than the total maximum offering amounts set forth above and throughout this prospectus. We have agreed to pay the placement agent the placement agent fees set forth in the table below. See “Plan of Distribution” in this prospectus for more information.

Per Share of Common Stock
and Accompanying
Warrant

Per Pre-Funded
Warrant and
Accompanying
Warrant

Total

Combined offering price to the public

Placement agent fees⁽¹⁾

Proceeds to us (before expenses)⁽²⁾

(1)

Represents a cash fee equal to 7.0% of the aggregate purchase price. We have also agreed to issue to the underwriter, or its designees, at the closing of this offering common share purchase warrants (the “Placement Agent’s Warrants”) to purchase the number of common shares equal to 5.0% of the aggregate number of shares of Common Stock and Pre-Funded Warrants sold in this offering. We have also agreed to reimburse the placement agent for certain expenses in connection with this offering. See “Plan of Distribution” beginning on page 82 of this prospectus for a description of the compensation to be received by the placement agent.

(2)

The amount of offering proceeds to us presented in this table does not give effect to any exercise of the Warrants or Pre-Funded Warrants.

Investing in our securities involves a high degree of risks, including the risk of losing your entire investment. See “Risk Factors” beginning on page 8 to read about factors you should consider before buying our securities.

Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

We anticipate that delivery of the shares of Common Stock (or Pre-Funded Warrants in lieu thereof) and Warrants offered hereby against payment on or about , 2025.

Maxim Group LLC

The date of this prospectus is , 2025.

TABLE OF CONTENTS

	Page
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS	ii
SUMMARY OF THE PROSPECTUS	1
SUMMARY RISK FACTORS	3
THE OFFERING	6
RISK FACTORS	8
USE OF PROCEEDS	37
CAPITALIZATION	38
DILUTION	39
MARKET PRICE OF OUR COMMON STOCK AND DIVIDENDS	40
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	41
BUSINESS	48
MANAGEMENT	63
DIRECTOR COMPENSATION	67
EXECUTIVE COMPENSATION	67
DESCRIPTION OF CAPITAL STOCK AND SECURITIES THAT WE ARE OFFERING	72
BENEFICIAL OWNERSHIP OF SECURITIES	79
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS	81
PLAN OF DISTRIBUTION	82
LEGAL MATTERS	86
EXPERTS	86
WHERE YOU CAN FIND ADDITIONAL INFORMATION	86
INDEX TO FINANCIAL STATEMENTS	F-1

You should rely only on the information contained in this prospectus. No one has been authorized to provide you with information that is different from that contained in this prospectus. This prospectus is dated as of the date set forth on the cover hereof. You should not assume that the information contained in this prospectus is accurate as of any date other than that date.

We and the placement agent are offering to sell, and seeking offers to buy, our securities only in jurisdictions where offers and sales are permitted. Neither we nor the placement agent have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of our securities and the distribution of this prospectus outside of the United States.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus 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 prospectus, including the risks described under “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this prospectus 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:

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our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern;

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the Company’s need for substantial additional funds, even after completion of this offering, and its ability to raise those funds;

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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;

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our ongoing evaluations of strategic alternatives;

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the ability of the Company to commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and services;

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the ability of LYMPHIR or any of our future product candidates to impact the quality of life of our target patient populations;

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the estimated markets for LYMPHIR or any of our future product candidates and the acceptance thereof by any market;

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our ability to procure cGMP commercial-scale supply;

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our dependence on third-party suppliers;

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risks arising from changes in the fields in which LYMPHIR and any of our future product candidates, if approved, may compete;

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risks relating to the results of research and development activities, including those from our existing and any new pipeline assets;

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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;

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the Company’s operating results and financial performance;

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uncertainties relating to preclinical and clinical testing, approval and commercialization of any future product candidates by the Company;

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the Company’s ability to manage and grow our business and execution of our business and growth strategies;

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the competitive environment in the life sciences and biotechnology industry;

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failure to maintain, protect and defend the Company’s intellectual property rights;

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changes in government laws and regulations, including laws governing intellectual property, and the enforcement thereof affecting the Company’s business;

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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;

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the effect of the transactions on the Company’s business relationships, operating results, and businesses generally;

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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 Merger, 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 prospectus.

TRADEMARKS

This document contains references to trademarks and service marks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the ® or ™ symbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

iii

SUMMARY OF THE PROSPECTUS

This summary highlights selected information from this prospectus and might not contain all of the information that is important to you in making an investment decision. Before investing in our securities, you should carefully read this entire prospectus, including our financial statements and the related notes included in this prospectus and the information set forth under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” See also the section entitled “Where You Can Find Additional Information.” Unless the context otherwise requires, all references in this prospectus to “Citius Oncology,” the “Company,” “we,” “us” and “our” in this prospectus refer to the parent entity formerly named TenX Keane Acquisition, as renamed Citius Oncology, Inc.

Our Company

Citius Oncology, Inc. is a biopharmaceutical company focused on developing and commercializing innovative targeted oncology therapies. Since inception, the Company has been engaged in business planning and research and development. We do not currently generate any revenue. The Company’s lead product candidate is LYMPHIR, 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 U.S. Food and Drug Administration (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.

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 license agreement with Eisai Co., Ltd. (“Eisai”) and the related asset purchase agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, Ltd. (collectively, “Dr. Reddy’s”).

On October 23, 2023, Citius Pharma and SpinCo entered into an agreement and plan of merger and reorganization (the “Merger Agreement”) with TenX Keane Acquisition, a Cayman Islands exempted company (“TenX”), and TenX Merger Sub Inc., a Delaware corporation and a wholly owned subsidiary of TenX (“Merger Sub”). On August 12, 2024, pursuant to the terms and conditions of the Merger Agreement, Merger Sub merged with and into SpinCo, with SpinCo surviving as a wholly owned subsidiary of TenX (the “Merger”) which was subsequently renamed Citius Oncology Sub. Prior to closing of the Merger (the “Closing”), TenX migrated to and domesticated as a Delaware corporation in accordance with Section 388 of the General Corporation Law of the State of Delaware and the Cayman Islands Companies Act (As Revised) (the “Domestication”). As part of the Domestication, TenX changed its name to “Citius Oncology, Inc.” (Nasdaq: CTOR). 10XYZ Holdings was the sponsor (the “Sponsor”), general partner and the sole stockholder of TenX, which was created as a special purpose acquisition company for the purpose of entering into a business combination with one or more business entities. TenX undertook the Merger to accomplish this goal. Joel Mayersohn, one of our directors, was a director of TenX.

Since the SpinCo’s inception, Citius Pharma has funded SpinCo and continues to fund Citius Oncology, and Citius Pharma and Citius Oncology are party to an amended and restated shared services agreement (the “A&R Shared Services Agreement”), which governs certain management and scientific services that Citius Pharma provides Citius Oncology.

Our address is 11 Commerce Drive, 1st Floor, Cranford, New Jersey 07016 and our telephone is (908) 967-6677.

Recent Developments

Eisai License Agreement

Pursuant to the terms of that certain Amended and Restated License, Development and Commercialization Agreement, as amended on August 9, 2018 and August 31, 2021 (the “License Agreement”), the rights and obligations of which the Company assumed at the Closing, upon the approval of LYMPHIR by the FDA in August 2024, the Company became obligated to pay Eisai a milestone payment of $5,900,000. In the course of developing LYMPHIR, the Company incurred an aggregate of $8,233,209.77 for various development and inventory costs that it owes to Eisai. All of these costs were reported in the Company’s financial statements for the periods in which they were incurred, with the great majority of them, other than the milestone payment incurred in August 2024, being incurred prior to the quarter ended December 31, 2024. The $5,900,00 milestone payment obligation was reported in the Company’s financial statements for the period in which FDA approval of LYMPHIR was obtained, which was in August 2024. An aggregate $6,048,052.67 of inventory costs have been incurred, all of which were included as an accrued obligation on the Company’s financial statements for the period ended December 31, 2024. Accounts receivable development costs of $185,317.70 were included on the Company’s financial statements for the period ended December 31, 2024. The remaining $1,999,839.40 of expense is included in the Company’s financial statements for the period ended March 31, 2025.

On March 28, 2025, the Company and Eisai entered into a letter agreement that amended the license agreement to provide for a payment schedule to Eisai for the milestone payment and certain unpaid invoices. The Company has agreed to pay Eisai on or before July 15, 2025, an aggregate amount of $2,535,318 and thereafter on the 15th of each of the next four months to pay Eisai $2,350,000 and make a final payment of $2,197,892 to Eisai on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of actual payment under the letter agreement at the rate of 2% per annum. The parties released each other from any and all claims, losses, damages, costs and expenses that arise from or related to the failure of the Company to pay the milestone payment or the other incurred costs under the license agreement except for any claims arising out of a breach of the letter agreement. All other terms of the license agreement remain in full force and effect.

Increase in Authorized Shares

On April 7, 2025, the Company filed a Certificate of Amendment to its certificate of incorporation with the Delaware Secretary of State to increase the total number of shares of capital stock which may be issued by the Company from 110,000,000 shares to 410,000,000, of which 400,000,000 shares are Common Stock, par value $0.0001, and 10,000,000 shares are undesignated preferred stock, par value of $0.0001 per share. As disclosed in the Company’s Information Statement filed on February 24, 2025, the Certificate of Amendment was first approved by the Company’s Board of Directors (the “Board”) on February 12, 2025, and subsequently by the holders of a majority of the issued and outstanding shares of the Company by written consent on February 13, 2025.

Nasdaq Listing

On April 23, 2025, The Nasdaq Stock Market LLC notified the Company that for the preceding 30 consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until October 20, 2025, to regain compliance with the Bid Price Rule. If at any time before October 20, 2025, the bid price of the Company's common stock closes at $1.00 per share or more for a minimum of ten consecutive trading days, Nasdaq will provide the Company with a written confirmation of compliance with the Bid Price Rule. On June 26, 2025, the Company received written notice of compliance from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) stating that for 10 consecutive trading days, from June 6, 2025 to June 24, 2025, the closing bid price of the Company’s common stock has been at $1.00 per share or greater, and accordingly, the Company regained compliance with Nasdaq Listing Rule 5550(a)(2). Nasdaq informed the Company in the compliance notice that it now considered this matter closed.

Summary Risk Factors

Our business and securities are subject to numerous risks and uncertainties, including those highlighted in the section entitled “Risk Factors” immediately following this prospectus summary, that represent challenges that we face in connection with the successful implementation of our strategy and the growth of our business.

●

Our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern.

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We require substantial additional funding, even after completion of this offering, 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 currently have only one approved product and we are heavily dependent on the planned launch and commercial success of LYMPHIR.

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We are required to make milestone and other 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.

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We are obligated to pay to Citius Pharma the fees for services under the A&R Shared Services Agreement and must repay the principal due on a promissory note issued in August 2024.

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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.

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A 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.

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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.

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LYMPHIR may not gain market acceptance among physicians, patients, healthcare payers or the medical community and may not generate significant revenue.

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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.

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We have a limited operating history upon which to evaluate our ability to successfully commercialize LYMPHIR and any future product candidate.

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The markets in which we operate are highly competitive and we might be unable to compete successfully against new entrants or established companies.

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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.

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Healthcare reform measures could hinder or prevent LYMPHIR’s, or any of our future product candidates that may be approved, commercial success.

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Any termination, or breach by, or conflict with our strategic partners could harm our business.

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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.

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If we are unable to retain or hire additional qualified personnel, our ability to grow our business might be harmed.

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The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

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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.

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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.

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We might not obtain the necessary U.S. or foreign regulatory approvals to commercialize any future product candidates.

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Our business depends on protecting our intellectual property.

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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.

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The market price of our Common Stock, is highly volatile, and you may lose some or all of your investment.

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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.

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If we do not maintain compliance with Nasdaq’s continued listing requirements, it could result in a suspension or delisting of the Common Stock.

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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.

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We do not intend to apply for any listing of the Warrants or Pre-Funded Warrants on any exchange or nationally recognized trading system, and we do not expect a market to develop for the warrants.

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The Certificate of Incorporation of the 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.

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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.

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Our operating results may fluctuate significantly.

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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.

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Volatility in our share price could subject us to securities litigation.

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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.

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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.

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Conflicts of interest may arise from our or our directors’ and officers’ relationship with Citius Pharma.

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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.

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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.

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Our Certificate of Incorporation provides for an exclusive forum provision.

Sources of Industry and Market Data

Where information has been sourced from a third party, the source of such information has been identified. Unless otherwise indicated, the information contained in this prospectus on the market environment, market developments, growth rates, market trends and competition in the markets in which we operate is taken from publicly available sources, including third-party sources, or reflects our estimates that are principally based on information from publicly available sources.

Emerging Growth Company and Controlled Company

In April 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our audited financial statements might not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

We have chosen to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company” we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal control over financial reporting pursuant to Section 404 of SOX, (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board (United States) regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the consolidated financial statements (auditor discussion and analysis) and (iv) disclose certain executive compensation-related items, such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation to median employee compensation. We may remain an “emerging growth company” until the last day of the fiscal year following the fifth anniversary of the completion of TenX’s IPO. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenue equals or exceeds $1.235 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an “emerging growth company” prior to the end of such five-year period.

By virtue of the fact that Citius Pharma holds more than 50% of the total voting power of the shares of our capital stock, we qualify as a “controlled company” within the meaning of the corporate governance standards of the Nasdaq. Under these rules, a listed company of which more than 50% of the voting power is held by an individual, group or another company is a “controlled company” and may elect not to comply with certain corporate governance requirements, including the requirement that (i) a majority of our Board consist of independent directors, (ii) we have a compensation committee that is composed entirely of independent directors and (iii) we have a nominating/corporate governance committee that is composed entirely of independent directors.

We are not currently relying on certain of these exemptions. To the extent we decide in the future to rely on any of these exemptions, holders of our Common Stock will not have the same protections afforded to stockholders of companies that are subject to all of the corporate governance requirements of Nasdaq.

The Offering

Shares of Common Stock and accompanying Warrants offered by us pursuant to this prospectus		Up to $15 million of shares of Common Stock (or Pre-Funded Warrant in lieu thereof) and Warrants to purchase up to $15 million of shares of Common Stock.

Public offering price		$ per share of Common Stock and accompanying Warrant, or $ per Pre-Funded Warrant and accompanying Warrant, as applicable.

Description of Warrants		The Warrants will be exercisable beginning on the effective date of the Warrant Stockholder Approval, provided however, if the Pricing Conditions are met, the Warrant Stockholder Approval will not be required and the Warrants will be exercisable on the Initial Exercise Date. The Warrants will expire five years from the Initial Exercise Date or the Warrant Stockholder Approval, as applicable. Notwithstanding the foregoing, we will not effect any exercise of Warrants to the extent that, after giving effect to an exercise, the holder of Warrants would exceed the Beneficial Ownership Limitation (as defined below). The terms of the Warrants will be governed by a warrant agent agreement, dated as of the closing date of this offering, that we expect to be entered into among us and Equiniti Company, LLC, or the Warrant Agent. This prospectus also relates to the offering of the shares of Common Stock issuable upon exercise of the Warrants. For additional information regarding the Warrants, see “Description of Our Capital Stock and Securities We Are Offering.”

Description of Pre-Funded Warrants		We are also offering to certain purchasers whose purchase of our Common Stock in this offering would otherwise result in the purchaser, together with its affiliates, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) (the “Beneficial Ownership Limitation”) of our outstanding shares of Common Stock immediately following the consummation of this offering, the opportunity to purchase Pre-Funded Warrants in lieu of Common Stock that would otherwise result in any such purchaser’s beneficial ownership exceeding the applicable Beneficial Ownership Limitation. Each Pre-Funded Warrant will be exercisable for one share of Common Stock. The purchase price of each Pre-Funded Warrant and the accompanying Warrant will equal the price at which the Common Stock and the accompanying Warrant are being sold to the public in this offering, minus $0.0001, and the exercise price of each Pre-Funded Warrant will be $0.0001 per share. The Pre-Funded Warrants will be exercisable immediately and may be exercised at any time until exercised in full. For each Pre-Funded Warrant we sell, the number of shares of Common Stock we are offering will be decreased on a one-for-one basis. Because we will issue an accompanying Warrant to purchase one share of Common Stock for each share of Common Stock and for each Pre-Funded Warrant sold in this offering, the number of Warrants sold in this offering will not change as a result of a change in the mix of the shares of our Common Stock and Pre-Funded Warrants sold.

Common Stock outstanding immediately prior to this offering		71,552,402 shares

Common Stock outstanding immediately after this offering⁽¹⁾		shares (assuming we sell only shares of Common Stock and no Pre-Funded Warrants, and none of the Warrants issued in this offering are exercised).

Representative’s Warrants		We will issue to the placement agent, upon closing of this offering, compensation warrants entitling the representative to purchase a number of shares of Common Stock equal to 5.0% of the aggregate number of shares of Common Stock issued in this offering. The Placement Agent’s Warrants may be exercised commencing six months after the date of the registration statement of which this prospectus is a part and will have a term of five years after such date. This prospectus also relates to the offering of the common shares issuable upon exercise of the Placement Agent’s Warrants.

Use of proceeds		We estimate that the net proceeds from this offering will be approximately $[_____] million, based on an assumed public offering price of $[_____] per share of Common Stock and accompanying Warrant, assuming no exercise of any Warrants and no sale of Pre-Funded Warrants, and after deducting discounts and commissions and estimated offering expenses payable by us. We plan to use the net proceeds we receive from this offering primarily for the commercialization of LYMPHIR, including milestone, royalty or other payments we are required to make pursuant to current license agreements, and working capital and general corporate purposes. If the gross proceeds from this offering equal or exceed $10 million, we must repay the full $3,800,111 principal due under the August 2024 promissory note issued to Citius Pharma. See “Use of Proceeds”.

Lock-up agreements		We and our directors and officers have agreed with the placement agent not to offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any of our Common Stock or securities convertible into our Common Stock for a period of 180 days from the date of this prospectus without the prior written consent of the placement agent. See “Plan of Distribution” on page 82 of this prospectus.

Risk factors		An investment in our securities is highly speculative and involves substantial risk. Please carefully consider the risks described under the heading “Risk Factors” on page 8 and other information included elsewhere in this prospectus for a discussion of factors to consider before deciding to invest in the securities offered hereby. Additional risks and uncertainties not presently known to us or that we currently deem to be immaterial may also impair our business and operations.

Nasdaq Capital Market Symbol		Our Common Stock is listed on Nasdaq under the symbol “CTOR”. There is no established trading market for the Warrants or Pre-Funded Warrants, and we do not expect a trading market for the Warrants or Pre-Funded Warrants to develop. We do not intend to list the Warrants or Pre-Funded Warrants on any securities exchange or other trading market. Without a trading market, the liquidity of the Warrants and Pre-Funded Warrants will be extremely limited.

(1)

The number of shares of Common Stock to be outstanding after this offering is based on 71,552,402 shares of Common Stock outstanding as of June 30, 2025, and excludes:

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options to purchase an aggregate of 18,500,000 shares of our Common Stock issued to our employees, directors and consultants under our 2023 Omnibus Stock Incentive Plan and 2024 Omnibus Stock Incentive Plan (collectively, the “Plans”); and

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11,500,000 shares of Common Stock available for future grants under the Plans.

Unless otherwise stated, all information in this prospectus assumes no exercise of the underwriters’ option to purchase additional securities.

RISK FACTORS

An investment in our securities involves a high degree of risk. You should carefully consider the risks described below before making an investment decision. In the course of conducting our business operations, we are exposed to a variety of risks. Any of the risk factors we describe below have affected or could materially adversely affect our business, prospects, financial condition and results of operations as could other risks not currently known to us or that we currently consider immaterial. The market price of shares of our Common Stock and the value of your Warrants could decline, possibly significantly or permanently, if one or more of these risks and uncertainties occurs, and, as a result, you may lose all or part of your investment.

Risks Related to the Company’s Business and Our Industry

Our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern.

As a result of our historical operating losses and expected future negative cash flows from operations, we have concluded that there is substantial doubt about our ability to continue as a going concern. Similarly, the report of our independent registered public accounting firm on our consolidated financial statements, which is included elsewhere in this prospectus, includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern. Our consolidated financial statements for the fiscal year ended September 30, 2024 have been prepared assuming we will continue as a going concern and do not include any adjustments that might result from uncertainty about our ability to continue as a going concern. You should not rely on our consolidated balance sheet as an indication of the amount of proceeds that would be available to satisfy claims of creditors, and potentially be available for distribution to stockholders, in the event of liquidation.

After giving effect to Citius Pharma’s registered direct offerings in April 2025 and June 2025, as well as a debt offering in June 2025, we expect to have sufficient funds to continue our operations through August 2025. We will need to raise additional capital in the future to support our operations beyond August 2025. The Company’s continued operations beyond August 2025, including our commercialization of LYMPHIR, will depend on our ability to successfully launch and generate substantial revenue from the sale of LYMPHIR and on our ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its product candidates. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our Common Stock and make it more difficult to obtain financing. If the Company is unable to raise sufficient capital, find strategic partners or generate substantial revenue from the sale of LYMPHIR, there will be a material adverse effect on its business, including the dissolution and liquidation of our Company. Further, the Company expects in the future to incur additional expenses as we continue our efforts to commercialize LYMPHIR and protect our intellectual property.

We require substantial additional funding in the near future, even after this offering, to support our operations, complete the commercialization of LYMPHIR, which may not be available on acceptable terms, or at all.

Our operations have consumed substantial amounts of cash since inception. We have significantly increased our spending to continue our commercialization efforts for LYMPHIR and advance development of LYMPHIR for other indications. Furthermore, following the Merger, we have additional costs associated with operating as a public company and require additional capital to fund our other operating expenses and capital expenditures. As a result, we continue to evaluate strategic alternatives, including but not limited to, partnerships, joint ventures, mergers, acquisitions, licensing or other strategic transactions.

As of March 31, 2025, our cash and cash equivalents were approximately $112 and we had an accumulated deficit of $53,673,344. The amount and timing of our future funding requirements will depend on many factors, some of which are outside of our control, including but not limited to:

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the costs and expenses associated with our ongoing commercialization efforts for LYMPHIR, including the costs of establishing or contracting for sales, marketing, and distribution capabilities for LYMPHIR;

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the degree of success we experience in commercializing LYMPHIR;

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the revenue generated by sales of LYMPHIR and other future product candidates that may be approved, if any;

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the extent to which LYMPHIR or any of our other potential product candidates, if approved for commercialization, is adopted by the physician community;

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the effect of competing products and product candidates and other market developments;

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the scope, progress, results and costs of conducting studies and clinical trials for our other future product candidates, if any, resulting from our ongoing research with LYMPHIR for other possible indications;

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the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates;

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the timing of the repayment of amounts owed to Citius Pharma, including fees for services under the A&R Shared Services Agreement and the principal due on a promissory note issued in August 2024;

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the costs of manufacturing LYMPHIR and any other potential product candidates we develop;

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the timing and amount of any milestone, royalty or other payments we are required to make pursuant to any current or future license agreements;

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the number and types of future product candidates we might develop and commercialize;

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any product liability or other lawsuits related to our products;

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the expenses needed to attract, hire and retain skilled personnel;

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the costs associated with being a public company;

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its need to implement additional internal systems and infrastructure, including financial and reporting systems;

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costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and

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the extent and scope of our general and administrative expenses.

Until we are able to generate significant revenue, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations or other strategic transactions. We cannot be sure that any additional funding, if needed, will be available on terms favorable to us, or at all. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Furthermore, any additional equity or equity-related financing may be dilutive to our stockholders, and debt or equity financing, if available, may subject us to restrictive covenants and significant interest costs. If we raise additional funds through collaborations or strategic alliances with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or technologies, or grant licenses on terms that may not be favorable to us. If we are unsuccessful in our efforts to raise additional financing on acceptable terms or execute on other strategic alternatives, we may be required to significantly reduce or cease our operations.

We currently have only one approved product and we are heavily dependent on the planned launch and commercial success of LYMPHIR.

We have one product LYMPHIR, which was approved for commercial sale in August 2024. We are pursuing other future product candidates, based on our ongoing research with LYMPHIR for other possible indications all of which are in the pre-clinical stage. We are entirely dependent upon the successful commercial launch of LYMPHIR to generate revenue for the foreseeable future. The commercial launch in the U.S. is not expected to occur until the second half of 2025. As a result, it is difficult to evaluate our current business and predict our future prospects. We cannot assure you that LYMPHIR will gain market acceptance among physicians, health care payors, patients and the medical community, which is critical to our commercial success. As a company, we have limited experience engaging in commercial activities and limited relationships with physicians, hospitals and payors. Market acceptance of LYMPHIR will depend on a number of factors, including:

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acceptance by physicians, major operators of clinics and patients of LYMPHIR as a safe and effective treatment for CTCL;

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the availability, cost and potential advantages of existing and any future alternative treatments;

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the effectiveness of our sales and marketing efforts;

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the availability of coverage, adequacy of reimbursement and favorability of pricing policies by third-party payors and government authorities;

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the prevalence and severity of adverse side effects; and

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the timing of market introduction of other competitive products, if any.

In order to successfully commercialize LYMPHIR, we will need to establish our marketing program, which we are in the process of doing. However, physicians may decide not to prescribe LYMPHIR for a variety of reasons, including perceived safety issues, inadequate coverage or reimbursement for LYMPHIR or the utilization of products developed by other parties, all of which are circumstances outside of our control. Demand for LYMPHIR may not develop as quickly as we expect, and we may be unable to generate revenue to the level that we currently expect. Even if we succeed in obtaining market acceptance of LYMPHIR, we may be unable to reach or sustain a level of profitability.

Our ability to effectively promote LYMPHIR will also depend on pricing and cost-effectiveness, including our ability to produce LYMPHIR at a competitive price. In addition, our efforts to educate the medical community and third-party payors on the benefits of LYMPHIR may require significant resources, may be constrained by FDA rules and policies on product promotion and may never be successful.

Under the terms of the License Agreement with Eisai, we are required to pay Eisai a $5.9 million development milestone payment upon initial approval by the FDA of LYMPHIR for the CTCL indication, which occurred in August 2024, and an aggregate of up to $22 million related to the achievement of net product sales thresholds. Under the terms of the agreement with Dr. Reddy’s, we are obligated to pay up to an aggregate of $40 million related to CTCL approvals in the U.S. and other markets, up to $70 million in development milestones for additional indications, and up to $300 million for commercial sales milestones. Further, under the agreement with Dr. Reddy’s, we are required to (i) use commercially reasonable efforts to make commercially available products in the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology trials, (iii) use commercially reasonable efforts to achieve each of the approval milestones, and (iv) complete each specified immuno-oncology investigator trial on or before September 1, 2025, the four-year anniversary of the effective date of the definitive agreement. Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory approval for such product in each such jurisdiction.

Pending further discussions with Dr. Reddy’s, Dr. Reddy’s agreed to a partial deferral without penalty of a milestone payment by Citius Oncology, which was triggered upon regulatory approval of LYMPHIR by the FDA and due on September 9, 2024, pursuant to the terms of the Asset Purchase Agreement. These development and milestone obligations impose substantial additional costs on us, and could divert resources from other aspects of our business and adversely affect the overall profitability of LYMPHIR. We need to obtain additional financing to satisfy these milestone payments, and cannot be sure that any additional funding will be available on terms favorable to us, or at all.

Additionally, on March 28, 2025, the Company and Eisai entered into a letter agreement that amended license agreement to provide for a payment schedule to Eisai for the milestone payment and certain unpaid invoices. The Company has agreed to pay Eisai on or before July 15, 2025, an aggregate amount of $2,535,318 and thereafter on the 15th of each of the next four months to pay Eisai $2,350,000 and make a final payment of $2,197,892 to Eisai on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of actual payment under the letter agreement at the rate of 2% per annum.

We 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.

We were formed in August 2021 and began operations in April 2022 when Citius Pharma transferred the assets related to LYMPHIR to us, including the license agreement with Eisai and the asset purchase agreement with of Dr. Reddy’s. Our ability to become profitable depends upon our ability to generate revenues from sales of LYMPHIR, and any future product candidates, if any, resulting from our ongoing research with LYMPHIR for other possible indications. We have been focused on product development and have not generated any revenues to date. We have incurred losses in each period of our operations, and we expect to continue to incur losses for the foreseeable future. These losses are likely to continue to adversely affect our working capital, total assets, and stockholders’ equity. The process of developing product candidates requires significant clinical development, laboratory testing and clinical trials. In addition, commercialization of LYMPHIR and any future approved product candidates requires that we establish sales, marketing, and manufacturing capabilities, through internal hiring and contractual relationships with others. We expect to incur substantial losses for the foreseeable future as a result of anticipated the commercial launch of LYMPHIR, increases in our research and development costs, including costs associated with conducting preclinical testing and clinical trials for any other potential products, and regulatory compliance activities. We incurred net losses of $7,735,552 for the quarter ended March 31, 2025. At March 31, 2025, the Company had stockholders’ equity of $35,642,632 and an accumulated deficit of $53,673,344. The Company is currently funded by Citius Pharma. Citius Pharma funded the Company with net cash used for our operating activities in the amounts of $14,270,648 for the year ended September 30, 2024 and $4,352,858 for the six months ended March 31, 2025.

As of March 31, 2025, the Company has outstanding liabilities totaling $16.4 million to third-party suppliers and manufacturers, primarily related to the development and commercialization of LYMPHIR, and an aggregate of $28.4 million of due and outstanding amounts under our license agreements, that, if left unpaid, could result in a delay in the commercialization of LYMPHIR, breach of contract, loss of licensing rights or other events that would have a material adverse effect on our business and operations.

In addition, in connection with the closing of the Merger, Citius Pharma made a loan to the Company. The loan is evidenced by an unsecured promissory note issued by the Company, dated August 16, 2024, in the principal amount of $3,800,111 to Citius Pharma. The promissory note bears no interest and is repayable in full upon a financing of at least $10 million by the Company, per the terms of the promissory note.

Our ability to generate revenues and achieve profitability will depend on numerous factors, including success in:

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successfully commercializing LYMPHIR and any future product candidates that receive regulatory approval;

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obtaining medical insurance coverage for LYMPHIR and any future product candidates;

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manufacturing commercial quantities of LYMPHIR and any future product candidates at acceptable cost levels;

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establishing a favorable competitive position for LYMPHIR and any future product candidates;

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receiving regulatory approvals for any future product candidates; and

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developing and testing future product candidates.

Many of these factors will depend on circumstances beyond the Company’s control.

Our 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.

We continue to evaluate strategic paths to provide the resources necessary to commercialize LYMPHIR and maximize stockholder value. Potential strategic paths may include partnerships, joint ventures, mergers, acquisitions, or licensing transactions, a combination of these, or other strategic transactions. There can be no assurance, however, that our evaluation will result in transactions or other alternatives, even when deemed necessary. There is no set timetable for our strategic process and we do not intend to provide updates unless or until the Board of Directors approves a specific action or otherwise determines that disclosure is appropriate or necessary.

Any potential transaction would be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry trends, the interest of third parties in a potential transaction with us, obtaining stockholder approval and the availability of financing to third parties in a potential transaction with us on reasonable terms. The process of reviewing alternative strategic paths may be time consuming and may involve the dedication of significant resources and may require us to incur significant costs and expenses. It could negatively impact our ability to attract, retain and motivate employees, and expose us to potential litigation in connection with this process or any resulting transaction. If we are unable to effectively manage the process, our financial condition and results of operations could be adversely affected. In addition, speculation regarding any developments related to the review of strategic alternatives and perceived uncertainties related to the future of our Company could cause our stock price to fluctuate significantly. Further, any alternative strategic paths that may be pursued and completed ultimately may not deliver the anticipated benefits or enhance stockholder value. There can be no guarantee that the process of evaluating alternative strategic paths will result in our Company entering into or completing potential transactions within the anticipated timing or at all.

In the event we do not successfully complete a strategic transaction, should this be deemed necessary, our Board of Directors may decide to pursue a dissolution and liquidation of our Company. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

There can be no guarantee that the process to identify strategic transactions will result in successfully completed transactions when necessary. If additional transactions are not completed that enable us to continue the commercialization of LYMPHIR and sustain our business operations, our Board of Directors may decide that it is in the best interest of our stockholders to dissolve our Company and liquidate our assets. In that event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such decision and, ultimately, such liquidation since the amount of cash available for distribution continues to decrease as we fund our operations and evaluate our strategic alternatives. In addition, if our Board were to approve and recommend, and our stockholders were to approve, a dissolution of our Company, we would be required under Delaware corporate law to pay our outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders. As a result of this requirement, a portion of our assets may need to be reserved pending the resolution of such obligations. In addition, we may be subject to litigation or other claims related to a dissolution and liquidation of our Company. If a dissolution and liquidation were pursued, our Board, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of our Common Stock could lose all or a significant portion of their investment in the event of a dissolution, liquidation or winding up of our Company.

We 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.

We have one approved product. Any future product candidates, if any, resulting from our ongoing research with LYMPHIR for other possible indications are and would be in the pre-clinical stage. We have relied and intend to continue to rely on third parties to conduct the research and development activities for any future product candidates. Further, we are developing our sales and marketing capability for LYMPHIR at this time and have contracted with Innovation Partners, a large third-party commercial sales and marketing organization with an existing commercial infrastructure and product launch experience to assist in our commercial efforts, but our product commercialization capabilities are unproven. Our success will depend upon our ability to develop such capabilities on our own and our ability to enter into collaboration agreements on favorable terms and to select an appropriate commercialization strategy for each product candidate that we choose to pursue and that receives approval, whether on our own or in collaboration. For LYMPHIR, we are preparing for the commercial manufacture and launch, but if we are not successful in implementing our strategy to commercialize LYMPHIR, we may never achieve, maintain, or increase profitability. Our ability to successfully commercialize any of our current or future product candidates will depend, among other things, on our ability to:

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successfully launch LYMPHIR;

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secure acceptance from physicians, health care payers, patients, and the medical community of LYMPHIR and any future product candidate;

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successfully complete pre-clinical and clinical trials for any future product candidates;

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receive marketing approvals from the FDA and similar foreign regulatory authorities for any future product candidates;

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maintain and establish commercial manufacturing arrangements with third-party manufacturers for LYMPHIR and any future product candidate;

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produce, through a validated process, sufficiently large quantities of the drug compound(s) to permit successful commercialization of LYMPHIR and any future product candidate;

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build and maintain strong sales, distribution, and marketing capabilities sufficient to launch commercial sales or establish collaborations with third parties for such commercialization of LYMPHIR and any future product candidate; and

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manage our spending as costs and expenses increase due to clinical trials, regulatory applications and development and commercialization activities.

There are no guarantees that we will be successful in completing these tasks. If we are unable to successfully complete these tasks, we may not be able to commercialize any of our current or future product candidates in a timely manner, or at all, in which case we may be unable to generate sufficient revenues to sustain and grow our business. If we experience unanticipated delays or problems, our development costs could substantially increase and our business, financial condition and results of operations will be adversely affected.

We have a limited operating history upon which to evaluate our ability to successfully commercialize LYMPHIR and any future product candidate.

We have one approved product candidate, LYMPHIR, while future product candidates, if any, resulting from our ongoing research with LYMPHIR for other possible indications, are and would be in the pre-clinical stage. As a result, our success is dependent upon our ability to commercialize LYMPHIR, and we, as a company, have not demonstrated an ability to perform the functions necessary for the approval or successful commercialization of any current or future product candidates. While various members of our executive management and key employees have significant prior experience in pharmaceutical development, as a company we have to date successfully completed only one late-stage clinical trial (much of which had been undertaken by Eisai prior to our in-licensing of the intellectual property for LYMPHIR) and we are undertaking commercialization activities for the first time for LYMPHIR. Despite our progress with LYMPHIR, our operations have been limited primarily to business planning, research and development, and raising capital. These operations provide a limited basis for you to assess our ability to successfully commercialize our current or future product candidates and the advisability of investing in the securities.

A 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.

Our commercial success will depend in part on the maintenance of our current and any future license agreements. Our license agreements impose, and we expect that future license agreements will impose on us, various diligence, milestone payment, royalty and other obligations. For example, under the license agreement and related purchase agreement for the intellectual property for LYMPHIR, we are required to use commercially reasonable diligence to develop and commercialize a product and to satisfy specified payment obligations for various developmental and regulatory milestones. Specifically, upon the approval of LYMPHIR, we became subject to the payment of an aggregate of $27.5 million under the license agreements covering LYMPHIR. Pending further discussions with Dr. Reddy’s, Dr. Reddy’s agreed to a partial deferral without penalty of a milestone payment by us, which was triggered upon regulatory approval of LYMPHIR by the FDA and due on September 9, 2024, pursuant to the terms of the Asset Purchase Agreement.

Additionally, on March 28, 2025, the Company and Eisai entered into a letter agreement that amended License Agreement to provide for a payment schedule to Eisai. The Company has agreed to pay Eisai on or before July 15, 2025, an aggregate amount of $2,535,318 and thereafter on the 15th of each of the next four months to pay Eisai $2,350,000 and make a final payment of $2,197,892 to Eisai on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of actual payment under the letter agreement at the rate of 2% per annum.

If we fail to comply with our obligations under the current license agreements or any future license agreements with any party, or we are subject to a bankruptcy, the licensor may have the right to terminate the license, in which event we would not be able to market products covered by the license. Each of our license agreements provides the licensor with a right to terminate the license agreement for our material breach or default under the agreement, including the failure to make any required milestone or other payments. Should the licensor under any of the license agreements exercise such a termination right, we would lose our right to the intellectual property under the respective license agreement, which loss would materially harm our business.

We do not have and do not intend to establish our own manufacturing facilities. Consequently, we lack the physical plant to formulate and manufacture our product candidates, which have to be produced by third-party manufacturers. If we fail to raise additional capital, and as a result are unable to abide by our contractual obligations with these third-party manufacturers and suppliers, including making timely payment, the necessary third-party support to commercialize LYMPHIR could be delayed or terminated.

We have secured supply agreements for LYMPHIR with the two third-party facilities who are in compliance with current good manufacturing practices (“cGMP”) as generally accepted by the FDA. We rely on these third-party contractors for our manufacturing. Manufacturing of drugs for clinical and commercial purposes must comply with the FDA’s cGMP and applicable non-U.S. regulatory requirements and before any of our collaborators can begin to commercially manufacture our product candidates, each must obtain regulatory approval of the manufacturing facility and process. If, for any reason, we become unable to rely on these sources or any future source or sources to manufacture LYMPHIR or any future product candidates, either for pre-clinical or clinical trials or for commercial quantities, then we would need to identify and contract with additional or replacement third-party manufacturers to manufacture compounds for preclinical, clinical, and commercial purposes. We might not be successful in identifying additional or replacement third-party manufacturers, or in negotiating acceptable terms with any that we might identify. If we are unable to secure and maintain third-party manufacturing capacity, the development and sales of LYMPHIR, and any future product candidates, and our financial performance might be materially and adversely affected.

Additionally, if any of our collaborators fails to comply with the cGMP requirements, we would be subject to possible regulatory action which could limit the jurisdictions in which we are permitted to sell LYMPHIR, or any future product candidate. As a result, our business, financial condition, and results of operations might be materially harmed.

Our reliance on a limited number of third-party manufacturers exposes us to the following risks:

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We might be unable to identify manufacturers for commercial supply on acceptable terms or at all because the number of potential manufacturers is limited and the FDA must approve any replacement contractor. This approval would generally require compliance inspections. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, the production of LYMPHIR and any future product candidate approved by the FDA;

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Our third-party manufacturers might be unable to formulate and manufacture LYMPHIR and any future product candidate in the volume and of the quality required to meet our clinical and commercial needs;

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Our contract manufacturers might not perform as agreed or might not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute LYMPHIR, and any future product candidate approved by the FDA, for commercialization;

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Currently, one of the contract manufacturers for LYMPHIR is foreign (located in Italy), which increases the risk of shipping delays, adds the risk of import restrictions, and adds the risk of political and environmental uncertainties that might affect those countries;

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Drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with cGMP and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards;

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If any third-party manufacturer makes improvements in the manufacturing process for our product candidates, we might not own, or might have to share, the intellectual property rights to the innovation with our licensors;

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Operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including a bankruptcy of the manufacturer or supplier or a natural disaster or a pandemic such as COVID-19; and

SEC Form S-1 filed by Citius Oncology Inc.