CTOR

Risk Factors This report contains forward-looking statements that involve risks and uncertainties.
Our actual results could differ materially from those discussed in this report.
Factors that could cause or contribute to these differences include, but are not limited to, those discussed below and elsewhere in this report.
If any of the following risks, or other risks not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected.
If that happens, the market price of our securities could decline, and stockholders may lose all or part of their investment.
Risks Related to Our Financial Position and Need for Additional Capital 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 .
At September 30, 2025, we estimated that we have sufficient capital to continue our operations through March 2026, after taking into account the $6.0 million raised by Citius Pharma in October 2025 and the $18.0 million raised by us in December 2025.
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.
The Company has generated no operating revenue to date and has principally raised capital through the issuance of equity instruments and funding through Citius Pharma to finance its operations.
However, the Company’s continued operations beyond March 2026 including, its continued commercialization of LYMPHIR, will depend on its ability to successfully launch LYMPHIR and generate substantial revenue from the sale of LYMPHIR and on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, or strategic relationships.
However, the Company can provide no assurances on the commercialization or future sales of LYMPHIR, or that financing or strategic relationships will be available on acceptable terms, or at all.
If the Company is unable to raise sufficient capital, find strategic partners or generate substantial revenue from the sale of LYMPHIR, there would be a material adverse effect on its business.
Further, the Company expects in the future to incur additional expenses as it continues to develop any future product candidates, including seeking regulatory approval, and protecting its intellectual property.
As of September 30, 2025, and without giving effect to subsequent capital raises in October and December 2025, our cash and cash equivalents were approximately $3.9 million, and we had an accumulated deficit of approximately $64 million.
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: ● the costs and expenses associated with our ongoing commercialization efforts for LYMPHIR, including the continuing costs of maintaining or contracting for sales, marketing, and distribution capabilities for LYMPHIR; ● the degree of success we experience in commercializing LYMPHIR; ● the revenue generated by sales of LYMPHIR and other future product candidates that may be approved, if any; ● the extent to which LYMPHIR or any of our other potential product candidates, if approved for commercialization, is adopted by the physician community; ● the effect of competing products and product candidates and other market developments; ● 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; ● the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates; ● 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 the promissory note issued to Citius Pharma in August 2024; ● the costs of manufacturing LYMPHIR and any other potential product candidates we develop; ● the timing and amount of any milestone, royalty or other payments we are required to make pursuant to any current or future license agreements; ● the number and types of future product candidates we might develop and commercialize; ● any product liability or other lawsuits related to our products; ● the expenses needed to attract, hire and retain skilled personnel; ● the costs associated with being a public company; ● its need to implement additional internal systems and infrastructure, including financial and reporting systems; ● costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and ● the extent and scope of our general and administrative expenses.
We expect to incur substantial losses for the foreseeable future as a result of the ongoing 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 a net loss of $24.7 million for the year ended September 30, 2025.
At September 30, 2025, the Company had stockholders’ equity of $44.9 million and an accumulated deficit of $64 million.
The Company has received significant funding from Citius Pharma.
Citius Pharma funded the Company with net cash used for our operating activities of approximately $8.9 million for the year ended September 30, 2025.
As of September 30, 2025, we have outstanding commitments totaling $38.4 million due to third-party suppliers and manufacturers, primarily related to the development and commercialization of LYMPHIR, and an aggregate of $22.7 million due under our license agreements, that, if left unpaid, could result in an interruption 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, as amended September 10, 2025, in the principal amount of $3,800,111 to Citius Pharma.
The promissory note bears no interest and is repayable in full upon the date at which the Company has closed a series of capital raises that in the aggregate provide gross proceeds of at least $30 million through the issuance of debt or equity securities or the royalty-backed monetization of LYMPHIR™.
Through December 10, 2025, the Company has raised $18 million in capital raises and the likelihood of raising an additional $12 million to trigger the repayment obligation is uncertain at this time.
Our ability to generate revenues and achieve profitability will depend on numerous factors, including success in: ● commercializing LYMPHIR and any future product candidates that receive regulatory approval; ● obtaining medical insurance coverage for LYMPHIR and any future product candidates; ● manufacturing commercial quantities of LYMPHIR and any future product candidates at acceptable cost levels; ● establishing a favorable competitive position for LYMPHIR and any future product candidates; ● receiving regulatory approvals for any future product candidates; and ● developing and testing future product candidates.
We continue to evaluate strategic paths to provide the resources necessary to successfully commercialize LYMPHIR and maximize stockholder value.
There is no set timetable for our strategic process, and we do not intend to provide updates unless or until the Board approves a specific action or otherwise determines that disclosure is appropriate or necessary.
In the event we do not successfully complete a strategic transaction, should this be deemed necessary, our Board may decide to pursue a dissolution and liquidation of our Company.
If additional transactions are not completed that enable us to successfully commercialize LYMPHIR and sustain our business operations, our Board may decide that it is in the best interest of our stockholders to dissolve our Company and liquidate our assets.
Risks Related to Our Business and Our Industry We have one approved product and have an unproven business strategy and may never achieve successful commercialization of LYMPHIR or any future product candidates or achieve or maintain profitability.
We have invested a significant portion of our efforts and financial resources to bring LYMPHIR to market.
Further, while we believe we have sufficient funds on hand for the successful commercialization of LYMPHIR, which began with its launch in December 2025, various factors could increase the cost to successfully commercialize LYMPHIR, which we expect would require us to obtain additional capital to complete those efforts.
Financing might not be available on acceptable terms or at all.
If we do not receive new marketing approvals in other jurisdictions for LYMPHIR, our ability to generate additional revenue will be jeopardized and, consequently, our business will be materially harmed.
Additionally, our ability to make LYMPHIR available within the U.S. is largely dependent upon the maintenance of our marketing approval.
The success of LYMPHIR will depend on a number of additional factors, including the following: ● our ability to negotiate, secure and maintain adequate pricing, coverage and reimbursement terms on a timely basis, or at all; ● the timing, scope and outcome of our commercial launch in the U.S. and in other potential jurisdictions; ● the maintenance and expansion of a commercial infrastructure capable of supporting product sales, marketing and distribution; ● the implementation and maintenance of marketing and distribution relationships with third parties; ● our ability to establish and maintain commercial manufacturing arrangements with third-party manufacturers; ● our ability or the ability of our third-party manufacturers to successfully produce commercial and clinical supply of LYMPHIR on a timely basis sufficient to meet the needs of our commercial and clinical activities; ● successful identification of eligible patients; ● acceptance of LYMPHIR as a treatment for the approved indication by patients, the medical community and third-party payors; ● effectively competing with other therapies; ● global trade policies; ● a continued acceptable safety profile of LYMPHIR; ● the costs, timing and outcome of post-marketing studies and trials required for LYMPHIR; ● protecting our rights in our intellectual property portfolio, obtaining and maintaining regulatory exclusivity; and ● our ability to successfully prepare and advance regulatory submissions for marketing approval for LYMPHIR in additional territories and for additional or expanded indications and whether and in what timeframe we may obtain such approval.
If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to continue to commercialize our products, either of which would have a material adverse effect on our business, results of operations and financial condition.
As a result, our success is dependent upon our ability to commercialize LYMPHIR, which was launched in December 2025, 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.
We 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 related to LYMPHIR.

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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 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 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 first 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: ● acceptance by physicians, major operators of clinics and patients of LYMPHIR as a safe and effective treatment for CTCL; ● the availability, cost and potential advantages of existing and any future alternative treatments; ● the effectiveness of our sales and marketing efforts; ● the availability of coverage, adequacy of reimbursement and favorability of pricing policies by third-party payors and government authorities; ● the prevalence and severity of adverse side effects; and ● 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.
As of September 30, 2024, our cash and cash equivalents were approximately $0 and we had an accumulated deficit of $39,278,587.
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: ● 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; ● the degree of success we experience in commercializing LYMPHIR; ● the revenue generated by sales of LYMPHIR and other future product candidates that may be approved, if any; ● the extent to which LYMPHIR or any of our other potential product candidates, if approved for commercialization, is adopted by the physician community; ● the effect of competing products and product candidates and other market developments; ● 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; ● the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates; ● the costs of manufacturing LYMPHIR and any other potential product candidates we develop; ● the timing and amount of any milestone, royalty or other payments we are required to make pursuant to any current or future license agreements; ● the number and types of future product candidates we might develop and commercialize; ● any product liability or other lawsuits related to our products; ● the expenses needed to attract, hire and retain skilled personnel; ● the costs associated with being a public company; ● its need to implement additional internal systems and infrastructure, including financial and reporting systems; ● costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and ● the extent and scope of our general and administrative expenses.
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 $ $21,148,747 for the year ended September 30, 2024.
At September 30, 2024, the Company had stockholders’ equity of $46,140,339 and an accumulated deficit of $39,278,587.
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.
As of September 30, 2024, have outstanding commitments totaling $25.7 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.
Our ability to generate revenues and achieve profitability will depend on numerous factors, including success in: ● successfully commercializing LYMPHIR and any future product candidates that receive regulatory approval; ● obtaining medical insurance coverage for LYMPHIR and any future product candidates; ● manufacturing commercial quantities of LYMPHIR and any future product candidates at acceptable cost levels; ● establishing a favorable competitive position for LYMPHIR and any future product candidates; ● receiving regulatory approvals for any future product candidates; and ● developing and testing future product candidates.
We continue to evaluate strategic paths to provide the resources necessary to commercialize LYMPHIR and maximize stockholder value.
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.
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.
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.
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 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: ● successfully launch LYMPHIR; ● secure acceptance from physicians, health care payers, patients, and the medical community of LYMPHIR and any future product candidate; ● successfully complete pre-clinical and clinical trials for any future product candidates; ● receive marketing approvals from the FDA and similar foreign regulatory authorities for any future product candidates; ● maintain and establish commercial manufacturing arrangements with third-party manufacturers for LYMPHIR and any future product candidate; ● produce, through a validated process, sufficiently large quantities of the drug compound(s) to permit successful commercialization of LYMPHIR and any future product candidate; ● 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 ● 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.

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