CTXR

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 us in October 2025 and the $18.0 million raised by Citius Oncology in December 2025.
However, the Company’s continued operations beyond March 2026 including its continued commercialization of LYMPHIR (through Citius Oncology) and its development plans for Mino-Lok, Halo-Lido and NoveCite, will depend on its ability to successfully launch LYMPHIR and/or obtain regulatory approval to market Mino-Lok and generate substantial revenue from the sale of LYMPHIR and/or Mino-Lok and on its 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.
However, the Company can provide no assurances on the commercialization, or future sales of LYMPHIR and/or the approval, commercialization, or future sales of Mino-Lok 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 and/or Mino-Lok (if approved), there would be a material adverse effect on its business.
We require substantial additional funding in the near future to support our operations, complete the commercialization of LYMPHIR, and continue the development of our other product candidates, which capital may not be available on acceptable terms, or at all.
Furthermore, following the Merger, Citius Oncology has additional costs associated with operating as a public company and requires additional capital to fund our other operating expenses and capital expenditures.
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 $4.3 million and we had an accumulated deficit of approximately $238.8 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 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; ● 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.
Our subsidiary, Citius Oncology, received approval for LYMPHIR in August 2024 and launched LYMPHIR in December 2025, but has not generated any revenues to date.
We expect Citius Oncology to begin generating revenues following the launch of LYMPHIR, which occurred in December 2025.
We incurred net losses of $39,740,269 and $39,425,839 for the years ended September 30, 2025 and 2024, respectively.
At September 30, 2025, we had stockholders’ equity of $77,527,600 and an accumulated deficit of $238,804,129.
Our net cash used in operating activities was $26,552,738 and $28,201,375 for the years ended September 30, 2025 and 2024, respectively.
As of September 30, 2025, we had outstanding liabilities of $38.4 million and outstanding commitments of $22.7 million to third parties for LYMPHIR licensing, supply and other costs, 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.
We and Citius Oncology continue to evaluate strategic paths to provide the resources necessary to successfully commercialize LYMPHIR, continue the development of our other product candidates, 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 or Citius Oncology 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 or Citius Oncology 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.
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 Nevada 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.
Risks Related to Our Business and our Industry If we are unable to execute our commercial strategy for LYMPHIR, fail to satisfy the conditions of our marketing approval for LYMPHIR, or if we experience significant delays in accomplishing such goals, our business will be materially harmed.
We have invested a significant portion of our efforts and financial resources to bring LYMPHIR to market.
Our ability to generate product revenues will depend heavily on the successful commercialization of LYMPHIR.
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.
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.
We expect to need to access the capital markets in the near future for additional capital for research and development and for operations.
We are primarily a commercial and late-stage development company with an unproven business strategy and may never achieve commercialization of all our therapeutic product candidates or profitability.
We, through Citius Oncology, have developed our sales and marketing capabilities for LYMPHIR 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 related to LYMPHIR.
Citius Oncology also has distribution agreements with three national companies and an agreement with EVERSANA to support the launch and commercialization of LYMPHIR.
Citius Pharma has no sales or marketing capabilities with respect to our other product candidates.
Our success will depend upon the sales and marketing infrastructure developed by Citius Oncology for LYMPHIR and also on Citius Pharma’s ability to develop such capabilities on its own or to enter into and maintain collaboration agreements on favorable terms and to select an appropriate commercialization strategy for each product candidate that it chooses to pursue and that receives approval, whether on its own or in collaboration.
Our ability to successfully commercialize any of our other product candidates will depend, among other things, on our ability to: ● successfully complete pre-clinical and clinical trials for our product candidates; ● receive marketing approvals from the FDA and similar foreign regulatory authorities for our product candidates; ● establish commercial manufacturing arrangements with third-party manufacturers for our product candidates; ● produce, through a validated process, sufficiently large quantities of our drug compound(s) to permit successful commercialization of our product candidates; ● build and maintain strong sales, distribution, and marketing capabilities sufficient to launch commercial sales of any approved products or establish collaborations with third parties for such commercialization; ● secure acceptance of any approved products from physicians, health care payers, patients, and the medical community; and ● manage our spending as costs and expenses increase due to clinical trials, regulatory applications and development and commercialization activities.
Citius Oncology has only recently launched its one product, LYMPHIR.
Citius Pharma has one late-stage stage product candidate, Mino-Lok, while our other product candidates are clinical stage.
As a result, our success is dependent upon Citius Oncology’s success in commercializing LYMPHIR and Citius Pharma’s ability to obtain regulatory approval for and commercialize our product candidates and we, as a company, have not demonstrated an ability to perform the functions necessary for the successful commercialization of any product candidates, given the recent launch of LYMPHIR.
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 of LYMPHIR) and have just launched LYMPHIR (through Citius Oncology).
Further, in December 2023, we terminated development of Mino-Wrap to devote resources to the development of LYMPHIR.

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Gone since FY2024

Risks Related to Our Business and our Industry We require substantial additional funding in the near future to support our operations, complete the commercialization of LYMPHIR, and continue the development of our other product candidates, which capital may not be available on acceptable terms, or at all.
Furthermore, following the Merger, Citius Oncology has additional costs associated with operating as a public company and require additional capital to fund our other operating expenses and capital expenditures.
As of September 30, 2024, our cash and cash equivalents were $3,251,880 and we had an accumulated deficit of $201,370,218.
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; ● 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.
Our subsidiary, Citius Oncology, received approval for LYMPHIR in August 2024 and has not generated any revenues to date.
We expect Citius Oncology to begin generating revenues following the launch of LYMPHIR in the first half of 2025.
We incurred net losses of $39,138,839 and $32,542,912 for the years ended September 30, 2024 and 2023, respectively.
At September 30, 2024, we had stockholders’ equity of $74,101,830 and an accumulated deficit of $201,370,218.
Our net cash used in operating activities was $28,201,375 and $29,060,212 for the years ended September 30, 2024 and 2023, respectively.
As of September 30, 2024, we had outstanding liabilities of $33.3 million and outstanding commitments of $21.8 million to third parties for LYMPHIR licensing, supply and other costs, 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.
We and Citius Oncology 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 or Citius Oncology 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 or Citius Oncology 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 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.
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, 2024, we estimated that we have sufficient capital to continue our operations through February 2025.
However, the Company’s continued operations beyond February 2025 including its commercialization of LYMPHIR (through Citius Oncology) and its development plans for Mino-Lok, Halo-Lido and NoveCite, will depend on its ability to successfully launch LYMPHIR and/or obtain regulatory approval to market Mino-Lok and generate substantial revenue from the sale of LYMPHIR and/or Mino-Lok and on its 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.
However, the Company can provide no assurances on the approval, commercialization, or future sales of LYMPHIR and/or Mino-Lok 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 and/or Mino-Lok, there would be a material adverse effect on its business.
Citius Oncology could be delayed in the launch of LYMPHIR.
While we believe we have sufficient funds on hand to commercially launch LYMPHIR, various factors could increase the cost to launch LYMPHIR, which we expect would require us to obtain additional capital to complete those efforts.
We will need to access the capital markets in the near future for additional capital for research and development and for operations.
We are primarily a late-stage development company with an unproven business strategy and may never achieve commercialization of our therapeutic product candidates or profitability.
We, through Citius Oncology, are developing our sales and marketing capabilities at this time for LYMPHIR 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 related to LYMPHIR.
We have no sales or marketing capabilities with respect to our other product candidates.
Our success will depend upon our ability to develop such capabilities on our own or to enter into and maintain 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.
Our ability to successfully commercialize any of our product candidates will depend, among other things, on our ability to: ● successfully complete pre-clinical and clinical trials for our product candidates; ● receive marketing approvals from the FDA and similar foreign regulatory authorities for our product candidates; ● establish commercial manufacturing arrangements with third-party manufacturers for our product candidates; ● produce, through a validated process, sufficiently large quantities of our drug compound(s) to permit successful commercialization of our product candidates; ● build and maintain strong sales, distribution, and marketing capabilities sufficient to launch commercial sales of any approved products or establish collaborations with third parties for such commercialization; ● secure acceptance of any approved products from physicians, health care payers, patients, and the medical community; and ● manage our spending as costs and expenses increase due to clinical trials, regulatory applications and development and commercialization activities.
Citius Oncology has one recently approved but not yet launched product, LYMPHIR, and Citius Pharma has one late-stage stage product candidate, Mino-Lok, while our other product candidates are clinical stage.
As a result, our success is dependent upon our ability to obtain regulatory approval for and commercialize our product candidates and we, as a company, have not demonstrated an ability to perform the functions necessary for the approval or successful commercialization of any 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 of LYMPHIR) and are just beginning to undertake commercialization activities, in each case for LYMPHIR (through Citius Oncology).
Further, in December 2023, we terminated development of Mino-Wrap to devote resources to the development of LYMPHIR, The resources expended on Suprenza and Mino-Wrap therefore did not provide us any benefit.
For example, while LYMPHIR received FDA approval in August 2024, we had incurred significant expenses in its development and planned commercialization; as of September 30, 2024, we had outstanding commitments of approximately $50.6 million to third parties for LYMPHIR licensing, supply and other costs.
While we anticipate that Citius Oncology will launch LYMPHIR in the first half of 2025, that timeline is subject to change for various reasons.
Moreover, we cannot predict whether or when we will obtain regulatory approval to commercialize our other product candidates that are under development, notably Mino-Lok.
Under the terms of the License Agreement with Eisai, Citius Oncology is 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.
Additionally, Citius Oncology is required to commercially launch a product in a territory within six months of receiving regulatory approval for such product in each such jurisdiction.
(the “Company”) is a guarantor of the obligations of Citius Oncology, Inc. under the Asset Purchase Agreement.
These development and milestone obligations impose substantial additional costs on us, and could divert resources from other aspects of the business, and adversely affect the overall profitability of LYMPHIR.
We, through Citius Oncology, need to obtain additional financing to satisfy these milestone payments, and cannot be sure that any additional funding, will be available on favorable terms, or at all.

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