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Item 1A. Risk Factors

2025-12-23 compared with 2024-12-27 · 651 added, 708 removed, 798 unchanged (63% of the section changed)

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

● 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;

● 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.

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

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

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.

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.

We require substantial additional funding

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strategic transactions.

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

● the degree of success we experience in commercializing

● 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;

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;

● the extent and scope of our general and administrative

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,

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.

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;

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 have a history of net losses and expect

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requires that we establish sales, marketing, and manufacturing capabilities, through internal hiring and contractual relationships with

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

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.

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.

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:

● 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;

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;

developing and testing future product candidates.

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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.

the resources necessary to successfully 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.

no assurance, however, that our evaluation will result in transactions or other alternatives, even when deemed necessary.

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.

Any potential transaction would be dependent on

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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

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.

a strategic transaction, should this be deemed necessary, our Board 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

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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.

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.

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.

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.

Risks Related to Our Business and Our Industry

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.

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:

● 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;

● 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.

unproven business strategy and may never achieve successful commercialization of LYMPHIR or any future product candidates or achieve or

maintain profitability.

We have one approved

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 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.

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;

● 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 have a limited operating history upon

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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.

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.

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.

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.

We have distribution agreements with three national companies and an agreement with EVERSANA to support the launch and commercialization

Our success will depend upon our third-party sales and marketing infrastructure.

If we are not successful in implementing

our strategy to commercialize our product candidates, we may never achieve, maintain, or increase profitability.

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.

We are and may be required to make milestone

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Under the terms of the License Agreement with

Eisai, we are required to pay Eisai a $5.9 million development milestone payment upon initial

Eisai, we were 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

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approval for such product in each such jurisdiction;

the launch of LYMPHIR in December 2025 satisfied this requirement in the U.S.

Pending further discussions with Dr.

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cannot be sure that any additional funding will be available on terms favorable to us, or at all.

On March 28, 2025, Citius Oncology 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.

We 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 $2.35 million 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.

During the year ended September 30, 2025, we recorded $218,032 in interest expense under the agreement.

parties released each other from any and all claims, losses, damages, costs and expenses that arise from or related to our failure 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.

During the year ended September 30, 2025 we

paid $3 million of the development milestone and the balance of $2.9 million is included in license fee payable at September 30, 2025.

On July 21, 2025, we made a payment to Eisai of $1,616,522 for other invoices and accumulated interest associated with the letter agreement.

A material breach or default under any of

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Specifically,

upon the approval of LYMPHIR, we became subject to the payment of an aggregate of $27.5 million under the license agreements covering

upon the approval of LYMPHIR, we became subject to payments of an aggregate of $33.4 million under the license and asset purchase agreements

covering LYMPHIR through Eisai and Dr.

Reddy’s separately.

Pending further discussions with 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.

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.

On March 28, 2025, Citius Oncology 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.

We agreed to pay Eisai on or before July 15, 2025, an aggregate amount of $2,535,318 and thereafter on the 15 th of

each of the next four months to pay Eisai $2.35 million 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.

During the year ended September 30, 2025, we recorded $218,032 in interest expense under the agreement.

parties released each other from any and all claims, losses, damages, costs and expenses that arise from or related to our failure 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.

During the year ended September 30, 2025 we

paid $3 million of the development milestone and the balance of $2.9 million is included in license fee payable at September 30, 2025.

On July 21, 2025, we made a payment to Eisai of $1,616,522 for other invoices and accumulated interest associated with the letter agreement.

If we fail to comply with our obligations under

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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.

with two third-party facilities who are in compliance with current good manufacturing practices (“cGMP”) as generally accepted

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.

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.

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.

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 commercialization 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

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manufacturers exposes us to the following risks:

● 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.

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

● 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;

● 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;

● 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;

● 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

● 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;

● 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;

● We might compete with other companies for access

to these manufacturers’ facilities and might be subject to manufacturing delays if the manufacturers give other clients higher priority.

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;

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;

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;

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;

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;

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;

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;

We might compete with other companies for access to these manufacturers’ facilities and might be subject to manufacturing delays if the manufacturers give other clients higher priority.

Each of these risks could delay our clinical trials

or the approval, if any, of our future product candidates by the FDA or any foreign regulatory agency or the commercialization of LYMPHIR

and could result in higher costs or deprive us of potential product revenues.

As a result, our business, financial condition, and results

of operations might be materially harmed.

We face significant risks in our development

efforts of LYMPHIR and any future product candidate.

Our business depends on the successful

development and commercialization of LYMPHIR.

or the approval, if any, of our future product candidates by the FDA or any foreign regulatory agency or the successful commercialization

of LYMPHIR and could result in higher costs or deprive us of potential product revenues.

As a result, our business, financial condition,

and results of operations might be materially harmed.

We face significant risks in our commercialization

efforts of LYMPHIR and development of any future product candidate.

Our business depends on the successful commercialization

We are not permitted to market any product candidate in the U.S.

until we receive

approval from the FDA, or in any foreign jurisdiction until we receive the requisite approvals from such jurisdiction.

approval from the FDA for LYMPHIR in August 2024.

The process of developing new drugs and/or therapeutic products is inherently

complex, unpredictable, time-consuming, expensive and uncertain.

We must make long-term investments and commit significant resources

before knowing whether our development programs will result in products that will receive regulatory approval and achieve market

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 obligations of approximately $54.1 million to third

parties for LYMPHIR licensing, supply and other costs.

Product candidates that appear to be promising at some or all stages of

development may not receive approval or reach the market for a number of reasons that may not be predictable based on results and

data of the clinical program.

Product candidates may be found ineffective or may cause harmful side effects during clinical trials,

may take longer to progress through clinical trials than had been anticipated, may not be able to achieve the pre-defined clinical

endpoints due to statistical anomalies even though clinical benefit may have been achieved, may fail to receive necessary regulatory

approvals, may prove impracticable to manufacture in commercial quantities at reasonable cost and with acceptable quality, or may

fail to achieve market acceptance.

until we receive approval from the FDA, or in any foreign

jurisdiction until we receive the requisite approvals from such jurisdiction.

We received approval from the FDA for LYMPHIR in August

The process of developing new drugs and/or therapeutic products is inherently complex, unpredictable, time-consuming, expensive

and uncertain.

We must make long-term investments and commit significant resources before knowing whether our development programs will

result in products that will receive regulatory approval and achieve market acceptance.

As an example, in response to the submission of

our BLA for LYMPHIR, the FDA issued a CRL on July 28, 2023.

The FDA required us to incorporate enhanced product testing and additional

controls agreed to with the FDA during the market application review.

There were no concerns relating to the safety and efficacy clinical

data package submitted with the BLA, or the proposed prescribing information.

In September 2023, we announced that the FDA had agreed

with our plans to address the requirements outlined in the CRL, which guidance provided us with a path for completing the necessary activities

to support the resubmission of the BLA for LYMPHIR and we received approval from the FDA in August 2024.

Product candidates that appear to be promising

at some or all stages of development may not receive approval or reach the market for a number of reasons that may not be predictable

based on results and data of the clinical program.

Product candidates may be found ineffective or may cause harmful side effects during

clinical trials, may take longer to progress through clinical trials than had been anticipated, may not be able to achieve the pre-defined

clinical endpoints due to statistical anomalies even though clinical benefit may have been achieved, may fail to receive necessary regulatory

approvals, may prove impracticable to manufacture in commercial quantities at reasonable cost and with acceptable quality, or may fail

to achieve market acceptance.

In addition, we expect that it will take time

for LYMPHIR to be accepted in the market, generate revenues and a return on investment.

For example, while LYMPHIR received FDA approval

in August 2024, we had incurred significant expenses in its development and planned commercialization prior to its launch in December

as of September 30, 2025, we had outstanding commitments of approximately $38.4 million to third parties for LYMPHIR licensing,

supply and other costs.

We cannot, therefore, predict the timing of any future revenues from LYMPHIR or any other product candidate.

The FDA has substantial discretion in the drug

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example, the FDA:

● may not find the data from clinical trials sufficient

to support the submission of a Biologics License Application (“BLA”) for our future product candidates or to obtain marketing

approval in the U.S., including any findings that the clinical and other benefits of our future product candidates outweigh their safety

As an example, in July 2023, the FDA issued a CRL to our BLA for LYMPHIR, which required us to incorporate enhanced product testing

and additional controls and which caused a delay of six months before we could resubmit the BLA;

● could determine that the information provided

by us is inadequate, contained clinical deficiencies or otherwise failed to demonstrate the safety and effectiveness of any of our future

product candidates for any indication;

● may disagree with the trial design or our interpretation

of data from preclinical studies or clinical trials, or may change the requirements for approval even after the FDA has reviewed and commented

on the design for the trials;

● may identify deficiencies in the manufacturing

processes or facilities of third-party manufacturers with which we enter into agreements for the manufacture of our future product candidates;

● may approve our future product candidates for

fewer or more limited indications than we request, or may grant approval contingent on the performance of costly post-approval clinical

● may change the FDA approval policies or adopt

new regulations that could adversely impact our future product candidate development programs;

● may not approve the labeling claims that we believe

are necessary or desirable for the successful commercialization of our future product candidates, or may require labeling claims that

impair the potential market acceptance of our future product candidates.

may not find the data from clinical trials sufficient to support the submission of a BLA for our future product candidates or to obtain marketing approval in the U.S., including any findings that the clinical and other benefits of our future product candidates outweigh their safety risks;

could determine that the information provided by us is inadequate, contained clinical deficiencies or otherwise failed to demonstrate the safety and effectiveness of any of our future product candidates for any indication;

may disagree with the trial design or our interpretation of data from preclinical studies or clinical trials, or may change the requirements for approval even after the FDA has reviewed and commented on the design for the trials;

may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for the manufacture of our future product candidates;

may approve our future product candidates for fewer or more limited indications than we request, or may grant approval contingent on the performance of costly post-approval clinical trials;

may change the FDA approval policies or adopt new regulations that could adversely impact our future product candidate development programs;

may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our future product candidates, or may require labeling claims that impair the potential market acceptance of our future product candidates.

These same risks are generally applicable to the

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to generate revenues from any approved product candidate or acquired approved product will depend on a number of factors, including:

● prevalence and severity of any side effects;

● perceptions by members of the health care community,

including physicians, about the safety and effectiveness of LYMPHIR;

● perceptions by members of the health care community,

including physicians, about the use of LYMPHIR versus the respective standards of care or other alternatives for the disease or problem

that we seek to address with LYMPHIR;

strength of sales, marketing and distribution support;

perceptions by members of the health care community, including physicians, about the safety and effectiveness of LYMPHIR;

perceptions by members of the health care community, including physicians, about the use of LYMPHIR versus the respective standards of care or other alternatives for the disease or problem that we seek to address with LYMPHIR;

results of any post-approval studies of the product;

● availability of coverage and reimbursement from

government and other third-party payers;

● the willingness of patients to pay out of pocket

in the absence of government or third-party coverage;

● the relative convenience and ease of administration

and dosing schedule;

● product labeling or product insert requirements

of the FDA or other regulatory authorities;

effective sales, marketing and distribution efforts by us and/or any future licensees and distributors, if any;

● price of any future products, if approved, both

in absolute terms and relative to alternative treatments;

● the effectiveness of our or any future collaborators’

sales and marketing strategies;

● patient access programs that require patients

to provide certain information prior to receiving new and refill prescriptions;

● requirements for prescribing physicians to complete

certain educational programs for prescribing drugs.

availability of coverage and reimbursement from government and other third-party payers;

the willingness of patients to pay out of pocket in the absence of government or third-party coverage;

the relative convenience and ease of administration and dosing schedule;

product labeling or product insert requirements of the FDA or other regulatory authorities;

prevalence and severity of any side effects;

price of any future products, if approved, both in absolute terms and relative to alternative treatments;

the effectiveness of our or any future collaborators’ sales and marketing strategies;

patient access programs that require patients to provide certain information prior to receiving new and refill prescriptions;

requirements for prescribing physicians to complete certain educational programs for prescribing drugs.

We expect sales of LYMPHIR to generate substantially

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LYMPHIR or any future product candidate if we fail to establish marketing, sales, and distribution capabilities.

Our strategy with our product candidates is to

outsource to third parties all or most aspects of the product development process, as well as much of our marketing, sales, and distribution

Currently, we are in the process of developing our sales, marketing and distribution capabilities 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 for LYMPHIR.

The development of a sales and distribution infrastructure requires

substantial resources, which may divert the attention of management and key personnel and defer the company’s product development

Contracting with third-party commercial sales and marketing organizations means that our revenues will depend on the efforts

Our strategy with LYMPHIR is to outsource to third

parties all or most aspects of the product development process, as well as much of our marketing, sales, and distribution activities.

We have developed our sales, marketing and distribution capabilities 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 for LYMPHIR.

In addition, we have entered into distribution agreements with Cardinal Health, Cencora and McKesson Corporation

and have contracted with EVERSANA to support the launch and commercialization of LYMPHIR.

The development and maintenance of a sales and

distribution infrastructure requires substantial resources, which may divert the attention of management and key personnel and defer our

product development efforts.

Contracting with third-party commercial sales and marketing organizations means that our revenues will depend

on the efforts of others.

These efforts may not be successful.

If the collaboration is terminated or is otherwise unsuccessful, we will experience delays

in product launch and sales and incur increased costs.

If the collaboration is terminated or is otherwise unsuccessful, we will

experience delays in product launch and sales and incur increased costs.

Our projections regarding the market opportunity for our LYMPHIR

may not be accurate, and the actual market for LYMPHIR may be smaller than we estimate.

Our projections of incidence rate of MF/SS and the people living with

CTCL and who have the potential to benefit from treatment with LYMPHIR are based on our beliefs and estimates.

These estimates have been

derived from a variety of sources, including SEER data from 2001 to 2007, and may prove to be incorrect.

The number of patients may turn

out to be lower than expected.

Additionally, the potentially addressable patient population for LYMPHIR may be limited or may not be amenable

to treatment with LYMPHIR and may also be limited by the cost of our treatments for patients, any future increase to such costs, and the

reimbursement of those treatment costs by third-party payors.

Even if we obtain significant market share for LYMPHIR, because the potential

target populations are small, we may never achieve profitability.

Our ability to generate product revenues

will be diminished if LYMPHIR, or any of our future product candidates that may be approved, sells for inadequate prices or patients are

unable to obtain adequate levels of reimbursement.

Our ability to commercialize our approved product

candidates, namely LYMPHIR, alone or with collaborators, will depend in part on the extent to which reimbursement will be available from:

government and health administration authorities;

private health maintenance organizations (HMOs) and health insurers;

other healthcare payers.

Significant uncertainty exists as to the reimbursement

status of newly approved healthcare products.

Healthcare payers, including Medicare, are challenging the prices charged for medical products

and services.

Government and other healthcare payers increasingly attempt to contain healthcare costs by limiting both coverage and the

level of reimbursement for drugs.

Even if our product candidates are approved by the FDA, insurance coverage might not be available, and

reimbursement levels might be inadequate, to cover our products.

If government and other healthcare payers do not provide adequate coverage

and reimbursement levels for LYMPHIR, or any of our future product candidates that may be approved, market acceptance of such products

could be reduced.

We cannot predict whether federal or state legislation will be passed that may impact reimbursement policies nor what

the impact of any such legislation would be on the healthcare industry in general or on our business specifically.

We are actively engaged with CMS in order to obtain

the necessary coverage to facilitate reimbursement for LYMPHIR.

However, we can offer no assurance as to any reimbursement coverage.

February, CMS assigned LYMPHIR a unique, permanent Healthcare Common Procedure Coding System J-code, which is expected to provide coding

clarity for physicians and facilities who administer LYMPHIR, thereby facilitating reimbursement.

This achievement is a key step in ensuring

that LYMPHIR is accessible to patients with commercial and government insurance (VA, DoD, Medicare) coverage.

Health administration authorities in countries

other than the U.S.

may not provide reimbursement for our products at rates sufficient for us to achieve profitability, or at all.

the U.S., these countries have considered health care reform proposals and could materially alter their government-sponsored health care

programs by reducing reimbursement rates.

Any reduction in reimbursement rates under Medicare or foreign health care programs could negatively

affect the pricing of our approved product candidates.

If we are not able to charge a sufficient amount for an approved product candidate,

then our margins and our profitability will be adversely affected.

The FDA and other regulatory agencies actively

enforce the laws and regulations prohibiting the promotion of off-label uses.

If we are found to have improperly promoted off-label

uses of LYMPHIR or any other product candidates, if approved, or if we are found to have improperly engaged in pre-approval promotion

If we are found to have improperly promoted any

off-label use of LYMPHIR or for any product candidates, if approved, or if we are found to have improperly engaged in pre-approval promotion

prior to the approval of such product candidates, we may become subject to significant liability.

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The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about

prescription products, such as LYMPHIR and any other product candidates that might be approved.

prescription products, such as LYMPHIR and any product candidates that might be approved.

In particular, a product may not be promoted

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If we cannot successfully manage the promotion of LYMPHIR or any

other product candidates that receive approval, we could become subject to significant liability, which would materially adversely affect

our business, financial condition and results of operations.

product candidates that receive approval, we could become subject to significant liability, which would materially adversely affect our

business, financial condition and results of operations.

The markets in which we operate are highly

competitive and we might be unable to compete successfully against new entrants or established companies.

Competition in the pharmaceutical and

medical products industries is intense and is characterized by costly sales and marketing infrastructures as well as extensive

research efforts and rapid technological progress.

We are aware of several pharmaceutical companies who commercially market products

for the same condition or conditions we are targeting for LYMPHIR.

There may also be companies who are actively engaged in the

development of therapies or products for at least some of these same conditions.

Many of these companies have substantially greater

research and development capabilities as well as substantially greater marketing, financial and human resources than we do.

addition, many of these companies have significantly greater experience than us in undertaking pre-clinical testing, clinical trials

and other regulatory approval procedures.

Our competitors may develop technologies and products that are more effective than those

we are researching and developing.

Such developments could render our product candidates, if approved, less competitive or possibly

We are also competing with respect to marketing capabilities and manufacturing efficiency, areas in which we have no

current capabilities and in which we have no experience as a company, although our executive officers do have pharmaceutical

commercialization and launch experience.

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

with LYMPHIR.

However, this experience might not translate into the successful development and launch of LYMPHIR, or any of our

Competition in the pharmaceutical and medical

products industries is intense and is characterized by costly sales and marketing infrastructures, as well as extensive research efforts

and rapid technological progress.

We are aware of several pharmaceutical companies who commercially market products for the same condition

or conditions we are targeting for LYMPHIR.

There may also be companies who are actively engaged in the development of therapies or products

for at least some of these same conditions.

Many of these companies have substantially greater research and development capabilities as

well as substantially greater marketing, financial and human resources than we do.

In addition, many of these companies have significantly

greater experience than us in undertaking pre-clinical testing, clinical trials and other regulatory approval procedures.

Our competitors

may develop technologies and products that are more effective than those we are researching and developing.

Such developments could render

our product candidates, if approved, less competitive or possibly obsolete.

We are also competing with respect to marketing capabilities

and manufacturing efficiency, areas in which we have no current capabilities and in which we have no experience as a company, although

our executive officers do have pharmaceutical commercialization and launch experience.

We have contracted with Innovation Partners, a

large third-party commercial sales and marketing organization with an existing commercial infrastructure and product launch experience,

and with EVERSANA, a large third-party provider of global commercialization services, to assist in our commercial efforts for LYMPHIR.

However, our prior experience and our third-party arrangements might not translate into the successful launch of LYMPHIR, or any of our

future product candidates.

Mergers, acquisitions, joint ventures and similar events may also significantly increase the competition

In addition, new developments, including the development of other drug technologies and methods of preventing the incidence

of disease, occur in the pharmaceutical and medical technology industries at a rapid pace.

These developments may render LYMPHIR or

any of our product candidates obsolete or noncompetitive.

Compared to us, many of our potential competitors have substantially

greater capital resources as well as greater access to strategic partners.

Mergers, acquisitions, joint ventures and similar events may also significantly increase the competition we

In addition, new developments, including the development of other drug technologies and methods of preventing the incidence of disease,

occur in the pharmaceutical and medical technology industries at a rapid pace.

These developments may render LYMPHIR or any of our product

candidates obsolete or noncompetitive.

Compared to us, many of our potential competitors have substantially greater capital resources,

as well as greater access to strategic partners.

As a result of these factors, our competitors

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more effective, more useful and less costly than our products and might also be more successful in manufacturing and marketing their products.

In addition, our competitors might be more effective in commercializing their products and as a result, our business and prospects might

be materially harmed.

Our ability to generate product revenues

will be diminished if LYMPHIR, or any of our future product candidates that may be approved, sells for inadequate prices or patients are

unable to obtain adequate levels of reimbursement.

Our ability to commercialize our product candidates,

namely LYMPHIR, alone or with collaborators, will depend in part on the extent to which reimbursement will be available from:

● government and health administration authorities;

● private health maintenance or organizations and

health insurers;

● other healthcare payers.

Significant uncertainty exists as to the reimbursement

status of newly approved healthcare products.

Healthcare payers, including Medicare, are challenging the prices charged for medical products

and services.

Government and other healthcare payers increasingly attempt to contain healthcare costs by limiting both coverage and the

level of reimbursement for drugs.

Even if product candidates are approved by the FDA, insurance coverage might not be available, and reimbursement

levels might be inadequate, to cover the products.

If government and other healthcare payers do not provide adequate coverage and reimbursement

levels for LYMPHIR, or any of our future product candidates that may be approved, market acceptance of such products could be reduced.

We cannot predict whether federal or state legislation will be passed that may impact reimbursement policies nor what the impact of any

such legislation would be on the healthcare industry in general or on our business specifically.

We are actively engaged with the Center for Medicare

and Medicaid Services (“CMS”) in order to obtain the necessary coverage to facilitate reimbursement for LYMPHIR.

we can offer no assurance as any reimbursement coverage.

Health administration authorities in countries

other than the U.S.

may not provide reimbursement for our products at rates sufficient for us to achieve profitability, or at all.

the U.S., these countries have considered health care reform proposals and could materially alter their government-sponsored health care

programs by reducing reimbursement rates.

Any reduction in reimbursement rates under Medicare or foreign health care programs could negatively

affect the pricing of our approved product candidates.

If we are not able to charge a sufficient amount for an approved product candidate,

then our margins and our profitability will be adversely affected.

In addition, our competitors might be more effective than us in commercializing their products and as a result, our business and prospects

might be materially harmed.

Healthcare reform measures could hinder

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with our strategic partners could harm our business .

If we or any of our current or future

collaborators fail to renew or terminate any of the collaboration or license agreements or if either party fails to satisfy their

obligations under any of the collaboration or license agreements or complete them in a timely manner, we could have difficulty

completing the commercialization of LYMPHIR and the development and commercialization of any future product candidate and

potentially lose significant sources of revenue, which could result in an adverse impact on our operations and financial condition

as well as volatility in any future revenue.

In addition, the agreements with our collaborators may have provisions that give rise

to disputes regarding the rights and obligations of the parties.

These and other possible disagreements could lead to termination of

the agreement or delays in collaborative research, development, supply, or commercialization of LYMPHIR and any future product

candidate, or could require or result in litigation or arbitration.

Any such conflicts with the collaborators could reduce our

ability to obtain future collaboration agreements and could have a negative impact on our relationship with existing collaborators,

adversely affecting our business and revenues.

Finally, any of our collaborations may prove to be unsuccessful.

If we or any of our current or future collaborators

fail to renew or terminate any of our collaboration or license agreements or if either party fails to satisfy its obligations under any

of our collaboration or license agreements or complete them in a timely manner, we could have difficulty continuing marketing and sales

efforts for LYMPHIR and the development and commercialization of any future product candidate and potentially lose significant sources

of revenue, which could result in an adverse impact on our operations and financial condition as well as volatility in any future revenue.

In addition, the agreements with our collaborators may have provisions that give rise to disputes regarding the rights and obligations

of the parties.

These and other possible disagreements could lead to termination of the agreement or delays in collaborative research,

development, supply, or commercialization of LYMPHIR and any future product candidate, or could require or result in litigation or arbitration.

Any such conflicts with the collaborators could reduce our ability to obtain future collaboration agreements and could have a negative

impact on our relationship with existing collaborators, adversely affecting our business and revenues.

Finally, any of our collaborations

may prove to be unsuccessful.

Under the license agreement for the intellectual

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We rely on the significant experience and

specialized expertise of the executive management and other key personnel and the loss of any of the executive management or key personnel

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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The loss of the services of any of Mr.

Holubiak or, Dr.

Czuczman, as well as any other member of our executive

management or any key employees could harm our ability to attract capital, commercialize LYMPHIR and develop any future product candidates.

Holubiak, Mr.

Bartushak or Dr.

Czuczman, as well as any other member of

our executive management or any key employees could harm our ability to attract capital, commercialize LYMPHIR and develop any future

product candidates.

We do not have key man life insurance policies.

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Pursuant to the A&R Shared Services Agreement

entered into in connection with the closing of the Merger, we utilize the services of a Citius Pharma clinical management team on a part-time

basis to assist us in managing the clinical and pre-clinical trials and intend to do so for future pre-clinical and clinical trials.

to the A&R Shared Services Agreement, we also utilize the services of Citius Pharma employees with expertise in product manufacturing

and commercialization for the planned launch of LYMPHIR.

While we believe these arrangements provide us with sufficient staffing for our

current and future development efforts, we will need to hire or contract with additional qualified personnel with expertise in preclinical

testing, clinical research and testing, government regulation, formulation and manufacturing and sales and marketing in connection with

the continued development, regulatory approval and commercialization of our current and future product candidates.

We compete for qualified

individuals with numerous pharmaceutical and biopharmaceutical companies, universities, and other research institutions.

entered into in connection with the closing of the Merger, we utilize the services of the Citius Pharma clinical management team on a

part-time basis to assist us in managing the clinical and pre-clinical trials and intend to do so for future pre-clinical and clinical

Pursuant to the A&R Shared Services Agreement, we also utilize the services of Citius Pharma employees with expertise in product

manufacturing and commercialization for the post-launch support of LYMPHIR.

While we believe these arrangements provide us with sufficient

staffing for our current and future development efforts, we will need to hire or contract with additional qualified personnel with expertise

in preclinical testing, clinical research and testing, government regulation, formulation and manufacturing and sales and marketing in

connection with the continued development, regulatory approval and commercialization of our current and future product candidates.

compete for qualified individuals with numerous pharmaceutical and biopharmaceutical companies, universities, and other research institutions.

Except for one director, our current Board members

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We will need to manage our anticipated growth

and increased operational activity, including as a result of the planned commercialization of LYMPHIR and of any future product candidates.

and increased operational activity, including as a result of the recent commercialization of LYMPHIR and of any future product candidates.

Our personnel, systems, and facilities currently in place may not be adequate to support this future growth.

Our need to effectively execute

the growth strategy will require that we:

● successfully commercialize LYMPHIR and any future

product candidates;

● manage our research and development activities

for future product candidates and our regulatory trials effectively;

● attract and motivate sufficient numbers of talented

employees or consultants;

● manage our internal development efforts effectively

while complying with our contractual obligations to licensors, licensees, contractors, collaborators and other third parties;

● develop internal sales and marketing capabilities

or establish collaborations with third parties with such capabilities;

● improve our operational, financial and management

controls, reporting systems and procedures.

our growth strategy will require that we:

successfully commercialize LYMPHIR and any future product candidates;

maintain and strengthen, as necessary, our collaborations with third parties for the sales and marketing of LYMPHIR;

manage our research and development activities for future product candidates and our regulatory trials effectively;

attract and motivate sufficient numbers of talented employees or consultants;

manage our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors, collaborators and other third parties;

develop internal sales and marketing capabilities or establish collaborations with third parties with such capabilities;

improve our operational, financial and management controls, reporting systems and procedures.

This planned future growth could place a strain

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to our management information and control systems in an efficient or timely manner and may discover deficiencies in existing systems and

If management is unable to effectively manage our expected growth, our expenses may increase more than expected, our ability

to generate or increase revenues could be reduced and we may not be able to implement our business strategy.

Our future financial performance

and our ability to compete effectively will depend, in part, on our ability to effectively manage any future growth.

If our management is unable to effectively manage our expected growth, our expenses may increase more than expected, our ability

to generate or increase our revenues could be reduced, and we may not be able to implement our business strategy.

Our future financial

performance and our ability to compete effectively will depend, in part, on our ability to effectively manage any future growth.

We are subject

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In addition, certain subjects in clinical trials may respond positively

to placebo treatment - these subjects are commonly known as “placebo responders” - making it more difficult to demonstrate

efficacy of the trial drug compared to placebo.

to placebo treatment – these subjects are commonly known as “placebo responders” – making it more difficult to

demonstrate efficacy of the trial drug compared to placebo.

If any of our future product candidates fail to

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significantly.

Risks Related to the Company’s Regulatory

and Legal Environment

Risks Related to Our Regulatory and Legal Environment

Following the regulatory approval of LYMPHIR,

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storage, distribution, advertising, promotion and record keeping.

Such regulatory approval is also subject to limitations on the indicated

uses or marketing of the products or to whom and how we may distribute the approved product.

Such regulatory approval is also subject to significant limitations

on the indicated uses or marketing of the products or to whom and how we may distribute the approved product.

Manufacturers of pharmaceutical products and their

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Further, regulatory agencies must approve these

manufacturing facilities before they can be used to manufacture our approved products and these facilities are subject to ongoing regulatory

In addition, regulatory agencies subject a pharmaceutical product, the product’s manufacturer and the manufacturer’s

manufacturing facilities before they can be used to manufacture an approved product and these facilities are subject to ongoing regulatory

In addition, regulatory agencies subject an approved pharmaceutical product, its manufacturer and the manufacturer’s

facilities to continual review and inspections.

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or delay regulatory approval of our future product candidates.

Contract manufacturing organizations and their vendors or suppliers may

also face changes in regulatory requirements from governmental agencies in the U.S.

CMOs and their vendors or suppliers may also face changes in regulatory

requirements from governmental agencies in the U.S.

and other countries.

We cannot predict the likelihood,

nature, extent or effects of government regulation that may arise from future legislation or administrative action, either in the U.S.

We cannot predict the likelihood, nature, extent or effects of

government regulation that may arise from future legislation or administrative action, either in the U.S.

or elsewhere.

If we are not able to maintain regulatory compliance, we might not be permitted to market any future approved products and

our business could suffer.

If we are not

able to maintain regulatory compliance, we might not be permitted to market any future approved products and our business could suffer.

We could be forced to pay substantial damage

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damage occurrence, and a medical expense per person limit of $25,000.

There can be no assurance that our existing insurance coverage will

extend to any other product candidates in the future.

Any product liability insurance coverage may not be sufficient to satisfy all liabilities

resulting from product liability claims.

A successful claim may prevent us from obtaining adequate product liability insurance in the

future on commercially desirable terms, if at all.

Even if a claim is not successful, defending such a claim would be time consuming and

expensive, may damage that product’s reputation, as well as ours, in the marketplace, and would likely divert management’s

attention, any of which could have a material adverse effect on us.

We intend to obtain similar product liability insurance coverage

There can be no assurance that our existing insurance coverage will extend to any other product candidates in the future.

Any product liability insurance coverage may not be sufficient to satisfy all liabilities resulting from product liability claims.

claim may prevent us from obtaining adequate product liability insurance in the future on commercially desirable terms, if at all.

if a claim is not successful, defending such a claim would be time consuming and expensive, may damage that product’s and our reputations

in the marketplace, and would likely divert management’s attention, any of which could have a material adverse effect on us.

We might not obtain the necessary U.S.

foreign regulatory approvals to commercialize any future product candidates.

We cannot assure you that we will receive

the approvals necessary to commercialize for sale any future product candidates that we might acquire or seek to develop in the

We will need FDA approval to commercialize our product candidates in the U.S.

In order to obtain FDA approval of any product

candidate, we must submit to the FDA a NDA or a BLA demonstrating that the product candidate is safe for humans and effective for

the intended use.

We cannot assure you that we will receive the

approvals necessary to commercialize for sale any future product candidates that we might acquire or seek to develop in the future.

will need FDA approval to commercialize any future product candidates in the U.S.

In order to obtain FDA approval of any product candidate,

we must submit to the FDA an NDA or a BLA demonstrating that the product candidate is safe for humans and effective for the intended use.

This demonstration requires significant research, pre-clinical studies, and clinical trials.

Satisfaction of the

FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product

candidate and requires substantial resources for research, development and testing.

We cannot predict whether our research and

clinical approaches will result in products that the FDA considers safe for humans and effective for their indicated uses.

has substantial discretion in the product approval process and might require us to conduct additional pre-clinical and clinical

testing, perform post-marketing studies or otherwise limit or impose conditions on any additional approvals we obtain.

process might also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA

policy that occur prior to or during a future product candidate’s regulatory review.

Delays in obtaining regulatory approvals

● delay commercialization of, and our ability to

derive product revenues from, any future product candidates;

Satisfaction of the FDA’s regulatory

requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial

resources for research, development and testing.

We cannot predict whether our research and clinical approaches will result in products

that the FDA considers safe for humans and effective for their indicated uses.

The FDA has substantial discretion in the product approval

process and might require us to conduct additional pre-clinical and clinical testing, perform post-marketing studies or otherwise limit

or impose conditions on any additional approvals we obtain.

The approval process might also be delayed by changes in government regulation,

future legislation or administrative action or changes in FDA policy that occur prior to or during a future product candidate’s

regulatory review.

Delays in obtaining regulatory approvals might:

delay commercialization of, and our ability to derive product revenues from, any future product candidates;

impose costly procedures on us;

● diminish any competitive advantages that we might

otherwise enjoy.

diminish any competitive advantages that we might otherwise enjoy.

Even if we comply with all FDA requests, the FDA

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There is no guarantee that we will ever be able to successfully develop any additional product candidate.

Risks Related to the Company’s Intellectual

Risks Related to Our Intellectual Property

Our business depends on protecting our intellectual

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the following:

● our patent rights might be challenged, invalidated,

or circumvented, or otherwise might not provide any competitive advantage;

● our competitors, many of which have substantially

greater resources than we do and many of which might make significant investments in competing technologies, might seek, or might already

have obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our product candidates either

our patent rights might be challenged, invalidated, or circumvented, or otherwise might not provide any competitive advantage;

our competitors, many of which have substantially greater resources than we do and many of which might make significant investments in competing technologies, might seek, or might already have obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our product candidates either in the U.S.

or in international markets;

countries other than the U.S.

might have less

restrictive patent laws than those upheld by U.S.

courts, allowing foreign competitors the ability to exploit these laws to create, develop,

and market competing products;

● as a matter of public policy regarding worldwide

health concerns, there might be significant pressure on the U.S.

government and other international governmental bodies to limit the scope

of patent protection both inside and outside the U.S.

might have less restrictive patent laws than those upheld by U.S.

courts, allowing foreign competitors the ability to exploit these laws to create, develop, and market competing products;

as a matter of public policy regarding worldwide health concerns, there might be significant pressure on the U.S.

government and other international governmental bodies to limit the scope of patent protection both inside and outside the U.S.

for product candidates that prove successful.

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federal courts, the USPTO or similar

authorities in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that may weaken us

authorities in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that may weaken our

and our licensors’ abilities to obtain new patents or to enforce existing patents that we and our licensors or partners may obtain

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and other technologies infringe the proprietary rights of other parties, we could incur substantial costs and we might have to:

● obtain licenses, which might not be available

on commercially reasonable terms, if at all;

obtain licenses, which might not be available on commercially reasonable terms, if at all;

abandon an infringing product candidate;

● redesign the product candidates or processes

to avoid infringement;

● stop using the subject matter claimed in the

patents held by others;

● pay damages;

● defend litigation or administrative proceedings

which might be costly whether the Company wins or loses, and which could result in a substantial diversion of our financial and management

Any of these events could substantially harm the

Company’s earnings, financial condition, and operations.

redesign our product candidates or processes to avoid infringement;

stop using the subject matter claimed in the patents held by others;

defend litigation or administrative proceedings which might be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.

Any of these events could substantially harm our

earnings, financial condition, and operations.

If our trademarks and trade names are not

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intellectual property may be ineffective and could result in substantial costs and diversion of resources.

Risks Related to the Company’s Common

Risks Related to Our Common Stock

The market price of our common stock is

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common stock has fluctuated significantly due to a number of factors, some of which are beyond our control, including those factors discussed

in this “ Risk Factors and Risk Factor Summary ” section and many others, such as:

in this “ Risk Factors” and “Risk Factor Summary ” section of this report and many others, such as:

the Company’s cash resources available

to continue commercialization and development of LYMPHIR;

● the Company’s ability to meet its contractual

● our ability to commercialize LYMPHIR or any future

product candidates, if approved;

● the level of success and the cost of our marketing

efforts for LYMPHIR and any future product candidates;

● unanticipated serious safety concerns related

to the use of LYMPHIR or any other product candidate;

● announcements regarding results of any pre-clinical

or clinical trials relating to our future product candidates;

to successfully commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other

third-party goods and services;

the Company’s ability to meet its contractual obligations;

the Company’s ability to commercialize LYMPHIR or any future product candidates, if approved;

the level of success and the cost of our marketing efforts for LYMPHIR and any future product candidates;

unanticipated serious safety concerns related to the use of LYMPHIR or any other product candidate;

announcements regarding results of any pre-clinical or clinical trials relating to our future product candidates;

adverse regulatory decisions;

● changes in laws or regulations applicable to

LYMPHIR or any future product candidates, including but not limited to clinical trial requirements for approvals and post-approval requirements;

● our dependence on third parties and on Citius

Pharma under the A&R Shared Services Agreement;

changes in laws or regulations applicable to LYMPHIR or any future product candidates, including but not limited to clinical trial requirements for approvals and post-approval requirements;

the Company’s dependence on third parties and on Citius Pharma under the A&R Shared Services Agreement;

future issuances of debt or equity securities;

● actual or anticipated fluctuations in our financial

condition and operating results, including fluctuations in our quarterly and annual results;

● our inability to establish additional partnerships,

the termination of license agreements by our existing partners or announcements by our partners regarding therapeutic candidates competitive

● the introduction of new technologies or enhancements

to existing technologies by us or others in the industry;

● the recruitment or departure of key scientific

or management personnel;

● announcements of significant acquisitions, strategic

partnerships, joint ventures or capital commitments by us or our competitors;

● our failure to meet the estimates and projections

of the investment community or that we may otherwise provide to the public;

● publication of research reports about us, the

indications we seek to treat or our industry, or oncology research in particular, or positive or negative recommendations or withdrawal

of research coverage by securities analysts;

actual or anticipated fluctuations in the Company’s financial condition and operating results, including fluctuations in our quarterly and annual results;

the Company’s inability to establish additional partnerships, the termination of license agreements by our existing partners or announcements by our partners regarding therapeutic candidates competitive with ours;

the introduction of new technologies or enhancements to existing technologies by us or others in the industry;

the recruitment or departure of key scientific or management personnel;

announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by the Company or our competitors;

the Company’s failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

publication of research reports about us, the indications we seek to treat or our industry, or oncology research in particular, or positive or negative recommendations or withdrawal of research coverage by securities analysts;

changes in the market valuations of similar companies;

overall performance of the equity markets;

● announcements or actions taken by Citius Pharma

as the Company’s majority stockholder;

● sales (or distributions) of our Common Stock

by Citius Pharma, or our other stockholders in the future;

announcements or actions taken by Citius Pharma as the Company’s majority stockholder;

sales (or distributions) of our common stock by Citius Pharma, or our other stockholders in the future;

trading volume of our common stock;

● legal disputes or other developments relating

to proprietary rights, including patents, litigation matters and our ability to obtain and maintain patent protection for LYMPHIR or any

future product candidates, government investigations and the results of any proceedings or lawsuits, including, but not limited to, patent

or stockholder litigation;

● significant lawsuits, including patent or stockholder

● the impact of any natural disasters or public

health emergencies, such as occurred with the COVID-19 pandemic;

● general economic, industry and market conditions

other events or factors, many of which are beyond our control;

● changes in accounting standards, policies, guidelines,

interpretations or principles.

legal disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain and maintain patent protection for LYMPHIR or any future product candidates, government investigations and the results of any proceedings or lawsuits, including, but not limited to, patent or stockholder litigation;

significant lawsuits, including patent or stockholder litigation;

the impact of any natural disasters or public health emergencies;

general economic, industry and market conditions other events or factors, many of which are beyond the Company’s control;

changes in accounting standards, policies, guidelines, interpretations or principles.

In addition, in the past, stockholders have initiated

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these companies’ stock.

Such litigation, if instituted against us, could cause us to incur substantial costs and divert our management’s

attention and resources, which could have a material adverse effect on our business, financial condition and results of operations.

Such litigation, if instituted against us, could cause the Company to incur substantial costs and divert

our management’s attention and resources, which could have a material adverse effect on our business, financial condition and results

of operations.

Future sales of a substantial number of

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LP, the sponsor of TenX, and securities held by certain directors and officers of the Company and Citius Pharma.

Such restrictions expire

Such restrictions expired

February 9, 2025, subject to certain exceptions.

Following the expiration of the lock-up period, such equity holders will not be restricted

Following the expiration of the lock-up period, such equity holders are not restricted

from selling or distributing shares of common stock held by them, other than by applicable securities laws.

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interests because of the future issuance of additional shares of common stock or securities convertible into common stock.

For the foreseeable future, to finance our operations,

including possible acquisitions or strategic transactions, we expect to issue equity securities, resulting in the dilution of the ownership

interests of the present stockholders.

The Company is currently authorized to issue an aggregate of 100,000,000 shares of Common Stock

and 10,000,000 shares of preferred stock, of which 71,552,402 shares are outstanding as of December 18, 2024.

We may also issue additional

shares of Common Stock or other securities that are convertible into or exercisable for Common Stock in financings as well as in connection

with hiring or retaining employees, or for other business purposes.

The future issuance of any such additional shares of Common Stock

or Common Stock equivalents may create downward pressure on the trading price of the Common Stock.

For the foreseeable future, until LYMPHIR generates

significant revenue, if at all, we will need to raise capital to finance our operations, including possible acquisitions or strategic

transactions.

To do so, we might be required to issue equity securities, resulting in the dilution of the ownership interests of our present

stockholders.

The Company is currently authorized to issue an aggregate of 400,000,000 shares of common stock and 10,000,000 shares of

preferred stock, of which 84,797,846 shares are outstanding as of December 23, 2025.

We may also issue additional shares of common stock

or other securities that are convertible into or exercisable for common stock in connection with hiring or retaining employees, or for

other business purposes.

The future issuance of any such additional shares of common stock or common stock equivalents may create downward

pressure on the trading price of the common stock.

Substantial sales of our common stock may

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Citius Pharma has stated its intention to effect

a pro rata distribution of the Common Stock it holds in Citius Oncology to Citius Pharma stockholders.

Approximately 92.3% of our outstanding

shares of Common Stock are owned by Citius Pharma.

a pro rata distribution of an undetermined amount of the common stock it holds in Citius Oncology to Citius Pharma stockholders at a yet-to-be

determined date in the future.

As of December 10, 2025, approximately 79% of our outstanding shares of common stock are owned by Citius

The timeline and details with respect to such distribution have not been announced.

Stockholders receiving shares of our Common Stock in such distribution may be able to sell those shares immediately in the public market.

Although we have no actual knowledge of any plan or intention of any significant Citius Pharma stockholder to sell our Common Stock following

the potential distribution, it is likely that some Citius Pharma stockholders, possibly including some of its larger stockholders, would

sell their shares of our Common Stock received in the potential distribution if we do not fit their investment objectives or in order

to cover the related tax liability.

The sales of significant amounts of our Common Stock or the perception in the market that this will

occur may decrease the market price of our Common Stock and increase the volatility of our Common Stock.

Stockholders receiving shares of our common

stock in such distribution may be able to sell those shares immediately in the public market.

Although we have no actual knowledge of

any plan or intention of any significant Citius Pharma stockholder to sell our common stock following the potential distribution, it is

likely that some Citius Pharma stockholders, possibly including some of its larger stockholders, would sell their shares of our common

stock received in the potential distribution if we do not fit their investment objectives or in order to cover the related tax liability.

The sales of significant amounts of our common stock or the perception in the market that this will occur may decrease the market price

of our common stock and increase the volatility of our common stock.

If we fail to meet the Nasdaq continued

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significant material adverse consequences, including:

● a limited availability of market quotations for

our securities;

● a limited amount of news and analyst coverage

● a decreased ability to issue additional securities

or obtain additional financing in the future.

a limited availability of market quotations for our securities;

a limited amount of news and analyst coverage for us;

a decreased ability to issue additional securities or obtain additional financing in the future.

In the event of a future delisting, we intend

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with The Nasdaq Capital Market, we may be subject to the so-called “penny stock” rules.

Securities and Exchange Commission

(the “SEC”) has adopted regulations that define a “penny stock” to be any equity security that has a market price

per share of less than $5.00, subject to certain exceptions, such as any securities listed on a national securities exchange, which is

the exception on which we rely.

For any transaction involving a “penny stock,” unless exempt, the rules impose additional

sales practice requirements on broker-dealers, subject to certain exceptions.

If the 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 on the secondary market.

The Certificate of Incorporation of 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.

The Board has the authority to issue up to 10,000,000

The SEC has adopted regulations that

define a “penny stock” to be any equity security that has a market price per share of less than $5.00, subject to certain

exceptions, such as any securities listed on a national securities exchange, which is the exception on which we rely.

For any transaction

involving a “penny stock,” unless exempt, the rules impose additional sales practice requirements on broker-dealers, subject

to certain exceptions.

If the 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 on the secondary

Our Certificate of Incorporation 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.

Our Board has the authority to issue up to 10,000,000

shares of preferred stock and to fix and determine the relative rights and preferences of any such preferred stock without further stockholder

As a result, the Board could authorize the issuance of one or more series of preferred stock that would grant preferential rights

As a result, our Board could authorize the issuance of one or more series of preferred stock that would grant preferential rights

to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock

and the right to the redemption of the preferred shares, together with a premium, prior to the redemption of the common stock.

the Board could authorize the issuance of a series of preferred stock that has greater voting power than the Common Stock or that is convertible

into Common Stock, which could decrease the relative voting power of the Common Stock or result in dilution to existing stockholders.

our Board could authorize the issuance of a series of preferred stock that has greater voting power than the common stock or that is convertible

into common stock, which could decrease the relative voting power of the common stock or result in dilution to our existing stockholders.

We have not paid cash dividends in the past

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Any return on investment may be limited to the capital appreciation,

if any, of the Common Stock.

if any, of our common stock.

We have not paid cash dividends on our common

Stock and we do not anticipate paying cash dividends in the foreseeable future.

The payment of dividends on our capital stock will depend

on our earnings, financial condition and other business and economic factors affecting us at such time as our Board may consider relevant.

In addition, our ability to pay dividends may be limited by covenants in any future outstanding indebtedness that we may incur.

we do not intend to pay dividends, a stockholder’s ability to receive a return on such stockholder’s investment will depend

on any future appreciation in the market value of the Common Stock.

There is no guarantee that the Common Stock will appreciate or even

maintain the price at which our stockholders have purchased it.

stock and we do not anticipate paying cash dividends on our common stock in the foreseeable future.

The payment of dividends on our common

stock will depend on our earnings, financial condition and other business and economic factors affecting us at such time as our Board

may consider relevant.

In addition, our ability to pay dividends may be limited by covenants in any future outstanding indebtedness that

we may incur.

Since we do not intend to pay dividends, a stockholder’s ability to receive a return on such stockholder’s investment

will depend on any future appreciation in the market value of the Company’s common stock.

There is no guarantee that our common

stock will appreciate or even maintain the price at which our stockholders have purchased it.

Our operating results may fluctuate significantly.

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Our net loss and other operating results will be affected by numerous factors, including:

● results of the launch and commercialization of

● variations in the level of expenses related to

the commercialization of LYMPHIR and any other aspects of Company’s development programs;

● the level of demand for LYMPHIR and the extent

of our market penetration;

● regulatory developments affecting LYMPHIR or

any future product candidates, including post-approval matters.

results of the launch and commercialization of LYMPHIR;

variations in the level of expenses related to the commercialization of LYMPHIR and any other aspects of Company’s development programs;

the level of demand for LYMPHIR and the extent of our market penetration;

regulatory developments affecting LYMPHIR or any future product candidates, including post-approval matters.

If our quarterly or annual operating results fall

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volume could decline.

The trading market for Common Stock may be

influenced by the research and reports that industry or securities analysts publish about us or our business.

We currently have

research coverage by three securities and industry analysts.

If any of the analysts who cover us issue an adverse opinion regarding

us, our business model, our intellectual property or our stock performance, or if our commercialization efforts for LYMPHIR, or any

clinical trials and operating results fail to meet the expectations of analysts, our stock price would likely decline.

more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial

markets, which in turn could cause our stock price or trading volume to decline.

The trading market for common stock may be influenced

by the research and reports that industry or securities analysts publish about us or our business.

We currently have research coverage

by three securities and industry analysts.

If any of the analysts who cover us issue an adverse opinion regarding us, our business model,

our intellectual property or our stock performance, or if our commercialization efforts for LYMPHIR, or any clinical trials and operating

results fail to meet the expectations of analysts, our stock price would likely decline.

If one or more of these analysts cease coverage

of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock

price or trading volume to decline.

We are a controlled company within the meaning

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requirements.

Citius Pharma continues to control approximately

92.3% of the voting power of the outstanding shares of Common Stock as of December 18, 2024.

As a result, the Company is a “controlled

company” within the meaning of the corporate governance standards of Nasdaq.

Under these corporate governance standards, a company

of which more than 50% of the voting power for the election of directors is held by an individual, group or another company is a “controlled

company” and may elect not to comply with certain corporate governance requirements.

Citius Pharma controls approximately 79% of the

voting power of the outstanding shares of common stock as of December 10, 2025.

As a result, the Company is a “controlled company”

within the meaning of the corporate governance standards of Nasdaq.

Under these corporate governance standards, a company of which more

than 50% of the voting power for the election of directors is held by an individual, group or another company is a “controlled company”

and may elect not to comply with certain corporate governance requirements.

For example, controlled companies:

● are not required to have a board that is composed

of a majority of “independent directors” as defined under the Nasdaq continued listing requirements;

● not required to have a compensation committee

that is composed entirely of independent directors or have a written charter addressing the committee’s purpose and responsibilities;

● are not required to have director nominations

be made, or recommended to the full board of directors, by its independent directors or by a nominating and corporate governance committee

that is composed entirely of independent directors, and to adopt a written charter or a board resolution addressing the nominations process.

are not required to have a board that is composed of a majority of “independent directors” as defined under the Nasdaq continued listing requirements;

not required to have a compensation committee that is composed entirely of independent directors or have a written charter addressing the committee’s purpose and responsibilities;

are not required to have director nominations be made, or recommended to the full board of directors, by its independent directors or by a nominating and corporate governance committee that is composed entirely of independent directors, and to adopt a written charter or a board resolution addressing the nominations process.

While we do not currently rely on these exemptions,

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The provisions in our governance documents include the following:

● a classified board of directors divided into

three classes, with only one class of directors being elected in each year and each class serving a three-year term, which may delay the

ability of stockholders to change the membership of a majority of the Board;

● no cumulative voting in the election of directors,

which limits the ability of minority stockholders to elect director candidates;

● in the event that Citius Pharma ceases to beneficially

own more than 50% of the voting power of the then-outstanding shares of stock entitled to vote generally in the election of directors

(the “Trigger Event,”), the approval of at least 66-2/3% of the shares entitled to vote will be required to remove a director

for cause, and the prohibition on removal of directors without cause;

● the ability of the Board to authorize the issuance

of shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without

stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;

● the ability of the Board to alter our Bylaws

without obtaining stockholder approval;

● upon the occurrence of the Trigger Event, the

required approval of at least 66-2/3% of the shares entitled to vote to adopt, amend or repeal the Bylaws or repeal the provisions of

our Certificate of Incorporation regarding the election and removal of directors;

● upon the occurrence of the Trigger Event, a prohibition

on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

● upon the occurrence of the Trigger Event, the

requirement that a special meeting of stockholders may be called only by the Board, the chair of the Board, the chief executive officer,

which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors;

● advance notice procedures that stockholders must

comply with in order to nominate candidates to the Board or to propose matters to be acted upon at a stockholders’ meeting, which

may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors

or otherwise attempting to obtain control of us;

● upon the occurrence of the Trigger Event, we

also become subject to the anti-takeover provisions contained in Section 203 of the General Corporation Law of the State of Delaware (“DGCL”).

Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or more of our capital stock

unless the holder has held the stock for three years or, among other exceptions, the Board has approved the transaction.

a classified board of directors divided into three classes, with only one class of directors being elected in each year and each class serving a three-year term, which may delay the ability of stockholders to change the membership of a majority of the Board;

no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

in the event that Citius Pharma ceases to beneficially own more than 50% of the voting power of the then-outstanding shares of stock entitled to vote generally in the election of directors (the “Trigger Event,”), the approval of at least 66-2/3% of the shares entitled to vote will be required to remove a director for cause, and the prohibition on removal of directors without cause;

the ability of the Board to authorize the issuance of shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;

the ability of the Board to alter our Bylaws without obtaining stockholder approval;

upon the occurrence of the Trigger Event, the required approval of at least 66-2/3% of the shares entitled to vote to adopt, amend or repeal the Bylaws or repeal the provisions of our Certificate of Incorporation regarding the election and removal of directors;

upon the occurrence of the Trigger Event, a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

upon the occurrence of the Trigger Event, the requirement that a special meeting of stockholders may be called only by the Board, the chair of the Board, the chief executive officer, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors;

advance notice procedures that stockholders must comply with in order to nominate candidates to the Board or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of us;

upon the occurrence of the Trigger Event, we also become subject to the anti-takeover provisions contained in Section 203 of the General Corporation Law of the State of Delaware (“DGCL”).

Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or more of our capital stock unless the holder has held the stock for three years or, among other exceptions, the Board has approved the transaction.

The Certificate of Incorporation provides

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We will be able to take advantage of these scaled disclosures for

so long as our Common Stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal

quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our Common Stock held by

non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

so long as our common stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter,

or our annual revenue is less than $100 million during the most recently completed fiscal year and our common stock held by non-affiliates

is less than $700 million measured on the last business day of our second fiscal quarter.

We cannot predict if investors will find our common

55 unchanged sentences

Mazur, Jaime Bartushak and Dr.

Myron Czuczman, continue

Czuczman, continue

to serve as our executive officers.

13 unchanged sentences

be precluded from pursuing certain growth initiatives.

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.

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 and

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.

Citius Pharma provides all of our operational

20 unchanged sentences

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.

The likelihood of a $10 million raise is uncertain at this

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 $50 million through the issuance of debt or equity securities or the royalty-backed monetization of LYMPHIR™.

the Company has raised $36 million in capital raises and the likelihood of raising an additional $14 million to trigger the repayment

obligation is uncertain at this time.

These costs we owe for services rendered by Citius

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interests may differ from those of public stockholders.

Citius Pharma holds approximately 92.3% of the

voting power of us as of December 18, 2024, which means that Citius Pharma controls the vote of all matters submitted to a vote of the

Company’s stockholders.

This control enables Citius Pharma to control the election of the members of the Board and all other corporate

In particular, for so long as Citius Pharma continues to own a majority of the Common Stock, Citius Pharma will be able to

cause or prevent a change of control of our Company or a change in the composition of the Board and could preclude any unsolicited acquisition

of our Company.

Citius Pharma holds approximately 79% of the voting power of us as

of December 10, 2025, which means that Citius Pharma controls the vote of all matters submitted to a vote of the Company’s stockholders.

This control enables Citius Pharma to control the election of the members of the Board and all other corporate decisions.

In particular,

for so long as Citius Pharma continues to own a majority of the common stock, Citius Pharma will be able to cause or prevent a change

of control of our Company or a change in the composition of the Board and could preclude any unsolicited acquisition of our Company.

Pursuant to the A&R Registration Rights Agreement

28 unchanged sentences

a change in control.

In addition, in the ordinary course of its

pharmaceutical business activities, Citius Pharma may engage in fields or activities where its interests conflict with our interests

or those of our other stockholders, such as investing in or advising businesses that directly or indirectly compete with certain

portions of the Company’s business or those businesses that are suppliers or customers of us.

The Certificate of Incorporation

will provide that, to the fullest extent permitted by law, none of Citius Pharma nor its affiliates or any person or entity who,

while a stockholder, director, officer or agent of us or any of our affiliates, is a director, officer, principal, partner, member,

manager, employee, agent and/or other representative of Citius Pharma and its affiliates (each an “Identified Person”)

will have any duty to refrain from (i) engaging in a corporate opportunity in the same or similar business activities or lines of

business in which we or our affiliates are engaged or that are deemed to be competing with us or any of our affiliates or (ii)

otherwise investing in or providing services to any person that competes with us or our affiliates engaging, directly or indirectly,

in the same or similar business activities or lines of business in which we operate.

In addition, to the fullest extent permitted by

law, no Identified Person will have any obligation to offer us or our affiliates the right to participate in any corporate

opportunity in the same or similar business activities or lines of business in which we or our affiliates are engaged or that are

deemed to be competing with us or any of our affiliates.

This means that Citius Pharma may pursue acquisition opportunities that may

be complementary to our business and, as a result, those acquisition opportunities may not be available to us.

In addition, Citius

Pharma may have an interest in pursuing acquisitions, divestitures and other transactions that, in its judgment, could enhance its

investment, even though such transactions might involve risks to our stockholders or may not prove beneficial.

In addition, in the ordinary course of its pharmaceutical

business activities, Citius Pharma may engage in fields or activities where its interests conflict with our interests or those of our

other stockholders, such as investing in or advising businesses that directly or indirectly compete with certain portions of the Company’s

business or those businesses that are suppliers or customers of us.

The Certificate of Incorporation provides that, to the fullest extent

permitted by law, none of Citius Pharma nor its affiliates or any person or entity who, while a stockholder, director, officer or agent

of us or any of our affiliates, is a director, officer, principal, partner, member, manager, employee, agent and/or other representative

of Citius Pharma and its affiliates (each an “Identified Person”) will have any duty to refrain from (i) engaging in a corporate

opportunity in the same or similar business activities or lines of business in which we or our affiliates are engaged or that are deemed

to be competing with us or any of our affiliates or (ii) otherwise investing in or providing services to any person that competes with

us or our affiliates engaging, directly or indirectly, in the same or similar business activities or lines of business in which we operate.

In addition, to the fullest extent permitted by law, no Identified Person will have any obligation to offer us or our affiliates the right

to participate in any corporate opportunity in the same or similar business activities or lines of business in which we or our affiliates

are engaged or that are deemed to be competing with us or any of our affiliates.

This means that Citius Pharma may pursue acquisition

opportunities that may be complementary to our business and, as a result, those acquisition opportunities may not be available to us.

In addition, Citius Pharma may have an interest in pursuing acquisitions, divestitures and other transactions that, in its judgment, could

enhance its investment, even though such transactions might involve risks to our stockholders or may not prove beneficial.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors