UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period ended:
OR
For the transition period from ______________ to ______________
Commission File Number
(Exact name of registrant as specified in its charter)
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant
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Indicate by check mark whether the registrant
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| ☒ | Smaller reporting company | ||
| Emerging growth company | |||
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As of February 10, 2026, there were
Citius Pharmaceuticals, Inc.
FORM 10-Q
TABLE OF CONTENTS
December 31, 2025
i
EXPLANATORY NOTE
In this Quarterly Report on Form 10-Q, and unless the context otherwise requires, the “Company,” “Citius Pharma,” “we,” “us,” and “our” refer to Citius Pharmaceuticals, Inc. and its wholly-owned subsidiary Leonard-Meron Biosciences, Inc., and its majority-owned subsidiaries, Citius Oncology, Inc. (Nasdaq: CTOR) (“Citius Oncology”) and NoveCite, Inc., taken as a whole.
Mino-Lok® is our registered trademark and LYMPHIRTM (denileukin diftitox) is a registered trademark of Citius Oncology. All other trade names, trademarks and service marks appearing in this quarterly report are the property of their respective owners. We have assumed that the reader understands that all such terms are source-indicating. Accordingly, such terms, when first mentioned in this report, appear with the trade name, trademark or service mark notice and then throughout the remainder of this report without trade name, trademark or service mark notices for convenience only and should not be construed as being used in a descriptive or generic sense.
ii
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in this Report and in other documents which we file with the Securities and Exchange Commission (the “SEC”). In addition, such statements could be affected by risks and uncertainties related to:
| ● | our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern; | |
| ● | our need for substantial additional funds and our ability to raise those funds; | |
| ● | our ongoing evaluation of strategic alternatives; | |
| ● | our ability to regain compliance with the continued listing requirements of the Nasdaq Stock Market LLC (“Nasdaq”); | |
| ● | the ability of Citius Oncology to commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and services; | |
| ● | our ability to recognize the anticipated benefits of the August 2024 reverse merger whereby Citius Oncology became a standalone publicly-traded company and our majority-owned subsidiary (the “Merger”), which may not be realized fully, if at all, or may take longer to realize than expected; | |
| ● | our ability to obtain regulatory approval for and successfully commercialize Mino-Lok; | |
| ● | the cost, timing, and results of our pre-clinical and clinical trials for our other product candidates; | |
| ● | our ability to apply for, obtain and maintain required regulatory approvals for our other product candidates; | |
| ● | the estimated markets for LYMPHIR, Mino-Lok or any of our future product candidates and the acceptance thereof by any market; | |
| ● | our ability to obtain, perform under and maintain financing and strategic agreements and relationships; | |
| ● | the commercial feasibility and success of our technology and our product candidates; | |
| ● | our ability to recruit and retain qualified management and technical personnel to carry out our operations; and | |
| ● | the other factors discussed in the “Risk Factors” section of our most recent Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with the SEC on December 23, 2025, as amended on January 28, 2026. |
Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the filing date of this Report.
iii
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements.
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| December 31, | September 30, | |||||||
| 2025 | 2025 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable, net of allowances | ||||||||
| Inventory | ||||||||
| Prepaid expenses | ||||||||
| Total Current Assets | ||||||||
| Operating lease right-of-use asset, net | ||||||||
| Deposits | ||||||||
| In-process research and development, net of accumulated amortization | ||||||||
| Goodwill | ||||||||
| Total Other Assets | ||||||||
| Total Assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| License payable | ||||||||
| Accrued expenses | ||||||||
| Accrued compensation | ||||||||
| Note payable | ||||||||
| Operating lease liability | ||||||||
| Total Current Liabilities | ||||||||
| Deferred tax liability | ||||||||
| Operating lease liability – noncurrent | ||||||||
| Total Liabilities | ||||||||
| Commitments and Contingencies | ||||||||
| Stockholders’ Equity: | ||||||||
| Preferred stock - $ | ||||||||
| Common stock - $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Citius Pharmaceuticals, Inc. Stockholders’ Equity | ||||||||
| Non-controlling interest | ||||||||
| Total Equity | ||||||||
| Total Liabilities and Equity | $ | $ | ||||||
See notes to unaudited condensed consolidated financial statements.
Reflects a 1-for-25 reverse stock split effective November 25, 2024.
1
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024
(Unaudited)
| Three Months Ended | ||||||||
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Revenue | $ | |||||||
| Cost of revenues | ( |
) | ||||||
| Gross Profit | ||||||||
| Operating Expenses | ||||||||
| Research and development | ||||||||
| Amortization of in-process research and development | ||||||||
| General and administrative | ||||||||
| Stock-based compensation – general and administrative | ||||||||
| Total Operating Expenses | ||||||||
| Operating Loss | ( |
) | ( |
) | ||||
| Other Income (Expense) | ||||||||
| Interest income | ||||||||
| Interest expense | ( |
) | ||||||
| Total Other Income (Expense) | ( |
) | ||||||
| Loss before Income Taxes | ( |
) | ( |
) | ||||
| Income tax expense | ||||||||
| Net Loss | ( |
) | ( |
) | ||||
| Net loss attributable to non-controlling interest | ||||||||
| Net loss applicable to common stockholders | $ | ( |
) | $ | ( |
) | ||
| Net Loss Per Share - Basic and Diluted | $ | ( |
) | $ | ( |
) | ||
| Weighted Average Common Shares Outstanding | ||||||||
| Basic and diluted (includes pre-funded warrants from the October 2025 offering) | ||||||||
See notes to unaudited condensed consolidated financial statements.
Reflects a 1-for-25 reverse stock split effective November 25, 2024.
2
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024
(Unaudited)
| Preferred | Common Stock | Additional Paid-In | Accumulated | Total Citius Pharmaceuticals, Inc. Stockholders’ | Non- Controlling | Total | ||||||||||||||||||||||||||
| Stock | Shares | Amount | Capital | Deficit | Equity | Interest | Equity | |||||||||||||||||||||||||
| Balance, September 30, 2025 | $ | $ | $ | ( | ) | $ | $ | $ | ||||||||||||||||||||||||
| Issuance of common stock, net of costs of $ | ||||||||||||||||||||||||||||||||
| October 2025 sale of common stock and pre-funded warrants, net of costs of $ | ||||||||||||||||||||||||||||||||
| December 2025 sale of common stock and pre-funded warrants by Citius Oncology, net of costs of $ | - | |||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of pre-funded warrants | ( | ) | ||||||||||||||||||||||||||||||
| Issuance of common stock for services | ||||||||||||||||||||||||||||||||
| Issuance of common stock warrant for note payable extension | - | |||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Net loss attributable to non-controlling interest | - | - | ( | ) | ||||||||||||||||||||||||||||
| Balance, December 31, 2025 | $ | $ | $ | ( | ) | $ | $ | $ | ||||||||||||||||||||||||
| Balance, September 30, 2024 | $ | $ | $ | ( | ) | $ | $ | $ | ||||||||||||||||||||||||
| Sale of common stock, net of costs of $ | ||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Net loss attributable to non-controlling interest | - | - | ( | ) | ||||||||||||||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | ( | ) | $ | $ | $ | ||||||||||||||||||||||||
See notes to unaudited condensed consolidated financial statements.
Reflects a 1-for-25 reverse stock split effective November 25, 2024.
3
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024
(Unaudited)
| 2025 | 2024 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation expense | ||||||||
| Issuance of common stock for services | ||||||||
| Issuance of common stock warrant | ||||||||
| Amortization of in-process research and development | ||||||||
| Amortization (accretion) of operating lease right-of-use asset | ( | ) | ||||||
| Deferred income tax expense | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable, net of allowances | ( | ) | ||||||
| Inventory | ( | ) | ( | ) | ||||
| Prepaid expenses | ( | ) | ( | ) | ||||
| Accounts payable | ( | ) | ||||||
| Accrued expenses | ||||||||
| Accrued compensation | ( | ) | ||||||
| Operating lease liability | ( | ) | ||||||
| Net Cash Used In Operating Activities | ( | ) | ( | ) | ||||
| Cash Flows From Investing Activities: | ||||||||
| License fee payments | ( | ) | ||||||
| Net Cash Used in Investing Activities | ( | ) | ||||||
| Cash Flows From Financing Activities: | ||||||||
| Net proceeds from common stock offerings | ||||||||
| Net Cash Provided By Financing Activities | ||||||||
| Net Change in Cash and Cash Equivalents | ( | ) | ||||||
| Cash and Cash Equivalents - Beginning of Period | ||||||||
| Cash and Cash Equivalents - End of Period | $ | $ | ||||||
| Supplemental Disclosures of Cash Flow Information and Non-cash Transactions: | ||||||||
| Interest paid | $ | $ | ||||||
See notes to unaudited condensed consolidated financial statements.
4
CITIUS PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024
(Unaudited)
1. NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Business
Citius Pharmaceuticals, Inc. (“Citius Pharma,” and together with its subsidiaries, the “Company”, “we” or “us”) is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products and stem cell therapies.
On March 30, 2016, Citius Pharma acquired Leonard-Meron
Biosciences, Inc. (“LMB”) as a wholly-owned subsidiary. We acquired all the outstanding stock of LMB by issuing shares of
our common stock. The net assets acquired included identifiable intangible assets of $
On September 11, 2020, we formed NoveCite, Inc.
(“NoveCite”), a Delaware corporation, of which we own
On August 23, 2021, we formed Citius Oncology,
Inc. (“Citius Oncology”), as a wholly-owned subsidiary in conjunction with the acquisition of LYMPHIR, which began operations
in April 2022. On August 12, 2024, Citius Pharma and Citius Oncology entered into a merger agreement with TenX Keane Acquisition, and
its wholly owned subsidiary, TenX Merger Sub Inc (“Merger Sub”), whereby Merger Sub merged with and into Citius Oncology.
After the merger and recapitalization (the “Merger”), the newly combined publicly traded company was owned
Since our inception, we have devoted substantially all our efforts to business planning, research and development, recruiting management and technical staff, and raising capital. We are subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, the Company’s ability to obtain additional financing, risks related to the development by the Company or its competitors of research and development stage products, regulatory approval and market acceptance of its products, competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners and the Company’s compliance with governmental and other regulations.
Basis of Presentation and Summary of Significant Accounting Policies
Basis of Preparation - The accompanying
unaudited condensed consolidated financial statements include the operations of Citius Pharmaceuticals, Inc., its wholly-owned subsidiary
LMB and its majority-owned subsidiaries NoveCite and Citius Oncology. On August 12, 2024, Citius Oncology, previously a wholly-owned subsidiary,
became a majority-owned subsidiary. As of December 31, 2025, Citius Oncology was approximately a
The operations of NoveCite and Citius Oncology are included in the consolidated results. The portion of equity that is not attributable to the Company is presented as a non-controlling interest within stockholders’ equity. Unless excluded by shareholder agreements, the portion of net loss attributable to non-controlling interests is included in the statement of operations. All significant inter-company balances and transactions have been eliminated in consolidation.
5
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state the condensed consolidated financial position of the Company as of December 31, 2025, and the results of its operations and cash flows for the three months ended December 31, 2025 and 2024. The operating results for the three months ended December 31, 2025 are not necessarily indicative of the results that may be expected for the year ending September 30, 2026. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025 filed with the Securities and Exchange Commission (“SEC”) on December 23, 2025, as amended on January 28, 2026.
Use of Estimates - The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates having relatively higher significance include the accounting for revenue recognition, in-process research and development, stock-based compensation, net realizable value of inventory and income taxes. Actual results could differ from those estimates and changes in estimates may occur.
Basic and Diluted Net Loss per Common Share - Basic and diluted net loss per common share applicable to common stockholders is computed by dividing net loss applicable to common stockholders in each period by the weighted average number of shares of common stock outstanding during such period. For the periods presented, common stock equivalents, consisting of stock options and warrants, were not included in the calculation of the diluted loss per share because they were anti-dilutive, with pre-funded warrants being included in the loss per share.
Recently Issued Accounting Standards
Other than as disclosed in our Form 10-K, we are not aware of any other recently issued accounting standards not yet adopted that may have a material impact on our financial statements.
2. GOING CONCERN UNCERTAINTY AND MANAGEMENT’S PLAN
The accompanying consolidated financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the
normal course of business. We incurred a net loss of $
The Company estimates that its available cash resources will be sufficient to fund its operations through May 2026. We will need to raise additional capital in the future to support our operations beyond May 2026, which raises substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the accompanying consolidated financial statements are issued.
6
The Company is currently engaged in capital raising
initiatives, as well as separate capital raising initiatives through its approximately
The Company has generated limited operating revenue, which commenced in December 2025, and has principally raised capital through the issuance of debt and equity instruments to finance its operations. However, the Company’s continued operations beyond May 2026, including its development plans for Mino-Lok, Halo-Lido and NoveCite, will depend on its ability to obtain regulatory approval for Mino-Lok 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, strategic relationships, or out-licensing of its product candidates. However, the Company can provide no assurances on regulatory approval, 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 its product candidates, including seeking regulatory approval, and protecting its intellectual property. The accompanying financial statements do not include any adjustments that might result from the outcome of the above uncertainty.
3. REVENUE RECOGNITION AND ACCOUNTS RECEIVABLE
Revenue Recognition
We recognize revenue in accordance with the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers. In determining the appropriate amount and timing of revenue to be recognized under this guidance, we perform the following five steps: (i) identify the contract(s) with our customer; (ii) identify the promised goods or services in the agreement and determine whether they are performance obligations, including whether they are distinct in the context of the agreement; (iii) measure the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations based on stand-alone selling prices; and (v) recognize revenue when (or as) we satisfy each performance obligation. Revenues are recognized when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.
We distribute LYMPHIR in the U.S. through third party specialty distributors who are our customers. The third-party specialty distributors subsequently resell our product to health care providers, hospitals and infusion centers. Separately, we have or may enter into payment arrangements with various third-party’s including government healthcare programs who provide coverage and or reimbursement for our product that have been prescribed to a patient.
Net Revenues
We recognize net revenue from LYMPHIR sales, net of variable consideration and consideration payable to parties other than our customers consisting of estimates related to allowances for sales returns, government chargebacks, patient coupon programs, and specialty distributor fees. Revenue is generally recognized when the customer obtains control of the Company’s product, which occurs at a point in time, upon delivery based on the contractual shipping terms of a contract.
We estimate variable consideration using the expected value method, constrained to amounts for which it is probable that a significant reversal of cumulative revenue will not occur when uncertainties are resolved. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, historical or expected utilization rates, new information regarding changes in applicable regulations and guidelines that would impact the amount of the actual allowance and our expectations regarding future utilization rates and channel inventory data. We will review the adequacy of our provisions for all gross-to-net adjustments on a quarterly basis. Amounts reserved for these adjustments are made when trends or significant events indicate that adjustment is appropriate reflecting actual experience.
The Company elected the practical expedient in ASC 606-10-32-18 and does not assess whether a significant financing component exists for contracts in which payment is expected within one year. No other practical expedients were applied.
7
Gross-to-Net Adjustments
Specialty Distributor Fees
We pay fees for distribution services, such as fees for certain data that customers provide us. We expect our customers will earn these fees and accordingly deduct these fees from gross product sales and accounts receivable at the time we recognize the related revenues.
Product Returns
Customers have the right to return products if they are damaged, defective, or expired, or as it is defined in their customer agreement. We have estimated product returns based on the experience of similar products in the market, and will continue to estimate returns based on our actual returns, sales data, and inventory levels in the distribution channel. These estimates are recorded as a reduction against gross product sales at the time of the sales.
Chargebacks
Chargebacks will occur when federal agencies who we contract with, or may contract with, can purchase off the Federal Supply Schedule or when Public Health Service 340B covered entities purchase directly from our customers at discounted prices. Our customers then charge us the difference between their purchase price and the discounted price. We estimate chargebacks considering the terms of the applicable arrangement and our visibility regarding utilization. These chargebacks are recorded in the same period as the related revenue, as a reduction against gross product sales and accounts receivable.
Co-payment Assistance
We offer co-payment assistance to patients with
commercial insurance that have coverage and are allowed such co-payment assistance. We estimate the average co-payment assistance amounts
for our products based on expected customer utilization and record any such amounts as a reduction from gross product revenue at the
time of sale.
| Three Months Ended | ||||
| December 31, 2025 | ||||
| Gross Product Revenue | $ | |||
| Gross-to-net adjustments: | ||||
| Net Revenue | $ | |||
Accounts receivable, net
Accounts receivable, net is stated at amounts
invoiced less allowances for distributor fees, chargebacks, and estimated returns. At December 31, 2025, these sales allowances totaled
$
8
4. INVENTORY
Inventory is stated at the lower of actual accumulated
costs or net realizable value related to the manufacturing of LYMPHIR commercial products, which became available for sale in December
2025. Cost is determined using the first-in, first-out (FIFO) method. No reserves
against inventory were deemed necessary based on an evaluation of the product expiration dating.
| December 31, 2025 |
September 30, 2025 |
|||||||
| Finished goods | $ | $ | ||||||
| Work in process | ||||||||
| Total | $ | $ | ||||||
Cost of Goods Sold
Cost of goods sold consists of direct and indirect costs associated with manufacturing and distributing LYMPHIR. These costs include amounts paid to third-party contract manufacturing organizations for production-related services, including raw materials, drug substance, drug product manufacturing, fill-finish activities, certain testing, and packaging. Cost of goods sold also includes distribution, storage shipping, and handling fees, as well as royalties owed under the Company’s licensing arrangements.
5. PREPAID EXPENSES
Prepaid expenses include advance payments made
for the preparation of long-lead time drug substance and product costs, which will be utilized in research and development activities
or in the manufacturing of LYMPHIR for sales. Other prepaid expenses include insurance, FDA program fees, service fees and marketing
costs.
| December 31, 2025 | September 30, 2025 | |||||||
| Prepaid manufacturing | $ | $ | ||||||
| Prepaid insurance | ||||||||
| Prepaid annual FDA program fee | ||||||||
| Prepaid annual service fees | ||||||||
| Prepaid marketing costs | ||||||||
| Total | $ | $ | ||||||
6. IN-PROCESS RESEARCH AND DEVELOPMENT, NET
In process research and development consists of
a beginning carrying value for LYMPHIR of $
| Year Ended September 30, | Amount | |||
| 2026 | $ | |||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| 2030 | ||||
| 2031 | ||||
| Thereafter | ||||
| Total | $ | |||
9
7. PATENT AND TECHNOLOGY LICENSE AGREEMENTS
Patent and Technology License Agreement – Mino-Lok
LMB has a patent and technology license agreement
with Novel Anti-Infective Therapeutics, Inc. (“NAT”) to develop and commercialize Mino-Lok® on an exclusive, worldwide
sub-licensable basis, as amended. LMB pays an annual maintenance fee each June until commercial sales of a product subject to the license
commence. The Company recorded an annual maintenance fee expense of $
LMB will also pay annual royalties on net sales
of licensed products, with a low double digit royalty rate (within a range of
Unless earlier terminated by NAT, based on the failure to achieve certain development and commercial milestones, the license agreement remains in effect until the date that all patents licensed under the agreement have expired and all patent applications within the licensed patent rights have been cancelled, withdrawn, or expressly abandoned.
License Agreement with Eterna
On October 6, 2020, our subsidiary, NoveCite,
entered into a license agreement with Novellus Therapeutics Limited (“Novellus”), whereby NoveCite acquired an exclusive,
worldwide license, with the right to sublicense, develop and commercialize a stem cell therapy based on the Novellus’s patented
technology for the treatment of acute pneumonitis of any etiology in which inflammation is a major agent in humans. Upon execution of
the license agreement, we paid $
In July 2021, Novellus was acquired by Brooklyn ImmunoTherapeutics, Inc. (“Brooklyn”). Pursuant to this transaction, the NoveCite license was assumed by Brooklyn with all original terms and conditions. In connection with that transaction, the stock subscription agreement was amended to assign to Brooklyn all of Novellus’s right, title, and interest in the stock subscription agreement and delete the anti-dilution protection and replace it with a right of first refusal whereby Brooklyn will have the right to purchase all or a portion of the securities that NoveCite intends to sell or in the alternative, at the option of NoveCite, Brooklyn may purchase that amount of the securities proposed to be sold by NoveCite to allow Brooklyn to maintain its then percentage ownership. In October 2022, Brooklyn changed its name to Eterna Therapeutics Inc. (“Eterna”).
10
We are responsible for the operational activities of NoveCite and bear all costs necessary to operate NoveCite. Our officers are also the officers of NoveCite and oversee the business strategy and operations of NoveCite. As such, NoveCite is accounted for as a consolidated subsidiary with a noncontrolling interest.
Eterna has no contractual rights in the profits or obligations to share in the losses of NoveCite, and the Company has not allocated any losses to the noncontrolling interest.
Under the license agreement, NoveCite is obligated
to pay Eterna up to an aggregate of $
Under the terms of the license agreement, in
the event that Eterna receives any revenue involving the original cell line included in the licensed technology, then Eterna shall remit
to NoveCite
The term of the license agreement continues on a country-by-country and licensed product-by-licensed product basis until the expiration of the last-to-expire royalty term. Either party may terminate the license agreement upon written notice if the other party is in material default. NoveCite may terminate the license agreement at any time without cause upon 90 days prior written notice.
Eterna will be responsible for preparing, filing, prosecuting, and maintaining all patent applications and patents included in the licensed patents in the territory, provided however, that if Eterna decides that it is not interested in maintaining a particular licensed patent or in preparing, filing, or prosecuting a licensed patent, NoveCite will have the right, but not the obligation, to assume such responsibilities in the territory at NoveCite’s sole cost and expense.
License Agreement with Eisai
In September 2021, we entered into an asset purchase agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, Ltd. (collectively, “Dr. Reddy’s”) and a license agreement with Eisai Co., Ltd. (“Eisai”) to acquire an exclusive license of E7777 (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. We renamed E7777 as I/ONTAK and also obtained the trade name of LYMPHIRTM for the product. We assigned these agreements to Citius Oncology effective April 1, 2022 and we received a Biologics License Application (“BLA”) approval from the FDA for LYMPHIR in August 2024.
Under the terms of these agreements, we acquired
Dr. Reddy’s exclusive license of E7777 from Eisai and other related assets owned by Dr. Reddy’s (which are now owned by Citius
Oncology). The exclusive license include rights to develop and commercialize E7777 in all markets except for Japan and certain parts
of Asia. Eisai retains exclusive development and marketing rights for the agent in Japan, China, Korea, Taiwan, Hong Kong, Macau, Indonesia,
Thailand, Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia, Laos, Afghanistan, Bangladesh,
Bhutan, Nepal, Mongolia, and Papua New Guinea. We paid Dr. Reddy’s a $
11
At the time of the FDA approval for LYMPHIR,
a $
Under the license agreement, Eisai was due a
$
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 $
The term of the license agreement will continue
until (i) March 30, 2026, if there has not been a commercial sale of a licensed product in the territory, or (ii) if there has been a
first commercial sale of a licensed product in the territory by March 30, 2026, the 10-year anniversary of the first commercial sale
on a country-by-country basis. The first commercial sale occurred in December 2025. The term of the license may be extended for additional
10-year periods for all countries in the territory by notifying Eisai and paying an extension fee equal to $
Under the purchase agreement with Dr. Reddy’s, we are required to (i) use commercially reasonable efforts to make commercially available products in the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology trials (both of which have been initiated), (iii) use commercially reasonable efforts to achieve each of the approval milestones, and (iv) complete each specified immuno-oncology investigator trial on or before the four-year anniversary of the effective date of the definitive agreement. Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory approval for such product in each such jurisdiction; though approved in August 2024, Dr. Reddy’s waived the six-month requirement and the launch of LYMPHIR in December 2025 satisfied this requirement in the U.S.
As part of the definitive agreement with Dr. Reddy’s, Citius Pharma acquired method of use patents in which LYMPHIR is administered in combination with the programmed cell death protein 1 (“PD-1”) pathway inhibitor drug class. PD-1 plays a vital role in inhibiting immune responses and promoting self-tolerance through modulating the activity of T-cells, activating apoptosis of antigen-specific T cells and inhibiting apoptosis of regulatory T cells.
12
The following patents were acquired and subsequently transferred to us:
| ● | US Provisional Application No. 63/070,645, which was filed on August 26, 2020, and subsequently published as US 2022/0062390 A1 on March 3, 2022, entitled Methods of Treating Cancer. |
| ● | International Patent Application Number: PCT/IB2021/0576733, which was filed with the World Intellectual Property Organization on August 23, 2021, and subsequently published as WO 2022/043863 A1 on March 3, 2022, entitled, Combination for Use in Methods of Treating Cancer. |
8. NOTE PAYABLE
On June 2, 2025, the Company borrowed $
On December 2, 2025, we extended the due date
to January 2, 2026 and the note was paid in full on January 5, 2026. As consideration for the extension, we issued a five-year warrant
to purchase
9. COMMON STOCK, STOCK OPTIONS, RESTRICTED STOCK AWARDS, AND WARRANTS
Authorized Common Stock and Reverse Stock Split
The Company filed a Certificate of Change with
the Secretary of State of the State of Nevada to (i) effect a
Series A Preferred Stock and Authorized Common Stock
On April 17, 2025, the Company entered into an
agreement with Leonard Mazur (Chairman and Chief Executive Officer of the Company), pursuant to which the Company sold
On April 17, 2025, the Company filed a certificate
of designation with the Nevada Secretary of State, designating the powers, rights, privileges and restrictions of the Series A Preferred
Stock. The certificate provides that each share of Series A Preferred Stock had
13
Pursuant to its terms, on June 9, 2025, the outstanding
share of Series A Preferred Stock was redeemed automatically for $
Common Stock Issued for Services
On July 1, 2025, we issued
On October 2, 2025, we issued
Common Stock Offerings
November 2024 Offering
On November 15, 2024, Citius Pharma sold
We paid the placement agent a fee of
January 2025 Offering
On January 7, 2025, Citius Pharma sold
We paid the placement agent a fee of
April 2025 Offering
On April 1, 2025, Citius Pharma sold
We paid the placement agent a fee of
14
June 2025 Offering
On June 11, 2025, Citius Pharma sold
We paid the placement agent a fee of
July 2025 Citius Oncology Offering
On July 17, 2025, Citius Oncology sold
Citius Oncology paid the placement agent a fee
of
September 2025 Citius Oncology Offering
On September 10, 2025, Citius Oncology sold
Citius Oncology paid the placement agent a fee
of
October 2025 Offering
On October 21, 2025, Citius Pharma sold
15
We paid the placement agent a fee of
December 2025 Citius Oncology Offering
On December 10, 2025, Citius Oncology sold
Citius Oncology paid the placement agent a fee
of
Citius Pharma At the Market Offering Agreement
On August 12, 2024, we entered into a sales agreement to sell from time to time during the term of the agreement shares of our common stock.
During the three months ended March 31, 2025,
we sold
During the three months ended June 30, 2025,
we sold
During the three months ended September 30, 2025,
we sold
During the three months ended December 31, 2025,
we sold
Citius Pharma Stock Option Plans
Under our 2014 Stock Plan, we reserved
Under our 2018 Stock Plan, we reserved
Under our 2020 Stock Plan, we reserved
16
Under our 2021 Stock Plan, we reserved
Under our 2023 Stock Plan, we reserved
The fair value of each stock option award is
estimated on the date of grant using the Black-Scholes option pricing model. Volatility is estimated using the trading activity of our
common stock. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with
the expected term assumption. The expected term of stock options granted, all of which qualify as “plain vanilla,” is based
on the average of the contractual term (generally
A summary of option activity under our stock option plans (excluding the NoveCite and Citius Oncology Stock Plans) is presented below:
| Option Shares | Weighted- Average Exercise Price | Weighted- Average Remaining Contractual Term | Aggregate Intrinsic Value | |||||||||||
| Outstanding at September 30, 2025 | $ | $ | ||||||||||||
| Granted | ||||||||||||||
| Exercised | ||||||||||||||
| Forfeited or expired | ( | ) | ||||||||||||
| Outstanding at December 31, 2025 | $ | $ | ||||||||||||
| Exercisable at December 31, 2025 | $ | $ | ||||||||||||
At December 31, 2025, unrecognized total compensation
cost related to unvested awards under the Citius Pharma stock plans of $
NoveCite Stock Plan - Under the
NoveCite 2020 Stock Plan, adopted November 5, 2020, we reserved
As of December 31, 2025, NoveCite has options
outstanding to purchase
Citius Oncology Stock Plan - Under
the Citius Oncology 2023 Stock Plan, adopted on April 29, 2023, Citius Oncology reserved
The fair value of each stock option award is
estimated on the date of grant using the Black-Scholes option pricing model. Volatility is estimated using the trading activity of Citius
Pharma common stock. until such time as Citius Oncology has sufficient history. The risk-free interest rate is based on the U.S. Treasury
yield curve in effect at the time of grant commensurate with the expected term assumption. The expected term of stock options granted
to employees and directors, all of which qualify as “plain vanilla,” is based on the average of the contractual term (generally
17
A summary of option activity under the Citius Oncology stock plans is presented below:
| Shares | Weighted- Average Exercise Price | Weighted- Average Remaining Contractual Term | Aggregate Intrinsic Value | |||||||||||
| Outstanding at September 30, 2025 | $ | $ | ||||||||||||
| Granted | ||||||||||||||
| Forfeited | ||||||||||||||
| Outstanding at December 31, 2025 | $ | $ | ||||||||||||
| Exercisable at December 31, 2025 | $ | $ | ||||||||||||
At December 31, 2025, unrecognized total compensation
cost related to unvested awards under the Citius Oncology stock plans of $
Restricted Stock Awards
On September 19, 2025, the Board of Directors
granted restricted stock awards of
At December 31, 2025, unrecognized total compensation
cost related to unvested restricted stock awards under the stock plans of $
Stock-based Compensation Expense
Stock-based compensation expense under all plans
for the three months ended December 31, 2025 and 2024 was $
Citius Pharma Warrants
We have reserved
| Exercise price | Expiration Dates | |||||||||
| August 2018 Offering Investors | $ | | ||||||||
| August 2018 Offering Agent | $ | | ||||||||
| September 2019 Offering Investors | $ | | ||||||||
| September 2019 Offering Underwriter | $ | | ||||||||
| January 2021 Offering Investors | $ | | ||||||||
| January 2021 Offering Agent | $ | | ||||||||
| February 2021 Offering Investors | $ | | ||||||||
| February 2021 Offering Agent | $ | | ||||||||
| May 2023 Offering Investors | $ | | ||||||||
| May 2023 Offering Agent | $ | | ||||||||
| April 2024 Offering Investors | $ | | ||||||||
| April 2024 Offering Agent | $ | | ||||||||
| November 2024 Offering Investors | $ | | ||||||||
| November 2024 Offering Agent | $ | | ||||||||
| January 2025 Offering Investors | $ | | ||||||||
| January 2025 Offering Agent | $ | | ||||||||
| April 2025 Offering Agent | $ | | ||||||||
| June 2025 Offering Investor | $ | | ||||||||
| June 2025 Offering Agent | $ | | ||||||||
| October 2025 Offering Investor | $ | | ||||||||
| October 2025 Placement Agent | $ | | ||||||||
| December 2025 Note Payable Extension | $ | | ||||||||
18
At December 31, 2025, the weighted average remaining
life of the outstanding warrants is
Citius Oncology Warrants
Citius Oncology has reserved
| Exercise price | Number | Expiration Dates | ||||||||
| July 2025 Offering Investors | $ | |||||||||
| July 2025 Offering Agent | $ | |||||||||
| July 2025 Prior Offering Agent | $ | |||||||||
| September 2025 Offering Investors | $ | |||||||||
| September 2025 Offering Agent | $ | |||||||||
| September 2025 Prior Offering Agent | $ | |||||||||
| December 2025 Offering Investors | $ | None | ||||||||
| December 2025 Offering Investors | $ | |||||||||
| December 2025 Placement Offering Agent | $ | |||||||||
| December 2025 Prior Offering Agent | $ | |||||||||
At December 31, 2025, the weighted average remaining
life of the outstanding warrants was estimated at
Citius Pharma Common Stock Reserved
A summary of common stock reserved for future issuances by Citius Pharma excluding all subsidiaries as of December 31, 2025 is as follows:
| Stock plan options outstanding | ||||
| Stock plan shares available for future grants | ||||
| Warrants outstanding | ||||
| Total |
Citius Oncology Common Stock Reserved
A summary of common stock reserved for future issuances by Citius Oncology as of December 31, 2025 is as follows:
| Stock plan options outstanding | ||||
| Restricted stock awards | ||||
| Stock plan shares available for future grants | ||||
| Warrants outstanding | ||||
| Total |
19
10. COMMITMENTS AND CONTINGENCIES
Operating Lease
Effective July 1, 2019, we entered into a 76-month
lease for office space in Cranford, NJ. On February 28, 2025, we extended the lease until February 28, 2030. A right-of-use asset of
$
We identified and assessed the following significant assumptions in recognizing our right-of-use assets and corresponding lease liabilities:
| ● | As the Cranford lease does not provide an implicit rate, we estimated the incremental borrowing rate in calculating the present value of the lease payments based on the remaining term as of the amendment date. |
| ● | Since we elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the combined lease component. |
| ● | The expected lease terms include noncancelable lease periods. |
The elements of lease expense are as follows:
| Lease cost | Three Months Ended December31, 2025 | Three Months Ended December31, 2024 | ||||||
| Operating lease cost | $ | $ | ||||||
| Variable lease cost | ||||||||
| Total lease cost | $ | $ | ||||||
| Other information | ||||||||
| Weighted-average remaining lease term - operating leases | ||||||||
| Weighted-average discount rate - operating leases | % | % | ||||||
Maturities of lease liabilities due under the Company’s non-cancellable leases are as follows:
| Year Ending September 30, | December 31, 2025 | |||
| 2026 (excluding the 3 months ended December 31, 2025) | $ | |||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| 2030 | ||||
| Total lease payments | ||||
| Less: interest | ( | ) | ||
| Present value of lease liabilities | $ | |||
20
| Leases | Classification | December 31, 2025 | September 30, 2025 | |||||||
| Assets | ||||||||||
| Lease asset | Operating | $ | $ | |||||||
| Total lease assets | $ | $ | ||||||||
| Liabilities | ||||||||||
| Current | Operating | $ | $ | |||||||
| Non-current | Operating | |||||||||
| Total lease liabilities | $ | $ | ||||||||
Interest expense on the lease liability was $
Commercial Manufacturing Contracts
Citius Oncology has entered into an agreement
with a contract manufacturing organization for the manufacture and supply of drug substance. The agreement runs through calendar year
2026, with an automatic renewal for a subsequent four-year term. Under this agreement, the Company is obligated to purchase minimum annual
quantities of batches at a set price per batch, subject to annual increases. Additionally, the Company is required to pay an annual service
fee of $
As of December 31, 2025, the Company also has
commercial supply agreements with two other vendors for the completion and packaging of finished drug products. Minimum purchase commitments
under these two agreements amount to approximately $
11. SUBSEQUENT EVENTS
On February 9, 2026, we received a notification
letter from the Nasdaq Stock Market LLC (“Nasdaq”) indicating that we were not in compliance with Nasdaq Listing Rule 5550(a)(2)
because the minimum bid price of our common stock on the Nasdaq Capital Market closed below $
21
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations for the three months ended December 31, 2025 and 2024 should be read together with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Report and in conjunction with the audited financial statements of Citius Pharmaceuticals, Inc. included in our Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025, as amended on January 28, 2026. The following discussion contains “forward-looking statements” that reflect our future plans, estimates, beliefs and expected performance. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors. We caution that assumptions, expectations, projections, intentions, or beliefs about future events may, and often do, vary from actual results and the differences can be material. Please see “Cautionary Note Regarding Forward-Looking Statements” on page iii of this Report.
Business
We are a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. On September 12, 2014, we acquired Citius Pharmaceuticals, LLC as a wholly-owned subsidiary. Citius Pharmaceuticals, LLC was dissolved on December 29, 2023.
On March 30, 2016, we acquired all of the outstanding stock of Leonard-Meron Biosciences, Inc. by issuing shares of our common stock. We acquired identifiable intangible assets of $19,400,000 related to in-process research and development and recorded goodwill of $9,346,796 for the excess of the purchase consideration over the net assets acquired.
On September 11, 2020, we formed NoveCite, Inc., of which we own 75% of the issued and outstanding capital stock.
On August 23, 2021, we formed Citius Acquisition Corp., or SpinCo, as a wholly-owned subsidiary in conjunction with the acquisition of LYMPHIR, but Citius Acquisition did not begin operations until April 2022, when Citius Pharma transferred to it the assets related to LYMPHIR, including the related license agreement with Eisai and the related asset purchase agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s. At this time, Citius Acquisition changed its name to Citius Oncology, Inc. In August 2024, as part of the merger, the new publicly-traded company and majority-owned subsidiary was named Citius Oncology, Inc.
In-process research and development of $19,400,000 represents the value of LMB’s leading drug candidate (Mino-Lok), which is an antibiotic solution used to treat catheter-related bloodstream infections and is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. Goodwill of $9,346,796 represents the value of LMB’s industry relationships and its assembled workforce. Goodwill will not be amortized but will be tested at least annually for impairment. In-process research and development of $73,400,000 represents the value of our exclusive license for LYMPHIR (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma and is being amortized on a straight-line basis over the remaining period of market exclusivity commencing upon revenue generation in December 2025.
Through December 31, 2025, we have devoted substantially all of our efforts to product development, raising capital, building infrastructure through strategic alliances and coordinating activities relating to our proprietary products. We have realized limited revenues from the sale of LYMPHIR, which commenced in December 2025.
Reverse Stock Split
Effective November 25, 2024, we executed a reverse stock split of our common stock, at a ratio of 1-for-25. All share amounts have been retroactively adjusted to reflect the split.
22
Patent and Technology License Agreements
Mino-Lok® - LMB has a patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc. (“NAT”) to develop and commercialize Mino-Lok on an exclusive, worldwide sub-licensable basis, as amended. Since May 2014, LMB has paid an annual maintenance fee, which began at $30,000 and has increased over five years to $90,000, where it will remain until the commencement of commercial sales of a product subject to the license. LMB will also pay annual royalties on net sales of licensed products, with a low double digit royalty rate (within a range of 10% to 15%). In limited circumstances in which the licensed product is not subject to a valid patent claim and a competitor is selling a competing product, the royalty rate is in the low to mid-single digits (within a range of 2% to 7%). After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties of $100,000 in the first commercial year which is prorated for a less-than-12-month period, increasing $25,000 per year to a maximum of $150,000 annually. LMB must also pay NAT up to $1,100,000 upon achieving specified regulatory and sales milestones. Finally, LMB must pay NAT a specified percentage of payments received from any sub-licensees.
NoveCite - On October 6, 2020, our subsidiary NoveCite entered into a license agreement with Novellus Therapeutics Limited, whereby NoveCite acquired an exclusive, worldwide license, with the right to sublicense, to develop and commercialize a stem cell therapy based on Novellus’s patented technology for the treatment of acute pneumonitis of any etiology in which inflammation is a major agent in humans. Upon execution of the license agreement, NoveCite paid $5,000,000 to Novellus and issued Novellus shares of Novecite’s common stock representing 25% of NoveCite’s outstanding equity. We own the other 75% of NoveCite’s outstanding equity.
In July 2021, Novellus was acquired by Brooklyn ImmunoTherapeutics and the NoveCite license was assumed by Brooklyn with all original terms and conditions. In October 2021, Brooklyn changed its name to Eterna Therapeutics Inc. (“Eterna”).
As part of the Novellus and Brooklyn merger transaction, the 25% non-dilutive position per the subscription agreement between Novellus and NoveCite was removed.
Under the license agreement, NoveCite is obligated to pay Eterna up to an aggregate of $51,000,000 in regulatory and developmental milestone payments. NoveCite also must pay a royalty equal to a mid-teens percentage of net sales, commencing upon the first commercial sale of a licensed product. This royalty is subject to downward adjustment on a product-by-product and country-by-country basis to a mid-single digit percentage (within a range of 4% to 8%) of net sales in any country in the event of the expiration of the last valid patent claim or if no valid patent claim exists in that country. The royalty will end on the earlier of (i) date on which a biosimilar product is first marketed, sold, or distributed by Eterna or any third party in the applicable country or (ii) the 10-year anniversary of the date of expiration of the last-to-expire valid patent claim in that country. In the case of a country where no licensed patent ever exists, the royalty will end on the later of (i) the date of expiry of such licensed product’s regulatory exclusivity and (ii) the 10-year anniversary of the date of the first commercial sale of the licensed product in the applicable country. In addition, NoveCite will pay to Eterna an amount equal to a mid-twenties percentage of any sublicensee fees it receives.
Under the terms of the license agreement, in the event that Eterna receives any revenue involving the original cell line included in the licensed technology, then Eterna shall remit to NoveCite 50% of such revenue.
LYMPHIR - In September 2021, the Company entered into an asset purchase agreement with Dr. Reddy’s and a license agreement with Eisai to acquire an exclusive license of E7777 (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. Citius Pharma assigned these agreements to Citius Acquisition Corp. effective April 1, 2022. We renamed E7777 as I/ONTAK and also obtained the trade name LYMPHIRTM for the product. Denileukin diftitox is referred to in this report as E7777, I/ONTAK or LYMPHIR, depending on the period of time and context that is being discussed.
Under the terms of these agreements, Citius Pharma acquired Dr. Reddy’s exclusive license of E7777 from Eisai and other related assets owned by Dr. Reddy’s (which are now owned by Citius Oncology). The exclusive license, through Citius Oncology, includes rights to develop and commercialize E7777 in all markets except for Japan and certain parts of Asia. Eisai retains exclusive development and marketing rights for the agent in Japan, China, Korea, Taiwan, Hong Kong, Macau, Indonesia, Thailand, Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia, Laos, Afghanistan, Bangladesh, Bhutan, Nepal, Mongolia, and Papua New Guinea. Citius Pharma paid Dr. Reddy’s a $40 million upfront payment which represents the acquisition date fair value of the in-process research and development acquired from Dr. Reddy’s. Dr. Reddy’s is entitled to up to $40 million in development milestone payments related to CTCL approvals in the U.S. and other markets, up to $70 million in development milestones for additional indications, as well as commercial milestone payments and low double-digit tiered royalties on net product sales (within a range of 10% to 15%), and up to $300 million for commercial sales milestones. Citius Oncology also must pay on a fiscal quarter basis tiered royalties equal to low double-digit percentages of net product sales (within a range of 10% to 15%). The royalties will end on the earlier of (i) the 15-year anniversary of the first commercial sale of the latest indication that received regulatory approval in the applicable country and (ii) the date on which a biosimilar product results in the reduction of net sales in the applicable product by 50% in two consecutive quarters, as compared to the four quarters prior to the first commercial sale of the biosimilar product. Citius Oncology will also pay Dr. Reddy’s an amount equal to a low-thirties percentage of any sublicense upfront consideration or milestone payments (or the like) received by us and the greater of (i) a low-thirties percentage of any sublicensee sales-based royalties or (ii) a mid-single digit percentage of such licensee’s net sales. Citius Pharma is a guarantor of Citius Oncology’s payment obligations under these agreements.
23
At the time of the FDA approval for LYMPHIR, a $27.5 million milestone payment became payable to Dr. Reddy’s under the terms of the asset purchase agreement for which a balance of $18.25 million remains due as of December 31, 2025. Dr. Reddy’s agreed to a partial deferral without penalty of this milestone payment.
Under the license agreement, Eisai was due a $5.9 million milestone payment, upon FDA approval, and additional commercial milestone payments related to the achievement of net product sales thresholds and an aggregate of up to $22 million related to the achievement of net product sales thresholds. We were also required to reimburse Eisai for up to $2.65 million of its costs to complete the Phase 3 pivotal clinical trial for LYMPHIR for the CTCL indication and reimburse Eisai for all reasonable costs associated with the preparation of a BLA for LYMPHIR. Eisai was responsible for completing the CTCL clinical trial, and CMC activities through the filing of the BLA for LYMPHIR with the FDA. We are responsible for development costs associated with potential additional indications.
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 $2,535,318 on July 15, 2025, $2,350,000 on the 15th of each of the subsequent four months, and make a final payment of $2,197,892 on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of payment at the rate of 2% per annum. During the three months ended December 31, 2025, we recorded $45,841 in interest expense under the agreement. The 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. On December 15, 2025, we paid Eisai the balance of the outstanding milestone approval fee and accumulated interest on the license fee. At December 31, 2025, we owe Eisai approximately $6.8 million for certain other unpaid invoices.
The term of the license agreement will continue until (i) March 30, 2026, if there has not been a commercial sale of a licensed product in the territory, or (ii) if there has been a first commercial sale of a licensed product in the territory by March 30, 2026, the 10-year anniversary of the first commercial sale on a country-by-country basis. The first commercial sale occurred in December 2025. The term of the license may be extended for additional 10-year periods for all countries in the territory by notifying Eisai and paying an extension fee equal to $10 million. Either party may terminate the license agreement upon written notice if the other party is in material breach of the agreement, subject to cure within the designated time periods. Either party also may terminate the license agreement immediately upon written notice if the other party files for bankruptcy or takes related actions or is unable to pay its debts as they become due. Additionally, either party will have the right to terminate the agreement if the other party directly or indirectly challenges the patentability, enforceability or validity of any licensed patent.
Under the purchase agreement with Dr. Reddy’s, we are required to (i) use commercially reasonable efforts to make commercially available products in the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology trials (both of which have been initiated), (iii) use commercially reasonable efforts to achieve each of the approval milestones, and (iv) to complete each specified immuno-oncology investigator trial on or before the four-year anniversary of the effective date of the definitive agreement. Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory approval for such product in each such jurisdiction; though approved in August 2024, Dr. Reddy’s waived the six months requirement and the launch of LYMPHIR in December 2025 satisfied this requirement in the U.S.
24
RESULTS OF OPERATIONS
Three months ended December 31, 2025 compared with the three months ended December 31, 2024
| Three Months Ended December 31, 2025 | Three Months Ended December 31, 2024 | |||||||
| Revenue | $ | 3,944,111 | — | |||||
| Cost of revenues | (789,208 | ) | — | |||||
| Gross profit | 3,154,903 | — | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,599,719 | 2,127,038 | ||||||
| Amortization of in-process research and development | 573,438 | — | ||||||
| General and administrative | 5,720,727 | 5,387,752 | ||||||
| Stock-based compensation – general and administrative | 4,280,227 | 2,524,824 | ||||||
| Total operating expenses | 12,174,111 | 10,039,614 | ||||||
| Operating loss | (9,019,208 | ) | (10,039,614 | ) | ||||
| Interest income | 45,097 | 22,608 | ||||||
| Interest expense | (155,538 | ) | — | |||||
| Loss before income taxes | (9,129,649 | ) | (10,017,006 | ) | ||||
| Income tax expense | 264,240 | 264,240 | ||||||
| Net loss | $ | (9,393,889 | ) | $ | (10,281,246 | ) | ||
Revenues
In 2025, the Company executed three service agreements with pharmaceutical specialty distributors who are our customers and who distribute LYMPHIR to healthcare organizations which include academic centers, community oncology practices, as well as infusion centers. The transaction price for gross product revenues under these customer specialty distributor agreements are based on the contractually stated wholesale acquisition cost (“WAC”). The transaction price is reduced for variable considerations, including product returns, chargebacks, co-payment assistance, and other gross-to-net adjustments, which are reasonably estimated by the Company and constrained to amounts that are probable not to result in a significant revenue reversal. As LYMPHIR is a newly launched product, any reasonable estimates made by the Company regarding certain gross-to-net adjustments will result from certain information, such as inventory held by distributors, market data or comparable products, until sufficient historical data becomes available.
Net product revenues for the three months ended December 31, 2025 were $3,944,111, as we began commercial distribution of LYMPHIR in December 2025. Gross profit on net product revenues for the three months ended December 31, 2025 was approximately 80%.
The Company believes that revenues will increase in the future as LYMPHIR gains market acceptance.
Research and Development Expenses
For the three months ended December 31, 2025, research and development expenses were $1,599,719, as compared to $2,127,038 during the three months ended December 31, 2024, a decrease of $527,319.
Research and development costs for Mino-Lok decreased by $304,186 to $80,830 for the three months ended December 31, 2025, as compared to $385,016 for the three months ended December 31, 2024, due primarily to decreased costs since the completion of the Phase 3 trial as well as catheter validation and combination studies. In November 2024, the Company held a Type C meeting with the FDA to discuss the results of the Phase 3 study and to obtain the FDA’s view on development plans for Mino-Lok. The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok.
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Research and development costs for Halo-Lido decreased by $8,377 to $2,319 for the three months ended December 31, 2025, as compared to $10,696 for the three months ended December 31, 2024. The Phase 2 study was completed in April 2023. Citius subsequently met with the FDA for an end of Phase 2 meeting to discuss next steps in the clinical development program.
Research and development costs for LYMPHIR decreased by $217,945 to $1,509,595 during the three months ended December 31, 2025, as compared to $1,727,540 for the three months ended December 31, 2024 primarily related pre commercial manufacturing implementation services related to product labeling and serialization.
Amortization of in-process research and development
Amortization of in-process research and development commenced upon revenue generation in December 2025. For the three months ended December 31, 2025 amortization was $573,438. In-process research and development is being amortized on a straight-line basis over the remaining FDA product exclusivity period which ends in August 2036.
General and Administrative Expenses
For the three months ended December 31, 2025, general and administrative expenses were $5,720,727, as compared to $5,387,752 during the three months ended December 31, 2024. General and administrative expenses increased by $332,975 in comparison with the prior period. Overall general and administrative expenses were consistent with the prior period. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.
Stock-based Compensation Expense
For the three months ended December 31, 2025 stock-based compensation expense was $4,280,227, as compared to $2,524,824 for the three months ended December 31, 2024. Stock-based compensation expense includes $324,177 for Citius Pharma stock options, $2,252,035 for Citius Oncology stock options and $1,704,015 for Citius Oncology restricted stock awards for the three months ended December 31, 2025. Stock-based compensation expense includes $716,345 for Citius Pharma stock options and $1,808,479 for Citius Oncology stock options for the three months ended December 31, 2024. Stock-based compensation expense for the most recently completed quarter increased by $1,755,403 in comparison to the prior period primarily due to the Citius Oncology restricted stock awards granted in September 2025.
Interest Income (Expense)
For the three months ended December 31, 2025, interest income was $45,097, as compared to interest income of $22,608 for the three months ended December 31, 2024. We have invested the remaining proceeds of our equity offerings in money market accounts.
For the three months ended December 31, 2025, interest expense was $155,538, as compared to $0 for the three months ended December 31, 2024. For the three months ended December 31, 2025, interest expense of $45,841 was related to the March 28, 2025 letter agreement with Eisai and interest expense on the note payable, including the fair value of the warrant issued to the lender was $109,697.
Income Taxes
The Company recorded deferred income tax expense of $264,240 for both the three months ended December 31, 2025 and 2024 related to the amortization for taxable purposes of our in-process research and development asset.
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Net Loss
For the three months ended December 31, 2025, we incurred a net loss of $9,393,889, as compared to a net loss for the three months ended December 31, 2024 of $10,281,246. The $887,357 decrease in net loss was primarily due to our gross profit on revenues of $3,154,903 offset by an increase of $2,134,497 in our total operating expenses, primarily related to the granting of restricted stock awards.
LIQUIDITY AND CAPITAL RESOURCES
Liquidity and Working Capital
We have incurred operating losses since inception and incurred a net loss of approximately $9.4 million for the three months ended December 31, 2025. At December 31, 2025, we had an accumulated deficit of approximately $247 million. At December 31, 2025, we had $7.7 million in cash and a negative working capital of approximately $262,000. Our net cash used in operations during the three months ended December 31, 2025 was approximately $13 million. Our primary source of cash flow since inception has been from financing activities. We have had limited revenue from sales of LYMPHIR, which commenced in December 2025.
During the three months ended December 31, 2025, Citius Pharma received net proceeds of approximately $5.8 million from equity offerings and Citius Oncology received approximately $15.1 million from an equity offering.
In order to satisfy our outstanding milestone payment obligations, as well as meet minimum purchase commitments under our agreements for the manufacture and supply of our drug product, in addition to generating income from the sale of LYMPHIR, we need to obtain substantial additional financing and cannot be sure that any additional funding will be available on terms favorable to us, or at all. As of December 31, 2025, our outstanding milestone payments and purchase commitments for 2025 include:
| ● | On March 28, 2025, we entered into a letter agreement to pay Eisai $2,535,318 on or before July 15, 2025, and $2,350,000 thereafter on the 15th of each of the next four months, and make a final payment of $2,197,892 on or before December 15, 2025, in each case with interest on each obligation from its original due date at the rate of 2% per annum. As of December 31, 2025, we have paid the milestone in full and owe a balance of approximately $6.8 million to Eisai for certain other invoices. |
| ● | At the time of the FDA approval for LYMPHIR, a $27.5 million milestone payment became payable to Dr. Reddy’s of which a balance of $18.25 million remains due as of December 31, 2025. Dr. Reddy’s has agreed to a partial deferral without penalty of this milestone payment. |
| ● | We entered into an agreement with a contract manufacturing organization for the manufacture and supply of drug substance. Under this agreement, we are obligated to purchase minimum annual quantities of batches at a set price per batch, subject to annual increases. As of December 31, 2025, the total minimum purchase commitment under this agreement was approximately $16.2 million, consisting of payments of $9.9 million and $6.3 million for calendar years 2025 and 2026, respectively with 2025 representing prior obligations which were not manufactured. |
| ● | As of December 31, 2025, we also have commercial supply agreements with two other vendors for the completion and packaging of finished drug products. Minimum purchase commitments under these two agreements are approximately $4.0 million consisting of purchase commitment obligations of $2.2 million in calendar years 2026 and $1.8 million in 2027. |
After giving effect to our recent equity offerings during the three months ended December 31, 2025, we expect that we and Citius Oncology collectively will have sufficient funds to continue our operations through May 2026. We will need to raise additional capital in the future to support our operations beyond May 2026. There is no assurance, however, that we will be successful in raising needed capital or that the proceeds will be received in an amount or in a timely manner to support our operations.
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Investing Activities
During the three months ended December 31, 2025, we paid the final $2,900,000 due to Eisai in connection with the LYMPHIR approval milestone and paid $1,500,000 in connection with the milestone payment due to Dr. Reddy’s. At December 31, 2025, we owe Dr. Reddy’s $18,250,000 representing the balance of the approval milestone.
Inflation
Our management believes that inflation has not had a material effect on our results of operations.
Off Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Critical Accounting Policies and Estimates
The preparation of our financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities as of the date of the financial statements and the amounts of revenues and expenses recorded during the reporting periods. We base our estimates on historical experience, where applicable, and other assumptions that we believe are reasonable under the circumstances. Actual results may differ from our estimates under different assumptions or conditions.
Our critical accounting policies and use of estimates as discussed in the footnotes to the condensed consolidated financial statements included within this Form 10-Q should also be read in conjunction with, the annual consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025, as amended January 28, 2026.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures designed to provide reasonable assurance that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the specified time periods and accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding disclosure.
Our Chief Executive Officer (who is our principal executive officer) and Chief Financial Officer (who is our principal financial officer and principal accounting officer), evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) as of December 31, 2025. In designing and evaluating disclosure controls and procedures, we recognize that any disclosure controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objective. As of December 31, 2025, based on the evaluation of these disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms.
Changes In Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
None.
Item 1A. Risk Factors.
There have been no material changes to the Company’s risk factors as disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with the SEC on December 23, 2025, as amended January 28, 2026.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
During the quarter ended December 31, 2025, we did not issue or sell any unregistered securities not previously disclosed.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
During the quarter ended December 31, 2025, none
of our directors or officers
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Item 6. Exhibits.
| * | Filed herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| CITIUS PHARMACEUTICALS, INC. | ||
| Date: February 13, 2026 | By: | /s/ Leonard Mazur |
| Leonard Mazur | ||
| Chief Executive Officer (Principal Executive Officer) | ||
| Date: February 13, 2026 | By: | /s/ Jaime Bartushak |
| Jaime Bartushak | ||
| Chief Financial Officer (Principal Financial and Accounting Officer) | ||
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