UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: March 31, 2026
OR
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ______________
to ______________
Commission File Number 001-41534
Citius Oncology, Inc.
(Exact name of registrant as specified in its
charter)
Delaware 99-4362660
( State or other jurisdiction of
incorporation or organization )
( IRS Employer
Identification No. )
11 Commerce Drive , First Floor , Cranford , NJ 07016
( Address of principal executive offices ) ( Zip Code )
(908) 967-6677
( Registrant’s telephone number, including
area code )
Securities registered pursuant to Section 12(b)
of the Act:
Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered
Common stock, $0.0001 par value CTOR Nasdaq Capital Market
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 14, 2026, there were 92,981,204 shares
of common stock, $0.0001 par value, of the registrant issued and outstanding.
Citius Oncology, Inc.
FORM 10-Q
TABLE OF CONTENTS
March 31, 2026
Page
PART I. FINANCIAL INFORMATION:
1
Item 1.
Financial Statements (Unaudited)
1
Condensed Consolidated Balance Sheets at March 31, 2026 and September 30, 2025
1
Condensed Consolidated Statements of Operations for the Three and Six Months Ended March 31, 2026 and 2025
2
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended March 31, 2026 and 2025
3
Condensed Consolidated Statements of Cash Flows for the Six Months Ended March 31, 2026 and 2025
4
Notes to Condensed Consolidated Financial Statements
5
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
17
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
26
Item 4.
Controls and Procedures
26
PART II. OTHER INFORMATION
27
Item 1.
Legal Proceedings
27
Item 1A.
Risk Factors
27
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
27
Item 3.
Defaults Upon Senior Securities
27
Item 4.
Mine Safety Disclosures
27
Item 5.
Other Information
27
Item 6.
Exhibits
28
SIGNATURES
29
i
EXPLANATORY NOTE
In this Quarterly Report on Form 10-Q, and unless
the context otherwise requires, the “Company,” “Citius Oncology,” “we,” “us,” and “our”
refer to Citius Oncology, Inc. and its wholly-owned subsidiary Citius Oncology Sub Inc. (“Citius Oncology Sub”) taken as
a whole.
LYMPHIR TM (denileukin diftitox) is
our registered trademark. 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 successfully
commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and
services;
●
our ability to regain
compliance with the continued listing requirements of the Nasdaq Stock Market LLC (“Nasdaq”);
●
the ability of LYMPHIR
or any of our future product candidates to impact the quality of life of our target patient populations;
●
the estimated markets for
LYMPHIR or any of our future product candidates and the acceptance thereof by any market;
●
our ability to recognize
the anticipated benefits of the August 2024 reverse merger whereby we became a standalone publicly-traded company and majority-owned
subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”), which may not be realized fully, if at all, or may take
longer to realize than expected;
●
our ability to procure
cGMP commercial-scale supply;
●
our ability to obtain,
perform under and maintain financing and strategic agreements and relationships;
●
our ability to manage and
grow our business and execution of our business and growth strategies;
●
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.
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 ONCOLOGY, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31,
2026
September 30,
2025
Current Assets:
Cash and cash equivalents
$ 2,632,634
$ 3,924,908
Accounts receivable, net of allowances
1,079,055
—
Inventory
22,659,590
22,286,693
Prepaid expenses
3,052,387
1,331,280
Total Current Assets
29,423,666
27,542,881
Other Assets:
In-process research and development, net of accumulated amortization
71,106,250
73,400,000
Deferred financing costs
169,252
—
Total Other Assets
71,275,502
73,400,000
Total Assets
$ 100,699,168
$ 100,942,881
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$ 8,883,239
$ 13,234,684
License payable
17,650,000
22,650,000
Accrued expenses
24,057,573
4,093,124
Due to related party
8,221,486
9,513,771
Total Current Liabilities
58,812,298
49,491,579
Deferred tax liability
2,817,990
2,784,960
Note payable to related party
3,800,111
3,800,111
Total Liabilities
65,430,399
56,076,650
Stockholders’ Equity:
Preferred stock - $ 0.0001 par value; 10,000,000 shares authorized: no shares issued and outstanding
—
—
Common stock - $ 0.0001 par value; 400,000,000 shares authorized at March 31, 2026 and September 30, 2025; 92,981,204 and 83,513,442 shares issued and outstanding at March 31, 2026 and September 30, 2025, respectively
9,298
8,351
Additional paid-in capital
131,443,191
108,897,836
Accumulated deficit
( 96,183,720 )
( 64,039,956 )
Total Stockholders’ Equity
35,268,769
44,866,231
Total Liabilities and Stockholders’ Equity
$ 100,699,168
$ 100,942,881
See notes to unaudited
condensed consolidated financial statements.
1
CITIUS ONCOLOGY, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND Six
Months Ended March 31, 2026 and 2025 (Unaudited)
Three Months Ended
Six Months Ended
March 31,
March 31,
March 31,
March 31,
2026
2025
2026
2025
Revenues
$ 1,667,298
$ —
$ 5,611,409
$ —
Cost of revenues
( 328,878 )
—
( 1,118,086 )
—
Gross Profit
1,338,420
—
4,493,323
—
Operating Expenses
Research and development
1,079,354
3,139,413
2,097,706
4,403,921
Amortization of in-process research and development
1,720,312
—
2,293,750
—
General and administrative
23,625,639
2,243,327
26,484,978
5,565,306
Stock-based compensation – general and administrative
3,526,710
2,088,572
7,482,760
3,897,050
Total Operating Expenses
29,952,015
7,471,312
38,359,194
13,866,277
Operating Loss
( 28,613,595 )
( 7,471,312 )
( 33,865,871 )
( 13,866,277 )
Other Income (Expense)
Interest income
43,721
—
72,009
—
Gain on sale of New Jersey net operating losses
1,762,000
—
1,762,000
—
Interest expense
( 33,031 )
—
( 78,872 )
—
Total Other Income, Net
1,772,690
—
1,755,137
—
Loss before Income Taxes
( 26,840,905 )
( 7,471,312 )
( 32,110,734 )
( 13,866,277 )
Income tax expense (benefit)
( 231,210 )
264,240
33,030
528,480
Net Loss
$ ( 26,609,695 )
$ ( 7,735,552 )
$ ( 32,143,764 )
$ ( 14,394,757 )
Net Loss Per Share - Basic and Diluted
$ ( 0.27 )
$ ( 0.11 )
$ ( 0.34 )
$ ( 0.20 )
Weighted Average Common Shares Outstanding
Basic and diluted (includes pre-funded warrants from the December 2025 offering)
100,027,204
71,552,402
93,657,757
71,552,402
See notes to unaudited
condensed consolidated financial statements.
2
CITIUS ONCOLOGY, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES
IN STOCKHOLDERS’ EQUITY
FOR THE THREE AND Six
Months Ended March 31, 2026 and 2025
(Unaudited)
Preferred Stock
Common Stock
Additional
Paid-In
Accumulated
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance, September 30, 2025
-
$ -
83,513,442
$ 8,351
$ 108,897,836
$ ( 64,039,956 )
$ 44,866,231
December 2025 sale of common stock and pre-funded warrants, net of costs of $ 2,872,989
-
-
1,284,404
129
15,125,360
-
15,125,489
Stock-based compensation expense
-
-
-
-
3,956,050
-
3,956,050
Net loss
-
-
-
-
-
( 5,534,069 )
( 5,534,069 )
Balance, December 31, 2025
-
-
84,797,846
8,480
127,979,246
( 69,574,025 )
58,413,701
Proceeds from exercise of pre-funded warrants
-
-
8,183,358
818
-
-
818
December 2025 offering costs
-
-
-
-
( 62,765 )
-
( 62,765 )
Stock-based compensation expense
-
-
-
-
3,526,710
-
3,526,710
Net loss
-
-
-
-
-
( 26,609,695 )
( 26,609,695 )
Balance March 31, 2026
-
$ -
92,981,204
$ 9,298
$ 131,443,191
$ ( 96,183,720 )
$ 35,268,769
Balance, September 30, 2024
-
$ -
71,552,402
$ 7,155
$ 85,411,771
$ ( 39,278,587 )
$ 46,140,339
Stock-based compensation expense
-
-
-
-
1,808,478
-
1,808,478
Net loss
-
-
-
-
-
( 6,659,205 )
( 6,659,205 )
Balance, December 31, 2024
-
-
71,552,402
7,155
87,220,249
( 45,937,792 )
41,289,612
Stock-based compensation expense
-
-
-
-
2,088,572
-
2,088,572
Net loss
-
-
-
-
-
( 7,735,552 )
( 7,735,552 )
Balance, March 31, 2025
-
$ -
71,552,402
$ 7,155
$ 89,308,821
$ ( 53,673,344 )
$ 35,642,632
See notes to unaudited
condensed consolidated financial statements.
3
CITIUS ONCOLOGY, INC.
Condensed
Consolidated STATEMENTS OF CASH FLOWS
FOR THE Six
Months Ended March 31, 2026 and 2025
(Unaudited)
2026
2025
Cash Flows From Operating Activities:
Net loss
$ ( 32,143,764 )
$ ( 14,394,757 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
7,482,760
3,897,050
Amortization of in-process research and development
2,293,750
-
Deferred income tax expense
33,030
528,480
Changes in operating assets and liabilities:
Accounts receivable, net of allowances
( 1,079,055 )
-
Inventory
( 372,897 )
( 7,070,487 )
Prepaid expenses
( 1,721,107 )
-
Accounts payable
( 4,351,445 )
3,964,688
Accrued expenses
19,964,449
8,722,168
Due to related party
( 1,292,285 )
4,352,858
Net Cash (Used In) Provided By Operating Activities
( 11,186,564 )
-
Cash Flows From Investing Activities
License payments
( 5,000,000 )
-
Net Cash Used In Investing Activities
( 5,000,000 )
-
Cash Flows From Financing Activities
Deferred financing costs
( 169,252 )
-
Net proceeds from issuance of common stock
15,063,542
-
Net Cash Provided by Financing Activities
14,894,290
-
Net Change in Cash and Cash Equivalents
( 1,292,274 )
-
Cash and Cash Equivalents – Beginning of Period
3,924,908
112
Cash and Cash Equivalents – End of Period
$ 2,632,634
$ 112
Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:
Interest Paid
$ 14,460
$ -
See notes to unaudited
condensed consolidated financial statements.
4
CITIUS ONCOLOGY, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE Six
Months Ended March 31, 2026 and 2025
(Unaudited)
1. NATURE OF OPERATIONS, BASIS OF PRESENTATION
AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Business
Citius Oncology, Inc. (“Citius Oncology”,
the “Company”, “we” or “us”) is a specialty pharmaceutical company dedicated to the development and
commercialization of critical care products targeting unmet needs with a focus on oncology products. We have developed E7777 (denileukin
diftitox), an approved oncology immunotherapy for the treatment of cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin
lymphoma. We have obtained the trade name of LYMPHIR for E7777. Revenue commenced in December 2025 with the commercial launch of LYMPHIR.
Since our inception, we have devoted substantially
all our efforts to business planning, research and development, and recruiting management and technical staff. 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, market acceptance
of any of its products approved for marketing, 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.
Since our inception, Citius Pharmaceuticals,
Inc. (“Citius Pharma”) (Nasdaq: CTXR) has funded and continues to partially fund the Company. Citius Pharma and the Company
are party to an amended and restated shared services agreement (the “A&R Shared Services Agreement”), which governs certain
management and scientific services that Citius Pharma provides the Company.
Merger
On August 23, 2021, Citius Pharma formed Citius
Acquisition Corp. (“SpinCo”) as a wholly-owned subsidiary in conjunction with the acquisition of LYMPHIR, which began operations
in April 2022, when Citius Pharma transferred the assets related to LYMPHIR to SpinCo, including the related license agreement and asset
purchase agreement (see Note 7).
On October 23, 2023, Citius Pharma and SpinCo
entered into an agreement and plan of merger and reorganization (the “Merger Agreement”) with TenX Keane Acquisition, a Cayman
Islands exempted company (“TenX”), and TenX Merger Sub Inc., a Delaware corporation and a wholly owned subsidiary of TenX
(“Merger Sub”).
On August 12, 2024, pursuant to the terms and
conditions of the Merger Agreement, Merger Sub merged with and into SpinCo, with SpinCo surviving as a wholly owned subsidiary of TenX
(the “Merger”) which was subsequently renamed Citius Oncology Sub, Inc. Prior to closing of the Merger, TenX migrated to
and domesticated as a Delaware corporation in accordance with Section 388 of the General Corporation Law of the State of Delaware and
the Cayman Islands Companies Act (As Revised) (the “Domestication”). As part of the Domestication, TenX changed its name
to “Citius Oncology, Inc.” (Nasdaq: CTOR). Immediately after the closing of the Merger, Citius Pharma owned approximately
92 % of the outstanding shares of common stock of the Company. As of March 31, 2026, Citius Pharma owned approximately 71 % of the outstanding
shares of common stock of the Company.
While the Merger Sub was the legal acquirer of
the Company, for accounting purposes, the Company was deemed to be the accounting acquirer. Accordingly, for accounting purposes, the
Merger was treated as the equivalent of the Company issuing stock for the assets and liabilities of the Merger Sub, accompanied by a
recapitalization. Total shares outstanding of the Company after the Merger and recapitalization increased to 71,552,402 . The net assets
of the merged entities are stated at historical cost, with no goodwill or other intangible assets recorded. Additionally, the historical
financial statements of SpinCo became the historical financial statements of the Company.
5
The Merger, net amount of $ 2,753,795 charged
to additional paid-in capital consists of $ 395,015 of net liabilities of TenX on the date of the Merger (cash of $ 163,500 less liabilities
of $ 559,015 ) plus directly related transaction costs of $ 2,358,780 .
As part of the Merger, Citius Pharma made capital
investments in the Company through cash contributions of $ 3,827,944 to fund transactions related to the Merger and by reclassifying to
additional paid-in capital intercompany receivables of $ 33,180,961 that were due from the Company to Citius Pharma. Simultaneously, Citius
Pharma advanced an additional $ 3,800,111 to the Company under the terms of a note payable (see Note 10).
Basis of Presentation and Summary of Significant
Accounting Policies
Basis of Preparation - The accompanying
unaudited condensed consolidated financial statements include the operations of Citius Oncology, Inc., and its wholly-owned subsidiary,
Citius Oncology Sub, Inc., which was formed in connection with Merger. All significant inter-company balances and transactions have been
eliminated in consolidation.
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 March 31, 2026, and the results of its operations and cash flows for the three and
six months ended March 31, 2026 and 2025. The operating results for the three and six months ended March 31, 2026 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.
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 unaudited condensed 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. The Company had a net loss of $ 32,143,764 for the six months ended March 31, 2026. The
Company has generated limited revenue, which commenced in December 2025, and has historically relied primarily on funding from Citius
Pharma to finance its operations. At March 31, 2026, the Company had $ 2,632,634 in cash and a negative working capital of $ 29.4 million.
6
On May 5, 2026, Citius Oncology received gross
proceeds of approximately $ 11.5 million from the exercise of certain warrants (See Note 12).
In addition, the Company entered into a loan
agreement for up to $ 25.0 million, with $ 10.0 million funded on May 6, 2026, up to $ 7.0 million available on the later of (A) the date
on which certain net revenue and liquidity milestones are achieved and (B) October 1, 2026, and continuing through December 31, 2026,
and up to $ 8.0 million available beginning on the later of (A) the date on which certain additional net revenue milestones are achieved
and (B) January 1, 2027, and continuing through March 31, 2027. The loans bear interest at the greater of the prime rate plus 6 % or 12.75 %.
The Loans are secured by an interest in all of the Company’s assets, including intellectual property, subject to agreed exceptions.
The maturity date of the Loans is November 1, 2029 (See Note 12). We expect that we and Citius Pharma collectively will have sufficient
funds to continue our operations through November 2026. We will need to raise additional capital to support our operations beyond November
2026, which raises substantial doubt about our ability to continue as a going concern within one year after the date that the accompanying
financial statements are issued.
The Company plans to continue to rely partially
on funding from Citius Pharma, to raise capital through equity and debt. financings and to generate revenue from sales of LYMPHIR. Both
the Company and Citius Pharma are actively engaged in capital raising efforts to extend the cash runway. The Company also has retained
Jefferies LLC as its exclusive financial advisor in evaluating strategic alternatives aimed at maximizing shareholder value. There is
no assurance, however, that Citius Pharma will have the resources to assist in funding the Company, that the Company will be successful
in raising the needed capital and, if funding is available, that it will be available on terms acceptable to the Company or that the
Company will find strategic partners or generate substantial revenue from the sale of LYMPHIR. The accompanying unaudited condensed consolidated
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 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.
7
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.
Gross-to-Net Adjustments
Specialty Distributor Fees
We pay fees for distribution services, such as
fees for certain data that customers provide us. We estimate our customers will earn these fees and deduct these fees from gross product
revenues 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 considering
experience from similar products in the market, historical return patterns, sales data, and inventory levels in the distribution channel.
These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of gross product revenue.
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.
We record estimates for these chargebacks at the time of sale as deductions from gross product revenues, with corresponding adjustments
to our accounts receivable reserves and allowances.
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 estimates as a reduction from gross product revenue. The Company has
deposited the estimated co-pay assistance reflected and included in the gross-to-net adjustments.
Three Months Ended
Six Months Ended
March 31, 2026
March 31, 2026
Gross Product Revenue
$ 2,003,760
$ 6,882,480
Gross-to-net adjustments:
336,462
1,271,071
Net Revenue
$ 1,667,298
$ 5,611,409
Accounts receivable
Accounts receivable is stated at amounts invoiced
less allowances for distributor fees, chargebacks, and estimated returns. At March 31, 2026, these sales allowances totaled $ 837,585 .
On a periodic basis, the Company evaluates its accounts receivable to establish an allowance for doubtful accounts. The allowance reflects
our current estimate of credit losses expected to occur over the life of the receivable. In developing our allowance for expected credit
losses, we use assumptions to capture the risk of loss, even if remote, based on a number of factors including existing contractual payment
terms, individual customer circumstances, historical payment patterns of our customers, a review of the local economic environment and
its potential impact on expected future customer payment patterns. Our collection risk is mitigated to a certain extent by the fact that
sales are collected in a reasonable period of time, allowing for the ability to reduce exposure on defaults if collection issues are
identified. We update our allowance as necessary to reflect expected credit losses over the remaining accounts receivable that are past
due. We do not currently expect our current or future exposures to credit losses to have a significant impact on us. The estimated allowance
for expected credit losses was $ 0 as of March 31, 2026.
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. A summary of inventory is as follows:
March 31,
2026
September 30,
2025
Finished goods
$ 15,707,625
$ 10,577,876
Work in process
6,951,965
11,708,817
Total
$ 22,659,590
$ 22,286,693
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 at March 31, 2026 and September
30, 2025 include $ 2,531,280 and $ 1,331,280 , respectively, of advance payments made for the preparation of long-lead time drug substance
and product costs, respectively, which will be utilized in research and development activities or in the manufacturing of LYMPHIR for
sales. Prepaid expenses at March 31, 2026 also include $ 221,107 for annual licensing fees paid to the FDA and $ 300,000 for prepaid marketing
costs.
6. IN-PROCESS RESEARCH AND DEVELOPMENT, NET
In process research and development consists
of a beginning carrying value for LYMPHIR of $ 73,400,000 and a net balance of $ 71,106,250 at March 31, 2026. Amortization of in-process
research and development commenced upon revenue generation in December 2025. For the three months ended March 31, 2026 and 2025, amortization
was $ 1,720,312 and $ 0 , respectively. For the six months ended March 31, 2026 and 2025, amortization was $ 2,293,750 and $ 0 , respectively.
In-process research and development for LYMPHIR is being amortized as follows on a straight-line basis over the remaining FDA product
exclusivity period which ends in August 2036. A summary of the expected future amortization expense for LYMPHIR in-process research and
development is as follows:
Year Ending September 30,
Amount
2026 (excluding the six months ended March 31,2026)
$ 3,440,625
2027
6,881,250
2028
6,881,250
2029
6,881,250
2030
6,881,250
2031
6,881,250
Thereafter
33,259,375
Total
$ 71,106,250
9
7. PATENT AND TECHNOLOGY LICENSE AGREEMENTS
License Agreement with Eisai
In September 2021, Citius Pharma 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. Citius Pharma
renamed E7777 as I/ONTAK and also obtained the trade name LYMPHIR TM for the product. Citius Pharma assigned these agreements
to us effective April 1, 2022. The Company received a Biologics License Application (“BLA”) approval from the FDA for LYMPHIR
in August 2024.
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 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 to 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.
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 $ 17,650,000 remains due as of March 31, 2026. 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. Citius Oncology was
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 chemistry, manufacturing, and controls (“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 15 th 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 six months ended March 31, 2026, we recorded
$ 78,872 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. On March 30, 2026 we paid Eisai $ 500,000 against the accounts payable balance. At March 31, 2026, we owe Eisai for other
unpaid invoices, consisting of $ 2,200,000 of accounts payable and $ 4,062,481 of accrued expenses.
10
The term of the license agreement will continue
until the 10-year anniversary of the first commercial sale on a country-by-country basis. The first commercial sale in the United States
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) 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.
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. STOCKHOLDER’S EQUITY
Authorized Capital Stock
The certificate of incorporation adopted on August
5, 2024, in connection with the Merger, authorized 110,000,000 shares, of which 100,000,000 shares are common stock with a par value
of $ 0.0001 , and 10,000,000 shares are preferred stock with a par value of $ 0.0001 . On April 7, 2025, pursuant to Board and stockholder
approval, the Company amended its Certificate of Incorporation to increase the authorized shares of common stock from 100,000,000 shares
to 400,000,000 shares.
Common Stock Offerings
July 2025 Offering
On July 17, 2025, we sold 6,818,182 shares of
common stock and warrants to purchase 6,818,182 shares of common stock, at $ 1.32 per share and accompanying warrant. The immediately
exercisable five-year warrants had an initial exercise price of $ 1.32 per share. In connection with the December 10, 2025 offering (discussed
below), we agreed to reduce the exercise price of the 6,818,182 warrants to $ 1.09 per share and extended the expiration date to January
20, 2031 . Gross proceeds from the offering were approximately $ 9.0 million and net proceeds were $ 7,546,988 , after deducting placement
agent fees and other offering expenses. The estimated fair value of the warrants issued to the investors on July 17, 2025 was approximately
$ 8,197,000 . The estimated fair value of the repriced warrants issued to the investors as of December 8, 2025 was approximately $ 5,301,000 .
11
We paid the placement agent a fee of 7.0 % of
the gross proceeds and expenses of $ 125,000 and granted the placement agent warrants to purchase 272,727 shares of common stock at an
exercise price of $ 1.65 per share. The warrants are exercisable commencing on January 17, 2026 and expire on July 17, 2030 . We also paid
an additional 7.0 % cash fee to a prior placement agent and issued warrants to purchase up to 477,273 shares of common stock at an exercise
price of $ 1.65 per share. The placement agent warrants are exercisable commencing on August 17, 2025 and expire on July 17, 2030 . The
estimated fair value of the placement agent warrants was approximately $ 905,000 .
September 2025 Offering
On September 10, 2025, we sold 5,142,858 shares
of common stock and warrants to purchase 5,142,858 shares of common stock at $ 1.75 per share and accompanying warrant. The warrants are
exercisable beginning on March 10, 2026 and expire on March 10, 2031 and had an initial exercise price of $ 1.84 per share. In connection
with the December 10, 2025 offering (discussed below), Citius Oncology agreed to reduce the exercise price of the 5,142,858 warrants
to $ 1.09 per share and extended the expiration date to January 20, 2031 . Gross proceeds from the offering were approximately $ 9.0 million
and net proceeds were $ 7,619,854 , after deducting placement agent fees and other offering expenses. The estimated fair value of the warrants
issued to the investors on September 10, 2025 was approximately $ 6,995,000 . The estimated fair value of the repriced warrants issued
to the investors as of December 8, 2025 was approximately $ 4,179,000 .
We paid the placement agent a fee of 7.0 % of
the gross proceeds and expenses of $ 125,000 . Additionally, we issued the placement agent warrants to purchase 205,714 shares of common
stock at an exercise price of $ 1.92 per share. The warrants are exercisable commencing on March 10, 2026 and expire on March 10, 2031 .
We also paid an additional 7.0 % cash fee to a prior placement agent and issued warrants to purchase up to 360,000 shares of common stock
at an exercise price of $ 2.1875 per share. The placement agent warrants are exercisable commencing on March 10, 2026 and expire on March
10, 2031 . The estimated fair value of the placement agent warrants was approximately $ 717,000 .
December 2025 Offering
On December 10, 2025, we sold 1,284,404 shares
of common stock and accompanying warrants to purchase 1,284,404 shares of common stock, at $ 1.09 per share and accompanying warrant,
and additionally sold 15,229,358 pre-funded warrants and accompanying warrants to purchase 15,229,358 shares of common stock at $ 1.0899
per pre-funded warrant and accompanying warrant. Aggregate gross proceeds from the offering were approximately $ 18.0 million and net
proceeds were $ 15,062,724 , after deducting placement agent fees and other offering expenses. The 15,229,358 pre-funded warrants are immediately
exercisable at $ 0.0001 per share and do not expire. During the three months ended March 31, 2026, 8,183,358 of the pre-funded warrants
were exercised for net proceeds of $ 818 . At March 31, 2026, 7,046,000 of the pre-funded warrants remain outstanding. The 16,513,762 warrants
have an exercise price of $ 1.09 and are exercisable for five years after stockholder approval, expected in February 2026. The estimated
fair value of the 16,513,762 warrants issued to the investors was approximately $ 13,196,000 .
We paid the placement agent a fee of 7.0 % of
the gross proceeds and expenses of $ 135,000 . Additionally, we issued to the placement agent warrants to purchase 1,155,963 shares of
common stock at an exercise price of $ 1.3625 per share. The warrants are exercisable commencing on stockholder approval, which was
effective on February 18, 2026, and expire on December 8, 2030 . We also paid an additional 7.0 % cash fee to a prior placement agent
and issued warrants to purchase up to 660,550 shares of common stock at an exercise price of $ 1.199 per share. The placement agent
warrants are exercisable commencing on stockholder approval and expire on December 8, 2030 . The estimated fair value of the
placement agent warrants was approximately $ 1,401,000 .
12
Stock Plans
Under the Citius Oncology 2023 Omnibus Stock
Incentive Plan, adopted on April 29, 2023, we reserved 15,000,000 common shares for issuance. On August 2, 2024, we reserved 15,000,000
common shares for issuance under the Citius Oncology 2024 Omnibus Stock Incentive Plan (the “2024 Plan”). We amended the
2024 Plan on October 27, 2025 to reserve an additional 15,000,000 shares of common stock for an aggregate of 30,000,000 shares of common
stock. The stock plans provide incentives to employees, directors, and consultants through grants of options, SARs, dividend equivalent
rights, restricted stock, restricted stock units, or other rights.
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 we have 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 10 years)
and the vesting period. For non-employee options, the expected term is the contractual term.
A summary of option activity under the stock plans is presented below:
Shares Weighted-
Average
Exercise
Price Weighted-
Average
Remaining
Contractual
Term Aggregate
Intrinsic
Value
Outstanding at September 30, 2025 18,100,000 $ 1.83 8.21 years $ 5,386,000
Granted -
-
Forfeited -
-
Outstanding at March 31, 2026 18,100,000 $ 1.83 7.52 years $ -
Exercisable at March 31, 2026 11,502,083 $ 1.89 7.30 years $ -
Stock-based compensation expense for stock options
for the three months ended March 31, 2026 and 2025 was $ 1,858,443 and $ 2,088,572 , respectively. Stock-based compensation expense for
stock options for the six months ended March 31, 2026 and 2025 was $ 4,110,478 and $ 3,897,050 , respectively.
At March 31, 2026, unrecognized total compensation
cost related to unvested awards under our stock plans of $ 3,704,204 is expected to be recognized over a weighted average period of 1.02
years.
Restricted Stock Unit Awards
On September 19, 2025, the Board of Directors
granted restricted stock unit awards of 11,600,000 shares of common stock to employees and directors. The restricted stock unit awards
vest on September 19, 2028 . The fair value of the common stock on the date of grant was $ 20,300,000 ($ 1.75 per share). On March 24, 2026,
the Board of Directors granted restricted stock unit awards of an aggregate 350,000 shares of common stock to an employee and a consultant.
The restricted stock unit awards vest on March 24, 2029. The fair value of the common stock on the date of grant was $ 203,000 ($ 0.58
per share).
Stock-based compensation expense for restricted
stock unit awards for the three months ended March 31, 2026 was $ 1,668,267 . Stock-based compensation expense for restricted stock unit
awards for the six months ended March 31, 2026 was $ 3,372,282 .
At March 31, 2026, unrecognized total compensation
cost related to unvested restricted stock unit awards under the stock plans of $ 16,926,977 is expected to be recognized over a weighted
average period of 2.48 years.
13
Warrants
We have reserved 38,653,029 shares of common
stock for the exercise of outstanding warrants. The following table summarizes the warrants outstanding at March 31, 2026:
Exercise
Price Number Expiration Dates
July 2025 Offering Investors $ 1.09 6,818,182 January 20, 2031
July 2025 Offering Agent $ 1.65 272,727 July 17, 2030
July 2025 Prior Offering Agent $ 1.65 477,273 July 17, 2030
September 2025 Offering Investors $ 1.09 5,142,858 January 20,2031
September 2025 Offering Agent $ 1.92 205,714 March 10, 2031
September 2025 Prior Offering Agent $ 2.1875 360,000 March 10, 2031
December 2025 Offering Investors $ 0.0001 7,046,000 None
December 2025 Offering Investors $ 1.09 16,513,762 January 20, 2031
December 2025 Placement Offering Agent $ 1.3625 1,155,963 December 8, 2030
December 2025 Prior Offering Agent $ 1.199 660,550 December 8, 2030
38,653,029
At March 31, 2026, the weighted average remaining
life of the outstanding warrants was estimated at 3.97 years and all warrants are exercisable. At March 31, 2026 the aggregate intrinsic
value of the warrants outstanding was $ 4,367,815 .
Common Stock Reserved
A summary of common stock reserved for future
issuances by the Company as of March 31, 2026 is as follows:
Stock plan options outstanding
18,100,000
Restricted stock awards
11,950,000
Stock plan shares available for future grants
14,950,000
Warrants outstanding
38,653,029
Total
83,653,029
9. COMMERCIAL MANUFACTURING CONTRACTS
The Company had previously entered into an
agreement with a contract manufacturing organization, (“CMO”) for the manufacture and supply of bulk drug substance,
(“BDS”) with the agreement continuing through calendar year 2026. The agreement was terminated effective February 2026
by the CMO due to the breach of payment obligations by the Company. Termination fees associated with this are approximately $ 20.1
million consisting of $ 17.1 million of charges associated with manufacturing which was previously committed in 2025 and 2026 but not
produced, as well as $ 1.2 million of un-invoiced but incurred charges related to previous manufactured batches and $ 1.8 million of
interest and other charges. These fees are included in General and Administrative Expense for the quarter ended March 31, 2026.
Separately, in March 2026 the CMO gave notice that it made a decision to terminate all production at the current site related to
microbial manufacturing and decommission the associated manufacturing lines. In March 2026 and in connection with the notice of
termination from the CMO, we recorded a contract cancellation fee of $ 19,733,307 net of invoices already included in accounts payable.
The Company has been evaluating new BDS suppliers
and anticipates entering into a letter of intent with a new CMO by June 30, 2026 with a subsequent master services agreement to follow.
At this time, based on stock on hand and availability of alternate suppliers, we anticipate no interruption in commercial supply for
the foreseeable future.
As of March 31, 2026, 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 $ 4.0 million consisting of purchase commitment obligations of $ 2.2 million in calendar year
2026 and $ 1.8 million in calendar year 2027.
14
10. RELATED PARTY TRANSACTIONS
Our officers and directors also serve as officers
of Citius Pharma. As of March 31, 2026, the Company does not have any employees. The Company and Citius Pharma entered into the A&R
Shared Services Agreement and under the terms of the agreement, Citius Pharma provides management and scientific services to us.
During the three months ended March 31, 2026,
Citius Pharma charged us $ 567,937 for reimbursement of general and administrative payroll, $ 469,000 for reimbursement of research and
development payroll, and $ 27,939 for the use of shared office space. During the three months ended March 31, 2025, Citius Pharma charged
us $ 567,937 for reimbursement of general and administrative payroll, $ 480,000 for reimbursement of research and development payroll,
and $ 30,368 for the use of shared office space.
During the six months ended March 31, 2026, Citius
Pharma charged us $ 1,065,874 for reimbursement of general and administrative payroll, $ 949,000 for reimbursement of research and development
payroll, and $ 55,878 for the use of shared office space. During the six months ended March 31, 2025, Citius Pharma charged us $ 1,135,874
for reimbursement of general and administrative payroll, $ 960,000 for reimbursement of research and development payroll, and $ 58,307
for the use of shared office space.
We have had limited cash, therefore most of our
expenditures were paid by Citius Pharma and reflected in the due to related party account.
Citius Pharma advanced cash to us for a non-interest
bearing, unsecured promissory note, dated August 16, 2024, in the principal amount of $ 3,800,111 . The note is repayable in full upon
a financing of at least $ 50 million by us. Management does not anticipate such repayment within the next twelve months and has classified
the note payable as a long-term liability (See Note 12).
11. GAIN ON SALE OF NEW JERSEY NET OPERATING
LOSSES
We recognized a gain of $ 1,762,000 for the six
months ended March 31, 2026, in connection with the sale of certain New Jersey income tax net operating losses to a third party under
the New Jersey Technology Business Tax Certificate Transfer Program.
12. SUBSEQUENT EVENTS
On April 22, 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 $ 1.00 per share for 30 consecutive business
days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until October
19, 2026, to regain compliance with the Bid Price Rule.
Warrant Inducement Transaction
On May 5, 2026, we entered into an agreement
with the holder of certain existing warrants to purchase up to 12,777,778 shares of common stock, which consists of all of the 6,818,182
shares underlying warrants originally issued on July 16, 2025, all of the 5,142,858 shares underlying warrants originally issued on September
10, 2025, and 816,738 shares underlying warrants originally issued December 10, 2025, each with an exercise price of $ 1.09 per share.
As an inducement to the holder for exercising the warrants in cash at a reduced exercise price of $ 0.90 per share, we issued to the holder
new warrants to purchase up to an aggregate of 25,555,556 shares of common stock, which have similar terms to the warrants exercised,
other than an exercise price of $ 0.90 . Gross proceeds were approximately $ 11.5 million, before deducting placement agent fees and expenses.
15
Loan Agreement
On May 5, 2026 the Company, entered into a Loan
Agreement that makes available term loans in an aggregate principal amount of up to $ 25.0 million (collectively, the “Loans”),
with (i) $ 10.0 million to be funded on May 6, 2026 (“Tranche 1”), (ii) up to $ 7.0 million beginning on the later of (A) the
date on which certain net revenue and liquidity milestones are achieved and (B) October 1, 2026, and continuing through December 31,
2026 (“Tranche 2”), and (iii) up to $ 8.0 million beginning on the later of (A) the date on which certain additional net revenue
milestones are achieved and one or more Tranche 2 Loans have been drawn and (B) January 1, 2027, and continuing through March 31, 2027
(“Tranche 3”).
The Loans bear interest at an annual rate equal
to the greater of (x) prime plus 6.00 % or 12.75 %. The Loans are secured by a lien upon and security interest in all of the Company’s
and its subsidiary’s assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loans is November
1, 2029 (the “Maturity Date”).
Pursuant to the Loan Agreement, the Lender will
have the right, at any time while any Loan is outstanding, to convert up to its pro rata share of $ 4.0 million of the outstanding principal
of the Loans (the “Conversion Option”) into shares of the Company’s common stock at a price per share equal to 120%
of the exercise price of the Lender Warrants (as defined below) (the “Conversion Price”), subject to certain terms and conditions,
including beneficial ownership limitations. In addition, the Company has agreed to use its reasonable best efforts to grant to each Lender
the right to invest up to its pro rata share of $ 1.0 million in any issuance of equity securities of the Company after the Closing Date,
on the same terms, conditions and pricing offered by the Company to other investors participating in such financing transaction (such
right, the “Participation Right”). The Participation Right terminates 30 days after the repayment in full of all of the obligations
under the Loan Agreement (other than inchoate indemnity obligations or other obligations that specifically survive termination).
Note Payable to Related Party
On May 4, 2026, the Company and Citius Pharma,
entered into a Third Amendment to Promissory Note (the “Third Amendment”), which amends the promissory note, dated August
16, 2024, as previously amended on September 10, 2025 and December 10, 2025, issued by the Company to Citius Pharma in the original
principal amount of $ 3,800,111 (the “Promissory Note”), to, among other things, (i) conform the payment and maturity provisions
of the Promissory Note to the May 6, 2026 subordination agreement, such that the entire unpaid principal balance of the Promissory Note
shall be payable on a date that is 91 days after the debt under the May 6, 2026 financing has been fully paid and the Loan Agreement
has been terminated, (ii) eliminate all prior maturity triggers related to capital raises, issuances of debt or equity securities, or
royalty-backed monetizations, (iii) prohibit prepayment of the Promissory Note in cash prior to the new maturity date, and (iv) add a
voluntary conversion feature allowing Citius Pharma, subject to the Company’s approval, to convert all or a portion of the outstanding
principal into shares of common stock at a conversion price equal to $ 0.90 per share. All other terms of the Promissory Note remain the
same.
16
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 and six months ended March 31, 2026 and 2025 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 Oncology, 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. 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
Citius Oncology is a specialty biopharmaceutical
company focused on developing and commercializing innovative targeted oncology therapies. We have developed E7777 (denileukin diftitox),
an approved oncology immunotherapy for the treatment of cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin lymphoma.
We have obtained the trade name of LYMPHIR for E7777 and revenue commenced in December 2025 upon the commercial launch of LYMPHIR.
We were incorporated in the Cayman Islands on
March 1, 2021, for the purpose of effecting a business combination with one or more businesses. In August 2024, we reincorporated in
Delaware and completed the Merger whereby we acquired SpinCo as a wholly owned subsidiary and changed our name to Citius Oncology, Inc.
SpinCo began operations in April 2022.
Since inception, we have devoted substantially
all of our efforts to business planning, research and development, recruiting management and technical staff and commercially launching
LYMPHIR. We are subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, our ability
to obtain additional financing, risks related to the development by us or our competitors of research and development stage products,
market acceptance of our approved products, competition from larger companies, dependence on key personnel, dependence on key suppliers
and strategic partners, and our compliance with governmental and other regulations.
License Agreement with Eisai
In September 2021, Citius Pharma 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 renamed E7777 as I/ONTAK
and also obtained the trade name LYMPHIR TM for the product. Citius Pharma assigned these agreements to us effective April
1, 2022. 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 us. The exclusive license 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. We 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.
We 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 our payment obligations under these
agreements.
17
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 $17.65 million remains due as of March 31, 2026. 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 15 th 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 six months ended March 31, 2026, we recorded
$78,872 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 March 31, 2026, we owe Eisai approximately $6.3 million for certain other unpaid invoices.
The term of the license agreement will continue
until the 10-year anniversary of the first commercial sale on a country-by-country basis. The first commercial sale in the United States
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) 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.
Recent Events
Commercial Launch Activities
On March 31, 2026, we provided an update on the
U.S. commercial launch of LYMPHIR, highlighting continued adoption across leading oncology centers, broad payer coverage progress, and
advancing investigator-led clinical studies. We expect continued expansion in prescribing activity, together with further clinical validation
through ongoing investigator-led studies. These trends support LYMPHIR’s potential not only for continued integration in the CTCL
treatment landscape, but also its potential as a part of a combination immunotherapy regimen in other cancers.
18
Key Early Launch Metrics :
● Growth
in orders from target institutions since launch, with initial accounts placing repeat orders;
● Strong
institutional uptake, with 83% of target accounts having added or actively progressing LYMPHIR
through formulary review;
● Broad
and expanding market access with 135 health plans representing 80% of covered lives, secured
and reimbursement systems established;
● No
reported reimbursement denials or prior authorization barriers;
● Increasing
demand for product education;
● Initial
penetration into community infusion centers underway with patients beginning to transition
from larger cancer centers;
● Commercial
buildout proceeding, with field team onboarding and expansion in progress with our contracted
sales organization; and,
● Commercial
supply remains well positioned to support anticipated U.S. demand, and international expansion.
On April 29, 2026, we announced the initial shipment
of LYMPHIR to Europe through a regional distribution partner, marking an important milestone in expanding access to the therapy for patients
outside the US. LYMPHIR will be made available to eligible patients through Named Patient Programs in accordance with local regulations
in each country. The initiation of European distribution represents a strategic step in our effort to extend access to LYMPHIR.
US Distribution Agreements
In 2025, the Company executed three service agreements
with U.S. 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.
19
International Distribution Agreements
On October 7, 2025, we entered into an exclusive
distribution agreement with Integris Pharma S.A., headquartered in Athens, Greece to make LYMPHIR available to eligible patients through
country-specific Named Patient Programs (NPPs). The partnership covers Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania,
Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia. NPPs are formally recognized pathways designed to give patients earlier access
to promising new medicines in advance of full marketing authorization and commercial availability in markets outside the US. Under these
programs, a treating physician may request a therapy for an individual patient when no adequate approved alternatives exist. In doing
so, NPPs bridge a critical gap between the completion of clinical trials in each region and broad market introduction, ensuring that
patients with serious illnesses are not left waiting for life-extending innovations. These programs provide access, where permitted by
local law, and do not constitute commercial approval of LYMPHIR outside the U.S.
On December 4, 2025, we announced an exclusive
distribution agreement with Er-Kim İlaç Sanayi ve Ticaret A.Ş. (“Er-Kim”), a leading pharmaceutical distributor
based in Turkey, for LYMPHIR. Under the agreement, Er-Kim will be the exclusive distributor of LYMPHIR in Turkey and key Gulf Cooperation
Council (GCC) countries, including Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the United Arab Emirates.
On February 11, 2026, we announced an exclusive
distribution agreement with Uniphar (“Uniphar”), a leading international healthcare services company, to support access
to LYMPHIR. Under the agreement, Uniphar will serve as our exclusive distribution partner in designated international territories in
Western and Eastern Europe. We will supply finished product and provide ongoing support in accordance with the agreement. LYMPHIR is
not approved for commercial use outside the U.S. and will be provided solely through country-specific managed access programs, which
do not constitute marketing authorization or a commercial launch.
Investigator Initiated Trials
On March 4, 2026, we announced positive topline
safety and efficacy results from an investigator-initiated Phase 1 trial evaluating LYMPHIR administered prior to commercial CD19 directed
CAR T therapy in patients with high risk relapsed or refractory diffuse large B cell lymphoma (DLBCL).
On March 10, 2026, we announced positive topline
results from a completed investigator-initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators. This
study evaluated the direct T-regulatory (Treg) cell depletion activity of LYMPHIR in combination with the PD-1 immune checkpoint inhibitor
pembrolizumab (KEYTRUDA ® ) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial
malignancies.
Discussions are ongoing regarding next-stage
development with respect to both investigator-initiated trials.
20
RESULTS OF OPERATIONS
Three months ended March 31, 2026 compared
with the Three months ended March 31, 2025
Three Months
Ended
March 31,
2026
Three Months
Ended
March 31,
2025
Revenue
$ 1,667,298
$ —
Cost of revenues
(328,878 )
—
Gross profit
1,338,420
—
Operating expenses:
Research and development
1,079,354
3,139,413
Amortization of in-process research and development
1,720,312
—
General and administrative
23,625,639
2,243,327
Stock-based compensation – general and administrative
3,526,710
2,088,572
Total operating expenses
29,952,015
7,471,312
Operating loss
(28,613,595 )
(7,471,312 )
Interest income
43,721
—
Gain on sale of New Jersey net operating losses
1,762,000
Interest expense
(33,031 )
—
Loss before income taxes
(26,840,905 )
(7,471,312 )
Income tax expense (benefit)
(231,210 )
264,240
Net loss
$ (26,609,695 )
$ (7,735,552 )
Revenues
Product revenues for the three months ended March
31, 2026 were $1,667,298, as we began commercial distribution of LYMPHIR in December 2025. Gross profit on product revenues for the three
months ended March 31, 2026 was approximately 80%.
We believe that revenues will increase in the
future as LYMPHIR gains market acceptance and have already seen initial accounts placing repeat orders, and on April 29, 2026, we announced
our initial shipment to Europe.
Research and Development Expenses
For the three months ended March 31, 2026, research
and development expenses were $1,079,354, as compared to $3,139,413 for the three months ended March 31, 2025. The decrease of $2,060,059
was primarily related to expense recognized in the three months ended March 31, 2025 for a pre-license inspection batch Lymphir previously
manufactured.
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 March 31, 2026, amortization was $1,720,312. 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 March 31, 2026, general
and administrative expenses were $23,625,639, as compared to $2,243,327 for the three months ended March 31, 2025. The increase of $21,382,312
was primarily related to a notice of termination from a contract manufacturing organization received in February 2026. In March 2026,
we recorded a contract cancellation fee of $19,733,307.
21
Stock-based Compensation Expense
For the three months ended March 31, 2026, stock-based
compensation expense was $3,526,710, as compared to $2,088,572 for the three months ended March 31, 2025. The increase of $1,438,138
in stock-based compensation expense was primarily related to the restricted stock unit awards granted in September 2025.
Interest Income
For the three months ended March 31, 2026, interest
income was $43,721, as compared to $0 for the three months ended March 31, 2025. We have invested some of the proceeds of our recent
equity offerings in a money market account.
Gain on sale of New Jersey net operating losses
We recognized a gain of $1,762,000 for the three
months ended March 31, 2026, in connection with the sale of certain New Jersey income tax net operating losses to a third party under
the New Jersey Technology Business Tax Certificate Transfer Program.
Interest Expense
For the three months ended March 31, 2026, interest
expense was $33,031, as compared to $0 for the three months ended March 31, 2025. Interest expense was related to the March 28, 2025
letter agreement with Eisai.
Income Taxes
The Company recorded a deferred income tax
benefit of $231,210 in the three months ended March 31, 2026 and a deferred income tax expense of 264,240 in the three months ended
March 31, 2025. Deferred income tax expense or benefit is related to the difference in amortization for taxable purposes of our in-process research and
development asset and the financial statement amortization.
Net Loss
For the three months ended March 31, 2026, we
incurred a net loss of $26,609,695, as compared to a net loss of $7,735,552 for the three months ended March 31, 2025. The increase of
$18,874,143 in net loss was due to the increase of $22,480,703 in operating expenses offset by the increase in gross profit of $1,338,420,
the increase in other income of $1,772,690 and the decrease in income tax expense of $495,450.
Six months ended March 31, 2026 compared with
the Six months ended March 31, 2025
Six Months
Ended
March 31,
2026
Six Months
Ended
March 31,
2025
Revenue
$ 5,611,409
$ —
Cost of revenues
(1,118,086 )
—
Gross profit
4,493,323
—
Operating expenses:
Research and development
2,097,706
4,403,921
Amortization of in-process research and development
2,293,750
—
General and administrative
26,484,978
5,565,306
Stock-based compensation – general and administrative
7,482,760
3,897,050
Total operating expenses
38,359,194
13,866,277
Operating loss
(33,865,871 )
(13,866,277 )
Interest income
72,009
—
Gain on sale of New Jersey net operating losses
1,762,000
—
Interest expense
(78,872 )
—
Loss before income taxes
(32,110,734 )
(13,866,277 )
Income tax expense
33,030
528,480
Net loss
$ (32,143,764 )
$ (14,394,757 )
22
Revenues
Product revenues for the six months ended March
31, 2026 were $5,611,409, as we began commercial distribution of LYMPHIR in December 2025. Gross profit on product revenues for the six
months ended March 31, 2026 was approximately 80%.
We believe that revenues will increase in the
future as LYMPHIR gains market acceptance and have already seen initial accounts placing repeat orders, and on April 29, 2026, we announced
our initial shipment to Europe.
Research and Development Expenses
For the six months ended March 31, 2026, research
and development expenses were $2,097,706, as compared to $4,403,921 for the six months ended March 31, 2025. The decrease of $2,306,215
was primarily related to was primarily related to expense recognized in the three months ended March 31, 2025 for a pre-license inspection
batch of LYMPHIR previously manufactured.
Amortization of in-process research and development
Amortization of in-process research and development
commenced upon revenue generation in December 2025. For the six months ended March 31, 2026, amortization was $2,293,750. 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 six months ended March 31, 2026, general
and administrative expenses were $26,484,978, as compared to $5,565,306 for the six months ended March 31, 2025. The increase of $20,919,672
was primarily related to a notice of termination from a contract manufacturing organization received in February 2026. In March 2026,
we recorded a contract cancellation fee of $19,733,307.
Stock-based Compensation Expense
For the six months ended March 31, 2026, stock-based
compensation expense was $7,482,760, as compared to $3,897,050 for the six months ended March 31, 2025. The increase of $3,585,710 in
stock-based compensation expense was primarily related to the restricted stock unit awards granted in September 2025.
Interest Income
For the six months ended March 31, 2026, interest
income was $72,009, as compared to $0 for the six months ended March 31, 2025. We have invested some of the proceeds of our recent equity
offerings in a money market account.
Gain on sale of New Jersey net operating losses
We recognized a gain of $1,762,000 for the six
months ended March 31, 2026, in connection with the sale of certain New Jersey income tax net operating losses to a third party under
the New Jersey Technology Business Tax Certificate Transfer Program.
23
Interest Expense
For the six months ended March 31, 2026, interest
expense was $78,872, as compared to $0 for the six months ended March 31, 2025. Interest expense was related to the March 28, 2025 letter
agreement with Eisai.
Income Taxes
The Company recorded a deferred income tax expense
of $33,030 for the six months ended March 31, 2026 and a deferred income tax expense of $528,480 for the six months ended March 31, 2025. Deferred income tax expense or benefit is related to the difference in amortization for taxable purposes of our in-process research and
development asset and the financial statement amortization.
Net Loss
For the six months ended March 31, 2026, we incurred
a net loss of $32,143,764, as compared to a net loss of $14,394,757 for the six months ended March 31, 2025. The increase of $17,749,007
in net loss was due to the increase of $24,492,917 in operating expenses offset by the increase in gross profit of $4,493,323, the increase
in other income of $1,755,137 and the decrease in income tax expense of $495,450.
LIQUIDITY AND CAPITAL RESOURCES
Liquidity and Working Capital
Citius Oncology has incurred operating losses
since inception and incurred a net loss of $32,143,764 for the six months ended March 31, 2026. At March 31, 2026, we had an accumulated
deficit of $131.4 million. The Company has had limited revenue commencing in December 2025 and has historically relied on funding from
Citius Pharma to finance our operations. At March 31, 2026, we had accrued expenses related to LYMPHIR of $XXXXX and other accrued expenses
of $YYY. At March 31, 2026, we had $2,632,634 in cash and a negative working capital of approximately $29.4 million.
On May 5, 2026, Citius Oncology received gross
proceeds of approximately $11.5 million from the exercise of certain warrants.
In addition, the Company entered into a loan
agreement for up to $25.0 million, with $10.0 million funded on May 6, 2026, up to $7.0 million available on the later of (A) the date
on which certain net revenue and liquidity milestones are achieved and (B) October 1, 2026, and continuing through December 31, 2026,
and up to $8.0 million available beginning on the later of (A) the date on which certain additional net revenue milestones are achieved
and (B) January 1, 2027, and continuing through March 31, 2027. The loans bear interest at the greater of the prime rate plus 6% or 12.75%.
The loans are secured by an interest in all of the Company’s assets, including intellectual property, subject to agreed exceptions.
The maturity date of the loans is November 1, 2029.
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 March 31, 2026, our
outstanding milestone payments and purchase commitments 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 15 th 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 March 31, 2026, we have paid the milestone in full
and owe a balance of approximately $6.3 million to Eisai for certain other invoices.
24
●
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 $17.65 million
remains due as of March 31, 2026. Dr. Reddy’s has agreed to a partial deferral without penalty of this milestone payment.
●
The Company had previously entered into an
agreement with a contract manufacturing organization, (“CMO”) for the manufacture and supply of bulk drug substance,
(“BDS”) with the agreement continuing through calendar year 2026. The agreement was terminated effective February 2026
by the CMO due to the breach of payment obligations by the Company. Termination fees associated with this are approximately $20.1
million consisting of $17.1 million of charges associated with manufacturing which was previously committed in 2025 and 2026 but not
produced, as well as $1.2 million of un-invoiced but incurred charges related to previous manufactured batches and $1.8 million of
interest and other charges. These fees are included in General and Administrative Expense for the quarter ended March 31, 2026.
Separately, in March 2026 the CMO gave notice that it made a decision to terminate all production at the current site related to
microbial manufacturing and decommission the associated manufacturing lines. In March 2026 and in connection with the notice of
termination from the CMO, we recorded a contract cancellation fee of $19,733,307 net of invoices already included in accounts payable.
The Company has been evaluating new BDS suppliers
and anticipates entering into a letter of intent with a new CMO by June 30, 2026 with a subsequent master services agreement to follow.
At this time, we anticipate no interruption in commercial supply for the foreseeable future.
●
As of March 31, 2026, 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 are approximately $4.0 million consisting of purchase commitment obligations
of $2.2 million in calendar years 2026 and $1.8 million in 2027.
We plan to continue to partially rely on funding
from Citius Pharma, to raise capital through equity and debt financings, and to generate revenue from sales of LYMPHIR. We also have
retained Jefferies LLC as our exclusive financial advisor in evaluating strategic alternatives aimed at maximizing shareholder value.
There is no assurance, however, that Citius Pharma will have the resources to continue partially funding us, that we will be successful
in raising the needed capital and, if funding is available, that it will be available on terms acceptable to us or that we will find
strategic partners or generate substantial revenue from the sale of LYMPHIR.
After giving effect to our May 2026 equity and
debt financings, we expect that we and Citius Pharma collectively will have sufficient funds to continue our operations through November
2026. We will need to raise additional capital in the future to support our operations beyond November 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.
Investing Activities
During the six months ended March 31, 2026, we
paid the final $2,900,000 due to Eisai in connection with the LYMPHIR approval milestone and paid $2,100,000 in connection with the milestone
payment due to Dr. Reddy’s. At March 31, 2026, we owe Dr. Reddy’s $17,650,000 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.
25
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.
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 March 31, 2026. 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 March
31, 2026, 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 March 31, 2026 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
26
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.
Item 2. Unregistered Sales of Equity Securities
and Use of Proceeds.
During the quarter ended March 31, 2026, 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 March 31, 2026, none
of our directors or officers adopted or terminated any contract or written plan for the purchase or sale of our securities.
27
Item 6. Exhibits.
4.1
Form of Warrant issued on May 6, 2026 (incorporated by reference to Exhibit 4.1 to the Form 8-K filed on May 6, 2026).
4.2
Form of Placement Agent Warrant issued on May 6, 2026 (incorporated by reference to Exhibit 4.2 to the Form 8-K filed on May 6, 2026).
4.3
Form of Lender Warrant issued on May 6, 2026 (incorporated by reference to Exhibit 4.3 to the Form 8-K filed on May 6, 2026).
10.1
Form of Warrant Inducement Agreement, dated as of May 5, 2026, by and between Citius Oncology, Inc. and the holder signatory thereto (incorporated by reference to Exhibit 10.1 to the Form 8-K filed on May 6, 2026).
10.2
Form of Warrant Amendment Agreement, dated as of May 5, 2026, by and between Citius Oncology, Inc. and the holder signatory thereto (incorporated by reference to Exhibit 10.2 to the Form 8-K filed on May 6, 2026).
10.3
Third Amendment to Promissory Note, dated May 4, 2026, by and between Citius Oncology, Inc. and Citius Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.3 to the Form 8-K filed on May 6, 2026).
10.4
Loan and Security Agreement, dated as of May 5, 2026, among the Company, Citius Sub, the Agent and the Lenders (incorporated by reference to Exhibit 10.4 to the Form 8-K filed on May 6, 2026).
10.5
Supplement to Loan and Security Agreement, dated as of May 5, 2026, among the Company, Citius Sub, the Agent and the Lenders (incorporated by reference to Exhibit 10.5 to the Form 8-K filed on May 6, 2026).
10.6
Subordination Agreement, dated as of May 5, 2026, among the Parent, the Agent and the Company (incorporated by reference to Exhibit 10.6 to the Form 8-K filed on May 6, 2026).+
31.1
Certification of the Principal Executive Officer pursuant to Exchange Act Rule 13a-14(a).*
31.2
Certification of the Principal Financial Officer pursuant to Exchange Act Rule 13a-14(a).*
32.1
Certification of the Principal Executive and Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.*
EX-101.INS
Inline XBRL Instance Document*
EX-101.SCH
Inline XBRL Taxonomy Extension
Schema Document*
EX-101.CAL
Inline XBRL Taxonomy Extension
Calculation Linkbase Document*
EX-101.DEF
Inline XBRL Taxonomy Extension
Definition Linkbase Document*
EX-101.LAB
Inline XBRL Taxonomy Extension
Label Linkbase Document*
EX-101.PRE
Inline XBRL Taxonomy Extension
Presentation Linkbase Document*
EX-104
Cover Page Interactive
Data File (formatted as Inline XBRL and contained in Exhibit 101)*
*
Filed herewith.
+
Certain portions of this
exhibit that are not material and would be competitively harmful if publicly disclosed have been redacted pursuant to Item 601(b)(10)(iv)
of Regulation S-K. Copies of the unredacted exhibit will be furnished to the SEC upon request.
28
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 ONCOLOGY, INC.
Date: May 15, 2026
By:
/s/ Leonard
Mazur
Leonard Mazur
Chief Executive Officer
(Principal Executive Officer)
Date: May 15, 2026
By:
/s/ Jaime
Bartushak
Jaime Bartushak
Chief Financial Officer
(Principal Financial and Accounting Officer)
29
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.