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: June 30, 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 001-38174
Citius Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Nevada 27-3425913
( 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, $0.001 par value CTXR 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 August 13, 2026, there were 27,452,570 shares
of common stock, $0.001 par value, of the registrant issued and outstanding.
Citius Pharmaceuticals, Inc.
FORM 10-Q
TABLE OF CONTENTS
June 30, 2026
Page
PART I. FINANCIAL INFORMATION:
1
Item 1.
Financial Statements (Unaudited)
1
Condensed Consolidated Balance Sheets at June 30, 2026 and September 30, 2025
1
Condensed Consolidated Statements of Operations for the Three and Nine Months Ended June 30, 2026 and 2025
2
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended June 30, 2026 and 2025
3
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended June 30, 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
24
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
34
Item 4.
Controls and Procedures
34
PART II. OTHER INFORMATION
35
Item 1.
Legal Proceedings
35
Item 1A.
Risk Factors
35
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
36
Item 3.
Defaults Upon Senior Securities
36
Item 4.
Mine Safety Disclosures
36
Item 5.
Other Information
36
Item 6.
Exhibits
37
SIGNATURES
38
i
EXPLANATORY NOTE
In this Quarterly Report on Form 10-Q, and unless
the context otherwise requires, the “Company,” “Citius Pharma,” “we,” “us,” and “our”
refer to Citius Pharmaceuticals, Inc. and its wholly-owned subsidiary Leonard-Meron Biosciences, Inc., and its majority-owned subsidiaries,
Citius Oncology, Inc. (Nasdaq: CTOR) (“Citius Oncology”) and NoveCite, Inc., taken as a whole.
Mino-Lok® is our registered trademark and
LYMPHIR ® (denileukin diftitox) is a registered trademark of Citius Oncology. All other trade names, trademarks and service
marks appearing in this quarterly report are the property of their respective owners. We have assumed that the reader understands that
all such terms are source-indicating. Accordingly, such terms, when first mentioned in this report, appear with the trade name, trademark
or service mark notice and then throughout the remainder of this report without trade name, trademark or service mark notices for convenience
only and should not be construed as being used in a descriptive or generic sense.
ii
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking
statements.” Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations,
strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements
are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These
statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore,
actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements
due to numerous factors discussed from time to time in this Report and in other documents which we file with the Securities and Exchange
Commission (the “SEC”). In addition, such statements could be affected by risks and uncertainties related to:
●
our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern;
●
our need for substantial additional funds and our ability to raise those funds;
●
our ongoing evaluation of strategic alternatives;
●
the ability of Citius Oncology to commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and services;
●
our ability to regain compliance with the continued listing requirements of the Nasdaq Stock Market LLC (“Nasdaq”);
●
our ability to recognize the anticipated benefits of the August 2024 reverse merger whereby Citius Oncology became a standalone publicly-traded company and our majority-owned subsidiary (the “Merger”), which may not be realized fully, if at all, or may take longer to realize than expected;
●
our ability to obtain regulatory approval for and successfully commercialize Mino-Lok;
●
the cost, timing, and results of our pre-clinical and clinical trials for our other product candidates;
●
our ability to apply for, obtain and maintain required regulatory approvals for our other product candidates;
●
the estimated markets for LYMPHIR, Mino-Lok or any of our future product candidates and the acceptance thereof by any market;
●
our ability to obtain, perform under and maintain financing and strategic agreements and relationships;
●
the commercial feasibility and success of our technology and our product candidates;
●
our ability to recruit and retain qualified management and technical personnel to carry out our operations; and
●
the other factors discussed in the “Risk Factors” section of our most recent Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with the SEC on December 23, 2025, as amended on January 28, 2026.
Any forward-looking statements speak only as of
the date on which they are made, and except as may be required under applicable securities laws, we do not undertake any obligation to
update any forward-looking statement to reflect events or circumstances after the filing date of this Report.
iii
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements.
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
June 30,
September 30,
2026
2025
ASSETS
Current Assets:
Cash and cash equivalents
$ 17,007,523
$ 4,252,290
Accounts receivable, net of allowances
686,235
-
Inventory
22,625,945
22,286,693
Prepaid expenses
3,011,660
1,395,490
Total Current Assets
43,331,363
27,934,473
Operating lease right-of-use asset, net
753,039
818,694
Deposits
38,062
38,062
In-process research and development, net of accumulated amortization
88,785,938
92,800,000
Goodwill
9,346,796
9,346,796
Total Other Assets
98,170,796
102,184,858
Total Assets
$ 142,255,198
$ 130,938,025
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$ 8,037,899
$ 13,693,692
License payable
15,650,000
22,650,000
Accrued expenses
25,913,962
4,190,253
Accrued compensation
1,871,320
3,292,447
Note payable
-
1,000,000
Operating lease liability
176,170
88,348
Total Current Liabilities
51,649,351
44,914,740
Deferred tax liability
7,696,443
7,770,760
Notes payable, net of deferred financing fees
6,410,161
-
Operating lease liability – noncurrent
590,787
724,925
Total Liabilities
66,346,742
53,410,425
Commitments and Contingencies
Stockholders’ Equity:
Preferred stock - $ 0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding
-
-
Common stock - $ 0.001 par value; 250,000,000 shares authorized; 27,452,570 and 18,067,744 shares issued and outstanding at June 30, 2026 and September 30, 2025, respectively
27,452
18,068
Additional paid-in capital
343,704,577
306,336,239
Accumulated deficit
( 277,118,897 )
( 238,804,129 )
Total Citius Pharmaceuticals, Inc. Stockholders’ Equity
66,613,132
67,550,178
Non-controlling interest
9,295,324
9,977,422
Total Equity
75,908,456
77,527,600
Total Liabilities and Equity
$ 142,255,198
$ 130,938,025
See notes to unaudited condensed consolidated financial
statements.
Reflects a 1-for-25 reverse stock split effective
November 25, 2024.
1
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND NINE MONTHS ENDED JUNE 30,
2026 AND 2025
(Unaudited)
Three Months Ended
Nine Months Ended
June 30,
June 30,
June 30,
June 30,
2026
2025
2026
2025
Revenues
$ 1,493,788
$ —
$ 7,105,197
$ —
Cost of revenues
( 491,843 )
—
( 1,609,929 )
—
Gross Profit
1,001,945
—
5,495,268
—
Operating Expenses
Research and development
1,053,869
1,621,325
4,287,106
7,514,888
Amortization of in-process research and development
1,720,312
—
4,014,062
—
General and administrative
6,149,173
4,447,008
38,261,001
14,626,882
Stock-based compensation – general and administrative
3,810,665
2,719,674
11,879,167
7,946,529
Total Operating Expenses
12,734,019
8,788,007
58,441,336
30,088,299
Operating Loss
( 11,732,074 )
( 8,788,007 )
( 52,946,068 )
( 30,088,299 )
Other Income (Expense)
Interest income
116,691
20,637
215,372
56,658
Gain on sale of New Jersey net operating losses
—
—
3,833,277
—
Amortization of deferred financing costs
( 179,492 )
—
( 179,492 )
—
Interest expense
( 231,732 )
( 172,262 )
( 420,301 )
( 172,262 )
Total Other Income (Expense), Net
( 294,533 )
( 151,625 )
3,448,856
( 115,604 )
Loss before Income Taxes
( 12,026,607 )
( 8,939,632 )
( 49,497,212 )
( 30,203,903 )
Income tax expense (benefit)
( 107,347 )
264,240
( 74,317 )
792,720
Net Loss
( 11,919,260 )
( 9,203,872 )
( 49,422,895 )
( 30,996,623 )
Net loss attributable to non-controlling interest
3,056,417
414,000
11,108,127
1,522,000
Net loss applicable to common stockholders
$ ( 8,862,843 )
$ ( 8,789,872 )
$ ( 38,314,768 )
$ ( 29,474,623 )
Net Loss Per Share - Basic and Diluted
$ ( 0.34 )
$ ( 0.80 )
$ ( 1.64 )
$ ( 3.27 )
Weighted Average Common Shares Outstanding
Basic and diluted (includes pre-funded warrants)
26,169,589
11,006,896
23,343,869
9,020,356
See notes to unaudited condensed consolidated financial
statements.
Reflects a 1-for-25 reverse stock split effective
November 25, 2024.
2
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES
IN STOCKHOLDERS’ EQUITY
FOR THE THREE AND NINE MONTHS ENDED JUNE 30,
2026 AND 2025
(Unaudited)
Preferred
Common Stock
Additional
Paid-In
Accumulated
Total Citius
Pharmaceuticals,
Inc.
Stockholders’
Non-
Controlling
Total
Stock
Shares
Amount
Capital
Deficit
Equity
Interest
Equity
Balance, September
30, 2025
-
18,067,744
$ 18,068
$ 306,336,239
$ ( 238,804,129 )
$ 67,550,178
$ 9,977,422
$ 77,527,600
Issuance of common stock, net of costs of $ 13,042
-
252,137
252
349,002
-
349,254
-
349,254
October 2025 sale of common stock and pre-funded warrants, net of costs of $ 75,868
-
1,460,000
1,460
5,401,471
-
5,402,931
-
5,402,931
December 2025 sale of common stock and pre-funded warrants by Citius Oncology, net of costs of $ 2,872,989
-
-
-
11,258,682
-
11,258,682
3,866,807
15,125,489
Issuance of common stock upon exercise
of pre-funded warrants
-
2,513,510
2,513
( 2,262 )
-
251
-
251
Issuance of common stock for services
83,036
83
107,427
-
107,510
--
107,510
Issuance of common stock warrant
for note payable extension
-
-
68,597
-
68,597
-
68,597
Stock-based compensation expense
-
-
-
3,441,544
-
3,441,544
838,683
4,280,227
Net loss
-
-
-
-
( 9,393,889 )
( 9,393,889 )
-
( 9,393,889 )
Net loss
attributable to non-controlling interest
-
-
-
-
1,173,104
1,173,104
( 1,173,104 )
-
Balance, December 31, 2025
-
22,376,427
22,376
326,960,700
( 247,024,914 )
79,958,162
13,509,808
93,467,970
Proceeds from exercise of Citius
Oncology pre-funded warrants
-
-
-
818
-
818
-
818
December 2025 offering costs
-
-
-
( 62,764 )
-
( 62,764 )
-
( 62,764 )
Stock-based compensation expense
-
-
-
2,876,460
-
2,876,460
911,815
3,788,275
Net loss
-
-
-
-
( 28,109,746 )
( 28,109,746 )
-
( 28,109,746 )
Net loss
attributable to non-controlling interest
-
-
-
-
6,878,606
6,878,606
( 6,878,606 )
-
Balance March 31, 2026
-
22,376,427
22,376
329,775,214
( 268,256,054 )
61,541,536
7,543,017
69,084,553
Issuance of common stock and pre-funded warrants in April 2026 registered direct offering, net of costs of $ 546,782
-
4,730,457
4,730
4,448,454
-
4,453,184
-
4,453,184
Proceeds from exercise of pre-funded
warrants
-
345,686
346
( 312 )
-
34
-
34
Citius Oncology net proceeds from exercise of warrants, net of costs of $ 1,770,000
-
-
-
6,397,475
-
6,397,475
3,332,525
9,730,000
Citius Oncology warrants issued
for loan agreement
-
-
-
492,652
-
492,652
256,628
749,280
Stock-based compensation expense
-
-
-
2,591,094
-
2,591,094
1,219,571
3,810,665
Net loss
-
-
-
-
( 11,919,260 )
( 11,919,260 )
-
( 11,919,260 )
Net loss
attributable to non-controlling interest
-
-
-
-
3,056,417
3,056,417
( 3,056,417 )
-
Balance
June 30, 2026
-
27,452,570
$ 27,452
$ 343,704,577
$ ( 277,118,897 )
$ 66,613,132
$ 9,295,324
$ 75,908,456
Balance, September 30, 2024
-
7,247,243
$ 7,247
$ 271,440,421
$ ( 201,370,218 )
$ 70,077,450
$ 4,024,380
$ 74,101,830
Sale of common stock, net of costs of $ 425,949
-
480,000
480
2,573,571
-
2,574,051
-
2,574,051
Stock-based compensation expense
-
-
-
2,524,824
-
2,524,824
-
2,524,824
Net loss
-
-
-
-
( 10,281,246 )
( 10,281,246 )
-
( 10,281,246 )
Net loss
attributable to non-controlling interest
-
-
-
-
513,000
513,000
( 513,000 )
-
Balance, December 31, 2024
-
7,727,243
7,727
276,538,816
( 211,138,464 )
65,408,079
3,511,380
68,919,459
Issuance of common stock, net of
costs
-
1,033,406
1,034
3,464,773
-
3,465,807
-
3,465,807
Stock-based compensation expense
-
-
-
2,702,031
-
2,702,031
-
2,702,031
Net loss
-
-
-
-
( 11,511,505 )
( 11,511,505 )
( 11,511,505 )
Net loss
attributable to non-controlling interest
-
-
-
-
595,000
595,000
( 595,000 )
-
Balance, March 31, 2025
-
8,760,649
8,761
282,705,620
( 222,054,969 )
60,659,412
2,916,380
63,575,792
Issuance of common stock, net of costs of $ 177,420
-
2,185,249
2,185
3,292,261
-
3,294,446
-
3,294,446
Issuance of common stock and pre-funded warrants in April 2025 registered direct offering, net of costs of $ 256,116
-
465,000
465
1,743,292
-
1,743,757
-
1,743,757
Issuance of common stock and pre-funded warrants in June 2025 registered direct offering, net of costs of $ 571,126
-
540,000
540
5,430,296
-
5,430,836
-
5,430,836
Issuance of common stock upon exercise
of pre-funded warrants
-
2,524,131
2,524
( 2,227 )
-
297
-
297
Sale of Series A preferred stock
100
-
-
100
-
100
-
100
Redemption of Series A preferred
stock
( 100 )
-
-
( 100 )
-
( 100 )
-
( 100 )
Stock-based compensation expense
-
-
-
2,719,674
-
2,719,674
-
2,719,674
Net loss
-
-
-
-
( 9,203,872 )
( 9,203,872 )
-
( 9,203,872 )
Net loss
attributable to non-controlling interest
414,000
414,000
( 414,000 )
-
Balance,
June 30, 2025
-
14,475,029
$ 14,475
$ 295,888,916
$ ( 230,844,841 )
$ 65,058,550
$ 2,502,380
$ 67,560,930
See notes to unaudited condensed consolidated financial
statements.
Reflects a 1-for-25 reverse stock split effective
November 25, 2024.
3
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE NINE MONTHS ENDED JUNE 30, 2026 AND
2025
(Unaudited)
2026
2025
Cash Flows From Operating Activities:
Net loss
$ ( 49,422,895 )
$ ( 30,996,623 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
11,879,167
7,946,529
Issuance of common stock for services
107,510
—
Issuance of common stock warrant
68,597
—
Amortization of in-process research and development
4,014,062
—
Amortization of operating lease right-of-use asset
65,655
152,212
Amortization of deferred financing costs
179,492
—
Deferred income tax expense (benefit)
( 74,317 )
792,720
Changes in operating assets and liabilities:
Accounts receivable, net of allowances
( 686,235 )
—
Inventory
( 339,252 )
( 8,940,201 )
Prepaid expenses
( 1,616,170 )
1,386,824
Accounts payable
( 5,655,793 )
5,166,831
Accrued expenses
19,961,209
8,506,648
Accrued compensation
( 1,421,127 )
1,481,023
Operating lease liability
( 46,316 )
( 167,911 )
Net Cash Used In Operating Activities
( 22,986,413 )
( 14,671,948 )
Cash Flows From Investing Activities:
License fee payments
( 7,000,000 )
—
Net Cash Used in Investing Activities
( 7,000,000 )
—
Cash Flows From Financing Activities:
Proceeds from (repayment of) note payable and advance from employee
( 1,000,000 )
1,300,000
Repayment of advance from employee
( 300,000 )
Net proceeds from loan agreement
9,635,000
—
Proceeds from exercise of warrants
9,731,103
—
Deferred Financing Costs
( 892,551 )
—
Proceeds from sale of Series A preferred stock
—
100
Redemption of Series A preferred stock
—
( 100 )
Net proceeds from common stock offerings
25,268,094
16,509,194
Net Cash Provided By Financing Activities
42,741,646
17,509,194
Net Change in Cash and Cash Equivalents
12,755,233
2,837,246
Cash and Cash Equivalents - Beginning of Period
4,252,290
3,251,880
Cash and Cash Equivalents - End of Period
$ 17,007,523
$ 6,089,126
Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:
Interest paid
$ 303,644
$ —
Operating lease right-of-use asset and liability recorded
$ —
$ 786,697
Warrants issued for loan agreement included in deferred financing costs
$ 749,280
$ —
Deferred financing costs included in accrued expenses
$ 1,762,500
$ —
See notes to unaudited condensed consolidated financial
statements.
4
CITIUS PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED JUNE 30, 2026 AND
2025
(Unaudited)
1. NATURE OF OPERATIONS, BASIS OF PRESENTATION
AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Business
Citius Pharmaceuticals, Inc. (“Citius Pharma,”
and together with its subsidiaries, the “Company”, “we” or “us”) is a late-stage biopharmaceutical
company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infectives
in adjunct cancer care, unique prescription products and stem cell therapies.
On March 30, 2016, Citius Pharma acquired Leonard-Meron
Biosciences, Inc. (“LMB”) as a wholly-owned subsidiary. We acquired all the outstanding stock of LMB by issuing shares of
our common stock. The net assets acquired included identifiable intangible assets of $ 19,400,000 related to in-process research and
development. We recorded goodwill of $ 9,346,796 for the excess of the purchase price over the net assets acquired.
On September 11, 2020, we formed NoveCite, Inc.
(“NoveCite”), a Delaware corporation, of which we own 75 % of the issued and outstanding capital stock (see Note 7).
On August 23, 2021, we formed Citius Oncology,
Inc. (“Citius Oncology”), as a wholly-owned subsidiary in conjunction with the acquisition of LYMPHIR, which began operations
in April 2022. On August 12, 2024, Citius Pharma and Citius Oncology entered into a merger agreement with TenX Keane Acquisition, and
its wholly owned subsidiary, TenX Merger Sub Inc (“Merger Sub”), whereby Merger Sub merged with and into Citius Oncology.
After the merger and recapitalization (the “Merger”), the newly combined publicly traded company was owned 92.3 % by Citius
Pharma, and is named “Citius Oncology, Inc.” (Nasdaq: CTOR). As of June 30, 2026, Citius Pharma owned approximately 62 % of
Citius Oncology.
Since our inception, we have devoted substantially
all our efforts to business planning, research and development, recruiting management and technical staff, and raising capital. We are
subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, the Company’s ability
to obtain additional financing, risks related to the development by the Company or its competitors of research and development stage products,
regulatory approval and market acceptance of its products, competition from larger companies, dependence on key personnel, dependence
on key suppliers and strategic partners and the Company’s compliance with governmental and other regulations.
Basis of Presentation and Summary of Significant
Accounting Policies
Basis of Preparation - The accompanying
unaudited condensed consolidated financial statements include the operations of Citius Pharmaceuticals, Inc., its wholly-owned subsidiary
LMB and its majority-owned subsidiaries NoveCite and Citius Oncology. On August 12, 2024, Citius Oncology, previously a wholly-owned subsidiary,
became a majority-owned subsidiary. As of June 30, 2026, Citius Oncology was approximately a 62 % majority-owned subsidiary.
The operations of NoveCite and Citius Oncology
are included in the consolidated results. The portion of equity that is not attributable to the Company is presented as a non-controlling
interest within stockholders’ equity. Unless excluded by shareholder agreements, the portion of net loss attributable to non-controlling
interests is included in the statement of operations. All significant inter-company balances and transactions have been eliminated in
consolidation.
5
The accompanying unaudited condensed consolidated
financial statements of the Company have been prepared on the same basis as the annual consolidated financial statements and, in the opinion
of management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state the condensed consolidated
financial position of the Company as of June 30, 2026, and the results of its operations and cash flows for the three and nine months
ended June 30, 2026 and 2025. The operating results for the three and nine months ended June 30, 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, as amended on January 28, 2026.
Use of Estimates - The process of preparing
financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”)
requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of financial statements and the reported amounts of revenues and expenses during the reporting period.
Estimates having relatively higher significance include the accounting for revenue recognition, in-process research and development, stock-based
compensation, net realizable value of inventory and income taxes. Actual results could differ from those estimates and changes in estimates
may occur.
Basic and Diluted Net Loss per Common Share
- Basic and diluted net loss per common share applicable to common stockholders is computed by dividing net loss applicable to common
stockholders in each period by the weighted average number of shares of common stock outstanding during such period. For the periods presented,
common stock equivalents, consisting of stock options and warrants, were not included in the calculation of the diluted loss per share
because they were anti-dilutive, with pre-funded warrants being included in the loss per share.
Recently Issued Accounting Standards
Other than as disclosed in our Form 10-K, we are
not aware of any other recently issued accounting standards not yet adopted that may have a material impact on our financial statements.
2. GOING CONCERN UNCERTAINTY AND MANAGEMENT’S
PLAN
The accompanying unaudited consolidated financial
statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities
in the normal course of business. We incurred a net loss of $ 49.4 million for the nine months ended June 30, 2026. The Company experienced
negative cash flows from operations of $ 23.0 million for the nine months ended June 30, 2026. At June 30, 2026, the Company had approximately
$ 17 million in cash and a negative working capital of approximately $ 8.3 million.
On April 24, 2026, Citius Pharma closed a
registered direct equity offering for net proceeds of approximately $ 4.5 million (See Note 9).
On May 5, 2026, Citius Oncology received net proceeds
of approximately $ 9.7 million from the exercise of warrants (See Note 9).
Citius Oncology entered into a term loan agreement
with two lenders for up to $ 25.0 million, with $ 10.0 million funded on May 6, 2026, up to $ 7.0 million available between October 1 and
December 31, 2026, if certain net revenue and liquidity milestones are achieved, and up to $ 8.0 million available between January 1 and
March 31, 2027, if certain additional net revenue milestones are achieved and a loan was drawn between October 1 and December 31, 2026.
The loans bear interest at the greater of the prime rate plus 6 % or 12.75 % and are secured by all of Citius Oncology’s assets, subject
to agreed exceptions. The loans mature on November 1, 2029 (See Note 8).
The Company estimates that its and Citius Oncology’s
collective available cash resources will be sufficient to fund our operations through November 2026. We will need to raise additional
capital in the future to support our operations beyond November 2026, which raises substantial doubt about the Company’s ability
to continue as a going concern within one year after the date that the accompanying consolidated financial statements are issued.
6
The Company is currently engaged in capital raising
initiatives, as well as separate capital raising initiatives through its subsidiary Citius Oncology, in an effort to extend its cash runway.
Citius Oncology has retained Jefferies LLC as its exclusive financial advisor in evaluating strategic alternatives aimed at maximizing
shareholder value.
The Company has generated limited operating revenue,
which commenced in December 2025, and has principally raised capital through the issuance of debt and equity instruments to finance its
operations. However, the Company’s continued operations beyond November 2026, including its development plans for Mino-Lok, Halo-Lido
and NoveCite, will depend on its ability to obtain regulatory approval for Mino-Lok and generate substantial revenue from the sale of
LYMPHIR and on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic
relationships, or out-licensing of its product candidates. However, the Company can provide no assurances on regulatory approval, commercialization,
or future sales of LYMPHIR or that financing or strategic relationships will be available on acceptable terms, or at all. If the Company
is unable to raise sufficient capital, find strategic partners or generate substantial revenue from the sale of LYMPHIR, there would be
a material adverse effect on its business. Further, the Company expects in the future to incur additional expenses as it continues to
develop its product candidates, including seeking regulatory approval, and protecting its intellectual property. The accompanying financial
statements do not include any adjustments that might result from the outcome of the above uncertainty.
3. REVENUE RECOGNITION AND ACCOUNTS RECEIVABLE
Revenue Recognition
We recognize revenue in accordance with the provisions
of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers. In determining the appropriate amount and timing
of revenue to be recognized under this guidance, we perform the following five steps: (i) identify the contract(s) with our customer;
(ii) identify the promised goods or services in the agreement and determine whether they are performance obligations, including whether
they are distinct in the context of the agreement; (iii) measure the transaction price, including the constraint on variable consideration;
(iv) allocate the transaction price to the performance obligations based on stand-alone selling prices; and (v) recognize revenue when
(or as) we satisfy each performance obligation. Revenues are recognized when control of the promised goods or services is transferred
to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.
We distribute LYMPHIR in the U.S. through third
party specialty distributors who are our customers. The third-party specialty distributors subsequently resell our product to health care
providers, hospitals and infusion centers. Separately, we have or may enter into payment arrangements with various third-parties including
government healthcare programs who provide coverage and reimbursement for our product that have been prescribed to a patient. Through
a regional distribution partner, we distribute LYMPHIR internationally as part of our Named Patient Program.
Net Revenues
We recognize net revenue from LYMPHIR sales, net
of variable consideration and consideration payable to parties other than our customers consisting of estimates related to allowances
for sales returns, government chargebacks, patient coupon programs, and specialty distributor fees. Revenue is generally recognized when
the customer obtains control of the Company’s product, which occurs at a point in time, upon delivery based on the contractual shipping
terms of a contract.
We estimate variable consideration using the expected
value method, constrained to amounts for which it is probable that a significant reversal of cumulative revenue will not occur when uncertainties
are resolved. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, historical
or expected utilization rates, new information regarding changes in applicable regulations and guidelines that would impact the amount
of the actual allowance and our expectations regarding future utilization rates and channel inventory data. We will review the adequacy
of our provisions for all gross-to-net adjustments on a quarterly basis. Amounts reserved for these adjustments are made when trends or
significant events indicate that adjustment is appropriate reflecting actual experience.
The Company elected the practical expedient in
ASC 606-10-32-18 and does not assess whether a significant financing component exists for contracts in which payment is expected within
one year. No other practical expedients were applied.
7
Gross-to-Net Adjustments
Specialty Distributor Fees
We pay fees for distribution services, such as
fees for certain data that customers provide us. We expect our customers will earn these fees and accordingly deduct these fees from gross
product sales and accounts receivable at the time we recognize the related revenues.
Product Returns
Customers have the right to return products if
they are damaged, defective, or expired, or as it is defined in their customer agreement. We have estimated product returns based on the
experience of similar products in the market, and will continue to estimate returns based on our actual returns, sales data, and inventory
levels in the distribution channel. These estimates are recorded as a reduction against gross product sales at the time of the sales.
Chargebacks
Chargebacks will occur when federal agencies who
we contract with, or may contract with, can purchase off the Federal Supply Schedule or when Public Health Service 340B covered entities
purchase directly from our customers at discounted prices. Our customers then charge us the difference between their purchase price and
the discounted price. We estimate chargebacks considering the terms of the applicable arrangement and our visibility regarding utilization.
These chargebacks are recorded in the same period as the related revenue, as a reduction against gross product sales and accounts receivable.
Co-payment Assistance
We offer co-payment assistance to patients with
commercial insurance that have coverage and are allowed such co-payment assistance. We estimate the average co-payment assistance amounts
for our products based on expected customer utilization and record any such amounts as a reduction from gross product revenue at the time
of sale. The Company has deposited the estimated co-pay assistance amounts, which are reflected and included in the gross-to-net adjustments.
Three Months
Ended
Nine Months
Ended
June 30,
2026
June 30,
2026
Gross Product Revenue
$
1,708,560
$
8,591,040
Gross-to-net adjustments:
214,772
1,485,843
Net Revenue
$
1,493,788
$
7,105,197
Accounts receivable, net
Accounts receivable, net is stated at amounts
invoiced less allowances for distributor fees, chargebacks, and estimated returns. At June 30, 2026, these sales allowances totaled $ 690,090 .
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 June 30, 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:
June 30,
2026
September 30,
2025
Finished goods
$ 15,673,980
$ 10,577,876
Work in process
6,951,965
11,708,817
Total
$ 22,625,945
$ 22,286,693
Cost of Revenue
Cost of goods sold consists of direct and indirect
costs associated with manufacturing and distributing LYMPHIR. These costs include amounts paid to third-party contract manufacturing organizations
for production-related services, including raw materials, drug substance, drug product manufacturing, fill-finish activities, certain
testing, and packaging. Cost of goods sold also includes distribution, storage shipping, and handling fees, as well as royalties owed
under the Company’s licensing arrangements.
5. PREPAID EXPENSES
Prepaid expenses include advance payments made
for the preparation of long-lead time drug substance and product costs, which will be utilized in research and development activities
or in the manufacturing of LYMPHIR for sales. Other prepaid expenses include insurance, service fees and marketing costs. A summary of
prepaid expenses is as follows:
June 30,
2026
September 30,
2025
Prepaid manufacturing
$ 2,531,280
$ 1,331,280
Prepaid insurance
180,380
-
Prepaid annual service fees
-
64,210
Prepaid marketing costs
300,000
-
Total
$ 3,011,660
$ 1,395,490
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 $ 69,385,938 at June 30, 2026. Amortization of in-process research
and development commenced upon revenue generation in December 2025. For the three months ended June 30, 2026 and 2025, amortization was
$ 1,720,312 and $0 , respectively. For the nine months ended June 30, 2026 and 2025, amortization was $ 4,014,062 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. The amortization of in-process research and development excludes $ 19,400,000 associated with the acquisition
of LMB and the Mino-Lok product candidate which will begin amortization upon approval. 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 nine months ended June 30, 2026)
$ 1,720,313
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
$ 69,385,938
9
7. PATENT AND TECHNOLOGY LICENSE AGREEMENTS
Patent and Technology License Agreement
– Mino-Lok
LMB has a patent and technology license agreement
with Novel Anti-Infective Therapeutics, Inc. (“NAT”) to develop and commercialize Mino-Lok ® on an exclusive,
worldwide sub-licensable basis, as amended. LMB pays an annual maintenance fee each June until commercial sales of a product subject to
the license commence. The Company recorded an annual maintenance fee expense of $ 90,000 in both 2026 and 2025.
LMB will also pay annual royalties on net sales
of licensed products, with a low double-digit royalty rate (within a range of 10 % to 15 %). In limited circumstances in which the licensed
product is not subject to a valid patent claim and a competitor is selling a competing product, the royalty rate is in the low- to mid-single
digits (within a range of 2 % to 7 %). After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties of $ 100,000
in the first commercial year which is prorated for a less than 12-month period, increasing $ 25,000 per year to a maximum of $ 150,000 annually.
LMB must also pay NAT up to $ 1,100,000 upon achieving specified regulatory and sales milestones. Finally, LMB must pay NAT a specified
percentage of payments received from any sub-licensees.
Unless earlier terminated by NAT, based on the
failure to achieve certain development and commercial milestones, the license agreement remains in effect until the date that all patents
licensed under the agreement have expired and all patent applications within the licensed patent rights have been cancelled, withdrawn,
or expressly abandoned.
License Agreement with Eterna
On October 6, 2020, our subsidiary, NoveCite,
entered into a license agreement with Novellus Therapeutics Limited (“Novellus”), whereby NoveCite acquired an exclusive,
worldwide license, with the right to sublicense, develop and commercialize a stem cell therapy based on the Novellus’s patented
technology for the treatment of acute pneumonitis of any etiology in which inflammation is a major agent in humans. Upon execution of
the license agreement, we paid $ 5,000,000 to Novellus, which was charged to research and development expense during the year ended September
30, 2021, and issued to Novellus shares of NoveCite’s common stock representing 25 % of the outstanding equity. We own the other
75 % of NoveCite’s outstanding equity. Pursuant to the terms of the original stock subscription agreement, if NoveCite issued additional
equity, subject to certain exceptions, NoveCite had to maintain Novellus’s ownership at 25 % by issuing additional shares to Novellus.
In July 2021, Novellus was acquired by Brooklyn
ImmunoTherapeutics, Inc. (“Brooklyn”). Pursuant to this transaction, the NoveCite license was assumed by Brooklyn with all
original terms and conditions. In connection with that transaction, the stock subscription agreement was amended to assign to Brooklyn
all of Novellus’s right, title, and interest in the stock subscription agreement and delete the anti-dilution protection and replace
it with a right of first refusal whereby Brooklyn will have the right to purchase all or a portion of the securities that NoveCite intends
to sell or in the alternative, at the option of NoveCite, Brooklyn may purchase that amount of the securities proposed to be sold by NoveCite
to allow Brooklyn to maintain its then percentage ownership. In October 2022, Brooklyn changed its name to Eterna Therapeutics Inc. (“Eterna”).
We are responsible for the operational activities
of NoveCite and bear all costs necessary to operate NoveCite. Our officers are also the officers of NoveCite and oversee the business
strategy and operations of NoveCite. As such, NoveCite is accounted for as a consolidated subsidiary with a noncontrolling interest.
Eterna has no contractual rights in the profits
or obligations to share in the losses of NoveCite, and the Company has not allocated any losses to the noncontrolling interest.
10
Under the license agreement, NoveCite is obligated
to pay Eterna up to an aggregate of $ 51,000,000 in regulatory and developmental milestone payments. NoveCite also must pay a royalty equal
to a mid-teens percentage of net sales, commencing upon the first commercial sale of a licensed product. This royalty is subject to downward
adjustment on a product-by-product and country-by-country basis to a mid-single digit percentage (within a range of 4 % to 8 %) of net sales
in any country in the event of the expiration of the last valid patent claim or if no valid patent claim exists in that country. The royalty
will end on the earlier of (i) date on which a biosimilar product is first marketed, sold, or distributed by Eterna or any third party
in the applicable country or (ii) the 10-year anniversary of the date of expiration of the last-to-expire valid patent claim in that country.
In the case of a country where no licensed patent ever exists, the royalty will end on the later of (i) the date of expiry of such licensed
product’s regulatory exclusivity and (ii) the 10-year anniversary of the date of the first commercial sale of the licensed product
in the applicable country. In addition, NoveCite will pay to Eterna an amount equal to a mid-twenties percentage of any sublicensee fees
it receives.
Under the terms of the license agreement, in the
event that Eterna receives any revenue involving the original cell line included in the licensed technology, then Eterna shall remit to
NoveCite 50 % of such revenue.
The term of the license agreement continues on
a country-by-country and licensed product-by-licensed product basis until the expiration of the last-to-expire royalty term. Either party
may terminate the license agreement upon written notice if the other party is in material default. NoveCite may terminate the license
agreement at any time without cause upon 90 days prior written notice.
Eterna will be responsible for preparing, filing,
prosecuting, and maintaining all patent applications and patents included in the licensed patents in the territory, provided however,
that if Eterna decides that it is not interested in maintaining a particular licensed patent or in preparing, filing, or prosecuting a
licensed patent, NoveCite will have the right, but not the obligation, to assume such responsibilities in the territory at NoveCite’s
sole cost and expense.
License Agreement with Eisai
In September 2021, we entered into an asset purchase
agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, Ltd. (collectively, “Dr. Reddy’s”)
and a license agreement with Eisai Co., Ltd. (“Eisai”) to acquire an exclusive license of E7777 (denileukin diftitox), an
oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. We renamed E7777 as I/ONTAK and also obtained the
trade name of LYMPHIR TM for the product. We assigned these agreements to Citius Oncology effective April 1, 2022 and we received
a Biologics License Application (“BLA”) approval from the FDA for LYMPHIR in August 2024.
Under the terms of these agreements, we acquired
Dr. Reddy’s exclusive license of E7777 from Eisai and other related assets owned by Dr. Reddy’s (which are now owned by Citius
Oncology). The exclusive license include rights to develop and commercialize E7777 in all markets except for Japan and certain parts of
Asia. Eisai retains exclusive development and marketing rights for the agent in Japan, China, Korea, Taiwan, Hong Kong, Macau, Indonesia,
Thailand, Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia, Laos, Afghanistan, Bangladesh,
Bhutan, Nepal, Mongolia, and Papua New Guinea. We paid Dr. Reddy’s a $ 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.
11
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 $ 15,650,000 remains due as of June 30, 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 nine months ended June 30, 2026, we recorded
$ 112,270 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 June 30, 2026, we owe Eisai for other unpaid invoices, consisting of $ 2,200,000 of accounts payable and $ 4,062,481 of accrued
expenses.
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.
12
8. DEBT AGREEMENTS
Note Payable
On June 2, 2025, the Company borrowed $ 1,000,000
from an unrelated lender. The note payable was due in full on December 2, 2025 with interest at 15 % compounded monthly. Leonard Mazur
(Chairman and Chief Executive Officer of the Company) personally guaranteed repayment of the note.
On December 2, 2025, we extended the due date
to January 2, 2026 and the note was paid in full on January 5, 2026. As consideration for the extension, we issued a five-year warrant
to purchase 75,000 shares of our common stock at $ 1.26 per share. The $ 68,597 fair value of the warrant was charged to interest expense
during the nine months ended June 30, 2026.
Interest expense on the note payable was $ 0 and
$ 11,507 for the three months ended June 30, 2026 and 2025, respectively. Interest expense, including the fair value of the warrant was
$ 109,697 and $ 11,507 for the nine months ended June 30, 2026 and 2025, respectively.
Term Loan Agreement
June 30,
2026
Notes payable principal balance
$ 10,000,000
Deferred financing costs, net of accumulated amortization
( 3,589,839 )
Notes payable, net of deferred financing costs
$ 6,410,161
On May 5, 2026, Citius Oncology entered into a
term loan agreement with two lenders for up to $ 25.0 million, with $ 10.0 million funded on May 6, 2026, up to $ 7.0 million available between
October 1 and December 31, 2026, if certain net revenue and liquidity milestones are achieved, and up to $ 8.0 million available between
January 1 and March 31, 2027, if certain additional net revenue milestones are achieved and a loan was drawn between October 1 and December
31, 2026.
The loans bear interest at the greater of the
prime rate plus 6 % or 12.75 % and are secured by all of Citius Oncology’s assets, subject to agreed exceptions. The Company will
pay interest only through November 2027 with subsequent monthly principal payments until maturity on November 1, 2029. A final payment
of $ 1,062,500 is due at maturity. Interest expense for the loan for the three months ended June 30, 2026 was $ 198,333 .
Citius Oncology issued five-year warrants to the
lenders to purchase 1,111,111 shares of common stock at an exercise price of $ 0.90 per share. The warrant shares were calculated based
on 10 % of the initial funding divided by $ 0.90 per share. The Company will issue additional warrant shares under the same formula, if
additional funds are drawn under the agreement. The estimated fair value of the warrants issued to the lenders on May 5, 2026 was approximately
$ 749,280 and was charged to deferred financing costs.
The lenders have the right, while any loan is
outstanding, to convert up to $ 4.0 million of the outstanding loans into shares of common stock at $ 1.08 per share, subject to certain
terms and conditions.
In addition, Citius Oncology granted the lenders
the right to invest up to $ 1.0 million in any issuance of equity securities on the same terms offered to other investors in such financing
transaction. The right terminates 30 days after the repayment in full of all of the obligations under the loan agreement.
In connection with the loan agreement, Citius
Oncology incurred deferred financing costs totaling $ 3,769,331 . Deferred financing costs consist of commitment fees of $ 250,000 , legal
fees of $ 207,551 , a final payment of $ 1,062,500 , placement fees of $ 1,500,000 , and the $ 749,280 fair value of the lenders’ warrants.
Deferred financing costs are being amortized on a straight-line basis over the 42-month life of the loan agreement. Amortization expense
for the three months ended June 30, 2026 was $ 179,492 .
13
9. STOCKHOLDERS’ EQUITY
Authorized Common Stock and Reverse Stock
Split
The Company filed a Certificate of Change with
the Secretary of State of the State of Nevada to (i) effect a 1-for-25 reverse stock split of the Company’s issued and outstanding
shares of common stock, and (ii) decrease the number of total authorized shares of common stock from 400,000,000 shares to 16,000,000
shares. The reverse stock split was intended for the Company to regain compliance with the minimum bid price requirement of $ 1.00 per
share of common stock for continued listing on the Nasdaq Capital Market. The reverse stock split became effective on November 25, 2024,
and the Company’s Common Stock began trading on a reverse stock split-adjusted basis on the Nasdaq Capital Market on November 26,
2024. All share amounts have been retroactively adjusted to reflect the split.
Series A Preferred Stock and Authorized
Common Stock
On April 17, 2025, the Company entered into an
agreement with Leonard Mazur (Chairman and Chief Executive Officer of the Company), pursuant to which the Company sold one share of Series
A Preferred Stock, par value $ 0.001 per share for $ 100 to Mr. Mazur. The Series A Preferred Stock was sold in connection with the June
9, 2025 special meeting of the stockholders for the purpose of approving an amendment to the Company’s Articles of Incorporation,
as amended, to increase the number of shares of the Company’s authorized common stock from 16,000,000 to 250,000,000 . The Company’s
stockholders approved the authorized share increase on June 9, 2025.
On April 17, 2025, the Company filed a certificate
of designation with the Nevada Secretary of State, designating the powers, rights, privileges and restrictions of the Series A Preferred
Stock. The certificate provides that each share of Series A Preferred Stock had 1,000,000,000 votes and voted together with the outstanding
shares of Common Stock as a single class, exclusively with respect to the authorized share increase proposal and was not entitled to vote
on any other matter. The Series A Preferred Stock was voted on the authorized share increase in the same proportion as the aggregate votes
cast by holders of common stock “for” and “against” the proposal. The Series A Preferred Stock otherwise had no
other voting rights, including in respect of any other proposal. The voting power attributable to the Series A Preferred Stock was disregarded
for purposes of determining whether a quorum was present at the special meeting, and the establishment of a quorum at the special meeting
was determined only with reference to the common stock.
Pursuant to its terms, on June 9, 2025, the outstanding
share of Series A Preferred Stock was redeemed automatically for $ 100 after the Company published the final results of the stockholder
vote on the authorized stock increase.
Common Stock Issued for Services
On July 1, 2025, we issued 20,000 shares of common
stock for media, and public and investor relations services and expensed the $ 26,600 fair value of the common stock issued.
On October 2, 2025, we issued 83,036 shares of
common stock for media, and public and investor relations services and expensed the $ 107,510 fair value of the common stock issued.
14
Common Stock Offerings
November 2024 Offering
On November 15, 2024, Citius Pharma sold 480,000
shares of common stock and warrants to purchase 480,000 shares of common stock. Gross proceeds were $ 3,000,000 and net proceeds were $ 2,574,051 ,
after deducting fees and expenses. The shares and warrants were sold at a combined offering price of $ 6.25 per share and accompanying
warrant. The immediately exercisable warrants have an exercise price of $ 6.25 per share and expire on November 19, 2029 . The estimated
fair value of the warrants issued to the investors was approximately $ 1,575,000 .
We paid the placement agent a fee of 7.0 % of the
gross proceeds and granted the placement agent immediately exercisable warrants to purchase 33,600 shares of common stock at an exercise
price of $ 7.8125 per share, which expire on November 15, 2029 . The estimated fair value of the warrants issued to the placement agent
was approximately $ 104,000 .
January 2025 Offering
On January 7, 2025, Citius Pharma sold 743,496
shares of common stock and warrants to purchase 743,496 shares of common stock. Gross proceeds were approximately $ 3,000,000 and
net proceeds were $ 2,657,167 , after deducting fees and expenses. The shares and warrants were sold at a combined offering price of
$ 4.035 per share and accompanying warrant. The immediately exercisable warrants have an exercise price of $ 3.91 per share and expire on
January 8, 2030 . The estimated fair value of the warrants issued to the investors was approximately $ 2,091,000 .
We paid the placement agent a fee of 7.0 %
of the gross proceeds and granted the placement agent immediately exercisable warrants, to purchase 52,045 shares of common
stock at $ 5.0438 per share, which expire on January 7, 2030 . The estimated fair value of the warrants issued to the placement agent
was approximately $ 138,000 .
April 2025 Offering
On April 1, 2025, Citius Pharma sold 465,000 shares
of common stock at $ 1.15 per share and pre-funded warrants to purchase 1,274,131 shares of common stock at $ 1.1499 per share. Gross proceeds
were $ 1,999,873 and net proceeds were $ 1,743,757 , after deducting fees and expenses. The immediately exercisable pre-funded warrants have
an exercise price of $ 0.0001 per share and do not expire. All 1,274,131 of the pre-funded warrants were exercised during the three
months ended June 30, 2025.
We paid the placement agent a fee of 7.0 %
of the gross proceeds and granted the placement agent warrants to purchase 121,739 shares of common stock at an exercise price
of $ 1.4375 per share, which are exercisable commencing on October 2, 2025 and expire on April 1, 2030 . The estimated fair value of
the warrants issued to the placement agent was approximately $ 100,000 .
June 2025 Offering
On June 11, 2025, Citius Pharma sold 540,000 shares
of common stock and pre-funded warrants to purchase 4,380,000 shares of common stock, and accompanying warrants to purchase 9,840,000
shares of common stock, at $ 1.22 per share and accompanying warrant (or $ 1.2199 per pre-funded warrant and accompanying warrant). The
immediately exercisable two-year warrants have an exercise price of $ 1.00 per share. On the expiration date, any warrants outstanding
will be exercised via cashless exercise. The pre-funded warrants are exercisable immediately at $ 0.0001 per share and do not expire. Gross
proceeds were $ 6,001,962 and net proceeds of the offering were $ 5,430,836 , after deducting fees and expenses. During the year ended September
30, 2025, all 4,380,000 pre-funded warrants were exercised. The estimated fair value of the 9,840,000 warrants issued to the investors
was approximately $ 4,867,000 .
We paid the placement agent a fee of 7.0 %
of the gross proceeds and expenses of $ 150,958 and granted placement agent warrants to purchase 344,400 shares of common stock at an exercise
price of $ 1.525 per share, which expire on June 11, 2027 . On the expiration date, any warrants outstanding will be exercised via
cashless exercise. The estimated fair value of the warrants issued to the placement agent was approximately $ 222,000 .
15
July 2025 Citius Oncology Offering
On July 17, 2025, Citius Oncology 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), Citius Oncology agreed to reduce the exercise price of the 6,818,182 warrants to $ 1.09 per share and extended the expiration date
of the warrants 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 . On May 6, 2026, all of the warrants were repriced to $ 0.90 per share and exercised in connection with
the warrant inducement transaction. The estimated fair value of the repriced warrants issued to the investors as of May 6, 2026 was approximately
$ 4,598,000 .
Citius Oncology 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. Citius
Oncology 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 Citius Oncology Offering
On September 10, 2025, Citius Oncology 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 of the warrants 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 . On May 6, 2026, all of the warrants were repriced to $ 0.90
per share and exercised in connection with the warrant inducement transaction. The estimated fair value of the repriced warrants issued
to the investors as of May 6, 2026 was approximately $ 3,468,000 .
Citius Oncology paid the placement agent a fee
of 7.0 % of the gross proceeds and expenses of $ 125,000 . Additionally, Citius Oncology 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 .
October 2025 Offering
On October 21, 2025, Citius Pharma sold 1,460,000
shares of common stock and 2,513,510 pre-funded warrants, and accompanying warrants to purchase 3,973,510 shares of common stock at $ 1.51
per share and accompanying warrant (or $ 1.5099 per pre-funded warrant and accompanying warrant). The immediately exercisable five-year
warrants have an exercise price of $ 1.40 per share. The immediately exercisable pre-funded warrants have an exercise price of $ 0.0001
per share and do not expire. Gross proceeds were approximately $ 6.0 million, before deducting placement agent fees and other expenses
and net proceeds were $ 5,402,931 . During the nine months ended June 30, 2026, all 2,513,510 pre-funded warrants were exercised. The estimated
fair value of the 3,973,510 warrants issued to the investors was approximately $ 4,995,000 .
We paid the placement agent a fee of 7.0 % of the
gross proceeds and expenses of $ 85,000 , and issued the placement agent warrants to purchase 278,146 shares of common stock at an exercise
price of $ 1.8875 per share. The warrants are exercisable commencing on October 21, 2025 and expire on October 20, 2030. The estimated
fair value of the warrants issued to the placement agent was approximately $ 330,000 .
16
December 2025 Citius Oncology Offering
On December 10, 2025, Citius Oncology sold 1,284,404
shares of its 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 nine months ended June 30, 2026, Citius Oncology received
net proceeds of $ 818 from the exercise of 8,183,358 pre-funded warrants. At June 30, 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, which
was effective on February 18, 2026. The estimated fair value of the 16,513,762 warrants issued to the investors was approximately $ 13,196,000 .
On May 6, 2026, all of the warrants were repriced to $ 0.90 per share and warrants to purchase 816,738 shares were exercised in connection
with the warrant inducement transaction and warrants to purchase 15,697,024 remain outstanding. The estimated fair value of the repriced
warrants issued to the investors as of May 6, 2026 was approximately $ 11,136,000 .
Citius Oncology paid the placement agent a fee
of 7.0 % of the gross proceeds and expenses of $ 135,000 . Additionally, Citius Oncology issued placement agent warrants to purchase 1,155,963
shares of its common stock at an exercise price of $ 1.3625 per share exercisable on or before December 8, 2030. Citius Oncology also paid
an additional 7.0 % cash fee to a prior placement agent and issued warrants to purchase up to 660,550 shares of its common stock at an
exercise price of $ 1.199 per share exercisable on or before December 8, 2030. The estimated fair value of the placement agent warrants
was approximately $ 1,401,000 .
April 2026 Registered Direct Offering
On April 24, 2026, Citius Pharma closed a
registered direct offering for the sale of 4,730,457 shares of common stock at $ 0.985 per share and 345,686 pre-funded warrants at $ 0.9849
per warrant. Net proceeds were $ 4,453,184 , after deducting placement agent fees and expenses. The pre-funded warrants were exercisable
at $ 0.0001 per warrant and were all exercised on April 24, 2026 for $ 34 . The Company issued immediately exercisable five-year warrants
to the investors for 5,076,143 shares of common stock at $ 0.86 per share. The estimated fair value of the warrants issued to the investors
was approximately $ 2,829,000 .
We paid the placement agent a fee of 7.0 % of the
gross proceeds and expenses of $ 85,000 , and issued the placement agent warrants to purchase 355,330 shares of common stock at an exercise
price of $ 1.2313 per share. The warrants are immediately exercisable and expire on April 23, 2031. The estimated fair value of the warrants
issued to the placement agent was approximately $ 184,000 .
May 2026 Warrant Inducement Transaction
On May 5, 2026, Citius Oncology entered into an
agreement with the holder of certain existing warrants to purchase 12,777,778 shares of common stock at $ 0.90 per share, which consists
of all of the 6,818,182 warrants issued in July 2025, all of the 5,142,858 warrants issued in September 2025, and 816,738 warrants issued
in December 2025, each with an exercise price of $ 1.09 per share. Exercise of the warrants for cash is subject to a beneficial ownership
limitation of 9.99 %. If the beneficial ownership limitation applies, the issuance of the shares of common stock are held in abeyance until
compliance with the beneficial ownership limitation.
As an inducement to the holder for exercising
the 12,777,778 warrants in cash at a reduced exercise price of $ 0.90 per share, Citius Oncology issued to the holder new five-year warrants
to purchase 25,555,556 shares at $ 0.90 per share. Net proceeds were $ 9,730,000 , after deducting placement agent fees and expenses of $ 1,770,000 .
The estimated fair value of the 25,555,556 warrants issued to the investors was approximately $ 17,233,000 . The combined fair value
of $ 18,342,000 was recognized as an equity issuance cost within additional paid-in capital with no impact on total stockholders’
equity.
Citius Oncology paid the placement agent a fee
of 7.0 % of the gross proceeds and expenses of $ 85,000 . Additionally, Citius Oncology issued placement agent warrants to purchase 894,444
shares at $ 1.125 per share. Citius Oncology also paid an additional 7.0 % cash fee to a prior placement agent and issued warrants to purchase
511,111 shares at $ 1.199 per share. The placement agent warrants are exercisable commencing on June 18, 2026, and expire on June 18, 2031 .
The estimated fair value of the placement agent warrants was approximately $ 903,000 .
17
Citius Pharma At the Market Offering Agreement
On August 12, 2024, we entered into a sales agreement
to sell from time to time during the term of the agreement shares of our common stock.
During the three months ended March 31, 2025,
we sold 289,910 shares for gross proceeds of $ 839,468 . Net proceeds after deducting broker fees and other offering expenses were $ 808,640 .
During the three months ended June 30, 2025, we
sold 2,185,249 shares for gross proceeds of $ 3,471,866 . Net proceeds after deducting broker fees and other offering expenses were $ 3,294,446 .
During the three months ended September 30, 2025,
we sold 442,715 shares for gross proceeds of $ 657,284 . Net proceeds after deducting broker fees and other offering expenses were $ 626,843 .
During the three months ended December 31, 2025,
we sold 252,137 shares for gross proceeds of $ 362,296 . Net proceeds after deducting broker fees and other offering expenses were $ 349,254 .
Citius Pharma Stock Option Plans
Under our 2014 Stock Plan, we reserved 34,667
shares of common stock. As of June 30, 2026, there were options to purchase 13,710 shares outstanding and no shares were available for
future grants.
Under our 2018 Stock Plan, we reserved 80,000
shares of common stock. As of June 30, 2026, there were options to purchase 67,200 shares outstanding and no shares available for future
grants.
Under our 2020 Stock Plan, we reserved 124,400
shares of common stock. As of June 30, 2026, there were options to purchase 66,000 shares outstanding and no shares available for future
grants.
Under our 2021 Stock Plan, we reserved 349,600
shares of common stock. As of June 30, 2026, options to purchase 330,000 shares were outstanding and no shares available for future grants.
Under our 2023 Stock Plan, we reserved 481,400
shares of common stock. As of June 30, 2026, options to purchase 359,400 shares were outstanding and 118,000 shares remain available for
future grants.
The fair value of each stock option award is estimated
on the date of grant using the Black-Scholes option pricing model. Volatility is estimated using the trading activity of our common stock.
The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term
assumption. The expected term of stock options granted, all of which qualify as “plain vanilla,” is based on the average of
the contractual term (generally 10 years) and the vesting period. For non-employee options, the expected term is the contractual term.
A summary of option activity under our stock option
plans (excluding the NoveCite and Citius Oncology Stock Plans) is presented below:
Option
Shares Weighted-
Average
Exercise
Price Weighted-
Average
Remaining
Contractual
Term Aggregate
Intrinsic
Value
Outstanding at September 30, 2025 839,510 $ 30.09 6.90 years $ 0.00
Granted -
-
Exercised -
-
Forfeited or expired ( 3,200 ) 234.98
Outstanding at June 30, 2026 836,310 $ 29.31 6.09 years $ 0.00
Exercisable at June 30, 2026 685,643 $ 33.07 5.66 years $ 0.00
At June 30, 2026, unrecognized total compensation
cost related to unvested awards under the Citius Pharma stock plans of $ 649,996 is expected to be recognized over a weighted average period
of 1.07 years.
18
NoveCite Stock Plan - Under the
NoveCite 2020 Stock Plan, we reserved 2,000,000 common shares of NoveCite. The NoveCite Stock Plan provides incentives to employees, directors,
and consultants through grants of options, SARs, dividend equivalent rights, restricted stock, restricted stock units, or other rights.
As of June 30, 2026, NoveCite has options outstanding
to purchase 1,911,500 common shares of NoveCite, all of which are exercisable, and 88,500 shares available for future grants. All of the
options were issued during the year ended September 30, 2021, vested over 36 months and have a term of 10 years. The weighted average
remaining contractual term of options outstanding under the NoveCite Stock Plan is 4.42 years and the weighted average exercise price
is $ 0.24 per share. At June 30, 2026, there is no unrecognized compensation cost related to these awards and no aggregate intrinsic value.
Citius Oncology Stock Plan - Under
the Citius Oncology 2023 Omnibus Stock Incentive Plan, we reserved 15,000,000 common shares of Citius Oncology. Under the Citius Oncology
2024 Omnibus Stock Incentive Plan, we reserved 15,000,000 common shares of Citius Oncology and amended the 2024 Stock Plan on October
27, 2025 to reserve an additional 15,000,000 shares for an aggregate of 30,000,000 shares of common stock under the Citius Oncology 2024
Omnibus Stock Incentive Plan. The Citius Oncology 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 Citius Oncology has sufficient history. The risk-free interest rate is based on the U.S. Treasury yield
curve in effect at the time of grant commensurate with the expected term assumption. The expected term of stock options granted to employees
and directors, all of which qualify as “plain vanilla,” is based on the average of the contractual term (generally 10 years)
and the vesting period. For non-employee options, the expected term is the contractual term.
A summary of option activity under the Citius Oncology stock plans
is presented below:
Shares Weighted-
Average
Exercise
Price Weighted-
Average
Remaining
Contractual
Term Aggregate
Intrinsic
Value
Outstanding at September 30, 2025 18,100,000 $ 1.83 8.21 years $ 5,386,000
Granted -
-
Forfeited -
-
Outstanding at June 30, 2026 18,100,000 $ 1.83 7.27 years $ -
Exercisable at June 30, 2026 11,316,667 $ 1.90 7.02 years $ -
At June 30, 2026, unrecognized total compensation
cost related to unvested awards under the Citius Oncology stock plans of $ 1,726,594 is expected to be recognized over a weighted average
period of 1.42 years.
Citius Oncology Restricted Stock Units
On September 19, 2025, Citius Oncology granted
restricted stock units of 11,600,000 shares of common stock to employees and directors. The restricted stock units 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, Citius Oncology granted
restricted stock units of 350,000 shares of common stock to an employee and a consultant. The restricted stock units vest on March 24,
2029. The fair value of the common stock on the date of grant was $ 203,000 ($ 0.58 per share).
19
At June 30, 2026, unrecognized total compensation
cost related to unvested restricted stock units under the stock plans of $ 15,224,629 is expected to be recognized over a weighted average
period of 2.23 years.
Stock-based Compensation Expense
Stock-based compensation expense under all plans
for the three months ended June 30, 2026 and 2025 was $ 3,810,665 (including $ 249,874 for Citius Pharma options, $ 1,858,443 for Citius
Oncology options and $ 1,702,348 for Citius Oncology restricted stock units) and $ 2,719,674 (including $ 594,437 for Citius Pharma options
and $ 2,125,237 for Citius Oncology options), respectively.
Stock-based compensation expense under all plans
for the nine months ended June 30, 2026 and 2025 was $ 11,879,167 (including $ 835,616 for Citius Pharma options, $ 5,968,921 for Citius
Oncology options and $ 5,074,630 for Citius Oncology restricted stock units) and $ 7,946,529 (including $ 1,924,242 for Citius Pharma options
and $ 6,022,287 for Citius Oncology options), respectively.
Citius Pharma Warrants
We have reserved 23,247,210 shares of common stock
for the exercise of outstanding warrants. The following table summarizes the warrants outstanding at June 30, 2026:
Exercise
Price Shares Expiration
Dates
August 2018 Offering Investors $ 28.75 156,863 August 14, 2026
August 2018 Offering Agent $ 39.84 7,576 August 8, 2026
September 2019 Offering Investors $ 19.25 111,732 September 27, 2026
September 2019 Offering Underwriter $ 27.97 7,774 September 27, 2026
January 2021 Offering Investors $ 30.78 123,648 July 27, 2026
January 2021 Offering Agent $ 40.44 14,065 July 27, 2026
May 2023 Offering Investors $ 37.50 500,000 May 8, 2028
May 2023 Offering Agent $ 37.50 35,000 May 3, 2028
April 2024 Offering Investors $ 18.75 857,143 October 30, 2029
April 2024 Offering Agent $ 21.875 60,000 April 25, 2029
November 2024 Offering Investors $ 6.25 480,000 November 18, 2029
November 2024 Offering Agent $ 7.8125 33,600 November 15, 2029
January 2025 Offering Investors $ 3.91 743,496 January 8, 2030
January 2025 Offering Agent $ 5.0438 52,045 January 7, 2030
April 2025 Offering Agent $ 1.4375 121,739 April 1, 2030
June 2025 Offering Investor $ 1.00 9,840,000 June 11, 2027
June 2025 Offering Agent $ 1.525 344,400 June 11, 2027
October 2025 Offering Investor $ 1.40 3,973,510 October 21, 2030
October 2025 Placement Agent $ 1.8875 278,146 October 20, 2030
December 2025 Note Payable Extension $ 1.26 75,000 January 2, 2031
April 2026 Offering Investors $ 0.86 5,076,143 April 24, 2031
April 2026 Offering Agent $ 1.2313 355,330 April 23, 2031
23,247,210
At June 30, 2026, the weighted average remaining
life of the outstanding warrants is 2.74 years, all warrants are exercisable and the aggregate intrinsic value of the warrants outstanding
was $ 0 .
20
Citius Oncology Warrants
Citius Oncology has reserved 53,947,473 shares
of common stock for the exercise of outstanding warrants. The following table summarizes the warrants outstanding at June 30, 2026:
Exercise
Price Number Expiration Dates
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 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 $ 0.90 15,697,024 May 22, 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
May 2026 Investor $ 0.90 25,555,556 May 22, 2031
May 2026 Offering Agent $ 1.125 894,444 June 18, 2031
May 2026 Prior Offering Agent $ 1.199 511,111 June 18, 2031
May 2026 Lenders $ 0.90 1,111,111 May 22, 2031
53,947,473
At June 30, 2026, the weighted average remaining
life of the outstanding warrants was estimated at 4.23 years and all warrants are exercisable. At June 30, 2026 the aggregate intrinsic
value of the warrants outstanding was $ 4,579,195 .
Citius Pharma Common Stock Reserved
A summary of common stock reserved for future
issuances by Citius Pharma excluding all subsidiaries as of June 30, 2026 is as follows:
Stock plan options outstanding
836,310
Stock plan shares available for future grants
118,000
Warrants outstanding
23,247,210
Total
24,201,520
Citius Oncology Common Stock Reserved
A summary of common stock reserved for future
issuances by Citius Oncology as of June 30, 2026 is as follows:
Stock plan options outstanding
18,100,000
Restricted stock units
11,950,000
Stock plan shares available for future grants
14,950,000
Warrants outstanding
53,947,473
Total
98,947,473
21
10. COMMITMENTS AND CONTINGENCIES
Operating Lease
Effective July 1, 2019, we entered into a 76-month
lease for office space in Cranford, NJ. On February 28, 2025, we extended the lease until February 28, 2030. A right-of-use asset of $ 786,697
was recognized as a non-cash asset and liability on the lease amendment date. We pay our proportionate share of real estate taxes and
operating expenses in excess of the base year expenses. These costs are variable lease payments and are not included in the determination
of the lease’s right-of-use asset or lease liability.
We identified and assessed the following significant
assumptions in recognizing our right-of-use assets and corresponding lease liabilities:
●
As the Cranford lease does not provide an implicit rate, we estimated the incremental borrowing rate in calculating the present value of the lease payments based on the remaining term as of the amendment date.
●
Since we elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the combined lease component.
●
The expected lease terms include noncancelable lease periods.
The elements of lease expense are as follows:
Lease cost Nine Months
Ended
June 30,
2026 Nine Months
Ended
June 30,
2025
Operating lease cost $ 144,251 $ 189,641
Variable lease cost 398 10,806
Total lease cost $ 144,649 $ 200,447
Other information
Weighted-average remaining lease term - operating leases 3.7 Years 4.7 Years
Weighted-average discount rate - operating leases 8.0 % 8.0 %
Maturities of lease liabilities due under the
Company’s non-cancellable leases are as follows:
Year Ending September 30,
2026 (excluding the 9 months ended June 30, 2026)
$ 57,093
2027
232,827
2028
237,686
2029
242,545
2030
102,849
Total lease payments
873,000
Less: interest
( 106,043 )
Present value of lease liabilities
$ 766,957
Leases
Classification
June 30,
2026
September 30,
2025
Assets
Lease asset
Operating
$ 753,039
$ 818,694
Total lease assets
$ 753,039
$ 818,694
Liabilities
Current
Operating
$ 176,170
$ 88,348
Non-current
Operating
590,787
724,925
Total lease liabilities
$ 766,957
$ 813,273
Interest expense on the lease liability was $ 48,532
and $ 21,590 for the nine months ended June 30, 2026 and 2025, respectively.
22
Commercial Manufacturing Contracts
Citius Oncology 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 Citius Oncology. 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 nine months ended June 30, 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.
In June 2026, Citius Oncology entered into a letter
of intent with a new CMO for the purposes of supplying BDS and expects to enter into a master services agreement. 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 June 30, 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.
11. GAIN ON SALE OF NEW JERSEY NET OPERATING
LOSSES
We recognized a gain of $ 3,833,277 for the nine
months ended June 30, 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. NASDAQ LISTING
On February 9, 2026, we received a notification letter from the Nasdaq
Stock Market LLC (“Nasdaq”) indicating that we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Bid
Price Rule”) 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 August 10, 2026, to regain compliance with the Bid Price Rule. The Company has timely requested an extension from Nasdaq to evidence compliance
with the Bid Price Rule.
On April 22, 2026, Citius Oncology received a
notification letter from Nasdaq indicating that it was not in compliance with the Bid Price Rule because the minimum bid price of its
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), Citius Oncology has a compliance period of 180 calendar days, or until October 19, 2026, to regain compliance with
the Bid Price Rule.
13. SUBSEQUENT EVENTS
On July 1, 2026, the Company initiated a voluntary
stock option surrender and cancellation program for outstanding and unexercised stock options previously issued to its employees, directors
and consultants under Citius Pharma’s stock plans for the years 2014, 2018, 2020, 2021 and 2023. Shares underlying any cancelled
stock options are returned to the Company’s 2023 Stock Plan and the holder receives no consideration for the cancellation. The program
remains open as of mid-August 2026.
23
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 nine months ended June 30, 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 Pharmaceuticals, Inc. included in our Annual Report on Form 10-K for the year ended September
30, 2025, filed with the SEC on December 23, 2025, as amended on January 28, 2026. The following discussion contains “forward-looking
statements” that reflect our future plans, estimates, beliefs and expected performance. Our actual results may differ materially
from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors. We caution that
assumptions, expectations, projections, intentions, or beliefs about future events may, and often do, vary from actual results and the
differences can be material. Please see “Cautionary Note Regarding Forward-Looking Statements” on page iii of this Report.
Business
We are a biopharmaceutical company dedicated to
the development and commercialization of first-in-class critical care products. On September 12, 2014, we acquired Citius Pharmaceuticals,
LLC as a wholly-owned subsidiary. Citius Pharmaceuticals, LLC was dissolved on December 29, 2023.
On March 30, 2016, we acquired all of the outstanding
stock of Leonard-Meron Biosciences, Inc. by issuing shares of our common stock. We acquired identifiable intangible assets of $19,400,000
related to in-process research and development and recorded goodwill of $9,346,796 for the excess of the purchase consideration over the
net assets acquired.
On September 11, 2020, we formed NoveCite, Inc.,
of which we own 75% of the issued and outstanding capital stock.
On August 23, 2021, we formed Citius Acquisition
Corp., or SpinCo, as a wholly-owned subsidiary in conjunction with the acquisition of LYMPHIR, but Citius Acquisition did not begin operations
until April 2022, when Citius Pharma transferred to it the assets related to LYMPHIR, including the related license agreement with Eisai
and the related asset purchase agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s. At this time, Citius
Acquisition changed its name to Citius Oncology, Inc. In August 2024, as part of the merger, the new publicly-traded company and majority-owned
subsidiary was named Citius Oncology, Inc.
In-process research and development of $19,400,000
represents the value of LMB’s leading drug candidate (Mino-Lok), which is an antibiotic solution used to treat catheter-related
bloodstream infections and is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. Goodwill
of $9,346,796 represents the value of LMB’s industry relationships and its assembled workforce. Goodwill will not be amortized but
will be tested at least annually for impairment. In-process research and development of $73,400,000 represents the value of our exclusive
license for LYMPHIR (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma and
is being amortized on a straight-line basis over the remaining period of market exclusivity commencing upon revenue generation in December
2025.
Through June 30, 2026, we have devoted substantially
all of our efforts to product development, raising capital, building infrastructure through strategic alliances and coordinating activities
relating to our proprietary products. We have realized limited revenues from the sale of LYMPHIR, which commenced in December 2025.
Reverse Stock Split
Effective November 25, 2024, we executed a reverse
stock split of our common stock, at a ratio of 1-for-25. All share amounts have been retroactively adjusted to reflect the split.
24
Patent and Technology License Agreements
Mino-Lok ® - LMB has a patent
and technology license agreement with Novel Anti-Infective Therapeutics, Inc. (“NAT”) to develop and commercialize Mino-Lok
on an exclusive, worldwide sub-licensable basis, as amended. Since May 2014, LMB has paid an annual maintenance fee, which began at $30,000
and has increased over five years to $90,000, where it will remain until the commencement of commercial sales of a product subject to
the license. LMB will also pay annual royalties on net sales of licensed products, with a low double-digit royalty rate (within a range
of 10% to 15%). In limited circumstances in which the licensed product is not subject to a valid patent claim and a competitor is selling
a competing product, the royalty rate is in the low to mid-single digits (within the range of 2% to 7%). After a commercial sale is obtained,
LMB must pay minimum aggregate annual royalties of $100,000 in the first commercial year which is prorated for a less-than-12-month period,
increasing $25,000 per year to a maximum of $150,000 annually. LMB must also pay NAT up to $1,100,000 upon achieving specified regulatory
and sales milestones. Finally, LMB must pay NAT a specified percentage of payments received from any sub-licensees.
NoveCite - On October 6, 2020, our subsidiary
NoveCite entered into a license agreement with Novellus Therapeutics Limited, whereby NoveCite acquired an exclusive, worldwide license,
with the right to sublicense, to develop and commercialize a stem cell therapy based on Novellus’s patented technology for the treatment
of acute pneumonitis of any etiology in which inflammation is a major agent in humans. Upon execution of the license agreement, NoveCite
paid $5,000,000 to Novellus and issued Novellus shares of Novecite’s common stock representing 25% of NoveCite’s outstanding
equity. We own the other 75% of NoveCite’s outstanding equity.
In July 2021, Novellus was acquired by Brooklyn
ImmunoTherapeutics and the NoveCite license was assumed by Brooklyn with all original terms and conditions. In October 2021, Brooklyn
changed its name to Eterna Therapeutics Inc. (“Eterna”).
As part of the Novellus and Brooklyn merger transaction,
the 25% non-dilutive position per the subscription agreement between Novellus and NoveCite was removed.
Under the license agreement, NoveCite is obligated
to pay Eterna up to an aggregate of $51,000,000 in regulatory and developmental milestone payments. NoveCite also must pay a royalty equal
to a mid-teens percentage of net sales, commencing upon the first commercial sale of a licensed product. This royalty is subject to downward
adjustment on a product-by-product and country-by-country basis to a mid-single digit percentage (within a range of 4% to 8%) of net sales
in any country in the event of the expiration of the last valid patent claim or if no valid patent claim exists in that country. The royalty
will end on the earlier of (i) date on which a biosimilar product is first marketed, sold, or distributed by Eterna or any third party
in the applicable country or (ii) the 10-year anniversary of the date of expiration of the last-to-expire valid patent claim in that country.
In the case of a country where no licensed patent ever exists, the royalty will end on the later of (i) the date of expiry of such licensed
product’s regulatory exclusivity and (ii) the 10-year anniversary of the date of the first commercial sale of the licensed product
in the applicable country. In addition, NoveCite will pay to Eterna an amount equal to a mid-twenties percentage of any sublicensee fees
it receives.
Under the terms of the license agreement, in the
event that Eterna receives any revenue involving the original cell line included in the licensed technology, then Eterna shall remit to
NoveCite 50% of such revenue.
LYMPHIR - In September 2021, the Company
entered into an asset purchase agreement with Dr. Reddy’s and a license agreement with Eisai to acquire an exclusive license of
E7777 (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. Citius Pharma assigned
these agreements to Citius Acquisition Corp. effective April 1, 2022. We renamed E7777 as I/ONTAK and also obtained the trade name LYMPHIR TM
for the product. Denileukin diftitox is referred to in this report as E7777, I/ONTAK or LYMPHIR, depending on the period of time and context
that is being discussed.
Under the terms of these agreements, Citius Pharma
acquired Dr. Reddy’s exclusive license of E7777 from Eisai and other related assets owned by Dr. Reddy’s (which are now owned
by Citius Oncology). The exclusive license, through Citius Oncology, includes rights to develop and commercialize E7777 in all markets
except for Japan and certain parts of Asia. Eisai retains exclusive development and marketing rights for the agent in Japan, China, Korea,
Taiwan, Hong Kong, Macau, Indonesia, Thailand, Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar,
Cambodia, Laos, Afghanistan, Bangladesh, Bhutan, Nepal, Mongolia, and Papua New Guinea. Citius Pharma paid Dr. Reddy’s a $40 million
upfront payment which represents the acquisition date fair value of the in-process research and development acquired from Dr. Reddy’s.
Dr. Reddy’s is entitled to up to $40 million in development milestone payments related to CTCL approvals in the U.S. and other markets,
up to $70 million in development milestones for additional indications, as well as commercial milestone payments and low double-digit
tiered royalties on net product sales (within a range of 10% to 15%), and up to $300 million for commercial sales milestones. Citius Oncology
also must pay on a fiscal quarter basis tiered royalties equal to low double-digit percentages of net product sales (within a range of
10% to 15%). The royalties will end on the earlier of (i) the 15-year anniversary of the first commercial sale of the latest indication
that received regulatory approval in the applicable country and (ii) the date on which a biosimilar product results in the reduction of
net sales in the applicable product by 50% in two consecutive quarters, as compared to the four quarters prior to the first commercial
sale of the biosimilar product. Citius Oncology will also pay Dr. Reddy’s an amount equal to a low-thirties percentage of any sublicense
upfront consideration or milestone payments (or the like) received by us and the greater of (i) a low-thirties percentage of any sublicensee
sales-based royalties or (ii) a mid-single digit percentage of such licensee’s net sales. Citius Pharma is a guarantor of Citius
Oncology’s payment obligations under these agreements.
25
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 $15.65 million remains due as of June 30, 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 nine months ended June 30, 2026, we recorded
$112,270 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 June 30, 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) to complete each specified immuno-oncology investigator trial on or before the four-year anniversary of the effective date of the
definitive agreement. Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory
approval for such product in each such jurisdiction; though approved in August 2024, Dr. Reddy’s waived the six-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, Citius Oncology 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. Citius Oncology expects 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.
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;
26
●
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, Citius Oncology 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 Citius Oncology’s
effort to extend access to LYMPHIR.
On July 21, 2026, Citius Oncology announced
the expansion of its commercial organization to include 21 additional commercial field-based professionals and the addition of eight medical
science liaisons dedicated to supporting complex clinical practitioner engagement and patient care. All personnel were expected to be
fully onboarded and deployed nationwide by August 2026, which target date was met. The expansion of the commercial and medical teams was
facilitated by the May 2026 financing and implemented by EVERSANA, Citius Oncology’s exclusive commercialization partner. EVERSANA
also provides Citius Oncology with an integrated suite of operations services including medical information, pharmacovigilance, revenue
cycle management, program management, data and analytics, channel management, and patient assistance.
On August 14, 2026, Citius Oncology provided an
update on the U.S. commercial launch of LYMPHIR highlighting increased institutional availability for LYMPHIR, accelerating institutional
vial orders and the expansion to a full commercial field organization.
Mid-Year Launch Metrics:
● 44 institutions have ordered LYMPHIR since its
launch including; academic oncology centers, leading National Comprehensive Cancer Network (NCCN) institutions, and community infusion
centers;
● Increased the number of new ordering institutions by 80% in the quarter ended June 30, 2026 compared to the quarter ended March 31, 2026;
● Grew the number of vials ordered by institutions from wholesalers
by 31% in the quarter ended June 30, 2026, compared to the quarter ended March 31, 2026, 926 vs. 708 vials respectively;
● 383
institutional vial orders of LYMPHIR were placed in July, an increase of 25% vs. the prior
quarters average; 1
● Expanded the commercial organization by 21 additional
field-based professionals and added eight medical science liaisons, executed by the Company’s exclusive commercialization partner,
EVERSANA;
● Engaged U.S. and international CTCL key opinion
leaders at the Sixth World Congress of Cutaneous Lymphomas in Montreal through scientific exchange and educational initiatives; and
● Continued to near-universal payer coverage, with no reimbursement
denials or prior authorization barriers reported to date.
1 Institutional vial orders are
vials of LYMPHIR ordered by prescribing institutions from wholesalers. Citius Oncology recognizes revenue when LYMPHIR vails are ordered
from Citius Oncology by wholesalers.
27
US Distribution Agreements
In 2025, Citius Oncology executed three service
agreements with U.S. pharmaceutical specialty distributors who are the 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. 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 Citius Oncology 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 Citius Oncology 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.
International Distribution Agreements
On October 7, 2025, Citius Oncology 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 U.S. 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, Citius Oncology 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, Citius Oncology 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 Citius Oncology’s exclusive distribution partner in designated
international territories in Western and Eastern Europe. Citius Oncology 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, Citius Oncology 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, Citius Oncology 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.
28
RESULTS OF OPERATIONS
Three months ended June 30, 2026 compared with
the Three months ended June 30, 2025
Three Months
Ended
June 30,
2026
Three Months
Ended
June 30,
2025
Revenue
$
1,493,788
—
Cost of revenues
(491,843
)
—
Gross profit
1,001,945
—
Operating expenses:
Research and development
1,053,869
1,621,325
Amortization of in-process research and development
1,720,312
—
General and administrative
6,149,173
4,447,008
Stock-based compensation – general and administrative
3,810,665
2,719,674
Total operating expenses
12,734,019
8,788,007
Operating loss
(11,732,074
)
(8,788,007
)
Interest income
116,691
20,637
Amortization of deferred financing costs
(179,492
)
—
Interest expense
(231,732
)
(172,262
)
Loss before income taxes
(12,026,607
)
(8,939,632
)
Income tax expense (benefit)
(107,347
)
264,240
Net loss
$
(11,919,260
)
$
(9,203,872
)
Revenues
Product revenues for the three months ended June
30, 2026 were $1,493,788, as Citius Oncology began commercial distribution of LYMPHIR in December 2025. Gross profit on product revenues
for the three months ended June 30, 2026 was approximately 67%.
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, Citius
Oncology announced its initial shipment to Europe.
Research and Development Expenses
For the three months ended June 30, 2026, research
and development expenses were $1,053,869, as compared to $1,621,325 during the three months ended June 30, 2025, a decrease of $567,456.
Research and development costs for Mino-Lok decreased
by $9,701 to $152,030 for the three months ended June 30, 2026, as compared to $161,731 for the three months ended June 30, 2025.
Research and development costs for Halo-Lido were
$2,027 for the three months ended June 30, 2026, as compared to $3,994 for the three months ended June 30, 2025. The Phase 2 study was
completed in April 2023. Citius subsequently met with the FDA for an end of Phase 2 meeting to discuss next steps in the clinical development
program.
Research and development costs for LYMPHIR decreased
by $561,779 to $893,821 during the three months ended June 30, 2026, as compared to $1,455,600 for the three months ended June 30, 2025.
The decrease was primarily related to a refund of FDA PDUFA fees for LYMPHIR.
29
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 June 30, 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 June 30, 2026, general
and administrative expenses were $6,149,173, as compared to $4,447,008 during the three months ended June 30, 2025. General and administrative
expenses increased by $1,702,165 in comparison with the prior period. The increase was primarily related to the expansion of Citius Oncology’s
commercial organization. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory,
accounting, and corporate development services, and investor relations expenses.
Stock-based Compensation Expense
For the three months ended June 30, 2026, stock-based
compensation was $3,810,665 as compared to $2,719,674 for the three months ended June 30, 2025. Stock-based compensation increased by
$1,090,991 primarily due to the Citius Oncology restricted stock units granted in September 2025.
Other Income (Expense)
For the three months ended June 30, 2026, interest
income was $116,691, as compared to interest income of $20,637 for the three months ended June 30, 2025. We have invested the remaining
proceeds of our equity offerings in money market accounts.
For the three months ended June 30, 2026, amortization
of deferred financing costs related to Citius Oncology’s May 2026 term loan agreement was $179,492. Deferred financing costs are
being amortized on a straight-line basis over the 42-month life of the loan agreement.
For the three months ended June 30, 2026, interest
expense was $231,732, as compared to $172,262 for the three months ended June 30, 2025 primarily related to Citius Oncology’s new
loan agreement.
Income Taxes
The Company recorded a deferred income tax benefit
of $107,347 in the three months ended June 30, 2026 and a deferred income tax expense of $264,240 in the three months ended June 30, 2025.
Deferred income tax expense or benefit is related to the difference in amortization for taxable purposes of Citius Oncology’s in-process
research and development asset and the financial statement amortization.
Net Loss
For the three months ended June 30, 2026, we incurred
a net loss of $11,919,260, as compared to a net loss of $9,203,872 for the three months ended June 30, 2025. The increase of $2,715,388
in the net loss was primarily due to the increase of $3,946,012 in operating expenses offset by the increase in gross profit of $1,001,945.
30
Nine months ended June 30, 2026 compared with
the nine months ended June 30, 2025
Nine Months
Ended
June 30,
2026
Nine Months
Ended
June 30,
2025
Revenue
$
7,105,197
—
Cost of revenues
(1,609,929
)
—
Gross profit
5,495,268
—
Operating expenses:
Research and development
4,287,106
7,514,888
Amortization of in-process research and development
4,014,062
—
General and administrative
38,261,001
14,626,882
Stock-based compensation – general and administrative
11,879,167
7,946,529
Total operating expenses
58,441,336
30,088,299
Operating loss
(52,946,068
)
(30,088,299
)
Interest income
215,372
56,658
Gain on sale of New Jersey net operating losses
3,833,277
—
Amortization of deferred financing costs
(179,492
)
—
Interest expense
(420,301
)
(172,262
)
Loss before income taxes
(49,497,212
)
(30,203,903
)
Income tax expense (benefit)
(74,317
)
792,720
Net loss
$
(49,422,895
)
$
(30,996,623
)
Revenues
Product revenues for the nine months ended June
30, 2026 were $7,105,197, as Citius Oncology began commercial distribution of LYMPHIR in December 2025. Gross profit on product revenues
for the nine months ended June 30, 2026 was approximately 77%.
We believe that revenues will increase in the
future as LYMPHIR gains market acceptance as Citius Oncology has already seen initial accounts placing repeat orders, and on April 29,
2026, Citius Oncology announced our initial shipment to Europe.
Research and Development Expenses
For the nine months ended June 30, 2026, research
and development expenses were $4,287,106, as compared to $7,514,888 during the nine months ended June 30, 2025, a decrease of $3,227,782.
Research and development costs for LYMPHIR decreased
by $2,865,388 to $3,959,231 during the nine months ended June 30, 2026, as compared to $6,824,619 for the nine months ended June 30, 2025,
which decrease was primarily related to expense recognized in the nine months ended June 30, 2025 for a pre-license inspection batch LYMPHIR
previously manufactured as well as a refund of FDA PDUFA fees associated with LYMPHIR.
Research and development costs for Mino-Lok decreased
by $369,979 to $299,338 for the nine months ended June 30, 2026, as compared to $669,317 for the nine months ended June 30, 2025, due
primarily to decreased costs for Mino-Lok clinical and non-clinical studies, as well as decreased manufacturing development costs. In
November 2024, the Company held a Type C meeting with the FDA to discuss the results of the Phase 3 study and to obtain the FDA’s
view on development plans for Mino-Lok. The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring
a pathway to support a future New Drug Application (NDA) submission for Mino-Lok.
Research and development costs for Halo-Lido decreased
by $8,594 to $6,096 for the nine months ended June 30, 2026, as compared to $14,690 for the nine months ended June 30, 2025. The Phase
2 study was completed in April 2023. Citius subsequently met with the FDA for an end of Phase 2 meeting to discuss next steps in the clinical
development program.
31
Amortization of in-process research and development
Amortization of in-process research and development
commenced upon revenue generation by LYMPHIR in December 2025. For the nine months ended June 30, 2026 amortization was $4,014,062. 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 nine months ended June 30, 2026, general
and administrative expenses were $38,261,001, as compared to $14,626,882 during the nine months ended June 30, 2025. General and administrative
expenses increased by $23,634,119 in comparison with the prior period. The increase of $23,634,119 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 as well as increased expense in the commercial organization related to the launch of LYMPHIR. Other general and administrative
expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services,
and investor relations expenses.
Stock-based Compensation Expense
Stock-based compensation expense under all plans
for the nine months ended June 30, 2026 and 2025 was $11,879,167 (including $835,616 for Citius Pharma options, $5,968,921 for Citius
Oncology options and $5,074,630 for Citius Oncology restricted stock units) and $7,946,529 (including $1,924,242 for Citius Pharma options
and $6,022,287 for Citius Oncology options), respectively.
Stock-based compensation expense for the nine
months ended June 30, 2026 increased by $3,932,638 in comparison to the prior period primarily due to the Citius Oncology restricted stock
units granted in September 2025.
Other Income (Expense)
For the nine months ended June 30, 2026, interest
income was $215,372, as compared to interest income of $56,658 for the nine months ended June 30, 2025. We have invested the remaining
proceeds of our equity offerings in money market accounts.
We recognized a gain of $3,833,277 for the nine
months ended June 30, 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.
For the nine months ended June 30, 2026, amortization
of deferred financing costs related to Citius Oncology’s May 2026 term loan agreement was $179,492. Deferred financing costs are
being amortized on a straight-line basis over the 42-month life of the loan agreement.
For the nine months ended June 30, 2026, interest
expense was $420,301, as compared to $172,262 for the nine months ended June 30, 2025. For the nine months ended June 30, 2026, interest
expense was $198,333 for the new loan agreement, $112,270 for the March 28, 2025 letter agreement with Eisai and 109,697 for the note
payable, including the fair value of the warrant issued to the lender. Interest expense for the nine months ended June 30, 2025 was $160,755
for the March 28, 2025 letter agreement with Eisai and $11,507 for the note payable.
Income Taxes
The Company recorded a deferred income tax benefit
of $74,317 for the nine months ended June 30, 2026 and a deferred income tax expense of $792,720 for the nine months ended June 30, 2025.
Deferred income tax expense is related to the amortization for taxable purposes of our in-process research and development asset offset
by the financial statement amortization of our in-process research and development asset.
Net Loss
For the nine months ended June 30, 2026, we incurred
a net loss of $49,422,895, as compared to a net loss of $30,996,623 for the nine months ended June 30, 2025. The increase of $18,426,272
in the net loss was due to the increase of $28,353,037 in operating expenses offset by the increase in gross profit of $5,495,268, the
increase in other income of $3,564,460 and the decrease in income tax expense of $867,037.
32
LIQUIDITY AND CAPITAL RESOURCES
Liquidity and Working Capital
We have incurred operating losses since inception
and incurred a net loss of approximately $49.4 million for the nine months ended June 30, 2026. At June 30, 2026, we had an accumulated
deficit of approximately $277.1 million. At June 30, 2026, we had approximately $17.0 million in cash and a negative working capital of
approximately $8.3 million. Our net cash used in operations during the nine months ended June 30, 2026 was approximately $23.0 million.
Our primary source of cash flow since inception has been from financing activities. We have had limited revenue from sales of LYMPHIR,
which commenced in December 2025.
On April 24, 2026, Citius Pharma closed a
registered direct offering for the sale of 4,730,457 shares of common stock at $0.985 per share and 345,686 pre-funded warrants at $0.9849
per warrant. Net proceeds were $4,453,184, after deducting placement agent fees and expenses. The pre-funded warrants were exercisable
at $0.0001 per warrant and were all exercised on April 24, 2026 for $34.
On May 5, 2026, Citius Oncology received net proceeds
of approximately $9.7 million from the exercise of certain warrants.
On May 5, 2026, Citius Oncology entered into a
term loan agreement with two lenders (the “Lenders”) for up to $25.0 million (the “Loan Agreement”), with $10.0
million funded on May 6, 2026, up to $7.0 million available between October 1 and December 31, 2026, if certain net revenue and liquidity
milestones are achieved (“Tranche 2”), and up to $8.0 million available between January 1 and March 31, 2027, if certain additional
net revenue milestones are achieved and a loan was drawn between October 1 and December 31, 2026 (“Tranche 3”). The loans
bear interest at the greater of the prime rate plus 6% or 12.75%. The loans are secured by all of Citius Oncology’s assets, 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 June 30, 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 June 30, 2026, we have paid the milestone in full and owe a balance of approximately $6.3 million to Eisai for certain other invoices.
●
At the time of the FDA approval for LYMPHIR, a $27.5 million milestone payment became payable to Dr. Reddy’s of which a balance of $15.65 million remains due as of June 30, 2026. Dr. Reddy’s has agreed to a partial deferral without penalty of this milestone payment.
●
Citius Oncology 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 Citius Oncology. 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 nine months ended June 30, 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.
Citius Oncology has been evaluating new BDS suppliers
and entered into a letter of intent with a new CMO in June 2026 and expects to enter into master services agreement. 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 June 30, 2026, we also have commercial supply agreements with two other vendors for the completion and packaging of finished drug products. Minimum purchase commitments under these two agreements are approximately $4.0 million consisting of purchase commitment obligations of $2.2 million in calendar years 2026 and $1.8 million in 2027.
After giving effect to our April 24, 2026 registered
direct offering and the Citius Oncology May 5, 2026 warrant exercise and Loan Agreement, we expect that we and Citius Oncology 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.
33
Investing Activities
During the nine months ended June 30, 2026, we
paid the final $2,900,000 due to Eisai in connection with the LYMPHIR approval milestone and paid $4,100,000 in connection with the milestone
payment due to Dr. Reddy’s. At June 30, 2026, we owe Dr. Reddy’s $15,650,000 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.
Critical Accounting Policies and Estimates
The preparation of our financial statements and
related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to
make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and
liabilities as of the date of the financial statements and the amounts of revenues and expenses recorded during the reporting periods.
We base our estimates on historical experience, where applicable, and other assumptions that we believe are reasonable under the circumstances.
Actual results may differ from our estimates under different assumptions or conditions.
Our critical accounting policies and use of estimates as discussed
in the footnotes to the condensed consolidated financial statements included within this Form 10-Q should also be read in conjunction
with, the annual consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended
September 30, 2025, filed with the SEC on December 23, 2025, as amended January 28, 2026.
Item 3. Quantitative and Qualitative Disclosures
About Market Risk.
Not applicable.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures
designed to provide reasonable assurance that information required to be disclosed in reports filed under the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the specified time periods
and accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate
to allow timely decisions regarding disclosure.
Our Chief Executive Officer (who is our principal
executive officer) and Chief Financial Officer (who is our principal financial officer and principal accounting officer), evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act)
as of June 30, 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 June
30, 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 June 30, 2026 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
34
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
None.
Item 1A. Risk Factors.
There have been no material changes to the Company’s
risk factors as disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with
the SEC on December 23, 2025, as amended January 28, 2026, except as set forth below.
Our majority-owned subsidiary, Citius Oncology,
has substantial indebtedness and debt service obligations, which could adversely affect our financial condition.
Citius Oncology has incurred significant indebtedness under the Loan
Agreement, which features a tiered tranche structure with a floating interest rate subject to a floor of 12.75% per annum. During the
interest-only period, Citius Oncology will not reduce the outstanding principal balance of the loan, and upon expiration of such period,
it will be required to make amortizing payments of principal and interest. In addition, Citius Oncology is obligated to make a final payment
of $1,062,500 at maturity, which creates a balloon-type obligation that Citius Oncology may be unable to satisfy from available cash flows
or other sources. There can be no assurance that its business will generate sufficient cash flow from operations or that future borrowings
or other sources of capital will be available to it in an amount sufficient to enable it to pay its indebtedness or to fund its other
liquidity needs. If Citius Oncology is unable to generate sufficient cash flow to service its debt and meet its other obligations, it
may need to refinance or restructure its debt, sell assets, reduce or delay capital expenditures, or seek additional equity capital, any
of which could have a material adverse effect on its business, financial condition, and results of operations which would directly impact
Citius Pharma.
Additional funding tranches under the Loan Agreement are conditioned
upon the achievement of specified milestones, and there can be no assurance that such milestones will be achieved.
The availability of Tranche 2 and Tranche 3 under the Loan Agreement
is conditioned upon Citius Oncology’s achievement of specified net revenue and liquidity milestones. If it fails to achieve the
required milestones within the applicable time periods, Tranche 2 and/or Tranche 3 will not become available to it, and Citius Oncology
will not have access to the additional committed capital contemplated by the Loan Agreement.
Citius Oncology’s failure to access these additional tranches
could significantly impair its ability to fund ongoing operations, pursue growth initiatives, or meet its working capital requirements.
In such event, Citius Oncology may be required to seek alternative sources of financing, which may not be available on terms acceptable
to it, or at all, or Citius Oncology may be required to curtail its operations or delay or abandon planned expenditures. Any of these
outcomes could have a material adverse effect on its business, financial condition, results of operations, and prospects, which would
directly impact Citius Pharma.
The Loan Agreement is secured by a lien on substantially all
of Citius Oncology’s assets, including its intellectual property, and the Lenders could foreclose on such assets upon an event of
default.
Citius Oncology’s obligations under the Loan Agreement are secured
by a first-priority lien on substantially all of its assets, including its intellectual property, accounts receivable, inventory, equipment,
and general intangibles. If an event of default occurs and is not cured within any applicable cure period, the Lenders would have the
right to foreclose on the collateral securing Citius Oncology’s obligations.
35
The foreclosure on, or loss of, substantially all of Citius Oncology’s
assets, including its intellectual property, could result in a complete loss of its ability to operate its business and would likely render
it unable to continue as a going concern. Citius Oncology’s intellectual property, including patents, trademarks, trade secrets,
and proprietary technology, constitutes a critical component of its competitive position and revenue-generating capabilities. The loss
of such assets to the Lenders in a foreclosure action would have a material adverse effect on its business and could result in a total
loss of its stockholder value, which would directly impact Citius Pharma.
The conversion of loan principal into shares of Citius Oncology’s
common stock and the exercise of Lender Warrants could result in significant dilution to its existing stockholders and may adversely affect
the market price of its common stock.
Under the terms of the Loan Agreement, the Lenders have the right to
convert up to $4.0 million of outstanding principal into shares of Citius Oncology’s common stock at a $1.08 per share conversion
price. In addition, Citius Oncology has issued warrants to the Lenders equal to 10% of the portion of the loans actually funded that are
exercisable at $0.90 per share. The conversion of loan principal and/or the exercise of these warrants would result in the issuance of
additional shares of its common stock and would dilute the ownership interest of its existing stockholders, including Citius Pharma. Such
anticipated dilution could depress the market price of its common stock, even before any actual conversion or exercise occurs. Furthermore,
the Lenders may sell any shares acquired upon conversion or exercise into the market, which could create downward pressure on its stock
price. Any or all of these factors could materially adversely affect the market price of its common stock and the value of an investment
in its securities, including the shares held by Citius Pharma.
Item 2. Unregistered Sales of Equity Securities
and Use of Proceeds.
During the quarter ended June 30, 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.
(a) None.
(b) None.
(c) During the quarter ended June 30, 2026, none of our directors or officers adopted , modified, or terminated
a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement for the purchase or sale of our securities.
36
Item 6. Exhibits.
4.1
Form of Warrant issued on April 24, 2026 (incorporated by reference to Exhibit 4.1 to the Form 8-K filed on April 24, 2026).
4.2
Form of Pre-Funded Warrant issued on April 24, 2026 (incorporated by reference to Exhibit 4.2 to the Form 8-K filed on April 24, 2026).
4.3
Form of Placement Agent Warrant issued on April 24, 2026 (incorporated by reference to Exhibit 4.3 to the Form 8-K filed on April 24, 2026).
10.1
Form of Securities Purchase Agreement, dated as of April 24, 2026, by and among Citius Pharmaceuticals, Inc. and the investor signatory thereto (incorporated by reference to Exhibit 10.1 to the Form 8-K filed on April 24, 2026).
10.2
Third Amendment to Promissory Note, dated May 4, 2026, by and between Citius Oncology, Inc. and Citius Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 to the Form 8-K filed on May 8, 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 Officer 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.
37
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
CITIUS PHARMACEUTICALS, INC.
Date: August 14, 2026
By:
/s/ Leonard Mazur
Leonard Mazur
Chief Executive Officer
(Principal Executive Officer)
Date: August 14, 2026
By:
/s/ Jaime Bartushak
Jaime Bartushak
Chief Financial Officer
(Principal Financial and Accounting Officer)
38
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.