Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
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 September 30, 2025, the end of our fiscal year. 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 September 30, 2025, based on the evaluation of these disclosure controls and procedures, our Chief
Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective in ensuring that information
required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized,
and reported within the time periods specified in the SEC’s rules and forms.
Management’s Annual Report on Internal
Control over Financial Reporting
Our management is responsible for establishing
and maintaining effective internal control over financial reporting as defined in Rule 13a-15(f) under the Exchange Act. Because
of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement
of our financial statements would be prevented or detected. Under the supervision of our Chief Executive Officer and Chief Financial
Officer, the Company conducted an evaluation of the effectiveness of our internal control over financial reporting as of September 30,
2025 using the criteria established in Internal Control- Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission (“COSO”) (2013 Framework).
Based on this evaluation, management has concluded
that our internal controls were effective and that we maintained effective controls over our financial reporting as of September 30,
2025.
Because of its inherent limitations, internal
control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future
periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
Changes in Internal Controls over Financial
Reporting
There were no changes in our internal controls
over financial reporting during the fourth quarter of fiscal 2025 that materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Attestation Report of Registered Public Accounting
Firm
Our independent registered public accounting
firm has not assessed the effectiveness of our internal control over financial reporting and, under SEC rules, will not be required to
provide an attestation report on the effectiveness of our internal control over financial reporting so long as we qualify as a “non-accelerated
filer”.
Item 9B. Other Information .
On December 2, 2025, we approved and entered into an amendment (the
“Pagoda Note Amendment”) to our existing unsecured promissory note with Pagoda. The original note provided for aggregate principal
of $1,000,000, bore interest at a per annum rate of 15.00% compounded monthly (or such lesser rate as the maximum permitted by applicable
law), and was scheduled to mature on December 2, 2025. Pursuant to the Pagoda Note Amendment, we extended the maturity date to January
2, 2026. In consideration for the extension, we issued to Pagoda a warrant to purchase 75,000 shares of our common stock. The warrant
has a five-year term commencing on the date of issuance and an exercise price equal to the closing price of our common stock on Nasdaq
on the date of issuance, which was $1.26 per share.
On December 10, 2025, in connection with a common stock transaction
effected by Citius Oncology, we amended the promissory note, dated August 16, 2024, as previously amended on September 10, 2025 (the “Note”),
issued by Citius Oncology to us to provide that the maturity of the Note would be the date at which Citius Oncology has closed a series
of capital raises that in the aggregate provide gross proceeds of at least $50 million through the issuance of debt or equity securities
or the royalty-backed monetization of LYMPHIR. All other terms of the Note remain the same.
On December 23, 2025, we extended the term of the Amended and Restated
Employment Agreement between us and Myron Holubiak for an additional 12 months until October 31, 2026, effective as of October 31, 2025.
Item 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections.
Not applicable.
77
PART III
Item 10. Directors, Executive Officers and
Corporate Governance
We have adopted a written Code of Ethics and Business
Conduct that applies to our directors, officers, and all employees. We intend to disclose any amendments to, or waivers from, our code
of ethics and business conduct that are required to be publicly disclosed pursuant to rules of the SEC by filing such amendment or waiver
with the SEC. Additionally, we have adopted an insider trading policy to establish guidelines for our employees, officers, directors,
and consultants regarding transactions in our securities and the disclosure of material nonpublic information related to our Company,
which are reasonably designed to promote compliance with insider trading laws, rules and regulations, and any listing standards applicable
to the registrant. Each of these policies can be found in the “Investors - Governance – Governance Documents” section
of our website, www.citiuspharma.com .
The other information required by this Item concerning
our directors and executive officers is incorporated by reference to the section captioned “Proposal No. 1—Election of Directors”
and “Corporate Governance” to be contained in our proxy statement related to the 2026 Annual Meeting of Stockholders (the
“Proxy Statement”), which information is expected to be filed with the SEC within 120 days of the end of our fiscal year
pursuant to General Instruction G(3) of Form 10-K. The information required by this Item concerning compliance with Section 16(a) of
the Exchange Act by our directors, executive officers and persons who own more than 10% of our outstanding common stock is incorporated
by reference from the section captioned “Section 16(a) Beneficial Ownership Reporting Compliance” to be contained in the
Proxy Statement.
Item 11. Executive Compensation
The information required by this Item concerning
directors and executive compensation is incorporated by reference from the sections captioned “Corporate Governance”, “Director
Compensation” and “Executive Compensation”, respectively, to be contained in the Proxy Statement.
Item 12. Security Ownership of Certain Beneficial
Owners and Management and Related Stockholder Matters
The following table sets forth the indicated
information as of September 30, 2025 with respect to our equity compensation plans:
Plan Category
Number of
securities
to be issued upon
exercise of
outstanding
options,
warrants
and rights
Weighted-
average
exercise
price of
outstanding
options, warrants
and rights
Number of
securities
remaining
available for
future
issuance under equity
compensation
plans
Equity compensation plans approved by security holders
2014 Stock Incentive Plan
16,910
$ 166.67
—
2018 Omnibus Stock Incentive Plan
67,200
27.20
—
2020 Omnibus Stock Incentive Plan
66,000
27.83
—
2021 Omnibus Stock Incentive Plan
330,000
41.67
—
2023 Omnibus Stock Incentive Plan
359,400
13.99
118,000
Total
839,510
$ 30.09
118,000
Our equity compensation plans consist of the
Citius Pharmaceuticals, Inc. 2023 Omnibus Stock Incentive Plan, 2021 Omnibus Stock Incentive Plan, 2020 Omnibus Stock Incentive Plan,
2018 Omnibus Stock Incentive Plan and 2014 Stock Incentive Plan, which were all approved by our stockholders. We do not have any equity
compensation plans or arrangements that have not been approved by our stockholders.
We no longer may grant awards under the 2014
Stock Incentive Plan, the 2018 Omnibus Stock Incentive Plan, the 2020 Omnibus Stock Incentive Plan or the 2021 Omnibus Stock Incentive
Plan.
The other information required by this Item is
incorporated by reference to the information under the section captioned “Security Ownership of Certain Beneficial Owners
and Management” to be contained in the Proxy Statement.
Item 13. Certain Relationships and Related
Transactions, and Director Independence
The information required by this Item is incorporated
by reference to the information under the sections captioned “Corporate Governance”, “Certain Relationships and Related
Transactions” and “Proposal No. 1—Election of Directors” to be contained in the Proxy Statement.
Item 14. Principal Accountant Fees and Services
The information required by this Item is incorporated
by reference to the information under the section captioned “Auditor and Audit Committee Matters” to be contained in the
Proxy Statement.
78
PART IV
Item 15. Exhibits and Financial Statement Schedules
Exhibit
Number
Description of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
2.1+
Agreement and Plan of Merger, dated as of October 23, 2023, by and among Citius Pharmaceuticals, Inc., Citius Oncology, Inc., TenX Keane Acquisition, and TenX Merger Sub Inc.
8-K
10/24/2023
2.1
3.1.1
Amended and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc.
8-K
9/18/2014
3.1
3.1.2
Certificate of Amendment to the Amended and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc., effective September 16, 2016.
8-K
9/21/2016
3.1
3.1.3
Certificate of Amendment to the Amended and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc., effective June 9, 2017.
8-K
6/8/2017
3.1
3.1.4
Certificate of Amendment to the Articles of Incorporation of Citius Pharmaceuticals Inc., dated June 21, 2021.
8-K/A
6/22/2021
3.1
3.1.5
Certificate of Designation of Series A Preferred Stock.
8-K
4/18/2025
3.1
3.1.6
Certificate of Amendment to the Articles of Incorporation of Citius Pharmaceuticals, Inc., dated June 9, 2025.
8-K
6/9/2025
3.1
3.1.7
Certificate of Change filed with the Secretary of State of Nevada on November 22, 2024.
8-K
11/26/2024
3.1
3.2.1
Amended and Restated Bylaws of Citius Pharmaceuticals, Inc.
8-K
2/9/2018
3.1
3.2.2
Amendment to the Amended and Restated Bylaws of Citius Pharmaceuticals, Inc.
8-K
4/18/2025
3.2
4.1
Form of Common Stock Purchase Warrant, dated August 13, 2018, as amended August 8, 2023.
10-K
12/29/2023
4.1
4.2
Form of Pre-Funded Common Stock Purchase Warrant, dated August 13, 2018.
8-K
8/13/2018
4.2
4.3
Form of Underwriter’s Common Stock Purchase Warrant, dated August 13, 2018, as amended August 8, 2023.
10-K
12/29/2023
4.3
4.4
Form of Investor Warrant issued April 3, 2019.
8-K
4/03/2019
4.1
4.5
Form of Placement Agent Warrant issued April 3, 2019.
8-K
4/03/2019
4.2
4.6
Form of Common Stock Purchase Warrant issued September 27, 2019.
8-K
9/27/2019
4.1
4.7
Form of Underwriters Common Stock Purchase Warrant issued September 27, 2019.
8-K
9/27/2019
4.3
4.8
Form of Investor Warrant issued on February 19, 2020.
8-K
2/19/2020
4.1
4.9
Form of Placement Agent Warrant issued on February 19, 2020.
8-K
2/19/2020
4.2
4.10
Form of Investor Warrant issued May 18, 2020.
8-K
5/18/2020
4.1
4.11
Form of Placement Agent Warrant issued May 18, 2020.
8-K
5/18/2020
4.2
4.12
Form of Underwriter Warrant issued August 10, 2020.
8-K
8/10/2020
4.1
4.13
Form of Investor Warrant issued January 27, 2021.
8-K
1/27/2021
4.1
4.14
Form of Placement Agent Warrant issued January 27, 2021.
8-K
1/27/2021
4.2
79
Exhibit
Number
Description
of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
4.15
Form of Registration Rights Agreement, dated January 24, 2021, by and between Citius Pharmaceuticals, Inc. and the purchasers signatory thereto.
8-K
1/27/2021
4.3
4.16
Form of Investor Warrant issued February 19, 2021.
8-K
2/19/2021
4.1
4.17
Form of Placement Agent Warrant issued February 19, 2021
8-K
2/19/2021
4.2
4.18
Form of Warrant issued May 8, 2023.
8-K
5/8/2023
4.1
4.19
Form of Placement Agent Warrant issued May 8, 2023.
8-K
5/8/2023
4.2
4.20
Form of Investor Warrant issued April 30, 2024.
8-K
4/30/2024
4.1
4.21
Form of Investor Warrant issued November 18, 2024.
8-K
11/18/2024
4.1
4.22
Form of Investor Warrant issued on January 8, 2025
8-K
1/8/2025
4.1
4.23
Form of Pre-funded Warrant issued on April 2, 2025
8-K
4/2/2025
4.1
4.24
Form of Placement Agent Warrant issued on April 2, 2025
8-K
4/2/2025
4.2
4.25
Form of Investor Warrant issued on June 11, 2025.
8-K
6/12/2025
4.1
4.26
Form of Pre-Funded Warrant issued on June 11, 2025.
8-K
6/12/2025
4.2
4.27
Form of Placement Agent Warrant issued on June 11, 2025.
8-K
6/12/2025
4.3
4.28
Form of Investor Warrant issued on October 21, 2025.
8-K
10/21/2025
4.1
4.29
Form of Pre-Funded Warrant issued on October 21, 2025.
8-K
10/21/2025
4.2
4.30
Form of Placement Agent Warrant issued on October 21, 2025.
8-K
10/21/2025
4.3
4.31
Form of Warrant issued on December 2, 2025.
X
4.32
Description of Common Stock.
10-K
12/27/2025
4.22
10.1*
Citius Pharmaceuticals, Inc. 2014 Stock Incentive Plan.
10-Q
8/15/2016
10.1
10.2*
Form of Citius Pharmaceuticals, Inc. 2014 Stock Incentive Plan Nonqualified Stock Option.
10-Q
8/15/2016
10.2
10.3*
Amended and Restated Employment Agreement between Myron Holubiak and Citius Pharmaceuticals, Inc., executed April 12, 2022, effective May 1, 2022.
10-Q
5/12/2022
10.1
10.4
Second Amendment to the Patent and Technology License Agreement between Novel Anti-Infective Technologies, LLC and Leonard-Meron Biosciences, Inc., dated March 20, 2017.
10-Q
5/15/2017
10.8
10.5*
Amended and Restated Employment Agreement between Leonard Mazur and Citius Pharmaceuticals, Inc., dated October 19, 2017.
10-K
12/11/2018
10.23
10.6*
Employment Agreement between Jaime Bartushak and Citius Pharmaceuticals, Inc., dated November 27, 2017.
8-K
12/1/2017
10.1
10.7*
Citius Pharmaceuticals, Inc. 2018 Omnibus Stock Incentive Plan
10-Q
2/14/2018
10.2
10.8
Form of Securities Purchase Agreement between Citius Pharmaceuticals, Inc. and the purchasers named therein, dated March 28, 2018.
8-K
3/29/2018
10.1
10.9+
Patent and Technology License Agreement, dated January 2, 2019, between the Board of Regents of the University of Texas System on behalf of the University of Texas M. D. Anderson Cancer Center and Citius Pharmaceuticals, Inc.
10-Q
2/14/2019
10.1
10.10
First Amendment, dated October 15, 2015, to Patent and Technology License Agreement, dated May 14, 2014, between Novel Anti-Infective Technologies, LLC and Leonard-Meron Biosciences, Inc.
10-Q
2/14/2019
10.2
10.11+
Patent and Technology License Agreement, dated May 14, 2014, between Novel Anti-Infective Technologies, LLC and Leonard-Meron Biosciences, Inc.
10-Q
5/12/2023
10.1
80
Exhibit
Number
Description
of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
10.12
Form of Securities Purchase Agreement, dated April 1, 2019, by and between Citius Pharmaceuticals, Inc. and the purchasers named therein.
8-K
4/03/2019
10.1
10.13*
Citius Pharmaceuticals, Inc. 2020 Omnibus Stock Incentive Plan.
Schedule 14A
12/20/2019
Appendix A
10.14*
Form of Notice of Stock Option Grant and Stock Option Award Agreement.
10-Q
2/13/2020
10.2
10.15
Form of Warrant Exercise Agreement, dated February 14, 2020, by and between Citius Pharmaceuticals, Inc. and the investor signatory thereto.
8-K
2/19/2020
10.1
10.16
Form of Warrant Exercise Agreement, dated February 14, 2020, by and between Citius Pharmaceuticals, Inc. and the investor signatory thereto.
8-K
2/19/2020
10.2
10.17
Form of Securities Purchase Agreement, dated May 14, 2020, by and between Citius Pharmaceuticals, Inc. and the purchasers signatory thereto.
8-K
5/18/2020
10.1
10.18*
Employment Agreement, effective as of July 14, 2020, between Citius Pharmaceuticals, Inc. and Myron Czuczman.
10-Q
8/14/2020
10.3
10.19+
License Agreement, dated October 6, 2020, between NoveCite, Inc. and Novellus Therapeutics, Limited.
10-K
12/16/2020
10.24
10.20
Form of Securities Purchase Agreement, dated January 24, 2021, by and between Citius Pharmaceuticals, Inc. and the purchasers signatory thereto.
8-K
1/27/2021
10.1
10.21
Form of Securities Purchase Agreement, dated February 16, 2021, by and between Citius Pharmaceuticals, Inc. and the purchasers signatory thereto.
8-K
2/19/2021
10.1
10.22*
Citius Pharmaceuticals, Inc. 2021 Omnibus Incentive Stock Plan.
Schedule 14A
4/12/2021
Appendix B
10.23*
Form of Notice of Stock Option Grant and Stock Option Award Agreement.
10-K
12/15/2021
10.29
10.24+
Asset Purchase Agreement, dated as of September 1, 2021, between Dr. Reddy’s Laboratories S.A. and Citius Pharmaceuticals, Inc.
10-K
12/15/2021
10.30
10.25+
Amended and Restated License, Development and Commercialization Agreement, dated as of February 26, 2018, between Eisai, Ltd. and Dr. Reddy’s Laboratories S.A.
10-K
12/15/2021
10.31
10.26+
Amendment to Amended and Restated License, Development and Commercialization Agreement, dated as of August 9, 2018, between Eisai, Ltd. and Dr. Reddy’s Laboratories S.A.
10-K
12/15/2021
10.32
10.27+
Amendment No. 2 to Amended and Restated License, Development and Commercialization Agreement, dated as of August 31, 2021, between Eisai, Ltd. and Dr. Reddy’s Laboratories S.A.
10-K
12/15/2021
10.33
10.28*
Citius Pharmaceuticals, Inc. 2023 Omnibus Stock Incentive Plan.
Schedule 14A
12/22/2022
Annex A
10.29
Form of Securities Purchase Agreement, dated May 3, 2023, by and between Citius Pharmaceuticals, Inc. and the purchasers signatory thereto.
8-K
5/8/2023
10.1
10.30+
Sponsor Support Agreement, dated as of October 23, 2023, by and among 10XYZ Holdings LP, TenX Keane Acquisition, Citius Pharmaceuticals, Inc. and Citius Oncology, Inc.
8-K
10/24/2023
10.1
81
Exhibit
Number
Description
of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
10.31+
Form of Amended and Restated Registration Rights Agreement.
8-K
10/24/2023
10.2
10.32+
Form of Amended and Restated Shared Services Agreement.
8-K
10/24/2023
10.3
10.33+
Form of Securities Purchase Agreement, dated as of April 25, 2024, by and among Citius Pharmaceuticals, Inc. and the investors signatory thereto.
8-K
4/30/2024
10.1
10.34+
Amended and Restated Shared Services Agreement, dated, August, 9, 2023, between Citius Pharmaceuticals, Inc. and Citius Oncology, Inc.
8-K
8/16/2024
10.1
10.35+
Amended and Restated Registration Rights Agreement, dated as of August 9, 2024, by and between Citius Oncology, Inc. and the signatories thereto.
8-K
8/16/2024
10.2
10.36+
Side Letter Agreement, dated August 12, 2024, by and by and among Citius Pharmaceuticals, Inc., Citius Oncology, Inc., TenX Keane Acquisition and TenX Merger Sub, Inc.
8-K
8/16/2024
10.3
10.37+
Promissory note, dated August 16, 2024, issued to Citius Pharmaceuticals, Inc. by Citius Oncology, Inc.
8-K
8/16/2024
10.4
10.38
Amendment to Promissory Note, dated September 10, 2025, by and between Citius Oncology, Inc. and Citius Pharmaceuticals, Inc.
X
10.39
Second Amendment to Promissory Note, dated December 10, 2025, by and between Citius Oncology, Inc. and Citius Pharmaceuticals, Inc.
X
10.40
Form of Securities Purchase Agreement, dated as of November 15, 2024, by and among Citius Pharmaceuticals, Inc. and the investors signatory thereto.
8-K
11/18/2024
10.1
10.41
Form of Securities Purchase Agreement, dated as of January 7, 2025, by and among Citius Pharmaceuticals, Inc. and the investors signatory thereto.
8-K
1/8/2025
10.1
10.42
Form of Securities Purchase Agreement, dated as of April 1, 2025, by and among Citius Pharmaceuticals, Inc. and the investor signatory thereto.
8-K
4/2/2025
10.1
10.43
Subscription and Investment Representation Agreement, dated April 17, 2025, by and between Citius Pharmaceuticals, Inc. and Leonard Mazur.
8-K
4/18/2025
10.1
10.44
Unsecured Promissory Note issued to Pagoda Resources, Inc., dated June 2, 2025.
8-K
6/3/2025
10.1
10.45
Amendment No. 1 to Unsecured Promissory Note issued to Pagoda Resources, Inc., dated December 2, 2025.
X
10.46
Form of Securities Purchase Agreement, dated as of June 9, 2025, by and among Citius Pharmaceuticals, Inc. and the investor signatory thereto.
8-K
6/12/2025
10.1
10.47
Form of Securities Purchase Agreement, dated as of October 20, 2025, by and among Citius Pharmaceuticals, Inc. and the investor signatory thereto.
8-K
10/21/2025
10.1
10.48*
First Amendment to Amended and Restated Employment Agreement by and between Myron Holubiak and Citius Pharmaceuticals, Inc., executed September 25, 2024, effective May 31, 2024.
X
10.49*
Second Amendment to Amended and Restated Employment Agreement by and between Myron Holubiak and Citius Pharmaceuticals, Inc., executed December 23, 2025, effective October 31, 2025.
X
19.1
Insider Trading Policy.
10-K
12/27/2024
19.1
21
Subsidiaries.
10-K
12/29/2023
21
23.1
Consent of Independent Registered Public Accounting Firm.
--
--
--
X
31.1
Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
--
--
--
X
31.2
Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
--
--
--
X
32.1
Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
--
--
--
X
97.1
Compensation Recovery Policy.
10-K/A
1/27/2025
97.1
EX-101.INS
INLINE XBRL INSTANCE DOCUMENT
--
--
--
X
EX-101.SCH
INLINE XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT
--
--
--
X
EX-101.CAL
INLINE XBRL TAXONOMY EXTENSION CALCULATION LINKBASE
--
--
--
X
EX-101.DEF
INLINE XBRL TAXONOMY EXTENSION DEFINITION LINKBASE
--
--
--
X
EX-101.LAB
INLINE XBRL TAXONOMY EXTENSION LABELS LINKBASE
--
--
--
X
EX-101.PRE
INLINE XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE
--
--
--
X
104
Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).
--
--
--
X
+
Portions of this exhibit
have been omitted pursuant to Item 601(b)10 of Regulation S-K or certain of the exhibits and schedules to this exhibit have been
omitted in accordance with Regulation S-K Item 601(b)(2) or 601(a)(5), as applicable. Citius Pharma agrees to
furnish supplementally an unredacted copy such exhibit, including any omitted exhibits and schedules, to the SEC upon its request.
*
Management contract or
compensatory plan.
Item 16. Form 10-K Summary.
Not applicable.
82
SIGNATURES
Pursuant to the requirements of Section 13 or
15(d) 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: December 23, 2025
By:
/s/
Leonard Mazur
Leonard Mazur
Chief Executive Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities
Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and
on the dates indicated.
Signature
Title
Date
/s/
Leonard Mazur
Chief Executive Officer
and Director
December
23, 2025
Leonard Mazur
(Principal Executive Officer)
/s/
Myron Holubiak
Executive Vice Chairman
and Director
December
23, 2025
Myron Holubiak
/s/ Jaimie
Bartushak
Chief Financial Officer
December
23, 2025
Jaime Bartushak
(Principal Financial Officer and Principal Accounting
Officer)
/s/
Suren Dutia
Director
December
23, 2025
Suren Dutia
/s/
Eugene Holuka
Director
December
23, 2025
Eugene Holuka
/s/
Dennis McGrath
Director
December
23, 2025
Dennis McGrath
/s/
Robert J. Smith
Director
December
23, 2025
Robert J. Smith
/s/
Carol Webb
Director
December
23, 2025
Carol Webb
83
CITIUS PHARMACEUTICALS, INC.
CONSOLIDATED FINANCIAL STATEMENTS
INDEX
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID # 392 ) F-2
Consolidated Balance Sheets F-3
Consolidated Statements of Operations F-4
Consolidated Statements of Changes in Stockholders’ Equity F-5
Consolidated Statements of Cash Flows F-6
Notes to Consolidated Financial Statements F-7
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Stockholders and Board of Directors of
Citius Pharmaceuticals, Inc.:
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheets of Citius Pharmaceuticals, Inc. (the Company) as of September 30, 2025 and 2024, and the related consolidated statements
of operations, changes in stockholders’ equity and cash flows for the years then ended, and the related notes to the consolidated
financial statements (collectively, the financial statements). In our opinion, the financial statements present fairly, in all material
respects, the financial position of the Company as of September 30, 2025 and 2024, and the results of its operations and its cash flows
for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Emphasis of a Matter Regarding Going Concern
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company
has suffered recurring losses and has a working capital deficit as of September 30, 2025. These conditions raise substantial doubt about
the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are described in Note
2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to
assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well
as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from
the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit
committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Wolf & Company, P.C.
We have served as the Company’s auditor since 2014.
Boston, Massachusetts
December 23, 2025
F- 2
CITIUS PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30, 2025 AND 2024
2025
2024
ASSETS
Current Assets:
Cash and cash equivalents
$ 4,252,290
$ 3,251,880
Inventory
22,286,693
8,268,766
Prepaid expenses
1,395,490
2,700,000
Total Current Assets
27,934,473
14,220,646
Operating lease right-of-use asset, net
818,694
246,247
Other Assets:
Deposits
38,062
38,062
In-process research and development
92,800,000
92,800,000
Goodwill
9,346,796
9,346,796
Total Other Assets
102,184,858
102,184,858
Total Assets
$ 130,938,025
$ 116,651,751
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$ 13,693,692
$ 4,927,211
License payable
22,650,000
28,400,000
Accrued expenses
4,190,253
17,027
Accrued compensation
3,292,447
2,229,018
Note payable
1,000,000
—
Operating lease liability
88,348
241,547
Total Current Liabilities
44,914,740
35,814,803
Deferred tax liability
7,770,760
6,713,800
Operating lease liability – non current
724,925
21,318
Total Liabilities
53,410,425
42,549,921
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 and 16,000,000 shares authorized at September 30, 2025 and 2024, respectively; 18,067,744 and 7,247,243 shares issued and outstanding at September 30, 2025 and 2024, respectively
18,068
7,247
Additional paid-in capital
306,336,239
271,440,421
Accumulated deficit
( 238,804,129 )
( 201,370,218 )
Total Citius Pharmaceuticals, Inc. Stockholders’ Equity
67,550,178
70,077,450
Non-controlling interest
9,977,422
4,024,380
Total Equity
77,527,600
74,101,830
Total Liabilities and Equity
$ 130,938,025
$ 116,651,751
See accompanying report of independent registered
public accounting firm and notes to the financial statements.
Reflects a 1-for-25 reverse stock split effective
November 25, 2024.
F- 3
CITIUS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND
2024
2025
2024
Revenues
$ —
$ —
Operating Expenses:
Research and development
9,156,474
11,906,601
General and administrative
18,532,843
18,249,402
Stock-based compensation – general and administrative
10,836,291
11,839,678
Total Operating Expenses
38,525,608
41,995,681
Operating Loss
( 38,525,608 )
( 41,995,681 )
Other Income (Expense):
Interest income
110,081
758,000
Interest expense
( 267,782 )
—
Gain on sale of New Jersey net operating losses
—
2,387,842
Total Other Income (Expense), Net
( 157,701 )
3,145,842
Loss before Income Taxes
( 38,683,309 )
( 38,849,839 )
Income tax expense
1,056,960
576,000
Net Loss
( 39,740,269 )
( 39,425,839 )
Net loss attributable to non-controlling interest
2,306,358
287,000
Deemed dividend on warrant extension
—
( 1,047,312 )
Net Loss Applicable to Common Stockholders
$ ( 37,433,911 )
( 40,186,151 )
Net Loss Per Share Applicable to Common Stockholders - Basic and Diluted
$ ( 3.38 )
( 5.97 )
Weighted Average Common Shares Outstanding
Basic and diluted
11,065,225
6,726,999
See accompanying report of independent registered
public accounting firm and notes to the financial statements.
Reflects a 1-for-25 reverse stock split effective
November 25, 2024.
F- 4
CITIUS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY
FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND
2024
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, 2023
—
6,354,371
$ 6,354
$ 253,056,133
$ ( 162,231,379 )
$ 90,831,108
$ 600,380
$ 91,431,488
Issuance of common stock for services
—
15,479
15
284,161
—
284,176
—
284,176
Issuance of common stock upon exercise of stock options
—
2,082
2
( 2 )
—
—
—
—
Sale of common stock, net of costs
—
875,311
876
13,802,808
—
13,803,684
—
13,803,684
Stock-based compensation expense
—
—
—
11,839,678
—
11,839,678
—
11,839,678
Merger, net of transaction costs of $ 2,358,780
—
—
—
( 3,831,357 )
—
( 3,831,357 )
—
( 3,831,357 )
Minority interest from Merger
—
—
—
( 3,711,000 )
—
( 3,711,000 )
3,711,000
—
Net loss
—
—
—
—
( 39,425,839 )
( 39,425,839 )
—
( 39,425,839 )
Net loss attributable to noncontrolling interest
—
—
—
—
287,000
287,000
( 287,000 )
—
Balance, September 30, 2024
—
7,247,243
7,247
271,440,421
( 201,370,218 )
70,077,450
4,024,380
74,101,830
November 2024 sale of common stock, net of costs of $ 425,949
—
480,000
480
2,573,571
—
2,574,051
—
2,574,051
January 2025 sale of common stock, net of costs of $ 342,833
—
743,496
744
2,656,423
—
2,657,167
—
2,657,167
April 2025 sale of common stock and pre-funded warrants, net of costs of $ 256,116
—
465,000
465
1,743,292
—
1,743,757
—
1,743,757
June 2025 sale of common stock and pre-funded warrants, net of costs of $ 571,126
—
540,000
540
5,430,296
—
5,430,836
—
5,430,836
July 2025 sale of common stock by Citius Oncology, net of costs of $ 1,453,012
—
—
—
3,770,278
—
3,770,278
( 3,776,710 )
7,546,988
September 2025 sale of common stock by Citius Oncology, net of costs of $ 1,380,146
—
—
—
4,090,493
—
4,090,493
( 3,529,361 )
7,619,854
Issuance of common stock for services
—
20,000
20
26,580
—
26,600
—
26,600
Issuance of common stock upon exercise of pre-funded warrants
—
5,654,131
5,654
( 5,088 )
—
566
—
566
Sales of common stock under at the market offering agreement, net of costs
—
2,917,874
2,918
4,727,011
—
4,729,929
—
4,729,929
Sale of Series A preferred stock
1
—
—
100
—
100
—
100
Redemption of Series A preferred stock
( 1 )
—
—
( 100 )
—
( 100 )
—
( 100 )
Stock-based compensation expense
—
—
—
9,882,962
—
9,882,962
953,329
10,836,291
Net loss
—
—
—
—
( 39,740,269 )
( 39,740,269 )
—
( 39,740,269 )
Net loss attributable to noncontrolling interest
—
—
—
—
2,306,358
2,306,358
( 2,306,358 )
—
Balance, September 30, 2025
—
18,067,744
$ 18,068
$ 306,336,239
$ ( 238,804,129 )
$ 67,550,178
$ 9,977,422
$ 77,527,600
See accompanying report of independent registered
public accounting firm and notes to the financial statements.
Reflects a 1-for-25 reverse stock split effective
November 25, 2024.
F- 5
CITIUS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND
2024
2025
2024
Cash Flows From Operating Activities:
Net loss
$ ( 39,740,269 )
$ ( 39,425,839 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
10,836,291
11,839,678
Issuance of common stock for services
26,600
284,176
Amortization of operating lease right-of-use asset
214,250
208,179
Depreciation
—
1,432
Deferred income tax expense
1,056,960
576,000
Changes in operating assets and liabilities:
Inventory
( 12,649,207 )
( 2,133,871 )
Prepaid expenses
( 64,210 )
( 945,389 )
Accounts payable
8,766,481
1,999,877
Accrued expenses
4,173,226
( 459,273 )
Accrued compensation
1,063,429
72,035
Operating lease liability
( 236,289 )
( 218,380 )
Net Cash Used In Operating Activities
( 26,552,738 )
( 28,201,375 )
Cash Flows From Investing Activities:
License payment
( 5,750,000 )
( 5,000,000 )
Net Cash Used In Investing Activities
( 5,750,000 )
( 5,000,000 )
Cash Flows From Financing Activities:
Proceeds from note payable and advance from employee
1,300,000
—
Repayment of advance from employee
( 300,000 )
—
Merger, net
—
( 3,831,357 )
Net proceeds from common stock offerings
32,303,148
13,803,684
Net Cash Provided By Financing Activities
33,303,148
9,972,327
Net Change in Cash and Cash Equivalents
1,000,410
( 23,229,048 )
Cash and Cash Equivalents – Beginning of Year
3,251,880
26,480,928
Cash and Cash Equivalents – End of Year
$ 4,252,290
$ 3,251,880
Supplemental Disclosures of Cash Flow Information and Non-cash Activities:
IPR&D Milestones included in License Payable
$ —
$ 28,400,000
Net Prepaid Manufacturing transferred to Inventory
$ 1,368,720
$ 6,134,895
Operating lease right-of-use asset and liability recorded
$ 786,697
$ —
Interest paid
$ 187,389
$ —
See accompanying report
of independent registered public accounting firm and notes to the financial statements.
F- 6
CITIUS PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND
2024
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Business
Citius Pharmaceuticals, Inc. (“Citius Pharma,”
the “Company,” “we,” or “us”) is a late-stage biopharmaceutical company dedicated to the development
and commercialization of 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, we 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.
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. (see Note 10).
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, risks related to the development
by us or our 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, our ability to obtain additional
financing and our compliance with governmental and other regulations.
Basis of Presentation
The accompanying consolidated financial statements
include the operations of Citius Pharmaceuticals, Inc., and 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 September 30, 2025, Citius Oncology was a 79.1% 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.
All share amounts and per share data reflect
a 1-for-25 reverse stock split which became effective on November 25, 2024.
2. GOING CONCERN UNCERTAINTY AND MANAGEMENT’S
PLAN
The accompanying consolidated financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the
normal course of business. We experienced negative cash flows from operations of $ 26,552,738 and $ 28,201,375 , for the years ended September
30, 2025 and 2024, respectively. We had a negative working capital of approximately $ 17 million at September 30, 2025. We estimate that
our available cash resources will be sufficient to fund its operations through March 2026 which raises substantial doubt about our ability
to continue as a going concern within one year after the date that the accompanying consolidated financial statements are issued.
F- 7
We have generated no operating revenue to date
and have principally raised capital through the issuance of debt and equity instruments to finance our operations. However, our continued
operations beyond March 2026, including our development plans for Mino-Lok, Halo-Lido and NoveCite, will depend on our ability to obtain
regulatory approval for Mino-Lok and generate substantial revenue from the sale of LYMPHIR and on our ability to raise additional capital
through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of our product candidates.
We 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 we are 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 our business. Further, we expect in the future to incur
additional expenses as we continue to develop our product candidates, including seeking regulatory approval, and protecting our intellectual
property. The accompanying financial statements do not include any adjustments that might result from the outcome of the above uncertainty.
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A summary of the significant accounting policies
followed by us in the preparation of the consolidated financial statements is as follows:
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 in-process research and development, goodwill, stock-based compensation
and income taxes. Actual results could differ from those estimates and changes in estimates may occur.
Cash and Cash Equivalents
We consider all highly liquid instruments with
maturities of less than three months at the time of purchase to be cash equivalents. From time to time, we may have cash balances in
financial institutions in excess of insurance limits. We have never experienced any losses related to these balances.
Prepaid Expenses
Prepaid expenses at September 30, 2025 and 2024
consist of $ 64,210 and $ 0 in prepaid annual service fees, respectively, and $ 1,331,280 and $ 2,700,000 of advance payments made for the
preparation of long-lead time drug substance and product costs, respectively, which will be utilized in research and development activities
or in the manufacturing of LYMPHIR for sales.
F- 8
Inventory
Inventory is stated at the lower of actual accumulated
costs or net realizable value as of September 30, 2025 and 2024, related to the manufacturing of LYMPHIR commercial products to be sold
commencing in 2025. No reserves against inventory were deemed necessary based on an evaluation of the product expiration dating.
September 30,
2025
September 30,
2024
Finished goods
$ 10,577,876
$ 6,134,895
Work in process
11,708,817
2,133,871
Total
$ 22,286,693
$ 8,268,766
During 2024 and 2025, $ 6,134,895 and $ 1,368,720
respectively, of prepaid manufacturing costs were transferred to inventory upon product approval and production commencement at our third-party
manufacturers.
Research and Development
Research and development costs, including upfront
fees and milestones paid to collaborators who are performing research and development activities under contractual agreements with us,
are expensed as incurred. We defer and capitalize our nonrefundable advance payments that are for research and development activities
until the related goods are delivered or the related services are performed. When we are reimbursed by a collaboration partner for work
we perform, we record the costs incurred as research and development expenses and the related reimbursement as a reduction to research
and development expenses in our consolidated statement of operations. Research and development expenses primarily consist of clinical
and non-clinical studies, materials and supplies, third-party costs for contracted services, and payments related to external collaborations
and other research and development related costs.
In-process Research and Development
We capitalize intangible assets purchased from
others for use in research and development activities as In Process Research & Development (IPR&D) when the assets acquired have
an alternative future use, we anticipate future economic benefit from that use and the assets acquired are not dependent on future development.
Milestone payments upon regulatory approval that meet the same criteria are capitalized when the payments are considered recoverable
based on expected future cash flows. Amortization of IPR&D over the exclusive regulatory period of the acquired asset commences upon
revenue generation.
In-process research and development includes
$ 19,400,000 representing the value of LMB’s drug candidate, Mino-Lok, an antibiotic lock solution in Phase 3 clinical development,
which if approved, would be 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. In-process research and development also includes $ 73,400,000
representing the value of Citius Oncology’s exclusive license for LYMPHIR (denileukin diftitox), a late-stage oncology immunotherapy
for the treatment of CTCL, a rare form of non-Hodgkin lymphoma and is expected to be amortized on a straight-line basis over a period
of twelve years commencing upon revenue generation. Citius Oncology’s In-process research and development consists of $ 40,000,000
paid to Dr. Reddy’s from the asset purchase agreement and approval milestone fees of $ 27,500,000 to Dr. Reddy’s and $ 5,900,000
to Eisai. Included in the IPR&D is the historical know-how, formula protocols, designs, and procedures that were needed to complete
Phase 3. In addition, the contracts acquired in connection with Dr. Reddy’s transaction with the clinical research and manufacturing
organization are at market rates and could be provided by multiple vendors in the marketplace. Therefore, there is no fair value associated
with the contracts acquired.
The Company reviews intangible assets annually
to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in
the remaining useful life of any intangible asset. If the carrying value of an asset exceeds its undiscounted cash flows, the Company
writes down the carrying value of the intangible asset to its fair value in the period identified. No impairment has occurred since the
acquisitions through September 30, 2025.
F- 9
Goodwill
Goodwill represents the value of LMB’s
industry relationships and its assembled workforce. Goodwill is not amortized but it is tested at least annually for impairment.
The Company evaluates the recoverability of goodwill
annually or more frequently if events or changes in circumstances indicate that the carrying value of an asset might be impaired, in
accordance with Accounting Standard Update (“ASU”) 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying
the Accounting for Goodwill Impairment issued by the Financial Accounting Standards Bureau (“FASB”). Goodwill is first
qualitatively assessed to determine whether further impairment testing is necessary. Factors that management considers in this assessment
include macroeconomic conditions, industry and market considerations, overall financial performance (both current and projected), changes
in management and strategy and changes in the composition or carrying amount of net assets. If this qualitative assessment indicates
that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, a one-step test is then performed
in accordance with ASU 2017-04. Under the simplified model, a goodwill impairment is calculated as the difference between the carrying
amount of the reporting unit and its fair value.
For its 2025 goodwill analysis, the Company performed a quantitative
assessment as of September 30, 2025. Based on this analysis, management concluded that the estimated fair value of the reporting unit
exceeded its carrying amount. Accordingly, no impairment charge was recorded, and goodwill continues to be carried at its current value.
Stock-Based Compensation
We recognize compensation costs resulting from
the issuance of stock-based awards to employees and directors as an expense in the consolidated statement of operations over the requisite
service period based on the fair value for each stock award on the grant date. The fair value of each option grant is estimated as of
the date of grant using the Black-Scholes option pricing model. We estimate volatility using the trading activity of our common stock.
Because our stock options have characteristics significantly different from those of traded options, and because changes in the input
assumptions can materially affect the fair value estimate, the existing model may not necessarily provide a reliable single measure of
fair value of our stock options.
We recognize compensation costs resulting from
the issuance of stock-based awards to non-employees as an expense in the consolidated statement of operations over the service period
based on the measurement of fair value for each stock award and record forfeitures as they occur.
Income Taxes
We follow accounting guidance regarding the recognition,
measurement, presentation, and disclosure of uncertain tax positions in the consolidated financial statements. Tax positions taken or
expected to be taken in the course of preparing our tax returns are required to be evaluated to determine whether the tax positions are
“more-likely-than-not” of being sustained by the applicable tax authorities. Tax positions not deemed to meet a more-likely-than-not
threshold would be recorded in the consolidated financial statements. There are no uncertain tax positions that require accrual or disclosure
as of September 30, 2025. Any interest or penalties are charged to expense. During the years ended September 30, 2025 and 2024, the Company
did not recognize any interest and penalties. Tax years subsequent to September 30, 2021 are subject to examination by federal and state
authorities.
The Company recognizes deferred tax assets and
liabilities based on differences between the financial reporting and tax basis of assets and liabilities, and operating loss and tax
credit carry forwards. Deferred tax assets and liabilities are measured using the enacted tax rates and laws that are expected to be
in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, for deferred tax assets
for which it does not consider realization of such assets to be “more-likely-than-not.” The deferred tax benefit or expense
for the period represents the change in the deferred tax asset or liability from the beginning to the end of the period.
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 options
and warrants were not included in the calculation of the diluted loss per share because they were anti-dilutive.
F- 10
Segment Reporting
The Company operates through a single operating
and reportable segment which is focused on developing and commercializing innovative targeted oncology therapies. The Company’s
lead product candidate is LYMPHIR, an engineered IL-2 diphtheria toxin fusion protein, for the treatment of patients with persistent
or recurrent CTCL, a rare form of non-Hodgkin lymphoma. LYMPHIR was approved by the FDA in August 2024. The Company manages all business
activities on a consolidated basis. The Company's Chief Operating Decision Maker ("CODM") is the Chief Executive Officer .
The accounting policies of the operating segment
are as described in Note 3. The CODM evaluates the performance of the operating segment and allocates resources based on amounts as reported
on the consolidated statements of operations and cash flows. Segment expenses are presented on the Company’s consolidated statements
of operations. The operating segment assets are reported on the consolidated balance sheet as total assets.
Concentrations of Credit Risk
We have no significant off-balance-sheet concentration
of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements.
Recently Adopted Accounting Standards
Reportable Segment Disclosures
In November 2023, the FASB issued ASU 2023-07,
Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures. The change in the standard improves reportable segment
disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The changes improve financial reporting
by requiring disclosure of incremental segment information on an annual and interim basis for all public entities to enable investors
to develop more decision-useful financial analyses. The guidance will be effective for annual reporting periods beginning after December
15, 2023, and for interim periods beginning after December 15, 2024. Early adoption is permitted. The standard will be applied retrospectively.
Since the Company has one reportable segment, adoption of this new standard did not have a material impact on the Company's consolidated
financial statements.
Recently Issued Accounting Standards
Income Tax Disclosures
In December 2023, the
FASB issued ASU 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures. The standard enhances the transparency, decision
usefulness and effectiveness of income tax disclosures by requiring consistent categories and greater disaggregation of information in
the reconciliation of income taxes computed using the enacted statutory income tax rate to the actual income tax provision and effective
income tax rate, as well as the disaggregation of income taxes paid (refunded) by jurisdiction. The standard also requires disclosure
of income (loss) before provision for income taxes and income tax expense (benefit) in accordance with U.S. Securities and Exchange Commission
(SEC) Regulation S-X 210.4-08(h), Rules of General Application – General Notes to Financial Statements: Income Tax Expense, and
the removal of disclosures no longer considered cost beneficial or relevant. The guidance will be effective for annual reporting periods
beginning after December 15, 2024. Early adoption is permitted. The standard will be applied on a prospective basis, with retrospective
application permitted. We are currently evaluating the impact of adoption of the standard on our financial statement disclosures.
F- 11
Disaggregation of
Income Statement Expenses
In November 2024, the
FASB issued ASU 2024-03, Income Statement Reporting–Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40),
Disaggregation of Income Statement Expenses. The standard update improves the disclosures about a public business entity’s expenses
by requiring more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation
and amortization) included within income statement expense captions. The guidance will be effective for annual reporting periods beginning
after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The standard updates
are to be applied prospectively with the option for retrospective application. We are currently evaluating the impact of adoption of
the standard on ours financial statement disclosures.
4. 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. We recorded an annual maintenance fee expense of $ 90,000 in both 2025 and 2024.
LMB will also pay annual royalties on net sales
of licensed products, with royalties ranging from the mid-single digits to the low double digits. 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. 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, 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,
NoveCite, paid an upfront payment of $ 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”). In this transaction, the NoveCite license was assumed by Brooklyn with all original
terms and conditions. The stock subscription agreement was amended to assign to Brooklyn all of Novellus’s rights 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 we have not allocated any losses to the noncontrolling interest.
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.
F- 12
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 continue 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 for the product. We assigned these agreements to Citius Oncology
effective April 1, 2022 and received a BLA approval from the FDA for LYMPHIR in August 2024.
Under the terms of these
agreements, we acquired Dr. Reddy’s exclusive license for E7777 from Eisai and other related assets (which are now owned by Citius
Oncology). The exclusive license rights, through Citius Oncology, 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. Dr. Reddy’s is entitled to
up to $ 40 million in development milestone payments related to CTCL approvals in the U.S. and other markets, up to $ 70 million in development
milestones for additional indications, as well as commercial milestone payments and low double-digit tiered royalties on net product
sales (within a range of 10 % to 15 %), and up to $ 300 million for commercial sales milestones. Citius Oncology also must pay on a fiscal
quarter basis tiered royalties equal to low double-digit percentages of net product sales (within a range of 10 % to 15 %). The royalties
will end on the earlier of (i) the 15-year anniversary of the first commercial sale of the latest indication that received regulatory
approval in the applicable country and (ii) the date on which a biosimilar product results in the reduction of net sales in the applicable
product by 50 % in two consecutive quarters, as compared to the four quarters prior to the first commercial sale of the biosimilar product.
Citius Oncology will also pay to Dr. Reddy’s an amount equal to a low-thirties percentage of any sublicense upfront consideration
or milestone payments (or the like) received by us and the greater of (i) a low-thirties percentage of any sublicensee sales-based royalties
or (ii) a mid-single digit percentage of such licensee’s net sales. Citius Pharma is a guarantor of Citius Oncology’s payment
obligations under these agreements.
At the time of the FDA
approval for LYMPHIR, a $ 27.5 million milestone became payable to Dr. Reddy’s, of which a balance of $ 19.75 million included in
license fee payable, remained due as of September 30, 2025. After discussions, Dr. Reddy’s agreed to a partial deferral without
penalty of this milestone payment. During the years ended September 30, 2025 and 2024, we paid $ 2,750,000 and $ 5,000,000 , respectively,
against the outstanding milestone fee.
F- 13
At the time of the FDA
approval for LYMPHIR, a $ 5.9 million milestone became payable to Eisai, of which a balance of $ 2.9 million included in license fee payable,
remained due as of September 30, 2025. During the year ended September 30, 2025, we paid $ 3,000,000 against the outstanding milestone
fee. Eisai is to receive 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 o required to reimburse Eisai for
up to $ 2.65 million of its costs to complete the Phase 3 pivotal clinical trial for the CTCL indication and reimburse Eisai for all reasonable
costs associated with the preparation of a Biologics License Application (“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 with
the FDA. The BLA was approved by the FDA on August 8, 2024. 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 on or before July 15, 2025, an aggregate amount of $ 2,535,318
and thereafter on the 15th of each of the next four months to pay Eisai $ 2,350,000 and make a final payment of $ 2,197,892 to Eisai on
or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of actual payment
under the letter agreement at the rate of 2 % per annum. During the year ended September 30, 2025, we recorded $ 218,032 in interest expense
under the agreement. 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. During the year ended
September 30, 2025 we paid $ 3,000,000 of the development milestone and the balance of $ 2,900,000 is included in license fee payable at
September 30, 2025. On July 21, 2025, we made a payment to Eisai of $1,616,522 for other invoices and accumulated interest associated
with the letter agreement.
The term of the license
agreement will continue until (i) March 30, 2026, if there has not been a commercial sale of a licensed product in the territory, or (ii)
if there has been a first commercial sale of a licensed product in the territory by March 30, 2026, the 10-year anniversary of the first
commercial sale on a country-by-country basis. We expect the first commercial sale to occur in the first quarter of 2026. 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; the launch of LYMPHIR in December 2025 satisfied this requirement in the U.S.
As part of the definitive
agreement with Dr. Reddy’s, we 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.
F- 14
The following patents
were acquired and subsequently transferred to Citius Oncology:
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.
5. NOTE PAYABLE AND ADVANCE FROM EMPLOYEE
On June 2, 2025, The Company borrowed $ 1,000,000
from an unrelated lender. The note payable is 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. Interest expense for the year ended
September 30, 2025 was $ 49,750 .
On May 28, 2025, an employee provided a $ 300,000
non-interest-bearing advance to the Company. On June 5, 2025, the Company repaid the employee in full.
6. COMMON STOCK, STOCK OPTIONS, RESTRICTED
STOCK AWARDS, AND WARRANTS
Authorized Common Stock and Reverse Stock
Split
We 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 our 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 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 our 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, we entered into an agreement
with Leonard Mazur (Chairman and Chief Executive Officer of the Company), pursuant to which we 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 our Articles of Incorporation, as amended, to increase the number of
shares of our authorized common stock from 16,000,000 to 250,000,000 . Our stockholders approved the authorized share increase on June
9, 2025.
On April 17, 2025, we 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 will have 1,000,000,000 votes and will vote together with
the outstanding shares of common stock as a single class, exclusively with respect to the authorized share increase proposal and shall
not be entitled to vote on any other matter. The Series A Preferred Stock will be 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 has no other voting rights, including in respect of any other proposal. The voting power attributable to
the Series A Preferred Stock will be disregarded for purposes of determining whether a quorum is present at the special meeting, and
the establishment of a quorum at the special meeting will be 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 we published the final results of the stockholder vote on
the authorized stock increase.
F- 15
Common Stock Issued for Services
On October 10, 2023, we issued 4,351 shares of
common stock for media, and public and investor relations services and expensed the $ 76,146 fair value of the common stock issued.
On January 17, 2024, we issued 5,128 shares of
common stock for general and business development advisory services and expensed the $ 98,079 fair value of the common stock issued.
On April 25, 2024, we issued 6,000 shares of
common stock for financial, general and business development advisory services and expensed the $ 109,950 fair value of the common stock
issued.
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.
Common Stock Offerings
On April 30, 2024 , Citius Pharma
sold 857,143 shares of common stock and warrants to purchase 857,143 shares of common stock, at a purchase price of $ 17.50 per share
and accompanying warrant for gross proceeds of $ 15,000,002 . The warrants have an exercise price of $ 18.75 per share, are exercisable
six months after issuance, and expire on October 30, 2029. The estimated fair value of the warrants issued to the investors was approximately
$ 11,206,000 .
Net proceeds were $ 13,718,951 after deducting
the placement agent fee of $ 1,050,000 , placement agent expenses of $ 135,000 , legal fees of $ 80,101 , and other offering expenses of $ 15,950 .
We also issued 60,000 warrants to the placement agent at an exercise price of $ 21.875 per share, that are exercisable six months from
the date of issuance and expire on April 25, 2029. The estimated fair value of the warrants issued to the placement agent was approximately
$ 756,000 .
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 . 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 7 % of the gross proceeds
and granted the placement agent immediately exercisable warrants to purchase 33,600 shares of common stock at an exercise price is $ 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 .
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 . 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 7 % 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 .
On April 1, 2025 , Citius Pharma
sold 465,000 shares of common stock, and pre-funded warrants to purchase 1,274,131 shares of common stock at an offering price of $ 1.15
and $ 1.1499 . 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 year ended September 30, 2025.
We paid the placement agent 7 % of the gross
proceeds and granted the placement agent warrants to purchase 121,739 shares of common stock at $ 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 .
F- 16
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 at offering prices of $ 1.22
and $ 1.2199 , respectively, along with immediately exercisable two-year warrants to purchase 9,840,000 shares of common stock at $ 1.00
per share. Gross proceeds were $ 6,001,962 and net proceeds of the offering were $ 5,430,836 after deducting fees and expenses. The
pre-funded warrants are exercisable immediately at $ 0.0001 per share and do not expire. During the year ended September 30, 2025 all
4,380,000 of the 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 $ 420,168
and other fees and expenses were $ 150,958 . In addition, we granted placement agent warrants to purchase 344,400 shares of common stock
at an exercise price equal to $ 1.525 per share. The warrants are exercisable six months after issuance and expire after five years. 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 .
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. The shares and warrants were sold at
a per unit price of $ 1.32 . The immediately exercisable five-year warrants have an exercise price of $ 1.32 per share. 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 was approximately $ 8,197,000 .
Citius Oncology paid the placement agent a fee
of 7.0 % of the gross proceeds and expenses of $ 125,000 , and issued the placement agent warrants to purchase up to 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 % fee to a prior placement agent and issued the prior placement agent 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 warrants issued to the placement agents was approximately
$ 905,000 .
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. The shares and warrants were sold at
a per unit price of $ 1.75 . The warrants are exercisable beginning on March 10, 2026 and expire on March 10, 2031 at an exercise price
of $ 1.84 per share. 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 was approximately
$ 6,995,000 .
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
up to 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 % fee to a prior placement agent and issued the prior placement agent 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 warrants issued to the placement agents was
approximately $ 717,000 .
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 our shares of common stock.
During the year ended September 30, 2024, Citius
Pharma sold 18,168 shares for gross proceeds of $ 252,140 . Net proceeds after deducting broker fees and other offering expenses were $ 84,735 .
During the three months ended March 31, 2025,
Citius Pharma sold 289,910 shares for gross proceeds of $ 839,468 . Net proceeds after deducting broker fees and other offering expenses
were $ 808,640 .
F- 17
During the three months ended June 30, 2025,
Citius Pharma 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,
Citius Pharma sold 442,715 shares for gross proceeds of $ 657,284 . Net proceeds after deducting broker fees and other offering expenses
were $ 626,843 .
Citius Pharma Stock Option Plans
Under our 2014 Stock Plan, we reserved 34,667
shares of common stock. As of September 30, 2025, there were options to purchase 16,910 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 September 30, 2025, there were options to purchase 67,200 shares outstanding and no shares were available
for future grants.
Under our 2020 Stock Plan, we reserved 124,400
shares of common stock. As of September 30, 2025, 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 September 30, 2025, options to purchase 330,000 shares were outstanding and no shares reserved for future
grants
Under our 2023 Stock Plan, we reserved for issuance
481,400 shares of common stock. As of September 30, 2025, 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 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.
The following assumptions were used in determining
the fair value of stock option grants for the years ended September 30, 2025 and 2024:
2025
2024
Risk-free interest rate
4.17 – 4.31 %
4.62 – 4.66 %
Expected dividend yield
0.00 %
0.00 %
Expected term
5.50 – 10 years
5.50 – 10 years
Expected volatility
85 %
85 – 86 %
A summary of option activity under our 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, 2024 656,084 $ 36.41 7.26 years $ 0.00
Granted 185,000 $ 9.50
Exercised —
Forfeited or expired ( 1,574 ) $ 242.80
Outstanding at September 30, 2025 839,510 $ 30.09 6.90 years $ 0.00
Exercisable at September 30, 2025 512,509 $ 39.70 5.88 years $ 0.00
F- 18
The weighted average grant date fair value of
the options granted during the year ended September 30, 2025 was estimated at $ 7.15 per share. All these options vest over terms of 12
to 36 months and have a term of 10 years.
At September 30, 2025, unrecognized total
compensation cost related to unvested awards under the Citius Pharma stock plans of $ 1,485,612 is expected to be recognized over a
weighted average period of 1.55 years.
NoveCite Stock Plan – Under
the NoveCite Stock Plan, we reserved 2,000,000 shares of common stock of NoveCite. As of September 30, 2025, there were options outstanding
to purchase 1,911,500 shares and 88,500 shares of common stock available for future grants.
During the year ended September 30, 2021, NoveCite
granted options to purchase 2,000,000 shares of common stock to employees at an exercise price of $ 0.24 per share, 88,500 shares were
forfeited, and options to purchase 1,911,500 shares were exercisable as of September 30, 2025. These options 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 5.39
years. No options were issued in fiscal years 2025 and 2024. At September 30, 2025, there is no remaining unrecognized total compensation
cost related to awards under the plan.
Citius Oncology Stock Plan - Under
the 2023 Citius Oncology Stock Plan, we reserved 15,000,000 shares of common stock of Citius Oncology. On August 2, 2024, Citius Oncology
reserved 15,000,000 shares under the Citius Oncology 2024 Stock 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. As of September 30, 2025, options to purchase 18,100,000 shares were outstanding, restricted stock awards of 11,600,000
have not vested and 300,000 shares remain available for future grants.
The following assumptions were used in determining
the fair value of the Citius Oncology stock option grants for the year ended September 30, 2025 and 2024:
2025
2024
Risk-free interest rate
4.08 - 4.18 %
4.66 %
Expected dividend yield
0.00
0.00 %
Expected term
5.50 - 6.50 years
6.50 years
Expected volatility
85 %
87 %
Volatility is estimated using the trading activity
of Citius Pharmaceuticals 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 plan
is presented below:
Shares Weighted-
Average
Exercise
Price Weighted-
Average
Remaining
Contractual
Term Aggregate
Intrinsic
Value
Outstanding at September 30, 2024 12,750,000 $ 2.15 8.78 years $ —
Granted 5,750,000 1.07
Forfeited ( 400,000 )
Outstanding at September 30, 2025 18,100,000 $ 1.83 8.21 years $ 5,386,000
Exercisable at September 30, 2025 9,781,250 $ 2.02 7.94 years $ 1,136,500
F- 19
On December 2, 2024, the Board of Directors granted
options to purchase 200,000 shares of common stock at an exercise price of $ 1.02 per share. On December 12, 2024, the Board of Directors
granted options to purchase 5,550,000 shares of common stock at an exercise price of $ 1.07 per share. The weighted average grant date
fair value of the options granted during the year ended September 30, 2025 was estimated at $ 0.80 per share. All these options vest over
terms of 12 to 36 months and have a term of 10 years.
At September 30, 2025, unrecognized total compensation
cost related to unvested awards of $ 7,814,682 is expected to be recognized over a weighted average period of 1.23 years.
Citius Oncology Restricted Stock Awards
On September 19, 2025, the Board of Directors
granted restricted stock awards of 11,600,000 shares of common stock to employees and directors. The restricted stock awards vest on
September 30, 2028. The fair value of the common stock on the date of grant was $ 20,300,000 ($ 1.75 per share).
Stock-based compensation expense for restricted
stock awards for the year ended September 30, 2025 was $ 203,741 .
At September 30, 2025, unrecognized total compensation
cost related to unvested restricted stock awards under the stock plans of $ 20,096,259 is expected to be recognized over a weighted average
period of 2.97 years.
Stock-based compensation expense - under
all plans for the years ended September 30, 2025 and 2024 was $ 10,836,291 (including $ 8,116,678 for Citius Oncology options and $ 203,741
for Citius Oncology restricted stock awards) and $ 11,839,678 (including $ 47,574 for the NoveCite plan and $ 7,498,817 for the Citius Oncology
plan). respectively.
Citius Pharmaceuticals Warrants
We reserved 14,479,372 shares of common stock
for the exercise of outstanding warrants. The following table summarizes the warrants outstanding at September 30, 2025:
Exercise
price Number 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
May 2020 Offering Investors 25.00 66,824 November 18, 2025
January 2021 Offering Investors 30.78 123,648 July 27, 2026
January 2021 Offering Agent 40.44 14,065 July 27, 2026
February 2021 Offering Investors 42.50 823,211 February 19, 2026
February 2021 Offering Agent 47.03 100,256 February 19, 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
14,479,372
F- 20
On April 2, 2024, we extended the term to April
5, 2025, for 51,780 warrants with an exercise price of $ 35.50 per share and extended the term to April 5, 2025, for 9,605 warrants with
an exercise price of $ 48.28 per share. We recorded a deemed dividend of $ 321,559 based on the excess of the fair value of the modified
warrants over the fair value of the warrants before the modification which increased the net loss attributable to common shareholders
for the year ended September 30, 2024.
On August 7, 2024, we extended the term to August
14, 2025, for 156,863 warrants with an exercise price of $ 28.75 per share and extended the term to August 8, 2025, for 7,576 warrants
with an exercise price of $ 39.84 per share. We recorded a deemed dividend of $ 375,511 based on the excess of the fair value of the modified
warrants over the fair value of the warrants before the modification which increased the net loss attributable to common shareholders
for the year ended September 30, 2024.
On September 25, 2024, we extended the term to
September 27, 2025, for 111,732 warrants with an exercise price of $ 19.25 per share and extended the term to September 27, 2025, for
7,774 warrants with an exercise price of $ 27.97 per share. We recorded a deemed dividend of $ 350,241 based on the excess of the fair
value of the modified warrants over the fair value of the warrants before the modification which increased the net loss attributable
to common shareholders for the year ended September 30, 2024.
On August 7, 2025, we extended the term to August
14, 2026 for 156,863 warrants with an exercise price of $ 28.75 per share and extended the term to August 8, 2026 for 7,577 warrants with
an exercise price of $ 39.84 per share. On August 7, 2025, we also extended the term to September 27, 2026 for 111,732 warrants with an
exercise price of $ 19.25 per share and 7,774 warrants with an exercise price of $ 27.97 per share. We did not record a deemed dividend
for the year ended September 30, 2025, as there was no increase in the fair value of the modified warrants over the fair value of the
warrants before the modification.
At September 30, 2025, the weighted average remaining
life of the outstanding warrants is 2.02 years, all warrants are exercisable, and the aggregate intrinsic value of the warrants
outstanding was $ 2,361,600 .
Citius Oncology Warrants
We have reserved 13,276,754 shares of common
stock for the exercise of outstanding warrants. The following table summarizes the warrants outstanding at September 30, 2025:
Exercise
price Number Expiration Dates
July 2025 Offering Investors $ 1.32 6,818,182 July 17, 2030
July 2025 Offering Agent 1.65 272,727 July 17, 2030
July 2025 Prior Offering Agent 1.65 477,273 July 17, 2030
September 2025 Offering Investors 1.84 5,142,858 March 10, 2031
September 2025 Offering Agent 1.92 205,714 March 10, 2031
September 2025 Prior Offering Agent 2.1875 360,000 March 10, 2031
13,276,754
At September 30, 2025, the weighted average remaining
life of the outstanding warrants is 5.08 years, all warrants are exercisable except for the September 2025 Offering warrants which become
exercisable on March 10, 2026, and the aggregate intrinsic value of the warrants outstanding was $ 6,125,681 .
Citius Pharma Common Stock Reserved
A summary of common stock reserved for future
issuances by Citius Pharma excluding our subsidiaries as of September 30, 2025 is as follows:
Stock plan options outstanding
839,510
Stock plan shares available for future grants
118,000
Warrants outstanding
14,479,372
Total
15,436,882
F- 21
Citius Oncology Common Stock Reserved
A summary of common stock reserved for future
issuances by Citius Oncology as of September 30, 2025 is as follows:
Stock plan options outstanding
18,100,000
Restricted stock awards
11,600,000
Stock plan shares available for future grants
300,000
Warrants outstanding
13,276,754
Total
43,276,754
7. RELATED PARTY TRANSACTIONS
During the year ended September 30, 2024, Citius
Pharma extended warrants held by our Chairman and Executive Vice Chairman (see Note 6) for 51,780 warrants on April 5, 2024, 156,863
warrants on August 7, 2024 and 111,732 warrants on September 25, 2024. During the year ended September 30, 2025, Citius Pharma extended
warrants held by our Chairman and Executive Vice Chairman (see Note 6) for 156,863 warrants and 111,732 warrants on August 7, 2025.
See also Note 10 for Merger transaction and transactions
consummated with our subsidiary to facilitate the Merger.
Citius Pharma is a party to a Shared Services
Agreement with Citius Oncology. Under the terms of the agreement, the Citius Pharma provides all executive, operational, financial, and
administrative support to Citius Oncology for a period of up to two (2) years. The quarterly allocated expense to Citius Oncology by
Citius Pharma is currently approximately $ 1,006,000 .
8. EMPLOYMENT AGREEMENTS
On October 19, 2017, the Company and its Chairman
of the Board, Leonard Mazur, entered into an employment agreement with a three-year term. Upon expiration, the agreement automatically
renews for successive periods of one-year unless terminated. Under the terms of the agreement, we are required to pay base compensation
plus incentives over the employment term plus severance benefits upon the occurrence of certain events as described in the agreement.
On November 27, 2017, we entered into an employment
agreement with Jaime Bartushak to serve as our Chief Financial Officer and Principal Financial Officer.. The agreement requires us to
pay base compensation plus incentives over the employment term plus severance benefits upon the occurrence of certain events as described
in the agreement.
On April 12, 2022, we entered into an employment
agreement with Myron Holubiak to serve as Executive Vice Chairman. Upon expiration, the agreement automatically renews for successive
periods of one-year unless terminated. The agreement requires us to pay base compensation plus incentives over the employment term plus
severance benefits upon the occurrence of certain events as described in the agreement.
On July 13, 2020, we entered into an employment
agreement with Myron Czuczman, M.D. to serve as Executive Vice President, Chief Medical Officer. The agreement requires us to pay base
compensation plus incentives over the employment term plus severance benefits upon the occurrence of certain events as described in the
agreement.
The Company has employment agreements with certain
other employees that require us to pay base compensation plus incentives over the employment term plus severance benefits upon the occurrence
of certain events as described in the agreement.
F- 22
9. 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 to February 28, 2030. A right-of-use asset of $ 786,697
was recognized as a non-cash asset and liability on the 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.
We estimated the incremental borrowing rate based on the remaining lease 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
Year
Ended
September 30,
2025
Year
Ended
September 30,
2024
Operating lease cost
$
269,143
$
238,823
Variable lease cost
32,692
25,809
Total lease cost
$
301,835
$
264,632
Other information
Weighted-average remaining lease term - operating leases
4.42 Years
1.1 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
$ 171,280
2027
232,827
2028
237,686
2029
242,545
2030
102,849
Total lease payments
987,187
Less: interest
( 173,914 )
Present value of lease liabilities
$ 813,273
Leases
Classification
September 30,
2025
September 30,
2024
Assets
Lease asset
Operating
$ 818,694
$ 246,247
Total lease assets
$ 818,694
$ 246,247
Liabilities
Current
Operating
$ 88,348
$ 241,547
Non-current
Operating
724,925
21,318
Total lease liabilities
$ 813,273
$ 262,865
Interest expense on the lease liability was $ 39,054
and $ 30,644 for the years ended September 30, 2025 and 2024, respectively. This amount is classified within general & administrative
expense.
F- 23
Commercial Manufacturing Contracts
We entered into an agreement with a Contract
Manufacturing Organization for the manufacture and supply of drug substance. The agreement runs through calendar 2026, with an automatic
renewal for a subsequent 4-year term. Under this agreement, we are obligated to purchase minimum annual quantities of batches at a set
price per batch, subject to annual increases. Additionally, we are required to pay an annual service fee of $ 250,000 . The agreement also
includes provisions for potential price increases based on increases in the manufacturer’s operating expenses or industry indices,
as well as significant termination fees and obligations. As of September 30, 2025, the total minimum purchase commitment under this agreement
was approximately $ 16.2 million consisting of payments of $ 8.5 million and $ 5.3 million for 2025 and 2026 respectively and approximately
$ 2.4 million for 2026 pass-throughs and consumable manufacturing components.
As of September 30, 2025, we also have commercial
supply agreements with two other vendors for the completion and packaging of finished drug products. Minimum purchase commitments under
these two agreements amount to approximately $ 4.9 million consisting of purchase commitment obligations of $ 1.2 million in 2025 and $ 1.9
million in 2026 and $ 1.8 million in 2027.
Legal Proceedings
We are not involved in any litigation that we
believe could have a material adverse effect on our financial position or results of operations. There is no action, suit, proceeding,
inquiry, or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to
the knowledge of our executive officers, threatened against or affecting us or our officers or directors in their capacities as such.
10. MERGER AGRFEEMENT
On October 23, 2023, the Company and its then
wholly owned subsidiary Citius Oncology entered into an agreement and plan of merger and reorganization (the “Merger Agreement”)
with TenX Keane Acquisition, a Cayman Islands exempted company (“TenX”), and TenX Merger Sub Inc., a Delaware corporation
and a wholly owned subsidiary of TenX (“Merger Sub”).
On August 12, 2024, pursuant to the terms and
conditions of the Merger Agreement, Merger Sub merged with and into Citius Oncology, with Citius Oncology surviving as a wholly owned
subsidiary of TenX (the “Merger”) which was subsequently renamed Citius Oncology Sub. Prior to the closing of the Merger,
TenX migrated to and domesticated as a Delaware corporation in accordance with Section 388 of the General Corporation Law of the State
of Delaware and the Cayman Islands Companies Act (As Revised) (the “Domestication”). As part of the Domestication, TenX changed
its name to “Citius Oncology, Inc.” (Nasdaq: CTOR). Immediately after the closing of the Merger, Citius Pharma owned approximately
92.3 % of the outstanding shares of common stock of Citius Oncology.
The Merger, net amount of $ 3,831,357 charged
to additional paid in capital consists of $ 395,515 of net liabilities of TenX on the date of the Merger (cash of $ 163,500 less liabilities
of $ 559,015 ) plus directly related transaction costs $ 2,358,780 and the cost of public rights in the amount of $ 1,077,062 .
As part of the Merger, we made capital investments
in Citius Oncology through cash contributions of $ 3,827,944 to fund transactions related to the Merger and by reclassifying to additional
paid in capital intercompany receivables of $ 33,180,961 that were due from Citius Oncology to us. Simultaneously, we advanced an additional
$ 3,800,111 to Citius Oncology under the terms of a non-interest bearing note payable. The note is repayable upon a capital raise by Citius
Oncology of at least $ 10,000,000 through the issuance of debt, equity or royalty financing. The Merger resulted in an initial 92.3 % ownership
interest by Citius Pharma in Citius Oncology.
F- 24
11. GAIN ON SALE OF NEW JERSEY NET OPERATING
LOSSES
We recognized a gain of $ 2,387,842 for the year
ended September 30, 2024, 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. INCOME TAXES
We recorded deferred income tax expense of $ 1,056,960
and $ 576,000 for the years ended September 30, 2025 and 2024 related to the amortization for taxable purposes of its in-process research
and development asset.
The income tax expense (benefit) differs from
the amount of income tax determined by applying the U.S. federal income tax rate to pretax income for the years ended September 30, 2025
and 2024 due to the following:
2025
2024
Computed “expected” tax benefit
( 21.0 )%
( 21.0 )%
Increase (decrease) in income taxes resulting from:
State taxes, net of federal benefit
( 6.3 )
( 6.3 )
Permanent differences
4.0
5.5
Increase in the valuation reserve
26.0
23.3
2.7 %
1.5 %
Deferred income taxes reflect the net tax effects
of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used
for income tax purposes. Significant components of our deferred tax assets and liabilities are as follows:
September 30,
2025
September 30,
2024
Deferred tax assets:
Net operating loss carryforward
$ 48,987,000
$ 39,888,000
Stock-based compensation
4,269,000
3,310,000
Capitalized research and development
6,695,000
5,762,000
Other
6,420,000
4,933,000
Valuation allowance on deferred tax assets
( 66,147,000 )
( 53,826,000 )
Total deferred tax assets
224,000
67,000
Deferred tax liabilities:
ROU Asset
( 224,000 )
( 67,000 )
In-process research and development
( 7,770,760 )
( 6,713,800 )
Total deferred tax liability
( 7,994,760 )
( 6,780,800 )
Net deferred tax liability
$ ( 7,770,760 )
$ ( 6,713,800 )
We recorded a valuation allowance against deferred
tax assets as the utilization of the net operating loss carry-forward and other deferred tax assets is uncertain. During the years ended
September 30, 2025 and 2024, the valuation allowance increased by $ 12,321,000 and $ 8,911,000 , respectively. The increase in the valuation
allowance during the years ended September 30, 2025 and 2024 was primarily due to our net operating loss. At September 30, 2025, we have
a federal net operating loss carryforward of approximately $ 181,000,000 . Federal net operating loss carryforwards of approximately $ 29,000,000
begin expiring in 2034 and carryforwards of approximately $ 152,000,000 generated in tax years beginning after 2017 may be carried forward
indefinitely. Use of federal net operating losses may be limited under Section 382 of the Internal Revenue Code due to changes in ownership.
As of September 30, 2025, we also have estimated
federal research and development credits of $ 5,297,000 to offset future income taxes. The tax credit carryforwards will begin to expire
in 2036.
On July 4, 2025, the “One Big Beautiful Bill Act” (“OBBBA”) was signed into law in the United States. The OBBBA
includes a broad range of tax reform provisions for businesses, including extensions of key Tax Cuts and Jobs Act provisions, modifications
to the international tax framework, and restoration of favorable tax treatment for certain business provisions. Certain provisions of
the legislation will become effective in 2025, while others are effective in 2026. The OBBBA was enacted during our fourth fiscal quarter
of 2025, and we have considered its potential effects and reflected the impact of the OBBBA on our financial position, results of operations,
and cash flows. We are in the process of evaluating the impact of these provisions on future periods, but we do not expect the OBBBA to
have a material impact on our consolidated financial statements.
F- 25
We account for uncertain tax positions in accordance
with the guidance provided in ASC 740, “Accounting for Income Taxes.” This guidance describes a recognition threshold and
measurement attribute for the financial statement disclosure of tax positions taken or expected to be taken in a tax return and requires
recognition of tax benefits that satisfy a more-likely-than-not threshold. ASC 740 also provides guidance on de-recognition, classification,
interest and penalties, accounting in interim periods and disclosure. There have been no reserves for uncertain tax positions recorded
by us to date.
13. SUBSEQUENT EVENTS
On October 20, 2025, Citius Pharmaceuticals,
Inc. entered into a securities purchase agreement with a certain institutional investor for the issuance and sale, in a registered direct
offering by the Company , of 1,460,000 shares of the Company’s common stock, par value $ 0.001 per share , and pre-funded warrants
to purchase up to 2,513,510 shares of common stock at an offering price of $ 1.51 and $ 1.5099 , respectively. The Company also issued to
the investor warrants to purchase up to 3,973,510 shares of common stock. The offering closed on October 21, 2025. Gross proceeds were
approximately $ 6.0 million, before deducting placement agent fees and other expenses.
On December 8, 2025, Citius Oncology entered into
a securities purchase agreement with a certain institutional investor in a registered direct offering for the purchase and sale of 1,284,404
shares of our common stock at an offering price of $ 1.09 per share of common stock. In a concurrent private placement, the Company also
agreed to sell such institutional investor warrants to purchase up to 1,284,404 shares of common stock, with an exercise price of $ 1.09
per share of our common stock, which are exercisable upon the requisite stockholder approval, and have a term of five years from the date
of the stockholder approval. The aggregate gross proceeds to the Company from the offering were approximately $ 18.0 million. Net proceeds
were approximately $ 15.2 million, after deducting placement agent fees and other offering expenses payable by the Company.
On December 8, 2025, Citius Oncology also entered
into a securities purchase agreement with such institutional investor to issue in a concurrent private placement pre-funded warrants to
purchase up to 15,229,358 shares of common stock and 15,229,358 warrants, at a combined price of $ 1.0899 per pre-funded warrant and accompanying
warrant. The pre-funded warrants are exercisable immediately, at an exercise price of $ 0.0001 per share, and will remain valid and exercisable
until all the pre-funded warrants are exercised in full.
In connection with the offering, Citius Oncology
agreed to pay the placement agent a cash fee of 7.0 % of the aggregate gross proceeds Citius Oncology received in the offering. In addition,
the Company granted warrants to the placement agent, or its designees, to purchase up to 1,155,963 shares of common stock. The terms of
the placement agent warrants are substantially the same as the terms of the warrants, except that the exercise price is $ 1.3625 per share
and expire five years from the commencement of sales in the offering.
F- 26