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, 2023, 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, 2023, 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, 2023 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, 2023.
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 2023 that materially affected,
or are reasonably likely to materially affect, our internal control over financial reporting.
Item
9B. Other Information.
None.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
65
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. This code of ethics and business conduct can be found in the “Investors
- Corporate Governance” 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 2024 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
“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, 2023 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
795,171
$ 6.38
—
2018 Omnibus Stock Incentive Plan
1,760,000
1.09
—
2020 Omnibus Stock Incentive Plan
1,820,000
1.13
—
2021 Omnibus Stock Incentive Plan
8,630,000
1.67
—
2023 Omnibus Stock Incentive
Plan
300,000
1.43
11,735,000
Total
13,305,171
$ 1.79
11,735,000
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 section captioned “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.
66
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
Amended
and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc.
8-K
9/18/2014
3.1
3.2
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
3.3
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
3.4
Certificate
of Amendment to the Articles of Incorporation of Citius Pharmaceuticals Inc., dated June 21, 2021.
8-K/A
6/22/2021
3.1
3.5
Amended
and Restated Bylaws of Citius Pharmaceuticals, Inc.
8-K
2/9/2018
3.1
4.1
Form of Common Stock Purchase Warrant, dated August 13, 2018, as amended August 8, 2023.
X
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.
X
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
67
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
Description
of Common Stock
10-K
12/22/2022
4.25
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
68
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
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
21
Subsidiaries.
--
--
--
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69
Exhibit
Number
Description
of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
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.
--
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104
Cover Page Interactive
Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).
+ 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.
70
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 29, 2023
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
29, 2023
Leonard Mazur
(Principal Executive Officer)
/s/
Myron Holubiak
Executive Vice Chairman
and Director
December
29, 2023
Myron Holubiak
/s/ Jaimie
Bartushak
Chief Financial Officer
December 29, 2023
Jaime Bartushak
(Principal Financial Officer and Principal Accounting
Officer)
/s/
Suren Dutia
Director
December
29, 2023
Suren Dutia
/s/
Carol Webb
Director
December
29, 2023
Carol Webb
/s/
Eugene Holuka
Director
December
29, 2023
Eugene Holuka
/s/
Dennis McGrath
Director
December
29, 2023
Dennis McGrath
71