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, 2021, 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, 2021, 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, 2021 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, 2021.
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 2021 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.
49
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 2022 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, 2021 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
855,171
$ 6.65
—
2018 Omnibus Stock Incentive Plan
1,820,000
1.08
—
2020 Omnibus Stock Incentive Plan
1,870,000
1.13
—
2021 Omnibus Stock Incentive Plan
1,210,000
2.07
7,530,000
Total
5,755,171
$ 2.13
7,530,000
Our equity compensation plans consist of the Citius
Pharmaceuticals, Inc. 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 or 2020 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.
50
PART IV
Item 15. Exhibits and Financial Statement Schedules
Exhibit
Number
Description of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
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 Registration Rights Agreement between the Purchasers named therein and Citius Pharmaceuticals Holdings, Inc., dated September 12, 2014.
8-K
9/18/2014
10.2
4.2
Form of Investor Warrant, dated September 12, 2014.
8-K
9/18/2014
10.3
4.3
Form of Common Stock Purchase Warrant, dated May 10, 2017.
10-Q
5/15/2017
10.4
4.4
Form of Representative’s Warrant, dated August 3, 2017.
8-K
8/4/2017
4.2
4.5
Form of Investor Warrant, dated December 15, 2017.
8-K
12/19/2017
4.1
4.6
Form of Placement Agent Warrant, dated December 15, 2017.
8-K
12/19/2017
4.2
4.7
Form of Investor Warrant, dated March 28, 2018.
8-K
3/29/2018
4.1
4.8
Form of Placement Agent Warrant, dated March 28, 2018.
8-K
3/29/2018
4.2
4.9
Form of Common Stock Purchase Warrant, dated August 13, 2018.
8-K
8/13/2018
4.1
4.10
Form of Pre-Funded Common Stock Purchase Warrant, dated August 13, 2018.
8-K
8/13/2018
4.2
4.11
Form of Underwriter’s Common Stock Purchase Warrant, dated August 13, 2018.
8-K
8/13/2018
4.3
4.12
Form of Investor Warrant issued April 3, 2019.
8-K
4/03/2019
4.1
4.13
Form of Placement Agent Warrant issued April 3, 2019.
8-K
4/03/2019
4.2
4.14
Form of Common Stock Purchase Warrant issued September 27, 2019.
8-K
9/27/2019
4.1
4.15
Form of Underwriters Common Stock Purchase Warrant issued September 27, 2019.
8-K
9/27/2019
4.3
4.16
Form of Investor Warrant issued on February 19, 2020.
8-K
2/19/2020
4.1
4.17
Form of Placement Agent Warrant issued on February 19, 2020.
8-K
2/19/2020
4.2
4.18
Form of Investor Warrant issued May 18, 2020.
8-K
5/18/2020
4.1
4.19
Form of Placement Agent Warrant issued May 18, 2020.
8-K
5/18/2020
4.2
4.20
Form of Underwriter Warrant issued August 10, 2020.
8-K
8/10/2020
4.1
4.21
Form of investor warrant issued January 27, 2021.
8-K
1/27/2021
4.1
51
Exhibit
Number
Description of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
4.22
Form
of placement agent warrant issued January 27, 2021.
8-K
1/27/2021
4.2
4.23
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
4.24
Form
of investor warrant issued February 19, 2021.
8-K
2/19/2021
4.1
4.25
Form of placement agent warrant issued February 19, 2021
8-K
2/19/2021
4.2
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
Employment Agreement between Myron Holubiak and Citius Pharmaceuticals, Inc., executed March 30, 2016, effective March 1, 2016.
8-K
4/5/2016
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
Future Advance Convertible Promissory Note between Leonard Mazur and Citius Pharmaceuticals, Inc., dated May 10, 2017.
10-Q
5/15/2017
10.1
10.6
Amended and Restated Demand Convertible Promissory Note between Leonard Mazur and Citius Pharmaceuticals, Inc., dated May 10, 2017.
10-Q
5/15/2017
10.3
10.7
Warrant Agent Agreement between VStock Transfer, LLC and Citius Pharmaceuticals, Inc., dated August 3, 2017.
8-K
8/4/2017
4.1
10.8
Amended and Restated Employment Agreement between Leonard Mazur and Citius Pharmaceuticals, Inc., dated October 19, 2017.
10-K
12/11/2018
10.23
10.9
Employment Agreement between Jaime Bartushak and Citius Pharmaceuticals, Inc., dated November 27, 2017.
8-K
12/1/2017
10.1
10.10
Form of Securities Purchase Agreement between Citius Pharmaceuticals, Inc. and the purchasers named therein, dated December 15, 2017.
8-K
12/19/2017
10.1
10.11
Citius Pharmaceuticals, Inc. 2018 Omnibus Stock Incentive Plan
10-Q
2/14/2018
10.2
10.12
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
10.13+
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
10.14
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
52
Exhibit
Number
Description of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
10.15+
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
10.3
10.16
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
10.17
Citius Pharmaceuticals, Inc. 2020 Omnibus Stock Incentive Plan.
Schedule 14A
12/20/2019
Appendix A
10.18
Form of Notice of Stock Option Grant and Stock Option Award Agreement.
10-Q
2/13/2020
10.2
10.19
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
10.20
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
10.21
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
10.22
Engagement letter, dated February 14, 2020, between Citius Pharmaceuticals, Inc. and the purchasers signatory thereto.
8-K
5/18/2020
10.2
10.23
Employment Agreement, effective as of July 14, 2020, between Citius Pharmaceuticals, Inc. and Myron Czuczman.
10-Q
8/14/2020
10.3
10.24
License Agreement, dated October 6, 2020, between NoveCite, Inc. and Novellus Therapeutics, Limited.+
10-K
12/16/2020
10.24
10.25
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
10.26
Engagement letter, dated January 23, 2021, between Citius Pharmaceuticals, Inc. and H. C. Wainwright & Co., LLC
8-K
1/27/2021
10.2
10.27
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
10.28
Citius Pharmaceuticals, Inc. 2021 Omnibus Incentive Stock Plan.
Schedule 14A
4/12/2021
Appendix B
10.29
Form of Notice of Stock Option Grant and Stock Option Award Agreement.
X
10.30+
Asset Purchase Agreement, dated as of September 1, 2021, between Dr. Reddy’s Laboratories S.A. and Citius Pharmaceuticals, Inc.
X
10.31+
Amended and Restated License, Development and Commercialization Agreement, dated as of February 26, 2018, between Eisai, Ltd. and Dr. Reddy’s Laboratories S.A.
X
53
Exhibit
Number
Description of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
10.32+
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.
X
10.33+
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.
X
21
Subsidiaries.
--
--
--
X
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
Certification 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
101.INS
Inline XBRL Instance Document
--
--
--
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
--
--
--
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase
Document.
--
--
--
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase
Document.
--
--
--
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
--
--
--
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase
Document.
--
--
--
X
104
Cover Page Interactive Data File (formatted as Inline
XBRL and contained in Exhibit 101).
--
--
--
X
+ Portions
of this exhibit have been omitted pursuant to Item 601(b)10 of Regulation S-K.
Item 16. Form 10-K Summary.
Not applicable.
54
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 15, 2021
By:
/s/ Myron Holubiak
Myron Holubiak
President and 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
Executive Chairman of the Board of Directors
December 15, 2021
Leonard Mazur
/s/ Myron Holubiak
President and Chief Executive Officer and Director
December 15, 2021
Myron Holubiak
(Principal Executive Officer)
/s/ Jaime Bartushak
Chief Financial Officer and Chief Accounting Officer
December 15, 2021
Jaime Bartushak
(Principal Financial Officer and Principal Accounting Officer)
/s/ Suren Dutia
Director
December 15, 2021
Suren Dutia
/s/ Carol Webb
Director
December 15, 2021
Carol Webb
/s/ William Kane
Director
December 15, 2021
William Kane
/s/ Howard Safir
Director
December 15, 2021
Howard Safir
/s/ Eugene Holuka
Director
December 15, 2021
Eugene Holuka
55