What changed in this filing

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Item 9A. Controls and Procedures

2023-12-29 compared with 2022-12-22 · 171 added, 190 removed, 54 unchanged (87% of the section changed)

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, 2022, 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, 2022, 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, 2022 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, 2022.

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

There were no changes in our internal controls

over financial reporting during the fourth quarter of fiscal 2022 that materially affected, or are reasonably likely to materially affect,

our internal control over financial reporting.

Controls and Procedures

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.

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.

Annual Report on Internal Control over Financial Reporting

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).

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.

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.

in Internal Controls over Financial Reporting

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.

Other Information.

Disclosure Regarding Foreign Jurisdictions

that Prevent Inspections.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable.

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 2023 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.

Directors, Executive Officers and Corporate Governance

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 .

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.

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.

Security Ownership of Certain Beneficial

Owners and Management and Related Stockholder Matters

The following table sets forth the indicated information

as of September 30, 2022 with respect to our equity compensation plans:

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.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

following table sets forth the indicated information as of September 30, 2023 with respect to our equity compensation plans:

Plan Category

3 unchanged sentences

issuance under equity

Equity compensation plans approved by security holders

Equity compensation plans approved by security

2014 Stock Incentive Plan

2 unchanged sentences

2021 Omnibus Stock Incentive Plan

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.

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

2023 Omnibus Stock Incentive

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.

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.

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.

Certain Relationships and Related Transactions, and Director Independence

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.

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

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.

Exhibits and Financial Statement Schedules

Description of Document

Amended and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc.

Certificate of Amendment to the Amended and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc., effective September 16, 2016.

Certificate of Amendment to the Amended and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc., effective June 9, 2017.

Certificate of Amendment to the Articles of Incorporation of Citius Pharmaceuticals Inc., dated June 21, 2021.

Amended and Restated Bylaws of Citius Pharmaceuticals, Inc.

Form of Registration Rights Agreement between the Purchasers named therein and Citius Pharmaceuticals Holdings, Inc., dated September 12, 2014.

Form of Investor Warrant, dated September 12, 2014.

Form of Representative’s Warrant, dated August 3, 2017.

Form of Investor Warrant, dated December 15, 2017.

Form of Placement Agent Warrant, dated December 15, 2017.

Form of Investor Warrant, dated March 28, 2018.

Form of Placement Agent Warrant, dated March 28, 2018.

Form of Common Stock Purchase Warrant, dated August 13, 2018.

Form of Pre-Funded Common Stock Purchase Warrant, dated August 13, 2018.

Form of Underwriter’s Common Stock Purchase Warrant, dated August 13, 2018.

Form of Investor Warrant issued April 3, 2019.

Form of Placement Agent Warrant issued April 3, 2019.

Form of Common Stock Purchase Warrant issued September 27, 2019.

Form of Underwriters Common Stock Purchase Warrant issued September 27, 2019.

Form of Investor Warrant issued on February 19, 2020.

Form of Placement Agent Warrant issued on February 19, 2020.

Form of Investor Warrant issued May 18, 2020.

Form of Placement Agent Warrant issued May 18, 2020.

Form of Underwriter Warrant issued August 10, 2020.

Form of Investor Warrant issued January 27, 2021.

Form of Placement Agent Warrant issued January 27, 2021.

Description of Document

Form of Registration Rights Agreement, dated January 24, 2021, by and between Citius Pharmaceuticals, Inc.

and the purchasers signatory thereto.

Form of Investor Warrant issued February 19, 2021.

Form of Placement Agent Warrant issued February 19, 2021

Description of Common Stock

Citius Pharmaceuticals, Inc.

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.

and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc.

of Amendment to the Amended and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc., effective September 16, 2016.

of Amendment to the Amended and Restated Articles of Incorporation of Citius Pharmaceuticals, Inc., effective June 9, 2017.

of Amendment to the Articles of Incorporation of Citius Pharmaceuticals Inc., dated June 21, 2021.

and Restated Bylaws of Citius Pharmaceuticals, Inc.

Form of Common Stock Purchase Warrant, dated August 13, 2018, as amended August 8, 2023.

of Pre-Funded Common Stock Purchase Warrant, dated August 13, 2018.

Form of Underwriter’s Common Stock Purchase Warrant, dated August 13, 2018, as amended August 8, 2023.

of Investor Warrant issued April 3, 2019.

of Placement Agent Warrant issued April 3, 2019.

of Common Stock Purchase Warrant issued September 27, 2019.

of Underwriters Common Stock Purchase Warrant issued September 27, 2019.

of Investor Warrant issued on February 19, 2020.

of Placement Agent Warrant issued on February 19, 2020.

of Investor Warrant issued May 18, 2020.

of Placement Agent Warrant issued May 18, 2020.

of Underwriter Warrant issued August 10, 2020.

of Investor Warrant issued January 27, 2021.

of Placement Agent Warrant issued January 27, 2021.

of Registration Rights Agreement, dated January 24, 2021, by and between Citius Pharmaceuticals, Inc.

and the purchasers signatory

of Investor Warrant issued February 19, 2021.

of Placement Agent Warrant issued February 19, 2021

of Warrant issued May 8, 2023.

of Placement Agent Warrant issued May 8, 2023.

of Common Stock

Pharmaceuticals, Inc.

2014 Stock Incentive Plan.

Form of Citius Pharmaceuticals, Inc.

of Citius Pharmaceuticals, Inc.

2014 Stock Incentive Plan Nonqualified Stock Option.

Amended and Restated Employment Agreement between Myron Holubiak and Citius Pharmaceuticals, Inc., executed April 12, 2022, effective May 1, 2022.

Second Amendment to the Patent and Technology License Agreement between Novel Anti-Infective Technologies, LLC and Leonard-Meron Biosciences, Inc., dated March 20, 2017.

Future Advance Convertible Promissory Note between Leonard Mazur and Citius Pharmaceuticals, Inc., dated May 10, 2017.

Amended and Restated Demand Convertible Promissory Note between Leonard Mazur and Citius Pharmaceuticals, Inc., dated May 10, 2017.

Amended and Restated Employment Agreement between Leonard Mazur and Citius Pharmaceuticals, Inc., dated October 19, 2017.

Employment Agreement between Jaime Bartushak and Citius Pharmaceuticals, Inc., dated November 27, 2017.

Form of Securities Purchase Agreement between Citius Pharmaceuticals, Inc.

and the purchasers named therein, dated December 15, 2017.

Citius Pharmaceuticals, Inc.

and Restated Employment Agreement between Myron Holubiak and Citius Pharmaceuticals, Inc., executed April 12, 2022, effective May

Amendment to the Patent and Technology License Agreement between Novel Anti-Infective Technologies, LLC and Leonard-Meron Biosciences,

Inc., dated March 20, 2017.

and Restated Employment Agreement between Leonard Mazur and Citius Pharmaceuticals, Inc., dated October 19, 2017.

Agreement between Jaime Bartushak and Citius Pharmaceuticals, Inc., dated November 27, 2017.

Pharmaceuticals, Inc.

2018 Omnibus Stock Incentive Plan

Form of Securities Purchase Agreement between Citius Pharmaceuticals, Inc.

of Securities Purchase Agreement between Citius Pharmaceuticals, Inc.

and the purchasers named therein, dated March 28, 2018.

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.

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.

Anderson Cancer Center and Citius Pharmaceuticals, Inc.

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.

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.

Patent and Technology License Agreement, dated May 14, 2014, between Novel Anti-Infective Technologies, LLC and Leonard-Meron Biosciences, Inc.

Description of Document

Form of Securities Purchase Agreement, dated April 1, 2019, by and between Citius Pharmaceuticals, Inc.

of Securities Purchase Agreement, dated April 1, 2019, by and between Citius Pharmaceuticals, Inc.

and the purchasers named therein.

Citius Pharmaceuticals, Inc.

Pharmaceuticals, Inc.

2020 Omnibus Stock Incentive Plan.

Form of Notice of Stock Option Grant and Stock Option Award Agreement.

Form of Warrant Exercise Agreement, dated February 14, 2020, by and between Citius Pharmaceuticals, Inc.

of Notice of Stock Option Grant and Stock Option Award Agreement.

of Warrant Exercise Agreement, dated February 14, 2020, by and between Citius Pharmaceuticals, Inc.

and the investor signatory thereto.

Form of Warrant Exercise Agreement, dated February 14, 2020, by and between Citius Pharmaceuticals, Inc.

of Warrant Exercise Agreement, dated February 14, 2020, by and between Citius Pharmaceuticals, Inc.

and the investor signatory thereto.

Form of Securities Purchase Agreement, dated May 14, 2020, by and between Citius Pharmaceuticals, Inc.

and the purchasers signatory thereto.

Engagement letter, dated February 14, 2020, between Citius Pharmaceuticals, Inc.

of Securities Purchase Agreement, dated May 14, 2020, by and between Citius Pharmaceuticals, Inc.

and the purchasers signatory thereto.

Employment Agreement, effective as of July 14, 2020, between Citius Pharmaceuticals, Inc.

Agreement, effective as of July 14, 2020, between Citius Pharmaceuticals, Inc.

and Myron Czuczman.

License Agreement, dated October 6, 2020, between NoveCite, Inc.

Agreement, dated October 6, 2020, between NoveCite, Inc.

and Novellus Therapeutics, Limited.

Form of Securities Purchase Agreement, dated January 24, 2021, by and between Citius Pharmaceuticals, Inc.

and the purchasers signatory thereto.

Engagement letter, dated January 23, 2021, between Citius Pharmaceuticals, Inc.

Wainwright & Co., LLC

Form of Securities Purchase Agreement, dated February 16, 2021, by and between Citius Pharmaceuticals, Inc.

and the purchasers signatory thereto.

Citius Pharmaceuticals, Inc.

of Securities Purchase Agreement, dated January 24, 2021, by and between Citius Pharmaceuticals, Inc.

and the purchasers signatory

of Securities Purchase Agreement, dated February 16, 2021, by and between Citius Pharmaceuticals, Inc.

and the purchasers signatory

Pharmaceuticals, Inc.

2021 Omnibus Incentive Stock Plan.

Form of Notice of Stock Option Grant and Stock Option Award Agreement.

Asset Purchase Agreement, dated as of September 1, 2021, between Dr.

of Notice of Stock Option Grant and Stock Option Award Agreement.

Purchase Agreement, dated as of September 1, 2021, between Dr.

Reddy’s Laboratories S.A.

and Citius Pharmaceuticals, Inc.

Amended and Restated License, Development and Commercialization Agreement, dated as of February 26, 2018, between Eisai, Ltd.

Reddy’s Laboratories S.A.

Amendment to Amended and Restated License, Development and Commercialization Agreement, dated as of August 9, 2018, between Eisai, Ltd.

and Restated License, Development and Commercialization Agreement, dated as of February 26, 2018, between Eisai, Ltd.

Laboratories S.A.

to Amended and Restated License, Development and Commercialization Agreement, dated as of August 9, 2018, between Eisai, Ltd.

Reddy’s Laboratories S.A.

Amendment No.

2 to Amended and Restated License, Development and Commercialization Agreement, dated as of August 31, 2021, between Eisai, Ltd.

Reddy’s Laboratories S.A.

Pharmaceuticals, Inc.

2023 Omnibus Stock Incentive Plan.

of Securities Purchase Agreement, dated May 3, 2023, by and between Citius Pharmaceuticals, Inc.

and the purchasers signatory thereto.

Support Agreement, dated as of October 23, 2023, by and among 10XYZ Holdings LP, TenX Keane Acquisition, Citius Pharmaceuticals,

and Citius Oncology, Inc .

of Amended and Restated Registration Rights Agreement.

of Amended and Restated Shared Services Agreement.

Subsidiaries.

Description of Document

Consent of Independent Registered Public Accounting Firm.

3 unchanged sentences

1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.

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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.

contract or compensatory plan.

Form 10-K Summary.

Not applicable.

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.

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.

December 29, 2023

/s/ Leonard Mazur

Leonard Mazur

Executive Officer

Executive Officer)

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.

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.

/s/ Leonard Mazur

Chief Executive Officer and Director

December 22, 2022

Leonard Mazur

(Principal Executive Officer)

/s/ Myron Holubiak

Executive Vice Chairman and Director

December 22, 2022

Myron Holubiak

/s/ Jaimie Bartushak

Executive Vice Chairman

Myron Holubiak

Chief Financial Officer

1 unchanged sentence

Jaime Bartushak

(Principal Financial Officer and Principal Accounting Officer)

/s/ Suren Dutia

December 22, 2022

/s/ Carol Webb

December 22, 2022

/s/ William Kane

December 22, 2022

/s/ Howard Safir

December 22, 2022

/s/ Eugene Holuka

December 22, 2022

(Principal Financial Officer and Principal Accounting

Eugene Holuka

Dennis McGrath

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures