What changed in this filing

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Item 9A. Controls and Procedures

2021-12-15 compared with 2020-12-16 · 167 added, 121 removed, 80 unchanged (78% of the section changed)

2 unchanged sentences

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, 2020, 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, 2020, 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

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.

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, 2020 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, 2020.

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

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 2020 that materially affected, or are reasonably likely to materially

affect, our internal control over financial reporting.

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.

Other Information.

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.

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 2021 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.

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.

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 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.

Executive Compensation

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

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

following table sets forth the indicated information as of September 30, 2020 with respect to our equity compensation plans:

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, 2021 with respect to our equity compensation plans:

Plan Category

7 unchanged sentences

2020 Omnibus Stock Incentive Plan

equity compensation plans consist of the Citius Pharmaceuticals, Inc.

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 or the 2018 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”

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

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

1—Election of Directors” to be contained in the Proxy Statement.

Principal Accountant Fees and Services

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.

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

Exhibits and Financial Statement Schedules

Description of Document

Registrant’s

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

1 unchanged sentence

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.

Placement Agent’s Unit Warrant in favor of Merriman Capital, Inc., dated September 12, 2014.

Form of Investor Warrant, dated September 12, 2014.

Form of Common Stock Purchase Warrant, dated May 10, 2017.

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

Form of Investor Warrant, dated December 15, 2017.

4 unchanged sentences

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.

1 unchanged sentence

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

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

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

4 unchanged sentences

Form of Underwriter Warrant issued August 10, 2020.

Form of investor warrant issued January 27, 2021.

Description of Document

Registrant’s

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 thereto.

of investor warrant issued February 19, 2021.

Form of placement agent warrant issued February 19, 2021

Citius Pharmaceuticals, Inc.

15 unchanged sentences

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

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.

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.

Anderson Cancer Center and Citius Pharmaceuticals, 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.

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

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

and the purchasers named

Pharmaceuticals, Inc.

2020 Omnibus Stock Incentive Plan.

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

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.

Description of Document

Registrant’s

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

and the investor signatory

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

and the investor signatory

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

and the purchasers signatory

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

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

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

and the purchasers named therein.

Citius 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.

and the investor signatory thereto.

Form 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.

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

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

and the purchasers signatory thereto.

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

and Myron Czuczman.

1 unchanged sentence

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.

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.

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.

Description of Document

Amendment 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.

Subsidiaries.

2 unchanged sentences

Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).

Certification of the Chief Executive Officer pursuant to 18 U.S.C.

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

Certification of the Chief Financial Officer pursuant to 18 U.S.C.

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

INSTANCE DOCUMENT

TAXONOMY EXTENSION SCHEMA DOCUMENT

TAXONOMY EXTENSION CALCULATION LINKBASE

TAXONOMY EXTENSION DEFINITION LINKBASE

TAXONOMY EXTENSION LABELS LINKBASE

TAXONOMY EXTENSION PRESENTATION LINKBASE

Portions of this exhibit have been omitted.

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

Inline XBRL Instance Document

Inline XBRL Taxonomy Extension Schema Document.

Inline XBRL Taxonomy Extension Calculation Linkbase

Inline XBRL Taxonomy Extension Definition Linkbase

Inline XBRL Taxonomy Extension Label Linkbase Document.

Inline XBRL Taxonomy Extension Presentation Linkbase

Cover Page Interactive Data File (formatted as Inline

XBRL and contained in Exhibit 101).

of this exhibit have been omitted pursuant to Item 601(b)10 of Regulation S-K.

Form 10-K Summary.

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.

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.

CITIUS PHARMACEUTICALS, INC.

December 15, 2021

/s/ Myron Holubiak

Myron Holubiak

and Chief 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.

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.

/s/ Leonard Mazur

Executive Chairman of the Board of Directors

December 15, 2021

Leonard Mazur

Chairman of the Board of Directors

/s/ Myron Holubiak

President and Chief Executive Officer and Director

December 15, 2021

Myron Holubiak

and Chief Executive Officer and Director

Executive Officer)

(Principal Executive Officer)

/s/ Jaime Bartushak

Chief Financial Officer and Chief Accounting Officer

December 15, 2021

Jaime Bartushak

Financial Officer and Chief Accounting Officer

Financial Officer and Principal Accounting Officer)

(Principal Financial Officer and Principal Accounting Officer)

/s/ Suren Dutia

December 15, 2021

/s/ Carol Webb

December 15, 2021

/s/ William Kane

December 15, 2021

/s/ Howard Safir

December 15, 2021

/s/ Eugene Holuka

December 15, 2021

Eugene Holuka

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