U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: June 30, 2022

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______________ to ______________

Commission File Number 001-38174

Citius Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Nevada		27-3425913
(State or other jurisdiction of incorporation or organization)		(IRS Employer Identification No.)

11 Commerce Drive, First Floor, Cranford, NJ 07016

(Address of principal executive offices and zip code)

(908) 967-6677

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class	Trading Symbol(s)	Name of Each Exchange on Which Registered
Common stock, $0.001 par value	CTXR	Nasdaq Capital Market
Warrants to purchase common stock	CTXRW	Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 10, 2022, there were 146,129,630 shares of common stock, $0.001 par value, of the registrant issued and outstanding.

Citius Pharmaceuticals, Inc.

FORM 10-Q

TABLE OF CONTENTS

June 30, 2022

		Page
PART I. FINANCIAL INFORMATION:		1

Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets at June 30, 2022 and September 30, 2021	1
	Condensed Consolidated Statements of Operations for the Three and Nine Months Ended June 30, 2022 and 2021	2
	Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended June 30, 2022 and 2021	3
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended June 30, 2022 and 2021	4
	Notes to Condensed Consolidated Financial Statements	5

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	21
Item 4.	Controls and Procedures	21

PART II. OTHER INFORMATION		22

Item 1.	Legal Proceedings	22
Item 1A.	Risk Factors	22
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	22
Item 3.	Defaults Upon Senior Securities	22
Item 4.	Mine Safety Disclosures	22
Item 5.	Other Information	22
Item 6.	Exhibits	23

	SIGNATURES	24

EXPLANATORY NOTE

In this Quarterly Report on Form 10-Q, and unless the context otherwise requires, the “Company,” “we,” “us,” and “our” refer to Citius Pharmaceuticals, Inc. and its wholly-owned subsidiaries Citius Pharmaceuticals, LLC, Leonard-Meron Biosciences, Inc., Citius Acquisition Corp., and its majority-owned subsidiary, NoveCite, Inc., taken as a whole.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in this report and in other documents which we file with the Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to:

	●	the cost, timing and results of our pre-clinical and clinical trials;

	●	our ability to raise funds for general corporate purposes and operations, including our pre-clinical and clinical trials;

●

our ability to obtain and maintain required regulatory approvals for our product candidates;

●

the commercial feasibility and success of our technology and product candidates;

●

our ability to recruit and retain qualified management and scientific and technical personnel to carry out our operations; and

●

the other factors discussed in the “Risk Factors” section of our most recent Annual Report on Form 10-K and elsewhere in this report.

Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the filing date of this report.

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

	June 30,			September 30,
	2022			2021
ASSETS
Current Assets:
Cash and cash equivalents	$	48,044,194		$	70,072,946
Prepaid expenses		2,790,319			2,741,404
Total Current Assets		50,834,513			72,814,350

Property and equipment, net		4,831			7,023

Operating lease right-of-use asset, net		691,593			822,828

Other Assets:
Deposits		38,062			38,062
In-process research and development		59,400,000			59,400,000
Goodwill		9,346,796			9,346,796
Total Other Assets		68,784,858			68,784,858

Total Assets	$	120,315,795		$	142,429,059

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable	$	1,690,520		$	1,277,095
Accrued expenses		1,301,199			621,960
Accrued compensation		1,277,501			1,906,000
Operating lease liability		191,902			177,237
Total Current Liabilities		4,461,122			3,982,292

Deferred tax liability		4,985,800			4,985,800
Operating lease liability – noncurrent		532,883			678,234
Total Liabilities		9,979,805			9,646,326

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; 400,000,000 shares authorized; 146,129,630 and 145,979,429 shares issued and outstanding at June 30, 2022 and September 30, 2021, respectively		146,129			145,979
Additional paid-in capital		231,287,208			228,084,195
Accumulated deficit		(121,697,727	)		(96,047,821	)
Total Citius Pharmaceuticals, Inc. Stockholders’ Equity		109,735,610			132,182,353
Non-controlling interest		600,380			600,380
Total Equity		110,335,990			132,782,733

Total Liabilities and Equity	$	120,315,795		$	142,429,059

See notes to unaudited condensed consolidated financial statements.

CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE AND NINE MONTHS ENDED JUNE 30, 2022 AND 2021

(Unaudited)

	Three Months Ended						Nine Months Ended
	June 30,			June 30,			June 30,			June 30,
	2022			2021			2022			2021
Revenues	$	—		$	—		$	—		$	—

Operating Expenses
Research and development		4,888,192			2,203,748			13,798,251			9,946,268
General and administrative		3,024,783			3,407,088			9,038,949			7,389,269
Stock-based compensation – general and administrative		1,003,677			373,570			2,929,279			993,114
Total Operating Expenses		8,916,652			5,984,406			25,766,479			18,328,651

Operating Loss		(8,916,652	)		(5,984,406	)		(25,766,479	)		(18,328,651	)

Other Income (Expense)
Interest income		53,020			103,413			116,573			186,224
Other income		—			59,917			—			59,917
Interest expense		—			(2,932	)		—			(10,839	)
Total Other Income, Net		53,020			160,398			116,573			235,302

Net Loss		(8,863,632	)		(5,824,008	)		(25,649,906	)		(18,093,349	)
Deemed dividend on warrant extension		—			1,450,876			—			1,450,876

Net Loss Applicable to Common Stockholders	$	(8,863,632	)	$	(7,274,884	)	$	(25,649,906	)	$	(19,544,225	)

Net Loss Per Share Applicable to Common Stockholders - Basic and Diluted	$	(0.06	)	$	(0.05	)	$	(0.18	)	$	(0.20	)

Weighted Average Common Shares Outstanding
Basic and diluted		146,129,630			137,151,269			146,061,108			96,002,039

See notes to unaudited condensed consolidated financial statements.

CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED JUNE 30, 2022 AND 2021

(Unaudited)

	Preferred		Common Stock				Additional Paid-In		Accumulated			Total Citius Pharmaceuticals, Inc. Shareholder’s			Non-Controlling		Total
	Stock		Shares		Amount		Capital		Deficit			Equity			Interest		Equity
Balance, October 1, 2021	$	—		145,979,429	$	145,979	$	228,084,195	$	(96,047,821	)	$	132,182,353		$	600,380	$	132,782,733
Issuance of common stock for services		—		50,201		50		95,834		—			95,884			—		95,884
Stock-based compensation expense		—		—		—		904,604		—			904,604			—		904,604
Net loss		—		—		—		—		(9,225,220	)		(9,225,220	)		—		(9,225,220	)
Balance, December 31, 2021		—		146,029,630		146,029		229,084,633		(105,273,041	)		123,957,621			600,380		124,558,001
Issuance of common stock for services		—		100,000		100		177,900		—			178,000			—		178,000
Stock-based compensation expense		—		—		—		1,020,998		—			1,020,998			—		1,020,998
Net loss		—		—		—		—		(7,561,054	)		(7,561,054	)		—		(7,561,054	)
Balance, March 31, 2022		—		146,129,630		146,129		230,283,531		(112,834,095	)		117,595,565			600,380		118,195,945
Stock-based compensation expense		—		—		—		1,003,677		—			1,003,677			—		1,003,677
Net loss		—		—		—		—		(8,863,632	)		(8,863,632	)		—		(8,863,632	)
Balance, June 30, 2022	$	—		146,129,630	$	146,129	$	231,287,208	$	(121,697,727	)	$	109,735,610		$	600,380	$	110,335,990


Balance, October 1, 2020	$	—		55,576,996	$	55,577	$	104,208,958	$	(70,593,867	)	$	33,670,668		$	—	$	33,670,668
Issuance of NoveCite common stock		—		—		—		1,799,640		(2,399,520	)		(599,880	)		600,380		500
Stock-based compensation expense		—		—		—		276,582		—			276,582			—		276,582
Net loss		—		—		—		—		(8,146,909	)		(8,146,909	)		—		(8,146,909	)
Balance, December 31, 2020		—		55,576,996		55,577		106,285,180		(81,140,296	)		25,200,461			600,380		25,800,841
Issuance of common stock in private placement offering, net of costs of $1,549,602		—		15,455,960		15,456		18,434,954		—			18,450,410			—		18,450,410
Issuance of common stock in registered direct offering, net of costs of $5,520,160		—		50,830,566		50,830		70,929,012		—			70,979,842			—		70,979,842
Issuance of common stock upon exercise of warrants		—		12,787,697		12,788		14,229,755		—			14,242,543			—		14,242,543
Issuance of common stock for services		—		50,000		50		67,950		—			68,000			—		68,000
Stock-based compensation expense		—		—		—		342,962		—			342,962			—		342,962
Net loss		—		—		—		—		(4,122,432	)		(4,122,432	)		—		(4,122,432	)
Balance, March 31, 2021		—		134,701,219		134,701		210,289,813		(85,262,728	)		125,161,786			600,380		125,762,166
Issuance of common stock upon exercise of warrants		—		11,208,210		11,208		16,876,383		—			16,887,591			—		16,887,591
Issuance of common stock upon exercise of stock options		—		70,000		70		82,564		—			82,634			—		82,634
Stock-based compensation expense		—		—		—		373,570		—			373,570			—		373,570
Net loss		—		—		—		—		(5,824,008	)		(5,824,008	)		—		(5,824,008	)
Balance, June 30, 2021	$	—		145,979,429	$	145,979	$	227,622,330	$	(91,086,736	)	$	136,681,573		$	600,380	$	137,281,953

See notes to unaudited condensed consolidated financial statements.

CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE NINE MONTHS ENDED JUNE 30, 2022 AND 2021

(Unaudited)

	2022			2021
Cash Flows From Operating Activities:
Net loss	$	(25,649,906	)	$	(18,093,349	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		2,929,279			993,114
Issuance of common stock for services		273,884			68,000
Amortization of operating lease right-of-use asset		131,235			121,339
Depreciation		2,192			761
Changes in operating assets and liabilities:
Prepaid expenses		(48,915	)		(1,149,158	)
Deposits		—			19,031
Accounts payable		413,425			(501,571	)
Accrued expenses		679,239			202,696
Accrued compensation		(628,499	)		(115,106	)
Accrued interest		—			(87,996	)
Operating lease liability		(130,686	)		(117,145	)
Net Cash Used In Operating Activities		(22,028,752	)		(18,659,384	)

Cash Flows From Investing Activities:
Purchase of property and equipment		—			(6,938	)
Net Cash Used In Investing Activities		—			(6,938	)

Cash Flows From Financing Activities:
Principal paid on notes payable – related parties		—			(172,970	)
Proceeds from sale of NoveCite, Inc. common stock		—			500
Net proceeds from private placement		—			18,450,410
Net proceeds from registered direct offering		—			70,979,842
Net proceeds from common stock warrant exercises		—			31,130,134
Net proceeds from common stock option exercises		—			82,634
Net Cash Provided By Financing Activities		—			120,470,550

Net Change in Cash and Cash Equivalents		(22,028,752	)		101,804,228
Cash and Cash Equivalents - Beginning of Period		70,072,946			13,859,748
Cash and Cash Equivalents - End of Period	$	48,044,194		$	115,663,976

See notes to unaudited condensed consolidated financial statements.

CITIUS PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED JUNE 30, 2022 AND 2021

(Unaudited)

1. NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Business

Citius Pharmaceuticals, Inc. (“Citius,” the “Company,” “we” or “us”) is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy.

On March 30, 2016, Citius acquired Leonard-Meron Biosciences, Inc. (“LMB”) as a wholly-owned subsidiary by issuing shares of its common stock.

On September 11, 2020, we formed NoveCite, Inc. (“NoveCite”), a Delaware corporation, of which we own 75% (7,500,000 shares) of the issued and outstanding capital stock (see Note 3).

On August 23, 2021, we formed Citius Acquisition Corp., as a wholly-owned subsidiary in conjunction with the acquisition of I/ONTAK (formerly E7777). Citius Acquisition Corp. was inactive until April 1, 2022 when it assumed the development of I/ONTAK.

In-process research and development (“IPR&D”) consists of (i) the $19,400,000 acquisition value of LMB’s leading drug candidate (Mino-Lok), which is an antibiotic solution 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, and (ii) the $40,000,000 acquisition value of the exclusive license for I/ONTAK (denileukin diftitox), which is a late-stage oncology immunotherapy for the treatment of cutaneous T-cell lymphoma (“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.

Goodwill of $9,346,796 represents the value of LMB’s industry relationships and its assembled workforce. Goodwill will not be amortized but will be tested at least annually for impairment.

Citius is subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by Citius or its competitors of research and development stage product candidates, market acceptance of its product candidates that might be approved, competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s ability to obtain additional financing and the Company’s compliance with governmental and other regulations.

Basis of Presentation and Summary of Significant Accounting Policies

Basis of Preparation — The accompanying condensed consolidated financial statements include the operations of Citius Pharmaceuticals, Inc., and its wholly-owned subsidiaries, Citius Pharmaceuticals, LLC, LMB, and Citius Acquisition Corp., and its majority-owned subsidiary NoveCite. All significant inter-company balances and transactions have been eliminated in consolidation.

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state the condensed consolidated financial position of the Company as of June 30, 2022, and the results of its operations and cash flows for the three and nine month periods ended June 30, 2022 and 2021. The operating results for the three- and nine-month periods ended June 30, 2022 are not necessarily indicative of the results that may be expected for the year ending September 30, 2022. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended September 30, 2021 filed with the Securities and Exchange Commission.

Use of Estimates — Our accounting principles require our management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting period. Estimates having relatively higher significance include stock-based compensation, accounting for leases, valuation of warrants, and income taxes. Actual results could differ from those estimates and changes in estimates may occur.

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 stock options and warrants, were not included in the calculation of the diluted loss per share because they were anti-dilutive.

Recently Issued Accounting Standards

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which, among other things, provides guidance on how to account for contracts on an entity’s own equity. This ASU eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, this ASU modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in this ASU are effective for public companies for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its consolidated financial statements.

In October 2021, the FASB issued ASU No. 2021-08, Business Combinations (Topic 805): Accounting for Acquired Contract Assets and Contract Liabilities. Under the new guidance (ASC 805-20-30-28), the acquirer should determine what contract assets and/or contract liabilities it would have recorded under Accounting Standards Codification (“ASC”) 606 (the revenue guidance) as of the acquisition date, as if the acquirer had entered into the original contract at the same date and on the same terms as the acquiree. The recognition and measurement of those contract assets and contract liabilities will likely be comparable to what the acquiree has recorded on its books under ASC 606 as of the acquisition date. ASU 2021-08 is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. ASU 2021-08 is effective for the Company in the first quarter of fiscal 2024. Early adoption is permitted, including in an interim period, for any period for which financial statements have not yet been issued. However, adoption in an interim period other than the first fiscal quarter requires an entity to apply the new guidance to all prior business combinations that have occurred since the beginning of the annual period in which the new guidance is adopted. The Company is currently evaluating the adoption date of ASU 2021-08 and the impact, if any, adoption will have on its financial position and results of operations.

2. LIQUIDITY 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. The Company experienced negative cash flows from operations of $22,028,752 for the nine months ended June 30, 2022. As a result of the Company’s common stock offerings and common stock warrant exercises during the year ended September 30, 2021, the Company had working capital of approximately $46,400,000 at June 30, 2022. The Company estimates that its available cash resources will be sufficient to fund its operations through August 2023.

The Company has generated no operating revenue to date and has principally raised capital through the issuance of debt and equity instruments to finance its operations. The Company’s continued operations beyond August 2023, including its development plans for Mino-Lok, Mino-Wrap, Halo-Lido, NoveCite and I/ONTAK, will depend on its ability to obtain regulatory approval to market Mino-Lok and/or I/ONTAK and generate substantial revenue from the sale of Mino-Lok and/or I/ONTAK and on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its product candidates. However, the Company can provide no assurances on regulatory approval, commercialization or future sales of Mino-Lok or I/ONTAK or that financing or strategic relationships will be available on acceptable terms, or at all. If the Company is unable to raise sufficient capital, find strategic partners or generate substantial revenue from the sale of Mino-Lok or I/ONTAK, there would be a material adverse effect on its business. Further, the Company expects to incur additional expenses as it continues to develop its product candidates, including seeking regulatory approval, and protecting its intellectual property.

3. 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. The Company recorded an annual maintenance fee of $90,000 in June 2022 and 2021.

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 an aggregate of $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.

Patent and Technology License Agreement – Mino-Wrap

On January 2, 2019, we entered into a patent and technology license agreement with the Board of Regents of the University of Texas System on behalf of the University of Texas M. D. Anderson Cancer Center (“Licensor”), whereby we in-licensed exclusive worldwide rights to the patented technology for any and all uses relating to breast implants. We intend to develop a liquefying gel-based wrap containing minocycline and rifampin for the reduction of infections associated with breast implants following breast reconstructive surgeries (“Mino-Wrap”). We are required to use commercially reasonable efforts to commercialize Mino-Wrap under several regulatory scenarios and achieve milestones associated with these regulatory options leading to an approval from the U.S. Food and Drug Administration (“FDA”).

Under the license agreement, the Company paid an annual maintenance fee of $60,000 and $45,000 in January 2022 and 2021, respectively. The annual maintenance fee increases by $15,000 per year up to a maximum of $90,000. Annual maintenance fees cease on the first sale of product. We also must pay up to an aggregate of $2.1 million in milestone payments, contingent on the achievement of various regulatory and commercial milestones. Under the terms of the license agreement, we also must pay a royalty of mid- to upper-single digit percentages of net sales, depending on the amount of annual sales, and subject to downward adjustment to lower- to mid-single digit percentages in the event there is no valid patent for the product in the United States at the time of sale. After the first sale of product, we will owe an annual minimum royalty payment of $100,000 that will increase annually by $25,000 for the duration of the term. We will be responsible for all patent expenses incurred by Licensor for the term of the agreement although Licensor is responsible for filing, prosecution and maintenance of all patents. Unless earlier terminated by Licensor, based upon the failure by us to achieve certain development and commercial milestones or for various breaches by us, the agreement expires on the later of the expiration of the patents or January 2, 2034.

License Agreement with Novellus

On March 31, 2020, we entered into an option agreement with a subsidiary of Novellus, Inc. (“Novellus”) to in-license from Novellus on a worldwide basis, a novel cellular therapy for acute respiratory distress syndrome (“ARDS”).

Our Board Chairman Leonard Mazur, who is also our largest stockholder, was at the time a significant shareholder of Novellus and subsequent to the option agreement and the license agreement discussed below, became a director of Novellus. As required by our Code of Ethics, the Audit Committee of our Board of Directors approved the entry into the option agreement with Novellus, as did the disinterested members of our Board of Directors.

On October 6, 2020, our subsidiary, NoveCite, exercised the option and signed an exclusive license agreement with Novellus. Upon execution of the agreement, we paid $5,000,000 to Novellus, which was charged to research and development expense in the three-month period ended December 31, 2020, and issued 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 stock subscription agreement between Novellus and NoveCite, if NoveCite issued additional equity, subject to certain exceptions, NoveCite had to maintain Novellus’s ownership at 25% by issuing additional shares to Novellus.

Citius is responsible for the operational activities of NoveCite, and bears all costs necessary to operate NoveCite. Citius’s 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.

Novellus has no contractual rights in the profits or obligations to share in the losses of NoveCite, and the Company has not allocated any losses to the noncontrolling interest.

NoveCite is obligated to pay Novellus up to an aggregate of $51,000,000 upon the achievement of various regulatory and developmental milestones. NoveCite also must pay a royalty equal to low double-digit percentages of net sales, commencing upon the sale of a licensed product. This royalty is subject to downward adjustment to an upper-single digit percentage 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) the date on which a biosimilar product is first marketed, sold, or distributed 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 Novellus an amount equal to a mid-twenties percentage of any sublicensee fees it receives.

Under the terms of the license agreement, in the event that Novellus receives any revenue involving the original cell line included in the licensed technology, then Novellus shall remit to NoveCite 50% of such revenue.

The term of the license agreement will 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.

Novellus 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 Novellus 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.

In July 2021, Novellus was acquired by Brooklyn ImmunoTherapeutics, Inc. (“Brooklyn”). In connection with that transaction, the stock subscription agreement between Novellus and NoveCite was amended to assign to Brooklyn all of Novellus’s right, title, and interest in the stock subscription agreement 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.

License Agreement with Eisai

In September 2021, the Company entered into a definitive agreement with Dr. Reddy's Laboratories SA, a subsidiary of Dr. Reddy's Laboratories, Ltd. (collectively, "Dr. Reddy's"), to acquire its exclusive license of I/ONTAK (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma.

Under the terms of this agreement, Citius acquired Dr. Reddy's exclusive license of I/ONTAK from Eisai Co., Ltd. ("Eisai") and other related assets owned by Dr. Reddy's. Citius's exclusive license includes rights to develop and commercialize I/ONTAK in all markets except for Japan and certain parts of Asia. Additionally, Citius retained an option on the right to develop and market the product in India. Eisai retains exclusive development and marketing rights for the agent in Japan and Asia. Citius paid a $40 million upfront payment which represents the acquisition date fair value of the in-process research and development acquired from Dr. Reddy’s. Dr. Reddy’s is entitled to up to an aggregate of $40 million in development milestone payments related to CTCL approvals in the U.S. and other markets, up to an aggregate of $70 million in development milestones for additional indications, as well as commercial milestone payments and low double-digit tiered royalties on net product sales, and up to an aggregate of $300 million for commercial sales milestones. We also must pay on a fiscal quarter basis tiered royalties equal to low double-digit percentages of net product sales. 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. We 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.

Under the license agreement, Eisai is to receive a $6.0 million development milestone payment upon initial approval and additional commercial milestone payments related to the achievement of net product sales thresholds (which increases to $7.0 million in the event we have exercised our option to add India to the licensed territory prior to FDA approval) and up to an aggregate of $22 million related to the achievement of net product sales thresholds. We also are required to reimburse Eisai for up to $2.65 million of its costs to complete the ongoing Phase 3 pivotal clinical trial for I/ONTAK for the CTCL indication and reimburse Eisai for all reasonable costs associated with the preparation of a BLA for I/ONTAK. Eisai will be responsible for completing the current CTCL clinical trial, and chemistry, manufacturing and controls activities through the filing of a BLA for I/ONTAK with the FDA. Citius will be responsible for development costs associated with potential additional indications.

The term of the license agreement will continue until (i) if there has not been a commercial sale of a licensed product in the territory, until the 10-year anniversary of the original license effective date, March 30, 2016, or (ii) if there has been a first commercial sale of a licensed product in the territory within the 10-year anniversary of the original license effective date, the 10-year anniversary of the first commercial sale on a country-by-country basis. 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.

Also under the 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, (iii) use commercially reasonable efforts to achieve each of the approval milestones, and (iv) 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.

4. NOTES PAYABLE

Notes Payable – Related Parties

Prior to June 30, 2021, we had outstanding notes payable held by our Chairman, Leonard Mazur, in the amount of $160,470 and notes payable held by our then Chief Executive Officer, Myron Holubiak, in the amount of $12,500. Notes with a principal balance of $104,000 accrued interest at the prime rate plus 1.0% per annum and notes with a principal balance of $68,970 accrued interest at 12% per annum.

In June 2021, we repaid the $172,970 principal balance of these notes and paid accrued interest of $38,917. Accrued interest of $59,917 was forgiven and was recorded as other income in the three and nine months ended June 30, 2021.

Interest expense on notes payable – related parties was $2,509 and $9,605 for the three and nine months ended June 30, 2021, respectively.

Paycheck Protection Program

On April 12, 2020, the Company applied for a forgivable loan through the Small Business Association’s Paycheck Protection Program (the “PPP”). The loan accrued interest at a rate of 1% and was forgivable if it was used to pay qualifying costs such as payroll, rent and utilities. On April 15, 2020, the Company received $164,583 from the PPP.

On July 28, 2021, the Small Business Administration gave full forgiveness of the PPP loan and the Company recorded a gain from debt extinguishment of $166,557 consisting of the principal balance and related accrued interest expense.

Interest expense was $423 and $1,234 for the three and nine months ended June 30, 2021, respectively.

5. COMMON STOCK, STOCK OPTIONS AND WARRANTS

Authorized Common Stock

On June 21, 2021, our stockholders approved an amendment to our Articles of Incorporation to increase the authorized number of shares of capital stock from 210,000,000 to 410,000,000 and the authorized number of common shares from 200,000,000 to 400,000,000.

Common Stock Offerings

On January 27, 2021, the Company closed a private placement for 15,455,960 common shares and warrants to purchase 7,727,980 common shares, at a purchase price of $1.294 per common share and accompanying warrant, for gross proceeds of $20,000,012. The 7,727,980 warrants are immediately exercisable at $1.231 per common share for a term of five and one-half years. The Company paid the placement agent a fee of 7% of the gross proceeds totaling $1,400,001 and issued the placement agent 1,081,917 immediately exercisable warrants at $1.6175 per common share for a term of five and one-half years. The Company also reimbursed the placement agent for $85,000 in expenses and incurred $64,601 in other expenses. Net proceeds from the offering were $18,450,410. The estimated fair value of the 7,727,980 warrants issued to the investors was approximately $7,582,000 and the estimated fair value of the 1,081,917 warrants issued to the placement agent was approximately $1,025,000.

On February 19, 2021, the Company closed a registered direct offering for 50,830,566 common shares and warrants to purchase up to 25,415,283 common shares, at a purchase price of $1.505 per share of common stock and accompanying warrant, for gross proceeds of $76,500,002. The 25,415,283 warrants are immediately exercisable at $1.70 per common share for a term of five years. The Company paid the placement agent a fee of 7% of the gross proceeds totaling $5,355,000 and issued the placement agent 3,558,140 immediately exercisable warrants at $1.881 per common share for a term of five years. The Company also reimbursed the placement agent for $85,000 in expenses and incurred $80,160 in other expenses. Net proceeds from the offering were $70,979,842. The estimated fair value of the 25,415,283 warrants issued to the investors was approximately $42,322,000 and the estimated fair value of the 3,558,140 warrants issued to the placement agent was approximately $5,850,000.

Common Stock Issued for Services

On November 2, 2021, the Company issued 50,201 shares of common stock for investor relations services and expensed the $95,884 fair value of the common stock issued.

On March 21, 2022, the Company issued 100,000 shares of common stock for media, public and investor relations services and expensed the $178,000 fair value of the common stock issued.

Stock Option Plans

Pursuant to our 2014 Stock Incentive Plan, we reserved 866,667 common shares for issuance to employees, directors and consultants. As of June 30, 2022, options to purchase 855,171 shares were outstanding and no shares remain available for future grants.

On February 7, 2018, our stockholders approved the 2018 Omnibus Stock Incentive Plan and we reserved 2,000,000 common shares for issuance to employees, directors and consultants. As of June 30, 2022, options to purchase 1,820,000 shares were outstanding and no shares remain available for future grants.

On February 10, 2020, our stockholders approved the 2020 Stock Plan and we reserved 3,110,000 common shares for issuance to employees, directors, and consultants. As of June 30, 2022, options to purchase 1,870,000 shares were outstanding and the remaining 1,240,000 shares were transferred to the 2021 Omnibus Stock Incentive Plan (“2021 Stock Plan”).

On May 24, 2021, our stockholders approved the 2021 Stock Plan and we reserved 8,740,000 shares for issuance to employees, directors, and consultants through options, SARs, dividend equivalent rights, restricted stock, restricted stock units, or other rights. As of June 30, 2022, options to purchase 4,855,000 shares were outstanding and there were 3,885,000 shares 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. 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, 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 our stock option plans (excluding the NoveCite Stock Plan) is presented below:

	Option Shares		Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at October 1, 2021		5,755,171	$	2.13	8.02 years	$	3,589,392
Granted		3,645,000		1.97
Exercised		—		—
Forfeited or expired		—		—
Outstanding at June 30, 2022		9,400,171	$	2.07	8.06 years	$	302,939

Exercisable at June 30, 2022		3,675,742	$	2.48	6.56 years	$	236,478

On October 11, 2021, the Board of Directors granted options to purchase 2,515,000 shares to employees, 375,000 shares to directors and 175,000 shares to consultants at $2.04 per share. On November 1, 2021, the Board of Directors granted options to purchase 200,000 shares to an employee at $1.87 per share. During January and February 2022, options to purchase 300,000 shares were granted to three new employees at exercise prices ranging from $1.44 to $1.49 per share. In April and June 2022, options to purchase 80,000 shares were granted to two new employees at exercise prices ranging from $0.90 to $1.47 per share. The weighted average grant date fair value of the options granted during the nine months ended June 30, 2022 was estimated at $1.67 per share. All of these options vest over terms of 12 to 36 months and have a term of 10 years.

On October 6, 2020, the Board of Directors granted stock options to purchase a total of 800,000 shares to employees, 175,000 shares to directors and 125,000 shares to consultants at $1.01 per share. On February 16, 2021, the Board of Directors granted stock options to purchase a total of 125,000 shares to directors at $1.69 per share. On June 10, 2021, the Board of Directors granted stock options to purchase 100,000 shares to employees and 10,000 shares to a consultant at $2.50 per share. The weighted average grant date fair value of the options granted during the nine months ended June 30, 2021 was estimated at $1.03 per share. All of these options vest over terms of 12 to 36 months and have a term of 10 years.

Stock-based compensation expense for the three months ended June 30, 2022 and 2021 was $1,003,677 (including $33,333 for the NoveCite Stock Plan) and $373,570 (including $18,833 for the NoveCite Stock Plan), respectively. Stock-based compensation expense for the nine months ended June 30, 2022 and 2021 was $2,929,279 (including $99,999 for the NoveCite Stock Plan) and $993,114 (including $50,222 for the NoveCite Stock Plan), respectively.

At June 30, 2022, unrecognized total compensation cost related to unvested awards under the Citius stock plans of $6,261,023 is expected to be recognized over a weighted average period of 2.1 years.

On November 5, 2020, the stockholders of NoveCite, approved NoveCite’s Stock Plan and we reserved 2,000,000 common shares of NoveCite for issuance. The NoveCite Stock Plan provides incentives to employees, directors, and consultants through grants of options, SARs, dividend equivalent rights, restricted stock, restricted stock units, or other rights. As of June 30, 2022, there were options outstanding to purchase 2,000,000 common shares of NoveCite and no shares available for future grants.

As of June 30, 2022, NoveCite has options outstanding to purchase 2,000,000 common shares at a weighted average exercise price of $0.24 per share, of which 376,665 are exercisable. All of these options vest 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 8.7 years. At June 30, 2022, unrecognized total compensation cost related to unvested awards under the NoveCite Stock Plan of $216,444 is expected to be recognized over a weighted average period of 1.7 years.

Warrants

As of June 30, 2022, we have reserved shares of common stock for the exercise of outstanding warrants as follows:

	Exercise price		Number		Expiration Date
2017 Public Offering Investors	$	4.13		1,622,989	August 8, 2022
2017 Public Offering Underwriter		4.54		65,940	February 2, 2023
December 2017 Registered Direct/Private Placement Offering Investors		4.63		640,180	June 19, 2023
December 2017 Registered Direct/Private Placement Offering Placement Agent		5.87		89,625	December 19, 2022
March 2018 Registered Direct/Private Placement Offering Investors		2.86		218,972	October 2, 2023
March 2018 Registered Direct/Private Placement Offering Placement Agent		3.73		46,866	March 28, 2023
August 2018 Offering Investors		1.15		3,921,569	August 14, 2023
August 2018 Offering Agent		1.59		189,412	August 8, 2023
April 2019 Registered Direct/Private Placement Offering Investors		1.42		1,294,498	April 5, 2024
April 2019 Registered Direct/Private Placement Offering Placement Agent		1.93		240,130	April 5, 2024
September 2019 Offering Investors		0.77		2,793,297	September 27, 2024
September 2019 Offering Underwriter		1.12		194,358	September 27, 2024
February 2020 Exercise Agreement Placement Agent		1.28		138,886	August 19, 2025
May 2020 Registered Direct Offering Investors		1.00		1,670,588	November 18, 2025
May 2020 Registered Direct Offering Placement Agent		1.33		155,647	May 14, 2025
August 2020 Underwriter		1.31		201,967	August 10, 2025
January 2021 Private Placement Offering Investors		1.23		3,091,192	July 27, 2026
January 2021 Private Placement Offering Agent		1.62		351,623	July 27, 2026
February 2021 Registered Direct Offering Investors		1.70		20,580,283	February 19, 2026
February 2021 Registered Direct Offering Agent		1.88		2,506,396	February 19, 2026
				40,014,418

In April 2021, we extended the term by three years to April 5, 2024 for 1,294,498 warrants for common stock with an exercise price of $1.42 per share and 240,130 warrants with an exercise price of $1.93 per share. We recorded a deemed dividend of $1,450,876 based on the excess of the fair value of the modified warrants over the fair value of the warrants before the modification, the effect of which was an increase in the net loss attributable to common shareholders in the statement of operations for the three and nine months ended June 30, 2021.

At June 30, 2022, the weighted average remaining life of the outstanding warrants is 3.0 years, all warrants are exercisable, and the aggregate intrinsic value of the warrants outstanding was $418,995.

Common Stock Reserved

A summary of common stock reserved for future issuances as of June 30, 2022 is as follows:

Stock plan options outstanding			9,400,171
Stock plan shares available for future grants			3,885,000
Warrants outstanding			40,014,418
Total			53,299,589

6. RELATED PARTY TRANSACTIONS

The Company had outstanding debt due to Leonard Mazur (Chairman of the Board) and Myron Holubiak (then Chief Executive Officer) (see Note 4).

Leonard Mazur was a director and significant shareholder of Novellus until July 2021. On October 6, 2020, the Company, through its subsidiary NoveCite, entered into an exclusive agreement with Novellus to develop cellular therapies (see Note 3).

In April 2021, we extended the term by three years for 1,294,498 warrants held by our Chairman and our Chief Executive Officer (see Note 5).

7. OPERATING LEASE

Effective July 1, 2019, Citius entered into a 76-month lease for office space in Cranford, NJ. Citius pays its proportionate share of real estate taxes and operating expenses in excess of the base year expenses. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability.

The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities:

●

As the Company’s lease does not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments based on the remaining lease term as of the adoption date.

●

Since the Company 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	Nine Months Ended June 30, 2022			Nine Months Ended June 30, 2021
Operating lease cost	$	179,116		$	179,118
Variable lease cost		772			194
Total lease cost	$	179,888		$	179,312

Other information
Weighted-average remaining lease term - operating leases		3.3 Years			4.3 Years
Weighted-average discount rate - operating leases		8.0	%		8.0	%

Maturities of lease liabilities due under the Company’s non-cancellable leases as of June 30, 2022 is as follows:

Year Ending September 30,	June 30, 2022
2022 (excluding the 9 months ended June 30, 2022)	$	60,737
2023		244,165
2024		249,024
2025		253,883
2026		21,460
Total lease payments		829,269
Less: interest		(104,484	)
Present value of lease liabilities	$	724,785

Leases	Classification	June 30, 2022		September 30, 2021
Assets
Lease asset	Operating	$	691,593	$	822,828
Total lease assets		$	691,593	$	822,828

Liabilities
Current	Operating	$	191,902	$	177,237
Non-current	Operating		532,883		678,234
Total lease liabilities		$	724,785	$	855,471

Interest expense on the lease liability was $47,881 and $57,779 for the nine months ended June 30, 2022 and 2021, respectively.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations for the three and nine months ended June 30, 2022 should be read together with our unaudited consolidated financial statements and related notes included elsewhere in this report and in conjunction with the audited financial statements of Citius Pharmaceuticals, Inc. included in our Annual Report on Form 10-K for the year ended September 30, 2021. The following discussion contains “forward-looking statements” that reflect our future plans, estimates, beliefs and expected performance. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors. We caution that assumptions, expectations, projections, intentions or beliefs about future events may, and often do, vary from actual results and the differences can be material. Please see “Cautionary Note Regarding Forward-Looking Statements” on page ii of this Report.

Historical Background

Citius Pharmaceuticals, Inc. (“Citius,” the “Company,” “we” or “us”) is a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products. On September 12, 2014, we acquired Citius Pharmaceuticals, LLC as a wholly-owned subsidiary and on March 30, 2016, we acquired Leonard-Meron Biosciences, Inc. (“LMB”) as a wholly-owned subsidiary. 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 Acquisition Corp., as a wholly-owned subsidiary. Citius Acquisition Corp. was inactive until April 1, 2022 when it assumed the development of I/ONTAK.

Through June 30, 2022, the Company has devoted substantially all of its efforts to business planning, acquiring our proprietary technology, research and development, recruiting management and technical staff, and raising capital.

Patent and Technology License Agreements

Our patent and technology license agreements are discussed in the footnotes to our unaudited consolidated financial statements included in this Report.

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. Since May 2014, LMB has paid an annual maintenance fee, which began at $30,000 and that increased over five years to $90,000, where it will remain until the commencement of commercial sales of a product subject to the license. 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 or, in the event the licensed product is not subject to a valid patent claim, the royalty is reduced to mid- to lower-single 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 single digits. After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties that increase in subsequent years. LMB must also pay NAT up to an aggregate of $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.

Mino-Wrap - On January 2, 2019, we entered into a patent and technology license agreement with the Board of Regents of the University of Texas System on behalf of the University of Texas M. D. Anderson Cancer Center (“Licensor”), whereby we in-licensed exclusive worldwide rights to the patented technology for any and all uses relating to breast implants. We intend to develop a liquefying gel-based wrap containing minocycline and rifampin for the reduction of infections associated with breast implants following breast reconstructive surgeries (“Mino-Wrap”). We are required to use commercially reasonable efforts to commercialize Mino-Wrap under several regulatory scenarios and achieve milestones associated with these regulatory options leading to an approval from the Food and Drug Administration (“FDA”).

Under the license agreement, we paid a nonrefundable upfront payment of $125,000. We paid annual maintenance fees of $60,000 and $45,000 in January 2022 and 2021, respectively. The annual maintenance fee increases annually by $15,000 per year up to a maximum of $90,000. Annual maintenance fees cease on the first sale of product. We also must pay up to an aggregate of $2.1 million in milestone payments, contingent on the achievement of various regulatory and commercial milestones. Under the terms of the license agreement, we also must pay a royalty of mid- to upper-single digit percentages of net sales, depending on the amount of annual sales, and subject to downward adjustment to lower- to mid-single digit percentages in the event there is no valid patent for the product in the United States at the time of sale. After the first sale of product, we will owe an annual minimum royalty payment of $100,000 that will increase annually by $25,000 for the duration of the term. We will be responsible for all patent expenses incurred by Licensor for the term of the agreement although Licensor is responsible for filing, prosecution and maintenance of all patents.

NoveCite – On October 6, 2020, our subsidiary NoveCite entered into a license agreement with Novellus Therapeutics Limited (“Licensor”) to develop and commercialize a stem cell therapy based on the Licensor’s patented technology for the treatment of acute pneumonitis of any etiology in which inflammation is a major agent in humans. NoveCite paid a $5,000,000 license fee and issued 25% of its outstanding equity to the Licensor. We own the other 75% of NoveCite’s currently outstanding equity. If NoveCite issues 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 that transaction, the stock subscription agreement between Novellus and NoveCite was amended to 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.

Under the license agreement, NoveCite is obligated to pay Licensor up to an aggregate of $51,000,000 in regulatory and developmental milestone payments. NoveCite also must pay a royalty equal to low double-digit percentages 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 an upper-single digit percentage 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) the date on which a biosimilar product is first marketed, sold, or distributed by Licensor 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 Licensor an amount equal to a mid-twenties percentage of any sublicensee fees it receives.

Under the terms of the license agreement, in the event that Licensor receives any revenue involving the original cell line included in the licensed technology, then Licensor shall remit to NoveCite 50% of such revenue.

I/ONTAK - In September 2021 the Company announced that it had entered into a definitive agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, Ltd. (collectively, “Dr. Reddy's”) to acquire its exclusive license of I/ONTAK (formerly E7777) (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin lymphoma.

Under the terms of this agreement, Citius acquired Dr. Reddy's exclusive license of I/ONTAK from Eisai Co., Ltd. (“Eisai”) and other related assets owned by Dr. Reddy's. Citius's exclusive license rights include rights to develop and commercialize E7777 in all markets except for Japan and certain parts of Asia. Additionally, Citius has an option on the right to develop and market the product in India. Eisai retains exclusive development and marketing rights for the agent in Japan and Asia. Dr. Reddy's received a $40 million upfront payment and is entitled to up to an aggregate of $40 million in development milestone payments related to CTCL approvals in the U.S. and other markets, up to an aggregate of $70 million in development milestones for additional indications, as well as commercial milestone payments and low double-digit tiered royalties on net product sales. Eisai is to receive a $6 million development milestone payment upon initial approval and additional commercial milestone payments related to the achievement of net product sales thresholds (which increases to $7 million in the event we have exercised our option to add India to the licensed territory prior to FDA approval). Eisai will be responsible for completing the current CTCL clinical trial, and chemistry, manufacturing and controls activities through the filing of a biologics license application (“BLA”) for I/ONTAK with the FDA. Citius will be responsible for development costs associated with potential additional indications.

RESULTS OF OPERATIONS

Three months ended June 30, 2022 compared with the three months ended June 30, 2021

	Three Months Ended June 30, 2022			Three Months Ended June 30, 2021
Revenues	$	—		$	—

Operating expenses:
Research and development		4,888,192			2,203,748
General and administrative		3,024,783			3,407,088
Stock-based compensation expense		1,003,677			373,570
Total operating expenses		8,916,652			5,984,406

Operating loss		(8,916,652	)		(5,984,406	)
Interest income		53,020			103,413
Other income		—			59,917
Interest expense		—			(2,932	)
Net loss	$	(8,863,632	)		(5,824,008	)

Revenues

We did not generate any revenues for the three months ended June 30, 2022 or 2021.

Research and Development Expenses

For the three months ended June 30, 2022, research and development expenses were $4,888,192 as compared to $2,203,748 during the three months ended June 30, 2021, an increase of $2,684,444.

Research and development costs for Mino-Lok® increased by $180,167 to $1,334,134 for the three months ended June 30, 2022 as compared to $1,153,967 for the three months ended June 30, 2021 due primarily to increased costs associated with the addition of Biorasi, LLC ("Biorasi"), a global clinical research organization (CRO), to help expand the Company's Phase 3 Mino-Lok trial to additional sites outside the United States.

Research and development costs for our Halo-Lido product candidate increased by $413,295 to $517,802 for the three months ended June 30, 2022 as compared to $104,507 for the three months ended June 30, 2021 due to start-up costs associated with the Phase 2b trial which enrolled its first patient in April, 2022. On February 15, 2022, Citius announced that the FDA issued a Study May Proceed Letter for our Phase 2b Halo-Lido study.

Research and development costs for our I/ONTAK product candidate, which we in-licensed in September 2021, was $1,992,897 during the three months ended June 30, 2022. On April 6, 2022, Citius announced the topline results from the pivotal Phase 3 trial and based on this data, Citius anticipates filing a BLA with the FDA in the second half of 2022. On July 12, 2022, we announced that we held a Type B pre-BLA meeting with the FDA to discuss the content and acceptability of the anticipated BLA.

We expect that research and development expenses will continue to increase as we continue to focus on our Phase 3 trials for Mino-Lok® and I/ONTAK, progress the Halo-Lido product candidate and continue our research and development efforts related to ARDS and Mino-Wrap.

General and Administrative Expenses

For the three months ended June 30, 2022, general and administrative expenses were $3,024,783 as compared to $3,407,088 during the three months ended June 30, 2021. General and administrative expenses decreased by $382,305 in comparison with the prior period. The primary reasons for the decrease were reduced costs for performance bonuses. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.

Stock-based Compensation Expense

For the three months ended June 30, 2022, stock-based compensation expense was $1,003,677 as compared to $373,570 for the three months ended June 30, 2021. For the three months ended June 30, 2022, stock-based compensation includes $33,333 in expense for the NoveCite stock option plan that was adopted in November 2020 as compared to $18,833 for the three months ended June 30, 2021. Stock-based compensation expense for the most recently completed quarter increased by $630,17 in comparison to the prior period primarily due to new grants made to employees (including new hires), directors and consultants.

Other Income (Expense)

Interest income for the three months ended June 30, 2022 was $53,020 as compared to interest income of $103,413 for the prior period. We have invested the remaining proceeds of our early 2021 equity offerings and common stock warrant exercises in money market accounts.

Other income for the three months ended June 30, 2021 consists of $59,917 of accrued interest on notes payable – related parties that was forgiven in June 2021.

There was no interest expense for the three months ended June 30, 2022 as compared to $2,932 in interest expense for the three months ended June 30, 2021. Interest expense was $2,509 for the three months ended June 30, 2021 on the notes payable – related parties that were repaid in full in June 2021. Interest expense was $423 for the three months ended June 30, 2021 on the Paycheck Protection Program loan that was forgiven in July 2021.

Net Loss

For the three months ended June 30, 2022, we incurred a net loss of $8,863,632 compared to a net loss for the three months ended June 30, 2021 of $5,824,008. The $3,039,624 increase in the net loss was primarily due to the increase of $2,684,444 increase in research and development expenses.

Nine months ended June 30, 2022 compared with the nine months ended June 30, 2021

	Nine Months Ended June 30, 2022			Nine Months Ended June 30, 2021
Revenues	$	—		$	—

Operating expenses:
Research and development		13,798,251			9,946,268
General and administrative		9,038,949			7,389,269
Stock-based compensation expense		2,929,279			993,114
Total operating expenses		25,766,479			18,328,651

Operating loss		(25,766,479	)		(18,328,651	)
Interest income		116,573			186,224
Other income		—			59,917
Interest expense		—			(10,839	)
Net loss	$	(25,649,906	)	$	(18,093,349	)

Revenues

We did not generate any revenues for the nine months ended June 30, 2022 or 2021.

Research and Development Expenses

For the nine months ended June 30, 2022, research and development expenses were $13,798,251 as compared to $9,946,268 during the nine months ended June 30, 2021, an increase of $3,851,983.

Research and development costs for Mino-Lok® increased by $232,468 to $3,216,419 for the nine months ended June 30, 2022 as compared to $2,983,951 for the nine months ended June 30, due primarily to increased costs associated with the addition of Biorasi to help expand the Company's Phase 3 Mino-Lok trial to additional sites outside the United States.

Research and development costs for our Halo-Lido product candidate increased by $1,641,199 to $2,219,279 for the nine months ended June 30, 2022 as compared to $578,080 for the nine months ended June 30, 2021 due to start-up costs associated with the Phase 2b trial which enrolled its first patient in April, 2022. On February 15, 2022, Citius announced that the FDA issued a Study May Proceed Letter for our Phase 2b Halo-Lido study.

During the nine months ended June 30, 2022, research and development costs for our proposed novel cellular therapy for ARDS decreased by $4,626,153 to $1,661,340 as compared to $6,287,493 for the nine months ended June 30, 2021. We expensed the $5,000,000 license fee paid to Novellus during the nine months ended June 30, 2021.

Research and development costs for our I/ONTAK product candidate, which we in-licensed in September 2021, was $6,513,262 during the nine months ended June 30, 2022. On April 6, 2022, Citius announced the topline results from the pivotal Phase 3 trial and based on this data, Citius anticipates filing a BLA with the FDA in the second half of 2022. On July 12, 2022, we announced that we held a Type B pre-BLA meeting with the FDA to discuss the content and acceptability of the anticipated BLA.

We expect that research and development expenses will continue to increase in fiscal 2022 as we continue to focus on our Phase 3 trials for Mino-Lok® and I/ONTAK, progress the Halo-Lido product candidate and continue our research and development efforts related to ARDS and Mino-Wrap.

General and Administrative Expenses

For the nine months ended June 30, 2022, general and administrative expenses were $9,038,949 as compared to $7,389,269 during the nine months ended June 30, 2021. General and administrative expenses increased by $1,649,680 in comparison with the prior period. The primary reasons for the increase were additional compensation costs for new employees, increased investor relations costs and additional insurance expense. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.

Stock-based Compensation Expense

For the nine months ended June 30, 2022, stock-based compensation expense was $2,929,279 as compared to $993,114 for the nine months ended June 30, 2021. For the nine months ended June 30, 2022, stock-based compensation includes $99,999 in expense for the NoveCite stock option plan that was adopted in November 2020 as compared to $50,222 for the nine months ended June 30, 2021. Stock-based compensation expense for the most recently completed quarter increased by $1,936,165 in comparison to the prior period primarily due to new grants made to employees (including new hires), directors and consultants.

Other Income (Expense)

Interest income for the nine months ended June 30, 2022 was $116,573 as compared to interest income of $186,224 for the prior period. We have invested the remaining proceeds of our early 2021 equity offerings and common stock warrant exercises in money market accounts.

Other income for the nine months ended June 30, 2021 consists of $59,917 of accrued interest on notes payable – related parties that was forgiven in June 2021.

There was no interest expense for the nine months ended June 30, 2022 as compared to $10,839 in interest expense for the nine months ended June 30, 2021. Interest expense was $9,605 for the nine months ended June 30, 2021 on the notes payable – related parties that were repaid in full in June 2021. Interest expense was $1,234 for the nine months ended June 30, 2021 on the Paycheck Protection Program loan that was forgiven in July 2021.

Net Loss

For the nine months ended June 30, 2022, we incurred a net loss of $25,649,906 compared to a net loss for the nine months ended June 30, 2021 of $18,093,349. The $7,556,557 increase in the net loss was primarily due to the increase of $3,851,983 in research and development expenses, the increase of $1,649,680 in general and administrative expenses and the increase of $1,936,165 in stock-based compensation.

LIQUIDITY AND CAPITAL RESOURCES

Liquidity and Working Capital

Citius has incurred operating losses since inception and incurred a net loss of $25,649,906 for the nine months ended June 30, 2022. At June 30, 2022, Citius had an accumulated deficit of $121,697,727. Citius’ net cash used in operations during the nine months ended June 30, 2022 was $22,028,752.

As a result of the Company’s common stock offerings and common stock warrant exercises during the year ended September 30, 2021, the Company had working capital of approximately $46,400,000 at June 30, 2022. At June 30, 2022, Citius had cash and cash equivalents of $48,044,194 available to fund its operations. The Company’s primary sources of cash flow since inception have been from financing activities. Our primary uses of operating cash were for in-licensing of intellectual property, product development and commercialization activities, employee compensation, consulting fees, legal and accounting fees, insurance and investor relations expenses.

Based on our cash and cash equivalents at June 30, 2022, we expect that we will have sufficient funds to continue our operations through August 2023. We expect to need to raise additional capital in the future to support our operations beyond August 2023. There is no assurance, however, that we will be successful in raising the needed capital or that the proceeds will be received in an amount or in a timely manner to support our operations.

Inflation

Our management believes that inflation has not had a material effect on our results of operations.

Off Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

Critical Accounting Policies and Estimates

The preparation of our financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities as of the date of the financial statements and the amounts of revenues and expenses recorded during the reporting periods. We base our estimates on historical experience, where applicable, and other assumptions that we believe are reasonable under the circumstances. Actual results may differ from our estimates under different assumptions or conditions.

Our critical accounting policies and use of estimates are discussed in, and should be read in conjunction with, the annual consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended September 30, 2021 as filed with the SEC.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable.

Item 4. Controls and Procedures

Evaluation of 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 June 30, 2022. 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 June 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.

Changes In Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended June 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II - OTHER INFORMATION

Item 1. Legal Proceedings

None.

Item 1A. Risk Factors

There has been no change in the Company’s risk factors since the Company’s Form 10-K filed with the SEC on December 15, 2021.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

Item 6. Exhibits

31.1		Certification of the Principal Executive Officer pursuant to Exchange Act Rule 13a-14(a).*

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

32.1		Certification of the Principal Executive and Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.*

EX-101.INS		Inline XBRL Instance Document*

EX-101.SCH		Inline XBRL Taxonomy Extension Schema Document*

EX-101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document*

EX-101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document*

EX-101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document*

EX-101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document*

EX-104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

Filed herewith.

SIGNATURES

Pursuant to the requirements 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: August 11, 2022	By:	/s/ Leonard Mazur
		Leonard Mazur
		Chief Executive Officer (Principal Executive Officer)

Date: August 11, 2022	By:	/s/ Jaime Bartushak
		Jaime Bartushak
		Chief Financial Officer (Principal Financial and Accounting Officer)

SEC Form 10-Q filed by Citius Pharmaceuticals Inc.