CTXR Citius Pharmaceuticals Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) December 27, 2024

 

Citius Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada		001-38174		27-3425913
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

11 Commerce Drive, 1st Floor, Cranford, NJ		07016
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code (908) 967-6677 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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		The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ☐

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On December 27, 2024, we issued a press release announcing our results of operations for the full year of fiscal 2024. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

 

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press release, dated December 27, 2024.
104		Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

 

 

SIGNATURE

 

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 hereunto duly authorized.

 

	CITIUS PHARMACEUTICALS, INC.
Date: December 27, 2024	/s/ Leonard Mazur
	Leonard Mazur
	Chairman and Chief Executive Officer

 

 

2

Exhibit 99.1

 

 

 

Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2024 Financial Results and Provides Business Update

 

Clinical and regulatory success in 2024 expected to drive value in 2025

 

CRANFORD, N.J., December 27, 2024 -- Citius Pharmaceuticals, Inc. (“Citius Pharma” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal full year ended September 30, 2024.

 

Fiscal Full Year 2024 Business Highlights and Subsequent Developments

 

-

Achieved U.S. Food and Drug Administration (FDA) approval of LYMPHIR™ (denileukin diftitox-cxdl), an immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL);

 

-

Advanced manufacturing, marketing and sales activities in preparation for commercial launch of LYMPHIR in the first half of 2025;

 

-

Completed the merger of Citius Pharma’s oncology subsidiary with TenX Keane to form Citius Oncology, Inc., a standalone publicly traded company which began trading on the Nasdaq exchange under the ticker symbol CTOR on August 13, 2024;

 

-

Supported two investigator-initiated trials to explore LYMPHIR’s potential as an immuno-oncology combination therapy being conducted at the University of Pittsburgh Medical Center and the University of Minnesota;

 

-

Shared interim trial results with the clinical community at the Society for Immunotherapy of Cancer Conference (SITC) of University of Pittsburgh Medical Center’s Phase I trial of LYMPHIR with checkpoint inhibitor pembrolizumab; and,

 

-

Met primary and secondary endpoints in the Phase 3 Pivotal Trial of Mino-Lok®, demonstrating a statistically significant improvement in time to catheter failure of infected catheters compared to other physician-selected anti-infective lock solutions.

 

Financial Highlights

 

-

Cash and cash equivalents of $3.3 million as of September 30, 2024;

 

-

R&D expenses were $11.9 million for the full year ended September 30, 2024, compared to $14.8 million for the full year ended September 30, 2023;

 

-

G&A expenses were $18.2 million for the full year ended September 30, 2024, compared to $15.3 million for the full year ended September 30, 2023;

 

-

Stock-based compensation expense was $11.8 million for the full year ended September 30, 2024, compared to $6.6 million for the full year ended September 30, 2023; and,

 

-

Net loss was $39.4 million, or ($5.97) per share for the full year ended September 30, 2024 compared to a net loss of $32.5 million, or ($5.57) per share for the full year ended September 30, 2023.

 

 

“In fiscal year 2024 we drove tremendous progress in our pipeline. It was a transformative year, marked by our first FDA approval and significant clinical milestones. The approval of LYMPHIR™ and the positive Phase 3 results for Mino-Lok® underscore our commitment to developing innovative therapies. Our team successfully responded to FDA comments related to the biologics license application for LYMPHIR and ultimately gained FDA approval. Productive engagement with the FDA regarding the positive results of our Phase 3 Mino-Lok® trial and Phase 2 Halo-Lido trial clarified our next steps for both programs. We anticipate continued engagement with the agency in the coming year and look forward to their guidance. Additionally, we are exploring strategic partnerships and licensing opportunities to maximize the potential of our portfolio and bring these important therapies to market efficiently,” stated Leonard Mazur, Chairman and CEO of Citius Pharma.

 

“Looking ahead, our priorities for fiscal year 2025 include launching LYMPHIR™ through our majority-owned subsidiary, Citius Oncology, driving the clinical and regulatory strategies for Mino-Lok® and Halo-Lido, fortifying our financial position, and applying a disciplined approach to resource allocation. We expect to launch LYMPHIR in the first half of 2025 and distribute CTOR shares to Citius Pharma shareholders by the end of the year, pending favorable market conditions. Our goal remains to deliver value for patients, healthcare providers, and shareholders. With a clear vision and a strong team, we are well-positioned to execute on our mission of bringing innovative therapies to market,” added Mazur.

 

Full Year 2024 Financial Results:

 

Liquidity

 

As of September 30, 2024, the Company had $3.3 million in cash and cash equivalents.

 

As of September 30, 2024, the Company had 7,247,243 common shares outstanding, as adjusted for the 1-for-25 reverse stock split of the Company’s common stock, effected on November 25, 2024.

 

During the year ended September 30, 2024, the Company received net proceeds of $13.8 million from the issuance of equity. The Company expects to raise additional capital to support operations.

 

Research and Development (R&D) Expenses

 

R&D expenses were $11.9 million for the full year ended September 30, 2024, compared to $14.8 million for the full year ended September 30, 2023. The decrease in R&D expenses primarily reflects the completion of the Halo-Lido trial and completion of activities related to the regulatory resubmission for LYMPHIR, offset by shutdown costs associated with the end of the Phase 3 trial for Mino-Lok.

 

We expect research and development expenses to decrease in fiscal year 2025 as we continue to focus on the commercialization of LYMPHIR through our majority-owned subsidiary, Citius Oncology and because we have completed the Phase 3 trial for Mino-Lok.

 

General and Administrative (G&A) Expenses

 

G&A expenses were $18.2 million for the full year ended September 30, 2024, compared to $15.3 million for the full year ended September 30, 2023. The increase was primarily due to costs associated with pre-launch and market research activities associated with LYMPHIR. 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 full year ended September 30, 2024, stock-based compensation expense was $11.8 million as compared to $6.6 million for the prior year. The increase of $5.2 million is largely due to the grant of options under the Citius Oncology stock plan. Stock-based compensation expense under the Citius Oncology stock plan was $7.5 million during the year ended September 30, 2024, compared to $2.0 million for the year ended September 30, 2023, as the plan was initiated in July 2023. For the years ended September 30, 2024 and 2023, stock-based compensation expense also includes $47,547 and $130,382, respectively, for the NoveCite stock option plan. In fiscal years 2023 and 2024, we granted options to our new employees and additional options to other employees, our directors, and consultants.

 

Net loss

 

Net loss was $39.4 million, or ($5.97) per share for the year ended September 30, 2024, compared to a net loss of $32.5 million, or ($5.57) per share for the year ended September 30, 2023, as adjusted for the reverse stock split. The increase in net loss reflects an increase in operating expense of $5.3 million offset by a decrease of $1.6 million in other income. Operating expense increased due to increases in stock-based compensation and general and administrative expenses, which were offset by decreased research and development expense.

 

About Citius Pharmaceuticals, Inc.

 

Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR™, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma’s late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.

 

Forward-Looking Statements

 

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as “will,” “anticipate,” “estimate,” “expect,” “plan,” “should,” and “may” and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma are: our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to commercialize LYMPHIR through our majority-owned subisity and any of our other product candidates that may be approved by the FDA; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; risks related to research using our assets but conducted by third parties; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to maintain compliance with Nasdaq’s continued listing standards; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our Securities and Exchange Commission (“SEC”) filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC’s website at www.sec.gov, including in Citius Pharma’s Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Investor Contact:

 

Ilanit Allen

ir@citiuspharma.com

908-967-6677 x113

 

Media Contact:

 

STiR-communications

Greg Salsburg

Greg@STiR-communications.com

 

-- Financial Tables Follow –

 

 

CITIUS PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

SEPTEMBER 30, 2024 AND 2023

 

		2024				2023
ASSETS
Current Assets:
Cash and cash equivalents		$	3,251,880			$	26,480,928
Inventory			8,268,766				—
Prepaid expenses			2,700,000				7,889,506
Total Current Assets			14,220,646				34,370,434
Property and equipment, net			—				1,432
Operating lease right-of-use asset, net			246,247				454,426
Other Assets:
Deposits			38,062				38,062
In-process research and development			92,800,000				59,400,000
Goodwill			9,346,796				9,346,796
Total Other Assets			102,184,858				68,784,858
Total Assets		$	116,651,751			$	103,611,150
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable		$	4,927,211			$	2,927,334
License payable			28,400,000				—
Accrued expenses			17,027				476,300
Accrued compensation			2,229,018				2,156,983
Operating lease liability			241,547				218,380
Total Current Liabilities			35,814,803				5,778,997
Deferred tax liability			6,713,800				6,137,800
Operating lease liability – non current			21,318				262,865
Total Liabilities			42,549,921				12,179,662
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; 16,000,000 shares authorized; 7,247,243 and 6,354,371 shares issued and outstanding at September 30, 2024 and 2023, respectively			7,247				6,354
Additional paid-in capital			271,440,421				253,056,133
Accumulated deficit			(201,370,218	)			(162,231,379	)
Total Citius Pharmaceuticals, Inc. Stockholders’ Equity			70,077,450				90,831,108
Non-controlling interest			4,024,380				600,380
Total Equity			74,101,830				91,431,488
Total Liabilities and Equity		$	116,651,751			$	103,611,150

 

Reflects a 1-for-25 reverse stock split effective November 25, 2024.

 

 

CITIUS PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE YEARS ENDED SEPTEMBER 30, 2024 AND 2023

 

		2024				2023
Revenues		$	—			$	—
Operating Expenses:
Research and development			11,906,601				14,819,729
General and administrative			18,249,402				15,295,584
Stock-based compensation – general and administrative			11,839,678				6,616,705
Total Operating Expenses			41,995,681				36,732,018
Operating Loss			(41,995,681	)			(36,732,018	)
Other Income:
Interest income, net			758,000				1,179,417
Gain on sale of New Jersey net operating losses			2,387,842				3,585,689
Total Other Income Net			3,145,842				4,765,106
Loss before Income Taxes			(38,849,839	)			(31,966,912	)
Income tax expense			576,000				576,000
Net Loss			(39,425,839	)			(32,542,912	)
Net loss attributable to non-controlling interest			287,000				—
Deemed dividend on warrant extension			(1,047,312	)			(1,151,208	)
Net Loss Applicable to Common Stockholders		$	(40,186,151	)			(33,694,120	)
Net Loss Per Share Applicable to Common Stockholders - Basic and Diluted		$	(5.97	)			(5.57	)
Weighted Average Common Shares Outstanding
Basic and diluted			6,726,999				6,051,789

 

Reflects a 1-for-25 reverse stock split effective November 25, 2024.

 

 

CITIUS PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE YEARS ENDED SEPTEMBER 30, 2024 AND 2023

 

		2024				2023
Cash Flows From Operating Activities:
Net loss		$	(39,425,839	)		$	(32,542,912	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation			11,839,678				6,616,705
Issuance of common stock for services			284,176				102,000
Amortization of operating lease right-of-use asset			208,179				191,648
Depreciation			1,432				2,668
Deferred income tax expense			576,000				576,000
Changes in operating assets and liabilities:
Inventory			(2,133,871	)			-
Prepaid expenses			(945,389	)			(5,036,926	)
Accounts payable			1,999,877				1,761,956
Accrued expenses			(459,273	)			(929,094	)
Accrued compensation			72,035				394,732
Operating lease liability			(218,380	)			(196,989	)
Net Cash Used In Operating Activities			(28,201,375	)			(29,060,212	)
Cash Flows From Investing Activities:
License payment			(5,000,000	)			-
Net Cash Used In Investing Activities			(5,000,000	)			-
Cash Flows From Financing Activities:
Proceeds from common stock option exercises			-				31,267
Merger, net			(3,831,357	)
Net proceeds from registered direct offerings			13,803,684				13,798,183
Net Cash Provided By Financing Activities			9,972,327				13,829,450
Net Change in Cash and Cash Equivalents			(23,229,048	)			(15,230,762	)
Cash and Cash Equivalents – Beginning of Year			26,480,928				41,711,690
Cash and Cash Equivalents – End of Year		$	3,251,880			$	26,480,928
Supplemental Disclosures of Cash Flow Information and Non-cash Activities:
IPR&D Milestones included in License Payable		$	28,400,000			$	-
Prepaid Manufacturing transferred to Inventory		$	6,134,895			$	-

 

Reflects a 1-for-25 reverse stock split effective November 25, 2024.

 

v3.24.4

Cover	Dec. 27, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 27, 2024
Entity File Number	001-38174
Entity Registrant Name	Citius Pharmaceuticals, Inc.
Entity Central Index Key	0001506251
Entity Tax Identification Number	27-3425913
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	11 Commerce Drive
Entity Address, Address Line Two	1st Floor
Entity Address, City or Town	Cranford
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07016
City Area Code	908
Local Phone Number	967-6677
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, $0.001 par value
Trading Symbol	CTXR
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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