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) November 25, 2024

 

Citius Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada

(State or other jurisdiction of incorporation)

 

001-38174		27-3425913
(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 8.01 Other Events.

 

On November 25, 2024, we issued a press release announcing a productive Type C meeting with the U.S. Food and Drug Administration to discuss our Phase 3 clinical trial of Mino-Lok^® in patients with central line-associated infections or catheter-related bloodstream infections and a pathway to approval. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press release, dated November 25, 2024.
104		Cover Page Interactive Date File (embedded within the Inline XBRL document).

 

 

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: November 25, 2024	/s/ Leonard Mazur
	Leonard Mazur
	Chairman and Chief Executive Officer

 

 

2

Exhibit 99.1

 

 

 

Citius Pharmaceuticals Reports Productive FDA Type C Meeting to Discuss Phase 3 Mino-Lok® Program and Pathway to Approval

 

CRANFORD, N.J., November 25, 2024 – Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) (“Citius Pharma” or the “Company”), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that the Company held a constructive in-person Type C meeting with the U.S. Food and Drug Administration (FDA). The meeting followed successful completion of the Company’s pivotal Phase 3 clinical trial of Mino-Lok^®, a novel catheter lock solution designed to salvage central venous catheters in patients suffering from central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The primary discussion centered on responses to the FDA’s questions related to Mino-Lok’s clinical trial data and a pathway to a future submission.

 

The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok. The meeting encompassed an extensive range of topics critical to the NDA process, including in-vitro, clinical efficacy and safety data, and regulatory considerations. Citius Pharma reaffirmed the potential of Mino-Lok to address a critical unmet medical need and its commitment to advancing the program.

 

“We are highly encouraged by the collaborative and substantive nature of our engagement with the FDA regarding the Mino-Lok program,” stated Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. “The FDA's comprehensive feedback supports our commitment to advancing this novel solution for patients who face life-threatening complications from catheter-related infections. The Agency’s guidance provides a strong framework for completing the remaining steps toward an NDA submission.”

 

“We believe Mino-Lok has demonstrated compelling clinical outcomes in the Phase 3 trial, supporting its potential to significantly enhance the management of catheter-related bloodstream infections. As a groundbreaking alternative to catheter removal, Mino-Lok, if approved, could reduce healthcare costs, mitigate patient risks, and improve clinical outcomes for individuals requiring central venous catheterization. Citius Pharmaceuticals remains committed to advancing the Mino-Lok® program and will continue to provide updates on regulatory and clinical developments as they unfold,” added Mazur.

 

About Mino-Lok®

 

Mino-Lok is a novel antibiotic lock solution that combines minocycline, ethanol with edetate disodium designed to treat patients with catheter-related blood stream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok is designed to offer an alternative to removing and replacing a central venous catheter (CVC), which may lead to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.

 

  

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 and Citius Oncology, are: risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; Citius Pharma’s ability to regain compliance with and continue to meet Nasdaq’s continued listing standards; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; risks related to research using our assets but conducted by third parties; our ability to commercialize LYMPHIR 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; 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 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 Securities and Exchange Commission (“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, 2023, filed with the SEC on December 29, 2023, as updated by our subsequent filings with the Securities and Exchange Commission. 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

 

 

 

 

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Cover	Nov. 25, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Nov. 25, 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
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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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