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) October 31, 2017

 

 

 

Citius Pharmaceuticals, Inc.

 

(Exact name of registrant as specified in its charter)

 

 

 

 

Nevada

 

(State or other jurisdiction of incorporation)

 

333-206903   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))

 

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 Material Information.

 

On October 31, 2017, Citius Pharmaceuticals, Inc. issued a press release entitled “Citius Pharmaceuticals, Inc. Receives “Fast Track” Designation by FDA for Mino-Lok TM Investigational Trial”. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. 

 

Item 9.01. Financial Statements and Exhibits

 

(d)        Exhibits.

 

Exhibit No.   Description of Exhibit
     
99.1   Press release dated October 31, 2017

 

2
 

 

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: October 31, 2017 By:  /s/ Myron Holubiak
    Myron Holubiak

President and Chief Executive Officer

 

 

 

 

3

Exhibit 99.1

 

CITIUS PHARMACEUTICALS, INC. RECEIVES “FAST TRACK” DESIGNATION BY FDA FOR MINO-LOK TM INVESTIGATIONAL TRIAL

 

CRANFORD, N.J. -- October 31, 2017 -- Citius Pharmaceuticals, Inc. ("Citius") (“Company”) (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today it has received official notice from the U. S. Food and Drug Administration (“FDA”) that the investigational program for Mino-Lok™ is designated “Fast Track”. Mino-Lok is a catheter lock solution that has entered phase 3 trials for an adjunctive treatment for catheter related blood stream infection (“CRBSI”). Fast Track is a designation by the FDA of an investigational drug to expedite review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.

A drug that receives Fast Track designation is eligible for the following:

· More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
· More frequent written correspondence from FDA about the design of the clinical trials;
· Priority review to shorten the FDA review process for a new drug from ten months to six months; and,
· Rolling Review, which means Citius can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.

There are currently no approved therapies to salvage infected central venous catheters (”CVCs”), a potential $750 million sector in the US alone. CRBSIs are responsible for mortality rates up to 25% in some patients, and contribute to significant morbidities. Citius is currently starting up sites for a phase 3 trial of Mino-Lok in the United States.

Mr. Myron Holubiak, Chief Executive Officer of Citius, commented “We are extremely pleased to receive Fast Track designation from the FDA. The agency has been very supportive and helpful in developing the trial design for Mino-Lok as salvage therapy for infected CVCs in CRBSI. We look forward to our continuing collaboration in developing Mino-Lok.”

About Citius Pharmaceuticals, Inc.

Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care and unique prescription products that use innovative, patented or proprietary formulations of previously-approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs; by using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. Citius develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.

Safe Harbor

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. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "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 are: risks related to our growth strategy; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. 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.

Contact:

Andrew Scott

Vice President, Corporate Development

(O) 908-967-6676

ascott@citiuspharma.com