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) May 26, 2020
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)) |
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 | ||
| Warrants to purchase common stock | CTXRW | 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 Material Information. |
On May 26, 2020, Citius Pharmaceuticals, Inc. issued a press release to announce that it is providing free access to Mino-Lok® for healthcare providers under an Expanded Access protocol to ease the burden associated with the COVID-19 pandemic. 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 May 26, 2020 |
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.
| Date: May 26, 2020 | CITIUS PHARMACEUTICALS, INC. |
| /s/ Myron Holubiak | |
|
Myron Holubiak
President and Chief Executive Officer |
Exhibit 99.1
Citius Announces Expanded Access Program for Investigational Phase 3 Mino-Lok®
| · | The COVID-19 pandemic has highlighted the need to provide Mino-Lok on a compassionate case basis |
| · | Many patients in hospitals receive medication, chemotherapy and nutrition via central venous catheters that can become infected and may require a removal and replacement procedure |
| · | These catheter replacement procedures are risky for the patients, further tax the healthcare system capacity, and compound the nurse and doctor labor shortage |
| · | The company's Mino-Lok® solution could salvage such infected catheters and eliminate the removal and replacement procedure, thus easing the burden on patients, healthcare professionals and systems |
CRANFORD, N.J., May 26, 2020 -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it is providing free access to Mino-Lok® for healthcare providers under an Expanded Access protocol to ease the burden associated with the COVID-19 pandemic.
Through the Expanded Access protocol, an infected central venous catheter can now be treated with Citius' Mino-Lok, potentially avoiding the need for the removal and replacement procedure. Given the challenges at today's hospitals, the patients, the hospital staff, and the hospital system at large stand to benefit greatly from free access to the Mino-Lok solution.
"Some of our investigators have told us that if Mino-Lok were approved by the FDA, they would already be using it – particularly in today's environment," commented Myron Holubiak, Chief Executive Officer of Citius. "We clearly must wait for the results of our clinical trial to fully market Mino-Lok, but we do believe that it can benefit patients and help ease the burden on the health care system. In these challenging times, we welcome the opportunity to help in any way we can."
Mino-Lok is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) in combination with an appropriate systemic antibiotic(s) to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion. Mino-Lok is currently in a Phase 3 clinical trial for the treatment of central line-associated bloodstream infections (CLABSIs). In early February 2020, the Company announced that the trial had reached the halfway point of enrollment.
Mino-Lok has the potential to change the standard of care, which currently calls for a procedure to remove and replace the infected catheter. Each year, up to 500,000 CVCs of the 7 million used become infected and lead to CLABSIs, increasing both patient morbidity risk and costs to the medical system. It has been shown that antibiotics alone are unable to penetrate the biofilm caused by bacteria, and there are currently no approved therapies for salvaging infected central venous catheters. According to DelveInsight, the market size of CLABSIs and closely associated catheter-related bloodstream infections (CRBSIs) in the global market is expected to reach $1.84 billion in 2028, up from $1.24 billion in 2017.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care
products, with a focus on anti-infectives and cancer care. For more information, please visit www.citiuspharma.com.
About Mino-Lok®
Mino-Lok® is an antibiotic lock solution being developed as an adjunctive therapy in patients with central
line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are very
serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients,
for whom venous access presents a challenge. There are currently no approved therapies for salvaging infected CVCs.
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 of providing Mino-Lok
under the expanded use program prior to approval for marketing by the FDA; our need for substantial additional funds; the estimated
markets for our product candidates, and the acceptance thereof by any market; risks associated with conducting trials for our product
candidates, including our Phase III trial for Mino-Lok; risks relating to the results of research and development activities;
risks associated with developing our product candidates, including that preclinical results may not be predictive of clinical
results and our ability to file an IND for such candidates; uncertainties relating to preclinical and clinical testing; the early
stage of products under development; risks related to our growth strategy; 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 ability to attract, integrate, and retain key personnel; 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) 908-967-6677 x105
ascott@citiuspharma.com