Citius Provides Update on Activities From IDWeek 2019

• Management held a Scientific Advisory Board Meeting to present progress on Mino-Lok Phase III trial and its plans for the development of Mino-Wrap
• Consensus at Clinical Investigators Meeting: “Mino-Lok has the potential to change the standard of care”
• Participated in Symposia on Advances in the Management of CLABSI

CRANFORD, N.J., Oct. 3, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (“Citius”) (“Company”) (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today reported Company activities at ID Week, the annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).

The Citius Scientific Advisory Board (SAB)
Citius held an in-person Scientific Advisory Board (SAB) meeting in conjunction with IDWeek. In attendance were chairman of the SAB, Dr. Issam Raad M.D., Chair of M.D. Anderson Cancer Center’s Department of Infectious Diseases and the Endowed Distinguished Professor of Medicine; Dr. Mark Rupp M.D., Professor and Chief of the Division of Infectious Diseases in the Department of Internal Medicine at the University of Nebraska Medical Center (UNMC); Dr. Leonard Mermel D.O., Professor of Medicine at Warren Alpert Medical School of Brown University Medical; and, Dr. George M. Viola M.D., Associate Professor of Infectious Diseases and the Clinical Medical Director of the Solid Cancer and Surgical-Related Infections Service at the University of Texas M.D. Anderson Cancer Center.

The Company presented progress on the Mino-Lok Phase III trial, along with the plans for the development of Mino-Wrap, the bioabsorbable gelatin wrap in development to prevent tissue expander infections post-mastectomy. Additionally, management presented possible strategic scenarios for discussion and advice.

“We appreciate the strategic insight provided by our SAB members,” said Mr. Myron Holubiak, Chief Executive Officer of Citius. “They are leaders in the field of infectious disease, and we are fortunate to have them as advisors. They provided expert clinical advice on all of our developing technologies, and we look forward to receiving their expertise and guidance as we progress.”

Clinical Investigator Meeting
Citius held an investigator meeting in Washington D.C. An update on the comprehensive Mino-Lok Phase III trial was provided by the Company to a set of principle investigators and their staff. Among those in attendance were clinical investigators from Mass General Hospital, William Beaumont Hospital, M.D. Anderson Cancer Center, and others.

Myron Holubiak reported, “We are making good progress with our Mino-Lok Phase III trial and expect to soon approach our interim analysis milestone. The consensus of the attendees confirms our belief that Mino-Lok has the potential to change the standard of care and would be a welcome addition for the adjunctive treatment of central line associated blood stream infections (CLABSIs).”

Symposium “Advances in the Prevention and Management of CLABSI and Device-Related Infections (DRI)”
A symposium was held on the following topics:

• The epidemiology, pathogenesis, and risk factors for CLABSI and DRI in various risk groups
• A review of collaborative studies, interventions, and efforts to improve the prevention and management of CBSI and DRI
• Effective strategies for the prevention and treatment of CLABSI and DRI

Dr. Ray Hachem, MD, FIDSA, Chaired the program and Dr. Anne-Marie Chaftari, MD and Dr. Issam Raad were featured speakers. The symposia provided a forum for a lively discussion on critical issues associated with device-associated infections and underscored the need for the development of new technologies to address their prevention and treatment.

Mr. Holubiak continued, “There is a surprisingly high-incidence of device-related infections that can be devastating to patients and often prove very costly to our healthcare system. Citius is committed to developing solutions to address this problem. Also with the recent $7 million capital raise, $2.5 million of which was contributed by Company management, the Company is in better financial condition to advance our Mino-Lok and Mino-Wrap solutions.”

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.

About Mino-Lok^®
Mino-Lok^® is an antibiotic lock solution used to treat patients with CLABSIs/CRBSIs. CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs), and in hemodialysis patients where venous access presents a challenge. There are currently no approved therapies to salvage infected central venous catheters (CVCs).

Mino-Lok^® is under investigation and not approved for commercial use.

About Mino-Wrap
Mino-Wrap is a novel approach to reducing post-operative infections associated with surgical implants. Mino-Wrap is a liquefying gel-based wrap containing minocycline and rifampin for reducing tissue expander (TE) infections following breast reconstructive surgeries. It is a laminate film comprised of porcine gelatin plasticized with glycerol. Mino-Wrap also contains the antibiotics minocycline and rifampin to reduce bacterial bioburden on implantable devices preventing colonization over a sustained period of time. In the setting of breast reconstruction, Mino-Wrap provides more durable antimicrobial protection of the implant-tissue interface than peri-operative irrigation with antibiotic solutions (the current standard of care). Both porcine gelatin (and collagen) as well as the combination of minocycline and rifampin have long histories of successful medical use in implantable devices in multiple anatomical settings.

IDWeek
IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).

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 associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment and opening study sites; risks associated with developing Mino-Wrap, including that preclinical results may not be predictive of clinical results and our ability to file an IND; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; the estimated markets for our product candidates and the acceptance thereof by any market; 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 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) 908-967-6677 x105
ascott@citiuspharma.com

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SOURCE Citius Pharmaceuticals, Inc.

Company Codes: NASDAQ-SMALL:CTXR