Citius Pharmaceuticals Inc. (NASDAQ: CXTR) Breaking News - November 7, 2017

International Study at MD Anderson Sister Institutions Supports Mino Lok™ Phase 2b Results: Poster Presented at ID Week
 

Results showed a 95% efficacy in salvaging infected catheters for Mino-Lok ™
 

CRANFORD, N.J., November 7, 2017 - PRNewswire -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius"), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced that international data on Mino Lok™ was recently presented at the ID Week Conference in San Diego, California.

The 44 patient study, was conducted in Brazil, Lebanon, and Japan and showed Mino Lok™ therapy was an effective intervention to salvage long term, infected central venous catheters (CVCs) in catheter related bloodstream infections in patients who had cancer with limited vascular access. The poster was recently presented at the IDSA (Infectious Disease Society of America) meeting showed 95% effectiveness for Mino-Lok therapy in achieving microbiological eradication of the CVCs as compared to 83% for the control.

Citius Chief Executive Officer, Mr. Myron Holubiak, commented, “it is extremely reassuring to note that Mino-Lok is as useful in clinics outside of the US as it is here in the number 1 rated cancer center. We are excited to advance this innovative product to a potentially greater than $1billion marketplace worldwide. We are beginning our phase 3 trials here in the U.S., and look forward to introducing Mino-Lok throughout the world.

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-infective, cancer care and unique prescription products using 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. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. www.citiuspharma.com  Mino-Lok™ is under investigation and not approved for commercial use.

About MD Anderson Cancer Center
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 45 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report’s “Best Hospital’s” survey. It has ranked as one of the nation’s top two hospitals since the survey began in 1990, and has ranked first for 11 of the past 14 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).
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.
For additional information, please contact:
Andrew Scott
Vice President, Corporate Development
908 967 6677; ascott@citiuspharma.com

SOURCE Citius Pharmaceuticals, Inc.

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Recent Citius Pharmaceuticals News:

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

CRANFORD, N.J., October 31, 2017 - PRNewswire -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius"), 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
 

SOURCE Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals to Present at the Dawson James 2017 Small Cap Growth Stock Conference
 

CRANFORD, N.J., October 17, 2017 - PRNewswire -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius"), a specialty pharmaceutical company dedicated to developing and commercializing adjunctive cancer care and critical care drug products, announced today that its Chief Executive Officer, Mr. Myron Holubiak, will present at the Dawson James 2017 Small Cap Growth Stock Conference. The Conference will be held on October 19, 2017 at the Wyndham Grand Hotel in Jupiter, Florida.

Event: Dawson James 2017 Small Cap Growth Stock Conference
Location: Wyndham Grand Hotel, Jupiter, Florida
Date: October 19, 2017 at 1:30 pm.

During the conference, Chief Executive Officer, Mr. Myron Holubiak will deliver the Company's corporate presentation and discuss recent business highlights. Management will also be available for one-on-one meetings. To arrange a meeting with management, please contact Mr. Andrew Scott: ascott@citiuspharma.com.

About Dawson James, Inc.

Dawson James Securities, a member of FINRA/SIPC, is a full service investment bank headquartered in Boca Raton, FL. The company has set out to create the highest-quality, full service investment firm specializing in the complex and fast-moving healthcare, biotechnology, technology and clean-tech sectors. For more information, please visit; http://www.dawsonjames.com.

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 using 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. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. 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.

For additional information, please contact:

Andrew Scott
Vice President, Corporate Development
908 967 6677; ascott@citiuspharma.com


SOURCE Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals Issues Shareholder Letter
 

Company Highlights Recent Nasdaq Uplisting and Additional Operational Milestones
 

CRANFORD, N.J., October 11, 2017 - PRNewswire -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius"), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company mailed a letter to its shareholders updating them on recent developments, financial results, and new business opportunities. Highlights include:

- Successfully uplisted to Nasdaq stock exchange where the company will gain access to broader investor audience.
- Received positive response from the U.S. Food and Drug Administration (FDA) for phase 3 trial amendments of Mino-Lok™, our proprietary product that address a potential $750 million sector.
- Secured funding of more than $26.8 million, including a recent raise of $6.8 million, with significant insider participation.
- Finalized the addition of South America to The Company's worldwide license for Mino-Lok™.
- Completed Phase 2a studies for Hydro-Lido, which could become the first FDA-approved product to address the estimated $500 million U.S. hemorrhoid marketplace.

"We are extremely pleased with the significant advancements that we have made and the foundation for long-term growth that we have established," stated Mr. Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals. "Having transitioned to a more senior exchange and completed key initiatives in advancing our unique technologies, we felt it necessary to provide a thorough update on the overall health and trajectory of the Company. We are confident, now that we now well-funded, to ideally be positioned as potential market leaders in two greatly underserved therapeutic areas. Management is committed to advancing the commercialization efforts of our products, Mino-Lok™ and Hydro-Lido, while remaining focused on our goal of improving shareholder value."

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

View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-issues-shareholder-letter-300534682.html

SOURCE Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc. Provides Phase 3 Update On Mino-Lok™ Clinical Trial Following FDA Meeting
 

CRANFORD, N.J., Sept. 5, 2017 - PRNewswire -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius"), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today it has received feedback from the U. S. Food and Drug Administration regarding amendments to the phase 3 study plan for Mino-Lok™, an adjunctive treatment for catheter related blood stream infection. There are currently no approved therapies to salvage infected central venous catheters ("CVCs"). Citius is currently recruiting sites for a phase 3 trial of Mino-Lok in the United States.

The FDA stated that they recognized that there is an unmet medical need in salvaging infected catheters and agreed that an open label, superiority design would address the Company's concerns and would be acceptable. They also reinforced their commitment to work with the Company to revise the trial design to meet the requirements of a new drug application.

Following the discussion with the FDA, Citius amended the phase 3 study design to remove the saline and heparin placebo control arm and to use an active control arm that conforms with today's current standard of care. The Company also noted that the dwell times and dosing schedules of the antibiotic lock therapy ("ALT") active control arm would be changed because there is an extreme level of variability and heterogeneity in how ALTs are dosed and used today.

Mr. Myron Holubiak, Chief Executive Officer of Citius, commented, "We are extremely pleased to work closely with the FDA to design a trial that meets today's need for better information and evidence as it relates to the treatment of infected CVCs and dosing schedules for ALTs. Experts agree that there is a great deal of variability allowed in the Infectious Disease Society of America (IDSA) guidelines with respect to the antibiotic chosen and the dwell times used for ALT's. We are confident that we will be able to demonstrate the superiority of our ready-to-use Mino-Lok over hospital compounded antibiotic solutions for which there have not been any largescale controlled studies or data driven evidence."

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


SOURCE Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc. Announces Closing of Public Offering
 

CRANFORD, N.J.,  Aug. 8, 2017 - PRNewswire -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius"), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today the closing of its previously announced underwritten public offering of 1,648,484 shares of its common stock and warrants to purchase up to an aggregate of 1,648,484 shares of its common stock at a combined offering price of $4.125. In addition, the underwriters partially exercised the over-allotment to purchase an additional 247,272 warrants. The warrants have a per share exercise price of $4.125, are exercisable immediately and will expire five years from the date of issuance. Gross proceeds to Citius from this offering are approximately $6,800,000 before deducting underwriting discounts and commissions and other estimated offering expenses payable by Citius.

Aegis Capital Corp. acted as the sole book-running manager for the offering and Dawson James Securities, Inc. acted as co-manager for the offering.

A registration statement on Form S-1 relating to these securities has been filed with the Securities and Exchange Commission and became effective on August 2, 2017.

The offering will be made only by means of a prospectus. A copy of the prospectus relating to the offering may be obtained by contacting Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY 10019, telephone: 212-813-1010, e-mail: prospectus@aegiscap.com. Investors may also obtain these documents at no cost by visiting the SEC's website at http://www.sec.gov. Before you invest, you should read the prospectus and other documents the Company has filed or will file with the Securities and Exchange Commission for more complete information about the Company and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)
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 using 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. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. www.citiuspharma.com

Safe Harbor Disclosure
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about Citius, including but not limited to statements with respect to Citius's planned use of proceeds. Citius may use words such as "may," "might," "should," "anticipate," "estimate," "expect," "projects," "intends," "plans," "believes" and words and terms of similar substance to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things, whether or not Citius will be able to raise capital, the final terms of the underwritten offering of common stock and warrants, market and other conditions, the satisfaction of customary closing conditions related to the underwritten offering of common stock and warrants, Citius's business and financial condition, and the impact of general economic, industry or political conditions in the United States or internationally. For additional disclosure regarding these and other risks faced by Citius, see disclosures contained in Citius's public filings with the SEC, including the "Risk Factors" in the company's Annual Report on Form 10-K for the fiscal year ended September 30, 2016, and under the heading "Risk Factors" of the prospectus for this offering. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. The forward-looking statements are made as of the date hereof, and Citius undertakes no obligation to update such statements as a result of new information.

Corporate Communications Contact:
For Investors:
Andrew Scott
Vice President, Corporate Development
(O) 908-967-6676
ascott@citiuspharma.com

SOURCE Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc. Prices $6,800,000 Public Offering And Listing On The Nasdaq Capital Market
 

CRANFORD, N.J.,  Aug. 3, 2017 - PRNewswire -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius"), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced the pricing of an underwritten public offering of 1,648,484 shares of its common stock and warrants to purchase up to an aggregate of 1,648,484 shares of its common stock at a combined offering price of $4.125 per share. The warrants will have a per share exercise price of $4.125, are exercisable immediately and will expire five years from the date of issuance. The gross proceeds to Citius from this offering are expected to be approximately $6,800,000, before deducting underwriting discounts and commissions and other estimated offering expenses. Citius has granted the underwriters a 45-day option to purchase up to an additional 247,272 shares of common stock and/or 247,272 additional warrants to cover over-allotments, if any. The offering is expected to close on August 8, 2017, subject to customary closing conditions. Shares of our Common Stock and Warrants will begin trading on August 3, 2017 under the symbols "CTXR" and "CTXRW," respectively on the Nasdaq Capital Market.

Aegis Capital Corp. is acting as the sole book-running manager for the offering and Dawson James Securities, Inc. is acting as co-Manager for the offering.

A registration statement on Form S-1 relating to these securities has been filed with the Securities and Exchange Commission and became effective on August 2, 2017.

The offering will be made only by means of a prospectus. A copy of the prospectus relating to the offering may be obtained, when available, by contacting Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY 10019, telephone: 212-813-1010, e-mail: prospectus@aegiscap.com. Investors may also obtain these documents at no cost by visiting the SEC's website at http://www.sec.gov. Before you invest, you should read the prospectus and other documents the Company has filed or will file with the Securities and Exchange Commission for more complete information about the Company and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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 using 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. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. www.citiuspharma.com

Corporate Communications Contact:
For Investors:
Andrew Scott
Vice President, Corporate Development
(O) 908-967-6676
ascott@citiuspharma.com

Safe Harbor
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about Citius, including but not limited to statements with respect to Citius's plans to consummate its proposed underwritten offering of common stock and warrants and the use of proceeds. Citius may use words such as "may," "might," "should," "anticipate," "estimate," "expect," "projects," "intends," "plans," "believes" and words and terms of similar substance to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things, whether or not Citius will be able to raise capital, the final terms of the underwritten offering of common stock and warrants, market and other conditions, the satisfaction of customary closing conditions related to the underwritten offering of common stock and warrants, Citius's business and financial condition, and the impact of general economic, industry or political conditions in the United States or internationally. For additional disclosure regarding these and other risks faced by Citius, see disclosures contained in Citius's public filings with the SEC, including the "Risk Factors" in the company's Annual Report on Form 10-K for the fiscal year ended September 30, 2016, and under the heading "Risk Factors" of the prospectus for this offering. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. The forward-looking statements are made as of the date hereof, and Citius undertakes no obligation to update such statements as a result of new information.

SOURCE Citius Pharmaceuticals, Inc.
 

Citius Pharmaceuticals Provides Shareholder Update on Recent Achievements
 

Company Highlights $3 Million Insider Investment, Product Line Updates and Recent Case Study Results

CRANFORD, N.J.,  /PRNewswire/ -- Citius Pharmaceuticals, Inc. (OTCQB: CTXR) ("Citius"), a specialty pharmaceutical company dedicated to developing and commercializing adjunctive cancer care and critical care drug products, today provided shareholders with an update regarding the company's recent more notable achievements.

RECENT COMPANY MILESTONES

The Company recently announced a $3 Million Equity Investment from their Executive Chairman, Mr. Leonard Mazur. The financial commitment reiterates management's confidence in Citius' strong portfolio and overall growth potential.

Citius made significant strides in both the development and commercialization efforts of their 2 premier products; Mino-Lok™ and Hydro-Lido. The Company completed a feasibility study of major academic sites with respect to conducting phase 3 trials for its Mino-Lok™ product, and has identified sites that are interested in participation. The Company reported positive results from the Phase 2a trial of their Hydrocortisone and Lidocaine combination product in patients with Grade I and II hemorrhoids.

The Mino-Lok™ product is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs). CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs), and in hemodialysis patients where maintaining venous access presents a challenge. Central venous catheters (CVCs) are life-saving vascular access ports in many patients requiring long-term intravenous therapy. Approximately 7 million CVCs are used annually and about 500,000 of those result in CRBSIs leading to serious, life threatening infections and morbidities.

The Company's topical Hydro-Lido product is being developed to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids. Hemorrhoids are a common gastrointestinal disorder characterized by pain, swelling, itching, tenderness, and bleeding. Hemorrhoids affect nearly 5% of the U.S. population, with 10 million patients reporting symptoms and a third seeking treatment from doctors. Between 50% and 90% of the U.S. population will experience inflamed hemorrhoids in their lifetime. Currently, over 25 million units of topical products for hemorrhoids are sold annually in the U.S. The estimated prescription market in the U.S. is over $1.0 billion.

In addition to product development, Citius strengthened its leadership and executive management team with the addition of Myron Holubiak as the Company's President and CEO. Mr. Holubiak is the former President of Roche Laboratories, Inc., a major research-based pharmaceutical company. Mr. Holubiak stated, "We are extremely pleased with the progress that we have made during the previous 12 months. We are confident that we have built a strong platform to realize our goal of becoming an important player in the critical care space and in adjunctive cancer care. We also have the luxury of owning an asset in Hydro-Lido that has the potential to be the first prescription hemorrhoid treatment with evidence of efficacy and safety. We still have a lot of work to do, but we've made significant progress towards addressing previously unmet and underserved medical needs. We believe that the commercial opportunities for Mino-Lok™ and Hydro-Lido, combined with current industry towards cost-effective therapies will allow us to create new markets and enhance our shareholder value."

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 using 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. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. 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
646-522-8410; ascott@citiuspharma.com

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SOURCE Citius Pharmaceuticals, Inc.

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About Citius Pharmaceuticals Inc.

Company Overview

Citius Pharmaceuticals (NASDAQ: CTXR) is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for large and growing markets. Citius products offer new and expanded indications for previously approved pharmaceutical products as a means to achieve leading market position or market exclusivity. By using previously approved drugs with substantial safety and efficacy data, Citius seeks to reduce the risks associated with pharmaceutical product development. Citius is currently advancing two proprietary product candidates, our Mino-Lok™ product and a Hydrocortisone-Lidocaine formulation. Citius believes the markets for its products are large and underserved by the current standard of care.

Highlights

Target large market opportunities that have unmet medical needs with cost-effective products; high growth categories with low developmental risk.

Mino-Lok™ product is advancing to Phase 3 clinical studies.

Positive results from a Phase 2a study for hydrocortisone-lidocaine formulation for Grade I and II hemorrhoids.

Experienced management team with demonstrated success developing and commercializing novel pharmaceutical products.


Development and Commercialization Strategy

Citius seeks to build a successful pharmaceutical company through the development and commercialization of innovative, efficacious, and cost-effective products that address compelling market opportunities. Citius seeks to leverage the FDA’s 505(b)(2) pathway for new drug approvals and bring products to market faster and with less cost as compared to other FDA new drug approval pathways.

Development and Commercialization Objectives

Identify later stage drug candidates that can be developed within a 3-4 year time horizon using a 505(b)(2) pathway.

License the most relevant and advanced technologies to provide superior product characteristics and intellectual property protection for 10 years.

Focus on therapeutic areas that are highly influenced by key opinion leaders (KOLs) and drugs that are prescribed by a relatively small number of physicians.

Provide cost-effective therapies that would be endorsed by patients, providers, and payers.


Mino-Lok™

Our Mino-Lok™ product is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs). 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.

Our Mino-Lok™ product is intended to salvage the CVC obviating the need to remove and replace the catheter. This is a recognized unmet medical need. There are no alternatives other than the removal and reinsertion of the CVC once the CVC becomes infected. Studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture.

Program Highlights

Partnership with a leading cancer center and support from key industry opinion leaders.

In a Phase 2b trial, our Mino-Lok™ product demonstrated a 100% efficacy rate in salvaging infected CVCs; the Mino-Lok™ product had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced.

FDA QIDP designation and patent protected until June 2024.

Advancing to a Phase 3 pivotal superiority trial.

Hydro-Lido

Citius is developing a topical formulation of hydrocortisone (3%) and lidocaine (5%), Hydro-Lido, to provide anti-inflammatory and anesthetic relief to patients suffering from Grade I and II hemorrhoids.

Although there are numerous prescription and over-the-counter products commonly used to treat hemorrhoids, none currently possess safety and efficacy data generated from rigorously conducted clinical trials. Citius believes its hydrocortisone-lidocaine product will become an important treatment option for physicians who want to provide their patients with a therapy that has demonstrated safety and efficacy in treating hemorrhoids. Citius has recently completed a Phase 2a clinical study in 211 hemorrhoid patients.


MANAGEMENT TEAM

Leonard Mazur, Chairman of the Board, Director

Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable accomplishments in founding, building and creating value and returns for investors. Mr. Mazur was the Chairman of Leonard Meron Biosciences, Inc. prior to its merger with Citius in March 2016. He is the cofounder and Vice Chairman of Akrimax Pharmaceuticals, LLC (“Akrimax”), a privately held pharmaceutical company specializing in producing cardiovascular and general pharmaceutical products. Akrimax was founded in September 2008 and has successfully launched prescription drugs while acquiring drugs from major pharmaceutical companies. From January 2005 to May 2012, Mr. Mazur also co-founded and served as the Chief Operating Officer of Triax Pharmaceuticals LLC (“Triax”), a specialty pharmaceutical company producing prescription dermatological drugs. Prior to joining Triax, he was the founder and, from 1995 to 2005, Chief Executive Officer of Genesis Pharmaceutical, Inc. (“Genesis”), a dermatological products company that marketed its products through dermatologists’ offices as well as co-promoting products for major pharmaceutical companies. In 2003, Mr. Mazur successfully sold Genesis to Pierre Fabre, a leading pharmaceutical company.
Mr. Mazur has extensive sales, marketing and business development experience from his tenures at Medicis Pharmaceutical Corporation, as executive vice president, ICN Pharmaceuticals, Inc. as Vice President, Sales & Marketing, Knoll Pharma (a division of BASF), and Cooper Laboratories, Inc.

Mr. Mazur is a member of the Board of Trustees of Manor College and is a recipient of the Ellis Island Medal of Honor. Mr. Mazur received both his BA and MBA from Temple University and has served in the U.S. Marine Corps Reserves.

Myron Holubiak, President and Chief Executive Officer, Director

Mr. Holubiak has extensive experience in managing and leading both large and emerging pharmaceutical and life sciences companies. Mr. Holubiak was co-founder, director and CEO of Leonard Meron Biosciences, Inc. prior to its merger with Citius in March 2016. Mr. Holubiak was the President of Roche Laboratories, Inc. (“Roche”), a major research-based pharmaceutical company, from December 1998 to August 2001. Prior to that, he held sales and marketing positions at Roche during his 19-year tenure. During his tenure as President of Roche, Holubiak helped transform Roche Labs into a leading antibiotic and biotechnology company. He was also founder of Emron, Inc., a health economics and managed care consulting company, and helped to create the Academy of Managed Care Pharmacy (AMCP). Mr. Holubiak was also a director of Bioscrip, Inc., a national home infusion company, from 2002 through 2016, and served as Chairman of the Board from 2012 through 2016. Since July 2010, Mr. Holubiak has served as a member of the board of directors of Assembly Biosciences, Inc. (“Assembly”) and its predecessor Ventrus Biosciences, Inc. Mr. Holubiak is also a trustee of the Academy of Managed Care Pharmacy Foundation. He received a BS in Molecular Biology and Biophysics from the University of Pittsburgh; he received advanced business training from the Harvard Business School and the University of London; and, advanced training in health economics from the University of York’s Centre for Health Economics.

Gary F. Talarico, EVP, Operations

Mr. Talarico has served as EVP, Operations since March 2016. Mr. Talarico has successfully built and led all commercial activities for a number of start-up companies. Most recently he was a founder, partner and Executive Vice President of Leonard Meron Biosciences; he was instrumental in acquiring its lead product. Previously, Mr. Talarico served as Senior Vice President of Triax Pharmaceuticals, from its founding to the sale of its assets. Mr. Talarico was a founder and Executive Vice President of Sales and Marketing for Reliant Pharmaceuticals, LLC; Reliant was later sold to GlaxoSmithKline plc. Before Reliant, he was Executive Vice President of Business Development for Ventiv Health. His earlier experience included Vice President of Sales for Medicis Pharmaceutical at its initial start-up, and Director of Sales at ICN Pharmaceuticals, Inc. Mr. Talarico is a graduate of Lewis University.
Jaime Bartushak, Chief Financial Officer

Mr. Bartushak is an experienced finance professional for early stage pharmaceutical companies, and has over 20 years of corporate finance, business development, restructuring, and strategic planning experience. Most recently in 2014, Mr. Bartushak helped lead the sale of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc. Mr. Bartushak is also one of the founders of Leonard-Meron Biosciences and was instrumental in their startup as well as obtaining initial investment capital.

Alan Lader, Ph.D., VP, Clinical Operations

Dr. Lader has served as VP, Clinical Operations since March of 2016. Dr. Lader has over 25 years of experience in medical research. Prior to joining Citius, Dr. Lader was the Director of Clinical Operations for Ischemix, Inc. Dr. Lader was an Instructor in Medicine at Harvard Medical School and Brigham and Women’s Hospital where he taught Integrated Human Physiology, and was Principal Investigator for NIH funded studies in mechanisms of lung cancer metastasis. Dr. Lader has authored over 20 publications in peer reviewed journals and has presented more than 20 abstracts in scientific meetings. He received his Ph.D. from University of South Carolina School of Medicine. He received an MS degree from Rensselaer Polytechnic Institute in Biomedical Engineering and a BS degree in Bioengineering from Syracuse University.

Andrew Scott, VP Corporate Development

Mr. Scott has 20 years of transactional experience in strategic planning, product identification, asset acquisition, and capital markets communication. He is a senior investment banker providing M&A and capital market services to several emerging biotech and pharma companies.
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