1. CRANFORD, N.J., March 23, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, will participate in the virtual Benzinga Biotech Small Cap Conference being held March 24-25, 2021. Citius Executive Chairman, Leonard Mazur, will present on Thursday, March 25 at 2:55 pm ET. Investors may register for the conference at the event website.

    During the corporate presentation, Mr. Mazur will discuss the Company's Phase 3 program for its lead product candidate Mino-Lok®, an antibiotic lock solution being developed to treat patients with catheter-related bloodstream infections (CRBSIs).

    "We are eagerly awaiting the third…

    CRANFORD, N.J., March 23, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, will participate in the virtual Benzinga Biotech Small Cap Conference being held March 24-25, 2021. Citius Executive Chairman, Leonard Mazur, will present on Thursday, March 25 at 2:55 pm ET. Investors may register for the conference at the event website.

    During the corporate presentation, Mr. Mazur will discuss the Company's Phase 3 program for its lead product candidate Mino-Lok®, an antibiotic lock solution being developed to treat patients with catheter-related bloodstream infections (CRBSIs).

    "We are eagerly awaiting the third interim efficacy analysis from our independent Drug Monitoring Committee regarding the Mino-Lok® Phase 3 trial in progress," said Mr. Mazur. "This pivotal trial is progressing according to plan, and we expect full enrollment this year. The antibiotic lock solution market is large and substantially underserved, with an estimated market opportunity of $750 million in the U.S. and over $1.5 billion worldwide."

    Citius issued its most recent Letter to Shareholders in February, highlighting recent updates on its business and clinical developments as well as news for its pipeline of products. To read the letter please visit the Company's Investor Info website at ir.citiuspharma.com.

    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.

    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," "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 are: our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates, including Mino-Lok®; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; risks relating to the results of research and development activities; 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 attract, integrate, and retain key personnel; 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; government regulation; 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, Special Projects

    (O) 908-967-6677 x105

    (M) 646-522-8410

     

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    SOURCE Citius Pharmaceuticals, Inc.

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  2. CRANFORD, N.J., March 4, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that it will present at the H.C. Wainwright Global Life Sciences Conference, to be held virtually on March 9-10, 2021. Myron Holubiak, Chief Executive Officer of Citius, will present an overview and provide an update on the Company's products under development, including its lead product candidate Mino-Lok, currently in Phase 3 trials.

    The webcast of this presentation will be available to view starting on Tuesday, March 9, at 7:00 a.m. Eastern Time. Mr. Holubiak will also conduct virtual one-on-one meetings with investors…

    CRANFORD, N.J., March 4, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that it will present at the H.C. Wainwright Global Life Sciences Conference, to be held virtually on March 9-10, 2021. Myron Holubiak, Chief Executive Officer of Citius, will present an overview and provide an update on the Company's products under development, including its lead product candidate Mino-Lok, currently in Phase 3 trials.

    The webcast of this presentation will be available to view starting on Tuesday, March 9, at 7:00 a.m. Eastern Time. Mr. Holubiak will also conduct virtual one-on-one meetings with investors during the conference.

    Webcast: https://journey.ct.events/view/262c140c-bae9-4791-bee8-7a03b2d8449a

    A replay of the presentation will also be available on the Company's website at https://www.citiuspharma.com/ for 90 days following the conference.

    The Company recently issued its February 2021 Letter to Shareholders, highlighting recent updates on its business and clinical developments as well as news for its pipeline of products. To view the letter in its entirety, please visit: https://www.citiuspharma.com/wp-content/uploads/2021/02/CTXR_Shareholder_Letter_Feb2021.pdf

    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.

    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: market and other conditions; our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates; our need for substantial additional funds; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; patent and intellectual property matters, our ability to attract, integrate, and retain key personnel; 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; government regulation; 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, Special Projects

    (O) 908-967-6677 x105

    (M) 646-522-8410

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    SOURCE Citius Pharmaceuticals, Inc.

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  3. CRANFORD, N.J., Feb. 19, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has closed its previously announced sale of an aggregate of 50,830,566 shares of its common stock and accompanying warrants to purchase up to an aggregate of 25,415,283 shares of its common stock, at a purchase price of $1.505 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The warrants have an exercise price of $1.70 per share, are immediately exercisable, and…

    CRANFORD, N.J., Feb. 19, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has closed its previously announced sale of an aggregate of 50,830,566 shares of its common stock and accompanying warrants to purchase up to an aggregate of 25,415,283 shares of its common stock, at a purchase price of $1.505 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The warrants have an exercise price of $1.70 per share, are immediately exercisable, and will expire five years from the issue date.

    The aggregate gross proceeds to the Company from the offering are approximately $76.5 million, before deducting the placement agent fees and other offering expenses payable by the Company. Citius currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures.

    The securities described above were offered pursuant to a "shelf" registration statement (File No. 333-248748) filed with the Securities and Exchange Commission (SEC) and declared effective on September 25, 2020, and an additional registration statement on Form S-3 (File No. 333-253179) filed on February 16, 2021 pursuant to Rule 462(b), which became effective automatically upon filing. The offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the securities that were offered has been filed with the SEC and is available at the SEC's website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the securities in the offering may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or emailing .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    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. 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, and includes all statements related to the intended use of net proceeds from the registered direct offering.  Factors that could cause actual results to differ materially from those currently anticipated are: market and other conditions; our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates; our need for substantial additional funds; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; patent and intellectual property matters, our ability to attract, integrate, and retain key personnel; 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; government regulation; 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

     

     

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    SOURCE Citius Pharmaceuticals, Inc.

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  4. CRANFORD, N.J., Feb. 17, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has entered into definitive agreements with certain healthcare-focused and institutional investors for the purchase of an aggregate of 50,830,566 shares of its common stock and accompanying warrants to purchase up to an aggregate of 25,415,283 shares of its common stock, at a purchase price of $1.505 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to take place on or about February 19, 2021, subject…

    CRANFORD, N.J., Feb. 17, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has entered into definitive agreements with certain healthcare-focused and institutional investors for the purchase of an aggregate of 50,830,566 shares of its common stock and accompanying warrants to purchase up to an aggregate of 25,415,283 shares of its common stock, at a purchase price of $1.505 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to take place on or about February 19, 2021, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The warrants have an exercise price of $1.70 per share, will be immediately exercisable, and will expire five years from the issue date.

    The aggregate gross proceeds to the Company from the offering are expected to be approximately $76.5 million, before deducting the placement agent fees and other offering expenses payable by the Company. Citius currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures.

    The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-248748) filed with the Securities and Exchange Commission (SEC) and declared effective on September 25, 2020, and an additional registration statement on Form S-3 (File No. 333-253179) filed on February 16, 2021 pursuant to Rule 462(b), which became effective automatically upon filing. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC's website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or emailing .   

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

    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.

    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. 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, and includes all statements related to the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering.  Factors that could cause actual results to differ materially from those currently anticipated are: market and other conditions; our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates; our need for substantial additional funds; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; patent and intellectual property matters, our ability to attract, integrate, and retain key personnel; 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; government regulation; 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

     

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    SOURCE Citius Pharmaceuticals, Inc.

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  5. CRANFORD, N.J., Feb. 16, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today issued a shareholder letter providing a corporate update on the Company's recent achievements and anticipated milestones for 2021.

    Highlights from the letter include:

    • Mino-Lok® pivotal trial interim analysis and review by the Data Monitoring Committee (DMC) expected in the second quarter
    • Halo-Lido IND (second quarter) and Phase 2b protocol to be filed afterwards
    • Mino-Wrap™ in pre-clinical development with plans to submit IND to the FDA by the end of the year
    • NoveCite i-MSCs development is progressing with: ongoing data generation…

    CRANFORD, N.J., Feb. 16, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today issued a shareholder letter providing a corporate update on the Company's recent achievements and anticipated milestones for 2021.

    Highlights from the letter include:

    • Mino-Lok® pivotal trial interim analysis and review by the Data Monitoring Committee (DMC) expected in the second quarter
    • Halo-Lido IND (second quarter) and Phase 2b protocol to be filed afterwards
    • Mino-Wrap™ in pre-clinical development with plans to submit IND to the FDA by the end of the year
    • NoveCite i-MSCs development is progressing with: ongoing data generation from our proof-of-concept sheep acute respiratory distress syndrome (ARDS) model demonstrating impressive interim results (studies to be completed in second quarter); FDA-required GLP animal toxicology studies have been implemented; and development of an i-MSC master cell bank (MCB) followed by cGMP manufacturing is underway
    • Private placement for gross proceeds of $20.0 million and investors' exercise of warrants generating $4.5 million in gross proceeds completed in January 2021 and February 2021, respectively

    "Our important achievements against the COVID headwinds last year give us great confidence that 2021 will be a banner year for advancing our three product platforms in the clinic, and our corporate decision to commence the development of NoveCite next-generation cellular therapies further expands our goal as a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for significant unmet medical needs" said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "Our advanced clinical program for Mino-Lok is moving forward with expected full enrollment for the Phase 3 pivotal trial this year. For Halo-Lido, we expect to file an Investigational New Drug Application (IND) for the combination by the second quarter  and initiate our Phase 2b trial by year-end. We also plan to start pre-clinical pharmacology and toxicology studies for Mino-Wrap within the next few months along with chemistry, manufacturing and controls (CMC) development, and we target filing an IND by the end of 2021. In addition to the plans described above for our NoveCite i-MSCs Program, we plan to submit an IND to the FDA and initiate our Phase 1 first-in-human clinical trial in COVID-19 ARDS by the end of the second quarter of 2022. Our recent $20 million private round of financing and investors' exercise of warrants for net proceeds of approximately $4.5 million provides significant financial runway to move forward with our three programs in the clinic, as well as manufacturing development for our unique induced-mesenchymal stem cell therapy for ARDS associated with COVID-19. We are excited about the road ahead and thankful as always for the ongoing support of our shareholders."

    To read the Shareholder Letter in its entirety, please visit the Company's Investor Info website at ir.citiuspharma.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 and cancer care. 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," "plan," "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 clinical trials and drug development, including anticipated development timelines and study results; 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 dependence on third-party suppliers; our need for substantial additional funds; patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; the estimated markets for our product candidates and the acceptance thereof by any market; 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; government regulation; 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

    (M) 646-522-8410

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    SOURCE Citius Pharmaceuticals, Inc.

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  6. NEW YORK, Feb. 8, 2021 /PRNewswire/ -- Virtual Investor Conferences, the leading proprietary investor conference series, today announced that the presentations from the February 4th Small and Microcap Showcase are now available for on-demand viewing.

    REGISTER OR LOGIN NOW TO VIEW THE PRESENTATIONS: https://bit.ly/3pPZeWX

    The company presentations will be available 24/7 for 90 days. Investors, advisors and analysts may download shareholder materials from the "virtual trade booth" for the next three weeks.

    Participating Companies:

    Full Company

    Legal Name - Presentation Name

    Ticker

    Keynote Presentation: Investing 101: Evaluating a Public Company's Corporate Communications Efforts

    Skyline Corporate Communications Group, LLC



    Lleidanetworks Serveis Telematics S. A.

    (OTCQX:LLEIF, BME: LLN, EPA: ALLLN)))

    Mirriad Advertising plc

    (OTCQB:MMDDF, LON: MIRI)))

    Alvopetro Energy Ltd.

    (OTCQX:ALVOF, TSXV:ALV)

    Genprex, Inc.

    (NASDAQ:GNPX)

    BioSig Technologies, Inc.

    (NASDAQ:BSGM)

    VolitionRx Limited

    (NYSE:VNRX)

    Earthasia International Holdings Ltd.

    (OTCQX:ETIHY, HKEx: 6128)))

    Citius Pharmaceuticals, Inc.

    (NASDAQ:CTXR)

    VERB Technology Company, Inc.

    (NASDAQ:VERB)

    Logiq, Inc.

    (OTCQX:LGIQ)

    Clean Energy Technologies, Inc.

    (OTCQB:CETY)

    Slinger Bag Inc.

    (OTCQB:SLBG)

    Skye Bioscience, Inc.

    (OTCQB:SKYE)

    Experion Holdings Ltd.

    (OTCQB:EXPFF, TSXV:EXP)

    BIGG Digital Assets Inc.

    (OTCQB:BBKCF, CSE:BIGG)

    NexTech AR Solutions

    (OTCQB:NEXCF, NEO: NTAR.NE, CSE:NTAR)

    To facilitate investor relations scheduling, for more information about the program and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com.

    About Virtual Investor Conferences®

    Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly-traded companies to meet and present directly with investors.

    A real-time solution for investor engagement, Virtual Investor Conferences is part of OTC Market Group's suite of investor relations services specifically designed for more efficient Investor Access.  Replicating the look and feel of on-site investor conferences, Virtual Investor Conferences combine leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

     

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    SOURCE VirtualInvestorConferences.com

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  7. Individual and institutional investors as well as advisors are invited to log-on to VirtualInvestorConferences.com to view presentations

    NEW YORK, Feb. 8, 2021 /CNW/ - Virtual Investor Conferences, the leading proprietary investor conference series, today announced that the presentations from the February 4th Small and Microcap Showcase are now available for on-demand viewing.

    REGISTER OR LOGIN NOW TO VIEW THE PRESENTATIONS: https://bit.ly/3pPZeWX

    The company presentations will be available 24/7 for 90 days. Investors, advisors and analysts may download shareholder materials from the "virtual trade booth" for the next three weeks.

    Participating Companies:

    Full Company
    Legal Name - Presentation Name

    Ticker

    Keynote Presentation: Investing 101:

    Individual and institutional investors as well as advisors are invited to log-on to VirtualInvestorConferences.com to view presentations

    NEW YORK, Feb. 8, 2021 /CNW/ - Virtual Investor Conferences, the leading proprietary investor conference series, today announced that the presentations from the February 4th Small and Microcap Showcase are now available for on-demand viewing.

    REGISTER OR LOGIN NOW TO VIEW THE PRESENTATIONS: https://bit.ly/3pPZeWX

    The company presentations will be available 24/7 for 90 days. Investors, advisors and analysts may download shareholder materials from the "virtual trade booth" for the next three weeks.

    Participating Companies:

    Full Company

    Legal Name - Presentation Name

    Ticker

    Keynote Presentation: Investing 101: Evaluating a Public

    Company's Corporate Communications Efforts

    Skyline Corporate Communications Group, LLC



    Lleidanetworks Serveis Telematics S. A.

    ((LLEIF, BME: LLN, EPA: ALLLN))

    Mirriad Advertising plc

    ((MMDDF, LON: MIRI))

    Alvopetro Energy Ltd.

    ((ALVOF, TSXV:ALV)

    Genprex, Inc.

    ((GNPX)

    BioSig Technologies, Inc.

    ((BSGM)

    VolitionRx Limited

    ((VNRX)

    Earthasia International Holdings Ltd.

    ((ETIHY, HKEx: 6128))

    Citius Pharmaceuticals, Inc.

    ((CTXR)

    VERB Technology Company, Inc.

    ((VERB)

    Logiq, Inc.

    (OTCQX: LGIQ)

    Clean Energy Technologies, Inc.

    ((CETY)

    Slinger Bag Inc.

    ((SLBG)

    Skye Bioscience, Inc.

    ((SKYE)

    Experion Holdings Ltd.

    ((EXPFF, TSXV:EXP)

    BIGG Digital Assets Inc.

    ((BBKCF, CSE:BIGG)

    NexTech AR Solutions

    ((NEXCF, NEO: NTAR.NE, CSE:NTAR)

    To facilitate investor relations scheduling, for more information about the program and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com.

    About Virtual Investor Conferences®

    Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly-traded companies to meet and present directly with investors.

    A real-time solution for investor engagement, Virtual Investor Conferences is part of OTC Market Group's suite of investor relations services specifically designed for more efficient Investor Access.  Replicating the look and feel of on-site investor conferences, Virtual Investor Conferences combine leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

    SOURCE VirtualInvestorConferences.com

    Cision View original content: http://www.newswire.ca/en/releases/archive/February2021/08/c5124.html

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  8. CRANFORD, N.J., Feb. 2, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, will present at the upcoming Virtual Investor Conferences Small and Microcap Showcase on Thursday, February 4, 2021. Citius Chairman of the Board Leonard Mazur will present an update on the Company's lead product candidate MinoLok, currently in Phase 3 trials, and an overview of three other active programs.

    Date:   Thursday, February 4, 2021
    Time:   1:00 p.m. ET
    Link:    https://bit.ly/3brvZ8w

    This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able…

    CRANFORD, N.J., Feb. 2, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, will present at the upcoming Virtual Investor Conferences Small and Microcap Showcase on Thursday, February 4, 2021. Citius Chairman of the Board Leonard Mazur will present an update on the Company's lead product candidate MinoLok, currently in Phase 3 trials, and an overview of three other active programs.

    Date:   Thursday, February 4, 2021

    Time:   1:00 p.m. ET

    Link:    https://bit.ly/3brvZ8w

    This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event. It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. Learn more about the event at www.virtualinvestorconferences.com.

    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.

    Contact:

    Andrew Scott

    Vice President, Corporate Development

    (O) 908-967-6677 x105

    (M) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-update-on-mino-lok-and-other-therapies-at-the-virtual-investor-conferences-small-and-microcap-showcase-on-february-4-301219900.html

    SOURCE Citius Pharmaceuticals, Inc.

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  9. NEW YORK, Jan. 28, 2021 /PRNewswire/ -- Virtual Investor Conferences, the leading proprietary investor conference series, today announced the agenda for the upcoming Small and Microcap Showcase.  Individual investors, institutional investors, advisors and analysts are invited to attend. The program opens at 8:45 AM ET on Thursday, February 4th  with the first live webcast at 9:00 AM ET.

    REGISTER NOW AT https://bit.ly/2KEhljn

    It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.

    "We are pleased to highlight a diverse array of companies participating in the Small and Microcap Virtual Investor Conference," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "We appreciate the collaboration of our co-sponsor Skyline Corporate Communications."

    "Skyline Corporate Communications Group, LLC is honored to again be invited as the event sponsor, and to deliver the keynote presentation. This virtual conference includes an exciting line-up of public company presentations across a diverse array of sectors. We would like to offer our sincere thanks to our partners at the OTC Markets Group for this opportunity, and look forward to hearing presentations from company executives as they inform us about their businesses and their Company's competitive advantages," said Scott Powell, President & CEO of Skyline Corporate Communications Group, LLC.

    February 4th Agenda:

    Eastern

    ET

    NYC

    Full Company

    Legal Name - Presentation Name

    Ticker

    9:00 AM

    Keynote Presentation: Investing 101: Evaluating a Public Company's Corporate Communications Efforts

    Skyline Corporate Communications Group, LLC



    9:30 AM

    Lleidanetworks Serveis Telematics S. A.

    ((LLEIF, BME: LLN, EPA: ALLLN))

    10:00 AM

    Mirriad Advertising plc

    ((MMDDF, LON: MIRI))

    10:30 AM

    Alvopetro Energy Ltd.

    ((ALVOF, TSXV:ALV)

    11:00 AM

    Genprex, Inc.

    ((GNPX)

    11:30 AM

    BioSig Technologies, Inc.

    ((BSGM)

    12:00 PM

    VolitionRx Limited

    ((VNRX)

    12:30 PM

    Earthasia International Holdings Ltd.

    ((ETIHY)

    1:00 PM

    Citius Pharmaceuticals, Inc.

    ((CTXR)

    1:30 PM

    VERB Technology Company, Inc.

    ((VERB)

    2:00 PM

    Logiq, Inc.

    (OTCQX: LGIQ)

    2:30 PM

    Clean Energy Technologies, Inc.

    ((CETY)

    3:00 PM

    Slinger Bag Inc.

    ((SLBG)

    3:30 PM

    Skye Bioscience, Inc.

    ((SKYE)

    4:00 PM

    Experion Holdings Ltd.

    ((EXPFF, TSXV:EXP)

    4:30 PM

    BIGG Digital Assets Inc.

    ((BBKCF, CSE:BIGG)

    To facilitate investor relations scheduling, for more information about the program and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com.

    About Virtual Investor Conferences®

    Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly-traded companies to meet and present directly with investors.

    A real-time solution for investor engagement, Virtual Investor Conferences is part of OTC Market Group's suite of investor relations services specifically designed for more efficient Investor Access.  Replicating the look and feel of on-site investor conferences, Virtual Investor Conferences combine leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/live-investor-conference--webinar-small-and-microcap-company-showcase-on-february-4th-301217214.html

    SOURCE VirtualInvestorConferences.com

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  10. Company executives will share vision and answer audience questions at VirtualInvestorConferences.com

    NEW YORK, Jan. 28, 2021 /CNW/ - Virtual Investor Conferences, the leading proprietary investor conference series, today announced the agenda for the upcoming Small and Microcap Showcase. Individual investors, institutional investors, advisors and analysts are invited to attend. The program opens at 8:45 AM ET on Thursday, February 4th  with the first live webcast at 9:00 AM ET.

    REGISTER NOW AT https://bit.ly/2KEhljn

    It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.

    "We are pleased to highlight…

    Company executives will share vision and answer audience questions at VirtualInvestorConferences.com

    NEW YORK, Jan. 28, 2021 /CNW/ - Virtual Investor Conferences, the leading proprietary investor conference series, today announced the agenda for the upcoming Small and Microcap Showcase. Individual investors, institutional investors, advisors and analysts are invited to attend. The program opens at 8:45 AM ET on Thursday, February 4th  with the first live webcast at 9:00 AM ET.

    REGISTER NOW AT https://bit.ly/2KEhljn

    It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.

    "We are pleased to highlight a diverse array of companies participating in the Small and Microcap Virtual Investor Conference," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "We appreciate the collaboration of our co-sponsor Skyline Corporate Communications."

    "Skyline Corporate Communications Group, LLC is honored to again be invited as the event sponsor, and to deliver the keynote presentation. This virtual conference includes an exciting line-up of public company presentations across a diverse array of sectors. We would like to offer our sincere thanks to our partners at the OTC Markets Group for this opportunity, and look forward to hearing presentations from company executives as they inform us about their businesses and their Company's competitive advantages," said Scott Powell, President & CEO of Skyline Corporate Communications Group, LLC.

    February 4th Agenda:

    Eastern

    ET

    NYC

    Full Company

    Legal Name - Presentation Name

    Ticker

    9:00 AM

    Keynote Presentation: Investing 101: Evaluating a Public Company's

    Corporate Communications Efforts

    Skyline Corporate Communications Group, LLC



    9:30 AM

    Lleidanetworks Serveis Telematics S. A.

    ((LLEIF, BME: LLN, EPA: ALLLN))

    10:00 AM

    Mirriad Advertising plc

    ((MMDDF, LON: MIRI))

    10:30 AM

    Alvopetro Energy Ltd.

    ((ALVOF, TSXV:ALV)

    11:00 AM

    Genprex, Inc.

    ((GNPX)

    11:30 AM

    BioSig Technologies, Inc.

    ((BSGM)

    12:00 PM

    VolitionRx Limited

    ((VNRX)

    12:30 PM

    Earthasia International Holdings Ltd.

    ((ETIHY)

    1:00 PM

    Citius Pharmaceuticals, Inc.

    ((CTXR)

    1:30 PM

    VERB Technology Company, Inc.

    ((VERB)

    2:00 PM

    Logiq, Inc.

    (OTCQX: LGIQ)

    2:30 PM

    Clean Energy Technologies, Inc.

    ((CETY)

    3:00 PM

    Slinger Bag Inc.

    ((SLBG)

    3:30 PM

    Skye Bioscience, Inc.

    ((SKYE)

    4:00 PM

    Experion Holdings Ltd.

    ((EXPFF, TSXV:EXP)

    4:30 PM

    BIGG Digital Assets Inc.

    ((BBKCF, CSE:BIGG)

    To facilitate investor relations scheduling, for more information about the program and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com.

    About Virtual Investor Conferences®

    Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly-traded companies to meet and present directly with investors.

    A real-time solution for investor engagement, Virtual Investor Conferences is part of OTC Market Group's suite of investor relations services specifically designed for more efficient Investor Access.  Replicating the look and feel of on-site investor conferences, Virtual Investor Conferences combine leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

    SOURCE VirtualInvestorConferences.com

    Cision View original content: http://www.newswire.ca/en/releases/archive/January2021/28/c5186.html

    View Full Article Hide Full Article
  11. CRANFORD, N.J., Jan. 27, 2021 /PRNewswire/ -- 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 has closed on the sale to certain institutional and accredited investors of approximately $20.0 million through the issuance of an aggregate of 15,455,960 shares of its common stock and warrants to purchase up to an aggregate of 7,727,980 shares of common stock, at a purchase price of $1.294 per share of common stock and associated warrant in a private placement priced at-the-market under Nasdaq rules.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The warrants have…

    CRANFORD, N.J., Jan. 27, 2021 /PRNewswire/ -- 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 has closed on the sale to certain institutional and accredited investors of approximately $20.0 million through the issuance of an aggregate of 15,455,960 shares of its common stock and warrants to purchase up to an aggregate of 7,727,980 shares of common stock, at a purchase price of $1.294 per share of common stock and associated warrant in a private placement priced at-the-market under Nasdaq rules.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The warrants have an exercise price of $1.231 per share, are exercisable immediately and have a term of five and one-half years.

    The Company currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures.

    The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

    Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors within five calendar days and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 75 days in the event of a "full review" by the Securities and Exchange Commission.

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

    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.

    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. 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, and includes all statements related to the intended use of net proceeds from the private placement.  Factors that could cause actual results to differ materially from those currently anticipated are: market and other conditions; our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates; our need for substantial additional funds; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; patent and intellectual property matters, market and other conditions; our ability to attract, integrate, and retain key personnel; 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; government regulation; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-closing-of-20-0-million-private-placement-offering-priced-at-the-market-301216476.html

    SOURCE Citius Pharmaceuticals, Inc.

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  12. CRANFORD, N.J., Jan. 25, 2021 /PRNewswire/ -- 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 has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $20.0 million through the issuance of an aggregate 15,455,960 shares of its common stock and warrants to purchase up to an aggregate of 7,727,980 shares of common stock, at a purchase price of $1.294 per share of common stock and associated warrant in a private placement priced at-the-market under Nasdaq rules. The closing of the private placement is expected to occur on or about…

    CRANFORD, N.J., Jan. 25, 2021 /PRNewswire/ -- 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 has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $20.0 million through the issuance of an aggregate 15,455,960 shares of its common stock and warrants to purchase up to an aggregate of 7,727,980 shares of common stock, at a purchase price of $1.294 per share of common stock and associated warrant in a private placement priced at-the-market under Nasdaq rules. The closing of the private placement is expected to occur on or about January 27, 2021, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The warrants have an exercise price of $1.231 per share, are exercisable immediately and have a term of five and one-half years.

    The Company currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures.

    The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

    Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors within five calendar days and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 75 days after today in the event of a "full review" by the Securities and Exchange Commission.

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

    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.

    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. 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, and includes all statements related to the completion of the private placement, the satisfaction of customary closing conditions related to the private placement and the intended use of net proceeds from the private placement.  Factors that could cause actual results to differ materially from those currently anticipated are: market and other conditions; our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates; our need for substantial additional funds; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; patent and intellectual property matters, market and other conditions; our ability to attract, integrate, and retain key personnel; 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; government regulation; 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



     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-20-0-million-private-placement-priced-at-the-market-301213766.html

    SOURCE Citius Pharmaceuticals, Inc.

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  13. CRANFORD, N.J., Jan. 6, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that it will be presenting at two virtual investor conferences during the month of January 2021.

    H.C. Wainwright BioConnect 2021 Virtual Conference – January 11 – 14, 2021
    A presentation by Citius President and CEO Myron Holubiak will be available on-demand beginning Monday, January 11 starting at 6:00 a.m. ET and will be available for 30 days following the conference. Investors may register in advance for the conference at the event website.

    MoneyShow Accredited Investors Virtual Expo – January 26 – 28, 2021
    Citius Chairman…

    CRANFORD, N.J., Jan. 6, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that it will be presenting at two virtual investor conferences during the month of January 2021.

    H.C. Wainwright BioConnect 2021 Virtual Conference – January 11 – 14, 2021

    A presentation by Citius President and CEO Myron Holubiak will be available on-demand beginning Monday, January 11 starting at 6:00 a.m. ET and will be available for 30 days following the conference. Investors may register in advance for the conference at the event website.

    MoneyShow Accredited Investors Virtual Expo – January 26 – 28, 2021

    Citius Chairman Leonard Mazur will present at 11:15 a.m. ET on Tuesday, January 26, 2021. Registration for the live streaming event is available on the Expo website. The Citius presentation may be accessed for 30 days following the Expo.

    "We have exciting developments to discuss at our January conferences and look forward to greeting investors virtually," said Mr. Myron Holubiak. "From our NoveCite subsidiary, interim data from a proof-of-concept large animal study of induced mesenchymal stem cell ("i-MSC") therapy in an in vivo model of Acute Respiratory Distress Syndrome ("ARDS") shows improvement in critical parameters, such as improved oxygenation, less systemic shock, and reduced lung injury, compared to the control group. For Mino-Lok we recently conducted a series of webinars to provide Phase 3 trial updates and discuss the role Mino-Lok may play in the treatment of Central Line Associated Blood Stream Infections ("CLABSIs"). In spite of the headwinds from the Covid-19 pandemic, we have been able to continue to recruit patients for our pivotal trial. Mino-Lok is nearing completion of its phase 3. Mino-Wrap's novel approach to reducing post-mastectomy infections associated with the use of a tissue expander is on track in its preclinical stage, and, finally, we expect to file an IND for Halo-Lido in the near term and initiate a Phase 2b trial later this year."

    Overview of Proprietary Product Candidates

    NoveCite Cells – i-MSCs: In October 2020, Citius signed an exclusive worldwide licensing agreement with Novellus, Inc., a privately-held biotechnology company creating new engineered cellular therapies, for a novel stem-cell therapy that would initially target Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients.

    Mino-Lok®: Mino-Lok is a late-stage development product in Phase III trials. Citius has partnered with MD Anderson Cancer Center (MDACC), a world-leading cancer center, to develop Mino-Lok. Mino-Lok has received Qualified Infectious Disease Product ("QIDP") designation providing fast track status, priority review, and additional market exclusivity.

    CITI 101 – Mino-Wrap: Mino-Wrap, or CITI 101, is a liquefying gel-based wrap containing minocycline and rifampin designed to provide inflammatory tissue protection and prevent infection and biofilm formation in tissue expanders and breast implants post-mastectomy. In January 2019, Citius signed a definitive license agreement with MDACC to develop and commercialize a novel approach to reducing postoperative infections associated with surgical implants estimated to be 12-14%.

    CITI-002 – Halo-Lido: Citius is developing a topical formulation of halobetasol, a corticosteroid, and lidocaine to provide anti-inflammatory and anesthetic symptomatic relief to people with hemorrhoids. Citius is advancing its combination therapy for hemorrhoids as being synergistic to its individual components and is pursuing a patent for the new halobetasol-lidocaine formulation. If this formulation is approved by the FDA, Citius would have the only FDA-approved prescription-strength product on the market proven to be safe and effective for the treatment of hemorrhoids.

    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.

    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 clinical trials and drug development; our need for substantial additional funds; the estimated markets for our product candidates and the acceptance thereof by any market; our dependence on third-party suppliers; patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; 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; government regulation; 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

    (M) 646-522-8410

     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-update-on-proprietary-product-candidates-at-two-virtual-conferences-in-january-301201800.html

    SOURCE Citius Pharmaceuticals, Inc.

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  14. CRANFORD, N.J., Dec. 15, 2020 /PRNewswire/ -- 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 has conducted a series of webinars to provide trial updates, discuss patient identification parameters, the challenges of running a trial in today's Covid-19 environment, and the role Mino-Lok may play  in the treatment of Central Line Associated Blood Stream Infections (CLABSIs).  Presentations were made by infectious disease experts from The University of Texas MD Anderson Cancer Center and Alan Lader, PhD, VP of Clinical Operations at Citius Pharmaceuticals provided a status report of the phase…

    CRANFORD, N.J., Dec. 15, 2020 /PRNewswire/ -- 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 has conducted a series of webinars to provide trial updates, discuss patient identification parameters, the challenges of running a trial in today's Covid-19 environment, and the role Mino-Lok may play  in the treatment of Central Line Associated Blood Stream Infections (CLABSIs).  Presentations were made by infectious disease experts from The University of Texas MD Anderson Cancer Center and Alan Lader, PhD, VP of Clinical Operations at Citius Pharmaceuticals provided a status report of the phase 3 trial which is now beyond its halfway point.

    Participating in the webinar were 18 clinical trial sites and 30 investigators or site staff from the following institutions:

    Anne Arundel Medical Center

    Ascension Via Christi Hospital

    Carolinas Medical Center

    Edward Hines Jr VA Hospital

    Indiana Blood and Marrow Transplant

    Lutheran Hospital in Illinois

    Manati Medical Center

    Ponce Research Institute

    Salem VA Medical Center

    University Hospitals Cleveland Medical Center

    University of Florida

    University of Kentucky

    University of Massachusetts Memorial Medical Center

    University of New Mexico

    VA Caribbean Healthcare System

    VA Sierra Nevada Health Care System

    A few key topics on the agenda included a review of the pathogens encountered to date, the benefits of Mino-Lok for a CLABSI patient with a mucosal barrier injury, the frequency of unnecessary removal of non-colonized CVCs in suspected CLABSI patients with bacteremia, how to handle patients with multiple catheters (case history), and the path forward for study completion.

    "Currently, the primary treatment for patients who become bacteremic because of the central lines being infected is to treat the patient aggressively with culture-directed antibiotics and to remove the central line which is believed to be the source of the infection and replaced when the patient's status improves. Patients and physicians need an effective and less invasive alternative to catheter exchange which utilizes much of the same set of resources needed to treat Covid-19 patients, especially in the ICU. We have been fortunate to be able to persevere in continuing this study in a challenging time, and we are hopeful to provide objective evidence that antibiotic locks can work, and become a viable alternative to remove and replace. Mino-Lok will be the first, and most extensively studied, antibiotic lock for salvaging catheters in patients with CLABSI," said Myron Holubiak, President and CEO.  "We initially held one webinar, but after receiving very positive feedback, we have decided to expand into a series of webinars," Holubiak continued. "This once again affirms there is definitely an unmet need and with that a great deal of interest in salvaging infected central lines."

    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). There are currently no approved therapies for salvaging infected CVCs. Mino-Lok is used 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. 

    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 trials for our product candidates, including  our Phase III trial for Mino-Lok, including during the COVID-19 pandemic; the estimated markets for our product candidates, and the acceptance thereof by any market; our need for substantial additional funds; 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

    (C) 646-522-8410

     

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    SOURCE Citius Pharmaceuticals, Inc.

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  15. CRANFORD, N.J., Dec. 9, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced its receipt of a written response and guidance from the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products to the Company's Pre-Investigational New Drug (Pre-IND) consultation request for its Mino-Wrap briefing package.  Through its global license agreement with the The University of Texas MD Anderson Cancer Center, Citius is developing Mino-Wrap, a novel approach to reducing post-mastectomy infections associated with the use of a tissue expander. The briefing package contained information…

    CRANFORD, N.J., Dec. 9, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced its receipt of a written response and guidance from the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products to the Company's Pre-Investigational New Drug (Pre-IND) consultation request for its Mino-Wrap briefing package.  Through its global license agreement with the The University of Texas MD Anderson Cancer Center, Citius is developing Mino-Wrap, a novel approach to reducing post-mastectomy infections associated with the use of a tissue expander. The briefing package contained information regarding pre-clinical data and a clinical development plan, along with questions for the FDA regarding safety and efficacy data that would be required to advance Mino-Wrap into clinical trials.

    The FDA granted a Written Response Only meeting regarding guidance and direction on the Mino-Wrap development plan.  The agency indicated that bio absorption simulation studies may provide information to support the development of Mino-Wrap and made suggestions on what should be provided relative to non-clinical support.  The FDA provided guidance on the design of the drug elution studies and agreed that a large animal pharmacology study would be appropriate.  They also agreed that a 28-day toxicology study appears appropriate and that microbiology support through existing data is acceptable.

     "The FDA provided us with valuable guidance and confirmed a number of our initial plans on the development of Mino-Wrap," said Myron Holubiak, President and CEO of Citius Pharmaceuticals.  "We are very pleased to have guidance support from the agency because this is such an under-recognized problem, and current preventative measures have not yielded very acceptable results. We think we have an important innovation for the prevention of post-operative infections associated with breast reconstructive surgery after mastectomies."

    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 is designed to provide 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.  

    About Tissue Expanders and Infection Risk

    A common breast reconstruction technique is tissue expansion, which involves expansion of the breast skin and muscle using a temporary tissue expander. A tissue expander is an empty breast implant that is filled with normal saline over 6 to 8 weeks until it reaches the breast size that is desired. In this type of reconstruction, the surgeon will either make a pocket under a large muscle in the chest and place a tissue expander in that space or place the expander above the large muscle. About 4 to 8 weeks after the tissue expansion is finished, a second surgery is required to remove the tissue expander and insert the permanent breast implant. The patient receives either microvascular flap reconstruction, or the insertion of a permanent breast implant. Infection is one of the most common complications of tissue expanders and implants during breast reconstruction, with an infection rate ranging from 2.5 to 24 percent.

    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.

    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: our ability to successfully undertake and complete clinical trials and the results from those trials for Mino-Wrap; our need for substantial additional funds; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; patent and intellectual property matters, market and other conditions; our ability to attract, integrate, and retain key personnel; 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; government regulation; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-receives-fda-response-and-guidance-to-pre-ind-consultation-submission-for-mino-wrap-301189525.html

    SOURCE Citius Pharmaceuticals, Inc.

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  16. CRANFORD, N.J., Dec. 8, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced interim data from a proof-of-concept ("POC") large animal study of its proprietary induced mesenchymal stem cell ("i-MSC") therapy for acute inflammatory respiratory conditions including COVID-19 related Acute Respiratory Distress Syndrome ("ARDS"). The available results of i-MSC therapy in the study show improvement in critical parameters, such as improved oxygenation, less systemic shock, and reduced lung injury, compared to the control group. The study was conducted in a widely accepted large animal model.

    As previously…

    CRANFORD, N.J., Dec. 8, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced interim data from a proof-of-concept ("POC") large animal study of its proprietary induced mesenchymal stem cell ("i-MSC") therapy for acute inflammatory respiratory conditions including COVID-19 related Acute Respiratory Distress Syndrome ("ARDS"). The available results of i-MSC therapy in the study show improvement in critical parameters, such as improved oxygenation, less systemic shock, and reduced lung injury, compared to the control group. The study was conducted in a widely accepted large animal model.

    As previously announced, Citius signed an exclusive worldwide licensing agreement with Novellus Therapeutics Limited to develop and commercialize iPSC-derived i-MSCs. In conjunction with the licensing agreement, the Company established a new subsidiary, NoveCite, Inc., to develop, manufacture and commercialize these induced mesenchymal stem cells. NoveCite has already filed a Pre-Investigational New Drug Application (Pre-IND) with the FDA and has received guidance on the requirements for the proposed trials.

    Citius believes that the NoveCite i-MSCs overcome some of the challenges of human donor-derived MSCs which are often associated with limited supply, batch inconsistencies, lower potency, and expensive manufacturing. i-MSCs are derived from engineered iPSCs (induced pluripotent stem cells), a process that facilitates the robust expansion of uniform MSCs that have higher potency, secrete higher levels of immunomodulatory proteins, and offer practically unlimited supply.

    "We believe Novellus's patented, non-immunogenic mRNA cell reprogramming is clearly a superior methodology to generating MSCs compared to the donor-derived model," said Myron Holubiak, Chief Executive Officer of Citius. "The Novellus process provides a consistent cell bank source, near unlimited supply, greater expansion potential with comparatively less senescent cells. These early results from our proof of concept study are encouraging and indicate potent action which could lead to a treatment candidate for COVID-19 related ARDS." Mr. Holubiak continued, "The development opportunities are significant, and we believe our breakthrough i-MSC therapy has the potential to be a strong catalyst for the advancement of our business strategy."

    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 NoveCite iMSC (i-MSC)

    NoveCite's mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The NC-i-MSCs produced from this clonal technique are differentiated from human donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in vitro studies, i-MSCs exhibit superior potency and high cell viability. i-MSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. The NoveCite i-MSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

    First generation (human donor-derived) MSCs are isolated from donated tissue followed by culture expansion. Since only a relatively small number of cells are isolated from each donation, first generation MSCs are increased by growing the cells in culture. Unfortunately, these type of MSCs start to lose potency, and ultimately become senescent. Each donation produces a limited number of MSCs, so a continuous supply of new donors is needed to produce commercial scale. The number and quality of MSCs that can be isolated from different donors can vary substantially.

    About Acute Respiratory Distress Syndrome (ARDS)

    ARDS is an inflammatory process leading to build-up of fluid in the lungs and respiratory failure. It can occur due to infection, trauma and inhalation of noxious substances. ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation. Survivors of ARDS are often left with severe long-term illness and disability.  ARDS is a frequent complication of patients with COVID-19. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

    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: the risks associated with developing the NoveCite technology as a treatment for ARDS; risks associated with developing any of our product candidates, including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market;  our need for substantial additional funds; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development, including the NoveCite technology; our ability to obtain, perform under and maintain licensing, financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; 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

    (M) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-subsidiary-novecite-announces-data-from-a-study-of-induced-mesenchymal-stem-cell-i-msc-therapy-in-an-in-vivo-model-of-acute-respiratory-distress-syndrome-ards-301188345.html

    SOURCE Citius Pharmaceuticals, Inc.

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  17. CRANFORD, N.J., Dec. 3, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that it will be participating in the Benzinga Global Small Cap Conference being held virtually on December 8 and 9, 2020. Citius Chairman Leonard Mazur will present at 11:30 am ET on Tuesday, December 8, 2020, and will host one-on-one investor meetings.

    Advanced investor registration for the conference and virtual one-to-one meeting requests can be accessed here

    We are currently advancing four proprietary product candidates: Mino-Lok®CITI-002 (halobetasol-lidocaine formulation or Halo-Lido), CITI-101 (Mino-Wrap), and…

    CRANFORD, N.J., Dec. 3, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that it will be participating in the Benzinga Global Small Cap Conference being held virtually on December 8 and 9, 2020. Citius Chairman Leonard Mazur will present at 11:30 am ET on Tuesday, December 8, 2020, and will host one-on-one investor meetings.

    Advanced investor registration for the conference and virtual one-to-one meeting requests can be accessed here

    We are currently advancing four proprietary product candidates: Mino-Lok®CITI-002 (halobetasol-lidocaine formulation or Halo-Lido), CITI-101 (Mino-Wrap), and CITI-401 (iMSC).  Mr. Mazur will discuss recent Company developments for these product candidates including:

    • Mino-Lok® is advancing in its Phase 3 trial
    • A positive second interim analysis report from the independent Drug Monitoring Committee (DMC) for the Mino-Lok pivotal Phase 3 trial
    • The signing of an exclusive worldwide license agreement with Novellus Therapeutics, Limited for a cellular therapy to treat acute respiratory distress syndrome (ARDS), a leading complication of COVID-19; and the formation of our Novecite, Inc. subsidiary.
    • Submission of a pre-investigational new drug (PIND) consultation request for Mino-Wrap with written response and guidance is expected
    • Update on Halo-Lido which is anticipated to begin Phase 2b trial in the first quarter of 2021

    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.

    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 clinical trials and drug development; our dependence on third-party suppliers; our need for substantial additional funds; patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; the estimated markets for our product candidates and the acceptance thereof by any market; 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; government regulation; 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

    (M) 646-522-8410

     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-corporate-update-at-benzinga-global-small-cap-conference-on-december-8-301186114.html

    SOURCE Citius Pharmaceuticals, Inc.

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  18. CRANFORD, N.J., Nov. 30, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced the completion of a Boston Analytical study "Silicone Disk Method for In Vitro Assessment of Antimicrobial Activity Against Resistant Staphylococcal Biofilms by Minocycline-EDTA-Ethanol and EDTA-Ethanol Lock Solutions." This study demonstrated that all three components of Mino-Lok (30 mg/mL EDTA, 19.5% ethanol and 1 mg/mL minocycline) were superior to EDTA/ethanol (30 mg/mL EDTA and 19.5% ethanol). There were two strains of Staphylococcus aureus used for the inocula and two samples of each strain were tested…

    CRANFORD, N.J., Nov. 30, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced the completion of a Boston Analytical study "Silicone Disk Method for In Vitro Assessment of Antimicrobial Activity Against Resistant Staphylococcal Biofilms by Minocycline-EDTA-Ethanol and EDTA-Ethanol Lock Solutions." This study demonstrated that all three components of Mino-Lok (30 mg/mL EDTA, 19.5% ethanol and 1 mg/mL minocycline) were superior to EDTA/ethanol (30 mg/mL EDTA and 19.5% ethanol). There were two strains of Staphylococcus aureus used for the inocula and two samples of each strain were tested as four reference groups. The test solutions were examined following incubation for the following three time points:  60 minutes; 90 minutes; and 120 minutes. The Colony Forming Units (CFU)/Disk value was assessed from 10 disks at each time-point for each group. The results indicate that when the exposure time is 60 minutes, the number of CFU/Disk under the MLT group is significantly smaller than the number of CFU/Disk under the EDTA/ethanol group in one strain and very close to significance (p-value = 0.0598) in the second strain. For all exposure times, the number of CFU/Disk was always lower in the MLT treated disks compared to the EDTA/ethanol treated disks.

    The researchers concluded that "… taken together, the results suggest that MLT can eradicate the biofilm quicker than EDTA/ethanol."

    "Staph aureus is one of the most worrisome pathogens in catheter related bloodstream infections (CRBSI). This pathogen receives special consideration even in the IDSA guidelines for treating CRBSI. We are very pleased to show that Mino-Lok appears to be more effective, and work more expeditiously, than even ethanol," commented Myron Holubiak, Chief Executive Officer of Citius. "It has been demonstrated in earlier studies and reports that all three components of Mino-Lok are necessary to eradicate MRSA and Candida parapsilosis. More recently we showed that MLT was effective in vitro against 10 strains of Candida Auris. All of these pathogens are of great concern in cancer patients with central lines. As we approach the final stages of our pivotal trial, we are very excited to be able to report new findings about Mino-Lok. Our pivotal trial is designed to show the superiority of Mino-Lok to standard antibiotic locks in time-to-catheter-failure. If all these studies prove to be successful, we believe ready to use Mino-Lok will be superior to local pharmacy mixed antibiotic locks in both efficacy and dosing schedules."

    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). There are currently no approved therapies for salvaging infected CVCs. Mino-Lok is used 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. 

    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 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; 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; our need for substantial additional funds; the estimated markets for our product candidates, and the acceptance thereof by any market; 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

    (M) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citius-announces-results-of-study-that-mino-lok-eradicates-s-aureus-biofilm-more-effectively-and-expeditiously-than-components-301180863.html

    SOURCE Citius Pharmaceuticals, Inc.

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  19. CRANFORD, N.J., Nov. 10, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that management will present at the Virtual Fall Investor Summit to be held virtually on November 16-18, 2020. Leonard Mazur, Chairman of Citius, will deliver a corporate overview of the Company on Monday, November 16, at 1:00 p.m. Eastern Time. Mr. Mazur will also conduct virtual one-on-one meetings with investors during the conference.

    Mr. Mazur will provide updates on Mino-Wrap, a novel approach to reducing post-operative infections associated with surgical implants, and Mino-Lok®, an antibiotic lock treatment for…

    CRANFORD, N.J., Nov. 10, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that management will present at the Virtual Fall Investor Summit to be held virtually on November 16-18, 2020. Leonard Mazur, Chairman of Citius, will deliver a corporate overview of the Company on Monday, November 16, at 1:00 p.m. Eastern Time. Mr. Mazur will also conduct virtual one-on-one meetings with investors during the conference.

    Mr. Mazur will provide updates on Mino-Wrap, a novel approach to reducing post-operative infections associated with surgical implants, and Mino-Lok®, an antibiotic lock treatment for catheter-related bloodstream infections (CRBSIs), being developed in collaboration with M.D. Anderson Cancer Center. Citius recently in-licensed its induced mesenchymal stem cells (iMSCs) on a worldwide basis through its majority-owned subsidiary NoveCite, Inc., to potentially treat and reduce the severity of acute respiratory distress syndrome (ARDS) associated with COVID-19.

    Webcast: https://www.webcaster4.com/Webcast/Page/2038/38394

    Recent Company highlights include:

    • The signing of an exclusive worldwide license agreement with Novellus Therapeutics, Limited for a cellular therapy to treat acute respiratory distress syndrome (ARDS), a leading complication of COVID-19
    • Received positive second interim analysis report from the independent Drug Monitoring Committee (DMC) for the Mino-Lok pivotal Phase 3 trial
    • Submission of a pre-investigational new drug (PIND) consultation request for Mino-Wrap with written response and guidance from the FDA expected in November 2020

    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.

    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 clinical trials and drug development; our dependence on third-party suppliers; our need for substantial additional funds; patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; the estimated markets for our product candidates and the acceptance thereof by any market; 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; government regulation; 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

    (M) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-at-virtual-fall-investor-summit-301169789.html

    SOURCE Citius Pharmaceuticals, Inc.

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  20. CRANFORD, N.J., Nov. 9, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that it will present at the H.C. Wainwright 6th Annual Israel Conference to be held virtually on November 12, 2020. Myron Holubiak, Chief Executive Officer of Citius, will provide an update of the Company's products under development and provide an overview on Thursday, November 12, at 2:30 p.m. Eastern Time. Mr. Holubiak will also conduct virtual one-on-one meetings with investors during the conference.

    Webcast: https://journey.ct.events/view/43d1a83f-22aa-464f-a250-de8240b51195

    The Company recently issued its October

    CRANFORD, N.J., Nov. 9, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced that it will present at the H.C. Wainwright 6th Annual Israel Conference to be held virtually on November 12, 2020. Myron Holubiak, Chief Executive Officer of Citius, will provide an update of the Company's products under development and provide an overview on Thursday, November 12, at 2:30 p.m. Eastern Time. Mr. Holubiak will also conduct virtual one-on-one meetings with investors during the conference.

    Webcast: https://journey.ct.events/view/43d1a83f-22aa-464f-a250-de8240b51195

    The Company recently issued its October 2020 Letter to Shareholders, highlighting recent updates on its business and clinical developments and news for its pipeline of products.

    To view the Company's Corporate Update Letter, please visit:

    https://www.citiuspharma.com/wp-content/uploads/2020/10/CTXR_October-2020_Shareholder-Letter_final.pdf

    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.

    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 clinical trials and drug development; our dependence on third-party suppliers; our need for substantial additional funds; patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; the estimated markets for our product candidates and the acceptance thereof by any market; 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; government regulation; 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

    (M) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-at-hc-wainwright-6th-annual-israel-conference-301168593.html

    SOURCE Citius Pharmaceuticals, Inc.

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  21. CAMBRIDGE, Mass., Oct. 13, 2020 /PRNewswire/ -- Novellus Therapeutics ("Novellus"), an engineered cellular medicines company, announced today that it has licensed its induced mesenchymal stem cells (iMSCs) on a worldwide basis to NoveCite, Inc., a newly formed subsidiary of Citius Pharmaceuticals, Inc. ("Citius") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products. NoveCite will develop and commercialize Novellus's iMSCs to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ("ARDS") associated with COVID-19. Novellus is a 25% equity holder in NoveCite. Novellus received a $5 million upfront payment, and is eligible to receive up…

    CAMBRIDGE, Mass., Oct. 13, 2020 /PRNewswire/ -- Novellus Therapeutics ("Novellus"), an engineered cellular medicines company, announced today that it has licensed its induced mesenchymal stem cells (iMSCs) on a worldwide basis to NoveCite, Inc., a newly formed subsidiary of Citius Pharmaceuticals, Inc. ("Citius") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products. NoveCite will develop and commercialize Novellus's iMSCs to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ("ARDS") associated with COVID-19. Novellus is a 25% equity holder in NoveCite. Novellus received a $5 million upfront payment, and is eligible to receive up to $51 million in development milestone payments, as well as low double-digit royalties.

    Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite

    iMSCs are a next-generation cell therapy product created from induced pluripotent stem cells (iPSCs) with the following advantages:

    • Created using a patented non-immunogenic mRNA cell reprogramming process
    • Derived from a single donor and produced from a clonal, perpetual master cell bank
    • Streamlined manufacturing process enables near-unlimited supply
    • Superior immunomodulatory protein secretion compared to donor-derived MSCs

    "Novellus's iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of their high potency as demonstrated in our pre-clinical studies, as well as our ability to cost-effectively provide high doses and repeat doses." said Myron Holubiak, CEO of Citius.

    "We are excited to be developing iMSCs because of their promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by COVID-19," said Matt Angel, Chief Science Officer of Novellus. He continued, "Our iMSCs have multimodal immunomodulatory mechanisms of action that make them promising for treatment of acute respiratory diseases."

    About Novellus Therapeutics Limited

    Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its patented non-immunogenic mRNA, high-specificity gene editing, mutation-free & footprint-free cell reprogramming and serum-insensitive mRNA lipid delivery technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit www.novellustx.com.

    About NoveCite, Inc.

    NoveCite, Inc. is a newly formed subsidiary of Citius Pharmaceuticals, 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.

    Contact:

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/novellus-therapeutics-exclusively-licenses-induced-mesenchymal-stem-cells-imscs-to-novecite-for-covid-19-related-acute-respiratory-distress-syndrome-ards-and-other-acute-respiratory-conditions-301150738.html

    SOURCE Novellus Therapeutics

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  22. CRANFORD, N.J., Oct. 7, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, announced that it has signed an exclusive agreement with Novellus Therapeutics Limited ("Novellus") to license iPSC-derived mesenchymal stem cells (iMSCs), and has created a new subsidiary, NoveCite, that will be focused on developing cellular therapies.

    NoveCite has a worldwide exclusive license from Novellus, an engineered cellular medicines company, to develop and commercialize NoveCite mesenchymal stem cells ("NC-iMSCs") to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ("ARDS") associated…

    CRANFORD, N.J., Oct. 7, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, announced that it has signed an exclusive agreement with Novellus Therapeutics Limited ("Novellus") to license iPSC-derived mesenchymal stem cells (iMSCs), and has created a new subsidiary, NoveCite, that will be focused on developing cellular therapies.

    NoveCite has a worldwide exclusive license from Novellus, an engineered cellular medicines company, to develop and commercialize NoveCite mesenchymal stem cells ("NC-iMSCs") to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ("ARDS") associated with COVID-19. Several cell therapy companies using donor-derived MSC therapies in treating ARDS have demonstrated that MSCs reduce inflammation, enhance clearance of pathogens and stimulate tissue repair in the lungs. Almost all these positive results are from early clinical trials or under the emergency authorization program.  

    NC-iMSCs are the next generation mesenchymal stem cell therapy.  They are believed to be differentiated and superior to donor-derived MSCs.  Human donor-derived MSCs are sourced from human bone marrow, adipose tissue, placenta, umbilical tissue, etc. and have significant challenges (e.g., variable donor and tissue sources, limited supply, low potency, inefficient and expensive manufacturing). iMSCs overcome these challenges because they:

    • Are more potent and secrete exponentially higher levels of immunomodulatory proteins;
    • Have practically unlimited supply for high doses and repeat doses;
    • Are from a single donor and clonal so they are economically produced at scale with consistent quality and potency, as well as being footprint free (compared to viral reprogramming methods); and,
    • Have significantly higher expansion capability.

    Globally, there are 3 million cases of ARDS every year out of which approximately 200,000 cases are in the United States. The COVID-19 pandemic has added significantly to the number of ARDS cases. Once the COVID patients advance to ARDS, they are put on mechanical ventilators.  Death rate among  patients on ventilators can be as high as 50% depending on associated co-morbidities.  There are no approved treatments for ARDS, and the current standard of care only attempts to provide symptomatic relief.

    "NoveCite iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of the high potency seen in Novellus' pre-clinical studies, and because iMSCs are iPSC-derived, and therefore overcome the manufacturing challenges associated with donor derived cells," said Myron Holubiak, Chief Executive Officer of Citius.

    "We are excited to be part of this effort because of the promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by COVID-19," said Dr. Matthew Angel, Chief Science Officer of Novellus.  "Our iMSC technology has multimodal immunomodulatory mechanisms of action that make it potentially promising therapy to treat acute respiratory diseases."

    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 Novellus, Therapeutics, Limited

    Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its patented non-immunogenic mRNA high specificity gene editing, mutation-free & footprint-free cell reprogramming and serum insensitive mRNA lipid delivery technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit www.novellus-inc.com.

    About NoveCite iMSC (NC-iMSC)

    NoveCite's mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The NC-iMSCs produced from this clonal technique are differentiated from human donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, NC-iMSCs exhibit superior potency and high cell viability. NC-iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. NC-iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

    First generation (human donor-derived) MSCs are isolated from donated tissue followed by "culture expansion". Since only a relatively small number of cells are isolated from each donation, first generation MSCs are increased by growing the cells in culture. Unfortunately, these type of MSCs start to lose potency, and ultimately become senescent. Each donation produces a limited number of MSCs, so a continuous supply of new donors is needed to produce commercial scale. The number and quality of MSCs that can be isolated from different donors can vary substantially.

    About Acute Respiratory Distress Syndrome (ARDS)

    ARDS is an inflammatory process leading to build-up of fluid in the lungs and respiratory failure. It can occur due to infection, trauma and inhalation of noxious substances. ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation. Survivors of ARDS are often left with severe long-term illness and disability.  ARDS is a frequent complication of patients with COVID-19. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

    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: the risks associated with developing the NoveCite technology as a treatment for ARDS; risks associated with developing any of our product candidates, including any licensed from Novellus, Inc., including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; our need for substantial additional funds; the estimated markets for our product candidates, including those for ARDS, 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, including the NoveCite technology; our ability to obtain, perform under and maintain licensing, financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; 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

    (M) 646-522-8410

     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-signs-an-exclusive-worldwide-licensing-agreement-with-novellus-therapeutics-for-unique-imsc-therapy-for-acute-inflammatory-respiratory-conditions-including-covid-19-related-acute-respiratory-distress-syndrom-301147409.html

    SOURCE Citius Pharmaceuticals, Inc.

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  23. CRANFORD, N.J., Sept. 30, 2020 /PRNewswire/ -- 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 the Mino-Lok Clinical Trial Material (CTM) at each of the clinical sites has been replaced with registration batch product.  This means that going forward subjects enrolled in the trial will be treated with Mino-Lok that was manufactured with same process that will be used commercially should FDA approval be obtained. 

    "We are extremely pleased to be able provide common packaging for the 2 Mino-Lok components and to resupply our clinical sites with registration product," said Myron Holubiak, Chief Executive…

    CRANFORD, N.J., Sept. 30, 2020 /PRNewswire/ -- 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 the Mino-Lok Clinical Trial Material (CTM) at each of the clinical sites has been replaced with registration batch product.  This means that going forward subjects enrolled in the trial will be treated with Mino-Lok that was manufactured with same process that will be used commercially should FDA approval be obtained. 

    "We are extremely pleased to be able provide common packaging for the 2 Mino-Lok components and to resupply our clinical sites with registration product," said Myron Holubiak, Chief Executive Officer of Citius.  Holubiak continues, "It's also important to note that we are prepared to immediately move to validation / commercial manufacturing upon completing our phase 3 clinical trial and receiving FDA clearance."

    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 associated with conducting clinical trials and drug development; our dependence on third-party suppliers;  our need for substantial additional funds; patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned NoveCite therapy for ARDS; the estimated markets for our product candidates and the acceptance thereof by any market; 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; government regulation; 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

    (M) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citiuss-mino-lok-trial-sites-resupplied-with-registration-batch-product-301141840.html

    SOURCE Citius Pharmaceuticals, Inc.

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  24. CRANFORD, N.J., Sept. 29, 2020 /PRNewswire/ -- 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 a Data Monitoring Committee (DMC) meeting was held to review the data being generated and analyzed in the Mino-Lok phase 3 trial, and to make recommendations to Citius as to any action that may be necessary regarding the study. 

    After reviewing these data, the DMC members stated that they did not find any safety signals; and they also recommended continuing the trial without any modifications. The DMC further requested to have an ad hoc meeting in the near future. 

    The Data Monitoring committee is…

    CRANFORD, N.J., Sept. 29, 2020 /PRNewswire/ -- 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 a Data Monitoring Committee (DMC) meeting was held to review the data being generated and analyzed in the Mino-Lok phase 3 trial, and to make recommendations to Citius as to any action that may be necessary regarding the study. 

    After reviewing these data, the DMC members stated that they did not find any safety signals; and they also recommended continuing the trial without any modifications. The DMC further requested to have an ad hoc meeting in the near future. 

    The Data Monitoring committee is an independent panel of experts that review progress regarding the safety and efficacy of drugs in clinical trials, and to determine if the trial may be futile in achieving its endpoints or if the trial should be modified in any way. 

    "We are very pleased with the outcome of the DMC's independent review of the Mino-Lok data.  This information is very encouraging and supports the confidence that we have long held in the safety and efficacy of Mino-Lok," said Myron Holubiak, Chief Executive Officer of Citius. "Despite challenges in recruiting patients recently due to the  COVID-19 pandemic, we have continued to recruit patients and are now approaching the late stage of our pivotal study." Holubiak continued, "I want to thank the DMC committee members for their thoughtful review, and also all of the study investigators and their staff that continue to support our trial in these challenging times." 

    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 relating to the results of research and development activities; risks associated with conducting clinical trials and drug development; our need for substantial additional funds; our dependence on third-party suppliers; patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned NoveCite therapy for ARDS; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; 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; government regulation; 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

    (M) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-reports-positive-results-from-recent-data-monitoring-committee-meeting-for-mino-lok-phase-3-trial-301140033.html

    SOURCE Citius Pharmaceuticals, Inc.

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  25. CRANFORD, N.J., Sept. 22, 2020 /PRNewswire/ -- 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 has achieved a number of significant milestones over the past several weeks for Mino-Lok®.

    Mino-Lok is an antibiotic lock solution being developed as an adjunctive therapy for patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). Mino-Lok contains three active drug substances (minocycline, ethanol and EDTA) which are combined into two vials, MLT01 (minocycline) and MLT02 (ethanol and EDTA).  Citius has manufactured three registration…

    CRANFORD, N.J., Sept. 22, 2020 /PRNewswire/ -- 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 has achieved a number of significant milestones over the past several weeks for Mino-Lok®.

    Mino-Lok is an antibiotic lock solution being developed as an adjunctive therapy for patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). Mino-Lok contains three active drug substances (minocycline, ethanol and EDTA) which are combined into two vials, MLT01 (minocycline) and MLT02 (ethanol and EDTA).  Citius has manufactured three registration lots of Mino-Lok using the commercial manufacturing process, which will be filed in the planned New Drug Application (NDA). Citius has placed all registration lots on stability at the appropriate ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) conditions to support the NDA filing. Citius has also developed a new exclusive synthesis process for disodium edetate ("EDTA"), a chelating agent which supplants heparin as the anti-clotting agent in Mino-Lok.

    NDAs are applications to request permission to market a drug product in the U.S. for a specific use. Chemistry, manufacturing, and controls (CMC) information is therefore submitted in the NDA to ensure product quality as it relates to the safety and efficacy of the drug product.

    "A typical drug approval contains one drug substance, so for all practical purposes our team has developed three products. Mino-Lok is unique in many ways, this being one of them," said Myron Holubiak, Chief Executive Officer of Citius. "It's important to know that we expect to be prepared to immediately move to validation/commercial manufacturing upon the completion of our Phase 3 clinical trial and receiving the required FDA clearance."

    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 associated with conducting clinical trials and drug development; our dependence on third-party suppliers patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned NoveCite therapy for ARDS; the estimated markets for our product candidates and the acceptance thereof by any market; 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; government regulation; 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

    (M) 646-522-8410

     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-achieves-chemical-manufacturing-and-control-milestones-for-mino-lok-301135361.html

    SOURCE Citius Pharmaceuticals, Inc.

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  26. CRANFORD, N.J., Sept. 15, 2020 /PRNewswire/ -- 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 has filed an amendment to its Mino-Lok phase 3 protocol. This amendment was designed to allow for more efficient follow-up and record-keeping of required clinical trial documentation given COVID-19 restrictions. With personal visits having been severely restricted, Citius issued instructions in the form of file notes to sites in April and has now formalized these instructions. The FDA released guidance on conduct of clinical trials of medical products during COVID-19 in March 2020, updated in July

    CRANFORD, N.J., Sept. 15, 2020 /PRNewswire/ -- 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 has filed an amendment to its Mino-Lok phase 3 protocol. This amendment was designed to allow for more efficient follow-up and record-keeping of required clinical trial documentation given COVID-19 restrictions. With personal visits having been severely restricted, Citius issued instructions in the form of file notes to sites in April and has now formalized these instructions. The FDA released guidance on conduct of clinical trials of medical products during COVID-19 in March 2020, updated in July 2020.

    "In these challenging times we are working closely with our Principle Investigators (PIs) and their staff to keep the enormous amount of record-keeping associated with any clinical trial as simple and accurate as possible," said Myron Holubiak, Chief Executive Officer of Citius. Holubiak continues, "We have been pleased with the responsiveness of our partners and internal team to today's ever-changing situation. Like all other companies, Citius is facing significant challenges in maintaining progress in its clinical trials. We are especially affected since our site-of-care is frequently the ICU, which is the most resource-stressed site in the hospital because of COVID-19. We expect to be able to conduct our Drug Monitoring Committee meeting as planned at the end of the month, and we look forward to our discussions with these independent experts."

    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 associated with conducting clinical trials and drug development;  patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned NoveCite therapy for ARDS; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; 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; government regulation; 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

    (M) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citius-files-addendum-to-mino-lok-phase-3-trial-record-keeping-protocol-to-advance-trials-with-covid-19-compliance-301131345.html

    SOURCE Citius Pharmaceuticals, Inc.

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  27. CRANFORD, N.J., Sept. 8, 2020 /PRNewswire/ -- 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 its management is scheduled to present at the H.C. Wainwright 22nd Annual Global Investment Conference to be held virtually on September 14-16, 2020. Leonard Mazur, Chairman of Citius, will present on Tuesday, September 15, at 11:00 a.m. Eastern Time where he will deliver a corporate overview of the Company.

    In addition he will be providing updates that include the recent expansion of the Company's intellectual property for Mino-Wrap, a novel approach to reducing post-operative infections associated…

    CRANFORD, N.J., Sept. 8, 2020 /PRNewswire/ -- 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 its management is scheduled to present at the H.C. Wainwright 22nd Annual Global Investment Conference to be held virtually on September 14-16, 2020. Leonard Mazur, Chairman of Citius, will present on Tuesday, September 15, at 11:00 a.m. Eastern Time where he will deliver a corporate overview of the Company.

    In addition he will be providing updates that include the recent expansion of the Company's intellectual property for Mino-Wrap, a novel approach to reducing post-operative infections associated with surgical implants, future plans to potentially treat and reduce the severity of acute respiratory distress syndrome (ARDS) associated with COVID-19, and Mino-Lok®, an antibiotic lock treatment for catheter-related bloodstream infections (CRBSIs), in collaboration with MDACC.

    Webcast: https://wsw.com/webcast/hcw7/ctxr/1629433

    Mr. Mazur will conduct virtual one-on-one meetings with investors during the conference. 

    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.

    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: the risk of successfully negotiating within the option period a license agreement with Novellus; risks associated with conducting clinical trials and drug development; market and other conditions; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds;, Inc. for our planned Novecite therapy for ARDS; the estimated markets for our product candidates and the acceptance thereof by any market; 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; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-at-hc-wainwright-virtual-22nd-annual-global-investment-conference-301124698.html

    SOURCE Citius Pharmaceuticals, Inc.

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  28. CRANFORD, N.J., Aug. 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced that it has expanded the intellectual property associated with its global license agreement with the MD Anderson Cancer Center ("MDACC").  Through this license agreement, Citius is developing Mino-Wrap, which is a novel approach to reducing post-mastectomy infections associated with the use of a tissue expander ("TE").

    The United States Patent and Trademark Office (USPTO) has issued patent 10,434,221 B2 and patent application publication US 2019/0388591 A1, both continuations of the initial patent for  "Antimicrobial…

    CRANFORD, N.J., Aug. 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced that it has expanded the intellectual property associated with its global license agreement with the MD Anderson Cancer Center ("MDACC").  Through this license agreement, Citius is developing Mino-Wrap, which is a novel approach to reducing post-mastectomy infections associated with the use of a tissue expander ("TE").

    The United States Patent and Trademark Office (USPTO) has issued patent 10,434,221 B2 and patent application publication US 2019/0388591 A1, both continuations of the initial patent for  "Antimicrobial Wraps for Medical Implants".

    The intellectual property expansion was granted to The Board of Regents of The University of Texas System on behalf of The University of Texas M. D. Anderson Cancer Center and enhances the design and use of Mino-Wrap. 

    "The frequency of post-mastectomy breast reconstruction, following breast cancer treatment, has been increasing on an annual basis. There are over 100,000 patients in the U.S. undergoing breast reconstruction procedures following mastectomies and approximately 80% of the time, a TE is used to prepare the surgical site for breast implants either immediately after mastectomy or in a separate procedure afterwards. The published rate of infection for TEs used in breast reconstructive surgery is between 2.5 % and 24%, with an estimated mean at around 12% to 14%.  These data points are concerning and not well understood. Through our agreement with MDACC, we believe Mino-Wrap has the potential to provide a significant reduction in the incidence of infection, sparing the patient the pain and discomfort of extended hospitalization and further aggressive and lengthy courses of antibiotics in an attempt to salvage the TEs. In many cases the TE is removed leading to a delay in lifesaving chemo-radiation therapy, which can be a devastating consequence for the patient. " said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We are especially pleased that the claims for Mino-Wrap intellectual property are being expanded and broadened as we develop the optimal design and application."

    The Company is also currently developing Mino-Lok®, an antibiotic lock treatment for catheter-related bloodstream infections (CRBSIs), in collaboration with MDACC. Mino-Lok is in phase 3 development.   

    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-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 is designed to provide 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. 

    About Tissue Expanders and Infection Risk

    A common breast reconstruction technique is tissue expansion, which involves expansion of the breast skin and muscle using a temporary tissue expander. A tissue expander is an empty breast implant that is filled with normal saline over 6 to 8 weeks until it reaches the breast size that is desired. In this type of reconstruction, the surgeon will either make a pocket under a large muscle in the chest and place a tissue expander in that space or place the expander above the large muscle. About 4 to 8 weeks after the tissue expansion is finished, a second surgery is required to remove the tissue expander and insert the permanent breast implant. The patient receives either microvascular flap reconstruction, or the insertion of a permanent breast implant. Infection is one of the most common complications of tissue expanders and implants during breast reconstruction, with an infection rate ranging from 2.5 to 24 percent.

    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).

    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: patent and intellectual property matters, market and other conditions; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned Novecite therapy for ARDS; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; 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; government regulation; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-improved-design-and-expansion-of-intellectual-property-for-mino-wrap-301118677.html

    SOURCE Citius Pharmaceuticals, Inc.

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  29. CRANFORD, N.J., Aug. 13, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that the company will deliver a presentation at the MoneyShow Las Vegas Virtual Expo that is being held August 18 – 20, 2020.

         Event: MoneyShow Las Vegas Virtual Expo

         Presentation Date: Wednesday, August 19, 2020

         Presentation Time: 4:50 PM ET

    Mr. Leonard Mazur, Chairman of Citius, will provide an overview of the Company, including the recent closing of a $9.6 million public offering of common stock, and the recent submission of a briefing package to the FDA Division of Anti-Infective Products…

    CRANFORD, N.J., Aug. 13, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that the company will deliver a presentation at the MoneyShow Las Vegas Virtual Expo that is being held August 18 – 20, 2020.

         Event: MoneyShow Las Vegas Virtual Expo

         Presentation Date: Wednesday, August 19, 2020

         Presentation Time: 4:50 PM ET

    Mr. Leonard Mazur, Chairman of Citius, will provide an overview of the Company, including the recent closing of a $9.6 million public offering of common stock, and the recent submission of a briefing package to the FDA Division of Anti-Infective Products regarding Mino-Wrap, a novel approach to reducing post-operative infections associated with surgical implants.

    To listen to the live webcast, investors will need to register for the MoneyShow Las Vegas Virtual Expo first at the following link:

    https://online.moneyshow.com/2020/august/moneyshow-las-vegas-virtual-expo/speakers/5476acba10114c999696c5b87c393151/leonard-mazur/?scode=050920 

    Once registered, investors can then access the MoneyShow Las Vegas Virtual Expo platform beginning the morning of August 18, 2020 at:

    https://online.moneyshow.com/2020/august/moneyshow-las-vegas-virtual-expo/platform/login

    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.

    Contact:

    Andrew Scott                

    Vice President, Corporate Development 

    (O) 908-967-6677 x105

     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-at-the-moneyshow-las-vegas-virtual-expo-301111898.html

    SOURCE Citius Pharmaceuticals, Inc.

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  30. CRANFORD, N.J., Aug. 10, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today the closing of its previously announced underwritten public offering of 9,159,524 shares of common stock of the Company, including the exercise in full by the underwriter of the option to purchase an additional 1,194,720 shares of common stock, at a price to the public of $1.05 per share.

    H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

    The gross proceeds to Citius, before deducting underwriting discounts and commissions and offering expenses, are approximately $9.6 million

    CRANFORD, N.J., Aug. 10, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today the closing of its previously announced underwritten public offering of 9,159,524 shares of common stock of the Company, including the exercise in full by the underwriter of the option to purchase an additional 1,194,720 shares of common stock, at a price to the public of $1.05 per share.

    H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

    The gross proceeds to Citius, before deducting underwriting discounts and commissions and offering expenses, are approximately $9.6 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including its Phase 3 clinical Mino-Lok® trial for the treatment of catheter related bloodstream infections, development of Mino-Wrap, its Phase 2b trial of Halo-Lido cream for the treatment of hemorrhoids, its other product development initiatives and working capital and capital expenditures.

    The shares of common stock were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-221492) originally filed with the Securities and Exchange Commission (the "SEC") on November 9, 2017, and declared effective by the SEC on December 15, 2017. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or e-mail at .

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

    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.

    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 and include, among others, statements regarding the intended use of net proceeds from the public offering. Factors that could cause actual results to differ materially from those currently anticipated are: market and other conditions; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned Novecite therapy for ARDS; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; 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; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-closing-of-9-6-million-bought-deal-offering-and-full-exercise-of-underwriters-option-to-purchase-additional-shares-301109357.html

    SOURCE Citius Pharmaceuticals, Inc.

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  31. CRANFORD, N.J., Aug. 5, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 5,714,286 shares of common stock of the Company, at a price to the public of $1.05 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about August 10, 2020, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering…

    CRANFORD, N.J., Aug. 5, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 5,714,286 shares of common stock of the Company, at a price to the public of $1.05 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about August 10, 2020, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to an additional 857,142 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Citius, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter's option to purchase additional common stock, are expected to be approximately $6.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including its Phase 3 clinical Mino-Lok trial for the treatment of catheter related bloodstream infections, development of Mino-Wrap, its Phase 2b trial of Halo-Lido cream for the treatment of hemorrhoids, its other product development initiatives and working capital and capital expenditures.  

    The shares of common stock are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-221492) originally filed with the Securities and Exchange Commission (the "SEC") on November 9, 2017, and declared effective by the SEC on December 15, 2017. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov.  Electronic copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or e-mail at .

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

    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.

    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 and include, among others, statements regarding the completion of the public offering, the satisfaction of customary closing conditions related to the public offering and the intended use of net proceeds from the public offering. Factors that could cause actual results to differ materially from those currently anticipated are: market and other conditions; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned Novecite therapy for ARDS; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; 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; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-6-0-million-bought-deal-offering-301107128.html

    SOURCE Citius Pharmaceuticals, Inc.

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  32. CRANFORD, N.J., Aug. 4, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products announced progress in the development of Mino-Wrap, a novel approach to reducing post-operative infections associated with surgical implants.

    Mino-Wrap is a gel-containing minocycline and rifampin film that is used to wrap the tissue expander ("TE") used in breast reconstructive surgeries.  In order to stimulate early consultation and potentially speed the development of Mino-Wrap, the company has submitted a briefing package to the FDA Division of Anti-Infective Products.  The briefing package contains information regarding pre-clinical…

    CRANFORD, N.J., Aug. 4, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products announced progress in the development of Mino-Wrap, a novel approach to reducing post-operative infections associated with surgical implants.

    Mino-Wrap is a gel-containing minocycline and rifampin film that is used to wrap the tissue expander ("TE") used in breast reconstructive surgeries.  In order to stimulate early consultation and potentially speed the development of Mino-Wrap, the company has submitted a briefing package to the FDA Division of Anti-Infective Products.  The briefing package contains information regarding pre-clinical data and a clinical development plan, along with questions for the FDA regarding safety and efficacy data that would be required to advance Mino-Wrap into clinical trials. The company will consider the feedback provided by the FDA in the development of the Pre-IND.  There is no set timeline for FDA to respond to a consultation package; however, based on pre-COVID-19 experience, we expect a response from FDA within 60 days.

    Mino-Wrap also marks the second collaboration with MD Anderson Cancer Center ("MDACC") who are the inventors of this novel approach to preventing post-mastectomy infections when tissue expanders are used. The Company is currently developing Mino-Lok®, an antibiotic lock treatment for catheter-related bloodstream infections (CRBSIs), in collaboration with MDACC. Mino-Lok is in phase 3 development.   

    "The published rate of infection for tissue expanders used in breast reconstructive surgery is between 2.5 % and 24%, with an estimated mean at around 12% to 14%.  We believe Mino-Wrap has the potential to provide a significant reduction in the incidence of infection, sparing the patient the pain and discomfort of extended hospitalization and further aggressive and lengthy courses of antibiotics in an attempt to salvage the TEs. In many cases the TE is removed leading to a delay in lifesaving chemo-radiation therapy, which can be a devastating consequence for the patient," said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We also are extremely honored to be working with the doctors and scientists at MD Anderson Cancer Center to develop another much-needed improvement in adjunctive cancer care. The early consultation with FDA allows for the identification of optimal strategies for our preclinical and clinical development programs.  We are pleased to be taking advantage of this collaborative approach with the agency."

    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 is designed to provide 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. 

    About Tissue Expanders and Infection Risk

    A common breast reconstruction technique is tissue expansion, which involves expansion of the breast skin and muscle using a temporary tissue expander. A tissue expander is an empty breast implant that is filled with normal saline over 6 to 8 weeks until it reaches the breast size that is desired. In this type of reconstruction, the surgeon will either make a pocket under a large muscle in the chest and place a tissue expander in that space or place the expander above the large muscle. About 4 to 8 weeks after the tissue expansion is finished, a second surgery is required to remove the tissue expander and insert the permanent breast implant. The patient receives either microvascular flap reconstruction, or the insertion of a permanent breast implant. Infection is one of the most common complications of tissue expanders and implants during breast reconstruction, with an infection rate ranging from 2.5 to 24 percent.

    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).

    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 FDA response to  our pre-IND briefing package for Mino-Wrap and, depending on the response, our ability to successfully undertake and complete clinical trials and the results from those trials; 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, including Mino-Wrap; 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

     

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    SOURCE Citius Pharmaceuticals, Inc.

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  33. CRANFORD, N.J., July 22, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("CITIUS") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today the formation of the Citius ARDS (Acute Respiratory Distress Syndrome) Scientific Advisory Board to provide the company expert guidance on  its planned development of induced mesenchymal stem cells (iMSCs) under option from Novellus, Inc. to treat and reduce the severity of acute respiratory distress syndrome (ARDS) associated with COVID -19. 

    The ARDS Advisory Board consultants are:
    Michael A. Matthay, MD, Professor of Medicine and Anesthesia at the University of California at San Francisco (UCSF), a Senior Associate…

    CRANFORD, N.J., July 22, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("CITIUS") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today the formation of the Citius ARDS (Acute Respiratory Distress Syndrome) Scientific Advisory Board to provide the company expert guidance on  its planned development of induced mesenchymal stem cells (iMSCs) under option from Novellus, Inc. to treat and reduce the severity of acute respiratory distress syndrome (ARDS) associated with COVID -19. 

    The ARDS Advisory Board consultants are:

    Michael A. Matthay, MD, Professor of Medicine and Anesthesia at the University of California at San Francisco (UCSF), a Senior Associate at the Cardiovascular Research Institute, and Associate Director of the Critical Care Medicine at UCSF. Dr. Matthay's basic research has focused on the pathogenesis and resolution of the acute respiratory distress syndrome (ARDS), with an emphasis on translational work and patient-based research, including clinical trials. Dr. Matthay's recent research has focused on the biology and potential clinical use of allogeneic bone marrow derived mesenchymal stromal cells (MSCs) for ARDS. He is currently leading the "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)," a United States Department of Defense supported study of MSCs for ARDS.

    Mitchell M. Levy, MD, Chief, Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, The Warren Alpert Medical School of Brown University, where he is Professor of Medicine.  Dr. Levy also serves as Medical Director of the Medical ICU at Rhode Island Hospital. He has been an investigator on numerous pharmacologic and biologic trials intended to treat sepsis, cardiovascular and pulmonary pathology. He has expertise in trial design, clinical trial execution and trial management and is one of the three founding members of the Surviving Sepsis Campaign (SSC). Dr. Levy is Past-President of the Society of Critical Care Medicine (2009). 

    Lorraine B. Ware, MD, Professor of Medicine and Ralph and Lulu Owen Endowed Chair, Professor of Pathology, Microbiology and Immunology, Vanderbilt University; Director, Vanderbilt Medical Scholars Program.  Dr. Lorraine Ware's comprehensive bench-to-bedside research program centers on the pathogenesis and treatment of sepsis and acute lung injury with a current focus on mechanisms of lung epithelial and endothelial oxidative injury by cell-free hemoglobin.  Dr. Ware is also a lead investigator for the "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)" study.

    "We are extremely pleased to have been able to attract such a prestigious group of experts to advise and guide us in the Company's planned development of iMSC's for the treatment of ARDS" said Mr. Myron Holubiak, CEO of Citius.  "These individuals are recognized opinion leaders and expert in the planning and execution of clinical trials in this therapeutic area. We will be seeking their advice in all phases of our clinical trial design."

    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 Citius iMSC

    Citius's planned induced mesenchymal stem cell (iMSC) product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary non-immunogenic and non-viral mRNA-based (non-viral) reprogramming process. Unlike the MSCs derived from bone marrow, placenta, umbilical cord, or adipose tissue these proprietary iMSCs are based on a clonal process and therefore are genetically homogeneous and exhibit superior potency and higher cell viability.  The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from an iMSC master cell bank. The master cell bank produces "off-the-shelf" iMSCs that are uniform as compared to MSCs using donor-sourced cells, which is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy.  In vitro studies demonstrate that iMSCs are shown to secrete higher levels of immunomodulatory proteins than donor-derived cells, and may reduce or prevent pulmonary injury associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19.

    About Acute Respiratory Distress Syndrome (ARDS)

    ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients – most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

    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:  the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned iMSCs therapy for ARDS; our need for substantial additional funds; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; 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; 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

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    SOURCE Citius Pharmaceuticals, Inc.

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  34. CRANFORD, N.J., July 20, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that the company will deliver a presentation at the MoneyShow Accredited Investor Virtual Event that is being held July 22 – 24, 2020.

    Event: MoneyShow Accredited Investor Virtual Event

    Presentation Date:  Wednesday, July 22, 2020

    Presentation Time:  10:40 AM ET

    Mr. Leonard Mazur, Chairman of Citius, will provide an update on the company's products under development. This presentation will be a live, interactive online event where investors can ask the Company questions in real-time. An archived webcast…

    CRANFORD, N.J., July 20, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that the company will deliver a presentation at the MoneyShow Accredited Investor Virtual Event that is being held July 22 – 24, 2020.

    Event: MoneyShow Accredited Investor Virtual Event

    Presentation Date:  Wednesday, July 22, 2020

    Presentation Time:  10:40 AM ET

    Mr. Leonard Mazur, Chairman of Citius, will provide an update on the company's products under development. This presentation will be a live, interactive online event where investors can ask the Company questions in real-time. An archived webcast will also be made available after the event.

    To listen to the live webcast, investors will need to register for the MoneyShow Accredited Virtual Event first at the following link:

    https://online.moneyshow.com/july-accredited-investor/registration/ 

    Once registered, investors can then access the MoneyShow Accredited Investor Virtual Event platform beginning the morning of July 22nd at:

    https://online.moneyshow.com/july-accredited-investor/platform/login 

    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.

    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: the risk of successfully negotiating a license agreement with Novellus, Inc. for a potential ARDS therapy within the option period; the ability to access the FDA's CTAP program for our planned ARDS therapy; risks associated with conducting our product candidates, including any licensed from Novellus, Inc., including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; our need for substantial additional funds; risks associated with developing Mino-Wrap,; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; 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; 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

     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-at-the-moneyshow-accredited-investor-virtual-event-301096248.html

    SOURCE Citius Pharmaceuticals, Inc.

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  35. CRANFORD, N.J., July 14, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that Myron S. Czuczman, M.D., has joined the company as Chief Medical Officer (CMO) and Executive Vice President. Dr. Czuczman was most recently Therapeutic Area Head, Vice President, Clinical Research and Development Global Lymphoma/CLL Program at Celgene Corporation.  At Celgene, he was responsible for worldwide clinical development in Lymphoma/CLL and for the development of all compounds from Proof-of-Principle through registration globally.

    Myron Holubiak, Citius CEO stated, "We are honored to have a…

    CRANFORD, N.J., July 14, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that Myron S. Czuczman, M.D., has joined the company as Chief Medical Officer (CMO) and Executive Vice President. Dr. Czuczman was most recently Therapeutic Area Head, Vice President, Clinical Research and Development Global Lymphoma/CLL Program at Celgene Corporation.  At Celgene, he was responsible for worldwide clinical development in Lymphoma/CLL and for the development of all compounds from Proof-of-Principle through registration globally.

    Myron Holubiak, Citius CEO stated, "We are honored to have a colleague as qualified as Dr. Czuczman join the Citius team.  He will be enormously helpful in furthering our development program for our planned iPSC-derived mesenchymal stem cell (iMSC) for the treatment of ARDS associated with CoVid-19.   This, coupled with the advanced Phase 3 trials underway for Mino-Lok® and preparing an IND for Mino-Wrap, add to the importance of bringing in an executive of Dr. Czuczman's expertise, experience, and caliber to the team."

    Prior to his tenure at Celgene, Dr. Czuczman served as Chief, Lymphoma/Myeloma Service in the Department of Medicine and Head of the Lymphoma Translational Research Laboratory in the Immunology Department at Roswell Park Comprehensive Cancer Center in Buffalo, NY where he attained the title of tenured Professor of Medicine and Oncology prior to joining Celgene.

    Dr. Czuczman received his M.D. from Pennsylvania State University of Medicine after graduating magna cum laude in Biochemistry from the University of Pittsburgh. He completed his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology fellowship training at Memorial Sloan-Kettering Cancer Center in New York, NY.

    Dr. Czuczman was a Founding Member and reviewer for the National Comprehensive Cancer Network (NCCN) Lymphoma Guidelines compendium panel for nearly twenty years and he has greater than 180 peer-reviewed publications.  He is a Diplomate in Internal Medicine, and is Board Certified in Medical Oncology and received numerous awards and accolades during his academic career.

    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.

    About Citius iMSC

    Citius's planned mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The iMSCs produced from this clonal technique are differentiated from adult donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, iMSCs exhibit superior potency and high cell viability. The iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

    About Acute Respiratory Distress Syndrome (ARDS)

    ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients – most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

    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: our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned Novecite therapy for ARDS; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; 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; 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

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    SOURCE Citius Pharmaceuticals, Inc.

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  36. CRANFORD, N.J., July 13, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced that it received notice from The Nasdaq Stock Market LLC ("NASDAQ") on July10, 2020 indicating that the Company has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) (the "Bid Price Rule") for continued listing on The NASDAQ Capital Market. Accordingly, the Company has regained compliance with the Bid Price Rule and NASDAQ considers the matter closed.

    About Citius Pharmaceuticals, Inc.

    Citius is a specialty pharmaceutical company dedicated to the development and commercialization…

    CRANFORD, N.J., July 13, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced that it received notice from The Nasdaq Stock Market LLC ("NASDAQ") on July10, 2020 indicating that the Company has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) (the "Bid Price Rule") for continued listing on The NASDAQ Capital Market. Accordingly, the Company has regained compliance with the Bid Price Rule and NASDAQ considers the matter closed.

    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 associated with continuing to meet the listing requirements of The Nasdaq Capital Market; risks associated with conducting clinical trials for our product candidates; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; risks associated with developing product candidates, including that preclinical results may not be predictive of clinical results and our ability to file an IND for any product candidate; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; 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; 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

     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-regains-compliance-with-nasdaq-listing-requirements-301091872.html

    SOURCE Citius Pharmaceuticals, Inc.

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  37. CRANFORD, N.J., June 29, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that its CEO, Myron Holubiak, is scheduled to appear as a featured guest on TD Ameritrade Network's The Watch List with host Nicole Petallides on Tuesday, June 30, 2020 at 1:20pm ET. Interested parties may view the live interview at https://tdameritradenetwork.com/.

    The Watch List, hosted by with Nicole Petallides, highlights a panel of experts ranging from industry-leading CEOs, analysts, and Wall Street influencers to discuss pressing topics moving the market and is intended to provide viewers with a status…

    CRANFORD, N.J., June 29, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that its CEO, Myron Holubiak, is scheduled to appear as a featured guest on TD Ameritrade Network's The Watch List with host Nicole Petallides on Tuesday, June 30, 2020 at 1:20pm ET. Interested parties may view the live interview at https://tdameritradenetwork.com/.

    The Watch List, hosted by with Nicole Petallides, highlights a panel of experts ranging from industry-leading CEOs, analysts, and Wall Street influencers to discuss pressing topics moving the market and is intended to provide viewers with a status update for the end of the trading day and beyond.

    Mr. Holubiak has extensive experience in managing and leading both large and emerging pharmaceutical and life sciences companies. He 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. As President of Roche, Mr. 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 its 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 was 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, as well as advanced training in health economics from the University of York's Centre for Health Economics.

    Ms. Petallides joined TD Ameritrade Network in December 2018 as a host based in New York City. Petallides was with FOX Business Network (FBN) where she anchored Fox Business Morning (2007) and FBN:AM (2016). For over a decade, she was the New York Stock Exchange (NYSE) floor correspondent appearing on Fox Business Network, Fox News Channel, Sky News and the syndicated program Top 30. Prior to joining FBN, she was an anchor at Bloomberg Television.

    About the TD Ameritrade Network

    The TD Ameritrade Network is a direct-to-consumer, broadband-delivered broadcast channel distributing original, live news broadcasts and educational content produced by TD Ameritrade Media Productions Company, a wholly-owned subsidiary of TD Ameritrade Holding Corporation and affiliate of the broker-dealers, investment advisers, and other regulated financial businesses of the TD Ameritrade  Holding Corporation. TD Ameritrade Media Productions Company is not a financial adviser, registered investment adviser, or broker-dealer.

    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 iMSC

    The mesenchymal stem cell therapy product that Citius is pursuing for in-licensing from Novellus, Inc. is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The iMSCs produced from this clonal technique are differentiated from adult donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, iMSCs exhibit superior potency and high cell viability. The iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

    About Acute Respiratory Distress Syndrome (ARDS)

    ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients – most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

    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: the risk of successfully negotiating a license agreement for a potential ARDS therapy with Novellus, Inc. within the option period; the ability to access the FDA's CTAP program for our planned ARDS therapy; risks associated with developing our product candidates, including any licensed from Novellus, Inc., including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; our need for substantial additional funds; risks associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; 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; 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

     

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    SOURCE Citius Pharmaceuticals, Inc.

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  38. CRANFORD, N.J., June 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that the Company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (iMSCs) to treat and reduce the severity of acute respiratory distress syndrome (ARDS) in patients with COVID-19.

    The FDA acknowledged that the Company could apply for fast track designation and also provided Citius with the chemistry, manufacturing, and control (CMC) requirements for the proposed trials…

    CRANFORD, N.J., June 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that the Company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (iMSCs) to treat and reduce the severity of acute respiratory distress syndrome (ARDS) in patients with COVID-19.

    The FDA acknowledged that the Company could apply for fast track designation and also provided Citius with the chemistry, manufacturing, and control (CMC) requirements for the proposed trials. The Company plans to initiate actions on the FDA's recommendations and follow up with the FDA with an Investigational New Drug (IND) application under the Coronavirus Treatment Acceleration Program (CTAP).

    Myron Holubiak, Chief Executive Officer of Citius, commented, "We appreciate the FDA's thoughtful guidance on our unique, allogenic mesenchymal stem cells derived from induced pluripotent stem cells (iPSCs). We understand that iPSC-derived stem cells are not the same as adult-donor derived cells and, therefore, would require different proof of concept studies. Since we believe in the advantages of iPSC MSCs over donor-derived cells, we intend to develop assays recommended by the FDA and demonstrate the safety of these MSCs in our preclinical studies.  We are committed to the successful completion of the required clinical trials to provide an effective and safe therapy for ARDS due to COVID-19."

    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 Citius iMSC

    Citius's mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The iMSCs produced from this clonal technique are differentiated from adult donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, iMSCs exhibit superior potency and high cell viability. The iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

    About Acute Respiratory Distress Syndrome (ARDS)

    ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients – most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

    About Coronavirus Treatment Acceleration Program (CTAP)

    In response to the pandemic, the FDA has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to accelerate the development of treatments for COVID-19. By redeploying staff, the FDA is responding to COVID-19-related requests and reviewing protocols within 24 hours of receipt. The FDA said CTAP "uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful." In practice, that means developers of potential treatments for COVID-19 would benefit from an unusually faster track at the FDA to shorten wait times at multiple steps of the process.

    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: the risk of successfully negotiating a license agreement for a potential ARDS therapy with Novellus, Inc. within the option period; the ability to access the FDA's CTAP program for our planned ARDS therapy; risks associated with developing our product candidates, including any licensed from Novellus, Inc., including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; our need for substantial additional funds; risks associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; 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; 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

     

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    SOURCE Citius Pharmaceuticals, Inc.

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  39. CRANFORD, N.J., June 22, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that Chief Executive Officer Myron Holubiak will deliver a virtual presentation at the Life Sciences Investor Forum on Thursday, June 25, 2020 at 11:00 AM ET

    Event: Life Sciences Investor Forum

    Presentation Date: Thursday, June 25, 2020

    Presentation Time: 11:00 AM ET

    Mr. Myron Holubiak will present an update on the Company, including its Phase 3 pivotal trial with Mino-Lok® that is currently more than half enrolled and its option to license a novel stem cell therapy for acute respiratory distress syndrome…

    CRANFORD, N.J., June 22, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that Chief Executive Officer Myron Holubiak will deliver a virtual presentation at the Life Sciences Investor Forum on Thursday, June 25, 2020 at 11:00 AM ET

    Event: Life Sciences Investor Forum

    Presentation Date: Thursday, June 25, 2020

    Presentation Time: 11:00 AM ET

    Mr. Myron Holubiak will present an update on the Company, including its Phase 3 pivotal trial with Mino-Lok® that is currently more than half enrolled and its option to license a novel stem cell therapy for acute respiratory distress syndrome (ARDS) in COVID-19 patients. This presentation will be a live, interactive online event where investors can ask the Company questions in real-time. An archived webcast will also be made available after the event.

    While attendance at this virtual event is free, it is recommended that investors pre-register at www.lifesciencesinvestorforum.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 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 Life Sciences Investor Forum

    Life Sciences Investor Forum is a leading proprietary investor conference series that provides an interactive forum for life sciences companies to meet with and present directly to investors. It is a realtime solution for investor engagement that is powered by Intrado Digital Media and specifically designed for more efficient investor access. Replicating the look and feel of on-site investor conferences, Life Sciences Investor Forum combines leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

    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, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; 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; 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; 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

     

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    SOURCE Citius Pharmaceuticals, Inc.

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  40. CRANFORD, N.J., June 2, 2020 /PRNewswire/ -- 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 has received positive feedback from the Food and Drug Administration (FDA) on its proposed catheter compatibility studies for the Company's Mino-Lok® therapy. The studies, if and when successfully completed, should allow Mino-Lok to be labeled for use with all commercially available central venous catheters (CVCs) and peripherally inserted central catheters (PICCs) on the U.S. market. It is further assumed that these studies will meet European and world standards. 

    The ability to be labeled without…

    CRANFORD, N.J., June 2, 2020 /PRNewswire/ -- 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 has received positive feedback from the Food and Drug Administration (FDA) on its proposed catheter compatibility studies for the Company's Mino-Lok® therapy. The studies, if and when successfully completed, should allow Mino-Lok to be labeled for use with all commercially available central venous catheters (CVCs) and peripherally inserted central catheters (PICCs) on the U.S. market. It is further assumed that these studies will meet European and world standards. 

    The ability to be labeled without restrictions with respect to catheter type would allow Mino-Lok unrestricted access to the full U.S. and world markets for an effective antibiotic lock therapy for central line-associated bloodstream infections (CLABSIs), which are estimated to be over $1.5 billion per year worldwide. The catheter compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study. The Company announced in early February 2020 that this pivotal trial had reached the halfway point for enrollment. The next milestone in the trial is the result of an interim efficacy analysis, which is expected to occur in the second half of 2020. 

    "We believe we continue to check all the boxes required for an NDA submission," commented Myron Holubiak, Chief Executive Officer of Citius. "According to our planned dosing recommendations, the Mino-Lok solution dwells in the catheter for two hours per day for 5 to 7 days. This would be between 10 to 14 hours of aggregate, but intermittent, exposure time of the catheter to Mino-Lok. We believe that this exposure is far lower than what is recommended for home-brewed antibiotic lock solutions, which should lead to less intrusive therapy and fewer days on therapy for patients."

    "The shorter dwell time for Mino-Lok also means that the catheter is available for its intended purpose, allowing treatment for the underlying disease to continue. Additionally, and more importantly, our pivotal trial is designed to show the superiority of Mino-Lok to standard antibiotic locks in time-to-catheter-failure. If all these studies prove to be successful, we believe ready-to-use Mino-Lok will be superior to home-brewed antibiotic locks in both efficacy and dosing schedules," Mr. Holubiak concluded.

    Mino-Lok is an antibiotic lock solution used to treat patients with CLABSIs and 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 procedures. It 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 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 FDA acceptance of our compatibility studies and, if so, the successful completion of and results from the studies; 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

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    SOURCE Citius Pharmaceuticals, Inc.

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  41. CRANFORD, N.J., May 26, 2020 /PRNewswire/ -- 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…

    CRANFORD, N.J., May 26, 2020 /PRNewswire/ -- 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

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    SOURCE Citius Pharmaceuticals, Inc.

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  42. CRANFORD, N.J., May 18, 2020 /PRNewswire/ -- Citius Pharmaceuticals Inc. (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced the closing of the previously announced registered direct offering priced at-the-market under Nasdaq rules.  In the offering, Citius sold 7,058,824 shares of its common stock, at a purchase price per share of $1.0625. Additionally, Citius issued to the investors unregistered warrants to purchase up to 3,529,412 shares of its common stock. 

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The gross proceeds of the offering were approximately $7.5 million and the net proceeds from the offering were approximately…

    CRANFORD, N.J., May 18, 2020 /PRNewswire/ -- Citius Pharmaceuticals Inc. (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced the closing of the previously announced registered direct offering priced at-the-market under Nasdaq rules.  In the offering, Citius sold 7,058,824 shares of its common stock, at a purchase price per share of $1.0625. Additionally, Citius issued to the investors unregistered warrants to purchase up to 3,529,412 shares of its common stock. 

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The gross proceeds of the offering were approximately $7.5 million and the net proceeds from the offering were approximately $6.8 million, after deducting placement agent fees and other offering expenses. Citius intends to use the net proceeds from the offering for general corporate purposes, including clinical trial expenses, research and development expenses, manufacturing expenses and general and administrative expenses.

    The warrants are exercisable immediately at an exercise price of $1.00 per share and will expire five and one-half years from the issue date.

    The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) were offered pursuant to a "shelf" registration statement (File No. 333-221492) filed with the Securities and Exchange Commission (SEC) and declared effective on December 15, 2017. The offering of such shares was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock was filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by emailing or by calling 646-975-6996.

    The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 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.

    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 the use of anticipated proceeds from the offering; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; 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) 908-967-6677 x105
     

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  43. CRANFORD, N.J., May 14, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced that it has entered into definitive agreements with several institutional and accredited investors for the purchase of 7,058,824 shares of its common stock, at a purchase price per share of $1.0625 for gross proceeds of approximately $7.5 million, in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, Citius has also agreed to issue to the investors unregistered warrants to purchase up to 3,529,412 shares of its common stock. The closing of the offering is expected to take place on or about May 18, 2020, subject…

    CRANFORD, N.J., May 14, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced that it has entered into definitive agreements with several institutional and accredited investors for the purchase of 7,058,824 shares of its common stock, at a purchase price per share of $1.0625 for gross proceeds of approximately $7.5 million, in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, Citius has also agreed to issue to the investors unregistered warrants to purchase up to 3,529,412 shares of its common stock. The closing of the offering is expected to take place on or about May 18, 2020, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The warrants have an exercise price of $1.00 per share, will be immediately exercisable, and will expire five and one-half years from the issue date.

    Citius intends to use the net proceeds from the offering for general corporate purposes, including clinical trial expenses, research and development expenses, manufacturing expenses and general and administrative expenses.

    The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) are being offered pursuant to a "shelf" registration statement (File No. 333-221492) filed with the Securities and Exchange Commission (SEC) and declared effective on December 15, 2017. Such shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock will be filed with the SEC and be available at the SEC's website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by emailing  or by calling 646-975-6996.

    The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 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.

    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 market conditions, the completion of the common stock and warrant financing, including the satisfaction of the closing conditions, and the use of anticipated proceeds; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; 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
     

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    SOURCE Citius Pharmaceuticals, Inc.

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  44. CRANFORD, N.J., May 13, 2020 /PRNewswire/ -- 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 data on NoveCite MSCs will be presented this week at the American Society of Gene and Cell therapy (ASGCT) annual meeting. NC-MSCs are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. Earlier this year, Citius signed an exclusive option agreement to in-license NC-MSCs for acute respiratory distress syndrome (ARDS), including in COVID-19 patients, from Novellus.

    The data to be presented show that NC-MSCs secrete higher…

    CRANFORD, N.J., May 13, 2020 /PRNewswire/ -- 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 data on NoveCite MSCs will be presented this week at the American Society of Gene and Cell therapy (ASGCT) annual meeting. NC-MSCs are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. Earlier this year, Citius signed an exclusive option agreement to in-license NC-MSCs for acute respiratory distress syndrome (ARDS), including in COVID-19 patients, from Novellus.

    The data to be presented show that NC-MSCs secrete higher levels of anti-inflammatory proteins compared to MSCs derived from bone marrow. From the abstract: "Comparative secretome analysis showed overexpression of multiple neuroprotective and anti-inflammatory factors, including CXCL1, VEGF-A, and CXCL5." In addition, NC-MSCs showed therapeutic benefit in an experimental autoimmune encephalomyelitis (EAE) mouse model, delaying disease progression and improving the clinical score compared to the control group, while bone marrow-derived MSCs showed no difference from the control.

    "We are pleased to present these data at the annual meeting of the ASGCT," said Matt Angel, PhD, co-founder and Chief Science Officer at Novellus. "While conventional MSCs have shown promise in the treatment of inflammatory lung disease, protein secretion and manufacturability remain challenges for these approaches. The data that will be presented this week show that iPSC-derived MSCs secrete higher levels of anti-inflammatory proteins, and exhibit greater expansion potential than bone marrow-derived MSCs. We believe that these properties make iPSC-derived MSCs especially well-suited for an allogeneic cell therapy for ARDS."

    "Last month Citius signed an exclusive option agreement with Novellus for worldwide development and commercial rights related to the use of these uniquely derived MSCs for the treatment of ARDS. The pre-clinical data that is being presented at the ASGCT annual meeting adds to our confidence in the higher potency of these MSCs, which we expect will result in better outcomes for patients with COVID-19 and ARDS," stated Myron Holubiak, CEO of Citius Pharmaceuticals. "We intend to study these cells in the clinic later this year to determine safety, efficacy, and the optimal dose of these cells in moderate to severe ARDS patients with COVID-19."

    Citius has submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) for use of these MSCs for patients with Acute Respiratory Distress Syndrome (ARDS) due to SARS-CoV-2 disease.

    Presentation Information:
    Title: Mesenchymal Stem Cells (MSCs) Generated Using mRNA Reprogramming Show Enhanced Growth Potential, Secretome, and Therapeutic Efficacy in a Demyelinating Disease Model
    Presenter: Harris, Jasmine, Novellus, Inc.
    Date and Time: Wednesday, May 13 | 5:30 PM - 6:30 PM

    About Acute Respiratory Distress Syndrome (ARDS)
    ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients – most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

    About Coronavirus Treatment Acceleration Program (CTAP)
    In response to the pandemic, the FDA has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to accelerate the development of treatments for COVID-19. By redeploying staff, the FDA is responding to COVID-19-related requests and reviewing protocols within 24 hours of receipt. The FDA said CTAP "uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful." In practice, that means developers of potential treatments for COVID-19 will benefit from an unusually faster track at the FDA to shorten wait times at multiple steps of the process.

    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 Novellus, Inc.
    Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit www.novellus-inc.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: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the ability to access the FDA's CTAP program for the MARCO trial; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and 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 any licensed from Novellus, 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

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  45. CRANFORD, N.J., May 12, 2020 /PRNewswire/ -- 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 the Company has issued its May 2020 Shareholder Letter.  The letter highlights the Company's exclusive option to license a novel stem-cell therapy to treat acute respiratory distress syndrome (ARDS) associated with COVID-19, and the clinical progress of the Company's core products: Mino-Lok®, Mino-Wrap™, and Halo-Lido.

    Recent Company Highlights include:

    • Submitting a pre-IND to the FDA under the Coronavirus Treatment Acceleration Program (CTAP) for a novel stem-cell therapy to treat ARDS associated with…

    CRANFORD, N.J., May 12, 2020 /PRNewswire/ -- 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 the Company has issued its May 2020 Shareholder Letter.  The letter highlights the Company's exclusive option to license a novel stem-cell therapy to treat acute respiratory distress syndrome (ARDS) associated with COVID-19, and the clinical progress of the Company's core products: Mino-Lok®, Mino-Wrap™, and Halo-Lido.

    Recent Company Highlights include:

    • Submitting a pre-IND to the FDA under the Coronavirus Treatment Acceleration Program (CTAP) for a novel stem-cell therapy to treat ARDS associated with COVID-19
    • Obtaining an exclusive option from Novellus, Inc. to license a stem-cell therapy to treat ARDS associated with COVID-19
    • Achieving 50% patient enrollment in the Phase 3 Mino-Lok® pivotal trial
    • Passing the interim futility analysis successfully in the ongoing Phase 3 trial of Mino-Lok vs. standard-of-care antibiotic locks

    "Despite the challenges presented by COVID-19, we are in the midst of an exciting time for Citius," said Myron Holubiak, Chief Executive Officer of Citius. "We're hard at work on a potentially groundbreaking treatment for ARDS associated with COVID-19, and our core therapies are making steady progress through their respective clinical development timelines. I look forward to sharing the future developments with our shareholders as we move forward with our pipeline and achieve clinical and regulatory milestones."

    To view the Company's Corporate Update Letter in its entirety, please visit:
    https://www.citiuspharma.com/wp-content/uploads/2020/05/CTXR_May2020ShareholderLetter_final.pdf

    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.

    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: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and 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 any licensed from Novellus, 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

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  46. CRANFORD, N.J., April 27, 2020 /PRNewswire/ -- 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 submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) on April 24. The Company has requested the Division's feedback to support the most expeditious pathway into the clinic to evaluate a novel cell therapy in patients suffering from COVID-19-related ARDS.

    The cells, called NoveCite Cells or NC-MSCs, are made by Novellus, Inc. ("Novellus"), a Cambridge-based…

    CRANFORD, N.J., April 27, 2020 /PRNewswire/ -- 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 submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) on April 24. The Company has requested the Division's feedback to support the most expeditious pathway into the clinic to evaluate a novel cell therapy in patients suffering from COVID-19-related ARDS.

    The cells, called NoveCite Cells or NC-MSCs, are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. NC-MSCs are mesenchymal stem cells derived from a single donor's fibroblasts that have been dedifferentiated into an induced pluripotent stem cell (iPSC) master cell bank, thereby avoiding the need to source additional donor cells. The iPSCs are then further differentiated into a mesenchymal stem cell (MSC) therapy. Citius and Novellus plan to develop NC-MSCs for the treatment of ARDS, and last month the companies signed an exclusive option agreement.

    The Company plans a multi-center randomized placebo-controlled dose-finding study followed by an expansion phase to assess the safety, tolerability, and efficacy of NC-MSCs in patients with moderate to severe ARDS due to COVID-19. The proposed trial, a Phase 1b/2 clinical trial, is titled "A Randomized Placebo-Controlled Dose-Finding Study Followed by a Dose Level Expansion to Assess the Safety and Efficacy of NoveCite MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to SARS-CoV-2 Disease (COVID-19)," or "MARCO". The primary objectives of this study are to evaluate the safety and efficacy of NoveCite cells as a treatment for subjects with moderate-to-severe ARDS due to COVID-19 and to identify therapeutic doses.

    "MSCs have an established track-record of clinical safety, and have shown promise in the treatment of inflammatory lung disease," said Matt Angel, PhD, co-founder and Chief Science Officer at Novellus, Inc. "Our research has shown that the NoveCite cells, being derived from mRNA-reprogrammed iPSCs, secrete higher levels of immunomodulatory proteins than donor-derived MSCs, and have unique manufacturing advantages."

    "We believe we have the key elements in place from a clinical design and manufacturing point of view to evaluate this novel cell therapy approach to deal with the current pandemic," said Myron Holubiak, Chief Executive Officer of Citius. "ARDS is a very serious complication for many patients suffering from COVID-19, and is believed to account for about 80% of the deaths in ventilated patients. There is no proven or FDA-approved treatment for it, other than oxygen therapy, including use of mechanical ventilation, and fluid management. Literature from previous investigational studies with MSCs in the treatment of lung injuries support the idea that MSCs could prove effective in treating COVID-19-related ARDS. We look forward to our FDA discussions and are excited to be at the cusp of what could be a novel and effective therapy for ARDS."

    About Acute Respiratory Distress Syndrome (ARDS)
    ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients – most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

    About Coronavirus Treatment Acceleration Program (CTAP)
    In response to the pandemic, the FDA has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to accelerate the development of treatments for COVID-19. By redeploying staff, the FDA is responding to COVID-19-related requests and reviewing protocols within 24 hours of receipt. The FDA said CTAP "uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful." In practice, that means developers of potential treatments for COVID-19 will benefit from an unusually faster track at the FDA to shorten wait times at multiple steps of the process.

    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 Novellus, Inc.
    Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit www.novellus-inc.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: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the ability to access the FDA's CTAP program for the MARCO trial; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and 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 any licensed from Novellus, 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

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    SOURCE Citius Pharmaceuticals, Inc.

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  47. CRANFORD, N.J., April 1, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today signed an exclusive six-month option agreement to in-license a stem-cell therapy for acute respiratory distress syndrome (ARDS) from a subsidiary of Novellus, Inc., a preclinical-stage biotechnology company based in Cambridge, MA.

    Novellus's patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid (mRNA) molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells (MSCs) with superior immunomodulatory properties. MSCs have been shown to be…

    CRANFORD, N.J., April 1, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today signed an exclusive six-month option agreement to in-license a stem-cell therapy for acute respiratory distress syndrome (ARDS) from a subsidiary of Novellus, Inc., a preclinical-stage biotechnology company based in Cambridge, MA.

    Novellus's patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid (mRNA) molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells (MSCs) with superior immunomodulatory properties. MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating a number of inflammatory diseases, including ARDS.

    "ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients. Currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven COVID-19 patients with ARDS responded to MSC therapy. Clearly this is an avenue that shows promise and should be pursued as a potential treatment for ARDS. We believe Novellus is at the forefront of creating allogeneic, iPSC-derived MSCs. These cells have the potential to overcome the limitations of MSCs derived from adult donors, which are telomere shortened and introduce variability into the manufacturing process," said Citius Chief Executive Officer Myron Holubiak.

    Novellus Chief Science Officer Matt Angel, PhD, stated, "Using our mRNA-based cell-reprogramming technology, Novellus can provide a near-unlimited supply of MSCs for treating patients with ARDS, including those critically ill from COVID-19. These will be allogeneic ('off-the-shelf') cells that in vitro have demonstrated much greater expansion potential and much higher immunomodulatory protein expression than donor-derived MSCs. We are excited to employ our technology to such an urgent medical crisis and believe that our MSCs represent an ideal source of cells to be used in this extremely important development effort."

    Holubiak added, "No effective pharmacotherapy for ARDS exists, and ARDS-related morbidity and mortality are high. MSCs have been studied in the treatment of lung injury, and we aim to build upon this work with Novellus's iPSC-derived MSCs to improve the immunomodulatory response in humans. We have assembled a team of experts who are dedicated to advancing this project to an Investigational New Drug (IND) application as quickly as possible."  

    About ARDS
    Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients – most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain, particularly while inhaling, and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

    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 Novellus, Inc.
    Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit www.novellus-inc.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: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and 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 any licensed from Novellus, 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

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    SOURCE Citius Pharmaceuticals, Inc.

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  48. CRANFORD, N.J., March 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today the publication of an in vitro study for Mino-Lok®, the Company's antibiotic lock solution used to treat patients with central line associated blood stream infections (CLABSIs) and catheter-related bloodstream infections (CRBSIs), in the March 2020 issue of Antimicrobial Agents and Chemotherapy.  The article, titled "Minocycline-EDTA-Ethanol Antimicrobial Catheter Lock Solution Is Highly Effective In Vitro for Eradication of Candida auris Biofilms," highlights the in vitro efficacy of Mino-Lok against various…

    CRANFORD, N.J., March 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today the publication of an in vitro study for Mino-Lok®, the Company's antibiotic lock solution used to treat patients with central line associated blood stream infections (CLABSIs) and catheter-related bloodstream infections (CRBSIs), in the March 2020 issue of Antimicrobial Agents and Chemotherapy.  The article, titled "Minocycline-EDTA-Ethanol Antimicrobial Catheter Lock Solution Is Highly Effective In Vitro for Eradication of Candida auris Biofilms," highlights the in vitro efficacy of Mino-Lok against various strains of Candida auris ("C. auris") from studies conducted at MD Anderson Cancer Center Labs.  

    Mr. Myron Holubiak, Chief Executive Officer of Citius, said, "We're happy to have the positive preclinical results of Mino-Lok published in the AAC Journal. Candida auris is a very problematic type of fungus, but the results from these in vitro studies showed that complete eradication of all strains of C. auris occurred within an hour of exposure to Mino-Lok. We anticipate completing our Phase 3 trial with Mino-Lok by the end of 2020, which will bring us one step closer to treating patients with infected catheters from any number of fungi or bacteria."  

    C. auris is a fungus that can cause serious bloodstream infections or death, particularly in hospital and nursing home patients with serious medical problems. More than one in three patients with invasive C. auris infection die. The fungus is often resistant to most antifungal agents commonly used to treat Candida infections. Although C. auris was just recently discovered in 2009, it has spread quickly and caused infections in more than a dozen countries. Patients who have been hospitalized in a healthcare facility a long time, have a central venous catheter or other lines or tubes entering their body, or have previously received antibiotics or antifungal medications, appear to be at highest risk of infection with this yeast.

    About Mino-Lok®

    Each year, more than 330,000 central venous catheters out of the 7 million used in the U.S. become infected and lead to CRBSIs, 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. Mino-Lok is an antibiotic lock solution that is being developed to treat patients with 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 penetrates biofilm, eradicates bacteria and salvages infected, indwelling vascular catheters while providing anticlotting properties. Mino-Lok has the potential to change the standard of care for the management of these serious infections.

    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 associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; 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; 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; 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
     

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    SOURCE Citius Pharmaceuticals, Inc.

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  49. CRANFORD, N.J., March 18, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that Chief Executive Officer Myron Holubiak will deliver a virtual presentation at the Spring Investor Summit on Wednesday, March 25, 2020 at 8:50 AM ET

    Event: Spring Investor Summit

    Presentation Date:  Wednesday, March 25, 2020

    Presentation Time:  8:50 AM ET

    Webcast Link: https://www.webcaster4.com/Player/Index?webcastId=33627&g=6a614df0-9eb8-433a-ad30-283a0b3fdec3&uid=5606594&sid=

    Mr. Holubiak will present an update on the Company, including a discussion of the recent positive outcome of its interim futility…

    CRANFORD, N.J., March 18, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that Chief Executive Officer Myron Holubiak will deliver a virtual presentation at the Spring Investor Summit on Wednesday, March 25, 2020 at 8:50 AM ET

    Event: Spring Investor Summit

    Presentation Date:  Wednesday, March 25, 2020

    Presentation Time:  8:50 AM ET

    Webcast Link: https://www.webcaster4.com/Player/Index?webcastId=33627&g=6a614df0-9eb8-433a-ad30-283a0b3fdec3&uid=5606594&sid=

    Mr. Holubiak will present an update on the Company, including a discussion of the recent positive outcome of its interim futility analysis for the Phase 3 Mino-Lok® pivotal trial, provide an overview of its other pipeline products, Mino-Wrap™ and Halo-Lido, and answer questions from investors.

    "Changing the Investor Summit from a traditional in-person event to a virtual one was a prudent decision in light of the current COVID-19 crisis," said Mr. Holubiak. "We are grateful for the opportunity to have this platform to connect with investors and interested parties to share our corporate strategy for the coming months."

    The Spring Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting small cap and microcap companies with qualified investors. The Summit will be held via webcast this year in light of the ongoing Coronavirus epidemic.

    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 associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; 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; 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; 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
     

     

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    SOURCE Citius Pharmaceuticals, Inc.

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  50. NEW YORK, NY / ACCESSWIRE / March 3, 2020 / Citius Pharmaceuticals, Inc. (NASDAQ:CTXR), is a specialty pharmaceutical company dedicated to the development and commercialization of drug products that address important unmet medical needs, will be presenting at this year's Spring Investor Summit on March 25th-26th in New York City.

    The Spring Investor Summit will take place at the Essex House, featuring 100 companies and over 500 institutional and retail investors.

    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…

    NEW YORK, NY / ACCESSWIRE / March 3, 2020 / Citius Pharmaceuticals, Inc. (NASDAQ:CTXR), is a specialty pharmaceutical company dedicated to the development and commercialization of drug products that address important unmet medical needs, will be presenting at this year's Spring Investor Summit on March 25th-26th in New York City.

    The Spring Investor Summit will take place at the Essex House, featuring 100 companies and over 500 institutional and retail investors.

    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.

    The Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors.

    To register as a presenting company: please contact Cassandra Miller ()

    To request complimentary investor registration: please visit our website at www.microcapconf.com

    News Compliments of ACCESSWIRE

    FOR MORE INFORMATION

    Please visit: www.microcapconf.com

    Or, contact Cassandra Miller at

    SOURCE: Citius Pharmaceuticals, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/578887/Citius-Pharmaceuticals-Inc-to-Present-at-the-Spring-Investor-Summit-on-March-25th-26th-in-New-York-City

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  51. CRANFORD, N.J., Feb. 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company will present at the Third Annual LD Micro Virtual Conference on Wednesday, March 4, 2020 at 11 AM ET

    Event: Third Annual LD Micro Virtual Conference

    Presentation Date:  Wednesday, March 4, 2020

    Presentation Time:  11:00 AM ET

    Webcast Link: https://www.webcaster4.com/Webcast/Page/2019/33349

    Chief Executive Officer Myron Holubiak will deliver an update on the Company, including a discussion of the recent positive outcome of its interim futility analysis for the Phase 3 Mino-Lok® pivotal trial…

    CRANFORD, N.J., Feb. 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company will present at the Third Annual LD Micro Virtual Conference on Wednesday, March 4, 2020 at 11 AM ET

    Event: Third Annual LD Micro Virtual Conference

    Presentation Date:  Wednesday, March 4, 2020

    Presentation Time:  11:00 AM ET

    Webcast Link: https://www.webcaster4.com/Webcast/Page/2019/33349

    Chief Executive Officer Myron Holubiak will deliver an update on the Company, including a discussion of the recent positive outcome of its interim futility analysis for the Phase 3 Mino-Lok® pivotal trial, provide an overview of its other pipeline products, Mino-Wrap™ and Halo-Lido, and answer questions from investors.

    The conference will be held via webcast and will feature over 40 companies in the small / micro-cap space.

    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 LD Micro
    LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies has transformed into an event platform hosting several influential conferences annually (Invitational, Summit, and Main Event).

    In 2015, LDM launched the first pure microcap index (the LDMi) to exclusively provide intraday information on the entire sector. LD will continue to provide valuable tools for the benefit of everyone in the small and microcap universe.

    Please see www.ldmicro.com for more information.

    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, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; 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; 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; 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
     

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    SOURCE Citius Pharmaceuticals, Inc.

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  52. CRANFORD, N.J., Feb. 25, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today cited independent research on the incidence of catheter-related blood stream infections (CRBSIs) in the world.

    DelveInsight had previously published a report on the incidence of CRBSI in North America, five European countries and Japan. This new report adds the major areas from the rest of the world (ROW). The report also provides an overview of various treatment practices, and CRBSI epidemiology segmented by the global major markets. The key findings were as follows:

    • Total Incident Population of Catheter Related Bloodstream…

    CRANFORD, N.J., Feb. 25, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today cited independent research on the incidence of catheter-related blood stream infections (CRBSIs) in the world.

    DelveInsight had previously published a report on the incidence of CRBSI in North America, five European countries and Japan. This new report adds the major areas from the rest of the world (ROW). The report also provides an overview of various treatment practices, and CRBSI epidemiology segmented by the global major markets. The key findings were as follows:

    • Total Incident Population of Catheter Related Bloodstream Infection (CRBSI) in the Global* market was found to be 4,114,882 in 2017 and expected to reach up to 4,228,815 in 2028.
    • Among the North America countries, United States had the highest incident population of CRBSI with 328,107 cases in 2017.
    • Total incident population of CRBSI in APAC region was found to be 3,105,930 cases in 2017; India accounted for highest number of cases among all the APAC countries.
    • Among LATAM region, Brazil accounted for highest incidence of CRBSI with 163,405 cases in 2017.
    • In MENA region, Saudi Arabia shows higher incidence of CRBSI with 28,118 cases in 2017 and 28,853 cases in 2028.

     *Global: United States; EU5 (Germany, France, Italy, Spain, UK); APAC (Japan, China, India, South Korea, Taiwan and Australia); LATAM (Argentina, Brazil, Mexico and Colombia); Middle East (Saudi Arabia and UAE) and Russia.

    "These data begin to show the extreme impact of catheter related bacteremia. The numbers are huge and we believe they are under-reported," said Myron Holubiak, the Chief Executive Officer of Citius. "Mino-Lok is the only treatment under investigation designed to salvage the contaminated catheter and preserve vascular access in patients with CRBSI, thus sparing the patient the challenges and risks of catheter removal and replacement. As has been reported previously, Mino-Lok is at the midway point of its phase 3 study in the US having passed the futility analysis; we believe that our study will be a major contribution to the study of CRBSI and the utility of antibiotic locks. More alternatives are needed to the practice of removing and replacing infected central venous lines."

    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 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 where venous access presents a challenge. There are currently no approved therapies to salvage infected CVCs. 

    About DelveInsight
    DelveInsight is a Business Consultant company and serves as a Knowledge partner across the value chain of the Pharmaceutical Industry. With the use of proprietary databases and analytical models, DelveInsight provides cutting-edge market and pipeline analysis and API intelligence across all therapy areas to the Pharma and biotech sector, helping clients to quantify market events and evaluate their impact on the valuation of products, portfolios, and companies. Additional information is available at www.delveinsight.com.

    DelveInsight's "Catheter-Related Blood Stream Infections (CRBSI)-Market Insights, Epidemiology & Market Forecast–2028" report provides an overview of the disease and market size of CRBSI for the global major pharmaceutical markets i.e., the United States, EU5 (Germany, France, Italy, Spain, and the UK), Japan, APAC (China, India, Taiwan, South Korea and Australia), LATAM (Brazil, Mexico, Argentina, Colombia and Russia) and Middle East (Saudi Arabia and United Arab Emirates). This report covers the overview, various treatment practices, and CRBSI epidemiology from 2017 to 2028, segmented by the global major markets.

    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: the estimated markets for our product candidates, including those in the DelveInsight report, and the acceptance thereof by any market; risks associated with conducting our Phase III trial for Mino-Lok, including completing patient enrollment; our need for substantial additional funds; risks relating to the results of research and development activities; risks associated with developing Mino-Wrap, including that preclinical results may not be predictive of clinical results and our ability to file an IND; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-cites-independent-estimates-of-total-available-world-market-for-mino-lok-301010555.html

    SOURCE Citius Pharmaceuticals, Inc.

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  53. CRANFORD, N.J., Feb. 10, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company will present at Noble Capital Markets' 16th Annual Investor Conference on Monday, February 17, 2020 at 4:00 PM ET. The conference is being held at the Seminole Hard Rock Hotel & Casino in Hollywood, Florida on February 16-18, 2020.

    Event: Noble Capital Markets' 16th Annual Investor Conference

    Presentation Date:  Monday, February 17, 2020

    Presentation Time:  4:00 PM ET – Terrace Ballroom A

    Location: Seminole Hard Rock Hotel & Casino – Hollywood, FL

    Mr. Leonard Mazur, Chairman of Citius, will deliver…

    CRANFORD, N.J., Feb. 10, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company will present at Noble Capital Markets' 16th Annual Investor Conference on Monday, February 17, 2020 at 4:00 PM ET. The conference is being held at the Seminole Hard Rock Hotel & Casino in Hollywood, Florida on February 16-18, 2020.

    Event: Noble Capital Markets' 16th Annual Investor Conference

    Presentation Date:  Monday, February 17, 2020

    Presentation Time:  4:00 PM ET – Terrace Ballroom A

    Location: Seminole Hard Rock Hotel & Casino – Hollywood, FL

    Mr. Leonard Mazur, Chairman of Citius, will deliver an update on the Company, including a discussion of the recent positive outcome of its interim futility analysis for the Phase 3 Mino-Lok® pivotal trial, and provide an overview of its other pipeline products, Mino-Wrap™ and Halo-Lido. Additionally, Mr. Mazur will also be available at the conference for one-on-one meetings with investors.  To arrange a meeting with the Company, please contact Mr. Andrew Scott: .

    Mr. Mazur's presentation will be available for playback at the link below approximately 24 hours following his live address and be archived for 90 days following the conference: http://noble.mediasite.com/Mediasite/Play/838b6f0a3a53473cbd89e1507a111a411d

    This is the 16th year Noble Capital Markets has hosted "NobleCon" and invited emerging growth companies to present to and meet with attending investors.  NobleCon will feature approximately 125 small growth companies presenting across four tracks occurring simultaneously, company executives meeting with investors in 1x1/face-to-face formats, and special panel sessions featuring key opinion leaders on topics such as cannabis, biotechnology, and mining, just to name a few.  Noble Capital Markets will be broadening access to investors worldwide by hosting the conference site on Channelchek.com, its web-based market platform that emphasizes emerging growth companies.  

    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 associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; 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; 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; 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
    (M) 646-522-8410
     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-at-noble-capital-markets-16th-annual-investor-conference-301001891.html

    SOURCE Citius Pharmaceuticals, Inc.

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  54. CRANFORD, N.J., Feb. 4, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical-care drug products, today announced that the Company's lead program, Mino-Lok vs. standard-of-care ("SOC") antibiotic locks, has randomized its 72nd patient, thereby passing the halfway point for enrollment in this Phase 3 trial. The Company previously announced the results of a futility analysis when it passed the threshold of 40% of patients completing end of therapy. That analysis showed a positive outcome, as it met the prespecified interim futility analysis criteria. The next major milestone in the Mino-Lok trial, expected to be achieved in…

    CRANFORD, N.J., Feb. 4, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical-care drug products, today announced that the Company's lead program, Mino-Lok vs. standard-of-care ("SOC") antibiotic locks, has randomized its 72nd patient, thereby passing the halfway point for enrollment in this Phase 3 trial. The Company previously announced the results of a futility analysis when it passed the threshold of 40% of patients completing end of therapy. That analysis showed a positive outcome, as it met the prespecified interim futility analysis criteria. The next major milestone in the Mino-Lok trial, expected to be achieved in the first half of 2020, will be the 75% interim analysis for superior efficacy. The endpoints for this analysis require that the time to catheter failure be at least 38 days for Mino-Lok vs. 21 days for SOC antibiotic locks. 

    "We are extremely happy that our trial is proceeding according to plan. The independent drug monitoring committee ("DMC") will next evaluate the clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus SOC antibiotic locks," said Myron Holubiak, Chief Executive Officer of Citius. "We believe that the Mino-Lok clinical trial will be a major contribution to the study of catheter-related bloodstream infections (CRBSI) and the utility of antibiotic locks. Effective alternatives are needed to the practice of removing and replacing infected central venous lines."

    About Mino-Lok®
    Each year, up to approximately 500,000 central venous catheters of the 7 million used in the U.S. become infected and lead to CRBSIs, 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. Mino-Lok is an antibiotic lock solution that is being developed to treat patients with 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 penetrates biofilm, eradicates bacteria and salvages infected, indwelling vascular catheters while providing anticlotting properties. Mino-Lok has the potential to change the standard of care for the management of these serious infections. The market potential for an effective antibiotic lock therapy is estimated to be $750+ million per year in the U.S. and approximately $1.5 billion worldwide.

    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 over 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," along with 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 III trial for Mino-Lok, including our ability to complete patient enrollment; risks relating to our need for substantial additional funds; possible changes in the estimated markets for our product candidates and the acceptance thereof by any market; risks relating to the results of research and development activities; risks associated with developing Mino-Wrap, including the risk that preclinical results may not be predictive of clinical results or of our ability to file an IND; uncertainties relating to preclinical and clinical testing; uncertainties associated with the early stage of products under development; risks related to our growth strategy; risks related to our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; uncertainties relating to our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; uncertainties relating to our ability to attract, integrate and retain key personnel; possible changes in government regulation; risks associated with patent and intellectual property matters; and risks relating to 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 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
    (M) 646-522-8410
     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-achieves-50-patient-enrollment-in-phase-3-mino-lok-pivotal-trial-300997922.html

    SOURCE Citius Pharmaceuticals, Inc.

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  55. CRANFORD, N.J., Feb. 3, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced that it received notice from The Nasdaq Stock Market LLC ("NASDAQ") on January 31, 2020 indicating that the Company has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) (the "Bid Price Rule") for continued listing on The NASDAQ Capital Market. Accordingly, the Company has regained compliance with the Bid Price Rule and NASDAQ considers the matter closed.

    About Citius Pharmaceuticals, Inc.

    Citius is a specialty pharmaceutical company dedicated to the development and commercialization…

    CRANFORD, N.J., Feb. 3, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced that it received notice from The Nasdaq Stock Market LLC ("NASDAQ") on January 31, 2020 indicating that the Company has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) (the "Bid Price Rule") for continued listing on The NASDAQ Capital Market. Accordingly, the Company has regained compliance with the Bid Price Rule and NASDAQ considers the matter closed.

    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 associated with continuing to meet the listing requirements of The Nasdaq Capital Market; risks associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; 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; 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; 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
    (M) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-regains-compliance-with-nasdaq-listing-requirements-300997231.html

    SOURCE Citius Pharmaceuticals, Inc.

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  56. Point Roberts, Washington and Vancouver, British Columbia--(Newsfile Corp. - January 27, 2020) - Investorideas.com, a leading investor news resource covering pharmaceutical and biotechnology stocks releases a special report on the opportunity within the specialty drug segment of the sector to address viral outbreaks and bacterial resistance, featuring Citius Pharmaceuticals, Inc. (NASDAQ:CTXR).

    Read the full article on Investorideas.com
    https://www.investorideas.com/News/2020/biotech/01270Specialization-FightingBacteriaViruses.asp

    Certain social and technological advancements as well as new and deadlier viral (coronavirus) and bacterial outbreaks are forcing innovative business approaches for this competitive sub-sector and specialty companies…

    Point Roberts, Washington and Vancouver, British Columbia--(Newsfile Corp. - January 27, 2020) - Investorideas.com, a leading investor news resource covering pharmaceutical and biotechnology stocks releases a special report on the opportunity within the specialty drug segment of the sector to address viral outbreaks and bacterial resistance, featuring Citius Pharmaceuticals, Inc. (NASDAQ:CTXR).

    Read the full article on Investorideas.com
    https://www.investorideas.com/News/2020/biotech/01270Specialization-FightingBacteriaViruses.asp

    Certain social and technological advancements as well as new and deadlier viral (coronavirus) and bacterial outbreaks are forcing innovative business approaches for this competitive sub-sector and specialty companies are answering the call!

    Looking at the current headline attention of the coronavirus, Infectioncontroltoday.com also addressed the current crisis of antimicrobial resistance. "Now that the planet's attention is turned toward infectious disease thanks to the spotting of coronavirus in the United States, the World Health Organization (WHO) took the opportunity to point to another problem: the growing shortage of antibiotics available to fight all pathogens."

    A WHO press release reported, "Tedros Adhanom Ghebreyesus, PhD, the director-general of WHO, said in the press release that "never has the threat of antimicrobial resistance been more immediate and the need for solutions more urgent. Numerous initiatives are underway to reduce resistance, but we also need countries and the pharmaceutical industry to step up and contribute with sustainable funding and innovative new medicines."

    Citius Pharmaceuticals, Inc. (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products is in the midst of bringing their products to market having recently announced a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok® vs. standard-of-care antibiotic locks.

    The analysis was conducted by the Mino-Lok trial Data Monitoring Committee ("DMC"), an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial. The Company reached and completed the pre-specified 40% enrollment required for the interim futility analysis in late September and, based on the analysis of the data and recommendations of the DMC, will proceed with the current trial as planned. Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, is expected in the first half of 2020. The market potential for an effective antibiotic lock therapy is estimated at $750 million per year in the US and approximately $1.5 billion per year worldwide.

    "We are extremely happy and proud that the first independent expert review of the patient data in our Mino-Lok trial concludes that our study is on track. Enrollment has continued since finalizing the 40% level futility report, and we have now reached the midpoint of our study. The DMC will evaluate clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus standard-of-care antibiotic locks," said Myron Holubiak, Chief Executive Officer of Citius. "We would also like to thank all of the patients, study investigators, and support personnel at the 32 clinical sites that are participating in our trial. Lastly, we also want to acknowledge the research and guidance of Dr. Issam Raad and his team at MD Anderson Cancer Center in advancing this novel therapy."

    Citius Pharmaceuticals, Inc. "Saving Lives of Hospital Patients with Catheters Infected by Deadly Bacteria" :

    Citius was recently featured in a recent edition of BiotechStock Review, which discussed the Citius "Mino-Lok" treatment - "created to kill infected catheters, Mino-Lok was developed clinicians and technologists at the M.D. Anderson Cancer Center. The Mini-Lok technology while complex is easy for investors to understand. Their market is huge, estimated at $500 million to $1 billion annually and fairly-easy for investors to identify. The need for Mino-Lok is rather obvious as we will later explain. Also, studies to date have proven it to be much safer, more effective and less expensive than the alternatives and once again, easy for investors to grasp. Finally, the time (they're in Phase III), path and cost to approval are modest in comparison to biotech companies creating drugs from scratch. A 'five-fecta' so to speak."

    Continued: "Part of the Citius business strategy is to build a successful company by developing and commercializing cost-effective products that address unmet medical needs. It seeks to leverage the FDA's 505(b)(2) pathway for new drug approvals and bring products to market faster and with lower cost than other FDA new drug approval pathways (meaning creating drugs from scratch)."

    Continued "The Mino-Lok solution was created to kill bacteria that cannot be eradicated using current methods, resulting in the catheter needing to be removed and replaced. A dangerous and complicated procedure, Mino-Lok is the first - and only - therapy under investigation that can be used to sterilize and save the infected catheter."

    Continued "Mino-Lok is a patented solution that combines Minocycline, an antibiotic from the Tetracycline family with two other well-known ingredients. Minocycline was patented around the time we were born, as in 60 years ago - and prescribed 2 million times last year. It's now a generic costing about $12 a dose. The list of use includes things like Anthrax and even the Bubonic Plague. So were guessing the FDA will recognize both its usefulness and safety profile."

    Fusionscienceacademy.com reports, "According to the Centers for Disease Control and Prevention (CDC), the leading federal agency focused on public health in the United States, over two million infections are caused by the antibiotic-resistant bacterial pathogens per year in the country, resulting in around 23,000 deaths."

    With antibiotic-resistant bacteria on the rise and new strains of viruses surfacing, opportunity abounds for the smaller specialty drug maker that can provide solutions.

    Learn more about biotech stocks at Investorideas.com https://www.investorideas.com/BIS/

    About Investorideas.com - News that Inspires Big Investing Ideas Investorideas.com is a recognized news source publishing third party news, research and original financial content. Learn about investing in stocks and sector trends with our news alerts, articles, podcasts and videos, looking at cannabis, crypto, AI and IoT, mining, sports biotech, water, renewable energy and more. Investor Idea's original branded content includes the following podcasts and columns : Crypto Corner , Play by Play sports and stock news column, Investor Ideas Potcasts Cannabis News and Stocks on the Move podcast and column, Cleantech and Climate Change , Exploring Mining the AI Eye .

    Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. Disclosure: this news article featuring CTXR is a paid for news release on Investorideas.com - third party (two thousand) More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ and tickertagstocknews.com Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp

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  57. CRANFORD, N.J., Dec. 19, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok® vs. standard-of-care antibiotic locks. The analysis was conducted by the Mino-Lok trial Data Monitoring Committee ("DMC"), an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial. The Company reached and completed the prespecified 40% enrollment required for the interim futility analysis in late September and, based on the analysis…

    CRANFORD, N.J., Dec. 19, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok® vs. standard-of-care antibiotic locks. The analysis was conducted by the Mino-Lok trial Data Monitoring Committee ("DMC"), an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial. The Company reached and completed the prespecified 40% enrollment required for the interim futility analysis in late September and, based on the analysis of the data and recommendations of the DMC, will proceed with the current trial as planned. Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, is expected in the first half of 2020.  The market potential for an effective antibiotic lock therapy is estimated at $750 million per year in the U.S. and approximately $1.5 billion per year worldwide.

    "We are extremely happy and proud that the first independent expert review of the patient data in our Mino-Lok trial concludes that our study is on track. Enrollment has continued since finalizing the 40% level futility report, and we have now reached the midpoint of our study. The DMC will evaluate clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus standard-of-care antibiotic locks," said Myron Holubiak, the Chief Executive Officer of Citius. "We would also like to thank all of the patients, study investigators, and support personnel at the 32 clinical sites that are participating in our trial. Lastly, we also want to acknowledge the research and guidance of Dr. Issam Raad and his team at MD Anderson Cancer Center in advancing this novel therapy."

    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 MD Anderson Cancer Center
    The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected facilities for 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) and is ranked No.1 for cancer care in U.S. News & World Report's most recent "Best Hospital's" survey. The center 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).

    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 where venous access presents a challenge. There are currently no approved therapies to salvage 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 associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment; our need for substantial additional funds; the estimated markets for our product candidates and the acceptance thereof by any market; risks relating to the results of research and development activities; risks associated with developing Mino-Wrap, including that preclinical results may not be predictive of clinical results and our ability to file an IND; 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
    (D) 908-956-7674
    (C) 646-522-8410

    Cision View original content:http://www.prnewswire.com/news-releases/citius-announces-positive-outcome-of-interim-futility-analysis-for-its-phase-3-mino-lok-pivotal-trial-300977419.html

    SOURCE Citius Pharmaceuticals, Inc.

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  58. CRANFORD, N.J., Dec. 4, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company will present at the 12th Annual LD Micro Main Event on Wednesday December 11, 2019 at 11:40 AM PT. The conference is being held at the Luxe Sunset Boulevard Hotel in Bel Air, California on December 10-12, 2019.

    Presentation Date:    Wednesday, December 11, 2019

    Presentation Time:    11:40 AM PT – Track 3

    Location:                     Luxe Sunset Boulevard Hotel – Bel Air, CA

    Mr. Leonard Mazur, Chairman of Citius, will deliver an overview of the Company, answer questions from investors, and be available for one-on-one meetings. To arrange a meeting with the Company, please contact Mr. Andrew Scott: .

    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 associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; 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; 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; 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
    (c) 646-522-8410
     

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    SOURCE Citius Pharmaceuticals, Inc.

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  59. CRANFORD, N.J., Nov. 8, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ:  CTXR) ("Citius" or the "Company"), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced that the Company has issued its October 2019 Corporate Update Letter.  The Letter highlights the progress of the Company's product candidates Mino-Lok®, Mino-Wrap™, and Halo-Lido, along with details on its strategic goals to develop breakthrough technologies to improve and enhance the lives of patients.

    Recent Company Highlights include:

    • Closing on a recent $7 million capital raise to advance ongoing research
    • A recent modification to the primary endpoint of the pivotal Phase III trial for Mino-Lok that substantially…

    CRANFORD, N.J., Nov. 8, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ:  CTXR) ("Citius" or the "Company"), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced that the Company has issued its October 2019 Corporate Update Letter.  The Letter highlights the progress of the Company's product candidates Mino-Lok®, Mino-Wrap™, and Halo-Lido, along with details on its strategic goals to develop breakthrough technologies to improve and enhance the lives of patients.

    Recent Company Highlights include:

    • Closing on a recent $7 million capital raise to advance ongoing research
    • A recent modification to the primary endpoint of the pivotal Phase III trial for Mino-Lok that substantially reduced the required trial sample size from 700 to approximately 144 subjects, significantly reducing the trial's expense and accelerating  its completion
    • An expanded relationship with MD Anderson Cancer Center for a worldwide license for Mino-Wrap and the preparation for a pre-IND meeting with the FDA
    • Reformulating the topical formulation (now Halo-Lido) for the treatment of hemorrhoids based on results from an initial Phase II study.  A toxicology study will be initiated by year-end ahead of an expanded Phase II study to start in 2020
    • Other corporate initiatives that include industry events and investor outreach

    To view the Company's Corporate Update Letter in its entirety, please visit: https://www.citiuspharma.com/wp-content/uploads/2019/11/CTXR-ShareholderLetter-Nov2019.pdf

    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 associated with conducting our Phase 3 trial for Mino-Lok®, including completing patient enrollment, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; 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; 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; 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
     

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  60. CRANFORD, N.J., Oct. 24, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing adjunctive cancer care and critical care drug products, announced today that the Company will present at the 5th Annual Dawson James Small Cap Growth Conference on Tuesday, Oct 29, 2019 at 4:30-4:50 PM ET in Track 2 - Preserve Ballroom B. The conference is being held at the Wyndham Grand Hotel in Jupiter, Florida on October 28-29, 2019.  

    Mr. Leonard Mazur, Chairman of Citius Pharmaceuticals will be delivering an overview of the company including recent highlights as well as answering questions from investors. Citius Pharmaceuticals, Inc. will also be available for one-on-one…

    CRANFORD, N.J., Oct. 24, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing adjunctive cancer care and critical care drug products, announced today that the Company will present at the 5th Annual Dawson James Small Cap Growth Conference on Tuesday, Oct 29, 2019 at 4:30-4:50 PM ET in Track 2 - Preserve Ballroom B. The conference is being held at the Wyndham Grand Hotel in Jupiter, Florida on October 28-29, 2019.  

    Mr. Leonard Mazur, Chairman of Citius Pharmaceuticals will be delivering an overview of the company including recent highlights as well as answering questions from investors. Citius Pharmaceuticals, Inc. will also be available for one-on-one meetings. To arrange a meeting with the Company, please contact Mr. Andrew Scott: .

    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.

    Contact:

    Andrew Scott                                                              
    Vice President, Corporate Development                                                       
    (O) 908-967-6677 x105
    (M) 646-522-8410
     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-at-the-5th-annual-dawson-james-small-cap-growth-conference-300944622.html

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  61. AUSTIN, TX / ACCESSWIRE / October 15, 2019 / The MicroCap Rodeo's inaugural event is set for October 15, and 16th, 2019 in Austin Texas at the Hilton downtown Austin. Focused on the best ideas concept, the MicroCap Rodeo brings some of the best stories to the event for two days of private meetings, presentations and after hours networking.

    This year's event is being sponsored by Lake Street Capital, Northland Securities, Lowenstein Sandler and Issuer Direct.

    Investors wishing to attend and request meetings. can register for free at https://microcaprodeo.com/signup.

    Investors not able to attend can listen to each company present via the below schedule:

    Date - Time
    Presenting Company
    Webcast URL
    Tuesday, October 15, 2019

    AUSTIN, TX / ACCESSWIRE / October 15, 2019 / The MicroCap Rodeo's inaugural event is set for October 15, and 16th, 2019 in Austin Texas at the Hilton downtown Austin. Focused on the best ideas concept, the MicroCap Rodeo brings some of the best stories to the event for two days of private meetings, presentations and after hours networking.

    This year's event is being sponsored by Lake Street Capital, Northland Securities, Lowenstein Sandler and Issuer Direct.

    Investors wishing to attend and request meetings. can register for free at https://microcaprodeo.com/signup.

    Investors not able to attend can listen to each company present via the below schedule:

    Date - Time
    Presenting Company
    Webcast URL
    Tuesday, October 15, 2019
    8:35AM-9:05AM CT
    Ammo Inc
    CHF-Solutions
    Comtech Telecommunications
    9:10AM-9:40AM CT
    Envision Solar International
    Genprex
    PFSWEB
    9:45AM-10:15AM CT
    Cytosorbents Medical, Inc.
    Digirad
    Mama Mancini's
    10:20AM-10:50AM CT
    OneSoft Solutions
    SRAX
    10:55AM-11:25AM CT
    GrowGeneration
    Marrone Bio Innovations Inc
    USIO
    11:30AM-12:00PM CT
    Crexendo
    DelMar Pharmaceuticals
    Amazing Energy
    1:30PM-2:00PM CT
    Daxor
    RF Industries
    2:05PM-2:35PM CT
    Dyadic
    Gold Resource Corporation
    Issuer Direct
    2:40PM-3:10PM CT
    Neovasc, Inc.
    Sutter Rock Capital
    TheMaven
    3:15-3:45PM CT
    Fed Nat
    Resonant
    Vermillion
    3:50PM-4:20PM CT
    CytoDyn
    Vapen MJ Ventures
    Wednesday, October 16, 2019
    8:35AM-9:05AM CT
    Akerna
    Edison Nation
    9:10AM-9:40AM CT
    Aviat Networks
    Delcath
    HyreCar
    9:45AM-10:15AM CT
    Citius Pharma
    Vuzix Corp
    Hudson Global
    10:20AM-10:50AM CT
    IMAC Holdings
    Summit Wireless
    Taronis Technologies
    10:55AM-11:25AM CT
    Medicine Man Technologies
    Salarius Pharmaceuticals
    11:30AM-12:00PM CT
    Hancock Jaffe Labs
    1:30PM-2:00PM CT
    Apollo Endosurgery
    Scopus Biopharma
    Not Available
    Jaguar Health
    2:05PM-2:35PM CT
    Augment Athletics
    SanMelix Laboratories
    Verdegen
    2:40PM-3:10PM CT
    American Prarie
    Parkboard Media
    Cyphx

    About the MicroCap Rodeo

    Bucking the trend of microcap conferences is the first-annual MicroCap Rodeo in Austin, Texas. This year's theme: Lassoing the "Best Ideas."

    Over two days in October, investors can harness top stocks for their portfolios. They'll meet with executive management teams from approximately 50-plus microcap companies across a wide variety of industries and gain an understanding into the key value drivers and potential trends for 2020. Complementing the interactive, in-depth 30-minute one-on-one meeting format will be four tracks of company presentations.

    When they're not wrangling great ideas, investors can dig into delicious Texas food, entertainment and surprise guests.

    Contact us for more information:

    SOURCE: MicroCap Rodeo

    View source version on accesswire.com:
    https://www.accesswire.com/563045/MicroCap-Rodeo-Investor-Conference--Lineup-for-October-15-and-16-2019

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  62. CRANFORD, N.J., Oct. 15, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company will present at the MicroCap Rodeo on Oct 16th at 9:45-10:15 AM in room 416B. The conference is being held at the Hilton Austin in Austin, Texas on October 15-16, 2019.

    Mr. Leonard Mazur, Chairman, of Citius Pharmaceuticals will be delivering a presentation, as well as answering questions from investors. Earlier in the month, Citius Pharmaceuticals, reached the interim analysis milestone for Mino-Lok® Phase III pivotal trial. To access Citius Pharmaceuticals live webcast please use the following link…

    CRANFORD, N.J., Oct. 15, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company will present at the MicroCap Rodeo on Oct 16th at 9:45-10:15 AM in room 416B. The conference is being held at the Hilton Austin in Austin, Texas on October 15-16, 2019.

    Mr. Leonard Mazur, Chairman, of Citius Pharmaceuticals will be delivering a presentation, as well as answering questions from investors. Earlier in the month, Citius Pharmaceuticals, reached the interim analysis milestone for Mino-Lok® Phase III pivotal trial. To access Citius Pharmaceuticals live webcast please use the following link: https://www.webcaster4.com/Webcast/Page/2134/31874

    Citius Pharmaceuticals, Inc. will also be available for one-on-one meetings. To arrange a meeting with the Company, please contact Mr. Andrew Scott: .

    About MicroCap Rodeo

    Bucking the trend of microcap conferences is the first-annual MicroCap Rodeo in Austin, Texas. This year's theme: Lassoing the "Best Ideas."

    Over two days in October, investors can harness top stocks for their portfolios. They'll meet with executive management teams from approximately 50-plus microcap companies across a wide variety of industries and gain an understanding into the key value drivers and potential trends for 2020. Complementing the interactive, in-depth 30-minute one-on-one meeting format will be four tracks of company presentations.

    When they're not wrangling great ideas, investors can dig into delicious Texas food, entertainment and surprise guests.

    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.

    Contact:

    Andrew Scott
    Vice President, Corporate Development
    (O) 908-967-6677 x105
     

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-at-the-microcap-rodeo-300938334.html

    SOURCE Citius Pharmaceuticals, Inc.

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  63. CRANFORD, N.J., Oct. 7, 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 that the data cutoff for the most recent patient treated and completing 8 weeks of observation has been reached. The Company is preparing the submission to the independent Drug Monitoring Committee ("DMC") for review and evaluation.

    The objective of the Phase III pivotal trial for Mino-Lok is to evaluate the efficacy and safety of Mino-Lok in salvaging colonized central venous catheters in subjects with catheter-related or central line-associated bloodstream infection (CRBSI/CLABSI) compared to the standard of care…

    CRANFORD, N.J., Oct. 7, 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 that the data cutoff for the most recent patient treated and completing 8 weeks of observation has been reached. The Company is preparing the submission to the independent Drug Monitoring Committee ("DMC") for review and evaluation.

    The objective of the Phase III pivotal trial for Mino-Lok is to evaluate the efficacy and safety of Mino-Lok in salvaging colonized central venous catheters in subjects with catheter-related or central line-associated bloodstream infection (CRBSI/CLABSI) compared to the standard of care using antibiotic locks.

    The primary endpoint for the trial is the time to a catheter failure event between randomization and the test of cure (TOC).

    The Mino-Lok protocol is based on reaching 92 catheter failure events for the trial, which corresponds to approximately 144 patients treated in both arms combined.

    There are 2 interim analyses planned:

    • Analysis of futility will be assessed upon reaching 37 catheter failure events (40% of the total number of anticipated events at approximately 58 patients); and
    • Analysis for superiority will be performed when 69 catheter failure events (75% of the total number of anticipated events at approximately 108 patients).

    "We are extremely pleased to have reached this important milestone in the pivotal trial. With the great work performed at such institutions such as MD Anderson Cancer Center, MedStar Georgetown University Hospital, Henry Ford Hospital, Cleveland Clinic, Carolinas Medical Center, and Massachusetts General Hospital, among others, we have been able to progress to our first analysis of the data. There is a huge medical need for a proven antibiotic lock. We are working hard to provide an alternative to submitting a very sick patient to two surgical procedures to remove and possibly replace a tunneled or implanted venous port. We believe that this pivotal trial will be the largest and best controlled clinical trial evaluating catheter salvage in diagnosed CLABSI patients to date. We are doing everything possible to keep the momentum going," said Myron Holubiak, Chief Executive Officer of Citius Pharmaceuticals, Inc.

    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.

    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, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; 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; 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; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-reaches-first-interim-analysis-milestone-for-mino-lok-pivotal-trial-300931410.html

    SOURCE Citius Pharmaceuticals, Inc.

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  64. 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…

    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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-provides-update-on-activities-from-idweek-2019-300930243.html

    SOURCE Citius Pharmaceuticals, Inc.

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  65. CRANFORD, N.J., Sept. 27, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced the closing of the previously announced underwritten at-the-market offering of 7,821,230 shares of its common stock (Common Stock) (or Common Stock equivalent) and common warrants to purchase up to an aggregate of 7,821,230 shares of Common Stock (the Offering). Each share of Common Stock (or Common Stock equivalent) was sold together with a common warrant to purchase one share of Common Stock at a combined effective price of $0.8951 per share and accompanying common warrant. The Company has granted the underwriter…

    CRANFORD, N.J., Sept. 27, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced the closing of the previously announced underwritten at-the-market offering of 7,821,230 shares of its common stock (Common Stock) (or Common Stock equivalent) and common warrants to purchase up to an aggregate of 7,821,230 shares of Common Stock (the Offering). Each share of Common Stock (or Common Stock equivalent) was sold together with a common warrant to purchase one share of Common Stock at a combined effective price of $0.8951 per share and accompanying common warrant. The Company has granted the underwriter a 30-day option to purchase up to an additional 1,173,184 shares of Common Stock and/or common warrants to purchase up to 1,173,184 shares of Common Stock.

    H.C. Wainwright & Co. acted as the sole book-running manager for the Offering.

    The gross proceeds of the Offering were approximately $7.0 million and the net proceeds from the Offering were approximately $6.1 million, after deducting underwriting discounts and commissions and other offering expenses. Citius intends to use the net proceeds from the Offering for general corporate purposes, including its Phase 3 clinical Mino-Lok trial for the treatment of catheter related bloodstream infections, the investigational new drug (IND) regulatory pathway for Mino-Wrap and its Phase 2b clinical trial of Halo-Lido cream for the treatment of hemorrhoids, and working capital and capital expenditures.

    The common warrants issued in the Offering are exercisable immediately at an exercise price of $0.77 per share and will expire five years from the date of issuance.

    A registration statement on Form S-1 (File No. 333-233759) relating to the securities was declared effective by the U.S. Securities and Exchange Commission (SEC) on September 24, 2019. The Offering was made only by means of a prospectus forming part of the effective registration statement. A final prospectus relating to and describing the terms of the Offering has been filed with the SEC. Electronic copies of the final prospectus relating to the Offering may be obtained for free by visiting the SEC's website at www.sec.gov or from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at or by telephone at 646-975-6996.

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

    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. 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: Citius' expectations regarding the use of proceeds from the Offering; risks associated with the design of our ongoing Phase 3 trial for Mino-Lok, including the recent change to the primary endpoint for that trial and our ability to show clinical significance of that endpoint; risks associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, patient retention and the reasons for catheter failure in the trial; risks associated with sourcing components of our product candidates; our dependence on third-party suppliers; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; risks relating to the results of research and development activities; risks associated with developing Mino-Wrap, including that preclinical results may not be predictive of clinical results and our ability to file an IND; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; 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; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-announces-closing-of-7-0-million-underwritten-offering-priced-at-the-market-300926956.html

    SOURCE Citius Pharmaceuticals, Inc.

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  66. CRANFORD, N.J., Sept. 25, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced the pricing of an underwritten offering of 7,821,230 shares of its common stock (Common Stock) (or Common Stock equivalent) and common warrants to purchase up to an aggregate of 7,821,230 shares of Common Stock (the Offering), priced at-the-market. Each share of Common Stock (or Common Stock equivalent) is being sold together with a common warrant to purchase one share of Common Stock at a combined effective price of $0.8951 per share and accompanying common warrant. The Company has granted the underwriter a 30-day…

    CRANFORD, N.J., Sept. 25, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced the pricing of an underwritten offering of 7,821,230 shares of its common stock (Common Stock) (or Common Stock equivalent) and common warrants to purchase up to an aggregate of 7,821,230 shares of Common Stock (the Offering), priced at-the-market. Each share of Common Stock (or Common Stock equivalent) is being sold together with a common warrant to purchase one share of Common Stock at a combined effective price of $0.8951 per share and accompanying common warrant. The Company has granted the underwriter a 30-day option to purchase up to an additional 1,173,184 shares of Common Stock and/or common warrants to purchase up to 1,173,184 shares of Common Stock.

    H.C. Wainwright & Co., LLC is acting as the sole book-running manager for the Offering.

    The common warrants will be exercisable immediately at an exercise price of $0.77 per share and will expire five years from the date of issuance. The shares of Common Stock (or Common Stock equivalent) and the accompanying common warrants can only be purchased together in the Offering but will be issued separately. The Offering is expected to close on or about September 27, 2019, subject to customary closing conditions.

    The gross proceeds of the Offering are expected to be approximately $7.0 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. Citius intends to use the net proceeds from the Offering for general corporate purposes, including its Phase 3 clinical Mino-Lok trial for the treatment of catheter related bloodstream infections, the investigational new drug (IND) regulatory pathway for Mino-Wrap and its Phase 2b clinical trial of Hydro-Lido cream for the treatment of hemorrhoids, and working capital and capital expenditures.

    A registration statement on Form S-1 (File No. 333-233759) relating to the securities was declared effective by the U.S. Securities and Exchange Commission (SEC) on September 24, 2019. The Offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the Offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus relating to the Offering may be obtained for free by visiting the SEC's website at www.sec.gov or from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at or by telephone at 646-975-6996.

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

    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. 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: the expected timing of the closing of the Offering and Citius's expectations regarding the use of proceeds from the Offering; risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the Offering; risks associated with the design of our ongoing Phase 3 trial for Mino-Lok, including the recent change to the primary endpoint for that trial and our ability to show clinical significance of that endpoint; risks associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, patient retention and the reasons for catheter failure in the trial; risks associated with sourcing components of our product candidates; our dependence on third-party suppliers; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; risks relating to the results of research and development activities; risks associated with developing Mino-Wrap, including that preclinical results may not be predictive of clinical results and our ability to file an IND; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; 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; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-announces-pricing-of-7-0-million-underwritten-offering-priced-at-the-market-300924966.html

    SOURCE Citius Pharmaceuticals, Inc.

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  67. CRANFORD, N.J., Sept. 4, 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 that the FDA responded to the Company's proposal to refine the endpoints in the current Phase 3 pivotal trial for Mino-Lok.

    The current Phase 3 trial being conducted compares Mino-Lok therapy (MLT) to antibiotic lock therapy (ALT) to not only disinfect colonized catheters causing bacteremias, but also to keep the treated catheters functioning and infection free for 8 weeks post therapy.

    The new proposed primary endpoint is planned to demonstrate a significant difference in the time to catheter failure when comparing…

    CRANFORD, N.J., Sept. 4, 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 that the FDA responded to the Company's proposal to refine the endpoints in the current Phase 3 pivotal trial for Mino-Lok.

    The current Phase 3 trial being conducted compares Mino-Lok therapy (MLT) to antibiotic lock therapy (ALT) to not only disinfect colonized catheters causing bacteremias, but also to keep the treated catheters functioning and infection free for 8 weeks post therapy.

    The new proposed primary endpoint is planned to demonstrate a significant difference in the time to catheter failure when comparing MLT to ALT. This is clinically important because eliminating the source of infection enables antibiotic treatment of the bacteremia to work more effectively and expeditiously. Additionally, if a catheter can be maintained for the time that it is needed, the patient does not need to be subjected to the procedures for removing and replacing the catheter that are associated with some serious adverse events.

    The FDA noted that time to catheter failure is an acceptable primary efficacy endpoint. They also instructed the Company to identify and consider the various types of reasons for catheter failure, and to show the clinical significance of this endpoint.

    "Citius is very pleased about the change in efficacy endpoints," said Mr. Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We believe this focus will allow us to demonstrate the real benefit of Mino-Lok therapy (MLT) which is that MLT works more efficiently and expeditiously to break up biofilm and eliminate the bacteria causing the bacteremia than current antibiotic lock therapies (ALTs). We now have a clearer way forward to prove the superior efficacy of Mino-Lok to ALTs, and we believe we can do this faster with fewer patients than originally planned. At this time Citius believes that the change to the primary endpoint will result in fewer than 150 total subjects in Phase 3 trial.  These changes would enable Citius to realize clinical trial cost savings approaching $10 million."

    The Company has recently submitted a response to the FDA with the new sample size estimate which the agency is reviewing.

    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 catheter-related blood stream infections (CRBSIs). CRBSIs are very serious life-threatening infections, especially in cancer patients receiving therapy through central venous catheters (CVCs), and in hemodialysis patients where venous access presents a challenge. The current Phase 3 trial is being conducted in 36 sites. There are currently no approved therapies to salvage infected central venous catheters (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 associated with the design of our ongoing Phase 3 trial for Mino-Lok, including the change to the primary endpoint for that trial and our ability to show clinical significance of that endpoint; risks associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, patient retention and the reasons for catheter failure in the trial; risks associated with sourcing components of our product candidates; our dependence on third-party suppliers; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; risks relating to the results of research and development activities; risks associated with developing Mino-Wrap, including that preclinical results may not be predictive of clinical results and our ability to file an IND; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; 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; 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

    Cision View original content:http://www.prnewswire.com/news-releases/citius-announces-change-to-primary-endpoint-in-mino-lok-phase-3-study-300910941.html

    SOURCE Citius Pharmaceuticals, Inc.

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  68. CRANFORD, N.J., Aug. 29, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company will be presenting at the 4th annual Disruptive Growth Conference on Wednesday, September 4th at 3:40PM EST in Presentation Room A/B.  During the conference, Executive Chairman, Mr. Leonard Mazur will be giving the presentation as well as answering questions from investors.

    Citius Pharmaceuticals, Inc. will also be available for one-on-one meetings. To arrange a meeting with the Company, please contact Mr. Andrew Scott: .

    The 2018 Disruptive Growth Conference will offer the exclusive opportunity…

    CRANFORD, N.J., Aug. 29, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company will be presenting at the 4th annual Disruptive Growth Conference on Wednesday, September 4th at 3:40PM EST in Presentation Room A/B.  During the conference, Executive Chairman, Mr. Leonard Mazur will be giving the presentation as well as answering questions from investors.

    Citius Pharmaceuticals, Inc. will also be available for one-on-one meetings. To arrange a meeting with the Company, please contact Mr. Andrew Scott: .

    The 2018 Disruptive Growth Conference will offer the exclusive opportunity to discover growth companies with disruptive technologies and business models covering the following sectors: communications, consumer, energy/alternative energy, healthcare, industrial, life sciences, natural resources, and technology.

    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 RHK Capital:
    Advisory Group Equity Services, Ltd. (dba RHK Capital) was founded in 1984. RHK Capital is a boutique investment banking firm specializing in small to medium-sized transactions. RHK is led by a management team with extensive financial industry experience and a desire to provide companies and individuals with the tools and expertise to accomplish their financial goals. In addition to investment banking, RHK has grown to include businesses in general securities, emerging market securities, distressed and high yield debt securities, investment management, mortgages, and business lending. As a division of Advisory Group Equity Services (AGES), all securities are offered through Advisory Group Equity Services Ltd., a registered broker-dealer, member of the Financial Industry Regulatory Authority and the Securities Investor Protection Corporation.

    About TAG Group:
    AGES as part of the holding company TAG Group, Inc., is a leading provider of estate, business and financial services for high net worth individuals and business entities.  TAG maintains a comprehensive network of legal, financial and accounting professionals who are committed to providing the highest level of service to their clients.  TAG maintains three separate and distinct operating units under its corporate umbrella, they are: Trust Advisory Group, Ltd., Advisory Group Equity Services, Ltd., and Estate Insurance Services, Ltd.

    About Reed Smith:
    Reed Smith is a dynamic international law firm dedicated to helping clients move their businesses forward.  Our long-standing relationships and international outlook make us the go-to partner for speedy resolution of complex transactions, disputes and regulatory matters.  At Reed Smith, we believe that the practice of law has the ability to drive progress.  We know your time is valuable and your matters are important. We are focused on outcomes, are highly collaborative, and have deep industry insight that, when coupled with our local market knowledge, allows us to anticipate and address your needs. You deserve purposeful, highly engaged client service that drives progress for your business.

    For those interested in attending, please visit www.DisruptNYC.com for more information.

    Contact:
    Andrew Scott
    Vice President, Corporate Development
    (o) 908-967-6677 x105
    11 Commerce Drive, 1st Floor
    Cranford, New Jersey 07016

    Cision View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-to-present-at-the-rhk-capital-4th-annual-disruptive-growth-conference-hosted-by-reed-smith-300908736.html

    SOURCE Citius Pharmaceuticals, Inc.

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