CRANFORD, N.J.

,

Nov. 5, 2021

/PRNewswire/ — Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, today announced the appointment of pharmaceutical industry veteran

Kelly Creighton

, PhD as Executive Vice President of Chemistry, Manufacturing and Controls (CMC). Mr. Creighton will be responsible for the global strategic regulatory and manufacturing development plans for Citius’s five pipeline programs.

“With two late Phase 3 trials nearing completion, we continue to prepare the organization for commercial success. Kelly is a seasoned pharmaceutical veteran whose accomplishments include more than 50 investigational new drug (IND) submissions and 20 approved market applications spanning multiple therapeutic areas including oncology, infectious disease and cell therapy. Kelly has been a longstanding advisor to the Citius team on all aspects of the regulatory pathway for Mino-Lok

^®

and we anticipate a seamless transition into this newly created in-house role. He brings an ideal blend of strategic thinking, leadership skills and deep global regulatory and product development expertise, which he will apply to our entire clinical program as we continue to develop the Citius pipeline,” stated

Myron Holubiak

, Chief Executive Officer of Citius.

Kelly Creighton

, PhD

joins Citius from Clinipace Worldwide, a leading global contract research organization, where he served as Vice President of Regulatory and Strategic Development. As a senior-level regulatory affairs and quality assurance expert with nearly two decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene and cellular therapies, and combination products, he has provided comprehensive regulatory strategy assessments, development plans and regulatory dossiers for programs across a wide range of therapeutic areas.  As head of a global CMC regulatory activities for investigational products, he has led teams throughout

North America

,

Europe

and the

Asia Pacific

region overseeing submissions and negotiations with regulatory authorities, as well as biosafety and environmental agencies in each of these regions. Kelly has directed the implementation of multiple CMC development plans including: contract manufacturing organization selection, product manufacturing, analytical development, product characterization, specification establishment, container closure systems and stability requirements. Additionally, his substantial product development experience extends to biologics/biosimilars, small molecule, gene and cellular therapies, cancer immunotherapies, live oncolytic biotherapeutics, and microbiome therapies. Twenty products for which he prepared regulatory marketing applications (NDAs, ANDAs, and BLAs) were approved in the US and EU. Additionally, he has performed internal and external quality assurance audits for drug products, drug substance, and tissue and cell therapy products.

Kelly earned his BS from

New Mexico State University

and his MSc and PhD from the

University of Nebraska

.

About Citius Pharmaceuticals, Inc.


Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company has two late-stage product candidates, Mino-Lok

^®

, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma (CTCL), which has completed enrollment in its Pivotal Phase 3 trial.  Mino-Lok

^®

was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Through its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary mesenchymal stem cell treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on acute respiratory distress syndrome (ARDS) associated with COVID-19.  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 attract, integrate, and retain key personnel; risks relating to the results of research and development activities, including those from existing and new pipeline assets; uncertainties relating to preclinical and clinical testing; our need for substantial additional funds; the early stage of products under development; our dependence on third-party suppliers; our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our ability to commercialize our products if approved by the FDA; 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 ability to procure cGMP commercial-scale supply; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by Covid-19. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings which are available on the SEC’s website at

www.sec.gov

, including in our Annual Report on Form 10-K for the year ended

September 30, 2020

, filed with the SEC on

December 16, 2020

and updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and 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.

Investor Relations for Citius Pharmaceuticals:



Ilanit Allen


Vice President, Investor Relations and Corporate Communications

T: 908-967-6677 x113

E:

[email protected]

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SOURCE Citius Pharmaceuticals, Inc.