Citius Pharmaceuticals, Inc. Provides Business Update, Highlights Upcoming Milestones

CRANFORD, N.J., May 3, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today provided a business update for the first quarter ended March 31, 2022 and reported on recent corporate developments and upcoming milestones.

Recent Highlights and Upcoming Milestones

• Citius anticipates filing a biologics license application (BLA) for I/ONTAK^® with the U.S. Food and Drug Administration (FDA) in the second half of 2022;
• Topline data from the Phase 3 study of cancer immunotherapy I/ONTAK are consistent with the previously-approved formulation of denileukin diftitox (ONTAK), and there are no new safety signals;
• Halo-Lido Phase 2b trial initiated in April 2022 with last patient enrollment anticipated by the end of 2022;
• Phase 3 Mino-Lok^® trial proceeding without modification as recommended by the independent data monitoring committee (DMC) following all three DMC reviews;
• Mino-Lok Phase 3 trial completion anticipated by end of 2022; and,
• Pre-clinical development ongoing for Citius' Mino-Wrap and induced mesenchymal stem cell programs.

"2022 is a year of important catalysts for Citius as we continue to make progress on multiple fronts.  We recently released topline results for I/ONTAK which were consistent with the prior FDA-approved and marketed formulation of denileukin diftitox (ONTAK). In preparation for a planned BLA submission in the second half of 2022, we are marshalling the necessary manufacturing and commercial resources to support the application, and ultimately a successful launch," stated Leonard Mazur, Chairman and CEO of Citius.

"Our Mino-Lok program continues to advance in accordance with the recommendations of the independent data monitoring committee, which advised us to continue with the trial as planned, following each of its three data reviews. We remain encouraged by the positive signal conveyed by the DMC guidance to proceed. Coupled with the recent ramp up in patient recruitment following an easing of COVID-related hospital restrictions, we believe our efforts to increase engagement with existing trial sites and to onboard additional sites will continue to drive trial enrollment and enable us to achieve the necessary trial events to support statistically significant results," added Mazur.

"In April, we initiated our Phase 2b Halo-Lido trial for the treatment of hemorrhoids. By the end of 2022, we expect to complete trial enrollment. A data readout will follow upon validation and analysis of the information provided in the electronic patient reported outcome tool (ePRO) designed with guidance from the FDA. The results will be used to design the Phase 3 trial. As this product would ultimately be marketed directly to consumers, rather than to targeted physician and hospital groups like our other pipeline candidates, we will evaluate alternatives to optimize the value of this asset as we advance the program. Citius considers all strategic alternatives to maximize the value of our portfolio, individually and collectively, on an ongoing basis. We believe we remain well capitalized to advance our programs through multiple catalysts this year, and we plan to continue building long-term value in the business by focusing on execution," concluded Mr. Mazur.

2022 Achieved and Anticipated Catalysts

• Report Topline results of I/ONTAK Phase 3 trial (April 2022)
• Initiate Halo-Lido Phase 2b trial (April 2022)
• Submit I/ONTAK BLA application (2H 2022)
• Complete enrollment in Mino-Lok Phase 3 trial (end of 2022)
• Complete enrollment in Halo-Lido Phase 2b trial (end of 2022)

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 "believe," "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; the estimated markets for our product candidates and the acceptance thereof by any market; our ability to commercialize our products if approved by the FDA; our dependence on third-party suppliers; the ability of our product candidates to impact the quality of life of our target patient populations; 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; market and other conditions; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy; patent and intellectual property matters; 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, 2021, filed with the SEC on December 15, 2021 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: ir@citiuspharma.com

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SOURCE Citius Pharmaceuticals, Inc.