Citius Pharmaceuticals Advances Efforts to Spin Off Oncology Asset, I/ONTAK, into a Standalone Public Company

03/30/2023

CRANFORD, N.J., March 30, 2023 /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 announced that Maxim Group LLC will serve as financial advisor to its wholly-owned subsidiary, Citius Acquisition Corp. Inc., in connection with the intended formation of a separate publicly-traded entity to commercialize and grow Citius' oncology asset, I/ONTAK. The U.S. Food and Drug Administration (FDA) is currently reviewing a biologics license application (BLA) for I/ONTAK and has set a targeted decision date (PDUFA) of July 28, 2023.

"Citius is committed to maximizing the value of I/ONTAK and advancing our pipeline. Maxim Group has a strong track record of executing strategic and financial transactions in the life science sector, and we look forward to working closely with them to optimize the structure and timing of contemplated I/ONTAK transactions," stated Leonard Mazur, Chairman and CEO of Citius. 

Any transactions would be subject to the satisfaction of customary conditions, including final approval from the Citius Board of Directors, regulatory approvals, and SEC filings. Upon closing of the transactions, Citius would continue to trade on the Nasdaq exchange under its current ticker CTXR.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.  There can be no assurance regarding the ultimate timing of proposed transactions or that the transactions will be completed at all.

About Maxim Group LLC

Maxim Group LLC is a full-service investment banking firm headquartered in New York with approximately 240 employees. Maxim Group provides a full array of financial services, including investment banking; private wealth management; and global institutional equity, fixed-income, and derivatives sales and trading, as well as equity research. The investment banking group focuses on middle market and emerging growth companies within the shipping, energy, health care, technology, retail, and business and financial services sectors. The institutional coverage of Maxim Group spans North and South America, Europe, and Asia. Maxim Group LLC is registered as a broker-dealer with the U.S. Securities and Exchange Commission and is a member of the following: Financial Industry Regulatory Authority (FINRA); Municipal Securities Rulemaking Board (MSRB); Securities Insurance Protection Corporation (SIPC); NASDAQ Stock Market and the NYSE Arca, Inc.

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's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections, 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 CTCL, for which a BLA is under review by the FDA. Mino-Lok® was granted Fast Track designation by the FDA. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and PTCL. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids. 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 decision whether to proceed with the spinoff, if at all, our ability to successfully complete the planned spinoff if undertaken and the benefits achieved by the planned spinoff; risks relating to the results of research and development activities, including those from existing and new pipeline assets; our ability to commercialize our products if approved by the FDA; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our need for substantial additional funds; our dependence on third-party suppliers; 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 procure cGMP commercial-scale supply; 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 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. These risks have been and may be further impacted by Covid-19 and could be impacted by any future public health risks. 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, 2022, filed with the SEC on December 22, 2022 and updated by our subsequent filings with the Securities and Exchange Commission. 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 Contact:
Ilanit Allen
ir@citiuspharma.com 
908-967-6677 x113

Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com

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SOURCE Citius Pharmaceuticals, Inc.