Citius Pharmaceuticals Advances Mino-Lok Phase 3 Trial Achieving 85 of 92 Events to Date CRANFORD, N.J.

Citius Pharmaceuticals

Advances Mino-Lok Phase 3 Trial Achieving 85 of 92 Events to Date

CRANFORD, N.J., April 24, 2023 -- 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, today announced that it has advanced

its clinical trial for Mino-Lok , an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream

infections. Of the 92 events required to complete the trial, the Company estimates that 85 events have been

achieved to date. The trial has enrolled 190 patients, of which 16 patients are in active treatment or pending study completion data review,

which may result in additional events. The multi-center Mino-Lok Phase 3 trial continues

to recruit patients at 35 clinical trial sites in the U.S. and India.

"We are encouraged by the progress

of our Phase 3 Mino-Lok trial in 2023. Last year, we announced the addition of multiple

trial sites in India to expedite trial completion. With an estimated 85 achieved events to date, we believe we are nearing the finish

line," stated Leonard Mazur, Chairman and CEO of Citius.

Mino-Lok Phase 3 Trial Design

Phase 3 pivotal superiority trial (NCT02901717) is a multi-center, randomized,

open-label, blinded study to determine the efficacy and safety of Mino-Lok (MLT), a novel antibiotic lock therapy that

combines minocycline with edetate disodium. The primary endpoint for this study is the time (in days following randomization) to a catheter

failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population. Additional secondary outcome measures

include overall success, microbiological eradication, and clinical cure, among others.

Patients diagnosed with catheter related blood stream

infections (CRBSI/CLABSI) and who meet all necessary criteria for the study are randomized in a 1:1 ratio to receive either Mino-Lok

therapy or standard of care antibiotic lock therapy.

Patients in the Mino-Lok arm receive

one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator

determines the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or

Infectious Diseases Society of America (IDSA) guidelines.

Mino-Lok is an antibiotic lock solution to treat

patients with catheter-related blood stream infections that Citius has licensed from The University of Texas MD Anderson Cancer Center.

Citius believes Mino-Lok provides a superior alternative to removing and replacing a central venous catheter (CVC), leading

to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok would be the

first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.

About Citius Pharmaceuticals, Inc.

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. At the end of March 2023, Citius completed enrollment in its Phase 2b trial of CITI-002, a topical formulation

for the relief of hemorrhoids. For more information, please visit www.citiuspharma.com.

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: risks relating to the results of research and development activities, including

those from existing and new pipeline assets, including Mino-Lok; 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; 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; 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