Citius Pharmaceuticals, Inc. Announces U.S. Food and Drug Administration Acceptance of Biologics License Application of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymp

Pharmaceuticals, Inc. Announces U.S. Food and Drug Administration Acceptance of Biologics License Application of Denileukin Diftitox

for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma

Drug User Fee Act (PDUFA) target action date is September 28, 2023

N.J., December 1, 2022 -- 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 the U.S. Food

and Drug Administration (FDA) has accepted the Company's Biologics License Application (BLA) for denileukin diftitox ("I/ONTAK"

or "E7777"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent

cutaneous T-cell lymphoma (CTCL). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK .

The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study (NCT01871727).

acceptance of the previously announced BLA submission for I/ONTAK is another important regulatory milestone for our oncology program.

With an anticipated PDUFA date of September 28, 2023, we look forward to the potential approval of this therapeutic for patients with

persistent or recurrent cutaneous T-cell lymphoma, a rare disease for which patients with advanced disease have limited treatment options,"

stated Leonard Mazur, Chairman and CEO of Citius.

is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent

specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein

synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK.

ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted

in a new formulation which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received

regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). In 2011 and 2013, the FDA granted

orphan drug designation to I/ONTAK for the treatment of PTCL and CTCL, respectively.

Cutaneous T-cell Lymphoma

T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous

lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions,

leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and

S zary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can

take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the

cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of

the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women

and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation,

for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.

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.

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.

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

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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 FDA may not approve our BLA for I/ONTAK; our need for substantial

additional funds; 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; our ability to successfully undertake and complete clinical and non-clinical trials and the

results from those trials for our product candidates; 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; 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

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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

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