Citius Pharmaceuticals Reports Topline Data from the Pivotal Phase 3 Study of Cancer Immunotherapy I/ONTAK (E7777) for the Treatment of Persistent or Recurrent Cutaneous T-Cell Lymphoma (CTCL) in Support of BLA Submissio

Citius Pharmaceuticals Reports Topline Data

from the Pivotal Phase 3 Study of Cancer Immunotherapy I/ONTAK (E7777) for the Treatment of Persistent or Recurrent Cutaneous T-Cell Lymphoma

(CTCL) in Support of BLA Submission

CRANFORD, N.J., April 6, 2022 -- 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 in oncology, anti-infectives in adjunct cancer care,

unique prescription products, and stem cell therapies, today reported topline results from the pivotal Phase 3 trial of I/ONTAK (E7777),

an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma

(CTCL). The topline results for I/ONTAK (denileukin diftitox), a purified and more bioactive formulation of previously marketed ONTAK ,

were consistent with the prior formulation. Moreover, no new safety signals were identified. Based on this data, Citius anticipates filing

a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2022.

"We are encouraged by the results of the

study, which we believe are clinically meaningful, and are hopeful that I/ONTAK will be an important treatment option for patients with

persistent or recurrent CTCL. There is no single standard of care for this orphan disease. We believe the full body of data from this

and prior studies will support a successful reintroduction of denileukin diftitox to the market. We are eager to move forward with a BLA

submission for the treatment of CTCL later this year. This important milestone brings Citius one step closer to launching its first commercial

product next year, if approved by the FDA," stated Myron Holubiak, Chief Executive Officer of Citius.

"The topline results demonstrated anti-tumor

activity in the treatment of persistent or recurrent CTCL, an incurable disease. Based on the topline data, I/ONTAK provided disease control

without cumulative toxicity. I/ONTAK has a unique dual mechanism of action that exerts both direct tumor cell killing and transient elimination

of immunosuppressive Tregs within the tumor microenvironment. The topline data further demonstrate that I/ONTAK has an average time to

response within one to two cycles of treatment in patients that have failed multiple prior therapies. If approved, we believe this biologic

with its observed efficacy and safety data, and which is already approved for CTCL and peripheral T-cell lymphoma (PTCL) patients in Japan,

would arm oncologists in the U.S. with an important additional treatment option for this devastating orphan disease," added Dr.

Myron Czuczman, Chief Medical Officer of Citius.

About I/ONTAK Pivotal Phase 3 Study 302 (E7777-G000-302)

Study (E7777-G000-302) is a pivotal, multicenter,

open-label, single-arm study of I/ONTAK (E7777) in subjects with persistent or recurrent CTCL (NCT01871727). All subjects were diagnosed

with Mycosis Fungoides or S zary Syndrome, with tumors assessed as positive for expression of the CD25 subunit of the IL-2 receptor.

The study was conducted in two parts with an

initial Lead-In Study to determine the optimal dose of I/ONTAK, followed by the Main Study. The Lead-In study was completed with 21 subjects

treated at doses of 6 to 15 g/kg/day. Final data collection for the Lead-In Study occurred in August 2015. The Protocol Steering

Committee selected a dose of 9 g/kg/day to be used for the Main Study. A total of 91 subjects with Stage I-IV CTCL were enrolled in

the Main Study. Study participants were administered 9 g/kg/day of I/ONTAK (E7777) by intravenous infusion over 60 minutes (+/-10

minutes) on 5 consecutive days per cycle every 21 days.

A total of 71 subjects with Stage I-III persistent

or recurrent CTCL from the Lead-In and Main Studies were assessed for efficacy with 69 subjects included in the Primary Efficacy Analysis

Set. Study 302 was completed in December 2021.

Summary of Topline Efficacy and Safety Data

The primary outcome measure of Study 302 is

the Objective Response Rate (ORR) based on the Global Response Score (GRS) (Olsen, JCO 2011). ORR is defined as the proportion of subjects

with a significant reduction in tumor size that can be classified as achieving either a partial response (PR) or a complete response (CR).

The study evaluated additional secondary and

exploratory endpoints that include progression free survival, duration of response, time to response, skin response, duration of skin

response, time to skin response, ORR (Prince, JCO 2010) and safety.

These results reflect preliminary topline data

and are subject to further analysis. These data as well as full detailed results will be presented at upcoming scientific conferences

and submitted for publication.

Selected Preliminary Efficacy Data Table

I/ONTAK 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 for

the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and

CTCL, respectively, making it potentially eligible for seven years of market exclusivity post-approval for each indication.

About Cutaneous T-cell Lymphoma

Cutaneous 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 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 systemic 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. Approximately 3,000 new cases are reported in the United

States every year, with an estimated 30,000 - 40,000 individuals living with the disease.

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.

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: risks associated with preparing and submitting and receiving approval for our planned biologics license application for I/ONTAK;

our ability to commercialize our products if approved by the FDA; 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 dependence

on third-party suppliers; our ability to successfully undertake and complete 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; 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