Citius Pharmaceuticals and Citius Oncology Announce Unique Permanent J-Code Issued for LYMPHIR by Centers for Medicare and Medicaid Services - Permanent J-Code (J9161) expected to be effective

Citius Pharmaceuticals and Citius Oncology Announce

Unique Permanent J-Code Issued for LYMPHIR by Centers for Medicare and Medicaid Services

- Permanent J-Code (J9161) expected to be effective April 1, 2025

- LYMPHIR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

CRANFORD, N.J., February 6, 2025 -

Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) and its oncology-focused subsidiary,

Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), today announced that LYMPHIR (denileukin diftitox-cxdl) has

been assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) by the Centers for Medicare & Medicaid

Effective April 1, 2025, healthcare providers

may use the permanent J-code, J9161 (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram), when submitting claims for

"The establishment of a permanent J-code

marks a critical milestone in supporting patient access to LYMPHIR, providing coding clarity for physicians and facilities who administer

LYMPHIR, and facilitating reimbursement. This achievement is a key step in ensuring that LYMPHIR is accessible to patients with commercial

and government insurance (VA, DoD, Medicare) coverage," stated Leonard Mazur, Chairman and CEO of Citius Pharma and Citius Oncology.

J-codes are unique identifiers utilized by U.S.

government and commercial payers, as well as physicians and their office staff, to streamline the billing and reimbursement process for

infused therapies and certain other treatments.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immune therapy for relapsed

or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It

is a recombinant fusion protein that combines the 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.

After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin

diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a

direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory

approval in Japan for the treatment of CTCL and PTCL. Subsequently, in 2021, Citius acquired an exclusive license with rights to develop

and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia. LYMPHIR was approved by the FDA in August 2024.

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 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.

LYMPHIR is an IL2-receptor-directed cytotoxin

indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic

IMPORTANT SAFETY INFORMATION

BOXED WARNING: CAPILLARY LEAK SYNDROME

Capillary leak syndrome (CLS), including life-threatening

or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold

LYMPHIR until CLS resolves, or permanently discontinue based on severity.

WARNINGS AND PRECAUTIONS

Capillary Leak Syndrome

LYMPHIR can cause capillary leak syndrome (CLS),

including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following

symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur

simultaneously to be characterized as capillary leak syndrome.

As defined, CLS occurred in 27% of patients in

the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients

with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset

from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution.

The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also

Regularly assess patients for weight gain, new

onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation

of each cycle of therapy and more often as clinically indicated.

Withhold, reduce dose, or permanently discontinue

based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal

LYMPHIR can cause serious visual impairment, including

changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade

1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution

of their visual impairment.

Perform baseline ophthalmic examination and monitor

as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision,

or blurred vision, refer for ophthalmologic evaluation.

Withhold LYMPHIR until visual impairment resolves

or permanently discontinue based on severity.

Infusion-Related Reactions

LYMPHIR can cause serious infusion-related reactions.

Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received

LYMPHIR, with Grade 3 infusion-related reactions in 3.4% [see Adverse Reactions (6.1)]. Eighty-three percent of infusion-related reactions

occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia.

Premedicate patients for the first three cycles

prior to starting a LYMPHIR infusion [see Dosage and Administration (2.3)]. Monitor patients frequently during infusion. For Grade 2 or

higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.

Interrupt or discontinue LYMPHIR based on severity

[see Dosage and Administration (2.4)]. Institute appropriate medical management.

LYMPHIR can cause hepatotoxicity. In the pooled

safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients,

with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to

resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved [see Adverse Reactions (6.1)]. Elevated

total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%.

Monitor liver enzymes and bilirubin at baseline

and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.

Embryo-Fetal Toxicity

Based on its mechanism of action, LYMPHIR can

cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the

initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective

contraception during treatment and for 7 days following the last dose of LYMPHIR.

The most common adverse reactions ( 20%), including

laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal

pain, rash, chills, constipation, pyrexia, and capillary leak syndrome

USE IN SPECIFIC POPULATIONS

Based on its mechanism of action, LYMPHIR can

cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate

for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.