Full Press Release Details
Citius Oncology Ships First International Order
of LYMPHIR to Europe
Order fulfilment expands international patient
access to LYMPHIR following initial U.S. launch
Distribution by regional partners through Named
Patient Programs in specific international markets
CRANFORD, N.J., April 29, 2026 -
Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned
subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced the initial shipment of LYMPHIR
(denileukin diftitox-cxdl) to Europe through one of its regional distribution partners, marking an important milestone in expanding access
to the therapy for patients outside the United States. LYMPHIR will be made available to eligible patients through Named Patient Programs
(NPPs) in accordance with local regulations in each country.
The initiation of European distribution represents
a strategic step in the Company's broader effort to extend access to LYMPHIR for patients with limited treatment options, while
continuing to prioritize disciplined and targeted market entry.
"Reaching this milestone underscores our
commitment to ensuring that patients in need can access LYMPHIR beyond the United States," said Leonard Mazur, Chairman and Chief
Executive Officer of Citius Oncology. "Through our distribution partners, we are enabling physicians to request LYMPHIR for appropriate
patients via established Named Patient Programs, providing a pathway to treatment where approved alternatives may be limited. Importantly,
this progress complements the strong early foundation we are building in the U.S., where we continue to see encouraging adoption across
key treatment centers."
In the United States, Citius Oncology continues
to execute its commercial launch strategy, with ongoing progress in formulary access, expanding payer coverage, and increasing engagement
across both academic and community oncology settings. The Company remains focused on supporting physician education and facilitating patient
access as LYMPHIR becomes integrated into clinical practice.
LYMPHIR was approved by the U.S. Food and Drug
Administration in August 2024 for the treatment of adult patients with Stage I-III relapsed or refractory cutaneous T-cell lymphoma
(CTCL) after at least one prior systemic therapy, and was commercially launched in the United States in December 2025.
LYMPHIR does not have marketing authorization
from the European Medicines Agency in Europe or other countries outside the United States. Access is being provided solely through Named
Patient Programs in accordance with applicable local laws and regulations.
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 (DT) 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 relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius
acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and
certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform
to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA
for the treatment of adults with relapsed or refractory Stage I-III CTCL who had had at least one prior systemic therapy. Management
estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust
intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology
use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more
information, please visit www.citiusonc.com.
Forward-Looking Statements
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 Oncology. 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 ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; our ability to
secure and maintain strategic partnerships and expand international access to LYMPHIR; the estimated markets for LYMPHIR and our product
candidates and the acceptance thereof by any market; risks relating to the results of research and development activities, including those
from our existing and any new pipeline assets; our need for substantial additional funds and our ability to raise additional money to
fund our operations for at least the next 12 months as a going concern; early-stage clinical data may not be predictive of results from
larger or later-stage studies; our ability to maintain Nasdaq's continued listing standards; our ability to use the latest technology
to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape;
our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability
to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements
and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life
of our target patient populations; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain
financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual
property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC")
filings. These risks have been and may be further 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 SEC filings which are available on the SEC's website at www.sec.gov,
including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December
23, 2025. 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.
LYMPHIR (denileukin diftitox-cxdl)
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