Full Press Release Details
Citius Oncology Provides Commercial Update on
LYMPHIR Launch Highlighting Early Adoption and Expanding Clinical Development
Broad institutional uptake among leading cancer
centers and payer coverage supports early prescribing momentum and clinical integration
CRANFORD, N.J., March 31, 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 provided a commercial update on the U.S.
launch of LYMPHIR (denileukin diftitox-cxdl) for the treatment of cutaneous T-cell lymphoma (CTCL), highlighting continued adoption
across leading oncology centers, broad payer coverage progress, and advancing investigator-led clinical studies.
"We are encouraged by the early commercial
indicators for LYMPHIR, including the pace of formulary adoption, breadth of payer coverage, and increasing repeat orders from leading
oncology centers," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. "As our commercial organization
continues to scale and institutions complete formulary inclusion, we expect continued expansion in prescribing activity, including into
community settings. Together with further clinical validation through ongoing investigator-led studies, these trends support LYMPHIR's
potential not only for continued integration in the CTCL treatment landscape, but also its potential as a part of a combination immunotherapy
regimen in other cancers."
Key Early Launch Metrics:
Commercial Execution Advancing with Expanding
Market Access and Field Deployment
Commercial execution continues to advance with
the onboarding of field teams, targeted deployment of medical education and digital campaigns, attendance at major medical meetings and
increasing interaction with physicians, pharmacy stakeholders, and community centers to support the finalization of order sets and initiate
patient treatment, which typically precedes broader patient start acceleration following formulary inclusion.
Commercial supply remains well positioned to support
anticipated U.S. demand, and international expansion is underway through executed distribution agreements across Europe and the Middle
Clinical Development Expands Through Leading
Academic Collaborations
In parallel, Citius Oncology is advancing LYMPHIR's
clinical development through collaborations with leading academic centers to further evaluate its potential across broader oncology settings.
At the University of Minnesota, an investigator-sponsored study is evaluating LYMPHIR prior to CAR-T therapy in relapsed/refractory diffuse
large B-cell lymphoma, with positive
topline data presented at the ASTCT 2026 Annual Meeting and additional analyses underway. At UPMC, a Phase I study evaluating LYMPHIR
in combination with pembrolizumab in solid tumors has been completed, with positive
topline results submitted for presentation at an upcoming oncology conference. Discussions are ongoing regarding next-stage development.
These efforts support a broader strategy to evaluate LYMPHIR as a potential combination therapy across immuno-oncology settings.
Together, these commercial and clinical developments support a disciplined
launch trajectory and provide a solid foundation for continued adoption of LYMPHIR.
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; 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;
the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; 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 secure strategic partnerships and expand international access to LYMPHIR; 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