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On November 4, 2026, our majority-owned
subsidiary, Citius Oncology, Inc., issued a press release announcing health-related quality of life results from pivotal Study 302 of
LYMPHIR® (denileukin diftitox-cxdl) in adults with relapsed or refractory cutaneous T-cell lymphoma, presented at the European Organisation
for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) 2026 Annual Meeting. A copy of the press release is
filed as Exhibit 99.1 to this Current Report on Form 8-K.
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Exhibit 99.1
Citius Oncology’s Positive Quality of Life Data for LYMPHIR® (denileukin diftitox-cxdl) in Relapsed or Refractory Cutaneous
T-Cell Lymphoma Presented at Premier Global CLTG Congress in Europe
Data featured in oral presentation at the European
Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) 2026 Annual Meeting in Berlin
Patients who responded to LYMPHIR reported sustained
improvement in skin-related quality of life measures
CRANFORD, N.J., November 4, 2026 — Citius Oncology, Inc.
(“Citius Oncology” or the “Company”) (Nasdaq: CTOR) today announced health-related quality of life (HRQoL) results
from pivotal Study 302 (NCT01871727) of LYMPHIR® (denileukin diftitox-cxdl) in adults with relapsed or refractory (r/r) cutaneous
T-cell lymphoma (CTCL). Christiane Querfeld, MD, PhD, of City of Hope, delivered an oral presentation at the European Organisation
for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) 2026 Annual Meeting, held October 8–10, 2026,
in Berlin, Germany.
“Patients and physicians have told us
that both clinical response and quality of life matter in CTCL treatment,” said Leonard Mazur, Chairman and Chief Executive
Officer of Citius Oncology. “These data add the patient’s voice to the efficacy and durability shown in our pivotal
trial. We were pleased to share the data at the EORTC-CLTG conference in Berlin and are proud to partner with the Cutaneous Lymphoma
Foundation on its November 2026 workshop to put quality of life at the center of CTCL care.”
“CTCL is a disease of the skin which symptomatic patients must deal with 24/7. Painful, itchy lesions take a real toll on their
well-being," said Dr. Myron Czuczman, Chief Medical Officer of Citius Oncology. "In Study 302, patients who responded to denileukin diftitox-cxdl
reported sustained quality of life improvements, and nearly a third of heavily pretreated patients with significant itch noted its decrease.
We believe these findings underscore how important quality of life considerations are as practitioners choose between various treatment
options for their patients with relapsed or refractory CTCL.”
Study 302 is the open-label, single-arm, multicenter registrational trial that supported the U.S. Food and Drug Administration (FDA) approval
of LYMPHIR. Adult patients with Stage I-III CTCL who had received at least one prior systemic treatment received LYMPHIR 9 mcg/kg as a
one-hour intravenous infusion on Days 1–5 of each 21-day cycle, for up to eight cycles.
Quality of life was an exploratory objective, assessed with two validated patient-reported outcome (PRO) instruments: the disease-specific
Skindex-29 and the general Functional Assessment of Cancer Therapy – General (FACT-G). Pruritus was measured on a 100-mm visual
analog scale (VAS). All analyses were descriptive. The study was not designed or powered to evaluate quality of life outcomes, no formal
statistical comparisons were performed, and these results are not included in the LYMPHIR Prescribing Information.
Key findings included:
| ● | Skin-related quality of
life: Among responders (n=25) in the primary analysis set (Stage I-III, n=69), mean change
from baseline in Skindex-29 Total Score ranged from −5.38 to −13.69 points across
assessments, compared with slightly positive to near-zero changes among non-responders (lower
scores indicate better quality of life). In the full analysis set (Stage I–IV, n=81),
sustained quality of life improvements among responders over non-responders were consistent
across all three Skindex-29 domains: symptoms, emotions, and functioning. |
| ● | Overall quality
of life: Among responders in the primary analysis set, FACT-G Total Score showed a sustained
benefit at the end of treatment, with a mean change from baseline of +3.21 at the end of
treatment, compared with −2.28 for non-responders. |
| ● | Pruritus:
Among 41 heavily pretreated patients with a baseline itch score of 20 mm or greater, 13 (32%;
95% CI, 18.1–48.1) achieved a clinically meaningful improvement, defined as a decrease
of at least 20 mm sustained for four weeks or longer. |
Citius Oncology is also partnering with the Cutaneous Lymphoma Foundation
on the Foundation’s first-ever Quality of Life Workshop, to be held in November 2026. The working meeting will bring together patients
and care partners, clinicians, researchers, advocacy organizations, and industry representatives to set priorities, standardize how quality
of life is measured in cutaneous lymphoma, and build a shared roadmap for patient care and well-being. More information about the workshop
is available at www.clfoundation.org/quality-life-workshop.
About LYMPHIR® (denileukin diftitox-cxdl)
LYMPHIR is a targeted immunotherapy 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 DT fragments that have entered cells to inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl
has demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal
action on IL-2R-expressing tumors. LYMPHIR was approved by the FDA and subsequently launched in the U.S. in December 2025. For more information,
please visit www.lymphirhcp.com.
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 after at least one prior systemic therapy. Management estimates the initial CTCL 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.
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical
company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma is the majority owner
of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed
or refractory Stage I–III CTCL who had at least one prior systemic therapy. Citius Pharma’s late-stage pipeline also includes
Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido),
a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed
in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline
next steps for both programs. For more information, please visit www.citiuspharma.com.
INDICATION
LYMPHIR is an IL2-receptor-directed cytotoxin indicated 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.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CAPILLARY LEAK SYNDROME
Capillary leak syndrome (CLS), including life-threatening or fatal
cases, has occurred 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: CLS occurred in 27% of patients in
the pooled safety population, including one fatal case. Monitor weight, new onset or worsening edema, dyspnea and blood pressure, and
check serum albumin before each treatment cycle. Withhold, reduce the dose of, or permanently discontinue LYMPHIR based on severity.
Visual Impairment: Visual impairment, most commonly blurred
vision, occurred in 9% of patients. Perform an ophthalmic examination at baseline and as clinically indicated. Refer patients with new
visual symptoms for ophthalmologic evaluation.
Infusion-Related Reactions: Infusion-related reactions occurred
in 69% of patients, most often in Cycles 1 and 2. Premedicate patients before each infusion in the first three cycles. Monitor patients
during infusion and interrupt or discontinue LYMPHIR based on severity.
Hepatotoxicity: Elevations of ALT and AST were common. Monitor
liver enzymes and bilirubin at baseline and during treatment. Withhold, reduce the dose of, or permanently discontinue LYMPHIR based on
severity.
Embryo-Fetal Toxicity: LYMPHIR can cause fetal harm. Verify
pregnancy status before starting treatment. Advise females of reproductive potential to use effective contraception during treatment and
for 7 days after the last dose.
ADVERSE REACTIONS
The most common adverse reactions (≥20%), including laboratory abnormalities,
were increased transaminases, decreased albumin, nausea, edema, decreased hemoglobin, fatigue, musculoskeletal pain, rash, chills, constipation,
pyrexia and capillary leak syndrome.
USE IN SPECIFIC POPULATIONS
Pregnancy: Advise pregnant women of the potential risk to a
fetus.
Lactation: Advise women not to breastfeed during treatment and
for 7 days after the last dose.
Females and Males of Reproductive Potential: Based on findings
in rats, LYMPHIR may impair male fertility.
Pediatric Use: Safety and effectiveness in pediatric patients
have not been established.
Geriatric Use: Clinical studies of LYMPHIR did not include sufficient
numbers of patients aged 65 and older to determine whether they respond differently from younger patients.
To report suspected adverse reactions, contact Citius Oncology at 1-844-459-6744
or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information, including the Boxed Warning,
at www.lymphirhcp.com.
Forward-Looking Statements
This press release contains “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 include: the exploratory and descriptive nature of the quality of life analyses from Study 302, and the risk that these results
may not be replicated in other studies or be indicative of outcomes for patients treated with LYMPHIR in clinical practice; regulatory
restrictions on our ability to communicate patient-reported outcome data to healthcare providers and payers; the possibility that the
Cutaneous Lymphoma Foundation’s Quality of Life Workshop may not take place as planned or achieve its objectives; 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;
our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; our ability to regain compliance with Nasdaq’s
continued listing standards; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; physician
and patient acceptance of LYMPHIR in a competitive treatment landscape; our ability to obtain, perform under, and maintain third-party
agreements and relationships, including obtaining a new bulk drug substance supplier; 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; our ability to secure and maintain strategic partnerships and expand international
access to LYMPHIR; risks relating to the results of research and development activities; our ability to procure cGMP commercial-scale
supply; 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. 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 and
Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 14, 2026. 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, except as required by law.
Contacts
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact: STiR-communications
Greg Salsburg
greg@stir-communications.com
