CTOR 8-K
Citius Oncology, Inc. (CTOR)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On December 1, 2025, Citius Oncology, Inc. (the “Company”) posted an updated Corporate Presentation on its website. A copy of the Corporate Presentation is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On December 1, 2025, the Company issued a press release announcing the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl), a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Corporate Presentation of December 2025 | |
| 99.2 | Press Release, dated December 1, 2025. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURES
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.
| CITIUS ONCOLOGY, INC. | |
| Date: December 1, 2025 | /s/ Leonard Mazur |
| Leonard Mazur | |
| Chairman and Chief Executive Officer |
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Exhibit 99.1
CORPORATE OVERVIEW NASDAQ: CTOR DECEMBER 2025
FORWARD LOOKING LANGUAGE NASDAQ: CTOR | 2 This presentation has been prepared by Citius Oncology, Inc . (the “Company”) for informational purposes only and not for any other purpose . Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the Company or any director, employee, agent, or adviser of the Company . This presentation does not purport to be all - inclusive or to contain all of the information you may desire . The information contained in this presentation and the comments and remarks of the representatives of the Company made during any presentation to which this presentation relates are integrally related and, as such, are intended to be delivered and understood together . Information provided in this presentation speaks only as of the date hereof . The Company assumes no obligation to update any statement after the date of this presentation as a result of new information, subsequent events or any other circumstances . This presentation does not constitute an offer or invitation for the sale or purchase of securities or to engage in any other transaction with the Company or its affiliates . The information in this presentation is not targeted at the residents of any particular country or jurisdiction and is not intended for distribution to, or use by, any person in any jurisdiction or country where such distribution or use would be contrary to local law or regulation . This presentation contains forward - looking statements that involve substantial risks and uncertainties . In some cases, you can identify forward - looking statements by the words “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “goal”, “objective”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “continue” and “ongoing”, or the negative of these terms, or other comparable terminology intended to identify statements about the future . These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward - looking statements . The forward - looking statements and opinions contained in this presentation are based upon estimates and information available to us as of the date of this presentation . While we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information . Factors that could cause actual results to differ from those discussed in the forward - looking statements include, but are not limited to : 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 ; 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 ; our ability to secure strategic partnerships and expand international access to LYMPHIR ; our ability to use the latest technology to support our commercialization efforts ; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market ; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations ; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets ; our ability to procure cGMP commercial - scale supply ; our ability to obtain, perform under and maintain financing and strategic agreements and relationships ; our ability to maintain Nasdaq’s continued listing standards ; market and other conditions ; risks related to our growth strategy ; patent and intellectual property matters ; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis ; government regulation ; and other assumptions described in this presentation underlying or relating to any forward - looking statements Investors are strongly encouraged to carefully review the Company’s SEC filings for a listing of the risks that could cause actual results to differ from these forward - looking statements . These forward - looking statements speak only as of the date of this presentation and should not be construed as statements of facts . As a matter of course, we do not make public projections as to our expected sales or profitability due to, among other reasons, the inherent uncertainty of the underlying assumptions and estimates . Similarly, as a matter of course, we do not comment on ongoing or potential partnership discussions, the expected timing of future financial raises or potential long - term strategic plans.
ABOUT CITIUS ONCOLOGY, INC. Biopharmaceutical company focused on developing and commercializing innovative targeted oncology therapies • NASDAQ: CTOR | Stand - alone public company since August 2024 • Majority - owned (~79%) subsidiary of Citius Pharmaceuticals (NASDAQ: CTXR) • Shared management services agreement with CTXR for operational efficiency • LYMPHIR : First commercial product launched December 2025 • $400M+ est. addressable U.S. market with strong growth opportunities 1 • Rights to all markets except India, Japan and certain parts of Asia • Mission: Deliver innovative, targeted oncology therapies that transform patient outcomes NASDAQ: CTOR | 3 1. Internal estimates based on IQVIA market research.
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 • First marketed product by Citius Oncology • Commercial supply shipped to national wholesalers • Accessible to providers and patients across the U.S. LYMPHIR NOW COMMERCIALLY AVAILABLE IN THE U.S. NASDAQ: CTOR | 4
EXPERIENCED MANAGEMENT TEAM Shared management services agreement with Citius Pharmaceuticals mitigates execution risk, maximizes capital efficiency and leverages industry expertise LEONARD MAZUR CHAIRMAN & CEO JAIME BARTUSHAK EVP, CFO & CBO DR. MYRON CZUCZMAN EVP, CHIEF MEDICAL OFFICER OMAR LANSARI DIR, MARKETING MICHAEL MCGUIRE VP, COMMERCIAL MYRON HOLUBIAK EXECUTIVE VICE CHAIRMAN NASDAQ: CTOR | 5
WHAT IS CUTANEOUS T - CELL LYMPHOMA (CTCL)? • Orphan cancer • Severe quality - of - life impact: pain, pruritus, skin lesions • Patients with persistent or recurrent CTCL require systemic therapy • Limited systemic treatment options Considered to be incurable, CTCL is a Subgroup of Non - Hodgkin Lymphomas (NHL) that can be Indolent or Aggressive and is Driven by Malignant T Cells CTCL is a general term for T - cell lymphoma that involves the skin, but may also involve the blood, lymph nodes, and internal organs CTCL accounts for approximately 4% of all non - Hodgkin lymphoma (NHL) 1 More prevalent in men than women and usually appears in patients in their 50s and 60s 60% 3 - 5% 37% CTCL Prevalence by Subtype 2,3,4 Mycosis Fungoides Sezary Syndrome Other CTCL NASDAQ: CTOR | 6 1. Dummer R, et al. Nat Rev Dis Primers. 2021;7(1):61. 2. Rangoonwala, HI and Cascella M. 2022, StatPearls Publishing: Treasure Island, FL. 3. Cleveland Clinic. Cutaneous T - Cell Lymphoma . 2023. Available from: https0://my.clevelandclinic.org/health/diseases/17940 - cutaneous - t - cel l - l ymphoma 4. Hristov AC, et al. Am J Hematol. 2019;94(9):1027 - 1041.
CTCL PATIENTS HAVE A HIGH DISEASE BURDEN T1 T4 Sézary cell T2 T3 Zackheim. J Am Acad Dermatol. 1999;40:418. Slide credit: clinicaloptions.com NASDAQ: CTOR | 7
DIFFERENTIATED MECHANISM OF ACTION (MOA) LYMPHIR targets the IL - 2 receptor, working both as a targeted therapy against malignant T - cells AND as an immunotherapy against Tregs IL - 2 receptor offers a unique treatment opportunity in CTCL Malignant T - cells and Tregs share a common marker: the IL - 2 receptor Targets Malignant Cells Binds to IL - 2 receptors to deliver diphtheria toxin, killing tumor cells directly NASDAQ: CTOR | 8 Eliminates Immunosuppressive Tregs Reduces number of Treg cells, subsequently enhancing anti - tumor immunity
COMPELLING CLINICAL DATA NASDAQ: CTOR | 9 LYMPHIR addresses CTCL’s heavy Quality of Life burden 1. Objective Response is Complete Response and Partial Response according to the ISCL/EORTC Global Response Score. 2. In the Primary Efficacy Analysis set, 84.4% (54/64) of skin evaluable subjects had a decrease in skin tumor burden, with 48.4% subjects with ≥50% reduction in skin tumor burden. Complete clearing of skin disease (skin CR) was observed in 12.5% (8/64) subjects. 3. The duration of response (DOR) was at least 6 months for 52% of responders and at least 12 months for 20% of responders (25/69 patients). OBJECTIVE RESPONSE RATE 1 36% 9% achieved complete response 27% achieved partial response Median number of months to achieve an objective response (complete or partial response) RAPID RESPONSE TIME 1.4 months Median months of disease control among patients who responded to E7777 3 DURABLE RESPONSE 6.5 months Reduction in skin tumor burden among evaluable patients 48.4% of patients with ≥50% reduction in skin tumor burden 2 REDUCED SKIN BURDEN 84.4%
DEMONSTRATED SAFETY Overall, LYMPHIR was well - tolerated with the use of pre - medications, close patient monitoring, and prompt initiation of supportive measures and drug management • No evidence of cumulative toxicity • Most patients experienced grade 1/2 treatment emergent adverse events (TEAEs) Grade ≥3 6% CAPILLARY LEAK SYNDROME 0% Grade ≥3 loss in visual acuity VISUAL IMPAIRMENT 6% Grade ≥3 INFUSION REACTION LYMPHIR’s full prescribing information: https://www.lymphirhcp.com/prescribing - information.pdf NASDAQ: CTOR | 10
OPPORTUNITIES FOR GROWTH BEYOND CTCL • University of Pittsburgh: an investigator - initiated trial is underway to evaluate LYMPHIR for potential use as an immuno - oncology therapy in combination with KEYTRUDA® in patients with recurrent or metastatic solid tumors (NCT05200559) • Encouraging preliminary results of interim analysis: • 15 evaluable patients showed 27% ORR; 33% Clinical Benefit Rate; median Progression Free Survival of 57 weeks (for patients that achieved a clinical benefit) • The data supports further evaluation of this combination across a broader range of solid tumor types • Phase 1 study data (n=25) anticipated Q1 2026 • University of Minnesota: LYMPHIR in combination with CAR T therapies (NCT04855253) • Phase 1 study to evaluate the potential benefit of LYMPHIR given prior to CAR T therapy in patients with high risk relapsed/refractory B - cell lymphomas • Preliminary study results anticipated Q1 2026 • Logical label expansion potential in PTCL where there is a high unmet need and no curative therapies Phase III Phase II Phase I Preclinical Investigational Indication Program data published Prelim Interim p C OMBINATION WITH PD - 1 I NHIBITOR (K EYTRUDA ® ) 1 UNIVERSITY OF PITTSBURG MEDICAL CENTER, HILLMAN CANCER CENTER C OMBINATION WITH CAR - T (K YMRIAH ) 1 UNIVERSITY OF MINNESOTA, MASONIC CANCER CENTER P ERIPHERAL T - C ELL L YMPHOMA LYMPHIR - P NASDAQ: CTOR | 11 1. KEYTRUDA is a registered trademark of Merck & Co., Inc. KYMRIAH is a registered trademark of Novartis Pharmaceuticals Corporation.
LYMPHIR IS COMPETITIVELY POSITIONED NASDAQ: CTOR | 12 Only FDA - Approved IL - 2 Receptor - Directed Therapy for CTCL • Novel mechanism : fusion protein targets IL - 2 receptors • Direct tumoricidal effect and transient T - reg depletion • Unique among systemic therapies • Patients are put on multiple alternate therapies and cycle to 2nd line treatments within 5 months , on average • Key growth drivers expected to increase overall market size and facilitate market penetration • Evolving treatment paradigm; incremental therapeutic option for pre - treated patients • Historically, market growth has followed introduction of new therapeutics • Competitively priced • No new therapy approved since 2018
COMPETITIVE DIFFERENTIATION Today’s CTCL treatments are non - curative LYMPHIR excels where current therapies are limited • Requires CD30+ biomarker • Peripheral neuropathy may limit use • Most effective in SS subsegment of CTCL (<5%) • Acts on blood disease rather than skin disease • ORR 21% in MF • Use limited by cumulative bone marrow toxicity • Quality of life issues • No biomarker needed • Broad label • No cumulative toxicity • Skin relief • Rapid response • No cumulative toxicity • No cumulative toxicity • Refined patient profile Limitations NASDAQ: CTOR | 13
COMMERCIAL INFRASTRUCTURE: DISTRIBUTION AND CHANNEL ACCESS 14 Patient - centric distribution strategy aims to promote timely product availability for eligible CTCL patients across all care settings • U.S. nationwide specialty distribution network fully operational • Cencora, Cardinal Health, and McKesson • Coverage across academic centers and community clinics • Commercial - ready inventory with a 60 - month shelf life is in place to meet projected demand 12 – 18 months post - launch • Permanent J - code: J9161 (effective April 2025) • NCCN Guidelines inclusion with Category 2A recommendation • Ex - U.S. strategy to leverage country - specific Named Patient Programs • Exclusive distribution agreement with Integris Pharma S.A. (Oct 2025) • Establishes coverage for 12 markets: Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia • Citius Pharma is in active discussions with multiple additional prospective distribution partners across several European Union member states, in South America, and in select Middle Eastern territories
CONCENTRATED PRESCRIBER BASE NASDAQ: CTOR | 15 10% of Providers (Physicians) Treat ≥3 Patients 90 17 7 15 12 0 10 20 30 40 50 60 70 Number of Accounts 80 90 100 20 - 40 41 - 60 61 - 80 81 - 120 121 - 475 Number of Patients Accounts by Number of Diagnosed Patients Source: IQVIA Medical (Dx) & Pharmacy (Rx) Claims Data IQVIA Citius CTCL HCP Targeting Report – September 2022 Copyright © 2022 IQVIA. All rights reserved. | Confidential Patients may be double counted if treated by multiple providers. Accounts include institutions with multiple prescribing physicians or centers of care. 3928, 90% 427, 10% Providers treating at least 1 patient Providers treating at least 3 patients 141 Accounts Diagnose ≥20 Patients
PATIENT AND HCPS CLUSTERED NEAR MAJOR CANCER CENTERS • Concentration of providers and accounts allows for a focused field force approach (~ 25 reps) • AI - driven targeting system enables identification of key treatment patterns, personalization of provider engagement, and more efficient allocation of commercial resources to optimize opportunities with providers and patients 60% of CTCL patients are concentrated in 10 states Powered by Bing © GeoNames, Microsoft, TomTom 6 NASDAQ: CTOR | 16 COUNT 795 CTCL PATIENTS BY STATE* ( TOTAL PATIENTS = 6 ,841 ) * Source: IQVIA Medical (Dx) & Pharmacy (Rx) Claims Data IQVIA Citius CTCL HCP Targeting Report – September 2022. Cumulative Data 2017 - 2021. Patient State based on patient ZIP 3. US Territories removed from visualization.
PROVIDER & PATIENT SUPPORT Citius Oncology Access & Education Tools • HCP portal: www.lymphirhcp.com • Reimbursement and prior authorization support • Patient assistance via Citius Advantage program • Comprehensive education & prescribing tools NASDAQ: CTOR | 17
MULTI - LAYERED PROTECTION: BARRIERS TO ENTRY 12 years of BLA exclusivity Orphan Drug Exclusivity (7 years) ODD designation granted for CTCL and PTCL (CTCL exclusivity determined upon BLA review) Complex Proprietary Manufacturing Process trade secret 2 Patents Pending LYMPHIR use as combination therapy with check point inhibitors NASDAQ: CTOR | 18
WHY CTOR? WHY NOW? LYMPHIR is poised for successful launch with potential upside opportunities beyond CTCL • LYMPHIR is the only IL - 2R targeted therapy for CTCL • FDA - approved treatment in a rare cancer indication with no curative therapies • Commercial U.S. launch: December 2025 • Estimated $400M+ addressable U.S. market 1 with potential upside potential driven by expanded indications, immuno - oncology opportunities, and international markets • Orphan indication with 12 - year BLA exclusivity • Concentrated prescriber base clustered around major cancer centers NASDAQ: CTOR | 19 1. Internal estimates based on IQVIA market research.
Exhibit 99.2
Citius Oncology Announces U.S. Commercial Launch of LYMPHIR™, a Novel Cancer Immunotherapy for Cutaneous T-Cell Lymphoma (CTCL)
LYMPHIR now available nationwide
CRANFORD, N.J., December 1, 2025 – Citius Oncology, Inc. (“Citius Oncology”) (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”) (Nasdaq: CTXR), today announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl). LYMPHIR is a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (r/r) Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
“LYMPHIR is an important new treatment option for the CTCL community, and its launch marks the beginning of a new chapter for Citius Oncology. With a median time to response of 1.4 months in the Phase 3 trial, we believe LYMPHIR may offer rapid skin relief, among other benefits, to patients suffering from severe and debilitating itching common with the disease,” said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. “This is our first marketed product and the culmination of years of development work and commercial preparation. LYMPHIR addresses a clear clinical need in a disease with limited treatment options. Ultimately, we expect LYMPHIR to be a meaningful addition to the treatment paradigm for CTCL and a value-driving catalyst for Citius Oncology shareholders. We estimate that LYMPHIR is entering a growing U.S. market valued at over $400 million, with further upside opportunities through international market access and potential expanded indications in the future. Our focus now is on execution to ensure that LYMPHIR reaches the patients who need it,” added Mazur.
The FDA approval of LYMPHIR was based on data from Pivotal Study 302 (NCT01871727), which evaluated the efficacy and safety of LYMPHIR in patients with Stage I–III CTCL who had received at least one prior systemic treatment. The study demonstrated an Objective Response Rate (ORR) of 36.2%, with 84% of evaluable patients experiencing a reduction in skin tumor burden. Moreover, LYMPHIR demonstrated meaningful activity on severe pruritus (itchiness), a significant quality of life issue for CTCL patients. Median time to response was 1.4 months. Importantly, LYMPHIR was not associated with cumulative toxicity.
“LYMPHIR is an important new tool in the fight against CTCL. It is the only FDA-approved systemic therapy for CTCL in more than seven years,” said Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma. “LYMPHIR’s direct tumoricidal activity and transient T-regulatory cell depletion offer a powerful new approach to disease control without cumulative toxicity. As such, LYMPHIR’s clinical profile makes it a compelling treatment option for physicians and patients facing the burden of relapsed or refractory CTCL.”
Commercial Access and Distribution
LYMPHIR is now available in the U.S. through specialty distributors nationwide. Healthcare providers can access treatment resources and prescribing information via the dedicated portal: www.lymphirhcp.com. The product has been assigned a permanent J-code (J9161), effective April 1, 2025, to facilitate reimbursement and streamline claims processing.
The launch is supported by medical education and payer access programs, alongside a field engagement strategy. LYMPHIR has also been included in the National Comprehensive Cancer Network (NCCN) Guidelines® for CTCL with a Category 2A recommendation.
Outside the U.S., Citius Oncology holds exclusive rights to develop and commercialize LYMPHIR in all global markets except India, Japan, and certain parts of Asia. The company recently announced a distribution agreement with Integris Pharma S.A. to initiate named-patient access programs in Greece, Cyprus, and other Southern European and Balkan countries. This partnership marks the first pillar in Citius Oncology’s international strategy and supports efforts to provide patients worldwide with access to LYMPHIR.
Patient and Provider Resources
To support informed treatment decisions and facilitate access to care, Citius Oncology has developed clinical, administrative and educational resources for healthcare providers, available at www.lymphirhcp.com. The site includes prescribing information, reimbursement support materials, and product ordering guidance. Additionally, the site features information about Citius Advantage, a dedicated patient assistance program that includes reimbursement and benefits support, prior authorization assistance, and coordination with specialty pharmacies for eligible patients to help reduce out-of-pocket costs and improve access to treatment.
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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 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 Sézary 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.
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was 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.
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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. In August 2024, the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of adults with relapsed or refractory Stage I–III CTCL who had 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. Citius Pharma owns 79% of Citius Oncology. For more information, please visit www.citiuspharma.com.
INDICATION
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 therapy.
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 occurred.
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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 to 3 g/dL.
Visual Impairment
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%. 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. 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. Institute appropriate medical management.
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Hepatotoxicity
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. 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.
ADVERSE REACTIONS
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
Pregnancy
Risk Summary
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.
Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
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Lactation
Risk Summary
No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.
Females and Males of Reproductive Potential
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman.
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR.
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose.
Infertility
Males
Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown.
Pediatric Use
Safety and effectiveness of LYMPHIR in pediatric patients have not been established.
Geriatric Use
Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Citius Oncology at 1-844-459-6744.
Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR.
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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, and, unless noted otherwise, that apply to Citius Oncology, are: 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; 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; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets;; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to maintain Nasdaq’s continued listing standards; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; 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, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025, as updated by our subsequent filings with the SEC. 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.
Investor Contact:
Ilanit Allen
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
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