Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology, Cardinal Health, Cencora, Integris Pharma, Er-Kim Pharma - LARVOL DELTA

Efficacy and Safety of E7777 (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma: Results from Pivotal Study 302 (ASH 2022) - P3 | "Approximately half (34 of 69; 49.3%) of patients had prior exposure to 1 or more FDA-approved targeted therapeutics: romidepsin, brentuximab, or mogamulizumab. In study 302, E7777 at a dose of 9 mcg/kg/day demonstrated clinical efficacy and clinically meaningful benefit in heavily pre-treated patients with relapsed/refractory CTCL. The ORR of 36.2% per IRC (42.3% by investigator assessment) showed that a substantial proportion of these heavily pretreated patients experienced clinical benefit after E7777 treatment similar to ONTAK. The observed tumor responses were rapid, durable, and deep."

Clinical • Cutaneous T-cell Lymphoma • Dermatology • Fatigue • Hematological Malignancies • Hepatology • Infectious Disease • Lymphoma • Oncology • Pruritus • T Cell Non-Hodgkin Lymphoma • IL2

Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. (PubMed, J Clin Oncol) - "Efficacy and safety results show that DD-cxdl would potentially fulfill a serious, unmet medical need for patients with R/R CTCL."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Fatigue • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • Skin Cancer • T Cell Non-Hodgkin Lymphoma • IL2

Safety and Effectiveness of Denileukin Diftitox-cxdl in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma: An All-Case Post-Marketing Study in Japan. (PubMed, Cancer Rep (Hoboken)) - P | "This is the first observational study to evaluate the safety and effectiveness of DD-cxdl in Japanese patients with relapsed or refractory PTCL and CTCL in daily clinical practice. No new safety concerns were identified. Clinicians should remain aware of the risk of capillary leak syndrome."

Journal • Observational data • P4 data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • IL2

Citius Oncology Reports Strong Commercial Momentum for its Cancer Treatment (Citius Pharma Press Release) - "LYMPHIR is now available in 42 institutions including academic oncology centers, leading National Comprehensive Cancer Network (NCCN) institutions and community infusion centers. During the quarter ended June 30, 2026, the number of new institutions increased 78% compared with the prior quarter. Vials ordered by institutions from wholesalers rose 31% during the quarter. Subsequent to the quarter ended June 30, 2026, following an increase in both the number of ordering institutions and vial demand, orders from wholesalers have begun to reflect this incremental demand. Citius revenue is recognized when wholesale orders for LYMPHIR are placed and filled...According to Company tracking, LYMPHIR has secured near-universal payer coverage."

Commercial • Cutaneous T-cell Lymphoma • Peripheral T-cell Lymphoma

Citius Oncology Reports Nationwide Deployment of LYMPHIR's Broadened Commercial Organization and Expanding Market Adoption (Citius Pharma Press Release) - "Citius Oncology has expanded its commercial organization to include 21 additional commercial field-based professionals and added eight medical science liaisons dedicated to supporting complex clinical practitioner engagement and patient care. All personnel are expected to be fully onboarded and deployed nationwide by August 2026...The expansion of the commercial and medical teams was facilitated by the Company's May 2026 financing and implemented by EVERSANA, Citius Oncology's exclusive commercialization partner....The Company reports continued expansion in the number of accounts ordering LYMPHIR, reflecting increasing physician familiarity with the product and growing utilization across both academic and community treatment settings. Citius Oncology expects continued growth in orders and patient adoption throughout the remainder of 2026."

Commercial • Cutaneous T-cell Lymphoma • Peripheral T-cell Lymphoma

Depletion of T-regulatory cells by denileukin diftitox-cxdl (E7777) in combination with pembrolizumab in relapsed/refractory (r/r) gynecologic malignancies: Phase 1 study results. (ASCO 2026) - P1/2 | "The results from this Phase I study of two immunomodulatory agents in combination, E7777 + P, in patients with r/r GYN tumors was well tolerated and demonstrated promising efficacy. A max tolerated dose wasn't established. No new significant safety signals or irAEs were reported."

Combination therapy • P1 data • Gynecologic Cancers • Oncology • IL2

HCC 21-166: T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=25 | Active, not recruiting | Sponsor: Alexander B Olawaiye, MD | Recruiting ➔ Active, not recruiting | N=70 ➔ 25 | Trial completion date: Dec 2027 ➔ Dec 2030 | Trial primary completion date: Dec 2025 ➔ May 2030

Checkpoint inhibition • Enrollment change • Enrollment closed • MSI-H • Platinum resistant • Trial completion date • Trial primary completion date • Endometrial Cancer • Epithelial Ovarian Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • CD4 • IL2 • MSI

Citius Oncology Highlights Phase 1 Data in an Investigator-Initiated Study of LYMPHIR (denileukin diftitox-cxdl) in Combination with Pembrolizumab in Recurrent or Refractory Gynecologic Malignancies (Citius Pharma Press Release) - "24% Overall Response Rate (ORR) among the 21 efficacy-evaluable patients (5 partial responses); Median duration of response (mDOR) had not yet been reached because only 1 of the 5 partial responders had progressed at the time of analysis...The current duration of response times (time since PR was achieved) were 4.2-35 months with a median of 21.1 months; 33% ORR in endometrial cancer patients previously treated with checkpoint inhibitors, including one patient with an ongoing response greater than three years...Median progression-free survival (mPFS) of 20.5 months (95% CI: 6.5 – NA) among the 10 patients who achieved clinical benefit; overall mPFS across all 21 efficacy-evaluable patients was 5.8 months (95% CI: 2.2 – NA)....A Phase 2 expansion study is being planned to further evaluate the combination in gynecologic cancers, including less heavily pre-treated and prior immunotherapy-exposed patient populations."

P1 data • Platinum resistant • Trial status • Endometrial Cancer • Epithelial Ovarian Cancer • Ovarian Cancer

Citius Oncology Announces Presentation of LYMPHIR Phase 1 Combination Study Data at the 2026 American Society of Clinical Oncology Annual Meeting (PRNewswire) - "24% Objective Response Rate, with an average of 21.1 month Duration of Response in responders, and favorable safety profile signals potential of LYMPHIR to augment immune checkpoint inhibitor efficacy....The Phase 1 study evaluated the safety, tolerability, and preliminary activity of denileukin diftitox-cxdl in combination with pembrolizumab in patients with relapsed or refractory gynecologic malignancies."

P1 data • Platinum resistant • Endometrial Cancer • Epithelial Ovarian Cancer

Citius Pharmaceuticals Q2 2026 Earnings: Revenue Misses $1.7 Million (Techno Trenz) - “Net product revenues for Q2 FY 2026 were $1.67 million, versus $0 in the prior year quarter, driven by the ongoing launch of LYMPHIR; Net product revenues for the first half of FY 2026 reached $5.6 million, compared with $0 in the first half of FY 2025.”

Commercial • Cutaneous T-cell Lymphoma

Citius Oncology, Inc. Secures Up to $36.5 Million in Debt and Equity Capital to Accelerate LYMPHIR Commercialization (Citius Pharma Press Release) - "Avenue Capital Group to provide up to $25 Million via Senior Credit Facility with an initial $10 million tranche funded at closing; additional tranches subject to certain conditions. Gross proceeds of approximately $11.5 million secured by a concurrent exercise of certain outstanding warrants held by single healthcare-focused institutional investor."

Financing • Cutaneous T-cell Lymphoma

Denileukin diftitox (Lymphir) for cutaneous T-cell lymphoma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • T Cell Non-Hodgkin Lymphoma

Citius Oncology Ships First International Order of LYMPHIR to Europe (Citius Pharma Press Release) - "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."

Commercial • Cutaneous T-cell Lymphoma

Targeting Cutaneous T-cell lymphoma in non-hodgkin lymphoma: What's new for investigational agents? (PubMed, Expert Opin Investig Drugs) - "Recent years have seen a shift away from chemotherapy with the approval of targeted therapies like mogamulizumab, brentuximab vedotin, and denileukin diftitox-cxdl. Though these novel agents have improved outcomes for patients with advanced-stage CTCL, most patients will continue to experience relapses. Emerging agents, including lacutamab, resminostat, and immune checkpoint inhibitors and biomarkers including CD5, CD70, and CD47/Sirpα represent the next frontier in maintaining durable remissions and improving quality of life (QoL) for these patients."

IO biomarker • Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD5 • CD70 • SIRPA

Emerging Therapeutic Strategies in Cutaneous T-Cell Lymphoma: A Comprehensive Review of Clinical Trials. (PubMed, Am J Clin Dermatol) - "The 2020-2025 period brought meaningful therapeutic advances for CTCL, including new FDA approvals, breakthrough designations, and emergence of cellular therapy. Future development should prioritize patient-reported outcomes as co-primary endpoints, prospective biomarker validation, and combination strategies with non-overlapping toxicity profiles."

IO biomarker • Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • Skin Cancer • T Cell Non-Hodgkin Lymphoma • CD70

Citius Oncology Provides Commercial Update on LYMPHIR Launch Highlighting Early Adoption and Expanding Clinical Development (Citius Pharma Press Release) - "Key Early Launch Metrics: Sequential growth in orders from target institutions since launch, with initial accounts already placing repeat orders, indicating early prescribing continuity; Strong institutional uptake, with 83% of target accounts having added or actively progressing LYMPHIR through formulary review; Broad and expanding market access with ~135 health plans, representing ~80% of covered lives, secured and reimbursement systems established; No reported reimbursement denials or prior authorization barriers...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 East."

Commercial • Cutaneous T-cell Lymphoma

Citius Oncology to Participate in USCLC Annual Workshop 2026, Highlighting LYMPHIR in Discussions with Leading Cutaneous Lymphoma Experts (PRNewswire) - "Citius Oncology's team will participate in the meeting to engage with clinicians and researchers regarding the treatment landscape for CTCL and discussions regarding clinical experience with LYMPHIR (denileukin diftitox-cxdl) which Citius Oncology recently launched in the U.S."

Clinical • Cutaneous T-cell Lymphoma

Citius Oncology Announces Preliminary Topline Phase 1 Data from Study of LYMPHIR (E7777) Dosing Prior to Commercial CAR‑T Therapy in High‑Risk Diffuse Large B‑Cell Lymphoma (Citius Pharma Press Release) - "Full results were presented at the 2026 ASTCT & CIBMTR Tandem Meetings...All patients (n=14) completed treatment and proceeded to CAR-T infusion; LYMPHIR was well tolerated, with no dose-limiting toxicities observed; No Grade ≥3 LYMPHIR-related immune adverse events or infusion reactions were reported; and; Data demonstrated effective Treg depletion, and promising efficacy signals of enhanced standard lymphodepletion with the use of Treg-targeting LYMPHIR...Overall response rate (ORR) was 86% at one month, including 57% complete responses (CR) and 29% partial responses (PR); One‑year progression‑free survival (PFS) was 77% (95% CI: 43–92%); One‑year overall survival (OS) was 84% (95% CI: 49–96%)."

P1 data • Diffuse Large B Cell Lymphoma

Citius Oncology Announces Positive Topline Results from Investigator‑Initiated Phase 1 Study of LYMPHIR in Combination with Pembrolizumab in Relapsed or Refractory Gynecologic Cancers (Citius Pharma Press Release) - "Patients with relapsed or refractory gynecological cancer have poor prognoses and very limited treatment options. This dose-escalation Phase 1 non-chemotherapy based clinical study aimed to establish a recommended dose of LYMPHIR in combination with pembrolizumab for a Phase 2 study. In 25 evaluable patients, no unexpected safety signals or serious immune-related adverse events were observed at any dose level...The trial explored efficacy and demonstrated a 24 % objective response rate (ORR) and a 48 % clinical benefit rate (CBR, defined as complete response, partial response and/or stable disease for six months or greater) among 21 evaluable patients. Full safety and clinical efficacy results are expected to be presented at an international cancer conference later this year."

MSI-H • P1 data • Platinum resistant • Trial status • Endometrial Cancer • Epithelial Ovarian Cancer

Citius Pharmaceuticals, Inc. Secures $3.8 million through New Jersey Economic Development Program (Citius Pharma Press Release) - "'As expected, this funding strengthened our balance sheet and enhances our financial flexibility as we continue executing on our strategy, including supporting the commercial launch of LYMPHIR and advancing our late-stage pipeline programs.'"

Financing • Cutaneous T-cell Lymphoma

Citius Pharmaceuticals, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR (Citius Pharma Press Release) - "Generated net proceeds of approximately $20.9 million from equity financings during the quarter, including capital raised at both Citius Pharma and Citius Oncology; Consolidated revenue was $3.9 million, reflecting initial U.S. sales of LYMPHIR at Citius Oncology."

Sales • Cutaneous T-cell Lymphoma

Citius Oncology Expands International Distribution of LYMPHIR to European Union Through Exclusive Agreement with Uniphar (Citius Pharma Press Release) - "Under the terms of the agreement, Uniphar will serve as the exclusive distribution partner for LYMPHIR in designated international territories in Western and Eastern Europe through country-specific managed access programs, where permitted by local law. Uniphar will oversee market access and distribution activities in selected territories. Citius Oncology will supply finished product and provide ongoing support in accordance with the agreement."

Commercial • Cutaneous T-cell Lymphoma

E7777 to Enhance Regulatory T-cell Depletion Prior to Commercial CAR-T19 for High Risk Diffuse Large B-cell Lymphoma (DLBCL): Results of Phase 1 Trial (NCT0485525) 2477 Characters (TCT-ASTCT-CIBMTR 2026) - "Fludarabine/cyclophosphamide lymphodepleting chemotherapy was administered on days -5,-4,-3...Axi-cel (n=5), liso-cel (n=5) and tisa-cel (n=4) were infused at day 0... Trial results demonstrate safety and promising efficacy of enhancing standard lymphodepletion with T-cell targeting immunotoxin E7777 (denileukin diftitox-cxdl, LYMPHIR TM ). Future strategies to optimize E7777 given prior to CAR-T cell infusion will be discussed. 1.Review the rationale and importance of lymphodepletion for CAR-T therapy 2.Understand the safety and toxicity of E7777 immunotoxin in the setting of commercial CAR-T therapy 3."

P1 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • IL2 • IL2RA

Denileukin diftitox (Lymphir) for cutaneous T-cell lymphoma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL (clinicaltrials.gov) - P1/2 | N=30 | Suspended | Sponsor: Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 ➔ Dec 2026 | Recruiting ➔ Suspended | Trial primary completion date: Dec 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Trial suspension • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • MYC