CTOR News & Events

Citius Oncology announced positive topline results from a completed investigator-initiated Phase1 clinical trial evaluating the direct T-regulatory, or Treg, cell depletion activity of lymphir - denileukin diftitox-cxdl - in combination with the PD-1 immune checkpoint inhibitor pembrolizumab - Keytruda - in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies. 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 and a 48% clinical benefit rate among 21 evaluable patients. Full safety and clinical efficacy results are expected to be presented at an international cancer conference later this year.

Citius Oncology (CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals (CTXR) announced positive topline safety and efficacy results from an investigator-initiated Phase 1 trial evaluating LYMPHIR, or E7777, denileukin diftitox-cxdl, administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma, or DLBCL. The trial was conducted by lead investigator, Dr. Veronika Bachanova, at the University of Minnesota and City of Hope. Full results were presented at the 2026 ASTCT & CIBMTR Tandem Meetings. The Phase 1 trial was designed to augment the lymphodepletion regimen prior to CAR-T infusion through the administration of LYMPHIR to potentially improve the anti-tumor activity of CAR-T therapies. LYMPHIR, an engineered fusion toxin that preferentially binds to the IL-2 receptor expressed on regulatory T-cells, or Tregs, is currently FDA-approved and commercially available for the treatment of relapsed or refractory cutaneous T-cell lymphoma, or CTCL, after one prior systemic therapy. All patients, n=14, completed treatment and proceeded to CAR-T infusion; LYMPHIR was well tolerated, with no dose-limiting toxicities observed; No Grade greater than or equal to3 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. The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes. Key Findings from the Phase 1 Trial include: Overall response rate was 86% at onemonth, including 57% complete responses and 29% partial responses; One-year progression-free survival was 77%.

Revenue of $3.9M during the quarter ended December 31, 2025 reflects sales related to the launch of Lymphir. Cash and cash equivalents totaled $7.3M as of December 31, 2025 .

Q1 consolidated revenue was $3.9M, reflecting initial U.S. sales of Lymphir at Citius Oncology (CTOR). Cash and cash equivalents totaled $7.7M as of December 31, 2025.