Citius Oncology Reports LYMPHIR Revenue and Positive Phase 1 CAR-T Combination Data

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) reported $3.9 million in revenue during the fiscal first quarter ended December 31, 2025, reflecting initial U.S. sales of LYMPHIR™ (denileukin diftitox-cxdl) following its December 2025 launch. Separately, majority-owned subsidiary Citius Oncology, Inc. (Nasdaq: CTOR) announced positive topline safety and efficacy results from an investigator-initiated Phase 1 trial evaluating LYMPHIR administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The Phase 1 trial, conducted at the University of Minnesota and City of Hope, demonstrated an 86% overall response rate (ORR) 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%), and one-year overall survival (OS) was 84% (95% CI: 49–96%). Full results were presented at the 2026 ASTCT® & CIBMTR® Tandem Meetings.

The Phase 1, open-label, dose-escalation study (NCT04855253) enrolled 14 patients with relapsed or refractory DLBCL exhibiting poor prognostic features, including double/triple hit genetics, primary refractory disease, and extranodal involvement. Participants received one dose of LYMPHIR (E7777) at 5, 7, or 9 µg/kg followed by low dose chemotherapy prior to standard commercial CD19-directed CAR-T cell therapy. All patients received an infusion of one of the following FDA-approved, commercially manufactured CAR-T products: axicabtagene ciloleucel (Yescarta®; Kite Pharma/Gilead Sciences), lisocabtagene maraleucel (Breyanzi®; Bristol Myers Squibb), or tisagenlecleucel (Kymriah®; Novartis).

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. A single LYMPHIR dose resulted in depletion of circulating Tregs in all but one patient. Reported adverse events included manageable Grade 1–2 capillary leak syndrome, fever, and transient liver enzyme elevations; Grade 3 cytopenias were consistent with expected lymphodepletion. CAR-T related cytokine release syndrome (CRS) occurred in 43% of patients (all Grade 1/2), and immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 21% (primarily low grade).

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 (Tregs), is currently FDA-approved and commercially available for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after one prior systemic therapy. 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.

Citius Oncology successfully launched LYMPHIR in the U.S. in December 2025 for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) following at least one prior systemic therapy. Initial specialty distributor sales were completed nationwide, enabling product availability across U.S. treatment centers. Patients have begun receiving LYMPHIR at leading cancer centers.

Citius Oncology deployed an AI-enabled commercial platform to support targeted physician engagement and efficient penetration of a highly concentrated prescriber base in this rare oncology market. Agreements have been negotiated with regional partners to enable patient access to LYMPHIR utilizing Named Patient Programs (NPPs) where permitted in territories throughout European and the Middle East.

Preliminary topline data from two investigator-initiated Phase I combination studies are evaluating the potential to expand clinical utility and future label expansion opportunities, including use in combination with pembrolizumab in patients with recurrent solid tumors and incorporation as part of lymphodepletion regimens prior to CAR-T therapy.

Cash and cash equivalents totaled $7.7 million as of December 31, 2025. The company generated net proceeds of approximately $20.9 million from equity financings during the quarter, including capital raised at both Citius Pharma and Citius Oncology. Research and development expenses were $1.6 million, compared to $2.1 million in the prior-year period, reflecting reduced clinical development activity. General and administrative expenses totaled $5.7 million, compared to $5.4 million in the prior-year period. Stock-based compensation expense totaled $4.3 million, compared to $2.5 million in the prior-year period. Net loss applicable to common stockholders was $8.2 million, or $(0.41) per share, compared to a net loss of $9.8 million, or $(1.30) per share, in the prior-year period.

Citius Pharma continues to advance Mino-Lok®, an antibiotic lock solution to salvage catheters when treating catheter-related bloodstream infections, and Halo-Lido (CITI-002), a topical prescription formulation for hemorrhoids. The Company remains engaged with the FDA regarding both programs.