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Citius Oncology Q4 LYMPHIR Sales Increase 120%
Citius Oncology announced preliminary, unaudited LYMPHIR unit sales to U.S. wholesalers and institutional vial orders for the fiscal fourth quarter ended September 30, 2026. Preliminary Fiscal Fourth Quarter 2026 Highlights: 792 units purchased by U.S. wholesalers for the three months ended September 30, 2026, compared to 360 units for the three months ended June 30, 2026, an increase of 120%; 950 LYMPHIR vials ordered by prescribing centers from wholesalers during the fiscal fourth quarter, compared to 926 for the fiscal third quarter; and As of the date of this release, 54 institutions have now ordered LYMPHIR, compared to 44 as of August 14, 2026, as last reported.
Citius Oncology Updates on LYMPHIR Order Growth
Citius Oncology (CTOR), a majority-owned subsidiary of Citius Pharmaceuticals, (CTXR), provided an update on the expanding base of institutions ordering LYMPHIR, or denileukin diftitox-cxdl through wholesalers, continued formulary progress at priority U.S. treatment centers, and other key indicators supporting the product's commercial launch."Our commercial progress is reflected in two closely connected measures: growth in the number of institutions ordering LYMPHIR and continued expansion of the formulary approvals that enable additional institutions to begin ordering the product and treating patients," said Leonard Mazur, Chairman and CEO of Citius Oncology. LYMPHIR is now available in 42 institutions including academic oncology centers, leading National Comprehensive Cancer Network institutions and community infusion centers. During the quarter ended June 30 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 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.
Citius Oncology Expands Commercial Team to Support Lymphir Launch
Citius Oncology (CTOR), majority-owned subsidiary of Citius Pharmaceuticals (CTXR), provided an update on the commercial launch of Lymphir - denileukin diftitox-cxdl -. 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. 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. As part of its commercialization strategy, Citius Oncology has also deployed a proprietary AI-driven commercial intelligence platform designed to enhance customer engagement, identify treatment opportunities, optimize resource allocation, and support data-driven decision-making across its commercial organization. Citius Oncology expects continued growth in orders and patient adoption throughout the remainder of 2026.
Citius Oncology Presents LYMPHIR Clinical Data
Citius Oncology (CTOR), a majority-owned subsidiary of Citius Pharmaceuticals (CTXR), highlighted Phase 1 clinical data presented May 30 at the American Society of Clinical Oncology Annual Meeting evaluating Lymphir in combination with pembrolizumab in patients with recurrent or refractory gynecologic malignancies. "LYMPHIR's ability to transiently deplete immunosuppressive regulatory T-cells may help address immune resistance in the tumor microenvironment and enhance the effect of checkpoint inhibitors. The encouraging clinical signals and tolerability profile observed in this study support continued clinical evaluation of this 'chemo-free' immunomodulatory approach, especially in tumors where resistance to checkpoint inhibitors remains a significant challenge," said Dr. Myron Czuczman, Chief Medical Officer of Citius Oncology. Key Efficacy and Safety findings presented at ASCO included: 24% Overall Response Rate among the 21 efficacy-evaluable patients (5 partial responses). Median duration of response had not yet been reached because only 1 of the 5 partial responders had progressed at the time of analysis (80% of PRs were continuing to experience clinical benefit). 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. 48% of efficacy-evaluable patients (10 of 21) achieved clinical benefit, defined as complete response, partial response, or durable stable disease lasting at least six months: Median progression-free survival 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); 5 patients had a PFS of greater than 20 months including 1 patient with greater than 30 months PFS;Of the 24/25 pts evaluable for dose limiting toxicities, only 1 case of reversible Gr 3 capillary leak syndrome was observed at the highest dose level. A maximum tolerated dose was not achieved. 16 serious adverse events were observed in seven patients treated at the highest dose level. No new safety signals or grade 3 or greater immune-related adverse events were observed.
Company Not Selling Up to 32.93M Shares of Common Stock
This filing relates to the offer and sale from time to time by the selling stockholder of up to 32.93M shares of common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.
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