CTOR News & Events

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.

Citius Oncology (CTOR), a majority-owned subsidiary of Citius Pharmaceuticals, (CTXR), announced the initial shipment of LYMPHIR to Europe through one of its regional distribution partners, marking an important milestone in expanding access to the therapy for patients outside the United States. LYMPHIR will be made available to eligible patients through Named Patient Programs, or NPPs, in accordance with local regulations in each country. The initiation of European distribution represents a strategic step in the Company's broader effort to extend access to LYMPHIR for patients with limited treatment options, while continuing to prioritize disciplined and targeted market entry. LYMPHIR was approved by the U.S. Food and Drug Administration in August 2024 for the treatment of adult patients with Stage I-III relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy, and was commercially launched in the United States in December 2025. LYMPHIR does not have marketing authorization from the European Medicines Agency in Europe or other countries outside the U.S. Access is being provided solely through Named Patient Programs in accordance with applicable local laws and regulations.

Citius Oncology provided a commercial update on the U.S. launch of lymphir for the treatment of cutaneous T-cell lymphoma, highlighting continued adoption across leading oncology centers, broad payer coverage progress, and advancing investigator-led clinical studies. Launch highlights include: sequential growth in orders from target institutions since launch, with initial accounts already placing repeat orders; institutional uptake of 83% of target accounts having added or actively progressing lymphir through formulary review; expanding market access with ~135 health plans, representing ~80% of covered lives; no reported reimbursement denials or prior authorization barriers; initial penetration into community infusion centers underway with patients beginning to transition from larger cancer centers; and commercial buildout proceeding, with field team onboarding in the coming month and broader field expansion in progress. International expansion is underway through executed distribution agreements across Europe and the Middle East. In parallel, Citius Oncology is advancing lymphir's clinical development through collaborations with leading academic centers to further evaluate its potential across broader oncology settings.

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.