Every 8-K that Citius Oncology, Inc. (CTOR) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CTOR and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CTOR filings page.
Citius Oncology, Inc. reported fiscal third quarter 2026 results driven by the U.S. launch of LYMPHIR for cutaneous T‑cell lymphoma. For the quarter ended June 30, 2026, the company generated $1,493,788 in revenue, with $7,105,197 in revenue over the first nine months of fiscal 2026. Institutional demand for LYMPHIR is growing: vial orders rose from 708 in the quarter ended March 31, 2026 to 926 in the quarter ended June 30, 2026, and institutions ordered 383 vials in July, the largest monthly total to date. LYMPHIR has been ordered by 44 institutions since launch.
Despite this commercial traction, the company remains loss‑making. The third quarter net loss was $8,923,846, and the nine‑month net loss was $41,067,610, reflecting total operating expenses of $9,718,762 in the quarter and $48,077,956 year‑to‑date, including substantial general and administrative and stock‑based compensation expenses. As of June 30, 2026, Citius Oncology held $16,563,705 in cash and cash equivalents, total assets of $112,093,103, liabilities of $71,708,109, and stockholders’ equity of $40,384,994. Management highlights expanding commercial and medical affairs teams and ongoing studies to support broader LYMPHIR adoption.
Citius Oncology, Inc. reported that its Board of Directors expanded to nine members and appointed Jonathan Peri, Ph.D., J.D. as an independent Class I director, effective August 10, 2026, serving until the 2028 annual meeting or until a successor is elected and qualified. The Board determined that he meets applicable Nasdaq and SEC independence standards, and he will participate in the compensation program for independent directors, which is under review.
The company highlights Dr. Peri’s three decades of leadership in higher education, financial services, law, and governance, including his role as President of Manor College and prior service as chief legal officer of Neumann University and lead advisory board director at First State Bank. Citius Oncology also reiterates that it launched LYMPHIR in December 2025 for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma and cites an initial CTCL market for LYMPHIR that management estimates currently exceeds $400 million.
Citius Oncology, Inc. reported commercial momentum for LYMPHIR, its FDA-approved therapy for relapsed or refractory Stage I–III cutaneous T‑cell lymphoma. During the quarter ended June 30, 2026, new institutions ordering LYMPHIR increased 78% quarter over quarter, while institutional vial orders rose 31%. LYMPHIR was available at 42 institutions, including academic centers, National Comprehensive Cancer Network sites, and community infusion centers, with revenue recognized when wholesale orders are placed and filled.
The company cites near‑universal payer coverage and is targeting formulary inclusion at 100 priority institutions by year‑end, after adding more than 20 additional institutions in the current quarter. Management estimates the initial cutaneous T‑cell lymphoma market for LYMPHIR currently exceeds $400 million, and notes increased engagement with CTCL experts and expanded commercial and medical affairs teams.
LYMPHIR carries a boxed warning for capillary leak syndrome, which occurred in 27% of treated patients, including 0.8% fatal cases, and it is associated with infusion‑related reactions in 69% of patients, visual impairment in 9%, and frequent liver enzyme elevations, alongside embryo‑fetal toxicity risk.
Citius Oncology, Inc. filed an update describing Phase 1 data for its drug LYMPHIR (denileukin diftitox-cxdl) combined with pembrolizumab in recurrent or refractory gynecologic cancers. In an investigator-initiated study of 25 heavily pre-treated patients, 21 were evaluable for efficacy.
The company reports that 48% of efficacy-evaluable patients (10 of 21) achieved clinical benefit, with a median progression-free survival of 20.5 months in this subgroup, and responses were seen even in patients previously treated with immune checkpoint inhibitors. LYMPHIR showed a manageable safety profile in this setting, according to investigators, though the study was not powered to prove efficacy.
Citius also highlights that LYMPHIR is FDA-approved and launched in the U.S. for adults with relapsed or refractory Stage I–III cutaneous T‑cell lymphoma after at least one prior systemic therapy, with management estimating the initial CTCL market opportunity for LYMPHIR currently exceeds $400 million.
Citius Oncology reported fiscal second quarter 2026 results that reflect the early launch of LYMPHIR and heavy one-time costs. Net product revenue was $1.7 million for the quarter and $5.6 million for the first half of fiscal 2026, with gross margins of about 80%. LYMPHIR’s rollout shows strong market access, with payer coverage near 100% of covered commercial lives and 83% of target accounts either on formulary or in review, plus an initial shipment to Europe.
The company remains deeply loss-making. Net loss was $26.6 million for the quarter and $32.1 million for the first half, driven largely by a $19.7 million one-time contract cancellation charge tied to a CMO termination and rising stock-based compensation. Cash and cash equivalents were $2.6 million as of March 31, 2026. Subsequent warrant exercises and a new senior secured term loan provided about $21.5 million in gross proceeds and access to up to $25 million total, and management expects combined resources at Citius Oncology and Citius Pharma to fund operations through November 2026.
Citius Oncology, Inc. entered into a warrant inducement transaction and a new senior secured loan to raise capital for LYMPHIR commercialization and general corporate purposes. A healthcare-focused investor agreed to immediately exercise warrants for 12,777,778 shares at $0.90 per share, providing approximately $11.5 million in gross proceeds, and received 25,555,556 new warrants at a $0.90 exercise price.
The company also entered into a Loan and Security Agreement providing up to $25.0 million in term loans, with $10.0 million funded at closing and additional tranches tied to revenue and liquidity milestones. The loans mature on November 1, 2029, carry a minimum annual interest rate of 12.75%, and are secured by substantially all assets. Lenders and agents receive fees, warrants and a conversion option, and a related-party promissory note was amended and subordinated to the new senior debt.
Citius Oncology, Inc. announced the initial shipment of its lymphoma therapy LYMPHIR (denileukin diftitox-cxdl) to Europe through a regional distribution partner, expanding access beyond the United States. Eligible patients will obtain the drug via country-specific Named Patient Programs under local regulations.
LYMPHIR is an IL‑2 receptor–directed cytotoxin approved by the FDA for adults with relapsed or refractory Stage I–III cutaneous T‑cell lymphoma after at least one prior systemic therapy and was launched in the U.S. in December 2025. Management estimates the initial market for LYMPHIR exceeds $400 million and is underserved by existing options. The product carries a boxed warning for capillary leak syndrome and other significant risks, including hepatotoxicity and serious infusion-related reactions, underscoring the need for careful monitoring in clinical use.
Citius Oncology, Inc. received a notice from Nasdaq that its common stock has failed to meet the minimum $1.00 per share bid price requirement for the last 30 consecutive business days under Nasdaq Listing Rule 5550(a)(2).
The company has 180 calendar days, until October 19, 2026, to regain compliance. If the stock trades at or above $1.00 for at least ten consecutive business days during this period, Nasdaq will confirm compliance. If compliance is not regained, Citius Oncology may qualify for an additional 180-day period, potentially using a reverse stock split to cure the deficiency.
The Nasdaq notice does not immediately affect trading, and the shares continue to trade on the Nasdaq Capital Market under the symbol CTOR. The company is evaluating options, but there is no assurance it will regain or maintain compliance, and failure could ultimately lead to delisting, subject to appeal rights.
Citius Oncology, Inc. reported an early commercial update on the U.S. launch of LYMPHIR for relapsed or refractory Stage I–III cutaneous T‑cell lymphoma. The company highlighted increasing formulary adoption at leading oncology centers, broad payer coverage progress, and growing repeat orders that support early prescribing momentum.
Citius is also expanding LYMPHIR’s clinical development through investigator-led studies, including use prior to CAR‑T therapy in diffuse large B‑cell lymphoma and in combination with pembrolizumab in solid tumors, both with positive topline data. Management estimates the initial LYMPHIR market currently exceeds $400 million and is underserved by existing therapies.
Citius Oncology, Inc. reported positive topline results from an investigator-initiated Phase 1 trial of LYMPHIR™ (denileukin diftitox-cxdl) combined with pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies.
Among 25 evaluable patients, no unexpected safety signals or serious immune-related adverse events were seen at any dose level. In 21 evaluable patients, the trial showed a 24% objective response rate and a 48% clinical benefit rate, defined as complete or partial response or stable disease for at least six months. Full safety and efficacy data are planned for presentation at an international cancer conference.
Citius Oncology, Inc. filed an 8-K to share positive topline Phase 1 data for LYMPHIR given before commercial CD19-directed CAR-T therapy in high-risk relapsed or refractory diffuse large B-cell lymphoma. In 14 treated patients, investigators reported an 86% overall response rate, including 57% complete responses and 29% partial responses.
The investigator-initiated, open-label, dose-escalation study used single doses of LYMPHIR at 5, 7, or 9 µg/kg followed by low-dose chemotherapy and FDA-approved CAR-T products such as Yescarta, Breyanzi, or Kymriah. LYMPHIR was reported as well tolerated with no dose-limiting toxicities. The company notes the Phase 1 trial was not designed or powered to assess clinical efficacy or long-term outcomes.
LYMPHIR is already FDA-approved and commercially available in the U.S. for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy and was launched by Citius Oncology in December 2025. Management estimates the initial market for LYMPHIR exceeds $400 million and is underserved by existing therapies.
Citius Oncology reported its first fiscal 2026 quarter, highlighted by the initial U.S. launch of LYMPHIR and the Company’s first commercial revenue. Revenue reached $3,944,111, all from initial LYMPHIR sales in December 2025, generating gross profit of $3,154,903.
Total operating expenses were $8,407,179, driven by general and administrative costs and $3,956,050 of stock-based compensation. Citius Oncology posted a net loss of $5,534,069, or $0.06 per share, improving from a $6,659,205 loss, or $0.09 per share, a year earlier. Cash and cash equivalents were $7,295,451, and stockholders’ equity was $58,413,701 as of December 31, 2025. Management emphasized the strategic shift to a commercial oncology business centered on LYMPHIR in a market they estimate currently exceeds $400,000,000.
Citius Oncology, Inc. reported results from its 2025 annual meeting. Stockholders approved an amendment to the 2024 Omnibus Stock Incentive Plan, increasing common shares authorized for issuance under the plan from 15,000,000 to 30,000,000 shares.
Votes on the plan amendment were 74,220,840 for, 106,247 against, 14,688 abstaining, and 3,462,017 broker non-votes. Class I directors Myron Holubiak (74,305,221 for; 36,554 withheld; 3,462,017 broker non-votes) and Joel Mayersohn (74,312,668 for; 29,107 withheld; 3,462,017 broker non-votes) were elected for terms expiring in 2028. Stockholders also ratified Wolf & Company, P.C. as independent auditor with 77,690,844 for, 36,459 against, and 76,489 abstaining.
Citius Oncology furnished an updated Corporate Presentation under Regulation FD. The company posted the presentation on October 23, 2025 and attached it as Exhibit 99.1 to a Form 8-K. The company states that the information in Item 7.01, including Exhibit 99.1, is not deemed “filed” for purposes of Section 18 of the Exchange Act and is not incorporated by reference into other filings except as specifically referenced.
Citius Oncology’s common stock trades on the Nasdaq Capital Market under the symbol CTOR.
Citius Oncology, Inc. reported that it issued warrants to a financial advisor to purchase up to 360,000 shares of common stock. These warrants have an exercise price of $2.1875 per share, become exercisable on March 10, 2026, and expire on March 10, 2031, and were issued in a private placement under Section 4(a)(2) of the Securities Act.
The board also approved an amendment to the company’s 2024 Omnibus Stock Incentive Plan, increasing the shares of common stock reserved for issuance under the plan from an aggregate of 15,000,000 shares to an aggregate of 30,000,000 shares. Aside from this increase in the share reserve, no other terms of the plan were changed.