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Citius Oncology, Inc. filed an S-3 shelf registering up to $200,000,000 of securities and a resale prospectus for up to 7,090,909 shares issuable upon warrant exercise. The company discloses its independent auditor included an explanatory paragraph expressing substantial doubt about the company’s ability to continue as a going concern and states it will need substantial additional funds even after this offering. The filing highlights material risks tied to commercializing LYMPHIR, procuring cGMP commercial-scale supply, dependence on third parties, uncertainties in preclinical and clinical development, potential inability to realize benefits of a prior merger, ongoing evaluations of strategic alternatives, compliance with Nasdaq listing standards, and possible litigation related to the merger. It states 78,370,584 shares were outstanding as of August 31, 2025, and estimates 85,461,493 shares outstanding after the offering (assuming full registration outcomes).
Citius Oncology, Inc. filed a Form 8-K dated August 12, 2025, reporting that it issued a press release announcing its results of operations for the third quarter of fiscal 2025. The press release is furnished as Exhibit 99.1 and is incorporated by reference into the report.
The company clarifies that the Item 2.02 disclosure (including Exhibit 99.1) is furnished and therefore is not deemed "filed" for purposes of Section 18 of the Exchange Act. Item 9.01 lists Exhibits 99.1 and 104 (cover page interactive data), and the filing is signed by Leonard Mazur, Chairman and Chief Executive Officer.
Citius Oncology, Inc. is commercializing LYMPHIR (denileukin diftitox), an FDA-approved immunotherapy for cutaneous T-cell lymphoma, and is preparing for a U.S. commercial launch in the second half of 2025 with distribution agreements in place with Cardinal Health and Cencora. The company has built inventory of $17.2 million and reports operational readiness to transition from development to commercial operations.
Financially, the company reported a $19.76 million net loss for the nine months ended June 30, 2025, an accumulated deficit of $59.04 million, only $112 in cash and negative working capital of approximately $34.7 million at June 30, 2025. Material near-term obligations include a remaining $22.5 million milestone to Dr. Reddy's, a $5.9 million Eisai milestone included in license payable, and minimum supply commitments of approximately $18.3 million (manufacturing) plus $4.5 million (packaging). The company completed a public offering on July 17, 2025 raising gross proceeds of $9.0 million (net approx. $7.44 million), which the company states extends runway through September 2025 but additional financing will be required thereafter.
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