aibioCitius Oncology hires Jefferies to explore strategic alternatives
Citius Oncology has set no timeline for its strategic review, and the release says there is no assurance it will produce a deal. Its parent owns 92% of the company and has funded it since the subsidiary was formed.
Key facts
- Companies
- Citius Oncology, Inc. (NASDAQ: CTOR), Citius Pharmaceuticals, Inc. (NASDAQ: CTXR)
- News type
- Distress
- Primary source
- Citius Oncology, Inc. 8-K (2025-01-06)
Citius Oncology, Inc. (Nasdaq: CTOR) said on January 6, 2025 that it has retained Jefferies LLC as its exclusive financial advisor to evaluate strategic alternatives aimed at maximizing shareholder value. The announcement was a press release filed as an exhibit to a Form 8-K on the same day. The release sets no timeline for the review, and it says there can be no assurance that the process will result in a transaction.
What the review covers
The company says the alternatives may include partnerships, joint ventures, mergers, acquisitions, licensing or other strategic transactions. It does not intend to disclose developments unless its board approves a specific transaction or course of action, or unless it decides disclosure is appropriate or necessary. The release gives no deadline, no price range and no named buyer. It names no counsel for the company or for Jefferies.
Chief Executive Leonard Mazur tied the review to the company's next step. "Now is an opportune time to review options that would be in the best interests of patients and shareholders," he said, as the company prepares to launch its first cancer therapy.
Who owns and funds the company
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) owns 92% of Citius Oncology, according to the release. The annual report for the year ended September 30, 2024, filed December 27, 2024, gives the parent's stake as 92.3% immediately after the merger closed on August 12, 2024. Citius Oncology was formerly TenX Keane Acquisition, a Cayman Islands company. It migrated to Delaware and changed its name under a merger agreement signed on October 23, 2023.
The annual report says Citius Pharma has funded the subsidiary since its formation in 2021 and continues to fund it. The two companies also operate under an amended and restated shared services agreement, under which the parent provides management and scientific services. The filings do not say how a sale or licensing deal at the subsidiary would treat that funding.
The one approved product
LYMPHIR, the company's primary asset, was approved by the FDA in August 2024 for relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy. The release says management estimates the initial market for LYMPHIR exceeds $400 million, is growing and is underserved by existing therapies. The annual report describes LYMPHIR as an engineered IL-2 diphtheria toxin fusion protein.
Because the manufacturing formulation changed, the annual report says, the FDA required a new clinical study. That study, E7777-G000-302, was a global, open-label, single-arm pivotal trial in patients with persistent or recurrent CTCL who had received at least one prior therapy. It began enrolling in May 2013 and reached its data cutoff for the primary analysis in December 2021. Eisai sponsored it, at 17 sites in the United States and three in Australia.
The lead-in phase enrolled 21 subjects and assessed the objective response rate, which the report defines as a greater than 50% reduction in tumor burden. The report says the study met its primary and secondary endpoints and identified no new safety signals compared with ONTAK, the earlier product. A single-arm design has no concurrent control group, so the comparison with ONTAK rests on the study's own terms.
The parent, Citius Pharma, acquired the drug's exclusive license from Dr. Reddy's Laboratories SA in 2021. Dr. Reddy's had licensed it in select markets from Eisai.
The parent's other programs
The release says the parent's late-stage pipeline includes Mino-Lok, an antibiotic lock solution whose Phase 3 trial met its primary and secondary endpoints, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoids. It says the company is working with the FDA to outline next steps for both programs, and it gives no date for those steps.
What the filings leave out
The release gives no cash, debt, revenue or net loss figures for Citius Oncology. It gives no date for a decision on the review. The annual report's business section gives no cash balance either.