Citius Pharmaceuticals Merges Subsidiary with TenX Keane to Form Citius Oncology, Inc.

Citius Pharmaceuticals, Inc., a biopharmaceutical company, has successfully merged its oncology subsidiary with TenX Keane Acquisition, a publicly traded special purpose acquisition company. The newly formed entity, Citius Oncology, Inc., is set to commence trading on the Nasdaq stock exchange under the ticker symbol CTOR on August 13, 2024.

This merger is seen as a pivotal milestone for Citius Pharma, offering enhanced financial and strategic flexibility. According to Leonard Mazur, Chairman and CEO of both Citius Pharma and Citius Oncology, the transaction positions Citius Oncology as a unique investment opportunity with greater capabilities to maximize the value of LYMPHIR™, an FDA-approved treatment for cutaneous T-cell lymphoma (CTCL). LYMPHIR, which received FDA approval in August 2024, targets adults with relapsed or refractory CTCL who have undergone at least one prior systemic therapy.

Mazur noted that the merger allows Citius Oncology to focus on launching LYMPHIR and pursuing additional oncology assets. He also indicated plans to distribute a portion of Citius Oncology's shares to Citius Pharma shareholders in the future. The merger provides Citius Pharma with the ability to concentrate on its other assets, including Mino-Lok, an antibiotic lock solution that has reached important milestones in its Phase 3 trial, bringing it closer to entering a $1.8 billion market.

Citius Oncology will operate under a shared services agreement with Citius Pharma, benefiting from the expertise of key members of the Citius Pharma team, including CEO Leonard Mazur, CFO Jaime Bartushak, and Chief Medical Officer Dr. Myron Czuczman. Myron Holubiak will serve as Executive Vice Chairman of the Citius Oncology Board of Directors.

In terms of the merger specifics, TenX acquired Citius Pharma's wholly owned oncology subsidiary through a merger, resulting in the formation of Citius Oncology, Inc. All shares of the subsidiary were converted into the right to receive common stock in Citius Oncology. Post-transaction, Citius Pharma retains approximately 90% ownership of the new public entity, with an additional 12.75 million existing options assumed by Citius Oncology.

Advisors involved in the transaction include Maxim Group LLC for Citius Pharma and Newbridge Securities Corporation for TenX. Legal advisors include Wyrick Robbins Yates & Ponton LLP for Citius Pharma and Citius Oncology, and The Crone Law Group P.C. for TenX.

Citius Oncology aims to develop and commercialize novel targeted oncology therapies, with LYMPHIR being its primary asset. LYMPHIR is an engineered IL-2-diphtheria toxin fusion protein that targets cells with IL-2 receptors using a toxin derived from diphtheria bacteria, leading to cell death and an enhanced immune response by reducing regulatory T-cells. This unique mechanism makes LYMPHIR the only IL-2 receptor-targeted therapy for CTCL, offering a novel option for patients.

LYMPHIR had previously received orphan drug designation from the FDA in 2011 and 2013 for the treatment of peripheral T-cell lymphoma (PTCL) and CTCL, respectively. It was also approved in Japan in 2021 for treating CTCL and PTCL. Citius Pharma acquired exclusive rights to develop and commercialize LYMPHIR in all markets outside Japan and certain parts of Asia.

Citius Pharmaceuticals, Inc. continues to focus on developing critical care products, with LYMPHIR now being advanced by Citius Oncology. Other late-stage pipeline products include Mino-Lok, which met primary and secondary endpoints in its Phase 3 trial, and CITI-002, a topical formulation for hemorrhoid relief, which completed a Phase 2b trial in 2023. Both programs are currently under active engagement with the FDA for next steps.