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Citius Oncology set to form following agreement between Citius Pharmaceuticals and TenX Keane

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Mergers and acquisitions Citius Pharmaceuticals CRO Oncology Rare disease orphan disease Research

A transaction between Citius Pharmaceuticals and TenX Keane which will result in the formation of Citius Oncology, Inc. is due to close in the first half of next year (2024).

Citius Pharmaceuticals is a biopharmaceutical company that develops and commercializes critical care products while TenX Keane is a publicly traded special purpose acquisition company. They announced last week (October 23) that they had entered into a definitive agreement for the proposed merger.

Upon closing, under the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024. 

Leonard Mazur, Chairman and CEO of Citius Pharma, said: “We believe this transaction will allow us to unlock the value of LYMPHIR, and solidly position Citius Pharma to advance our diversified pipeline. This transaction will enable Citius Oncology, with access to the broader capital markets, to better support the successful commercialization of LYMPHIR, if approved, and explore additional potential targeted oncology therapies.

“Our majority ownership position and shared services agreement ensure that the Citius Pharma management team will remain fully engaged with the development and commercialization efforts at Citius Oncology. As previously announced, the Company is in the process of formulating a plan of distribution of a portion of the shares of Citius Oncology to its shareholders. At Citius Pharma, we intend to focus on completing the Mino-Lok trial and continuing to evaluate next steps with our Halo-Lido program.”

Citius Oncology will serve as a platform to develop and commercialize novel targeted oncology therapies. The company is seeking approval from the US Food and Drug Administration (FDA) of LYMPHIR for an orphan indication in the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma.

Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. If approved, LYMPHIR would be unique as the only IL-2 receptor-targeted CTCL therapy, offering a novel option to patients cycling through multiple treatments. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets, and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning.

Preparations are underway for a Biologics License Application (BLA) resubmission in early 2024. If approved, LYMPHIR could be commercially available as early as the second half of 2024 for the treatment of CTCL. Additional value-creating opportunities in larger markets include potential indications in peripheral T-cell lymphoma or as a combination therapy with CAR-T and PD-1 inhibitors, and in markets outside the US Currently, two investigator-initiated trials are underway to explore LYMPHIR's potential as an immuno-oncology combination therapy.

The transaction is expected to provide Citius Oncology with improved access to the public equity markets and thereby facilitate the commercialization of LYMPHIR and position the company to explore additional value-creating opportunities more fully.

“We are very pleased to announce the proposed merger with Citius Oncology,” said Xiaofeng Yuan, chairman and CEO of TenX.

“After undertaking a comprehensive process with external advisors to explore and evaluate numerous potential business combination targets, our board and management team believe that this transaction with Citius Oncology represents the best opportunity to create substantial value for our stockholders.

“This business combination, if consummated, will result in TenX investors owning an equity stake in a company that is focused on developing and commercializing LYMPHIR to improve the lives of patients with CTCL and additional potential upside from combinations with other drugs as immuno-oncology therapies with even larger addressable markets. We are thrilled to support Citius Oncology at an inflection point in its development and to provide an avenue for Citius to expeditiously meet its development milestones.”

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