Citius Pharmaceuticals, Inc. and TenX Keane Acquisition announced a merger of TenX and Citius Pharma’s oncology subsidiary, forming Citius Oncology, Inc., set to list on Nasdaq. Citius Pharma receives 67.5 million Citius Oncology shares at $10 each, holding a 90% majority. The new entity aims to commercialize novel oncology therapies, with LYMPHIR for CTCL at the forefront, expecting FDA approval. The market for LYMPHIR, the only IL-2 receptor-targeted therapy for CTCL, exceeds $400 million. The deal, closing in 2024’s first half, should boost Citius Oncology’s market access and support further development, including combination therapies and international expansion.
Citius Pharmaceuticals, Inc. (“Citius Pharma” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition (“TenX”) (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma’s wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange. The newly combined public company will be named Citius Oncology, Inc. (“Citius Oncology”). 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.
CITIUS ONCOLOGY OVERVIEW
Citius Oncology will serve as a platform to develop and commercialize novel targeted oncology therapies. The company is seeking approval from the U.S. 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.
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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 U.S. 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.
Source: Biospace