NASDAQ:XFOR
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Business Update
Licensing Agreement with Norgine Includes €28.5 Million Upfront Payment
On January 13, 2025, X4 Pharmaceuticals, Inc. (NASDAQ:XFOR) announced an exclusive licensing and supply agreement with Norgine, a European specialty pharmaceutical company that generates greater than €500 million in annual revenues, that covers Europe, Australia, and New Zealand. The agreement calls for an upfront payment of €28.5 million and X4 is also eligible to receive up to €226 million in potential regulatory and commercial milestone payments along with tiered, double-digit royalties up to the mid-twenties.
Under the terms of the agreement, X4 will retain all rights to mavorixafor outside of Europe, Australia, and New Zealand. In addition, X4 remains responsible for the ongoing Phase 3 4WARD clinical trial evaluating mavorixafor in chronic neutropenia (CN). The companies will collaborate on regulatory filings and we anticipate X4 filing a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for mavorixafor for the treatment of WHIM syndrome soon. Mavorixafor has been granted Orphan Drug Designation by both the EMA and FDA.
Mavorixafor is a small molecule, oral antagonist of the chemokine receptor C-X-C receptor type 4 (CXCR4), which regulates the movement of immune cells within the body. Stimulation by its cognate ligand, CXCL12, leads to the maturation and mobilization of white blood cells (neutrophils, lymphocytes, and monocytes) into the bloodstream. Since CXCR4 antagonism results in increased trafficking of white blood cells, therapeutic inhibition of the CXCR4/CXCL12 axis could be utilized to treat a wide variety of medical conditions including chronic neutropenic disorders and certain types of cancer.
XOLREMDI® (mavorixafor) was approved for the treatment of WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome by the U.S. FDA in April 2024. In addition, it is currently in Phase 3 development for chronic neutropenia (CN) in the 4WARD trial, with full enrollment of that trial expected in mid-2025.
Conclusion
We had anticipated a licensing agreement for mavorixafor in overseas markets, and the deal with Norgine will help to strengthen the balance sheet and provides an excellent partner for X4 in Europe, Australia, and New Zealand. Looking ahead to 2025, we are excited to follow the commercial launch of XOLREMDI, the MAA filing for mavorixafor for the treatment of WHIM in the E.U., and are expecting the 4WARD trial to be fully enrolled by mid-year. We have advanced our model forward a year and incorporated the licensing deal into our model, which has increased our valuation to $3.25 per share.
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