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X4 Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Corporate Updates
XFORX4 Pharmaceuticals(XFOR) GlobeNewswire·2025-05-01 10:01

Core Insights - X4 Pharmaceuticals is making significant progress in its Phase 3 clinical trial for mavorixafor, targeting chronic neutropenia, with full enrollment expected by Q3 or Q4 2025 and top-line data anticipated in the second half of 2026 [1][5] - The company has generated 3.5millioninnetU.S.revenuesfromXOLREMDIsinceitslaunchinMay2024,indicatingapositivemarketresponse[1][4]−AstrategicrestructuringisunderwaytooptimizethepromotionofXOLREMDIandfocusonmavorixafor,withexpectedannualsavingsof3.5 million in net U.S. revenues from XOLREMDI since its launch in May 2024, indicating a positive market response [1][4] - A strategic restructuring is underway to optimize the promotion of XOLREMDI and focus on mavorixafor, with expected annual savings of 30-35 million [6] Financial Performance - For Q1 2025, X4 reported net revenue of 28.8million,with28.8 million, with 27.9 million from license and other revenues and 0.9 million from product revenue [10][20] - Research and Development (R&D) expenses decreased to 18.5 million from 19.9 million in Q1 2024, while Selling, General, and Administrative (SG&A) expenses also fell to 15.0 million from 17.4million[10][20]−Thecompanyachievedanetincomeof17.4 million [10][20] - The company achieved a net income of 0.3 million in Q1 2025, a significant improvement from a net loss of 51.8millioninthesameperiodof2024[10][20]ClinicalDevelopments−The4WARDtrialisapivotalPhase3studyevaluatingmavorixaforinpatientswithchronicneutropenia,aimingtodemonstratesignificantincreasesinabsoluteneutrophilcount(ANC)andreductionsininfectionrates[5][15]−Recentanalysesofclinicaltrialdatahavebolsteredconfidenceinthepotentialsuccessofthe4WARDtrial,suggestingthatmavorixaformayeffectivelyelevateANCandreduceinfectionrates[5]−X4hasreceivedaNoticeofAllowanceforapatentrelatedtomavorixafor,whichisexpectedtoexpireinMarch2041,enhancingthecompany′sintellectualpropertyposition[5]MarketExpansion−X4hasenteredintotwointernationalpartnershipsforthecommercializationofmavorixafor,expandingitsglobalreach[9]−TheMarketingAuthorizationApplication(MAA)formavorixaforinthetreatmentofWHIMsyndromehasbeenvalidatedforreviewbytheEuropeanMedicinesAgency,withpotentialapprovalinthefirsthalfof2026[9]StockandCashPosition−AsofMarch31,2025,X4hadacashpositionof51.8 million in the same period of 2024 [10][20] Clinical Developments - The 4WARD trial is a pivotal Phase 3 study evaluating mavorixafor in patients with chronic neutropenia, aiming to demonstrate significant increases in absolute neutrophil count (ANC) and reductions in infection rates [5][15] - Recent analyses of clinical trial data have bolstered confidence in the potential success of the 4WARD trial, suggesting that mavorixafor may effectively elevate ANC and reduce infection rates [5] - X4 has received a Notice of Allowance for a patent related to mavorixafor, which is expected to expire in March 2041, enhancing the company's intellectual property position [5] Market Expansion - X4 has entered into two international partnerships for the commercialization of mavorixafor, expanding its global reach [9] - The Marketing Authorization Application (MAA) for mavorixafor in the treatment of WHIM syndrome has been validated for review by the European Medicines Agency, with potential approval in the first half of 2026 [9] Stock and Cash Position - As of March 31, 2025, X4 had a cash position of 87.7 million, which is expected to support operations into the first half of 2026 [10] - A one-for-thirty reverse stock split was executed on April 28, 2025, reducing the number of outstanding shares significantly [7]