Meaningful and durable increases in functional neutrophils observed over 6-month trial with oral once-daily mavorixafor Majority of physicians and chronic neutropenia participants chose to significantly reduce G-CSF dosing when using mavorixafor in combination therapy BOSTON, May 14, 2025 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced the acceptance of two abstracts for poster presentation at the ...

Driving progress for patients with chronic neutropenic disorders Investor Deck – May 2025 ABBEY Living with Chronic Neutropenia Forward-Looking Statements This presentation including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer sessions and any documents or materials distributed at or in connection with the presentation, contains forward-looking statements within the meaning ...

Financial Performance - The company reported revenue of $28.8 million for the three months ended March 31, 2025, compared to no revenue in the same period in 2024, marking a significant increase [164]. - The company reported a net income of $0.3 million for the three months ended March 31, 2025, a significant improvement from a net loss of $51.8 million in the same period in 2024 [164]. - Net income for the three months ended March 31, 2025 was $0.3 million, compared to a net loss of $51.8 million in the same period of 2024 [183]. - Other income for the three months ended March 31, 2025 increased by approximately $25 million compared to the same period in 2024, primarily due to a significant gain from the change in fair value of Class C warrants [174]. Expenses - The cost of revenue for the same period was $4.7 million, primarily due to amortization of an intangible asset and royalty payments [168]. - Research and development expenses decreased by $2 million to $18 million for the three months ended March 31, 2025, compared to $20 million in the prior year, mainly due to reduced pre-clinical drug candidate programs [171]. - Selling, general and administrative expenses also decreased by approximately $2 million to $15 million, attributed to lower compensation expenses and reduced commercialization launch costs [173]. - Net cash used in operating activities for the three months ended March 31, 2025 was $12.4 million, a decrease from $33.6 million in the same period of 2024 [184]. - Cash used in investing activities for the three months ended March 31, 2025 was $3.1 million, down from $5.3 million in the same period of 2024 [185]. Strategic Initiatives - The company completed a strategic restructuring in February 2025, resulting in a 30% reduction in workforce, which is expected to decrease annual spending by $30 to $35 million [159]. - The company is progressing with a pivotal Phase 3 clinical trial (the "4WARD" study") for mavorixafor, aiming to enroll 150 participants and complete enrollment by Q3 or Q4 2025 [157]. - The company launched XOLREMDI in the U.S. for WHIM syndrome and is actively engaging with physicians and patient advocacy organizations to promote awareness [152]. Financing and Capital Needs - The Hercules Loan Agreement allows for a term loan facility of up to $107.5 million, with $75.0 million borrowed to date [179]. - The company anticipates needing to raise additional capital to fund operations and satisfy covenants, which may include equity offerings and debt financings [182]. - The company has a Minimum Cash Covenant requiring a minimum cash level of $15.0 million, which is 20% of outstanding borrowings under the Hercules Loan Agreement [181]. - The company expects operating expenses in 2025 to be lower than those in 2024, excluding the sale of non-financial assets [188]. Shareholder Actions - A reverse stock split of 1-for-30 was approved by shareholders on April 17, 2025, to reduce the number of outstanding shares [162]. Cash Position - The company had cash, cash equivalents, and short-term marketable securities of $87.0 million as of March 31, 2025, with an accumulated deficit of $515.1 million [180]. - The company continues to maintain a valuation allowance against all remaining net deferred tax assets due to expected ongoing operating losses [176].

X4 Pharmaceuticals (XFOR) Q1 2025 Earnings Call May 01, 2025 08:30 AM ET Speaker0 Please stand by. Your program is about to begin. Greetings, and welcome to the X4 Pharmaceuticals First Quarter twenty twenty five Financial and Operating Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference call is being recorded. It is now my pleasure to introduce your host, Dan Ferry from LifeSci A ...

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 $3.5 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 $28.8 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 $17.4 million [10][20] - The company achieved a net income of $0.3 million in Q1 2025, a significant improvement from a net loss of $51.8 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]

BOSTON, April 24, 2025 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that it will report financial results for the first quarter ended March 31, 2025 and provide corporate updates on Thursday, May 1, 2025. The company will host a conference call and webcast on the same day at 8:30 a.m. EDT. The conference call can be accessed by dialing 1-800-343-4849 from the United States or 1-203-518-9848 int ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) ________________________________________________________________________________________________________ Delaware (857) 529-8300 (Registrant's telephone number, including area code) (State or other jurisdiction of incorporation or organization) 61 North Beacon Street, 4th Floo ...

X4 Pharmaceuticals, Inc. (NASDAQ:XFOR) Q4 2024 Earnings Conference Call March 25, 2025 8:30 AM ET Company Participants Daniel Ferry - IR, LifeSci Advisors Paula Ragan - CEO Adam Mostafa - CFO Christophe Arbet-Engels - Chief Medical Officer Mark Baldry - CCO Conference Call Participants Stephen Willey - Stifel Ed Tenthoff - Piper Sandler Ayan Hussein - Cantor Fitzgerald Doug MacPherson - H.C. Wainwright David Bautz - Zacks Small-Cap Research Operator Greetings, and welcome to the X4 Pharmaceuticals Fourth Qu ...

X4 Pharmaceuticals (XFOR) Q4 2024 Earnings Call March 25, 2025 08:30 AM ET Company Participants Dan Ferry - Managing DirectorPaula Ragan - Founder, President & CEOAdam Mostafa - CFOChristophe Arbet-Engels - Chief Medical OfficerMark Baldry - Chief Commercial OfficerAyan Hussein - Equity Research AssociateDouglas Macpherson - Equity Research Associate Conference Call Participants Stephen Willey - AnalystDavid Bautz - Senior Analyst Operator Greetings and welcome to the X4 Pharmaceuticals Fourth Quarter and F ...

Financial Performance - X4 Pharmaceuticals reported net revenues of $2.6 million for XOLREMDI® since its launch in May 2024, with expectations for increased sales in 2025 [3]. - X4 reported a net loss of $37.5 million for the full year 2024, compared to a net loss of $101.2 million in 2023 [20]. - Product revenue for Q4 2024 was $1.434 million, compared to $0 in Q4 2023, indicating a significant increase [28]. - The net loss for Q4 2024 was $39.821 million, compared to a net loss of $19.130 million in Q4 2023, representing a 108.5% increase in losses [28]. Expenses - Research and Development (R&D) expenses for the full year 2024 were $81.6 million, up from $72.0 million in 2023 [15]. - Selling, General, and Administrative (SG&A) expenses for the full year 2024 were $61.5 million, compared to $35.5 million in 2023 [15]. - Research and development expenses for Q4 2024 were $21.702 million, up from $15.272 million in Q4 2023, reflecting a 42.5% increase [28]. - Selling, general and administrative expenses rose to $15.145 million in Q4 2024 from $9.927 million in Q4 2023, a 52.5% increase [28]. - A strategic restructuring announced in February 2025 is expected to reduce spending by $30-35 million annually [12]. Cash and Assets - X4 had a cash position of $102.8 million as of December 31, 2024, and expects sufficient funds to support operations into the first half of 2026 [15]. - Total current assets decreased to $112.175 million as of December 31, 2024, down from $122.076 million as of December 31, 2023 [30]. - Cash and cash equivalents decreased to $55.699 million from $99.216 million year-over-year, a decline of 43.8% [30]. - The company reported a total stockholders' equity of $22.149 million as of December 31, 2024, down from $51.099 million a year earlier, a decrease of 56.7% [30]. - Total liabilities increased to $124.298 million as of December 31, 2024, compared to $96.159 million as of December 31, 2023, marking a 29.3% increase [30]. Clinical Trials and Regulatory Challenges - The company anticipates full enrollment in the Phase 3 4WARD trial for chronic neutropenia by Q3 or Q4 2025, with top-line data expected in the second half of 2026 [1]. - The 4WARD trial is now activated at approximately 90% of targeted sites worldwide [14]. - The ongoing Phase 3 clinical trial for mavorixafor may face delays or unsatisfactory outcomes, impacting future commercialization efforts [25]. - X4 Pharmaceuticals anticipates potential challenges in obtaining and maintaining regulatory approvals for mavorixafor, which could affect its market strategy [25]. Licensing and Partnerships - X4 entered into a licensing agreement with Norgine Pharma UK, receiving €28.5 million upfront and potential milestone payments of up to €226 million [6]. - The company recognized a gain of $105 million from the sale of a priority review voucher (PRV) in 2024 [20].