XFOR 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• We are a biopharmaceutical company developing and commercializing novel therapeutics for the treatment of rare hematology diseases. We continue to progress our global, pivotal Phase 3 clinical trial, (the “4WARD” trial) to evaluate the efficacy, safety, and tolerability of oral, once-daily mavorixaf…

• We have one commercially approved product, XOLREMDI® (mavorixafor), which has received accelerated approval in the United States from the FDA for use as an oral, once-daily therapy in patients 12 years of age and older with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome,…

• In January 2025, the EMA validated for processing our Marketing Authorization Application seeking regulatory approval to commercialize mavorixafor for WHIM syndrome in the European Union. On April 29, 2026, the European Commission granted marketing authorization for XOLREMDI® (mavorixafor) capsules …

• The following table summarizes the results of our operations for the three months ended March 31, 2026 and 2025:

• Net product sales were $2.5 million and $0.9 million for the three months ended March 31, 2026 and 2025, respectively. Net product revenue growth over the prior year quarter was primarily due to an increase in the number of patients who have been prescribed the Company’s drug product. Gross-to-net a…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that relate to future events or to our future operations or fin…

• •our ability to raise additional capital or achieve sufficient revenue to properly fund our business and operating plan as well as our ability to continue as a going concern;

• •our expectations and goals for commercialization of XOLREMDI® , which has been approved for use as an oral, once-daily therapy to increase the number of circulating mature neutrophils and lymphocytes in patients 12 years of age and older with WHIM (warts, hypogammaglobulinemia, infections, and myel…

• •our expectations that the intended effects of the reverse stock split will occur and that we will be able to maintain compliance with Nasdaq’s listing requirements and this will positively impact our ability to raise capital;

• •the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and related preparatory work and the period during which the results of the trials will become available, as well as our research and development programs;

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods

• specified in the SEC’s rules and forms and accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.

• Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of March 31, 2026, and have concluded that, based on such eva…

• There were no changes in our internal control over financial reporting that occurred during the three months ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and accumu…

• Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of September 30, 2025, and have concluded that, based on such…

• There were no changes in our internal control over financial reporting that occurred during the three months ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• In connection with her departure from the Company, Dr. Paula Ragan, the Company’s former President and Chief Executive Officer and a former director, terminated a Rule 10b5-1 trading arrangement on August 14, 2025. The terminated Rule 10b5-1 trading arrangement was originally adopted on June 28, 202…

• In connection with his departure from the Company, Adam Mostafa, the Company’s former Chief Financial Officer, terminated a Rule 10b5-1 trading arrangement on August 14, 2025. The terminated Rule 10b5-1 trading arrangement was originally adopted on June 28, 2024, and provided for the sale 11,229 sha…

• On September 4, 2025, Mark Baldry, the Company’s former Chief Commercial Officer, adopted a written trading arrangement for the sale of Company securities intended to satisfy the affirmative defense conditions of Rule 10b5-1(c). In connection with his departure from the Company, Mr. Baldry terminate…

• (1) The number of shares that were to be sold in accordance with these trading arrangements was indeterminable at the time of the filing of this Quarterly Report on Form 10-Q for the period ended September 30, 2025. Upon vesting of performance-

• based restricted stock units, a sell-to-cover trade would have occurred to satisfy any applicable tax withholding obligations on behalf of the employee. The number of shares sold in the sell-to-cover would have varied based on the market price of the Company’s common stock at the time of settlement …