X4 Pharmaceuticals Files 2023 Annual Report on Form 10-K

TL;DR

<b>X4 Pharmaceuticals filed its 2023 10-K, detailing its business operations and a prior year gain from asset sales.</b>

AI Summary

X4 Pharmaceuticals, Inc (XFOR) filed a Annual Report (10-K) with the SEC on March 21, 2024. X4 Pharmaceuticals, Inc. filed its 2023 Form 10-K on March 21, 2024. The company was formerly known as Arsanis, Inc. and changed its name on September 20, 2010. In 2022, X4 Pharmaceuticals recognized a $0.5 million gain from the sale of non-financial assets (intellectual property). The company's principal business is in Biological Products (No Diagnostic Substances) under SIC code 2836. X4 Pharmaceuticals is incorporated in Delaware with its principal business address in Boston, MA.

Why It Matters

For investors and stakeholders tracking X4 Pharmaceuticals, Inc, this filing contains several important signals. The filing provides a comprehensive overview of X4 Pharmaceuticals' financial performance and business activities for the fiscal year ended December 31, 2023. Disclosure of the $0.5 million gain from the sale of intellectual property in 2022 offers insight into the company's asset monetization strategies.

Risk Assessment

Risk Level: low — X4 Pharmaceuticals, Inc shows low risk based on this filing. The filing is a standard annual report (10-K) with no immediate red flags or significant negative disclosures, indicating a low level of immediate risk based solely on this document.

Analyst Insight

Review the full 10-K filing for detailed financial statements, risk factors, and management discussion to assess the company's operational and financial health.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-21 — Filing Date (Filed as of date)
• 001-38295 — SEC File Number (SEC file number)
• 2836 — SIC Code (Standard Industrial Classification)
• $0.5 million — Gain on Sale of Non-Financial Assets (Recognized in the year ended December 31, 2022)

Key Players & Entities

• X4 Pharmaceuticals, Inc. (company) — Filer name
• Arsanis, Inc. (company) — Former company name
• 2023-12-31 (date) — Conformed period of report
• 2024-03-21 (date) — Filed as of date
• $0.5 million (dollar_amount) — Gain from sale of non-financial asset in 2022
• Boston, MA (location) — Business address city and state

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-21: Filing Date — Date the 10-K was officially filed with the SEC.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This filing provides the official annual financial and business overview for X4 Pharmaceuticals.)

ASC Topic 610-20

Accounting Standards Codification Topic 610-20, Gains and Losses from the Derecognition of Nonfinancial Assets. (This standard was used by X4 Pharmaceuticals to account for the gain on the sale of intellectual property in 2022.)

Key Financial Figures

• $0.001 — hares of the registrant's common stock, $0.001 par value per share outstanding. DOCU
• $100,000 — ome, based on drug costs alone, exceeds $100,000 per year in the United States for thera

Filing Documents

• xfor-20231231.htm (10-K) — 1976KB
• ex1037catalentamendement3.htm (EX-10.37) — 16KB
• ex-231x4x10xkpwcconsentxfy.htm (EX-23.1) — 2KB
• ex-311q42023.htm (EX-31.1) — 10KB
• ex-312q42023.htm (EX-31.2) — 10KB
• ex-321q42023.htm (EX-32.1) — 5KB
• ex971compensationrecoupmen.htm (EX-97.1) — 42KB
• xfor-20231231_g1.jpg (GRAPHIC) — 46KB
• 0001628280-24-012578.txt (&nbsp;) — 9681KB
• xfor-20231231.xsd (EX-101.SCH) — 70KB
• xfor-20231231_cal.xml (EX-101.CAL) — 76KB
• xfor-20231231_def.xml (EX-101.DEF) — 347KB
• xfor-20231231_lab.xml (EX-101.LAB) — 716KB
• xfor-20231231_pre.xml (EX-101.PRE) — 573KB
• xfor-20231231_htm.xml (XML) — 1302KB

BUSINESS

BUSINESS 5 Item 1A.

RISK FACTORS

RISK FACTORS 29 Item 1B. UNRESOLVED STAFF COMMENTS 66

CYBERSECURITY

Item 1C. CYBERSECURITY 66 Item 2.

PROPERTIES

PROPERTIES 67 Item 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 67 Item 4 . MINE SAFETY DISCLOSURES 68 PART II Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 69 Item 6. [RESERVED] 69 Item 7.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 70 Item 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 79 Item 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 79 Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES 79 Item 9A.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 79 Item 9B. OTHER INFORMATION 80

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 80 PART III Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 81 Item 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 81 Item 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 81 Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 81 Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 81 PART IV Item 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES 82

FORM 10-K SUMMARY

Item 16. FORM 10-K SUMMARY 86 2 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), 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 financial performance. These statements may be identified by such forward-looking terminology as "may," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue" or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, including risks described in the section titled "Risk Factors" and elsewhere in this report, regarding, among other things: the timing of and our ability to obtain and maintain regulatory approval of our existing product candidates or any product candidates that we may develop in the future, and any related restrictions, limitations, or warnings in the label of any approved product candidates; 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; the potential benefits, including clinical utility, that

BUSINESS

ITEM 1. BUSINESS Overview We are a late clinical-stage biopharmaceutical company discovering and developing novel therapeutics for the treatment of rare diseases and those with limited treatment options, with a focus on conditions resulting from dysfunction of the immune system. Our lead clinical candidate is mavorixafor, a small-molecule selective antagonist of chemokine receptor CXCR4, that is being developed as an oral, once-daily therapy. Due to its ability to increase the mobilization of mature, functional white blood cells into the bloodstream, we believe that mavorixafor has the potential to provide therapeutic benefit across a variety of chronic neutropenic disorders, including WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, primary immunodeficiency. We are currently seeking approval from the U.S. Food and Drug Administration ("FDA") for the use of oral, once-daily mavorixafor in the treatment of people aged 12 years and older with WHIM syndrome following the October 2023 acceptance of our New Drug Application ("NDA") by the FDA. The FDA has granted the NDA Priority Review, establishing a goal of six months review from the date of acceptance and assigning a Prescription Drug User Fee Act ("PDUFA") target action date of April 30, 2024. At this time, the FDA has notified us that they are not planning to hold an advisory committee meeting to review the filing. Due to mavorixafor's Rare Pediatric Disease designation in the U.S. for WHIM syndrome, should mavorixafor be approved, we are eligible to receive a Priority Review Voucher ("PRV"), which may be used to obtain Priority Review for a subsequent application or sold to another drug sponsor. The NDA is supported by our successfully completed global, pivotal, Phase 3 clinical trial ("4WHIM") that evaluated the safety and efficacy of mavorixafor in 31 people with WHIM syndrome. The 4WHIM trial met its primary endpoint and a key secondary endpoint, demonstrating statis

View Full Filing

View this 10-K filing on SEC EDGAR