X4 Pharmaceuticals Files 8-K Report

Ticker: XFOR · Form: 8-K · Filed: Jun 27, 2024 · CIK: 1501697

X4 Pharmaceuticals, Inc 8-K Filing Summary
FieldDetail
CompanyX4 Pharmaceuticals, Inc (XFOR)
Form Type8-K
Filed DateJun 27, 2024
Risk Levellow
Pages7
Reading Time8 min
Key Dollar Amounts$0.001
Sentimentneutral

Sentiment: neutral

Topics: regulatory-filing, 8-k

TL;DR

X4 Pharma filed an 8-K on 6/27, check for updates.

AI Summary

On June 27, 2024, X4 Pharmaceuticals, Inc. filed an 8-K report. The filing primarily concerns other events and financial statements/exhibits, with no specific material events detailed in the provided text. The company is incorporated in Delaware and headquartered in Boston, MA.

Why It Matters

This 8-K filing indicates that X4 Pharmaceuticals has submitted required regulatory documentation to the SEC, which may contain updates or disclosures relevant to investors.

Risk Assessment

Risk Level: low — The filing is a routine 8-K submission without immediate disclosure of significant negative or positive events.

Key Numbers

  • 001-38295 — SEC File Number (Identifies the company's filing history with the SEC.)
  • 27-3181608 — IRS Employer Identification No. (Company's tax identification number.)

Key Players & Entities

  • X4 Pharmaceuticals, Inc. (company) — Registrant
  • 0001628280-24-030243 (filing_id) — Accession Number
  • June 27, 2024 (date) — Date of Report
  • Boston, Massachusetts (location) — Principal Executive Offices
  • Delaware (jurisdiction) — State of Incorporation

FAQ

What specific 'Other Events' are detailed in this 8-K filing?

The provided text for the 8-K filing does not specify the details of the 'Other Events' beyond listing it as an item information category.

Are there any new financial statements or exhibits included with this filing?

The filing lists 'Financial Statements and Exhibits' as an item information category, but the specific content of these exhibits is not detailed in the provided text.

What was the former name of X4 Pharmaceuticals, Inc.?

The former name of X4 Pharmaceuticals, Inc. was Arsanis, Inc., with a date of name change on September 20, 2010.

What is the primary business of X4 Pharmaceuticals, Inc.?

X4 Pharmaceuticals, Inc. is in the 'BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES)' industry, SIC code 2836.

When was X4 Pharmaceuticals, Inc. incorporated?

X4 Pharmaceuticals, Inc. is incorporated in Delaware.

Filing Stats: 2,002 words · 8 min read · ~7 pages · Grade level 17.2 · Accepted 2024-06-27 08:01:09

Key Financial Figures

  • $0.001 — ich registered Common Stock, par value $0.001 per share XFOR The Nasdaq Stock Market

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On June 27, 2024, X4 Pharmaceuticals, Inc. (the "Company") issued a press release titled "X4 Pharmaceuticals Announces Positive Interim Clinical Data from Ongoing Six-Month Phase 2 Trial of Mavorixafor in Chronic Neutropenia (CN) and Initiation of Pivotal Phase 3 CN Trial". A copy of the press release is attached hereto as Exhibit 99.1. On June 27, 2024, the Company posted a corporate presentation on the Company's website to provide updates and summaries of its business. A copy of the corporate presentation is attached as Exhibit 99.2 to this report. The information in this Item 7.01, including Exhibits 99.1 and 99.2 to this report, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"). The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 and 99.2 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events. On June 27, 2024, the Company announced positive new clinical data from its ongoing Phase 2 clinical trial evaluating the safety and efficacy of mavorixafor, an oral CXCR4 antagonist, in the treatment of people with chronic neutropenia (CN). An interim analysis of data from the ongoing six-month study showed that once-daily oral mavorixafor was generally well tolerated and durably increased participants' absolute neutrophil counts (ANC) both as a monotherapy and in combination with stable doses of injectable granulocyte colony-stimulating factor (G-CSF), the only therapy approved in the U.S. for severe chronic neutropenia. The company also announced that it is currently screening patients for enrollment into its global, pivotal Phase 3 clinical trial, the 4WARD study, evaluating the efficacy, safety, and tolerability of oral, once-daily mavorixafor (with or without stable doses of G-CSF) in people with congenital, acquired primary autoimmune, or idiopathic CN who are experiencing recurrent and/or serious infections. The 52-week trial is a randomized, double-blind, placebo-controlled, multicenter study aiming to enroll 150 participants. Interim Analysis of Data from Phase 2 Clinical Study of Mavorixafor in CN The Phase 2 study of mavorixafor is a six-month, open-label clinical trial that enrolled a total of 23 participants diagnosed with idiopathic, congenital, or cyclic CN. The interim analysis included results from the two treatment groups in the study (mavorixafor monotherapy and mavorixafor with stable-dose G-CSF) that most closely mirror the participant population of the newly initiated Phase 3 4WARD trial. Fifteen participants were enrolled across these two groups and, as of the May 14, 2024 interim analysis data cut-off date, seven had completed the study, and five remain ongoing. Data from a third treatment group of eight participants receiving mavorixafor and dose-adjusted G-CSF are expected to be presented later this year.

Forward-Looking Statements

Forward-Looking Statements This Form 8-K contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," or other similar terms or expressions that concern X4's expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, implied or express statements regarding X4's expectations as to plans for commercial launch of XOLREMDI (mavorixafor), which is approved in the U.S. for use in patients 12 years of age and older with WHIM syndrome (the "Indication"); X4's belief in its readiness for commercial launch of XOLREMDI; the potential benefit of XOLREMDI in the Indication; the potential number of patients in the United States with WHIM syndrome and the potential market for XOLREMDI due to unmet potential patient needs; 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; and the mission and goals for our business. Any forward-looking statements in this Form 8-K are based on management's current expectations and beliefs. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond X4's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: X4's launch and commercialization efforts in the U.S. with respect to XOLREMDI may not be successful, and X4 may be unable to generate revenues at the levels or on the timing

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. Exhibit No. Description 99.1 Press Release, dated June 27, 2024 99.2 Corporate Presentation, dated June 27, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934 the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. X4 PHARMACEUTICALS, INC. Date: June 27, 2024 By: /s/ Adam Mostafa Adam Mostafa Chief Financial Officer

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