UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
| FORM | | ||||
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Data of earliest event reported): October 7, 2020
| (Exact name of registrant as specified in its charter) | ||||||||
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
| (Address of principal executive offices) | (Zip Code) | ||||||||||
(857 ) 529-8300
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (240.12b-2 of this chapter). Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☒
Item 8.01 | Other Events. | ||||
X4 Pharmaceuticals, Inc. (the “Company”) has re-assessed the impacts of the continuing COVID-19 pandemic on the Company’s ongoing Phase 1b dose-escalation trial of its lead product candidate, mavorixafor, in patients with Waldenström’s macroglobulinemia (“WM”). Following such re-assessment, the Company now expects to release initial data results from this trial in the first half of 2021.
This Current Report on Form 8-K contains forward-looking statements within the meaning of 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 the Company's expectations, strategy, plans or intentions. Forward-looking statements include, without limitation, statements regarding the anticipated and potential impact of the ongoing COVID-19 pandemic on the Company’s business and operations; the anticipated timing of data and results from its Phase 1b dose-escalation trial of its lead product candidate, mavorixafor, in patients with WM, including with respect to the impact of the COVID-19 pandemic and the ability of patients already enrolled to continue in the trial; and the expected timing of guidance and data disclosures from the Company’s current clinical trials, including its WM Phase 1b clinical trial, on its financial outlook. Any forward-looking statements in this Current Report on Form 8-K are based on management's current expectations and beliefs. Actual events or results may differ materially from those expressed or implied by any forward-looking statements contained herein, including, without limitation, the risks and uncertainties described in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on August 4, 2020, and in other filings the Company makes with the SEC from time to time. The Company undertakes no obligation to update the information contained in this Current Report on Form 8-K to reflect new events or circumstances, except as required by law.
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: October 7, 2020 | By: | /s/ Derek Meisner | |||||||||
| Derek Meisner | |||||||||||
| General Counsel | |||||||||||