Item 8.01 Other Events.
On November 3, 2023, Xilio Therapeutics, Inc. (the “Company”) issued a press release announcing preliminary data from its ongoing Phase 1/2 clinical trial evaluating XTX202 in patients with advanced solid tumors and outlining plans for potential key milestones across its clinical-stage pipeline, subject to obtaining sufficient additional capital. The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information contained on, or accessible through, the websites referenced in the press release is not incorporated by reference into this Current Report on Form 8-K and should not be considered to be a part hereof.
Cautionary Note Regarding Forward-Looking Statements
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, including, without limitation, statements regarding plans, timing and expectations related to: activating clinical trial sites for the Phase 1 dose escalation portion of the clinical trial evaluating XTX101 in combination with atezolizumab; reporting preliminary Phase 1 safety data for XTX301; additional plans and anticipated milestones for XTX101, XTX202 and XTX301 in 2024 and 2025, subject to obtaining sufficient additional capital; the potential benefits of any of the Company’s current or future product candidates in treating patients, including without limitation XTX202; and the Company’s strategy, goals and anticipated financial performance, milestones, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this Current Report on Form 8-K are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this Current Report on Form 8-K, including, without limitation, risks and uncertainties related to: ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of the Company’s current or future product candidates; the Company’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; the Company’s advancement of multiple early-stage programs; interim or preliminary preclinical or clinical data or results, which may not be predictive of future preclinical or clinical data or results; the Company’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; the potential for results from preclinical studies or clinical trials for the Company’s product candidates not supporting further development of such product candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of current or future clinical trials; the Company’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; the Company’s ability to obtain and maintain sufficient cash resources to fund its operations beyond the end of the second quarter of 2024; the impact of international trade policies on the Company’s business, including U.S. and China trade policies; and the Company’s ability to maintain its clinical trial collaboration with Roche to develop XTX101 in combination with atezolizumab. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s most recent Quarterly Report on Form 10-Q and any other filings that the Company has made or may make with the SEC in the future. Any forward-looking statements contained in this Current Report on Form 8-K represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company explicitly disclaims any obligation to update any forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
