Full Press Release Details
Xilio Therapeutics Reports Pipeline and Business Progress and Third Quarter 2021 Financial Results
Anticipate First Patient Dosing in Phase 1/2 Clinical Trial for XTX202, a Tumor-Selective IL-2, in First Quarter of 2022
Advancing Phase 1/2 Clinical Trial for XTX101, a Tumor-Selective Anti-CTLA-4
Successfully Closed IPO in Fourth Quarter of 2021, Raising Approximately $130 Million in Gross Proceeds to Advance Pipeline of Tumor-Selective Immuno-Oncology Programs
WALTHAM, Mass., December 2, 2021 - Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, today reported recent pipeline and business progress and third quarter 2021 financial results.
"Xilio made significant progress in 2021 as we transitioned to a clinical stage organization with XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, and XTX202, a tumor-selective IL-2, in clinical development," said Ren Russo, Pharm. D., president and chief executive officer of Xilio. "With the recent completion of our IPO and a strong and experienced team in place, we are well-positioned to leverage our geographically precise solutions (GPS) platform to advance our pipeline of immuno-oncology therapies that have the potential to achieve meaningful anti-tumor activity while minimizing serious, systemic effects for the benefit of cancer patients."
Recent Pipeline and Business Progress
Checkpoint Inhibitor Program
Recent Business Highlights
Anticipated Milestones in 2022
Xilio currently anticipates the following milestones in 2022:
Third Quarter 2021 Financial Results
About Xilio Therapeutics
Xilio Therapeutics is a biotechnology company focused on harnessing the immune system to achieve deep and durable clinical responses to improve the lives of patients with cancer. The company is using its proprietary geographically precise solutions (GPS) platform to rapidly engineer novel molecules, including cytokines and other biologics, that are designed to optimize their therapeutic index. These molecules are designed to localize activity within the tumor microenvironment without systemic effect, resulting in the potential to achieve enhanced anti-tumor activity. Xilio is building a pipeline of wholly-
owned, tumor-selective, GPS-enabled cytokine and checkpoint inhibitor product candidates, including XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody; XTX202, a tumor-selective IL-2; XTX301, a tumor-selective IL-12; and XTX401, a tumor-selective IL-15. For more information, please visit www.xiliotx.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, strategies, timelines and expectations for Xilio's current or future approved product candidates, including without limitation, plans and timing related to the initiation of a Phase 1/2 clinical trial for XTX202, the presentation of preliminary clinical data for XTX101 and XTX202 and the submission of an IND for XTX301; the potential benefits of any of Xilio's current or future product candidates in treating patients; Xilio's ability to fund its operating expenses and capital expenditure requirements with its cash and cash equivalents; and Xilio'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," "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 press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, 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 Xilio's current or future product candidates; preclinical and clinical supply of current or future product candidates; Xilio's advancement of multiple early-stage programs; Xilio'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; results from preclinical studies or clinical trials for Xilio's product candidates, which may not support further development of such product candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of current or future clinical trials; Xilio's ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio's ability to obtain and maintain sufficient cash resources to fund current or future operating expenses and capital expenditure requirements; and the impact of the COVID-19 pandemic on Xilio's business, operations, strategy, goals and anticipated milestones. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Xilio's filings with the U.S. Securities and Exchange Commission (SEC), including Xilio's final prospectus related to its initial public offering, and any other filings that Xilio makes with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio'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, Xilio explicitly disclaims any obligation to update any forward-looking statements.
| THRUST Strategic Communications | |
| For Investor Inquiries: Monique Allaire, THRUST Strategic Communications monique@thrustsc.com | For Media Inquiries: Dan Budwick, 1AB dan@1abmedia.com |
XILIO THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||
| 2021 | 2020 | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 99,767 | $ | 19,238 | ||
| Other assets | 20,958 | 17,079 | ||||
| Total assets | 120,725 | 36,317 | ||||
| Liabilities and Stockholders' Deficit | ||||||
| Liabilities | 34,292 | 41,602 | ||||
| Convertible preferred stock | 222,888 | 78,002 | ||||
| Stockholders' deficit | (136,455) | (83,287) | ||||
| Total liabilities, convertible preferred stock and stockholders' deficit | 120,725 | 36,317 |
XILIO THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Operating expenses (1) | ||||||||||||
| Research and development | $ | 10,470 | $ | 11,460 | $ | 39,836 | $ | 26,243 | ||||
| General and administrative | 5,491 | 3,163 | 15,652 | 7,725 | ||||||||
| Total operating expenses | 15,961 | 14,623 | 55,488 | 33,968 | ||||||||
| Loss from operations | (15,961) | (14,623) | (55,488) | (33,968) | ||||||||
| Other income (expense), net | ||||||||||||
| Other expense, net | (290) | (196) | (611) | (479) | ||||||||
| Total other income (expense), net | (290) | (196) | (611) | (479) | ||||||||
| Net loss and comprehensive loss | $ | (16,251) | $ | (14,819) | $ | (56,099) | $ | (34,447) | ||||
| Net loss per share, basic and diluted | $ | (21.27) | $ | (24.19) | $ | (76.18) | $ | (72.02) | ||||
| Weighted average common shares outstanding, basic and diluted | 763,869 | 612,657 | 736,416 | 478,283 | ||||||||
| (1) Operating expenses include the following amounts of non-cash equity-based compensation expense: | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Research and development expense | $ | 378 | $ | 183 | $ | 864 | $ | 240 | ||||
| General and administrative expense | 713 | 500 | 2,023 | 690 | ||||||||
| Total equity-based compensation expense | $ | 1,091 | $ | 683 | $ | 2,887 | $ | 930 |