Clinical programs for XTX202, a tumor-selective IL-2, and XTX101, a tumor-selective anti-CTLA-4, continue to advance with preliminary data anticipated in 2022
On track with plans to submit IND for XTX301, a tumor-selective IL-12, in second half of 2022
Strong financial position with $177 million in cash and cash equivalents as of March 31, 2022, with cash runway anticipated into first half of 2024
WALTHAM, Mass., May 12, 2022 (GLOBE NEWSWIRE) — Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, today announced pipeline and business highlights and reported financial results for the first quarter ended March 31, 2022.
“Leveraging our geographically precise solutions (GPS) platform, we are developing a pipeline of tumor-selective immunotherapies that have the potential to achieve meaningful anti-tumor activity while minimizing serious, systemic effects,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “We continue to progress enrollment in our Phase 1 clinical programs, XTX101 and XTX202, with planned preliminary data readouts later this year, and we remain on track with our plans to submit an IND application for XTX301 in the second half of 2022. With our strong financial position and an outstanding team in place, we believe we are well-positioned to advance our pipeline of tumor-selective immuno-oncology programs with the goal of transforming the lives of people living with cancer.”
Pipeline and Business Progress
Cytokine Programs
Upcoming Presentations
Presentation title: A first-in-human, multicenter, phase 1/2, open-label study of XTX202, a masked and tumor-selective recombinant human interleukin-2 (IL-2) protein, in patients with advanced solid tumors
Session date and time: Sunday, June 5, 2022, 8:00-11:00 AM CDT
Abstract number: TPS2697
Checkpoint Inhibitor Program
First Quarter 2022 Financial Results
Financial Guidance
As a result of prioritization within the company’s preclinical portfolio, Xilio now anticipates that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the first half of 2024.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage 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 its clinical-stage programs, XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, and XTX202, a tumor-selective IL-2, as well as its earlier pipeline, including XTX301, a tumor-selective IL-12. For more information, please visit www.xiliotx.com and follow us on Twitter (@xiliotx) and LinkedIn (Xilio Therapeutics, Inc.).
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 and timing related to reporting preliminary Phase 1 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 existing 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 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 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; Xilio’s ability to obtain and maintain sufficient 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; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; 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 sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (SEC), including Xilio’s most recent Annual Report on Form 10-K and any other filings that Xilio has made or may make 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.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
For Investor Inquiries:
Sal Giovine
Chief Financial Officer
investors@xiliotx.com
For Media Inquiries:
Julissa Viana
Vice President, Corporate Communications
media@xiliotx.com
XILIO THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
March 31, | December 31, | ||||||
2022 | 2021 | ||||||
Assets | |||||||
Cash and cash equivalents | $ | 176,959 | $ | 198,053 | |||
Other assets | 19,393 | 20,007 | |||||
Total assets | $ | 196,352 | $ | 218,060 | |||
Liabilities and Stockholders’ Equity | |||||||
Liabilities | $ | 30,231 | $ | 32,631 | |||
Stockholders’ equity | 166,121 | 185,429 | |||||
Total liabilities and stockholders’ equity | $ | 196,352 | $ | 218,060 | |||
XILIO THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended March 31, |
|||||||
2022 | 2021 | ||||||
Operating expenses (1) | |||||||
Research and development | $ | 14,920 | $ | 11,621 | |||
General and administrative | 6,304 | 4,899 | |||||
Total operating expenses | 21,224 | 16,520 | |||||
Loss from operations | (21,224 | ) | (16,520 | ) | |||
Other expense, net | |||||||
Other expense, net | (129 | ) | (147 | ) | |||
Total other expense, net | (129 | ) | (147 | ) | |||
Net loss and comprehensive loss | $ | (21,353 | ) | $ | (16,667 | ) | |
Net loss per share, basic and diluted | $ | (0.78 | ) | $ | (23.53 | ) | |
Weighted average common shares outstanding, basic and diluted | 27,367,377 | 708,264 | |||||
(1) Operating expenses include the following amounts of non-cash equity-based compensation expense: | |||||||
Three Months Ended March 31, |
|||||||
2022 | 2021 | ||||||
Research and development expense | $ | 596 | $ | 135 | |||
General and administrative expense | 1,433 | 659 | |||||
Total equity-based compensation expense | $ | 2,029 | $ | 794 |
FORT WORTH, Texas, Dec. 24, 2024 (GLOBE NEWSWIRE) -- CorVel Corporation (NASDAQ: CRVL) today announced…
- Proprietary data and samples from TRACERx and Achilles’ Material Acquisition Platform (MAP) will be…
If you are male and in your 40's and 50's and feel your testosterone levels…
Transforming Anxiety into Positive Energy: A New Approach by The Anxiety ClinicBondi Junction, New South…
Embracing Mental Well-Being During the Festive SeasonCarlton North, Australia--(Newsfile Corp. - December 24, 2024) -…
If you are researching the strongest over the counter weight loss supplements in 2025 -…