1. WALTHAM, Mass., Jan. 20, 2022 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (NASDAQ:XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, today announced that the first patient has been dosed in the company's Phase 1/2 clinical trial evaluating XTX202 for the treatment of solid tumors. XTX202 is a modified form of IL-2 that is designed to localize activity in the tumor microenvironment (TME), with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity.

    "We are pleased to begin patient dosing in our Phase 1/2 clinical trial with XTX202, a novel tumor selective IL-2 candidate with the potential to increase the…

    WALTHAM, Mass., Jan. 20, 2022 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (NASDAQ:XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, today announced that the first patient has been dosed in the company's Phase 1/2 clinical trial evaluating XTX202 for the treatment of solid tumors. XTX202 is a modified form of IL-2 that is designed to localize activity in the tumor microenvironment (TME), with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity.

    "We are pleased to begin patient dosing in our Phase 1/2 clinical trial with XTX202, a novel tumor selective IL-2 candidate with the potential to increase the therapeutic benefit of IL-2," said Marty Huber, M.D., president of research and development and chief medical officer of Xilio Therapeutics. "XTX202 has been designed to be active only within the TME, with the goal of reducing dose limiting toxicity and enhancing anti-tumor activity. We look forward to advancing this trial to further our understanding of XTX202 as a potential therapy for the treatment of people living with cancer."

    Leveraging its proprietary geographically precise solutions (GPS) platform, Xilio designed XTX202 to be masked with a protein domain to prevent binding activity until the protein domain is cleaved off by TME-associated proteases. XTX202 is intended to be activated selectively in the TME, resulting in localized anti-tumor activity without dose-limiting toxicities. In preclinical studies, XTX202 exhibited tumor-selective biological activity and anti-tumor activity comparable to aldesleukin, a high-dose IL-2 therapy, at its maximum tolerated dose, while minimizing the severe toxicity observed with aldesleukin. In non-human primate models, XTX202 was well-tolerated at doses up to 10 mg/kg weekly.

    The Phase 1/2 clinical trial is a first-in-human, multi-center, open-label trial that will evaluate XTX202 as a monotherapy in patients with advanced solid tumors. The Phase 1 portion of the trial consists of a dose-escalation monotherapy cohort designed to evaluate the safety and tolerability of XTX202 and determine the recommended Phase 2 dose. Following completion of the Phase 1 portion, Xilio plans to initiate Phase 2 expansion cohorts with XTX202 monotherapy evaluating the objective response rate in patients with renal cell carcinoma or melanoma who previously received an anti-PD-1 treatment regimen. Xilio also plans to initiate one or more additional Phase 1 trials aimed at demonstrating utility of XTX202 in combinations with other agents such as anti-PD-1 agents or tyrosine kinase inhibitors. More information on the trial can be found at https://clinicaltrials.gov (NCT05052268).

    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 people living 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 to initiate Phase 2 expansion cohorts with XTX202 monotherapy; plans to initiate one or more additional Phase 1 trials aimed at demonstrating utility of XTX202 in combinations with other agents; plans, strategies, timelines and expectations for Xilio's current or future approved product candidates; plans and timing related to initial data for Xilio's product candidates; the potential benefits of any of Xilio's current or future product candidates in treating patients, including the ability of XTX202 to increase the therapeutic benefit of IL-2; 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; 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 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 Quarterly Report on Form 10-Q 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.

    For Investor Inquiries:

    Sal Giovine, CFO, Xilio Therapeutics

    For Media Inquiries: 

    Dan Budwick, 1AB



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  2. WALTHAM, Mass., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (NASDAQ:XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, today announced the appointment of Yuan Xu, Ph.D., to its board of directors.

    "Yuan is an industry veteran who brings broad, strategic leadership experience as a private and public company CEO, and deep technical expertise, including leading manufacturing scale-up at some of the world's most successful pharmaceutical companies," said Dan Lynch, chairman of the board of directors of Xilio Therapeutics. "Yuan's addition to the board will be invaluable as Xilio advances two programs through the clinic, with initial data readouts anticipated for both…

    WALTHAM, Mass., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (NASDAQ:XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, today announced the appointment of Yuan Xu, Ph.D., to its board of directors.

    "Yuan is an industry veteran who brings broad, strategic leadership experience as a private and public company CEO, and deep technical expertise, including leading manufacturing scale-up at some of the world's most successful pharmaceutical companies," said Dan Lynch, chairman of the board of directors of Xilio Therapeutics. "Yuan's addition to the board will be invaluable as Xilio advances two programs through the clinic, with initial data readouts anticipated for both programs in 2022, and a pipeline of additional pre-clinical development candidates. We look forward to benefiting from her leadership and expertise as we advance the development of our tumor-selective therapies."

    "Xilio has built a unique platform with the potential to deliver highly meaningful immuno-oncology therapies without the challenging toxicity and associated dose-limiting side effects that currently prevent many patients from receiving their full therapeutic benefit," said Dr. Xu. "I am pleased to join the board of directors as we work to advance Xilio's mission of addressing the needs of people living with cancer through important tumor-selective cytokine and checkpoint inhibitor product candidates, including XTX101 and XTX202."

    Dr. Xu is a biopharmaceutical executive with more than 25 years of experience, most recently serving as chief executive officer of Legend Biotech Corporation (Legend Biotech) from March 2018 until August 2020. In this capacity, she played a leading role in Legend Biotech's initial public offering, clinical development of Legend Biotech's autologous CAR T-cell therapy cilta-cel, and a strategic partnership with Janssen Biotech, Inc. Prior to Legend Biotech, Dr. Xu served as senior vice president at Merck & Co., Inc. (Merck) from August 2015 to August 2017, where she led discovery, preclinical and technical development, and manufacturing for Merck's biologics and vaccines subdivision. Dr. Xu also served as general manager and vice president of biologics at Gilead Sciences, Inc. (Gilead) from March 2014 to August 2015, where she led biologics and vaccines development and oversaw all operational aspects of Gilead's Oceanside manufacturing facility as site head. Prior to Gilead, Dr. Xu served as vice president at Novartis and led several functions in the U.S. and Europe, including the biotherapeutics development unit focusing on innovative medicines. Earlier in her career, Dr. Xu held positions of increasing responsibility at Amgen Inc., Chiron, Inc., GlaxoSmithKline PLC and Genentech Inc. Dr. Xu currently serves as a member of the boards of directors of Fate Therapeutics, Inc. and Akero Therapeutics, Inc., as well as a scientific advisory board member and manufacturing advisory board member of Resilience. Dr. Xu received a B.S. in biochemistry from Nanjing University, a Ph.D. in biochemistry from the University of Maryland and completed her post-doctoral training in virology and gene therapy at the University of California, San Diego.

    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; plans and timing related to initial data for Xilio's product candidates; the potential benefits of any of Xilio's current or future product candidates in treating patients; 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; 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 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 Quarterly Report on Form 10-Q 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.

    For Investor Inquiries:

    Monique Allaire, THRUST Strategic Communications

    For Media Inquiries: 

    Dan Budwick

     



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  3. 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., Dec. 02, 2021 (GLOBE NEWSWIRE) -- 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…

    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., Dec. 02, 2021 (GLOBE NEWSWIRE) -- 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 René 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

    Cytokine Programs

    • In October 2021, the U.S. Food and Drug Administration (FDA) cleared Xilio's investigational new drug application (IND) to evaluate XTX202, a tumor-selective interleukin-2 (IL-2), as a potential treatment for patients with solid tumors. XTX202 is designed to localize activity in the tumor microenvironment, with the goal of overcoming the known toxicity challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity.
    • In November 2021, at the Society for Immunotherapy in Cancer's 36th Annual Meeting, Xilio reported data from preclinical studies for XTX301, a tumor-selective interleukin-12 (IL-12). Findings demonstrated selective anti-tumor activity and favorable tolerability with minimal systemic effects observed in mouse models evaluating a murine surrogate for XTX301 and non-human primate models evaluating XTX301.

    Checkpoint Inhibitor Program

    • In September 2021, Xilio initiated patient dosing in its Phase 1/2 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, for the treatment of solid tumors as a monotherapy and in combination with pembrolizumab, an anti-PD-1. XTX101 is designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations, as well as the inability to use existing anti-CTLA-4 therapies at their full dose in combination with other immuno-oncology therapies.

    Recent Business Highlights

    • On October 26, 2021, Xilio closed its initial public offering (IPO). In connection with the IPO, Xilio issued and sold 7,353,000 shares of common stock at a public offering price of $16.00 per share, and on November 1, 2021, Xilio issued and sold an additional 766,106 shares of common stock at a public offering price of $16.00 per share pursuant to the partial exercise by the underwriters of their option to purchase additional shares. Xilio received aggregate gross proceeds of approximately $129.9 million or aggregate net proceeds of approximately $116.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by Xilio.
    • Appointed Tim Hunt as Xilio's chief culture and corporate affairs officer in October 2021.
    • Appointed Sara Bonstein, chief financial officer of Insmed, Inc., to Xilio's board of directors in August 2021.

    Anticipated Milestones in 2022

    Xilio currently anticipates the following milestones in 2022:

    • Initiation of a Phase 1/2 clinical trial to evaluate XTX202 in multiple solid tumor types in the first quarter of 2022
    • Presentation of preliminary data for the monotherapy cohort of the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the middle of 2022
    • Presentation of preliminary Phase 1 data for XTX202 in patients with multiple solid tumor types in the second half of 2022
    • Presentation of preliminary data from the combination cohort for the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the second half of 2022
    • Submission of an IND for XTX301 in the second half of 2022

    Third Quarter 2021 Financial Results

    • Cash Position and Guidance: Cash and cash equivalents were $99.8 million as of September 30, 2021, compared to $19.2 million as of December 31, 2020. Cash and cash equivalents as of September 30, 2021 do not include $116.3 million in estimated net proceeds from Xilio's October 2021 IPO. Xilio believes that its existing cash and cash equivalents, together with the net proceeds from its IPO, will enable it to fund its operating expenses and capital expenditure requirements into 2024.
    • Research & Development (R&D) Expenses: R&D expenses were $10.5 million for the third quarter of 2021, compared to $11.5 million for the third quarter of 2020. This decrease was primarily driven by lower comparable costs associated with manufacturing development activities for the XTX101 and XTX202 programs, partially offset by higher personnel-related costs due to increased headcount and preclinical research and clinical development expenses.
    • General & Administrative (G&A) Expenses: G&A expenses were $5.5 million for the third quarter of 2021, compared to $3.2 million for the third quarter of 2020. This increase was primarily driven by higher personnel-related costs due to increased headcount and higher professional fees related to ongoing business activities and preparations related to operating as a public company.
    • Net Loss: Net loss was $16.3 million for the third quarter of 2021, compared to $14.8 million for the third quarter of 2020.

    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.

    For Investor Inquiries:

    Monique Allaire,

    THRUST Strategic Communications

    For Media Inquiries: 

    Dan Budwick, 1AB

       



    XILIO THERAPEUTICS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands)

    (Unaudited)

      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)

    (Unaudited)

      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 



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  4. WALTHAM, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (NASDAQ:XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, today announced data from preclinical studies of XTX301, an engineered tumor-selective interleukin-12 (IL-12) product candidate, demonstrating selective anti-tumor activity and favorable tolerability with minimal systemic activity. These data are highlighted in a poster at the Society for Immunotherapy in Cancer's 36th Annual Meeting (SITC), which is being held virtually and in Washington, D.C., from November 10-14, 2021. In addition, Xilio will present an overview (poster #519) of its Phase 1/2 clinical trial design of XTX101, its tumor-selective anti-CTLA-4…

    WALTHAM, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (NASDAQ:XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, today announced data from preclinical studies of XTX301, an engineered tumor-selective interleukin-12 (IL-12) product candidate, demonstrating selective anti-tumor activity and favorable tolerability with minimal systemic activity. These data are highlighted in a poster at the Society for Immunotherapy in Cancer's 36th Annual Meeting (SITC), which is being held virtually and in Washington, D.C., from November 10-14, 2021. In addition, Xilio will present an overview (poster #519) of its Phase 1/2 clinical trial design of XTX101, its tumor-selective anti-CTLA-4 monoclonal antibody product candidate, in patients with solid tumors.

    "The presentations at SITC exemplify the progress we've made at Xilio in 2021 with our pipeline of clinical and preclinical-stage tumor selective antibody and cytokine product candidates," said Martin Huber, M.D., president of R&D and chief medical officer of Xilio. "IL-12 has the potential to be a meaningful treatment for patients with cancer, but current therapies are encumbered with severe toxicities due to their peripheral activity, leading to sub-optimal dosing and limited efficacy. Using our GPS platform, we have engineered XTX301 to achieve systemic delivery of tumor-selective IL-12, while avoiding the known side effect challenges. These preclinical data showcase our engineering efforts to activate XTX301 only when it is within the tumor microenvironment, resulting in the potential to achieve an optimized therapeutic index and enhanced anti-tumor activity. We look forward to further advancing this program, with plans to submit an investigational new drug application to the FDA in the second half of 2022."

    XTX301, a Protein-Engineered IL-12, Exhibits Tumor-Selective Activity in Mice Without Peripheral Toxicities and is Well Tolerated in Non-human Primates (#719)

    Data reported in the poster build upon earlier preclinical findings reported by Xilio, which demonstrated that XTX301 was activated in a protease-dependent manner, including in human tumor samples ex vivo. Key findings from the poster are from preclinical studies in mouse and non-human primate (NHP) models, including comparisons between XTX301 and XTX300, a non-masked control version of XTX301, as well as corresponding murine surrogate molecules mXTX301 and mXTX300. In these preclinical studies:

    • XTX301 showed no detectable binding to IL-12 receptors in its masked form. Cleavage of the masked molecule by matrix metalloproteinases (MMPs) restored binding of XTX301 to IL-12 receptors, demonstrating that the masking domain prevents interaction with the receptor.
    • XTX301 demonstrated equivalent in vitro potency compared to the non-masked control.
    • XTX301 became pharmacologically active upon MMP cleavage in primary human immune cells.
    • mXTX301 demonstrated up to 90% tumor growth inhibition in mouse models, was well-tolerated and induced minimal peripheral immune activation.
    • mXTX301 induced an approximately three-fold increase in immune infiltrate within tumors compared to the vehicle control and approximately 150-fold less peripheral immune activation, thereby avoiding the body weight loss and morbidity in mice that was associated with doses of non-masked control required for tumor growth inhibition.
    • In an NHP model, XTX301 was well-tolerated, with minimal systemic toxicity observed at doses up to 1.5 mg/kg. In addition, XTX301 exhibited minimal elevation in liver enzymes and peripheral T cell and natural killer (NK) cell activation, showing a 50-fold improvement in tolerability compared to the non-masked control.

    About XTX301

    Xilio has leveraged its geographically precise solutions (GPS) platform to engineer XTX301, a novel IL-12 product candidate that is masked with a protein domain to prevent binding to IL-12 receptors and downstream signaling activity until the masking domain is cleaved off by tumor microenvironment-associated proteases. In preclinical studies, XTX301 has demonstrated protease-dependent activation in human tumor cells ex vivo and has been well-tolerated with minimal systemic activity in studies in non-human primates.

    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 Therapeutics' current or future approved product candidates, including plans to submit an investigational new drug application for XTX301 to the U.S. Food and Drug Administration; the potential benefits of any of Xilio Therapeutics' current or future product candidates in treating patients; and Xilio Therapeutics' 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 Therapeutics' current or future product candidates; preclinical and clinical supply of current or future product candidates; Xilio Therapeutics' advancement of multiple early-stage efforts; Xilio Therapeutics' 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 preclinical and clinical results for Xilio Therapeutics' 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 Therapeutics' ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio Therapeutics' 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 Therapeutics' 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 Therapeutics' filings with the U.S. Securities and Exchange Commission (SEC), including Xilio Therapeutics' final prospectus related to its initial public offering, and any other filings that Xilio Therapeutics makes with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio Therapeutics' 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 Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

    For Investor Inquiries:

    Monique Allaire,

    THRUST Strategic Communications

     For Media Inquiries: 

    Dan Budwick, 1AB

      



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  5. WALTHAM, Mass., Oct. 26, 2021 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Xilio) a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, today announced the closing of its previously announced initial public offering of 7,353,000 shares of its common stock at a price to the public of $16.00 per share. The aggregate gross proceeds to Xilio from the offering were approximately $117.6 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Xilio. In addition, Xilio has granted the underwriters a 30-day option to purchase up to an additional 1,102,950 shares of its common stock at the initial public offering price less underwriting discounts and…

    WALTHAM, Mass., Oct. 26, 2021 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Xilio) a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, today announced the closing of its previously announced initial public offering of 7,353,000 shares of its common stock at a price to the public of $16.00 per share. The aggregate gross proceeds to Xilio from the offering were approximately $117.6 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Xilio. In addition, Xilio has granted the underwriters a 30-day option to purchase up to an additional 1,102,950 shares of its common stock at the initial public offering price less underwriting discounts and commissions.

    The shares began trading on the Nasdaq Global Select Market on October 22, 2021 under the ticker symbol "XLO."

    Morgan Stanley, Cowen and Guggenheim Securities acted as joint book-running managers for the offering. Raymond James acted as lead manager for the offering.

    A registration statement relating to the shares sold in the offering was filed with the Securities and Exchange Commission (SEC) and was declared effective on October 21, 2021. Copies of the registration statement can be accessed through the SEC's website at www.sec.gov. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC by mail at Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at (866) 718-1649 or by email at ; Cowen and Company, LLC by mail at Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (833) 297-2926 or by email at ; and Guggenheim Securities, LLC by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    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 Investor Inquiries:

    Monique Allaire,

    THRUST Strategic Communications

      

    For Media Inquiries: 

    Dan Budwick, 1AB



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