Core Insights - Xilio Therapeutics announced preliminary Phase 1 data for XTX301, a tumor-activated IL-12, showing an improved tolerability profile compared to historical data for rhIL-12, with no dose-limiting toxicities reported [1][2] - The company plans to present initial data from its ongoing Phase 2 trial for vilastobart (XTX101) in combination with atezolizumab at the ASCO GI Cancers Symposium in January 2025 [1][3] XTX301 (IL-12) Preliminary Data - As of November 25, 2024, 34 patients with advanced solid tumors were treated with XTX301 at doses ranging from 5 µg/kg to 60 µg/kg, administered either once every three weeks or once every six weeks [4] - No maximum tolerated dose has been established, and the company continues to enroll patients in Phase 1A and Phase 1B trials [5] - Preliminary results indicated sustained interferon gamma signaling without evidence of tachyphylaxis, which has historically limited other IL-12 agents [6] - No measurable activated XTX301 was detected in peripheral circulation, and no Grade 4 or Grade 5 treatment-related adverse events were reported [7] Vilastobart (XTX101) Phase 2 Trial - Initial data from the ongoing Phase 2 trial for vilastobart in combination with atezolizumab will be presented at the ASCO GI Symposium [3] - The trial focuses on patients with metastatic microsatellite stable colorectal cancer [1][3] - The combination aims to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment [9] Financial Update - On December 18, 2024, Xilio completed an additional private placement with Gilead, raising approximately $8.2 million, bringing the total investment from Gilead to $25 million [8] - The company anticipates that its existing cash and cash equivalents will be sufficient to fund operations into the third quarter of 2025 [8] Company Overview - Xilio Therapeutics is a clinical-stage biotechnology company focused on developing tumor-activated immuno-oncology therapies aimed at improving cancer treatment outcomes while minimizing systemic side effects [11] - The company utilizes a proprietary platform to advance a pipeline of novel immuno-oncology molecules designed to optimize therapeutic indices by localizing anti-tumor activity within the tumor microenvironment [11]

Core Insights - Xilio Therapeutics, Inc. has appointed Caroline (Holda) Hensley as the new chief legal officer, enhancing its executive team with her extensive legal and biotechnology experience [1][2][3] Company Overview - Xilio Therapeutics is a clinical-stage biotechnology company focused on discovering and developing tumor-activated immuno-oncology therapies aimed at improving cancer treatment outcomes while minimizing systemic side effects [4] - The company utilizes a proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical immuno-oncology molecules, including tumor-activated cytokines, antibodies, bispecifics, and immune cell engagers [4]

Financial Position - Xilio Therapeutics reported a cash position of $61.3 million as of September 30, 2024, up from $44.7 million as of December 31, 2023, representing a 37.9% increase[9]. - The company anticipates that its existing cash will be sufficient to fund operations through the end of Q2 2025[10]. Revenue Generation - License revenue for the third quarter of 2024 was $2.3 million, compared to $0 for the same quarter in 2023, indicating a significant revenue generation from licensing agreements[9]. Expenses - Research and Development (R&D) expenses decreased to $10.8 million in Q3 2024 from $11.1 million in Q3 2023, a reduction of approximately 2.9%[9]. - General and Administrative (G&A) expenses remained stable at $6.3 million for both Q3 2024 and Q3 2023[9]. - Research and development expenses for the three months ended September 30, 2024, were $384 million, down from $548 million in the same period last year, representing a decrease of 30%[18]. - General and administrative expenses for the nine months ended September 30, 2024, totaled $3,643 million, a decrease from $3,782 million year-over-year, reflecting a reduction of 3.7%[18]. - Total stock-based compensation expense for the three months ended September 30, 2024, was $1,574 million, compared to $1,861 million in the prior year, indicating a decline of 15.4%[18]. Net Loss - The net loss for Q3 2024 was $14.0 million, an improvement from a net loss of $16.7 million in Q3 2023, reflecting a 16.2% reduction in losses[9]. Clinical Trials and Research - Xilio plans to present initial Phase 1C dose escalation data for vilastobart in combination with atezolizumab at the SITC Annual Meeting in November 2024[1]. - Initial Phase 2 data for vilastobart in combination with atezolizumab is expected to be reported in Q4 2024, involving approximately 20 patients with microsatellite stable colorectal cancer (MSS CRC)[4]. - Xilio continues to enroll patients in the ongoing Phase 1A and Phase 1B clinical trials for XTX301, with safety and pharmacokinetic data expected in Q4 2024[6]. - Xilio is advancing multiple research-stage programs, including XTX501, a tumor-activated bispecific PD-1/IL-2, with initial IND-enabling activities currently underway[8].

Will present initial Phase 1C dose escalation data for vilastobart (XTX101), a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab, in a late-breaker poster presentation at the SITC Annual Meeting Expect to report initial Phase 2 data in microsatellite stable colorectal cancer (MSS CRC) for vilastobart in combination with atezolizumab in the fourth quarter of 2024 Expect to report Phase 1 data for XTX301, a tumor-activated IL-12, in the fourth quarter of 2024 WALTHAM, Mass., Nov. 07, ...

Initiated enrollment in Phase 2 clinical trial of XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab in patients with microsatellite stable colorectal cancer (MSS CRC) Initiated enrollment in Phase 1B monotherapy dose expansion for XTX301, a tumor-activated IL-12, in patients with advanced solid tumors; Phase 1A monotherapy dose escalation ongoing with no dose-limiting toxicities observed to date Expect to report clinical data for XTX101 and XTX301 in the fourth quarter of ...

(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40925 Xilio Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 85-1623397 (St ...

Exhibit 99.1 Xilio Therapeutics Announces Pipeline and Business Updates and First Quarter 2024 Financial Results WALTHAM, Mass., May 14, 2024 -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical- stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced pipeline progress and business updates and reported financial results for the first quarter ended March 31, 2024. Plan to report clinical data for XTX101 and XTX301, a tum ...

Table of Contents ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. Commission file number: 001-40925 XILIO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State of Other Jurisdiction of incorporation or Organization) (I.R.S. Employer Identification No.) 828 Winter Street, Suite 300, Waltham, MA 02451 (Address of principal executive offices) (Zip code) Delaware 85-1623397 UNITED STATES SE ...

Exhibit 99.1 XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 designed to block CTLA-4 and deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). XTX101 is currently being evaluated in combination with atezolizumab in an ongoing Phase 1 clinical trial in patients with advanced solid tumors. Xilio Therapeutics Announces Pipeline and Business Updates and Fourth Quarter and Full Year 2023 Financial Results Anticipates cash runway in ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40925 Xilio Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 85-1623397 ...