Financial Reporting and Compliance - The company is permitted to provide only two years of audited financial statements and reduced disclosures under the JOBS Act [646]. - The company may continue to qualify as a smaller reporting company with less than $100 million in annual revenue, allowing it to avoid certain auditor attestation requirements [649]. - The company has incurred substantial costs due to compliance with public company regulations, including the Sarbanes-Oxley Act and Dodd-Frank Act [652]. - The company is engaged in a process to document and evaluate its internal control over financial reporting, which is both costly and challenging [654]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [791]. Taxation and Financial Impact - Changes in tax laws, including a reduction of the corporate tax rate from 35% to 21%, may adversely affect the company's financial condition [661]. - The Tax Act requires corporations to capitalize and amortize research and development expenditures over five years starting in 2022 [663]. Corporate Governance and Legal Matters - Provisions in the company's corporate charter may discourage or prevent beneficial acquisitions and limit stockholder actions [665]. - The company is governed by Section 203 of the Delaware General Corporation Law, which restricts mergers with stockholders owning over 15% of voting stock for three years [669]. - The company’s restated certificate of incorporation designates Delaware courts as the exclusive forum for certain disputes, potentially increasing litigation costs [670].

Financial Performance - The net loss for Q4 2024 was $13.1 million, compared to $17.7 million in Q4 2023, and the full-year net loss was $58.2 million, down from $76.4 million in 2023[15]. - Net loss for Q4 2024 was $13.093 million, an improvement from a net loss of $17.655 million in Q4 2023, representing a reduction of approximately 25.5%[23]. - Total assets increased to $71.075 million in December 2024, up from $60.926 million in December 2023, reflecting a growth of approximately 16.7%[21]. - Total liabilities rose to $53.477 million in December 2024, compared to $24.099 million in December 2023, indicating a substantial increase of 121.5%[21]. - The company reported total operating expenses of $15.353 million for Q4 2024, down from $18.130 million in Q4 2023, a decrease of approximately 15.5%[23]. - Stock-based compensation expense for the year ended December 31, 2024, was $6.434 million, down from $7.382 million in 2023, a decrease of about 12.8%[23]. - General and administrative expenses for the year ended December 31, 2024, totaled $24.778 million, a decrease from $26.997 million in 2023, reflecting a reduction of approximately 8.1%[23]. - Research and development expenses for the year ended December 31, 2024, were $41.211 million, down from $52.136 million in 2023, a decrease of about 21.0%[23]. - General & Administrative (G&A) expenses were $6.5 million for Q4 2024, slightly up from $6.4 million in Q4 2023, and totaled $24.8 million for the full year, down from $27.0 million in 2023[15]. Revenue and Payments - The company received $52.0 million in upfront payments from AbbVie as part of a collaboration agreement, with potential total contingent payments of approximately $2.1 billion[10]. - License revenue for Q4 2024 was $1.7 million, and $6.3 million for the full year, compared to no license revenue in 2023[10]. - License revenue for Q4 2024 reached $1.724 million, compared to $0 in Q4 2023, marking a significant increase[23]. - The company has deferred revenue of $32.780 million as of December 31, 2024, indicating a new revenue stream[21]. Cash Position - Cash and cash equivalents were $55.3 million as of December 31, 2024, an increase from $44.7 million as of December 31, 2023[10]. - Xilio expects its current cash position, along with the recent upfront payments, to fund operations into Q1 2026[11]. Clinical Development - Xilio reported a preliminary 27% objective response rate for vilastobart in patients without liver metastases during the Phase 2 trial, with a low incidence of immune-related adverse events, including only 5% reporting colitis[2][3]. - Xilio plans to submit an IND application for XTX501 in the middle of 2026, following promising preclinical studies[5][8]. - The company anticipates nominating a development candidate for its PSMA program in the ATACR format in Q3 2025 and submitting an IND application in Q1 2027[10]. Shareholder Information - The weighted average common shares outstanding increased to 64,675,807 in Q4 2024, compared to 27,557,021 in Q4 2023, indicating a significant increase of 134.5%[23].

Core Insights - Xilio Therapeutics announced promising updates regarding its pipeline, particularly the initial Phase 2 data for vilastobart, a tumor-activated anti-CTLA-4, showing a preliminary 27% objective response rate in patients without liver metastases [2][5] - The company is advancing multiple masked T cell engager programs, including a collaboration with AbbVie to develop novel tumor-activated immunotherapies [2][12] - Financial results for the fourth quarter and full year ended December 31, 2024, indicate a net loss of $13.1 million for Q4 2024, down from $17.7 million in Q4 2023, and a total net loss of $58.2 million for the year, compared to $76.4 million in 2023 [18][25] Pipeline and Business Updates - Vilastobart is designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment, with ongoing Phase 2 trials expected to report additional data in mid-2025 [3][15] - XTX301, another investigational product, aims to stimulate anti-tumor immunity and reprogram the tumor microenvironment of poorly immunogenic tumors [6][16] - The company is also advancing XTX501, a tumor-activated bispecific PD-1/IL-2, with plans to submit an IND application in mid-2026 [7] Collaboration and Financial Highlights - In February 2025, Xilio entered a collaboration agreement with AbbVie, receiving $52 million in upfront payments and potential total contingent payments of approximately $2.1 billion [12][18] - As of December 31, 2024, Xilio's cash and cash equivalents were $55.3 million, an increase from $44.7 million at the end of 2023, providing sufficient funds to support operations into Q1 2026 [14][18] - License revenue for Q4 2024 was $1.7 million, with total revenue for the year at $6.3 million, marking a significant increase from no revenue in 2023 [18][25]

Core Insights - Xilio Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-activated immuno-oncology therapies aimed at improving cancer treatment outcomes without the systemic side effects associated with current therapies [3]. Group 1 - The company will have its president and CEO, René Russo, participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on March 3, 2025, at 9:50 am EST [1]. - A live webcast of the event will be available on the Xilio Therapeutics website, with a replay accessible for 30 days post-presentation [2]. Group 2 - Xilio Therapeutics utilizes a proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical immuno-oncology molecules, which are designed to optimize therapeutic efficacy by targeting the tumor microenvironment [3].

Core Viewpoint - Xilio Therapeutics has announced a collaboration with AbbVie to develop novel tumor-activated immunotherapies, including masked T cell engagers, with an upfront payment of $52 million, extending its cash runway into Q1 2026 [1][11]. Collaboration and Financial Details - The collaboration includes a cash payment of $42 million and an equity investment of $10 million from AbbVie [11]. - Xilio is eligible for up to approximately $2.1 billion in additional contingent payments, which consist of option-related fees and development, regulatory, and sales-based milestones [11]. - The company anticipates that its existing cash, along with the upfront payment from AbbVie, will be sufficient to fund operations into the first quarter of 2026 [7]. Product Development and Pipeline - Xilio is advancing three wholly-owned preclinical programs targeting prostate-specific membrane antigen (PSMA), claudin 18.2 (CLDN18.2), and six-transmembrane epithelial antigen of prostate 1 (STEAP1) [5]. - The PSMA program is expected to nominate a development candidate in Q3 2025 and submit an investigational new drug application (IND) in Q1 2027 [5]. - The CLDN18.2 program aims to nominate a candidate in Q4 2025 and submit an IND in Q2 2027 [5]. - The STEAP1 program plans to nominate a candidate in the first half of 2026 and submit an IND in the second half of 2027 [5]. Technology and Innovation - Xilio's tumor-activation platform is designed to improve tolerability and enhance T cell activation through tumor-selective activation [2][4]. - The company is developing bispecific and tri-specific molecules using its advanced formats, ATACR and SEECR, to enhance potency and T cell activation [4]. Investor Engagement - Xilio will host an investor conference call and webcast to discuss these developments [8].

Core Insights - Xilio Therapeutics announced a preliminary response rate of 27% in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) who do not have liver metastases, indicating potential efficacy of the combination therapy [1][4] - The combination of vilastobart (XTX101) and atezolizumab (Tecentriq) demonstrated a differentiated safety profile with low incidence of immune-related adverse events [1][7] - The company plans to present further data at the American Society of Clinical Oncology 2025 Gastrointestinal Cancer Symposium [1][2] Clinical Trial Data - As of January 13, 2025, 40 patients were treated with vilastobart at a dose of 100 mg every six weeks and atezolizumab at 1200 mg every three weeks, with a median age of 55 years [3] - Among patients without liver metastases, the objective response rate was 27%, with three partial responses reported [4][5] - The preliminary disease control rate was 55% for patients without liver metastases and 14% for those with liver metastases [6] Safety Profile - The combination therapy was generally well-tolerated, with only 5% of patients reporting colitis and a low incidence of immune-related adverse events [7][9] - Common treatment-related adverse events included fatigue (30%), diarrhea (20%), and infusion-related reactions (13%) [9] Future Development Plans - Xilio plans to report updated Phase 2 data in mid-2025 and is exploring opportunities for partnerships to expand development beyond the initial trial [10][11] - The ongoing Phase 1C dose escalation trial is evaluating vilastobart at a 150 mg dose level in combination with atezolizumab [11] Company Overview - Xilio Therapeutics is focused on developing tumor-activated immuno-oncology therapies aimed at improving cancer treatment outcomes while minimizing systemic side effects [14]

Core Points - Xilio Therapeutics, Inc. announced the grant of a non-qualified stock option to its newly hired Chief Legal Officer, Caroline Hensley, effective January 1, 2025 [1] - The stock option allows the purchase of 375,000 shares at an exercise price of $0.955 per share, which matches the closing price on December 31, 2024 [2] - The stock option has a ten-year term, with 25% vesting on the first anniversary of employment and the remaining 75% vesting in 36 equal monthly installments [2] - The grant is part of Xilio Therapeutics' 2022 Inducement Stock Incentive Plan and complies with Nasdaq Listing Rule 5635(c)(4) [3] 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 [4] - The company utilizes a proprietary platform to advance a pipeline of novel I-O molecules, including tumor-activated cytokines, antibodies, bispecifics, and immune cell engagers [4]

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][4] - 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][5] - No maximum tolerated dose has been established, and the company continues to enroll patients in the ongoing Phase 1 clinical trial [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 across all dose levels, 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 Cancers Symposium [1][3] - The trial focuses on patients with metastatic microsatellite stable colorectal cancer [3][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]

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]