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]

Financial Performance - For the nine months ended September 30, 2024, the company reported a net loss of $45.1 million, compared to a net loss of $58.7 million for the same period in 2023[114]. - The accumulated deficit as of September 30, 2024, was $370.7 million, indicating significant ongoing operating losses[114]. - The company incurred a net loss of $45.1 million during the nine months ended September 30, 2024, with net cash used in operating activities of $4.2 million[148]. - Net loss for the three months ended September 30, 2024, was $14.0 million, an improvement of $2.7 million compared to a net loss of $16.7 million in Q3 2023[129]. - The company experienced a net cash used in operating activities of $55.2 million during the nine months ended September 30, 2023, primarily driven by a net loss of $58.7 million[149]. - Total operating expenses for the nine months ended September 30, 2024, were $51.6 million, a decrease of $9.4 million from $61.0 million in the same period in 2023[136]. Revenue Generation - The company has not generated any revenue from product sales since inception and does not expect to do so for at least the next several years[116]. - License revenue for the three months ended September 30, 2024, was $2.3 million, a significant increase from $0 for the same period in 2023[130]. - Total revenue for the three months ended September 30, 2024, was $2.3 million, compared to $0 in the same period in 2023[129]. - License revenue for the nine months ended September 30, 2024, was $4.6 million, compared to $0 for the same period in 2023[137]. Cash and Funding - As of September 30, 2024, the company had cash and cash equivalents of $61.3 million, which is expected to fund operations through the end of the second quarter of 2025[115]. - The company raised an aggregate of $430.5 million in gross proceeds through various financing activities, including $225.5 million from preferred units and convertible preferred stock[143]. - During the nine months ended September 30, 2024, net cash provided by financing activities was $21.0 million, primarily from the sale of common stock and prefunded warrants[151]. - The company anticipates that its existing cash will be sufficient to fund operations through the end of the second quarter of 2025, but there is substantial doubt about its ability to continue as a going concern[157]. - The company plans to raise additional capital through equity or debt financings, collaborations, or licensing transactions to fund its operations[157]. Research and Development - The company is advancing clinical development for vilastobart in a Phase 2 trial, with initial data expected in Q4 2024 for approximately 20 patients[110]. - The company plans to report safety, pharmacokinetic, and pharmacodynamic data for XTX301 in Q4 2024 as part of its Phase 1 clinical trial[110]. - The company anticipates that research and development expenses will remain approximately the same or continue to increase as it advances its programs[121]. - Total research and development expenses for the nine months ended September 30, 2024, were $32.4 million, down $8.0 million from $40.4 million in the same period in 2023[138]. - Research and development expenses decreased by $0.3 million from $11.1 million in Q3 2023 to $10.8 million in Q3 2024[131]. - The company has devoted substantially all financial resources to research and development, with significant expenses expected to continue for the foreseeable future[189]. Workforce and Restructuring - A strategic portfolio reprioritization in March 2024 led to a workforce reduction of 15 employees, approximately 21% of the workforce[126]. - Restructuring expenses for the nine months ended September 30, 2024, were $0.9 million, associated with workforce reduction announced in March 2024[141]. Regulatory and Compliance Risks - The company received a deficiency letter from Nasdaq regarding its stock price falling below $1.00 per share, with a compliance period until March 10, 2025[184]. - If compliance is not regained by March 10, 2025, the company may qualify for an additional 180-day compliance period by transferring its listing to the Nasdaq Capital Market[185]. - The company may consider a reverse stock split to regain compliance with Nasdaq listing requirements, but there is no guarantee of success[187]. - The company has substantial doubt about its ability to continue as a going concern if it cannot secure additional capital[176]. - Regulatory authorities may impose additional requirements or restrictions on product candidates post-approval due to safety concerns[232]. Clinical Trials and Product Development - The company is currently evaluating vilastobart in combination with atezolizumab in Phase 1 and Phase 2 clinical trials for advanced solid tumors and microsatellite stable colorectal cancer[201]. - The company is also evaluating XTX301 in a Phase 1 clinical trial, including ongoing monotherapy dose escalation and expansion[201]. - The company has not yet demonstrated the ability to successfully complete late-stage clinical trials or obtain regulatory approvals[196]. - The risk of failure for current and future product candidates is high, with significant uncertainty in preclinical studies and clinical trials[212]. - Clinical trials may experience substantial delays, increasing costs and limiting revenue generation capabilities[215]. - The company may face difficulties in patient enrollment for clinical trials, which could lead to significant delays or abandonment of trials[227]. Competition and Market Risks - If vilastobart is approved, it may face competition from established anti-CTLA-4 therapies such as Yervoy and Imjudo, as well as several other companies with similar programs[304]. - Currently, there are no approved IL-12 therapies for cancer treatment, but multiple companies are developing modified IL-12 delivery programs, posing potential competition for XTX301[306]. - The company is aware of several competitors developing bispecific PD-1 targeted IL-2 therapies, which could impact the development of its research-stage product candidate XTX501[307]. - The company competes in the immunotherapy market for cancer treatment, facing competition from major pharmaceutical and biotechnology companies, as well as academic institutions and research organizations[302]. Manufacturing and Supply Chain Risks - Manufacturing biologics is complex, and the company may experience production issues that could delay development or commercialization[259]. - The company relies on third-party contract development and manufacturing organizations (CDMOs), which are subject to significant regulation and may face capacity limitations or supply interruptions[263]. - A significant disruption in supply from WuXi Biologics could adversely affect the company's business and lead to delays in clinical trials and regulatory approvals[270]. - The company relies on WuXi Biologics for manufacturing processes, exposing it to risks such as price increases and manufacturing delays[268]. Environmental and Geopolitical Risks - Compliance with environmental, health, and safety laws is critical, as failure to comply could result in substantial fines and adversely affect the company's operations[274]. - The company is exposed to geopolitical risks, particularly related to operations in China, which could disrupt manufacturing and supply chains[273].