Financial Estimates - As of December 31, 2025, Xilio Therapeutics, Inc. estimates cash and cash equivalents of approximately $137.5 million[4] - The cash balance estimate is based on preliminary, unaudited information and management estimates for the fiscal year ended December 31, 2025[5] Leadership Changes - The company announced the appointment of Sara M. Bonstein as chair of the Board, succeeding Paul Clancy who retired on January 6, 2026[7]

Received $35.8 million in gross proceeds from Series B warrant exercises, including full exercise by Coastlands Capital, Frazier Life Sciences and Gilead Sciences, Inc., and extended anticipated cash runway into second quarter of 2027 Achieved development milestone for masked antibody-based program under AbbVie agreement Nominated development candidate for wholly-owned masked T cell engager program targeting CLDN18.2 Appoints Sara Bonstein as chair of board of directors WALTHAM, Mass., Jan. 08, 2026 (GLOBE ...

Core Insights - Xilio Therapeutics reported a quarterly loss of $0.03 per share, which aligns with the Zacks Consensus Estimate, showing improvement from a loss of $0.22 per share a year ago [1] - The company posted revenues of $19.07 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 28.51%, compared to revenues of $2.26 million in the same quarter last year [2] - Xilio Therapeutics shares have declined approximately 19% year-to-date, contrasting with a 16.5% gain in the S&P 500 [3] Financial Performance - The company has not surpassed consensus revenue estimates over the last four quarters [2] - The current consensus EPS estimate for the upcoming quarter is -$0.12 on revenues of $7.96 million, and for the current fiscal year, it is -$0.45 on revenues of $45.65 million [7] Market Outlook - The earnings outlook and management's commentary during the earnings call will be crucial for the stock's immediate price movement [3][4] - The Zacks Rank for Xilio Therapeutics is currently 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry is currently in the top 35% of Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Another company in the same industry, Immatics, is expected to report a quarterly loss of $0.50 per share, with revenues projected to decline by 77.9% year-over-year [9]

Financial Performance - The company reported net losses of $45.4 million and $45.1 million for the nine months ended September 30, 2025 and 2024, respectively, and a net loss of $58.2 million for the year ended December 31, 2024[124]. - The net loss for the three months ended September 30, 2025, was $16.3 million, compared to a net loss of $14.0 million for the same period in 2024, indicating a decline of $2.3 million[140]. - For the nine months ended September 30, 2025, collaboration and license revenue increased by $25.5 million to $30.1 million from $4.6 million in the same period in 2024[150]. - Total operating expenses for the nine months ended September 30, 2025, were $60.2 million, compared to $51.6 million for the same period in 2024, reflecting an increase of $8.7 million[149]. - The loss from operations for the nine months ended September 30, 2025, was $30.1 million, a decrease of $16.8 million compared to a loss of $47.0 million for the same period in 2024[149]. Cash and Capital Resources - As of September 30, 2025, the company had an accumulated deficit of $429.1 million[124]. - The company had cash and cash equivalents of $103.8 million as of September 30, 2025, which, along with a $17.5 million development milestone received from Gilead, is expected to fund operations into the first quarter of 2027[125]. - Financing activities provided net cash of $51.9 million for the nine months ended September 30, 2025, compared to $21.0 million for the same period in 2024[166]. - The company anticipates substantial future capital requirements to support ongoing research and development activities, with expected continued operating losses and negative cash flows[168]. - The company filed a universal shelf registration statement to register for sale up to $250.0 million of various securities, effective May 8, 2025[160]. Revenue and Expenses - Collaboration and license revenue increased by $16.8 million from $2.3 million for the three months ended September 30, 2024, to $19.1 million for the three months ended September 30, 2025[141]. - Total revenue for the three months ended September 30, 2025, was $19.1 million, compared to $2.3 million for the same period in 2024, reflecting a significant increase[140]. - Research and development expenses rose by $3.6 million from $10.8 million for the three months ended September 30, 2024, to $14.3 million for the same period in 2025[143]. - General and administrative expenses increased by $0.4 million from $6.3 million for the three months ended September 30, 2024, to $6.7 million for the same period in 2025[143]. - General and administrative expenses increased by $4.0 million from $18.3 million in the nine months ended September 30, 2024, to $22.3 million in the same period of 2025[153]. Clinical Development - The company is advancing vilastobart in a Phase 2 clinical trial for MSS mCRC and anticipates reporting additional data in the first half of 2026[120]. - Efarindodekin alfa's Phase 2 trial for advanced solid tumors was initiated in Q3 2025, achieving a $17.5 million milestone under the agreement with Gilead[120]. - The company is actively seeking a partner to develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS mCRC and other tumor types[120]. - The company is currently engaged in clinical trials for vilastobart and efarindodekin alfa, with ongoing preclinical development for future product candidates[175]. Market and Operational Risks - The company faces substantial doubt about its ability to continue as a going concern without securing additional capital or implementing other strategies[177]. - The company is subject to market risks, including volatility from economic conditions and potential impacts on capital access[177]. - The company is focused on the costs and timing of future commercialization activities for product candidates that receive regulatory approval[175]. Accounting and Compliance - 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[128]. - The company has incurred significant operating losses and will need substantial additional capital to support ongoing operations and strategies[125]. - The company recognized no restructuring expenses for the nine months ended September 30, 2025, compared to $0.9 million in the same period of 2024[154]. - There have been no material changes to the company's contractual obligations during the nine months ended September 30, 2025[178]. - The company has not made changes to its critical accounting policies, except for estimates related to the fair value of common stock warrant liabilities[179].

Core Insights - Xilio Therapeutics has reported promising clinical data for its investigational therapies, vilastobart and efarindodekin alfa, demonstrating significant potential in treating advanced solid tumors and microsatellite stable metastatic colorectal cancer [2][3][4] Pipeline and Business Updates - Vilastobart has shown a 40% objective response rate (ORR) in heavily pretreated patients with microsatellite stable metastatic colorectal cancer (mCRC) without liver metastases, particularly in those with high plasma tumor mutational burden (TMB) [4][3] - Efarindodekin alfa is being evaluated as a monotherapy in an ongoing Phase 1/2 clinical trial, with early data indicating a well-tolerated safety profile and promising anti-tumor activity [5][9] - XTX501, a bispecific PD-1/IL-2, is advancing towards an IND submission planned for mid-2026 [6][3] Financial Results - As of September 30, 2025, Xilio reported cash and cash equivalents of $103.8 million, a significant increase from $55.3 million at the end of 2024, primarily due to collaboration agreements and a public offering [11][12] - Collaboration and license revenue for Q3 2025 was $19.1 million, compared to $2.3 million in Q3 2024, reflecting growth from partnerships with AbbVie and Gilead [15] - The net loss for Q3 2025 was $16.3 million, an increase from $14.0 million in Q3 2024, driven by higher research and development expenses [15][24] Research and Development Highlights - Xilio's masked T cell engager programs are designed to enhance anti-tumor activity while minimizing systemic toxicity, with promising preclinical data supporting their best-in-class potential [10][8] - The company is actively seeking partnerships to further develop vilastobart in combination with PD-(L)1 or PD1-VEGF therapies for MSS CRC and other tumor types [4][3] Future Outlook - Xilio anticipates sufficient cash runway to fund operations into the first quarter of 2027, supported by recent financial milestones and ongoing collaborations [12][11] - The company plans to nominate development candidates for its CLDN18.2 and STEAP1 programs in late 2025 and early 2026, respectively, with IND applications expected in 2027 [14]

Group 1 - Xilio Therapeutics held a conference call to discuss key data updates presented at the Society for Immunotherapy of Cancer (SITC) conference [2][3] - The call featured participation from key executives including the CEO, Chief Medical Officer, and Chief Financial and Operating Officer, along with clinical investigators from the Vilastobart study [3] Group 2 - Details of the SITC presentation can be found in press releases on Xilio's Investor Relations section of their website [2]

Summary of Xilio Therapeutics Conference Call Company Overview - **Company**: Xilio Therapeutics (NasdaqGS:XLO) - **Focus**: Development of novel masked biologics using proprietary protein engineering technology - **Key Products**: Velastigard (anti-CTLA-4), efarindodekin alfa (IL-12), XTX501 (PD-1/IL-2) Industry Context - **Industry**: Oncology, specifically focusing on immunotherapy for colorectal cancer - **Target Condition**: Microsatellite stable colorectal cancer (MSSCRC), which constitutes 95% of all colon cancers Key Data Updates - **SITC Conference**: Presented new clinical data for Velastigard in combination with Tislelizumab for MSSCRC - **Clinical Data**: - Velastigard demonstrated a **26% overall response rate** in late-line metastatic MSSCRC without liver metastases, compared to a **2% response rate** for Tislelizumab as monotherapy [8][9][10] - In a biomarker-defined population with high plasma tumor mutational burden (TMB), the overall response rate was **40%** [14][15] Biomarker Insights - **Plasma TMB**: - Approximately **55%** of MSSCRC patients have high plasma TMB (greater than 10 mutations per megabase) [12][15] - High plasma TMB correlates with better response rates to Velastigard and Tislelizumab combination therapy [12][14] - Plasma-based TMB assays are more sensitive and provide a comprehensive assessment compared to traditional tissue-based assays [11][19] Safety Profile - **Safety Data**: - Velastigard showed a **7% incidence of colitis**, significantly lower than traditional anti-CTLA-4 therapies [16][17] - Discontinuation rate for the combination therapy was only **5%**, indicating a favorable safety profile [17] Future Development Plans - **Partnerships**: Actively seeking partnerships to develop Velastigard in combination with PD-1, PD-L1, or newer PD-1 bispecifics [43][44] - **Regulatory Path**: Plans to assess the regulatory pathway for future development using plasma TMB as a predictive biomarker [43][44] - **Upcoming Milestones**: Additional phase two data for Velastigard expected in the first half of 2026 [47] Additional Clinical Programs - **Efarindodekin alfa**: Phase one data showed deep monotherapy responses and a well-tolerated safety profile [45] - **Masked T-cell Engagers**: Preclinical data demonstrated broad applicability and potential for reduced systemic toxicity [46] Conclusion - Xilio Therapeutics is positioned to leverage its innovative masking technology to address significant unmet medical needs in oncology, particularly in MSSCRC, with promising clinical data supporting the efficacy and safety of its lead product, Velastigard. The identification of plasma TMB as a predictive biomarker enhances the potential for targeted therapies in this patient population.

Vilastobart Clinical Data and Opportunity - Vilastobart, in combination with atezolizumab, showed a 40% Overall Response Rate (ORR) in MSS mCRC patients without liver metastases and with high plasma TMB[30, 42] - 63% of plasma TMB-evaluable patients had high plasma TMB (≥10 mutations/Mb) in the Phase 2 trial, including all TMB-evaluable responders[32, 33, 42] - A statistically significant correlation (p=0.05) was observed between plasma TMB status and response to vilastobart plus atezolizumab[33, 42] - The combination of vilastobart and atezolizumab demonstrated a differentiated safety profile, with a low discontinuation rate of 5% and only 7% of patients experiencing colitis of any grade[35, 36, 42] Market and Competitive Landscape - Approximately 95% of mCRC patients are MSS, and standard of care in 3L+ provides minimal benefit (1-6% ORR)[23] - Real-world data indicates that approximately 55% of patients with MSS CRC have high plasma TMB, which is substantially higher than historically reported with tissue-based TMB assays[28, 42] - Next-generation anti-CTLA-4 agents in development show promising clinical efficacy in MSS mCRC, with ORRs ranging from 8-29% and discontinuation rates due to AEs up to ~30%[21] Technology and Pipeline - Xilio's clinically-validated platform technology is being applied across diverse mechanisms and architectures, including antibodies, cytokines, bispecifics, and T cell engagers[13, 14] - Efarindodekin Alfa (tumor-activated IL-12) demonstrated promising clinical efficacy with a generally well-tolerated safety profile in Phase 1 in patients with advanced solid tumors[44] - Masked T cell engager programs demonstrated potent anti-tumor activity with favorable tolerability across a diverse range of targets in preclinical models[50, 51, 52] Financial Outlook and Milestones - The company anticipates a cash runway into Q1 2027, including a $175 million development milestone received under the Gilead license in Q4 2025[53] - Anticipated milestones include reporting updated Phase 2 data for vilastobart in combination with atezolizumab in metastatic MSS mCRC in 1H 2026 and IND submissions for at least two masked T cell engager programs in 2027[53]

Core Insights - Xilio Therapeutics announced a 40% objective response rate (ORR) in heavily pre-treated patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without liver metastases and with high plasma tumor mutational burden (TMB) [1][2][9] - Approximately 55% of patients with MSS CRC are estimated to have high plasma TMB, indicating a significant patient population with unmet medical needs [1][2][5] - The company will host a conference call on November 10, 2025, to discuss these findings with leading cancer experts [1][12] Clinical Data - The Phase 2 trial evaluated vilastobart, a tumor-activated anti-CTLA-4, in combination with atezolizumab (Tecentriq) [1][15] - A statistically significant correlation was found between plasma TMB status and response, with a p-value of 0.05 [9][13] - Among evaluable patients, 62.5% were classified as TMB-high, and all responders were TMB-high, demonstrating deep and durable responses with reductions in target lesions of up to 71% [13] Safety Profile - The combination of vilastobart and atezolizumab showed a differentiated and generally well-tolerated safety profile, with treatment-related adverse events primarily being Grade 1 or 2 [10] - Only 5% of patients discontinued treatment due to adverse events, and 7% experienced colitis of any grade [10] Biomarker Potential - Plasma-based TMB assays are more sensitive than traditional tissue-based assays and can provide a comprehensive assessment of mutational load, accounting for tumor heterogeneity [4][6] - The use of plasma TMB as a predictive biomarker could help identify MSS mCRC patients who may benefit from vilastobart treatment [2][3] Development Plans - Xilio is actively seeking a partner to further develop vilastobart in combination with PD-(L)1 or PD1-VEGF for MSS CRC and other tumor types [11]

Core Insights - Xilio Therapeutics, Inc. presented new data at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, showcasing the potential of its masked T cell engager programs and tumor-activated therapies, including efarindodekin alfa and vilastobart [1][2] Group 1: Masked T Cell Engager Programs - Xilio is advancing multiple preclinical programs for masked T cell engagers targeting tumor-associated antigens such as PSMA, CLDN18.2, and STEAP1, with a collaboration with AbbVie [3] - The company's masked T cell engager programs utilize advanced formats like ATACR and SEECR, designed to enhance T cell activation and durability [4] - Preclinical data indicate that Xilio's masking technology can significantly expand the therapeutic window for T cell engagers, demonstrating potent anti-tumor activity and reduced systemic toxicity in murine models [5] Group 2: Efarindodekin Alfa - Efarindodekin alfa is an investigational tumor-activated IL-12 being evaluated in a Phase 1/2 clinical trial for patients with advanced solid tumors, with promising Phase 1 data showing a generally well-tolerated safety profile and encouraging anti-tumor activity [7][11] - As of September 2, 2025, 62 patients had been treated, with a median age of 66 years, and most patients had received multiple prior lines of therapy [7] - The treatment demonstrated partial responses in patients with advanced solid tumors, including a 33% decrease in target lesions for HPV-negative head and neck squamous cell carcinoma and a 55% decrease for uveal melanoma [11] Group 3: Vilastobart - Vilastobart is an investigational tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody being evaluated in combination with atezolizumab for advanced solid tumors and MSS mCRC [9][19] - New data presented at SITC suggest that circulating tumor DNA (ctDNA) may serve as an early biomarker for response to vilastobart treatment, with significant reductions in ctDNA correlating with treatment response [10][18] - The combination therapy is currently in Phase 1C and Phase 2 trials, with ongoing evaluations of safety and efficacy [19] Group 4: Development Plans - Xilio plans to nominate development candidates for its CLDN18.2 and STEAP1 programs in late 2025 and early 2026, respectively, with expectations to advance at least two programs into IND enabling studies by 2027 [6] - The company has completed enrollment in the Phase 1A and Phase 1B portions of the clinical trial for efarindodekin alfa, with ongoing evaluations [8][13]