Earnings summaries and quarterly performance for Xilio Therapeutics.
Executive leadership at Xilio Therapeutics.
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Xilio Therapeutics Announces Q3 2025 Financial Results and Pipeline Updates
XLO
Earnings
Guidance Update
New Projects/Investments
- Xilio Therapeutics reported collaboration and license revenue of $19.1 million and a net loss of $16.3 million for the third quarter ended September 30, 2025.
- The company's cash and cash equivalents were $103.8 million as of September 30, 2025, and it anticipates a cash runway into the first quarter of 2027. This includes a $17.5 million development milestone payment received from Gilead in Q4 2025.
- Key pipeline updates include vilastobart demonstrating a 40% objective response rate (ORR) in specific metastatic colorectal cancer patients and efarindodekin alfa achieving a $17.5 million development milestone from Gilead.
- Xilio plans to submit an Investigational New Drug (IND) application for XTX501 in mid-2026 and for at least two masked T cell engager programs in 2027.
Nov 13, 2025, 12:35 PM
Xilio Therapeutics Announces Q3 2025 Financial Results and Pipeline Updates
XLO
Earnings
Guidance Update
New Projects/Investments
- Xilio Therapeutics reported a net loss of $16.3 million for the third quarter ended September 30, 2025, compared to $14.0 million for the same period in 2024.
- The company's cash and cash equivalents totaled $103.8 million as of September 30, 2025, an increase from $55.3 million at December 31, 2024, driven by collaboration payments and a public offering.
- Collaboration and license revenue significantly increased to $19.1 million for the quarter ended September 30, 2025, up from $2.3 million in the prior year period.
- Xilio anticipates its cash and cash equivalents, including a $17.5 million development milestone received in the fourth quarter of 2025, will fund operations into the first quarter of 2027.
- Key pipeline progress includes late-breaking Phase 2 data for vilastobart demonstrating a 40% objective response rate (ORR) in heavily pretreated MSS mCRC patients without liver metastases and high plasma tumor mutational burden , promising monotherapy anti-tumor activity for efarindodekin alfa , and plans to submit an IND application for XTX501 in mid-2026.
Nov 13, 2025, 12:30 PM
Xilio Presents Updated Clinical Data for Vilastobart and Pipeline Progress
XLO
Product Launch
New Projects/Investments
Guidance Update
- Xilio presented updated Phase 2 data for vilastobart in combination with atezolizumab for patients with MSS mCRC without liver metastases and high plasma TMB, achieving a 40% Overall Response Rate (ORR), as of November 7, 2025.
- The vilastobart combination demonstrated a differentiated safety and tolerability profile in Phase 2, with no Grade 5 treatment-related adverse events (TRAEs) and a low incidence of colitis (7% of patients).
- The company's pipeline also includes Efarindodekin Alfa (XTX301), which showed promising Phase 1 efficacy and a well-tolerated safety profile, and Masked T cell engager programs with development candidates nominated for PSMA (Q3 2025) and CLDN18.2 (Q4 2025).
- Key anticipated milestones include reporting updated Phase 2 data for vilastobart in 1H 2026, IND submission for XTX501 in Mid 2026, and IND submissions for at least two masked T cell engager programs in 2027.
- Xilio maintains strategic partnerships with Roche, Gilead, and AbbVie for various programs, including co-funding, licensing options, and multi-program collaborations.
Nov 10, 2025, 9:30 PM
Xilio Therapeutics Presents Positive Velastigard Clinical Data and Pipeline Updates
XLO
New Projects/Investments
- Xilio Therapeutics presented positive Phase 2 clinical data for Velastigard in combination with Tislelizumab for microsatellite stable colorectal cancer (MSSCRC) at the SITC conference.
- In a biomarker-defined population with high plasma tumor mutational burden (TMB), Velastigard demonstrated a 40% overall response rate (ORR) in MSSCRC patients without liver metastases, a statistically significant correlation.
- Velastigard exhibited a differentiated safety profile with low systemic activation and a 7% rate of colitis, approximately half the incidence seen with systemically active anti-CTLA-4 combinations.
- The company is actively seeking a partner to develop Velastigard in combination with PD-1/PD-L1 or newer PD-1 bispecifics for MSSCRC and other tumor types.
- Xilio anticipates reporting additional Phase 2 data for Velastigard in MSSCRC in H1 2026, submitting an IND for XTX501 in mid-2026, and providing updates on masked T-cell engagers in early 2026.
Nov 10, 2025, 9:30 PM
Xilio Therapeutics Presents Positive Velastigard Clinical Data for MSSCRC
XLO
- Xilio Therapeutics presented new clinical data for Velastigard, its FC-enhanced tumor-activated anti-CTLA-4, in combination with Tislelizumab for microsatellite stable colorectal cancer (MSSCRC) at the SITC conference.
- The combination demonstrated a 40% Overall Response Rate (ORR) in heavily pretreated MSSCRC patients without liver metastases and with high plasma Tumor Mutational Burden (TMB) , a significant improvement over the 0-6% response rates of current standard-of-care therapies.
- Plasma TMB was identified as a statistically significant predictive biomarker for response, with approximately 55% of all MSSCRC patients having high plasma TMB.
- The safety profile of Velastigard in combination with Tislelizumab was favorable, showing minimal additional toxicity beyond Tislelizumab monotherapy, with a 7% incidence of colitis and a 5% discontinuation rate.
- Xilio is actively seeking a partner for Velastigard's development and plans to assess the appropriate regulatory path for this novel biomarker-driven strategy.
Nov 10, 2025, 9:30 PM
Xilio Therapeutics discusses SITC data updates for Vilastobart
XLO
New Projects/Investments
- Xilio Therapeutics presented new clinical data for Vilastobart in combination with Atezolizumab, demonstrating a 40% overall response rate (ORR) in late-line metastatic microsatellite stable colorectal cancer (MSS CRC) patients without liver metastases and with high plasma tumor mutational burden (TMB).
- This 40% ORR represents a significant improvement over the 0%-6% response rate observed with current standard-of-care therapies in this patient population.
- Plasma-based TMB was identified as a predictive biomarker, with approximately 55% of MSS CRC patients having high plasma TMB, indicating a substantial addressable patient population.
- The combination demonstrated a differentiated safety profile, with a 7% incidence of colitis of any grade and a 5% discontinuation rate due to toxicity, which is lower than other anti-CTLA-4 combinations.
- Xilio plans to seek a partner for Vilastobart's development and assess the appropriate regulatory path for this novel biomarker-driven strategy.
Nov 10, 2025, 9:30 PM
Xilio Therapeutics Announces Positive Phase 2 Data for Vilastobart
XLO
New Projects/Investments
M&A
- Xilio Therapeutics announced positive late-breaking Phase 2 data for vilastobart in combination with atezolizumab in heavily pre-treated patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without liver metastases and with high plasma tumor mutational burden (TMB).
- The study demonstrated a 40% objective response rate (ORR) in this patient population, with a statistically significant correlation between plasma TMB status and response.
- The company estimates that approximately 55% of patients with MSS CRC have high plasma TMB, representing a meaningful patient population who could benefit from this combination treatment.
- Vilastobart in combination with atezolizumab showed a generally well-tolerated safety profile, with treatment-related adverse events primarily Grade 1 or 2.
- Xilio is actively seeking a partner to further develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS CRC and other tumor types.
Nov 7, 2025, 2:05 PM
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