XLO

On track for planned IND submission in mid-2026 and Phase 1 initiation in the second half of 2026 for XTX501, a potential best-in-class bispecific PD-1 / masked IL-2 Presented new preclinical data for XTX601, a potential first-in-class masked T cell engager targeting CLDN18.2, at the AACR annual meeting Advancing potential first-in-class multi-specific, masked T cell engager targeting PSMA and STEAP1 Achieved development milestone under AbbVie collaboration and extended cash runway into early 2028 WALTHAM, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked 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, 2026. “We ended the first quarter of 2026 with strong momentum across our pipeline of highly differentiated I-O therapies leveraging our best-in-class masking technology,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “XTX501 has the potential to be a foundational backbone therapy for combination regimens across a broad range of solid tumors, and we are on track to advance this program into the clinic this year. In addition, our recent data for our CLDN18.2 program presented at AACR further demonstrate the power of our masking technology to unlock the potential of T cell engagers. This progress, together with the recent achievement of another financial milestone under our AbbVie collaboration, highlights the productivity of our pipeline and underscores our ability to maximize the value of our clinically-validated masking technology.” Pipeline Progress and Business Updates XTX501: bispecific PD-1 / masked IL-2 XTX501 is a novel bispecific PD-1 / masked IL-2 that has the potential to be a foundational “backbone” therapy for combination treatment with other agents. XTX501 is designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1 therapy) and tumor-selective pharmacodynamics consistent with its intended mechani...

XTX501, a potential best-in-class bispecific PD-1 / masked IL-2, on track for planned IND submission in mid-2026 and Phase 1 initiation in the second half of 2026 Advancing potential first-in-class multi-specific, masked T cell engager targeting PSMA and STEAP1 Plan to present new preclinical data at AACR for potential first-in-class masked T cell engager program targeting CLDN18.2 Extended cash runway through the end of 2027 WALTHAM, Mass., March 23, 2026 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, today announced pipeline progress and business updates and reported financial results for the fourth quarter and full year ended December 31, 2025. “As we enter 2026, we are well-positioned to leverage our clinically validated masking technology to continue advancing our next generation of multi-specific I-O therapies toward the clinic,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “We are encouraged by the progress the field has recently made with masked T cell engagers for prostate cancer, and we are excited to be advancing a potential first-in-class multi-specific masked T cell engager targeting both PSMA and STEAP1 with built-in co-stimulatory signaling designed to enhance potency and durability of response. We believe that targeting both PSMA and STEAP1, which are the most prevalent tumor-associated antigens expressed in prostate cancer, will minimize resistance due to antigen escape. In addition, this quarter we continued to make strong progress advancing XTX501, our potential best-in-class bispecific PD-1 / masked IL-2, toward a planned IND submission mid-year.” Pipeline Progress and Business Updates XTX501: bispecific PD-1 / masked IL-2 XTX501 is a novel bispecific PD-1 / masked IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function. XTX501 incorporates masking and is designed to overcome IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1 therapy) and tumor-selective pharmacodynamics consistent with its intended mechanism of action. Xilio is currently...

Reported late-breaking Phase 2 data at SITC for vilastobart demonstrating a 40% ORR in heavily pretreated patients with MSS mCRC without liver metastases and high plasma tumor mutational burden Presented Phase 1 data at SITC for efarindodekin alfa showing promising monotherapy anti-tumor activity and generally well-tolerated safety profile in patients with advanced solid tumors Announced new preclinical data at SITC for masked T cell engager programs supporting best-in-class potential and showing efficient masking, potent anti-tumor activity and broad therapeutic index Anticipate cash runway into the first quarter of 2027 WALTHAM, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2025. “As we advance our robust pipeline of innovative masked immunotherapies, we continue to provide additional validation of our proprietary masking technology and ability to deliver differentiated molecules across a wide range of targets and design formats,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “At SITC, we presented compelling data across our clinical and preclinical programs, including data supporting the best-in-class potential of our masked T cell engager programs to meaningfully widen the therapeutic window relative to non-masked T cell engagers as well as our unique ability to incorporate co-stimulation to substantially improve the durability of T cell response.” Dr. Russo added, “For our clinical-stage programs, we continue to be encouraged by the promising data for both vilastobart and efarindodekin alfa, which have each shown differentiated clinical efficacy and safety for patients with high unmet need. In particular, new data for vilastobart leveraging plasma TMB as a predictive biomarker showed a 40% response rate in patients with MSS mCRC without liver metastases, supporting the significant opportunity for vilastobart as a combination therapy. As we look ahead to 2026, we are focused on execution across our clinical programs, while rapidly advancing XTX501, our bispecific PD-1/IL-2, toward a planned IND submission in mid 2026 and our mask...

Revenue: US$8.08m (up 243% from 2Q 2024). Net loss: US$15.8m (loss widened by 14% from 2Q 2024). US$0.16 loss per share. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is expected to decline by 4.4% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 20%. Performance of the American Biotechs industry. The company's shares are up 6.9% from a week ago. What about risks? Every company has them, and we've spotted 5 warning signs for Xilio Therapeutics (of which 1 is a bit concerning!) you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Announced updated Phase 2 data at ASCO for vilastobart, a tumor-activated, Fc-enhanced, anti-CTLA-4, demonstrating deep and durable responses and a meaningfully differentiated safety and tolerability profile for an anti-CTLA-4 combination therapy On track with plans to nominate first development candidates for wholly owned masked T cell engager programs in second half of 2025 $121.6 million in cash and cash equivalents as of June 30, 2025, with anticipated cash runway through end of third quarter of 2026 WALTHAM, Mass., Aug. 14, 2025 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2025. “During the second quarter, we continued to make strong progress across our pipeline of novel tumor-activated immuno-oncology therapies, and with our recent financing, we believe that we are well-positioned to execute on our strategic goals,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “We believe our masked T cell engager molecules have the potential to be best-in-class, and we anticipate nominating our first development candidates for our wholly owned programs later this year. In addition, we are very encouraged by the clinical progress for XTX301, our tumor-activated IL-12 advancing in partnership with Gilead, and we look forward to providing a program update in the near-term. We also recently reported updated Phase 2 combination data for vilastobart at ASCO and believe these data not only highlight the significant opportunity for vilastobart across a range of I-O combinations and tumor types, but also provide further clinical validation for our proprietary masking technology and approach.” Pipeline and Business Updates Vilastobart: tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). Vilastobart is currently being evaluated in combination with atezolizumab (Tecentriq®) in Phase 1C combination dose escalation in patients with advanced solid...

Updated Phase 2 data to be presented at ASCO for vilastobart, a tumor-activated, Fc-enhanced, anti-CTLA-4, in combination with atezolizumab in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) Advancing multiple masked T cell engager programs utilizing Xilio’s novel ATACR and SEECR formats, with first development candidates anticipated in second half of 2025 WALTHAM, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- 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, 2025. “In the first quarter, we presented encouraging initial Phase 2 data for vilastobart, our tumor-activated anti-CTLA-4, in combination with atezolizumab in patients with late-line MSS CRC. These data included a preliminary 27% objective response rate in late-line MSS CRC patients without liver metastases accompanied by a differentiated safety profile with a low incidence of colitis and other immune-related adverse events, which are common dose-limiting adverse events for other CTLA-4 agents,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “MSS CRC is an immunologically cold tumor type that is very difficult to treat and increasing in incidence, particularly in younger people for whom no immunotherapy treatment options are currently available. We look forward to reporting updated Phase 2 data at the upcoming ASCO meeting, including additional response assessments and further follow-up on the previously reported data. This quarter was also marked by strong execution across our pipeline, as we continue to advance XTX301, our tumor-activated IL-12, in monotherapy dose escalation in partnership with Gilead, and multiple novel masked T cell engager programs internally and as part of our recently announced collaboration with AbbVie.” Pipeline and Business Updates Vilastobart: tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). Vilastobart is currently being evaluated in combi...