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WALTHAM, Mass. - Xilio Therapeutics, Inc. (NASDAQ:XLO), a biotechnology firm specializing in immuno-oncology therapies, announced progress in its product pipeline alongside its fourth quarter and full-year financial results for 2024. According to InvestingPro data, the company’s stock has shown resilience with an 11.6% return over the past year, despite high price volatility. The company highlighted promising initial Phase 2 data for vilastobart, a tumor-activated anti-CTLA-4 monoclonal antibody, in metastatic microsatellite stable colorectal cancer (MSS CRC) patients. The data revealed a 27% objective response rate in patients without liver metastases, supporting vilastobart’s differentiated safety profile, with a low incidence of immune-related adverse events and only 5% of patients reporting colitis. Further data from the ongoing Phase 2 trial is expected by mid-2025.
Xilio also announced a collaboration with AbbVie, initiated in the first quarter of 2025, to develop novel tumor-activated immunotherapies, including masked T cell engagers. This partnership includes a $52.0 million upfront payment to Xilio, with potential future payments totaling approximately $2.1 billion. InvestingPro analysis suggests the stock is currently undervalued, with analysts setting ambitious price targets between $4 and $5 per share.
The company’s financial results indicated a solid cash position, with $55.3 million in cash and cash equivalents as of December 31, 2024, increased from $44.7 million the previous year. InvestingPro data reveals the company holds more cash than debt on its balance sheet, though it’s quickly burning through cash with negative free cash flow of $17.7 million in the last twelve months. Get access to 5 more exclusive ProTips and comprehensive financial metrics with InvestingPro. The reported license revenue for the fourth quarter was $1.7 million, and $6.3 million for the full year, stemming from an agreement with Gilead Sciences. Research and development expenses decreased year-over-year, reflecting lower investment in certain early-stage programs and discontinuation of XTX202, a masked IL-2. General and administrative expenses also saw a slight decrease from the previous year.
Xilio’s pipeline includes XTX301, a tumor-activated IL-12, which showed good tolerability and sustained interferon gamma signaling in a Phase 1 trial in advanced solid tumors, with no dose limiting toxicity. The company plans to continue enrolling patients for further dose escalation and expansion.
Looking ahead, Xilio is preparing for Investigational New Drug (IND) application enabling studies for XTX501, a masked PD-1/IL-2 bispecific, with an IND submission planned for mid-2026. The company’s proprietary tumor-activation platform is also being used to advance preclinical programs for masked T cell engagers targeting PSMA, CLDN18.2, and STEAP1, with development candidate nominations and IND submissions scheduled for 2025 and beyond.
Xilio expects its current funds, bolstered by the collaboration with AbbVie, to support operations into the first quarter of 2026. With a current market capitalization of $38.6 million and a Financial Health Score of 2.22 (rated as ’Fair’ by InvestingPro), the company’s focus remains on advancing its pipeline while managing its resources. This update is based on a press release statement from the company.
In other recent news, Xilio Therapeutics, Inc. announced a significant collaboration and option agreement with pharmaceutical giant AbbVie to develop novel tumor-activated immunotherapies. This deal, made public on February 12, 2025, combines AbbVie’s oncology expertise with Xilio’s proprietary tumor-activation technology. The collaboration will focus on developing antibody-based immunotherapies, including masked T-cell engagers, using Xilio’s clinically-validated platform for tumor-activated biologics. Xilio is set to receive $52.0 million in upfront payments, which includes a $10.0 million equity investment from AbbVie. Additionally, Xilio could earn up to approximately $2.1 billion in contingent payments, option-related fees, milestones, and tiered royalties. This strategic alliance marks a significant milestone for Xilio, leveraging its technology with AbbVie’s resources in the oncology market. The financial terms underscore the potential value of Xilio’s tumor-activated biologics platform. This collaboration validates Xilio’s approach to immuno-oncology, potentially accelerating the development and commercialization of its cancer therapies.
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