Xilio Therapeutics (NASDAQ:XLO) reported Q2 2025 financial results and pipeline updates. The company's lead candidate vilastobart showed promising Phase 2 data with a 26% objective response rate in metastatic MSS colorectal cancer patients without liver metastases. The therapy demonstrated deep, durable responses and a differentiated safety profile.\n\nFinancial highlights include $121.6 million in cash and cash equivalents, a net loss of $15.8 million, and revenue of $8.1 million. The company completed a follow-on offering raising $50.0 million in initial gross proceeds, with potential for additional $100.0 million from warrant exercises.\n\nXilio expects to nominate development candidates for its masked T cell engager programs in H2 2025 and projects cash runway through Q3 2026.\n\nXilio reports promising tumor-activated immunotherapy data while securing runway through Q3 2026 with $121.6M cash position. Xilio Therapeutics' Q2 results reveal significant progress across their innovative tumor-activated immunotherapy pipeline. The standout program is vilastobart, their masked anti-CTLA-4 antibody, which demonstrated a 26% objective response rate in microsatellite stable colorectal cancer patients without liver metastases. This represents an impressive clinical achievement in a notoriously difficult-to-treat population, particularly with a better safety profile than traditional CTLA-4 inhibitors like ipilimumab, which are often limited by severe immune-related toxicities.\n\nTheir proprietary masking technology appears to be gaining clinical validation across multiple platforms. Beyond vilastobart, their IL-12 program (XTX301) has completed Phase 1A dose escalation with Gilead as partner, while their masked PD-1/IL-2 bispecific (XTX501) is advancing toward IND submission by mid-2026. Most promising is their emerging portfolio of masked T cell engagers targeting PSMA, CLDN18.2, and STEAP1, with development candidates expected in Q3-Q4 2025.\n\nFinancially, Xilio has significantly strengthened its position with $121.6 million in cash as of June 30, extending runway through Q3 2026. This represents a substantial improvement from $55.3 million at 2024 year-end, bolstered by their $50 million June financing (with potential for $100 million more if warrants are exercised). While quarterly net loss increased to $15.8 million from $13.9 million year-over-year, this reflects planned investment in clinical programs. R&D expenses increased to $15.3 million, primarily supporting vilastobart development and early-stage programs. The $8.1 million in collaboration revenue from AbbVie and Gilead partnerships provides additional validation of their technology platform.\n\nIn May 2025, Xilio announced promising updated Phase 2 data for vilastobart in combination with atezolizumab in patients with metastatic MSS CRC at the American Society of Clinical Oncology (ASCO) Annual Meeting. These data demonstrated a preliminary 26% objective response rate in heavily pre-treated metastatic MSS CRC patients without liver metastases, including deep and durable responses accompanied by substantial decreases in tumor biomarkers and improvements in clinical symptoms, as well as a differentiated and well-tolerated safety profile with a low incidence of colitis and other immune-related adverse events, which have historically limited the potential for anti-CTLA-4 therapies. For more information, read the press release here.\n\nXilio anticipates reporting additional data from the Phase 2 trial in the first half of 2026. Based on the encouraging clinical data to date, Xilio believes vilastobart has the potential to be an I-O combination agent of choice and be combined with a range of existing and next-generation agents. Xilio continues to engage strategic partners on potential opportunities to accelerate and expand further development for vilastobart.\n\nXTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic “cold” tumors towards an inflamed or “hot” state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. related to Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is evaluating XTX301 as a monotherapy in an ongoing Phase 1 clinical trial in patients with advanced solid tumors. Xilio recently completed enrollment in Phase 1A monotherapy dose escalation and evaluation of those patients is ongoing. In addition, Xilio continues to enroll patients in Phase 1B monotherapy dose expansion of the ongoing Phase 1 clinical trial of XTX301.\n\nXTX501 is a novel, tumor-activated bispecific PD-1/IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function. XTX501 incorporates masking designed to overcome IL-2 receptor-mediated clearance and peripheral activity. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1) and tumor-selective pharmacodynamics consistent with its intended mechanism of action. Xilio is continuing to advance XTX501 in investigational new drug (IND)-enabling studies and plans to submit an IND application for XTX501 in the middle of 2026.\n\nXilio is leveraging its proprietary, clinically validated tumor-activation platform to advance multiple preclinical programs for masked T cell engagers, including wholly owned programs targeting the tumor-associated antigens for PSMA, CLDN18.2 and STEAP1 and an additional program in collaboration with AbbVie. Xilio’s masked T cell engager programs include bispecific molecules designed using its advanced tumor-activated cell engager (ATACR) format, which consists of a T cell engager with a masked CD3 targeting domain, and tri-specific molecules designed using its selective effector-enhanced cell engager (SEECR) format. The SEECR format builds upon the ATACR format by adding co-stimulatory signaling designed to further enhance potency and T cell activation. Xilio anticipates nominating development candidates for its PSMA program (ATACR format), CLDN18.2 program (ATACR format) and STEAP1 program (SEECR format) in the third quarter of 2025, fourth quarter of 2025 and first half of 2026, respectively. Xilio anticipates advancing at least two of these programs into initial IND-enabling studies and submitting IND applications for those programs in 2027.\n\nIn June 2025, Xilio closed a follow-on public offering of prefunded warrants and accompanying common stock warrants and received initial gross proceeds of approximately $50.0 million before deducting underwriting discounts and commissions and offering expenses. In connection with the offering, Xilio issued Series B and Series C common stock warrants and will receive up to $100.0 million of additional gross proceeds by the second half of 2026 if all of those warrants are exercised in cash at their initial exercise price of $0.75 per warrant. The financing was co-led by new investors Coastlands Capital and Frazier Life Sciences and included participation from Gilead Sciences, Inc., Logos Capital, Samsara BioCapital and other new and existing institutional investors.\n\nIn June 2025, Xilio announced the appointment of Akintunde (Tunde) Bello, Ph.D., to the company’s board of directors.\n\nCash Position: Cash and cash equivalents were $121.6 million as of June 30, 2025, compared to $55.3 million as of December 31, 2024. In the second quarter of 2025, Xilio received $47.0 million in net proceeds from its June 2025 follow-on public offering after deducting underwriting discounts and commissions and offering expenses payable by the company.\n\nCollaboration and License Revenue: Collaboration and license revenue was $8.1 million for the quarter ended June 30, 2025, compared to $2.4 million for the quarter ended June 30, 2024. Collaboration and license revenue for the quarter ended June 30, 2025 consisted of revenue recognized in connection with Xilio’s collaborations with AbbVie and Gilead, and collaboration and license revenue for the quarter ended June 30, 2024 consisted of revenue recognized in connection with Xilio’s collaboration with Gilead.\n\nResearch & Development (R&D) Expenses: R&D expenses were $15.3 million for the quarter ended June 30, 2025, compared to $11.2 million for the quarter ended June 30, 2024. The increase was primarily driven by increased clinical development activities related to vilastobart, increased costs related to early-stage programs and indirect research and development and increased personnel-related costs, which were partially offset by decreased costs related to clinical development activities for XTX202, a tumor-activated IL-2, as a result of discontinuing further investment in that program. For the quarter ended June 30, 2025, R&D expenses also included manufacturing activities related to IND-enabling studies and preclinical development activities for XTX501, which were not separately tracked for the quarter ended June 30, 2024 as the company had not yet begun performing IND-enabling studies. For the quarter ended June 30, 2024, R&D expenses also included a $1.0 million development milestone under the CTLA-4 monoclonal antibody license agreement with WuXi Biologics (Hong Kong) Limited for which there was no comparable cost for the quarter ended June 30, 2025.\n\nGeneral & Administrative (G&A) Expenses: G&A expenses were $7.1 million for the quarter ended June 30, 2025, compared to $5.8 million for the quarter ended June 30, 2024. The increase was primarily driven by an increase in professional and consulting fees, including legal fees and other professional costs, and an increase in personnel-related costs, which were partially offset by a decrease in costs related to directors’ and officers’ liability insurance.\n\nNet Loss: Net loss was $15.8 million for the quarter ended June 30, 2025, compared to $13.9 million for the quarter ended June 30, 2024.\n\nBased on its current operating plans, Xilio anticipates that its cash and cash equivalents as of June 30, 2025 will be sufficient to enable it to fund its operating expenses and capital expenditure requirements through the end of the third quarter of 2026.\n\nVilastobart 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). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq®) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety and tolerability of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.\n\nXTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic “cold” tumors towards an inflamed or “hot” state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is evaluating the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors in the Phase 1 portion of a first-in-human, multi-center, open-label Phase 1/2 clinical trial. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.\n\nXilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated, or masked, immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is leveraging its proprietary platform to advance a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc).

Cancer Drug Breakthrough: Xilio's Vilastobart Delivers Strong Results with Fewer Side Effects

Xilio Therapeutics reported strong Phase 2 clinical data for its lead candidate vilastobart in metastatic microsatellite stable (MSS) colorectal cancer, showing a 26% objective response rate with a favorable safety profile compared to traditional CTLA-4 inhibitors. The company highlighted progress across its tumor-activated immunotherapy pipeline, including IL-12 (XTX301) and masked PD-1/IL-2 bispecific (XTX501) programs. Financially, Xilio reported $121.6 million in cash as of June 30, 2025, following a $50 million follow-on offering with potential for an additional $100 million from warrant exercises. Revenue from collaborations with AbbVie and Gilead reached $8.1 million. The company expects to nominate development candidates for its masked T cell engager programs targeting PSMA, CLDN18.2, and STEAP1 in Q3–Q4 2025 and anticipates cash runway through Q3 2026.