Xilio Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents were $122.2 million as of September 30, 2026, a decrease from $137.5 million as of December 31, 2025.
• Collaboration and license revenue was $10.0 million for the quarter ended September 30, 2026, compared to $19.1 million for the same quarter in 2025.
• Research and development expenses were $14.8 million for the quarter ended September 30, 2026, an increase from $14.3 million in the same quarter of 2025.
• General and administrative expenses were $6.9 million for the quarter ended September 30, 2026, compared to $6.7 million in the same quarter of 2025.
• Net loss was $5.9 million for the quarter ended September 30, 2026, compared to a net loss of $16.3 million for the quarter ended September 30, 2025.
• Deferred revenue was $25.3 million as of September 30, 2026, down from $60.7 million as of December 31, 2025.
• Total liabilities were $66.6 million as of September 30, 2026, compared to $119.4 million as of December 31, 2025.
• Stockholders' equity was $68.2 million as of September 30, 2026, compared to $35.3 million as of December 31, 2025.
• Net loss per share (basic and diluted) was $(0.30) for the quarter ended September 30, 2026, compared to $(1.58) for the same quarter in 2025.
• Stock-based compensation expense was $1.9 million for the quarter ended September 30, 2026, compared to $1.1 million in the same quarter of 2025.

Guidance and Future Outlook:

• Xilio anticipates its existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into the first quarter of 2028.
• The company plans to report initial Phase 1 data for XTX501 in patients with metastatic NSCLC in the fourth quarter of 2027.
• Xilio plans to submit an Investigational New Drug (IND) application for XTX602 in the fourth quarter of 2027.
• Xilio plans to submit an IND application for XTX701 in the fourth quarter of 2027.
• The company expects to deliver an option data package for efarindodekin alfa to Gilead Sciences in the first half of 2027.
• Potential additional gross proceeds of up to $36.2 million could be realized in the fourth quarter of 2026 if all outstanding Series C warrants are exercised.
• Potential near-term milestone and option extension fees of up to $31.0 million could be achieved under the AbbVie collaboration through the first half of 2027.

Business Segments and Product Lines:

• Dosed the first patient in the Phase 1 portion of the clinical trial for XTX501, a PD-1/masked IL-2 bispecific, in patients with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors.
• XTX501 combines selective inhibition of the PD-1/PD-L1 pathway with potent IL-2-driven expansion of T cells, utilizing proprietary masking technology to overcome toxicity and clearance issues associated with non-masked IL-2 therapies.
• Advanced XTX602, a dual-masked CLDN18.2-targeting multi-specific T cell engager (TCE) with built-in CD2 co-stimulation, toward an IND filing; it targets gastrointestinal cancers (gastric, pancreatic, and esophageal).
• Advanced XTX701, a masked PSMAxSTEAP1-targeting multi-specific TCE with built-in CD2 co-stimulation, toward an IND filing; it targets metastatic castration-resistant prostate cancer.
• Both XTX602 and XTX701 incorporate masks for the CD3 binding domain and tumor-associated antigen binding domains to minimize peripheral toxicity and on-target, off-tumor engagement.
• Efarindodekin alfa, a masked IL-12, is being evaluated as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors.
• Collaborations with AbbVie and Gilead remain active sources of collaboration and license revenue.

Market and Competitive Landscape:

• XTX501 is designed to be a foundational backbone immunotherapy regimen for solid tumors by leveraging two validated mechanisms in a single molecule.
• XTX602 is a potential first-in-class dual-masked CLDN18.2-targeting TCE designed to overcome gastrointestinal toxicity associated with non-masked molecules.
• XTX701 targets PSMA and STEAP1, which are collectively expressed in approximately 95% of metastatic castration-resistant prostate cancer, aiming to address antigen heterogeneity and limit resistance.
• The company's proprietary masking technology and modular TCE architecture allow for flexibility in incorporating additional tumor-associated antigen binding domains.

Risks and Challenges:

• Clinical trial results may not be replicated or predictive of future results, and initial data may not support further development.
• There is a risk that product candidates may not demonstrate safety and efficacy or receive regulatory approval on a timely basis, if at all.
• The company may face delays in initiating, conducting, or completing preclinical studies and clinical trials.
• Xilio may need to obtain additional cash resources to advance its pipeline.
• The company relies on maintaining collaboration and license agreements with AbbVie and Gilead.
• Risks include geopolitical uncertainties, international trade policies, and the ability to obtain and maintain patent protection.

Management Commentary and Tone:

• René Russo, Pharm.D., President and CEO, stated that XTX501 has the potential to become a foundational backbone immunotherapy regimen for solid tumors.
• Management highlighted that XTX501 is designed to simultaneously leverage PD-1/PD-L1 inhibition and high potency IL-2 expansion while overcoming toxicity and rapid clearance limitations of non-masked therapies.
• The company expressed confidence in executing across its preclinical pipeline, advancing masked, multi-specific TCE programs with built-in co-stimulation toward IND filings in 2027.

Other Key Points:

• Xilio appointed Yariv Houvras, M.D., Ph.D., as Chief Medical Officer in September 2026.
• The company reported a 1-for-14 reverse stock split effective March 13, 2026, with all share and per share data adjusted retroactively.
• A change in the fair value of common stock warrant liabilities resulted in a gain of $4.8 million for the quarter ended September 30, 2026, compared to a loss of $15.4 million in the same period of 2025.
• The decrease in collaboration and license revenue was driven by reduced revenue recognition under agreements with AbbVie and Gilead.
• The increase in R&D expenses was driven by increased preclinical activities for masked TCE programs, clinical trial startup activities for XTX501, and higher personnel-related costs.