AI Earnings Predictions for Xilio Therapeutics Inc. (XLO)

EX-99.1

2 xlo-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Xilio Therapeutics Reports Third Quarter 2026 Financial Results and Provides Pipeline and Business Updates

Dosed first patient in Phase 1/2 clinical trial for XTX501, a potential best-in-class PD-1/masked IL-2 bispecific, for patients with metastatic NSCLC, and plan to report initial Phase 1 data in the fourth quarter of 2027

Advancing XTX602, a dual-masked CLDN18.2-targeting multi-specific TCE with co-stimulation, and XTX701, a masked PSMAxSTEAP1-targeting multi-specific TCE with co-stimulation, toward planned IND applications in the fourth quarter of 2027

WALTHAM, Mass., November 10, 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 third quarter ended September 30, 2026.

“In the third quarter, we initiated our Phase 1/2 clinical trial for XTX501, a PD-1/masked IL-2 bispecific that we believe has the potential to become a foundational backbone immunotherapy regimen for solid tumors,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “By incorporating masking and tumor-selective activation of a high potency, alpha-optimized IL-2 with inhibition of PD-1/PD-L1 in a single molecule, XTX501 is designed to simultaneously leverage these two validated mechanisms, while overcoming the toxicity and rapid clearance that have limited non-masked IL-2 therapies. We also continued to execute across our preclinical pipeline, advancing our programs for masked, multi-specific TCEs with built-in co-stimulation toward planned IND filings next year.”

Pipeline Progress and Business Updates

XTX501: PD-1/masked IL-2 bispecific

XTX501 is a novel, investigational PD-1/masked IL-2 (alpha-optimized) bispecific antibody fusion protein that combines two complementary mechanisms in a single molecule: selective inhibition of the PD-1/PD-L1 pathway and potent IL-2-driven expansion of T cells. The PD-1 binding arm is designed to selectively direct IL-2 activity to PD-1 positive, antigen-experienced T cells and enhance their function. The IL-2 binding arm incorporates a masked, high potency IL-2 variant with an alpha-optimized receptor binding profile. By leveraging Xilio’s proprietary masking technology, XTX501 aims to overcome IL-2 receptor-mediated clearance, peripheral activity and tolerability challenges associated with non-masked IL-2 therapies.

• Xilio recently dosed the first patient in the Phase 1 portion of the trial for XTX501 in patients with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors. For more information, read the press release here.

• Xilio recently presented a trial-in-progress poster highlighting the design of the Phase 1/2 clinical trial of XTX501 at the Society for Immunotherapy of Cancer (SITC) 41st Annual Meeting.

• Xilio plans to report initial Phase 1 data in patients with metastatic NSCLC in the fourth quarter of 2027.

Masked T Cell Engager (TCE) Programs

Xilio is leveraging its proprietary, clinically-validated masking technology and modular TCE architecture to advance two wholly-owned masked TCE programs, as well as an additional masked TCE program in collaboration with AbbVie Group Holdings Limited (AbbVie).

As part of the core design, Xilio’s TCEs incorporate a masked CD3 binding domain, a tumor-associated antigen (TAA) binding domain and built-in co-stimulation. The company’s modular architecture enables the flexibility to incorporate additional TAA binding domains and mask the TAA binding domain(s) and/or co-stimulatory signaling domain. Upon tumor-selective activation, the molecules are designed to release the mask(s) and deliver a potent TCE with a short half-life in the tumor microenvironment.

XTX602: dual-masked CLDN18.2-targeting multi-specific TCE with co-stimulation

XTX602 is a potential first-in-class, dual-masked CLDN18.2-targeting multi-specific TCE with built-in CD2 co-stimulation. CLDN18.2 is a TAA expressed in gastrointestinal cancers (gastric, pancreatic and esophageal). By incorporating masks for both the CLDN18.2 and the CD3 binding domains, XTX602 is designed to overcome potential gastrointestinal toxicity associated with non-masked CLDN18.2-targeting molecules. In addition, the CD2 co-stimulatory domain is built directly into the molecule to enable enhanced T cell activation, expansion and durability of T cell response.

• Investigational new drug application (IND)-enabling studies for XTX602 are ongoing, and Xilio plans to submit an IND for XTX602 in the fourth quarter of 2027.

XTX701: masked PSMAxSTEAP1-targeting multi-specific TCE with co-stimulation

XTX701 is a potential first-in-class, masked PSMAxSTEAP1-targeting multi-specific TCE with built-in CD2 co-stimulation. PSMA and STEAP1 are TAAs collectively expressed in appr

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