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Biotechnology: Pharmaceutical Preparations
Quarterly ResultAug 12, 2026, 07:46 AM

Xilio Receives FDA IND Clearance for XTX501; Q2 Net Loss $6.4M

AI Summary

Xilio Therapeutics announced its second quarter 2026 financial results and provided pipeline updates. The company received FDA clearance for its investigational new drug (IND) application for XTX501, a bispecific PD-1 / masked IL-2, with Phase 1 dosing expected to begin in the second half of 2026. Financially, Xilio reported a reduced net loss of $6.4 million for Q2 2026, compared to $15.8 million in Q2 2025, and an increase in collaboration and license revenue to $18.7 million. The company projects its cash and cash equivalents of $136.0 million will fund operations into the first quarter of 2028.

Key Highlights

  • Received FDA clearance for the IND application for XTX501, a bispecific PD-1 / masked IL-2.
  • Expects to initiate dosing for XTX501 Phase 1 in H2 2026, with initial data in H2 2027.
  • Advancing IND-enabling studies for masked T cell engager programs targeting CLDN18.2 and PSMA+STEAP1.
  • Plans to submit INDs for CLDN18.2 and PSMA+STEAP1 programs in H2 2027.
  • Q2 2026 Collaboration and license revenue increased to $18.7 million from $8.1 million in Q2 2025.
  • Q2 2026 Net loss significantly reduced to $6.4 million from $15.8 million in Q2 2025.
  • Cash and cash equivalents were $136.0 million as of June 30, 2026.
  • Anticipates existing cash runway into the first quarter of 2028.