Kali Therapeutics Named to 2026 Endpoints 11 List of Promising Biotech Startups

San Mateo, Calif. – Kali Therapeutics, a clinical-stage biotechnology company developing next-generation immune-resetting and multi-specific therapies, has been named a recipient of the 2026 Endpoints 11. This annual list identifies the 11 most promising private biotechnology companies as curated by the Endpoints News editorial team.

Founded in July 2024, Kali was selected based on its differentiated T-cell engager platform and its pace of execution. In just over two years, the company has advanced two candidates into clinical trials and licensed its lead program to Sanofi. The honorees were chosen after a months-long selection process involving hundreds of private companies and were announced at an awards gala in Boston on September 24, 2026.

The award follows a year of significant progress for Kali Therapeutics. The company received FDA clearance for its Investigational New Drug application for KT501, with the first patient dosed in March 2026 in a Phase 1a trial for rheumatoid arthritis. Additionally, Kali Therapeutics entered into a worldwide exclusive license agreement with Sanofi for KT501, which includes $180 million in upfront and near-term payments, with up to $1.05 billion in potential milestone payments and tiered royalties.

Kali Therapeutics' proprietary CD3-masking platform is designed to decouple potency from toxicity. This approach aims to enable deep B-cell depletion in both peripheral blood and tissue while limiting cytokine release. The platform underpins a pipeline that includes KT502, a CD19 x CD3 bispecific T-cell engager in Phase 1 clinical trial, and KT209, a CD19 x CD20 x CD3 trispecific antibody undergoing IND-enabling activities with a first-in-human study planned for the first half of 2027. The company is also extending the platform's application beyond B-cell depletion to other cell types implicated in autoimmune and inflammatory diseases.