Kali Therapeutics Named to the 2026 Endpoints 11, Recognizing Biotech's Most Promising Startups

SAN MATEO, Calif., Sept. 25, 2026 /PRNewswire/ -- Kali Therapeutics, a clinical-stage biotechnology company pioneering next-generation immune-resetting and multi-specific therapies, today announced its selection as a winner of the 2026 Endpoints 11, the annual list of the 11 most promising private biotechnology companies curated by the Endpoints News editorial team.

Founded in July 2024, Kali was selected by Endpoints News editors on the strength of its differentiated T-cell engager platform and the pace of its execution — in just over two years, the company has advanced two candidates into the clinic and licensed its lead program to Sanofi. The 2026 honorees were chosen following a monthslong selection process spanning hundreds of private companies and were announced at an awards gala held at The State Room in Boston on Thursday, September 24, 2026.

"We are honored to be named an Endpoints 11 company and to stand alongside a group of teams taking real scientific risk," said Weihao Xu, Founder and Chief Executive Officer of Kali Therapeutics. "This recognition belongs to everyone at Kali who has moved our proprietary CD3-masking platform from an engineering idea to two molecules in the clinic in a little over two years — and, most of all, to the patients and investigators who have joined our trials. Our ambition has not changed: to pursue a durable immune reset that has the potential to offer people with autoimmune disease something more than another chronic therapy."

The award follows a year of rapid progress, including FDA clearance of the Investigational New Drug application for KT501, first patient dosing in the Phase 1a rheumatoid arthritis trial in March 2026, and a worldwide exclusive license of KT501 to Sanofi for $180 million in upfront and near-term payments, with up to $1.05 billion in potential milestones and tiered royalties.

"We backed Weihao and this team at founding and worked closely with them since then. The pace of execution has been remarkable — from company formation to the clinic and a worldwide partnership with Sanofi in roughly two years," said Derek Yuan, Ph.D., Partner at LYFE Capital, Kali's earliest institutional investor, and a member of the company's Board of Directors. "What drew us in from the start was the promise of durable remission for patients. Kali's proprietary engineering offers a way to bring the potency of T-cell engagers to autoimmune disease without accepting the toxicity that has limited the modality, and the data generated so far have reinforced that thesis. We are proud to support Kali from the beginning and to continue backing the team as the platform expands."

Kali's proprietary CD3-masking platform is designed to decouple potency from toxicity, enabling deep B-cell depletion in both peripheral blood and tissue while limiting cytokine release. The approach 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 with IND-enabling activities underway and a first-in-human study planned for the first half of 2027. Kali is also extending the platform beyond B-cell depletion, applying the same masking approach to additional cell types implicated in autoimmune and inflammatory disease.

About Kali Therapeutics

Founded in July 2024, Kali Therapeutics is a clinical-stage biotechnology company headquartered in San Mateo, California, dedicated to developing transformative therapies for autoimmune and inflammatory diseases. By combining advanced protein engineering and high-throughput experimental techniques, Kali Therapeutics streamlines the drug discovery and research process. The company's proprietary immune cell engager platform enables precise optimization of the functionality, manufacturability, and developability of biologics with first-in-class or best-in-class potential, leveraging T-cell engagers with precise targeting and controlled cytotoxicity to enable a transformative immune system reset and regeneration. For more information, visit kalitherapeutics.com and follow the company on LinkedIn.

About the Endpoints 11

The Endpoints 11 is an annual award from Endpoints News recognizing the most promising private biotechnology companies in the industry. Honorees are chosen by the Endpoints editorial team following a monthslong review, with an emphasis on differentiated science, strong leadership, and the financial capacity to execute. Endpoints News is part of the Financial Times' FT Specialist group. Full profiles of the 2026 honorees are available at endpoints.news.

SOURCE Kali Therapeutics