Kyverna Therapeutics may consider it had an “exceptional start to the year,” but that didn’t immunize the cell therapy biotech from the wider industry trend of layoffs.
The Californian company waved goodbye to 16% of its staff in the first three months of 2025, Kyverna revealed in its first-quarter earnings report May 13. This formed part of a wider strategy to “streamline the organization to support the company's late-stage development and commercialization objectives while preserving cash runway into 2027,” the biotech explained.
By the beginning of March, Kyverna had 112 employees, of which 84 were involved in R&D activities, according to an earlier Securities and Exchange Commission filing.
The company’s main focus is the CD19-directed CAR-T called KYV-101, which Kyverna is evaluating in a phase 2 trial in stiff person syndrome (SPS), a rare autoimmune neurological disorder launched into public attention by Céline Dion’s diagnosis. Enrollment in that study is now complete, with a top-line readout and a potential approval submission to the FDA both penciled in for the first half of 2026.
Kyverna’s CEO Warner Biddle told Fierce back in January that SPS is “our tip of the spear that will allow us to establish a base as the first autoimmune CAR company.”
The biotech is also preparing a phase 3 study for KYV-101 in myasthenia gravis ahead of a phase 2 study readout expected in the second half of this year. These plans will be funded by the $242.6 million with which the company ended March.
“We are pleased to report an exceptional start to the year, marked by rapid execution against our focused strategy to advance development of KYV-101 and build Kyverna into a robust clinical and commercial-ready organization,” Biddle said in yesterday’s release.
“Importantly, we have now aligned with the FDA on the registrational pathway for our two lead indications, SPS and MG, laying the foundation for accelerating our potential first-in-class neuroinflammation franchise,” Biddle added. “Having recently completed enrollment in KYSA-8, our registrational study in SPS, we now anticipate filing our first BLA in the first half of 2026 and are strategically investing in pre-launch activities.”
Interest in CAR-T therapies for autoimmune disease exploded last year following a series of promising results in patients with systemic lupus erythematosus from academic studies out of Germany.
The enthusiasm led to Kyverna’s upsized IPO last year, although the company’s stock has sunk 90% from its $22 launch price in February 2024 to just $2.32 by Tuesday.
KYV-101 was one of the first CAR-Ts to report data from a lupus clinical trial, and Kyverna remains on track to report data from a pair of early-stage lupus nephritis studies in the second half of the year. The company is also eyeing up potential other autoimmune opportunities for the CAR-T, including multiple sclerosis.
Coming up behind is KYV-102, a next-gen CD19 CAR-T that uses the company’s whole-blood rapid manufacturing approach. The biotech hopes this will “improve the CAR-T patient experience, eliminate apheresis and broaden CAR-T access,” with plans to submit a request later this year for the therapy to enter the clinic.