Kyverna Therapeutics Advances Autoimmune CAR-T Pipeline Amid Organizational Restructuring

Kyverna Therapeutics, a California-based cell therapy biotech, has reported significant progress in its autoimmune CAR-T program despite implementing strategic layoffs. The company's first-quarter earnings report for 2025 reveals a complex landscape of clinical advancements, financial maneuvering, and organizational changes.

Pipeline Progress and Clinical Milestones

Kyverna's lead candidate, KYV-101, a CD19-directed CAR-T therapy, has reached several critical milestones. The company has completed enrollment in its phase 2 trial for stiff person syndrome (SPS), a rare autoimmune neurological disorder. With top-line data and a potential FDA submission expected in the first half of 2026, Kyverna is positioning itself at the forefront of autoimmune CAR-T therapy.

In addition to SPS, Kyverna is advancing KYV-101 in myasthenia gravis, with a phase 3 study in preparation following an anticipated phase 2 readout in the second half of 2025. The company's CEO, Warner Biddle, emphasized the strategic importance of these indications, stating, "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."

Kyverna is also exploring KYV-101's potential in lupus nephritis, with data from early-stage studies expected later this year. The company's pipeline expansion includes KYV-102, a next-generation CD19 CAR-T utilizing a whole-blood rapid manufacturing approach, which aims to improve patient experience and broaden access to CAR-T therapies.

Financial Position and Organizational Changes

Despite reporting an "exceptional start to the year," Kyverna implemented a 16% reduction in its workforce during the first quarter of 2025. This move aligns with a broader industry trend of biotech layoffs and is part of Kyverna's strategy to "streamline the organization to support the company's late-stage development and commercialization objectives while preserving cash runway into 2027."

The company ended March with $242.6 million in cash, providing runway for its ambitious clinical program. However, Kyverna's stock has faced significant challenges, plummeting 90% from its IPO price of $22 in February 2024 to $2.32 by mid-May 2025.

Market Positioning and Future Outlook

Kyverna's focus on autoimmune applications for CAR-T therapy positions it in a rapidly evolving and competitive landscape. The company's approach gained traction following promising results in systemic lupus erythematosus from academic studies in Germany last year.

CEO Warner Biddle outlined the company's strategic vision, stating, "We are strategically investing in pre-launch activities" in anticipation of filing their first Biologics License Application (BLA) in the first half of 2026. With plans to expand into other autoimmune indications, including multiple sclerosis, Kyverna aims to establish itself as "the first autoimmune CAR company."

As the pharmaceutical industry closely watches the development of CAR-T therapies for autoimmune diseases, Kyverna's progress in the coming months will be critical in determining its position in this emerging market segment.