KYTX · Kyverna Therapeutics, Inc.

Kyverna Therapeutics reported its first quarter 2026 financial results, highlighting a net loss of $39.7 million ($0.66 per share) compared to a net loss of $37.4 million in the same period last year. R&D expenses decreased to $30.1 million from $37.4 million, while G&A expenses were $11.3 million. The company ended the quarter with $236.4 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028. The key operational highlight was the initiation of a rolling BLA submission for miv-cel in stiff person syndrome (SPS) following a positive pre-BLA meeting with the FDA, where alignment was reached on using the single-arm KYSA-8 trial as the basis for submission. The primary endpoint is the Timed 25-foot Walk test at 16 weeks. The company anticipates completing the submission in Q4 2026 and is seeking priority review under RMAT designation. Additionally, Kyverna presented primary analysis data from KYSA-8 at AAN 2026, demonstrating statistically significant and durable clinical benefit across all endpoints, with 100% of patients remaining free of immunotherapies at Week 16. The company also reported progress in its gMG Phase 3 trial and positive updated data from the PMS IIT. The appointment of Nadia Dac as Chief Commercial Officer underscores the company's focus on commercial readiness for a potential 2027 launch in SPS. Overall, the quarter marked a significant regulatory milestone, positioning Kyverna as a leader in autoimmune CAR T therapy.