KYTX News & Events

Kyverna reported a net loss of $39.7M for the first quarter ended March 31. Research and development expenses were $30.1M, while general and administrative expenses were $11.3M for the period. The company ended the quarter with $236.4M in cash, cash equivalents, and marketable securities, which is expected to provide a cash runway into 2028. During the quarter, Kyverna initiated a rolling BLA submission for miv-cel in stiff person syndrome and continued enrollment in its Phase 3 trial for generalized myasthenia gravis. "As the first company to submit a BLA for an autoimmune CAR T therapy, gaining alignment with the FDA on a single-arm trial and a clear path to submission for miv-cel is a significant milestone for not only Kyverna but also the field," said CEO Warner Biddle.

Kyverna Therapeutics (KYTX) announced the appointment of veteran commercial leader Nadia Dac as chief commercial officer, effective May 4. Dac most recently served as chief commercial officer at Omeros (OMER).

Kyverna Therapeutics announced positive primary analysis results from its registrational trial, KYSA-8, of miv-cel in stiff person syndrome. The data will be presented today in a late-breaking oral presentation at the American Academy of Neurology Annual Meeting in Chicago. In KYSA-8, a single dose of miv-cel delivered rapid, statistically significant and clinically meaningful improvements across all primary and secondary endpoints at 16 weeks, with the majority of patients regaining function, and all patients discontinuing chronic immunotherapies - outcomes not previously observed in SPS. Further, miv-cel was well-tolerated. "The results from our KYSA-8 registrational trial mark a defining moment for Kyverna, and more importantly, for patients living with stiff person syndrome," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "We see compelling evidence that a one-time therapy can reset the immune system, reverse the course of disease, and free patients from lifelong treatment burden. With no approved therapies, we believe miv-cel could redefine the treatment paradigm for this debilitating, progressive disease. We are preparing our BLA submission for this initial indication, and the data strengthen our confidence in miv-cel's therapeutic potential in myasthenia gravis, as well as other neurologic autoimmune diseases."