Kyverna Therapeutics Updates on Business and Q2 2024 Financials

Kyverna Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to developing cell therapies for autoimmune disease patients, recently announced its business achievements and financial outcomes for the second quarter ending June 30, 2024. The company’s lead candidate, KYV-101, has shown significant promise in both safety and efficacy within the scope of CAR T-cell therapies for autoimmune diseases.

Peter Maag, the Chief Executive Officer of Kyverna, expressed optimism about KYV-101, highlighting its potential to harness CD19-directed CAR T therapy for effective B cell depletion in tissues. This potential is enhanced by a fully human CAR and CD28 costimulatory domain designed by the NIH to improve tolerability. Maag emphasized the company's ongoing commitment to bringing hope to patients suffering from autoimmune disorders and indicated that more clinical data would be shared throughout the year.

During the second quarter of 2024, Kyverna presented data on CAR usage from KYV-101 across 50 patients with 15 different autoimmune conditions in CAR T centers located in the US and Europe. Importantly, no severe ICANS or CRS (Grade ≥3) was reported in the first 36 autoimmune disease patients treated with KYV-101. This CAR construct, designed by the NIH, aims to enhance tolerability, marking a notable success in Kyverna’s safety profile.

Kyverna also received two RMAT (Regenerative Medicine Advanced Therapy) designations from the U.S. FDA for KYV-101. These designations cover the treatment of patients with Stiff-Person Syndrome and myasthenia gravis, further validating the clinical evidence supporting KYV-101's potential. Additionally, Kyverna achieved a 100% manufacturing success rate for all 36 cumulative autoimmune patients treated with KYV-101 as of July 31, 2024.

In a significant clinical milestone, a myasthenia gravis patient treated with KYV-101 was reported to be disease-free one year post-treatment. The company continues to progress its global KYSA clinical trial program in various indications within rheumatology and neurology. Ongoing trials include Phase 1/2 studies for lupus nephritis (KYSA-1 and KYSA-3), systemic sclerosis (KYSA-5), and Phase 2 trials for myasthenia gravis (KYSA-6), multiple sclerosis (KYSA-7), and stiff-person syndrome (KYSA-8).

Looking ahead, Kyverna plans to present neurology case reports at the ECTRIMS conference in September 2024 and provide updates on the KYSA clinical trials at the ACR conference in November 2024. The company also anticipates regulatory phase transitions in 2025, following RMAT meetings with the FDA.

Financially, for the second quarter ending June 30, 2024, Kyverna reported a net loss of $28.8 million, equating to a net loss per common share of $0.67. This contrasts with a net loss of $13.1 million, or $20.86 per common share, for the same period in 2023. For the first half of 2024, net cash used in operating activities was $49.7 million, compared to $22.7 million during the first half of 2023. As of June 30, 2024, Kyverna had $346.2 million in cash, cash equivalents, and marketable securities.

Kyverna Therapeutics remains focused on its mission to advance cell therapies for autoimmune diseases. Their lead candidate, KYV-101, is undergoing clinical development across various conditions in rheumatology and neurology. This includes Phase 2 trials for multiple sclerosis, myasthenia gravis, and stiff-person syndrome, and a Phase 1/2 trial for systemic sclerosis. Kyverna's pipeline also features next-generation CAR T-cell therapies designed for B cell-driven autoimmune diseases.

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