Kyverna Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported cash, cash equivalents, and marketable securities of $170.6 million as of September 30, 2026, down from $279.3 million as of December 31, 2025.
• Operating runway is expected to extend into 2028, inclusive of amounts available for draw from the Oxford Finance amended loan facility.
• Research and development expenses were $27.0 million for the quarter, a decrease from $30.5 million in the same period of 2025; year-to-date R&D was $81.9 million compared to $103.7 million in 2025.
• General and administrative expenses were $15.9 million for the quarter, an increase from $8.3 million in the same period of 2025; year-to-date G&A was $41.9 million compared to $26.8 million in 2025.
• Total operating expenses were $42.9 million for the quarter versus $38.7 million in Q3 2025; year-to-date total operating expenses were $123.8 million versus $130.5 million in 2025.
• Reported a net loss of $41.9 million ($0.68 per share) for the quarter, compared to a net loss of $36.8 million ($0.85 per share) in Q3 2025; year-to-date net loss was $120.0 million ($1.96 per share) versus $123.6 million ($2.85 per share) in 2025.
• Interest income was $1.7 million for the quarter compared to $2.0 million in Q3 2025; year-to-date interest income was $5.9 million compared to $7.2 million in 2025.
• Interest expense was $0.7 million for the quarter compared to $0.007 million in Q3 2025; year-to-date interest expense was $2.1 million compared to $0.045 million in 2025.
• Total assets were $189.4 million as of September 30, 2026, down from $293.8 million as of December 31, 2025.
• Current liabilities were $25.1 million as of September 30, 2026, down from $36.5 million as of December 31, 2025.
• Loan payable, net, was $25.0 million as of September 30, 2026, up from $24.7 million as of December 31, 2025.
• Stockholders' equity was $133.2 million as of September 30, 2026, down from $232.3 million as of December 31, 2025.

Guidance and Future Outlook:

• Anticipates a potential FDA approval and commercial launch of miv-cel in 2027.
• Expects enrollment for the KYSA-6 Phase 3 gMG trial to be completed in mid-2027.
• Plans to share its development strategy for Progressive Multiple Sclerosis (PMS) by early 2027.
• Management believes miv-cel's clinical profile and manufacturing process can support a strong launch in SPS if approved.

Business Segments and Product Lines:

• Completed submission of a rolling Biologics License Application (BLA) for miv-cel in stiff person syndrome (SPS), seeking priority review under RMAT designation.
• BLA submission is based on positive data from the KYSA-8 registrational trial in SPS.
• One-year SPS data presented at MS Toronto 2026 showed miv-cel reversed disability and achieved durable efficacy with nearly all patients remaining off chronic immunotherapies after a single dose.
• Primary analysis of KYSA-8 was published in JAMA Neurology; additional one-year biomarker data will be presented at ASH 2026.
• Enrollment for the KYSA-6 registrational trial in generalized myasthenia gravis (gMG) is on track.
• Phase 2 longer-term follow-up data for gMG (presented September 2026) showed robust, durable effects up to 1.5 years with the majority of patients maintaining minimal symptom expression.
• Updated Phase 1 data for PMS from a Stanford University Investigator-initiated trial showed improved disability scores and robust CAR T penetration in the CNS without chronic immunotherapies, with durable results beyond two years in the first patient.
• Received FDA RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS).
• Deprioritized the KYV-102 program to focus on late-stage neurologic indications with miv-cel.
• Advancing lifecycle management activities for miv-cel to broaden patient access and lower costs.
• Over 100 patients have been treated with miv-cel across various autoimmune diseases to date.

Market and Competitive Landscape:

• miv-cel is positioned as a potential first approved therapy for SPS and the first approved CAR-T therapy in an autoimmune disease.
• miv-cel has received three FDA RMAT designations (SPS, gMG, and naSPMS).
• The therapy is designed to reset the immune system with a single dose, potentially freeing patients from lifelong disease and chronic immunotherapies.
• Clinical data demonstrates a consistent, well-tolerated safety profile with no high-grade cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS).

Risks and Challenges:

• Uncertainties related to market conditions and the ability to enroll patients in clinical trials on anticipated timelines.
• Possibility that the FDA may not accept the BLA for filing, grant priority review, require additional data, or may not approve miv-cel on the anticipated timeline or at all.
• Risks associated with the ability to successfully commercialize miv-cel if approved.
• Intellectual property rights risks.
• Potential that results from prior clinical trials and preclinical studies may not be predictive of future results.

Management Commentary and Tone:

• CEO Warner Biddle expressed pride in submitting the first BLA for a CAR T-cell therapy in autoimmune disease, describing it as paving the way for a potential new standard of care.
• Management highlighted the differentiated construct design and established manufacturing process as key supports for a strong launch.
• The company is advancing commercial readiness by hiring key leaders in CAR T, neurology, and rare disease launches, initiating field infrastructure, and preparing treatment centers for potential patient access.
• Management views SPS as the lead indication but believes the opportunity extends to transforming the treatment paradigm for a broader range of neurologic autoimmune diseases.

Other Key Points:

• The company is building an integrated patient support and reimbursement network to streamline the treatment journey.
• Recruiting efforts continue for a focused group of field-based sales and medical specialists.
• The company has executed targeted site activation engagements with CAR-T experts, neurologists, and payers.
• The press release includes a detailed "Forward-looking Statements" section outlining various risks and disclaimers regarding future expectations.