Kyverna Therapeutics filings document a late-stage clinical biopharmaceutical company developing cell therapies for autoimmune diseases. Its Form 8-K disclosures frequently cover Regulation FD updates for miv-cel clinical data, business and financial results, and material corporate events involving leadership, board composition, and commercial organization changes.
The company's proxy and governance filings describe director elections, board committees, executive compensation, stockholder voting matters, and equity incentive arrangements, including inducement awards. SEC records also identify Kyverna's Nasdaq-listed common stock and provide formal disclosure around its CAR T development strategy, clinical programs in neuroimmunology, capital planning, risk factors, and public-company governance.
Kyverna Therapeutics, Inc. (KYTX) is the subject of a joint Schedule 13G in which Orin Hirschman and AIGH Capital Management LLC report beneficial ownership of 3,650,000 common shares, or 5.9% of the class. Both report sole voting and sole dispositive power over 3,650,000 shares, and shared voting and dispositive power of 0 shares. Hirschman is identified as managing member of AIGH Capital Management LLC and president of AIGH Investment Partners, LLC.
Kyverna Therapeutics, Inc. reported one-year topline results from its registrational KYSA-8 trial of miv-cel in stiff person syndrome (SPS): among 26 patients followed to 12 months, median improvement from baseline on the timed 25-Foot Walk was 49%. Of patients who achieved clinically meaningful improvement at the primary analysis, 95% sustained that benefit; 92% remained free of chronic SPS immunotherapies. The data were based on a July 2026 database lock.
In the Phase 2 portion of KYSA-6 for generalized myasthenia gravis (gMG), all 7 patients had clinically meaningful improvement in MG-ADL and QMG at 24 weeks. Five had follow-up of at least one year, extending to 1.5 years; 57% maintained minimal symptom expression, and 6 of 7 remained off immunosuppressants at last follow-up. Both trial updates reported no cases of IEC-HS; neither reported high-grade CRS or ICANS. Kyverna said its rolling SPS BLA submission is on track for completion in Q4 2026, and KYSA-6 Phase 3 enrollment is expected to finish in mid-2027.
Bain Capital Life Sciences Opportunities III, LP, an investment fund organized in Delaware, reported beneficial ownership of Kyverna Therapeutics, Inc. common stock. As of the close of business on June 30, 2026, the fund held 2,885,000 shares of common stock.
This position represents 4.75% of Kyverna’s outstanding common shares, based on 60,795,212 shares outstanding as reported by Kyverna for the quarter ended March 31, 2026. The Bain Capital Life Sciences entities have shared voting and dispositive power over these shares and no sole voting or dispositive power.
Kyverna Therapeutics is a late-stage clinical immunology company developing CAR T therapies for neurologic autoimmune diseases, led by mivocabtagene autoleucel (miv-cel/KYV-101). For the six months ended June 30, 2026, the company reported a net loss of $78.0 million, an improvement from $86.7 million a year earlier, driven mainly by lower research and development expenses of $54.9 million versus $73.2 million, partially offset by higher general and administrative expenses of $26.1 million versus $18.6 million.
Cash, cash equivalents and marketable securities totaled $199.4 million at June 30, 2026, with net cash used in operating activities of $81.9 million in the first half. Management expects existing cash, an undrawn $125.0 million capacity under a term loan facility, and an at-the-market equity program to fund operations for at least 12 months. Clinically, Kyverna reported positive Phase 2 data in stiff person syndrome, initiated a rolling BLA submission supported by RMAT and orphan designations, advanced its Phase 3 trial in generalized myasthenia gravis, secured an ElevateBio commercial supply agreement, and received RMAT designation for non-active secondary progressive multiple sclerosis.
Kyverna Therapeutics reported second quarter 2026 results and a business update centered on its lead CAR T-cell therapy miv-cel. The FDA granted RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis, expanding its regulatory momentum across neuroimmunology.
The company has begun a rolling BLA for stiff person syndrome, submitted the CMC module, and expects to complete the filing in Q4 2026 while planning to seek priority review and preparing for a potential 2027 commercial launch. Enrollment continues in the Phase 3 KYSA-6 trial in generalized myasthenia gravis, with completion targeted by mid-2027 and additional Phase 2 data expected in Q3 2026.
Kyverna reported $199.4 million in cash, cash equivalents and marketable securities as of June 30, 2026, which together with its loan facility is expected to fund operations into 2028. In Q2 2026, R&D expenses were $24.8 million, G&A expenses were $14.8 million, and net loss was $38.3 million, or $0.63 per share.
BlackRock, Inc. has reported beneficial ownership of 3,103,757 shares of KYVERNA THERAPEUTICS INC common stock on a Schedule 13G. This represents 5.1% of the company’s outstanding common shares as of the reporting date.
BlackRock has sole voting power over 3,069,290 shares and sole dispositive power over 3,103,757 shares, with no shared voting or dispositive power. Various underlying clients have rights to dividends or sale proceeds, but no single client holds more than five percent of the total outstanding common shares.
Kyverna Therapeutics entered a new Clinical and Commercial Supply Agreement with ElevateBio that replaces their prior development and manufacturing arrangement for miv-cel, its autologous CD19-directed CAR T-cell therapy for autoimmune diseases. ElevateBio will provide development, clinical and commercial manufacturing under statements of work, and Kyverna agreed to order at least certain minimum quantities of miv-cel in specified years and after regulatory approvals.
The agreement runs for an initial term of five years, then automatically renews for successive one-year periods, and includes annual price and fee adjustments tied to the Producer Price Index for Pharmaceutical Preparation Manufacturing, along with customary quality, audit and confidentiality provisions. A joint press release notes ElevateBio’s clinical manufacturing success rate of more than 98% for miv-cel and states that Kyverna remains on track to complete its rolling Biologics License Application submission for stiff person syndrome in the fourth quarter of 2026, supporting potential launches in stiff person syndrome and generalized myasthenia gravis and other ongoing studies.
Kyverna Therapeutics, Inc. amended its existing non-dilutive term loan facility with Oxford Finance, which provides up to $150.0 million in multiple tranches. The company previously drew $25.0 million from Term A and now has extended access to the remaining $15.0 million of Term A Loans through December 31, 2026 in exchange for an upfront fee of $187,500.
If Kyverna does not use the full remaining Term A amount by that date, it will pay a 1.0% non‑utilization fee on the undrawn balance. Contingent on drawing the remaining Term A funds, availability periods for the Term B Loan of $5.0 million to $20.0 million and two $20.0 million Term C tranches will be extended or restructured around specific clinical and revenue milestones.
Under those same conditions, Kyverna will also become subject to minimum revenue covenants beginning with a quarter ending as early as June 30, 2027, with the start date tied to how much cash it raises from other capital sources over certain periods.
Kyverna Therapeutics, Inc. reported results from its 2026 annual stockholder meeting. Of 60,530,293 common shares outstanding as of March 30, 2026, 43,987,007 shares were represented, about 73% of shares entitled to vote, which was sufficient to constitute a quorum.
Stockholders elected Class II directors Ian Clark and Christi Shaw to serve until the 2029 annual meeting or until their successors are elected and qualified. Clark received 31,505,902 votes for and 3,255,231 votes withheld, while Shaw received 34,528,865 votes for and 232,268 votes withheld, with 9,225,874 broker non-votes on each nominee.
Stockholders also ratified the Audit Committee’s appointment of BDO USA, P.C. as the independent registered public accounting firm and independent auditor for the year ending December 31, 2026, with 43,830,300 votes for, 80,223 votes against, and 76,484 abstentions.
Kyverna Therapeutics director Ian T. Clark received new equity awards. He was granted 5,093 restricted stock units of common stock, bringing his direct common share holdings to 21,727. He also received options for 20,582 shares at an exercise price of $8.59, expiring in 2036.
Both the RSUs and options will fully vest on the earlier of May 27, 2027, or immediately before Kyverna’s 2027 annual stockholders’ meeting, as long as he remains in continuous service through that date.