Full Press Release Details
Advancing first-to-market autoimmune CAR T opportunity in stiff person syndrome (SPS) with key launch preparation activities underway; BLA submission anticipated in 1H 2026
Progressing enrollment for FDA-aligned Phase 3 trial in generalized myasthenia gravis (gMG)
Positive progressive multiple sclerosis data underscore valuable pipeline-in-a-product opportunitywith miv-cel
Cash and cash equivalents of $279 million provide expected runway into 2028, funding SPS BLA filing, commercial launch, and Phase 3 gMG trial
EMERYVILLE, Calif., March 26, 2026(GLOBE NEWSWIRE)-- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the fourth quarter and full year ended December 31, 2025.
“We continue to cement our leadership in autoimmune CAR T supported by our unique construct and a growing body of transformative clinical data that reinforces miv-cel’s differentiated profile,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We are advancing the first CAR T for stiff person syndrome, a serious and debilitating disease with no FDA-approved treatments, representing a significant unmet need and meaningful commercial opportunity. Our market entry will establish the foundation for our neuroimmunology franchise with expansion into generalized myasthenia gravis and potentially other indications, such as progressive multiple sclerosis, where miv-cel has shown promising clinical benefit.”
Fourth Quarter 2025 Highlights and Recent Business Updates
Neuroimmunology CAR T Franchise
Additional Pipeline Opportunities
Corporate Updates
Anticipated Milestones
Financial Results for the Fourth Quarter and Full-Year Ended December 31, 2025Kyverna reported $279.3 million in cash, cash equivalents, and marketable securities as of December 31, 2025. The Company expects to have a cash runway into 2028, funding its SPS BLA filing and commercial launch and its Phase 3 gMG trial.
Research and Development (R&D) expenses were $30.0 million and $133.7 million for the fourth quarter and full year ended December 31, 2025, respectively, compared to $33.5 million and $112.5 million for the same periods last year. R&D expenses for the fourth quarter and full year ended December 31, 2025 included $1.0 million and $3.6 million of non-cash stock-based compensation expenses, respectively.
General and Administrative (G&A) expenses were $9.3 million and $36.1 million for the fourth quarter and full year ended December 31, 2025, respectively, compared to $7.6 million and $30.1 million for the same periods last year. G&A expenses for the fourth quarter and full year ended December 31, 2025 included $1.7 million and $6.5 million, respectively, of non-cash stock-based compensation expenses.
Net loss for the fourth quarter and full year ended December 31, 2025 was $37.8 million and $161.3 million, respectively, compared to a net loss of $37.5 million and $127.5 million, respectively, for the same periods last year.
About miv-cel (mivocabtagene autoleucel, KYV-101)Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, miv-cel has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases.
About Kyverna TherapeuticsKyverna Therapeutics, Inc. (Nasdaq: KYTX) is a late-stage clinical biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. The Company’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its initial indications in stiff person syndrome and generalized myasthenia gravis. The Company is also advancing additional clinical and investigator-sponsored studies, including in progressive multiple sclerosis and rheumatoid arthritis, to inform future priority indications and develop next-generation CAR T platforms to improve access and patient experience. For more information, please visithttps://kyvernatx.com.
Forward-looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: Kyverna’s first-to-market autoimmune CAR T opportunity; the potential for miv-cel to be the first CAR T for SPS; the potential commercial launch of miv-cel in SPS and its potential to be a meaningful commercial opportunity and establish the foundation for expansion into myasthenia gravis and other indications; miv-cel’s promise in SPS, myasthenia gravis, progressive multiple sclerosis and potentially other indications; Kyverna’s potential readiness for commercial launch of miv-cel in SPS, including the sufficiency of its manufacturing capacity and cash runway and the activities such cash runway is expected to support; Kyverna’s anticipated timing for its BLA submission; Kyverna’s potential first-in-class neuroimmunology CAR T franchise; the potential for outpatient administration of miv-cel in SPS; miv-cel’s potential to deliver durable, drug-free, disease-free remission in patients with gMG or other autoimmune disease; and Kyverna’s expected upcoming pipeline milestones, including for SPS, gMG and additional pipeline opportunities. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; the possibility that the FDA or other regulatory agencies may require additional trials or studies to support its intended BLA submission; intellectual property rights; and other factors discussed in the “Risk Factors” section of Kyverna’s Annual Report on Form 10-K for the year ended December 31, 2025 to be filed with the U.S. Securities and Exchange Commission on or about the date hereof. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, please contact:Investors:InvestorRelations@kyvernatx.comMedia:Media@kyvernatx.com
| Kyverna Therapeutics, Inc.Statements of Operations and Comprehensive Loss(in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating expenses | |||||||||||||||
| Research and development | $ | 30,014 | $ | 33,483 | $ | 133,720 | $ | 112,473 | |||||||
| General and administrative | 9,268 | 7,558 | 36,107 | 30,131 | |||||||||||
| Total operating expenses | 39,282 | 41,041 | 169,827 | 142,604 | |||||||||||
| Loss from operations | (39,282 | ) | (41,041 | ) | (169,827 | ) | (142,604 | ) | |||||||
| Interest income | 1,905 | 3,575 | 9,094 | 15,359 | |||||||||||
| Interest expense | (444 | ) | (27 | ) | (489 | ) | (142 | ) | |||||||
| Other expense, net | 17 | 4 | (85 | ) | (90 | ) | |||||||||
| Total other income, net | 1,478 | 3,552 | 8,520 | 15,127 | |||||||||||
| Net loss | (37,804 | ) | (37,489 | ) | (161,307 | ) | (127,477 | ) | |||||||
| Other comprehensive income (loss) | |||||||||||||||
| Unrealized gain (loss) on marketable securities, net | 68 | (48 | ) | (8 | ) | 101 | |||||||||
| Total other comprehensive income (loss) | 68 | (48 | ) | (8 | ) | 101 | |||||||||
| Net loss and other comprehensive loss | $ | (37,736 | ) | $ | (37,537 | ) | $ | (161,315 | ) | $ | (127,376 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.80 | ) | $ | (0.87 | ) | $ | (3.64 | ) | $ | (3.33 | ) | |||
| Weighted-average shares of common stock outstanding, basic and diluted | 47,155,840 | 43,196,247 | 44,259,999 | 38,334,571 |
| Kyverna Therapeutics, Inc.Balance Sheets(in thousands) | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents and available-for-sale marketable securities | $ | 279,253 | $ | 285,979 | ||||
| Prepaid expenses and other current assets | 3,700 | 4,622 | ||||||
| Total current assets | 282,953 | 290,601 | ||||||
| Restricted cash | 551 | 552 | ||||||
| Property and equipment, net | 1,546 | 3,347 | ||||||
| Operating lease right-of-use assets | 3,568 | 6,468 | ||||||
| Finance lease right-of-use assets | 305 | 841 | ||||||
| Other non-current assets | 4,903 | 2,836 | ||||||
| Total assets | $ | 293,826 | $ | 304,645 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | $ | 36,487 | $ | 33,756 | ||||
| Non-current liabilities | 25,063 | 4,302 | ||||||
| Stockholders’ equity | 232,276 | 266,587 | ||||||
| Total liabilities and stockholders’ equity | $ | 293,826 | $ | 304,645 |