Kyverna Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results
Kyverna Therapeutics (Nasdaq: KYTX) reported Q2 2025 financial results and provided key business updates. The company maintains a strong cash position of $211.7 million, expected to fund operations into 2027. Key highlights include completion of patient enrollment in the registrational Phase 2 trial for stiff person syndrome (SPS), with topline data and BLA submission anticipated in 1H 2026.
The company plans to initiate a Phase 3 registrational trial for myasthenia gravis (MG) by year-end 2025, involving approximately 60 patients, with interim Phase 2 data expected in Q4 2025. For Q2 2025, Kyverna reported a net loss of $42.1 million ($0.97 per share), compared to $28.8 million ($0.67 per share) in Q2 2024. R&D expenses increased to $35.8 million from $27.3 million year-over-year.
Kyverna Therapeutics (Nasdaq: KYTX) ha comunicato i risultati finanziari del secondo trimestre 2025 e fornito aggiornamenti aziendali chiave. L'azienda mantiene una solida posizione di cassa di 211,7 milioni di dollari, prevista per finanziare le operazioni fino al 2027. Tra i punti salienti vi è il completamento dell'arruolamento dei pazienti nello studio registrativo di Fase 2 per la sindrome della persona rigida (SPS), con dati principali e presentazione della BLA attesi nella prima metà del 2026.
L'azienda prevede di avviare uno studio registrativo di Fase 3 per la miastenia gravis (MG) entro la fine del 2025, che coinvolgerà circa 60 pazienti, con dati intermedi della Fase 2 attesi nel Q4 2025. Per il Q2 2025 Kyverna ha riportato una perdita netta di 42,1 milioni di dollari (0,97 $ per azione), rispetto a 28,8 milioni di dollari (0,67 $ per azione) nel Q2 2024. Le spese di ricerca e sviluppo sono aumentate a 35,8 milioni di dollari rispetto ai 27,3 milioni dell'anno precedente.
Kyverna Therapeutics (Nasdaq: KYTX) informó los resultados financieros del segundo trimestre de 2025 y ofreció actualizaciones clave del negocio. La compañía mantiene una sólida posición de caja de 211,7 millones de dólares, que se espera financie las operaciones hasta 2027. Entre los aspectos destacados, completó el reclutamiento de pacientes en el ensayo registracional de fase 2 para el síndrome de la persona rígida (SPS), con datos principales y la presentación de la BLA previstas en la primera mitad de 2026.
La compañía planea iniciar un ensayo registracional de fase 3 para la miastenia gravis (MG) antes de finalizar 2025, con aproximadamente 60 pacientes, y se esperan datos interinos de la fase 2 en el Q4 de 2025. En el Q2 2025 Kyverna reportó una pérdida neta de 42,1 millones de dólares (0,97 $ por acción), frente a 28,8 millones de dólares (0,67 $ por acción) en el Q2 2024. Los gastos de I+D aumentaron a 35,8 millones de dólares desde 27,3 millones interanual.
Kyverna Therapeutics (Nasdaq: KYTX)� 2025� 2분기 재무실적� 주요 사업 업데이트� 발표했습니다. 회사� 운영 자금� 2027년까지 충당� 것으� 보이� 미화 2�1,170� 달러� 탄탄� 현금 포지션을 유지하고 있습니다. 주요 내용으로� 강직� �(person) 증후�(Stiff Person Syndrome, SPS)� 대� 등록� 2�(Phase 2) 임상에서 환자 등록� 완료되었으며, 주요 결과와 BLA 제출� 2026� 상반기에 예상된다� 점입니다.
회사� 2025� 말까지 � 60명을 대상으� 하는 등록� 3�(Phase 3) 시험� 미astenia gravis(MG) 대상으� 시작� 계획이며, 2025� 4분기� 2� 중간 데이터가 기대됩니�. 2025� 2분기 Kyverna� 순손실은 미화 4,210� 달러(주당 0.97달러)�, 2024� 2분기� 2,880� 달러(주당 0.67달러)와 대비됩니다. 연구개발 비용은 전년 동기 2,730� 달러에서 미화 3,580� 달러� 증가했습니다.
Kyverna Therapeutics (Nasdaq: KYTX) a publié ses résultats financiers du deuxième trimestre 2025 et des mises à jour clés sur ses activités. La société dispose d'une solide position de trésorerie de 211,7 millions de dollars, suffisante selon elle pour financer ses opérations jusqu'en 2027. Parmi les points marquants, l'achèvement du recrutement des patients dans l'essai d'enregistrement de phase 2 pour le syndrome de la personne raide (SPS), avec des résultats principaux et le dépôt de la BLA attendus au 1er semestre 2026.
La société prévoit d'initier d'ici la fin 2025 un essai d'enregistrement de phase 3 pour la myasthénie grave (MG), impliquant environ 60 patients, et des données intermédiaires de la phase 2 sont attendues au T4 2025. Pour le T2 2025, Kyverna a enregistré une perte nette de 42,1 millions de dollars (0,97 $ par action), contre 28,8 millions de dollars (0,67 $ par action) au T2 2024. Les dépenses de recherche et développement ont augmenté pour atteindre 35,8 millions de dollars, contre 27,3 millions l'année précédente.
Kyverna Therapeutics (Nasdaq: KYTX) legte die Finanzergebnisse für das 2. Quartal 2025 vor und gab wichtige geschäftliche Updates. Das Unternehmen verfügt über eine starke Barposition von 211,7 Millionen US-Dollar, die voraussichtlich die Geschäftstätigkeit bis 2027 finanziert. Zu den Highlights zählt der Abschluss der Patientenrekrutierung in der registrierenden Phase�2‑Studie für das Stiff‑Person‑Syndrom (SPS); die Topline‑Daten und die Einreichung der BLA werden für das erste Halbjahr 2026 erwartet.
Das Unternehmen plant, bis Ende 2025 eine registrierende Phase�3‑Studie bei Myasthenia gravis (MG) zu initiieren, mit rund 60 Patienten; Zwischenzahlen aus Phase 2 werden für Q4 2025 erwartet. Für Q2 2025 meldete Kyverna einen Nettoverlust von 42,1 Millionen US-Dollar (0,97 $ je Aktie), gegenüber 28,8 Millionen US-Dollar (0,67 $ je Aktie) im Q2 2024. Die F&E‑Aufwendungen stiegen auf 35,8 Millionen US-Dollar gegenüber 27,3 Millionen im Vorjahreszeitraum.
- Strong cash position of $211.7 million providing runway into 2027
- Completed enrollment for registrational Phase 2 trial in SPS
- Expanding clinical pipeline with multiple indication trials including MS and RA
- Successfully completed end-of-Phase 2 FDA meeting for MG program
- Increased net loss to $42.1 million in Q2 2025 from $28.8 million in Q2 2024
- R&D expenses rose 31% year-over-year to $35.8 million
- G&A expenses increased 41% year-over-year to $8.6 million
Insights
Kyverna's strong SPS/MG pipeline progress and solid cash position support key upcoming catalysts through 2026.
Kyverna's Q2 update demonstrates impressive execution on their CAR T autoimmune platform with particularly strong progress in their neuroimmunology franchise. The company has completed enrollment in their registrational Phase 2 trial for stiff person syndrome (SPS), positioning them for topline data and a potential BLA submission in 1H 2026. This represents a significant near-term catalyst as the first potential regulatory approval for the company.
After successful FDA discussions, Kyverna is advancing to a registrational Phase 3 trial in myasthenia gravis (MG) by year-end with just ~60 patients - an impressively small and efficient trial design that suggests strong confidence in their efficacy signals. The interim Phase 2 MG data expected in Q4 2025 will provide crucial validation for their neuroimmunology approach.
Financially, Kyverna maintains a strong position with $211.7 million in cash/equivalents, providing runway into 2027 through their first BLA filing. Their quarterly R&D expenses increased to $35.8 million from $27.3 million year-over-year, reflecting expanded clinical programs. The net loss widened to $42.1 million ($0.97/share) compared to $28.8 million ($0.67/share) in 2024, aligning with their clinical acceleration.
The company is efficiently exploring additional indications through investigator-initiated trials in multiple sclerosis and rheumatoid arthritis, with data expected later this year that could further validate their platform. The advancement of KYV-102 with its simplified manufacturing process (eliminating apheresis) represents an important strategic enhancement to potentially broaden access to their therapies.
What's most notable is Kyverna's focused prioritization on their late-stage neuroimmunology programs while still maintaining momentum across other indications, suggesting a disciplined approach to capital allocation during this pivotal period.
Kyverna's CAR T therapy shows promising advancement in treating difficult autoimmune neurological conditions with significant unmet needs.
From a neurological perspective, Kyverna's progress with KYV-101 represents a potentially groundbreaking approach for treating autoimmune neurological diseases that have historically been challenging to manage with conventional therapies. The completed enrollment for their registrational trial in stiff person syndrome is particularly significant as SPS is an ultra-rare, severely debilitating neurological disorder with limited treatment options. Current SPS therapies like benzodiazepines, baclofen, and IVIG provide only partial symptomatic relief with substantial side effects.
The advancement of their myasthenia gravis program to Phase 3 with a remarkably small sample size (~60 patients) suggests the clinical effect seen thus far must be robust. MG is a condition where current treatments like cholinesterase inhibitors, corticosteroids, and immunosuppressants often provide inadequate control with concerning side effect profiles. A one-time CAR T treatment that provides durable remission would represent a paradigm shift in treatment approach.
The company's expansion into multiple sclerosis through investigator-initiated trials is equally compelling. MS has seen advances with B-cell depleting therapies like ocrelizumab, but these require ongoing administration and don't address long-lived plasma cells. The upcoming ECTRIMS presentations from Stanford and UCSF will be critical in understanding if KYV-101's more comprehensive approach to B-cell depletion translates to clinical benefit in this indication.
What makes KYV-101 particularly promising from a neurological standpoint is its potential to provide deep, durable disease modification through targeted depletion of autoreactive B cells rather than just symptomatic management. If successful, this could fundamentally change treatment algorithms across multiple neuroimmunological conditions that currently lack disease-modifying options.
Topline data for registrational Phase 2 trial of KYV-101 in stiff person syndrome (SPS) and
BLA submission anticipated in 1H 2026
Registrational Phase 3 KYV-101 trial in myasthenia gravis (MG) to include ~60 patients with enrollment to initiate by
year-end 2025; interim Phase 2 data expected in Q4 2025
Strong cash position to support upcoming milestones
EMERYVILLE, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the quarter ended June 30, 2025.
“The second quarter was marked by continued strong execution of our focused strategy, as we achieved key clinical and regulatory milestones to advance our potential first-in-class neuroimmunology CAR T franchise,� said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We anticipate this momentum will continue in the second half of the year with the initiation of our Phase 3 registrational trial in MG. We believe this is an efficient and well-powered trial given the substantial clinical effect size that has been observed in this patient population treated with KYV-101. More broadly, we are well-positioned to deliver on multiple near-term value-creating milestones with our interim Phase 2 MG data readout expected in the fourth quarter of this year as well as anticipated topline registrational data for SPS and BLA filing in the first half of next year. We look forward to sharing more details on these programs at our upcoming KOL event, where we will highlight KYV-101’s differentiated clinical profile, our Phase 3 trial design for MG and the market opportunity for our neuroimmunology franchise.�
Second Quarter 2025 Highlights and Recent Business Updates
KYSA-8 Registrational Phase 2 Trial for Stiff Person Syndrome (SPS)
- Patient enrollment for the registrational trial was completed in the second quarter of 2025. Kyverna remains on track to report topline data from this study and submit its first BLA in the first half of 2026.
KYSA-6 Registrational Phase 2/3 Trial for Myasthenia Gravis (MG)
- Following a successful end-of-Phase 2 meeting with the FDA, Kyverna is expanding its existing KYSA-6 trial to include a Phase 3 portion, which the Company expects to begin enrolling by year-end 2025. The Phase 3 portion of the registrational trial will include approximately 60 patients; further details on the study design will be shared during the Company’s virtual KOL event on August 28, 2025.
- Kyverna has completed enrollment of the Phase 2 portion of the KYSA-6 trial and plans to report interim data in the fourth quarter of 2025.
KYSA-1 and KYSA-3 Trials for Lupus Nephritis (LN)
- Kyverna has concluded enrollment for KYSA-1 and KYSA-3 and plans to share the full data set from its Phase 1 LN trials in a peer-reviewed publication in 2026 as the Company continues to prioritize accelerating its late-stage neuroimmunology indications.
Additional Indications: Multiple Sclerosis (MS) and Rheumatoid Arthritis (RA)
- Kyverna is efficiently exploring additional opportunities for KYV-101 through sponsored clinical trials and investigator-initiated trials (IITs) across several other autoimmune diseases, including MS and RA. Data from these efforts will inform the Company’s indication expansion strategy.
- Phase 1 IIT data of KYV-101 in MS to be showcased at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in September 2025, including an oral presentation on KYV-101 from Stanford University and a poster presentation from the University of California, San Francisco (UCSF).
- Phase 1/2 IIT data of KYV-101 in RA from Charité � University of Berlin to be highlighted at the American College of Rheumatology (ACR) Convergence 2025 meeting in October 2025.
KYV-102
- Kyverna expects to file an investigational new drug (IND) application for KYV-102 in the fourth quarter of 2025. KYV-102 is produced with the Company’s next-generation proprietary whole blood, rapid manufacturing process, incorporating the same construct as KYV-101. KYV-102 provides the opportunity to broaden access through the elimination of apheresis.
Corporate Updates
- In June 2025, Kyverna Therapeutics announced the appointment of Marc Grasso, M.D., as Chief Financial Officer. Dr. Grasso brings over 25 years of public company, capital markets and investment banking experience. His appointment marks a strategic addition to Kyverna’s executive team as the company advances its late-stage clinical and commercial efforts in autoimmune cell therapy.
- Kyverna will host a virtual KOL event, “A Spotlight on Kyverna’s Neuroimmunology CAR T Franchise,� on Thursday, August 28, 2025, from 11:00 am � 1:30 pm ET. The event will be webcast live and those who intend to join can pre-register for the webcast .
Anticipated Milestones
Kyverna has issued the following guidance on upcoming program milestones:
- ʳ:
- Report topline registrational Phase 2 data in 1H 2026
- BLA filing in 1H 2026
- ѳ:
- Report interim Phase 2 data in Q4 2025
- Initiate enrollment for registrational Phase 3 trial by year-end 2025 (New)
- :
- Report Phase 1 data in a peer-reviewed publication in 2026
- Additional Indications:
- MS: Report Phase 1 IIT data in Q3 2025 (New)
- RA: Report Phase 1/2 IIT data in Q4 2025 (New)
- Future Pipeline:
- File KYV-102 IND application in Q4 2025
- File KYV-102 IND application in Q4 2025
Financial Results for the Quarter Ended June 30, 2025
Kyverna reported
Research and Development (R&D) expenses were
General and Administrative (G&A) expenses were
For the quarter ended June 30, 2025, the Company reported a net loss of
About KYV-101
KYV-101 is a fully human, autologous, CD19 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, KYV-101 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 Therapeutics
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through late-stage clinical development with registrational trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications for the Company to advance into late-stage development. Additionally, its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using its proprietary whole blood rapid manufacturing process. For more information, please visit .
Forward-looking Statements
Statements 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 strategic priorities and focus and anticipation of continued momentum in the execution of its clinical and regulatory strategy; the expected timing for releasing topline data for its registrational Phase 2 trial in stiff person syndrome; the potential for KYV-101 to be a first-in-class neuroimmunology CAR T franchise; the anticipated number of patients to be enrolled in the registrational Phase 2/3 trial in MG; Kyverna’s anticipated milestones and timing thereof, including the anticipated timing for a BLA submission, the anticipated timing for initiating the registrational Phase 2/3 trial in MG, and the anticipated timing for reporting data from clinical trials and IITs; KVY-101’s differentiated clinical profile; Kyverna’s anticipated cash runway; Kyverna’s upcoming KOL event and the topics anticipated to be discussed at such event, including the trial design for the registrational Phase 3 trial in MG; Kyverna’s indication expansion strategy and exploration of additional opportunities for KYV-101 in other autoimmune diseases, including in MS and RA; and Kyverna’s clinical trials, IITs and named-patient activities. 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 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 most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. 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.
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Kyverna Therapeutics, Inc. | |||||||||||||||
Statements of Operations and Comprehensive Loss | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||||||
Operating expenses | |||||||||||||||
Research and development | $ | 35,816 | $ | 27,321 | $ | 73,249 | $ | 49,797 | |||||||
General and administrative | 8,594 | 6,114 | 18,569 | 12,996 | |||||||||||
Total operating expenses | 44,410 | 33,435 | 91,818 | 62,793 | |||||||||||
Loss from operations | (44,410 | ) | (33,435 | ) | (91,818 | ) | (62,793 | ) | |||||||
Interest income | 2,364 | 4,694 | 5,189 | 7,429 | |||||||||||
Interest expense | (14 | ) | (39 | ) | (38 | ) | (83 | ) | |||||||
Other expense, net | (21 | ) | (23 | ) | (49 | ) | (49 | ) | |||||||
Total other income, net | 2,329 | 4,632 | 5,102 | 7,297 | |||||||||||
Net loss | (42,081 | ) | (28,803 | ) | (86,716 | ) | (55,496 | ) | |||||||
Other comprehensive loss | |||||||||||||||
Unrealized loss on available-for-sale marketable securities, net | (19 | ) | (36 | ) | (125 | ) | (41 | ) | |||||||
Total other comprehensive loss | (19 | ) | (36 | ) | (125 | ) | (41 | ) | |||||||
Net loss and other comprehensive loss | $ | (42,100 | ) | $ | (28,839 | ) | $ | (86,841 | ) | $ | (55,537 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.97 | ) | $ | (0.67 | ) | $ | (2.01 | ) | $ | (1.66 | ) | |||
Weighted-average shares of common stock outstanding, basic and diluted | 43,225,365 | 43,125,709 | 43,220,498 | 33,439,886 |
Kyverna Therapeutics, Inc. | ||||||||
Condensed Balance Sheets | ||||||||
(in thousands) | ||||||||
(Unaudited) | ||||||||
June 30, | December 31, | |||||||
2025 | 2024 | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents and available-for-sale marketable securities | $ | 211,677 | $ | 285,979 | ||||
Prepaid expenses and other current assets | 2,650 | 4,622 | ||||||
Total current assets | 214,327 | 290,601 | ||||||
Restricted cash | 551 | 552 | ||||||
Property and equipment, net | 2,162 | 3,347 | ||||||
Operating lease right-of-use assets | 5,049 | 6,468 | ||||||
Finance lease right-of-use assets | 366 | 841 | ||||||
Other non-current assets | 4,053 | 2,836 | ||||||
Total assets | $ | 226,508 | $ | 304,645 | ||||
Liabilities and stockholders� equity | ||||||||
Current liabilities | $ | 39,789 | $ | 33,756 | ||||
Non-current liabilities | 2,342 | 4,302 | ||||||
Stockholders� equity | 184,377 | 266,587 | ||||||
Total liabilities and stockholders� equity | $ | 226,508 | $ | 304,645 |
