Kyverna Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results
Kyverna Therapeutics (NASDAQ: KYTX) has provided its Q4 and full-year 2024 financial results, reporting significant progress in its autoimmune CAR T-cell therapy programs. The company ended 2024 with $286.0 million in cash, projecting runway into 2027.
Key developments include:
- 70% enrollment completion in the registrational Phase 2 KYSA-8 trial for stiff person syndrome, with topline data expected in 1H 2026
- Completed initial patient cohort enrollment for myasthenia gravis Phase 2 trial, with interim data expected in 2H 2025
- Advancing two Phase 1/2 trials in lupus nephritis with data expected in 2H 2025
The company reported a net loss of $127.5 million ($3.33 per share) for 2024, compared to $60.4 million ($89.61 per share) in 2023. Net cash used in operations was $114.3 million, up from $52.4 million in 2023.
Kyverna Therapeutics (NASDAQ: KYTX) ha fornito i risultati finanziari del quarto trimestre e dell'intero anno 2024, riportando progressi significativi nei suoi programmi di terapia CAR T-cell per le malattie autoimmuni. L'azienda ha chiuso il 2024 con 286,0 milioni di dollari in cassa, prevedendo un finanziamento fino al 2027.
Sviluppi chiave includono:
- Completamento del 70% dell'arruolamento nella fase registrativa 2 dello studio KYSA-8 per la sindrome della persona rigida, con dati preliminari attesi nel primo semestre del 2026
- Completato l'arruolamento del gruppo iniziale di pazienti per lo studio di fase 2 sulla miastenia grave, con dati intermedi attesi nel secondo semestre del 2025
- Avanzamento di due studi di fase 1/2 sulla nefriti lupica con dati attesi nel secondo semestre del 2025
L'azienda ha riportato una perdita netta di 127,5 milioni di dollari (3,33 dollari per azione) per il 2024, rispetto a 60,4 milioni di dollari (89,61 dollari per azione) nel 2023. Il denaro netto utilizzato nelle operazioni 猫 stato di 114,3 milioni di dollari, in aumento rispetto ai 52,4 milioni di dollari del 2023.
Kyverna Therapeutics (NASDAQ: KYTX) ha presentado sus resultados financieros del cuarto trimestre y del a帽o completo 2024, informando sobre avances significativos en sus programas de terapia CAR T-cell para enfermedades autoinmunes. La compa帽铆a termin贸 2024 con 286,0 millones de d贸lares en efectivo, proyectando financiamiento hasta 2027.
Desarrollos clave incluyen:
- 70% de finalizaci贸n de inscripci贸n en el ensayo de fase 2 KYSA-8 para el s铆ndrome de persona r铆gida, con datos preliminares esperados en la primera mitad de 2026
- Finalizaci贸n de la inscripci贸n del grupo inicial de pacientes para el ensayo de fase 2 de miastenia grave, con datos intermedios esperados en la segunda mitad de 2025
- Avance de dos ensayos de fase 1/2 en nefritis l煤pica con datos esperados en la segunda mitad de 2025
La compa帽铆a report贸 una p茅rdida neta de 127,5 millones de d贸lares (3,33 d贸lares por acci贸n) para 2024, en comparaci贸n con 60,4 millones de d贸lares (89,61 d贸lares por acci贸n) en 2023. El efectivo neto utilizado en operaciones fue de 114,3 millones de d贸lares, un aumento respecto a los 52,4 millones de d贸lares en 2023.
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Kyverna Therapeutics (NASDAQ: KYTX) a fourni ses r茅sultats financiers du quatri猫me trimestre et de l'ann茅e compl猫te 2024, rapportant des progr猫s significatifs dans ses programmes de th茅rapie CAR T-cell pour les maladies auto-immunes. L'entreprise a termin茅 2024 avec 286,0 millions de dollars en esp猫ces, pr茅voyant un financement jusqu'en 2027.
Les d茅veloppements cl茅s comprennent :
- 70 % d'ach猫vement de l'inscription dans l'essai de phase 2 KYSA-8 pour le syndrome de la personne rigide, avec des donn茅es pr茅liminaires attendues au premier semestre 2026
- Ach猫vement de l'inscription du groupe initial de patients pour l'essai de phase 2 sur la myasth茅nie grave, avec des donn茅es interm茅diaires attendues au second semestre 2025
- Avancement de deux essais de phase 1/2 sur la n茅phrite lupique avec des donn茅es attendues au second semestre 2025
L'entreprise a rapport茅 une perte nette de 127,5 millions de dollars (3,33 dollars par action) pour 2024, contre 60,4 millions de dollars (89,61 dollars par action) en 2023. La tr茅sorerie nette utilis茅e dans les op茅rations s'茅levait 脿 114,3 millions de dollars, en hausse par rapport 脿 52,4 millions de dollars en 2023.
Kyverna Therapeutics (NASDAQ: KYTX) hat seine finanziellen Ergebnisse f眉r das 4. Quartal und das gesamte Jahr 2024 ver枚ffentlicht und erhebliche Fortschritte in seinen CAR-T-Zelltherapieprogrammen f眉r Autoimmunerkrankungen gemeldet. Das Unternehmen schloss das Jahr 2024 mit 286,0 Millionen Dollar in bar ab und prognostiziert eine Finanzierung bis 2027.
Wesentliche Entwicklungen umfassen:
- 70% Abschluss der Rekrutierung in der registrierenden Phase-2-Studie KYSA-8 f眉r das steife Personensyndrom, mit ersten Daten, die im 1. Halbjahr 2026 erwartet werden
- Abschluss der Rekrutierung der ersten Patientengruppe f眉r die Phase-2-Studie zur Myasthenia gravis, mit Zwischenberichten, die im 2. Halbjahr 2025 erwartet werden
- Fortschritte bei zwei Phase-1/2-Studien zu Lupusnephritis mit Daten, die im 2. Halbjahr 2025 erwartet werden
Das Unternehmen berichtete von einem Nettoverlust von 127,5 Millionen Dollar (3,33 Dollar pro Aktie) f眉r 2024, verglichen mit 60,4 Millionen Dollar (89,61 Dollar pro Aktie) im Jahr 2023. Der Netto-Cashflow aus dem operativen Gesch盲ft betrug 114,3 Millionen Dollar, ein Anstieg von 52,4 Millionen Dollar im Jahr 2023.
- Strong cash position of $286.0 million with runway into 2027
- 70% enrollment completion in registrational Phase 2 SPS trial
- Received RMAT and Orphan Drug designations for multiple programs
- Clear regulatory pathway with FDA alignment on registrational trial design
- Net loss increased to $127.5 million in 2024 from $60.4 million in 2023
- Cash burn rate increased with operating cash use of $114.3 million vs $52.4 million in 2023
Insights
Kyverna Therapeutics has demonstrated solid execution with clinical progress across multiple autoimmune indications, most notably reaching alignment with the FDA on a registrational Phase 2 trial design for their lead program in stiff person syndrome (SPS). This regulatory clarity significantly de-risks their path to market, with 70% enrollment completed and a BLA filing targeted for 2026.
The company's strong cash position of
Kyverna's strategic focus on three priority indications (SPS, myasthenia gravis, and lupus nephritis) with multiple readouts expected in 2025-2026 creates several near-term catalysts. The regulatory designations secured (RMAT, Fast Track, Orphan Drug) offer potential accelerated approval pathways and market exclusivity.
Their KYV-101 autologous CAR T-cell therapy leverages a differentiated fully human CD19 CAR with potent CD28 co-stimulation, potentially offering profound clinical outcomes in autoimmune diseases. The company's progress in manufacturing readiness with ElevateBio further supports their commercialization timeline.
The management team strengthening with experienced industry leaders enhances execution capabilities during this critical transition toward late-stage development and potential commercialization.
Kyverna's clinical progress with KYV-101 represents a significant advancement in applying CAR T-cell therapy beyond oncology into autoimmune diseases. Their fully human CD19 CAR T-cell product with CD28 co-stimulation appears well-positioned in this emerging therapeutic area.
The FDA alignment on a registrational Phase 2 trial design for SPS is particularly noteworthy, as it establishes a clear regulatory pathway in a rare disease with high unmet need. The RMAT designation further validates the potential transformative impact of this therapy.
Their three-pronged clinical strategy targeting distinct autoimmune mechanisms (neurological with SPS, neuromuscular with myasthenia gravis, and rheumatological with lupus nephritis) demonstrates a thoughtful approach to platform expansion. The sustained efficacy observed in lupus nephritis patients at >6-month follow-up suggests potential durability of response.
The next-generation KYV-102 program incorporating proprietary whole-blood rapid manufacturing could significantly improve patient access by eliminating apheresis, addressing a key limitation of current CAR T therapies. This manufacturing innovation could provide substantial competitive advantage in the autoimmune space where broader patient populations may benefit.
The successful onboarding of ElevateBio for clinical manufacturing support addresses a critical aspect of CAR T development, as manufacturing consistency and scalability remain challenging hurdles in cell therapy commercialization. This partnership strengthens Kyverna's ability to execute on their ambitious clinical timeline across multiple indications.
Accelerating clinical path to commercialization in stiff person syndrome, myasthenia gravis and lupus nephritis
Aligned with the
Biologics License Application (BLA) filing targeted for 2026听听
Clinical data in myasthenia gravis and lupus nephritis expected in 2H 2025听听
Strong balance sheet extends cash runway into 2027 through key clinical and regulatory catalysts
"Kyverna's first year as a public company was a transformative one, as we demonstrated our leadership position in autoimmune CAR T. We have treated the most CAR T patients in neuroinflammatory and rheumatologic diseases with our differentiated construct, and our clinical experience to date highlights the potential for profound clinical outcomes in autoimmune patients," said Warner Biddle, Chief Executive Officer of Kyverna. "Kyverna has entered 2025 and its next phase of growth with the right strategy and a strong team in place to advance late-stage development of KYV-101 in our three priority indications 鈥� stiff person syndrome, myasthenia gravis and lupus nephritis 鈥� each with a clear and rapid path to market. We are pleased with our progress in our lead indication, stiff person syndrome, following alignment with the FDA on our registrational trial, KYSA-8, which is an important milestone as we advance KYV-101 toward its first BLA filing in 2026."听听听 听
Fourth Quarter 2024 Highlights and Recent Business Updates
KYV-101: Autologous, fully human CD19 CAR T-cell product candidate, incorporating highly potent CD28 co-stimulation.听 KYV-101 is currently being evaluated in company-sponsored KYSA trials and investigator-initiated trials in numerous B cell mediated autoimmune diseases with a prioritized focus in stiff person syndrome, myasthenia gravis and lupus nephritis.
Stiff Person Syndrome (SPS)
- Kyverna has aligned with the FDA on a registrational Phase 2 design for its ongoing KYSA-8 trial in SPS, which has enrolled
70% of study participants. Completion of enrollment is expected in mid-2025. - The Company expects to report topline data from this study in the first half of 2026 and anticipates submitting its first BLA in 2026. The Company received a Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation from the FDA for this program.
- Kyverna continues to progress its chemistry, manufacturing, and controls (CMC) readiness efforts in support of this anticipated BLA filing and has successfully onboarded ElevateBio to manufacture Kyverna's clinical trial product for KYV-101 in SPS.
Myasthenia Gravis (MG)
- Kyverna's Phase 2 trial in MG, KYSA-6, has completed patient enrollment in an initial 6-patient cohort and the Company plans to report interim data from this cohort in the second half of 2025. The Company continues to engage in positive dialogue with the FDA and plans to provide an update on the registrational path for KYV-101 in the first half of this year.
- The Company received an RMAT Designation and Fast Track Designation from the FDA as well as Orphan Drug Designation from both the FDA and European Medicines Agency for this program.
Lupus Nephritis (LN)
- Kyverna is currently advancing two Phase 1/2 trials in LN, KYSA-1 and KYSA-3. Kyverna has completed the dose-escalation cohort of KYSA-1 and is now treating patients at the target dose and expects to report Phase 1 data from both of these trials in the second half of 2025. The Company has received Fast Track Designation from the FDA for this program.
- In November 2024, Kyverna presented clinical data at American College of Rheumatology (ACR) Convergence 2024 demonstrating positive sustained efficacy and durability at >6-month follow-up observed in patients with severe LN treated with KYV-101 at the target dose.
Additional Indications
- Kyverna is efficiently exploring additional opportunities for KYV-101 beyond the Company's priority indications through sponsored clinical trials and investigator-initiated trials (IITs) across numerous other autoimmune diseases, including systemic sclerosis and multiple sclerosis. Data from these efforts will inform selection of the next priority indication(s) to accelerate into late-stage development.
KYV-102: Next-generation candidate incorporating our patented fully human CD19 CAR T and the Company's proprietary whole-blood rapid manufacturing approach, which aims to improve the CAR T patient experience, eliminate apheresis and broaden CAR T access.
- Kyverna expects to file an investigational new drug application for KYV-102 in the second half of 2025.
Corporate Updates
- Strengthened management team with addition of Warner Biddle, Chief Executive Officer; Naji Gehchan, MD, MSc, MBA, Chief Medical and Development Officer; Dan Maziasz, Chief Business Officer; Cara Bauer PhD, Chief Human Resources Officer; and Tracy Rossin, Senior Vice President of Corporate Affairs, Communications and Investor Relations.
- Appointed Christi Shaw and Mert Aktar to the Board of Directors, bringing decades of industry leadership in corporate strategy and manufacturing expertise, including gene and cell therapy.
Anticipated Milestones
Kyverna has issued the following guidance on upcoming program milestones:
- SPS:
- Complete Pivotal Phase 2 Enrollment mid-2025
- Report Topline Pivotal Phase 2 Data 1H 2026
- BLA filing in 2026
- MG:
- Confirm Registrational Path with Regulators 1H 2025
- Report Interim Phase 2 Data 2H 2025
- LN:
- Report Phase 1 Data 2H 2025
- Future Pipeline:
- File KYV-102 IND application 2H 2025
Financial Results for the Year Ended December 31, 2024
Kyverna reported
For the year ended December 31, 2024, the Company reported a net loss of
During the year ended December 31, 2024, net cash used in operating activities was
About KYV-101
Uniquely designed, KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate with highly potent CD28 co-stimulation and designed for tolerability, which is under investigation for B-cell-driven autoimmune diseases.听 With KYV-101, Kyverna is pioneering a durable disease-clearing approach aiming for deep B cell depletion, an immune system reset, and long-term remission in autoimmune diseases.听
KYV-101 is currently being evaluated in a company-sponsored, open-label, pivotal Phase 2 trial in stiff person syndrome, a Phase 2 trial in myasthenia gravis and Phase 1/2 trials for lupus nephritis, as well as in investigator-initiated trials and company-sponsored trials for multiple indications. The clinical experience to date with KYV-101 highlights the potential for transformative clinical outcomes in autoimmune patients.听
About KYV-102
KYV-102 leverages the same fully human, clinically validated CD19 CAR-T construct as KYV-101.听 It incorporates the Ingenui-T platform, a proprietary, next-generation process that utilizes whole blood with a rapid manufacturing approach.听听
Kyverna intends to broaden CAR T patient access with KYV-102 by eliminating the need for apheresis starting material and reducing the manufacturing turnaround time from conventionally manufactured CAR T products.听
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 clinical development with Phase 2 trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis.听 The Company is also harnessing investigator-initiated trials and other KYSA studies, including in multiple sclerosis and systemic sclerosis, to inform the next priority indications for the Company to advance into late-stage development.听 Its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases.听 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; the status of its Phase 2 trial in stiff person syndrome as a pivotal trial; the potential for KYV-101 to be the first-to-market in stiff person syndrome; the potential for KYV-102 to improve the patient experience and broaden CAR T access; anticipated milestones and timing thereof, including anticipated timing for the first intended BLA submission for KYV-101 and timing for reporting data as well as expected completion of enrollments; the speed at which any approvals may be obtained; Kyverna's engagement with regulators; Kyverna's anticipated cash runway; and Kyverna's clinical trials, investigator initiated trials 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 conclude that Kyverna's Phase 2 trial in stiff person syndrome is not sufficient to be registration-enabling and may require additional trials or studies to support its intended BLA submission; 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
For more information, please contact:
Investors: [email protected]
Media: [email protected]
Kyverna Therapeutics, Inc. Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited) | ||||||||
Year Ended December 31, | ||||||||
2024 | 2023 | |||||||
Operating expenses | ||||||||
Research and development | $ | 112,473 | $ | 49,923 | ||||
General and administrative | 30,131 | 12,483 | ||||||
Total operating expenses | 142,604 | 62,406 | ||||||
Loss from operations | (142,604) | (62,406) | ||||||
Interest income | 15,359 | 2,282 | ||||||
Interest expense | (142) | (187) | ||||||
Other expense, net | (90) | (55) | ||||||
Total other income, net | 15,127 | 2,040 | ||||||
Net loss | (127,477) | (60,366) | ||||||
Other comprehensive income | ||||||||
Unrealized gain on available-for-sale marketable securities, net | 101 | 30 | ||||||
Total other comprehensive income | 101 | 30 | ||||||
Net loss and other comprehensive loss | $ | (127,376) | $ | (60,336) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (3.33) | $ | (89.61) | ||||
Weighted-average shares of common stock outstanding, basic and diluted | 38,334,571 | 673,622 | ||||||
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Kyverna Therapeutics, Inc. Condensed Balance Sheets (in thousands) (Unaudited) | ||||||||
December 31, | ||||||||
2024 | 2023 | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents and available-for-sale marketable securities | $ | 285,979 | $ | 57,543 | ||||
Prepaid expenses and other current assets | 4,622 | 3,121 | ||||||
Restricted cash | 552 | 565 | ||||||
Property and equipment, net | 3,347 | 2,326 | ||||||
Operating lease right-of-use assets | 6,468 | 6,494 | ||||||
Finance lease right-of-use assets | 841 | 1,790 | ||||||
Other non-current assets | 2,836 | 3,356 | ||||||
Total assets | $ | 304,645 | $ | 75,195 | ||||
Liabilities, redeemable convertible preferred stock and stockholders' | ||||||||
Current liabilities | $ | 33,756 | $ | 19,859 | ||||
Non-current liabilities | 4,302 | 6,159 | ||||||
Redeemable convertible preferred stock | 鈥� | 180,574 | ||||||
Stockholders' equity (deficit) | 266,587 | (131,397) | ||||||
Total liabilities, redeemable convertible preferred stock and | $ | 304,645 | $ | 75,195 | ||||
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FAQ
What is the status of KYTX's stiff person syndrome trial and when is the BLA filing expected?
How much cash does KYTX have and what is their runway?
When will KYTX report clinical data for myasthenia gravis and lupus nephritis trials?
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