We are a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our goal is to bring disease-modifying therapeutic benefits to patients suffering from autoimmune diseases through our patient-centered approach, our broad platform, our insights into treating immune disorders and the learnings from successful application of cell therapy in other areas of medicine. Our cell therapy approach to the treatment of autoimmune diseases is supported by the scientific publication of multiple autoimmune case studies using CD19 CAR T-cell treatment as well as early clinical data from our ongoing trials illustrating the disease-modifying potential of these therapies. This validation provides us with a clear path to continue advancing our lead product candidate, KYV-101, through clinical development across two broad areas of autoimmune disease: rheumatology and neurology. Our lead program, KYV-101, is an autologous CD19 CAR T-cellproduct candidate made from an underlying chimeric antigen receptor, or CAR, that we have licensed from the National Institutes of Health, or the NIH. This underlying CAR in KYV-101 has completed a 20-patientPhase 1 trial in oncology conducted by the NIH, and the results from this Phase 1 trial published in Nature Medicine reported improved tolerability in the clinic among adult oncology patients using the same CAR construct in KYV-101, as compared to the CAR used to create Yescarta®. This underlying CAR in KYV-101 was designed by the NIH to improve tolerability through a systematic comparison of CARs created with alternate domain structures, identifying the use of a fully human CD19 binding domain and optimized hinge and transmembrane domains. We believe that these differentiated properties of the underlying CAR construct in KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies. We intend to develop KYV-101 in two broad areas of autoimmune disease: rheumatology and neurology. Our initial rheumatology development focus is on lupus nephritis, or LN, and systemic sclerosis, or SSc. We are conducting two trials of KYV-101 in patients with LN, an autoimmune disease in which more than half of patients do not achieve a complete response to current therapies and are at risk of developing kidney failure. In addition to LN, we received Investigational New Drug, or IND, clearance in October 2023 for a Phase 1/2 study in SSc. We intend to initially focus our neurology development on myasthenia gravis, or MG, and multiple sclerosis, or MS. We received IND clearance in November 2023 for a Phase 2 study in MG, and we received IND clearance in December 2023 for a Phase 2 study in MS. We believe our approach may present a significant advantage over current standard-of-care therapies for autoimmune diseases by aiming to directly deplete B cells and potentially resetting disease-contributing B cells. We are also actively developing an allogeneic, off-the-shelf approach to further broaden patient access. To this end, we have partnered with Intellia Therapeutics, Inc., or Intellia, a leader in the field of gene editing, to develop KYV-201, an allogeneic CD19 CAR T-cell product candidate. Our research-stage programs are focused on developing product candidates to treat other autoimmune diseases, such as inflammatory bowel disease, or IBD, which includes Crohn’s disease and ulcerative colitis, and extend beyond CD19 CAR-T approaches, including regulatory T cells, or T-regs, and novel humanized CAR constructs developed by us for use in autoimmune diseases. Translating transformational experience with cell therapies to autoimmune diseases We believe the success of cell therapies such as CAR T-cell therapies in oncology have paved the way for the application of cell therapies in other therapeutic areas. Pathologic B cells are the cause of a number of hematological malignancies, such as B-cell lymphoma. In recent years, multiple engineered cell therapies have been approved that can eliminate these B cells, resulting in long-term complete responses in lymphoma patients refractory to other therapies. One of the most widely used, studied and clinically validated engineered cell therapies is CAR T-cell therapy, a form of immunotherapy whereby the patient’s T cells are engineered to express a CAR that recognizes and binds to a specific antigen present on tumor cells to generate an anti-tumor immune response. CAR T cells for this therapy are generated by isolating T cells from the patient and introducing a CAR construct that directs these modified T cells to attack B cells based on the expression of a common antigen, CD19. Autoimmune diseases affect organs throughout the body. A common characteristic of many of these diseases is the presence of autoantibodies, antibodies produced by the body’s B cells that mistakenly attack other cells and tissues in the body. Given that the therapeutic benefit associated with B-cell depletion is common between B-cell-driven hematologic malignancies and autoimmune diseases, we anticipated that CD19 CAR T cells would have therapeutic benefits in autoimmune diseases, a result that has now been observed in the publication of a number of case studies. In academic clinical data published in Nature Medicine in September 2022, a CD19 CAR T-celltherapy was observed to induce clinical remission in all five systemic lupus erythematosus, or SLE, patients with lupus nephritis. All patients experienced significant improvements in Systemic Lupus Erythematosus Disease Activity Index 2000, or SLEDAI-2K, scores. Scores of zero, corresponding to no disease activity on such index, were achieved in four patients by three months post treatment and a score of two in one patient due to residual low-level proteinuria that was likely due to previously accumulated kidney damage. Several other important observations were the elimination of autoantibodies, B-cell reconstitution after an average time of 110 days of CAR T infusion in all patients, preservation of vaccination responses, and that treatment was well tolerated, with either no or mild cytokine release syndrome, or CRS. Further, in clinical data published in the New England Journal of Medicine in 2021, a 20-year-old woman with severe and refractory SLE was observed to experience rapid remission of symptoms and autoantibody levels following a single treatment with autologous CD19 CAR T cells. This patient has been in remission for at least 600 days and is included in the Nature Medicine publication mentioned above. We believe the foregoing academic clinical data, including the rapid depletion of B cells upon initiation of treatment and subsequently observed naïve B-cell reconstitution, suggest that CD19 CAR T-cell therapy could potentially lead to significant clinical benefit and reset the immune system with a single, well-tolerated treatment. However, the foregoing data was obtained by a third party outside of a formal clinical trial setting and we are seeking to validate this premise through well-controlled, multicenter clinical trials that demonstrate statistically significant results. High prevalence and unmet need across autoimmune diseases Over 80 diseases are classified as autoimmune diseases affecting up to 8% of the U.S. population. Moreover, the prevalence of autoimmunity is on the rise in the United States. Over the last 25 years, researchers have observed a 44% increase in the presence of antinuclear antibodies, the autoantibody in lupus, affecting 41 million people. These autoantibodies represent an early sign of autoimmune diseases, which develop in about 30% of these individuals over a five- to ten-year period. The chronic and debilitating nature of these diseases leads to both high medical costs and reduced quality of life, creating a significant burden for patients, their families and the health care system. It is estimated that sales for autoimmune disease therapies were greater than $80 billion globally in 2021. Despite the availability of many approved drugs, there remains substantial unmet clinical need, as existing therapies are rarely considered curative and the majority of patients do not respond optimally, if at all, to these therapies. Current autoimmune disease treatments such as hematopoietic stem cell transplantation, or HSCT, and the use of B-cell-targeting monoclonal antibodies have led to therapeutic responses, but the majority of patients do not benefit either because of unacceptable toxicity risks or due to weak or short-lived activity. The HSCT process leads to depletion of the patient’s immune system, and is a procedure associated with potentially life-threatening complications and its use to treat autoimmune disease is primarily as a salvage therapy for patients with severe refractory disease. Poor or mixed results have also been reported from patients with SLE, inflammatory myositis and autoimmune hepatitis when using monoclonal antibodies targeted against CD20, such as rituximab. We believe that the poor efficacy of anti-CD20 antibodies for these indications may be due in part to limited antibody activity in diseased tissue due to the weak tissue-penetrating ability of antibodies. We were incorporated in Delaware in June 2018 under the name BAIT Therapeutics, Inc., and changed our name to Kyverna Therapeutics, Inc. in October 2019. Our principal executive offices are located at 5980 Horton St., STE 550, Emeryville, CA.
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Here are 1-3 brief analogies for Kyverna Therapeutics (KYTX):
- Like Kite Pharma (a Gilead company), but focused on developing CAR T-cell therapies for autoimmune diseases instead of cancer.
- The Novartis (Kymriah) of autoimmune cell therapies.
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Kyverna Therapeutics' major product is:
- KYV-101: An autologous CD19-targeted CAR T-cell therapy candidate currently in clinical development for the treatment of various autoimmune diseases.
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Kyverna Therapeutics (KYTX) is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. As a company in the clinical development phase, it does not currently have commercialized products generating sales to "major customers" in the traditional sense.
At its current stage, Kyverna Therapeutics is primarily engaged in research and development and conducting clinical trials for its lead product candidates. Therefore, it does not sell its products to other companies or directly to individuals.
If its therapies are successfully developed and approved in the future, its ultimate "customers" would typically be:
- Healthcare Providers: Hospitals, clinics, and medical centers that administer advanced therapies to patients.
- Payers: Insurance companies and government healthcare programs that cover the cost of approved treatments.
- Patients: Individuals suffering from autoimmune diseases who would ultimately receive the treatments prescribed by their physicians.
However, these are potential future channels, and Kyverna does not currently have commercial customers purchasing its therapies.
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- Lonza Group AG (LONN)
- Charles River Laboratories International, Inc. (CRL)
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Warner Biddle, Chief Executive Officer
Mr. Biddle has over 30 years of global experience in senior commercial and franchise leadership roles. Prior to joining Kyverna, he served as Senior Vice President, Global Head of Commercial at Kite Pharma (a Gilead Company), where he led multiple product launches including Yescarta® and Tecartus®, driving significant growth in the cell therapy market. He also acted as interim Head of Kite in 2023. Before Kite, Mr. Biddle spent a decade at Genentech, where he successfully led the Breast/Gynecology, Skin Cancer, and Ophthalmology franchises. He also held senior commercial and franchise leadership roles at Novartis and GlaxoSmithKline (GSK) in various international markets.
Marc Grasso, M.D., Chief Financial Officer
Dr. Grasso brings more than 25 years of public company, capital markets, and investment banking management experience. Prior to Kyverna, he served as the Chief Financial Officer for Alector, Inc., a late-stage clinical biotechnology company. He also held the positions of Chief Financial Officer and Chief Business Officer at Kura Oncology, another clinical-stage biopharmaceutical company. Dr. Grasso has worked in various leadership roles in the financial services and investment banking industries, including as a Managing Director at Stifel, where he was responsible for building and managing the west coast life sciences and biotechnology investment banking business.
James Chung, M.D., Ph.D., Chief Medical Officer
Dr. Chung has extensive biopharmaceutical industry experience, working across the entire drug development process with a focus on autoimmune diseases. He joined Kyverna from Amgen, where he was most recently Executive Medical Director, head of Inflammation and Neuroscience, Global Medical Organization, and Global Development Leader for Enbrel®. His career at Amgen, spanning over 16 years, included advancing inflammation programs from first-in-human to proof-of-concept as the Early Development Inflammation Therapeutic Area Head. Before Amgen, Dr. Chung began his industry career at Pfizer as an Associate Director in Clinical Sciences, serving as the Early Clinical Leader for several inflammation programs.
Dan Maziasz, Chief Business Officer
Mr. Maziasz brings over 25 years of leadership and business experience from various biotechnology and large pharmaceutical companies. Most recently, he served as Chief Business Officer at Atara Biotherapeutics. Prior to Atara, Mr. Maziasz was Vice President, Corporate Strategy and Business Development at Kite Pharma before its acquisition by Gilead Sciences. He also spent more than a decade at Amgen, holding roles in business development, corporate strategy, finance, and commercial functions across the US, Europe, and Asia.
Karen Walker, Chief Technology Officer
Ms. Walker possesses broad and deep industry experience in developing biopharmaceuticals and cell and gene therapy products. She has held positions at Roche/Genentech, Seattle Genetics, Novartis, and other leading pharmaceutical companies.
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Kyverna Therapeutics faces clear emerging threats primarily from intensifying competition in the development of CD19 CAR T-cell therapies for autoimmune diseases.
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Direct Competition from Established Pharmaceutical Companies: Large, well-resourced pharmaceutical companies, notably Novartis, are actively pursuing their own autologous CD19 CAR T-cell therapy programs for autoimmune conditions. Novartis's YTB323 program, targeting diseases like Systemic Lupus Erythematosus (SLE), has shown positive early clinical data, indicating a formidable competitor with significant development, manufacturing, and commercialization capabilities that could challenge Kyverna's market positioning.
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Emergence of Allogeneic (Off-the-Shelf) Cell Therapies: The potential emergence of more scalable and accessible allogeneic CD19 CAR T-cell or CAR-NK therapies from other developers represents a significant technological threat. If these "off-the-shelf" approaches demonstrate compelling clinical data and a favorable safety profile, they could offer substantial advantages over Kyverna's autologous (patient-specific) approach in terms of manufacturing efficiency, cost, and logistics, potentially disrupting the market for autologous cell therapies in autoimmune indications.
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Kyverna Therapeutics (KYTX) is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. Its lead product candidate, KYV-101, is being developed for several indications.
The addressable markets for the diseases Kyverna Therapeutics' main product, KYV-101, targets are as follows:
- Myasthenia Gravis (MG): The global market for generalized myasthenia gravis drugs is projected to reach $10.2 billion by 2033. Other estimates for the global myasthenia gravis treatment market include $1.8 billion in 2024, growing to $3.8 billion by 2034, and $6.7 billion by 2032 across the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan). North America holds the largest patient pool and market for MG treatment.
- Lupus Nephritis (LN): The global lupus nephritis market size was estimated at $2.31 billion in 2024 and is projected to reach $2.17 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.3%. Another report indicates the market in the top 7 markets (US, EU4, UK, and Japan) was $2.4 billion in 2024 and is expected to reach $6.0 billion by 2035. North America held the major market share, with the U.S. market size at $730.46 million in 2024.
- Multiple Sclerosis (MS): The global multiple sclerosis market was valued at $28.28 billion in 2024 and is projected to grow to $39.39 billion by 2033. Another source estimates the global market at $26.18 billion in 2023, poised to grow to $46.44 billion by 2033. North America is the dominant region in the multiple sclerosis market. The U.S. multiple sclerosis therapeutic market size was $6.99 billion in 2023 and is expected to reach approximately $12.77 billion by 2033.
- Systemic Sclerosis (SSc): The global systemic sclerosis market was valued at US$2,384.73 million in 2024 and is expected to reach US$4,132.66 million by 2033. Other estimates include a global market size of USD 1.65 billion in 2023, projected to reach USD 2.60 billion by 2032, and nearly USD 1850 million in 2023 across the 7 major markets, expected to increase by 2034. North America is expected to hold 45.6% of the global systemic sclerosis market in 2024 and dominate the market.
- Stiff Person Syndrome (SPS): Unable to size the market for this product.
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Kyverna Therapeutics (NASDAQ: KYTX) is a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases. Expected drivers of future revenue growth for Kyverna Therapeutics over the next 2-3 years primarily center around the advancement and potential commercialization of its lead product candidate, KYV-101, and the development of next-generation therapies and expanded indications:
- Commercialization of KYV-101 in Stiff Person Syndrome (SPS): Kyverna has aligned with the U.S. Food and Drug Administration (FDA) on a registrational Phase 2 trial design for KYV-101 in SPS, a debilitating disease with no currently approved therapies. The company anticipates reporting topline data from this pivotal study in the first half of 2026 and plans to submit its first Biologics License Application (BLA) in 2026. This represents a clear and rapid path to market for its lead product.
- Advancement of KYV-101 in Myasthenia Gravis (MG): Kyverna plans to initiate a Phase 3 registrational trial for KYV-101 in myasthenia gravis by year-end 2025, with interim Phase 2 data expected in the fourth quarter of 2025. Success in this indication could address a significant unmet need for patients seeking alternative therapies.
- Expansion of KYV-101 into Lupus Nephritis (LN): The company expects to report Phase 1 data for KYV-101 in lupus nephritis in the second half of 2025. Positive results could pave the way for further development and eventually unlock another substantial market for KYV-101.
- Development and Commercialization of Next-Generation CAR T-cell Therapies (KYV-102): Kyverna is developing KYV-102, an autologous CD19 CAR T-cell product candidate designed for rapid manufacturing using whole blood. The company plans to file an Investigational New Drug (IND) application for KYV-102 in the second half of 2025. This next-generation therapy aims to improve the patient experience, broaden CAR T access, and potentially lower manufacturing costs, which could significantly expand market adoption.
- Broadening Indications for KYV-101 in Other Autoimmune Diseases: Kyverna is also exploring the potential of KYV-101 in other large autoimmune disease markets, such as multiple sclerosis (MS) and rheumatoid arthritis (RA), through investigator-initiated trials. Early signals in MS and positive outcomes in refractory RA suggest significant commercial opportunities if these programs advance to late-stage development.
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Share Issuance
- Kyverna Therapeutics completed its Initial Public Offering (IPO) on February 8, 2024.
- In the IPO, the company issued 14.5 million shares at $22 per share, raising gross proceeds of $319 million.
- As of June 30, 2025, and August 4, 2025, Kyverna had approximately 43.24 million and 43.25 million shares of common stock outstanding, respectively.
Inbound Investments
- On October 31, 2025, Kyverna Therapeutics secured a loan facility with Oxford Finance LLC for up to $150 million in non-dilutive capital.
- The company is scheduled to draw an initial $25 million from this facility on November 3, 2025.
- Additional tranches from the $150 million loan facility are available upon the achievement of key clinical and commercial milestones.
Capital Expenditures
- Over the last 12 months, capital expenditures totaled approximately -$638,000.
