Kyverna Therapeutics (KYTX) Conference Call Summary Company Overview - **Company**: Kyverna Therapeutics - **Focus**: Development of CAR T therapies for autoimmune diseases, specifically targeting Stiff Person Syndrome (SPS) and Myasthenia Gravis (MG) [3][4] Key Points and Arguments 1. Clinical Trials and Progress - Kyverna is conducting two late-stage pivotal registrational trials for SPS and MG, with KYV-101 showing promising early clinical data [3][4] - The company has treated its hundredth patient with KYV-101, indicating confidence in its efficacy and safety profile [9] - The Phase III trial design for KYV-101 in MG has been aligned with the FDA, allowing for rapid execution [4][17] 2. Market Opportunity - There is a significant unmet need in the SPS market, which is larger than previously estimated, and Kyverna aims to establish a first-mover advantage [4][11] - The company plans to expand its reach into other autoimmune diseases, including multiple sclerosis and rheumatoid arthritis, based on early data [12][13] 3. Unique Therapeutic Approach - KYV-101 is a CD19 CAR T therapy with a CD28 co-stimulatory domain, designed for improved efficacy and safety in autoimmune conditions [8][10] - The therapy aims for deep B cell depletion, which is believed to reset the autoimmune response, leading to long-term drug-free remissions [10][28] 4. Patient Impact and Case Studies - Initial patients treated with KYV-101 have shown significant clinical improvements, including one patient with SPS who regained mobility after years of decline [18][36] - The first MG patient treated with KYV-101 experienced a remarkable recovery, walking unaided after being wheelchair-bound [57][66] 5. Regulatory and Commercialization Strategy - Kyverna anticipates filing a Biologics License Application (BLA) in 2026 for both indications, with strong engagement from the SPS community [46][47] - The company is focused on establishing a new standard of care for SPS and MG, aiming to disrupt the current treatment landscape [47][68] Additional Important Content - The conference highlighted the collaborative efforts of leading experts in CAR T therapy and autoimmune diseases, emphasizing the scientific rationale behind targeting B cells [21][48] - The discussion included insights into the mechanisms of action of CAR T therapies and their potential to provide durable remissions in autoimmune diseases [34][35] - The challenges faced by patients with SPS and MG, including the inadequacy of current therapies, were underscored, reinforcing the need for innovative treatments like KYV-101 [14][41][60] This summary encapsulates the critical insights from the Kyverna Therapeutics conference call, focusing on the company's advancements in CAR T therapies for autoimmune diseases and the potential impact on patient care and market dynamics.

These statements speak only as of the date of this presentation, and Kyverna undertakes no obligation to update or revise these statements. This presentation also contains estimates made by independent parties relating to industry market size and other data. These estimates involve a number of assumptions and limitations and you are cautioned not to give undue weight on such estimates. We have not independently verified the accuracy or completeness of such information, and we do not take any responsibility ...

KYV-101 has the potential to deliver durable, drug-free, disease-free remission in myasthenia gravis and set a new treatment standard for stiff person syndrome Innovative FDA-aligned KYSA-6 Phase 3 trial design for myasthenia gravis supports clear and rapid path to BLA Webcast today August 28th, at 11 am ET EMERYVILLE, Calif., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimm ...

EMERYVILLE, Calif., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that Warner Biddle, Chief Executive Officer of Kyverna, will present at the following upcoming conferences: 2025 Wells Fargo Healthcare ConferenceFormat: Fireside ChatDate: Wednesday, September 3rd, 2025Time: 11:00 a.m. ET Morgan Stanley 23rd Annual Global Healthcare ConferenceFo ...

On Wednesday, William Blair initiated coverage on Kyverna Therapeutics Inc. KYTX, a small-cap biotechnology company focused on cell therapies for autoimmune disorders. 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. Topline data for the registrational Phase 2 trial of KYV-101 in stiff person syn ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ________________ Kyverna Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 83-1365411 (State or other jurisdic ...

[Kyverna Therapeutics Business Update and Second Quarter 2025 Financial Results](index=1&type=section&id=Kyverna%20Therapeutics%20Business%20Update%20and%20Second%20Quarter%202025%20Financial%20Results) [Business Highlights and Clinical Pipeline Update](index=1&type=section&id=Business%20Highlights%20and%20Clinical%20Pipeline%20Update) Kyverna executed its Q2 2025 clinical strategy, completing enrollment for the registrational Phase 2 SPS trial and advancing the MG trial to Phase 3, while preparing for KYV-102 IND filing [KYV-101 Program Updates](index=1&type=section&id=KYV-101%20Program%20Updates) KYV-101 achieved full enrollment for the registrational SPS trial, with a BLA target in 1H 2026, and the MG trial progressed to a registrational Phase 3, while LN trials concluded to prioritize neuroimmunology - Completed patient enrollment for the registrational Phase 2 trial (KYSA-8) for Stiff Person Syndrome (SPS) in Q2 2025[4](index=4&type=chunk) - Expanded the Myasthenia Gravis (MG) trial (KYSA-6) to include a registrational Phase 3 portion following a successful end-of-Phase 2 meeting with the FDA[5](index=5&type=chunk) - Concluded enrollment for Lupus Nephritis (LN) trials (KYSA-1 and KYSA-3) to prioritize accelerating late-stage neuroimmunology indications[6](index=6&type=chunk) - Data from investigator-initiated trials (IITs) in Multiple Sclerosis (MS) and Rheumatoid Arthritis (RA) will be presented in Q3 and Q4 2025, respectively, to inform indication expansion strategy[7](index=7&type=chunk)[8](index=8&type=chunk) [Future Pipeline: KYV-102](index=2&type=section&id=Future%20Pipeline%3A%20KYV-102) Kyverna plans to file an IND for KYV-102 in Q4 2025, leveraging a proprietary whole blood, rapid manufacturing process to enhance patient access by eliminating apheresis - The company expects to file an Investigational New Drug (IND) application for KYV-102 in the fourth quarter of 2025[9](index=9&type=chunk) - KYV-102 is produced with a next-generation proprietary whole blood, rapid manufacturing process, which eliminates the need for apheresis and has the potential to broaden patient access[9](index=9&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) Kyverna appointed Marc Grasso as CFO in June 2025 and will host a virtual KOL event on August 28, 2025, to discuss its neuroimmunology CAR T franchise - Appointed Marc Grasso, M.D., as Chief Financial Officer in June 2025, bringing over 25 years of public company and investment banking experience[12](index=12&type=chunk) - A virtual KOL event titled "A Spotlight on Kyverna's Neuroimmunology CAR T Franchise" is scheduled for August 28, 2025[12](index=12&type=chunk) [Anticipated Milestones](index=2&type=section&id=Anticipated%20Milestones) Key upcoming milestones include interim Phase 2 MG data and Phase 3 enrollment by year-end 2025, SPS topline data and BLA filing in 1H 2026, and a KYV-102 IND application in Q4 2025 Anticipated Milestones Table | Program | Milestone | Anticipated Timing | | :--- | :--- | :--- | | **Myasthenia Gravis (MG)** | Report interim Phase 2 data | Q4 2025 | | | Initiate enrollment for registrational Phase 3 trial | By year-end 2025 | | **Stiff Person Syndrome (SPS)** | Report topline registrational Phase 2 data | 1H 2026 | | | BLA filing | 1H 2026 | | **Lupus Nephritis (LN)** | Report Phase 1 data in peer-reviewed publication | 2026 | | **Multiple Sclerosis (MS)** | Report Phase 1 IIT data | Q3 2025 | | **Rheumatoid Arthritis (RA)** | Report Phase 1/2 IIT data | Q4 2025 | | **Future Pipeline (KYV-102)** | File IND application | Q4 2025 | [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Kyverna reported a Q2 2025 net loss of **$42.1 million** ($0.97 per share) with **$211.7 million** cash, extending its runway into 2027, primarily due to increased R&D expenses [Financial Performance Summary](index=3&type=section&id=Financial%20Performance%20Summary) As of June 30, 2025, Kyverna held **$211.7 million** in cash, providing a runway into 2027, with increased R&D and G&A expenses leading to a **$42.1 million** net loss for Q2 2025 - Cash, cash equivalents, and marketable securities totaled **$211.7 million** as of June 30, 2025, which is expected to provide a cash runway into 2027[14](index=14&type=chunk) Financial Metric (Q2 2025 vs Q2 2024) | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | **$35.8 M** | **$27.3 M** | | G&A Expenses | **$8.6 M** | **$6.1 M** | | Net Loss | **$42.1 M** | **$28.8 M** | | Net Loss per Share | **$0.97** | **$0.67** | [Financial Statements](index=5&type=section&id=Financial%20Statements) Unaudited financial statements show Q2 2025 total operating expenses of **$44.4 million** and a net loss of **$42.1 million**, with total assets of **$226.5 million** and stockholders' equity of **$184.4 million** as of June 30, 2025 Statement of Operations Highlights (Three Months Ended June 30) | (in thousands) | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | **$35,816** | **$27,321** | | General and administrative | **$8,594** | **$6,114** | | **Total operating expenses** | **$44,410** | **$33,435** | | **Net loss** | **$(42,081)** | **$(28,803)** | Condensed Balance Sheet Highlights | (in thousands) | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, marketable securities | **$211,677** | **$285,979** | | Total assets | **$226,508** | **$304,645** | | Total stockholders' equity | **$184,377** | **$266,587** |

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 devel ...

Core Insights - Kyverna Therapeutics, Inc. is hosting a webcast event on August 28, 2025, to discuss its neuroimmunology franchise, focusing on KYV-101 and its potential applications in myasthenia gravis (MG) and stiff person syndrome (SPS) [1][2] Company Overview - Kyverna Therapeutics is a clinical-stage biopharmaceutical company specializing in cell therapies for autoimmune diseases, with its lead candidate, KYV-101, advancing through late-stage clinical development [4] - The company is conducting registrational trials for KYV-101 in MG and SPS, along with ongoing Phase 1/2 trials for lupus nephritis [4] - Kyverna is also exploring next-generation CAR T-cell therapies and has plans to expand into broader autoimmune indications with KYV-102, utilizing a proprietary whole blood rapid manufacturing process [4] Webcast Details - The webcast will feature presentations from the management team and renowned Key Opinion Leaders (KOLs), followed by a Q&A session [2][3] - The event aims to provide an in-depth look at KYV-101's differentiation and its potential for durable drug-free, disease-free remission, as well as a high-level overview of Kyverna's commercial strategy [6]

Summary of Qiverna Therapeutics Conference Call Company Overview - **Company**: Qiverna Therapeutics - **Focus**: Development of CAR T cell therapies for autoimmune diseases, specifically targeting Stiff Person Syndrome (SPS), Myasthenia Gravis (MG), and Lupus Nephritis [1][2] Core Points and Arguments Clinical Development Progress - **KYV-101**: Lead CAR T cell therapy candidate is advancing through late-stage clinical development with pivotal trials for SPS and MG, and ongoing trials for Lupus Nephritis [3][4] - **SPS Trial**: Fully enrolled pivotal Phase II trial with results expected in the first half of 2026; BLA filing also anticipated in the first half of 2026 [3][8] - **MG Trial**: Initial six patients enrolled in Phase II trial, with results expected in the second half of 2023; FDA has approved a pivot to a pivotal Phase III trial design [3][20] - **Lupus Nephritis**: Ongoing studies with results expected in the second half of 2023 [8][23] Unique Therapy Design - **KYV-101 Design**: Features a CD28 co-stimulatory domain, providing deep B cell depletion and an immune reset, which is believed to enhance efficacy and safety compared to competitors [4][5] - **Safety Profile**: No high-grade CRS (Cytokine Release Syndrome) or ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome) observed in over 70 treated patients [5][6] Market Opportunity - **SPS Market**: Estimated 4,500 patients currently known, with potential to identify 2,000 to 6,000 more as awareness increases; first mover advantage anticipated [17][18] - **MG Market**: Addressable market for second-line plus patients estimated at 30,000 to 40,000, significantly larger than SPS [21] Competitive Differentiation - **Efficacy**: KYV-101 shows significant reductions in MG ADL scores, with some patients achieving scores of zero, which is not seen with existing therapies [19][22] - **Transformational Impact**: Patients treated with KYV-101 have reported improved mobility and quality of life, with many able to discontinue background immunosuppressants [10][16] Future Developments - **Next Generation Product**: KYV-102, a whole blood rapid manufacturing construct, aims to simplify the patient journey and reduce costs; IND filing expected in the second half of 2023 [9][24] - **Pipeline Expansion**: Plans to explore additional indications beyond current focus areas, leveraging existing clinical studies [9][25] Important but Overlooked Content - **Compassionate Use Program**: Data from over 40 patients treated under this program shows no high-grade CRS or ICANS, reinforcing the safety profile of KYV-101 [6][14] - **Neuroinflammation Franchise**: Establishing a franchise around neuroinflammation diseases, leveraging synergies between SPS and MG treatment centers [11][12] Financial Position - **Cash Runway**: Sufficient funding to support operations and clinical milestones through 2027 [26]