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]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Kyverna Therapeutics, Inc. due to a class action complaint alleging that the company made false and misleading statements regarding its IPO and clinical data [1][2] Group 1: Legal Investigation - The investigation is focused on whether Kyverna's board of directors breached their fiduciary duties to the company [1] - A class action complaint was filed on December 9, 2024, related to the company's IPO conducted on February 8, 2024 [1] Group 2: Allegations of Misleading Information - The complaint states that Kyverna possessed adverse data related to one of its ongoing trials, which was not disclosed [2] - The undisclosed adverse data negatively impacted the company's lead product, making the trends and results in the offering documents misleading [2] - The company's discussion of risk factors was inadequate, failing to describe the risks associated with withholding clinical data [2] Group 3: Investor Impact - Investors suffered damages when the market learned the truth about Kyverna's misleading public statements [2]

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 March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ________________ Commission File Number: 001-41947 Kyverna Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware ...

EMERYVILLE, Calif., May 13, 2025– 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 March 31, 2025. "We are pleased to report an exceptional start to the year, marked by rapid execution against our focused strategy to advance development of KYV-101 and build Kyverna into a robust clinical and commercial-ready organi ...

Enrollment complete in registrational Phase 2 KYV-101 trial in stiff person syndrome (SPS); on track for topline data in 1H 2026; biologics license application (BLA) filing now anticipated in 1H 2026 Advancing into registrational Phase 3 KYV-101 trial in myasthenia gravis (MG) following successful end-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA); Phase 2 MG data anticipated in 2H 2025Company to host KOL event in Q3 2025, spotlighting its accelerating neuroinflammation franchise Strong fin ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-41947 Kyverna Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 83-1365411 (State or other jurisdict ...

Exhibit 99.1 Kyverna Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results Accelerating clinical path to commercialization in stiff person syndrome, myasthenia gravis and lupus nephritis 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. KYV-101 is currently being evaluated in company-sponsored KYSA trials and investigator- initiated tr ...

Core Insights - Kyverna Therapeutics is advancing its clinical programs for KYV-101, targeting stiff person syndrome, myasthenia gravis, and lupus nephritis, with a clear path to commercialization [2][7][17] - The company has aligned with the FDA on a registrational Phase 2 trial design for KYSA-8 in stiff person syndrome, with 70% enrollment completed and topline data expected in the first half of 2026 [7][11] - Financially, Kyverna reported $286 million in cash and equivalents as of December 31, 2024, providing a cash runway into 2027 [11][21] Clinical Development - KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate, currently in pivotal Phase 2 trials for stiff person syndrome and myasthenia gravis, and Phase 1/2 trials for lupus nephritis [3][15] - The company expects to report interim data from the Phase 2 trial in myasthenia gravis in the second half of 2025, and Phase 1 data from lupus nephritis trials in the same timeframe [6][7] - Kyverna is also exploring additional indications for KYV-101 through investigator-initiated trials across various autoimmune diseases [9][17] Financial Performance - For the year ended December 31, 2024, Kyverna reported a net loss of $127.5 million, or $3.33 per share, compared to a net loss of $60.4 million, or $89.61 per share, in 2023 [12][20] - Operating expenses increased significantly, with research and development costs rising to $112.5 million from $49.9 million in the previous year [20] - The company’s total assets as of December 31, 2024, were $304.6 million, a substantial increase from $75.2 million in 2023 [21] Strategic Initiatives - Kyverna has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for its programs [7][8] - The company is strengthening its management team to support its growth strategy, with key appointments in executive roles [13] - Future plans include filing an investigational new drug application for KYV-102 in the second half of 2025, which aims to improve patient access to CAR T therapies [9][16]

Core Insights - Kyverana Therapeutics (NASDAQ: KYTX) is preparing for multiple catalysts in the coming years, aiming to be among the first to potentially receive regulatory approval for a CAR-T therapy [2] Group 1 - The company is focused on developing CAR-T therapies, which are a type of immunotherapy used to treat certain types of cancer [2] - Kyverana Therapeutics is part of a broader trend in the biotech industry, where companies are increasingly investing in innovative therapies to address unmet medical needs [2]

Core Viewpoint - Kyverna Therapeutics, Inc. (KYTX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Kyverna Therapeutics indicates an expected loss of -$3.29 per share for the fiscal year ending December 2024, reflecting a year-over-year change of 96.3% [9]. - Over the past three months, analysts have raised their earnings estimates for Kyverna Therapeutics by 7.9% [9]. Zacks Rating System - The Zacks rating system is based solely on a company's changing earnings picture, which is crucial for stock price movements [2][3]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Kyverna Therapeutics to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10][11].