[Business Update and Financial Results Overview](index=1&type=section&id=Business%20Update%20and%20Financial%20Results%20Overview) Kyverna reported full-year 2024 financial results and business highlights, emphasizing its leadership in CAR T-cell therapies for autoimmune diseases and a strong balance sheet - Kyverna reported its full-year 2024 financial results and business highlights, emphasizing its leadership in developing CAR T-cell therapies for autoimmune diseases[1](index=1&type=chunk)[2](index=2&type=chunk) - The company is accelerating the clinical path for its lead candidate, KYV-101, in three priority indications: stiff person syndrome (SPS), myasthenia gravis (MG), and lupus nephritis (LN)[1](index=1&type=chunk)[2](index=2&type=chunk) - A strong balance sheet is expected to extend the company's cash runway into **2027**, funding operations through key clinical and regulatory milestones[1](index=1&type=chunk)[12](index=12&type=chunk) [Clinical Pipeline and Program Updates](index=1&type=section&id=Clinical%20Pipeline%20and%20Program%20Updates) The company provided updates on its clinical pipeline, including progress for lead candidate KYV-101 in multiple indications and the development of next-generation KYV-102 [KYV-101 Program](index=1&type=section&id=KYV-101%20Program) The company's lead candidate, KYV-101, an autologous, fully human CD19 CAR T-cell therapy, is being prioritized for development in Stiff Person Syndrome, Myasthenia Gravis, and Lupus Nephritis, with significant clinical trial progress and regulatory alignment achieved [Stiff Person Syndrome (SPS)](index=1&type=section&id=Stiff%20Person%20Syndrome%20(SPS)) The KYV-101 program for Stiff Person Syndrome is advancing with a registrational Phase 2 trial, targeting BLA filing in 2026, and has received multiple FDA designations - Kyverna has aligned with the FDA on a registrational Phase 2 trial design for KYSA-8 in SPS, which is currently **70% enrolled**[1](index=1&type=chunk)[6](index=6&type=chunk) - Key upcoming milestones for the SPS program include completing enrollment by **mid-2025**, reporting topline data in the **first half of 2026**, and targeting a Biologics License Application (BLA) filing in **2026**[1](index=1&type=chunk)[6](index=6&type=chunk) - The program has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the FDA[6](index=6&type=chunk) [Myasthenia Gravis (MG)](index=1&type=section&id=Myasthenia%20Gravis%20(MG)) The KYV-101 program for Myasthenia Gravis has completed initial enrollment for its Phase 2 trial, with interim data expected in late 2025, and holds multiple FDA and EMA designations - The Phase 2 trial in MG, KYSA-6, has completed enrollment for its initial **6-patient cohort**[5](index=5&type=chunk) - Interim data from this cohort is expected to be reported in the **second half of 2025**[5](index=5&type=chunk) - The program has received RMAT, Fast Track, and Orphan Drug designations from the FDA, as well as Orphan Drug Designation from the European Medicines Agency[7](index=7&type=chunk) [Lupus Nephritis (LN)](index=2&type=section&id=Lupus%20Nephritis%20(LN)) The KYV-101 program for Lupus Nephritis is advancing two Phase 1/2 trials, with Phase 1 data expected in late 2025, and has received Fast Track Designation from the FDA - Kyverna is advancing two Phase 1/2 trials (KYSA-1 and KYSA-3) and expects to report Phase 1 data from both in the **second half of 2025**[10](index=10&type=chunk) - The company has received Fast Track Designation from the FDA for this program[10](index=10&type=chunk) - Positive clinical data presented in **November 2024** showed sustained efficacy and durability at over **6-month follow-up** in patients with severe LN treated with KYV-101[10](index=10&type=chunk) [Additional Indications](index=2&type=section&id=Additional%20Indications) Kyverna is exploring additional opportunities for KYV-101 through sponsored and investigator-initiated trials in other autoimmune diseases - Kyverna is exploring additional opportunities for KYV-101 through sponsored and investigator-initiated trials in diseases such as systemic sclerosis and multiple sclerosis[9](index=9&type=chunk) [KYV-102 Program](index=2&type=section&id=KYV-102%20Program) KYV-102 is a next-generation candidate utilizing the same CD19 CAR T as KYV-101 but incorporates a proprietary whole-blood rapid manufacturing process. This approach aims to improve the patient experience and broaden access to CAR T therapy by eliminating the need for apheresis - Kyverna plans to file an investigational new drug (IND) application for KYV-102 in the **second half of 2025**[9](index=9&type=chunk) [Corporate Updates and Anticipated Milestones](index=2&type=section&id=Corporate%20Updates%20and%20Anticipated%20Milestones) The company announced key leadership appointments and outlined anticipated clinical and regulatory milestones for its pipeline programs [Corporate Updates](index=2&type=section&id=Corporate%20Updates) The company strengthened its leadership by appointing a new CEO, Warner Biddle, and making several other key additions to the management team. The Board of Directors was also enhanced with the appointment of Christi Shaw and Mert Aktar, who bring extensive industry and manufacturing expertise - Strengthened management team with key hires including a new CEO, Chief Medical and Development Officer, and Chief Business Officer[11](index=11&type=chunk) - Appointed Christi Shaw and Mert Aktar to the Board of Directors, adding significant corporate strategy and cell therapy manufacturing expertise[11](index=11&type=chunk) [Anticipated Milestones](index=2&type=section&id=Anticipated%20Milestones) Kyverna has provided clear guidance on its upcoming clinical and regulatory milestones through 2026, focusing on completing enrollments, reporting trial data for its three priority indications, and filing its first BLA for KYV-101 Upcoming Program Milestones | Program | Milestone | Anticipated Timing | | :--- | :--- | :--- | | **SPS** | Complete Pivotal Phase 2 Enrollment | mid-2025 | | | Report Topline Pivotal Phase 2 Data | 1H 2026 | | | BLA filing | 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](index=4&type=section&id=Financial%20Results) Kyverna reported its full-year 2024 financial performance, including a significant increase in cash position and operating expenses, leading to a wider net loss [Financial Highlights for Full Year 2024](index=4&type=section&id=Financial%20Highlights%20for%20Full%20Year%202024) For the year ended December 31, 2024, Kyverna reported a strong cash position of $286.0 million, providing a cash runway into 2027. The company's net loss increased to $127.5 million from $60.4 million in the prior year, driven by higher operating expenses Key Financial Metrics (Year Ended Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Cash, Cash Equivalents, and Marketable Securities | $286.0 million | $57.5 million | | Net Loss | $127.5 million | $60.4 million | | Net Loss Per Common Share | $3.33 | $89.61 | | Net Cash Used in Operating Activities | $114.3 million | $52.4 million | - The company expects its cash, cash equivalents, and marketable securities of **$286.0 million** to provide a cash runway into **2027**[12](index=12&type=chunk) [Statements of Operations](index=6&type=section&id=Statements%20of%20Operations) The company's operating expenses more than doubled in 2024, primarily due to a significant increase in research and development costs from $49.9 million to $112.5 million. This led to a wider loss from operations and a net loss of $127.5 million for the year Statements of Operations (in thousands) | Line Item | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | 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) | | Total other income, net | $15,127 | $2,040 | | **Net loss** | **($127,477)** | **($60,366)** | [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) As of December 31, 2024, Kyverna's balance sheet showed significant growth, with total assets increasing to $304.6 million from $75.2 million in 2023. This was primarily driven by a substantial rise in cash and marketable securities. Stockholders' equity turned positive to $266.6 million from a deficit of $131.4 million, reflecting financing activities during the year Condensed Balance Sheets (in thousands) | Line Item | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $285,979 | $57,543 | | **Total assets** | **$304,645** | **$75,195** | | Total liabilities | $38,058 | $26,018 | | **Stockholders' equity (deficit)** | **$266,587** | **($131,397)** | [About Kyverna and its Products](index=4&type=section&id=About%20Kyverna%20and%20its%20Products) This section provides an overview of Kyverna Therapeutics, its lead product candidates KYV-101 and KYV-102, and their therapeutic potential [About KYV-101](index=4&type=section&id=About%20KYV-101) KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate designed for tolerability with a potent CD28 co-stimulation domain. It is being investigated for its potential to achieve deep B cell depletion and long-term remission in various B-cell-driven autoimmune diseases - KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate designed for B-cell-driven autoimmune diseases[14](index=14&type=chunk) - It is currently being evaluated in a pivotal Phase 2 trial for stiff person syndrome, a Phase 2 trial for myasthenia gravis, and Phase 1/2 trials for lupus nephritis[15](index=15&type=chunk) [About KYV-102](index=4&type=section&id=About%20KYV-102) KYV-102 is a next-generation therapy that uses the same clinically validated CD19 CAR-T construct as KYV-101. It incorporates the proprietary Ingenui-T platform, which enables a rapid manufacturing process using whole blood, aiming to eliminate the need for apheresis and broaden patient access - KYV-102 leverages the same CAR-T construct as KYV-101 but incorporates the Ingenui-T platform, a proprietary, next-generation process[16](index=16&type=chunk) - The platform utilizes whole blood with a rapid manufacturing approach, aiming to eliminate the need for apheresis and reduce manufacturing turnaround time[16](index=16&type=chunk) [About Kyverna Therapeutics](index=4&type=section&id=About%20Kyverna%20Therapeutics) Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on the curative potential of cell therapy for patients with autoimmune diseases. Its lead candidate, KYV-101, is advancing through multiple clinical trials, and its pipeline includes next-generation autologous and allogeneic CAR T-cell therapies - Kyverna is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases[17](index=17&type=chunk) - The company's lead candidate, KYV-101, is in Phase 2 trials for stiff person syndrome and myasthenia gravis, and Phase 1/2 trials for lupus nephritis[17](index=17&type=chunk)

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].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased common stock of Kyverna Therapeutics, Inc. during its IPO on February 8, 2024, about the lead plaintiff deadline of February 7, 2025, for a class action lawsuit [1]. Group 1: Class Action Details - Investors who purchased Kyverna common stock may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by February 7, 2025 [3]. - The lawsuit claims that Kyverna's IPO registration statement and prospectus misrepresented facts regarding the clinical trial results of its lead product candidate, KYV-101, leading to investor damages when the true information was revealed [5]. Group 2: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions, highlighting its own achievements, including the largest securities class action settlement against a Chinese company at the time [4]. - The firm has been consistently ranked among the top firms for securities class action settlements, recovering hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4].

NEW YORK, Feb. 4, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Kyverna Therapeutics, Inc. ("Kyverna" or the "Company") (NASDAQ: KYTX).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.The class action concerns whether Kyverna and certain of its o ...

LOS ANGELES, Feb. 4, 2025 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against Kyverna Therapeutics, Inc. ("Kyverna" or "the Company") (NASDAQ: KYTX) for violations of the federal securities laws.Shareholders who purchased the Company's securities pursuant and/or traceable to the Company's offering documents issued in connection with its initial public offering ("IPO") conducted on February 8, 2024, are encouraged to contact the firm before February 7, 2025.CASE DETAILS:  Th ...

NEW YORK, Feb. 3, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Kyverna Therapeutics, Inc. (NASDAQ: KYTX).Shareholders who purchased shares of KYTX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/kyverna-therapeutics-inc-loss-submission-form/?id=126263&from=4 CLASS PERIOD: T ...

Core Viewpoint - Rosen Law Firm is reminding investors of Kyverna Therapeutics, Inc. about the upcoming lead plaintiff deadline for a class action lawsuit related to the company's IPO on February 8, 2024 [1][2]. Group 1: Class Action Details - Investors who purchased Kyverna common stock may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by February 7, 2025 [2]. - The lawsuit claims that Kyverna's IPO registration statement and prospectus contained misstatements and omissions regarding the clinical trial results of its lead product candidate, KYV-101 [4]. Group 2: Legal Representation - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [3]. - The firm has achieved significant settlements in the past, including the largest securities class action settlement against a Chinese company at the time [3]. - In 2019, Rosen Law Firm secured over $438 million for investors, showcasing its capability in recovering funds for clients [3]. Group 3: Case Specifics - The lawsuit alleges that Kyverna misrepresented patient "improvement" indicators while failing to disclose adverse data known at the time of the IPO, leading to artificially inflated stock prices [4]. - When the true details about the clinical trials became public, investors reportedly suffered damages [4].

NEW YORK, Jan. 31, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Kyverna Therapeutics, Inc. ("Kyverna Therapeutics, Inc." or the "Company") (NASDAQ: KYTX) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Kyverna Therapeutics, Inc. investors who were adversely affected by alleged securities fraud. This lawsuit is on behalf of all those who purchased or otherwise acquired Kyverna common stock pursuant and/or traceable to the Company's o ...