Kyverna Therapeutics Provides Business Update and Reports Full Year 2023 Financial Results
- Advanced clinical development in two broad areas of autoimmune disease: rheumatology and neurology
- Strong balance sheet, bolstered by recent public offering, expected to fund operations into 2026
"2023 was a momentous year for Kyverna as we brought KYV-101 into the clinic in both the US and
Full Year 2023 and Recent Business Highlights
- Advanced clinical development of KYV-101, our proprietary CD19 chimeric antigen receptor (CAR) T-cell therapy for autoimmunity, in clinical trials and investigator-initiated trials across the US and
Europe - Treated 14 autoimmune patients cumulatively with KYV-101 as of
December 31, 2023 , including two patients with multiple sclerosis, three patients with lupus nephritis, and six patients with myasthenia gravis - Received FDA clearance to initiate Phase 2 trials for KYV-101 in multiple sclerosis and myasthenia gravis, as well as a Phase 1/2 trial in systemic sclerosis
- Initiated enrollment and dosed patients in our two clinical trials for KYV-101 in lupus nephritis: a Phase 1/2 trial in
Germany and a Phase 1 trial in the US - Received FDA Fast Track Designations for KYV-101 for the treatment of patients with refractory myasthenia gravis, for the treatment of patients with refractory progressive multiple sclerosis, and for the treatment of patients with lupus nephritis
- Partnered with ElevateBio's BaseCamp to advance Kyverna's Ingenui-T manufacturing process
- Strengthened balance sheet with approximately
$366.9 million in gross proceeds from our initial public offering inFebruary 2024
Upcoming Milestones
- Interim patient data releases and symposia at
EULAR in second quarter of 2024, ECTRIMS in third quarter of 2024 and ACR in fourth quarter of 2024 - Regulatory progress in rheumatology and neurology in the US and
Europe - Ongoing progress with Ingenui-T, our manufacturing process designed to improve patient experience and manufacturing efficiencies
- Updates on KYV-201, our allogeneic CD19 CAR T-cell product candidate
Financial Results for the Year Ended
For the year ended
During the year ended
Kyverna reported
About Kyverna Therapeutics
Kyverna is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.
Our lead CAR T-cell therapy candidate, KYV-101 is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1 trials in
Kyverna's pipeline includes next-generation chimeric antigen receptor (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. For more information, please visit www.kyvernatx.com.
Forward-looking Statements
This press release contains forward looking statements that are based on management's beliefs and assumptions and on information currently available to management of
For more information, please contact:
Investor Contact:
InvestorRelations@kyvernatx.com
Media Contact:
kyvernatx@consortpartners.com
Kyverna Therapeutics, Inc. |
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Statements of Operations and Comprehensive Loss |
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(in thousands, except share and per share data) |
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Year Ended |
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2023 |
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2022 |
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Revenue |
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Collaboration revenue - related party |
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$ |
— |
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$ |
7,025 |
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Operating expenses |
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Research and development |
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49,923 |
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28,402 |
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General and administrative |
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12,483 |
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8,007 |
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Total operating expenses |
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62,406 |
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36,409 |
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Loss from operations |
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(62,406) |
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(29,384) |
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Interest income |
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2,282 |
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565 |
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Interest expense |
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(187) |
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(65) |
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Other expense, net |
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(55) |
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(9) |
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Total other income, net |
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2,040 |
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491 |
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Net loss |
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(60,366) |
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(28,893) |
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Other comprehensive gain (loss) |
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Unrealized gain (loss) on available-for-sale marketable securities, net |
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30 |
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(26) |
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Total other comprehensive gain (loss) |
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30 |
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(26) |
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Net loss and other comprehensive loss |
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$ |
(60,336) |
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$ |
(28,919) |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(89.61) |
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$ |
(63.43) |
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Weighted-average shares of common stock outstanding, basic and diluted |
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673,622 |
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455,478 |
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Kyverna Therapeutics, Inc. |
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Balance Sheets |
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(in thousands, except share and per share data) |
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2023 |
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2022 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
34,647 |
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$ |
37,735 |
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Available-for-sale marketable securities |
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22,896 |
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13,587 |
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Prepaid expenses and other current assets |
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3,121 |
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1,929 |
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Total current assets |
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60,664 |
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53,251 |
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Restricted cash |
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565 |
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554 |
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Property and equipment, net |
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2,326 |
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2,575 |
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Operating lease right-of-use assets |
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6,494 |
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8,214 |
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Finance lease right-of-use assets |
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1,790 |
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1,652 |
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Other non-current assets |
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3,356 |
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678 |
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Total assets |
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$ |
75,195 |
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$ |
66,924 |
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Liabilities, redeemable convertible preferred stock and stockholders' |
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Current liabilities |
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Accounts payable |
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$ |
4,358 |
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$ |
1,451 |
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Accrued compensation |
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2,812 |
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1,411 |
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Accrued license expense – related party |
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6,250 |
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6,250 |
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Other current liabilities |
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3,519 |
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565 |
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Operating lease liabilities, short-term portion |
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1,964 |
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1,672 |
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Finance lease liabilities, short-term portion |
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956 |
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605 |
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Total current liabilities |
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19,859 |
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11,954 |
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Operating lease liabilities, net of short-term portion |
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5,238 |
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7,209 |
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Finance lease liabilities, net of short-term portion |
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921 |
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1,078 |
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Other long-term liabilities |
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— |
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6 |
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Total liabilities |
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26,018 |
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20,247 |
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Commitments and contingencies |
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Redeemable convertible preferred stock, |
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180,574 |
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120,674 |
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Stockholders' deficit |
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Common stock, |
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— |
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— |
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Additional paid-in capital |
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4,642 |
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1,706 |
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Accumulated other comprehensive income (loss) |
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4 |
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(26) |
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Accumulated deficit |
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(136,043) |
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(75,677) |
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Total stockholders' deficit |
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(131,397) |
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(73,997) |
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Total liabilities, redeemable convertible preferred stock and |
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$ |
75,195 |
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$ |
66,924 |
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