Kyverna Therapeutics Provides Business Update and Reports Full Year 2023 Financial Results
- Advanced clinical development of proprietary CD19 CAR T-cell therapy, KYV-101, in autoimmune diseases
- Received FDA clearances for Phase 2 trials in multiple sclerosis and myasthenia gravis
- Partnered with ElevateBio's BaseCamp for manufacturing process advancement
- Strengthened balance sheet with $366.9 million from public offering
- Upcoming milestones include patient data releases and regulatory progress
- Reported net loss of $60.4 million for 2023 with $57.5 million in cash reserves
- Increased net loss from $28.9 million in 2022 to $60.4 million in 2023
- Net cash used in operating activities rose from $36.1 million in 2022 to $52.4 million in 2023
Insights
The financial results presented by Kyverna Therapeutics highlight a significant year-over-year increase in net loss, from $28.9 million to $60.4 million and a corresponding rise in net loss per common share. This uptick in losses can be attributed to the company's ramped-up investment in clinical trials and research activities, which is common for clinical-stage biopharmaceutical companies focusing on novel therapies. The reported cash burn rate, reflected in the $52.4 million of net cash used in operating activities, is also higher than the previous year's $36.1 million. This acceleration in cash burn is indicative of the company's aggressive development strategy.
However, the successful initial public offering (IPO) in February 2024, which raised approximately $366.9 million, is a positive signal for the company's financial health. This capital infusion is expected to fund operations into 2026, providing a substantial runway for the company to advance its clinical programs and potentially reach critical development milestones. Investors will likely focus on the company's ability to manage its cash reserves effectively and the progress of its clinical trials, which could drive future valuations.
Kyverna Therapeutics' progress in advancing KYV-101 through clinical trials is a key development, as successful outcomes in these trials could position the company as a leader in cell therapy for autoimmune diseases. The FDA Fast Track Designations for KYV-101 in multiple indications are particularly noteworthy, as they may expedite the review process and could lead to an earlier market entry if clinical outcomes are positive.
The therapeutic areas targeted by Kyverna—multiple sclerosis, lupus nephritis and myasthenia gravis—represent markets with significant unmet medical needs and the potential for high-impact treatments. The company's proprietary CD19 chimeric antigen receptor (CAR) T-cell therapy, if proven effective, could disrupt current treatment paradigms and offer new hope to patients with refractory conditions. The long-term implications for stakeholders include not only the potential health benefits for patients but also the economic impact of introducing novel, possibly more effective therapies into the healthcare system.
The landscape of autoimmune disease treatment is rapidly evolving and Kyverna Therapeutics' strategic positioning in both rheumatology and neurology could be advantageous. The autoimmune disease treatment market is expected to grow significantly and innovations in cell therapy are being closely monitored by industry participants and investors. Kyverna's engagement with ElevateBio's BaseCamp to improve its Ingenui-T manufacturing process signals an awareness of the importance of manufacturing efficiency and patient experience in the competitive biopharmaceutical space.
As the company releases interim patient data at upcoming conferences such as EULAR, ECTRIMS and ACR, stakeholders should pay close attention to the scientific community's reception of these data. Positive feedback and results could enhance investor confidence and drive interest in the company's stock, while any setbacks could have the opposite effect. Kyverna's ability to navigate the regulatory landscape in the US and Europe will also be a critical factor in its long-term success and potential market share capture.
- 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
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 December 31, 2023
For the year ended December 31, 2023, the company reported a net loss of
During the year ended December 31, 2023, net cash used in operating activities was
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 Kyverna Therapeutics, Inc. ("Kyverna", "we", "our," or the "Company"). All statements other than statements of historical facts contained in this press release are forward looking statements. Forward looking statements include, but are not limited to, statements concerning: the Company's future results of operations and financial position, business strategy, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies and named patient activities, ongoing clinical trials, research and development costs, plans for manufacturing, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the Company's Annual Report on Form 10-K for the year ended December 31, 2023 to be filed with the SEC on or about the date hereof. Actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. When evaluating Kyverna's business and prospects, careful consideration should be given to these risks and uncertainties. These statements speak only as of the date of this press release, and Kyverna undertakes no obligation to update or revise these statements.
For more information, please contact:
Investor Contact:
George Thampy
Kyverna Therapeutics
InvestorRelations@kyvernatx.com
Media Contact:
Consort Partners for Kyverna
kyvernatx@consortpartners.com
Kyverna Therapeutics, Inc. | ||||||||
Statements of Operations and Comprehensive Loss | ||||||||
(in thousands, except share and per share data) | ||||||||
Year Ended December 31, | ||||||||
2023 | 2022 | |||||||
Revenue | ||||||||
Collaboration revenue - related party | $ | — | $ | 7,025 | ||||
Operating expenses | ||||||||
Research and development | 49,923 | 28,402 | ||||||
General and administrative | 12,483 | 8,007 | ||||||
Total operating expenses | 62,406 | 36,409 | ||||||
Loss from operations | (62,406) | (29,384) | ||||||
Interest income | 2,282 | 565 | ||||||
Interest expense | (187) | (65) | ||||||
Other expense, net | (55) | (9) | ||||||
Total other income, net | 2,040 | 491 | ||||||
Net loss | (60,366) | (28,893) | ||||||
Other comprehensive gain (loss) | ||||||||
Unrealized gain (loss) on available-for-sale marketable securities, net | 30 | (26) | ||||||
Total other comprehensive gain (loss) | 30 | (26) | ||||||
Net loss and other comprehensive loss | $ | (60,336) | $ | (28,919) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (89.61) | $ | (63.43) | ||||
Weighted-average shares of common stock outstanding, basic and diluted | 673,622 | 455,478 | ||||||
Kyverna Therapeutics, Inc. | ||||||||
Balance Sheets | ||||||||
(in thousands, except share and per share data) | ||||||||
December 31, | ||||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 34,647 | $ | 37,735 | ||||
Available-for-sale marketable securities | 22,896 | 13,587 | ||||||
Prepaid expenses and other current assets | 3,121 | 1,929 | ||||||
Total current assets | 60,664 | 53,251 | ||||||
Restricted cash | 565 | 554 | ||||||
Property and equipment, net | 2,326 | 2,575 | ||||||
Operating lease right-of-use assets | 6,494 | 8,214 | ||||||
Finance lease right-of-use assets | 1,790 | 1,652 | ||||||
Other non-current assets | 3,356 | 678 | ||||||
Total assets | $ | 75,195 | $ | 66,924 | ||||
Liabilities, redeemable convertible preferred stock and stockholders' | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 4,358 | $ | 1,451 | ||||
Accrued compensation | 2,812 | 1,411 | ||||||
Accrued license expense – related party | 6,250 | 6,250 | ||||||
Other current liabilities | 3,519 | 565 | ||||||
Operating lease liabilities, short-term portion | 1,964 | 1,672 | ||||||
Finance lease liabilities, short-term portion | 956 | 605 | ||||||
Total current liabilities | 19,859 | 11,954 | ||||||
Operating lease liabilities, net of short-term portion | 5,238 | 7,209 | ||||||
Finance lease liabilities, net of short-term portion | 921 | 1,078 | ||||||
Other long-term liabilities | — | 6 | ||||||
Total liabilities | 26,018 | 20,247 | ||||||
Commitments and contingencies | ||||||||
Redeemable convertible preferred stock, | 180,574 | 120,674 | ||||||
Stockholders' deficit | ||||||||
Common stock, | — | — | ||||||
Additional paid-in capital | 4,642 | 1,706 | ||||||
Accumulated other comprehensive income (loss) | 4 | (26) | ||||||
Accumulated deficit | (136,043) | (75,677) | ||||||
Total stockholders' deficit | (131,397) | (73,997) | ||||||
Total liabilities, redeemable convertible preferred stock and | $ | 75,195 | $ | 66,924 | ||||
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SOURCE Kyverna Therapeutics
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