UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2024 ( |
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On November 13, 2024, Kyverna Therapeutics, Inc. (the “Company”) issued a press release providing a business update and reporting financial results for the quarter ended September 30, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”).
In accordance with General Instructions B.2 of Form 8-K, the information in Item 2.02 of this Current Report and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On November 8, 2024, James Chung, M.D., Ph.D., Chief Medical Officer of the Company, resigned from the Company, to be effective as of November 22, 2024. Dr. Chung’s resignation was not the result of any dispute or disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
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Description |
99.1 |
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Press Release issued by Kyverna Therapeutics, Inc. dated November 13, 2024. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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KYVERNA THERAPEUTICS, INC. |
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Date: November 13, 2024 |
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By: |
/s/ Warner Biddle |
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Warner Biddle |
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Chief Executive Officer |
Exhibit 99.1
Kyverna Therapeutics Provides Business Update and Reports Third Quarter 2024 Financial Results
Multiple Key Leadership Appointments, Including Warner Biddle as CEO, Bringing Clinical, Commercial and Strategic Expertise in Cell Therapy
Continuing to Advance Broad KYSA Clinical Development Program: Presented Clinical Data Highlighting Potential for KYV-101 in SPS, MG and MS at ECTRIMS and Plan to Share Updated Clinical Data in LN at Company Symposium at ACR Convergence 2024
Strong Financial Position; Ended the Quarter With $321.6 Million in Cash, Cash Equivalents and Marketable Securities
EMERYVILLE, Calif., November 13, 2024 – 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 third quarter ended September 30, 2024.
“With KYV-101 advancing towards later stages of development, we are scaling Kyverna to bring the transformative impact of our differentiated CAR T therapies to patients with a range of B cell-driven autoimmune diseases. Since I joined the company in September, we have made significant progress, both clinically and operationally, to maintain Kyverna’s leadership position,” said Warner Biddle, Chief Executive Officer of Kyverna. “At ECTRIMS, we shared promising clinical data highlighting KYV-101’s potential to reset the immune system and durably improve symptoms of neuroinflammatory diseases. At ACR Convergence 2024 later this week, we will share the latest clinical data from lupus nephritis patients demonstrating the potential for durable treatment effect at the target clinical dose.”
Mr. Biddle continued, “In order to deliver on the long-term opportunity for KYV-101, we are working to sharpen our focus, leveraging our clinical datasets and academic partnerships, and continue executing our KYSA clinical trial programs. In 2025 we will share our long-term plan in both neuroinflammatory and rheumatologic diseases.”
Third Quarter 2024 and Recent Business Highlights
KYV-101 Clinical Data Updates:
Also at ACR Convergence 2024, Kyverna will present one oral and two poster presentations outlining its approach to understanding mechanisms of immune reset and detailing Kyverna’s next-generation CAR T-cell therapies, including preclinical data on Ingenui-T, the Company’s 3-day manufacturing process using autologous whole blood as starting material.
KYV-101 Clinical Development Program Updates:
As of November 2024, Kyverna initiated Phase 2 dosing with KYV-101, received RMAT designation in two indications and received Orphan Drug Designation in three indications.
Corporate, Operational & Manufacturing Updates
In addition, Kyverna announced today that James Chung, M.D., Ph.D., the Company’s Chief Medical Officer, will step down from his position to pursue external opportunities, effective November 22, 2024. Kyverna has initiated a search for an external candidate to replace Dr. Chung.
Financial Results for the Quarter Ended September 30, 2024
For the quarter ended September 30, 2024, the company reported a net loss of $34.3 million, or a net loss per common share of $0.80, compared to a net loss of $15.5 million, or a net loss per common share of $23.27, for the same period in 2023.
During the nine months ended September 30, 2024, net cash used in operating activities was $77.2 million, compared to $33.8 million for the same period in 2023.
Kyverna reported $321.6 million in cash, cash equivalents, and available-for-sale marketable securities as of September 30, 2024.
About Kyverna Therapeutics
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) 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 across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for Stiff-Person Syndrome, myasthenia gravis, and multiple sclerosis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center Phase 1/2 trials in the United States and Germany for patients with lupus nephritis.
Kyverna's pipeline includes next-generation 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 filed with the SEC on March 26, 2024 and any subsequent Quarterly Reports on Form 10-Q filed by the Company. 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:
Precision AQ on behalf of Kyverna Therapeutics
Investors: InvestorRelations@kyvernatx.com
Media: media@kyvernatx.com
Kyverna Therapeutics, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses |
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Research and development |
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$ |
29,193 |
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$ |
13,644 |
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$ |
78,990 |
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$ |
32,760 |
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General and administrative |
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9,577 |
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2,638 |
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22,573 |
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8,269 |
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Total operating expenses |
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38,770 |
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16,282 |
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101,563 |
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41,029 |
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Loss from operations |
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(38,770 |
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(16,282 |
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(101,563 |
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(41,029 |
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Interest income |
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4,355 |
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880 |
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11,784 |
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1,493 |
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Interest expense |
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(32 |
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(50 |
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(115 |
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(140 |
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Other expense, net |
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(45 |
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(13 |
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(94 |
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(23 |
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Total other income, net |
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4,278 |
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817 |
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11,575 |
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1,330 |
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Net loss |
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(34,492 |
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(15,465 |
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(89,988 |
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(39,699 |
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Other comprehensive income |
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Unrealized gain on available-for-sale marketable securities, net |
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190 |
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5 |
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149 |
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31 |
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Total other comprehensive income |
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190 |
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5 |
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149 |
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31 |
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Net loss and other comprehensive income (loss) |
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$ |
(34,302 |
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$ |
(15,460 |
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$ |
(89,839 |
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$ |
(39,668 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.80 |
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$ |
(23.27 |
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$ |
(2.45 |
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$ |
(62.75 |
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Weighted-average shares of common stock outstanding, basic and diluted |
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43,155,858 |
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664,656 |
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36,702,183 |
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632,624 |
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Kyverna Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
(unaudited)
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September 30, |
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December 31, |
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2024 |
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2023 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
104,663 |
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$ |
34,647 |
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Available-for-sale marketable securities |
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216,924 |
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22,896 |
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Prepaid expenses and other current assets |
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3,787 |
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3,121 |
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Total current assets |
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325,374 |
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60,664 |
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Restricted cash |
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564 |
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565 |
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Property and equipment, net |
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3,151 |
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2,326 |
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Operating lease right-of-use assets |
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7,153 |
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6,494 |
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Finance lease right-of-use assets |
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1,078 |
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1,790 |
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Other non-current assets |
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1,876 |
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3,356 |
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Total assets |
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$ |
339,196 |
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$ |
75,195 |
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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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$ |
9,932 |
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$ |
4,358 |
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Accrued compensation |
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4,440 |
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2,812 |
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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 accrued expenses and current liabilities |
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6,432 |
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3,519 |
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Operating lease liabilities, short-term portion |
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3,000 |
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1,964 |
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Finance lease liabilities, short-term portion |
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931 |
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956 |
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Total current liabilities |
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30,985 |
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19,859 |
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Operating lease liabilities, net of short-term portion |
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4,968 |
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5,238 |
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Finance lease liabilities, net of short-term portion |
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237 |
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921 |
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Other non-current liabilities |
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296 |
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— |
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Total liabilities |
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36,486 |
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26,018 |
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Commitments and contingencies (Note 7) |
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Redeemable convertible preferred stock, no par value; no shares authorized, issued and outstanding as of September 30, 2024; $0.00001 par value, 114,556,997 shares authorized as of December 31, 2023; 114,556,997 shares issued and outstanding as of December 31, 2023; liquidation preference of $181,273 as of December 31, 2023 |
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— |
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180,574 |
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Stockholders’ equity (deficit) |
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Preferred stock, 10,000,000 shares authorized, $0.00001 par value, no shares issued and outstanding as of September 30, 2024; no shares authorized, issued, and outstanding as of December 31, 2023 |
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— |
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— |
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Common stock, $0.00001 par value; 490,000,000 and 140,492,016 shares authorized as of September 30, 2024 and December 31, 2023, respectively; 43,167,337 and 1,250,103 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively |
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— |
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— |
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Additional paid-in capital |
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528,588 |
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4,642 |
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Accumulated other comprehensive income |
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153 |
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4 |
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Accumulated deficit |
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(226,031 |
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(136,043 |
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Total stockholders’ equity (deficit) |
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302,710 |
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(131,397 |
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Total liabilities, redeemable convertible preferred stock and |
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$ |
339,196 |
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$ |
75,195 |
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