8-K
Kyverna Therapeutics, Inc. (KYTX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 26, 2024
KYVERNA THERAPEUTICS, INC.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-41947 | 83-1365441 |
|---|---|---|
| (State or Other Jurisdiction<br><br>of Incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
| 5980 Horton St., STE 550<br><br>Emeryville, CA | 94608 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: (510) 925-2492
N/A
(Former Name or Former Address, if Changed Since Last Report)
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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br><br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.00001 per share | KYTX | The Nasdaq Stock Market LLC |
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 March 26, 2024, Kyverna Therapeutics, Inc. (the “Company”) issued a press release providing a business update and reporting financial results for the full year ended December 31, 2023. 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 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit<br><br>Number | Description |
|---|---|
| 99.1 | Press Release issued by Kyverna Therapeutics, Inc., dated March 26, 2024. |
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.
| KYVERNA THERAPEUTICS, INC. | ||
|---|---|---|
| Date: March 26, 2024 | By: | /s/ Peter Maag, Ph.D. |
| Peter Maag, Ph.D. | ||
| Chief Executive Officer |
EX-99.1
Exhibit 99.1
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
EMERYVILLE, Calif., March 26, 2024 – Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today reported its business highlights and financial results for the full year ended December 31, 2023.
“2023 was a momentous year for Kyverna as we brought KYV-101 into the clinic in both the US and Europe,” said Peter Maag, Chief Executive Officer of Kyverna. “We are excited to build on our leadership position in 2024 and continue to execute diligently on our promise to bring hope to patients living with autoimmune disorders.”
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 in February 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 December 31, 2023
For the year ended December 31, 2023, the company reported a net loss of $60.4 million, or a net loss per common share of $89.61, compared to a net loss of $28.9 million, or a net loss per common share of $63.43, for the same period in 2022.
During the year ended December 31, 2023, net cash used in operating activities was $52.4 million, compared to $36.1 million for the same period in 2022.
Kyverna reported $57.5 million in cash, cash equivalents, and available-for-sale marketable securities as of December 31, 2023. Subsequent to December 31, 2023, the Company raised approximately $366.9 million in gross proceeds from its initial public offering that was completed in February 2024.
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 the United States and Germany for patients with lupus nephritis.
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)
| 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’ deficit | |||||
| 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, 0.00001 par value, 114,556,997 and 97,462,067 shares authorized as of December 31, 2023 and 2022, respectively; 114,556,997 and 82,504,003 shares issued and outstanding as of December 31, 2023 and 2022, respectively; liquidation preference of 181,273 and 121,273 as of December 31, 2023 and 2022, respectively. | 180,574 | 120,674 | |||
| Stockholders’ deficit | |||||
| Common stock, 0.00001 par value; 140,492,016 and 117,000,000 shares authorized as of December 31, 2023 and 2022, respectively; 1,250,103 and 1,007,537 shares issued and outstanding as of December 31, 2023 and 2022, respectively; 8,125 and 454,950 shares subject to repurchase as of December 31, 2023 and 2022, respectively. | — | — | |||
| 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 stockholders’ deficit | 75,195 | $ | 66,924 |
All values are in US Dollars.