Kyverna Therapeutics Provides Business Update and Reports Second Quarter 2024 Financial Results

August 12, 2024
  • Actively recruiting clinical trials in neurology and rheumatology with KYV-101
  • No severe ICANS or CRS reported in first 36 autoimmune disease patients treated with KYV-101
  • Received FDA RMAT Designation for KYV-101 for treatment of patients with Stiff-Person Syndrome
  • Received FDA RMAT Designation for KYV-101 for treatment of patients with Myasthenia Gravis
  • Reported clinical experience with first KYV-101 patient disease-free at 1 year after treatment

EMERYVILLE, Calif., Aug. 12, 2024 /PRNewswire/ -- 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 second quarter ended June 30, 2024.

"We have shown promising initial safety and efficacy for our lead product candidate, KYV-101, and continue to lead the way in bringing CAR T-cell therapies to patients with autoimmune diseases in the US and Europe," said Peter Maag, Chief Executive Officer of Kyverna. "We believe that KYV-101 brings the power of CD19-directed CAR T therapy to deliver deep tissue-based B cell depletion using a fully human CAR and CD28 costimulatory domain designed by the NIH to improve tolerability. We look forward to sharing more clinical data throughout the rest of 2024 as we strive to fulfill our promise to bring hope to patients living with autoimmune disorders."

Second Quarter 2024 and Recent Business Highlights

  • Presented clinical data showing use of the CAR in KYV-101 across 50 patients including 15 different autoimmune conditions at CAR T centers in the US and Europe
  • Expanded KYV-101 safety experience with no severe ICANS or CRS Grade ≥3 reported in 36 autoimmune patients treated as of July 31, 2024, using CAR construct designed by the NIH to improve tolerability
  • Received two U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designations for KYV-101: one for the treatment of patients with Stiff-Person Syndrome, and one for the treatment of patients with myasthenia gravis, building on the emerging body of clinical evidence
  • Achieved 100% manufacturing success rate across all 36 cumulative autoimmune patients treated with KYV-101 as of July 31, 2024
  • Reported clinical experience of a myasthenia gravis patient who is now free of disease one year after treatment with KYV-101
  • Progressed the global KYSA clinical trial program in multiple indications across rheumatology and neurology: Phase 1/2 trials in lupus nephritis (KYSA-1 and KYSA-3), a Phase 1/2 trial in systemic sclerosis (KYSA-5), a Phase 2 trial in myasthenia gravis (KYSA-6), a Phase 2 trial in multiple sclerosis (KYSA-7), and a Phase 2 trial in stiff-person syndrome (KYSA-8)

Upcoming Milestones

  • Neurology case reports at ECTRIMS in September 2024
  • Rheumatology KYSA Clinical Trial updates at ACR in November 2024
  • Guidance on anticipated regulatory phase transitions in 2025, following RMAT meetings with the FDA

Financial Results for the Quarter Ended June 30, 2024
For the quarter ended June 30, 2024, the company reported a net loss of $28.8 million, or a net loss per common share of $0.67, compared to a net loss of $13.1 million, or a net loss per common share of $20.86, for the same period in 2023.

During the six months ended June 30, 2024, net cash used in operating activities was $49.7 million, compared to $22.7 million for the same period in 2023.

Kyverna reported $346.2 million in cash, cash equivalents, and available-for-sale marketable securities as of June 30, 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, myasthenia gravis and stiff-person syndrome, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 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 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:
Investor Contact:
George Thampy
Kyverna Therapeutics
InvestorRelations@kyvernatx.com

Media Contact:
Consort Partners for Kyverna
kyvernatx@consortpartners.com

 

Kyverna Therapeutics, Inc.

Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(unaudited)




Three Months Ended June 30,



Six Months Ended June 30,




2024



2023



2024



2023


Operating expenses













Research and development


$

27,321



$

10,405



$

49,797



$

19,116


General and administrative



6,114




2,897




12,996




5,631


Total operating expenses



33,435




13,302




62,793




24,747


Loss from operations



(33,435)




(13,302)




(62,793)




(24,747)


Interest income



4,694




264




7,429




613


Interest expense



(39)




(46)




(83)




(90)


Other expense, net



(23)




(7)




(49)




(10)


Total other income, net



4,632




211




7,297




513


Net loss



(28,803)




(13,091)




(55,496)




(24,234)


Other comprehensive (loss) gain













Unrealized (loss) gain on available-for-sale marketable securities, net



(36)




8




(41)




26


Total other comprehensive (loss) gain



(36)




8




(41)




26


Net loss and other comprehensive loss


$

(28,839)



$

(13,083)



$

(55,537)



$

(24,208)


Net loss per share attributable to common stockholders, basic and diluted


$

(0.67)



$

(20.86)



$

(1.66)



$

(40.40)


Weighted-average shares of common stock outstanding, basic and diluted



43,125,709




627,589




33,439,886




599,917


 

Kyverna Therapeutics, Inc.

Condensed Balance Sheets

(in thousands, except share and per share data)

(unaudited)




June 30,



December 31,




2024



2023


Assets







Current assets







Cash and cash equivalents


$

131,618



$

34,647


Available-for-sale marketable securities



214,619




22,896


Prepaid expenses and other current assets



2,586




3,121


Total current assets



348,823




60,664


Restricted cash



574




565


Property and equipment, net



3,366




2,326


Operating lease right-of-use assets



7,825




6,494


Finance lease right-of-use assets



1,315




1,790


Other non-current assets



1,213




3,356


Total assets


$

363,116



$

75,195


Liabilities, redeemable convertible preferred stock and stockholders'
   equity (deficit)







Current liabilities







Accounts payable


$

4,861



$

4,358


Accrued compensation



2,722




2,812


Accrued license expense – related party



6,250




6,250


Other accrued expenses and current liabilities



5,775




3,519


Operating lease liabilities, short-term portion



2,867




1,964


Finance lease liabilities, short-term portion



1,003




956


Total current liabilities



23,478




19,859


Operating lease liabilities, net of short-term portion



5,722




5,238


Finance lease liabilities, net of short-term portion



407




921


Total liabilities



29,607




26,018


Commitments and contingencies







Redeemable convertible preferred stock, no par value; no shares authorized, issued and outstanding as of June 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






180,574


Stockholders' equity (deficit)







Preferred stock, 10,000,000 shares authorized, $0.00001 par value, no shares issued and outstanding as of June 30, 2024; no shares
authorized, issued, and outstanding as of  December 31, 2023







Common stock, $0.00001 par value; 490,000,000 and 140,492,016 shares authorized as of June 30, 2024 and December 31, 2023,
respectively; 43,146,852 and 1,250,103 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively







Additional paid-in capital



525,085




4,642


Accumulated other comprehensive (loss) income



(37)




4


Accumulated deficit



(191,539)




(136,043)


Total stockholders' equity (deficit)



333,509




(131,397)


Total liabilities, redeemable convertible preferred stock and
   stockholders' equity (deficit)


$

363,116



$

75,195


 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kyverna-therapeutics-provides-business-update-and-reports-second-quarter-2024-financial-results-302220289.html

SOURCE Kyverna Therapeutics