- Advanced clinical development in two broad areas of
autoimmune disease: rheumatology and neurology
- Treated 30 patients cumulatively as of May 14, 2024, including eight patients with
myasthenia gravis, seven patients with lupus nephritis, and four
patients with multiple sclerosis
- Strong balance sheet, bolstered by recent public
offering
EMERYVILLE, Calif., May 14, 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 first quarter ended March
31, 2024.
"We continue to build momentum in the clinical development of
our lead product candidate, KYV-101, as we seek to bring autoimmune
CAR T-cell therapies to more patients across 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."
First Quarter 2024 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 30 patients cumulatively as of May 14, 2024, including eight patients with
myasthenia gravis, seven patients with lupus nephritis, and four
patients with multiple sclerosis
- Published early clinical data showing first-in-disease use of
KYV-101 in patients with refractory progressive multiple
sclerosis
- KYV-101 granted Orphan Drug Designation by the U.S. Food and
Drug Administration for the treatment of myasthenia gravis
- 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),
and a Phase 2 trial in multiple sclerosis (KYSA-7)
- 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 Quarter Ended March 31, 2024
For the quarter ended March 31,
2024, the company reported a net loss of $26.7 million, or a net loss per common share of
$1.12, compared to a net loss of
$11.1 million, or a net loss per
common share of $12.10, for the same
period in 2023.
During the quarter ended March 31,
2024, net cash used in operating activities was $25.5 million, compared to $11.5 million for the same period in 2023.
Kyverna reported $369.8 million in
cash, cash equivalents, and available-for-sale marketable
securities as of March 31, 2024,
inclusive of approximately $336.2
million in net proceeds raised from its initial public
offering that was completed in February
2024, after deducting underwriting discounts and commissions
and other offering costs.
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 1/2 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
March 31,
|
|
|
|
2024
|
|
|
2023
|
|
Operating
expenses
|
|
|
|
|
|
|
Research and
development
|
|
$
|
22,476
|
|
|
$
|
8,711
|
|
General and
administrative
|
|
|
6,882
|
|
|
|
2,734
|
|
Total operating
expenses
|
|
|
29,358
|
|
|
|
11,445
|
|
Loss from
operations
|
|
|
(29,358)
|
|
|
|
(11,445)
|
|
Interest
income
|
|
|
2,735
|
|
|
|
349
|
|
Interest
expense
|
|
|
(44)
|
|
|
|
(44)
|
|
Other expense,
net
|
|
|
(26)
|
|
|
|
(3)
|
|
Total other income,
net
|
|
|
2,665
|
|
|
|
302
|
|
Net loss
|
|
|
(26,693)
|
|
|
|
(11,143)
|
|
Other comprehensive
gain (loss)
|
|
|
|
|
|
|
Unrealized gain (loss)
on available-for-sale marketable securities, net
|
|
|
(5)
|
|
|
|
18
|
|
Total other
comprehensive gain (loss)
|
|
|
(5)
|
|
|
|
18
|
|
Net loss and other
comprehensive loss
|
|
$
|
(26,698)
|
|
|
$
|
(11,125)
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
|
$
|
(1.12)
|
|
|
$
|
(12.10)
|
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
|
|
23,754,062
|
|
|
|
921,260
|
|
Kyverna Therapeutics, Inc.
Condensed Balance
Sheets
(in thousands,
except share and per share data)
(unaudited)
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
|
2024
|
|
|
2023
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
224,287
|
|
|
$
|
34,647
|
|
Available-for-sale
marketable securities
|
|
|
145,507
|
|
|
|
22,896
|
|
Prepaid expenses and
other current assets
|
|
|
5,694
|
|
|
|
3,121
|
|
Total current
assets
|
|
|
375,488
|
|
|
|
60,664
|
|
Restricted
cash
|
|
|
570
|
|
|
|
565
|
|
Property and
equipment, net
|
|
|
2,714
|
|
|
|
2,326
|
|
Operating lease
right-of-use assets
|
|
|
8,486
|
|
|
|
6,494
|
|
Finance lease
right-of-use assets
|
|
|
1,552
|
|
|
|
1,790
|
|
Other non-current
assets
|
|
|
1,174
|
|
|
|
3,356
|
|
Total
assets
|
|
$
|
389,984
|
|
|
$
|
75,195
|
|
Liabilities,
redeemable convertible preferred stock and stockholders'
equity (deficit)
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
7,451
|
|
|
$
|
4,358
|
|
Accrued
compensation
|
|
|
1,363
|
|
|
|
2,812
|
|
Accrued license
expense – related party
|
|
|
6,250
|
|
|
|
6,250
|
|
Other accrued expenses
and current liabilities
|
|
|
3,083
|
|
|
|
3,519
|
|
Operating lease
liabilities, short-term portion
|
|
|
2,739
|
|
|
|
1,964
|
|
Finance lease
liabilities, short-term portion
|
|
|
979
|
|
|
|
956
|
|
Total current
liabilities
|
|
|
21,865
|
|
|
|
19,859
|
|
Operating lease
liabilities, net of short-term portion
|
|
|
6,461
|
|
|
|
5,238
|
|
Finance lease
liabilities, net of short-term portion
|
|
|
667
|
|
|
|
921
|
|
Total
liabilities
|
|
|
28,993
|
|
|
|
26,018
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
Redeemable convertible
preferred stock, no par value; no shares authorized, issued
and
outstanding as of
March 31, 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 $181,250 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
March 31, 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 March 31, 2024 and
December 31, 2023, respectively; 43,115,244 and
1,250,103
shares issued and
outstanding as of March 31, 2024 and December 31, 2023,
respectively
|
|
|
—
|
|
|
|
—
|
|
Additional paid-in
capital
|
|
|
523,728
|
|
|
|
4,642
|
|
Accumulated other
comprehensive income (loss)
|
|
|
(1)
|
|
|
|
4
|
|
Accumulated
deficit
|
|
|
(162,736)
|
|
|
|
(136,043)
|
|
Total stockholders'
equity (deficit)
|
|
|
360,991
|
|
|
|
(131,397)
|
|
Total liabilities,
redeemable convertible preferred stock and
stockholders' equity (deficit)
|
|
$
|
389,984
|
|
|
$
|
75,195
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/kyverna-therapeutics-provides-business-update-and-reports-first-quarter-2024-financial-results-302145168.html
SOURCE Kyverna Therapeutics