- 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 /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 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)
|
|
|
|
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'
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
|
|
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SOURCE Kyverna Therapeutics