- 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
|
|
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SOURCE Kyverna Therapeutics