On track to submit New Drug Application (NDA)
for KarXT in schizophrenia with the U.S. FDA in the third quarter
of 2023, with a product launch in the second half of 2024, assuming
approval
Initiated the Phase 3 ADEPT-3 open label
extension trial in the third quarter of 2023, and on track to
commence the Phase 3 ADEPT-2 trial in the second half of 2023
Announced the appointment of Jonathan Rosin to
Chief Human Resources Officer and the promotion of Jason Brown to
Chief Financial Officer
$1.4 billion in cash expected to fund
operations through 2026
Conference call and webcast to take place today
at 8:00 a.m. ET
Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage
biopharmaceutical company driven to create and deliver
transformative medicines for people living with psychiatric and
neurological conditions, today announced financial results for the
second quarter of 2023 and provided a general business update.
“We’ve made significant progress in the second quarter across
our business, but most importantly in generating, analyzing, and
preparing the data required for our NDA submission in
schizophrenia,” said Bill Meury, president and chief executive
officer of Karuna Therapeutics. “Looking ahead, we remain focused
on our NDA submission, which is on track for later this quarter,
and building the commercial infrastructure in preparation for the
potential launch of KarXT in the second half of 2024.”
“Beyond the EMERGENT program, we continue to activate additional
clinical trial sites to support recruitment in our ARISE trial,
with data on track for the second half of 2024. We also initiated
the ADEPT-3 open label extension trial in psychosis in Alzheimer’s
earlier this quarter, with the full Phase 3 ADEPT program expected
to be underway in the coming months following the initiation of
ADEPT-2, our second pivotal safety and efficacy trial in this
program,” added Mr. Meury.
KEY PIPELINE HIGHLIGHTS
Karuna is advancing a pipeline of novel drug candidates for the
treatment of various psychiatric and neurological conditions led by
KarXT (xanomeline-trospium), an oral, investigational
M1/M4-preferring muscarinic agonist.
KarXT
KarXT is being evaluated in Phase 3 clinical trials as a
potential treatment for schizophrenia as a monotherapy and
adjunctive therapy, as well as for psychosis in Alzheimer’s
disease.
- Schizophrenia
- Presented additional data analyses from the EMERGENT program
evaluating KarXT in schizophrenia at the American Society of
Clinical Psychopharmacology (ASCP) Annual Meeting and the 2023
Congress of the Schizophrenia International Research Society (SIRS)
in the second quarter of 2023.
- In the EMERGENT-3 trial, KarXT demonstrated a statistically
significant and clinically meaningful improvement in the Clinical
Global Impression – Severity (CGI-S) score, a prespecified
secondary endpoint, compared to placebo starting at week 2 and
maintained such improvement throughout the trial to week 5 (-1.1
KarXT vs. -0.6 placebo; p<0.0001), consistent with the
EMERGENT-1 and EMERGENT-2 trials.
- In an exploratory pooled analysis of the EMERGENT-2 and
EMERGENT-3 trials, KarXT was associated with statistically
significant and clinically meaningful improvements in cognitive
function compared to placebo at week 5 in patients with cognitive
impairment at baseline (0.41 KarXT vs. 0.13 placebo; p<0.01,
Cohen’s d=0.52) as measured by the CANTAB composite score.
Additionally, there was no significant correlative relationship
between changes in Positive and Negative Syndrome Scale (PANSS)
total score and changes in CANTAB composite score in the KarXT
group, suggesting that improvements observed in cognition were
largely independent of improvements in PANSS-related symptoms.
- Completed enrollment in the EMERGENT-5 trial in the second
quarter of 2023.
- Topline data from the EMERGENT-4 and EMERGENT-5 trials
evaluating the long-term safety of KarXT in schizophrenia are
anticipated in 2024.
- The Phase 1b trial evaluating the effect of KarXT on 24-hour
ambulatory blood pressure in adults with schizophrenia completed
enrollment in the second quarter of 2023.
- Topline data from the trial is expected in the fourth quarter
of 2023.
- The Company remains on track to submit an NDA for KarXT in
schizophrenia with the FDA in the third quarter of 2023, with a
launch in the second half of 2024, if approved.
- Adjunctive treatment in
schizophrenia
- Topline data from the ARISE trial evaluating the efficacy
and safety of KarXT in schizophrenia when combined with a
background antipsychotic is anticipated in the second half of
2024.
- Psychosis in Alzheimer’s disease
- The ADEPT-1 trial is ongoing, with the ADEPT-2 trial on
track to initiate in the second half of 2023.
- Topline data from the ADEPT-1 and ADEPT-2 trials are
anticipated in 2025.
- Initiated the ADEPT-3 open-label extension trial in the
third quarter of 2023.
Early-stage and discovery programs
The Karuna pipeline also includes clinical-stage candidate
KAR-2618, a TRPC4/5 inhibitor for the treatment of mood and anxiety
disorders, as well as pre-clinical muscarinic, TRPC4/5, and
target-agnostic compounds for the treatment of psychiatric and
neurological conditions.
- The Company plans to share next steps on the development of
KAR-2618 for the treatment of mood and anxiety disorders in the
second half of 2023.
BUSINESS UPDATES
- Announced key leadership appointments. In a separate
press release, the Company today announced the appointment of
Jonathan Rosin to Chief Human Resources Officer in July 2023, and
the promotion of Jason Brown to Chief Financial Officer. Mr. Brown
succeeds Troy Ignelzi who will remain at Karuna for a transition
period through the end of the third quarter of 2023.
ANTICIPATED UPCOMING MILESTONES
- NDA submission of KarXT in schizophrenia (3Q 2023)
- Initiation of the Phase 3 ADEPT-2 trial (2H 2023)
- Topline data from the Phase 3 EMERGENT-4 trial (2024)
- Topline data from the Phase 3 EMERGENT-5 trial (2024)
- Launch of KarXT in schizophrenia, if approved (2H 2024)
- Topline data from the Phase 3 ARISE trial (2H 2024)
- Topline data from the Phase 3 ADEPT-1 trial (2025)
- Topline data from the Phase 3 ADEPT-2 trial (2025)
SECOND QUARTER 2023 FINANCIAL RESULTS
The Company reported a net loss of $103.2 million for the second
quarter of 2023, as compared to $64.9 million for the prior year
period. The increase in net loss for the quarter was driven by
research and development expenses related to the Company’s ongoing
KarXT clinical programs, NDA-supporting activities,
pre-commercialization activities, increased employee headcount
across the organization, and higher stock-based compensation.
Research and development expenses were $92.5 million for the
second quarter of 2023, as compared to $52.5 million for the prior
year period. The increase in research and development expenses for
the quarter was primarily driven by expenses related to the KarXT
clinical programs, NDA-supporting activities, increased employee
headcount, and higher stock-based compensation.
General and administrative expenses were $27.4 million for the
second quarter of 2023, as compared to $17.8 million for the prior
year period. The increase in general and administrative expenses
for the quarter was primarily driven by the Company’s
pre-commercialization activities, increased employee headcount, and
higher stock-based compensation.
The Company ended the quarter with $1.4 billion in cash, cash
equivalents, and available-for-sale investment securities compared
to $1.1 billion as of December 31, 2022. The increase was primarily
the result of the completion of the Company’s follow-on public
offering in March 2023, which resulted in net proceeds of $436.7
million. The Company expects that current cash, cash equivalents,
and available-for-sale investment securities as of June 30, 2023
will enable the Company to fund its operating expenses and capital
expenditure requirements through the end of 2026.
CONFERENCE CALL AND WEBCAST DETAILS
The second quarter 2023 financial results and business update
will be discussed during a conference call and webcast today at
8:00 a.m. ET. A webcast of the live call may be accessed on the
Investors section of the Karuna website at investors.karunatx.com.
A replay of the webcast will be available for up to 30 days
following the event.
About Karuna Therapeutics
Karuna Therapeutics is a clinical-stage biopharmaceutical
company driven to create and deliver transformative medicines for
people living with psychiatric and neurological conditions. At
Karuna, we understand there is a need for differentiated and more
effective treatments that can help patients navigate the challenges
presented by these severe and disabling disorders. Utilizing our
extensive knowledge of neuroscience, we are harnessing the untapped
potential of the brain in pursuit of novel pathways to develop
medicines that make meaningful differences in peoples’ lives. For
more information, please visit www.karunatx.com.
Forward Looking Statements
This press release contains forward looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, including statements regarding our expectations about the
timing of our ongoing and planned clinical trials and regulatory
filings, our goals to develop and commercialize our product
candidates, our liquidity and capital resources and other
statements identified by words such as “could,” “expects,”
“intends,” “may,” “plans,” “potential,” “should,” “will,” “would,”
or similar expressions and the negatives of those terms. Forward
looking statements are not promises or guarantees of future
performance, and are subject to a variety of risks and
uncertainties, many of which are beyond our control, and which
could cause actual results to differ materially from those
contemplated in such forward-looking statements. These factors
include risks related to our limited operating history, our ability
to obtain necessary funding, our ability to generate positive
clinical trial results for our product candidates and other risks
inherent in clinical development, the timing and scope of
regulatory approvals, changes in laws and regulations to which we
are subject, competitive pressures, our ability to identify
additional product candidates, risks relating to business
interruptions resulting from the coronavirus (COVID-19) pandemic,
and other risks set forth under the heading “Risk Factors” of our
Annual Report on Form 10-K for the year ended December 31, 2022 and
in our subsequent filings with the Securities and Exchange
Commission. Our actual results could differ materially from the
results described in or implied by such forward looking statements.
Forward-looking statements speak only as of the date hereof, and,
except as required by law, we undertake no obligation to update or
revise these forward-looking statements.
Karuna Therapeutics, Inc.
Unaudited Consolidated Statements of
Operations
(in thousands, except share and per share
data)
Three Months Ended
Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
License and other revenue
$
-
$
5,278
$
654
$
5,278
Operating expenses:
Research and development
92,490
52,487
177,957
96,293
General and administrative
27,417
17,843
51,670
32,631
Total operating expenses
119,907
70,330
229,627
128,924
Loss from operations
(119,907
)
(65,052
)
(228,973
)
(123,646
)
Other income, net:
Interest income
16,597
490
27,942
727
Sublease income
147
147
294
286
Total other income, net
16,744
637
28,236
1,013
Net loss before income taxes
(103,163
)
(64,415
)
(200,737
)
(122,633
)
Income tax provision
—
(528
)
—
(528
)
Net loss attributable to common
stockholders
$
(103,163
)
$
(64,943
)
$
(200,737
)
$
(123,161
)
Net loss per share, basic and diluted
$
(2.75
)
$
(2.17
)
$
(5.55
)
$
(4.13
)
Weighted average common shares
outstanding used in computing net loss
per
share, basic and diluted
37,524,640
29,896,332
36,170,166
29,851,396
Karuna Therapeutics, Inc.
Unaudited Consolidated Balance Sheet
Data
(in thousands)
June 30, 2023
December 31, 2022
Cash, cash equivalents and investments
$
1,434,477
$
1,124,044
Working capital
1,413,344
1,120,823
Total assets
1,472,103
1,163,334
Total stockholders’ equity
$
1,419,563
$
1,126,238
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230803699470/en/
Investor: Alexis Smith +1 (518) 338-8990
asmith@karunatx.com
Karuna Therapeutics (NASDAQ:KRTX)
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