New Drug Application (NDA) for KarXT for the
treatment of schizophrenia in adults under review with a
Prescription Drug User Fee Act (PDUFA) action date of September 26,
2024
Results from the Phase 3 EMERGENT-2 trial of
KarXT in schizophrenia published in The Lancet
Announced appointments of Andrew Miller, Ph.D.
as President of Research and Development and Mia Kelley, J.D. as
General Counsel
Previously announced proposed acquisition of
Karuna by Bristol Myers Squibb expected to close in the first half
of 2024
$1.3 billion in cash, cash equivalents, and
available-for-sale investment securities
Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical
company driven to discover, develop, and deliver transformative
medicines for people living with psychiatric and neurological
conditions, today announced financial results for the fourth
quarter and full year ended December 31, 2023, and provided a
general business update.
“2023 was a landmark year for Karuna, marked by the FDA
acceptance of our NDA for KarXT for the treatment of schizophrenia
in adults, with a potential launch in the second half of this year,
and the continued advancement of our late-stage pipeline of KarXT
as a potential adjunctive treatment for schizophrenia and in
psychosis in Alzheimer’s disease,” said Bill Meury, president and
chief executive officer of Karuna Therapeutics. “We look forward to
continuing the work to bring KarXT and other potentially
transformative medicines to patients living with serious mental
illnesses, and we believe the pending acquisition of Karuna by
Bristol Myers Squibb will accelerate our ability to achieve this
mission.”
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
The NDA for KarXT for the treatment of schizophrenia in adults
is under review by the U.S. Food and Drug Administration (FDA) with
a PDUFA action date of September 26, 2024. KarXT is also being
evaluated in Phase 3 clinical trials as a potential adjunctive
treatment for schizophrenia and as a potential treatment for
psychosis in Alzheimer’s disease.
- Schizophrenia
- The NDA for KarXT for the treatment of schizophrenia in
adults was accepted for review by the FDA in the fourth quarter of
2023 and assigned a PDUFA action date of September 26,
2024.
- Results from the EMERGENT-2 trial published in The Lancet in
December 2023. The published manuscript, titled “Efficacy and
safety of the muscarinic receptor agonist KarXT
(xanomeline-trospium) in schizophrenia (EMERGENT-2) in the USA:
results from a randomised, double-blind, placebo-controlled,
flexible-dose phase 3 trial,” is available online, and appears in
the January 13, 2024 print issue.
- Announced positive results from the Phase 1b
Ambulatory Blood Pressure Monitoring trial in schizophrenia in the
fourth quarter of 2023. Results from the trial demonstrate that
KarXT was not associated with clinically meaningful increases in
blood pressure in adults with schizophrenia.
- Presented additional data from the EMERGENT program at the
2023 Neuroscience Education Institute (NEI) Congress and the CNS
Summit in the fourth quarter of 2023. Poster presentations
included new pooled efficacy and safety analyses across the three
completed EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials, where:
- KarXT demonstrated statistically significant and clinically
meaningful improvements in symptoms of schizophrenia as measured by
the Positive and Negative Syndrome Scale (PANSS) total score from
baseline to week 5 compared to placebo (p<0.0001), the primary
endpoint in the trials.
- KarXT demonstrated statistically significant improvements
across all secondary efficacy measures, including the PANSS
positive subscale score (p<0.0001), PANSS negative subscale
score (p<0.0001), PANSS Marder negative factor score
(p<0.0001), and CGI-S score (p<0.0001).
- KarXT was generally well tolerated, with common adverse
reactions (>5% and at least twice
placebo) being mostly cholinergic in nature, mild to moderate in
severity, and transient over time. Further, KarXT was not
associated with weight gain, adverse changes in metabolic
parameters, or extrapyramidal symptoms.
- Interim long-term data from the EMERGENT-4 & 5 trials to
be presented at upcoming medical congresses in the spring.
- Adjunctive treatment in
schizophrenia
- Topline data from the Phase 3 ARISE trial evaluating the
efficacy and safety of KarXT in schizophrenia when combined with a
background antipsychotic is anticipated in 2025.
- Psychosis in Alzheimer’s disease
- Topline data from the Phase 3 ADEPT-1 and ADEPT-2 trials
evaluating KarXT in psychosis in Alzheimer’s disease is anticipated
in 2026.
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 is on track to initiate a Phase 1b trial of
KAR-2618 in major depressive disorder (MDD) in 2024.
BUSINESS UPDATES
- Key leadership appointments. In January 2024, the
Company appointed Andrew Miller, Ph.D. as President of Research and
Development and Mia Kelley, J.D. as General Counsel. Dr. Miller
succeeds Steve Paul, M.D., who continues to serve on the Company’s
Board of Directors and was appointed as a member of the Company’s
Scientific Advisory Board.
- Proposed acquisition of Karuna Therapeutics by Bristol Myers
Squibb. In December 2023, Karuna and Bristol Myers Squibb
announced they have entered into a definitive merger agreement
under which Bristol Myers Squibb has agreed to acquire Karuna for
$330.00 per share in cash, for a total equity value of $14.0
billion, or $12.7 billion net of estimated cash acquired. The
Boards of Directors of both companies have unanimously approved the
transaction. The transaction is expected to close in the first half
of 2024, subject to customary closing conditions, including
approval of Karuna stockholders and receipt of required regulatory
approvals.
ANTICIPATED UPCOMING MILESTONES
- Topline data from the Phase 3 EMERGENT-4 trial (2H 2024)
- Topline data from the Phase 3 EMERGENT-5 trial (2H 2024)
- KarXT in schizophrenia PDUFA action date (September 26,
2024)
- Launch of KarXT in schizophrenia, if approved (2H 2024)
- Initiation of the Phase 1b trial of KAR-2618 in major
depressive disorder (2024)
- Topline data from the Phase 3 ARISE trial (2025)
- Topline data from the Phase 3 ADEPT-1 trial (2026)
- Topline data from the Phase 3 ADEPT-2 trial (2026)
FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS
The Company reported a net loss of $113.8 million for the fourth
quarter of 2023, and a net loss of $433.7 million for the year
ended 2023, as compared to $76.2 million and $276.3 million for the
prior year periods, respectively. The increase in net loss for the
year was primarily attributable to higher operating expenses of
$495.4 million compared to $300.3 million for the prior year
period, driven by research and development expenses related to the
Company’s ongoing KarXT clinical programs, NDA-supporting
activities, pre-commercialization activities, the $15.0 million
upfront license payment for Goldfinch Bio’s TRPC4/5 channel
candidates, increased employee headcount across the organization,
higher stock-based compensation, and expenses associated with the
pending acquisition of Karuna by Bristol Myers Squibb.
Research and development expenses were $82.2 million for the
fourth quarter of 2023, and $364.1 million for the year ended 2023,
as compared to $66.0 million and $224.2 million for the prior year
periods, respectively. The increase in research and development
expenses for the year was primarily driven by expenses related to
the Company’s KarXT clinical programs, NDA-supporting activities,
the upfront license payment for Goldfinch Bio’s TRPC4/5 channel
candidates, increased employee headcount, and higher stock-based
compensation.
General and administrative expenses were $47.4 million for the
fourth quarter of 2023, and $131.3 million for the year ended 2023,
as compared to $24.3 million and $76.1 million for the prior year
periods, respectively. The increase in general and administrative
expenses for the year was primarily driven by the Company’s
pre-commercialization activities, increased employee headcount,
higher stock-based compensation, and expenses associated with the
pending acquisition of Karuna by Bristol Myers Squibb.
The Company ended the year 2023 with $1.3 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.
About Karuna Therapeutics
Karuna Therapeutics is a biopharmaceutical company driven to
discover, develop, 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 serious mental illness. 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, the proposed
acquisition of Karuna by Bristol Myers Squibb, 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, the
proposed acquisition of Karuna by Bristol Myers Squibb, changes in
laws and regulations to which we are subject, competitive
pressures, our ability to identify additional product candidates,
risks relating to business interruptions, and other risks set forth
under the heading “Risk Factors” of our Annual Report on Form 10-K
for the year ended December 31, 2023 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
Year Ended
December 31,
December 31,
2023
2022
2023
2022
License and other revenue
$
—
$
5,278
$
654
$
10,637
Operating expenses:
Research and development
82,192
66,004
364,101
224,247
General and administrative
47,394
24,310
131,330
76,066
Total operating expenses
129,586
90,314
495,431
300,313
Loss from operations
(129,586
)
(85,036
)
(494,777
)
(289,676
)
Other income, net:
Interest income
16,285
9,567
61,179
14,178
Sublease income
147
147
588
580
Total other income, net
16,432
9,714
61,767
14,758
Net loss before income taxes
(113,154
)
(75,322
)
(433,010
)
(274,918
)
Income tax provision
(670
)
(890
)
(670
)
(1,418
)
Net loss attributable to common
stockholders
$
(113,824
)
$
(76,212
)
$
(433,680
)
$
(276,336
)
Net loss per share, basic and diluted
$
(3.01
)
$
(2.22
)
$
(11.73
)
$
(8.74
)
Weighted average common shares outstanding
used in computing net loss per share, basic and diluted
37,780,998
34,406,182
36,959,049
31,629,013
Karuna Therapeutics, Inc.
Unaudited Consolidated Balance Sheet Data (in thousands)
December 31, 2023
December 31, 2022
Cash, cash equivalents and investments
$
1,260,780
$
1,124,044
Working capital
1,247,184
1,120,823
Total assets
1,336,209
1,163,334
Total stockholders’ equity
$
1,254,235
$
1,126,238
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version on businesswire.com: https://www.businesswire.com/news/home/20240222875274/en/
Investors: Alexis Smith +1 (617) 352-9917
asmith@karunatx.com
Media: Julie Ciardiello +1 (917) 647-0159
julie.ciardiello@karunatx.com
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