On track to initiate Phase 3 trials
within the EMERGENT program, the clinical program evaluating KarXT
for the treatment of acute psychosis in patients with
schizophrenia, by the end of 2020
Topline data from Phase 1b trial in healthy
elderly volunteers expected by the end of 2020
Plans to initiate Phase 2 trial evaluating
KarXT as adjunctive therapy with standard of care for the treatment
of psychosis in patients with schizophrenia who remain symptomatic
on existing therapies
$367.6 million in cash, cash equivalents and
short-term investments expected to fund multiple milestones,
including the Phase 3 program to NDA submission, and operations for
at least the next three years
Karuna Therapeutics, Inc. (NASDAQ: KRTX), an innovative
clinical-stage biopharmaceutical company committed to developing
novel therapies with the potential to transform the lives of people
with disabling and potentially fatal neuropsychiatric disorders,
today announced financial results for the second quarter of 2020
and provided a general business update.
“We’ve made tremendous progress in advancing our clinical
development programs evaluating KarXT in neuropsychiatric
disorders, including schizophrenia and dementia-related psychosis,
where the standards of care are simply insufficient,” said Steve
Paul, M.D., chief executive officer, president and chairman of
Karuna Therapeutics. “We remain focused on initiating Phase 3
trials within our EMERGENT program following a successful
End-of-Phase 2 meeting with the FDA in the second quarter. This
important next step brings us closer to providing a new, unique and
differentiated treatment option to patients with
schizophrenia.”
Dr. Paul continued: “Our commitment to discover and develop more
effective treatments for neuropsychiatric disorders is not only
underscored by our clinical-stage programs, but also the expansion
of our drug discovery efforts. These discovery efforts have enabled
us to broaden our approach to CNS drug discovery and development
with the goal of enhancing Karuna’s pipeline of novel drug
candidates for treating a wide range of neuropsychiatric
disorders.”
Pipeline Updates KarXT, a proprietary oral modulator of
muscarinic cholinergic receptors, is Karuna’s lead product
candidate combining xanomeline, a novel muscarinic agonist, with
trospium, a U.S. Food & Drug Administration (FDA) approved
muscarinic antagonist that does not appreciably cross the
blood-brain-barrier, to preferentially stimulate muscarinic
receptors in the central nervous system (CNS). KarXT is currently
being evaluated as a potential treatment for neuropsychiatric
disorders, including schizophrenia and dementia-related
psychosis.
- KarXT in schizophrenia: The Company previously announced
a positive outcome of its End-of-Phase 2 meeting with the FDA for
KarXT for the treatment of acute psychosis in patients with
schizophrenia. The outcome of the meeting supports the progression
of KarXT into Phase 3 development. The formal minutes from the
meeting also confirmed that the completed Phase 2 trial, along with
one successful Phase 3 efficacy and safety trial, and additional
safety data to meet regulatory requirements, would be acceptable to
support a New Drug Application (NDA) filing.
- The Company is on track to initiate the first Phase 3 trial
within its EMERGENT program, the clinical program evaluating KarXT
for the treatment of acute psychosis in adults with schizophrenia,
by the end of 2020. The EMERGENT program includes the completed
positive Phase 2 clinical trial (EMERGENT-1) and additional planned
efficacy and safety trials to support an NDA filing, including:
- EMERGENT-2: A five-week inpatient trial evaluating the
efficacy and safety of KarXT in adults with schizophrenia. The
EMERGENT-2 trial design shares many characteristics with the
completed EMERGENT-1 trial, including duration of treatment,
primary endpoint and patient population. EMERGENT-2 is a 1:1
randomized, flexible-dose, double-blind, placebo-controlled trial
enrolling approximately 250 adults in the U.S., and will evaluate
the change in Positive and Negative Syndrome Scale (PANSS) total
score at Week 5 of KarXT versus placebo as the primary outcome
measure. EMERGENT-2 is expected to commence by the end of
2020.
- EMERGENT-3: A five-week inpatient trial evaluating the
safety and efficacy of KarXT in adults with schizophrenia. This
trial will share characteristics of the completed EMERGENT-1 trial
and planned EMERGENT-2 trial, including duration of treatment,
patient population and primary outcome measure. Details of the
EMERGENT-3 trial will be finalized by the end of 2020, with
initiation expected in the first half of 2021.
- EMERGENT-4: A 52-week, outpatient, open-label long-term
safety and tolerability extension trial of EMERGENT-2 and
EMERGENT-3.
- EMERGENT-5: A 52-week, outpatient, open-label long-term
trial evaluating the safety of KarXT in adults with schizophrenia
who have not been enrolled in the EMERGENT-2 or EMERGENT-3 trials.
This trial is expected to commence the first half of 2021.
- The Company plans to initiate a Phase 2 trial evaluating
KarXT as an adjunctive therapy with standard of care for the
treatment of psychosis in patients with schizophrenia who remain
symptomatic on existing therapies. The Company previously
planned to initiate a Phase 1b trial assessing potential Drug-Drug
Interactions with a selection of currently marketed antipsychotics
in healthy volunteers, but based on multiple considerations,
including the evaluation of existing preclinical and clinical data
supporting the potential of KarXT to augment traditional
antipsychotic drugs, the Company will move forward directly to
initiate a Phase 2 trial. The trial will evaluate the efficacy and
safety of KarXT when dosed in conjunction with background
antipsychotic treatment and its potential to improve symptoms in
patients who had not achieved an adequate response on their current
antipsychotic treatment.
- Data evaluating KarXT as an adjunctive therapy is intended
to support a supplemental NDA filing assuming the successful
development of KarXT as a monotherapy for the treatment of adults
with schizophrenia. The Company plans to initiate this trial
following the initiation of the Phase 3 trials within the EMERGENT
program.
- The use of KarXT for the treatment of negative and cognitive
symptoms in patients with schizophrenia remains of interest.
The Company will collect data on the potential benefit of KarXT on
negative and cognitive symptoms of schizophrenia as part of the
EMERGENT program and the Company’s adjunctive therapy trial. The
Company continues to evaluate the timing of potential trial designs
specifically directed towards the negative and cognitive symptoms
of schizophrenia.
- KarXT in dementia-related psychosis: The multi-cohort,
placebo-controlled, inpatient Phase 1b trial evaluating the safety
and tolerability of KarXT in healthy elderly volunteers is ongoing.
The trial is designed to demonstrate safety and tolerability of
KarXT in healthy elderly volunteers with the goal of selecting the
most appropriate dose and dose-titration schedule to carry forward
into future studies in patients with dementia-related psychosis.
- Topline data from the Phase 1b trial is anticipated by the
end of 2020. Due to the particular vulnerability of the elderly
population to COVID-19, the Company continues to monitor the
ongoing COVID-19 pandemic and may elect to pause recruitment in
this trial out of an abundance of caution for the health and safety
of the elderly volunteers.
- KarXT in pain: As previously announced, the Company will
not move forward to develop KarXT in pain.
Business Updates
- The Company recently announced a drug discovery
collaboration with PsychoGenics, a phenotypic drug discovery
platform company, to identify potential novel drug candidates for
the treatment of severe neuropsychiatric disorders. The
multi-year drug discovery collaboration leverages behavioral and
physiological phenotypic screening and machine learning to identify
novel neuropsychiatric treatments. Under the terms of the
agreement, Karuna will provide an upfront payment to PsychoGenics
for access to its proprietary platforms. Both parties are eligible
to receive payments upon reaching pre-specified development,
regulatory and commercial milestones, as well as royalties on net
sales, for products developed under the agreement.
- Recruitment of top talent remains a key organizational
priority to meet corporate and product development objectives.
The Company continues to grow its leadership team with the addition
of new strategic hires across functional areas, including Clinical
Operations, Regulatory and Commercial.
Second Quarter 2020 Financial Results The Company
reported a net loss of $17.0 million for the second quarter of
2020, as compared to $15.1 million for the prior year period. The
increase in net loss for the period was due to higher research and
development expenses related to preparation for the initiation of
the Company’s Phase 3 clinical trials within its EMERGENT program
but was partially offset by lower general and administrative stock
compensation expense.
Research and development expenses were $10.8 million for the
second quarter of 2020, as compared to $6.8 million for the prior
year period. The increase in research and development expenses for
the period was primarily driven by expenses related to the
preparation for the initiation of the Company’s Phase 3 clinical
trials within its EMERGENT program, including CRO start-up costs
and clinical trial material manufacturing. In addition, the Company
had additional expenses related to its Phase 1b trials in healthy
elderly volunteers and experimentally induced pain, increased
personnel-related costs due to the increase in employee headcount,
as well as expenses associated with consulting fees and the
Company’s discovery programs.
General and administrative expenses were $7.0 million for the
second quarter of 2020, as compared to $8.3 million for the prior
year period. The decrease in general and administrative expenses
was primarily due to the acceleration of option awards as a result
of the Company’s IPO and was partially offset by increased expenses
related to increased employee headcount and higher costs related to
the support of business operations as a publicly traded
company.
The Company ended the quarter with $367.6 million in cash, cash
equivalents, and short-term investments compared to $389.4 million
as of December 31, 2019. The Company expects that its current cash,
cash equivalents, and short-term investments as of June 30, 2020
will enable the Company to fund its operating expenses and capital
expenditure requirements for at least the next three years. This
includes multiple potential clinical and development milestones,
including an NDA submission of KarXT for the treatment of acute
psychosis in patients with schizophrenia, pending the outcomes of
the Company’s planned clinical trials. Additional activities which
may be funded include the completion of the Phase 1b and potential
Phase 2 trial for the treatment of dementia-related psychosis and
continued investment into pipeline expansion, including evaluating
KarXT as an adjunctive therapy in patients with schizophrenia.
About Karuna Karuna is a clinical-stage biopharmaceutical
company committed to developing and delivering first-in-class
therapies with the potential to transform the lives of people with
CNS disorders – which remain among the most disabling and
potentially fatal disorders worldwide. Galvanized by the
understanding that today’s neuropsychiatric patients deserve
better, Karuna’s mission is to harness the untapped potential of
the brain’s complex biology in pursuit of novel therapeutic
pathways that will advance the standard of care. For more
information, please visit 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 our cash resources, the timing of
advancing of our planned clinical trials and regulatory filings,
interim trial results, our goals to develop and commercialize our
product candidates, our identification of additional product
candidates, 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, 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, 2019 and
our Quarterly Report on Form 10-Q for the quarter ended June 30,
2020. 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 June
30,
Six Months Ended June
30,
2020
2019
2020
2019
Revenue
—
—
—
—
Operating expenses:
Research and development
$
10,819
$
6,784
$
15,239
$
13,751
General and administrative
7,006
8,286
12,641
12,892
Total operating expenses
17,825
15,070
27,880
26,643
Loss from operations
(17,825
)
(15,070
)
(27,880
)
(26,643
)
Other income (expense):
Interest income
779
452
2,176
567
Interest income, net
—
—
—
11
Accretion of debt discount
—
(522
)
—
(945
)
Change in fair value of derivative
—
—
—
(135
)
Total other income (expense), net
779
(70
)
2,176
(502
)
Net loss before income taxes
(17,046
)
(15,140
)
(25,704
)
(27,145
)
Income tax provision
—
—
—
—
Net loss attributable to common
stockholders
$
(17,046
)
$
(15,140
)
$
(25,704
)
$
(27,145
)
Net loss per share, basic and diluted
$
(0.65
)
$
(146.02
)
$
(0.98
)
$
(507.76
)
Weighted average common shares outstanding
used in computing net loss per share, basic and diluted
26,186,493
103,684
26,114,464
53,460
Karuna Therapeutics, Inc. Unaudited
Consolidated Balance Sheet Data (in thousands)
June 30, 2020
December 31, 2019
Cash, cash equivalents and short-term
investments
$
367,585
$
389,397
Working capital
370,787
389,748
Total assets
377,816
393,024
Total stockholders’ equity
$
371,803
$
389,916
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200805005318/en/
Investors Alexis Smith 518-338-8990
asmith@karunatx.com
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