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Karuna Completes $80 Million Series B Financing

$12 million in extension funding announced

Karuna awarded U.S. Patent covering lead product candidate, KarXT

BOSTON–(BUSINESS WIRE)–Karuna
Therapeutics, Inc
. (“Karuna”) focused on targeting muscarinic
receptors for the treatment of neuropsychiatric disorders, including
psychosis in schizophrenia, psychosis in Alzheimer’s disease, and pain,
has raised an additional $12 million of funding as an extension of its
Series B financing previously announced in March 2019. This brings the
total Series B financing round to $80 million, including the issuance of
$5 million in shares upon conversion of debt into equity. In addition,
Karuna was recently awarded its first U.S. patent for its proprietary KarXT
technology.

The new investment comes from Sofinnova Investments, which joins initial
Series B financing participants ARCH Venture Partners, Fidelity
Management & Research Company, Eventide Asset Management, Pivotal
bioVenture Partners, Partner Fund Management, Wellcome Trust, Sands
Capital, Alexandria Venture Investments, and founder PureTech Health.
Sofinnova Investments will hold an observer seat on Karuna’s board of
directors.

“We are grateful for the support of all our investors who share our
commitment to developing and delivering novel therapies to patients with
disabling neuropsychiatric disorders,” said Steve Paul, M.D., Karuna’s
chairman and chief executive officer. “The significant funding of
Karuna’s Series B will allow our team to further explore KarXT’s
therapeutic benefit in new indications outside of our ongoing Phase 2
clinical trial for the treatment of acute psychosis in patients with
schizophrenia, including geriatric psychosis and pain and advance
development of novel KarXT formulations and our early stage discovery
pipeline.”

“The Karuna team has developed a novel muscarinic receptor program which
we believe offers exciting potential for treating several
neuropsychiatric indications where demand for new therapies remains
largely unmet,” said James Healey, M.D., Ph.D., general partner of
Sofinnova Investments. “I look forward to helping the company in its
efforts to realize the full potential of KarXT and potentially expanding
its pipeline for multiple differentiated programs targeting
neuropsychiatric disorders affecting millions of patients worldwide.”

KarXT, Karuna’s lead product candidate, is currently being evaluated in
a Phase 2 clinical trial as a potential treatment for acute psychosis in
patients with schizophrenia. Proceeds from the financing will be used to
advance the development of KarXT into several new indications, including
geriatric psychosis and pain, progress new formulations of KarXT, expand
the pipeline, and continue to build company infrastructure.

On March 26, 2019 the United States Patent and Trademark Office (USPTO)
issued U.S. Patent No. 10,238,643, that covers the combination of
xanomeline and trospium (known as KarXT), where the use of trospium is
designed to alleviate the side effects of xanomeline. This intellectual
property forms the basis of Karuna’s KarXT program being evaluated
across a variety of diseases in ongoing and planned clinical work.
Karuna co-founder and chief operating officer, Andrew Miller, Ph.D., is
a named inventor on the KarXT patent.

About KarXT
KarXT (Karuna-Xanomeline-Trospium),
Karuna’s lead product candidate for the treatment of psychosis in
schizophrenia, consists of xanomeline, a novel muscarinic cholinergic
receptor agonist that has demonstrated therapeutic benefit in
placebo-controlled human trials in schizophrenia and Alzheimer’s
disease, and trospium chloride, an FDA-approved and well-established
muscarinic receptor antagonist that has been shown to not meaningfully
enter the central nervous system (CNS). KarXT is designed to
preferentially target and stimulate M1/M4 muscarinic receptors in the
brain while inhibiting their stimulation in peripheral tissues to
improve tolerability. Karuna has completed two Phase 1 clinical trials
in which clinically meaningful reductions in side effects were observed
compared to xanomeline alone and in which KarXT was well tolerated in
healthy volunteers. A proprietary co-formulation of xanomeline and
trospium in a single capsule was used in the second Phase 1 clinical
trial and is now being evaluated in an ongoing Phase 2 clinical trial in
patients with schizophrenia experiencing acute psychosis. Preliminary
results from this trial are anticipated by late 2019. A Phase 1b
experimental pain trial in healthy volunteers and clinical work towards
geriatric psychosis are expected to begin later this year.

About Karuna Therapeutics
Karuna is an innovative
clinical-stage biopharmaceutical company primarily focused on developing
novel therapies to address disabling neuropsychiatric conditions
characterized by significant unmet medical need. Karuna is currently
conducting a Phase 2 clinical trial of its lead product candidate, KarXT
(Karuna-Xanomeline-Trospium), for the treatment of acute psychosis in
patients with schizophrenia and expects preliminary results in late
2019. Karuna also plans to initiate clinical trials of KarXT to evaluate
its potential therapeutic benefit in other CNS disorders, including
psychosis in Alzheimer’s disease, or AD, as well as pain. Karuna, which
was founded by PureTech
Health
 (LSE: PRTC), has a worldwide exclusive license for xanomeline
and has a patent portfolio more broadly covering selective muscarinic
targeting enabled by the KarXT approach. For more information, visit karunatx.com.

Contacts

Investors
Jason Brown
+1 857 449 2239
[email protected]

U.S. Media
Tom Donovan
+1 857 559 3397
[email protected]

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