TIDMPRTC
PureTech Health PLC
01 April 2019
1 April 2019
PureTech Health plc
PureTech Health Affiliate Karuna Therapeutics Completes Extended
$80 Million Series B Financing
Total includes newly announced $12 million in extension
funding
Funding to drive investigation of further potential indications
for lead product candidate, KarXT
First US Patent awarded for KarXT
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) axis, today announced
that its affiliate Karuna Therapeutics, Inc. ("Karuna") has raised
an additional $12 million as an extension of its Series B financing
announced in March 2019. This brings the round total to $80
million, including the issuance of $5 million in shares upon
conversion of debt into equity. The extension funding is provided
by Sofinnova Investments, which will also hold an observer seat on
the Company's board of directors.
Additionally, Karuna recently was awarded its first US patent
for its lead product candidate, KarXT, currently being evaluated in
a Phase 2 clinical trial as a potential treatment for acute
psychosis in patients with schizophrenia.
Eric Elenko, PhD, chief innovation officer at PureTech Health,
said: "Top tier investors have responded strongly to the promise of
Karuna's KarXT and its underlying muscarinic receptor-targeting
approach to neuropsychiatric disorders. We welcome their support in
driving the expansion of this platform's potential to address a
number of underserved patient populations."
The full text announcement from Karuna Therapeutics is as
follows:
Karuna Completes $80 Million Series B Financing
$12 million in extension funding announced
Karuna awarded US Patent covering lead product candidate,
KarXT
BOSTON, April 1, 2019 - 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 US 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, MD, 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
programme which we believe offers exciting potential for treating
several neuropsychiatric indications where demand for new therapies
remains largely unmet," said James Healey, MD, PhD, 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 programmes
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 US 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 programme being evaluated across a variety of diseases in
ongoing and planned clinical work. Karuna co-founder and chief
operating officer, Andrew Miller, PhD, 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 characterised 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.
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing BIG medicines for dysfunctions of the
Brain-Immune-Gut axis. The Company has gained deep insights into
the connection between these systems and the resulting role in
diseases that have proven resistant to established therapeutic
approaches. By harnessing this emerging field of human biology,
PureTech Health is developing new categories of medicines with the
potential to have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies with an unbiased, non-binary, and capital efficient
R&D model across its affiliates and its internal labs.
PureTech's affiliates include seven clinical-stage platforms with
two product candidates that have been filed with the US Food and
Drug Administration (FDA) for review and other novel pre-clinical
programmes. The PureTech Health pipeline includes ground-breaking
platforms and therapeutic candidates that were developed in
collaboration with some of the world's leading experts.
PureTech's internal research and development is centred on
tissue-selective immunomodulation for the treatment of oncology,
autoimmune, and CNS-related disorders, with a near-term focus on
targeting newly-discovered, foundational immunosuppressive
mechanisms in oncology and novel approaches that harness the
lymphatic infrastructure.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Ownership Information
PureTech's percentage ownership of Karuna Therapeutics following
the financing is approximately 36.2% on a diluted basis. This
calculation of PureTech's holding includes issued and outstanding
shares as well as options and warrants to purchase shares, but
excludes unallocated shares authorised to be issued pursuant to
equity incentive plans.
Forward Looking Statement
This press release contains statements that are or may be
forward-looking statements, including statements that relate to the
company's future prospects, developments and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, those risks and uncertainties described in the risk factors
included in the regulatory filings for PureTech Health plc. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements,
neither the company nor any other party intends to update or revise
these forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
This information is provided by RNS, the news service of the
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END
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