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PureTech Health PLC
18 December 2015
PureTech Health plc
Operating Company Gelesis Closes $31.5 Million Growth
Financing
PureTech Health plc ("PureTech", LSE: PRTC), a
cross-disciplinary healthcare company developing novel medicines to
tackle fundamental healthcare needs in disruptive ways, is pleased
to note that its operating company, Gelesis, today announced the
successful completion of a $31.5 million growth financing
round.
New institutional investors, including Cormorant Asset
Management, joined current investors Invesco Asset Management,
PureTech and Priztker/Vlock Family Office in this financing round.
Proceeds of the financing will be used to complete a six-month U.S.
Food and Drug Administration (FDA) pivotal trial of Gelesis100 in
overweight and obese patients with topline data available in the
first half of 2017, support commercial readiness activities and
complete first-in-human studies of Gelesis200 for patients with
prediabetes and type 2 diabetes.
Michael MacLean, Chief Financial Officer of PureTech said:
"Gelesis has the potential to address a medical need that affects
over a billion people. The company has accelerated its timelines by
around one year since the PureTech IPO. We are pleased to welcome
these new investors at this exciting stage as Gelesis moves towards
a pivotal trial readout and readies for potential
commercialization."
The full text of the announcement from Gelesis is as
follows:
Gelesis Closes $31.5 Million Growth Financing
Proceeds to enable completion of a U.S. FDA pivotal trial for a
weight loss indication and commercialization readiness activities,
as well as initiation of human studies for a second product focused
on glycaemic control
BOSTON, Massachusetts, December 18, 2015 -- Gelesis, a clinical
stage biotechnology company focused on the development of
first-in-class products to safely induce weight loss and improve
glycaemic control, announced today that it has closed a $31.5
million growth financing round. New institutional investors,
including Cormorant Asset Management, joined current investors
Invesco Asset Management, PureTech and the Priztker/Vlock Family
Office in this financing round. The financing brings the total
capital raised since inception to over $90 million.
Gelesis plans to use the proceeds from the financing to enable
completion of a six-month U.S. Food and Drug Administration (FDA)
pivotal trial of Gelesis100 with topline data expected to be
available in the first half of 2017, as well as to support
commercial readiness activities in preparation for a potential
launch.
Gelesis100 is a first-in-class, orally administered capsule
containing small hydrogel particles designed to employ multiple
mechanisms of action along the gastrointestinal tract to safely
induce weight loss and improve glycaemic control in overweight and
obese patients.
In a multicenter, double-blind, placebo-controlled
proof-of-concept study, Gelesis100 showed statistically significant
weight loss in overweight and obese subjects, with particularly
dramatic weight loss in prediabetics. In July 2015, Gelesis
announced the expansion of the Gelesis100 GLOW study to multiple
U.S. sites, allowing it to serve as a U.S. pivotal trial. The
expansion of the GLOW study accelerated the clinical timeline by
approximately one year, and Gelesis anticipates enrolling patients
in U.S. sites in 2016 and filing for FDA approval in the first half
of 2017.
Funds will also be used for the expected completion of
first-in-human studies of its glycaemic control product,
Gelesis200, with anticipated read-out of a three-month
proof-of-concept study expected in the second half of 2016.
Gelesis200 was created with the same proprietary technology
platform as Gelesis100 and its properties are optimized to improve
glycaemic control in patients with prediabetes and type 2 diabetes
who may or may not require weight loss.
"We appreciate the support of Gelesis' new and existing
investors as we aim to bring novel therapies to the market to
address the obesity and diabetes epidemics," said Yishai Zohar,
Co-founder and Chief Executive Officer of Gelesis. "We look forward
to completing our U.S. pivotal trial of Gelesis100 and, if
approved, we believe it has the potential to address the
significant unmet need for an orally dosed, safe and efficacious
therapy to induce weight loss and improve glycaemic control."
About Gelesis
Gelesis is a clinical stage biotechnology company focused on the
development of novel therapies to induce weight loss and improve
glycaemic control in overweight and obese patients, including those
with prediabetes and diabetes. Gelesis100, one of the company's
product candidates and a first-in-class therapeutic, is currently
being evaluated in a six-month pivotal study. Gelesis is also
developing Gelesis200, created from the same proprietary technology
platform as Gelesis100, as a product optimized to improve glycaemic
control in prediabetics and type 2 diabetics who may or may not
require weight loss.
The Gelesis executive and advisory team includes leading experts
in obesity and its related comorbidities, clinical research and
development, and advanced biomaterials, including Caroline Apovian,
M.D., Professor of Medicine and Pediatrics at Boston University
School of Medicine; Louis J. Aronne, M.D., FACP, Director of the
Comprehensive Weight Control Program at New York-Presbyterian
Hospital/Weill Cornell Medical Center; Arne Astrup, M.D., Head of
Department of Nutrition, Exercise and Sports at University of
Copenhagen; Ken Fujioka, M.D., Director of the Nutrition and
Metabolic Research Center and the Center for Weight Management at
the Scripps Clinic; Allan Geliebter, Ph.D., Senior Attending
Psychologist, St. Luke's-Roosevelt Hospital; James Hill, Ph.D.,
Professor of Medicine & Pediatrics, University of Colorado; Lee
M. Kaplan, MD, Ph.D., Director of the Obesity, Metabolism &
Nutrition Institute, Bennett Shapiro, M.D., Co-founder and
Non-Executive Director at PureTech and former Executive Vice
President of Research for Merck; and Angelo Tremblay, Ph,D.,
professor, Department of Kinesiology at Laval University.
Gelesis investors include Cormorant Asset Management, PureTech
Health PLC (LSE: PRTC), Invesco Asset Management, the
Priztker/Vlock Family Office, and other prominent biotech and
finance investors.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is a
cross-disciplinary healthcare company, developing innovative
products that could potentially improve the lives of billions of
patients. PureTech has a pipeline of 12 operating companies, seven
of which are "growth stage" with external validation including
strategic partnerships, outside funding, proof-of-concept and/or
peer review in prestigious scientific journals. PureTech also has a
pipeline of ten "concept phase" initiatives resulting from review
of more than 650 ideas annually. PureTech is focused on areas
including immune and inflammatory disorders; cognitive and
psychiatric disorders; diabetes and obesity; oncology; and
infectious diseases, and has over 110 patents and patent
applications. PureTech's leading team and board, along with an
advisory network of more than 50 expert founder-scientists and
advisors across multiple disciplines, gives PureTech access to
potentially ground-breaking science and technological innovation.
For more information, visit www.puretechhealth.com and connect with
us on Twitter.
Ownership Information
Of the $31.5 million raised in this financing, Invesco
contributed approximately $14.0 million for the purchase of
1,128,122 preferred shares. Invesco is a substantial shareholder of
PureTech pursuant to the Listing Rules, and thus this transaction
is a smaller related party transaction falling within the scope of
Listing Rule 11.1.10R. PureTech contributed approximately $7.0
million and PureTech's percentage ownership of Gelesis remains
substantially the same as it was prior to the financing, at 22.5%
on a diluted basis(1) . With this financing round and the
acceleration of the US trial commencement, PureTech believes that
its ownership adjusted value has increased by more than $7.0
million from the previously reported balance(2) .
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.
(1) 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.
(2) Ownership adjusted value represents PureTech's interest in
the equity value of Gelesis = (Business Enterprise Value - Debt +
Cash) x PureTech's percentage ownership plus PureTech's royalty
interest in Gelesis.
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