TIDMPRTC
RNS Number : 3197G
PureTech Health PLC
01 March 2018
1 March 2018
PureTech Health plc
PureTech's Gelesis Raises $30 Million to Prepare for Potential
Launch of Lead Product
Proceeds to be used for manufacturing and commercialisation
preparations and advancement of the Company's clinical development
pipeline
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an
advanced, clinical-stage biopharmaceutical company, announced today
that Gelesis, an affiliate of PureTech Health, has successfully
completed a $30 million financing round. Proceeds of the financing
will be used to support commercial-stage manufacturing, product
launch preparations, company operations, and the clinical
advancement of the Gelesis pipeline of additional product
candidates for gastrointestinal disorders, including Type 2
diabetes and non-alcoholic steatohepatitis/non-alcoholic fatty
liver disease (NASH/NAFLD). Gelesis plans to submit Gelesis100 for
regulatory approval in the US and Europe in 2018.
Dr. Bharatt Chowrira, President and Chief of Business and
Strategy at PureTech Health commented: "We are delighted to
announce this important financing for a key affiliate, which
further strengthens the business and positions them well for their
next stage of growth. This is an exciting time at PureTech Health
as two of our affiliates, Gelesis and Akili, plan to file for
regulatory approvals and prepare for the potential launches of new
medicines designed to address major needs. Gelesis has the
potential to make a huge impact in addressing some of the world's
biggest public health issues associated with obesity and its
related co-morbidities."
The full text of the announcement from Gelesis is as
follows:
Gelesis Raises $30 Million to Prepare for Potential Launch of
Lead Product
Proceeds to be used for manufacturing and commercialisation
preparations and advancement of the Company's clinical development
pipeline
BOSTON, Massachusetts, March 1, 2018 -- Gelesis, a biotechnology
company developing first-in-class mechanotherapeutics to treat
chronic diseases related to the gastrointestinal (GI) pathway,
today announced that it has closed a $30 million financing round.
The proceeds from the financing will be used to support
commercial-stage manufacturing, product launch preparations,
company operations, and clinical advancement of the Company's
pipeline of additional product candidates for gastrointestinal
disorders, including Type 2 diabetes and non-alcoholic
steatohepatitis/non-alcoholic fatty liver disease (NASH/NAFLD). The
Company also plans to submit Gelesis100 for regulatory approvals in
the US and Europe in 2018.
"We look forward to submitting Gelesis100 for regulatory
approvals. If approved by US and European regulatory authorities,
we believe that Gelesis100 would be the first and only oral
prescription of its kind designed to act mechanically in the GI
system to help people achieve clinically meaningful weight loss,"
said David Pass, PharmD, Chief Operating Officer and Head of
Commercial at Gelesis. "In quantitative research evaluating the
pivotal study results with over 600 people struggling to manage
their weight, more than 70% found Gelesis100 extremely or very
appealing based on its clinically proven efficacy and strong safety
profile, and over 90% of these people were likely to ask their
doctor for the product. Additionally, of over 200 clinicians
polled, 79% of obesity specialists and 63% of primary care
physicians stated that they were extremely or very likely to
prescribe the product if asked."
About Gelesis100
Gelesis100 is a new approach to weight loss that is designed to
employ multiple mechanisms of action along the GI tract to promote
satiety and induce weight loss. Gelesis100 is non-systemic and
administered orally in capsules containing small hydrogel
particles, which are made from two natural components that form a
novel 3D structure. The novel hydrogel is manufactured through
Gelesis' multi-step, proprietary process and protected by 9
families of patents through 2033, several of which have already
been allowed or issued in major markets.
Gelesis100 capsules are taken with water prior to a meal, after
which the small hydrogel particles are released from the capsules
in the stomach and rapidly absorb water, hydrating to approximately
100 times their original size. Gelesis100 is designed to mix
homogeneously with food and travel through the GI tract inducing
satiety, reducing hunger, and causing weight loss. Once in the
large intestine, Gelesis100 releases most of the water, which is
reabsorbed by the body. The small gel particles pass through the
body without being absorbed and are safely eliminated in the same
manner as food.
Gelesis100 has been studied in more than 500 patients across
five clinical studies throughout the United States, Canada, and
Europe and has shown weight loss, increased satiety, reduced
hunger, and a consistently strong safety profile.
About Gelesis
Gelesis is developing a novel mechanobiology platform to treat
obesity and other chronic diseases related to the GI pathway.
Gelesis' proprietary approach is designed to act mechanically in
the GI pathway to potentially alter the course of chronic diseases
safely and effectively. In September 2017, Gelesis completed a
pivotal trial for weight loss evaluating its lead product candidate
Gelesis100. Additionally, Gelesis is conducting a proof-of-concept
study for its second candidate, Gelesis200, which is optimised for
weight loss and glycaemic control in patients with type 2 diabetes
and prediabetes. New hydrogel compositions based on the Gelesis
mechanobiology platform technology are also being explored through
an expanded pipeline with preclinical studies in other GI-related
conditions such as non-alcoholic fatty liver disease (NAFLD),
non-alcoholic steatohepatitis (NASH) and intestinal mucositis.
The Gelesis executive and advisory team includes some of the
world's leading experts in obesity, chronic disease research, and
clinical development, as well as materials science innovators,
commercialisation experts, and entrepreneurs. Gelesis is an
affiliate of PureTech Health (PRTC.L), an advanced, clinical-stage
biopharmaceutical company. For more information, visit
www.gelesis.com or connect with us on Twitter @GelesisInc.
About PureTech Health
PureTech Health (PRTC.L) is an advanced, clinical-stage
biopharmaceutical company developing novel medicines targeting
serious diseases that result from dysfunctions in the nervous,
immune, and gastrointestinal systems (brain-immune-gut or the "BIG"
axis), which together represent the adaptive human systems.
PureTech Health is at the forefront of understanding and addressing
the biological processes and crosstalk associated with the BIG
axis. By harnessing this emerging field of human biology, PureTech
Health is pioneering new categories of medicine with the potential
to have great impact on people with serious diseases. PureTech
Health is advancing a rich pipeline of innovative therapies that
includes two pivotal stage programmes, multiple human
proof-of-concept studies and a number of early clinical and
pre-clinical programmes. PureTech's research and development
pipeline has been advanced in collaboration with some of the
world's leading scientific experts, who along with PureTech's team
of biopharma pioneers, entrepreneurs and seasoned Board, identify,
invent, and clinically de-risk new medicines. With this experienced
team pursuing cutting edge science, PureTech Health is building the
biopharma company of the future focused on improving and extending
the lives of people with serious disease. For more information,
visit www.puretechhealth.com or connect with us on Twitter
@puretechh.
Ownership Information
Of the $30 million raised in this financing by Gelesis, Invesco
contributed approximately $18.0 million to subscribe for 1,405,152
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. The funds from this financing will be drawn
down by Gelesis in its discretion.
The valuation of Gelesis has increased from the valuation at the
last round in line with the progress of the company. As noted in
the recent Trading Update, PureTech Health will no longer be
publicly disclosing the detailed valuations of its private
affiliates, unless otherwise required by law. This decision was
made after consultation with strategic advisors and key
shareholders to protect the interests of PureTech's private
affiliates by not having dated values in the public domain that may
affect valuations that could be ascribed by potential external
partners. PureTech contributed approximately $5.0 million and
PureTech's percentage ownership of Gelesis remains substantially
the same as it was prior to the financing, at approximately 20.5%
on a diluted basis(1) and approximately 19.2% on a fully-diluted
basis.(2) PureTech Health also has the right to receive a 2%
royalty on the sales of certain Gelesis products, including
Gelesis100.
(1) This calculation of PureTech's holding includes issued and
outstanding shares (assuming all $30 million is drawn down by
Gelesis) as well as options and warrants to purchase shares, but
excludes unallocated shares authorised to be issued pursuant to
equity incentive plans.
(2) This calculation includes issued and outstanding shares
(assuming all $30 million is drawn down by Gelesis), outstanding
options and warrants to purchase shares, and 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
PureTech'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. 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 PureTech Health nor any other party intends to update or
revise these forward-looking statements, whether as a result of new
information, future events or otherwise.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Contact:
PureTech Health FTI Consulting (EU
media)
Allison Mead Talbot Ben Atwell, Rob
+1 617 651 3156 Winder
amt@puretechhealth.com +44 (0) 20 3727
1000
ben.atwell@FTIconsulting.com
This information is provided by RNS
The company news service from the London Stock Exchange
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