RCS - PureTech Health PLC - PRTC: Gelesis' Plenity Now Broadly Available in US

Puretech HealthAnnouncement

01/12/2021 12:10

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RNS Number : 1198U  PureTech Health PLC  01 December 2021

1 December 2021

PureTech Health plc

 

PureTech Founded Entity Gelesis Announces FDA-Cleared Weight Management
Approach, Plenity®, Now Broadly Available and Leading Nutrition Authority Joy
Bauer, MS, RDN, CDN, Joins as Chief Nutrition Officer

 

Plenity® is transforming weight management with a clinically proven approach
made from naturally derived building blocks

 

As Chief Nutrition Officer, Bauer will focus on educating healthcare
professionals and offering nutrition counseling to Plenity members

 

PureTech Health plc (https://puretechhealth.com/) (Nasdaq: PRTC, LSE: PRTC)
("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted
today that its Founded Entity, Gelesis, Inc. ("Gelesis") announced that
Plenity®, an FDA cleared weight management approach, is now broadly available
across the United States to adults who meet the prescription criteria. Gelesis
also announced the appointment of leading health and nutrition authority Joy
Bauer, MS, RDN, CDN, as Chief Nutrition Officer. In this new role, Bauer will
offer nutrition counseling and education for Plenity members and engage with
and educate healthcare professionals about the product.

 

Bauer is one of the nation's leading health and nutrition authorities. She is
a beloved media personality and a #1 New York Times bestselling author with 14
bestsellers to her credit. In the earlier part of her career, Bauer was the
Director of Nutrition and Fitness for the Department of Pediatric Cardiology
at Mount Sinai Medical Center in New York City, as well as the clinical
dietitian for their neurosurgical team.

 

She has worked closely with Plenity since spring 2021 on healthcare provider
support, establishing awareness and educating registered dietitian
nutritionists (RDNs) on the safety profile and clinical evidence for Plenity.
As part of her expanded role with the company, she will continue to build
education and advocacy to support RDNs in recommending Plenity to their
patients through professional educational content, key events, and outreach to
members of the Academy of Nutrition and Dietetics and other certified
nutrition professionals.

 

Plenity is available by prescription via a stigma-free telehealth consultation
with a physician trained in weight management support, with free, unlimited
follow-up visits as needed. The pandemic continues to prove out the importance
of convenient access to healthcare, and the Plenity experience-including both
the digital model and the strong efficacy to safety profile-is built to
address that. A Plenity subscription costs $98 for a four-week supply ($1.75
per meal) and, if prescribed, the product arrives in two business days.

 

The full text of the announcement from Gelesis is as follows:

 

Gelesis' FDA-Cleared Weight Management Approach, Plenity®, Now Broadly
Available and Leading Nutrition Authority Joy Bauer, MS, RDN, CDN, Joins as
Chief Nutrition Officer

 

Plenity® is transforming weight management with a clinically proven approach
made from naturally derived building blocks

 

As Chief Nutrition Officer, Bauer will focus on educating healthcare
professionals and offering nutrition counseling to Plenity members

 

BOSTON, December 1, 2021 - Gelesis, a consumer-focused biotherapeutics
company, is proud to announce Plenity®, an FDA cleared weight management
approach, is now broadly available across the United States to adults who meet
the prescription criteria. The company is also pleased to announce the
appointment of leading health and nutrition authority Joy Bauer, MS, RDN, CDN,
as Chief Nutrition Officer. In this new role, Bauer will offer nutrition
counseling and education for Plenity members and engage with and educate
healthcare professionals about the product.

 

For adults who are looking to lose weight, there is often a lot standing in
the way, like weight bias, fad diets, false promises, and the very real
feeling of hunger. Plenity challenges the notion that people should live life
feeling deprived and combines an FDA-cleared prescription product with a
supporting member experience. Plenity is not a diet, a magic pill, or a drug;
it is a clinically proven weight management treatment that aims to help adults
on their journey.

 

Plenity is designed to help people feel satisfied with smaller portions so
they can eat less and lose weight. It is FDA-cleared to aid in weight
management in adults with excess weight or obesity, as defined by a Body Mass
Index (BMI) of 25 to 40 kg/m², when used in conjunction with diet and
exercise. It is taken orally as three capsules with 16 oz. of water twice a
day, 20 minutes before lunch and dinner. If a dose is missed, it can be taken
with the meal or immediately following the meal. Plenity is not a drug; it is
non-systemic and not habit forming. Plenity instead uses a novel biomimetic
approach inspired by the composition and mechanical properties of vegetables
that makes adults feel fuller faster with smaller portions. In clinical
trials, the safety profile was similar to placebo.

 

"No one should feel deprived of enjoying the foods they love. We now have the
opportunity to share a weight management aid that can help improve a person's
chances at success, and that's extraordinary," says Bauer. "Plenity is
entirely different from any other weight loss tool: it's simple, the
technology is impressive, and it's inspired by vegetables. Most importantly,
the whole experience is centered around enabling people to make smart
lifestyle choices while continuing to enjoy the foods they love. These two
factors are essential for long-term weight management success - I've seen it
firsthand throughout my career in clinical, community and private practice."

 

Bauer is one of the nation's leading health and nutrition authorities. She is
a beloved media personality and a #1 New York Times bestselling author with 14
bestsellers to her credit. In the earlier part of her career, Bauer was the
Director of Nutrition and Fitness for the Department of Pediatric Cardiology
at Mount Sinai Medical Center in New York City, as well as the clinical
dietitian for their neurosurgical team.

 

She has worked closely with Plenity since spring 2021 on healthcare provider
support, establishing awareness and educating registered dietitian
nutritionists (RDNs) on the safety profile and clinical evidence for Plenity.
As part of her expanded role with the company, she will continue to build
education and advocacy to support RDNs in recommending Plenity to their
patients through professional educational content, key events, and outreach to
members of the Academy of Nutrition and Dietetics and other certified
nutrition professionals.

 

Plenity is available by prescription via a stigma-free telehealth consultation
with a physician trained in weight management support, with free, unlimited
follow-up visits as needed. The pandemic continues to prove out the importance
of convenient access to healthcare, and the Plenity experience-including both
the digital model and the strong efficacy to safety profile-is built to
address that. Visit MyPlenity.com to start an online consultation or talk to
one's own doctor about whether Plenity is right for you. A Plenity
subscription costs $98 for a four-week supply ($1.75 per meal) and, if
prescribed, the product arrives in two business days.

 

As part of a Plenity prescription, members can access a curated member
experience centered on many of the barriers that stand in the way of
sustainable weight management. This includes evidence-based information from
medical experts, personalized content, and a private online member community.
Plenity members can also tap into a network of partners for behavioral
support. With this partnership, Bauer will create dedicated content for
members, such as nutrition education, live virtual events, recipes, and
thought pieces on rethinking weight management. A group of Plenity members
will also be able to access one-on-one coaching as well as events to augment
their weight management journey with Plenity.

 

"Joy understands that the weight loss journey is deeply personal, and
throughout her career she's helped countless people reach their individual
goals. We share the same core beliefs that you should be able to enjoy foods
you love with people you love, and that you should not have to choose between
loving yourself and wanting to change yourself," says Elaine Chiquette,
Pharm.D., Chief Scientific Officer at Gelesis. "We are honored to welcome Joy
to this expanded role and to be able to offer our members access to Joy's
knowledge and expertise."

 

Gelesis and Capstar Special Purpose Acquisition Corp. (NYSE: CPSR) announced
in July that they entered into a definitive business combination agreement.
Upon completion of the transaction, the combined company's securities are
expected to be traded on the New York Stock Exchange under the symbol "GLS."
Gelesis will use the proceeds of the transaction to support future broad
consumer activation around Plenity.

 

Important Safety Information about Plenity

 

●     Patients who are pregnant or are allergic to cellulose, citric
acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take
Plenity.

●     To avoid impact on the absorption of medications:

o  For all medications that should be taken with food, take them after
starting a meal.

o  For all medications that should be taken without food (on an empty
stomach), continue taking on an empty stomach or as recommended by your
physician.

●     The overall incidence of side effects with Plenity was no
different than placebo. The most common side effects were diarrhea, distended
abdomen, infrequent bowel movements, and flatulence.

●     Contact a doctor right away if problems occur. If you have a
severe allergic reaction, severe stomach pain, or severe diarrhea, stop using
Plenity until you can speak to your doctor.

 

Rx Only. For the safe and proper use of Plenity or more information, talk to a
healthcare professional, read the Patient Instructions for Use
(https://www.myplenity.com/siteassets/components/pdfs/ACQ_Plenity-Patient-Instructions-of-Use.pdf)
, or call 1-844-PLENITY.

 

About Gelesis

Gelesis is a consumer-centered biotherapeutics company advancing a novel
category of treatments for weight management and gut related chronic diseases.
Our non-systemic superabsorbent hydrogels are the first and only made entirely
from naturally derived building blocks, and they are inspired by the
composition (i.e., water & cellulose) and mechanical properties (e.g.,
elasticity or firmness) of raw vegetables. They are conveniently administered
in capsules to create a much larger volume of small, non-aggregating hydrogel
pieces that become an integrated part of the meals, and act locally in the
digestive system. Our portfolio includes Plenity®, an FDA-cleared product to
aid in weight management, as well as potential therapies in development for
patients with Type 2 Diabetes, Non-alcoholic Fatty Liver Disease
(NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Functional Constipation.
For more information, visit gelesis.com (https://www.gelesis.com/) , or
connect with us on Twitter @GelesisInc.

 

Additional Information and Where to Find It

In July 2021, Gelesis entered into a business combination agreement with
Capstar Special Purpose Acquisition Corp. (NYSE: CPSR) ("Capstar"), a special
purpose acquisition company, as amended in November 2021.

 

Capstar has filed a Registration Statement on Form S-4 with the SEC, which
includes a proxy statement/prospectus, that will be both the proxy statement
to be distributed to Capstar shareholders in connection with its solicitation
of proxies for the vote by Capstar shareholders with respect to the proposed
business combination and other matters as may be described in the Registration
Statement, as well as the prospectus relating to the issuance of certain
securities to be issued in the proposed business combination. After the
Registration Statement is declared effective, the proxy statement/prospectus
and other relevant documents will be sent to Capstar and Gelesis shareholders.
Capstar also will file other documents regarding the proposed transaction with
the SEC. This press release does not contain all the information that should
be considered concerning the proposed business combination and is not intended
to form the basis of any investment decision or any other decision in respect
of the proposed business combination. Before making any voting decision,
Capstar's shareholders and other interested persons are advised to read, when
available, the preliminary proxy statement/prospectus included in the
Registration Statement, the amendments thereto and the definitive proxy
statement/prospectus and all other relevant documents filed or that will be
filed with the SEC in connection with the proposed transaction as they become
available because they will contain important information about Gelesis,
Capstar and the proposed transaction.

 

When available, the definitive proxy statement/prospectus and other relevant
materials for the proposed business combination will be mailed to shareholders
of Capstar as of a record date to be established for voting on the proposed
business combination. Investors and security holders will also be able to
obtain free copies of the Registration Statement, the proxy
statement/prospectus and all other relevant documents filed or that will be
filed with the SEC by Capstar, without charge, once available, through the
website maintained by the SEC at www.sec.gov (http://www.sec.gov) . The
documents filed by Capstar with the SEC also may be obtained free of charge at
Capstar's website at www.capstarspac.com, or by written request to: Capstar
Special Purpose Acquisition Corp., 405 West 14th Street, Austin, TX 78701,
Attention: R. Steven Hicks, Chief Executive Officer, (512) 340-7800.

 

Participants in the Solicitation

Capstar and its directors and executive officers may be deemed participants in
the solicitation of proxies from Capstar's shareholders with respect to the
proposed business combination. The names of those directors and executive
officers and a description of their interests in Capstar is contained in
Capstar's final prospectus dated July 6, 2020 relating to its initial public
offering and in subsequent filings with the SEC, which are available free of
charge at the SEC's web site at www.sec.gov. To the extent such holdings of
Capstar's securities may have changed since that time, such changes have been
or will be reflected on Statements of Changes in Beneficial Ownership on
Form 4 filed with the SEC. Additional information regarding the interests of
such participants will be contained in the proxy statement/prospectus for the
proposed business combination when available.

 

Gelesis and its directors and executive officers may also be deemed to be
participants in the solicitation of proxies from the shareholders of Capstar
in connection with the proposed business combination. A list of the names of
such directors and executive officers and information regarding their
interests in the proposed business combination will be included in the proxy
statement/prospectus for the proposed business combination when available.

 

Forward-Looking Statements

Certain statements, estimates, targets and projections in this press release
may constitute "forward-looking statements" within the meaning of the federal
securities laws. The words "anticipate," "believe," continue," "could,"
"estimate," "expect," "intend," "may," "might," "plan," "possible,"
"potential," "predict," "project," "should," "strive," "would" and similar
expressions may identify forward-looking statements, but the absence of these
words does not mean that statement is not forward looking. Forward-looking
statements are predictions, projections and other statements about future
events that are based on current expectations and assumptions and, as a
result, are subject to risks and uncertainties. Forward-looking statements
include, but are not limited to, the competitive environment in which Gelesis
operates, the expected future operating and financial performance and market
opportunities of Gelesis and statements regarding Gelesis' expectations,
hopes, beliefs, intentions or strategies regarding the future. In addition,
any statements that refer to projections, forecasts, or other
characterizations of future events or circumstances, including any underlying
assumptions, are forward-looking statements. Forward-looking statements speak
only as of the date they are made. Readers are cautioned not to put undue
reliance on forward-looking statements, and Gelesis and Capstar assume no
obligation and do not intend to update or revise these forward-looking
statements, whether as a result of new information, future events, or
otherwise. Gelesis and Capstar give no assurance that any expectations set
forth in this press release will be achieved. Various factors could cause
actual future results, performance or events to differ materially from those
described herein. Some of the factors that may impact future results and
performance may include, without limitation: (i) the size, demand and growth
potential of the markets for Plenity®, Gelesis' other product candidates and
its ability to serve those markets; (ii) the degree of market acceptance and
adoption of Gelesis' products; (iii) Gelesis' ability to develop innovative
products and compete with other companies engaged in the weight loss industry;
(iv) Gelesis' ability to complete successfully the full commercial launch of
Plenity® and its growth plans, including new possible indications and the
clinical data from ongoing and future studies about liver and other diseases;
(v) the inability of the parties to successfully or timely consummate the
proposed business combination, including the risk that any required regulatory
approvals are not obtained, are delayed or are subject to unanticipated
conditions that could adversely affect the combined company or the expected
benefits of the business combination or that the approval of the shareholders
of Capstar is not obtained; (vi) failure to realize the anticipated benefits
of the business combination, including as a result of a delay or difficulty in
integrating the businesses of Capstar and Gelesis; (vii) the amount of
redemption requests made by Capstar shareholders; (viii) the ability of
Capstar or the combined company to issue equity or equity-linked securities or
obtain debt financing in connection with the proposed business combination or
in the future; (ix) the outcome of any legal proceedings that may be
instituted against Capstar, Gelesis, the combined company or others following
the announcement of the proposed business combination and any definitive
agreements with respect thereto; (x) the ability to meet stock exchange
listing standards at or following the consummation of the proposed business
combination; (xi) the risk that the proposed business combination disrupts
current plans and operations of Gelesis as a result of the announcement and
consummation of the proposed business combination, and as a result of the
post-transaction company being a publicly listed issuer; (xii) the regulatory
pathway for Gelesis' products and responses from regulators, including the FDA
and similar regulators outside of the United States, (xiii) the ability of
the combined company to grow and manage growth profitably, maintain
relationships with customers and suppliers and retain Gelesis' management and
key employees; (xiv) costs related to the proposed business combination,
including costs associated with the post-transaction company being a publicly
listed issuer; (xiv) changes in applicable laws or regulations; (xv) the
possibility that Gelesis or the combined company may be adversely affected by
other economic, business, regulatory and/or competitive factors;
(xvi) Gelesis' estimates of expenses and profitability; (xvii) ongoing
regulatory requirements, (xviii) any competing products or technologies that
may emerge, (xix) the volatility of the telehealth market in general, or
insufficient patient demand; (xx) the ability of Gelesis to defend its
intellectual property and satisfy regulatory requirements; (xxi) the impact
of the COVID 19 pandemic on Gelesis' business; (xxii) the limited operating
history of Gelesis; and (xxiii) those factors discussed in Capstar's final
prospectus dated July 6, 2020, Annual Report on Form 10-K for the fiscal
year ended December 31, 2020 and the Registration Statement on Form S-4, in
each case, under the heading "Risk Factors", and other documents of Capstar
filed, or to be filed, with the SEC, by Capstar. These filings address other
important risks and uncertainties that could cause actual results and events
to differ materially from those contained in the forward-looking statements.

 

Non-Solicitation

This press release is not a proxy statement or solicitation of a proxy,
consent or authorization with respect to any securities or in respect of the
proposed business combination and shall not constitute an offer to sell or a
solicitation of an offer to buy the securities of Capstar, Gelesis or the
combined company, nor shall there be any sale of any such securities in any
state or jurisdiction in which such offer, solicitation, or sale would be
unlawful prior to registration or qualification under the securities laws of
such state or jurisdiction. No offer of securities shall be made except by
means of a prospectus meeting the requirements of the Securities Act of 1933,
as amended.

 

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering,
developing and commercializing highly differentiated medicines for devastating
diseases, including inflammatory, fibrotic and immunological conditions,
intractable cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, among others. The Company has created a
broad and deep pipeline through the expertise of its experienced research and
development team and its extensive network of scientists, clinicians and
industry leaders. This pipeline, which is being advanced both internally and
through PureTech's Founded Entities, is comprised of 25 therapeutics and
therapeutic candidates, including two that have received both U.S. FDA
clearance and European marketing authorization, as of the date of PureTech's
most recently filed Half Year Report and corresponding Form 6-K. All of the
underlying programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and then
advanced by the PureTech team through key validation points based on the
Company's unique insights into the biology of the brain, immune and gut, or
BIG, systems and the interface between those systems, referred to as the BIG
Axis.

 

For more information, visit www.puretechhealth.com or connect with us on
Twitter @puretechh.

 

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical fact should
be considered forward-looking statements, including without limitation
statements that relate to the competitive environment in which Gelesis
operates, the expected future operating and financial performance and market
opportunities of Gelesis, Dr. Bauer's role with Gelesis, education and
advocacy programs related to Plenity and associated Gelesis strategies,
Plenity subscription costs, the business combination agreement between Gelesis
and Capstar Special Purpose Acquisition Corp. (NYSE: CPSR) or matters related
thereto, and Gelesis' future prospects, development plans, and strategies. The
forward-looking statements are based on current expectations and are subject
to known and unknown risks, uncertainties and other important factors that
could cause actual results, performance and achievements to differ materially
from current expectations, including, but not limited to, those risks,
uncertainties and other important factors described under the caption "Risk
Factors" in our Annual Report on Form 20-F for the year ended December 31,
2020 filed with the SEC and in our other regulatory filings. 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, we disclaim any obligation to update or revise these
forward-looking statements, whether as a result of new information, future
events or otherwise.

 

 Contact:

 Investors                EU media
 Allison Mead Talbot      Ben Atwell, Rob Winder

 +1 617 651 3156          +44 (0) 20 3727 1000

 amt@puretechhealth.com   ben.atwell@FTIconsulting.com

 

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