RCS - PureTech Health PLC - PRTC's Gelesis Receives $30M Plenity Order from Ro

Puretech HealthAnnouncement

18/11/2021 12:15

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RNS Number : 7558S  PureTech Health PLC  18 November 2021

18 November 2021

PureTech Health plc

 

PureTech Founded Entity Gelesis Receives $30 Million Plenity® Order from Ro

 

Gelesis' new commercial manufacturing facility is now producing Plenity® at
large scale, enabling supply to meet the growing demand

 

PureTech Health plc (https://puretechhealth.com/) (Nasdaq: PRTC, LSE: PRTC)
("PureTech" or the "Company"), a clinical-stage biotherapeutics company,
announced today that its Founded Entity, Gelesis, Inc. ("Gelesis") received a
$30 million fully paid pre-order for the company's first commercial product
for weight management, Plenity®, from Ro, a leading U.S. direct-to-patient
healthcare company. Plenity was initially made available through a beta launch
in 2020, and demand quickly outpaced supply while Gelesis worked to construct
a larger manufacturing facility. Gelesis' first commercial-scale manufacturing
line at the facility is now complete and validated.

 

As Gelesis' exclusive telehealth partner in the U.S., Ro provides patients
with access to telehealth options for weight management including the ability
to communicate with a healthcare provider and, if safe and appropriate, to
receive a prescription for Plenity through myplenity.com and Ro's digital
clinics. The telehealth experience complements in-person healthcare provider
care (available through any provider and powered by GoGoMeds), making it
easier for people to seek treatment on their own time and their own terms. The
first month of the beta launch, in October 2020, demand exceeded the limited
manufacturing supply. Since then, Gelesis has sold as much product as it can
make and nearly 70,000 people have started their weight management journey
with Plenity through Ro's platform. Ro projects Plenity will have 1,500% YoY
revenue growth (Dec. 2020 to Dec. 2021) and anticipates weight management will
continue to be among the company's top treatment requests on the Ro platform.

 

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

 

Gelesis Receives $30 Million Plenity® Order from Ro

 

Gelesis' new commercial manufacturing facility is now producing Plenity® at
large scale, enabling supply to meet the growing demand

 

BOSTON, November 18, 2021 - Gelesis announced today that leading U.S.
direct-to-patient healthcare company  Ro has placed a $30 million fully paid
pre-order for the company's first commercial product for weight management,
Plenity®. Plenity was initially made available through a beta launch in 2020,
and demand quickly outpaced supply while Gelesis worked to construct a larger
manufacturing facility. Gelesis' first commercial-scale manufacturing line at
the facility is now complete and validated.

 

As Gelesis' exclusive telehealth partner in the U.S., Ro provides patients
with access to telehealth options for weight management including the ability
to communicate with a healthcare provider and, if safe and appropriate, to
receive a prescription for Plenity through myplenity.com and Ro's digital
clinics.  The telehealth experience complements in-person healthcare provider
care (available through any provider and powered by GoGoMeds), making it
easier for people to seek treatment on their own time and their own terms.

 

The first month of the beta launch, in October 2020, demand exceeded the
limited manufacturing supply. Since then, Gelesis has sold as much product as
it can make and nearly 70,000 people have started their weight management
journey with Plenity through Ro's platform. Ro projects Plenity will have
1,500% YoY revenue growth (Dec. 2020 to Dec. 2021) and anticipates weight
management will continue to be among the company's top treatment requests on
the Ro platform. From a random sample of 20,000 people taking Plenity, over
90% had tried at least two weight loss methods before Plenity, with previous
attempts including weight loss plans, specialized diets, and prescription
weight loss medications. Given the widespread frustrations with other weight
loss methods as well as the bias, stigmatization, and insurance challenges
that often hinder care, Gelesis is committed to expanding access to its weight
management treatment. Notably, over 50% of early members surveyed say they
would not have otherwise gone to their doctor for a prescription.

 

"Our beta launch demonstrated the high level of pent-up demand for a unique
product like Plenity. Ro has been a terrific partner and worked
collaboratively with us to build out a patient-centric user experience for
people looking for help with their weight," said David Pass, Pharm.D., Chief
Operating & Commercial Officer at Gelesis. "Each month we have been
selling as much as we can make, and with this pre-order and our manufacturing
facility coming on-line, we are excited to build on the momentum and help more
and more people achieve their goals."

 

"Gelesis and Ro set out on a shared mission to expand access to high-quality
treatment for those patients seeking support in weight management goals-and
we've done just that for tens of thousands of patients who receive Plenity
through Ro's platform," said Zachariah Reitano, co-founder and CEO of Ro.
"Today, we are thrilled to expand this partnership through additional supply
of Plenity-guaranteeing the ability to help patients across the country with
the treatment and the tools they need."

 

Plenity is the first therapeutic superabsorbent hydrogel of its kind and is
made entirely from naturally derived building blocks. This first commercial
scale manufacturing line represents a major research and development milestone
for Gelesis. This first line in the new state-of-the-art facility has just
been completed and two additional lines are in construction. Gelesis
anticipates that once all lines are completed, the facility will be capable of
supplying growing demand through 2023.

 

Plenity is designed to help people feel satisfied with smaller portions so
they can lose weight. It is FDA-cleared to aid in weight management in adults
with excess weight or obesity, 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, non-systemic, and not habit forming. It uses a
novel biomimetic approach inspired by the composition and mechanical
properties of vegetables.

 

Ro currently powers digital health clinics that provide a personalized
end-to-end telehealth experience from medical diagnosis to the delivery of
prescriptions and over-the-counter products. Plenity is the only weight
management treatment available through Ro's digital clinics. Ro's portfolio
currently includes treatment for sexual health, dermatology, mental health,
fertility and more.

 

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."

 

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://urldefense.proofpoint.com/v2/url?u=https-3A__www.myplenity.com_siteassets_components_pdfs_ACQ-5FPlenity-2DPatient-2DInstructions-2Dof-2DUse.pdf&d=DwMGaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=GoIJabpH_EVTzQkNqYRRMuyArAaVgnpMcYbuoTsONA0&m=yugv8p8wScXBsXtjbuk_W7izcYqJnz6zCLjDIilNvMQ&s=NJMzWAwN4b3YtMXz3gFXHE7_RdsQUd0wr_WFG-SPfww&e=)
, 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.

 

About Ro

Ro is the healthcare technology company building a patient-centric healthcare
system. Ro's vertically-integrated, direct-to-patient platform powers a
personalized, end-to-end healthcare experience from diagnosis, to delivery of
medication, to ongoing care. With a nationwide provider network, in-home care
API, and proprietary pharmacy distribution centers, Ro is the only company to
seamlessly connect telehealth and in-home care, diagnostics, and pharmacy
services nationwide to provide high-quality, affordable healthcare without the
need for insurance. Since 2017, Ro has facilitated more than eight million
digital healthcare visits in nearly every county in the United States,
including 98% of primary care deserts. Ro also provides its patient-centric
solutions including Workpath, its in-home care API, and Kit, its at-home
diagnostic testing service, to other healthcare companies. Visit Ro.co for
more information.

 

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 business combination agreement between Gelesis
and Capstar Special Purpose Acquisition Corp. (NYSE: CPSR) or matters related
thereto, commercial demand and revenue projections for Plenity, 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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