Gelesis’ new commercial manufacturing facility
is now producing Plenity® at large scale, enabling supply to meet
the growing demand
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.
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Gelesis receives $30 million Plenity
order from Ro, a leading U.S. direct-to-patient healthcare company.
(Photo: Business Wire)
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:
- For all medications that should be taken with food, take them
after starting a meal.
- 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, 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, 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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211118005288/en/
Media Relations Katie
Sullivan ksullivan@gelesis.com
Investor Relations Lynne
Collier, ICR lynne.collier@icrinc.com
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