Gelesis

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23.3% Equity plus Royalties

Plenity®³

Initial Indication(s):

Weight management

Stage of Development:

Commercial

Plenity®
For adolescents

Initial Indication(s):

Adolescent weight management

Stage of Development:

Pending Discussion with FDA⁷

GS200

Initial Indication(s):

Weight management in type 2 diabetes (T2D)/prediabetes

Stage of Development:

Clinical Trial Complete

GS300

Initial Indication(s):

Non-alcoholic steatohepatitis/Non-alcoholic fatty liver disease

Stage of Development:

Clinical

GS500

Initial Indication(s):

Functional constipation

Stage of Development:

Pivotal

¹ As of November 11, 2022, PureTech’s beneficial ownership of Gelesis was approximately 23.3%. PureTech is eligible to receive additional earnout shares in accordance with the terms of the business combination agreement. PureTech is also eligible to receive certain payments from Gelesis under its license agreement, including sublicense payments and royalties on sales of certain products, including Plenity.
²These therapeutic candidates are regulated as devices and their development has been approximately equated to phases of clinical development. With the exception of Plenity, candidates are investigational and have not been cleared by the FDA for use in the U.S.
³ 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.
⁷ Contingent on FDA review of the research plan.

SELECT PROGRAM:

Plenity^®

Gelesis' investigational therapeutic candidates

Plenity^®, FDA-cleared and approved to market in Europe

Gelesis is developing a novel category of therapies for obesity and GI-related chronic diseases. Given challenges associated with pharmacological and invasive surgical treatments for obesity, Gelesis designed an approach with an oral, non-invasive, non-systemic mechanism of action and a highly favorable safety and efficacy profile.

Gelesis is progressing a global commercialization strategy for its first product, Plenity, to broaden global access to a weight loss option. Plenity is now broadly available across the U.S. to adults who meet the prescription criteria. Gelesis’ first commercial-scale manufacturing line is complete and validated as of November 2021.

In December 2021, Gelesis announced that Plenity is now broadly available across the United States to adults who meet the prescription criteria. 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.
In April 2019, Gelesis received clearance from the FDA for its first product, Plenity (Gelesis100), an aid for weight management in adults with excess weight or obesity, a BMI of 25-40 kg/m², when used in conjunction with diet and exercise.
In June 2020, Gelesis received a CE Mark for Plenity as a class III medical device indicated for weight loss adults with a BMI of 25-40 kg/m2, when used in conjunction with diet and exercise, which allows Gelesis to market Plenity throughout the European Economic Area and in other countries that recognize the CE Mark.
In January 2022, Gelesis announced the completion of its business combination with Capstar Special Purpose Acquisition Corp. (NYSE: CPSR) (“Capstar”) to become Gelesis Holdings, Inc. The company began trading on the New York Stock Exchange under the ticker symbol “GLS” on January 14, 2022.
In January 2022, Gelesis launched the “Who Said?” marketing campaign across the U.S., which challenges many long-held cultural and societal assumptions around weight loss. Plenity’s multichannel campaign encompasses TV, digital, social and Out of Home (OOH) to grow awareness of Plenity’s novel approach to weight management. In March 2022, Gelesis announced preliminary results from its broad awareness media campaign, noting that within the first three weeks, Gelesis saw a 3-fold increase in web traffic and 3.5-fold increase in the number of individuals seeking a new prescription compared to previous months when supply was limited.
In December 2021, Gelesis announced the appointment of leading health and nutrition authority Joy Bauer, MS, RDWN, CDN as Chief Nutrition Officer of Plenity. In this role, Bauer will offer nutrition counseling and education for Plenity members and engage with and educate healthcare professionals about the product.
In January 2022, Gelesis appointed Inogen Co-Founder and former CFO, Ali Bauerlein, to its board of directors and Audit Committee. Ms. Bauerlein brings success in scaling to over $300 million revenue in a direct-to-consumer business model and public company execution as Gelesis plans to scale Plenity to meet growing consumer demand.
Gelesis has a partnership with Ro, a leading U.S. direct-to-patient healthcare company, to support the U.S. commercialization of Plenity. 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% year-over-year 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. In June 2022, Ro placed a $15 million pre-paid order for Plenity. This was in addition to previous Plenity pre-orders from Ro totaling $40 million.
Gelesis also has a partnership with China Medical System Holdings Ltd. (CMS), for the commercialization of Plenity in China, which was announced in June 2020. Pursuant to the terms of the deal, CMS provided $35 million upfront in a combination of licensing fees and equity investment, with the potential for an additional $388 million in future milestone payments as well as royalties.

For more information, visit www.myplenity.com.

GLOW Clinical Study Details

The Gelesis Loss of Weight (GLOW) study was a multicenter, double-blind, placebo-controlled pivotal study designed to assess change in body weight in 436 adults with overweight or obesity (BMI ≥ 27 and ≥ 40 kg/m2) after six months of treatment. The study had two predefined co-primary endpoints: at least 35 percent of patients taking Plenity achieving more than five percent weight loss (categorical endpoint) and placebo-adjusted weight loss with a super-superiority margin of three percent. In addition, a prespecified analysis of simple superiority was also performed. The study met and exceeded the predefined categorical endpoint, with 59 percent of adults in the treatment group achieving weight loss of five percent or greater and losing on average 10 percent of their weight (22 pounds) and 3.5 inches from their waists within six months. The study did not meet the three percent super-superiority endpoint but demonstrated superiority of the Plenity treatment over the placebo group (–6.4 percent vs. –4.4 percent, P=0.0007). Plenity-treated individuals had twice the odds of achieving at least five percent weight loss as compared to placebo (adjusted odds ratio: 2.0, P=0.0008).

Important Safety Information

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.

Note: Gelesis’ completed and ongoing studies have been approved by the applicable reviewing Institutional Review Boards, or IRBs, as nonsignificant risk device studies. Gelesis also has ongoing discovery efforts to expand its pipeline. Our board designees represent a minority of the members of the board of directors of Gelesis, and we do not control the clinical or regulatory development or commercialization of Gelesis’ therapeutics and therapeutic candidates. We have an interest in Gelesis’ therapeutic candidates through our minority equity investment as well as our right to royalty payments as a percentage of net sales pursuant to a license agreement between us and Gelesis. Gelesis is well protected with a robust intellectual property portfolio. Gelesis was incorporated in February 2006.