Puretech Ownership1
Therapeutic Candidate2
Initial Indication(s)
Stage of Development
23.4% Equity plus Royalties
Plenity®3

Weight management

Commercial
Plenity®
For adolescents

Adolescent weight management

Pending Discussion with FDA7
GS200

Weight management in type 2 diabetes (T2D)/prediabetes

Clinical Trial Complete
GS300

Non-alcoholic steatohepatitis/Non-alcoholic fatty liver disease

Clinical
GS500

Functional constipation

Pivotal

1 As of August 15, 2022, PureTech’s beneficial ownership of Gelesis was approximately 23.4%. 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.
These 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. 

 

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.



Press Releases


PureTech Founded Entity Gelesis Announces Two Presentations at ObesityWeek 2022

November 2, 2022


PureTech Founded Entity Gelesis Presented Clinical Data from the LIGHT-UP Study at the International Congress of Endocrinology that Suggests New Gelesis Oral Hydrogel May Improve Insulin Sensitivity and Favorably Impact Metabolic Syndrome

August 25, 2022


PureTech Founded Entity Gelesis Announces Additional $15 Million Pre-Order for Plenity®, Bringing Total Pre-Paid Orders from Ro for Plenity to $55 Million

June 21, 2022


PureTech Founded Entity Gelesis Presents Study of Proprietary Hydrogel That Demonstrates How Gut Bacteria Contributes to Weight Loss and Beneficial Metabolic Effects

June 6, 2022


PureTech Founded Entity Gelesis Announces Clinical Data Demonstrating Weight Loss with GS200 in Adults with Prediabetes and Type 2 Diabetes Presented at the European Congress on Obesity 2022

May 4, 2022


PureTech Founded Entity Gelesis Announces its Proprietary Superabsorbent Hydrogel Induced Beneficial Changes to the Gut Microbiota and Expanded Akkermansia, a Bacterial Species Associated with Gut Health and Weight Loss, in New Study

April 29, 2022


PureTech Founded Entity Gelesis® Releases Preliminary National Launch Results for Plenity®: Record-Breaking Levels of Prescriptions and Online Traffic

March 16, 2022


PureTech Founded Entity Gelesis to Launch Plenity® National Media Campaign That Challenges Restrictive Dieting Norms

January 31, 2022


PureTech Founded Entity Gelesis, the Maker of Plenity® for Weight Management, Will Debut as a Publicly Traded Company Following the Closing of its Business Combination with Capstar

January 14, 2022


PureTech Founded Entity Gelesis Appoints Inogen Co-Founder and Former CFO Ali Bauerlein to Board of Directors and Audit Committee

January 5, 2022


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

December 1, 2021


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

November 18, 2021


PureTech is Pleased to Note Publication in Nature’s Scientific Reports Featuring the Gelesis Foundational Biomimetic Platform for Treating Obesity and Conditions Related to Diet-Induced Gut Damage

November 1, 2021


PureTech Founded Entity Gelesis, the Maker of Plenity®, to Become a Publicly Traded Company via Merger with Capstar Special Purpose Acquisition Corp.

July 19, 2021


PureTech Founded Entity Gelesis Presents Findings on Plenity®-Induced Weight Loss at the American Association of Clinical Endocrinology (AACE) 2021 Annual Virtual Meeting

May 27, 2021


PureTech Founded Entity Gelesis Appoints Procter & Gamble Veteran Jane Wildman to Board of Directors

April 26, 2021


PureTech Founded Entity Gelesis Presents Pre-Clinical Data Suggesting Proprietary Hydrogel (GS300 Prototype) Reverses the Damage to the Intestines Induced by a High Fat Diet

November 13, 2020


PureTech Founded Entity Gelesis Presents Plenity® Efficacy and Safety Data at the European and International Congress on Obesity 2020

September 4, 2020


PureTech Founded Entity Gelesis Announces Partnership for Commercial Launch of Plenity® in China

June 18, 2020


PureTech Founded Entity Gelesis Receives Approval to Market PLENITY™ in Europe as a Weight Loss Treatment 

June 2, 2020


PureTech Affiliate Gelesis Named One of the World’s Most Innovative Companies for 2020 by Fast Company

March 11, 2020


PureTech Health Affiliate Gelesis Announces Partnership with Ro to Support US Commercialisation of Plenity™

December 17, 2019


PureTech Health Affiliate Gelesis Secures Over $84 Million in New Capital to Support US Commercialisation of PLENITY™

December 9, 2019


PureTech Affiliate Gelesis Presents Additional Data Highlighting Therapeutic Benefits of Plenity at ObesityWeek 2019

November 5, 2019


PureTech Health Affiliate Gelesis Announces Promising Pilot Clinical Data From Prototype of GS500 In Development for Chronic Idiopathic Constipation

May 20, 2019


PureTech Health Affiliate Gelesis Announces $10.6 (€9.4) Million Grant to Support Commercial Manufacturing of PLENITY™

April 25, 2019


PureTech Health Affiliate Gelesis Announces Successful FDA Milestone for First Product, PLENITY

April 14, 2019


PureTech’s Affiliate Gelesis Presents Data at ENDO Demonstrating Lead Product Candidate’s Positive Effect on Patients With Prediabetes, Untreated Diabetes, and Elevated Insulin Resistance

March 25, 2019


PureTech Health Affiliate Gelesis Presents Preclinical Data Showing Pipeline Candidate Restores Gut Barrier Function

March 25, 2019


PureTech's Affiliate Gelesis Announces Three Presentations at Endocrine Society Annual Meeting

March 21, 2019


Pivotal Weight Loss Data for Gelesis100 Published in Obesity, Including Predictors of Response

November 13, 2018


PureTech's Gelesis to Present Expanded Pivotal Data for Lead Product Candidate at ObesityWeek 2018

November 5, 2018