Gelesis - Product candidates

Developing a novel category of therapies for obesity and GI-related chronic diseases

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

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Advancing a novel category of treatments for weight management and gut related chronic diseases

22.8% Equity plus Royalties⁴

COMMERCIAL

Description

Advancing a novel category of treatments for weight management and gut related chronic diseases

Puretech Ownership¹

22.8% Equity plus Royalties⁴

Stage of Development

COMMERCIAL

¹Represents the percentage of Gelesis’ outstanding common stock held by PureTech as of May 12, 2023. On a beneficial ownership basis (as calculated in accordance with SEC rules), PureTech owns 88.4% of the outstanding share capital of Gelesis as of May 26, 2023. On April 27, 2023, PureTech submitted a non-binding proposal to acquire all of the outstanding equity and equity-linked securities of Gelesis. Please see PureTech’s Schedule 13D filings with respect to Gelesis on file with SEC for additional information. 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.

PLENITY®

GELESIS' INVESTIGATIONAL THERAPEUTIC CANDIDATES

Developing a novel category of therapies for obesity and GI-related chronic diseases

Gelesis is a consumer-centered biotherapeutics company and the maker of Plenity,®² which is inspired by nature and FDA cleared for weight management in the broadest patient population of any prescription weight management product. Since launch, Plenity has helped over 200,000 people and generated $39.5 million in revenue. The accumulated safety data demonstrates unprecedented real-world tolerability consistent with clinical studies.

Program Discovery Process by the PureTech Team
- Working with leading obesity experts, we conducted a worldwide search for compelling technologies meeting key criteria for a novel approach to obesity and overweight. We agreed that the ideal characteristics included an orally administered, mechanically acting device with a favorable safety and tolerability profile. We identified and in-licensed the core intellectual property from an academic collaborator and subsequently co-invented additional intellectual property around a novel class of biocompatible, superabsorbent hydrogels, forming the basis for Gelesis’ portfolio.
Milestones Achieved & Developmental Status
- Gelesis received clearance from the FDA for its first product, Plenity® (Gelesis100), an aid for weight management in adults with excess weight or obesity, BMI of 25-40 kg/m², when used in conjunction with diet and exercise, in April 2019. In June 2020, Gelesis received a CE Mark for Plenity. The product became broadly available in the US in December 2021.
- In 2022, Gelesis reported product revenue, net, was $25.6 million compared to $11.2 million in 2021, a 129% increase year-over-year.
- In 2022, Gelesis acquired 121,500 new members compared to 61,400 new members during 2021, a 98% increase year-over-year, and sold 374,000 units in 2022 compared to 174,000 units in 2021, a 115% increase.
- In March 2023, Gelesis announced that it has filed an initial 510(k) application with the FDA to change the classification of Plenity from prescription-only to be available over the counter (“OTC”). Gelesis has stated they believe that this shift would double Plenity’s addressable market, should significantly reduce the company’s customer acquisition costs, and could open up new, broader partnership opportunities. An OTC classification would make Plenity widely available and easily accessible, empowering individuals struggling with excess weight with an easier path to an effective, affordable, and trusted weight management product. Plenity’s unprecedented safety and efficacy profile has been demonstrated in over 200,000 patients to date. As a result of this potential change to OTC and the impact it may have on the company’s commercial strategy, as well as its current levels of liquidity, Gelesis significantly reduced its operating costs. Gelesis is evaluating strategic alternatives, including potential financing and commercial partnerships in various geographies.
Expected Milestones
- Based on Gelesis’ timelines, Plenity could receive clearance from the FDA to market as an OTC product as soon as the third quarter of 2023.

Note: Gelesis’ completed and ongoing studies have been approved by the applicable reviewing Institutional Review Boards (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.

² 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.