Gelesis (GLSS) Files $60M IPO

Gelesis (NASDAQ: GLSS) files a $60 million IPO on form S-1 with the SEC. The company plans to list on the NASDAQ under the symdol "GLSS"

The offering is being made through Piper Jaffray, Stifel and Guggenheim Securities.

About the Company:

We are a biotechnology company focused on the development of first-in-class products to induce weight loss and improve glycemic control, or management of blood sugar levels, in overweight and obese patients, including those with prediabetes and type 2 diabetes. Our product candidates are based on our proprietary hydrogel technology that works mechanically, as opposed to via a chemical mode of action, and exclusively in the gastrointestinal, or GI, tract rather than systemically or through surgical intervention. We believe our product candidates, if approved, have the potential to address the obesity and diabetes epidemics by providing safe and effective treatments that can help large patient populations, including those not served by existing treatments.

Our lead product candidate, Gelesis100, is an orally administered capsule that contains small hydrogel particles designed to employ multiple mechanisms of action along the GI tract to induce weight loss and improve glycemic control. For optimal safety and efficacy, these hydrogel particles are engineered to rapidly absorb and release water at specific locations in the GI tract. We have completed our 3 month proof of concept, or POC, FLOW study, a 128-patient, randomized, double-blind, placebo-controlled, parallel-group, clinical trial for Gelesis100 that demonstrated statistically significant, defined by a p value < 0.05, weight loss and improvement of glycemic parameters in overweight and obese patients, including prediabetics. Gelesis100 exhibited a safety profile that was similar to that of placebo with no serious adverse events observed. In November 2014, we initiated the GLOW study, a 168-patient, randomized, double-blind, placebo-controlled, parallel-group, 6 month clinical trial to study the ability of Gelesis100 to induce weight loss and improve glycemic control in overweight and obese patients, including those with prediabetes and mild type 2 diabetes. We expect to report data from this trial in the first half of 2016. Although Gelesis100 is an orally administered capsule, we anticipate it will be regulated as a medical device.

In addition to efficacy, safety is valued as a key weight loss product property by physicians and patients. We believe Gelesis100 will provide the following safety advantages over available therapies:

• acts mechanically in the GI tract and is not absorbed into the blood stream, avoiding acute and chronic side effects caused by systemically acting therapies;
• passes with food through the GI tract; no procedure is required for introduction or removal;
• has a natural cycling effect similar to food, preventing habituation, adaptation, and irritation of the GI tract associated with some therapies; and
• is engineered using components that are Generally Recognized as Safe, or GRAS, by the U.S. Food and Drug Administration, or FDA, and widely used in the food industry.

We currently retain worldwide sales and marketing rights for our product candidates. If approved by regulatory authorities, we intend to launch our product candidates by establishing internal sales and marketing teams or collaborating with strategic partners. We currently expect our lead product candidate, Gelesis100, if approved for the initial indication of weight loss in overweight and obese patients, will be launched in 2019 in the United States. If the GLOW study is successful, we intend to file for a CE Mark for Gelesis100 in Europe for the initial indication of weight loss for overweight and obese patients. Upon receipt of a CE Mark, we intend to launch Gelesis100 in certain European countries as early as 2018 through strategic collaborations with established sales and marketing partners.

S-1

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