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July 30, 2015 3:20 PM ET

Biotechnology

Company Overview of Gelesis, Inc.

Company Overview

Gelesis, Inc., a biotechnology company, focuses on the development of products to induce weight loss and enhance glycemic control in overweight and obese patients. Its lead product candidate is Gelesis100, an orally administered capsule that contains small hydrogel particles designed to employ various mechanisms of action along the gastrointestinal tract to induce weight loss and enhance glycemic control. The company also develops Gelesis200, a novel hydrogel that is in pre-clinical development stage for the treatment of prediabetics and type 2 diabetics. Gelesis, Inc. was founded in 2006 and is headquartered in Boston, Massachusetts.

500 Boylston Street

Suite 1600

Boston, MA 02116

United States

Founded in 2006

14 Employees

Phone:

617-456-4718

Key Executives for Gelesis, Inc.

Founder, Chief Executive Officer, President and Director
Age: 52
Principal Financial Officer and Senior Financial Consultant
Age: 58
Chief Medical Officer
Age: 63
Chief Business Officer
Age: 58
Chief Project Scientist
Age: 43
Compensation as of Fiscal Year 2015.

Gelesis, Inc. Key Developments

Gelesis Expands Ongoing Weight Loss Study

Gelesis announced plans to expand its ongoing GLOW (Gelesis Loss Of Weight) study to serve as a U.S. pivotal trial. Gelesis received positive confirmation from the U.S. Food and Drug Administration (FDA) that GLOW is a nonsignificant risk (NSR) device study, allowing the Company to expand the study to multiple U.S. sites. The FDA's NSR designation allows Gelesis to proceed with the study in the U.S. without submitting and obtaining approval of an investigational device exemption (IDE) application because Gelesis100 does not present a potential for serious risk to the health, safety, or welfare of a subject. NSR devices are those that are generally considered to be low risk based on their intended use in the study. Examples of NSR devices include daily wear contact lenses, dental filling materials, and jaundice monitors for infants. The GLOW study is a randomized, double-blind, placebo-controlled, parallel-group study designed to assess the effect of repeated administration of Gelesis100 over six months on body weight and glycemic control parameters in overweight and obese subjects, including those with prediabetes and type 2 diabetes. The primary endpoints for the study are placebo-adjusted change in total body weight from baseline to end of treatment, and percent of patients with at least 5% weight loss. The secondary endpoints include changes in key glycemic control parameters. The GLOW study was initiated in November 2014 and is currently being conducted in nine sites across four European countries. The expansion of the study will result in a study population of at least 336 patients (currently 168 patients) across the U.S. and Europe. Contingent upon successful completion of the GLOW study, this expansion should allow the Company to announce topline data and file for FDA approval in the first half of 2017, as opposed to the previously planned submission in the first half of 2018.

Gelesis Seeks Acquisitions

Gelesis, Inc. intends to use a portion of net proceeds of IPO for the acquisition of, or investment in, technologies, solutions or businesses that complement its business, but it has no present commitments or agreements to enter into any such transaction.

Gelesis Announces Appointment of Directors

Gelesis announced the appointment of two new directors, Meghan Fitzgerald and Robert Forrester, who bring additional commercialization and finance expertise to its Board. Ms. Fitzgerald is the EVP of Strategy, M&A, and Health Policy and an Executive Committee Member at Cardinal Health. She has previously held senior positions at Medco Health Solutions, Inc., Pfizer Global Pharmaceuticals, Merck and Sanofi. Mr. Forrester is the CEO of Verastem, and brings to the board 14 years of experience as CEO, COO, and CFO at both private and public life sciences companies, including Forma Therapeutics, CombinatoRx and Coley.

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Date
Target
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March 26, 2015
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