Gelesis has raised $30 million as it prepares to file for approval of its weight loss device. The financing equips Gelesis to get its manufacturing and commercial arms ready for launch should regulators look favorably on its mixed late-phase data.
Boston-based Gelesis’ top priority is Gelesis100, a hydrogel-packed capsule. The capsule releases the hydrogel particles in the stomach, where they take on water and increase in size. Gelesis thinks filling the stomach with hydrogel particles before mealtimes will suppress peoples’ appetites, leading to weight loss.
Clinical data generated last year lend some credence to the idea without making a wholly compelling case for the device. But success against one of the two co-primary endpoints has proven to be good enough to persuade investors to write more checks.
Invesco contributed $18 million. PureTech Health, which lists Invesco among its backers, put in $5 million to keep its share of Gelesis around 20%. Invesco and PureTech have played a central role in getting Gelesis to this point. And the investors placed a higher valuation on Gelesis than previously, suggesting they see the mixed clinical data as a net positive for the company.
Having access to $30 million sets Gelesis up to prepare for the introduction of Gelesis100. The plan is to file for approval in the U.S. and Europe this year. In parallel, Gelesis will invest in the commercial manufacturing and sales infrastructure it will need to stand a shot at making a success of the launch.
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The pitch for Gelesis is partly based on safety. While the signs of efficacy were mixed, the device has an edge over existing devices, surgical procedures and drugs in terms of safety and invasiveness. That could enable Gelesis to position its device as a first-line option for patients to try before advancing, if needed, to riskier interventions.
As it stands, responsibility for making this case to regulators and payers falls squarely on Gelesis. But the company is open to offloading some of the burden to a partner.
“Gelesis reports that it has received interest from other parties and is considering partnership(s) for launch,” Jefferies analyst Peter Welford wrote in a note to investors. “Given the large addressable patient population for Gelesis100, and wide prescriber base, we believe that it would be sensible to consider a commercial partnership, particularly for the fragmented European market.”