Yishai Zohar, Gelesis CEO (Gelesis)

PureTech-backed Gele­sis wins biotech's lat­est SPAC deal, plan­ning to bring weight loss prod­uct to up to 150M Amer­i­cans

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The lat­est PureTech-found­ed biotech is head­ing to the New York Stock Ex­change, and it comes through a new SPAC re­verse merg­er.

De­vel­op­ing weight-man­age­ment pills that are on the cusp of a na­tion­al roll­out, Gele­sis will re­verse merge with Cap­star Spe­cial Pur­pose Ac­qui­si­tion Corp., the en­ti­ties an­nounced Mon­day morn­ing. The deal will give Gele­sis ac­cess to the $376 mil­lion raised from the SPAC, as well as an­oth­er $100 mil­lion in PIPE fund­ing.

The merg­er is ex­pect­ed to close be­fore the end of 2021 with Gele­sis earn­ing a pro for­ma im­plied val­ue of $1.3 bil­lion with the deal.

Gele­sis de­cid­ed to go with a SPAC rather than a more tra­di­tion­al IPO, CEO Yishai Zo­har told End­points News in an in­ter­view, be­cause it high­ly val­ued the SPAC team’s com­mer­cial ex­pe­ri­ence, which will aid in a rapid roll­out lat­er this year.

“What we thought was very ap­peal­ing for us is the idea that we will emerge with a SPAC that has a very strong con­sumer and com­mer­cial ex­per­tise,” Zo­har told End­points. “We re­al­ize that our la­bel is such that we need a very wide con­sumer ap­proach and strat­e­gy. We want­ed to build those ca­pa­bil­i­ties.”

That ex­per­tise comes from a syn­di­cate with a va­ri­ety of busi­ness ex­pe­ri­ence. Cap­star’s CEO is R. Steven Hicks, a Texas tele­com mag­nate whose for­mer com­pa­ny AMFM is the US’ largest ra­dio sta­tion op­er­a­tor with more than 450 sta­tions na­tion­wide. There’s al­so lead di­rec­tor Ro­dri­go de la Torre, the head of fi­nance and strat­e­gy for Taco Bell Glob­al since April 2019 who pre­vi­ous­ly served in a se­nior role at Piz­za Hut In­ter­na­tion­al.

Some of the SPAC cash is al­so slat­ed to ramp up man­u­fac­tur­ing of the pills, which are brand­ed un­der the name Plen­i­ty.

Gele­sis is the third PureTech en­ti­ty to go pub­lic af­ter Karuna Ther­a­peu­tics hit Nas­daq with a tra­di­tion­al IPO in 2019 and Vor Bio­phar­ma fol­lowed suit ear­li­er this year. Gele­sis’ SPAC raise, how­ev­er, dwarfs both of the pre­vi­ous to­tals: Karuna raised $89.2 mil­lion in its IPO and Vor pulled in $176.9 mil­lion.

The biotech is at­tempt­ing to make its mark on weight man­age­ment through the use of pills that mim­ic the feel­ing of eat­ing veg­eta­bles, Gele­sis said in an in­vestor call Mon­day morn­ing. With a reg­i­men to be tak­en pri­or to meals, Plen­i­ty ex­pands by ab­sorb­ing wa­ter and fills up to 25% of the stom­ach by vol­ume, mak­ing pa­tients feel fuller be­fore eat­ing.

Plen­i­ty has been cleared by the FDA as a de­vice, Zo­har not­ed, and the com­pa­ny says it’s re­ceived the broad­est la­bel of any weight main­te­nance treat­ment — in­di­vid­u­als with a BMI be­tween 25 and 40 are el­i­gi­ble for pre­scrip­tion. Fur­ther­more, he said, pa­tients do not need co­mor­bidi­ties to take Plen­i­ty, a key re­quire­ment for oth­er such drugs and de­vices al­ready on the mar­ket.

In the US alone, that ac­counts for about 150 mil­lion adults.

Gele­sis had ini­ti­at­ed a be­ta launch pro­gram in late 2020 that saw mem­ber­ship rise above 48,000 and is plan­ning full-scale na­tion­al com­mer­cial­iza­tion by the end of the year. For the be­ta, the pills were priced at $98 per 28-day sup­ply, with that fig­ure ex­pect­ed to re­main the same once Plen­i­ty up­scales, a Gele­sis spokesper­son told End­points in an email.

The biotech is not dis­clos­ing sales num­bers for the be­ta pro­gram, the spokesper­son added.

With the news of the deal, Gele­sis is tout­ing the safe­ty and ef­fi­ca­cy for the pills as well. In pre­vi­ous stud­ies com­plet­ed for the prod­uct, Zo­har says 59% of adults saw greater than 5% weight loss and 26% lost more than 10%. Com­pared to place­bo, Plen­i­ty dou­bled a pa­tient’s chances of los­ing at least 5% of their weight.

Plen­i­ty’s side ef­fect pro­file was sta­tis­ti­cal­ly no dif­fer­ent than place­bo, with no se­ri­ous ad­verse events.

One such pre­vi­ous tri­al, how­ev­er, said Plen­i­ty failed to demon­strate a 3% mean dif­fer­ence of weight loss be­tween the drug arm and the place­bo group, a fig­ure reg­u­la­tors typ­i­cal­ly have looked for in the past. But be­cause over­all risk pro­files were so low, and be­cause Plen­i­ty worked well for those who did re­spond, the FDA cleared the prod­uct with as broad a la­bel as it did, Zo­har said.

“The beau­ty of our ap­proach is be­cause of its fa­vor­able safe­ty and tol­er­a­bil­i­ty pro­file; there’s no harm for every­one to try and see if they’re a re­spon­der,” Zo­har said. “With weight loss, be­cause it’s such a het­ero­ge­neous prob­lem, it’s very usu­al that you don’t have one so­lu­tion that ap­plies for every­one.”

Gele­sis is pri­mar­i­ly go­ing to fo­cus on sell­ing Plen­i­ty in the US un­til the com­pa­ny has beefed up man­u­fac­tur­ing, though it al­so signed a part­ner­ship to mar­ket the prod­uct in Greater Chi­na, Zo­har said.

Af­ter hun­dreds of SPACs flood­ed the mar­ket late last year and in 2021’s first quar­ter, merg­ers start­ed to hit the gas ped­al once the cal­en­dar turned to spring. Over­all, SPACs have steered more than $15 bil­lion to the life sci­ences in­dus­try in 2021, ac­cord­ing to the End­points tal­ly.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

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