2019's sec­ond uni­corn Gos­samer rais­es $276M in up­sized IPO of­fer­ing, MP­M's Har­poon makes its Nas­daq de­but with $75.6M boun­ty

Meet 2019’s newest biotech uni­corn — Gos­samer Bio — which is mak­ing its de­but on Nas­daq Fri­day with an up­sized $276 mil­lion of­fer­ing.

The drug de­vel­op­er — with a val­u­a­tion of $1 bil­lion, ac­cord­ing to Re­nais­sance Cap­i­tal — is run by for­mer Re­cep­tos ex­ec­u­tives, and fol­lows the year’s first uni­corn Alec­tor $ALEC that raised $176 mil­lion at a $19 mid­point price. In­vestors are ea­ger­ly an­tic­i­pat­ing the per­for­mance of both, with an eye on oth­er IPO’s wait­ing in line, af­ter a tur­bu­lent De­cem­ber rav­aged stocks across the board, in­clud­ing Mod­er­na $MR­NA that saw a third of its colos­sus $7.5 bil­lion val­u­a­tion evap­o­rate soon af­ter its keen­ly watched mar­ket de­but.

Gos­samer post­ed its prospec­tus one day be­fore the US shut­down be­gan, and had its plans stymied by the par­a­lyzed SEC through­out the pro­longed or­deal. Re­fus­ing to let a lit­tle thing like that de­rail its plans, the com­pa­ny said it would use a rarely used path to forge ahead: Em­ploy­ing a fixed price and fore­go­ing the typ­i­cal­ly lengthy SEC re­view of their prospec­tus to green light the list­ing in fa­vor of en­abling their reg­is­tra­tion by lock­ing in their IPO price (at $16) 20 days be­fore mak­ing a mar­ket de­but. The move was short lived how­ev­er, as two days af­ter an­nounc­ing its strat­e­gy, the shut­down came to an end, and Gos­samer de­cid­ed to re­vert to its orig­i­nal route, but asked the SEC for an ac­cel­er­at­ed re­view.

“I think what was im­por­tant for us was that we con­tin­ue to stay on our op­er­a­tional plan, in terms of be­ing able to raise fi­nanc­ing” to fund Gos­samer’s clin­i­cal pro­grams, CEO Sheila Gu­jrathi told End­points News, when asked about the com­pa­ny’s ur­gency to at­tain a pub­lic list­ing.

The IPO funds raised by Gos­samer have eclipsed ex­pec­ta­tions, as the San Diego-based com­pa­ny was orig­i­nal­ly ex­pect­ing to sell rough­ly $14.4 mil­lion shares at $16 per share gen­er­at­ing $230 mil­lion in gross pro­ceeds. But it looks like in­vestors liked what they saw, and the com­pa­ny has now sold $17.25 mil­lion shares at the same price point, bring­ing in a $276 mil­lion boun­ty. It will be­gin trad­ing un­der the sym­bol $GOSS to­day.

Pre­ced­ing the IPO, the biotech had raised $330 mil­lion in two rounds of fund­ing. Al­to­geth­er, the com­pa­ny now has enough cap­i­tal to fund it well in­to 2021, Gu­jrathi said.

Fa­heem Has­nain on stage at the End­points News / Pharm­Cube #BI­IS18 sum­mit in Shang­hai, Oc­to­ber 2018End­points News

Click on the im­age to see the full-sized ver­sion

The com­pa­ny, orig­i­nal­ly named FSG Bio, was found­ed by for­mer Re­cep­tos CMO Gu­jrathi and Fa­heem Has­nain, the ex-Re­cep­tos CEO, in 2015, short­ly af­ter Re­cep­tos was ac­quired by Cel­gene. Af­ter the Re­cep­tos buy­out, “it was a pret­ty im­me­di­ate de­ci­sion” to form an­oth­er com­pa­ny, Gu­jrathi said. Cur­rent­ly 14 se­nior ex­ec­u­tives and di­rec­tors to­geth­er hold near­ly 33% of Gos­samer, whose two biggest share­hold­ers are ARCH Ven­ture Part­ners with 17.5% and Omega Fund V with 15.1%.

The biotech is fo­cused on im­munol­o­gy, in­flam­ma­tion and on­col­o­gy, has three drugs in the clin­ic, and an­oth­er in pre­clin­i­cal test­ing. Its lead ex­per­i­men­tal drug, GB001, is cur­rent­ly in a mid-stage study in asth­ma pa­tients that com­menced last Oc­to­ber. An in­ter­im analy­sis is ex­pect­ed in 2020, with the full dataset lat­er in the year, Gu­jrathi said.

Patrick Baeuer­le

An­oth­er IPO that priced on Fri­day is that of on­col­o­gy com­pa­ny Har­poon Ther­a­peu­tics, which has raised $75.6 mil­lion in gross pro­ceeds via the sale of 5.4 mil­lion shares at $14 per share. Months af­ter rais­ing $70 mil­lion in a ven­ture round, the im­munother­a­py de­vel­op­er (which has an al­liance in place with Ab­b­Vie and was cre­at­ed in part by MPM part­ner Patrick Baeuer­le) filed for an IPO last De­cem­ber. The biotech has de­vel­oped T cell en­gager tech­nol­o­gy called Tri­TAC that is de­signed to sur­pass the ini­tial gen­er­a­tion of BiTE’s, with a longer half-life and sta­bil­i­ty to im­prove ef­fi­ca­cy and safe­ty. 

The San Fran­cis­co-based com­pa­ny will al­so trade on the Nas­daq un­der the sym­bol $HARP to­day.

In­vestors pony up $476M for the lat­est round of biotech IPOs to hit the Street

Three biotechs — and a genome se­quenc­ing play­er — have caught the lat­est tide to the Gold Coast of IPOs, round­ing out the first half of 2019 with 23 new drug de­vel­op­ers mak­ing it on Nas­daq.

Most of these com­pa­nies filed their IPOs al­most si­mul­ta­ne­ous­ly, though we’re still wait­ing on word of fel­low class­mate Bridge­Bio’s pric­ing af­ter CEO Neil Ku­mar set the terms at $14 to $16 a share on Mon­day in search of a $240 mil­lion (or so) wind­fall. If he’s suc­cess­ful, that would take the one-week haul past the $700 mil­lion mark, a fresh sign that in­vestors’ en­thu­si­asm for new­ly coined pub­lic biotechs hasn’t cooled.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Robert Forrester, Verastem

Ve­rastem CEO For­rester steps to the ex­it as the board hunts com­mer­cial-savvy ex­ec for the be­lea­guered biotech

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture.

The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Merck waved off a looming forced retirement for Ken Frazier last September, the board cited flexibility in CEO transition as a key factor in the decision. Having Frazier — who’s also chairman of the company — around beyond his 65th birthday in 2019 would ensure they install the best person at the best time, they said.

The board has evidently begun that process with a clear preference for internal candidates, sources told Bloomberg. CFO Robert Davis, chief marketing officer Michael Nally, and chief commercial officer Frank Clyburn are all in the running, according to an insider.

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In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.

Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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