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.

There was al­so one hitch in the roll­out of new IPOs, though. We hear that Vivek Ra­maswamy’s Der­ma­vant has de­cid­ed to post­pone its $100 mil­lion IPO quest for now.

Here’s what you need to know about each of the new­ly pub­lic biotechs to hit the Street:

Akero: $92 mil­lion will go to NASH R&D

Akero has reaped an up­sized $92 mil­lion wind­fall on the promise of its NASH can­di­date, which has just en­tered Phase IIa test­ing. The com­pa­ny, which re­lo­cat­ed to San Fran­cis­co right as it ap­point­ed Gilead vet An­drew Cheng as CEO, priced 5.75 mil­lion shares at $16, the high end of its range.

An­drew Cheng Akero

The pro­ceeds will go to­ward the tri­al as well as man­u­fac­tur­ing and oth­er ef­forts to beef up the clin­i­cal pipeline of NASH and oth­er meta­bol­ic drugs.

AKR-001 is a long-act­ing ana­log of FGF21, a meta­bol­ic hor­mone that CSO Tim Rolph has been work­ing with for the past 8 years when he was still lead­ing re­search for Pfiz­er. This par­tic­u­lar com­pound was in-li­censed from Am­gen and be­lieved to help “redi­rect calo­ries away from the liv­er, re­duce liv­er fat, al­le­vi­ate he­pa­to­cyte stress, in­hib­it in­flam­ma­tion and re­solve fi­bro­sis in pa­tients with NASH, as well as re­duce sus­cep­ti­bil­i­ty to car­dio­vas­cu­lar dis­ease.”

Am­gen held a 7.8% stake pri­or to the IPO, while Ap­ple Tree Part­ners was the biggest share­hold­er with 18.5%. At­las, ven­Bio and Ver­sant each claimed 15.2%. Akero went with the sym­bol $AKRO.

Pre­vail: $125 mil­lion for the lat­est gene ther­a­py play­er to hit Wall Street

Parkin­son’s fight­er Pre­vail has raised $125 mil­lion in a pub­lic de­but, sur­pass­ing its orig­i­nal goal of $100 mil­lion, by of­fer­ing 7.4 mil­lion shares at the mid­point of $17. Found­ed in 2017 in part­ner­ship with Or­biMed and The Sil­ver­stein Foun­da­tion, the New York-based com­pa­ny closed a $50 mil­lion round just a few months ago.

Asa Abe­liovich Pre­vail

Founder and CEO Asa Abe­liovich vows to de­vel­op a broad­er set of AAV gene ther­a­pies for neu­rode­gen­er­a­tive dis­eases, with a fo­cus on ge­net­i­cal­ly de­fined pa­tient pop­u­la­tions. In Parkin­son’s, that means tar­get­ing the GBA1 mu­ta­tion — an un­der­ly­ing dri­ver of the (less com­mon) neu­ro­log­i­cal man­i­fes­ta­tions of a com­mon lyso­so­mal stor­age dis­or­der known as Gauch­er dis­ease. Ad­di­tion­al pro­grams in­clude PR006 for fron­totem­po­ral de­men­tia with GRN mu­ta­tion and PR004 for the treat­ment of synu­cle­inopathies, pre­clin­i­cal stud­ies of which are to be fund­ed by the IPO wind­fall.

Atre­ca: $125 mil­lion for a pre­clin­i­cal on­col­o­gy biotech

Red­wood City, CA-based Atre­ca raised $125 mil­lion from its IPO, sell­ing 7.4 mil­lion shares at $17 a pop, with in­sid­ers de­clar­ing an in­ter­est in close to half that amount. That amount match­es its $125 mil­lion mega-crossover round from last fall, leav­ing the com­pa­ny well fund­ed for the R&D ef­fort ahead.

John Or­win Atre­ca

The still pre­clin­i­cal work at Atre­ca cen­ters on a plat­form tech that takes tis­sue sam­ples from can­cer pa­tients to ex­plore for ide­al an­ti­bod­ies, CEO John Or­win told me at the time, us­ing B cells as their sound­ing board. 

The biotech ex­pects to sub­mit an FDA ap­pli­ca­tion to test its lead ex­per­i­men­tal drug, ATRC-101, in hu­mans in late 2019, and kick off an ear­ly-stage tri­al in ear­ly 2020. Bak­er Broth­ers Life Sci­ences and its af­fil­i­ates own 22.8% of the com­pa­ny’s class A shares — and all of its B shares — while oth­er big share­hold­ers in­clude: Hadley Har­bor Mas­ter In­vestors (12.5%), Bill & Melin­da Gates Foun­da­tion (9%) and Box­er Cap­i­tal (6.9%). Atre­ca is list­ed un­der the sym­bol $BCEL.

Per­son­alis: $134 mil­lion for can­cer ge­nomics play­er

Per­son­alis casts it­self as a lead play­er in the can­cer ge­nomics field, a hot but crowd­ed space these days. And de­spite lots of com­pe­ti­tion, the com­pa­ny bagged $134 mil­lion from the sale of 7.9 mil­lion shares at $17 a pop — well past the $115 mil­lion they ini­tial­ly pen­ciled in.

The biotech has banked on the promise of the genome se­quenc­ing tech it sells to phar­mas (in­clud­ing Mer­ck and Pfiz­er), biotechs, uni­ver­si­ties and oth­er med­ical re­search in­sti­tutes.

Its Im­munoID NeXT plat­form, Per­son­alis says, is “the first tech­nol­o­gy to en­able com­pre­hen­sive analy­sis of both a tu­mor and its im­mune mi­croen­vi­ron­ment from a sin­gle sam­ple and pro­vides util­i­ty across im­muno-on­col­o­gy, tar­get­ed, and per­son­al­ized ther­a­pies.” And that’s one of sev­er­al prod­ucts it plans to com­mer­cial­ize lat­er this year.

Here’s a se­lect list of prime ri­vals from the S-1:

Guardant Health, Inc., Foun­da­tion Med­i­cine, Inc., which was ac­quired by Roche Hold­ings, Inc. in Ju­ly 2018, Roche Mol­e­c­u­lar Sys­tems, Inc., NanoS­tring Tech­nolo­gies, Inc., Per­son­al Genome Di­ag­nos­tics, Inc., and Adap­tive Biotech­nolo­gies


With con­tri­bu­tion by John Car­roll.

So­cial im­age: Shut­ter­stock

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.