Three more biotechs tum­ble on­to Wall Street to­day, rais­ing $475M as the IPO par­ty rocks on

It’s just an­oth­er day in the 2020 biotech IPO boom. Three went pub­lic this morn­ing and a fourth gained 75 per­cent on its Nas­daq trad­ing de­but.

Lead­ing the pack is the bi­o­log­i­cal an­a­lyt­ics-fo­cused com­pa­ny Berke­ley Lights, which priced at $22 per share and raised $178.2 mil­lion. Next up is ALX On­col­o­gy, which at $19 per share raised $161.5 mil­lion. Then comes T-cell biotech Pan­dion, re­vis­ing pre­vi­ous num­bers to $18 per share and of­fer­ing an up­sized 2 mil­lion more shares, rais­ing $135 mil­lion.

Ad­di­tion­al­ly, Soft­bank Group-backed Re­lay Ther­a­peu­tics opened on Thurs­day and leapt from its ini­tial $20 IPO price to more than $35 at mar­ket close.

Pan­dion hit the high end of their range, while ALX and Berke­ley Lights both priced above the range.

2020 has al­ready been a ‘his­toric’ year for biotech IPOs, with 13 com­pa­nies hav­ing raised over $200 mil­lion be­fore Au­gust. On­ly two reached that mark in 2019, and sev­en passed the thresh­old in 2018.

So far this year, 38 biotechs have filed for an IPO com­pared with 26 at this point last year, ac­cord­ing to Brad Lon­car.

There had been hints of an ex­cit­ing year brew­ing all the way back in Jan­u­ary. Things slowed down fol­low­ing the ex­treme mar­ket volatil­i­ty caused by the Covid-19 pan­dem­ic in March. But the rel­a­tive­ly small biotech Zen­tal­is raised $165 mil­lion at the be­gin­ning of April, ig­nit­ing a new surge of IPO fundrais­ing in the sec­tor.

SPACs, or spe­cial pur­pose ac­qui­si­tion com­pa­nies, are al­so get­ting in on the ac­tion. As Nas­daq head of cap­i­tal mar­kets Jay Heller told End­points News ear­li­er this week, SPACs now make up al­most 35 per­cent of all new list­ings af­ter com­pris­ing just three per­cent of the IPO mar­ket in 2014.

Though Berke­ley Lights doesn’t pro­duce any drugs, they have de­vel­oped a “dig­i­tal cell bi­ol­o­gy” plat­form that can an­a­lyze liv­ing cells in a mul­ti­tude of ways and use this in­for­ma­tion to de­liv­er live bi­ol­o­gy to their cus­tomers. In the­o­ry, this can help ac­cel­er­ate drug de­vel­op­ment and pro­duc­tion and they part­nered with Sanofi and Pfiz­er on an­ti­body dis­cov­ery.

ALX On­col­o­gy has al­ready had a suc­cess­ful fundrais­ing year, haul­ing in $105 mil­lion in Feb­ru­ary to fund a range of mid-stage stud­ies on its on­ly pipeline can­di­date — an an­ti­body tar­get­ing CD47. Some in the in­dus­try have seen promise in this area, as Gilead bought the biotech Forty Sev­en for near­ly $5 bil­lion in Jan­u­ary. ALX’s can­di­date hopes to re­duce tox­i­c­i­ty by not at­tract­ing macrophages.

Pan­dion signed a part­ner­ship with Astel­las last year for up to $800 mil­lion to de­vel­op an­ti­body treat­ments for au­toim­mune dis­or­ders. The com­pa­ny al­so earned $85 mil­lion from a Se­ries B round back in April. Its lead can­di­date PT101, which aims to boost im­mune re­spons­es by ex­pand­ing T cell pop­u­la­tions, is cur­rent­ly in a Phase Ia clin­i­cal tri­al.

The sharp in­crease in Re­lay Ther­a­peu­tics’ ear­ly trad­ing could al­low Soft­back’s Vi­sion Fund to sell their stake at a huge prof­it. In 2018 the group in­vest­ed $300 mil­lion in the biotech for 32 per­cent of the com­pa­ny, a sum that is now val­ued at about $1 bil­lion. The Vi­sion Fund al­so in­vest­ed ear­ly in Uber and Slack, but Re­lay is on­ly the ninth of its 88 in­vest­ments to go pub­lic. In the 12 month pe­ri­od end­ing last March, the Vi­sion fund post­ed an in­vest­ment loss of $17 bil­lion.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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