Three more biotechs go pub­lic Fri­day as noth­ing seems able to slow down the 2020 train

An­oth­er day, an­oth­er three biotechs price their IPOs. Such is 2020 in the biotech in­dus­try.

Fri­day’s win­ners are Kro­nos Bio, Shat­tuck Labs and Spruce Bio­sciences, all of whom are set to hit Nas­daq. Kro­nos raised the most of the bunch at $250.8 mil­lion. Shat­tuck al­so topped the $200 mil­lion-mark with a $202 mil­lion raise, while Spruce fol­lowed up with $90 mil­lion.

In terms of pric­ing, all three priced above their ranges. Kro­nos did so at $19 per share, Shat­tuck at $17 per share and Spruce at an up­sized $15 a share.

The lat­est fig­ures from in­de­pen­dent an­a­lyst Brad Lon­car peg the com­bined biotech in­dus­try raise at over $11 bil­lion across four dozen IPOs through late Au­gust. That to­tal sur­passed the en­tire amount raised by biotechs that went pub­lic in all of 2019, and more than half had raised more than $200 mil­lion on their own — a group that now in­cludes Kro­nos and Shat­tuck.

In a re­cent in­ter­view, Nas­daq’s head of health­care list­ings Jor­dan Saxe told End­points News the tal­ly was 56 IPOs with a to­tal $11.3 bil­lion raised. With three more biotechs go­ing pub­lic Fri­day, the num­ber is now clos­er to 60, a num­ber not seen in any of the last four years. And more are com­ing, with Galec­to fil­ing its S-1 on Thurs­day.

Sev­er­al fac­tors have con­tributed to the ex­plod­ing mar­ket, Saxe said, no­tably with the Covid-19 pan­dem­ic high­light­ing an al­ready-im­pres­sive amount of in­no­va­tion in the field. Saxe added that a “con­ser­v­a­tive” es­ti­mate of the fi­nal 2020 IPO num­ber will end up be­tween 65 and 70.

Kro­nos is the high­est-pro­file of the bunch, with 30-year Gilead R&D vet­er­an Nor­bert Bischof­berg­er run­ning the show since the com­pa­ny launched in 2018. The biotech re­cent­ly ac­quired en­tosple­tinib, which was shelved when Bischof­berg­er still worked at Gilead, as well as an­oth­er SYK in­hibitor, lan­raplenib.

Per the biotech’s S-1, around $80 to $90 mil­lion of the IPO funds will go to­ward a Phase II/III tri­al to study en­tosple­tinib, now called EN­TO, in com­bi­na­tion with in­duc­tion chemother­a­py to treat acute myeloid leukemia pa­tients with NPM1 mu­ta­tions. An­oth­er $20 to $30 mil­lion will fund a Phase I/II tri­al in a CDK9 in­hibitor, with the rest go­ing to­ward their SYK and oth­er pro­grams. That’s all on top of $278 mil­lion in VC mon­ey.

Shat­tuck’s move to go pub­lic is the lat­est in a busy few months. Back in June, the com­pa­ny net­ted a $118 mil­lion Se­ries B and now in­tends to use the IPO cash to push its lead pro­gram, a CD47 in­hibitor and CD40 ag­o­nist, from Phase I to Phase II in ovar­i­an can­cer. The biotech al­so plans to fin­ish a Phase I tri­al for its Take­da-part­nered can­di­date, SL-279252, for ad­vanced sol­id tu­mors and lym­phoma.

Fi­nal­ly, Spruce has al­so had a packed year af­ter pulling in a $88 mil­lion Se­ries B in Feb­ru­ary, and they fo­cus their pipeline on clas­sic con­gen­i­tal adren­al hy­per­pla­sia. The com­pa­ny is un­der­go­ing two Phase IIb tri­als for tildac­er­font, a non-steroidal treat­ment for CAH, in adult pa­tients with both good and poor dis­ease con­trol. About $5 mil­lion will be used to wrap up these tri­als, while an­oth­er $20 mil­lion will help com­mer­cial­ize the can­di­date. $40 mil­lion will help fund ad­di­tion­al CAH re­search in pe­di­atric pa­tients.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.