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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Kimberly Smith, ViiV R&D chief (ViiV Healthcare)

Af­ter sting­ing FDA set­back, Glax­o­SmithK­line's Vi­iV fi­nal­ly notch­es US ap­proval for long-act­ing HIV in­jec­tion

GlaxoSmithKline’s HIV unit ViiV was dealt a stinging loss back in late 2019 when the FDA slammed the brakes on its application for a once-monthly injection based on manufacturing issues. Now, with that roadblock in the rearview, ViiV has finally made good on its promise to change the HIV game.

The FDA on Thursday approved ViiV’s Cabenuva (cabotegravir and rilpivirine) as a long acting, once-monthly therapy for HIV-positive adults who are virologically suppressed and on a stable antiviral regimen.