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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.