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.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.