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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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