Three more com­pa­nies price IPOs, bring­ing this year's raise up to $11.78B

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The biotech IPO rush con­tin­ues, as three more com­pa­nies — Nu­va­lent, Icosavax and Rally­bio — priced their pub­lic de­buts on Wednes­day and Thurs­day. So far, 92 com­pa­nies have priced or filed for IPOs this year, rais­ing a mas­sive $11.78 bil­lion and sur­pass­ing last year’s count of 91 pub­lic de­buts.

Here’s what you need to know about the lat­est com­pa­nies jump­ing on­to the Nas­daq:

Nu­va­lent hits Wall Street six months post-launch

Deer­field-backed Nu­va­lent emerged from stealth just six months ago, and it’s cel­e­brat­ing its half-birth­day with its very own stock tick­er.

Matt Shair

The tar­get­ed ther­a­py start­up priced an up­sized $166 mil­lion IPO on Thurs­day, of­fer­ing 9.8 mil­lion shares at $17 apiece, the mid­point of a $16 to $18 range. Much of that ($60 mil­lion to $65 mil­lion, ac­cord­ing to the S-1/A) will be used to launch the com­pa­ny’s first-in-hu­man tri­al lat­er this year for NLV-520, which is billed as a high­ly se­lec­tive ROS1 in­hibitor.

Nu­va­lent first set out to solve a prob­lem that oc­curs in tar­get­ed can­cer ther­a­pies, where mu­ta­tions tend to arise and thwart the ther­a­pies from ac­com­plish­ing their mis­sions. But Har­vard pro­fes­sor Matt Shair, who found­ed Nu­va­lent, be­lieves chem­istry can evolve fast enough to keep up with the dis­eases, he told End­points News in Jan­u­ary.

The com­pa­ny plans on launch­ing a Phase I/II tri­al for NLV-520 in non-small cell lung can­cer and oth­er ad­vanced sol­id tu­mors in the sec­ond half of this year. An­oth­er $55 mil­lion to $60 mil­lion is tagged for the com­pa­ny’s sec­ond lead can­di­date, an ALK in­hibitor, which is head­ed for the clin­ic in the first half of 2022, the S-1/A states. And $45 to $50 mil­lion will be set aside for dis­cov­ery pro­grams, in­clud­ing ones tar­get­ing ALK, IXDN and HER2 Ex­on 20 in­ser­tions.

Nu­va­lent filed its S-1 pa­pers ear­li­er this month, pen­cil­ing in a $100 mil­lion raise — though many com­pa­nies in the last year and a half have gone on to raise much more than those ini­tial es­ti­mates.

Deer­field, which helped launch the com­pa­ny with a $50 mil­lion Se­ries A back in Jan­u­ary, will still own just over 51% of shares af­ter the of­fer­ing. Mean­while, Shair holds a 5.23% piece of the pie.

Nu­va­lent will trade un­der the tick­er $NU­VL.

Icosavax kicks off pub­lic de­but with $182M raise

Icosavax scored a big goal with its soc­cer ball-shaped virus-like par­ti­cles on Wednes­day, pric­ing an up­sized $182 mil­lion IPO.

The Seat­tle-based com­pa­ny, which had ini­tial­ly pen­ciled in a $100 mil­lion raise, end­ed up of­fer­ing just over 12.1 mil­lion shares at $15 apiece. A vast ma­jor­i­ty of the funds ($120 mil­lion) are go­ing straight to IVX-A12, a com­bi­na­tion vac­cine can­di­date tar­get­ing both res­pi­ra­to­ry syn­cy­tial virus (RSV) and hu­man metap­neu­movirus (hM­PV), for which there are cur­rent­ly no ap­proved vac­cines. Icosavax plans on fil­ing an IND for that pro­gram in the first half of 2022.

Neil King

Icosavax’s tech orig­i­nat­ed in Neil King’s lab at the Uni­ver­si­ty of Wash­ing­ton, where re­searchers built on years-old re­search of how some vi­ral pro­teins could spon­ta­neous­ly as­sem­ble them­selves. That re­sult­ed in a virus-like par­ti­cle shaped like a soc­cer ball — the “white” parts mak­ing up the struc­ture and the “black” spots rep­re­sent­ing the dis­played anti­gens, King told End­points back in April.

King’s us­ing that same tech to de­vel­op a “su­per-sea­son­al” flu vac­cine with the NIH, though Icosavax isn’t in­volved in that.

The com­pa­ny was orig­i­nal­ly work­ing on a vac­cine for just RSV, dubbed IVX-121, which is en­ter­ing a clin­i­cal tri­al in Bel­gium lat­er this year, with topline da­ta ex­pect­ed in the first half of next year. It’s al­so work­ing on two Covid-19 vac­cine can­di­dates, IVX-411 and IVX-421. The for­mer en­tered a Phase I/II tri­al in Aus­tralia last month, with proof-of-con­cept da­ta com­ing in the first half of 2022.

RA Cap­i­tal Man­age­ment, Qim­ing, Adams Street Part­ners, Aven­tis and Nan­oDi­men­sion will each own be­tween 7% and 10% af­ter the of­fer­ing, while CEO Adam Simp­son has a 2.2% stake.

Icosavax will trade un­der the tick­er $ICVX.

Rally­bio prices IPO at the low end of its range, rais­ing slight­ly less than ex­pect­ed

Af­ter read­ing out proof-of-con­cept da­ta for its lead pro­gram ear­li­er this month, Mar­tin Mack­ay’s Rally­bio has priced its pub­lic of­fer­ing at the low end of a $13 to $15 range, reel­ing in just a bit less than it had pen­ciled in on its S-1.

Mar­tin Mack­ay

Mack­ay found­ed Rally­bio back in 2018, af­ter spend­ing 30 years at Big Phar­mas and big biotechs like Alex­ion. Along with Stephen Uden and Jeff Fry­er — two oth­er Alex­ion cast­aways — Mack­ay set out to launch a new com­pa­ny with a fo­cus on rare dis­eases.

On Wednes­day, the com­pa­ny of­fered 6.2 mil­lion shares at $13 apiece, rais­ing $80.6 mil­lion de­spite ini­tial­ly shoot­ing for a $100 mil­lion raise, ac­cord­ing to an S-1 filed ear­li­er this month. A ma­jor­i­ty of the IPO funds — be­tween $75 mil­lion and $83 mil­lion — are tagged for the com­pa­ny’s lead pro­gram for FNAIT, or fe­tal and neona­tal al­loim­mune throm­bo­cy­tope­nia.

FNAIT is a rare con­di­tion in which a fe­tus has anti­gens on platelet cells that a moth­er lacks, lead­ing the moth­er’s body to mount an im­mune re­sponse that can po­ten­tial­ly cause fe­tal brain bleed­ing.

Rally­bio’s pre­ven­ta­tive can­di­date, RLYB211 can­di­date, is de­signed to give moth­ers a poly­clon­al an­ti-HPA-1a an­ti­body in the hopes of tamp­ing down that im­mune re­sponse. Ear­li­er this month, the com­pa­ny re­leased proof-of-con­cept da­ta from an on­go­ing Phase I/II study that sug­gest­ed the can­di­date can “rapid­ly and com­plete­ly clear” HPA-1a pos­i­tive platelets from those with­out nat­ur­al anti­gen de­fense.

An­oth­er $35.0 mil­lion to $41.0 mil­lion is slat­ed for the com­pa­ny’s com­ple­ment pro­gram, in­clud­ing com­ple­tion of a Phase I tri­al for RLYB116 in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria (PNH), a rare blood dis­ease, and gen­er­al­ized myas­the­nia gravis (gMG), a neu­ro­mus­cu­lar dis­ease.

Rally­bio will list un­der the tick­er $RLYB.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.