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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.