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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Raju Mohan, Ventyx Biosciences CEO

Months af­ter a mam­moth raise, Ven­tyx Bio­sciences dips back in­to ven­ture well

Several months after emerging from what CEO Raju Mohan called “quiet mode” with a mammoth $114 million raise, Ventyx Biosciences is now making its plans for the clinic loud and clear.

The California-based immune modulation player kicked the week off with a $51 million Series B, while also naming some key hires ahead of its big clinical push.

The CMO slot is going to Jörn Drappa, former CMO at Viela Bio before it was bought out by Horizon Therapeutics earlier this year. The AstraZeneca vet stayed on at Horizon for a while as executive VP of R&D before making the jump to Ventyx.