Chamath Palihapitiya (Scott Eells/Bloomberg via Getty Images)

A dry-pow­der lung dis­ease drug and next-gen an­tibi­otics: Two biotechs and an $880M slate of SPACs land on Wall Street with big ideas

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An­oth­er cou­ple of biotech com­pa­nies and four SPACs are hit­ting Wall Street, adding to yet an­oth­er busy week for IPOs.

Aerovate Ther­a­peu­tics is tak­ing its dry-pow­der ver­sion of a pop­u­lar can­cer drug pub­lic, rak­ing in more than $121 mil­lion. Acurx Phar­ma­ceu­ti­cals snared a mod­est $14.8 mil­lion raise to tack­le the loom­ing threat of an­timi­cro­bial re­sis­tance. And Chamath Pal­i­hapi­tiya, the so-called ‘SPAC King,’ has round­ed up $880 mil­lion across four blank check com­pa­nies.

Here’s every­thing you need to know about the newest biotechs to hit Nas­daq:

Aerovate cel­e­brates its first birth­day with an up­sized de­but

Just shy of a full year af­ter emerg­ing from stealth mode, Aerovate Ther­a­peu­tics is launch­ing on­to Nas­daq with an up­sized of­fer­ing.

The Boston-based up­start priced 8.68 mil­lion shares at $14 — the mid­point of a $13 to $15 range. Just last week, Aerovate said it would on­ly of­fer 7.2 mil­lion shares. But with the up­sized of­fer­ing, the com­pa­ny is plan­ning to rake in about $121.5 mil­lion.

Aerovate launched out of RA Cap­i­tal’s in­cu­ba­tor last Au­gust with a $72.6 mil­lion round to de­vel­op a dry-pow­der ver­sion of No­var­tis’ land­mark can­cer drug Gleevec, al­so known as ima­tinib. The com­pa­ny thinks it can im­prove the ef­fi­ca­cy of ima­tinib in pul­monary ar­te­r­i­al hy­per­ten­sion and curb some of the side ef­fects by de­liv­er­ing the pow­der di­rect­ly to the lungs via an in­haler.

Tim­o­thy Noyes

For­mer CEO Ben Dake al­so told End­points News the prod­uct would be more at­trac­tive than a liq­uid neb­u­liz­er, which re­quires pa­tients to mix their own so­lu­tions. Re­searchers have al­ready com­plet­ed a Phase I tri­al, which showed that re­peat­ed dos­es of up to 90 mg of the can­di­date (dubbed AV-101) were “well-tol­er­at­ed” with no se­ri­ous ad­verse events re­port­ed.

Cur­rent CEO Tim­o­thy Noyes, who took the helm just a cou­ple of months ago, ini­tial­ly filed for a $100 mil­lion IPO. But in the last year or so, it has been com­mon for com­pa­nies to raise much more than what they pen­cil in on their S-1s.

Aerovate has tagged $71.6 mil­lion in IPO funds to con­duct a Phase IIb/III tri­al for AV-101, which is ex­pect­ed to be­gin in the sec­ond half of this year. An­oth­er $28.1 mil­lion is go­ing to­ward CMC for the can­di­date, ac­cord­ing to an S-1/A, and $10.4 mil­lion will be set aside to fund a com­mer­cial launch.

The com­pa­ny will list un­der the tick­er $AVTE.

De­spite Big Phar­ma’s re­treat, Acurx hits the gas on next-gen an­tibi­otics

Acurx Phar­ma­ceu­ti­cals has land­ed on Wall Street with a slate of next-gen an­tibi­otics de­signed to tack­le an­timi­cro­bial re­sis­tance.

The Stat­en Is­land, NY-based com­pa­ny — which had ini­tial­ly pen­ciled in a $15 mil­lion raise on its S-1 — end­ed up of­fer­ing 2.87 mil­lion shares at $6 apiece, pulling in about $14.8 mil­lion.

Tedros Ad­hanom Ghe­breye­sus

The up­start launched in 2017 to fight off in­fec­tions caused by bac­te­ria list­ed as pri­or­i­ty pathogens by the WHO, CDC and FDA. The pub­lic de­but comes at a time when new an­tibi­ot­ic in­no­va­tion is starved of fi­nanc­ing. WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus said back in No­vem­ber that an­timi­cro­bial re­sis­tance is just as dan­ger­ous as the Covid-19 pan­dem­ic and “threat­ens to un­wind a cen­tu­ry of med­ical progress and leave us de­fense­less against in­fec­tions that to­day can be treat­ed eas­i­ly.”

But de­spite the ris­ing threat of an­timi­cro­bial re­sis­tance, Big Phar­ma has re­treat­ed from the risky field, fraught with cheap gener­ics and poor fi­nan­cial re­turns.

Acurx is work­ing on an­tibi­otics de­signed to block the DNA Poly­merase II­IC en­zyme, the pri­ma­ry cat­a­lyst for DNA repli­ca­tion of sev­er­al Gram-pos­i­tive bac­te­r­i­al cells. The com­pa­ny pre­vi­ous­ly said it plans to launch a Phase IIb tri­al for its lead can­di­date, ibeza­pol­stat, this year in C. dif­fi­cile in­fec­tions. A Phase IIa was ter­mi­nat­ed ear­ly, af­ter just 10 of 20 an­tic­i­pat­ed pa­tients en­rolled, ac­cord­ing to the S-1/A.  All 10 pa­tients re­spond­ed to the treat­ment, Acurx said.

About $4 mil­lion of the IPO pro­ceeds will be set aside for ibeza­pol­stat’s Phase IIb tri­al, the S-1/A states. An­oth­er $6 mil­lion will be used to com­plete the pre­clin­i­cal de­vel­op­ment of ACX-375C, a sec­ond an­tibi­ot­ic in the lead op­ti­miza­tion stage.

Acurx is list­ed un­der the tick­er $ACXP.

‘SPAC King’ brings in $880M across four firms

Kishen Mehta

Chamath Pal­i­hapi­tiya, the so-called “Pied Piper of SPACs,” filed SEC pa­per­work ear­li­er this month to launch four blank-check com­pa­nies, each pen­cil­ing in $200 mil­lion rais­es. On Wednes­day, each of those SPACs priced at $10 a share, bring­ing in a to­tal of $880 mil­lion.

The blank check com­pa­nies, called So­cial Cap­i­tal Su­vret­ta Hold­ings Corps. I through IV, each tar­get dif­fer­ent sec­tors of the in­dus­try, with a fo­cus on neu­rol­o­gy, on­col­o­gy, “the or­gan space sub­sec­tor” and im­munol­o­gy. They’re co-led by pres­i­dent and di­rec­tor Kishen Mehta, who cur­rent­ly serves as port­fo­lio man­ag­er at Su­vret­ta. Each of the SPACs of­fered 22 mil­lion shares.

Pal­i­hapi­tiya has been a promi­nent fig­ure in the SPAC realm, hav­ing pre­vi­ous­ly launched six of them span­ning mul­ti­ple in­dus­tries. One of those firms took fel­low bil­lion­aire Richard Bran­son’s space tourism com­pa­ny Vir­gin Galac­tic pub­lic.

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.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.

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.