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.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UP­DAT­ED: Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

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