An­oth­er busy week for IPOs be­gins with an off-the shelf cell ther­a­py play­er sniff­ing around uni­corn sta­tus

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A flur­ry of biotechs are ex­pect­ed to hit Nas­daq this week, with two com­pa­nies, Am­brx Bio­phar­ma and Cen­tu­ry Ther­a­peu­tics, set­ting the terms for their pub­lic de­buts, with ex­pect­ed rais­es at $126 mil­lion and $200 mil­lion, re­spec­tive­ly. Alza­mend Neu­ro is al­so join­ing in with a $12.5 mil­lion raise and two pre­clin­i­cal Alzheimer’s treat­ments in tow.

The newest rais­es bring the to­tal num­ber of biotech and bio­phar­ma com­pa­nies to file or price their IPOs this year to 69, ac­cord­ing to End­points News’ tal­ly. 

Af­ter ditch­ing its last ef­fort to go pub­lic, sec­ond time’s the charm for Am­brx

Am­brx Bio­phar­ma is fi­nal­ly gear­ing up to go pub­lic af­ter its last ef­fort flopped back in 2014.

The La Jol­la, CA-based biotech plans to of­fer 7 mil­lion shares at a range of $17 to $19, which would amount to a $126 mil­lion raise.

The last at­tempt to go pub­lic sent the com­pa­ny scram­bling, as the board OK’d a rad­i­cal­ly dif­fer­ent strat­e­gy to move for­ward, ap­prov­ing a plan to sell it­self to a syn­di­cate of Chi­nese in­vestors and phar­ma com­pa­nies. Last No­vem­ber, the com­pa­ny nabbed a $200 mil­lion crossover raise, mark­ing the cul­mi­na­tion of its piv­ot to Chi­na. Since 2015, it has inked dis­cov­ery deals with BeiGene, Suzhou-based Mab­Space, Shang­hai-based NovoCodex, and oth­ers.

Am­brx plans to dump $87.8 mil­lion in IPO pro­ceeds in­to its HER2-tar­get­ing an­ti­body-drug con­ju­gate ARX788, which is be­ing stud­ied in sol­id tu­mors, in­clud­ing breast and gas­tric can­cers. The most ad­vanced tri­al is a Phase II/III eval­u­at­ing the can­di­date in HER2-pos­i­tive metasta­t­ic breast can­cer in Chi­na, ac­cord­ing to the F-1/A.

An­oth­er $16.6 mil­lion is tagged for the Phase I de­vel­op­ment of a sec­ond can­di­date in the com­pa­ny’s ADC pipeline, ARX517, in prostate can­cer. A to­tal of $31.5 mil­lion is go­ing to­ward pre­clin­i­cal can­di­dates, in­clud­ing for IND-en­abling and Phase I stud­ies of its en­gi­neered pre­ci­sion bi­o­log­ics.

Am­brx plans to list un­der the tick­er $AMAM.

Cen­tu­ry Ther­a­peu­tics looks to jump on­to Nas­daq with al­lo­gene­ic cell ther­a­pies

There could soon be an­oth­er biotech uni­corn in town as Cen­tu­ry Ther­a­peu­tics has set the terms for a $200 mil­lion IPO. The com­pa­ny plans on of­fer­ing 10.6 mil­lion shares at a range of $18 to $20, the mid­point of which would bring its mar­ket val­ue to $1.1 bil­lion.

La­lo Flo­res

The com­pa­ny had pen­ciled in a $100 mil­lion raise on its S-1 back in May, but in the last year that num­ber has be­come a place­hold­er for com­pa­nies who go on to raise much more.

The news comes just a few months af­ter CEO La­lo Flo­res steered the com­pa­ny to a $160 mil­lion raise. Cen­tu­ry launched with a $250 mil­lion megaround back in 2019 to cre­ate a port­fo­lio of CAR-T and CAR-NKs us­ing in­duced pluripo­tent stem cells. It plans on fil­ing an IND for its lead can­di­date, CN­TY-101, in B-cell lym­phoma next year.

Flo­res will use $50 mil­lion of the IPO funds to prep CN­TY-101 for the clin­ic and ini­ti­ate a Phase I tri­al, ac­cord­ing to the com­pa­ny’s S-1/A. An­oth­er $110 mil­lion is set aside for its oth­er can­di­dates: CN­TY-103, for which Cen­tu­ry plans on fil­ing an IND in glioblas­toma in the first half of 2023; CN­TY-102, which will be IND-ready by the sec­ond half of 2023;  and CN­TY-104, which is be­ing de­vel­oped to treat AML and won’t be ready for an IND un­til mid-2024.

When Cen­tu­ry goes pub­lic, it plans to trade un­der the tick­er $IP­SC.

Alza­mend Neu­ro at­tracts in­vestors with its own be­ta-amy­loid Alzheimer’s ap­proach

The week af­ter Bio­gen’s con­tro­ver­sial ap­proval for its Alzheimer’s drug Aduhelm, Alza­mend Neu­ro priced a $12.5 mil­lion IPO to take its own slate of neu­rode­gen­er­a­tive drugs in­to the clin­ic.

The Tam­pa-based biotech is putting up 2.5 mil­lion shares at $5 apiece — rais­ing a bit more than the $11.5 mil­lion it pen­ciled in on its S-1 back in May.

The lead can­di­date, AL001, is an ion­ic cocrys­tal of lithi­um cre­at­ed at the Uni­ver­si­ty of South Flori­da. While con­ven­tion­al lithi­um salts have long been used as a pro­phy­lac­tic for de­pres­sion — and are cur­rent­ly used as a mood sta­bi­liz­er for pa­tients with bipo­lar dis­or­der — they re­quire mul­ti­ple dos­es through­out the day to reach ther­a­peu­tic con­cen­tra­tions in the blood. Cur­rent lithi­um drugs like lithi­um chlo­ride and lithi­um car­bon­ate suf­fer tox­i­c­i­ties and poor phys­io­chem­i­cal prop­er­ties. But Alza­mend thinks it doesn’t have to be that way.

Sci­en­tists at USF set out to make a new lithi­um cocrys­tal com­po­si­tion that would al­low for low­er dos­ing, with im­proved phys­io­chem­i­cal prop­er­ties. Alza­mend plans on sub­mit­ting an IND for AL001 by the end of the month, and tagged $5.3 mil­lion in IPO funds for topline read­outs on Phase I tri­als in mild to mod­er­ate Alzheimer’s.

The com­pa­ny’s sec­ond pre­clin­i­cal can­di­date, AL002, is a cell ther­a­py that aims to re­store the abil­i­ty of a pa­tient’s im­mune sys­tem to fight off Alzheimer’s and is set to re­ceive $3.6 mil­lion in IPO mon­ey.

Like Aduhelm, Alza­mend says its AL002 is de­signed to clear be­ta-amy­loids, sticky plaques that ac­cu­mu­late in pa­tients’ brains. One the­o­ry is that as peo­ple age, their im­mune sys­tems be­come un­able to pro­duce nat­ur­al be­ta-amy­loid an­ti­bod­ies, which lead to the plaque build-up caus­ing Alzheimer’s symp­toms. How­ev­er, nu­mer­ous failed tri­als from oth­er com­pa­nies’ amy­loid-clear­ing drugs have led some sci­en­tists to be­lieve that amy­loid is mere­ly a symp­tom of the dis­ease, rather than the root cause.

Alza­mend says both can­di­dates have shown a pos­i­tive ef­fect on be­ta-amy­loids in pre­clin­i­cal tri­als. An­oth­er $305,000 in IPO pro­ceeds is set aside to pay li­cense fees and mile­stones to USF, ac­cord­ing to an S-1/A.

Alza­mend will list un­der $ALZN.

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.

Tien Lee, Aardvark Therapeutics CEO

Emerg­ing from stealth mode, Aard­vark rounds up enough cash to put its lead drug through Prad­er-Willi PhII

When Aardvark Therapeutics CEO Tien Lee started his work on the biotech’s lead candidate, appetite suppression was the goal for the small molecule.  Soon after, his team started to see added benefits with lower blood glucose levels and anti-inflammatory activity. On the tail end of that, the company has emerged from stealth mode and announced today that they’ve raised enough cash in the B round to cover mid-stage development work.

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.

Covid-19 roundup: Pfiz­er im­pos­es vac­cine man­date for US work­ers; WHO calls for mora­to­ri­um on boost­ers, while some coun­tries make plans any­way — re­port

As the US struggles to keep pace with the fast-spreading Delta variant, big companies like Walmart and Disney are imposing vaccine mandates for some workers. It may come as no surprise that Pfizer — the Big Pharma behind the US’ first authorized Covid-19 vaccine — is joining them.

Pfizer will start requiring all US employees and contractors to get vaccinated, or participate in weekly Covid-19 testing, spokesperson Pamela Eisele told Reuters. Workers outside the US are strongly urged to get a vaccine if they can, according to the report. And those with medical conditions or religious objections can seek accommodations.

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.

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.