IPO mar­ket con­tin­ues to churn with a pair of Covid-19 biotechs seek­ing Nas­daq, while mi­to­chon­dria-fo­cused Re­neo de­buts

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Biotech con­tin­ues to see a huge flow of com­pa­nies look­ing to make their pub­lic de­buts as the sec­ond quar­ter gets un­der­way.

Two Eu­ro­pean biotechs work­ing on Covid-19 vac­cines, Vac­citech and Val­ne­va, both filed their SEC pa­per­work over the week­end, while mi­to­chon­dr­i­al dis­ease com­pa­ny Re­neo Phar­ma­ceu­ti­cals priced its own IPO last Fri­day. Per End­points News’ tal­ly, the IPO count this year has now sur­passed 40 biotechs that have priced or filed, rough­ly on pace to match 2020’s record of 92.

Both Vac­citech and Val­ne­va put down the now-stan­dard $100 mil­lion place­hold­er for their raise, while Re­neo priced at $15 per share with $94 mil­lion in funds.

Vac­citech of­fi­cial­ly files and warns of blood clot risk

Vac­citech had re­port­ed­ly con­fi­den­tial­ly filed for their IPO ear­li­er last week, ac­cord­ing to the Fi­nan­cial Times, but their S-1 of­fi­cial­ly dropped on Fri­day.

The British biotech is most fa­mous for cre­at­ing the tech­nol­o­gy be­hind the As­traZeneca/Ox­ford Uni­ver­si­ty Covid-19 vac­cine, with its co-founder Sarah Gilbert hav­ing head­ed up that re­search. Vac­citech’s push to go pub­lic comes just a cou­ple of weeks af­ter rais­ing an im­pres­sive $168 mil­lion for a Se­ries B round, led by Lon­don in­vest­ment firm M&G and joined by Gilead and Ten­cent, among oth­ers.

As a re­sult of that March raise, Vac­citech’s val­u­a­tion sky­rock­et­ed to as much as $450 mil­lion af­ter be­ing val­ued at as lit­tle as $86 mil­lion two years ago.

Con­cerns have arisen over the As­traZeneca shot due to a rare side ef­fect of blood clots in younger re­cip­i­ents, how­ev­er, which may lim­it some of the op­ti­mism sur­round­ing Vac­citech. Last week, the EMA and MHRA both re­quest­ed that clots be list­ed as a very rare po­ten­tial risk to the vac­cine, though they not­ed the ben­e­fits of get­ting the shot con­tin­ue to out­weigh those risks.

Vac­citech not­ed these con­cerns in its S-1 “risk fac­tor” sec­tion, writ­ing that in ad­di­tion to the pos­i­tive risk-ben­e­fit pro­file of the vac­cine, “there can be no as­sur­ance that the vac­cine is not as­so­ci­at­ed with an in­crease in the over­all risk of throm­boem­bol­ic events.” As­traZeneca al­so paused its vac­cine tri­al in chil­dren last week as the clot­ting wor­ries have con­tin­ued.

The biotech plans to list un­der the tick­er $VACC.

De­spite UK sup­ply deal, Val­ne­va wary of ex­port ten­sions

Val­ne­va, mean­while, is a small­er play­er in the Covid-19 field, though they’re backed by one promi­nent en­ti­ty — the UK gov­ern­ment.

Head­quar­tered across the Eng­lish chan­nel in Saint-Herblain, France, Val­ne­va has com­mit­ments to de­liv­er 100 mil­lion vac­cines to Britain by 2022. The UK has ad­di­tion­al op­tions for an­oth­er 90 mil­lion in sup­ply be­tween 2023 and 2025, though they haven’t opt­ed-in just yet.

Should all the op­tions be ex­er­cised, the val­ue of the deal would equal €1.4 bil­lion, or about $1.69 bil­lion.

But Val­ne­va, like Vac­citech, high­light­ed a po­ten­tial risk that’s been in the news re­cent­ly, not­ing in its S-1 that ex­port re­stric­tions may af­fect its abil­i­ty to de­liv­er those shots promised to the UK. Thanks to Brex­it, the com­pa­ny said any lim­its on im­ports or ex­ports may pose a “sub­stan­tial” risk as the shots are man­u­fac­tured in the UK but pack­aged in the EU.

Fri­day’s fil­ing comes just a few days af­ter the biotech re­port­ed new pos­i­tive vac­cine da­ta from a Phase I/II tri­al, and a Phase III could be­gin as soon as the end of April. Val­ne­va test­ed three dos­ing lev­els, and like many oth­er Covid-19 shots be­ing test­ed or au­tho­rized, it was ad­min­is­tered in two jabs three weeks apart.

Val­ne­va is al­so work­ing on a Ly­me dis­ease vac­cine with Pfiz­er, and launched a Phase II study for that can­di­date in March. It plans on list­ing on the tick­er $VALN in Nas­daq, and al­ready trades on the French stock mar­ket as well.

Re­neo takes its mi­to­chon­dr­i­al dis­ease pro­gram to Nas­daq

Re­neo’s Nas­daq de­but last week came af­ter it raised a $95 mil­lion Se­ries B in De­cem­ber.

Gre­go­ry Flesh­er

Backed by No­vo Ven­tures and Abing­worth, Re­neo had enough cash be­fore­hand to take them through the com­ple­tion of three ear­ly- to mid-stage tri­als for their lead pro­gram, REN001, CEO Gre­go­ry Flesh­er told End­points at the time. With­in its S-1, Re­neo has now de­tailed its plans to use the IPO funds to com­plete those stud­ies in pri­ma­ry mi­to­chon­dr­i­al my­opathies, fat­ty acid ox­i­da­tion dis­or­ders and McAr­dle dis­ease.

REN001 is a PPAR-delta ag­o­nist, and the three con­di­tions Re­neo is look­ing at are re­lat­ed to dif­fer­ent parts of mi­to­chon­dr­i­al func­tion. A once-dai­ly pill, REN001 has the abil­i­ty to help cells ex­press cer­tain genes with­in the mi­to­chon­dria that in­crease a pa­tient’s me­tab­o­lism.

Though it’s not a gene ther­a­py, the ul­ti­mate goal is to help pa­tients re­plen­ish mi­to­chon­dria cells once old ones die off while si­mul­ta­ne­ous­ly boost­ing en­zyme pro­duc­tion.

Re­neo priced at the low end of its range, us­ing the tick­er $RPHM.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

Pfizer CEO Albert Bourla has inked a deal with Harper Business for a book to tell the “behind-the-scenes” story of the company’s race to develop a vaccine, the Associated Press reports.

The book is titled “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” and is set to be released Nov. 9. Bourla plans to donate the proceeds to charity, the AP reported.

Dan Vahdat, Huma CEO (Yang Guanyu/Xinhua/Alamy Live News)

With back­ing from Bay­er, a Lon­don firm will pitch its 'hos­pi­tals at home' con­cept for de­cen­tral­ized tri­als

Money is flying for companies promising to revolutionize the way clinical trials are conducted. Leaps by Bayer is the latest to get behind one of these players, leading a $200 million venture round for Huma Therapeutics and its digital “hospital at home” tech.

London-based Huma unveiled a $130 million Series C on Wednesday, which it will use to expand its digital platform in the US, Asia and the Middle East. As part of the round, the company can exercise another $70 million commitment later on.

David Halbert, Caris Life Sciences CEO (Caris via Twitter)

The grow­ing liq­uid biop­sy field sees a uni­corn en­trant as Caris pulls in $830M megaround

Caris Life Sciences has pulled in another massive raise, and this time they’re reportedly one step closer to launching their IPO.

The AI-focused Caris pulled in an $830 million growth equity round, the company announced Tuesday afternoon, earning a valuation of about $7.83 billion. Tuesday’s raise also brings their total financing amount to $1.3 billion since 2018 and $1.14 billion since last October. According to the Wall Street Journal, which first reported on the raise, Caris expects to complete their IPO sometime within the next 12 months.