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.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

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Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

Covid-19 roundup: High­er an­ti­body counts seen in spaced-out vac­cine in­ter­vals — study; Roche CEO com­pares IP waiv­er to East Ger­man 'ex­per­i­ments'

Near the outset of the UK’s vaccination campaign, the British government outlined plans to space out shots in larger intervals in order to get more people their first shot. Now, a study has come out saying the approach can drive a higher antibody response — at least in older populations.

In a study with 175 people older than 80, the antibody response was 3.5 times higher in individuals who received their second Pfizer/BioNTech shot 12 weeks after their first, compared to those who followed the typical three-week period. Antibody levels were measured about two to three weeks after the follow-up jabs.