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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.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.