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

Ed­i­tor’s note: In­ter­est­ed in fol­low­ing bio­phar­ma’s fast-paced IPO mar­ket? You can book­mark our IPO Track­er here.

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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

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.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

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.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

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.