Dipal Doshi, Entrada CEO

IPO flood­gates open up af­ter sum­mer lull as five more biotechs file for Nas­daq

It’s once again open sea­son for biotech IPOs, as the sum­mer drought has giv­en way to an au­tumn flood.

Five com­pa­nies filed to go pub­lic on Fri­day, in­clud­ing four pen­cil­ing in $100 mil­lion fundrais­es: Evotec, En­tra­da Ther­a­peu­tics, Au­ra Bio­sciences and Vaxxin­i­ty. The fifth biotech, Blue Wa­ter Vac­cines, is es­ti­mat­ing a more mod­est $24 mil­lion.

The com­bined in­dus­try raise sur­passed $14 bil­lion last week af­ter two more biotechs priced, per the End­points News tal­ly, and the sec­tor re­mains on pace to eclipse last year’s record of $16.5 bil­lion. It could come down to the wire, how­ev­er, af­ter a third quar­ter lull that saw the low­est lev­els of IPO num­bers since the start of 2020.

Af­ter swing­ing deals, Evotec swings pub­lic

Ger­man biotech Evotec has racked up a ver­i­ta­ble sta­ble of bio­phar­ma part­ners, and now it’s tak­ing its tal­ents to Nas­daq.

Evotec has made its name with its range of plat­form plays aimed at help­ing its col­lab­o­ra­tors de­vel­op drugs. The biotech has, over the last 25 years, built a suite of five dif­fer­ent tech­nolo­gies that it uti­lizes in part­ner­ships cov­er­ing small mol­e­cules, omics, bi­o­log­ics, cell ther­a­py and gene ther­a­py.

Some of Evotec’s more promi­nent re­cent deals come from Take­da, shoot­ing for the first small mol­e­cule lig­and for RNA in a March part­ner­ship, and No­vo Nordisk, which plans to shell out near­ly $180 mil­lion per kid­ney dis­ease pro­gram. Ad­di­tion­al­ly, Evotec has spent time build­ing out its man­u­fac­tur­ing ca­pa­bil­i­ties, ac­quir­ing a for­mer Glax­o­SmithK­line R&D site in Italy over the sum­mer af­ter buy­ing a French plant in April.

No­vo Hold­ings and T. Rowe Price are the big win­ners from the IPO, hold­ing 11% and 10% stakes in Evotec, re­spec­tive­ly, ac­cord­ing to the F-1. Mubadala In­vest­ment Com­pa­ny, the UAE’s sov­er­eign wealth fund that pur­chased $236 mil­lion worth of shares last Oc­to­ber, al­so nets a 5.6% stake pre-of­fer­ing.

The biotech al­so says its pipeline con­tains more than 130 drug can­di­dates. Most of the IPO funds will be di­rect­ed to­ward con­tin­ued man­u­fac­tur­ing ex­pan­sion.

When Evotec starts trad­ing, it will do so un­der the tick­er $EVO. — Max Gel­man

En­tra­da looks to ride en­do­so­mal es­cape ve­hi­cles to Nas­daq 

Half a year af­ter lock­ing down a hefty $116 mil­lion crossover round, En­tra­da Ther­a­peu­tics says it’s ready for its pub­lic de­but.

The Boston-based biotech filed its S-1 pa­pers on Fri­day, pen­cil­ing in a $100 mil­lion raise, which has be­come the stan­dard for com­pa­nies that of­ten go on to raise much more.

The plat­form, based on De­hua Pei’s lab re­search at Ohio State Uni­ver­si­ty, in­volves a new tech­nol­o­gy En­tra­da calls en­do­so­mal es­cape ve­hi­cles. EEVs are es­sen­tial­ly cyclic pep­tides that trig­ger a process en­abling cell mem­branes to take in bi­o­log­ic con­ju­gates, CEO Di­pal Doshi told End­points News back in March.

Pri­or­i­ty num­ber one is neu­ro­mus­cu­lar dis­eases like Duchenne mus­cu­lar dy­s­tro­phy. In such dis­eases, pa­tients have mu­ta­tions that pre­vent the trans­la­tion of RNA in­to pro­teins — in Duchenne’s case, dy­s­trophin.

Oligonu­cleotides con­nect­ed to the EEVs force the cells to skip these mu­ta­tions in their ge­net­ic code, Doshi said, al­low­ing for the cre­ation of dy­s­trophin. Through this method, the dy­s­trophin can then get in­to the ap­pro­pri­ate mus­cles.

En­tra­da’s lead can­di­date, EN­TR-601-44, is ex­pect­ed to en­ter the clin­ic in DMD next year — and some of the IPO funds will be used to help get it there.

Be­fore piv­ot­ing to oligonu­cleotides, En­tra­da’s main fo­cus was en­zyme re­place­ment ther­a­pies, with a pri­ma­ry tar­get of the mi­to­chon­dr­i­al dis­ease known as MNGIE. While the start­up has com­plet­ed IND-en­abling stud­ies, it’s now look­ing for an­oth­er com­pa­ny to take the pro­gram in­to the clin­ic.

“We con­tin­ue to be­lieve that the pro­gram will have an im­por­tant role in the fu­ture treat­ment of pa­tients with MNGIE,” the com­pa­ny said in the S-1, not­ing that it’s still ex­plor­ing po­ten­tial part­ner­ships.

MPM Cap­i­tal and 5AM Ven­tures, which have been around since the launch round, hold a con­sid­er­able pro­por­tion of shares, with 20.74% and 19.94% pieces of the pie, re­spec­tive­ly. Doshi, on the oth­er hand, has a 5.14% stake, ac­cord­ing to the S-1.

The com­pa­ny plans to trade un­der the tick­er $TR­DA. — Nicole De­Feud­is 

Laser-fo­cused on sol­id tu­mor plat­form, Au­ra sets its sights on Wall Street

Elis­a­bet de los Pinos

Au­ra Bio­sciences CEO Elis­a­bet de los Pinos hint­ed at a forth­com­ing IPO af­ter se­cur­ing a Se­ries E round back in March.

That day has ap­par­ent­ly come, as the com­pa­ny sub­mit­ted its S-1 pa­pers last Fri­day, pen­cil­ing in a $100 mil­lion raise.

Au­ra’s plat­form cen­ters around virus-like par­ti­cles, which can be con­ju­gat­ed with drugs or loaded with nu­cle­ic acids to cre­ate virus-like drug con­ju­gates, or VD­Cs. The vi­ral nanopar­ti­cles  — mod­eled af­ter the hu­man pa­pil­lo­mavirus — are light-ac­ti­vat­ed, mean­ing they se­lec­tive­ly de­stroy the mem­brane of can­cer cells up­on ac­ti­va­tion with an oph­thalmic laser.

AU-011, Au­ra’s first VDC can­di­date, is be­ing de­vel­oped for pri­ma­ry choroidal melanoma, an eye can­cer for which no oth­er drugs ex­ist. The cur­rent ap­proach to treat­ment is ra­dioac­tiv­i­ty, which can cause ir­re­versible dam­age to the reti­na and lead to blind­ness.

“The cy­to­tox­ic pay­load for the drug in the clin­ic is ac­ti­vat­ed with light, so it’s very safe,” de los Pinos told End­points News in March. “And be­cause of the cell ac­tiv­i­ty of the virus-like par­ti­cles, not bind­ing to reti­na, it pre­serves vi­sion.”

Au­ra plans to present six- to 12-month da­ta from a Phase II dose es­ca­la­tion tri­al in 2022, and if all goes well, launch a piv­otal tri­al in the sec­ond half of 2022, ac­cord­ing to the S-1. There’s al­so an IND com­ing in the sec­ond half of 2022 for choroidal metas­tases, the com­pa­ny said.

Ma­trix Cap­i­tal Man­age­ment and Medicxi, which led Au­ra’s Se­ries E and D rounds, re­spec­tive­ly, each hold 10.1% of the com­pa­ny’s shares. De los Pinos has a 3% stake.

Au­ra will trade un­der the tick­er $AU­RA.  — Nicole De­Feud­is 

All my vaxxes live in Texas

Dal­las vac­cine biotech Vaxxin­i­ty, re­brand­ed from the con­sol­i­da­tion of CO­V­AXX and Unit­ed Neu­ro­science in April, is shoot­ing for a quick IPO.

The biotech cen­ters its ef­forts around de­vel­op­ing pep­tide-based vac­cines for chron­ic dis­eases, ar­gu­ing the cur­rent vac­cine mar­ket strug­gles to ward off per­sis­tent con­di­tions. Vaxxin­i­ty al­so be­lieves this ap­proach can cap­ture some of the mar­ket share from mon­o­clon­al an­ti­bod­ies, say­ing its can­di­dates can be man­u­fac­tured more cheap­ly.

As its for­mer name im­plies, the com­pa­ny has a Covid-19 vac­cine can­di­date in de­vel­op­ment and has se­cured $2.8 bil­lion worth of ad­vance pur­chase com­mit­ments with Brazil, Ecuador, Pe­ru and oth­er coun­tries to de­liv­er more than 140 mil­lion dos­es of its vac­cine. There are al­so pipeline pro­grams for Alzheimer’s and Parkin­son’s dis­eases, as well as mi­graines.

Most of the IPO funds will go to­ward clin­i­cal tri­als for the neu­rode­gen­er­a­tive in­di­ca­tions, ac­cord­ing to the S-1. Vaxxin­i­ty did not spell out the stakes of its prin­ci­pal share­hold­ers but said there had been in­vest­ment from Unit­ed Bio­med­ical and Prime Movers Lab.

When Vaxxin­i­ty goes pub­lic, it will trade un­der the tick­er $VAXX. — Max Gel­man

Blue Wa­ter tak­ing uni­ver­sal flu shot pub­lic

Blue Wa­ter Vac­cines is pen­cil­ing in $24 mil­lion to take its flu shot pro­grams pub­lic.

Every­thing is pre­clin­i­cal so far, but the biotech is work­ing on a uni­ver­sal flu vac­cine as well as what it calls an “H1 pre-pan­dem­ic shot” that it hopes will pro­vide long-last­ing pro­tec­tion. Both pro­grams are li­censed from the Uni­ver­si­ty of Ox­ford.

Pre­clin­i­cal proof of con­cept stud­ies are slat­ed to be­gin for the uni­ver­sal shot in the first half of next year, while the pre-pan­dem­ic shot will launch IND-en­abling stud­ies in the same time pe­ri­od. Blue Wa­ter al­so has two norovirus vac­cine can­di­dates un­der its belt, in ad­di­tion to a vac­cine pro­gram for the bac­te­ria Strep­to­coc­cus pneu­mo­ni­ae.

When the of­fer­ing is com­plet­ed, the com­pa­ny will hire a new CEO in Joseph Her­nan­dez, who pre-of­fer­ing owns about 37% of shares. Cincin­nati Cor­ner­stone In­vestors owns the high­est stake, how­ev­er, at about 41%.

Once Blue Wa­ter goes pub­lic, it will trade un­der the tick­er $BWV. — Max Gel­man

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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René Russo, Xilio CEO (Alicia Petitti for Xilio)

Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

It’s been a busy fall on Wall Street — and this week, we’ve got another biotech going public after Ventyx yesterday.

Massachusetts solid-tumor biotech Xilio Therapeutics made its public debut today, joining 149 other biotechs that have gone public so far this year.

Back on October 1st, Xilio filed its S-1 with the SEC to make its IPO debut for $100 million — the next step in financing after completing a $95 million Series C back in February.

Luc Boblet, Egle Therapeutics CEO

A new Treg play­er emerges with $46M and back­ing from Take­da

In recent years, the chorus of biotechs and Big Pharma backers targeting regulatory T cells — also known as “Tregs” — for cancer and autoimmune diseases has only grown louder.

The newest voice is from Egle Therapeutics, which sang out a $46.4 million Series A round on Friday led by LSP and Bpifrance through their InnoBio 2 fund. Takeda’s venture arm also chipped in, about a year after the pharma struck a research pact with the Paris-based upstart.

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