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

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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