With two de­buts and a SPAC, bio­phar­ma notch­es an­oth­er busy week as IPO raise soars past $7B

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Af­ter a slight lull in the IPO mar­ket ear­li­er this month, the in­dus­try re­turned in full force this week by cel­e­brat­ing two new Nas­daq en­trants in ad­di­tion to a SPAC merg­er.

Centes­sa comes in as the biggest win­ner, pulling in a $330 mil­lion haul and pric­ing above its ex­pect­ed range at $20 per share Fri­day. The 10-in-1 hold­ing com­pa­ny marks the fourth-largest IPO raise among biotechs in 2021, com­ing ahead of all debu­tants ex­cept for Sana, Zymer­gen and Re­cur­sion.

Day One al­so launched its IPO on Thurs­day, net­ting $160 mil­lion af­ter pric­ing at $16 per share. The pe­di­atric can­cer biotech end­ed its first trad­ing ses­sion well in the black, clos­ing up more than 60% from its de­but price. Al­so Thurs­day, San Diego-based eF­FEC­TOR Ther­a­peu­tics an­nounced it was go­ing pub­lic in a $235 mil­lion SPAC deal, which in­clud­ed a $60 mil­lion PIPE fi­nanc­ing.

The two IPOs this week sent the to­tal 2021 IPO raise hurtling past $7 bil­lion, with the in­dus­try rais­ing $7.21 bil­lion among the 45 com­pa­nies that have de­buted, per the End­points News tal­ly. Biotech re­mains on pace to eclipse last year’s record to­tals of 91 pub­lic de­buts and a $16.5 bil­lion com­bined raise.

A cou­ple small biotechs and an­oth­er SPAC fil­ing added to the ma­nia, with mi­cro­cap an­tibi­ot­ic biotech Acurx Phar­ma­ceu­ti­cals and fe­male can­cer biotech Con­text Ther­a­peu­tics each pen­cil­ing in $15 mil­lion rais­es in S-1 fil­ings Thurs­day.

Francesco De Ru­ber­tis’ 10-in-1 play heads to Nas­daq

Centes­sa’s im­pres­sive haul comes just a few months af­ter the com­pa­ny raised $250 mil­lion in their Se­ries A.

Francesco De Ru­ber­tis

The goal for Francesco De Ru­ber­tis’ lega­cy play is to cre­ate a new kind of phar­ma com­pa­ny, one that’s rolled up 11 Medicxi sub­sidiaries in­to one out­fit (in­clud­ing two that even­tu­al­ly merged). Among the play­ers are Jim Hunt­ing­ton’s Uni­ver­si­ty of Cam­bridge spin­out Z Fac­tor as well as In­ex­ia, a three-year-old biotech whose as­sets were trans­ferred ear­li­er this year to Orex­ia.

Centes­sa has spent the last few weeks beef­ing up its C-suite in an­tic­i­pa­tion of Fri­day’s de­but, ap­point­ing the for­mer head of on­col­o­gy R&D at Dai­ichi Sankyo, An­toine Yver, as CMO. Yver will head up a port­fo­lio um­brel­la that cur­rent­ly in­cludes 16 pro­grams, four of which have al­ready reached the clin­i­cal stage — the ma­jor­i­ty of the IPO funds are ex­pect­ed to be fun­neled to­ward this quar­tet.

De­spite the pos­i­tive mo­men­tum, Centes­sa will be mov­ing for­ward with­out for­mer Op­er­a­tion Warp Speed chief Mon­cef Slaoui, who was oust­ed from sev­er­al com­pa­ny board seats af­ter a “sub­stan­ti­at­ed” case of sex­u­al ha­rass­ment for which he apol­o­gized. There was no men­tion of Slaoui in the S-1.

When Centes­sa be­gins trad­ing on Fri­day, it will do so un­der the tick­er $CN­TA.

Day One push­ing to­ward a new dawn for pe­di­atric can­cer

Day One has al­so seen lots of pos­i­tive mo­men­tum so far in 2021, and is look­ing to cap­i­tal­ize with its IPO this week.

Je­re­my Ben­der

Back in Feb­ru­ary, the biotech raised $130 mil­lion in a Se­ries B led by RA Cap­i­tal, as Day One con­tin­ued to ad­vance its lead pro­gram for child­hood gliomas. CEO Je­re­my Ben­der told End­points at the time that the can­di­date had made rapid progress in the nine months since the biotech emerged from stealth, al­low­ing for the quick raise.

Ef­forts at Day One have cen­tered around an old Take­da pro­gram from the be­gin­ning, for­mer­ly named TAK-580. It cost Day One just $1 mil­lion in ex­change for a 12% Take­da eq­ui­ty stake. The com­pound, now called DAY101, is a pan-RAF in­hibitor that can cross the blood-brain bar­ri­er, block­ing mu­ta­tions that dri­ve can­cer in both child­hood and adult gliomas.

The ini­tial in­di­ca­tion Day One hopes for is pe­di­atric low-grade gliomas, the most com­mon form of child­hood brain can­cer. With­in its S-1, the biotech said it’s look­ing to fund not on­ly a Phase II tri­al for DAY101, but al­so launch a new Phase III study for the front­line treat­ment of pe­di­atric low grade gliomas next year. If all goes well, DAY101 could see a com­mer­cial launch in 2023.

Day One went pub­lic Thurs­day on the tick­er $DAWN.

SPAC deal push­es blank check rais­es past $14.5 bil­lion

eF­FEC­TOR Ther­a­peu­tics is the third com­pa­ny to go pub­lic this week, and they did so on the coat­tails of a re­verse merg­er.

The San Diego biotech rode the coat­tails of Lo­cust Walk Ac­qui­si­tion to Nas­daq on Thurs­day, get­ting $175 mil­lion in funds from the blank-check com­pa­ny and an­oth­er $60 mil­lion in PIPE fi­nanc­ing. It’s the 11th life sci­ences biotech or com­pa­ny to use the SPAC method this year and eighth in Q2.

SPACs them­selves flood­ed the mar­ket to­ward the end of last sum­mer and crest­ed in­to a tidal wave ear­li­er this year — about 300 SPACs priced their IPOs through­out the en­tire mar­ket be­fore the end of March. Sev­er­al celebri­ties got in­to the game, in­clud­ing star ath­letes Alex Ro­driguez and Shaquille O’Neal.

The heavy ac­tion drew the eye of reg­u­la­tors, with the SEC vol­un­tar­i­ly ask­ing large fi­nan­cial in­sti­tu­tions for doc­u­ments re­gard­ing how they were in­ter­nal­ly polic­ing SPAC fund­ing. Over the next two months, SPAC de­buts have slowed but merg­ers have be­gun pick­ing up, with eF­FEC­TOR the lat­est to take this route.

Fund­ing from the deal will help the biotech com­plete its Phase IIb tri­al for its lead can­di­date, an oral small-mol­e­cule in­hibitor of mi­to­gen-ac­ti­vat­ed pro­tein ki­nas­es 1 and 2, in com­bi­na­tion with Keytru­da. There are al­so plans to launch mul­ti­ple Phase IIa stud­ies for an­oth­er pro­gram, a small-mol­e­cule in­hibitor of eIF4A.

Once the merg­er is com­plet­ed, eF­FEC­TOR will trade un­der the tick­er $EFTR.

Acurx, Con­text and Spar­ta Health­care Ac­qui­si­tion file their S-1s

Three more fil­ings round­ed out the busy week, with two biotechs plan­ning their own IPOs and an­oth­er SPAC shoot­ing for at least a nine-fig­ure raise.

Michael Han­d­ley

Acurx Phar­ma­ceu­ti­cals and Con­text Ther­a­peu­tics each filed their S-1s this week, putting down $15 mil­lion for their ini­tial es­ti­mates. Mean­while, a SPAC from Cy­to­com CEO Michael Han­d­ley is pen­cil­ing in $100 mil­lion for its blank check raise.

The Stat­en Is­land, NY-based Acurx is work­ing on a slate of an­tibi­otics that look to block the DNA poly­merase II­IC en­zyme. They’re ex­pect­ed to be­gin a Phase IIb tri­al for their lead can­di­date, ibeza­pol­stat, this year in pa­tients with C. dif­fi­cile in­fec­tions.

Con­text is fo­cus­ing on can­cers found in women, in­clud­ing ovar­i­an, breast and en­dome­tri­al. They ex­pect to read out Phase II re­sults for its on­ly clin­i­cal can­di­date lat­er this year, for ovar­i­an can­cer pa­tients who ex­press high lev­els of prog­es­terone re­cep­tor. The com­pa­ny is al­so run­ning an­oth­er Phase II tri­al look­ing at the pro­gram in com­bi­na­tion with Arim­idex in PR+ en­dome­tri­al pa­tients, with da­ta ex­pect­ed in the first half of next year.

Acurx plans to trade un­der the tick­er $ACXP, Con­text un­der the tick­er $CN­TX and Han­d­ley’s SPAC on $SP­TAU.

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.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.