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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.