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.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Con­sor­tium of 5 drug reg­u­la­tors plot path to in­crease har­mo­niza­tion through 2024

A group of drug regulators from Australia, Canada, Singapore, Switzerland and the UK on Tuesday unveiled their strategic plans for the next three years, laying out how they’ll work together on reviewing new drugs to reduce duplication across borders.

While understanding that the biopharma industry is truly global, the group, known collectively as the Access Consortium, seeks to better align their respective regulatory and policy approaches for pharmaceuticals, with an aim to facilitate faster access to high quality, safe and effective health products.

Neu­rona Ther­a­peu­tics is dash­ing to the clin­ic with its cell ther­a­py for epilep­sy — but first, an­oth­er ven­ture round

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.

Viswa Colluru, Enveda Biosciences

A Re­cur­sion vet­er­an is map­ping plant life to chart a course to new ther­a­pies — and in­vestors like what they see

One of the earliest employees at AI biotech Recursion Pharmaceuticals is leading a new company, and he’s just closed a hefty Series A to get things moving.

Enveda Biosciences pulled in $51 million in the raise, the company announced Tuesday morning, with the goal of pushing some of its preclinical programs further along. Led by CEO Viswa Colluru, Enveda aims to research how machine learning can utilize natural biology to create new therapies for Wilson’s Disease, NASH and Parkinson’s disease, among others.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.