Re­cur­sion lays out $300M+ goal in IPO terms; Evotec and Bris­tol My­ers team up to spin out Ger­man re­search

Re­cur­sion is near­ly ready to make its pub­lic de­but, and the biotech set out what the po­ten­tial raise might look like Mon­day.

Re­cur­sion set its IPO terms, plan­ning to raise $306 mil­lion by of­fer­ing shares in the $16 to $18 range. With 18 mil­lion shares like­ly to be of­fered, that would com­mand a mar­ket val­ue of about $3 bil­lion, ac­cord­ing to Re­nais­sance Cap­i­tal.

That’s a much high­er fig­ure than the $100 mil­lion ini­tial­ly pen­ciled in their S-1, though that num­ber has es­sen­tial­ly been a place­hold­er for many biotechs that have gone pub­lic through­out the last 12 months’ boom.

The IPO comes af­ter Re­cur­sion’s Se­ries D in Sep­tem­ber 2020, which at $239 mil­lion marked one of the largest, if not the sin­gle largest, fund­ing rounds for an ar­ti­fi­cial in­tel­li­gence-fo­cused biotech. Re­cur­sion al­so signed on­to a deal with Bay­er, promis­ing up to $100 mil­lion in mile­stones for each of up to 10 pro­grams the com­pa­nies could pur­sue.

Re­cur­sion plans to list un­der the tick­er $RXRX. — Max Gel­man

Col­lab­o­ra­tion be­tween Evotec and Bris­tol My­ers to cre­ate Ger­man spin-off com­pa­nies

Evotec and Bris­tol My­ers Squibb have col­lab­o­rat­ed to launch a $20 mil­lion project to bring to­geth­er the aca­d­e­m­ic re­search from the Rhine-Main-Neckar re­gion of Ger­many and ad­vance ther­a­peu­tic op­tions in­to drug dis­cov­ery and de­vel­op­ment projects.

Named be­LAB2122, the col­lab­o­ra­tion is part of Evotec’s BRIDGE (Bio­med­ical Re­search, In­no­va­tion and De­vel­op­ment Gen­er­a­tion Ef­fi­cien­cy) pro­grams. It is the fifth BRIDGE project launched by Evotec, in­clud­ing in Ox­ford and Toron­to.

Ap­prox­i­mate­ly 30-40% of all FDA ap­proved drugs come from Eu­ro­pean sci­en­tists, ac­cord­ing to Thomas Han­ke, the head of aca­d­e­m­ic part­ner­ships at Evotec.

“Aca­d­e­m­ic projects need to be put on an in­dus­try-ro­bust plat­form, and that’s what we do with our BRIDGEs,” Han­ke said in a video on the com­pa­ny’s YouTube page.

The BRIDGE will tap in­to Eu­rope’s aca­d­e­m­ic clus­ters of life sci­ence with the goal of cre­at­ing spin­out com­pa­nies. The col­lab­o­ra­tion comes at a time when the ef­fi­cient trans­la­tion of sci­ence to a busi­ness is be­com­ing in­creas­ing­ly im­por­tant.

The project is sup­port­ed by BioRN, Rhein Neckar, the Eu­ro­pean Mol­e­c­u­lar Bi­ol­o­gy Lab­o­ra­to­ry and the Ger­man Can­cer Re­search Cen­ter, among oth­ers. The BRIDGE pro­gram has been in ex­is­tence since 2016, and will cel­e­brate its 5th an­niver­sary in No­vem­ber. — Josh Sul­li­van

vTv earns break­through ther­a­py des­ig­na­tion for Type 1 di­a­betes treat­ment

North Car­oli­na biotech vTv Ther­a­peu­tics has won a break­through ther­a­py des­ig­na­tion for its new lead pro­gram.

The FDA hand­ed down the BTD for TTP399 as an ad­junct to in­sulin for the treat­ment of type 1 di­a­betes, vTv an­nounced Tues­day. A once-dai­ly oral glu­cok­i­nase ac­ti­va­tor, TTP399 re­cent­ly com­plet­ed a ran­dom­ized Phase II study that showed sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in HbA1c rel­a­tive to place­bo, the com­pa­ny said.

In­vestors wel­comed the news, with vTv shares $VTVT up more than 30% in ear­ly Tues­day trad­ing.

vTv’s Phase II study was con­duct­ed in two parts. The first part ran­dom­ly as­signed 20 par­tic­i­pants un­der­go­ing con­tin­u­ous glu­cose mon­i­tor­ing and sub­cu­ta­neous in­sulin in­fu­sion, while the sec­ond part ran­dom­ly as­signed 85 pa­tients re­ceiv­ing mul­ti­ple dai­ly in­jec­tions of in­sulin or in­fu­sions. Pa­tients re­ceived ei­ther 800 mg of TTP399 or place­bo and were treat­ed for 12 weeks.

Af­ter that pe­ri­od, the dif­fer­ence in change from HbA1c base­line com­pared to place­bo was -0.7% in part 1 and -0.21% in part 2. Though vTv did not re­port a p-val­ue, they said these fig­ures met sta­tis­ti­cal sig­nif­i­cance. Re­searchers al­so saw se­vere or symp­to­matic hy­po­glycemia events de­crease by 40% rel­a­tive to place­bo in part 2.

It’s a key en­dorse­ment for vTv fol­low­ing their set­back in Alzheimer’s a few years ago with a sep­a­rate pro­gram. Their for­mer lead drug azeli­ragon failed two parts of a piv­otal study back in 2018, but they not­ed that a small sub­group of pa­tients who al­so had di­a­betes saw some ben­e­fit. — Max Gel­man

StoneWise reels in $100M for AI plat­form

StoneWise, a Bei­jing-based biotech look­ing to bridge AI and drug dis­cov­ery, now has $100 mil­lion more to work with.

The com­pa­ny com­plet­ed Se­ries B and B+ rounds on Mon­day, ac­cord­ing to Deal­Stree­tA­sia. Leg­end Cap­i­tal led the B round, while Light­speed Chi­na and Greater Bay Home­land In­vest­ments Lim­it­ed co-led the B+, the news agency re­port­ed. The com­pa­ny said it has com­plet­ed four rounds of fi­nanc­ing in the last year, in­clud­ing a $10 mil­lion Se­ries A, fol­lowed by a Se­ries A+.

In Feb­ru­ary 2020, StoneWise shared the elec­tron­ic struc­ture da­ta from more than 1,400 nu­cle­o­side in­hibitors against var­i­ous RNA poly­meras­es, and used its AI plat­form to rank dozens of nu­cle­o­sides from these mol­e­cules as po­ten­tial in­hibitors against SARS-CoV-2 RNA poly­merase. — Nicole De­Feud­is 

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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