Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

Spring­Works and Sat­suma — both biotech spin­outs that have closed B rounds in April — are load­ing up with IPO cash to boost their re­spec­tive late-stage plans.

Spring­Works

Lara Sul­li­van

Bain-backed Spring­Works is the bet­ter-known com­pa­ny of the two, and it’s gun­ning for a larg­er wind­fall of $115 mil­lion to add to $228 mil­lion from pre­vi­ous fi­nanc­ings. In the process, the Stam­ford, CT-based team is al­so draw­ing the cur­tains on the part­ner­ships it has in mind for the pair of as­sets it had ini­tial­ly li­censed from Pfiz­er.

To be sure, the com­pa­ny is still flush with cash. In an SEC fil­ing, Spring­Works says it’s been go­ing through the $102 mil­lion Se­ries A for the op­er­a­tions, with $185.3 in cash and cash equiv­a­lents re­main­ing at last count. The new in­fu­sion from a pub­lic de­but should ex­tend the run­way to 2022.

Pfiz­er’s Lara Sul­li­van got the sup­port in Au­gust 2017 to split off four promis­ing as­sets that nev­er­the­less didn’t make the in­ter­nal R&D cut in­to a new shop. As soon as the deal was sealed ex­ecs got to work re­pur­pos­ing the drugs for rare tu­mors, rack­ing up or­phan drug and fast track des­ig­na­tions along the way. Nirogace­s­tat, a gam­ma sec­re­tase in­hibitor, is in a Phase III tri­al for the treat­ment of desmoid tu­mors (rare soft tis­sue tu­mors); mir­dame­tinib, a MEK in­hibitor, is be­ing test­ed in Phase IIb for neu­rofi­bro­mato­sis type 1-as­so­ci­at­ed plex­i­form neu­rofi­bro­mas.

Both of these tar­gets are well de­fined, with mul­ti­ple tri­als for re­lat­ed drugs over the past decade or more. The gam­ma sec­re­tase in­hibitor was born in the Alzheimer’s field, where Eli Lil­ly ex­pe­ri­enced a colos­sal dis­as­ter years ago. That MEK in­hibitor, Spring­Works ex­ecs say, al­so has po­ten­tial to make good as a back­bone com­bi­na­tion drug in on­col­o­gy, fol­low­ing oth­er ap­proved ther­a­pies. In fact, Pfiz­er had re­cent­ly bagged one such drug — Mek­tovi — in its $11.4 bil­lion buy­out of Ar­ray Bio­phar­ma.

With po­ten­tial­ly reg­is­tra­tional tri­als on the way, Pfiz­er stands to re­ceive $462 mil­lion in mile­stones — or more if Spring­Works in-li­cens­es some of the com­pounds that the phar­ma gi­ant has agreed to make avail­able once a year un­til next Oc­to­ber.

Mean­while, Saqib Is­lam, who was pro­mot­ed to CEO af­ter serv­ing as the first CFO and CBO, has al­so cham­pi­oned a cou­ple of col­lab­o­ra­tions with BeiGene and Glax­o­SmithK­line.

The for­mer fea­tures a Phase Ib com­bo tri­al of mir­dame­tinib and li­fi­rafenib for a one-two punch of MEK and RAF in sol­id tu­mors. The lat­ter pairs nirogace­s­tat with be­lan­tam­ab mafodotin, an an­ti-BC­MA ADC that GSK R&D chief Hal Bar­ron has tout­ed for tough cas­es of mul­ti­ple myelo­ma.

Then there’s BGB-3245, a pre­clin­i­cal BRAF in­hibitor from BeiGene that cov­ers both V600 and non-V600 BRAF mu­ta­tions. Owned by a joint ven­ture with the Chi­na-based part­ner dubbed Map­Kure, the drug can even­tu­al­ly form the back­bone of a reg­i­men (again, to­geth­er with mir­dame­tinib) that com­petes di­rect­ly with Pfiz­er.

For all his ef­forts Is­lam was re­ward­ed with a com­pen­sa­tion pack­age worth more than $1.7 mil­lion, the ma­jor­i­ty of which was in stock. Sul­li­van, the for­mer pres­i­dent, re­ceived close to $1.3 mil­lion in 2018.

Sat­suma

John Kollins and his team at Sat­suma Phar­ma­ceu­ti­cals have been much more laser-fo­cused, but still busy. The San Fran­cis­co biotech closed a $62 mil­lion Se­ries B in April, bring­ing in a slate of new in­vestors, and jumped right in­to a Phase III ef­fi­ca­cy tri­al for its mi­graine drug/de­vice last month. Now it’s look­ing to pile up its cash re­serves as it pen­cils in a $86 mil­lion IPO.

The com­pa­ny was spun out of Japan’s Shin Nip­pon Bio­med­ical Lab­o­ra­to­ries two years ago with a sin­gu­lar mis­sion: To de­vel­op a dry-pow­der nasal for­mu­la­tion of the gener­ic drug di­hy­droer­go­t­a­mine, de­liv­ered by a tech from the par­ent com­pa­ny.

DHE works by tight­en­ing blood ves­sels in the brain and in­hibit­ing the re­lease of pro-in­flam­ma­to­ry sub­stances. Un­like the much-watched CGRP class, it is de­signed for acute treat­ment in­stead of pre­ven­tion. Al­though nasal sprays are cur­rent­ly avail­able, they are gen­er­al­ly con­sid­ered less ef­fec­tive than the in­jectable ver­sions — some­thing Sat­suma is out to change.

A Phase I tri­al among 42 healthy vol­un­teers showed that STS101 in­duced the tar­get DHE plas­ma con­cen­tra­tion with­in 10 min­utes, and hit all mea­sures of drug ex­po­sure.

Sat­suma in­tends to re­cruit 1,140 pa­tients for the Phase III study it’s just kick­start­ed, re­lease topline da­ta and com­mence a 12-month safe­ty tri­al in Q2 2020, then file an NDA by the end of 2021.

CEO Kollins — an alum of Athena Neu­ro­sciences and Am­gen-ac­quired Im­munex — and his head of op­er­a­tions, Mic Iwashima, have spent $23.9 mil­lion ex­e­cut­ing the quick leap to late-stage de­vel­op­ment. There’s still $47.6 mil­lion in the bank, in­clud­ing a $5 mil­lion loan from Sil­i­con Val­ley Bank. The cur­rent head­count of full-time em­ploy­ees sits at 11.

To re­al­ize all of its plans, though, Sat­suma will like­ly need to ex­pand dras­ti­cal­ly. From the S-1:

If ap­proved, we plan to com­mer­cial­ize STS101 in the Unit­ed States by build­ing a spe­cial­ized sales or­ga­ni­za­tion fo­cus­ing on headache spe­cial­ists, as well as gen­er­al neu­rol­o­gists and pri­ma­ry care physi­cians who are high pre­scribers of mi­graine ther­a­peu­tics.

Its plans to seek ex-US part­ners for the drug al­so calls for a larg­er busi­ness de­vel­op­ment team.

For now, though, much of the IPO pro­ceeds should go to­ward the Phase III tri­als.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Joel Dudley, new partner at Innovation Endeavors (Tempus Labs)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs from 2020.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.