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.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

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'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.