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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.