Jim Tananbaum, Foresite Capital CEO (Business Wire)

Fore­site pulls Gem­i­ni Ther­a­peu­tics to Nas­daq in a quick $216M SPAC flip

Jim Tanan­baum was look­ing for a spe­cif­ic type of com­pa­ny, one with a ge­net­ics-dri­ven plat­form, when he launched Fore­site Cap­i­tal’s first blank check com­pa­ny. And he’s found it in Gem­i­ni Ther­a­peu­tics.

Just two months af­ter FS De­vel­op­ment Corp land­ed on Nas­daq with $121 mil­lion in the bank, it will give way to Gem­i­ni fol­low­ing a merg­er and con­cur­rent pri­vate place­ment to­tal­ing $95 mil­lion.

At­las Ven­ture, Light­stone Ven­tures and Or­biMed — the orig­i­nal in­vestors lead­ing Gem­i­ni’s $42.5 mil­lion launch round three years ago — are on the ros­ter Fore­site has cor­ralled, along­side ex­ist­ing in­vestor Wu Cap­i­tal. Fi­deli­ty, Welling­ton Man­age­ment, Box­er Cap­i­tal of Tavi­s­tock Group, Alyeska In­vest­ment Group, Su­vret­ta Cap­i­tal Man­age­ment, CVF, DAF­NA Cap­i­tal and Acorn Bioven­tures tagged along.

In a year where biotech SPAC is gath­er­ing near­ly as much steam as IPOs, the sub­se­quent merg­er deals are slow­er to fol­low. Spon­sors — from 5AM, Cas­din, Cor­morant, Deer­field, EcoR1 to MPM — ap­pear to be tak­ing their time (they have two years max) to iden­ti­fy the right biotech to take pub­lic.

But Fore­site chief Tanan­baum, who dou­bled as pres­i­dent and CEO of FS De­vel­op­ment Corp, quick­ly saw some­thing to like about Gem­i­ni’s ap­proach of tai­lor-mak­ing treat­ments for sub­pop­u­la­tions of pa­tients with mac­u­lar de­gen­er­a­tion based on their ge­net­ic vari­ants.

Ja­son Meyen­burg

It spawned a pipeline span­ning re­com­bi­nant pro­tein, mon­o­clon­al an­ti­body and gene ther­a­py, which will con­tin­ue to be over­seen by Gem­i­ni CEO Ja­son Meyen­burg.

The biotech high­light­ed three main groups of pro­grams that will ben­e­fit from the new cash: GEM103, the lead prod­uct can­di­date for dry AMD, cur­rent­ly in Phase IIa for pa­tients with a com­ple­ment Fac­tor H mu­ta­tion; oth­er clin­i­cal pro­grams in cer­tain wet AMD pa­tients with sec­ondary mac­u­lar at­ro­phy; and fu­ture pro­grams to treat in­ter­me­di­ate AMD as well as sys­temic dis­eases as­so­ci­at­ed with com­ple­ment Fac­tor H dys­func­tion.

Hav­ing pre­vi­ous­ly con­sid­ered go­ing pub­lic, Gem­i­ni’s pro­file fits per­fect­ly with what he’d con­sid­er an ide­al can­di­date for a blank check hunter, At­las’ Bruce Booth ob­served in a blog post as he cel­e­brates his firm’s first SPAC ex­it:

The op­ti­mal biotech merg­er tar­get pro­file, in my opin­ion, is the “pre-crossover” pri­vate com­pa­ny that has an emerg­ing prod­uct pipeline with an ex­pec­ta­tion of mean­ing­ful clin­i­cal news flow over the next 1-3 years. It ob­vi­ous­ly needs to be a sto­ry that will ap­peal to biotech pub­lic mar­ket in­vestors. This like­ly means the com­pa­ny has raised $25-100M in pre­ferred stock fi­nanc­ings, but hasn’t yet built a ros­ter of cus­tom­ary crossover in­vestors yet. In lieu of the crossover/IPO two-step di­lu­tion of a tra­di­tion­al path, and the risk of mar­ket volatil­i­ty, ac­cess­ing the pub­lic mar­kets via a de­fined SPAC timetable may be smarter.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Lit­tle Zosano takes an­oth­er beat­ing as the FDA slaps down their ap­pli­ca­tion for a mi­graine patch

Zosano $ZSAN has officially come up short in its bid to develop a migraine patch.

The FDA rejected the company’s application to repurpose the triptan zolmitriptan in a new delivery system as Qtrypta, Zosano said Wednesday morning, issuing a CRL for the microneedle patch. Regulators cited inconsistent exposure levels across multiple clinical trials as the main reason for the thumbs down.

Investors did not take too kindly to the news, with Zosano shares plunking down around 25%. The company is requesting a Type A meeting to “provide clarity on the next steps for the program,” CEO Steven Lo said in a statement.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.

Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.