Bob Azelby, Eliem CEO

Weeks out from an $80M launch, a pain and CNS start­up is back with a fresh raise. Can an IPO be far be­hind?

Not two months af­ter launch­ing out of RA Cap­i­tal’s in­cu­ba­tor, Eliem Ther­a­peu­tics is re­turn­ing to the firm — and oth­ers — to raise an­oth­er heap of cash. And this time, an IPO could po­ten­tial­ly be in the works.

Eliem has put to­geth­er a $60 mil­lion Se­ries B round co-led by RA Cap­i­tal as it seeks to fur­ther ad­vance two lead clin­i­cal can­di­dates across four tri­als. The biotech de­clined an in­ter­view and fur­ther de­clined to com­ment on an emailed ques­tion re­gard­ing fi­nanc­ing plans, sug­gest­ing they may be hun­ker­ing down in prepa­ra­tion for an S-1 fil­ing with the SEC.

Though the Se­ries B proved to be small­er than the $80 mil­lion launch round in March, Eliem has an­nounced $140 mil­lion in funds be­tween the 60-day span of the two an­nounce­ments.

Eliem spawned out of con­ver­sa­tions from RA man­ag­ing di­rec­tor An­drew Levin and long­time pain re­searcher Va­lerie Moris­set, who had re­cent­ly re­tired from biotech to start a new chap­ter in the VC world. Dis­cus­sions re­volved around the pro­drug of an en­do­cannabi­noid known as palmi­toylethanolamide, or PEA, and af­ter ini­tial skep­ti­cism Moris­set agreed to hop on board as pres­i­dent and CSO.

The pro­drug, dubbed ETX-810, is the lead pro­gram in a pipeline of four neu­ro as­sets Eliem even­tu­al­ly hopes to bring to pa­tients. It’s part of a fam­i­ly of en­do­cannabi­noid hope­fuls that have thus far come up short for Big Phar­mas look­ing to in­vest in the area. Part of what drew Moris­set to the com­pa­ny, she told End­points News in March, was the sheer amount of clin­i­cal lit­er­a­ture show­ing how PEA could be used for chron­ic pain con­di­tions.

They’re hope­ful that the pro­drug ap­proach can lead to bet­ter re­sults. ETX-810 is cur­rent­ly in two Phase IIa stud­ies look­ing at di­a­bet­ic pe­riph­er­al neu­ro­path­ic pain and lum­bosacral radic­u­lar pain, and Eliem is now putting timeta­bles on the da­ta read­outs for the first half of 2022.

In ad­di­tion to the pain-re­lat­ed in­di­ca­tions, how­ev­er, Eliem is al­so work­ing on a host of oth­er CNS can­di­dates. Next up be­hind ETX-810 is a GA­BA-pos­i­tive al­losteric mod­u­la­tor, al­so from RA Cap­i­tal, which the com­pa­ny is call­ing ETX-155. Eliem plans to take this pro­gram in­to two Phase IIa stud­ies for ma­jor de­pres­sive dis­or­der and hor­mone-re­lat­ed de­pres­sive dis­or­ders, as well as a Phase Ib tri­al for epilep­sy.

Da­ta here are ex­pect­ed in the sec­ond half of 2022 and the first half of 2023, re­spec­tive­ly.

Fur­ther down the pipeline are two pre­clin­i­cal pro­grams: a Kv7.⅔ chan­nel open­er dis­cov­ered in-house, where Eliem hopes to go in­to pain and epilep­sy, and an­oth­er ear­ly-stage re­search pro­gram po­ten­tial­ly for gen­er­al­ized anx­i­ety and de­pres­sion.

In­ter­me­di­ate Cap­i­tal Group co-led the round with RA Cap­i­tal. Oth­er in­vestors in­clud­ed Ac­cess Biotech­nol­o­gy, Sam­lyn Cap­i­tal, Acorn Bioven­tures and LifeArc.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aus­tralian spin­out eyes the clin­ic with a pro­phy­lac­tic nasal spray for Covid-19

Whether patients are immunocompromised or just don’t like needles, one fledgling Australian biotech says it has an alternative to Covid-19 vaccines that doesn’t involve a jab in the arm — and on Tuesday, it pulled in a fresh round of funding to take it into the clinic.

ENA Respiratory, which spun out of ENA Therapeutics last year, has pulled in nearly $24.7 million (AU $30 million) to advance its nasal spray for respiratory viral infections, the company said Tuesday.

Someit Sidhu, JATT

An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans

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

The SPAC train has slowed down since the extraordinarily high levels from late 2020 into early this year, but Tuesday saw the filing of a new blank-check company targeting the life sciences industry.

Jatt Acquisition submitted its SEC paperwork Tuesday, penciling in an estimated raise of $120 million as it sets its sights on a reverse merger partner. The SPAC is run by Someit Sidhu, a co-founder of Pathios Therapeutics, as well as CEO of Akaza Bioscience and Izana Bioscience. Sidhu will control about 97% of the blank-check company’s shares, per the S-1.

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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