IPOs con­tin­ue to bus­tle as three more biotechs pre­pare to make the Nas­daq leap

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The biotech IPO mar­ket con­tin­ues to charge full-steam ahead, with three more com­pa­nies sub­mit­ting their Nas­daq pitch­es to the SEC late Fri­day.

The lead­ers among the pack are Ada­gio Ther­a­peu­tics and Cas­tle Creek Bio­sciences, each pen­cil­ing in $100 mil­lion ini­tial­ly. Fol­low­ing up the rear is Eliem Ther­a­peu­tics, jot­ting down $80 mil­lion for its raise es­ti­mate less than six months af­ter launch­ing out of RA Cap­i­tal’s in­cu­ba­tor.

Fri­day’s fil­ings come a week af­ter End­points News’ con­ver­sa­tion with Nas­daq of­fi­cial Jor­dan Saxe, who said the in­sti­tu­tion is in con­ver­sa­tions with about 250 biotechs over the next 12 to 18 months. Per the End­points tal­ly, the biotechs that have al­ready priced have raised more than $10 bil­lion com­bined.

In ad­di­tion to the three fil­ings, French biotech Dy­nacure with­drew its ap­pli­ca­tion for an IPO af­ter not pric­ing last week.

Our own John Car­roll took a deep look in­to Ada­gio’s high-pro­file quest for Nas­daq, which pre­mi­um sub­scribers can read here. For the best of the rest, check out the news be­low.

Cas­tle Creek takes for­mer Fi­bro­cell pro­grams pub­lic

Ahead of a high-stakes Phase III read­out in the sec­ond half of next year, Cas­tle Creek is seek­ing to join the Nas­daq ranks.

The Ex­ton, PA-based biotech is fo­cus­ing its ef­forts around a pro­gram called dabo­cema­gene aut­ofi­cel, or D-Fi, to treat re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa, a some­times fa­tal rare dis­ease caused by a lack of col­la­gen in the skin re­sult­ing in un­con­trol­lable blis­ter­ing. It’s a pro­gram that comes from the small ac­qui­si­tion of the biotech Fi­bro­cell back in Sep­tem­ber 2019.

Cas­tle Creek has been work­ing on rare dis­eases in­volv­ing the skin since in­cep­tion, with a for­mer lead pro­gram in a broad­er epi­der­mol­y­sis bul­losa pop­u­la­tion. But that can­di­date, a top­i­cal re­for­mu­la­tion of the IL-1 be­ta an­ti-in­flam­ma­to­ry drug di­ac­ere­in, failed a Phase II study in Oc­to­ber 2018.

Jeff Aronin

Co-founder Michael Der­by had told End­points at the time that Cas­tle Creek planned to ad­vance the pro­gram in­to Phase III de­spite the fail­ure, but it’s un­clear if those plans ever came to fruition. Di­ac­ere­in is no longer list­ed among the biotech’s pipeline, and its on­ly men­tions in the S-1 re­volve around the old li­cens­ing agree­ments Cas­tle Creek signed to re-en­gi­neer it as a top­i­cal drug.

The biotech will con­tin­ue to charge for­ward with the new­er can­di­date, and plans to launch a sec­ond Phase III study be­fore the end of 2021 in the dom­i­nant ver­sion of dy­s­troph­ic epi­der­mol­y­sis bul­losa. Though Cas­tle Creek did not di­vulge ex­act fig­ures in its SEC pa­per­work, it’s ex­pect­ed a sig­nif­i­cant por­tion of these funds will go to­ward the two stud­ies and “pre-com­mer­cial” ac­tiv­i­ties for D-Fi.

There’s al­so an­oth­er Fi­bro­cell gene ther­a­py for mod­er­ate to se­vere lo­cal­ized scle­ro­der­ma in the works, and some IPO funds will be used to wrap up an on­go­ing Phase I/II tri­al, Cas­tle Creek not­ed. The biotech comes from maven Jeff Aronin and his port­fo­lio of com­pa­nies un­der the Paragon um­brel­la. Once it prices, Cas­tle Creek ex­pects to trade un­der the tick­er $CCBS.

Eliem for a dream: From stealth to Nas­daq in four months

Eliem Ther­a­peu­tics is aim­ing to com­plete a quick rise to Nas­daq af­ter launch­ing at the end of March.

There had been signs of an IPO af­ter the biotech’s $60 mil­lion Se­ries B, when com­pa­ny spokes­peo­ple de­clined in­ter­view re­quests ahead of the fil­ing. Eliem like­ly rep­re­sents one of the fastest Nas­daq push­es for biotech in re­cent mem­o­ry, go­ing from launch to fil­ing for an IPO in less than four months.

Should it price, Eliem will have a pipeline of four neu­ro as­sets led by a pro­drug of an en­do­cannabi­noid known as palmi­toylethanolamide, or PEA. The can­di­date is known as ETX-810, and CSO Va­lerie Moris­set pre­vi­ous­ly told End­points the biotech is look­ing at a va­ri­ety of chron­ic pain in­di­ca­tions.

ETX-810 is cur­rent­ly in two Phase IIa stud­ies look­ing at di­a­bet­ic pe­riph­er­al neu­ro­path­ic pain and lum­bosacral radic­u­lar pain. Da­ta read­outs are ex­pect­ed for the first half of 2022.

Eliem is al­so de­vel­op­ing a GA­BA-pos­i­tive al­losteric mod­u­la­tor, which the com­pa­ny is call­ing ETX-155. Re­searchers plan 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.

Both pro­grams come from RA Cap­i­tal, where the biotech was in­cu­bat­ed. Both will al­so be the pri­ma­ry fo­cus­es for the IPO raise.

Once Eliem goes pub­lic, it will trade un­der the tick­er $ELYM.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.