5 cash-hun­gry biotechs crowd in­to Nas­daq in search of a $600M-plus wind­fall

The queue to get in­to Nas­daq just got a lot longer.

On Fri­day af­ter the mar­kets closed 5 more biotech’s tossed their S-1s in­to the mix, mark­ing at least 22 IPO pitch­es for the year to date. That falls in line next to the 20 biotechs that had gone pub­lic by this time last year — which marked an­oth­er busy year for pub­lic mar­ket de­buts and the cash they spin for R&D work.

We broke it out on a case-by-case ba­sis:

Der­ma­vant

Vivek Ra­maswamy Roivant

Vivek Ra­maswamy is a crea­ture of habit. He cre­ates drug de­vel­op­ers un­der his um­brel­la com­pa­ny Roivant, beefs up their pipelines with drugs aban­doned or gath­er­ing dust on Big Phar­ma shelves, hires an ex­pe­ri­enced leader to run the shop, and then steers the firm to an IPO. Af­ter tak­ing Ax­o­vant and My­ovant pub­lic — in a pair of IPOs that raised more than half a bil­lion dol­lars — Der­ma­vant is be­ing groomed for a pub­lic de­but. Af­ter buy­ing tap­inarof from GSK $GSK, the biotech is gun­ning for a $100 mil­lion IPO, un­der the sym­bol $DRMT, ac­cord­ing to a fil­ing post­ed on Fri­day.

Bridge­Bio

Neil Ku­mar End­points

Af­ter rais­ing about $299 mil­lion in Jan­u­ary, start­up mill Bridge­Bio is prim­ing it­self for a $225 mil­lion IPO. The Pa­lo Al­to, Cal­i­for­nia-based com­pa­ny has birthed a pletho­ra of star­tups such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, to fo­cus on ge­net­ic dis­eases, en­com­pass­ing der­ma­tol­ogy, on­col­o­gy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy. Run by Neil Ku­mar, Bridge­Bio now has 16 pro­grams, of which 4 are in or ap­proach­ing late-stage de­vel­op­ment. KKR owns a 10% stake in Bridge­Bio, which plans to list un­der the sym­bol $BBIO, ac­cord­ing to a fil­ing post­ed on Fri­day.

Atre­ca

Bank­ing in a be­he­moth $125 mil­lion last Sep­tem­ber — in its third round of fi­nanc­ing — the pre­clin­i­cal biotech Atre­ca is aim­ing for a $100 mil­lion pub­lic de­but. Run by John Or­win — who was in charge of Re­lyp­sa un­til its $1.5 bil­lion takeover — the com­pa­ny is fo­cused on im­munother­a­pies, by us­ing tis­sue sam­ples from can­cer pa­tients to gath­er ide­al an­ti­bod­ies, em­ploy­ing B cells as their sound­ing board, for use in sol­id tu­mors.

John Or­win Atre­ca

The Red­wood City, Cal­i­for­nia-based play­er ex­pects to sub­mit an FDA ap­pli­ca­tion to test its lead ex­per­i­men­tal drug, ATRC-101, in hu­mans in late 2019, and kick off an ear­ly-stage tri­al in ear­ly 2020. Bak­er Broth­ers Life Sci­ences and its af­fil­i­ates own 22.8% of the com­pa­ny’s class A shares — and all of its B shares — while oth­er big share­hold­ers in­clude: Hadley Har­bor Mas­ter In­vestors (12.5%), Bill & Melin­da Gates Foun­da­tion (9%) and Box­er Cap­i­tal (6.9%). Atre­ca is plan­ning to list un­der the sym­bol $BCEL, ac­cord­ing to a fil­ing post­ed on Fri­day.

Pre­vail Ther­a­peu­tics

Wad­ing deep­er in­to the biotech wa­ters, for­mer Co­lum­bia pro­fes­sor Asa Abe­liovich is tak­ing his Parkin­son’s gene ther­a­py project to the Nas­daq, look­ing to raise $100 mil­lion for Pre­vail Ther­a­peu­tics af­ter clos­ing a $50 mil­lion round just two months ago.

Asa Abe­liovich Pre­vail

Found­ed in 2017 in part­ner­ship with Or­biMed and The Sil­ver­stein Foun­da­tion,  the New York-based com­pa­ny vows to de­vel­op a broad­er set of AAV gene ther­a­pies for neu­rode­gen­er­a­tive dis­eases, with a fo­cus on ge­net­i­cal­ly de­fined pa­tient pop­u­la­tions. In Parkin­son’s, that means tar­get­ing the GBA1 mu­ta­tion — an un­der­ly­ing dri­ver of the (less com­mon) neu­ro­log­i­cal man­i­fes­ta­tions of a com­mon lyso­so­mal stor­age dis­or­der known as Gauch­er dis­ease. Ad­di­tion­al pro­grams in­clude PR006 for fron­totem­po­ral de­men­tia with GRN mu­ta­tion and PR004 for the treat­ment of synu­cle­inopathies, pre­clin­i­cal stud­ies of which are to be fund­ed by the IPO wind­fall.

Abe­liovich, who helped co-found high pro­file Alzheimer’s biotech Alec­tor, owns 10.1% of the stock. But Or­biMed has the li­on’s share here: Its 48.6% own­er­ship dwarfs Re­genxbio’s 9.1%, RA Cap­i­tal’s 8.1%, Pon­tif­ax’ 5.9% or EcoR1 Cap­i­tal’s 5.8%. Pre­vail plans to list as $PRVL.

Akero Ther­a­peu­tics

It’s bare­ly been a year since Akero threw its NASH can­di­date in­to the crowd­ed space from out of left field. In the months that fol­lowed, it added $70 mil­lion to its orig­i­nal $65 mil­lion cash re­serve, wooed Gilead vet An­drew Cheng as CEO, and se­cured an IND for the next phase in the clin­ic. And if it all goes ac­cord­ing to plan, it will be cel­e­brat­ing its biotech an­niver­sary with $86 mil­lion in IPO mon­ey.

An­drew Cheng Akero

In the S-1, Akero once again out­lined the case for its FGF21 ana­log — in-li­censed from Am­gen $AMGN — in dis­rupt­ing dis­ease pro­gres­sion, start­ing from the fat ac­cu­mu­la­tion that is be­lieved to cause cell stress. Af­ter treat­ing 83 type 2 di­a­betes pa­tients with the drug, in­ves­ti­ga­tors ob­served bet­ter plas­ma lipopro­tein lev­els and in­sulin sen­si­tiv­i­ty, in­di­cat­ing “the po­ten­tial of AKR-001 to redi­rect calo­ries away from the liv­er, re­duce liv­er fat, al­le­vi­ate he­pa­to­cyte stress, in­hib­it in­flam­ma­tion and re­solve fi­bro­sis in pa­tients with NASH, as well as re­duce sus­cep­ti­bil­i­ty to car­dio­vas­cu­lar dis­ease” — a ma­jor cause of death for these pa­tients.

The biotech, now lo­cat­ed in San Fran­cis­co, al­so dis­closed that Am­gen gained a 7.8% stake from the deal in ad­di­tion to the $5 mil­lion up­front pay­ment. Clin­i­cal mile­stones to­tal $40 mil­lion and Akero could pay $75 mil­lion more if the drug makes it to the mar­ket. Ap­ple Tree Part­ners is the biggest share­hold­er here with 18.5%, while At­las, ven­Bio and Ver­sant each claims 15.2%. The pro­ceeds will go to­ward a planned Phase IIa tri­al con­firm­ing this the­o­ry as well as man­u­fac­tur­ing and oth­er ef­forts to beef up the clin­i­cal pipeline.


Im­age: Shut­ter­stock

Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

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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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

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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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the execs at Nasdaq would like nothing better than to see that momentum continue into the first half of next year.

Since January, 72 biotech and biopharma companies have hit Wall Street, according to Nasdaq head of healthcare listings Jordan Saxe, together raising $13.2 billion.

The latest is Flagship’s Foghorn Therapeutics, which priced its shares last night at $16 apiece, the midpoint of a $15 to $17 range. The Cambridge, MA-based biotech — which initially filed for a $100 million raise on Oct. 2 — is netting $120 million from a 7.5 million-share offering. The proceeds will go right into its gene traffic control platform, including two lead preclinical oncology candidates.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.