In an end-of-year IPO blitz, 4 biotechs pitch new of­fer­ings to­tal­ing $370M

An im­muno-on­col­o­gy com­pa­ny fo­cused on a more po­tent T cell at­tack. Two biotechs that grabbed as­sets off the re­main­dered shelves at Big Phar­ma. And one gene ther­a­py up­start look­ing to cure Duchenne mus­cu­lar dy­s­tro­phy, one of the most con­tro­ver­sial fields in bio­phar­ma R&D.

Al­to­geth­er, the group of 4 mount­ed a last minute wave of IPO fil­ings dur­ing the wan­ing hours of 2017. And if they come even close to rais­ing the $370 mil­lion pen­cilled in for their S-1s we’ll have a good idea whether the ven­ture-backed brigade of pri­vate biotechs can con­tin­ue a sol­id run that sparked up the sec­ond half of last year.

Or not.

The phar­ma as­sets were ob­tained for lit­tle or no cash down, ask­ing in­vestors to pay for the re­search that will be need­ed to prove whether they are ac­tu­al­ly new drugs in the mak­ing. Duchenne mus­cu­lar dy­s­tro­phy has been both a mine field and a trea­sure map. And im­muno-on­col­o­gy rep­re­sents one of the most in­tense­ly com­pet­i­tive fields in drug R&D to­day.

So in case you were ask­ing, there are no sure things in biotech. Here’s the break­down.

Ar­mo Bio sets the stage for a piv­otal I/O pitch with $86M IPO

Pe­ter Van Vlas­se­laer

Com­pa­ny: Ar­mo Bio­Sciences
Ini­tial IPO tar­get: $86 mil­lion
CEO + stake: Pe­ter Van Vlas­se­laer (8.1%)
Found­ed: 2012
Based: Red­wood City, CA

Ar­mo Bio­Sciences’ $67 mil­lion mez­za­nine round at the end of last Au­gust set the stage for this $86 mil­lion IPO.

Cel­gene and Google’s GV came back along­side Klein­er Perkins and Or­biMed as well as a broad­er syn­di­cate in­clud­ing Chi­na’s Qim­ing Ven­ture Part­ners for the C round back­ing a new tech­nol­o­gy aimed at whip­ping up a more po­tent CD8-pos­i­tive T cell at­tack on can­cer cells — ground ze­ro in the cur­rent on­slaught of can­cer R&D pro­grams.

Ar­mo is fol­low­ing what has be­come a well trav­eled path­way in can­cer drug de­vel­op­ment, piv­ot­ing from ear­ly stage to late-stage stud­ies. And it’s sell­ing the po­ten­tial of a lead ther­a­py that has gar­nered some pos­i­tive re­sults in a hand­ful of pa­tients. The key pitch in the S-1:

The com­bi­na­tion with AM0010 and FOL­FOX showed in PDAC (pan­cre­at­ic duc­tal ade­no­car­ci­no­ma) pa­tients with a me­di­an num­ber of two pri­or ther­a­pies, a mPFS of 2.6 months. The mOS for the com­bi­na­tion of AM0010 and FOL­FOX is 10.2 months with a me­di­an fol­low-up time of 20.3 months with a range be­tween 15.8 and 25.9 months as of Oc­to­ber 2017. At that time, the one year sur­vival rate was 42.9%. These re­sults are of par­tic­u­lar in­ter­est com­pared to a mOS of 4.3 months, mPFS of 1.7 months and one-year sur­vival of 18.5% re­port­ed in a study of FOL­FOX in the sec­ond-line set­ting.

The first in­ter­im analy­sis of the Phase III is due in “ear­ly 2018,” with a 2020 read­out on the sec­ond in­ter­im analy­sis that could trig­ger a mar­ket­ing ap­pli­ca­tion. There’s al­so a pro­gram for non-small cell lung can­cer.

Klein­er Perkins con­trols about 20% of the shares now, trailed by Or­biMed at 19% and DAG Ven­tures at 11%. GV is in for 5.6% of the eq­ui­ty. The stock will be list­ed un­der the sym­bol $AR­MO.


An­oth­er drug off of No­var­tis’ back shelf trig­gers a quick­ie $85M IPO from PureTech

Chen Schor

Com­pa­ny: resTOR­bio
Ini­tial IPO tar­get: $85 mil­lion
CEO + stake: Chen Schor (8.8%)
Found­ed: 2017
Based: Cam­bridge, MA

Nine months af­ter PureTech ramped up a new com­pa­ny called resTOR­bio and then picked up a pair of drugs from No­var­tis’ out­li­cens­ing shelf, the biotech has giv­en birth to an $85 mil­lion IPO pitch.

ResTOR­bio’s for­tunes will rest on mTORC1 in­hibitors with a po­ten­tial to treat a va­ri­ety of ag­ing-re­lat­ed ail­ments, start­ed with res­pi­ra­to­ry tract in­fec­tions for the el­der­ly. A Phase IIb study cov­er­ing the south­ern and north­ern hemi­spheres is ex­pect­ed to read out in the sec­ond half of this year.

No­var­tis let go of resTOR­bio’s lead drug — RTB101 — for a batch of stock for NI­BR ac­count­ing for 9.4% of the shares, with no mon­ey down. A suc­cess­ful de­vel­op­ment pro­gram could trig­ger up to $24 mil­lion in mile­stones with roy­al­ties due on any sales, and the biotech has so far front­ed a to­ken $300,000 for their progress to date.

PureTech, which is run by Daphne Zo­har, owns 44.4% of the com­pa­ny with an­oth­er 20% held by Or­biMed.

PureTech ex­ec and resTOR­bio’s CEO Chen Schor holds 8.8% of the stock, which will be list­ed as $TORC.


Can Men­lo’s $1M drug deal with Mer­ck in­spire a $98M IPO to pay for Phase III?

Steven Bas­ta

Com­pa­ny: Men­lo Ther­a­peu­tics
Ini­tial IPO tar­get: $98 mil­lion
CEO + stake: Steven Bas­ta (3.7%)
Found­ed: 2011 (as Tiger­cat)
Based: Red­wood City, CA

Can a low-pro­file biotech with a sin­gle as­set picked up for $1 mil­lion up­front paid to Mer­ck pull off a $98 mil­lion IPO in ear­ly 2018?

Red­wood City, CA-based Men­lo Ther­a­peu­tics in­tends to find out.

The biotech, which had $75 mil­lion in cash in the bank at the end of Sep­tem­ber, has com­plet­ed a suc­cess­ful Phase II for pru­ri­tus. The group that found­ed the com­pa­ny picked up ser­lop­i­tant back in 2012 for what amounts to lunch mon­ey in this busi­ness, bag­ging rights to a drug (MK0594) that Mer­ck had put through a cou­ple of tri­als for al­co­hol de­pen­dence (ter­mi­nat­ed) and over­ac­tive blad­der.

The drug is an NK-1 re­cep­tor an­tag­o­nist, which the biotech’s ex­ecs be­lieve is a key me­di­a­tor to the urge to scratch or cough. Tamp that down and Men­lo be­lieves its drug can help peo­ple with a va­ri­ety of ail­ments tied to pru­ri­tus as well as chron­ic cough­ing. And once it goes in­to Phase III, Men­lo says it will owe Mer­ck an­oth­er $3 mil­lion along with up to $25 mil­lion in de­vel­op­ment and reg­u­la­to­ry mile­stones with an­oth­er $50 mil­lion in goal cash built on top of that — pro­vid­ed they can steer it to the mar­ket.

The S-1 pitch is es­sen­tial­ly based on da­ta from two Phase II stud­ies that were re­port­ed out last Sep­tem­ber. In­ves­ti­ga­tors re­port­ed a bor­der­line suc­cess (p<0.05) on the re­duc­tion from base­line VAS pru­ri­tus score and a change from base­line in av­er­age-itch VAS score at 8 weeks (p<0.001).

Vi­vo Cap­i­tal is the big share­hold­er, with 25% of the eq­ui­ty. Remedi­tex Ven­tures weighs in at 18% and Pre­sidio Part­ners con­trols 16.5% of the stock.

Bag­ging dis­cards off Big Phar­ma’s back shelves — or their re­jects — has be­come a pop­u­lar, though not nec­es­sar­i­ly suc­cess­ful, strat­e­gy. Vivek Ra­maswamy is build­ing a mul­ti­fac­eted en­ter­prise us­ing that ap­proach, though his first for­ay out with Ax­o­vant ran in­to a brick wall of fail­ure.

Men­lo plans to trade as $MN­LO.


Can a gene ther­a­py up­start fo­cused on a con­tro­ver­sial tar­get like Duchenne MD win over in­vestors to the tune of $100M?

Ilan Gan­ot

Com­pa­ny: Sol­id Bio­Sciences
Ini­tial IPO tar­get: $100 mil­lion
CEO + stake: Ilan Gan­ot (N/A)
Found­ed: 2013
Based: Cam­bridge, MA

It was clear at the end of Q1 last year that Sol­id’s $50 mil­lion round was aim­ing at a crossover to the pub­lic mar­kets, and the biotech did not dis­ap­point, post­ing its $100 mil­lion IPO on the last busi­ness day of the year.

Found­ed by Duchenne dad Ilan Gan­ot, the com­pa­ny has gained the sup­port of RA Cap­i­tal and its close con­fed­er­ates at Bain for a gene ther­a­py aimed at noth­ing less than a cure of DMD. By in­tro­duc­ing a syn­thet­ic dy­s­trophin trans­gene con­struct, called mi­crody­s­trophin, via a vi­ral vec­tor, the com­pa­ny hopes to prove it can do what Sarep­ta and oth­ers have been grop­ing for with one de­ci­sive in­ter­ven­tion.

The fact that not every­one in the field — in­clud­ing some at the FDA — is con­vinced that dy­s­trophin is the right bio­mark­er for ad­dress­ing this dis­ease, there’s ob­vi­ous­ly a long way to go in prov­ing it works.

The S-1 lists the in­vestors, but doesn’t spell out what per­cent­ages of the eq­ui­ty they own — a miss­ing fea­ture which will need to be patched in.

The biotech plans to list as $SLDB.

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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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.

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.

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.