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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Ben Dake (Source: Aerovate)

RA Cap­i­tal-backed Aerovate launch­es with $72.6M to treat PAH with a re­pur­posed can­cer med

The landmark cancer drug imatinib has been on the market since 2001, first sold by Novartis as Gleevec and in recent years as a generic. Now, a new Boston biotech is aiming to repurpose the drug as a treatment for pulmonary arterial hypertension.

Aerovate emerged from stealth Thursday and announced a $72.6 million Series A, which will be used to develop and run trials for its candidate AV-101 — a dry powder version of imatinib meant to be used with an inhaler. The company emerged from RA Capital’s incubator and funding was led by Sofinnova.