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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it's free.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it's free.

In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it's free.

Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it's free.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”