Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Ex­act­ly one year af­ter kick­ing off a piv­otal Phase III study for its lead drug — a com­pan­ion for can­cer pa­tients re­ceiv­ing ra­dio­ther­a­py — Galera is look­ing to the Nas­daq for some new cash to com­plete the clin­i­cal work and fu­el its com­mer­cial dri­ve.

CEO Mel Sorensen has pen­ciled in an $86 mil­lion ask, which was filed on the same day as liv­er dis­ease com­pa­ny 89bio and rare dis­ease di­ag­nos­tics shop Cen­to­gene. The trio marks the first batch of IPO fil­ings in the wake of two high­ly an­tic­i­pat­ed but ul­ti­mate­ly dis­ap­point­ing pub­lic de­buts by BioN­Tech and Vir, sig­nal­ing dwin­dling biotech fer­vor on Wall Street. 89bio and Cen­to­gene are seek­ing $70 mil­lion and $69 mil­lion, re­spec­tive­ly.

Galera’s pitch is cen­tered square­ly around GC4419, a mimet­ic drug of the nat­u­ral­ly oc­cur­ring en­zyme su­per­ox­ide dis­mu­tase. By spurring the con­ver­sion of ex­cess su­per­ox­ide— which ac­cu­mu­lates quick­ly un­der ra­di­a­tion — in­to hy­dro­gen per­ox­ide, the biotech be­lieves it can al­le­vi­ate se­vere oral mu­cosi­tis, an un­pleas­ant side ef­fect char­ac­ter­ized by in­flam­ma­tion and ul­cer­a­tion of the mu­cous mem­brane lin­ing the di­ges­tive tract. Not on­ly that, but the hy­dro­gen per­ox­ide will help kill can­cer cells.

The first in­di­ca­tion they are aim­ing at is lo­cal­ly ad­vanced head and neck can­cer, and a 365-pa­tient Phase III tri­al is un­der­way. A sec­ond pro­gram for esophagi­tis, pri­mar­i­ly tar­get­ing pa­tients with tho­racic tu­mors or lung can­cer, will al­so ben­e­fit from the IPO, as will an­oth­er sim­i­lar drug primed for in­creas­ing the po­ten­cy of stereo­tac­tic body ra­di­a­tion ther­a­py.

That first Phase III was launched with the help of a whop­ping $150 mil­lion fundraise last Sep­tem­ber, in­clud­ing $70 mil­lion in Se­ries C cash and an $80 mil­lion roy­al­ty agree­ment with what is now known as Black­stone Life Sci­ences. It end­ed up with 7.4% of the stock $GRTX, the least among the group of well-heeled ma­jor in­vestors in­clud­ing NEA (20.4%), No­var­tis (17.0%), No­vo (15%) and Sofinno­va (12.2%).

Un­der the deal with Black­stone, it had agreed to build and train a sales force of around 40 reps in the US, Galera wrote in the S-1.

Sorensen, who took over as CEO from founder Robert Beard­s­ley in 2012, took home a com­pen­sa­tion worth $521,624 last year. COO Beard­s­ley’s pack­age came close at $423,405, while CBO Arthur Fratam­i­co and CMO Jon Holm­lund were both en­ti­tled to slight­ly more than $400,000.

89Bio, mean­while, has leapt di­rect­ly from Se­ries A to the pub­lic mar­kets just one year af­ter emerg­ing out of Or­biMed’s cra­dle. The lead prod­uct can­di­date is an FGF21 ana­log carved out of Te­va’s pipeline, now with hu­man da­ta from healthy vol­un­teers to boast.

De­ploy­ing FGF21 to tack­le NASH — a red hot field of its own — isn’t a new con­cept, but 89Bio be­lieves its gly­coP­E­Gy­la­tion meth­ods can stand out due to bet­ter tol­er­a­bil­i­ty and dura­bil­i­ty.

With the new cash in­fu­sion, the com­pa­ny $ETNB aims to wrap up an on­go­ing Phase Ib/IIa tri­al whose topline da­ta are ex­pect­ed in the sec­ond half of 2020, while al­so fund­ing a Phase II in se­vere hy­per­triglyc­eridemia.

Or­biMed con­tin­ues to con­trol the largest chunk of eq­ui­ty at 41.2%, while Lon­gi­tude Ven­ture Part­ners claims 24.9%, RA Cap­i­tal gets 21.6% and Pon­tif­ax has 11.5%.

For the busy year, CEO Ro­han Palekar nabbed a com­pen­sa­tion pack­age worth $708,161 while Ram Wais­bourd got $318,002 for dou­bling as CBO and COO.

Cen­to­gene $CNTG, a Ger­man out­fit, is ded­i­cat­ing its pro­ceeds to de­vel­op­ing new bio­mark­ers and dou­bling down out­reach to po­ten­tial phar­ma part­ners, in ad­di­tion to ex­pand­ing its tech plat­form.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

Gilead dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Alex Karnal (Deerfield)

Deer­field vaults to the top of cell and gene ther­a­py CD­MO game with $1.1B fa­cil­i­ty at Philadel­phi­a's newest bio­phar­ma hub

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.

Tri­fec­ta of sick­le cell dis­ease ther­a­pies ex­tend life ex­pectan­cy, but are not cost-ef­fec­tive — ICER

Different therapeutic traits brandished by the three approved therapies for sickle cell disease all extend life expectancy, but their impact on quality of life is uncertain and their long-term cost-effectiveness is not up to scratch according to the thresholds considered reasonable by ICER, the non-profit concluded in a draft guidance report on Thursday.

Sickle cell disease (SCD), which encompasses a group of inherited red blood cell disorders that typically afflict those of African ancestry, impacts hemoglobin — and is characterized by episodes of searing pain as well as organ damage.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.