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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.