Co­di­ak files for an IPO, again, this time shoot­ing for a nine-dig­it raise

Sec­ond time’s the charm?

Co­di­ak Bio­sciences is fil­ing for an IPO once again, sub­mit­ting pa­per­work Wednes­day, af­ter back­ing out of its pre­vi­ous at­tempt in Ju­ly 2019 due to un­fa­vor­able mar­ket con­di­tions. The com­pa­ny is pric­ing in a new raise of $100 mil­lion, up from $86 mil­lion in its ini­tial pur­suit.

There have al­ready been four dozen biotech IPOs so far this year, net­ting the sec­tor more than $11 bil­lion.

Doug Williams

The Cam­bridge, MA-based out­fit is head­ed by the ex-Bio­gen re­search chief Doug Williams, who has about a 5% stake in the com­pa­ny, ac­cord­ing to the S-1. Ma­jor in­vestors hold the li­on’s share of the stock, with ARCH Ven­ture Funds own­ing 28.3%, Flag­ship Ven­ture Funds hold­ing 18.9% and Fi­deli­ty tak­ing 14.1% of the pie.

Co­di­ak has fo­cused its re­search on a plat­form that re­pur­pos­es ex­o­somes as de­liv­ery ve­hi­cles for a range of ther­a­peu­tic pay­loads, from small mol­e­cules to pro­teins to nu­cle­ic acids. Specif­i­cal­ly, the biotech has honed in on a pro­gram that us­es a STING path­way ag­o­nist, li­censed from a French com­pa­ny called Kay­la Ther­a­peu­tics. Its lead can­di­date, dubbed ex­oST­ING, over­ex­press­es Co­di­ak’s pro­pri­etary scaf­fold pro­tein PT­GFRN and is loaded with a syn­thet­ic CDN to tar­get this path­way.

By trans­port­ing the com­pound di­rect­ly to anti­gen pre­sent­ing cells, Co­di­ak hopes to har­ness the po­ten­tial of the STING path­way while avoid­ing tox­i­c­i­ty that stems from “leak­age” out of the tu­mor. Co­di­ak aims to use some of this new fund­ing to con­duct a Phase I/II tri­al, study­ing ex­oST­ING in pa­tients with ad­vanced/metasta­t­ic, re­cur­rent, in­jectable sol­id tu­mors.

Some of the mon­ey will al­so go to­ward an­oth­er of Co­di­ak’s pro­grams, ex­oIL-12. The run­ner-up in the pipeline is en­gi­neered to fa­cil­i­tate tu­mor re­ten­tion and sus­tained ac­tiv­i­ty us­ing the same scaf­fold pro­tein as ex­oST­ING. Mon­ey from the raise will sup­port a Phase I tri­al in healthy vol­un­teers and ear­ly stage cu­ta­neous T cell lym­phoma.

The re­main­der of the funds will help ex­pand Co­di­ak’s en­gEx plat­form, in­clud­ing the ad­vance­ment of R&D for oth­er pre­clin­i­cal and dis­cov­ery pro­grams, as well as mis­cel­la­neous cor­po­rate pur­pos­es.

Williams has led the com­pa­ny through sev­er­al im­pres­sive fundrais­ing rounds, col­lect­ing $162.8 mil­lion in the com­pa­ny’s first two years af­ter be­ing found­ed in 2017. Co­di­ak al­so inked a $56 mil­lion deal with Jazz and a $72.5 mil­lion pact with Sarep­ta to de­vel­op the first mul­ti­ple-dose gene ther­a­py.

The ex­o­some field is grow­ing, how­ev­er, as Co­di­ak gained a no­table com­peti­tor at the end of Ju­ly, when Mantra Bio came out of stealth with a $25 mil­lion Se­ries A. Found­ed by Alex Mok, Katie Planey, and Ter­ry Gaige, the biotech is seek­ing to solve some of the tra­di­tion­al ex­o­some prob­lems us­ing a com­pu­ta­tion­al plat­form to find tar­gets, de­sign ex­o­somes and then build a set of them in their lab.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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