Cir­cled by ri­val phar­ma gi­ants and a biotech pow­er­house, Ko­di­ak asks for a $100M-plus IPO for new eye drug

Ko­di­ak Sci­ences was nev­er one of those biotechs that liked to tout every fi­nanc­ing round or talk up its drug prospects. Helmed by biotech vet and for­mer MPM ven­ture part­ner Vic­tor Perl­roth, it turns out the biotech has been steadi­ly jock­ey­ing a new oph­thal­mol­o­gy drug right to the thresh­old of a soon-to-launch Phase II tri­al. And he’s aim­ing straight at cut­ting the legs out from un­der a block­buster fierce­ly de­fend­ed by one of the tough­est play­ers in drug R&D — once he com­pletes a $100 mil­lion-plus IPO.

And he has a an­oth­er pair of ma­jor league ri­vals look­ing to beat him to the punch.

Ko­di­ak — not to be con­fused with Doug Williams’ Co­di­ak — got start­ed in 2009; a few years af­ter Perl­roth sold off Avidia to Am­gen for $290 mil­lion in cash, plus an­oth­er $90 mil­lion in mile­stones.

Vic­tor Perl­roth

The com­pa­ny has burned through $85.7 mil­lion so far, ac­cord­ing to the S-1, which is close to the $93 mil­lion in rev­enue it’s not­ed rais­ing since launch, in­clud­ing a $33 mil­lion mez­za­nine round that came in last April, with Per­cep­tive Ad­vi­sors and Ar­row­Mark Part­ners lead­ing the round.

So far, those are the on­ly in­vestors that Ko­di­ak has pub­licly ac­knowl­edged. As a re­sult, Perl­roth is the biggest in­vestor high­light­ed in the IPO, with 24% of the shares, while co-founder Stephen Charles has 10%. That’s an un­usu­al­ly high founder fig­ure, if you com­pare it to the av­er­age ven­ture-backed biotech go­ing pub­lic.

Stephen Charles

The in­vest­ment cash has pushed a lead drug through a small, 9-pa­tient Phase I dos­ing and safe­ty study, which Ko­di­ak says came through with fly­ing col­ors. Now, though, the next step will cost con­sid­er­ably more than any­thing they’ve done so far.

The Pa­lo Al­to, CA-based biotech is lay­ing the ground­work for two Phase II stud­ies of its lead drug — KSI-301. The first will be an up­com­ing 400-pa­tient head-to-study pitch­ing its drug di­rect­ly against Eylea for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion, Re­gen­eron’s cash cow. They’re go­ing af­ter a 16-week dos­ing sched­ule for eye in­jec­tions, com­pared to an 8-week dose that Re­gen­eron has in the la­bel, hop­ing to show that its less fre­quent in­jec­tion is non­in­fe­ri­or to the block­buster stan­dard. An­oth­er Phase II will ex­plore its ef­fi­ca­cy in di­a­bet­ic retinopa­thy.

Re­gen­eron re­cent­ly scored an ap­proval for a once-every-12 week dos­ing sched­ule, but Ko­di­ak’s S-1 notes that can on­ly start in the sec­ond year of treat­ment.

The cur­rent an­ti-VEGF drugs, Lu­cen­tis, Avastin and Eylea, have some lim­i­ta­tions that Ko­di­ak hopes to ex­ploit. 

For ex­am­ple, Lu­cen­tis was test­ed and failed to suc­cess­ful­ly ex­tend the treat­ment in­ter­val to 12-week dos­ing, with pa­tients go­ing back to pre-treat­ment base­line or even los­ing vi­sion at the end of the first year of treat­ment, on av­er­age. The Lu­cen­tis U.S. prod­uct la­bel­ing refers to this reg­i­men as an op­tion which is “not as ef­fec­tive” as month­ly dos­ing. Re­cent­ly, the FDA al­lowed an up­date to EYLEA’s la­bel­ing to al­low 12-week dos­ing, but on­ly in the sec­ond year of treat­ment (af­ter one full year of in­ten­sive treat­ment). The la­bel­ing refers to it as “not as ef­fec­tive as the rec­om­mend­ed every 8-week dos­ing.” Even a small de­vi­a­tion from per la­bel dos­ing can be dev­as­tat­ing for vi­sion. Miss­ing as few as one or two in­jec­tions in a year from EYLEA’s rec­om­mend­ed dos­ing, re­sults in al­most one line of vi­sion lost.

Ko­di­ak’s S-1 al­so notes that No­var­tis has a late-stage (the high­ly tout­ed ri­val brolu­cizum­ab), while Al­ler­gan is al­so a po­ten­tial com­peti­tor in the field with abic­i­par. There’s more, with Roche in hot pur­suit of RG7716 af­ter its first Phase II wrap ear­li­er this year.

Ko­di­ak couldn’t have cho­sen a more ag­gres­sive group of ma­jor league play­ers to take on. But they ap­pear ready to make a game try at beat­ing the lot.

The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.