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.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.