Oys­ter Point in­vestors bet $93M on a PhI­II study aimed at dis­rupt­ing a ma­jor con­sumer mar­ket and top­pling Al­ler­gan


Every­one who ever felt the tears well up in their eyes as they bit in­to a red hot chili pep­per should be able to quick­ly gain a ba­sic un­der­stand­ing of what Oys­ter Point Phar­ma is try­ing to do. The team there be­lieves they’re on to a new and bet­ter way to treat dry eye dis­ease. And they now have a whop­ping $93 mil­lion round from some so­phis­ti­cat­ed in­vestors will­ing to back a Phase III to give it a fi­nal push — hope­ful­ly to­ward reg­u­la­tors.

The con­cept is sim­ple: use an in­tranasal ther­a­py to stim­u­late the trigem­i­nal parasym­pa­thet­ic path­way to kick up nat­ur­al tear pro­duc­tion. And they have a re­for­mu­la­tion of Chan­tix — OC-01 — which com­ple­ments an in-house NCE — OC-02 — to pick from for the piv­otal. There’s some mixed but most­ly pos­i­tive mid-stage da­ta on dis­play — some of which reg­u­la­tors ev­i­dent­ly be­lieve are good enough to stand in as a well-con­trolled tri­al need­ed to back up their Phase III.

Sound easy? Any­thing but.

Ste­fan Vi­torovic

While a whole host of biotech star­tups are go­ing af­ter rare dis­eases or can­cer nich­es to keep stud­ies small and com­mer­cial prospects man­age­able, Oys­ter Point staffers — all 8 of them — are go­ing af­ter a com­mon ail­ment suf­fered by tens of mil­lions. In biotech land, it’s ab­solute­ly es­sen­tial that you make a con­vinc­ing case that you can man­age com­mer­cial­iza­tion work on your own; you may even claim that that is your strat­e­gy. 

Part­ners and po­ten­tial buy­ers are put on alert that they don’t have to take any of­fer on the ta­ble. And you have to be able to con­trol your own des­tiny.

Gulp.

Sure, the big com­mer­cial out­fit at Brent Saun­ders’ Al­ler­gan now dom­i­nates the space with Resta­sis — which faces cheap gener­ic com­pe­ti­tion, says Oys­ter Point. But on­ly a frac­tion of pa­tients are be­ing treat­ed prop­er­ly, and Resta­sis and the oth­er prod­ucts are de­liv­ered via eye drops. This new path­way is bet­ter.

That’s Oys­ter Point’s sto­ry, and they’re stick­ing to it as they set out to prove their case.

“Com­pa­nies like us have to plan to take it all the way to the goal line,” Oys­ter Point CEO Jef­frey Nau tells me. Maybe some­body would buy the com­pa­ny, he adds in re­sponse to my ob­vi­ous query, but ei­ther route “is vi­able.”

An IPO could work as well to fund a launch.

Set­ting aside the fea­si­bil­i­ty of a tiny biotech field­ing a con­sumer prod­uct for dry eye dis­ease, Nau’s clear­ly pumped by the $93 mil­lion B round, which does give him a clear shot at tak­ing one of his drugs through a large Phase III study with about 600 or so pa­tients and on to an NDA. The CEO ex­pects to kick that study off at the mid-point of this year, with a read­out in ear­ly 2020.

Nau says his syn­di­cate is back­ing what he be­lieves is the largest sin­gle round ever as­sem­bled for an oph­thal­mol­o­gy up­start. The mon­ey is com­ing from two new lead in­vestors, In­vus Op­por­tu­ni­ties and Fly­ing L Part­ners al­lied with Fal­con Vi­sion. NEA and Ver­sant, which launched the com­pa­ny, are back, joined by Vi­da Ven­tures, where co-founder Ste­fan Vi­torovic has cham­pi­oned their strat­e­gy.

Their mon­ey will al­low the com­pa­ny to quadru­ple its staff in the near-term. And they can even think in terms of the com­mer­cial plan. Which they can han­dle. On their own. If needs be.

Let the Phase III be­gin.


Im­age: Jef­frey Nau. OYS­TER POINT

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,800+ biopharma pros reading Endpoints daily — and it's free.

Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,800+ biopharma pros reading Endpoints daily — and it's free.

Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,800+ biopharma pros reading Endpoints daily — and it's free.

Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.

Rajiv Shukla, Constellation Alpha Holdings

Can­del gets busy IPO week mov­ing with down­sized raise as Ra­jiv Shuk­la's third SPAC goes pub­lic

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a week that’s expected to see several biotechs price their IPOs, Candel Therapeutics got things kicked off Tuesday with a muted opener.

The company helmed by former GlaxoSmithKline vet Paul Peter Tak made its way to Nasdaq thanks to a $72 million raise, which was downsized by about 15% than originally anticipated, according to Renaissance Capital. Candel priced at $8 per share after initially seeking to launch in the $13 to $15 range.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,800+ biopharma pros reading Endpoints daily — and it's free.