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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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