The End­points 11: Here are some of the most promis­ing star­tups in biotech. And Covid-19 is­n't go­ing to stop them

Quite often when I highlight a private, typically early-stage biotech company for these annual awards, I’m asked what I look for in a company. How do you define an Endpoints 11 company?

[Register for the Endpoints 11 event here. No cost to attend.]

There’s a simple enough answer. First, I look for big ideas among the private biotechs which qualify for review, a swing for the fences. I’m drawn to people who are willing to gamble a chunk of their lives on new drug ideas, and in that regard, the stakes here are huge. Drug development is long and hard, and you could easily be wagering 10 or more years of your life on something. So go big or go home if you aren’t planning to do something transformative.

I want a team directing these projects that have the talent, vigor and knowhow to make it happen. Track records are key and earlier failures can be a big plus — depending on how that played out.

People are always more important than money. That’s a mantra of mine that always earns quick nods in any biotech group. But making sure that a company has enough lucre to make it through to proof of concept, and beyond, is also key to the selection process.

Still, you’ll find companies below that raised a few million to get started, and biotechs that appear to have found the key to Fort Knox. So it’s variable.

And then there’s the noise factor. I want to choose companies that can earn widespread recognition for success — or make a hell of a noise if they fail. None of these companies below will slink off to an anonymous midnight burial if they fall short of victory. They’ll make a noise heard throughout the global industry, and we can all learn from it.

This year, with a pandemic raging around the world, I wanted to focus more on culture than particular assets. Each of these biotechs is sorting out the R&D work, but I want to let the execs reflect more on the most important points of starting a company than the specific program goals in mind. Building companies these days takes some newfound ingenuity, and it’s important to share these points with everyone.

There are some other trends you’ll see reflected in the stories below. The intersection of biotech and Big Pharma is taking on a different tone at times, with an eye to assembling large networks of experts to tackle complex problems. And the inflow of billions of dollars of fresh investment capital allows for a new breed of startup conspiring to sire transformative therapies. That’s not cheap, and success is not guaranteed. But it is always fascinating.

Let me sum up here by noting that the biggest healthcare crisis in 100 years has helped make biotech the place to be, fortunately for all of us. These companies aren’t squandering the opportunity. And that deserves a special shout out all on its own.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

Endpoints Premium

Premium subscription required

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

CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

A long­time Pfiz­er chief's ul­tra-qui­et biotech re-emerges with new cash and plans for the clin­ic

In August 2018, a tiny biotech spinout from Cornell announced they had hired former high-ranking Pfizer executive Geno Germano as CEO. And then they said nothing else. For two years. Literally, the company, called Elucida Oncology, did not issue a single other press release until this past October, when they hired a chief medical officer.

Now, though, Elucida seems to be ready to start taking the lid off their operations. On Tuesday at JP Morgan, Germano walked investors through the nanoparticle technology they’ve been developing for cancer. And the same day, the company announced a new financing, raising $44 million in a Series “A-1” round meant to propel them into the clinic this year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.

Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Billionaire Peter Thiel has made significant and sometimes controversial pushes into life sciences over the past few years, and one of his startups out of Berlin has made a new acquisition less than two months after achieving unicorn status.

ATAI Life Sciences purchased a majority stake Tuesday in Recognify Life Sciences, a company focused on developing treatments for cognitive impairment associated with schizophrenia. The financial terms of the deal weren’t disclosed, but the acquisition follows up a $125 million Series C in November co-led by Thiel, leading to a post-money valuation of about $1 billion for ATAI.