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Readout @ JPM

A biotech IPO record is in play

One of the bigger stories of JPM Week may not have anything to do with JPM at all, strictly speaking. Sana Biotechnology, a two-year-old cell therapy company that has already raised an eye-watering amount from venture capitalists, filed to go public this week — and the prospectus made for interesting reading. 

Along with disclosing details about the company’s pipeline, which includes programs for cancer, multiple sclerosis, and heart failure, it also showed that Sana is lining itself up to have a gargantuan valuation after the offering closes — especially for a company that’s still at least a year away from beginning its first human trials. 

Sana hasn’t priced its shares yet. But this morning, STAT staff did some rough, back-of-the-envelope calculations: Sana says it will have 593 million shares outstanding after the offering. Assuming the company prices its IPO in the usual range for a biotech — between $15 to $20 per share — that means it could be worth $9 billion to $12 billion when everything is said and done. (Moderna, for comparison’s sake, was worth about $7.5 billion immediately after its 2018 debut.)

STAT has been following Sana since 2019, when the company was still in stealth mode. (We first reported that the company’s original name was significantly more profane.) Notably, Sana wasn’t on this year’s JPM schedule after appearing last year. Perhaps now we know why. 

Talkspace goes public

Last year's SPAC trend is carrying on full steam ahead with the new year — and Talkspace, the virtual therapy startup that took the stage this morning, is the latest health care company to get on board.

The company, which presented just hours after announcing a $1.4 billion SPAC merger, estimated it would bring in $125 million in net revenue this year and told investors that it currently has more than 46,000 active members. (Talkspace covers more than 39 million people through partnerships with employers and employee assistance programs, according to its presentation this morning.)

The company has previously attracted criticism for some of its marketing and data privacy practices. But like other telemental health startups, Talkspace has reported a surge in use as the pandemic has kept people home and put more pressure on their mental health. Talkspace co-founder and CEO Oren Frank told STAT's Mario Aguilar that while he is "not happy that we grew the company with that tailwind because no one wants to benefit from such a huge global pandemic ... we have had an extremely busy year doing everything that we can do in order to facilitate the help that we can.”

A small cardiology company bets on a massive idea

The biggest coup in recent cardiology history is the advent of medicines that can dramatically reduce bad cholesterol and improve the rates of heart attack, stroke, and death over the long term. But, because they’re at once expensive and inconvenient, those drugs have never reached the critical mass necessary to change the standard of care and line the pockets of their inventors. 

That might change if you could pack all that potency into a convenient pill, and Esperion Therapeutics, a small firm with a pair of FDA-approved cholesterol drugs, intends to find out.

Esperion used the occasion of J.P. Morgan to announce that it bought the rights to an oral treatment that targets PCSK9, a protein found in the liver that regulates LDL “bad” cholesterol. The allure is pretty simple. The two approved PCSK9 treatments, injectable antibodies sold by Amgen and partners Sanofi and Regeneron Pharmaceuticals, have demonstrated LDL reductions of around 60% and led to long-term improvements in patient outcomes. If an oral treatment could replicate those benefits, it would be a medical and commercial coup.

It’ll be years before Esperion’s gamble could possibly pay out. The drug is in the earliest stages of development, and the company declined to say when it might enter its first human trial. And the company isn’t alone in its quest for a PCSK9 pill: Last year, AstraZeneca paid an undisclosed sum for a Cambridge, Mass., firm called Dogma Therapeutics to acquire a similar project.

The best number from the pandemic: 95%

Ugur Sahin and Özlem Türeci, the CEO and chief medical officer of BioNTech, which developed the first approved Covid-19 vaccine with partner Pfizer, joined STAT for a virtual event Wednesday. Sahin said that even he was surprised by the 95% efficacy of the vaccine. He’d expected, at most, 80% efficacy. And Türeci explained how a Lancet article had helped make Sahin make the case to her that the company, which they’d founded together, should pivot from its efforts in cancer to develop a Covid-19 vaccine. It also mattered, she said, that she knew Sahin; the two, in addition to working together, are married.

In the space of 40 minutes, Sahin and Türeci dove through a long list of topical questions about the vaccine. They understand, Sahin said, why countries are looking at making the tradeoff of waiting longer to give the second dose, but right now they can only speak to the data of the vaccine as tested, with the doses given. They can’t speak to whether there is an elevated rate of allergic reactions with the vaccine, Türeci said. But Sahin emphasized that new formulations may lack PEG, which might be the cause of allergic reactions, though it’s not clear. They also might not need to be kept super-cold, and he said that he thought changes to the formulation could come quickly. The vaccine works every bit as well, Tureci emphasized, in people over 65 as those under 65.

Sahin said that they think of BioNTech not as an mRNA company, but as “next-generation immune engineers.” They’re as excited about the CAR-T therapies they are developing for cancer as their technology to deliver antibodies as mRNA. And, as Pfizer CEO Albert Bourla also pointed out, the two companies are working together on a vaccine for another potential cause of pandemics: seasonal influenza.

Vaccine talk

“SARS-CoV-2 is not going away, we are going to deal with this virus forever, like flu," said Moderna CEO Stephane Bancel, speaking Wednesday on a Covid-19 vaccine panel during the lunch break at the JPM meeting. 

Bancel said he does not believe the variants originating in the U.K., South Africa, or Brazil pose a problem for the company’s vaccine, adding that he’d like to see testing done to determine conclusively whether the mRNA-based vaccines would be effective as a single dose.

Moncef Slaoui, the outgoing Operation Warp Speed chief, also appeared on the JPM panel. He said he expects the one-dose Covid vaccine being developed by Johnson & Johnson to show an efficacy rate of 80-85% when study results read out later this month.

Thanks for reading! More tomorrow.

Wednesday, January 13, 2021

STAT

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