AI start­up BioX­cel Ther­a­peu­tics shoots for $69M IPO with drugs for Alzheimer's, can­cer

A new ar­ti­fi­cial in­tel­li­gence start­up is toe­ing the IPO wa­ters, an­nounc­ing plans for a $69 mil­lion pub­lic of­fer­ing that may test in­vestors’ ap­petite for risk.

BioX­cel Ther­a­peu­tics, found­ed less than a year ago, says it’s ap­ply­ing big da­ta and ma­chine learn­ing to its hunt for new ther­a­peu­tics. The com­pa­ny is tak­ing a “re-in­no­va­tion ap­proach,” ap­ply­ing its pro­pri­etary al­go­rithms to ex­ist­ing ap­proved drugs and clin­i­cal­ly val­i­dat­ed prod­uct can­di­dates to find op­por­tu­ni­ties to tweak or im­prove the ther­a­pies.

“We be­lieve that this dif­fer­en­ti­at­ed ap­proach has the po­ten­tial to re­duce the cost and time of drug de­vel­op­ment in dis­eases with sub­stan­tial un­met med­ical need,” the com­pa­ny said in a state­ment.

The com­pa­ny’s two most ad­vanced clin­i­cal pro­grams in­clude BX­CL501, a for­mu­la­tion of dexmedeto­mi­dine, de­signed to treat ag­i­ta­tions re­sult­ing from neu­ro­log­i­cal and psy­chi­atric dis­or­ders. Dex, as it’s called, is al­so sold un­der Pfiz­er’s brand name Pre­cedex, among oth­er names. BioX­cel has start­ed a Phase Ib study us­ing an IV for­mu­la­tion of Dex in mild prob­a­ble Alzheimer’s pa­tients, and plans to start a study in schiz­o­phre­nia pa­tients in the first half of 2018.

The com­pa­ny’s oth­er pro­gram is BX­CL701, an I/O agent to treat a rare form of prostate can­cer and pan­cre­at­ic can­cer. The drug is a small mol­e­cule in­hibitor of dipep­tidyl pep­ti­dase 8-9 and fi­brob­last ac­ti­va­tion pro­tein (FAP), and it’s in Phase I/II tri­als, ac­cord­ing to the com­pa­ny’s web­site.

Funds from the IPO will be used to sup­port both pro­grams through Phase II clin­i­cal de­vel­op­ment and po­ten­tial­ly one reg­is­tra­tion tri­al, the com­pa­ny said in an SEC state­ment.

The IPO win­dow was wide open dur­ing the last half of 2017, with many spec­u­lat­ing 2018 would be sim­i­lar­ly friend­ly to those seek­ing to go pub­lic. It will be in­ter­est­ing to keep on eye on BioX­cel’s per­for­mance af­ter list­ing to judge just how open in­vestors are to young com­pa­nies head­ing to the Nas­daq. The com­pa­ny will be list­ed un­der stock sym­bol $BTAI.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Overnight for­tunes are be­ing made in biotech these days — and it's both en­cour­ag­ing and more than a lit­tle bit scary

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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