Two more biotechs price IPOs, bring­ing to­tal raise to record heights

Atea Phar­ma­ceu­ti­cals and SQZ Biotech­nolo­gies have priced their pub­lic de­buts, adding to this year’s record biotech IPO raise — a pot spilling over $13 bil­lion that dwarfs the to­tal rais­es of the last four years.

Last Fri­day, Nas­daq head of health­care list­ings Jor­dan Saxe count­ed 72 biotech and bio­phar­ma IPOs this year, to­geth­er rais­ing $13.2 bil­lion. He pegged a “fair es­ti­mate” of 75 de­buts and just un­der $14 bil­lion in pro­ceeds to round out the year.

On Thurs­day, Atea priced an up­sized of­fer­ing at $24 per share — the high end of a $22 to $24 range. The Boston-based biotech ini­tial­ly sought a $100 mil­lion raise, ac­cord­ing to an S-1 filed ear­li­er this month. On Mon­day, Atea set the terms at 11 mil­lion shares, which would have net­ted $232.1 mil­lion at the mid­point of its price range. But on Thurs­day, the com­pa­ny bumped its of­fer­ing up to 12.5 mil­lion shares, reel­ing in $300 mil­lion.

Atea is work­ing on an­tivi­ral ther­a­peu­tics to treat sin­gle-strand­ed ri­bonu­cle­ic acid (ss­R­NA) virus­es. It plans on pour­ing $300 mil­lion in­to its lead can­di­date, AT-527, which is cur­rent­ly in a Phase II tri­al to treat mod­er­ate Covid-19, with topline re­sults ex­pect­ed in the first half of next year. This month, Roche agreed to pay $350 mil­lion for de­vel­op­ment and com­mer­cial­iza­tion rights to AT-527 out­side of the US.

An­oth­er $60 mil­lion will see Atea’s AT-787 pro­gram for he­pati­tis C virus (HCV) through a Phase II tri­al, ac­cord­ing to the com­pa­ny’s S-1/A. About $40 mil­lion will go to­ward AT-752 for the treat­ment of dengue, and $60 mil­lion will go to­ward de­vel­op­ment of AT-889, AT-934 and oth­er can­di­dates for the treat­ment of res­pi­ra­to­ry syn­cy­tial virus (RSV).

As of June, the rough­ly six-year-old biotech had burned through $68.2 mil­lion.

SQZ, on the oth­er hand, priced at the low end of its range: over 4.4 mil­lion shares at $16 apiece. The biotech filed for a $75 mil­lion IPO ear­li­er this month, and ac­cord­ing to the S-1/A, pric­ing shares at $17 (the mid­point of the com­pa­ny’s range), would have brought in just $66.7 mil­lion.

The biotech, pro­nounced “squeeze,” launched from the lab of MIT’s Bob Langer in 2013. Cur­rent CEO Ar­mon Sharei helped dis­cov­er the tech­nol­o­gy as a PhD stu­dent, which squeezes cells through a mi­croflu­idic chip, cre­at­ing an open­ing for drug­mak­ers to slip ma­te­ri­als in­to the cell more ef­fec­tive­ly.

Us­ing IPO pro­ceeds and ex­ist­ing cash, SQZ plans on throw­ing $75 mil­lion in­to its lead can­di­date, SQZ-PBMC-HPV, de­signed to at­tack HPV+ tu­mors. The can­di­date is in Phase I as a monother­a­py and com­bi­na­tion ther­a­py with oth­er im­muno-on­col­o­gy agents for HPV16+ ad­vanced or metasta­t­ic sol­id tu­mors. “We ex­pect to ini­ti­ate the com­bi­na­tion por­tion of the tri­al in the first half of 2021 and ex­pect ini­tial da­ta in the sec­ond half of 2021,” the S-1/A states.

An­oth­er $25 mil­lion will go to the first clin­i­cal tri­al of its oth­er HPV+ can­di­date, SQZ-AAC-HPV. As of June, the com­pa­ny had blown through $96.8 mil­lion.

Sharei, whose 2019 base salary was $460,000, holds just over 3.6% of the com­pa­ny’s shares, ac­cord­ing to the S-1/A.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: 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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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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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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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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News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.