Cir­ius with­draws $86M IPO as vaunt­ed 'Year of NASH' draws to bru­tal close

Cir­ius Ther­a­peu­tics didn’t wait for the gov­ern­ment shut­down to end be­fore it filed its IPO in Jan­u­ary. It was, as JP Mor­gan an­a­lysts had pre­dict­ed the month pri­or, “The Year of NASH” and Cir­ius be­lieved their Phase II pro­gram could raise $86 mil­lion.

To­day, eleven months and a slew of in­dus­try-wide NASH fail­ures lat­er, Cir­ius is with­draw­ing their IPO. The news adds per­haps 2019’s fi­nal nail in ex­pec­ta­tions that were first buried months ago.

Cir­ius was far from im­mune to the NASH tri­al fail­ures. The biotech has one prod­uct: MS­DC-0602K, a mol­e­cule de­signed to bind to part of the mi­to­chon­dria and bal­ance the me­tab­o­lism in pa­tients with NASH with fi­bro­sis. In Cir­ius’s S-1, they billed their 402-per­son EM­I­NENCE tri­al as “to our knowl­edge… the largest Phase 2b clin­i­cal tri­al fo­cused on the treat­ment of NASH.”

If so, it proved to al­so be the most vo­lu­mi­nous Phase IIb tri­al fail­ure in NASH his­to­ry. Cir­ius an­nounced last month their drug missed its pri­ma­ry end­point, fail­ing to de­crease pa­tients’ NAS score by at least 2 points against place­bo with sta­tis­ti­cal sig­nif­i­cance. Cir­ius said oth­er re­sults from the study still “po­ten­tial­ly” sup­port launch­ing a Phase III tri­al, but the news ap­pears to have sapped the biotech’s last hopes for their IPO.

Cir­ius joined some large play­ers, most no­tably Gilead, who saw their NASH dreams dashed or set back in 2019. The Cal­i­for­nia-based big biotech saw three dif­fer­ent tri­al fail­ures for its NASH drug, both as a monother­a­py and in com­bi­na­tion. Days ago, Boehringer dumped a NASH drug they ac­quired for $250 mil­lion af­ter a Phase I raised safe­ty con­cerns.

The strug­gles aren’t lim­it­ed to the clin­ic. In­vestors have ex­pressed skep­ti­cism about NASH drugs’ com­mer­cial prospects. Al­though NASH – or non­al­co­holic steato­hep­ati­tis – is thought to af­fect about 50 mil­lion Amer­i­cans and is marked by dam­ag­ing liv­er scar­ring and fat buildup, most pa­tients have nev­er heard of the con­di­tion and don’t know they have it. It re­quires a painful biop­sy to di­ag­nose, lim­it­ing the num­ber who will ever ac­tu­al­ly be di­ag­nosed. Re­im­burse­ment is al­so a ques­tion; broad­ly, Amer­i­can pay­ers have tried to lim­it their ex­po­sure to chron­ic ther­a­pies.

The re­sult has been few NASH buy­outs in 2019, al­though a cou­ple biotechs proved suc­cess­ful on pub­lic mar­kets with 89bio and Gen­fit fetch­ing $85 mil­lion and $107 mil­lion re­spec­tive­ly.

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.

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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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.

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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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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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.

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.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.