Roy Smythe, SomaLogic CEO

It's a brave new world for So­ma­Log­ic, as the pro­teomics biotech rides Eli Cas­d­in's newest SPAC to Nas­daq with $1.2B val­u­a­tion

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The bur­geon­ing field of pro­teomics has court­ed heavy in­vest­ment over the last few years, and on Mon­day a promi­nent pro­teomics biotech scored a new heap­ing of cap­i­tal.

So­ma­Log­ic an­nounced plans to re­verse-merge with Eli Cas­din and Kei­th Meis­ter’s sec­ond SPAC on Mon­day, dubbed CM Life Sci­ences II, fetch­ing the com­pa­ny a $1.23 bil­lion val­u­a­tion. The deal gives So­ma­Log­ic a cash in­fu­sion of $276 mil­lion from the SPAC’s IPO last month, as well as a pri­vate in­vest­ment of $375 mil­lion from a syn­di­cate of new and re­turn­ing in­vestors.

Once the merg­er clos­es some­time in the third quar­ter, the com­bined com­pa­ny will trade on the tick­er $SLGC.

Cas­din and Meis­ter had teamed up last sum­mer for their first blank check com­pa­ny, rais­ing what was then a mas­sive $385 mil­lion be­fore the SPAC flood­gates opened this year. Meis­ter, who is him­self a Carl Ic­ahn pro­tégé once viewed as the bil­lion­aire’s right-hand man, launched the SPAC in Au­gust 2020 and teamed up with Cas­din and his bio­phar­ma team.

The cash to­tal swelled to $443 mil­lion when the shell com­pa­ny an­nounced its in­tent to merge with Se­ma4 in Feb­ru­ary, giv­ing the J&J and Sanofi-part­nered pa­tient da­ta, test­ing and ge­nomics plat­form a $2 bil­lion val­u­a­tion. It was one of the largest life sci­ences SPAC deals to date as cash con­tin­ues to flow al­most un­fet­tered in­to SPACs.

Now the duo is back at it again with Mon­day’s So­ma­Log­ic agree­ment, bring­ing the Boul­der, CO-based biotech to Nas­daq. It’s one of a num­ber of biotechs look­ing to un­der­stand the hu­man body by look­ing at pro­teins, rather than DNA and RNA, and the deal comes just three months af­ter the com­pa­ny’s Se­ries A ex­ten­sion.

So­ma­Log­ic CEO Roy Smythe told End­points News that the “con­text” of the mar­ket helped fu­el their de­ci­sion to go pub­lic short­ly af­ter last year’s fundraise.

“We in­tend­ed on some time­line af­ter that Se­ries A to con­tem­plate a pub­lic tran­si­tion to think about when to do that,” Smythe told End­points. “We had been talk­ing about mak­ing a de­ci­sion pri­or to this, and the SPAC has some ad­van­tages de­pend­ing on your per­spec­tive as a com­pa­ny.”

With the merg­er, So­ma­Log­ic can now “dou­ble down” on its strat­e­gy of both col­lect­ing pro­teom­ic da­ta and cre­at­ing ap­pli­ca­tions for clin­i­cal tri­als us­ing that da­ta, Smythe added. The com­pa­ny says it has a to­tal of 20 val­i­dat­ed test­ing tools, known as So­maSig­nal, with an­oth­er 100 or so in de­vel­op­ment.

SPACs have trig­gered what’s be­come a gold rush on Wall Street, with more than $170 bil­lion poured in­to the hold­ing com­pa­nies so far this year. That’s al­ready eclipsed the fig­ure from all of 2020, Reuters re­port­ed last week, which hit $157 bil­lion.

That rush has on­ly brought in more mon­ey with a myr­i­ad of in­vestors try­ing to cap­i­tal­ize. There was the high-pro­file Richard Bran­son SPAC that merged with 23andMe in Feb­ru­ary, and Fore­site and Per­cep­tive, among oth­ers, have launched new blank check com­pa­nies in re­cent months.

The So­ma­Log­ic merg­er al­so comes short­ly af­ter the SEC opened an in­quiry in­to how Wall Street banks are man­ag­ing their risks in the blank check deals, ask­ing fi­nan­cial in­sti­tu­tions to vol­un­tar­i­ly pro­vide in­for­ma­tion about how they’re in­ter­nal­ly polic­ing SPACs.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

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Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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As­traZeneca-Alex­ion merg­er slides through FTC re­view af­ter sup­posed M&A crack­down pos­es no bar­ri­ers

The AstraZeneca-Alexion megamerger received a good sign Friday, despite warning signs of the tides turning against large M&A pharma deals.

US regulators at the FTC have cleared the acquisition for approval, AstraZeneca announced, all but signing off on the deal to go through once it officially closes in the third quarter. AstraZeneca originally said it was planning to buy out Alexion back in December for $39 billion.

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