With SPAC­s' high tide long gone, Blue Wa­ter ditch­es sec­ond blank check voy­age

The SPAC wa­ters have been chop­py for a few quar­ters, and the lead­ers of Blue Wa­ter Vac­cines are join­ing the wave of blank-check op­er­a­tors ditch­ing plans to dock their boat on Wall Street.

Joseph Her­nan­dez

While the Blue Wa­ter duo of Joseph Her­nan­dez and Jon Garfield was suc­cess­ful in get­ting their first SPAC to merge with a biotech, testos­terone drug mak­er Clarus Ther­a­peu­tics, and al­so take their own biotech pub­lic in Feb­ru­ary, they have de­cid­ed to back out of the SPAC mar­ket, fol­low­ing the suit of many oth­ers.

Blue Wa­ter Vac­cines CEO Her­nan­dez and CFO Garfield had filed their sec­ond SPAC, apt­ly named Blue Wa­ter Ac­qui­si­tion II, for a $75 mil­lion IPO in Oc­to­ber 2021, a month af­ter their first blank check com­plet­ed its merg­er with Clarus, tak­ing the Illi­nois biotech pub­lic with $25.3 mil­lion in gross pro­ceeds.

But they have pulled the IPO plans for their sec­ond at­tempt, ac­cord­ing to an SEC fil­ing Thurs­day morn­ing. They had planned to merge with a life sci­ences or phar­ma­ceu­ti­cal ser­vices com­pa­ny in the US or Eu­rope.

Clarus, which mar­kets the drug Jaten­zo, is a mere shell of the typ­i­cal $10 that most SPACs trade at. Since land­ing on Nas­daq last au­tumn, Clarus $CRXT has sunk to 28 cents per share.

Mean­while, Blue Wa­ter Vac­cines raised $20 mil­lion in its IPO back in Feb­ru­ary, one of very few biotechs to go pub­lic in the mar­ket dol­drums of 2022. The pre­clin­i­cal com­pa­ny, look­ing at vac­cines for uni­ver­sal flu, norovirus, ro­tavirus and malar­ia vac­cines, priced at $9 but has since fall­en to about $2.50 per share $BWV.

The de­ci­sion to pull the sec­ond Blue Wa­ter SPAC comes af­ter In­no­va­tus Life Sci­ences Ac­qui­si­tion with­drew its $175 mil­lion IPO two weeks ago.

But the SPAC merg­er win­dow isn’t com­plete­ly shut. Two deals were an­nounced in re­cent weeks, with a com­pa­ny at­tempt­ing to re­vive an old Am­gen car­dio drug and a Phase I biotech in the re­nal and in­flam­ma­to­ry dis­ease space.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.