SPAC ex­tends dead­line to merge — again; Flag­ship's Evelo bor­rows $45M to re­fi­nance debt

A SPAC deal an­nounced in Au­gust may need a bit more time to dot all the i’s and cross all the t’s.

Ocean Bio­med­ical and its blank check part­ner, Aes­ther Health­care Ac­qui­si­tion Corp., ex­tend­ed the dead­line to wrap their merg­er talks by three months, they said Fri­day. The two en­ti­ties will now have un­til March 16, 2023, to merge and bring Ocean to Nas­daq.

This is the sec­ond time Aes­ther and Ocean have ex­tend­ed their merg­er dead­line, and it’s the last time they’ll be able to do so. Should they be un­able to fin­ish their dis­cus­sions and put to­geth­er the req­ui­site raise, the SPAC will have to re­turn its mon­ey to in­vestors.

The merg­er has proven em­blem­at­ic of the 2022 biotech bear mar­ket, as Ocean was one of sev­er­al can­di­dates Aes­ther sought to com­bine with. Talks pre­vi­ous­ly fell apart with at least three po­ten­tial part­ners, in­clud­ing an elec­tric ve­hi­cle parts mak­er, be­fore Ocean and Aes­ther agreed to re­verse-merge.

Flag­ship biotech re­fi­nances debt

A Flag­ship-found­ed biotech is look­ing to se­cure more cash through a loan.

Evelo Bio­sciences is bor­row­ing $45 mil­lion from Hori­zon Tech­nol­o­gy Fi­nance Cor­po­ra­tion, the com­pa­ny an­nounced Fri­day, in or­der to re­fi­nance its ex­ist­ing debt that would have start­ed af­fect­ing its bal­ance sheet next March. The new loan al­lows Evelo to on­ly pay in­ter­est for three years on most of the new loan, be­fore a two-year pe­ri­od where it would have to re­pay the rest.

$35 mil­lion of the to­tal $45 mil­lion will be sub­ject to this, while the re­main­ing $10 mil­lion will be re­paid on Jan. 1, 2028, when the loan ma­tures, ac­cord­ing to SEC fil­ings.

The out­stand­ing loan bal­ance will al­so be charged in­ter­est at one of two rates. It can be charged at 11% in­ter­est, or it can be charged at what­ev­er the Wall Street Jour­nal’s “Prime Rate” plus “Loan Rate Spread” is list­ed as, whichev­er is high­er.

Evelo al­so “re­paid in full all out­stand­ing in­debt­ed­ness” to its pre­vi­ous lender, K2 HealthVen­tures.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

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