Ashleigh Palmer, Provention Bio CEO

Proven­tion Bio takes a $125M loan to ad­vance Eli Lil­ly’s once-re­ject­ed di­a­betes drug

Amidst the on­go­ing biotech mar­ket slow­down, com­pa­nies are try­ing var­i­ous ways to stay afloat. Some are go­ing pub­lic, and some are tak­ing on debt.

The newest en­trant to the bor­row­ers’ club is New Jer­sey-based Proven­tion Bio, which has se­cured a term loan fa­cil­i­ty of up to $125 mil­lion with Her­cules Cap­i­tal.

The fund­ing will be avail­able in five tranch­es, with the first tranche of $25 mil­lion drawn at clos­ing. The com­pa­ny has the op­tion to draw the sec­ond tranche of $40 mil­lion up­on ap­proval of teplizum­ab, sub­ject to cer­tain con­di­tions.

Teplizum­ab is an ex­per­i­men­tal an­ti-CD3 mon­o­clon­al an­ti­body in­tend­ed to de­lay clin­i­cal type 1 di­a­betes in at-risk peo­ple. The com­pa­ny in-li­censed the drug from Macro­Gen­ics af­ter Eli Lil­ly dumped it as it had failed in a piv­otal di­a­betes study.

In Ju­ly 2021, the FDA is­sued a com­plete re­sponse let­ter to Proven­tion, say­ing that the com­mer­cial pro­duc­tion of teplizum­ab had failed to show phar­ma­co­ki­net­ic com­pa­ra­bil­i­ty with the drug sub­stance man­u­fac­tured for clin­i­cal tri­als.

How­ev­er, the com­pa­ny is hop­ing that the drug will make it to the mar­ket this year. This Ju­ly, Proven­tion an­nounced that the FDA has ex­tend­ed its re­view pe­ri­od by three months for the BLA for teplizum­ab.

Thier­ry Chauche

“This term loan fa­cil­i­ty sig­nif­i­cant­ly strength­ens our bal­ance sheet ahead of teplizum­ab’s po­ten­tial com­mer­cial launch and pro­vides the Com­pa­ny with ad­di­tion­al fi­nan­cial flex­i­bil­i­ty as we con­tin­ue to work to change the land­scape for pa­tients with type 1 di­a­betes,” said the com­pa­ny’s CFO, Thier­ry Chauche, in a press state­ment.

Mean­while, the third and fourth tranch­es will com­bine for $35 mil­lion in the ag­gre­gate, sub­ject to sat­is­fac­tion of cer­tain un­spec­i­fied con­di­tions. And the avail­abil­i­ty of the fifth tranche of up to $25 mil­lion is sub­ject to the ap­proval of the lenders.

Proven­tion joins a list of com­pa­nies that are re­sort­ing to bor­row­ing loans to sus­tain their op­er­a­tions and push their pipeline. For ex­am­ple, Al­ladapt Im­munother­a­peu­tics, which fo­cus­es on IgE-me­di­at­ed food al­ler­gies, en­tered in­to a loan agree­ment with Her­cules Cap­i­tal for up to $50 mil­lion ear­li­er this week. The funds will be used to sup­port the clin­i­cal de­vel­op­ment of Al­ladapt’s lead as­set, ADP101, through the ini­ti­a­tion of a Phase III tri­al, as well as the com­ple­tion of its man­u­fac­tur­ing fa­cil­i­ty, the com­pa­ny an­nounced.

Atai Life Sci­ences, which de­vel­ops treat­ments for men­tal health dis­or­ders, al­so took a loan of $175 mil­lion with Her­cules Cap­i­tal last month. The com­pa­ny drew $15 mil­lion at clos­ing and has the op­tion to draw an­oth­er $45 mil­lion, split across two tranch­es, next year. The new funds would be used to de­vel­op its pipeline which in­cludes psilo­cy­bin ther­a­py.

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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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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Richard Murray, Jounce Therapeutics CEO

Jounce nix­es Redx of­fer as I/O biotech in­stead goes with Con­cen­tra Bio­sciences’ takeover bid

A minority shareholder has won out in the Jounce Therapeutics takeover battle, with the once-ambitious immunotherapy biotech now choosing to be acquired by Kevin Tang’s Concentra Biosciences rather than follow through with an already-announced deal that would have brought the UK’s Redx onto Nasdaq.

Via its new merger partner, Jounce is expected to get $1.85 per share from Concentra, which was formed by Tang Capital Partners, the owner of about 10% of Jounce shares. Two weeks ago, Concentra laid out a $1.80 per share proposal plus more for the ability to swoop up 80% of proceeds from licenses of legacy programs out of Jounce’s pipeline.

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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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Max Colao, OncoVerity CEO

Tiny mul­ti­omics biotech se­cures for­mer J&J drug, new ex­ecs and new fi­nanc­ing

A new spinout from Belgium’s argenx seeks to give new life to a candidate once in-licensed to J&J.

OncoVerity announced Monday afternoon that it had in-licensed cusatuzumab from argenx. The biotech also appointed two new C-suite executives and secured a $30 million Series A round.

CEO Max Colao joins OncoVerity after working as Aurinia’s commercial chief, and stints at Alexion and Amgen. New CMO Clay Smith has been associate chief of the University of Colorado’s hematology division.

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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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