With $1.2B NASH deal be­hind them, Nim­bus rais­es $65M for I/O, oth­er R&D

You might re­mem­ber Nim­bus for the mas­sive NASH deal it inked with Gilead a cou­ple years back — earn­ing a re­mark­able $400 mil­lion up­front. The com­pa­ny’s bread and but­ter has been team­ing up with heavy­weights like Gilead, Cel­gene, and Genen­tech to take its promis­ing ros­ter of drugs through de­vel­op­ment. But now, Nim­bus is step­ping out with plans to push for­ward its own in­ter­nal set of pro­grams — and the com­pa­ny’s back­ers just put up $65 mil­lion to fi­nance the work.

Don Nichol­son

Nim­bus’ CEO Don Nichol­son tells me the com­pa­ny want­ed to make a bet on some of its un­en­cum­bered pro­grams: a STING ag­o­nist ap­plied to im­muno-on­col­o­gy (not to be con­fused with the STING an­tag­o­nist part­nered with Cel­gene) and an un­named can­di­date Nichol­son is keep­ing un­der wraps.

The first thing that struck me about Nim­bus’ new fundrais­ing round is that the com­pa­ny al­ready seemed well-cap­i­tal­ized. It’s had back­ing from the likes of At­las Ven­ture, SR One, Lil­ly Ven­tures and even Bill Gates, among oth­ers. And af­ter earn­ing its $400 mil­lion up­front pay­ment from Gilead back in 2016, it quick­ly scored an­oth­er $200 mil­lion just six months af­ter. That’s half of a deal that could to­tal $1.2 bil­lion if all mile­stones are met, and Nichol­son says those aren’t post-mar­ket­ing biobucks — they’re “fair­ly prox­i­mal” mile­stones.

But Nichol­son said the “li­on’s share” of the Gilead mon­ey went back to his in­vestors, as the com­pa­ny’s work­ing hard to keep Nim­bus off the pub­lic mar­kets (for now). While most VCs push for IPOs to get pay­outs, Nichol­son said his syn­di­cate was hap­py with their part­ner­ship ap­proach in­stead.

“The deals we did with Gilead and hope­ful­ly Cel­gene are very pos­i­tive for our in­vestors,” Nichol­son said. “That was sub­stan­tial­ly more mon­ey than most biotechs will make when they do a pub­lic of­fer­ing.”

Jeb Keiper

The com­pa­ny’s CFO Jeb Keiper not­ed in its press re­lease that Nim­bus al­ready had a “nine fig­ure” bal­ance sheet of re­sources to work with. Why raise mon­ey now? Nichol­son said it has a lot to do with com­pa­ny struc­ture (its as­sets live in sep­a­rate com­pa­nies un­der one um­brel­la LLC), and its in­ter­nal pro­grams need­ed their own cap­i­tal to get go­ing.

Al­though Nim­bus is keep­ing its cards close to the vest, Nichol­son did say its pro­grams will fo­cus on meta­bol­ic dis­or­ders, on­col­o­gy, and im­munol­o­gy.

For this re­cent fi­nanc­ing round, all of Nim­bus’ pre­vi­ous in­vestors par­tic­i­pat­ed, in­clud­ing At­las Ven­ture, SR One, Lil­ly Ven­tures, Bill Gates, Pfiz­er Ven­ture In­vest­ments, Light­stone Ven­tures, and Schrödinger.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Athena Countouriotis, Avenzo Therapeutics CEO (website via Nasdaq)

Ex-Turn­ing Point ex­ecs plan to have their next bet, Aven­zo, on the Nas­daq next sum­mer

The crew at Turning Point Therapeutics is back together for a new biotech that wants to acquire early-stage oncology small molecules, including antibody drug conjugates, and potentially form partnerships with China-based drug developers for ex-China rights as it eyes a speedy leap onto the Nasdaq around this time next year, CEO Athena Countouriotis told Endpoints News.

After selling Turning Point to Bristol Myers Squibb, announced at the onset of last year’s ASCO confab, she and colleague Mohammad Hirmand founded Avenzo Therapeutics. The CEO and CMO already have approximately $200 million in seed and Series A financing from five big-name investors to evaluate which drugs to bring into its pipeline. That includes SR One, OrbiMed, Foresite Capital, Citadel’s Surveyor Capital and Lilly Asia Ventures. Bidding wars for assets have led Avenzo to miss out on some deals in recent months, but the biotech has three active term sheets and hopes to bring in its first asset in the third quarter, Countouriotis said in a Friday morning interview.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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