SPAC again: NewAmsterdam takes blank-check route to fund phase 3 trials for Amgen offcast

Once the hottest ticket for an ambitious biotech to go public, special purpose acquisition company (SPAC) deals almost died out earlier in the year. But there has been a steady trickle in recent months, with NewAmsterdam Pharma Co. the latest to take the blank-check route.

The Dutch biotech, which is focused on developing an Amgen reject drug for major cardiometabolic diseases, has merged with SPAC company Frazier Lifesciences Acquisition Corp. The combined entity, led by NewAmsterdam’s CEO Michael Davidson, M.D., and his management team, began trading on the Nasdaq this morning.

With $490 million to play with, the enhanced NewAmsterdam expects to have a sufficient cash runway to last into 2026. This will take it past readouts of its three ongoing phase 3 trials for its sole candidate obicetrapib.

The cholesteryl ester transfer protein (CETP) inhibitor is being studied as an adjunct to maximally tolerated statin therapy for patients with high-risk cardiovascular disease. Data from two of the trials—in patients with established atherosclerotic cardiovascular disease and those with heterozygous familial hypercholesterolemia—are due to read out in 2024. A third trial in patients with a history of atherosclerotic cardiovascular disease with inadequately controlled low-density lipoprotein cholesterol is due to report back in 2026.

Meanwhile, a phase 2 trial in combination with ezetimibe—the generic version of Zetia—is expected to read out next year.

“Following the close of this transaction, we are well-positioned to execute on [our] vision, with late-stage trials ongoing across the globe, a leading pharmaceutical partner to support commercialization efforts in Europe, if our product candidate is approved, and what we believe to be sufficient capital to fund our business through all expected key phase 3 data readouts for cardiovascular disease,” Davidson said in a release Nov. 23.

Obicetrapib has a colorful history, having been acquired by Amgen for $300 million upfront in its 2015 takeover of Dezima. The CETP class had already been tarnished by failures at Pfizer and Roche at that point, before Eli Lilly and, most critically, Merck dumped their programs amid disappointing data. Amgen exited the field weeks after Merck in 2017 and three years later off-licensed obicetrapib to NewAmsterdam, which has a number of links back to Dezima.

More recently, NewAmsterdam sold the European rights for obicetrapib to Italy’s Menarini Group in June this year in a deal worth over 1 billion euros, but retained the license for other markets as well as the rights to develop the drug for Alzheimer’s disease and certain other conditions.

The Dutch biotech was founded in 2019 by venture capital firm Forbion and Chief Scientific Officer John Kastelein, M.D.—a backer and co-founder, respectively, of Dezima. NewAmsterdam's recent clinical work on obicetrapib was boosted by a $196 million series A round in January 2021.

Once an industry staple, so-called blank-check deals in biotech were all but left for dead at the start of 2022, with zero SPAC mergers occurring in the first quarter. But the last few months have seen a steady, if shallow, stream of SPAC deals, including OculisEstrella Biopharma and Aum Biosciences all announcing their intentions in October.