NewAmsterdam Pharma, a late clinical-stage company focused on the research and development of transformative oral therapies for major cardiometabolic diseases, and Frazier Lifesciences Acquisition Corporation (FLAC), a special purpose acquisition company sponsored by an affiliate of Frazier Healthcare Partners, have entered into a definitive business combination agreement.
Upon closing of the transaction, a newly formed holding company, NewAmsterdam Pharma Company N.V. (NewAmsterdam) will be led by Michael Davidson, M.D., Chief Executive Officer of the company. NewAmsterdam’s ordinary shares are expected to be listed on Nasdaq under the ticker symbol “NAMS.”
NewAmsterdam is expected to receive approximately $235 million from an upsized and oversubscribed PIPE at $10.00 per share plus funds held in FLAC’s trust account following any redemptions.
The PIPE was co-led by Frazier Healthcare Partners and Bain Capital Life Sciences, and includes new investors RA Capital Management, GMT Capital, Medicxi, Panacea Venture and other institutional investors, in addition to existing NewAmsterdam shareholders Forbion, LSP Dementia Fund and Morningside Ventures.
The proceeds from this transaction, combined with the upfront payment of $123 million (€115 million) received from NewAmsterdam’s recently announced licensing agreement with the Menarini Group and NewAmsterdam’s existing cash and cash equivalents, would bring NewAmsterdam’s total pro forma cash balance to at least $470 million, which the company believes would be sufficient to fund operations through 2026, beyond the readout of NewAmsterdam’s Phase 3 PREVAIL CVOT study and two other pivotal Phase 3 studies.
The transaction is expected to close in the second half of 2022, subject to approval by FLAC’s shareholders and the satisfaction or waiver of certain other customary closing conditions. The Boards of Directors of both the company and FLAC have unanimously approved the transaction. Following the close of the transaction, James Topper, M.D., Ph.D., managing partner at Frazier Healthcare Partners and chairman of the Board of Directors and Chief Executive Officer of FLAC, and Nicholas Downing, M.D., principal at Bain Capital Life Sciences, will join the NewAmsterdam Board of Directors.
“Today’s announcement marks a major milestone for NewAmsterdam. We believe that the transaction, if consummated, would provide us with the necessary capital to fund our business through 2026 and beyond multiple Phase 3 data readouts for obicetrapib, including our ongoing cardiovascular outcomes trial, and a potential global product launch,” said Dr. Davidson.
“Cardiovascular disease remains a significant unmet need and is the number one cause of death in western countries, with high LDL levels being the chief culprit responsible for adverse outcomes and two-thirds of patients not reaching LDL goals despite the wide availability of statins. Adding a potential new convenient oral therapy that has been observed to confer an additional 51% of LDL-lowering on top of high dose statins could transform the treatment paradigm for this large patient population.
“We are grateful to the FLAC team, as well as our new and existing investors, for their support throughout this transaction and look forward to a continued partnership as we mature into a publicly traded company and pursue our mission of improving patient care globally for this large patient population with substantial unmet need despite existing therapies.”
“We founded FLAC in hopes of acquiring a therapeutics-focused company with near-term inflection points, experienced and highly credentialed leadership and sufficient capital to support planned operations well into the future,” said James Topper, M.D., Ph.D., managing partner at Frazier Healthcare Partners and chairman of the Board of Directors and Chief Executive Officer of FLAC.
“We have found exactly this in NewAmsterdam. NewAmsterdam’s lead program, obicetrapib, is a potentially first- and best-in-class once-daily, oral CETP inhibitor, for which potent LDL-lowering activity on top of high-intensity statins and a positive safety and tolerability profile have been observed in clinical trials.
“We congratulate NewAmsterdam on their recent success in securing a $1B+ partnership with the Menarini Group for Europe and we are eager to support NewAmsterdam’s world-class team as it advances obicetrapib through Phase 3 development and aims to deliver a new transformative oral therapy to the tens of millions of people worldwide who remain at high-risk of experiencing a major adverse cardiac event, despite the availability of statins and other prescription therapies.”
Proceeds from the transaction are expected to provide NewAmsterdam with the capital needed to further develop obicetrapib through several value-creating clinical and regulatory milestones, including the following:
- Data from the ongoing Phase 3 BROADWAY trial of obicetrapib in adults with heterozygous familial hypercholesterolemia (HeFH) and/or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low‑density lipoprotein cholesterol (LDL-C) on top of high intensity statins in 2024;
- Data from the ongoing Phase 3 BROOKLYN trial of obicetrapib in adults with HeFH, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies in 2024;
- Data from the ongoing Phase 3 PREVAIL study, a global cardiovascular outcomes trial, in patients with ASCVD who have inadequate control of their LDL-C despite being on maximally tolerated lipid-modifying therapies in 2026;
- Data from the ongoing Phase 2b ROSE2 trial, evaluating the combination of obicetrapib with ezetimibe as an adjunct to high-intensity statin therapy in 2023;
- Potential new drug application filings for obicetrapib in the United States, Europe, Japan and China and potential commercial launch.