NewAmsterdam Pharma Provides Corporate Update and Reports Third Quarter 2023 Financial Highlights

-- BROADWAY Phase 3 trial enrollment completed; on-track to report topline data for Phase 3 BROOKLYN and BROADWAY trials in 2H 2024 –

-- Announced initial data from Phase 2a clinical trial evaluating obicetrapib in patients with early Alzheimer’s Disease (“AD”) who carry an apolipoprotein E4 (“ApoE4”) mutation; biomarker data suggest improvements in brain cholesterol metabolism and disease pathology --

-- Expanded leadership team with key senior hires, appointing William “BJ” Jones as Chief Commercial Officer and Ian Somaiya as Chief Financial Officer --

NAARDEN, The Netherlands and MIAMI, Nov. 13, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease with residual elevation of low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided a corporate update and announced financial highlights for the quarter ended September 30, 2023.

“We experienced strong momentum in the third quarter, continuing the foundational work required to scale NewAmsterdam into a robust clinical and commercial organization,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We recently expanded our leadership team with appointments of BJ Jones as Chief Commercial Officer and Ian Somaiya as Chief Financial Officer. Together, they bring tremendous expertise and functional knowledge, which will enable us to invest in the continued development of obicetrapib, while building a strategic go-to-market approach to support a potential launch. We look forward to their many contributions as we continue toward our goal of establishing NewAmsterdam as a global leader in cardiometabolic disease.”

Dr. Davidson continued, “We recently announced initial data from our Phase 2a trial evaluating obicetrapib in patients with early AD who carry the ApoE4 mutation. We are encouraged by these data, which suggest CETP inhibition may offer a novel approach to reducing the risk of AD in this targeted patient population. We continue to make meaningful progress across our pivotal Phase 3 clinical trials, with topline data from BROOKLYN and BROADWAY expected in the second half of 2024 and enrollment on track in PREVAIL. With our strong clinical expertise, growing leadership team and robust financial position, we believe we are well-positioned to execute on our mission of delivering safe, convenient and effective treatment options for patients with metabolic diseases.”

Third Quarter 2023 Highlights and Recent Progress

Clinical Development Updates:

NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily cholesteryl ester transfer protein (“CETP”) inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy for high-risk cardiovascular disease patients. The Company is currently conducting three pivotal Phase 3 clinical trials of obicetrapib: BROOKLYN, evaluating the effect of obicetrapib on LDL-C levels in patients with heterozygous familial hypercholesterolemia (“HeFH”) as an adjunct to maximally tolerated lipid-lowering therapy, which completed enrollment in April 2023; BROADWAY, evaluating the effect of obicetrapib on top of maximally tolerated lipid-lowering therapy in patients with HeFH and/or established atherosclerotic cardiovascular disease (“ASCVD”), which completed enrollment in July 2023; and PREVAIL, a CVOT (“cardiovascular outcomes trial”) in patients with a history of ASCVD with inadequately controlled LDL-C despite treatment with maximally tolerated lipid-modifying therapies, expected to complete enrollment in the first quarter of 2024.

• At the American Heart Association (AHA) Scientific Sessions in November 2023, NewAmsterdam presented previously reported data from its Phase 2b dose-finding trial evaluating obicetrapib as an adjunct to stable statin therapy in Japanese patients with dyslipidemia. As previously disclosed, patients treated with obicetrapib 2.5 mg, 5 mg or 10 mg achieved a median reduction in LDL-C of 24.8%, 31.9%, and 45.8%, respectively, as compared to patients treated with placebo, who achieved a median reduction in LDL-C of 0.9%. In addition, patients treated with obicetrapib 10 mg achieved a median reduction in ApoB of 29.7%, compared to a 0.4% reduction in patients treated with placebo, and a median reduction in non-HDL-C of 37.0%, as compared to a 0.4% reduction in patients treated with placebo. The p-value for each endpoint in the obicetrapib arms of the trial compared to placebo was