NewAmsterdam Pharma Provides Corporate Update and Reports Third Quarter 2023 Financial Highlights - Seite 2

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 <0.0001.
• In October 2023, NewAmsterdam and other scientists published an article in 21st Century Cardiology, “Recent Advances and Emerging Therapies in the Management of Dyslipidemia.” The publication details the significant need for novel therapeutic agents for the treatment of dyslipidemia and highlights the potential for obicetrapib as an oral, low-dose and once-daily 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 patient.

NewAmsterdam is also advancing obicetrapib as a potential therapy for patients with early AD and at least one copy of the ApoE4 mutation.