NewAmsterdam Pharma Announces Q2 Financial Results and Corporate Update

NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS), a late-stage biopharmaceutical company specializing in oral, non-statin treatments for cardiovascular disease (CVD), has released its financial results for the first half of 2024, highlighting significant milestones in its development programs. The company focuses on addressing the needs of patients with elevated low-density lipoprotein cholesterol (LDL-C) who are not adequately managed by existing therapies.

The company's CEO, Michael Davidson, M.D., expressed satisfaction with the company's progress, especially the promising outcomes from the Phase 3 BROOKLYN trial. This pivotal trial evaluated obicetrapib in patients with heterozygous familial hypercholesterolemia (HeFH), achieving its primary endpoint of significant LDL-C reduction compared to placebo. The safety profile of obicetrapib was comparable to that of a placebo, with over half of the treated patients reaching the LDL-C guideline-directed treatment goal of less than 70 mg/dl.

Davidson highlighted the company's recent R&D Day, where they introduced REMBRANDT, a Phase 3 study assessing the fixed-dose combination (FDC) of obicetrapib and ezetimibe on coronary atherosclerotic plaque in adults with or at high risk of atherosclerotic cardiovascular disease (ASCVD). He also noted the extension of US patent protection for obicetrapib until 2043, bolstered by a strong financial position of $430.7 million in cash.

NewAmsterdam is on track to report topline data from its pivotal Phase 3 BROADWAY trial in the fourth quarter of 2024 and from the Phase 3 TANDEM trial in the first quarter of 2025. The company is also advancing the PREVAIL cardiovascular outcomes trial (CVOT).

In July 2024, NewAmsterdam announced positive data from the Phase 3 BROOKLYN trial, demonstrating a significant LS mean LDL-C reduction of 36.3% at day 84 and 41.5% at day 365 in the obicetrapib group compared to placebo. Secondary biomarkers such as HDL-C, non-HDL-C, lipoprotein(a), and apolipoprotein B also showed statistically significant improvements. The safety profile was favorable, with no significant differences from the placebo in terms of blood pressure, liver enzymes, hs-CRP, or renal function.

The company completed patient enrollment for the Phase 3 TANDEM trial, evaluating the FDC of obicetrapib and ezetimibe, with topline data expected in early 2025. In recent months, NewAmsterdam presented new data on obicetrapib at the European Atherosclerosis Society Congress and the National Lipid Association Scientific Sessions.

On the corporate front, NewAmsterdam appointed Mark C. McKenna and Wouter Joustra to its Board of Directors, while Sander Slootweg departed. The US Patent and Trademark Office issued a new patent for obicetrapib, covering its amorphous hemicalcium form, extending protection until 2043. The company hosted an R&D Day, discussing obicetrapib's clinical development and commercialization strategy.

Financially, NewAmsterdam reported a cash position of $430.7 million as of June 30, 2024, up from $340.5 million at the end of 2023, driven by a follow-on offering and warrant exercises. Revenue for the second quarter of 2024 was $2.3 million, compared to $1.7 million in the same period in 2023. The increase was attributed to the recognition of previously deferred revenue. R&D expenses for the quarter were $38.4 million, up from $34.3 million in the prior year, primarily due to ongoing Phase 3 trials. SG&A expenses rose to $16.5 million from $9.9 million, reflecting increased personnel costs and commercial preparation. The net loss for the quarter was $39.0 million, or $0.41 per diluted share, slightly higher than the $38.3 million loss in the same period last year.

Obicetrapib, a low-dose CETP inhibitor, has shown promising LDL-lowering effects in multiple Phase 2 and 3 trials, with a side effect profile similar to placebo. NewAmsterdam's extensive Phase 3 program includes trials like BROADWAY and TANDEM, aiming to further establish obicetrapib's efficacy and safety. The company also initiated the PREVAIL trial to assess obicetrapib's potential in reducing major adverse cardiovascular events.

NewAmsterdam has partnered with the Menarini Group for the commercialization of obicetrapib in Europe, both as a monotherapy and in combination with ezetimibe.

Overall, NewAmsterdam is making significant strides in developing obicetrapib as a key LDL-C lowering therapy, supported by robust clinical data and a strong financial foundation.