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About NewAmsterdam Pharma
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to transforming patient care in the field of cardiovascular disease (CVD). With a focus on populations where existing therapies are insufficient or poorly tolerated, NewAmsterdam aims to address significant unmet medical needs through innovative, non-statin LDL-C lowering treatments.
Core Product: Obicetrapib
At the heart of NewAmsterdam’s development pipeline is obicetrapib, a next-generation, oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor. Designed to overcome the limitations of current LDL-C lowering therapies, obicetrapib offers a once-daily, highly selective treatment option. It is being developed both as a monotherapy and in a fixed-dose combination with ezetimibe, targeting patients at risk of CVD who struggle to achieve LDL-C goals despite maximally tolerated statins or other lipid-lowering therapies.
Clinical Development Program
NewAmsterdam is conducting a comprehensive Phase 3 clinical development program involving over 12,250 patients worldwide. Key trials include:
- BROADWAY: Evaluates obicetrapib monotherapy in patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH).
- BROOKLYN: Focuses on LDL-C reduction in HeFH patients on maximally tolerated lipid-lowering therapy.
- TANDEM: Assesses the fixed-dose combination of obicetrapib and ezetimibe for LDL-C lowering in ASCVD and HeFH patients.
- PREVAIL: A cardiovascular outcomes trial (CVOT) designed to evaluate obicetrapib’s ability to reduce major adverse cardiovascular events (MACE).
These trials have demonstrated statistically significant LDL-C reductions and a safety profile comparable to placebo, positioning obicetrapib as a promising alternative for patients with limited options.
Market Position and Differentiation
NewAmsterdam operates in the highly competitive cardiovascular treatment market, which includes statins, PCSK9 inhibitors, and other lipid-lowering therapies. The company differentiates itself through its focus on CETP inhibition, offering a novel mechanism of action that addresses residual cardiovascular risk factors beyond LDL-C reduction, such as lipoprotein(a) and small LDL particles.
With robust intellectual property protection extending until 2043 and exclusive European commercialization rights granted to the Menarini Group, NewAmsterdam is strategically positioned to capture a significant share of the LDL-C lowering market.
Addressing Unmet Needs in CVD
Cardiovascular disease remains the leading cause of death globally, with millions of patients failing to achieve LDL-C targets despite available therapies. NewAmsterdam aims to bridge this gap by offering a safe, effective, and convenient oral treatment option. Obicetrapib’s potential to reduce LDL-C and improve cardiovascular outcomes could transform the treatment landscape for patients with ASCVD, HeFH, and other high-risk conditions.
Commitment to Innovation and Patient Care
NewAmsterdam’s mission is underpinned by a commitment to rigorous clinical research, operational excellence, and patient-centric innovation. By addressing critical gaps in CVD treatment, the company seeks to improve health outcomes for millions of patients worldwide.
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS), a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for cardiovascular disease patients with elevated LDL-C, has announced the grant of inducement share options to a new non-executive hire. The Compensation Committee approved options for 59,200 ordinary shares under the 2024 Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4).
The options have an exercise price of $17.25 per share, matching the closing market price on August 1, 2024. The shares will vest over four years, with 25% vesting after one year and the remainder vesting in 36 monthly installments, subject to continued employment. This grant is part of NewAmsterdam's strategy to attract and retain key talent in its mission to develop innovative cardiovascular treatments.
NewAmsterdam Pharma (Nasdaq: NAMS) announced positive topline data from its Phase 3 BROOKLYN clinical trial evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia (HeFH). The trial met its primary endpoint, achieving a 36.3% reduction in LDL-C compared to placebo at day 84 (p<0.0001), which was sustained at 41.5% reduction at day 365 (p<0.0001). Obicetrapib was observed to be well-tolerated with safety results comparable to placebo and no increase in blood pressure. The treatment discontinuation rate for obicetrapib was 7.6% versus 14.4% for placebo. The trial involved 354 patients randomized 2:1 to receive 10 mg obicetrapib or placebo once daily. These results support obicetrapib's potential to significantly reduce LDL-C in a challenging patient population over one year.
NewAmsterdam Pharma (Nasdaq: NAMS) has announced it will report topline data from its Phase 3 BROOKLYN clinical trial (NCT05425745) on Monday, July 29, 2024. The trial evaluates obicetrapib in patients with heterozygous familial hypercholesterolemia. NewAmsterdam, a late-stage biopharmaceutical company, is developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C. The company will host a live webcast and conference call to review the results on July 29, 2024, at 8:30 a.m. ET. Participants can register for the webcast or telephone conference, and an archived replay will be available on the company's website.
NewAmsterdam Pharma (Nasdaq: NAMS) has announced significant changes to its Board of Directors. Mark C. McKenna and Wouter Joustra have been appointed as temporary non-executive directors, while Sander Slootweg has departed. McKenna brings over 20 years of pharmaceutical industry experience, including leadership roles at Prometheus Biosciences and Salix Pharmaceuticals. Joustra, a General Partner at Forbion, contributes expertise in capital markets and life sciences investment.
These appointments come at a important time for NewAmsterdam, as the company approaches pivotal Phase 3 data readouts for its oral, non-statin medicines targeting cardiovascular disease patients with elevated LDL-C. The new directors are expected to provide valuable insights and support as NewAmsterdam aims to make a significant impact on the CVD landscape.
NewAmsterdam Pharma has completed enrollment for its pivotal Phase 3 TANDEM clinical trial, which evaluates a fixed-dose combination of obicetrapib and ezetimibe in patients with Heterozygous Familial Hypercholesterolemia (HeFH) or Atherosclerotic Cardiovascular Disease (ASCVD) or its risk factors. The trial includes 407 patients whose LDL-C levels are not adequately controlled despite existing therapies. The primary goal is to assess changes in LDL-C levels, with secondary goals focusing on lipoprotein(a), apolipoprotein B, and non-HDL-C.
Topline data is expected in Q1 2025. The trial is double-blind and placebo-controlled. This milestone aims to advance obicetrapib as a convenient, once-daily treatment for dyslipidemia, potentially improving health outcomes globally if approved.
NewAmsterdam Pharma (Nasdaq: NAMS) announced that its Compensation Committee approved inducement share options for three new non-executive employees. A total of 195,000 ordinary shares were granted under the 2024 Inducement Plan, in line with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $20.58 per share, matching the closing price on July 1, 2024. The shares will vest over four years, starting with 25% on the one-year anniversary of the vesting commencement date, followed by 36 equal monthly installments, subject to continued employment.
NewAmsterdam Pharma announced that the United States Patent and Trademark Office (USPTO) has issued a new composition of matter patent for obicetrapib, extending its patent protection until July 2043. This patent covers amorphous obicetrapib hemicalcium, the solid form to be used in the company's products, and will be listed in the FDA's Orange Book if approved. The USPTO has issued or allowed nine patents for obicetrapib and its applications. CEO Michael Davidson highlighted that this new patent extends protection more than 9 years beyond the previous patent, facilitating ongoing Phase 3 trials and long-term benefits from obicetrapib's innovation.
NewAmsterdam Pharma (Nasdaq: NAMS), a biopharmaceutical company developing oral, non-statin medicines for cardiovascular disease (CVD) patients with elevated LDL-C, announced the approval of inducement share options for five new non-executive hires. The Compensation Committee granted options for a total of 90,000 ordinary shares under the 2024 Inducement Plan. These options, priced at $18.92 per share based on the June 3, 2024 market close, will vest over four years: 25% after one year and the remaining 75% in equal monthly installments over the next three years, contingent upon continued employment. The grants adhere to Nasdaq Listing Rule 5635(c)(4).
NewAmsterdam Pharma, a late-stage clinical biopharmaceutical company developing non-statin medicines for cardiovascular disease patients with elevated LDL-C, announced its management's participation in two upcoming investor conferences.
On June 5, 2024, the company will attend the Jefferies Global Healthcare Conference in New York, where CEO Michael Davidson and CFO Ian Somaiya will engage in a fireside chat at 3:00 p.m. ET.
On June 10, 2024, CEO Michael Davidson will present a corporate overview at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach at 10:40 a.m. ET. Live webcasts of both events will be available on the company's investor relations website, with replays accessible post-event.
NewAmsterdam Pharma (Nasdaq: NAMS) announced it will present new clinical and preclinical data on obicetrapib, a novel oral therapy for hypercholesterolemia, at two major upcoming medical meetings. The data, derived from the OCEAN, ROSE, and ROSE2 Phase 2 trials, show obicetrapib's impact on key lipid and lipoprotein biomarkers. The presentations will occur at the European Atherosclerosis Society (EAS) 92nd Congress in Lyon, France, and the National Lipid Association (NLA) 2024 Scientific Sessions in Las Vegas, Nevada. The company is also on track to report topline data from its Phase 3 BROOKLYN trial in HeFH by Q3 2024 and its Phase 3 BROADWAY trial in ASCVD by Q4 2024.
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