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NewAmsterdam Pharma Company N.V. - namsw STOCK NEWS

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NewAmsterdam Pharma Co NV is a late-stage biopharmaceutical company with a mission to improve patient care in populations with metabolic diseases. Their product, obicetrapib, is a next-generation, oral, low-dose CETP inhibitor designed to overcome the limitations of current LDL-C lowering treatments. The company is focused on developing innovative therapies for cardiovascular diseases where existing treatments are inadequate or not well-tolerated.

The latest updates from the company include financial results for the fourth quarter and full year of 2023, corporate developments, and ongoing clinical trials of obicetrapib. With significant progress in clinical execution, NewAmsterdam aims to revolutionize patient outcomes and deliver value to its shareholders.

2023 was marked by positive clinical data from various Phase 2 trials, demonstrating significant LDL-lowering and a favorable safety profile. The company is currently conducting pivotal Phase 3 trials, including BROOKLYN, BROADWAY, PREVAIL, and TANDEM, to evaluate the efficacy and safety of obicetrapib in different patient populations.

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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.

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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.

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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.

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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.

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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).

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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.

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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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NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) provides corporate updates and financial results for the first quarter of 2024. The company enrolled over 9,500 patients in Phase 3 trials, reported strong financial position with $481.1 million in cash, and is on track to report topline data from upcoming trials. NewAmsterdam continues to develop obicetrapib, focusing on improving LDL-C goals for patients at risk of cardiovascular disease.

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NewAmsterdam Pharma Company N.V. announced the grant of inducement share options to three non-executive new hires under the 2024 Inducement Plan. The options cover 30,000 ordinary shares, with an exercise price of $21.97 per share. The shares will vest over four years, with 25% vesting after one year and the rest in monthly installments, contingent on continued service.

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NewAmsterdam Pharma Company N.V. will host an R&D Day event on May 16, 2024, to discuss obicetrapib's clinical development path and NewAmsterdam's commercial strategy with key opinion leaders in cardiovascular disease. The event will feature renowned specialists and will be live webcasted.

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FAQ

What is NewAmsterdam Pharma known for?

NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on improving patient care in metabolic diseases, particularly cardiovascular.

What is obicetrapib and its significance?

Obicetrapib is a next-generation CETP inhibitor developed by NewAmsterdam to overcome the limitations of current LDL-C lowering treatments, offering potential benefits for patients at risk of cardiovascular diseases.

What are the company's key achievements in 2023?

In 2023, NewAmsterdam reported significant progress in clinical execution, positive data from Phase 2 trials, and expansion of their team, emphasizing commitment to revolutionizing patient outcomes and delivering value to shareholders.

What are the upcoming milestones for NewAmsterdam?

NewAmsterdam expects to achieve milestones like topline results from BROOKLYN and BROADWAY, initiation of the TANDEM trial, completion of PREVAIL enrollment, and strategic investments in the commercial organization.

How does obicetrapib differ from existing therapies?

Obicetrapib aims to be a once-daily oral CETP inhibitor with strong tolerability and LDL-lowering effects, potentially offering an improved treatment option for patients with cardiovascular risks.

What is the focus of NewAmsterdam's clinical development strategy?

NewAmsterdam's clinical development strategy revolves around multiple pivotal Phase 3 trials evaluating obicetrapib's efficacy and safety in different patient populations at risk of cardiovascular diseases.

NewAmsterdam Pharma Company N.V.

Nasdaq:NAMSW

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