NewAmsterdam Pharma Reports Q1 2024 Financials and Corporate Update

NewAmsterdam Pharma Company N.V., a biopharmaceutical firm (Nasdaq: NAMS), has released significant corporate updates and financial results for the first quarter of 2024. The company, which focuses on developing non-statin oral medications for cardiovascular disease patients with elevated LDL cholesterol, has reported several advancements in its clinical development efforts.

During the past months, NewAmsterdam has accomplished notable milestones. The company recently completed enrollment for the PREVAIL cardiovascular outcomes trial (CVOT) and initiated the pivotal Phase 3 TANDEM trial. These studies, along with the ongoing BROOKLYN and BROADWAY trials, aim to assess the potential benefits of obicetrapib, a CETP inhibitor, in improving LDL-C levels and reducing cardiovascular events. The trials are expected to yield crucial data, with topline results from BROOKLYN and BROADWAY anticipated in the third and fourth quarters of 2024, respectively.

CEO Michael Davidson emphasized the importance of these developments, noting the growing patient and physician interest in obicetrapib. The market potential for obicetrapib is substantial, given the millions of individuals suffering from hypercholesterolemia and ASCVD who are not meeting LDL-C targets despite existing therapies.

NewAmsterdam is gearing up for a potential global launch of obicetrapib, should it receive regulatory approval. The company plans to share further details about its pre-launch and commercial strategies during an R&D Day event on May 16, 2024.

Clinical trials are progressing well, with the TANDEM trial having dosed its first patient in March 2024. Additionally, the Phase 3 PREVAIL CVOT trial has surpassed its enrollment target, enrolling over 9,500 patients by April 2024. NewAmsterdam also presented promising data from its Phase 2 ROSE2 trial at the 2024 American College of Cardiology Congress, showcasing the efficacy of obicetrapib combined with ezetimibe in reducing LDL levels.

Corporate updates reveal strategic changes and financial maneuvers. William H. Lewis was appointed as Chair of the Board of Directors in January 2024, bringing extensive experience in the pharmaceutical and finance sectors. In February, the company raised $190 million through a public offering, which will support the ongoing development and commercial readiness of obicetrapib. Juliette Audet was appointed as Chief Business Officer in April, stepping down from the Board of Directors to focus on her new role.

Financially, NewAmsterdam ended the quarter with $481.1 million in cash, up from $340.5 million at the end of 2023. The increase is attributed to proceeds from the public offering and warrant exercises, partially offset by R&D and administrative expenses. The company recognized $1.4 million in revenue for the first quarter, a decrease from the same period in 2023 due to fewer milestone achievements in clinical development. R&D expenses rose slightly to $42.4 million, while SG&A expenses increased to $14.5 million, reflecting the company's expansion and preparation for obicetrapib's potential commercial launch.

Net loss for the quarter was $93.8 million, compared to $42.0 million in the first quarter of 2023, primarily driven by increased operational expenses and fair value changes in warrants and earnouts.

Obicetrapib, NewAmsterdam's lead product, is a CETP inhibitor designed to lower LDL cholesterol in patients who do not respond well to current treatments. The company is conducting several Phase 3 trials to evaluate the efficacy of obicetrapib both as a monotherapy and in combination with ezetimibe. The PREVAIL trial aims to determine the drug's potential to reduce major cardiovascular events, with over 9,500 patients enrolled.

NewAmsterdam Pharma remains committed to addressing unmet needs in cardiovascular disease treatment, with ongoing efforts to bring obicetrapib to market and improve patient outcomes globally.