NewAmsterdam Pharma Updates and Q1 Financial Results

NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS), a biopharmaceutical firm focused on developing non-statin oral medications for patients with cardiovascular disease (CVD) and high low-density lipoprotein cholesterol (LDL-C), has provided significant updates and financial results for the quarter ending March 31, 2024. The company, which boasts a strong cash position of $481.1 million at the end of the first quarter, is advancing its multi-pronged clinical development strategy for obicetrapib, a novel CETP inhibitor.

Michael Davidson, M.D., CEO of NewAmsterdam, highlighted several key milestones the company has achieved. The completion of enrollment in the PREVAIL trial, a major cardiovascular outcomes trial (CVOT) involving over 9,500 patients, stands out. Furthermore, NewAmsterdam has initiated the TANDEM trial, which evaluates a fixed-dose combination of obicetrapib and ezetimibe. Alongside these trials, the ongoing BROOKLYN and BROADWAY Phase 3 trials are expected to yield significant insights into the efficacy of obicetrapib in improving existing therapies by helping patients achieve their LDL-C targets.

The market for obicetrapib seems promising, particularly for patients with hypercholesterolemia who do not adequately respond to current statin therapies and PCSK9 inhibitors. NewAmsterdam is preparing for a potential global launch of obicetrapib, emphasizing its substantial market opportunity. Davidson expressed optimism about improving health outcomes for CVD patients globally if regulatory approvals are obtained.

In terms of clinical development, NewAmsterdam has made considerable progress. In March 2024, the company initiated TANDEM, a pivotal Phase 3 trial evaluating a fixed-dose combination of obicetrapib and ezetimibe for adult patients with conditions like HeFH and ASCVD. This trial targets those whose LDL-C levels remain high despite using maximally tolerated lipid-modifying therapies. In April 2024, NewAmsterdam announced reaching the enrollment target for the PREVAIL CVOT, which focuses on patients with a history of ASCVD. This achievement was buoyed by positive patient and physician engagement worldwide.

Additional data from the Phase 2 ROSE2 clinical trial, presented at the 2024 American College of Cardiology Congress, showed the impact of combining obicetrapib with ezetimibe as an adjunct to high-intensity statin therapy. This combination influenced multiple lipid biomarkers, including LDL particle number and small dense LDL-C.

Corporate updates include the appointment of William H. Lewis as the new Chair of the Board of Directors and Juliette Audet as Chief Business Officer. Lewis brings over 30 years of experience in pharmaceuticals and finance, while Audet has a robust background in pharmaceutical business development.

Financially, NewAmsterdam has demonstrated robust management with increased R&D investments and strategic growth. The company reported a decrease in revenue from $8.6 million in Q1 2023 to $1.4 million in Q1 2024, primarily due to milestone-dependent revenue recognition. R&D expenses increased to $42.4 million, reflecting ongoing Phase 3 trials, while SG&A expenses rose to $14.5 million, attributed to team expansion and preparations for a potential commercial launch of obicetrapib. The company reported a net loss of $93.8 million for the quarter, compared to $42.0 million in the previous year.

Obicetrapib, NewAmsterdam's flagship product, aims to address the limitations of current LDL-lowering treatments. The ongoing Phase 3 pivotal trials—BROADWAY and BROOKLYN—are assessing its efficacy as a monotherapy adjunct to statins. The TANDEM trial, evaluating the combination of obicetrapib and ezetimibe, continues to progress. The PREVAIL CVOT, which began in March 2022, aims to determine obicetrapib’s potential in reducing major adverse cardiovascular events.

NewAmsterdam Pharma remains committed to its mission of enhancing treatment options for patients with metabolic diseases, particularly those inadequately served by current therapies. The company's future milestones include announcing topline data from the BROOKLYN trial in Q3 2024, the BROADWAY trial in Q4 2024, and the TANDEM trial in Q1 2025.