NewAmsterdam Pharma Updates Corporate Progress and Q3 Financials

NewAmsterdam Pharma Company N.V., a clinical biopharmaceutical firm, announced the financial results for the quarter and the nine months ending September 30, 2024. The company, which focuses on developing non-statin oral medicines for patients with cardiovascular diseases at risk due to elevated low-density lipoprotein cholesterol (LDL-C), reported significant advancements in its clinical trials.

Chief Executive Officer Michael Davidson, M.D., highlighted a successful quarter marked by efficient execution across their Phase 3 clinical trials. The crucial Phase 3 TANDEM trial, evaluating a fixed-dose combination of obicetrapib and ezetimibe, witnessed an acceleration in patient enrollment, allowing the company to anticipate the release of topline data by the fourth quarter of 2024. Similarly, the Phase 3 BROADWAY trial is on schedule to report topline data within the same timeframe, while the extensive 9,500-patient PREVAIL cardiovascular outcomes trial continues to progress.

Dr. Davidson emphasized the considerable potential to meet the unmet needs within the cardiovascular disease sector, a leading cause of death globally. With the recently secured patent ensuring exclusivity through 2043 in the U.S., sufficient cash reserves to fund pivotal Phase 3 outcomes, and a skilled leadership team, NewAmsterdam Pharma is poised to advance its mission. The company remains focused on clinical execution and aims to commercialize obicetrapib, pending approval, to significantly improve patient care for those living with hyperlipidemia.

NewAmsterdam's clinical development program is comprehensive, including the pivotal Phase 3 TANDEM and BROADWAY trials. The TANDEM trial, due to faster enrollment, is expected to provide topline results by late 2024 and involves patients with heterozygous familial hypercholesterolemia and/or atherosclerotic cardiovascular disease. The BROADWAY trial also promises topline results within the same period, assessing obicetrapib as a monotherapy in adults with HeFH and/or established ASCVD.

The company’s global Phase 3 clinical development encompasses four studies with over 12,250 patients, including three for obicetrapib monotherapy and one for the fixed-dose combination of obicetrapib and ezetimibe. Upcoming milestones include presenting additional safety and efficacy data from the Phase 3 BROOKLYN trial at the AHA Scientific Sessions in Chicago and announcing topline data from the BROADWAY trial by the end of 2024.

Financially, NewAmsterdam reported a cash position of $422.7 million as of September 30, 2024, up from $340.5 million at the end of 2023. This increase stemmed from the follow-on offering, milestone achievements, and warrant exercises, counterbalanced by R&D expenses and administrative costs. Revenue for the third quarter of 2024 was $29.1 million, a significant rise from $2.9 million in the same period in 2023, driven by clinical development milestones from Menarini.

Research and development expenses decreased to $35.7 million in the third quarter of 2024 from $43.4 million in the same period last year, mainly due to the completion or near completion of several clinical trials. However, selling, general, and administrative expenses increased to $18.4 million, reflecting the company’s expansion and preparations for the potential commercial launch of obicetrapib.

Net loss for the third quarter of 2024 was $16.6 million, a notable reduction from the $47.1 million loss recorded in the same period in 2023. The reduction in net loss is attributed to the detailed financial changes mentioned above.

Obicetrapib, the company's flagship product, is a novel, oral CETP inhibitor being developed to address the limitations of current LDL-lowering treatments. Observations from multiple Phase 2 and Phase 3 trials have shown significant LDL-C reduction and a safety profile comparable to placebo. The upcoming BROADWAY trial will further assess obicetrapib as a monotherapy for additional LDL-lowering in CVD patients, while the TANDEM trial will evaluate its combination with ezetimibe.

Overall, NewAmsterdam continues to make notable strides in its mission to provide effective, well-tolerated LDL-lowering therapies, positioning itself as a key player in addressing cardiovascular diseases. With ongoing Phase 3 trials and a strong financial foundation, the company is set to achieve significant milestones in the near future.