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5/7/2026
Good day, everyone. My name is June and I will be your conference operator today. At this time, we would like to welcome you to the new Amsterdam Prevail update call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, and if you have joined via the webinar, please use the raised hand icon, which can be found at the bottom of your webinar application. At this time, I would like to turn the call over to Matthew Phillippe, Executive Vice President, Head of Investor Relations.
Thank you, and good morning, everybody. Thanks for joining our call today. I'm excited to have Michael Davidson, CEO, John Kastelein, Chief Scientific Officer, and Ian Samaya, our Chief Financial Officer, on the call today. The presentation we'll be discussing is available on our investor site, so please feel free to access it there. However, before we begin, I let Michael share some exciting news. I would like to remind everyone and direct everyone to slide two and remind that this call will contain forward-looking statements within the meaning of federal securities law. These statements may include but are not limited to those related to potential clinical benefits of our product candidates, our clinical trial progress and design, and our expectations regarding the contemplated interim analysis of our prevailed trial and trial completion. Each of these forward-looking statements is subject to risks and uncertainties that could cause actual results to differ materially from those in such statements. These risks and uncertainties are discussed in our annual report on Form 10-K filed with the Securities and Exchange Commission on February 18, 2026, and in subsequent SEC filings, including our Form 10-Q for the quarter ended March 31, 2026, which we're filing with the SEC today. Our filings are available at sec.gov and on our website, newamsterdampharma.com. Except as required by law, we assume no obligation to update forward-looking statements publicly, even if new information becomes available in the future. With that, I'm excited to present and introduce Michael Davidson, CEO of New Amsterdam. Michael.
Thanks, Matt. Good morning, everyone, and welcome to our Prevail Update call. Today I'm excited to provide an update on the clinical development of Obacetrapib, including the latest timelines for completion of the PREVAIL trial. We recently marked the two-year anniversary of the last patient enrolled in PREVAIL, and have observed some encouraging trends in the blinded data. As previously disclosed, the first year blinded event random prevail is tracking in line with what we saw on Broadway, which John will discuss in more detail shortly. This is consistent with the intent of the design of this trial. Importantly, the year one to year two overall MACE rate has been lower than anticipated, a trend we find encouraging when viewed against historical LDL-C outcome studies in this population. As a result, we have decided to conduct an interim analysis in the fourth quarter of 2026. This timing aligns with a minimum 2.5-year follow-up for the trial, and we expect results in the first quarter of 2027. Should the trial not stop for efficacy at the interim, we continue to anticipate completion by the end of 2027. With the recent expansion of the primary endpoint of MACE4 to include total coronary rather than urgent revascularization and an expected median follow-up of nearly 3.5 years, the interim analysis will now occur with substantially more events than approximately 950 events we had previously projected. This gives us a statistically more power for the primary 4-point MACE endpoint, but the statistical power to detect a 3-point benefit remains unchanged. In Broadway, we observed a 0.79 hazard ratio for the exploratory MACE 4 endpoint. Should we see a comparable hazard ratio in both May 3 and May 4, we will be well-powered to detect the difference at the interim. These data remain preliminary as we continue to complete adjudication of year two events, but they signal a potentially meaningful and encouraging trend. We look forward to sharing additional details at our annual investor day on August 5, 2026. With that, I'd like to turn the call over to my dear friend and colleague, John Kastelein. John?
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