NewAmsterdam Pharma pany N.V.(NAMS) - 2024 Q2 - Quarterly Results

Corporate Update and Second Quarter Financial Results NewAmsterdam Pharma reported strong Q2 2024 results, including positive BROOKLYN trial data, extended patent protection, and a robust financial position Second Quarter 2024 Highlights NewAmsterdam Pharma reported significant progress in Q2 2024, highlighted by positive topline data from the pivotal Phase 3 BROOKLYN trial for obicetrapib, which successfully met its primary endpoint for LDL-C reduction - Reported positive topline data from the pivotal Phase 3 BROOKLYN trial, achieving its primary endpoint of reducing LDL-C in patients with HeFH[1] - Secured a new composition of matter patent in the U.S., extending intellectual property protection for obicetrapib into 2043[1][2] - Maintained a strong financial position with $430.7 million in cash as of June 30, 2024[1] - Enrollment for the pivotal Phase 3 TANDEM trial is complete, with topline data anticipated in Q1 2025[1] - The pivotal Phase 3 BROADWAY trial is on track to report topline data in Q4 2024[1] CEO Commentary CEO Michael Davidson, M.D., expressed satisfaction with the company's execution in the first half of 2024, emphasizing the positive and statistically significant results from the Phase 3 BROOKLYN trial - The CEO highlighted the positive results from the Phase 3 BROOKLYN trial in a difficult-to-treat HeFH patient population, noting the LDL-C lowering was consistent with Phase 2 studies and the safety profile was comparable to placebo[2] - The company's strong position is supported by a new U.S. composition of matter patent extending protection to 2043 and a cash balance of $430.7 million[2] - Future catalysts include topline data from the BROADWAY trial in Q4 2024 and the TANDEM trial in Q1 2025, alongside the advancement of the PREVAIL cardiovascular outcomes trial (CVOT)[2] Clinical and Corporate Development NewAmsterdam advanced its clinical pipeline with positive BROOKLYN trial results, completed TANDEM enrollment, initiated REMBRANDT, and strengthened its IP and governance Clinical Development Updates The company announced positive topline data from the Phase 3 BROOKLYN trial, where obicetrapib met its primary endpoint with a significant reduction in LDL-C and a safety profile comparable to placebo Phase 3 BROOKLYN Trial Topline Results | Metric | Result | p-value | | :--- | :--- | :--- | | LS Mean LDL-C Reduction (Day 84) | 36.3% vs placebo | < 0.0001 | | LS Mean LDL-C Reduction (Day 365) | 41.5% vs placebo | < 0.0001 | - In the BROOKLYN trial, obicetrapib was well-tolerated with safety results comparable to placebo, showing no increase in blood pressure or adverse effects on liver enzymes, hs-CRP, or renal function[4] - Patient enrollment was completed in the pivotal Phase 3 TANDEM trial, which evaluates a fixed-dose combination of obicetrapib and ezetimibe[4] - A new Phase 3 trial, REMBRANDT, was initiated to evaluate the fixed-dose combination of obicetrapib and ezetimibe on coronary atherosclerotic plaque characteristics[4] Corporate Updates In Q2 2024, NewAmsterdam made key changes to its Board of Directors, appointing Mark C. McKenna and Wouter Joustra - Appointed Mark C. McKenna and Wouter Joustra to its Board of Directors in July 2024[5] - The USPTO issued U.S. Patent No. 12,006,305, a composition of matter patent for obicetrapib, providing intellectual property protection until July 2043[5] - Hosted an R&D Day in May 2024 to discuss obicetrapib's clinical development, commercial strategy, and the cardiovascular disease landscape[5] Upcoming Potential Milestones NewAmsterdam anticipates several key milestones for its pivotal Phase 3 program - Q4 2024: Announce topline data from the Phase 3 BROADWAY trial for obicetrapib monotherapy[6] - Q1 2025: Announce topline data from the Phase 3 TANDEM trial evaluating a fixed-dose combination of obicetrapib and ezetimibe[6] - Full data from the Phase 3 BROOKLYN trial will be presented at an upcoming medical conference and published in a major medical journal[6] Financials NewAmsterdam's Q2 2024 financials show increased R&D and SG&A expenses leading to a net loss, offset by a strengthened cash position from a follow-on offering Second Quarter Financial Results For the second quarter of 2024, NewAmsterdam reported a net loss of $39.0 million Q2 2024 Financial Summary (Three Months Ended June 30) | Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Revenue | $2.3 million | $1.7 million | | R&D Expenses | $38.4 million | $34.3 million | | SG&A Expenses | $16.5 million | $9.9 million | | Net Loss | $39.0 million | $38.3 million | | Net Loss per Share | $0.41 | $0.47 | - Cash position increased to $430.7 million as of June 30, 2024, from $340.5 million at December 31, 2023, mainly driven by proceeds from a follow-on offering and warrant exercises[7] - The increase in R&D expenses was primarily due to clinical costs for ongoing Phase 3 trials, while the rise in SG&A expenses was driven by personnel costs and investments to support planned commercial launch[7] Financial Statements The unaudited condensed consolidated financial statements detail the company's financial position and performance Condensed Consolidated Balance Sheet Highlights (in thousands USD) | Account | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash | $430,708 | $340,450 | | Total Assets | $446,690 | $347,097 | | Total Liabilities | $59,251 | $58,704 | | Total Shareholders' Equity | $387,439 | $288,393 | Condensed Consolidated Statement of Operations (Six Months Ended June 30, in thousands USD) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Revenue | $3,680 | $10,346 | | Operating Loss | ($108,057) | ($82,335) | | Net Loss | ($132,774) | ($80,309) | | Net Loss per Share | ($1.45) | ($0.98) | Condensed Consolidated Statement of Cash Flows (Six Months Ended June 30, in thousands USD) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net Cash Used in Operating | ($108,581) | ($61,168) | | Net Cash Used in Investing | ($594) | ($12) | | Net Cash Provided by Financing | $202,838 | $8,726 | | Net Change in Cash | $93,663 | ($52,454) | Company and Product Overview NewAmsterdam Pharma is a late-stage biopharmaceutical company developing obicetrapib, a novel CETP inhibitor, to address unmet needs in LDL-lowering therapies About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to address the limitations of current LDL-lowering treatments - Obicetrapib is a novel, oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor designed to overcome limitations of current LDL-lowering therapies[8] - The Phase 3 PREVAIL cardiovascular outcomes trial (CVOT) completed enrollment in April 2024 with over 9,500 patients randomized to assess obicetrapib's potential to reduce major adverse cardiovascular events[8] - Commercialization rights for obicetrapib in Europe have been exclusively granted to the Menarini Group[8] About NewAmsterdam NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on improving care for patients with metabolic diseases where current therapies are inadequate or poorly tolerated - NewAmsterdam is a late-stage biopharmaceutical company focused on metabolic diseases with inadequately met needs[9] - The company's mission is to develop a safe, well-tolerated, and convenient LDL-lowering therapy, with its lead candidate being obicetrapib, an oral, low-dose, once-daily CETP inhibitor[9]