BROOKLYN Topline Results July 2024 Nasdaq: NAMS Exhibit 99.2
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Additional risks related to NewAmsterdam’s business include, but are not limited to: uncertainty regarding outcomes of the company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property-related claims; the Company’s ability to attract and retain qualified personnel; and the Company’s ability to continue to source the raw materials for its product candidate, together with the risks described in the Company’s filings made with the U.S. Securities and Exchange Commission from time to time. If any of these risks materialize or NewAmsterdam’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that are presently unknown by the Company or that NewAmsterdam currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect NewAmsterdam’s expectations, plans, or forecasts of future events and views as of the date of this Presentation and are qualified in their entirety by reference to the cautionary statements herein. NewAmsterdam anticipates that subsequent events and developments will cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing NewAmsterdam’s assessments as of any date subsequent to the date of this Presentation. 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HeFH Overview Heterozygous familial hypercholesterolemia (“HeFH”), a genetic disorder that affects 1 in 250 persons, or approximately 30 million people worldwide, is characterized by elevated levels of low-density lipoprotein cholesterol (“LDL-C”) from birth. Without treatment, the condition is associated with premature complications and death from accelerated development of atherosclerotic cardiovascular disease. Source: Eur Heart J, Volume 34, Issue 45, 1 December 2013, Pages 3478–3490
Study Design and Baseline Characteristics Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies: A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants with a History of HeFH and LDL‑C ³70 mg/dL who are Not Adequately Controlled by Their Lipid‑Modifying Therapies Key Inclusion Criteria HeFH LDL-C ≥70 mg/dL Maximally tolerated lipid lowering therapy Key Exclusion Criteria HoFH Uncontrolled hypertension Endpoints Primary: LDL-C at day 84 Secondary: ApoB, Lp(a), non-HDL-C, HDL-C Safety: AE’s, vitals, laboratory Study Design Baseline Lipid Modifying Therapy Any statin 89% High intensity statin: 79% Ezetimibe: 54% PCSK9i 14% Other 8% Regions N. America S. Africa Europe Demographics 53% Female 57 years of age BMI: 29 kg/m2 Baseline Lipids (obicetrapib 10mg mean) Placebo Obicetrapib 10 mg (2:1 randomization) N = 354 13-months 1º endpoint Note: AEs: adverse events; ApoB: apolipoprotein B; HoFH: Homozygous FH
Disposition of All Randomized Participants Placebo Obicetrapib 10 mg Total Randomized 118 236 354 Completed treatment 101 (85.6) 218 (92.4) 319 (90.1) Discontinued treatment 17 (14.4) 18 (7.6) 35 (9.9) Discontinued due to AE’s 7 (5.9) 8 (3.4) 15 (4.2) Subject decision 4 (3.4) 4 (1.7) 8 (2.3) Withdraw of consent 3 (2.5) 3 (1.3) 6 (1.7) Death 2 (1.7) 2 (0.8) 4 (1.1) Lost to follow-up 1 (0.8) 1 (0.4) 2 (0.6) Completed the study 110 (93.2) 226 (95.8) 336 (94.9) Discontinued study early 8 ( 6.8) 10 ( 4.2) 18 ( 5.1) Adverse event 0 ( 0.0) 1 ( 0.4) 1 ( 0.3)
Additional Baseline Details of All Randomized Patients Placebo N=118 Obicetrapib 10 mg N=236 Total N=354 Mean Age (years) 56.6 57.0 56.9 Sex (F) n (%) 65 (55.1) 125 (53.0) 190 (53.7) Region n (%) EMEA 83 ( 70.3) 182 ( 77.1) 265 ( 74.9) North America 35 ( 29.7) 54 ( 22.9) 89 ( 25.1) Race n (%) White 110 ( 93.2) 219 ( 92.8) 329 ( 92.9) African American 3 ( 2.5) 3 ( 1.3) 6 ( 1.7) Height (mean) 169.4 169.9 169.8 Weight (mean) 85.2 85.2 85.2 BMI (mean) 29.6 29.3 29.4 HeFH Genotyping + or DLCN >8 points or SB definite 84 ( 71.2) 172 ( 72.9) 256 ( 72.3) SB possible FH diagnosis 33 ( 28.0) 61 ( 25.8) 94 ( 26.6)
Additional Baseline Details of All Randomized Patients Placebo N=118 Obicetrapib 10 mg N=236 Total N=354 Diabetes n (%) Yes 26 ( 22.0) 47 ( 19.9) 73 ( 20.6) No 92 ( 78.0) 189 ( 80.1) 281 ( 79.4) Statin treatment High Dose 80 ( 67.8) 186 ( 78.8) 266 ( 75.1) Low or Moderate Dose 19 ( 16.1) 23 ( 9.7) 42 ( 11.9) None 19 ( 16.1) 27 ( 11.4) 46 ( 13.0) Ezetimibe use Yes 59 ( 50.0) 127 ( 53.8) 186 ( 52.5) No 59 ( 50.0) 109 ( 46.2) 168 ( 47.5)
Statistically Significant LDL-C Reduction Observed at Primary Endpoint of Day 84 and Maintained Through Day 365 LS Mean % change vs. placebo LDL-C reduction over time (ITT population) 36.3% 41.5% 38.2% 38.3% Note: * = p<0.0001. Martin Hopkins mean changes at baseline, day 30, Day 180, Day 270 and LS mean by PUC at Day 84 and Day 365. * *
Greater Proportion of Patients in Obicetrapib Arm Achieved LDL-C Goal % of patients achieving LDL-C thresholds
LDL-C Responder Analysis in Obicetrapib 10mg arm 34% of patients in obicetrapib arm with >50% LDL-C reduction
Results Consistent with Data Reported from the Company's Prior Clinical Trials Note: LS mean change calculated by PUC. Obicetrapib 10mg for all studies
Overview of Treatment-Emergent Adverse Events – Safety Population Placebo N=118 n (%) Obicetrapib 10 mg N=234 n (%) Total N=352 n (%) Any treatment-emergent AEs (TEAEs) 83 ( 70.3) 149 ( 63.7) 232 ( 65.9) Any TEAEs by maximum severity Mild 47 ( 39.8) 84 ( 35.9) 131 ( 37.2) Moderate 28 ( 23.7) 57 ( 24.4) 85 ( 24.1) Severe 8 ( 6.8) 8 ( 3.4) 16 ( 4.5) Any study drug related TEAEs 8 ( 6.8) 10 ( 4.3) 18 ( 5.1) Any study drug-related TEAEs by maximum severity Mild 5 ( 4.2) 5 ( 2.1) 10 ( 2.8) Moderate 3( 2.5) 5 ( 2.1) 8 ( 2.3) Severe 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) Any TEAEs leading to discontinuation of study drug 8 ( 6.8) 10 ( 4.3) 18 ( 5.1) Any treatment-emergent serious AEs (TESAEs) 8 ( 6.8) 13 ( 5.6) 21 ( 6.0) Any treatment-emergent non-serious AEs 82 ( 69.5) 145 ( 62.0) 227 ( 64.5) Any study drug-related TESAEs 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) Any TEAEs leading to death 2 ( 1.7) 3 ( 1.3) 5 ( 1.4)
Overview of Treatment-Emergent Adverse Events >5% in Either Population Placebo N=118 n (%) Obicetrapib 10 mg N=234 n (%) Total N=352 n (%) Any non-serious treatment-emergent AEs 52 (44.1) 95 (40.6) 147 (41.8) Influenza 7 (5.9) 21 (9.0) 28 (8.0) Covid-19 8 (6.8) 15 (6.4) 23 (6.5) Hypertension 8 (6.8) 14 (6.0) 22 (6.3) Nasopharyngitis 5 (4.2) 15 (6.4) 20 (5.7) Diarrhea 8 (6.8) 9 (3.8) 17 (4.8) Upper respiratory tract infection 4 (3.4) 12 (5.1) 16 (4.5) Back pain 6 (5.1) 7 (3.0) 13 (3.7) Headache 6 (5.1) 7 (3.0) 13 (3.7) Fatigue 7 (5.9) 2 (0.9) 9 (2.6)
Overview of Adverse Events of Special Interest Placebo N=118 n (%) Obicetrapib N=234 n (%) AST or ALT > 3 x ULN 0 (0) 0 (0) Bilirubin > 2 x ULN 2 ( 1.7) 0 (0) CK > 5 x ULN 4 ( 3.4) 3 (1.3 ) NODM or worsening of glycemic control 26 (22.0) 48 (20.5) eGFR < 30 mL/min/1.73m2 or a 25% decrease in eGFR from baseline 10 (8.5) 10 (4.3) Increase of Serum Creatinine ≥ 0.3 mg/dL from baseline 9 (7.6) 5 (2.1) Macular degeneration 0 (0) 0 (0)
Conclusions Primary endpoint met with LS mean reduction in LDL-C at day 84 versus placebo of 36.3% (p<0.0001). LDL-C reduction sustained at day 365 of 41.5% (p<0.0001) 77% of patients receiving obicetrapib achieved LDL-C below 100 mg/dl, with 51% below 70 mg/dl, and 24% below 50 mg/dl 34% of patients in the treatment arm achieved a greater than 50% reduction from baseline in LDL-C at day 84 Reduction in LDL-C seen regardless of background therapy or number of therapies Observed to be generally well-tolerated with safety results comparable to placebo, with no increase in blood pressure or any difference from placebo in liver enzymes, hs-CRP, or renal function Consistent results for non-HDL-C, ApoB, and Lp(a) compared to data observed in Phase 2 studies that will be presented at an upcoming scientific conference
Study Design and Baseline Characteristics of Ongoing Phase 3 Trials Key Inclusion Criteria ASCVD or HeFH LDL-C ≥55 mg/dL w/risk factors, or LDL-C≥ 100 mg/dL Maximally tolerated lipid lowering therapy 13-months Placebo Obicetrapib 10 mg (2:1 randomization) N = 2532 13-months 1º endpoint – day 84 Baseline Lipids (mean) Baseline Lipid Modifying Therapy Any statin 91% High intensity statin: 65% Ezetimibe: 26% PCSK9i 4% Other 11% Key Inclusion Criteria ASCVD LDL-C ≥55 mg/dL w/risk factors, or LDL-C≥ 100 mg/dL Maximally tolerated lipid lowering therapy Placebo Obicetrapib 10 mg (1:1 randomization) N = 9541 54-months LDL-C endpoint Baseline Lipids (mean) Baseline Lipid Modifying Therapy Any statin >90% High intensity statin: 70% Ezetimibe: 23%
Note: Other than as noted, the pipeline represents trials that are currently ongoing. Projections are subject to inherent limitations. Actual results may differ from expectations. The timing of regulatory submissions is subject to additional discussions with regulators. Phase 3 BROADWAY Trial Lipid Mono Study (HeFH or ASCVD; LDL-C ≥ 55 mg/dL; n=2,532) Phase 3 BROOKLYN Trial Lipid Mono Study (HeFH; LDL-C ≥ 70 mg/dL; n=354) Phase 3 CVOT PREVAIL Trial (ASCVD or HeFH; LDL-C ≥ 55 mg/dL; n=9,541) Phase 2b Japan Trial (LDL-C ≥ 70 mg/dL; n=100) Phase 2b ROSE2 Trial (LDL-C ≥ 70 mg/dL; n=114) Phase 3 FDC Trial (LDL-C ≥ 70 mg/dL; n=407) Phase 2a Alzheimer’s Disease Trial (ApoE4 carrier; n=10–15) Ezetimibe FDC Product (obicetrapib 10mg + ezetimibe 10mg) Alzheimer’s Product (proprietary dose/formulation incorporating obicetrapib) Cardiovascular Neuro- metabolic 2022 2023 2024 2025 2026 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H Numerous catalysts expected throughout 2024-2026 Enrollment complete Ph3 readout CVOT readout Initiation Ph2 readout LEGEND Alzheimer’s Ph2a TANDEM FDC Ph3 ROSE2 Ph2b Obicetrapib Monotherapy Product (obicetrapib 10mg) BROADWAY Ph3 BROOKLYN Ph3 PREVAIL CVOT LDL regulatory filing MACE regulatory filing Japan Ph2b LDL regulatory filing Multiple Potential Pivotal Data Readouts in Next 12 Months
LDL-C at day 84 BROOKLYN LDL-C Reduction Applied to PREVAIL Baseline Data Continues to Suggest Hypothetical 20%+ MACE Benefit ~37 mg/dL drop in absolute LDL-C anticipated ~6% drop for a 10mg/dL move Expected to result in more absolute LDL-C reduction LDL-C PREVAIL baseline LDL-C lowering in BROOKLYN 37 mg/dL 103 mg/dL(1) 36% 22% drop Estimated MACE** benefit Note: Actual results may differ from hypothetical calculation. Source: Cholesterol Treatment Trialists Collaboration. Lancet. 2010 376:1670-81 Circulation. 2021;144:e564–e593 17065: Obicetrapib Lowers LDL-C in Patients Taking High Intensity Statins. (1) Represents estimated average baseline LDL to be enrolled, not entry criteria. ** MACE includes cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization in adults. LDL-C at day 365 Expected to result in more absolute LDL-C reduction LDL-C PREVAIL baseline LDL-C lowering in BROOKLYN 43 mg/dL 103 mg/dL(1) 41% 25% drop Estimated MACE** benefit
