Newamsterdam Pharma Company N.v. · NASDAQ:NAMS
Newamsterdam Pharma — Investor Presentation (June 2023)
33 slides from Newamsterdam Pharma's investor presentation, Jun 5, 2023
Slide 1: NewAmsterdam Pharma
MI” NewAmsterdam Pharma
Slide 2: Disclaimer
Disclaimer This presentation (together with oral statements made in connection herewith, this “Presentation”) is for informational purposes only. This Presentation shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shall there be any sale of securities
Slide 3: Summary of clinical data
NewAmsterdam Pharma a ye) Summary of clinical data *
Slide 4: Obicetrapib and Ezetimibe lower LDL-C in patients on high intensity statins: ROSE2
2 The combination of Obicetrapib and Ezetimibe observed to lower LDL-C in Patients on High Intensity Statins: Results from the ROSE2 Trial (NCT05266586). Christie M Ballantyne, Stephen J Nicholls, Marc Ditmarsch, John J Kastelein, Douglas Kling, Danielle L Curcio, Michael H Davidson 4
Slide 5: ROSE2 trial: Obicetrapib and high intensity statin therapy
ROSE2 trial: Obicetrapib and high intensity statin therapy Objective To evaluate the effect of obicetrapib 10 mg in combination with ezetimibe 10 mg on top of HIS on LDL-C Inclusion criteria Trial design • A stable dose of High Intensity Statins Obicetrapib 10mg (n=39) Safety (A 40 / 80; R 20 / 40)
Slide 6: Patient disposition
Patient disposition Screened (N=231) Screen failures (N=112) Randomized (N=119) N=40 N=39 N=40 N=119 Discontinued treatment (N=9) N=4 N=3 N=2 N=9 Primary efficacy assessment N=40 N=26 N=31 N=97 (on-treatment) (N=97) Safety population (N=119) N=40 N=39 N=40 N=119 Obicetrapib 10 mg Placebo Obicetrapib
Slide 7: Baseline characteristics
Baseline characteristics Placebo Obicetrapib 10 mg Obicetrapib 10mg / Ezetimibe 10 mg N=40 (%) N=26 (%) N=31 (%) Mean Age (yrs) 60.6 64.8 63.5 Female % 35 34.6 38.7 Mean BMI (kg/m2) 30.8 29.9 31.8 Race % White 75 88.5 93.5 Black / African American 22.5 11.5 6.5 Statin use (%) Atorvastatin 40/80 mg 7
Slide 8: Obicetrapib/ezetimibe lowers LDL-C by 63.4% on top of HIS in ROSE2
Obicetrapib/ezetimibe observed to lower LDL-C by 63.4% on top of HIS in ROSE2 LDL-C (mg/dL), on-treatment population Median (min, max) LDL-C levels (mg/dL) at baseline & EoT Placebo Obicetrapib 10 mg Obi 10 / Eze 10 10 Time Placebo Obi 10 mg Obi 10 / Eze 10 % change from baseline (median) 0 95.5 100
Slide 9: LDL goal attainment with ezetimibe + obicetrapib combination
Positive LDL goal attainment observed with ezetimibe + obicetrapib combination, including >87% of patients observed to attain <55 mg/dl LDL-C levels % of patients observed with the following LDL-C levels: <100 mg/dl <70 mg/dl <55 mg/dl % of on-treatment patients at target 100% 93.5% 88.5% 87.1% 66.7
Slide 10: LDL-P as a predictor of cardiovascular risk
LDL-P believed to be one of the most robust predictors of cardiovascular risk • Small dense LDL particles are more likely to be trapped Low LDL-P confers a lower risk in arterial wall than larger-sized LDL particles — even in patients with high LDL-C • High LDL-P levels typically signify that a pati
Slide 11: Reduction in total and small LDL particles
ROSE2 showed significant reduction in total and small LDL particles, bringing patients who had baseline elevated LDL-P to optimal parameters(1) Patients taking the Obi/Eze combo Total LDL-P Small LDL-P observed to achieve optimal LDL-P profiles Lipoprotein ROSE2 ROSE2 % change from baseline (median)
Slide 12: ROSE2: Non-HDL-C and ApoB percent change from baseline
ROSE2: Non-HDL-C and ApoB percent change from baseline (Day 84) Non-HDL-C (mg/dL), on-treatment population ApoB (mg/dL), on-treatment population 10 Placebo Obicetrapib 10 mg Obi 10 / Eze 10 10 Placebo Obicetrapib 10 mg Obi 10 / Eze 10 5 % change from baseline (median) % change from baseline (median)
Slide 13: ROSE2 Safety: TEAEs, TESAEs, and withdrawal overview
ROSE2 Safety: TEAEs, TESAEs, and withdrawal overview (safety population) Placebo Obicetrapib 10 mg Obi 10 mg / Eze 10 mg N= 40, N (%) N= 39, N (%) N= 40, N (%) TEAEs (%) TEAEs 16 (40) 8 (20.5) 11 (27.5) Related TEAEs 2 (5.0) 4 (10.3) 5 (12.5) Severe TEAEs 2 (5.0) 1 (2.6)(1) 0 (0) TESAEs TESAEs, tota
Slide 14: Stronger LDL-lowering with ezetimibe in obicetrapib combo
Stronger LDL-lowering observed with ezetimibe in obicetrapib combo vs. ezetimibe with statins, potentially due to a synergistic mechanism of action for obi/eze combo(1) Obicetrapib is designed to promote more cholesterol excretion Eze on top Eze on top into the intestines (via TICE) while ezetimibe
Slide 15: ROSE Phase 2b: obicetrapib LDL-C lowering with high intensity statins
In ROSE Phase 2b clinical trial, obicetrapib demonstrated robust LDL-C lowering as adjunct to high intensity statins1 Preparative ultra-centrifugation (PUC) is “gold-standard” for LDL-C quantification Median (min, max) LDL-C levels (mg/dL) at baseline and EoT Placebo Obicetrapib 5mg Obicetrapib 10mg
Slide 16: Lp(a) percent reduction from baseline in ROSE and ROSE2
Lp(a) percent reduction from baseline in ROSE1 and ROSE22 • Lp(a) is emerging as a strong and independent marker of CVD risk and an exciting new CVD drug target ROSE ROSE2 Placebo Obicetrapib 5mg Obicetrapib 10mg Obicetrapib 10mg Obi 10mg / Eze 10mg 10 10 4 Lp(a) % change from baseline (median) Lp(a
Slide 17: Lipid biomarker changes for obicetrapib 10mg across phase 1/2 studies
Changes in lipid biomarkers for obicetrapib 10mg monotherapy across phase 1/2 studies Phase 1 MAD TULIP TA-8995-06 ROSE ROSE2 Japan N=10 per arm N=35 per arm N=13 per arm N=40 per arm N= 26 per arm N=26 per arm 0 -10 Median % change from baseline -20 -24.2 -26.3 -30 -29.6 -29.8 -29.7 -32.7 -35.8 -37
Slide 18: Obicetrapib safety profile in ROSE and across multiple studies
Obicetrapib safety profile in ROSE and across multiple studies: overview of AEs, SAEs and withdrawals Well tolerated safety profile; Similar rates of drug discontinuation were observed for obicetrapib and placebo ROSE Safety Pooled Safety Comparator(1) Obicetrapib Pooled 5mg + 10mg(2) Placebo Obicet
Slide 19: Unmet need remains despite statins; "lower is better" paradigm
Despite availability of statins, tremendous unmet need remains – with resurgance of the “lower-is better” paradigm 15 Risk of CV ≥70 LDL-C death, MI, LDL-C 55-≤70 LDL-C Cumulative incidence rate (%) stroke goals Deaths in Thousands Male deaths 40-≤55 LDL-C removed 10 in ≤20 LDL-C 2013 5 Female death
Slide 20: Clinical development
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Slide 21: Current cash expected to fund obicetrapib development through milestones
Current cash expected to fund obicetrapib development through several value-creating milestones 2022 2023 2024 2025 2026 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H Phase 3 BROADWAY Trial Lipid Mono trial BROADWAY Ph3 (HeFH or ASCVD; LDL-C ≥ 55 mg/dL; LDL n=2,400) regulatory filing Phase 3 BROOKLYN Trial BROOKLYN
Slide 22: Clinical Trial Progress Update
Clinical Trial Progress Update 22
Slide 23: BROADWAY enrollment on schedule to finish mid-2023
BROADWAY enrollment on schedule to finish mid-2023 5000 • ASCVD or HeFH with 4500 LDL ≥ 55 mg/dL; 4000 n=2400 3500 • Randomization 2:1; 3000 obicetrapib 10 2500 mg:placebo 2000 • Primary endpoint: LDL-C 1500 1000 • Baseline LDL-C = 102 500 mg/dL; Woman: 35%; 0 Average age: 65 years Projected Screene
Slide 24: PREVAIL enrollment on schedule to complete 1Q 2024
PREVAIL enrollment currently on schedule to complete 1Q 2024 20000 • ASCVD with LDL ≥ 70 18000 mg/dL; n=9000 16000 14000 • Randomization: 1:1; Obi 10 mg vs placebo 12000 10000 • Primary endpoint: 8000 MACE-4 6000 • Baseline LDL: 110 mg/dL; 4000 Women: 31%; Average 2000 age: 65 years 0 Data as of May
Slide 25: Update on phase 3 trial enrollment
Update on phase 3 trial enrollment BROOKLYN BROADWAY PREVAIL HeFH with LDL ≥ 70 mg/dL ASCVD or HeFH with LDL ≥ 55 mg/dL ASCVD with LDL ≥ 70 mg/dL N=300 N=2400 N=9000 Randomization: 2:1 Randomization: 2:1 Randomization: 1:1 Obi 10 mg vs placebo Obi 10 mg vs placebo Obi 10 mg vs placebo Primary Endpoi
Slide 26: Pooled phase trial blood pressure data
Pooled phase 2 trial blood pressure data Systolic Diastolic Placebo Obicetrapib 5mg Obicetrapib 10mg Placebo Obicetrapib 5mg Obicetrapib 10mg 4 4 LS mean mmHg change vs. baseline LS mean mmHg change vs. baseline 3 3 2 2 1 1 0 0 -1 -1 -2 -2 -3 -3 -4 -4 BL 4 8 Week 12 BL 4 8 Week 12 Placebo (N) 229 22
Slide 27: BROOKLYN: Aggregate blinded average blood pressure is stable
BROOKLYN: Aggregate blinded average blood pressure is stable over time Average Systolic BP (mmHg) by Visit Average Diastolic BP (mmHg) by Visit SCRN BSLN DY30 DY84 SCRN BSLN DY30 DY84 Visit Visit BROOKLYN Medical Monitoring Meeting 10 May 2023; Data cut-off 25 April 2023 27
Slide 28: BROADWAY: Aggregate blinded average blood pressure is stable
BROADWAY: Aggregate blinded average blood pressure is stable over time Average Systolic BP (mmHg) by Visit SCRN BSLN DY30 DY84 DY180 DY270 Visit Average Diastolic BP (mmHg) by Visit SCRN BSLN DY30 DY84 DY180 DY270 Visit BROADWAY Medical Monitoring Meeting 10 May 2023; Data cut-off 25 April 2023 28
Slide 29: PREVAIL: Aggregate blinded average blood pressure is stable
PREVAIL: Aggregate blinded average blood pressure is stable over time Average Systolic BP (mmHg) by Visit Average Diastolic BP (mmHg) by Visit SCRN BSLN BSLN DY90 DY180 SCRN BSLN DY90 DY180 Visit Visit PREVAIL Medical Monitoring Meeting 10 May 2023; Data cut-off 25 April 2023 29
Slide 30: Selected Fixed Dose Combination of Obicetrapib + Ezetimibe
We have selected a Fixed Dose Combination (FDC) of Obicetrapib + Ezetimibe • We recently completed a bioavailability study comparing two FDC formulations of obicetrapib + ezetimibe to the component products • An FDC formulation was selected based on comparable bioavailability Fixed-Dose Combo Tablet
Slide 31: Fixed dose combination Obi + Eze: Development update
Fixed dose combination Obi + Eze: Development update • FDC formulation observed to have comparable pharmacokinetic (PK) profiles to individual products 10.000 1000.0 FDC Obi 10mg/Eze 10mg FDC Obi 10mg/Eze 10mg Eze 10mg Obi 10mg 1.0000 Mean plasma concentration (ng/mL) Mean plasma concentration (ng/m
Slide 32: Proposed fixed dose combination phase 3 trial design
Proposed fixed dose combination phase 3 trial design Inclusion criteria Trial design Eze 10mg (n=100) Safety • LDL-C ≥ 70 mg/dL • ASCVD, ASCVD risk equiv, or HeFH Obi 10mg (n=100) Safety • Randomized (1:1:1:1), • 18-75 years double-blind, placebo- controlled Obi/Ezi 10mg (n=100) Safety Primary endpo
Slide 33: Summary of key messages
Summary of key messages • ROSE2: 63% median LDL-C reduction observed in patients on high intensity statins with obicetrapib 10mg in combination with ezetimibe • Japan Phase 2: 46% median LDL-C reduction observed with obicetrapib 10mg; largely consistent with observed results from obicetrapib 10mg ac
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