Newamsterdam Pharma Company N.v. · NASDAQ:NAMS
Newamsterdam Pharma — Investor Presentation (September 2025)
38 slides from Newamsterdam Pharma's investor presentation, Sep 2, 2025
Slide 1: Corporate Presentation
Corporate Presentation September 2, 2025 Nasdaq: NAMS
Slide 2: Disclaimer
Disclaimer This presentation (together with oral statements made in connection herewith, this “Presentation”) is for informational purposes only. Forward Looking Statements Certain statements included in this Presentation that are not historical facts are forward-looking statements for purposes of t
Slide 3: Obicetrapib Could Address Significant Unmet Need in Cardiometabolic Diseases
of favorable safety/tolerability data comparable to placebo. Blinded data in >9,500 patients Obicetrapib and Obicetrapib plus Ezetimibe Could Address Significant Unmet Need in Cardiometabolic Diseases Source: Company data for obicetrapib 10mg monotherapy, *Pooled data includes BROOKLYN, TANDEM, BROA
Slide 4: Previous 18 Months Were a Time of Groundwork, Goals and Growth
Secured funding to support US Commercial launch, if approved, with cash at 2Q25 of ~$780M Previous 18 Months Were a Time of Groundwork, Goals and Growth Published BROADWAY in NEJM Published TANDEM in The Lancet Announced Alzheimer’s topline Full AD data to be presented at AAIC on July 30 Building wo
Slide 5: Obicetrapib Could Address the ~30M Patients in US on Drug but not at Goal
Obicetrapib Could Address the ~30M Patients in US on Drug but not at Goal US Branded Lipid Lowering Market Potential key factors limiting penetration include product limitations and market access hurdles: Low prescriber enthusiasm for existing TPPs Payors restrict access Of the ~30M treated patients
Slide 6: Currently, Treatment of Hyperlipidemia is One-Dimensional
Currently, Treatment of Hyperlipidemia is One-Dimensional LDL-C, low-density lipoprotein cholesterol; LLT, lipid lower therapy LDL-C ↓ Traditional LLTs
Slide 7: The Future of Hyperlipidemia Treatment Goes Beyond LDL-C
The Future of Hyperlipidemia Treatment Goes Beyond LDL-C Note: NODM = New onset diabetes mellitus ApoE4 LDL-P ↓ Small LDL-P ↓ NODM ↓ HDL-C ↑ ApoA1 ↑ LDL-C ↓ Non-HDL-C ↓ ApoB ↓ sdLDL-C ↓ Lp(a) ↓ Obicetrapib
Slide 8: Source references
* Source: Toth, Peter P. et al. Atherosclerosis. Volume 235, Issue 2, 585 - 591. ^Hoogeveen RC, Gaubatz JW, Sun W, Dodge RC, Crosby JR, Jiang J, Couper D, Virani SS, Kathiresan S, Boerwinkle E, Ballantyne CM. Small dense low-density lipoprotein-cholesterol concentrations predict risk for coronary he
Slide 9: Tailwinds are Making Lipid Lowering Space More Conducive to Commercial Success
Tailwinds are Making Lipid Lowering Space More Conducive to Commercial Success 1 Very large opportunity – even small amounts of penetration can result in significant financial success We have seen LLT market growth each year for the last 5 years 2 Non-statin growth continues in the high double digit
Slide 10: Resulting in Continued Growth and Acceleration of Brand Use
Resulting in Continued Growth and Acceleration of Brand Use Source: Based on third party prescription data on file 1. All Lipid Lowering therapies: Statins, Ezetimibe and combinations; PCSK9 and BPA; 2. Non-Statins : Ezetimibe and combinations; PCSK9 and BPA; 3. Branded: PCSK9 and BPA; 4. Merative M
Slide 11: Majority of ASCVD/HeFH Patients are not Achieving LDL-C Targets
Majority of ASCVD/HeFH Patients are not Achieving LDL-C Targets 10% achieved LDL-C <55 mg/dL 10% 24% ~1/4 achieved LDL-C <70 mg/dL 29% <1/3 achieved LDL-C <100 mg/dL ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein-cholester
Slide 12: CV Events Took an Alarming Turn Following Removal of LDL-C Guidelines in 2013
CV Events Took an Alarming Turn Following Removal of LDL-C Guidelines in 2013 1. Martin SS, Aday AW, Allen NB, et al. 2025 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. doi: https://doi.org/10.1161/cir.0000000000001303 | 2. Yumi
Slide 13: Physicians have Limited Treatment Options to Meet Patients Needs
Physicians have Limited Treatment Options to Meet Patients Needs Approved Approved Approved Approval 15% 13% 7% MACE Benefit 17% 25% Observed LDL-C Reduction Injectable (mAb) Oral (small molecule) Administration 140-150mg 180mg 10mg Dosing No No No Food Effect Safe, injection site reactions Tendon r
Slide 14: Limited New Therapies on the Horizon
Limited New Therapies on the Horizon Approval Current Phase Observed LDL-C Reduction Administration Dosing Food Effect Safety & Tolerability Available and investigational treatment options have limitations Lp(a) lowering Note: The above data do not represent head-to-head comparisons. Actual results
Slide 15: Obicetrapib Program Designed to Overcome Limitations of Prior CETP Inhibitors
Obicetrapib Program Designed to Overcome Limitations of Prior CETP Inhibitors Note: The above trials and data do not represent head-to-head comparisons. Actual results may differ from expectations. Sources: 1. Barter et al. NEJM.2007; 2. Schwartz et al. NEJM.2012; 3. Lincoff et al. NEJM.2017 4. Bowm
Slide 16: Consistent LDL-C Reduction Observed Across Phase 2 and Phase 3 Trials
Consistent LDL-C Reduction Observed Across Our Phase 2 and Phase 3 Trials Obicetrapib 10 mg monotherapy Note: ROSE at week 8, ROSE2, BROOKLYN, BROADWAY, and TANDEM as of week 12. Obicetrapib plus ezetimibe Monotherapy reductions of 35-40% Combo reductions of 50-60%
Slide 17: LDL-C Responder Analysis
LDL-C Responder Analysis at day 84 34% of patients with >50% LDL-C reduction Note: each line represents a single patient in the obicetrapib 10 mg arm, five patients increase more than 100% in the BROADWAY study. TANDEM data for the FDC of obicetrapib and ezetimibe 33% of patients with >50% LDL-C red
Slide 18: Greater Proportion of Patients in Obicetrapib Arm Achieved LDL-C Goal
Greater Proportion of Patients in Obicetrapib Arm Achieved LDL-C Goal % of patients achieving LDL-C thresholds at Day 84 % of patients achieving LDL-C thresholds at Day 84
Slide 19: Over 70% of Patients on Obicetrapib+Ezetimibe Achieved Less than 55 mg/dL
Over 70% of Patients on Obicetrapib+Ezetimbe Achieved Less than <55 mg/dL % of patients achieving LDL-C thresholds at Day 84
Slide 20: Exploratory Endpoint: Major Adverse Cardiovascular Events (MACE)
Exploratory Endpoint: Major Adverse Cardiovascular Events (MACE) Placebo N = 844 Obicetrapib N= 1686 Hazard Ratio 95% CI All-cause mortality – no. (%) 12 (1.4) 19 (1.1) 0.83 (0.40-1.71) Coronary heart death – no. (%) 5 (0.6) 8 (0.5) 0.80 (0.26-2.44) First 4-point MACE – no. (%) 44 (5.2) 70 (4.2) 0.7
Slide 21: Kaplan-Meier Curve Separates Driven by Attenuation of Events in the Obicetrapib Arm
Kaplan-Meier Curve Separates at Day 200 Driven by Attenuation of Events in the Obicetrapib Arm 4-point MACE: CHD death, Non-fatal myocardial infarction, non-fatal stroke, coronary revascularization (1) While not powered to detect a MACE benefit, we observed positive MACE data as part of our review o
Slide 22: Explaining BROADWAY's Observed 21% MACE Reduction
Explaining BROADWAY’s Observed 21% MACE Reduction Based on the CTT line, the expectation for a 33% reduction in LDL-C from placebo would be a 9% MACE reduction, after 12 months LDL-P reduction potentially provides 6-7% additional MACE reduction Lp(a) reduction potentially provides an additional 5% M
Slide 23: Overview of Events of Special Interest
Overview of Events of Special Interest Placebo N= 843 n (%) Obicetrapib N= 1685 n (%) AST or ALT > 3 x ULN 8 ( 0.9) 10 ( 0.6) Bilirubin > 2 x ULN 4 ( 0.5) 2 ( 0.1) CK > 5 x ULN 3 ( 0.4) 5 ( 0.3) NODM or worsening of glycemic control 338 ( 40.1) 592 ( 35.1) - AE indicating new/worse type 1 or 2 diabe
Slide 24: BROADWAY Designed to be a Predictor of PREVAIL
BROADWAY Designed to be a Predictor of PREVAIL Key Inclusion Criteria 13-months Placebo Obicetrapib 10 mg (2:1 randomization) N = 2532 13-months 1º endpoint – week 12 Baseline Lipids Baseline Lipid Modifying Therapy Any statin: 91% High intensity statin: 65% Ezetimibe: 26% PCSK9i: 4% SGLT2i: 11% GLP
Slide 25: PREVAIL Designed to Apply Lessons Learned from Previous CVOTs
PREVAIL Designed to Apply Lessons Learned from Previous CVOTs to Reduce Risk and Demonstrate Obicetrapib’s Full Benefit Greater LDL-C lowering activity anticipated Targeting higher baseline LDL-C patients Higher absolute LDL-C reduction expected to lead to greater MACE benefit Longer duration of fol
Slide 26: Clinical Trial Program Timeline
2022 2023 2024 2025E 2026E 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H Phase 3 BROADWAY Trial Lipid Mono Study (HeFH or ASCVD; LDL-C ≥ 55 mg/dL; n=2,530) 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 3 RUBENS Tri
Slide 27: Achievements Pave the Way for Potential Future Value Inflection Milestones
Achievements Pave the Way for Potential Future Value Inflection Milestones 2025 BROADWAY full data presentation and publication 1H 2025 TANDEM full data presentation and publication EMA regulatory submission 2H 2025 2024 Complete enrollment for PREVAIL CVOT 1Q 2024 Initiate TANDEM Phase 3 trial BROO
Slide 28: Obicetrapib and Alzheimer's Disease
Obicetrapib and Alzheimer’s Disease
Slide 29: CETPi Bears Therapeutic Potential for Both Multi-infarct Dementia and Alzheimer's Disease
CETPi Bears Therapeutic Potential for Both Multi-infarct Dementia and Alzheimer’s Disease Alzheimer's disease Healthy brain Alzheimer’s disease results in the generalized degeneration of the brain, with over 50M people affected WW and an economic burden of >$1 trillion (2) There is emerging evidence
Slide 30: Elevated Cholesterol Levels in the Brain Precede Formation of Amyloid-Beta Plaques
+ Elevated Cholesterol Levels in the Brain Precede Formation of Amyloid-Beta (Aβ) Plaques During early development, oligodendrocytes synthesize large quantities of cholesterol for myelination In adults, when myelination is complete, glial cells and, to a lesser extent, neurons account for the steady
Slide 31: ApoE4 is a Risk Factor for Both CVD and Alzheimer's Disease
ApoE4 is a Risk Factor for Both CVD and Alzheimer’s Disease1-5 % of population with this genotype APOE2/E3 11% APOE3/E3 61% APOE2/E2 0.5% APOE4/E2 = 2% APOE4/E3 = 24% APOE4/E4 = 2% Cholesterol transport and clearance Lipid accumulation in brain Aβ aggregation Total Cholesterol HDL-C receptor + bindi
Slide 32: CETP Loss-of-Function Genotype May be Associated with Slower Memory Decline
CETP Loss-of-Function (LoF) Genotype May be Associated with Slower Memory Decline and Lower AD Risk Source :JAMA, January 13, 2010—Vol 303, No. 2 2 LoF CETP genes 1 LoF CETP gene Normal CETP CETP’s potential involvement in CNS cholesterol homeostasis is supported by genomic data CETP LoF may be asso
Slide 33: CETP Knock-in Mice Have Increased Brain Cholesterol Levels
+ HDL correlation - LDL correlation NOR score (%) p=0.015 r2=0.5837 p=0.0365 r2=-0.4042 Plasma HDL (mmol/L) 3 2 1 0 0 20 40 60 80 100 NOR score (%) 2.5 1.5 1.0 0 0 20 40 60 80 100 0.5 2.0 Plasma LDL (mmol/L) Control diet 1% cholesterol diet WT CETP CETP transgenic mice have lower plasma HDL-C levels
Slide 34: Obicetrapib Alzheimer's Biomarker Sub-study Design
Safety FU Safety FU Obicetrapib on Top of Max Tolerated Lipid-Modifying Therapy: Alzheimer’s Biomarker Sub-study Placebo (n=800) Objective: To evaluate the effect of obicetrapib on biomarkers related to Alzheimer’s Disease compared to placebo over 12-months Visit: Days: 1 -28 to -1 6 270 2 1 4 84 3
Slide 35: Significant Reduction in p-tau217 Progression Over Months
Significant Reduction in p-tau217 Progression Over 12 Months with Greater Reductions as ApoE4 Risk Factors Increase Full Analysis Set* (n=1515) 2.99% benefit between obicetrapib and placebo (P=0.019) ApoE4 Carriers* (n=367) 5.74% treatment benefit in ApoE4 carriers (P=0.022) *Results reflect adjustm
Slide 36: Intellectual Property
Intellectual Property
Slide 37: Comprehensive Patent Portfolio with Composition of Matter IP into 2043
Comprehensive Patent Portfolio with Composition of Matter IP into 2043 Note: Regulatory approval and exclusivity dates are illustrative and shown for information purposes only; actual results may differ, Filled colors = granted patents & dotted lines = pending patents; one patent only to be selected
Slide 38: Thank You
Thank You
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