Newamsterdam Pharma Company N.v. · NASDAQ:NAMS
Newamsterdam Pharma — Investor Presentation (January 2025)
34 slides from Newamsterdam Pharma's investor presentation, Jan 10, 2025
Slide 1: Corporate Presentation January 2025
Exhibit 99.2 Corporate Presentation January 2025 Nasdaq: NAMS
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: Obicetrapib and Obicetrapib plus Ezetimibe Could Address Significant Unmet Need in Cardiometabolic Diseases
Obicetrapib and Obicetrapib plus Ezetimibe Could Address Significant Unmet Need in Cardiometabolic Diseases 30mm+ >3,500 pts Significant unmet need for oral LDL-C of favorable safety/tolerability patients in the US alone are not lowering therapy as adjunct to statins data comparable to placebo. achi
Slide 4: Previous Months Were a Time of Groundwork, Goals and Growth
Previous 18 Months Were a Time of Groundwork, Goals and Growth Doubled in size (~70) with Secured funding to support Building world-class Completed and announced new hires and offices in US Commercial launch, if commercial and MSL results for BROOKLYN, Amsterdam, NL, Miami, FL, approved, with cash a
Slide 5: Obicetrapib Designed to Address the ~30M Patients in US on Drug but not at Goal
Obicetrapib Designed to Address the ~30M Patients in US on Drug but not at Goal ~43 million ~18 million Treated primary prevention Not at goal of LDL-C patients <100mg/dl Of the ~30M treated patients not at goal, ~72 million ~19 million ~8 million ~18M were “far from Treated secondary High Risk ASCV
Slide 6: Lipid Lowering Therapy (LLT) Market is a Growing Opportunity
Lipid Lowering Therapy (LLT) Market is a Growing Opportunity 1 2 3 4 5 2 3 4 Patients on Lipid lowering Therapy Patients on Non-statin Treatment Patients on Branded Treatment Branded sales driving market 11.0% 1.3% 0.1% opportunity ($ millions) 56MM 4.0MM 700K 19.6% 31% 4.3% Growth Growth Growth 600
Slide 7: Majority of ASCVD/HeFH Patients are not Achieving LDL-C Targets
Majority of ASCVD/HeFH Patients are not Achieving LDL-C Targets Primary prevention HeFH ASCVD patients with an Very high risk ASCVD patients with LDL-C target of LDL<70 or patients with an LDL-C 2 an LDL-C target <100 mg/dL <55 mg/dL (2017-2018) target <55 mg/dL (2020- 1 3 (2011-2017) 2021) LDL-C <
Slide 8: 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 CVD Mortality Trends for US Males and Females, 1980 to 2020 Trends in Prevalence of High LDL-C in US Adults, 2 NHANES 1999-2018 with History of ASCVD 550 100 530 LDL-C Goals Removed In 75 510 2013 490 50 470 25 450 430 0
Slide 9: Physicians have Limited Treatment Options to Meet Patients Needs
Physicians have Limited Treatment Options to Meet Patients Needs (5) (5) (1) (2) (3) Obicetrapib Obi + Eze Ezetimibe Nexletol PCSK9i Approved Approved Approved Approval LDL-C data 2024 LDL-C data 2024 7% 13% 15% MACE Benefit 21%* TBD Observed LDL-C 49-54% 25% 17% 45-50% 35-40% Reduction Oral Oral Or
Slide 10: Limited New Therapies on the Horizon
Limited New Therapies on the Horizon (3) (4) (1) (2) Obicetrapib Obi + Eze MK-0616 AZD0780 LDL-C data 2026E TBD LDL-C data 2024 Approval LDL-C data 2024 (CVOT data 2029E) Phase 2b Phase 3 Phase 3 Phase 3 Current Phase ongoing ongoing completed completed 50-59% Observed LDL-C 35-40% 49-54% 30%-38% Re
Slide 11: Obicetrapib Program Designed to Overcome Limitations of Prior CETP Inhibitors
Obicetrapib Program Designed to Overcome Limitations of Prior CETP Inhibitors (3) (1) (2) (4) (5) Evacetrapib Torcetrapib Dalcetrapib Anacetrapib Obicetrapib (6) Observed LDL-C reduction 25% 7% 11-21% 17% 35-40% CETP inhibition 35% 30% 65% 80% 97% Dosing 60mg 600mg 100mg 100mg 10mg Blood pressure in
Slide 12: Consistent LDL-C Reduction Observed Across Our Phase 2 and Phase 3 Trials
Consistent LDL-C Reduction Observed Across Our Phase 2 and Phase 3 Trials Obicetrapib 10 mg monotherapy Obicetrapib plus ezetimibe ROSE ROSE2 BROOKLYN TANDEM BROADWAY ROSE2 TANDEM 0.0% 0.0% -10.0% -10.0% -20.0% -20.0% -30.0% -30.0% -40.0% -40.0% -50.0% -50.0% -60.0% -60.0% On-treatment mean LS mean
Slide 13: Consistent LDL-C Reduction Observed Over One Year Trial Duration
Consistent LDL-C Reduction Observed Over One Year Trial Duration LS Mean % change vs. placebo LDL-C reduction over time (ITT population) 41.5% 38.2% 38.3% 36.3% * * 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 36 5. 13
Slide 14: Consistent LDL-C Reduction Observed Over One Year Trial Duration
Consistent LDL-C Reduction Observed Over One Year Trial Duration LDL-C at day 84 and 365 Mean LDL-C reduction over time Day 84 (primary endpoint) Day 365 (secondary endpoint) 5% 0% 0% 1% -5% -1% -1% -1% -5% -3% -10% -10% -15% -15% -20% -20% -25% -25% -24% -30% -30% -29% -35% -33% -33% -34% -33% -33%
Slide 15: LDL-C Responder Analysis
LDL-C Responder Analysis at day 84 34% of patients with >50% LDL-C reduction 33% of patients with >50% LDL-C reduction 100% 80% 60% 40% 20% 0% -20% -40% -60% -80% -100% 61% of patients with >50% LDL-C reduction 15 Note: each line represents a single patient in the obicetrapib 10 mg arm, five patient
Slide 16: 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 16
Slide 17: 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 17
Slide 18: Exploratory Endpoint: Major Adverse Cardiovascular Events (MACE)
Exploratory Endpoint: Major Adverse Cardiovascular Events (MACE) (1) BROADWAY MACE Data Placebo Obicetrapib Hazard Ratio 95% CI N = 844 N= 1686 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. (%
Slide 19: Kaplan-Meier Curve Separates at Day 90
Kaplan-Meier Curve Separates at Day 200 HR=0.79 95% CI (0.54-1.15) 4-point MACE: CHD death, Non-fatal myocardial infarction, non-fatal stroke, coronary revascularization 19 Note: While not powered to detect a MACE benefit, we observed positive MACE data as part of our review of the exploratory endpo
Slide 20: Observed MACE Reduction in BROADWAY Suggests Potential Benefit Beyond LDL-C
Observed MACE Reduction in BROADWAY Suggests Potential Benefit Beyond LDL-C 30% CTT regression Line Observed MACE reduction 25% in BROADWAY •The CTT regression line (dotted lines) > 4 years of treatment represents the expected relationship 3 years of treatment between a mean absolute reduction in 20
Slide 21: Obicetrapib Observed to Impact Multiple Factors Believed to be Associated with MACE
Obicetrapib Observed to Impact Multiple Factors Believed to be Associated with MACE LDL-C ↓ Non-HDL-C ↓ ApoB ↓ LDL-P ↓ sdLDL-C ↓ Small LDL-P ↓ Lp(a) ↓ Oxidized LDL-P ↓ HDL-C ↑ NODM ↓ MACE ApoA1 ↑ REDUCTION Note: NODM = New onset diabetes mellitus 21
Slide 22: Overview of Events of Special Interest
Overview of Events of Special Interest Placebo N= 843 Obicetrapib N= 1685 n (%) 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) (p = 0.015) NODM or worsening of glycemic control 338 ( 40.1) 592 ( 35.1) - AE indicating new/worse type
Slide 23: Multiple Positive Data Readouts Provide Momentum into Next 2 Months
Multiple Positive Data Readouts Provide Momentum into Next 12 Months 2022 2023 2024 2025E 2026E 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H Phase 3 BROADWAY Trial Lipid Mono Study BROADWAY Ph3 (HeFH or ASCVD; LDL-C ≥ 55 mg/dL; LDL n=2,530) regulatory filing BROOKLYN Ph3 Phase 3 BROOKLYN Trial Lipid Mono Study (He
Slide 24: Study Design and Baseline Characteristics of Phase 3 Trials
Study Design and Baseline Characteristics of Phase 3 Trials 1º endpoint – week 12 N = 354 1º endpoint – week 12 N = 2530 LDL-C endpoint N = 9541 Obicetrapib 10 mg (2:1 randomization) Obicetrapib 10 mg 13 (2 -: m 1o r na thn sdomization) Obicetrapib 10 mg (1:1 randomization) Placebo Placebo Placebo 1
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 Higher absolute LDL-C reduction expected to lead Targeting higher baseline LDL-C patients to greater MACE benefit Longer duration of fol
Slide 26: 2024 Achievements Pave the Way for Potential 2025 Value Inflection Milestones
2024 Achievements Pave the Way for Potential 2025 Value Inflection Milestones 4Q 2024 1Q 2024 3Q 2024 Complete enrollment for Initiate TANDEM BROOKLYN Phase 3 BROADWAY Phase 3 TANDEM Phase 3 BROADWAY Phase 3 topline PREVAIL CVOT Phase 3 trial topline topline topline 2024 2H 2025 1H 2025 EMA regulato
Slide 27: Obicetrapib and Alzheimer's Disease
Obicetrapib and Alzheimer’s Disease 27
Slide 28: CETP Knock-in Mice Observed to Increase Brain Cholesterol Levels and CETPi Observed to Rescue Cognition
CETP Knock-in Mice Observed to Increase Brain Cholesterol Levels and CETPi Observed to Rescue Cognition in Preclinical Models of CETP-induced AD ▪ Source: Felix Oestereich, et al., The Cholesteryl Ester Transfer Protein (CETP) raises Cholesterol Levels in the Brain and affects Presenilin-mediated Ge
Slide 29: CETP Loss-of-Function Genotype may be Associated with Slower Memory Decline and Lower AD Risk
CETP Loss-of-Function (LoF) Genotype may be Associated with Slower Memory Decline and Lower AD Risk • CETP’s potential involvement in CNS cholesterol homeostasis is supported by genetic data • CETP LoF genotype may be associated with lower CETP activity & a corresponding increase in HDL levels CETP
Slide 30: Initial Data for Obicetrapib 10mg Observed to Decrease 24s- & 27-hydroxycholesterol
Initial Data for Obicetrapib 10mg Observed to Decrease 24s- & 27-hydroxycholesterol (“OH”) in both Plasma and Cerebrospinal Fluid (“CSF”) • In separate trials with different protocols and endpoints, Simvastatin was observed to only reduce 24s- and 27-OH in plasma • Obicetrapib was observed to be wel
Slide 31: Clinical events and exclusivity timelines
Clinical events and exclusivity timelines 31
Slide 32: Comprehensive Patent Portfolio with Composition of Matter IP into 2043
Comprehensive Patent Portfolio with Composition of Matter IP into 2043 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 7/43 US (1) COM EU 7/43 Proprietary form (COM) patent family** PTE 2/34 9/39* US Species (2) Selection SPC 2 2/34 /34 9/39* EU 8/
Slide 33: Growing Team of Cardiometabolic Experts with Deep Experience
Growing Team of Cardiometabolic Experts with Deep Experience Across Clinical Development and Commercialization Michael Davidson, M.D. John Kastelein, M.D. Douglas Kling William ‘BJ’ Jones Ian Somaiya Louise Kooij Juliette Audet CEO CSO COO CCO CFO CAO CBO Bob Rambo Annie Neild Matthew Philippe Chris
Slide 34: Thank You
Thank You 34
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