Newamsterdam Pharma Company N.v. · NASDAQ:NAMS

Newamsterdam Pharma — Technical Presentation (December 2024)

20 slides from Newamsterdam Pharma's technical presentation, Dec 10, 2024

  1. Slide 1: BROADWAY Topline Results

    BROADWAY Topline Results December 10, 2024

  2. 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

  3. Slide 3: Pursuing a New Treatment Paradigm for Cardiometabolic Disease

    Pursuing a New Treatment Paradigm for Cardiometabolic Disease • In the three trials completed to date, we have successfully achieved each primary endpoint (p<0.0001) of LS mean difference with imputation at day 84 versus placebo. • LDL-C reductions across our phase 3 studies: BROADWAY BROOKLYN TANDE

  4. Slide 4: Majority of ASCVD/HeFH patients do not achieve LDL-C Targets

    Majority of ASCVD/HeFH patients do not achieve 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 an LDL-C target <100 mg/dL <55 mg/dL (2017-2018)2 target <55 mg/dL (2020- (2011-2017)1 2021)3 Target: LDL-C

  5. Slide 5: Trial Design and Baseline Characteristics

    Trial 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 Underlying HeFH and/or Atherosclerotic Cardiovascular Disease (AS

  6. Slide 6: Disposition of All Randomized Participants

    Disposition of All Randomized Participants Placebo Obicetrapib 10 mg Randomized 844 1686 Completed treatment 739 (87.6) 1499 (88.9) Discontinued treatment 105 (12.4) 187 (11.1) Discontinued due to AE’s 43 (5.1) 68 (4.0) Subject decision 33 (3.9) 57 (3.4) Lost to follow-up 12 (1.4) 30 (1.8) Withdraw

  7. Slide 7: Demographics

    Demographics Placebo Obicetrapib 10 mg N=844 N=1686 Mean Age (years) 65.3 65.4 <65 years 360 (42.7) 706 (41.9) 65 to 74 years 352 (41.7) 683 (40.5) 75+ years 132 (15.6) 297 (17.6) Sex (F) n (%) 280 (33.2) 573 (34.0) Region n (%) North America 313 ( 37.1) 591 ( 35.1) Eastern Europe 282 ( 33.4) 580 (

  8. Slide 8: Demographics

    Demographics Placebo Obicetrapib 10 mg N=884 N=1686 Height (cm) 170.1 169.9 Weight (kg) 86.3 85.2 BMI (mean) 29.7 29.4 < 25 kg/m² 162 ( 19.2) 352 ( 20.9) 25 - 30 kg/m² 334 ( 39.6) 657 ( 39.0) > 30 kg/m² 346 (41.0) 676 (40.1) Diabetes n (%) 336 ( 39.8) 624 ( 37.0) HeFH 143 ( 16.9) 284 ( 16.8) Statin

  9. Slide 9: 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% Mean % change from baseline -10% -10% % change from placebo -15% -15% -20% -20% -25% -25%

  10. Slide 10: LDL-C % change versus baseline

    Median change from baseline of 40% Obicetrapib 10mg at day 84 100% 80% 60% LDL-C % change versus baseline 40% 20% 0% -20% -40% -60% 33% >50% LDL-C reduction -80% -100% 10 Note: each line represents a single patient in the obicetrapib 10 mg arm, five patients increase more than 100%

  11. Slide 11: Half of the patients on obicetrapib 10 mg achieved less than <55 mg/dL

    Half of the patients on obicetrapib 10 mg achieved less than <55 mg/dL % of patients achieving LDL-C thresholds at: Day 84 Day 365 11

  12. Slide 12: Consistent observed LDL-C reduction across Phase 2 and Phase 3 trials

    Consistent observed LDL-C reduction for obicetrapib across our Phase 2 and Phase 3 trials Analysis of obicetrapib 10 mg monotherapy ROSE ROSE2 BROOKLYN TANDEM BROADWAY 0.0% -5.0% -10.0% % change versus placebo -15.0% -20.0% -25.0% -30.0% -35.0% -40.0% -45.0% On-treatment mean LS mean Median 12 Note:

  13. Slide 13: Expectation heading into BROADWAY was no difference in MACE (HR=1.0)

    Expectation heading into BROADWAY was no difference in MACE (HR=1.0) Separation of curves after one year not seen in prior CETP CVOT trials Month 12 Curves are for the primary efficacy endpoint, which in IMPROVE-IT was defined as the composite of death from cardiovascular disease, a major coronary e

  14. Slide 14: Exploratory endpoint: Major adverse cardiovascular events (MACE)

    Exploratory endpoint: Major adverse cardiovascular events (MACE) BROADWAY MACE Data(1) 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. (%)

  15. Slide 15: Kaplan-Meier curve separates at day 200

    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 15 Note: While not powered to detect a MACE benefit, we observed positive MACE data as part of our review of the exploratory endpo

  16. Slide 16: Relative Risk Reduction of MACE

    Observed MACE reduction in BROADWAY suggests potential benefit beyond LDL-C 30% CTT regression Line 25% Observed MACE reduction in BROADWAY •The CTT regression line (dotted lines) > 4 years of treatment Relative Risk Reduction of MACE represents the expected relationship 20% 3 years of treatment bet

  17. Slide 17: MACE REDUCTION

    Obicetrapib observed to impact multiple factors believed to be associated with MACE LDL-C ↓ Non-HDL-C ↓ ApoB ↓ LDL-P ↓ sdLDL-C ↓ Lp(a) ↓ Small LDL-P ↓ Oxidized LDL-P ↓ MACE HDL-C ↑ NODM ↓ REDUCTION ApoA1 ↑ 17 Note: NODM = New onset diabetes mellitus

  18. Slide 18: Safety population: Adverse event comparable to placebo

    Safety population: Adverse event comparable to placebo Placebo N= 843 Obicetrapib 10 mg N= 1685 n (%) n (%) Any treatment-emergent AEs (TEAEs) 513 ( 60.9) 1007 ( 59.8) Any TEAEs by maximum severity Mild 228 ( 27.0) 481 ( 28.5) Moderate 217 ( 25.7) 408 ( 24.2) Severe 68 ( 8.1) 118 ( 7.0) Any trial dr

  19. Slide 19: 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) NODM or worsening of glycemic control 338 ( 40.1) 592 ( 35.1) (p = 0.015) - AE indicating new/worse type

  20. Slide 20: Key observations from overall phase 3 program

    Key observations from overall phase 3 program Efficacy •Obicetrapib monotherapy: 33-36% based on BROOKLYN and BROADWAY data •Obicetrapib + ezetimibe FDC: 49% based on TANDEM data •Obicetrapib or obicetrapib+ezetimibe gets vast majority of patients to LDL-C goal Tolerability •Adverse events, vital si

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