Newamsterdam Pharma Company N.v. · NASDAQ:NAMS

Newamsterdam Pharma — Technical Presentation (November 2024)

15 slides from Newamsterdam Pharma's technical presentation, Nov 20, 2024

  1. Slide 1: TANDEM Topline Results

    TANDEM Topline Results November 20, 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: Results overview

    Results overview • TANDEM successfully met all co-primary endpoints with statistical significance: − FDC vs. placebo − FDC vs. ezetimibe − FDC vs. obicetrapib monotherapy, and − Obicetrapib vs. placebo • Continued support for potential synergistic benefit of the combination, highlighting potential b

  4. Slide 4: Majority of ASCVD/HeFH Patients have not Demonstrated Achievement of LDL-C Targets

    Majority of ASCVD/HeFH Patients have not Demonstrated Achievement of LDL-C Targets Primary prevention HeFH ASCVD patients with an Very high risk ASCVD Despite availability of patients with LDL-C target of LDL<70 or patients with an LDL-C treatments continue to see an LDL-C target <100 mg/dL <55 mg/d

  5. Slide 5: Study Design and Baseline Characteristics

    Study Design and Baseline Characteristics A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hyperc

  6. Slide 6: Additional baseline details of all randomized patients

    Additional baseline details of all randomized patients Placebo (n=102) Ezetimibe (n=101) Obicetrapib (n=102) Obicetrapib and Ezetimibe (n=102) Mean Age (years) 66.1 67.6 66.7 67.3 Sex (F) n (%) 51 (50.0%) 45 (44.6%) 33 (32.4%) 48 (47.1%) Race n (%) White 84 (82.4%) 82 (81.2%) 85 (83.3%) 86 (84.3%) A

  7. Slide 7: Obicetrapib/ezetimibe FDC observed to lower LDL-C approx. 50%

    Obicetrapib/ezetimibe FDC observed to lower LDL-C approx. 50% Ezetimibe Obicetrapib Obicetrapib and (n=101) (n=102) Ezetimibe (n=102) Day 84 – from placebo Mean % -23.3 -35.5 -52.2 Median % -22.6 -37.2 -54.0 LS mean % -20.7 -31.9 -48.6 Comparison to pbo - (p<0.0001) (p<0.0001) Comparison to eze 10 m

  8. Slide 8: Over 60% of individuals on the FDC saw a more than 50% decrease in LDL-C

    Over 60% of individuals on the FDC saw a more than 50% decrease in LDL-C Obicetrapib 10mg and ezetimibe 10mg fixed-dose combination 61% >50% LDL-C reduction 8 Note: each line represents a single patient in the fixed-dose combination arm

  9. Slide 9: Over 70% of patients on the FDC achieved less than <55 mg/dL

    Over 70% of patients on the FDC achieved less than <55 mg/dL Responder Analysis 9

  10. Slide 10: Continued support for potential synergistic effects in combination

    Continued support for potential synergistic effects in combination 18.5% projected greater reduction in LDL-C in the 100 68 combination than in the ezetimibe monotherapy arm 31.9% mg/dL mg/dL Mean baseline in Observed LDL-C Post treatment baseline • Ezetimibe monotherapy showed a 20.7% placebo 24.5%

  11. Slide 11: Observed On-treatment LDL-C reduction for ROSE, ROSE2, BROOKLYN & TANDEM

    Observed On-treatment LDL-C reduction for ROSE, ROSE2, BROOKLYN & TANDEM On-Treatment Analysis of obicetrapib 10 mg 11 Note: ROSE at week 8, ROSE2, BROOKLYN, and TANDEM as of week 12.

  12. Slide 12: Observed Lp(a) reduction in TANDEM

    Observed Lp(a) reduction in TANDEM Lp(a) 12

  13. Slide 13: Safety results consistent with our prior studies

    Safety results consistent with our prior studies Placebo (n=102) Ezetimibe Obicetrapib Obicetrapib / (n=101) (n=102) Ezetimibe (n=102) Any study drug-related TEAEs 4 (3.9%) 3 (3.0%) 7 (6.9%) 3 (2.9%) Any study drug-related TEAEs leading to 2 (2.0%) 1 (1.0%) 6 (5.9%) 1 (1.0%) discontinuation of study

  14. Slide 14: Lipid Lowering Therapy (LLT) Market is a Growing Opportunity

    Lipid Lowering Therapy (LLT) Market is a Growing Opportunity 1 2 3 4 5 11.0% 1.3% 0.1% Patients on Lipid lowering Therapy2 Patients on Non-statin3 Treatment Patients on Branded4 Treatment Branded sales driving market opportunity ($ millions) 56MM 4.0MM 700K 19.6% 31% 4.3% Growth Growth Growth 5.4% 6

  15. Slide 15: Conclusions

    Conclusions • TANDEM successfully hit all co-primary endpoints, observed to lower LDL-C by approximately 50%, including: − A greater than 60% reduction in more that 50% of patients, − More than 70% of patients achieved LDL-C below 55 mg/dL • 18.5% synergy projected with combination, highlighting pot

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