Newamsterdam Pharma Company N.v. · NASDAQ:NAMS
Newamsterdam Pharma — SPAC Merger (September 2022)
48 slides from Newamsterdam Pharma's SPAC merger presentation, Sep 21, 2022
Slide 1: Analyst Day September 21, 2022
The following presentation was made available by NewAmsterdam Pharma Company B.V. on September 21, 2022: Filed by NewAmsterdam Pharma Company B.V. Pursuant to Rule 425 under the Securities Act of 1933, as amended, and deemed filed pursuant to Rule 14a-12 of the Securities Exchange Act of 1934, as am
Slide 2: Disclaimer
Disclaimer This presentation (this“Presentation”) is for informational purposes only to assist interested parties in making their own evaluation of the proposed transaction (the“Transaction”) among Frazier Lifesciences Acquisition Corporation(“FLAC”), NewAmsterdam Pharma Holding B.V.(“NewAmsterdam”
Slide 3: Today's agenda
Today’s agenda Presenters Topic Time (ET) Michael Davidson Jamie Topper CEO, CEO and Chairman, NewAmsterdam Pharma FLAC Introduction to NewAmsterdam Pharma and Frazier Lifesciences Acquisition Corporation 1:00PM – 1:10PM 1 Michael Davidson John Kastelein CEO, CSO, Cholesteryl ester transfer protein
Slide 4: Introduction to NewAmsterdam Pharma and Frazier Lifesciences Acquisition Corporation
Introduction to NewAmsterdam Pharma and Frazier Lifesciences Acquisition Corporation 4
Slide 5: Frazier Lifesciences Acquisition Corporation (FLAC) overview
Frazier Lifesciences Acquisition Corporation (FLAC) overview Frazier Life Sciences acts as sponsor to FLAC Frazier Life Sciences is a fully-integrated investment firm $8.1B across 15 funds Creation Private Public Proven expertise in company creation, private and public investing Extensive operating
Slide 6: FLAC has identified NewAmsterdam as an attractive acquisition target
FLAC has identified NewAmsterdam as an attractive acquisition target Since inception, FLAC has undergone extensive opportunity identification and diligence; met with 42 companies, entered into CDA with 16 companies and submitted 3 term sheets Therapeutics focused business Preclinical through commerc
Slide 7: Investment highlights
Investment highlights ✓ Significant unmet need for strong and convenient LDL-lowering therapy as an adjunct to statins: 30mm+ patients in US/EU5 are not achieving LDL-lowering goals on SoC ✓ Obicetrapib has the potential to be a first-in-class, low-dose, once-daily oral CETP inhibitor for lowering L
Slide 8: Net proceeds expected to fund obicetrapib development through several milestones
Net proceeds expected to fund obicetrapib development through several value- creating milestones 2022 2023 2024 2025 2026 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Cardiovascular Disease = Regulatory submission Phase 3: “BROADWAY”: LDL-C ≥ 70 mg/dL N=2,400 Lipid Mono Study Phase 3:
Slide 9: Expert cardiometabolic leadership backed by top tier investors
Expert cardiometabolic leadership backed by top tier investors Michael Davidson, M.D. John Kastelein, M.D. Douglas Kling Lina Gugucheva Louise Kooij Marc Ditmarsch, M.D. CEO CSO COO CBO CFO CDO SANDER JULIETTE JASON GAURAV LOU MICHAEL JOHN SEASONED SLOOTWEG AUDET DINGES GUPTA LANGE DAVIDSON KASTELEI
Slide 10: CETP inhibition to treat cardiovascular disease
CETP inhibition to treat cardiovascular disease 10
Slide 11: Elevated levels of LDL-C are the root cause of cardiovascular disease
Elevated levels of LDL-C are the root cause of cardiovascular disease • Cardiovascular disease (CVD) is the leading cause of death among adults worldwide • Hyperlipidemia nearly doubles the risk of developing CVD • Elevated levels of LDL cholesterol (LDL-C) are the root cause of atherosclerosis, the
Slide 12: Despite availability of statins, CVD remains the leading cause of death worldwide
Despite availability of statins, CVD remains the leading cause of death worldwide (1) 231 million Adults in US/EU5 with hypercholesterolemia (2) 84 million Treated with prescription medication Key factors limiting penetration (3) <1 million post- 22 million (3) 8 million (4) Still above include stat
Slide 13: Current post-statin LDL-lowering products all fall short of the profile patients need
Current post-statin LDL-lowering products all fall short of the profile patients need Patients need a drug that Ezetimibe Nexletol PCSK9 fits the following profile: (1) (1) Modest Modest Strong Strong Efficacy Oral, Oral, Injectable, Oral, Low Dose High Dose High Dose Administration/ 10mg 180mg ~140
Slide 14: CETP role in transport of cholesterol esters
CETP role in transport of cholesterol esters Electron micrograph CETP curves CETP penetrates CETP directly transfers cholesterol against HDL HDL surface esters from HDL to LDL HDL LDL HDL CE PL PL TG CETP C-terminal opening N-terminal opening is where CETPi occurs CETP CE HDL LDL Note: Figures adapt
Slide 15: ApoB 'traps' LDL-C particles in the arterial wall to form plaques
ApoB ‘traps’ LDL-C particles in the arterial wall to form atherosclerotic plaques ApoB is a molecule that envelopes LDL-C particles in a 1:1 ratio ApoB-containing particles can become trapped in the arterial wall LDL-R upregulation reduces total ApoB concentrations and halts plaque build-up If ApoB
Slide 16: Genetic support that CETPi drives CVD benefit through LDL reduction
Genetic support that CETPi drives CVD benefit through LDL reduction Analysis of >1mm patient-years’ shows loss-of-function protection equivalent to targets of other LDL-lowering drugs Odds ratio for CVD Decreased Increased per decrease in LDL-C CVD risk CVD risk of 10 mg/dL (95% CI) • A 16% reductio
Slide 17: CETPi upregulates LDL-R and improves LDL and ApoB clearance through the liver
CETPi upregulates LDL-R and improves LDL and ApoB clearance through the liver Same mechanism of action as most existing LDL-lowering drugs Most current LDL-lowering therapies work by promoting LDL receptor upregulation CETPi PCSK9i STATINS EZETIMIBE OBICETRAPIB Decreases Designed to block Blocks Dec
Slide 18: NewAmsterdam's Obicetrapib
NewAmsterdam’s Obicetrapib 18
Slide 19: Obicetrapib program designed to overcome limitations of all prior CETP inhibitors
Obicetrapib program designed to overcome limitations of all prior CETP inhibitors SAFETY We believe that all prior CETPi were developed with a misguided focus on HDL increase (rather than LDL decrease) as the primary MoA for CVD risk reduction, OFF-TARGET TOXICITY, T O R C E T R A P I B leading to i
Slide 20: >50% LDL-C reduction would be virtually identical to PCSK9 injectables
>50% LDL-C reduction efficacy would be virtually identical to PCSK9 injectables and is substantially better than other oral therapies Cross trial comparison of LDL-C reduction across different approaches (in %) Obicetrapib Anacetrapib Evacetrapib Dalcetrapib Ezetimibe Nexletol Repatha Praluent Leqvi
Slide 21: ROSE Phase 2b: robust LDL-C lowering as adjunct to high intensity statins
In ROSE Phase 2b clinical trial, obicetrapib demonstrated robust LDL-C lowering as adjunct to high intensity statins 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 22: ApoB & non-HDL-C percent change from baseline observed in ROSE
ApoB & non-HDL-C percent change from baseline observed in ROSE clinical trial Lipidologists view ApoB and non-HDL-C as most important biomarkers for CVD risk reduction (in addition to LDL-C) Non-HDL-C ApoB Placebo Obicetrapib 5mg Obicetrapib 10mg Placebo Obicetrapib 5mg Obicetrapib 10mg 10 10 5 0 0
Slide 23: Obicetrapib observed to increase HDL-C and reduce Lipoprotein(a)
Obicetrapib observed to increase HDL-C and reduce Lipoprotein(a) These observed lipid changes may add further health benefits that may further strengthen product profile HDL-C Lp(a) Placebo Obicetrapib 5mg Obicetrapib 10mg Placebo Obicetrapib 5mg Obicetrapib 10mg 10 180 165 4 160 0 135 140 -10 120 1
Slide 24: ROSE waterfalls: LDL-C % change from baseline
ROSE waterfalls: LDL-C % change from baseline at Day 56 LDL-C reduction of >60% was observed in LDL-C reduction of >60% was observed in 20% of obicetrapib 5mg patients 40% of obicetrapib 10mg patients Note: Each bar represents one subject in the trial. 24 CONFIDENTIAL
Slide 25: Consistent LDL-C lowering and HDL-C increase across three Phase 2 studies
Consistent LDL-C lowering and HDL-C increase observed across three Phase 2 studies of obicetrapib LDL-C levels decrease HDL-C levels increase 200 184 -5 180 165 157 160 -15 135 140 127 121 120 -25 100 -30 80 -35 60 -41 40 -45 -46 -46 20 -51 -51 -55 0 5mg 10mg 5mg 10mg 5mg 5mg Obi + 5mg 10mg 5mg 10mg
Slide 26: Phase 1 & 2: Pooled TEAEs, TESAEs and withdrawals overview
Phase 1 & 2: Pooled TEAEs, TESAEs and withdrawals overview Strong safety profile observed across all of our Phase 1 & 2 clinical studies (1) (2) Comparator Pooled Obicetrapib (5, 10mg) (N=231) (N=309) TEAEs (%) TEAEs, total 136 (58.9) 173 (55.9) TEAEs, related 45 (19.5) 49 (15.8) TEAEs, severe 5 (2.
Slide 27: ROSE safety: TEAEs, TESAEs and withdrawals overview
ROSE safety: TEAEs, TESAEs and withdrawals overview Positive safety profile observed and no drop-outs due to TEAEs Placebo Obicetrapib 5mg Obicetrapib 10mg (N=40) (N=40) (N=40) TEAEs (%) TEAEs, total 19 (47.5) 15 (37.5) 8 (20.0) TEAEs, related 4 (10.0) 2 (5.0) 1 (2.5) TEAEs, severe 1 (2.5) 0 0 TESAE
Slide 28: Obicetrapib does not show an effect on blood pressure
Obicetrapib does not show an effect on systolic and diastolic blood pressure • In the TULIP study, obicetrapib did not show any effect on blood pressure, aldosterone and electrolytes • A dedicated meta-analysis of the obicetrapib ROSE, TULIP and OCEAN study did not reveal any signal in systolic and
Slide 29: MACE benefits in CVOT of anacetrapib (REVEAL) informing CVOT design
MACE benefits in CVOT of anacetrapib (REVEAL) observed to be exactly as expected, informing NewAmsterdam’s CVOT design At 4.1 years, two important learnings: ABSOLUTE Learning 1: Predictable MACE benefit Learning 2: Baseline levels were too low REDUCTION • 9% drop in MACE is exactly predicted by the
Slide 30: Obicetrapib and the emerging treatment paradigm for cardiovascular disease
Obicetrapib and the emerging treatment paradigm for cardiovascular disease Dr. Paul Ridker 30
Slide 31: Obicetrapib's clinical development plan
Obicetrapib’s clinical development plan 31
Slide 32: Obicetrapib CDP for cardiovascular disease & Alzheimer's disease
Obicetrapib CDP for cardiovascular disease & Alzheimer's disease The current development plan supports a potential 2025 launch for lipid indication Preclinical Phase 1 Phase 2 Phase 3 Next Anticipated Milestone 2H 2023 Phase 3 BROADWAY Trial Phase 3 BROADWAY Trial Completion Lipid Mono Study (LDL-C
Slide 33: CVD clinical development program designed to support broad CVD label
CVD clinical development program designed to support broad CVD label Phase 3 BROADWAY Trial (initiated): Phase 3 BROOKLYN Trial (initiated): • 2,400 patients with ASCVD or HeFH on statins• 300 patients with HeFH on statins Lipid Mono • LDL-C ≥ 70 mg/dL + risk enhancers • LDL-C ≥ 70 mg/dL Program • P
Slide 34: PREVAIL trial designed to address limitations of previous CETPi CVOTs
Applying lessons from prior CVOTs, PREVAIL trial is designed to address limitations of previous CETPi CVOTs ✓ Superior LDL-lowering activity anticipated • Obicetrapib 10mg observed to lower LDL by 51% in a Phase 2b clinical trial ✓ Target higher baseline LDL patients for greater potential absolute L
Slide 35: REVEAL supports translation from absolute LDL reduction to MACE benefit
REVEAL supports translation from absolute LDL reduction to MACE benefit EXPERIENCE: REVEAL (anacetrapib) PREDICTION: PREVAIL (obicetrapib) ~ ~ 61 11 100 51% 50 17% (1) mg/dL mg/dL mg/dL anticipated mg/dL Low Drug showed modest Results in SMALL absolute Enrich for higher Stronger expected Expected to
Slide 36: PREVAIL study design informed by REVEAL long-term follow-up
PREVAIL study design informed by REVEAL long-term follow-up Higher event rates & treatment effects + lower numbers needed to treat HIGH RISK groups enriched in PREVAIL HIGHER RISK subgroups have much higher event rates & positive treatment effects REVEAL total study 15.6% population 11.9% RR decreas
Slide 37: HDL effects offer pipeline expansion opportunities in Alzheimer's & diabetes
HDL effects potentially offer pipeline expansion opportunities in Alzheimer’s & diabetes • HDL is the “vacuum cleaner” of the body, POSITIVE TISSUE EFFECTS IN THE BRAIN HDL sucking toxic forms of cholesterol out of • Increasing HDL is expected to promote peripheral tissues to promote healthy cell he
Slide 38: Market opportunity and transaction overview
Market opportunity and transaction overview 38
Slide 39: Obicetrapib has potential to solve a substantial unmet need in dyslipidemia
Obicetrapib has potential to solve a substantial unmet medical need in dyslipidemia (1) 231mm Patients with >30mm patients not sufficiently addressed by available treatment options hyperlipidemia OBICETRAPIB 10mg Fewer than 1mm patients treated with current branded options: ✓ >50% LDL-lowering obser
Slide 40: US market research indicates prescriber and payor enthusiasm
US market research indicates prescriber and payor enthusiasm towards obicetrapib, supporting a potentially significant commercial opportunity Enthusiasm from prescribers: Enthusiasm from payors: CURRENT PRODUCTS PRODUCTS IN DEVELOPMENT “Biggest need (is) a product PCSK9i PCSK9i PERCEIVED PRODUCT Nex
Slide 41: Low potential COGs may enable attractive pricing and broad market access
Greater observed LDL-C lowering capability and low potential COGs may enable attractive pricing + broad market access Prior authorization and step-through requirements plague existing brands: $$$$ PRICE IS TOO HIGH There is a lot of documentation involved as we’re really for meaningful access (~$6K)
Slide 42: Projected exclusivity timelines in the EU and US
Projected exclusivity timelines in the EU and US Assumes EU approval on June 1, 2025 and US approval on July 1, 2027 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2041 2042 SPC max EU approval 6/35 6/36 EU Data exclusivity (8 + 2 years) 2/41 6/1/25 Regulat
Slide 43: Menarini partnership overview
Menarini partnership overview Partnership with Menarini brings in significant non-dilutive capital and could enable NewAmsterdam to simultaneously launch obicetrapib in different markets with the ideal partner to optimize the commercial opportunity in the EU RIGHT PARTNER RIGHT TIME RIGHT DEAL MENAR
Slide 44: Transaction overview
Transaction overview Transaction overview Illustrative post-money valuation at close PF Transaction (USD in mm) • Frazier Lifesciences Acquisition Corporation (NASDAQ: “FLAC”) to combine with NewAmsterdam at an implied $491mm pre-money equity value and a $326mm pro NewAmsterdam Illustrative Share Pr
Slide 45: Net proceeds expected to fund obicetrapib development through several milestones
Net proceeds expected to fund obicetrapib development through several value- creating milestones 2022 2023 2024 2025 2026 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Cardiovascular Disease = Regulatory submission Phase 3: “BROADWAY”: LDL-C ≥ 70 mg/dL N=2,400 Lipid Mono Study Phase 3:
Slide 46: Closing remarks
NewAmsterdam /Y % Pharma v , Closing remarks
Slide 47: Investment highlights
Investment highlights ✓ Significant unmet need for strong and convenient LDL-lowering therapy as an adjunct to statins: 30mm+ patients in US/EU5 are not achieving LDL-lowering goals on SoC ✓ Obicetrapib has the potential to be a first-in-class, low-dose, once-daily oral CETP inhibitor for lowering L
Slide 48: NewAmsterdam Pharma
I” NewAmsterdam Ab Pharma