Moonlake Immunotherapeutics · NASDAQ:MLTX
Moonlake Immunotherapeutics — Helix Acquisition — SPAC Merger (January 2022)
33 slides from Moonlake Immunotherapeutics's SPAC merger presentation, Jan 19, 2022
Slide 1: MoonLake Immunotherapeutics Investor Presentation January 2022
1 © 2022 MoonLake Immunotherapeutics AG Investor Presentation January 2022 www.moonlaketx.com
Slide 2: Disclaimer (1/2)
2 Disclaimer (1/2) Important Information for Investors This confidential presentation (“Presentation”) is for informational purposes only and is being provided to interested parties solely in their capacity as potential investors for the purpose of evaluating a potential private offering of securiti
Slide 3: Disclaimer (2/2)
3 Disclaimer (2/2) © 2022 | MoonLake Immunotherapeutics AG Trademarks This Presentation may contain trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners . Solely for convenience, some of the trademarks, service marks, trade names
Slide 4: MoonLake Executive Team
4 MoonLake Executive Team ~100 years of combined experience in Immunology – across R&D, Clinical, Regulatory, Launch, Commercial & BD J. Santos da Silva (CEO) MSc, PhD • 20+ years experience and end - to - end knowledge in immunology • McK Sr. Partner advising top immunology cos in major business &
Slide 5: Our focus: Unlocking the potential of the nanobody Sonelokimab
5 Our focus: Unlocking the potential of the innovative nanobody Sonelokimab □ We are developing Sonelokimab (SLK), a nanobody with potential to change Immunology practice A tri - specific IL - 17A & F nanobody that has shown high therapeutic activity in Psoriasis , as measured by psoriasis area seve
Slide 6: The Helix + MoonLake combination creates significant opportunity
6 The Helix + MoonLake combination creates significant opportunity + ▪ Combination with Helix accelerates MoonLake’s ambitions and Phase II development programs for SLK ▪ Helix investors access an asset with a novel MoA , differentiated clinical data and high PoS , positioned for impact in a $40bn+
Slide 7: A distinctive molecule
A distinctive molecule MoonLake
Slide 8: SLK is a tri-specific anti-IL-17 nanobody
8 SLK is a tri - specific anti - IL - 17A & F nanobody SOURCE: Merck KGaA , Darmstadt, Germany, MoonLake V HH C H 2 Pre se nt a ti o n Phase 0/ 1 : Frozen liquid solution containing 60 mg/mL of API Phase 2: Freeze dried formulation with two doses: 60mg and 120mg FD ; now using pre - filled syringe A
Slide 9: SLK is the only nanobody among IL-17, IL-23 & TNF inhibitors
9 SLK is the only nanobody among IL - 17, IL - 23 & TNF inhibitors SOURCE: MoonLake IL-17A IL-17A– IL-17F IL-17F IL-17RA IL-17RA IL-17RC IL-17E IL-17RB IL-17RA IL-17C IL-17RA IL-17RE IL-17RB IL-17B IL-17D Unknown receptor Unknown ligand IL-17RD IL-17RA IL-17F IL-17A IL-17RD IL-17RA – IL-17B ? ? Bime
Slide 10: BKZ illustrates potential of IL-17A/F inhibition
10 BKZ illustrates potential of IL - 17A & F inhibition SOURCE: Reich K, et al. N Engl J Med. 2021 Apr 23. doi : 10.1056/NEJMoa2102383 , MoonLake Therapeutic difference 13% Weeks Weeks SLK and BKZ achieve higher PASI75 scores at week 4 than other leading molecules A 13% therapeutic difference to SEC
Slide 11: Potential for higher efficacy of SLK versus the IL-17 market leader
11 Potential for higher efficacy of SLK versus the IL - 17 market leader PASI: Psoriasis Area and Severity Index SOURCE: Merck KGaA , Darmstadt, Germany, MoonLake 0 2 5 22 29 35 33 49 53 59 57 0 2 5 5 5 9 21 34 34 37 34 15 2 35 1 15 8 7 3 4 5 14 9 20 10 11 17 12 13 16 6 18 19 20 21 5 22 23 24 0 10 2
Slide 12: SLK has a differentiated safety profile to date
12 SLK has a differentiated safety profile to date 1 Papp KA, Weinberg M, Morris A, Reich K. The Lancet. 2021;397(10284): 1564 - 1575 SOURCE: MoonLake Team and selected bibliography (see Slide 33 for more detail on sources) • Favorable overall safety profile including infection rate similar to Secuk
Slide 13: Expanding the potential
13 Expanding the potential
Slide 14: 1. MoonLake Upside potential
14 1. MoonLake Upside potential
Slide 15: SLK to unlock value in Inflammatory Diseases
15 SLK to unlock value in IL - 17A & F Inflammatory Diseases SOURCE: Nguyen et al. J Eur Acad Dermatol Venereol . 2021;Ingram. Br J Dermatol. 2020; Scotti et al. Semin Arthritis Rheum. 2018; Ogdie et al. Rheumatology (Oxford). 2013; Tekin et al. J Rheumatol . 2019; Alinaghi et al. J Am Acad Dermatol
Slide 16: SLK has potential in significantly growing $40bn+ market
16 SLK has potential in significantly growing $40bn+ market SOURCE: IQVIA, Clarivate’s Market Forecast Assumptions file for Psoriasis – May 2021 (2019 - 2029, part of Disease Landscape & For ecast) DRG's Market Forecast Assumptions file for Psoriatic Arthritis – January 2021 (2019 - 2029, part of Di
Slide 17: 2. Unmet needs beyond PsO
17 2. IL - 17A & F Unmet needs beyond PsO
Slide 18: IL-17A/F inhibition across select indications underscores SLK potential
18 Inhibition of IL - 17A & F across select indications underscores SLK potential SOURCE: MoonLake, selected references on clinical trial results (see slide 33 for more detail on sources; BKZ is phase 2, ind ire ct comparator data PsA is phase 3; in AS, IXE and ADA is from direct comparator trials;
Slide 19: IL-17A/F inhibition elevates Psoriatic Arthritis treatment goal to ACR50
19 IL - 17A & F inhibition is the first mechanism to elevate Psoriatic Arthritis (PsA) treatment goal to ACR 50 – potential to outperform Humira a Placebo data for BE ACTIVE are from Week 12 1 Mease PJ, et al. Arthritis Rheum 2005;52:3279 – 89; 2 Enbrel (etanercept) US PI, Nov, 2017; 3 Antoni C, et
Slide 20: IL-17A/F inhibition elevates treatment goal to ASAS40 in Ankylosing Spondylitis
20 IL - 17A & F inhibition is the first mechanism to elevate treatment goal to ASAS40 in Ankylosing Spondylitis (AS, r - axSpA) ASAS40, Assessment of SpondyloArthritis international Society 40 response [defined as an improvement of at least 40% and absolute improvement of at least 2 units (on a 10 -
Slide 21: IL-17A/F inhibition elevates Hidradenitis suppurativa goal to HiSCR75
21 IL - 17A & F inhibition is the first mechanism to elevate Hidradenitis suppurativa (HS) treatment goal to HiSCR 75 HiSCR75, at least 75% reduction in Hidradenitis Suppurativa Clinical response (reduction in total abscess and nodule count an d n o increase from baseline in abscess or draining fist
Slide 22: 3. SLK nanobody Differentiation potential
22 3. SLK nanobody Differentiation potential
Slide 23: Differentiation: What sets SLK apart from BKZ and other mAbs?
23 Differentiation: What sets SLK apart from BKZ and other mAbs? SOURCE: MoonLake KOL Ad Boards © 2022 | MoonLake Immunotherapeutics AG Safety Affinity Penetration “IL - 17A & F inhibition without the infections” “Strong on A, balanced on F” “3x smaller + Albumin binding”
Slide 24: Safety: SLK clinical data supports a superior safety profile vs BKZ
24 Reference level for SEC, IXE, BRO Safety: SLK clinical data supports a superior safety profile vs BKZ a For SLK Phase II and BKZ Phase II (BE ABLE 1), “initial period” is Weeks 0 – 12 b For SLK Phase II, “1 year” is Weeks 12 – 52 for Week 12 completers; for BKZ Phase II extension (BE ABLE 2), “1
Slide 25: Safety: Skin levels of IL-17A and IL-17F need differential control
25 Safety: Skin levels of IL - 17A & F in PsO patients need to be differentially controlled for optimal benefit - risk profile Baseline IL - 17 A and IL - 17 F levels in the dermis ( dISF ) of healthy volunteers (HV, circles) and lesional (L, squares) and nonlesional (NL, triangles) skin from patien
Slide 26: Affinity: Superior SLK safety could be due to modulated dimer inhibition
26 Affinity: Superior SLK safety could be due to its modulated dimer inhibition SOURCE: Merck KGaA, Darmstadt, Germany, MoonLake IC50 ( nM ) Methodology Interaction/ read - out IL - 17AA IL - 17AF IL - 17FF SLK Alphascreen IL - 17RA 0.039 0.066 0.183 IL - 17RC 0.029 0.026 0.013 Secukinumab Alphascre
Slide 27: Penetration: Tri-specific SLK has potential for enrichment at joints
27 Penetration: Tri - specific SLK has potential for differential enrichment at joints SOURCE: MoonLake and selected bibliography (see slide 33 for more detail on sources) Albumin and albumin - bound drugs enrich at sites of joint inflammation ( murine RA model ) 3h after iv aminofluorescein - label
Slide 28: Penetration: Molecules the size of SLK are superior at penetrating tissues
28 Penetration: Molecules the size of SLK are superior at penetrating tissues SOURCE: MoonLake, Adapted from data from Li Z, et al. mAbs 2016;8:1:113 – 119 © 2022 | MoonLake Immunotherapeutics AG ▪ Biodistribution coefficients (BC) measures concentration of antibody - like proteins in tissue compare
Slide 29: MoonLake value creation
29 MoonLake value creation
Slide 30: SLK has a proven benefit-risk profile for Psoriasis
30 30 © 2022 | MoonLake Immunotherapeutics AG SLK has a proven benefit - risk profile for Psoriasis (incl. vs BKZ) SLK is a distinctive molecule with enhanced enrichment in deep skin & joints and binding of targets with better - than - mAb affinity and specificity – a potentially winning benefit - r
Slide 31: Initiating multiple phase II studies in A/F Inflammatory Diseases in 2022
31 Develop ment 117 Operations 49 Initiating multiple phase II studies in A/F Inflammatory Diseases in 2022 SOURCE: MoonLake 2021 2023 2024 2025 2022 Start - up PsA Phase II PE: 16/48wk 240 pts HS Phase II PE:12wk/24wk 210 pts AS Phase II PE: 16/48wk 240 pts Research Program Pre - study/Stud
Slide 32: Transaction overview and summary
32 Transaction overview and summary © 2021 | Confidential and Proprietary | MoonLake Immunotherapeutics AG © 2022 | MoonLake Immunotherapeutics AG 32 Run - way ▪ To at least mid - 2025 High - potential Biotech ▪ Four multi - billion dollar indications ▪ World - class Phase II program, raising bar fo
Slide 33: Additional supporting documents
33 Additional supporting documents Literature of relevance Risankizumab Blauvelt A, et al. JAMA Dermatol . 2020 Apr 8. [ Epub ahead of print ] ( PsO randomized withdrawal ); Reich K, et al. Lancet. 2019 Aug 17;394(10198):576 - 586 ( PsO vs. ADA) Gordon KB, et al. Lancet. 2018 Aug 25;392(10148):650