Moonlake Immunotherapeutics · NASDAQ:MLTX

Moonlake Immunotherapeutics — Investor Day (June 2023)

38 slides from Moonlake Immunotherapeutics's investor day presentation, Jun 26, 2023

  1. Slide 1: MoonLake Immunotherapeutics R&D Day: Results MIRA trial

    W: moonlaketx.com | E: info@moonlaketx.com© 2023 | Proprietary | MoonLake TX MoonLake Immunotherapeutics R&D Day Webcast Presentation Document – Results MIRA trial June 26th 2023

  2. Slide 2: Welcome to our R&D Day

    © 2023 | Proprietary | MoonLake TXSource: Welcome to our R&D Day MoonLake Corporate 2 Cowen conference (March 6-8) AAD (March 18) Capital Markets Day (April 19) Kempen conference (April 25-26) HCW & Guggenheim meetings (Mar 30/Apr 5-6) Jefferies conference (Jun 7-9) AGM (Jun 7) HS data R&D Day (toda

  3. Slide 3: Instructions for this session

    © 2023 | Proprietary | MoonLake TXSource: Instructions for this session MoonLake Corporate 3 Please take note of the disclaimer on the following page You can submit your questions through the Q&A function in the bottom left – questions are only visible to the moderators – we will address as many que

  4. Slide 4: Corporate Disclaimer

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 4 Disclaimer Forward Looking Statements Certain statements in this presentation may constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include

  5. Slide 5: Introduction

    © 2023 | Proprietary | MoonLake TX Introduction 5

  6. Slide 6: Corporate Guidance: Meet or beat Bimekizumab on HiSCR75

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 6 Guidance: Meet or beat Bimekizumab on HiSCR75 end of June Bimekizumab (Bimzelx) Adalimumab (Humira) Secukinumab (Cosentyx) 15 (22) Primary Analysis Sonelokimab (SLK) ITT-mNRI (All-ABX) (mNRI-HS-ABX) ITT-NRI ITT-NRI (+ITT-mNRI) ITT-mNRI 1

  7. Slide 7: The key messages

    © 2023 | Proprietary | MoonLake TXSource: The key messages MoonLake Corporate 7 MLTX’s MIRA trial is a SUCCESS – Setting a new bar in HS ▪ HiSCR75 at wk 12 primary end point met – first time ever, “Beat” scenario, landmark data ▪ Other end points met at wk 12, early wk16 data promising – impact of S

  8. Slide 8: MIRA Trial Results

    © 2023 | Proprietary | MoonLake TX MIRA Trial Results 8

  9. Slide 9: Today's focus is on HS, a devastating and high prevalence disease

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 9 Today’s focus is on HS, a devastating and high prevalence disease Market size 10+ USD billion sales by 2035 50% Improvement for half of pts only2%+ Global prevalence 7 avg # of years to diagnosis, globally 1 Drug approved (Humira) H&E DA

  10. Slide 10: The MIRA trial in HS has the design of a pivotal study

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 10 The MIRA trial in HS has the design of a pivotal study Key design elements of MIRA ▪ Global study (North America and Europe) with approx. 60 sites ▪ Double-blind, placebo-controlled, active reference arm ▪ N=234 patients randomized ▪ Mod

  11. Slide 11: Key MIRA design elements are comparable to pivotal HS trials

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 11 Key MIRA design elements are comparable to pivotal HS trials Study element PIONEER I / II1 (Humira®) SUNSHINE/ SUNRISE2 (Cosentyx®) BE HEARDI / II3 (Bimzelx®) MIRA (Sonelokimab) Stage Phase 3 Phase 3 Phase 3 Phase 2 Size n=307 / n=326 n=

  12. Slide 12: Current status of patient exposure & disposition of the MIRA trial

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical Current status of patient exposure & disposition of the MIRA trial Disposition Patient exposure 12 318 Screened 84 screen failed 234 Rando- mized 68 Placebo 67 Sonelokimab 120mg 66 Sonelokimab 240mg 33 Adalimumab (reference arm) Completed:

  13. Slide 13: MIRA baseline characteristics are comparable to pivotal HS trials

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 13 The MIRA baseline characteristics are comparable to pivotal HS trials Patient characteristic PIONEER I / II1 SUNSHINE / SUNRISE2 BE HEARD I / II3 MIRA Age (years), mean 34.9 – 37.8 35.5 – 37.3 36.7 / 36.6 37.6 Gender, female, % 59.5 – 69

  14. Slide 14: All arms of the MIRA trial are well balanced

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 14 All arms of the MIRA trial are well balanced Patient characteristics Overall MIRA (n=234) Placebo (n=68) Sonelokimab 120mg (n=67) Sonelokimab 240mg (n=66) Adalimumab (n=33) Age, yrs, mean (SD) 37.6 39.3 (13.1) 37.6 (10.5) 36.2 (11.6) 37.

  15. Slide 15: SLK reaches the highest scores vs other molecules, including in HiSCR75

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 15 SLK reaches the highest scores vs other molecules, including in HiSCR75 38 19 24 17 15 11 SLK BKZ ADA POV UPA SEC 29 18 16 13 SLK BKZ ADA POV UPA SEC n.d. n.d. HiSCR75 delta to PLC (Primary endpoint for SLK) Percent delta for best doses,

  16. Slide 16: SLK reaches high response rates across all HiSCR endpoints

    Source: © 2023 | Proprietary | MoonLake TX 27.9 65.7 0 10 20 30 40 50 60 70 0 2 4 6 8 10 12 16 MoonLake Clinical 16 SLK reaches high response rates across all HiSCR endpoints 14.7 43.3 0 10 20 30 40 50 0 2 4 6 8 10 12 16 7.4 22.4 0 10 20 30 0 2 4 6 8 10 12 16 HiSCR75 response (Primary endpoint) Perc

  17. Slide 17: SLK significantly improves IHS4 and changes morphology of tunnels

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 17 SLK significantly improves IHS4 and changes morphology of tunnels IHS4 adjusted mean change Percent (%) change from baseline over time, ITT 1 IHS4 score is calculated as ∑ (n of nodules x1, n of abcesses x2, n of draining tunnels x4) *,

  18. Slide 18: SLK efficiently reduces HS lesions, including draining tunnels

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 18 SLK efficiently reduces HS lesions, including draining tunnels -31.7 -58.2 -55.9 -60 -50 -40 -30 -20 -10 0 0 2 4 6 8 10 12 -26.1 -57.7 -37.8 -60 -50 -40 -30 -20 -10 0 0 2 4 6 8 10 12 PLC SLK 120mg SLK 240mg Change in AN counts Percent (%

  19. Slide 19: SLK produces high level of inflammatory remission already at week 12

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 19 SLK produces high level of inflammatory remission already at week 12 41.1 23.8 SLK 120mg PLC PLC - SLK 120mg 37.51 Lesion counts as a measure of remission ▪ “Inflammatory remission” best measured by direct counts of relevant lesions that

  20. Slide 20: Patient reported outcomes are improved significantly with SLK

    Source: © 2023 | Proprietary | MoonLake TX 17.0 40.0 54.3 0 10 20 30 40 50 60 0 2 4 6 8 10 12 MoonLake Clinical 20 Patient reported outcomes are improved significantly with SLK -1.9 -3.9 -4.4 -5 -4 -3 -2 -1 0 0 4 8 12 PLC SLK 120mg SLK 240mg Weeks † p=0.020 † † p=0.0027 1 Absolute DLQI ≤ 5 response

  21. Slide 21: Safety: no new signals, underlining SLK's favorable benefit-risk profile

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 21 Safety: no new signals, underlining SLK’s favorable benefit-risk profile Patients with events1, n (%) Placebo (N=68) Sonelokimab 120 mg (N=67) Sonelokimab 240 mg (N=66) Adalimumab (N=33) Any TEAE 45 (66.2) 53 (79.1) 52 (78.8) 27 (81.8) A

  22. Slide 22: Reference arm validates SLK results, provides important info for Ph3

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 22 Reference arm validates SLK results, provides important info for Ph3 ▪ A small (n=33) patient arm was run in parallel with the main arms to − Control placebo responses for HiSCR responses and other endpoints − Test adalimumab in our hand

  23. Slide 23: Guidance: What to expect from the second part of the MIRA trial

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 23 Guidance: What to expect from the second part of the MIRA trial 24-week results planned for early Q4 ▪ Early unverified data from Week 16 suggests cross-over of patients from placebo elevates responses across different end-points – this

  24. Slide 24: Research & Clinical Summary

    © 2023 | Proprietary | MoonLake TXSource: Research & Clinical Summary A new bar, a new era The scientific rationale for a unique molecule ▪ SLK has unique IL-17F and A binding properties, a key inflammation MoA ▪ SLK has enhanced tissue penetration, reaching where mAbs cannot What MIRA shows – clini

  25. Slide 25: Moving Forward

    © 2023 | Proprietary | MoonLake TX Moving Forward 25

  26. Slide 26: Setting a new bar in HS

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 26 Setting a new bar in HS 38 19 24 17 15 11 SLK POV UPA SECBKZ ADA 29 18 16 13 SLK BKZ ADA POV UPA SEC n.d. n.d. HiSCR75 delta to PLC (Primary endpoint for SLK) Percent delta for best doses, primary analysis HiSCR50 delta to PLC (Primary e

  27. Slide 27: Beat Scenario: SLK is now a potentially leading asset in HS

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 27 Beat Scenario: SLK is now a potentially leading asset in HS Primary Analysis HiSCR75 (Delta of best dose to PLC, ppt)1 1 2 + SLK: Monthly Dosing + Higher Primary Endpoint + Favorable safety profile 3 Bimekizumab (Bimzelx®) 17.5 (22.5) I

  28. Slide 28: The HS biologics market to be USD 10bn+ in the US alone

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate, DRG/Clarivate, academic journals, CBO 28 The HS biologics market to be USD 10bn+ in the US alone $1.6bn 2022 $10.1bn 2035 Key drivers US HS Biologics Market estimation 1 For example, ‘Hurley III Hidradenitis Suppurativa Has an Aggressive

  29. Slide 29: Differentiation: SLK combines properties like no other asset

    Source: © 2023 | Proprietary | MoonLake TXDRG, MoonLake Corporate 29 Differentiation: SLK combines properties like no other asset A winning MoA… … and a differentiated molecule ▪ Highest efficacy IL-17A & F inhibition showed highest & most durable responses (BKZ & SLK) ▪ Safer inhibition Long histor

  30. Slide 30: Size matters: IL-17A & F is the most attractive MoA in deep inflammation

    Source: © 2023 | Proprietary | MoonLake TX Adaptive T cells Th, Tc cells Innate lymphocytes gdTcells, ILC3, MAIT Neutrophils IL-23 IL-1a IL-1b IL-18 IL-6 TGFb TCR activation TNFa IL-12 C5a d if fe re n ti a l a c ti v a ti o n d if fe re n ti a l p ro d u c ti o n IL-17A IL-17F H&E IL-19 IL-36 CXCL1

  31. Slide 31: SLK rapidly becoming a leading asset across inflammation

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 31 SLK rapidly becoming a leading asset across inflammation Trial Patients (n) SLK leading asset PsA primary endpoint data for SLK expected to be announced in the coming months Leading MoA HS Highest ever primary endpoint (HiSCR75), larges

  32. Slide 32: There are MANY opportunities for SLK

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 32 There are MANY opportunities for SLK MLTX Core indications Other Adjacent indications Other indications (Onco, CV) Addressable Market Size NSCLC Nr-axSpA PM DM GCA Takayasu SLE LN SSc Behcet's PPP GPP Pityriasis (PRP) Pyoderma (PG) BC R

  33. Slide 33: SLK a potential leading drug in Type 3 diseases

    Source: © 2023 | Proprietary | MoonLake TX Neutrophil Th17 Th22 ILC3 IL-17 IL-22 IL-23 MoonLake Corporate 33 SLK a potential leading drug in Type 3 diseases Th2 cell ILC2 Mast cell BasophilTfh Eosinophil IL-4 IL-13 IL-5 IL-31 Type 2 Macrophage Th1 ILC1 NK IL-12 IFN IL-2 IL-6TNF Type 1 Primary immun

  34. Slide 34: Important anticipated catalysts in the short-term

    Source: © 2023 | Proprietary | MoonLake TX Jun-23: Ph2b 1ry End-point (12 wk) readout ✓ MoonLake Corporate 34 Our time: Important anticipated catalysts in the short-term Q2 2023 Q3 2023 Q4 2023 Q1 2024 Rest of 2024 + Additional views ▪ Thus far, all MLTX trials delivered on or ahead of schedule ▪ Al

  35. Slide 35: MLTX operates from a position of strength

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Finance 35 MLTX operates from a position of strength June 30, 2022 September 30, 2022 December 31, 2022 March 31, 2023 92.7 83.5 72.1 63.1 June 30, 2023 (projected) 63.6 -9.2 -11.31 -9.11 +0.5 Discipline – Cash burn demonstrating cost-efficient set

  36. Slide 36: MLTX becomes a leader in I&I

    © 2023 | Proprietary | MoonLake TXSource: MLTX becomes a leader in I&I MoonLake Corporate 36 ▪ Best in class – SLK is a unique molecule among all “next gen IL-17s”, as now shown in HS and PsO ▪ Rarefied air – only two molecules can inhibit all IL-17 pro-inflammatory dimers, only SLK combines that Mo

  37. Slide 37: Q&A

    © 2023 | Proprietary | MoonLake TX Q&A 37

  38. Slide 38: W: moonlaketx.com | E: info@moonlaketx.com

    W: moonlaketx.com | E: info@moonlaketx.com

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