Moonlake Immunotherapeutics · NASDAQ:MLTX

Moonlake Immunotherapeutics — Technical Presentation (November 2023)

42 slides from Moonlake Immunotherapeutics's technical presentation, Nov 6, 2023

  1. Slide 1: R&D Day Webcast Presentation – Results ARGO trial

    W: moonlaketx.com | E: info@moonlaketx.com© 2023 | Proprietary | MoonLake TX MoonLake Immunotherapeutics R&D Day Webcast Presentation Document – Results ARGO trial November 6th 2023

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

    © 2023 | Proprietary | MoonLake TXSource: Welcome to our R&D Day MoonLake Corporate 2 Date: November 6th, 2023 Time: 8am EDT Location: Nasdaq (Webcast) Sub-topicsTopic Lead Timing - Conclusions - Overall value of MLTX - Path forward Moving Forward Jorge Santos da Silva 10 mins - Key messagesIntro Jo

  3. Slide 3: Disclaimer: Forward Looking Statements

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 3 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

  4. Slide 4: Instructions for this session

    © 2023 | Proprietary | MoonLake TXSource: Instructions for this session MoonLake Corporate 4 Please take note of the disclaimer on the prior page You can submit your questions through the Q&A function – we will address as many questions as possible at the end of this session For any technical issues

  5. Slide 5: Introduction

    © 2023 | Proprietary | MoonLake TX Introduction 5

  6. Slide 6: PsA: IL-17F dependent multi-domain disease in difficult-to-reach tissues

    Source: © 2023 | Proprietary | MoonLake TX 6 PsA: IL-17F dependent multi-domain disease in difficult-to-reach tissues …with 3x IL-17F vs IL-17A1… IL-17A PsA IL-17F PsA Nail psoriasis Axial disease Enthesitis Dactylitis MoonLake Medical, Clinical pictures K. Reich 1 van Baarsen LG, et al. Arthritis R

  7. Slide 7: The key messages

    © 2023 | Proprietary | MoonLake TXSource: The key messages MoonLake Corporate 7 MLTX’s ARGO trial is a SUCCESS ▪ Joints: ACR50 primary endpoint met at wk 12 for 60mg and 120mg induction doses – up to 47% ACR50 (p<0.01 vs placebo) ▪ Skin: PASI90 secondary endpoint met at wk 12 also for 60mg and 120mg

  8. Slide 8: ARGO Trial Results

    © 2023 | Proprietary | MoonLake TX ARGO Trial Results 8

  9. Slide 9: ARGO: Phase 2 trial design

    Source: © 2023 | Proprietary | MoonLake TX 9 ARGO: Phase 2 trial design ▪ Global study with approx. 50 sites, with 207 patients randomized ▪ Double-blind, placebo-controlled, active reference arm ▪ Active PsA (TJC68 ≥3, SJC≥3, current active PsO and/or confirmed PsO) ▪ ACR50 as primary endpoint, PAS

  10. Slide 10: Clinical Baseline: All arms of the ARGO trial are well balanced

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 10 Baseline: All arms of the ARGO trial are well balanced Main arms Active reference Patient characteristics Overall ARGO (n=207) Placebo (n=40) Sonelokimab 60mg NI (n=41) Sonelokimab 60mg (n=41) Sonelokimab 120mg (n=43) Adalimumab (n=42) A

  11. Slide 11: Clinical Disposition: drop-out rate of <4%

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical Disposition: The ARGO trial has a drop-out of rate of < 4% Disposition (Part A) 11 Note: Part A (week 12)database lock 12th October 2023. AE =Adverse Event, Wdw by S = Withdrawal by Subject; Completed Part A = completed treatment up to Week

  12. Slide 12: ACR50: SLK reaches the highest scores seen at week 12

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 12 ACR50: SLK reaches the highest scores seen at week 12 37 46 47 SLK 60mg NI SLK 60mg SLK 120mg ARGO ARGO ARGO 40 30 33 35 31 26 Ixekizumab Guselkumab Risankizumab ADEPT FUTURE 2 SPIRIT-P1/P2 BE OPTIMAL / BE COMPLETE DISCOVER 1/2 KEEPSAKE

  13. Slide 13: ACR50 primary endpoint responses increase over time

    Source: © 2023 | Proprietary | MoonLake TX 37.5 78.0 0 10 20 30 40 50 60 70 80 0 2 4 6 8 10 12 MoonLake Clinical 13 ACR50 primary endpoint responses increase over time ACR20 response Percent (%) pts reaching score, ITT-NRI Weeks Primary endpoint met for 60mg and 120mg – SLK 60mg NI not significantly

  14. Slide 14: Beyond week 12: continued ACR50 improvement for main doses

    Source: © 2023 | Proprietary | MoonLake TX ACR50 responses at week 16 Percent (%) of patients in each arm, ITT1 MoonLake Clinical 14 Beyond week 12: continued ACR50 improvement for main doses 46.5 53.5 Week 12 Week 16 +7.0 46.3 53.6 Week 12 Week 16 +7.3 SLK ACR50 response increases with monthly main

  15. Slide 15: Beyond week 12: the same is observed for ACR70

    Source: © 2023 | Proprietary | MoonLake TX ACR70 responses at week 16 Percent (%) of patients in each arm, ITT1 MoonLake Clinical 15 Beyond week 12: the same is observed for ACR70 25.6 37.2 Week 12 Week 16 +11.6 29.3 34.1 Week 12 Week 16 +4.8 ACR70 response also continues to increase with monthly ma

  16. Slide 16: SLK reaches the highest PASI90 scores already at week 12

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 16 SLK reaches the highest PASI90 scores already at week 12 50 77 59 SLK 60mg NI SLK 60mg SLK 120mg ARGO ARGO ARGO 56 45 52 44 55 55 Ixekizumab Guselkumab Risankizumab ADEPT FUTURE 2 SPIRIT-P1/P2 BE OPTIMAL / BE COMPLETE DISCOVER 1/2 KEEPSA

  17. Slide 17: ARGO met PASI90 key secondary endpoint in PsA

    Source: © 2023 | Proprietary | MoonLake TX 84.6 0 10 20 30 40 50 60 70 80 90 0 2 4 6 8 10 12 26.9 MoonLake Clinical 17 ARGO met PASI90 key secondary endpoint in PsA PASI75 response Percent (%) pts reaching score, ITT-NRI Weeks ▪ All doses significantly respond across PASI scores ▪ Above all comparab

  18. Slide 18: The 120mg is the most effective dose for moderate-to-severe skin PsO

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 18 The 120mg is the most effective dose for moderate-to-severe skin PsO 57 29 83 17 86 57 PASI90 PASI100 0 0 PASI responses in ARGO patients with PASI ≥ 10 Percent (%) pts reaching score per arm, Week 12, ITT-NRI Similar skin to our PsO tri

  19. Slide 19: Beyond week 12: Cross overs show continued PASI90 improvement

    Source: © 2023 | Proprietary | MoonLake TX PASI90 responses at week 16 MoonLake Clinical 19 Beyond week 12: Cross overs show continued PASI90 improvement 16.7 45.8 PLC Week 12 ► SLK 120mg Week 16 +29.1 59.3 66.7 Week 12 Week 16 +7.476.9 73.1 Week 12 Week 16 Placebo switch to SLK rapidly elevates PAS

  20. Slide 20: Beyond week 12: Cross overs show continued PASI100 improvement

    Source: © 2023 | Proprietary | MoonLake TX PASI100 responses at week 16 MoonLake Clinical 20 Beyond week 12: Cross overs show continued PASI100 improvement 16.7 37.5 PLC Week 12 ► SLK 120mg Week 16 +20.8 48.1 59.3 Week 12 Week 16 +11.2 57.7 53.8 Week 12 Week 16 Placebo switch to SLK rapidly elevates

  21. Slide 21: How does SLK compare to BKZ in ACR50 and PASI90?

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 21 How does SLK compare to BKZ in ACR50 and PASI90? 20.0 42.9 46.3 53.6 ADA SLK (60mg) SLK (60mg) Week 16 PLC +3 10.0 45.7 43.9 ADA BKZPLC -2 15.4 50.0 76.9 73.1 ADA SLK (60mg) SLK (60mg) Week 16 PLC +27 ARGO Week 12 (Primary endpoint) ACR5

  22. Slide 22: SLK brings over 40% of patients to both ACR50 and PASI90 at week 12

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 22 SLK brings over 40% of patients to both ACR50 and PASI90 at week 12 Note: Nominal p-values from a logistic regression with covariates for sex and prior biologic use; all patients with BSA>=3% at baseline, and distribution of such patient

  23. Slide 23: In ACR70 SLK further differentiates

    Source: © 2023 | Proprietary | MoonLake TX ACR70 response (% of patients) MoonLake Clinical 23 Let’s look further: In ACR70 SLK further differentiates 29 26 21 18 SLK 60mg SLK 120mg BKZ1 160mg IZO2 80mg 34 37 24 20 SLK 60mg SLK 120mg BKZ1 160mg IZO2 80mg Week 12 Week 16 Note: Comparisons across tria

  24. Slide 24: SLK brings in patients to both ACR50 and PASI100

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 24 Let’s look further: SLK brings 1 in 3 patients to both ACR50 and PASI100 Note: Comparisons across trials, with inherent limitations. No head-to-head trials. Nominal p-values from a logistic regression with covariates for sex and prior bi

  25. Slide 25: MDA: A composite of ambitious clinical response targets in joints & skin

    Source: © 2023 | Proprietary | MoonLake TXProf Joseph Merola 25 MDA: A composite of ambitious clinical response targets in joints & skin 23% Responder 77% Non-responder >3 in 4 patients do not achieve MDA within 6 months of biologic initiation1 Achievement of MDA clinical responses with any biologic

  26. Slide 26: Minimal Disease Activity (MDA) response in ARGO

    Source: © 2023 | Proprietary | MoonLake TX Minimal Disease Activity (MDA) response in ARGO Percent (%) of patients in each arm, ITT-NRI MoonLake Clinical 26 Achievement of leading MDA responses already at week 12 for SLK At week 12, MDA responses of SLK already above what would was observed in data

  27. Slide 27: SLK has highest responses in deep tissue inflammation

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 27 SLK has highest responses in deep tissue inflammation -10.2 -9.1 -8.4 Nail PsO Severity Index ((m)NAPSI) Note: Comparisons across trials, with inherent limitations. No head-to-head trials. Nominal p-values, from MMRM including co-variate

  28. Slide 28: SLK impacts outcomes reported by patients and physicians

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Clinical 28 SLK impacts outcomes reported by patients and physicians Physician global assessment of disease (PhGADA) Percent (%) of patients, MMRM PsA Impact of Disease (PsAID-12) Note: Comparisons across trials, with inherent limitations. No head-t

  29. Slide 29: Safety: adverse events summary

    Source: © 2023 | Proprietary | MoonLake TX Placebo Sonelokimab 60 mg NI Sonelokimab 60 mg Sonelokimab 120 mg Adalimumab (active reference) Patients with events, n (%) 39 41 41 43 42 Any TEAE 15 (38.5%) 12 (29.3%) 14 (34.1%) 17 (39.5%) 14 (33.3%) Any SAE 0 0 1 (2.4%)2 0 0 Any TEAE leading to disconti

  30. Slide 30: SLK continues to show a favorable benefit-risk profile

    © 2023 | Proprietary | MoonLake TXSource: ▪ From the ARGO trial ― No notable signals and no new signals ― No MACE, no IBD, no malignancies, no SI/B ― mAb-like ISR levels, no liver signals ― Less than 3% oral candidiasis on 60mg, none in 120mg - No discontinuations due to candidiasis ▪ Beyond the ARG

  31. Slide 31: Guidance: What to expect from the second part of the ARGO trial

    Source: © 2023 | Proprietary | MoonLake TX 31 Guidance: What to expect from the second part of the ARGO trial Notes: 1 Randomization stratified by sex and prior exposure to biologics; 2 At Week 0/Day 1, all eligible participants were randomized 1:1:1:1:1; 3 In the cross-over period, starting at Week

  32. Slide 32: A clear path towards Phase 3

    Source: © 2023 | Proprietary | MoonLake TX A clear path towards Phase 3 MoonLake Clinical 32 ▪ Dose-response pattern in line with findings in plaque-type Psoriasis (PsO, 313 patients) and Hidradenitis Suppurativa (HS, 234 patients) ▪ Doses with optimal benefit-risk profile identified for PsA – 60 mg

  33. Slide 33: Research & Clinical Summary

    © 2023 | Proprietary | MoonLake TXSource: Research & Clinical Summary 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 ▪ Direct evidence in animal models of differ

  34. Slide 34: Moving Forward

    © 2023 | Proprietary | MoonLake TX Moving Forward 34

  35. Slide 35: SLK is a potential leader in large inflammatory diseases

    Source: © 2023 | Proprietary | MoonLake TX PsO Phase 2b 313 Largest delta vs market leader Cosentyx™ at PASI100, compared to BKZ, IL-23, etc. ✓ IL-17A & F IL-23 & IL-17A MoonLake Corporate 35 SLK is a potential leader in large inflammatory diseases Trial Patients (n) SLK leading asset PsA ARGO 24 we

  36. Slide 36: Differentiation: SLK combines properties like no other asset

    Source: © 2023 | Proprietary | MoonLake TXDRG, MoonLake Corporate 36 Differentiation: SLK combines properties like no other asset A promising MoA… … and a differentiated molecule ▪ Highest responses IL-17A & F inhibition showed highest & most durable responses (BKZ & SLK) ▪ Favorable safety profile

  37. Slide 37: SLK is a potential leader in Type 3 diseases

    Source: © 2023 | Proprietary | MoonLake TX Neutrophil Th17 Th22 ILC3 IL-17 IL-22 IL-23 MoonLake Corporate 37 SLK is a potential leader 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 immune c

  38. Slide 38: MLTX has a full set of expected catalysts to year end, more in 2024

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Corporate 38 MLTX has a full set of expected catalysts to year end, more in 2024 2023 Jun 26 HS primary data Successful Ph2b 1ry endpoint at wk 12 SLK shows promising results in all scores incl. innovative HISCR75 & DT100 Fast onset, favorable safet

  39. Slide 39: MLTX operates from a position of strength

    Source: © 2023 | Proprietary | MoonLake TXMoonLake Finance 39 MLTX operates from a position of strength June 30, 2023 September 30, 2023 (preliminary) 501.8 496.0 -5.8 Strong balance sheet with USD 496M in cash, cash equivalents and short-term marketable debt securities as per September 30, 2023 Low

  40. Slide 40: MLTX has the potential to become a leader in I&I

    © 2023 | Proprietary | MoonLake TXSource: MLTX has the potential to become a leader in I&I MoonLake Corporate 40 ▪ Best in class potential – SLK is a promising molecule as shown by Ph 2b data in HS and PsO, and now the primary endpoint data in PsA ▪ Rarefied air – only 2 molecules can inhibit all IL

  41. Slide 41: Q&A

    © 2023 | Proprietary | MoonLake TX Q&A 41

  42. Slide 42: W: moonlaketx.com | E: info@moonlaketx.com

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

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