Moonlake Immunotherapeutics · NASDAQ:MLTX

Moonlake Immunotherapeutics — Investor Day (March 2024)

102 slides from Moonlake Immunotherapeutics's investor day presentation, Mar 11, 2024

1. Slide 1: MoonLake Immunotherapeutics R&D Day

   W: moonlaketx.com | E: info@moonlaketx.com © 2024 | Proprietary | MoonLake TX MoonLake Immunotherapeutics March 10 th 2024 R&D Day San Diego, during AAD

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

   Welcome to our R&D Day Agenda Sub - topics Topic Speaker Timing Date: March 10th, 2024 Time: 09.00 - 11:30 PST Location: Westin San Diego Bayview (Webcast also available) Logistics - Welcome & session details Introduction Matthias Bodenstedt 5 mins - PsA, a multi - domain challenge - SLK in a compet

3. Slide 3: Disclaimer

   Disclaimer Source: MoonLake Corporate © 2024 | Proprietary | MoonLake TX 3 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 statement

4. Slide 4: Instructions for this session

   Instructions for this session Please take note of the disclaimer on the previous page You can submit your questions through the Q&A function – questions are only visible to the moderators – we will address as many questions as possible at the end of this session The presentation and a replay will be

5. Slide 5: MoonLake company overview

   © 2024 | Proprietary | MoonLake TX Source: Founded in 2021 in Switzerland Nanobody ® technology Iicensed in initial private round Unique molecule with sonelokimab , tri - specific IL - 17A & IL - 17F Nanobody ® to elevate treatment in inflammation in a $40bn+ market Public on Nasdaq since April 2022

6. Slide 6: A differentiated molecule – Do you still Antibody?

   A differentiated molecule – Do you still Antibody? Sonelokimab is a ~40kDa humanized Nanobody® consisting of three VHH domains covalently linked by flexible spacers - around a quarter of the size of traditional antibodies With 2 domains, it binds with high affinity to IL - 17A and IL - 17F – a third

7. Slide 7: It's all about the dimers

   It’s all about the dimers IL - 17A and IL - 17F function as dimers to drive inflammation, through activation of IL - 17RA & RC receptor complexes Different IL - 17RA & RC chains combine to form complexes, and those have different affinity for different dimers 1,2 Not all IL - 17 - targeting therapeu

8. Slide 8: SLK rapidly becoming a leader in large inflammatory diseases

   Source: © 2024 | Proprietary | MoonLake TX PsA incl. critical composite scores Phase 2b (ARGO) Placebo - controlled with Humira 207 IL - 17A & F TNF & IL - 17A x Highest responses in skin/joints, MoonLake Corporate 8 SLK rapidly becoming a leader in large inflammatory diseases Trial Patients (n) SLK

9. Slide 9: PsA Going beyond in Rheumatology

   © 2024 | Proprietary | MoonLake TX PsA Going beyond in Rheumatology 9

10. Slide 10: PsA – A multidomain challenge

    © 2024 | Confidential and Proprietary | MoonLake TX 10 PsA – A multidomain challenge Prof. Joseph F. Merola

11. Slide 11: Disclosures

    11 © 2024 | Proprietary | MoonLake TX Prof. Merola is a consultant and/or investigator for Amgen, Boehringer Ingelheim, Bristol - Myers Squibb, AbbVie, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Sun Pharma, Biogen, Pfizer, MoonLake Immunotherapeutics Disclosures

12. Slide 12: PsA is a multidomain disease, involving joints and skin

    12 PsA is a multidomain disease, involving joints and skin 1 https:// www.psoriasis.org/psoriasis - statistics/ Accessed Mar 2024 2 Merola et al Dermatol Ther 2023;13:2635 – 2648 3 Luce et al AAD 2024;Poster 50361 4 Coates et al Nat Rev Rheumatol 2022;18:465 – 479 | Dactylitis and nai/skin images co

13. Slide 13: PsA is common and often underdiagnosed and undertreated

    41% already had joint symptoms, but in most cases had not discussed treating these symptoms with their doctor 6 13 PsA is common and often underdiagnosed — and undertreated 1 Johns Hopkins Medicine [https:// www.hopkinsarthritis.org/arthritis - info/psoriatic - arthritis ] Accessed Mar 2024 2 Nation

14. Slide 14: The symptom burden of PsA leads to substantial work impairment

    14 The symptom burden of PsA leads to substantial work impairment Using treatments that better resolve symptoms will have wide - ranging benefits for patients and society A >30% and >25% prevalence in PsA of anxiety and depression 2 4 in 5 patients report fatigue, 3 with a major impact on physical a

15. Slide 15: High clinical response in skin, in addition to joints, is critical

    15 High clinical response in skin, in addition to joints, is critical for patients Image credits: skin — courtesy of Prof. Kristian Reich, joints — Mochizuki et al Case Rep Rheumatol 2018:2018:4216938 1 Quality of life data from 402 patients with PsA and moderate - to - severe skin involvement (≥3%

16. Slide 16: Most patients currently do not achieve MDA, even with biologics

    16 Most patients currently do not achieve MDA, even with biologics Treatment ceiling in PsA: advances in PsA treatment have led to success in some domains, but achievement of MDA with biologics remains challenging, even for newer therapies % of patients who achieved MDA in a US real - world study Pa

17. Slide 17: IL-17i preferred biologic class across PsA domains

    Radiographic progression Nails Dactylitis Enthesitis Axial 17 Psoriasis Peripheral arthritis Preferred biologic(s) 1 IL - 17i TNFi IL - 12/23i IL - 23i IL - 17i is the only biologic class preferred in all clinical domains of PsA 1 Preferred biologic classes are based on the expert interpretation of

18. Slide 18: Can we optimize IL-17 inhibition?

    49 62 46 67 Week 16 ITT - NRI Week 48 ITT - NRI SEC A only BKZ A+F SEC A only BKZ A+F +13 Improvement 18 Can we optimize IL - 17 inhibition? PASI 100 BE RADIANT Phase 3b H2H BKZ vs SEC 1 IL - 17A - only inhibitor Secukinumab mAb IL - 17A+IL - 17F inhibitor Bimekizumab mAb As the class of choice for

19. Slide 19: IL-17A and IL-17F dual inhibition newly validated MOA in PsA

    3 41 PLC ADA ref BKZ 10 46 44 PLC ADA ref BKZ 19 IL - 17A and IL - 17F dual inhibition is a newly validated MOA in PsA Bimekizumab IL - 17A and IL - 17F inhibitor (160 mg Q4W) | BE OPTIMAL (Phase 3 PsA ) 1 1 NRI, non - responder impuation; McInnes et al Lancet 2023;401:25 – 37; 2 Merola et al Lancet

20. Slide 20: Sonelokimab is a novel humanized Nanobody targeting IL-17A+IL-17F

    20 Sonelokimab is a novel humanized Nanobody ® targeting IL - 17A+IL - 17F Anti - IL - 17A Anti - albumin Anti - IL - 17A or IL - 17F A A A F F F Inhibits IL - 17A/A, IL - 17A/F, and IL - 17F/F dimers Sonelokimab Nanobody ® ~40 kDa 1,2 © 2024 | Proprietary | MoonLake TX IL, interleukin; mAb, monoclo

21. Slide 21: SLK achieved high levels of response in joints and skin by Week 12

    21 SLK achieved high levels of response in joints and skin by Week 12 Sonelokimab IL - 17A and IL - 17F inhibitor (Nanobody) | ARGO (Phase 2 PsA ) ▪ Both bio - naïve and - experienced patients were enrolled in the study Inhibition of IL - 17A and IL - 17F with a Nanobody showed promising efficacy in

22. Slide 22: SLK Nanobody showed promising responses in composite scores

    22 The SLK Nanobody ® also showed promising responses in composite scores 8 16 27 ADA ref SLK 60 mg PLC Sonelokimab ARGO Week 12 ITT - NRI SLK treatment provided a multidomain response in the ARGO trial that met stringent, high - threshold endpoints such as MDA and ACR 70 + PASI 100 Multidomain endp

23. Slide 23: Summary

    23 © 2024 | Proprietary | MoonLake TX Summary Week 12 data in the ARGO trial set high expectations of continuing increases in key endpoints, as well as multidomain composites , to Week 24 with SLK treatment • Unmet need across multiple domains demands novel PsA therapies • MDA is a PsA - specific ,

24. Slide 24: ARGO trial 24 week data

    © 2024 | Confidential and Proprietary | MoonLake TX 24 ARGO trial 24 wk data Kristian Reich

25. Slide 25: PsA: IL-17F dependent multi-domain disease in difficult-to-reach tissues

    1 van Baarsen LG, et al. Arthritis Res Ther. 2014; 16:426 - 436; 2 Schett G, et al. Nature Reviews Rheumatology. 2017; 13:731 - 741; 3 Prinz JC, et al. J Exp Med. 2020 Jan 6;217(1):e20191397; 4 Sweet K, et al. RMD Open 2021;7e001679; 5 Shao M, et al. Clin Immunol 2020;213:108374; 6 Lories RJ and McI

26. Slide 26: ARGO: Phase 2 trial design

    ARGO: Phase 2 trial design Key design elements of ARGO ▪ 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, PASI90 as key s

27. Slide 27: Disposition: ARGO drop-out rate of 5% in Part B

    Disposition: The ARGO trial had a drop - out of rate of 5% in Part B Disposition (Part A+B) Part B Database lock 7th February 2024. AE =Adverse Event, Wdw by S = Withdrawal by Subject; Completed Part A = completed treatment up to Week 10 and completed assessments to Week 12; 3 patients did not subse

28. Slide 28: SLK efficacy in joints continues to improve to wk 24

    46.3 61.0 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Weeks ACR70 response (Secondary endpoint) 70 +15pp 29.3 25.6 43.2 0 2 4 6 8 10 12 14 16 18 20 22 24 0 50 +16pp SLK efficacy in joints continues to improve to wk 24, with high responses Percent (%) pts reaching score, NRI 1 Cross overs Weeks Cross overs P

29. Slide 29: Skin outcomes continue to improve to wk 24, beyond competitors

    Skin outcomes continue to improve to wk 24, beyond competitors PASI90 response Percent (%) pts reaching score, NRI 1 57.7 63.0 75.0 0 4 8 12 16 20 24 Weeks 0 90 15.4 48.1 Percent (%) pts reaching score, NRI 1 Cross overs PASI100 response Cross overs PASI response rates with SLK continue to increase

30. Slide 30: Most patients meet both joint and skin outcomes

    Most patients meet both joint & skin outcomes – a differentiated profile 31 33 8 22 23 16 46 52 42 34 31 25 +18pp +6pp +11pp +7pp Patients reaching both ACR50 and PASI90 Patients achieving both ACR50 and PASI100 Percent (%) pts reaching score, NRI 1 Percent (%) pts reaching score 42 44 8 25 58 59 46

31. Slide 31: SLK efficacy shown with a higher treatment goal

    SLK efficacy is further shown with a higher the treatment goal Almost 50% of patients reach both ACR70 & PASI100 with SLK At week 24 delta to adalimumab in this high bar composite score is close to 30pp Strong signal of elevated efficacy vs adalimumab 2 on this higher hurdle endpoint 1 Subset of par

32. Slide 32: MDA: composite of ambitious clinical response targets

    1 Data from the CorEvitas registry (N=1,251); Ogdie et al. ACR 2021;abstract 1344; 2 BSA, body surface area; HAQ - DI, Health Assessment Questionnaire Disability Index; PASI, Psoriasis Area and Severity Index; PRO, patient - reported outcome; S/TJC, swollen/tender joint count; VAS, visual analog sca

33. Slide 33: Impact of SLK on MDA is clear

    44 37 36 61 51 62 45 22 3 +16pp Impact of SLK on MDA is clear: 60%+ of patients reach this high goal Patients reaching Minimal Disease Activity (MDA) Percent (%) pts reaching score 42 41 48 48 0pp BE OPTIMAL 2 (NRI) Note: Comparison across trials have inherent limitations. No head - to - head trials

34. Slide 34: SLK also shows higher responses in deep-tissue

    SLK also shows higher responses in deep - tissue at wk 24 73 65 50 61 56 SLK 60 SLK 120 PLC - > ADA SLK 120 BKZ N.d. ADA +12pp 67 86 100 60 SLK 60 SLK 120 PLC - > SLK 120 ADA +26pp Percent (%) of pts with LEI 2+ at baseline that improved 2+ pt Leeds Enthesitis Index (LEI) Nail PsO Resolution (mNAPSI

35. Slide 35: Part B crossover signals potential of SLK in TNF non-responders

    Part B crossover signals potential of SLK in TNF non - responders Note: Comparison across trials have inherent limitations. No head - to - head trials 1 Subset of participants with BSA >=3% at baseline, ITT - NRI up to Week 24, except that participants who were re - assigned from their original trea

36. Slide 36: Higher 120mg efficacy in key subgroups

    Higher 120mg efficacy in key subgroups 39 33 62 33 42 86 63 57 All PASI >=10 All PASI >=10 +52pp +24pp +3pp +1pp ACR70 PASI100 1 ITT - NRI up to Week 24, except that participants who were re - assigned from their original treatment arm at Week 12 as per protocol had last observation carried forward

37. Slide 37: Safety: adverse events overview

    Part A + B Part A Sonelokimab Sonelokimab Adalimumab Sonelokimab Sonelokimab 120mg 60mg (active reference) 120mg w/induction 6 0 mg w/induction Placebo 97 82 42 43 41 39 Patients with events, n 57 (58.8%) 37 (45.1%) 14 (33.3%) 17 (39.5%) 14 (34.1%) 15 (38.5%) Any TEAE 4 (4.1%) 2 1 (2.4%) 2 0 0 1 (2.

38. Slide 38: PK data shows ARGO PsA doses behave as expected

    PK data shows ARGO PsA doses behave as expected 0 2 4 6 24 Weeks 0.01 0.1 1 10 100 3 μg/ml* 8 10 12 14 16 18 20 22 Last dose SLK 60mg SLK 120mg PLC ʇ SLK 120mg ADA - > SLK 120mg Sonelokimab geometric mean trough concentration (μg/mL) SLK trough concentrations Trough concentrations of crossed over ar

39. Slide 39: No signs of clinically relevant immunogenicity

    No signs of clinically relevant immunogenicity SLK 120mg geometric mean trough concentration (μg/mL) by ADA status SLK trough concentrations were unaffected by treatment - emergent ADA status 0.01 0.10 1 10 100 Weeks 0 0 2 4 6 8 10 12 14 16 18 20 22 24 0 2 4 6 8 10 12 14 16 18 20 22 24 Weeks 10 20 3

40. Slide 40: PsA: A clear path towards Phase 3

    PsA: A clear path towards Phase 3 (current plan) What know now from ARGO ▪ 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 & 120mg (with

41. Slide 41: IL-17 expected to become largest MoA in PsA

    41 IL - 17 expected to become largest MoA in PsA in the next years 1.1 1.6 2.2 5.5 7.3 7.9 2021 2031E 2035E 2 6.5 9.0 PsA market size estimates 1 USD m ▪ IL - 17 becomes largest drug class in the next years in PsA (already estimated as 35 - 40% of market in 2031) ▪ Most data sources, incl. DRG/Cariv

42. Slide 42: ARGO results confirm SLK as the potential leader in PsA

    Source: © 2024 | Proprietary | MoonLake TX 42 PsA: ARGO results confirm SLK as the potential leader in PsA MoonLake Corporate Unprecedented multi - domain response 60% of patients reach MDA and ~60% reach ACR50+PASI90 , at wk 24 - confirming consistent multi - domain impact of SLK Greater depth of r

43. Slide 43: HS Franchise building indication

    © 2024 | Proprietary | MoonLake TX HS Franchise building indication 43

44. Slide 44: HS – A devastating disease

    © 2024 | Confidential and Proprietary | MoonLake TX 44 HS – A devastating disease Prof Kenneth B. Gordon

45. Slide 45: Disclosures

    45 © 2024 | Proprietary | MoonLake TX Prof Gordon has received honoraria and/or research support from the following pharmaceutical companies: AbbVie, Amgen, Arcutis, Bristol - Myers Squibb, Boehringer Ingelheim, Dermavant, DICE, Incyte, Eli Lilly, Janssen, LEO Pharma, MoonLake Immunotherapeutics, No

46. Slide 46: Hidradenitis suppurativa: a challenge and an opportunity

    …we need HS therapies that are developed with all patients in mind — reflecting many millions of people …we need HS therapies that provide sustained and significant improvements to patients’ lives …we need HS therapies that treat all types of lesions , with the opportunity for inflammatory remission

47. Slide 47: HS is characterized by a profound burden for patients and society

    47 HS is characterized by a profound burden for patients and society NIS, National Inpatient Sample Symptoms 1 Key symptoms include... • Pain • Malodorous drainage • Low mood/depression …and may be more burdensome in patients with draining tunnels Hospitalizations Hospitalization and ER visits are c

48. Slide 48: Chronic inflammation in HS progresses to irreversible tissue destruction

    48 Chronic inflammation in HS progresses to irreversible tissue destruction Resolution of nodules, abscesses and tunnels in a ‘Window of Opportunity’ may offer the possibility of remission Figure adapted from Martorell et al Actas Dermosifiliogr 2016;107(Suppl 2):32 – 42 Cutaneous damage HS activity

49. Slide 49: Can we treat HS more effectively in the Window of Opportunity?

    © 2024 | Proprietary | MoonLake TX 2 Can we treat HS more effectively in the ‘Window of Opportunity’? We need • More treatment options • Better therapies • Shorter time to treatment to allow health systems to move patients onto treatment more quickly, and to keep them there 49 HS Psoriasis 12 Only 2

50. Slide 50: Current adalimumab therapy has high discontinuation rates

    50 Current therapy with adalimumab has high discontinuation rates <1 year Median drug survival Adalimumab in US patients with HS 1 1 in 3 US patients with HS discontinue adalimumab within 6 months 1 Patient groups with the highest burden of drug discontinuation… 1 Women Medicaid coverage Younger adu

51. Slide 51: What do we need from an effective therapy in HS?

    51 What do we need from an effective therapy in HS? The consequences of uncontrolled HS are substantial for all aspects of patients’ lives and society 1 Ingram et al EHSF 2023;T6 - O - 15 2 Ring et al Br J Dermatol 2024;doi:10.1093/bjd/ljae042 5 Schneider - Burrus et al Br J Dermatol 2023;188:122 –

52. Slide 52: Treatment goals have not been advanced in eight years

    52 Treatment goals have not been advanced in eight years Additional therapeutics with alternative mechanisms of action and higher levels of response urgently needed 26 28 42 59 HiSCR 50 response, (%) 180 183 180 N = 180 163 163 153 154 N = SEC Q4W Placebo ADA Placebo +16 +31 Adalimumab (Humira ®1 )

53. Slide 53: Can targeting IL-17A + IL-17F advance treatment goals in HS?

    29 45 48 32 54 52 BKZ Placebo BKZ BKZ Placebo BKZ BKZ BKZ Placebo BKZ BKZ Placebo Q2W Q4W Q2W Q4W Q2W Q4W Q2W Q4W Primary endpoint HiSCR 50 at Week 16 (ITT - mNRI) BE HEARD I BE HEARD II PBO N=~73, BKZ N=~290 per arm 53 Can targeting IL - 17A + IL - 17F advance treatment goals in HS? +19 Bimekizumab

54. Slide 54: Elevated IL-17A + IL-17F in HS: rationale for targeting both

    54 Elevated IL - 17A + IL - 17F in HS: rationale for targeting both cytokines Both IL - 17A and IL - 17F are elevated in HS lesions, including inflammatory nodules and draining tunnels 1 10 100 IL - 17F (pg/mL) 0.1 1 10 100 IL - 17A (pg/mL) * P <0.05 * P <0.05 * P <0.05 0.1 Perilsional Nodule Tunnel

55. Slide 55: Can Nanobodies improve outcomes in HS?

    55 Can Nanobodies ® improve outcomes in HS? Albumin - binding domains target inflammation Smaller biologics higher tissue uptake 1 Accumulation of Nanobodies ® 24 h after treatment 2 Distribution of anti - TNF Nanobodies ® +/ - albumin - binding site 24h after a single injection in mice with collage

56. Slide 56: High levels of response with sonelokimab in the MIRA trial

    27.9 65.7 53.0 Placebo N=68 SLK 120 mg N=67 SLK 240 mg N=66 14.7 43.3 34.8 0 20 40 60 80 Placebo N=68 SLK 120 mg N=67 SLK 240 mg N=66 Participants achieving response (%) 56 High levels of response were seen with sonelokimab in the MIRA trial MIRA efficacy at Week 12 SLK achieved pain responses at th

57. Slide 57: Ultrasound sub-study of draining tunnel changes with SLK

    57 An exploratory ultrasound sub - study measured direct evidence of draining tunnel changes with SLK Imaging lesions beneath the skin shows a direct effect on tunnels Baseline Week 12 • Case study of a participant randomized to the sonelokimab 240 mg treatment arm • Reduction in tunnel diameter and

58. Slide 58: After MIRA: what I would like to see in a Phase 3 program

    58 A key goal of Phase 3 will be to show consistency with Phase 2, while always maintaining a patient - centered focus After MIRA: what I would like to see in a Phase 3 program ENDPOINT SELECTION High level endpoints, such as HiSCR 75 , DT 100 , IHS4 - 100 Looking at high level endpoints and includi

59. Slide 59: SLK differentiation & Phase 3 program

    © 2024 | Confidential and Proprietary | MoonLake TX 59 SLK differentiation & Phase 3 program Kristian Reich

60. Slide 60: Recap: Setting a new bar in HS for primary endpoints

    Note : This is a comparison across trials, with inherent limitations . No head - to - head trials . 1 POV used mean AN count reduction as primary endpoint 2 Estimation of HiSCR 75 delta to PLC at wk 16 using the avg . response of the 2 crossed - over groups from PLC to SLK doses at wk 12 (PLC platea

61. Slide 61: HS: Response with SLK increases through week 24

    HS: Response with SLK increases through week 24, with monthly dose HiSCR90 response Percent (%) pts reaching score Weeks Weeks Significant increase in number of patients reaching HiSCR75 with convenient monthly injection Deepening of responses with monthly maintenance dosing, as close to 40% of pati

62. Slide 62: HS: SLK allows aim for inflammatory remission

    4 in 10 pts 1 in 4 pts HS: SLK allows patients & physicians to aim for inflammatory remission Monthly SLK deepens IHS4 response (e.g., IHS4 - 90 and IHS4 - 100) About 1 in 4 four HS patients on monthly SLK 120mg achieve inflammatory remission (IHS4 - 100) 1 ITT - NRI data up to Wk 12; as observed da

63. Slide 63: HS: results confirm SLK as the potential leader

    Source: © 2024 | Proprietary | MoonLake TX 63 HS: The results are staggering and confirm SLK as the potential leader MoonLake Corporate Higher HiSCR75 with Q4W dosing 57% of patients reach HiSCR75 at week 24 with 120mg ( 10ppt +) Greater depth of responses 40% patients reach HiSCR90 and IHS4 - 90 by

64. Slide 64: HS: Very positive FDA & EMA EoP2 meeting

    1 Randomization stratified by Hurley stage status (II vs. III) and prior biologic use (Y/N). Patients in Hurley stage III limited to ~40%; 2 responder: HiSCR75 on two consecutive visits 4 weeks apart Source: MoonLake Clinical Development © 2024 | Proprietary | MoonLake TX HS: Very positive FDA & EMA

65. Slide 65: HS: VELA builds on the success of MIRA

    Source: © 2024 | Proprietary | MoonLake TX MoonLake ClinDev 65 2. HS: VELA builds on the success of MIRA Announcing Phase 3 HS program: VELA I VELA II The MoonLake HS clinical trials continue to be the only ones with HiSCR75 as the primary endpoint

66. Slide 66: HS: Pivotal-like MIRA design replicated in Ph3

    Source: MoonLake Clinical © 2024 | Proprietary | MoonLake TX 66 HS: Pivotal - like MIRA design is replicated in Ph3, in contrast to other trials 1 Glatt et al. JAMA Dermatol 2021;157:1279 – 88; 2 NCT03248531; 3 Kimball et al. AAD 2023;oral presentation; 4 NCT04242498; 5 Sensitivity analysis presente

67. Slide 67: HS is the next large indication in Derm

    © 2024 | Confidential and Proprietary | MoonLake TX 67 HS is the next large indication in Derm Jorge Santos da Silva

68. Slide 68: Recap: HS market expected to grow to >$10bn by 2035

    Source: MoonLake Commercial, DRG/Clarivate, academic journals, CBO; Komodo Health © 2024 | Proprietary | MoonLake TX Recap: The HS market is expected to growth to >10bn USD by 2035 $2bn+ $10bn+ 2035 Today Future TNF α (mAb) AbbVie Only ~50% of patients achieve HiSCR50 at wk 12 IL - 17 A (mAb) Novart

69. Slide 69: Large market size substantiated by real-world data

    Market: Large market size is substantiated by real - world data Note: Biologics (Bx) includes other targeted therapies (e.g., JAKs, PDE4i); 1. Patients ≥18 years with a HS diagnosis in 2016 - 2023; Extrapolated based on ~75% claims coverage rate (U.S. claims data); 2. historic average of annually ne

70. Slide 70: Claims alone show ~2M HS patients

    Market: Claims alone show ~2M HS patients – not incl. undiagnosed 2.0 2.9 0.9 1.9 4.8 1. Includes patients ≥18 years with a HS diagnosis in 2016 - 2023; Extrapolated based on ~75% claims coverage – showing a 0.8% of U.S. Population HS diagnosed and treated; 2. Scaling the 2M patients (0.8%) to 2.1%

71. Slide 71: HS patients face challenging journey after diagnosis

    1. HS patients receiving respective care in the first year after diagnosis; 2. HS patients receiving respective care in years 2 and 3 post diagnosis, as a % of year 1 patients, 3. Consecutively on drug for >24m Source: Market research, © 2023 Komodo Health, Inc. All rights reserved. © 2024 | Proprie

72. Slide 72: Adalimumab with limited duration of response in real world

    Source: MoonLake Commercial, © 2023 Komodo Health, Inc. All rights reserved.. N Engl J Med 2016; 375:422 - 434; JAMA Dermatol. 2022 Feb; 158(2): 1 – 5. © 2024 | Proprietary | MoonLake TX Trial results: Maintenance of response ~55% did not maintain response after 9m ~35% ~55% ~30% <6 months <12 month

73. Slide 73: Biologics growth in HS

    17 21 12 11 25 15 32 17 17 7 13 6 19 22 29 32 50 56 240 - 310 9 39 13 10 9 40 +24% 1. Patients with a HS - relevant biologics prescription in the respective year and a preceding HS diagnosis; includes JAKs and PDE4i; 2. Annual growth in Bx for patients with a preceding AD diagnosis in 2017 - 2023; 3

74. Slide 74: Humira accounts for most of current $2bn+ biologics market

    0.5 0.5 0.3 0.5 Market: Humira accounts for most of current $2bn+ biologics market Competitors Patients treated (k) 1 2023 claims not 100% captured yet (time lag) HS market (2023 – Q4 claims not fully covered) X 2023 fill rate (yrs) 2 X Net price (USDk) 3 = Revenue (USDbn) Total 1. Includes patients

75. Slide 75: PsO shows clinical differentiation wins over time-to-market

    1. Patients with a biologics prescription in the respective year and a preceding PsO diagnosis; Source: Market research, © 2023 Komodo Health, Inc. All rights reserved. © 2024 | Proprietary | MoonLake TX 35% 9% 32% 11% 28% 13% 2% 23% 13% 5% 23% 11% 9% 36% 21% 10% 12% 18% 9% 19% 7% 154 262 305 367 41

76. Slide 76: The HS market might be even larger than $10bn in 2035

    U.S. adults HS Biologics Market estimation 4.8m based on claims extrapolation 1 ~10% analogs ~15% (PsA, axSpA 3 ) ~8% Diagnosed prevalence Biologics adoption 1. Patients ≥18 years with a HS diagnosis in 2016 - 2023; Extrapolated based on ~75% claims coverage rate, further conservatively extrapolatin

77. Slide 77: Targeting: SLK blockbuster status in concentrated landscape

    1. Based on Komodo Health claims data: Includes patients with a Bx prescription in 2022 and a HS diagnosis in 2015 - 2022 Source: Market research, © 2023 Komodo Health, Inc. All rights reserved., MoonLake Commercial © 2024 | Proprietary | MoonLake TX 0 20 40 60 % of HCOs % of pts 15 states in the U.

78. Slide 78: Bimzelx confirms A&F as winning MoA

    Note: Comparisons across trials, with inherent limitations. No head - to - head trials. 1 Warren et al., EADV 2021, P0353 Source: MoonLake Commercial, IQVIA, Barclays Research, RAPID Weekly Audit, November 2023 - December 2023 (Copyright IQVIA), Company statements © 2024 | Proprietary | MoonLake TX

79. Slide 79: HS: SLK is most convenient

    Source: Product leaflets, Company information, MoonLake Commercial © 2024 | Proprietary | MoonLake TX 79 HS: SLK is most convenient Maintenance injection schedule 15s injection time per 1ml syringe 1 3s injection time per 1ml syringe Substantially fewer and quicker injections (5x faster injection) N

80. Slide 80: Recap: HS provides a sizable market with high unmet need

    © 2024 | Proprietary | MoonLake TX Source: Recap: HS provides a sizable market with high unmet need MoonLake Commercial 80 ▪ Sizeable, underdiagnosed market: 2m patients today, >240k newly diagnosed patients every year ▪ Albeit starting from a small base (~13k in 2016) biologics market is growing ra

81. Slide 81: New indications: New frontiers for SLK and MLTX

    © 2024 | Proprietary | MoonLake TX New indications New frontiers for SLK and MLTX 81

82. Slide 82: SLK is a unique molecule targeting IL-17 A & F

    1 Liu S, et al. Nat Commun. 2013;4:1888; 2 Goepfert A, et al. Immunity. 2020 Mar 17;52(3):499 - 512 Source: MoonLake Research © 2024 | Proprietary | MoonLake TX 82 SLK is a unique molecule: Nanobody® that targets IL - 17 A & F IL - 17A and IL - 17F function as dimers to drive inflammation, through a

83. Slide 83: IL-17A & F is at the crux of many inflammation pathways

    Source: © 2024 | Proprietary | MoonLake TX Adaptive T cells Th, Tc cells Innate lymphocytes Tcells, ILC3, MAIT Neutrophils IL - 23 IL - 1 IL - 1 IL - 18 IL - 6 TGF TCR activation TNF IL - 12 C5a differential activation differential production IL - 17A IL - 17F IL - 19 IL - 36 CXCL1 CXCL8 CCL20 MoonL

84. Slide 84: Many diseases involve IL-17A&F as a key pathway

    84 Many diseases involve IL - 17A&F as a key pathway, beyond HS and PsA MLTX Core indications Other Adjacent indications Other indications (Onco, CV) Addressable Market Size USD bn NSCLC Nr - axSpA PM DM GCA Takayasu SLE LN SSc Behcet's PPP GPP Pityriasis (PRP) Pyoderma (PG) BC RCC GC OC A - HCC AIH

85. Slide 85: MLTX will expand its portfolio of SLK indications

    ▪ MLTX has a robust late - stage development program ongoing ― HS Phase 3 ― PsA Phase 3 ― Commercialization - enabling data in 2025/2026 ▪ Portfolio expansion is driven on the strengths of MLTX ― Focus on building the leadership of SLK in Derm & Rheum (vs. “opening” new TAs) ― Significant value that

86. Slide 86: How the new indications drive value for MLTX

    How the new indications drive value for MLTX 1 Merola J. et al. (2018). Dermatologic Therapy; 31:e12589 . doi.org/10.1111/dth.12589 and Chimenti et al. (2020). Biologics;14:53 - 75. doi: 10.2147/BTT; 2 Passeron et al. (2023). JAMA Dermatol . doi:10.1001/jamadermatol.2023.5051; 3 Limited disease cont

87. Slide 87: PPP: Elevating position as leading innovator in Derm

    1. Passeron et al. (2023). JAMA Dermatol . doi:10.1001/jamadermatol.2023.5051; 2 Brunasso A. & Massone C (2021). Fac Rev .; Twelves et al. (2019. J Allergy Clin Immunol, 143(3):1021 - 1026 . and Misiak - Galazka, M. (2020). Am J Clin Dermatol 21, 355 – 370 .; 3 Merola J. et al. (2018). Dermatologic

88. Slide 88: How the new indications drive value: PPP and Juvenile HS

    How the new indications drive value for MLTX PPP (Phase 2) ▪ “HS - like” disease, key priority for Derms, large unmet need ▪ Up to ~10 - 15% of PsO patients have palmoplantar involvement 1 ▪ IL17 A&F relevance shown through BKZ case series 2 Derm Rheum ▪ First clinical trial in juvenile HS , address

89. Slide 89: How the new indications drive value: axSpA

    How the new indications drive value for MLTX PPP (Phase 2) ▪ “HS - like” disease, key priority for Derms, large unmet need ▪ Up to ~10 - 15% of PsO patients have palmoplantar involvement 1 ▪ IL17 A&F relevance shown through BKZ case series 2 axSpA (Phase 2) ▪ Multi - bn markets (r/nr - axSpA) with l

90. Slide 90: axSpA: Broadening leadership in Rheum

    1. BKZ with durable response and effective in treating co - morbidities (i.e., uveitis) based on BE MOBILE trial results; 2. Based on U.S. claims data and estimations for AS: Unique patients diagnosed between 2015 - 2023 (ICD - 10 code: M45.*) and assuming 50:50 split between AS and nr - axSpA as pe

91. Slide 91: How the new indications drive value: PsA

    How the new indications drive value for MLTX 1 Merola J. et al. (2018). Dermatologic Therapy; 31:e12589 . doi.org/10.1111/dth.12589 and Chimenti et al. (2020). Biologics;14:53 - 75. doi: 10.2147/BTT; 2 Passeron et al. (2023). JAMA Dermatol . doi:10.1001/jamadermatol.2023.5051; 3 Limited disease cont

92. Slide 92: New indications provide sizeable opportunity in multi-bn markets

    Source: MoonLake Internal Opportunity Model, © 2024 Komodo Health, Inc. All rights reserved. Reprinted with permission. © 2024 | Proprietary | MoonLake TX 92 New indications provide sizeable opportunity in multi - bn markets 1 See Bimekizumab case series: Passeron et al. (2023). JAMA Dermatol. doi:1

93. Slide 93: New indications enrich the potential catalyst calendar 2024-25

    1 Assuming current Phase 3 planning is agreed with regulators (+/ - 6 months) Source: MoonLake team © 2024 | Proprietary | MoonLake TX New indications further enrich the potential catalyst calendar in 2024 - 25 Jun - 23: Ph2b 1ry end - point (12 wk) Q2 2023 Q3 2023 Q4 2023 H1 2025 Mar - 24: PsA Ph2b

94. Slide 94: Potential new indications could further build out SLK's potential

    Source: © 2024 | Proprietary | MoonLake TX MoonLake Corporate 94 Potential new indications could further build out SLK’s potential $8bn+ (2035) MoonLake continues to address the most pressing unmet needs in inflammatory diseases The additional programs result in USD 3Bn+, continuing to push the pote

95. Slide 95: Overview of R&D programs at MLTX

    Source: © 2024 | Proprietary | MoonLake TX Moonlake Clinical 95 Taking a step back: Overview of R&D programs at MLTX Phase 3 (BLA enabling) PsA Phase 3 (2025/26) HS Phase 3 (2025/26) Juv HS Phase 3 (2026) Next wave (Ph 3 enabling) PPP Phase 2 (2025) axSpA Phase 2 (2025) PsA Phase 2 (2025) Research (

96. Slide 96: Moving Forward

    © 2024 | Proprietary | MoonLake TX Moving Forward 96

97. Slide 97: SLK combines properties like no other asset

    Note: Comparisons across trials, with inherent limitations. No head - to - head trials. 1 Based on analysis of 2023 sales of 11 indications (PsO, RA, Asthma, AD, AxSpA, CU, SLE, PsA, COPD, CD, UC) – 2030 ranges are even higher Source: DRG, MoonLake Corporate © 2024 | Proprietary | MoonLake TX 97 SLK

98. Slide 98: Strategic path forward remains unchanged

    Strategic path forward remains unchanged Current owner Source: MoonLake © 2024 | Proprietary | MoonLake TX 98 Better owner

99. Slide 99: Operating from a position of strength: over $500m in cash

    Operating from a position of strength: over $500m in cash on the B/S Cash, cash equivalents and short - term marketable debt securities in USD M 564 September 30, 2023 16 Q4 2023 Q4 - 2023 ATM December cash burn proceeds 31, 2023 (excl. ATM) 31 53 Post - period ATM proceeds Pro Forma Cash 496 511 In

100. Slide 100: Focus on strengthening SLK as leader in Type 3 diseases

     Source: MoonLake Corporate © 2024 | Proprietary | MoonLake TX Neutrophil Th17 Th22 ILC3 IL - 17 IL - 22 IL - 23 100 Focus on strengthening the story of SLK as leader in Type 3 diseases Th2 cell ILC2 Mast cell T fh Basophil Eosinophil IL - 4 IL - 13 IL - 5 IL - 31 Type 2 Macrophage Th1 ILC1 NK IL - 1

101. Slide 101: Q & A

     © 2024 | Proprietary | MoonLake TX Q & A 101

102. Slide 102: Contact details

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

MoonLake Immunotherapeutics — Investor Day (March 2024) on 6ix