Moonlake Immunotherapeutics · NASDAQ:MLTX
Moonlake Immunotherapeutics — Investor Day (June 2026)
43 slides from Moonlake Immunotherapeutics's investor day presentation, Jun 22, 2026
Slide 1: MoonLake Immunotherapeutics Investor Day
© 2026 | Proprietary | MoonLake TX MoonLake Immunotherapeutics Investor Day June 22nd, 2026
Slide 2: Welcome to our Investor Day
© 2026 | Proprietary | MoonLake TX Source: Welcome to our Investor Day MoonLake Corporate Strategy Agenda Sub-topics Topic Speaker Timing Proposed Label Update on BLA progress BLA strategy Jorge 20 mins Welcome MLTX & SLK summary Introduction Jorge 10 mins Final Week 52 Phase 3 VELA data Update on V
Slide 3: Legal Disclaimer: Forward Looking Statements
Source: © 2026 | Proprietary | MoonLake TX MoonLake Legal 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, b
Slide 4: MoonLake corporate summary
© 2026 | Proprietary | MoonLake TX Source: Founded in 2021 in Switzerland Unique molecule with SLK, tri-specific IL-17A & F Nanobody® to elevate treatment in inflammation in markets with significant unmet needs and multi-bn $ potential Public on Nasdaq since April 2022 with cash runway to end of 202
Slide 5: A differentiated IL-17A and F molecule
Source: © 2026 | Proprietary | MoonLake TX 5 A differentiated IL-17A and F molecule: Do you still Antibody? Ig, immunoglobulin; VH, heavy chain variable domain; VHH, variable heavy domain of heavy chain; VL, light chain variable domain; 1 Hamers-Casterman, C., et al. Nature. 1993; 363:446–448; 2 Jov
Slide 6: MLTX is approaching registration in Derm and Rheum indications
Source: © 2026 | Proprietary | MoonLake TX MoonLake Corporate Strategy 6 MLTX is approaching registration in Derm and Rheum indications Dermatology Rheumatology Phase 2 P-OLARIS ongoing Phase 3 Registration Psoriasis PsO completed PsO Expected next steps Hidradenitis suppurativa MIRA completed VELA-
Slide 7: SLK consistently shows a leading profile across multiple indications
Source: © 2026 | Proprietary | MoonLake TX MoonLake Corporate Strategy 7 SLK consistently shows a leading profile across multiple indications Approximate responses; Selected data subject to change until final CSR is issued. 1 mNRI 120mg (VELA), ITT-NRI 120mg (MIRA): 34.4% for VELA-1 at Week 16, 34.1
Slide 8: 2026 is a catalyst-rich year for MLTX
Source: © 2026 | Proprietary | MoonLake TX Today MoonLake Corporate Strategy 8 2026 is a catalyst-rich year for MLTX FDA interaction Trial data Timeline not scaled, non-exhaustive; All future milestones are anticipated dates 2026 up to 60 days ▪IZAR-2: Ph3 PE readout ▪P-OLARIS: Interim readout IZAR-
Slide 9: SLK on schedule to be a potential best-in-class in HS
Source: © 2026 | Proprietary | MoonLake TX MoonLake Corporate Strategy 9 We believe SLK is on schedule to be a potential best-in-class in HS Leading Efficacy Leading performance across elevated treatment goals & time points incl. lesion counts, quality of life & pain scores 67% HiSCR75 at 1 year ~1
Slide 10: Final data from the VELA program in HS
© 2026 | Proprietary | MoonLake TX Final data from the VELA program in HS 10
Slide 11: HS is a major I&I challenge with very significant unmet needs
Source: © 2026 | Proprietary | MoonLake TX MoonLake Medical Affairs & Research 11 HS is a major I&I challenge with very significant unmet needs ...we need HS therapies that treat all types of lesions, with the opportunity for inflammatory remission HS is progressive and results in irreversible tissu
Slide 12: Phase 3 design and endpoints of VELA trials
Source: © 2026 | Proprietary | MoonLake TX MoonLake Clinical 12 Recap: Phase 3 design and endpoints of VELA trials Lesions PROs Phase 3 study design for VELA-1 and VELA-2 – identical, global, randomized, double-blind, placebo-controlled 52-week trials Placebo Group 1 (n=283/2762) Group 2 (n=138/1412
Slide 13: Consistent and high HiSCR75 response in pivotal trials
Source: © 2026 | Proprietary | MoonLake TX MoonLake Corporate Strategy 13 SLK pivotal trials: Consistent & high HiSCR75 response in pivotal trials SLK HS Pivotal trials HiSCR75 response in SLK treated patients (%) HiSCR75 response in PBO treated patients (%) VELA-1 34.4 (week 16) 17.5 (week 16) p<0.
Slide 14: VELA is a landmark HS program with high patient retention
Source: © 2026 | Proprietary | MoonLake TX MoonLake Clinical 14 VELA is a landmark HS program with high patient retention rate Convenient dosing High VELA-OLE acceptance reflects confidence in strength of 120mg in Q4W maintenance dosing High retention rates in the VELA trials ~26% Low drop-out rate
Slide 15: VELA demonstrates leading SLK long-term HiSCR75 efficacy
Source: © 2026 | Proprietary | MoonLake TX 67 60 40 47 0 10 20 30 40 50 60 70 0 4 8 12 16 24 32 40 48 52 54 MoonLake Clinical 15 VELA program demonstrates leading SLK long-term HiSCR75 efficacy Absolute HiSCR75 response across parental Phase 3 programs (pooled studies, %) # randomized pts with data
Slide 16: Crossover arms in VELA show consistently high responses
Source: © 2026 | Proprietary | MoonLake TX MoonLake Clinical 16 Crossover arms in VELA show consistently high responses Data subject to change until final CSR is issued; Data shown: (m)NRI until primary endpoint (grey), then as observed (blue); Cross-over percentage point increase shown for "AO to A
Slide 17: SLK shows the scorecard of a potential best-in-class drug in HS
Source: © 2026 | Proprietary | MoonLake TX MoonLake Clinical 17 SLK shows the scorecard of a potential best-in-class drug in HS Comparisons across trials are subject to inherent limitations, as no head-to-head clinical trials have been conducted; Data subject to change until final CSR is issued; The
Slide 18: SLK demonstrates a favorable safety profile at Week 16
Source: © 2026 | Proprietary | MoonLake TX MoonLake Medical & Safety SLK demonstrates a favorable safety profile at Week 16 Comparisons across trials are subject to inherent limitations, as no head-to-head clinical trials have been conducted; SLK and BKZ comparison based on numerical incidence rates
Slide 19: No new safety signals post Week 16
Source: © 2026 | Proprietary | MoonLake TX MoonLake Medical & Safety No new signals emerged post Week-16 Comparisons across trials are subject to inherent limitations, as no head-to-head clinical trials have been conducted; SLK and BKZ comparison based on numerical incidence rates; Methods to descri
Slide 20: VELA-TEEN met its endpoint
Source: © 2026 | Proprietary | MoonLake TX MoonLake Regulatory 20 VELA-TEEN met its endpoint PK analysis of VELA-TEEN – results ▪Results indicate that adolescent estimates are within the range of adult exposures and are supportive of exposure matching ▪Adolescent data show less variability than the
Slide 21: Rapid onset and high response rates in adolescents
Source: © 2026 | Proprietary | MoonLake TX MoonLake Clinical 21 SLK shows rapid onset and high response rates in adolescents Total participants at each timepoint; VELA-TEEN trial is ongoing with the number of participants reaching W16 and W24 expected to increase over time; VELA-TEEN and VELA-1/-2 a
Slide 22: VELA-TEEN shows favorable safety profile with no new signals
Source: © 2026 | Proprietary | MoonLake TX MoonLake Medical & Safety 22 VELA-TEEN data shows favorable safety profile with no new signals Data subject to change until final CSR is issued; 1 VELA-TEEN trial is ongoing – not all patients reached Week 28 yet Treatment-emergent adverse events (TEAE), n
Slide 23: SLK offers convenience in induction and maintenance
Source: © 2026 | Proprietary | MoonLake TX MoonLake Medical, BKZ Instructions for Use and FDA label 23 Convenience: SLK offers convenience in induction and maintenance These data are derived from different clinical trials at different points in time, with differences in trial design and patient popu
Slide 24: BLA strategy
© 2026 | Proprietary | MoonLake TX BLA strategy 24
Slide 25: What matters in a label: Sections 14, 5 and 2
Source: © 2026 | Proprietary | MoonLake TX MoonLake Regulatory 25 What matters in a label: Sections 14, 5 and 2 FDA label example, secukinumab example Potential areas of differentiation Clinical response of trials incl. supplementary text, figures and additional clinical data – enabling potential di
Slide 26: Competitor data leaves space for SLK to compete
Source: © 2026 | Proprietary | MoonLake TX MoonLake Regulatory 26 Competitor data leaves space for SLK to compete as the leading drug Section 5 Section 2 Section 14 p-values are not included in respective labels Delta-to-placebo not shown in SEC label SEC does not demonstrate statistical significanc
Slide 27: Base scenario for Sec. 14 table
Source: © 2026 | Proprietary | MoonLake TX MoonLake Regulatory 27 Building on feedback, this is our base scenario for Sec. 14 table For illustrative purposes only; Comparisons across trials are subject to inherent limitations, as no head-to-head clinical trials have been conducted; Potential label o
Slide 28: Upside case includes other HS responses in Sec. 14 table
Source: © 2026 | Proprietary | MoonLake TX MoonLake Regulatory 28 "Upside case" also includes other HS responses in Sec. 14 table Efficacy data relevant for potential label (in brackets delta to placebo) IHS4-55, % 53.3 (19.4) 62.7 (33.3) Pain NRS-3, % 28.3 (16.8) 22.0 (19.9) HiSQOL, CfB1 -8.7 (-5.7
Slide 29: Further differentiation potential in Sec. 5 and Sec. 2
Source: © 2026 | Proprietary | MoonLake TX MoonLake Regulatory 29 SLK has further differentiation potential in Sec. 5 and Sec. 2 SLK differentiation potential Section 5 Warnings and Precautions ▪ Suicidal Ideation and Behavior ▪ Infections ▪ Tuberculosis ▪ Liver Biochemical Abnormalities ▪ Inflammat
Slide 30: VELA-TEEN provides potential for Priority Review
Source: © 2026 | Proprietary | MoonLake TX MoonLake Regulatory 30 VELA-TEEN provides potential for Priority Review of the HS BLA 1 Secukinumab received FDA approval for adolescent HS population in March 2026 FDA Priority Review Eligibility criteria: 1. "Evidence of increased effectiveness in treatme
Slide 31: HS BLA timeline: acceptance expected by end of November 2026
Source: © 2026 | Proprietary | MoonLake TX MoonLake Regulatory 31 HS BLA timeline: BLA acceptance expected by end of November 2026 FDA pre-BLA process expected to be fully completed with submission at end of Sep 2026 Granting of PDUFA date as well as decision on Priority Review expected at end of No
Slide 32: Commercializing SLK in HS
© 2026 | Proprietary | MoonLake TX Commercializing SLK in HS 32
Slide 33: Continued growth in real-world data confirms $10bn+ market potential
Source: © 2026 | Proprietary | MoonLake TX Company information. Analyst research. MoonLake IR, Unique U.S. patients from prescription data, MoonLake Commercial, © 2026 Komodo Health, Inc. All rights reserved 33 Continued growth in real-world data confirms market potential at $10bn+ Market trends con
Slide 34: HS is a naïve market with great conditions for a biotech launch
Source: © 2026 | Proprietary | MoonLake TX MoonLake Commercial, Cantor, Evaluate Pharma, Unique U.S. patients from prescription data; MoonLake Commercial, © 2026 Komodo Health, Inc. All rights reserved. MMIT 2026 34 +2.9m patients diagnosed with HS in the US Only 3% of HS patients treated with biolo
Slide 35: US Derm market research ranked important attributes for Bx selection in HS
Source: © 2026 | Proprietary | MoonLake TX 77% 74% 68% 67% 66% 65% 63% 58% 57% 54% 50% 39% 36% 20% 20% 16% 11% 7% Overall efficacy Favorable safety profile Positive impact on quality of life Ability to control flares Pain reduction Reduction/improvement in lesions Prevention of new lesions Maintenan
Slide 36: On track to seize the opportunity in HS in the US
Source: © 2026 | Proprietary | MoonLake TX MoonLake Commercial 36 We are on track to seize the opportunity in HS in the US ▪US entity incorporated ▪Distribution operation setup (state licenses, 3PL / SP setup, serialization, 1st commercial batches ready) ▪Strategic positioning and GTM model with foc
Slide 37: Closing remarks
© 2026 | Proprietary | MoonLake TX Closing remarks 37
Slide 38: MLTX has gathered the data to propose a leading label
Source: © 2026 | Proprietary | MoonLake TX MoonLake Corporate Strategy 38 MLTX has gathered the data to propose a leading label Section 5 Warnings & precautions No signal observed for SIB, hepatic events or TB reactivation – possible advantages also in other dimensions, e.g., diarrhea, IBD Section 2
Slide 39: SLK data in HS supports strong payor value story
Source: © 2026 | Proprietary | MoonLake TX MoonLake Corporate Strategy 39 Overall SLK data in HS supports strong payor value story Comparisons across trials are subject to inherent limitations, as no head-to-head clinical trials have been conducted; The VELA parental trials were 52-week while the Bi
Slide 40: Rheumatology (PsA) starts reading pivotal data soon
Source: © 2026 | Proprietary | MoonLake TX Today MoonLake Corporate Strategy 40 Catalyst-rich year: Rheumatology (PsA) starts reading pivotal data soon FDA interaction Trial data Timeline not scaled, non-exhaustive; All future milestones are anticipated dates 2026 up to 60 days ▪IZAR-2: Ph3 PE reado
Slide 41: What to expect from the IZAR-1 readout in PsA
Source: © 2026 | Proprietary | MoonLake TX MoonLake Corporate Strategy 41 What to expect from the IZAR-1 readout in PsA General disclosures in PsA ▪ Recent disclosures of PsA data, e.g., bimekizumab showed only limited information – mainly focusing on "stat sig" descriptions without disclosing absol
Slide 42: Q & A
© 2026 | Proprietary | MoonLake TX Q & A Please submit your questions via the dedicated Q&A function in the portal
Slide 43: Slide 43
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