Moonlake Immunotherapeutics · NASDAQ:MLTX
Moonlake Immunotherapeutics — Investor Day (February 2026)
49 slides from Moonlake Immunotherapeutics's investor day presentation, Feb 23, 2026
Slide 1: MoonLake Immunotherapeutics Investor Day
MoonLake Immunotherapeutics Investor Day February 23rd, 2026 © 2026 | Proprietary | MoonLake TX
Slide 2: Welcome to our Investor Day
Welcome to our Investor Day Agenda Date: February 23rd, 2026 Topic Sub-topics Speaker Timing Time: 8.00 am EST Introduction Welcome Matthias 10 mins MLTX & SLK summary Key points for the session axSpA update axSpA market update Kristian 20 mins S-OLARIS program overview Efficacy & safety overview HS
Slide 3: Disclaimer
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, but are not limited to, statements regarding our expectations
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 “Ask a question” function on the top right of your screen – questions are only visible to the moderators – we will address as many questions as possible at the end of this
Slide 5: Founded in 2021 in Switzerland
Founded in 2021 in Switzerland Unique molecule with sonelokimab, tri-specific IL- 17A & F Nanobody® to elevate treatment in inflammation in a $40bn+ market Public on Nasdaq since April 2022 and ~$800m raised through equity to date, plus up to $500m non-dilutive facility, with current cash runway to
Slide 6: A differentiated IL-17A and F molecule: Do you still Antibody?
A differentiated IL-17A and F molecule: Do you still Antibody? Nanobodies® are much smaller They can be designed to have multiple than traditional antibodies and different binding domains What is a Nanobody®?1,2 A next-generation biologic A humanized fragment of a naturally occurring antibody class
Slide 7: SLK consistently shows a leading profile across multiple indications
SLK consistently shows a leading profile across multiple indications Dermatology Rheumatology HS (incl. Adol) PPP PsO PsA axSpA Estimated Market size 10-15bn 3-4bn 20-25bn 10-15bn 10-15bn ($, 2035) (11-15% growth from ‘22) (12% growth from ‘22) (8% growth from ‘25) (4% growth from ‘25) (7% growth fr
Slide 8: SLK consistently shows a leading profile across multiple indications
SLK consistently shows a leading profile across multiple indications Dermatology Rheumatology HS (incl. Adol) PPP PsO PsA axSpA Estimated Market size 10-15bn 3-4bn 20-25bn 10-15bn 10-15bn ($, 2035) (11-15% growth from ‘22) (12% growth from ‘22) (8% growth from ‘25) (4% growth from ‘25) (7% growth fr
Slide 9: An active catalyst flow for MLTX expected in 2026
An active catalyst flow for MLTX expected in 2026 Timeline not scaled FDA interaction Trial data Derm event Rheum event 2026 Q1 Mid-year Q4 Focus of today VELA VELA IZAR-2 VELA-TEEN VELA-TEEN VELA VELA IZAR-1 up to 60 days AAD EULAR HS BLA EADV SHSA/ACR submission HS BLA S-OLARIS: PE VELA-TEEN: acce
Slide 10: S-OLARIS
S-OLARIS axSpA Phase 2 readout © 2026 | Proprietary | MoonLake TX 10
Slide 11: axSpA is an attractive opportunity in a ~$10-15bn market in 2035
axSpA is an attractive opportunity in a ~$10-15bn market in 2035 Projected market Axial Spondyloarthritis (axSpA) at a glance Biologics patients (2020-2038 in US)1 size (2038) % CAGR What real-world data shows: 400k $10-15bn2 ▪ ~1.2m unique patients with positive diagnosis 350k +6% for axSpA (M45X)
Slide 12: Elevating the bar with biomarker control and imaging at depth
Elevating the bar with biomarker control and imaging at depth SLK administration Assessments and major milestones A Phase 2 open-label imaging study to explore the effects of sonelokimab Assessments (as shown on next pages): in patients with active axial spondyloarthritis ▪ ASAS40 score Screening Tr
Slide 13: Competition: What have other axSpA trials shown?
Competition: What have other axSpA trials shown? Black box warning Overview of comparable biologics approved in axSpA (not based on H2H trials) Bolded = primary endpoint ▪ Several biologics are approved for axSpA, yet a Patients substantial unmet need achieving 45%7 48%1 42%3-4 52%5-6 48%9 persists
Slide 14: 80+% ASAS40 responders at Week 12 with SLK
80+% ASAS40 responders at Week 12 with SLK ASAS40 responders, % of patients ▪ S-OLARIS data show Sonelokimab 60mg (mNRI1) Competitor range2 unprecedented speed of onset – with 77% of 87 patients achieving 81 77 ASAS40 by Week 4 70 ▪ Response rises to over 51 53 80% by Week 12 – 42 outperforming comp
Slide 15: 80+% show a shift to inactive or low disease activity by Week 12
80+% show a shift to inactive or low disease activity by Week 12 ASDAS-CRP Categories1 (As Observed) High and Very High Disease Activity Inactive and Low Disease ▪ SLK shows rapid onset of effect in ASDAS-CRP – with over 80% of patients reaching inactive ASDAS-CRP Category (%) 19% 19% or low disease
Slide 16: ~90% experience clinically important improvement by Week 12
~90% experience clinically important improvement by Week 12 ASDAS-CRP4 Clinically Important Improvement1 (%) Sonelokimab 60mg (mNRI2) Competitor range3 ▪ ~90% of patients achieved a clinically important 94 improvement as per ASDAS- 89 CRP score at Week 12 81 ▪ Additionally, 58% of patients 65 60 59
Slide 17: SLK shows strong reduction of structural damage
SLK shows strong reduction of structural damage Mean change from baseline in SPARCC MRI score in SIJs at primary endpoint vs baseline Sonelokimab 60mg1 Competitor range2 Week 12 Week 14/16 SLK achieved a 21.8- -2.5 point reduction in inflammatory lesions -6.3 in the SIJ as measured by SPARCC MRI – o
Slide 18: SLK shows disease modifying effects deep in joints as early as week 12
SLK shows disease modifying effects deep in joints as early as week 12 Change in mean SUVmax score (SIJ) – corresponding to disease modification1 by reduction of bone re-modeling Example PET image of patient participating in S-OLARIS Week 12 6.7 -43%* SLK shows rapid onset of disease-modifying effec
Slide 19: Distinct axSpA serum biomarker signature modulated by SLK
Distinct axSpA serum biomarker signature modulated by SLK Correlation of Key Biomarkers with SLK ASDAS-CRP response, Week 12 ▪ Modulation of these markers shows that SLK attenuates chronic inflammatory signalling and interrupts the disease cascade implicated in structural progression in axSpA ▪ Resp
Slide 20: Safety profile of sonelokimab was favorable throughout entire study
Safety profile of sonelokimab was favorable throughout entire study S-OLARIS to Week 12 ARGO to Week 12 Treatment-emergent adverse events (TEAE), n (%) Sonelokimab Sonelokimab 60 mg N=26 Sonelokimab 60 mg N=41 demonstrated a Any TEAE 14 (53.8) 14 (34.1) clean safety profile Any Serious TEAE 1 (3.8)c
Slide 21: Conclusions
Conclusions axSpA is an attractive opportunity in a ~$10-15bn market in 2035 Current therapeutic options show limited efficacy, with only ~40– 50% of patients achieving ASAS40 SLK raises the efficacy bar, with S-OLARIS showing patients with 80+% ASAS40 and ~90% clinically important improvement by We
Slide 22: HS BLA update
HS BLA update © 2026 | Proprietary | MoonLake TX 22
Slide 23: Recent FDA feedback provided regulatory clarity for BLA process
Recent FDA feedback provided regulatory clarity for BLA process Preparation for FDA meeting Next steps for MLTX Following VELA read-out on ▪ No additional clinical trials needed in HS, as two well-controlled September 29th, 2025 trials are required to establish substantial evidence of effectiveness
Slide 24: Why does MIRA matter?
Why does MIRA matter? MIRA VELA-1/2 Bimekizumab Secukinumab Phase 2 Phase 3 Phase 2 Phase 2 Regulatory One adequate & Two adequate & well Proof-of-concept No Phase 2 trial considerations well controlled trial controlled trials Small POC study integrating Progress to Ph3 relied on Large RCT with simi
Slide 25: What matters in a label: Sections 14, 5 and 2
What matters in a label: Sections 14, 5 and 2 FDA label example, secukinumab example Potential areas of differentiation Section 14 Clinical response of trials incl. supplementary text, figures and additional clinical data – enabling potential differentiation on efficacy and PROs (where SEE is primar
Slide 26: What matters in a label: The information you should expect
What matters in a label: The information you should expect Section 14 Clinical response of trials incl. supplementary text, figures and additional clinical data – enabling potential differentiation on efficacy and PROs (where SEE Bimekizumab label is primarily reflected) – Secukinumab competitors on
Slide 27: Building on feedback, this is our base scenario for Sec. 14
Building on feedback, this is our base scenario for Sec. 14 Absolute response (Delta-to-placebo); VELA data reflects composite strategy analysis (ITT-mNRI) Potential label options for sonelokimab reflecting MLTX’s current views based on data and prior regulatory correspondence IL-17A and F mAb Sonel
Slide 28: An “upside case” also includes other responses in the Sec. 14 table
An “upside case” also includes other responses in the Sec. 14 table Absolute response (Delta-to-placebo); VELA data reflects composite strategy analysis (ITT-mNRI) Potential label options for sonelokimab reflecting MLTX’s current views based on data and prior regulatory correspondence IL-17A and F m
Slide 29: Potential inclusion of VELA-2 data for SEE only supports Sec.14 further
Potential inclusion of VELA-2 data for SEE only supports Sec.14 further Absolute response (Delta-to-placebo); VELA data reflects composite strategy analysis (ITT-mNRI) Potential label options for sonelokimab reflecting MLTX’s current views based on data and prior regulatory correspondence IL-17A and
Slide 30: Warnings & Precautions + Dosage: SLK has differentiation potential
Warnings & Precautions + Dosage: SLK has differentiation potential SLK differentiation potential ▪ Suicidal Ideation and Behavior ▪ Infections No TEAEs of SIB reported in Phase 3 trials. Section 5 C-SSRS validated for risk identification and ▪ Infections ▪ Hypersensitivity Reactions Warnings and mon
Slide 31: Long-term data: HiSCR75 response of SLK increases over time
Long-term data: HiSCR75 response of SLK increases over time Long-term HiSCR75 response rates at end of parental trial (OC), in % of patients Sonelokimab (120mg) Bimekizumab (320mg) Secukinumab (300mg) 69 67 Strong long-term 64 efficacy data 56 establishes potential beneficial 43 commercial 38 positi
Slide 32: Long-term data: Pain and HiSQoL continue to improve over time
Long-term data: Pain and HiSQoL continue to improve over time Pain response (OC) HiSQOL improvement (OC) SLK 120mg (VELA-1/2) PBO > SLK 120mg (VELA-1/2) 60 0 PBO > SLK 120mg (VELA-1/2) SLK 120mg (VELA-1/2) ▪ Continuous improvement of (at least 3 point reduction of Pain NRS)1 50 44.3 relevant quality
Slide 33: VELA-TEEN: SLK also shows rapid onset of effect in adolescent patients
VELA-TEEN: SLK also shows rapid onset of effect in adolescent patients HiSCR response rates (As observed), in % of patients SLK shows strong HiSCR responses at week 16 – with week 24 scores continuing to improve as more patients come in 83 We are aiming for 76 67 67 further differentiation in our la
Slide 34: Clean safety profile signals leading benefit risk ratio across program
Clean safety profile signals leading benefit risk ratio across program VELA-TEEN to Week 281 Treatment-emergent adverse events (TEAE), n (%) Sonelokimab 120 mg N=27 Any TEAE 13 (48.1) Any Serious TEAE 0 Sonelokimab is also Any TEAE leading to discontinuation 1 (3.7)2 showing a clean Most frequent TE
Slide 35: BLA submission timeline remains as planned
BLA submission timeline remains as planned Timeline not scaled ▪ Regulatory clarity obtained at a 2025 2026 stage where other companies typically do not get it Q4 Q1 Q2 Q3 Q4 ▪ Clear guidance to complete a BLA, with the full preclinical and HS PE read-out HS additional data HS commercial clinical pa
Slide 36: Other updates & guidance
Other updates & guidance © 2026 | Proprietary | MoonLake TX 36
Slide 37: PPP: A fast-growing disease with a continued unmet need
PPP: A fast-growing disease with a continued unmet need Palmoplantar pustulosis (PPP) at a glance Projected market Biologics patients (2020-2038 in US)3 size (2038) What real-world data shows: % CAGR ▪ ~185k unique patients with 40k positive diagnosis for PPP $4-5bn4 35k (L40.3) in 2015-2025 in US +
Slide 38: PPP: The Phase 2 LEDA trial read-out in Q4 2025
PPP: The Phase 2 LEDA trial read-out in Q4 2025 SLK administration Endpoints and major milestones A Phase 2, multi-center, open-label study to explore the effects of Primary clinical endpoint: sonelokimab in patients with moderate-to-severe PPP ▪ % CfB of PPPASI at week 16 Screening Treatment Safety
Slide 39: PPP: SLK shows strong results in the key endpoints for Phase 3
PPP: SLK shows strong results in the key endpoints for Phase 3 Sonelokimab 120mg (mNRI) Sonelokimab 120mg (OC) Competitor range2 PPPGA 0/1+2 pts (BL > 2) response rate, in % of patients PPPASI75 response rate, in % of patients 44.4 42 43 34 33.1 29.0 22.6 13 3.2 3 Week 2 Week 4 Week 6 Week 8 Week 16
Slide 40: PPP: Phase 3 design aims for an expedited read-out
PPP: Phase 3 design aims for an expedited read-out As per current MoonLake plan – subject to FDA interactions PBO-controlled Maintenance ▪ Phase 3 program backed 124 SLK 120 mg Q2W Sonelokimab 120 mg Q2W by Phase 2 data and an optimized dosing regimen – Optional: Up-titration if no PPPGA0/1 at wk38
Slide 41: PsA: Breaking the treatment level – SLK is the next-gen treatment
PsA: Breaking the treatment level – SLK is the next-gen treatment Treatment levels and positioning for existing products in PsA1 xx 2025 revenue ($bn)2 Multi-domain focused Orals TNFs & JAKs IL-12 & IL-23 IL-17A only Next gen drugs (IL-17 A&F) ▪ PsA prevalence continues to grow – ~20% ACR50 + ACR (5
Slide 42: PsA: The IZAR program is a key potential catalyst for MoonLake in 2026
PsA: The IZAR program is a key potential catalyst for MoonLake in 2026 IZAR-1 IZAR-2 Phase 3 clinical trial in bio-naïve and Phase 3 clinical trial in bio-experienced radiographic patients with PsA patients with PsA, with a Risankizumab reference arm Recruitment Recruitment completed Recruitment ong
Slide 43: Finance: Additional funding further strengthened our balance sheet
Finance: Additional funding further strengthened our balance sheet Cash position by quarter, in USD m MLTX continues to operate at a Cash 511.0 547.1 Impact from equity raise cash burn well below peers Impact from first tranche of debt facility position1, 480.1 Cash position excluding debt facility
Slide 44: Finance: OpEx stabilized at ~$65m/quarter
Finance: OpEx stabilized at ~$65m/quarter (incl. non-cash expense) Operating expense by quarter, in USD m 511.0 547.1 Operating expenses stabilized R&D G&A at around $65m per quarter which includes non-cash 71.4 expense such as share-based 65.2 compensation 60.7 R&D expense now beyond the 49.6 47.5
Slide 45: Finance: We amended the debt facility to fund future growth
Finance: We amended the debt facility to fund future growth X Original facility terms (Mar 2025) Updated facility terms (Feb 2026) Updated Cost of capital $75m Closing of loan facility $75m Closing of loan facility 8.45% cash interest rate2,3 Drawn March 2025 Drawn March 2025 0.25% reduction upon BL
Slide 46: Closing Remarks
Closing Remarks © 2026 | Proprietary | MoonLake TX 46
Slide 47: Recap: An active catalyst flow for MLTX is expected in 2026
Recap: An active catalyst flow for MLTX is expected in 2026 Timeline not scaled FDA interaction Trial data Derm event Rheum event 2026 Q1 Mid-year Q4 Focus of today VELA VELA IZAR-2 VELA-TEEN VELA-TEEN VELA VELA IZAR-1 up to 60 days AAD EULAR HS BLA EADV SHSA/ACR submission HS BLA S-OLARIS: PE VELA-
Slide 48: Q&A
Q&A © 2026 | Proprietary | MoonLake TX 48
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