Moonlake Immunotherapeutics · NASDAQ:MLTX
Moonlake Immunotherapeutics — Investor Day (September 2023)
71 slides from Moonlake Immunotherapeutics's investor day presentation, Sep 11, 2023
Slide 1: MoonLake Immunotherapeutics Capital Markets Day
Slide 2: Disclaimer
Disclaimer O moontake Forward Looking Statements Certain statements in this presentation may constitute “forward-looking statements" within the meaning of the US. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding our ex
Slide 3: Instructions for this session
{eo} MoonLake Instructions for this session S&S Bea < 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 presentat
Slide 4: Welcome to our Capital Markets Day
Welcome to our Capital Markets Day O woontake Logistics Agenda Date: September 11", 2023 Topic Sub-topics Speaker Timing Time: 11:30-13:00 EDT F Location: Nasdaq Marketsite 1OFL, 4 Times Introduction - Welcome & session details Jorge Santos 15 mins - Where MLTX stands and next catalysts da Siva Psor
Slide 5: Introduction
Introduction
Slide 6: MoonLake company overview
(@) MoonLake © Founded in 2021 in Switzerland f © Nanobody® technology licensed in initial private . ‘i round 6 po you still Antibody © Unique molecule with sonelokimab, tri-specific IL- if 4 3 f | | > | | 17A & IL-17F Nanobody® to elevate treatment in olutionizing Immunother Spy inflammation in a $
Slide 7: High interest in a differentiated molecule - Do you still Antibody?
High interest in a differentiated molecule —- Do you still Antibody? {e) MoonLake Nanobodies® are much smaller than traditional antibodies Conventional IgG 150kDa) IL-17A & IL-17F They can be designed to have multiple and different binding domains - . J°-%’ © CQ 3 + “tome anioay Cur @ owe Sonelokima
Slide 8: It's all about the dimers
It's all about the dimers Illustrative 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!? Not all IL-17-targeting therapeut
Slide 9: The broad IL-17 class is expected to lead in a growing market
The broad IL-17 class is expected to lead in a growing market [e) MoonLake Global sales, USD 8n 52 Prevalence (%) Hidradenitis Suppurativa (1s) os = Driven by IL-17s (40%) on base built by Humira™ as only therapy % C2 * Several failures (e.g, IL-23,IL-36, TYK-2, IRAK, IL-1) SS ap Psoriatic Arthritis
Slide 10: Why IL-17A & F is a highly attractive MoA
Why IL-17A & Fis a highly attractive MoA [e) MoonLake HS Example Multiple stimuli induce Different cell types IL-17A and F as IL-17A and F induce multiple subsets of immune cells preferentially produce “bottleneck” in pro-inflammatory effectors, to produce IL-17A and F IL-17 A and/or F HS pathology
Slide 11: SLK rapidly becoming a leader in large inflammatory diseases
SLK rapidly becoming a leader in large inflammatory diseases [e) MoonLake agg HS PsO Trial Patients (n) || Leading Moa | | SLK leading asset | Highest ever primary endpoint a 234 ee (HiSCR75), largest delta to placebo at HiSCR75 and 50 ILI7A &E Largest delta vs market leader Phase 2b 313 Cosentyx™ a
Slide 12: PsO: SLK has a winning next gen IL-17 profile
PsO: SLK has a winning “next gen IL-17” profile in PSO (@) MoonLake Phase 1 & Precli J Am Acad Dermatou Votume 81, Numper | Phase 2 clinical data THE LANCET = Leading efficacy in +4 ® ILI7A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase
Slide 13: PsO: SLK has best relative performance for highest PASI
PsO: SLK has best relative performance in PsO for highest PASI Oo MoonLake PASI 100 delta to in-trial active comparator secukinumab Key Notes 25 Le® ILITA&F mAb a. IL-17A.& F Nanobody 1L-23 mAb Secukinumab 25 ———,. ef LIZA &F mAb IL-17A.& F Nanobody 1L-23 mAb Secukinumab All selected trials are doub
Slide 14: Global Ph2 trials to open the SLK pipeline-of-indications
We drive large global Ph2 trials to open the SLK pipeline-of-indications Oo MoonLake Approach fo clinical design Global Phase 2 program = Trials started for Hidradenitis Suppurativa (HS) and Psoriatic Arthritis (PsA), high unmet need diseases * Trials illustrate our pivotal design approach: — Larger
Slide 15: HS: SLK reaches the highest scores vs others
HS: SLK reaches the highest scores vs others, including HiSCR75 [e) MoonLake HiSCR75 delta to PLC (Primary endpoint for SLK) HiSCRS5O delta to PLC (Primary endpoint for others!) Percent delta for best doses, pamary analysis Percent delta for best doses, primary analysis *p=0.0002 *p<0.0001 29 38 SLK
Slide 16: HS: SLK improves IHS4 and changes tunnel morphology
HS: SLK significantly improves IHS4 and changes morphology of tunnels [e) MoonLake IHS4 adjusted mean change Direct evidence of DT changes Percent (%) change from baseline over time, IT 0 2 4 6 8 WwW 12 oO “Adjustedmean IHS4 score change ako ra signiicanly altferent for both arms -20 -30 Deep dermal
Slide 17: SLK is the potential leader in Type 3 diseases
SLK is the potential leader in Type 3 diseases {eo} MoonLake E.g., Prometheus’ aTLlA rece Pathway iypell Primary immune cells!2 Macrophage Thr Cl NK IFNy TNE Key cytokines! Diseasesrelated Pemphigus. TP to dysregulated SLE, other CID immunity Rheumatoid Arthritis fexamples)*® Caps, DIRA E.g., Dupixe
Slide 18: Summary
merging pe = Best in class —SLK can potentially be a unique molecule among alll “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 MoA with unique molecular characteristics = MLTX = Robust trials —
Slide 19: MLTX has an intense set of expected catalysts to year end
MLTX has an intense set of expected catalysts to year end O Mmoontake 2023 2024 ~ Today —— auiet period ——— June 26 September 11 October November December January HS primary Capital HS 24-week PsA primary FDA EoP2 R&D Day 2023 data Markets Day data data meeting during/after JPM. (+10-K end of Feb) S
Slide 20: Psoriatic Arthritis (PsA): Unmet need & evolving landscape
oO Psoriatic Arthritis (PSA) Unmet need & evolving landscape oz | reetay oontatere [a0]
Slide 21: Disclosures
Disclosures O woontake + J. F. 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, and MoonLake Immunotherapeutics
Slide 22: PsA is common, underdiagnosed and undertreated
PsA is a common condition that is underdiagnosed and undertreated Oo MoonLake 30% of patients with psoriasis develop PsA! Global prevalence of psoriasis: ~125 million people! ~2 in 5 patients ~2 in 5 patients with PsA diagnosed with PsA were underdiagnosed are not on biologics in the PREPARE non-int
Slide 23: PsA is a multidomain disease, including joints and skin
PsA is a multidomain disease, including joints and skin Oo MoonLake Novel treatments for PsA are primarily assessed on improvements in joints and skin'? >70% of patients with active PsA have 2+ domain involvement* Patients with domain 27% Other domains Patients with Enthesi Dactyitis 2+ domains Freq
Slide 24: Significant skin involvement continues to be prevalent in PsA
Significant skin involvement continues to be prevalent in PsA Oo MoonLake 42% >40% of patients with PsA have moderate-to- severe skin disease Moderate 5 Mild Skin involvement in PsA typically affects ~10% of body surface area,! indicative of significant disease
Slide 25: IL-17i is the only biologic class preferred in all domains of PsA
IL-17iis the only biologic class preferred in all domains of PsA Oo MoonLake Joints Skin Other domains Preferred Peripheral biologic(s)! arthritis ( IL-17i TNFi IL-12/23i IL-23i
Slide 26: >1/3 of patients do not achieve MDA
>3 in 4 patients do not achieve MDA within 6 months of biologic initiation! 17% Non-responder % of patients who were MDA responders MDA (Minimal Disease Activity) denotes a patient who has achieved 25 of the following 7 criteria: i a, 3. 4. 5. 6 7. Joints: TIC <1 Joints: SJC <1 Skin: PASI <1 (or BSA
Slide 27: The symptom burden of PsA remains wide-ranging and substantial
The symptom burden of PsA remains wide-ranging and substantial [e) MoonLake Many patients report a moderate-to- severe psychosocial impact of PsA! 69 10-40% of patients with PsA. . experience depression and 60 56 anxiety? 4in 5 patients with PsA report 30 x fatigue, with a major impact on %0 physica
Slide 28: High clinical response in skin, in addition to joints, is critical
High clinical response in skin, in addition to joints, is critical for patients Oo MoonLake PsA is associated with a multitude of -_ couinpad ii quality-of-life impairments? These may be especially pronounced in patients with multidomain PsA, such <0 0 10 » % sae as skin involvement, who report: Qol
Slide 29: Innovations in drug targets and structures
(eo) MoonLake It may be that innovations in both drug targets and drug structures are needed to move the needle in PsA...
Slide 30: Can we optimize IL-17 inhibition?
Can we optimize IL-17 inhibition? O Mmoontake As the class of choice for addressing all domains in PsA, innovation on MOA is centered on optimizing IL-17i, based on increasing evidence that IL-17F drives psoriatic inflammation in addition to IL-17A. kin Moderate-to-severe psoriasis @d IL-17A-only in
Slide 31: IL-17A and IL-17F dual inhibition newly validated as an MOA in PsA
IL-17A and IL-17F dual inhibition is newly validated as an MOA in PsA Oo MoonLake Bimekizumab IL-17A and IL-17F inhibitor (160 mg @4W) | BE COMPLETE (Pha * Patients enrolled in the study had a previous inadequate response to, or intolerance of, TNF inhibitors PLC>BKZ —BKZ>BKZ 1 year (OLE)? Week 16!
Slide 32: Innovation in molecular design of drug structures
What about innovation in the molecular design of drug structures?
Slide 33: Molecular design features for targeting musculoskeletal inflammation
Molecular design features for targeting musculoskeletal inflammation Oo MoonLake Smaller biologics > higher tissue uptake! Albumin-binding domains target inflammation Accumulation of Nanobodies® 24 h after treatment? Distribution of anti-TNF Nanoboaies® +/- albumin-binding site 24h after a single in
Slide 34: Next-generation IL-17i: two approaches for optimizing PsA outcomes
Next-generation IL-17i: two approaches for optimizing PsA outcomes [e) MoonLake Can we innovate on both target and structure ‘Small size, to improve outcomes in PsA? albumin-binding Trokibep! Innovating on... ligand trap, || “2 Bimekaumab Z e i tas ia @ Ab (INF-IR}? + structure with small size + alb
Slide 35: Sonelokimab: potential to innovate on both target and structure
Sonelokimab: potential to innovate on both target and structure Oo MoonLake Sonelokimab: best of both worlds? 7A and IL-17F inhibition Small, albumin-binding Nanobody® Psoriasis IL-17F in skin! PASI 100 Week 16, Phase 2b HISCR 75, PBO-adj | DT 100 Week 12, Phase 2b Not head-to-head data | Complete r
Slide 36: Summary
Summary O Mmoontake * There remains an unmet need across the multiple domains of PsA, demanding novel therapies — innovation will stem from both drug targets and structures + IL-17A and IL-17F inhibition has the potential to optimize outcomes across PsA domains * There are some promising indications
Slide 37: MLTX R&D Update
(eo) MoonLake MLTX R&D Update
Slide 38: Key learnings from Prof. Merola
{eo} MoonLake re) Key learnings from Prof. Merola = PsA is a multi-domain disease with joint and skin as main manifestations = Current therapies are limited in their control of different PsA (@) domains — a major unmeet need = IL-17 is a key pathway in PsA; delivering IL-17A and IL-17F inhibition wi
Slide 39: Like in the skin, IL-17A and IL-17F have key roles in PsA
1. Like in the skin, IL-17A and IL-17F have key roles in PsA {eo} MoonLake Innate and adaptive Myeloid cells iymehoeyiss ia Je: 6 T cells Macrophages ¥' MAIT cells Dendtitic cells Tells (CD4 or CD8) Inflamed joints Neutrophils andentheses IL-17A and IL-17F Pro-inflammatory cytokines + Inflammation +
Slide 40: Direct inhibition of IL-17A+IL-17F is the optimal therapeutic approach
1. Direct inhibition of IL-17A+IL-17F is the optimal therapeutic approach Oo MoonLake Why do IL-23i not succeed in all domains of PsA? Adaptive T cells i Innate-like lymphocytes © © @ @ © S IL-23-dependent? i IL-23-independent? Psoriasis ‘Axiol —Enthesitis Dactyliis Nails Preferred Peripheral biolog
Slide 41: IL-17F is prevalent in synovial tissue and lesional skin in PsA
1. IL-17F is prevalent in synovial tissue and lesional skin in PsA [e) MoonLake IL-17F and its receptor elevated in PsA joints’ IL-17F elevated in PsA skin 10D/mmé, normatized to healthy control (HC) 1oD/mme 19.297 PsA . é t PsA HC OA 7,322 RA RA HC OA 1Lv7F IL-t7RC WAZA LATE + Accumulation of IL-17
Slide 42: Inhibiting F in addition to A further suppresses inflammatory pathways
1. Inhibiting F in addition to A further suppresses inflammatory pathways (eo) MoonLake + An antibody targeting IL-17A + IL-17F was compared Bixeiciiyl with an antibody with matched affinity for IL-I7A alone Inhibition of inflammation in an assay + Adding IL-17F achieved greater suppression than Joi
Slide 43: Sonelokimab: How to optimize IL-17 inhibition in multi-domain PsA
2. Sonelokimab: How to optimize IL-17 inhibition in multi-domain PsA [e) MoonLake Dual inhibition Nanobody Targeting IL-1 7A+IL-17F Small size, albumin-binding — Best of both —= worlds? Anti- + albumin
Slide 44: Albumin-binding: Optimizing target engagement in inflamed joints
2. Albumin-binding: Optimizing target engagement in inflamed joints Oo MoonLake Mouse collagen-induced arthritis model (ankle joints) 8 h after TNFi treatment! 7.5 ) Drug colocalization with TNF target >10x higher with a Nanobody® 1. Traditional mAb (148 kDa) 2. Only binds TNF {not albumin} Ozoraliz
Slide 45: Sonelokimab: Optimizing target engagement in primate PsA model
2. Sonelokimab: Optimizing target engagement in primate PsA model {eo} MoonLake Arthritic joint assessment for SLK' Clinical improvement with SLK versus mAb? Collagen-induced arthritis ~~ Vehicle 9 EXD ILIA & ILI7F ~ > mab? lOoma/kg, HE SLK 28ma/kg, > a, Immunization 0 7 14 21 28 35 42 49 86 ime {ca
Slide 46: Small size does not compensate for a narrow IL-17 MoA in PsO
2. Small size does not compensate for a narrow IL-17 MoA in PsO. [e) MoonLake PASI 90 at Week 12 in PsO studies Ixekizumab! IL-17A inhibit Traditional mAb | Small synthetic ligand trap Similar level of response ‘Maximum response with 80 | with both @4w and @2w mg, no increase with higher = doses dos
Slide 47: How to optimize IL-17 inhibition in multi-domain PsA
2. How to optimize IL-17 inhibition in multi-domain PsA O Moontake Skin & ACR 50 at Week 16 in PsA studies PASI 90 at Week 16 in PsA studies Bimekizumab IL-17A+F inh’ Joints Bimekizumab IL-17A+F inh’ Izokibep IL- inhibitor + Smallsynthetic ligand trap | + Traditional mab + Small synthetic ligand tra
Slide 48: ARGO: A robust Phase 2 trial design
3. ARGO: A robust phase 2 trial design for valid study results Oo MoonLake Key design elements of ARG * Global study (North America an : ; . Screening Placebo-controlled period satety Europe) with approx. 60 sites (up to 4 weeks) active reference (no H2H) Placebo/active reference crossover _ Follow-
Slide 49: Pivotal-like ARGO PsA study design in preparation for Phase 3
3. Pivotal-like ARGO PsA study design in preparation for Phase 3 Study elemen NCT04713072', IZO BE ACTIVE?, BKZ BE OPTIMAL®, BKZ lla Ph2 Ph 3, Biologic-naive Stage Size Design Dose arms Key inclusion criteria - CASPAR - WC, SIC - Failed cCDMARDs Study regions FDA-approved study Primary endpoint(s) S
Slide 50: ARGO baseline characteristics similar to previous studies
3. ARGO baseline characteristics similar to previous studies Oo MoonLake NCT04713072', IZO E ACTIVE?, BKZ OPTIMAL®, BKZ BE COMPLETE“, BKZ ARGO, Ph2 Rl Ph 3, Biologic-ndive Ph 3, TNF- Ph Key characteristics Sex, female, % 50-60 49.0 53.2 52.5 49.3 Duration of PsA, yrs, mean (+SD) 7.1 (47.8) 7 (£NRS)
Slide 51: Research & Clinical Summary
{e) MoonLake Research & Clinical Summary * PsA is driven by both IL-17A and IL-17F in the key domains of joints and skin * Small size, albumin binding plus IL-17A- and IL-17F-targeting may deliver optimal disease control « Sonelokimab has the potential to elevate treatment outcomes in skin and joint
Slide 52: Upcoming Data
Upcoming Data
Slide 53: Outlook to our planned ARGO PsA primary readout in November
Outlook to our planned ARGO PsA primary readout in November Oo MoonLake 2023 2024 November PsA primary data ACRSO and PASI90 scorst at week 12 “Best of two worlds” next-gen IL-17 Deamon Expected to be Phase 3-ready in three an multi-billion dollar indications ne enondiscoe 800+ patients across Ph1s
Slide 54: PsA: IL-17F dependent multi-domain disease in difficult-to-reach tissues
PsA: IL-17F dependent multi-domain disease in difficult-to-reach tissues (@) MoonLake PsA is a multi-domain deep-tissue disease... «With 3x IL-17F vs IL-17A'... ..and causing devastating damage Plaques Psoriasis isease Activity ' TF f d ; | | : Joint & spine disease Nail Psoriasis (PsA starts as ent
Slide 55: PsA: Ample opportunity to elevate treatment goals vs other MoAs
PsA: Ample opportunity to elevate treatment goals vs other MoAs (@) MoonLake Relative performance across main endpoints in PsA HE ie ev Debunking myths Percentage point delta to respective placebo (ppt)', earliest prespecified analysis = Humira still the reference in PsA, 60 despite safety concerns
Slide 56: PsA: Ample opportunity to elevate treatment goals vs other MoAs
PsA: Ample opportunity to elevate treatment goals vs other MoAs (@) MoonLake Relative performance across main endpoints in PsA BB ev ev Dp anv Debunking myths Percentage point delta to respective placebo (ppt) 60 55 50 4s SLK zone ee Eas --.___ (week 12) 4 “0 *s J) zo 16 cnr) Neongen BKZ 16 (IR eenn
Slide 57: PsA: We expect SLK to perform at or above other assets
PsA: We expect SLK to perform at or above other assets in other scores (@) MoonLake Dcvis zo 16 wks 16 wks BE BE SELECT SELECT DISC 15 DISC 26 KE KEEPs. ADAPT? FUTURE FUTURE SPIRIT SPIRIT comp! OPTIM? PsA 13 PsA 24 i 2 ue reds nie eae PLE DRUG ADelia ACR5O 7-43 110-44 19-52 9-38 9-36 14-33 11-33 9-2
Slide 58: IL-17 expected to become largest MOA in PsA in the next years
IL-17 expected to become largest MOA in PsA in the next years [e) MoonLake PsA market size estimates’ Key notes USD m ~153 HiBio Non-Bio ~103 20355? = 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/Carivate hav
Slide 59: Outlook to our planned MIRA HS 24-week readout in October
Outlook to our planned MIRA HS 24-week readout in October 2023 October HS 24-week data Expected increased efficacy at highest scores with maintenance dosing Confirmation of 120mg as winning dose TNF-IR patient rescue with SLK 2024 “Best of two worlds” next-gen IL-17 Expected to be Phase 3-ready in t
Slide 60: HS: MIRA trial Part B (week 24)
HS: MIRA trial Part B (week 24) Oo MoonLake Ke Placebo-controlled period Screening [up to 4 weeks} Active reference (no H2H) ‘cd Focus - Weeks 12-24 Placebo/active reference crossover 1 Satety ' follow-up Main readouts from Part B fo week 24: . = Main scores: — HiSCR75 — HiSCRSO & HiSCR 90 Group 1 G
Slide 61: HS: Our focus areas for the HS 24-wk data readout
HS: Our focus areas for the HS 24-wk data readout in October Higher HiSCR75 with Q4W dosing More patients reaching this higher endpoint at 6 months with 120mg monthly dose (beyond the 43% at week! 2) Greater depth of responses Prolonged exposure to SLK showing more responses on other HiSCRs, includi
Slide 62: HS: We expect new data to re-affirm SLK's potential in a large market
HS: We expect new data to re-affirm SLK’s potential in a large market [e) MoonLake US HS Biologics Market estimation, examples of main MoAs ILI7A & F (small bio} {eo} MoonLake *—| ¥ Leading HiSCR75 response Y Speed and depth of response ¥ Sustained responses across scores Y Effect on tunnels (penetr
Slide 63: SLK to continue moving the bar
{eo} MoonLake re) SLK to continue moving the bar The scientific rationale for a unique molecule * SLK has unique IL-I7F and A binding properties, a key inflammation MoA (@) ® IL-17F plays critical & independent roles in several inflammatory diseases ® SLK has enhanced tissue penetration, reaching wh
Slide 64: Financial Update
Financial Update
Slide 65: Successful raises in Q2 put MLTX in a strong financial position
Successful raises in Q2 put MLTX in a strong financial position O woontake Changes in cash! balance in USD M Successful equity raise in Q2-2023 ® Follow-on offering upsized from $250m to $400m "= Multiple time oversubscribed with demand from existing and new shareholders Additional gross proceeds fr
Slide 66: MLTX continues operating efficiently and effectively
LTX continues operating efficiently and effectively Ce) MoonLake + R&D expense between $7m and 9m! for 4 8.7 consecutive quarters R&D expense . + Expected fo stay similar in Q@3 and Q4 2023 in USD M + Ramp-up in 2024 with planned commencement of Phase 3 programs + No milestones under the license agr
Slide 67: Strong share price and even more value to be created
Strong share price and even more value to be created Average daily Share price in USD trading volume Analyst coverage in ‘000 100 + 1600 il WEDBUSH 90 + 1'400 Weedhan 80 + iii Ea HCW 1'200 NewaINWRISHT 70 mo) 1'000 60 4 may an MBIIG Ges) 50 4 800 ‘0 i ead 600 Jefferies 30 4 400 EER 20 4 10 +3: 127 2
Slide 68: We expect to remain intensely engaged with the market
We expect to remain intensely engaged with the mar September 11'h Capital Markets Day, NYC LEERINK wl \WEDBUSH July 11-12 August 8-9 Leerink Partners Wedbush Therapeutics PacGrow HC Forum, NYC Conference, NYC SB), 25" World Congress ‘of Dermatology it) sincarone 2023 July 3-8 World Congress of Derma
Slide 69: Strategic path forward remains unchanged
LS tegic path forward remains unchanged Current owner = Phase 3 preparation well under way incl. study designs, end-of-Ph2 meeting prep, clinical supply, autoinjector partnership, and org ramp up Well funded to drive execution with strong conviction of existing shareholders and new investors HS and
Slide 70: Q&A
Slide 71: MoonLake
(@) MoonLake _ We moonlaketx.com | E: info@moonlaketxcom
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