Slide 1: Licaminlimab in Dry Eye Disease Topline Results
Licaminlimab in Dry Eye Disease Topline Results 10 June 2024
Slide 2: Safe Harbor Statements
Safe Harbor Statements Cautionary note on forward-looking statements These slides and the accompanying oral presentation contain forward-looking statements and information. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “i
Slide 3: RELIEF Phase 2b Topline Results – Speakers
RELIEF Phase 2b Topline Results – Speakers Riad Sherif, M.D. Snehal Shah, Pharm D. Victor Perez, M.D. George Ousler, M.S. Chief Executive Officer, President of Research & Professor of Ophthalmology and Senior Vice President, Oculis Holding AG Development, Director of Cornea Research Anterior Segment
Slide 4: RELIEF Ph2b Successfully Executed with Positive Results in DED
RELIEF Ph2b Successfully Executed with Positive Results in DED EFFICACY • Licaminlimab showed rapid onset and meaningful improvements in multiple sign efficacy endpoints in full trial population • TNFR1 genetic biomarker, previously identified in Ph2 symptom trial, showed a predictive and pronounced
Slide 5: Three Positive Phase Trials Now Completed in DED
Three Positive Phase 2 Trials Now Completed in DED First time precision medicine approach applied to DED, significantly de-risking Phase 3 clinical program and offering a transformative product profile Phase 2 Randomized Controlled Consistent positive results across studies (signs and Studies in DED
Slide 6: Dry Eye Market and Unmet Needs
Dry Eye Market and Unmet Needs
Slide 7: Large and Growing DED Opportunity
Large and Growing DED Opportunity Market still underpenetrated and unsatisfied Dry Eye Rx drug market in Significant unmet need and market opportunity G7 countries in 20211 • Large and growing unmet medical need with ~10 million Secretagogues, Corticosteroids diagnosed moderate to severe DED patient
Slide 8: Despite New Treatment Options, Unsatisfied Market with Only 13% of Patients Experiencing Lasting Relief
Despite New Treatment Options, Unsatisfied Market with Only 13% of Patients Experiencing Lasting Relief 1 Several cyclosporines approved: Rx Treatments2 2002 2016 2018 2020 2021 2023 Discontinuation & switching is commonplace in DED3 53% – 70% discontinued after a single script • 85%- 90% of discont
Slide 9: Novel Anti-TNF-α Eye Drop for Ocular Inflammation
Novel Anti-TNF-α Eye Drop for Ocular Inflammation Clinically proven MoA with potential transformative impact in ocular inflammation Clinically proven MoA Anti-inflammation and anti-apoptosis MoA approved as systemic treatment for ocular disease and with transformative impact in other areas Topical
Slide 10: Licaminlimab Dual MoA and Potent Inhibitor of TNF-α
Licaminlimab Dual MoA and IPotent Inhibitor of TNF- Ig llu G st ra tio n o f f ra gm en t t ec hn DUAL MoA: olo gy Fa b ANTI-INFLAMMATORY & ANTI-APOPTOTIC Re gio n ns eu th tr at ali b ze in T d t NF o sc (O Fv C * Inflammation S- 02 ) TNF- inhibitor potencies Inhibits release of inflammatory factor
Slide 11: Two Prior Successful Phase Trials Showed Improvements on Symptoms and Identified TNFR1 Genetic Biomarker
Two Prior Successful Phase 2 Trials Showed Improvements on Symptoms and Identified TNFR1 Genetic Biomarker EFFICACY • Significantly reduced ocular discomfort in patients treated with licaminlimab vs. vehicle at Day 29 Rapid onset of action with relief of symptoms starting on Day 15 SAFETY • Well-tol
Slide 12: Phase 2b RELIEF Study Design and Topline Results
Phase 2b RELIEF Study Design and Topline Results
Slide 13: Trial Objectives
Trial Objectives Designed to address three goals of licaminlimab development plan 1 Evaluate efficacy of licaminlimab in the treatment of signs of DED 2 Confirm differentiated response to licaminlimab in subjects with the TNFR1 genetic biomarker in signs of DED 3 Select primary sign efficacy endpoin
Slide 14: RELIEF Phase 2b in Signs of DED
RELIEF Phase 2b in Signs of DED Designed to identify the most relevant endpoint in signs and assess TNFR1 genetic biomarker in signs in DED Phase 2b study design: Primary Objective: Patient Population: Randomized, masked, vehicle- Evaluate efficacy and safety in Moderate to severe corneal staining c
Slide 15: Secondary Trial Objective: Confirm the TNFR1 Genetic Biomarker
Secondary Trial Objective Confirm the TNFR1 genetic biomarker as a predictor of response to licaminlimab Simple genetic testing procedure: 1. Patient supplies saliva sample which is shipped to lab 2. Lab runs commercial identification assay on saliva for TNFR1 genetic biomarker 3. Assay uses TaqMan
Slide 16: Aligned with FDA Guidance on Developing Drugs for DED
Aligned with FDA Guidance on Developing Drugs for DED TRIAL DESIGN CONSIDERATIONS • Safety and efficacy should be demonstrated in at least two adequate and well-controlled, multicenter independent trials • Efficacy for a sign and efficacy for a symptom do not have to be demonstrated in the same tria
Slide 17: Subject Disposition
Subject Disposition Full analysis population Randomized (ITT) N = 122 Licaminlimab Vehicle n = 62 n = 60 Discontinued trial Discontinued study AE: n = 2 AE: n = 1 Protocol violation: n = 1 Administrative: n = 1* Other: n = 1* Subject choice: n = 1 Completed Completed n = 58 n = 57 TNFR1 Completed TN
Slide 18: Subject Demographics
Subject Demographics TNFR1 genetic biomarker Parameter Licaminlimab Vehicle Parameter Licaminlimab Vehicle (n = 62) (n = 60) (n = 62) (n = 60) Mean age, years 62.4 63.1 TNFR1-related genotype, n (%) Age ≥ 65 years, n (%) 35 (56.5) 28 (46.7) Positive 12 (19.4) 11 (18.3) Female, n (%) 46 (74.2) 42 (70
Slide 19: Baseline Values for DED Signs
Baseline Values for DED Signs Well-balanced between treatment and vehicle in both populations Full population TNFR1 Genotype group Efficacy Measures Licaminlimab Vehicle Licaminlimab Vehicle Mean Baseline Values (n = 62) (n = 60) (n = 12) (n = 11) Inferior Corneal Staining 1.79 1.82 1.71 1.86 Total
Slide 20: Lifitegrast Approval Endpoint
Lifitegrast Approval Endpoint Oculis Mean change (SD) from baseline and treatment difference (lifitegrast – vehicle) in inferior corneal staining score in 12-week studies in patients with DED St\Jdy 1 Study2 (1) (I] Vetlc:le Xt dra 01”erence Vehicle Xt (1 a D1fference Vast (N =58) (N- 58) (95~0) V•S
Slide 21: Licaminlimab Effect on Inferior Corneal Staining
Licaminlimab Effect on Inferior Corneal Staining Meaningful treatment effect in the full population and more pronounced in TNFR1-related genotype group Pre- to Post-CAE change from baseline at Day 43 Difference in means of OCS-02 vs Vehicle Efficacy Measures Full Population TNFR1 Genotype Treatment
Slide 22: Licaminlimab Effect on Inferior Corneal Staining: TNFR1 Genetic Biomarker Population
Licaminlimab Effect on Inferior Corneal Staining TNFR1 Genetic Biomarker Population Mean change from baseline (Pre- to Post-CAE) Visit Licaminlimab Vehicle Difference Favors Licaminlimab (N = 12) (N = 11) (90% CI) Baseline 1.46 1.23 -0.38 Day 15 -0.29 +0.09 -0.38 (-1.012, 0.247) Day 15 -0.59 Day 43
Slide 23: Both Groups Showed Positive and Meaningful Improvements on Multiple Signs
Both Groups Showed Positive and Meaningful Improvements on Multiple Signs Pre- to Post-CAE change from baseline at Day 43 Difference in means of OCS-02 vs Vehicle; (CI)* Efficacy Measures Full Population TNFR1 Genotype Treatment Effect Favors Treatment Effect Favors (accepted by regulators) Licaminl
Slide 24: Efficacy Summary
Efficacy Summary All study goals achieved 1 Evaluated efficacy of licaminlimab in the treatment of signs of DED • Treatment in favor of licaminlimab observed in multiple signs, with rapid onset which continued to increase over time 2 Confirmed response to licaminlimab in subjects with TNFR1 genetic
Slide 25: Safety Overview
Safety Overview Safety population Licaminlimab (n=61) Vehicle (n=59) Patients with Any Ocular TEAEs (Study Eye)*, n (%) 7 (11.5%) 6 (10.2%) Patients with Any Ocular TEAEs (Fellow Eye)*, n (%) 9 (14.8%) 7(11.9%) Patients with any serious ocular TEAEs+, n (%) 0 (0%) 1 (1.7%) Retinal detachment 0 (0%)
Slide 26: Safety Summary
Safety Summary SAFETY Low incidence of adverse events reported with licaminlimab similar to vehicle • OcularTEAEs were similar across treatment groups : 7 (11.5%) with licaminlimab versus 6 (10.2%) with vehicle • No ocular SAEs were reported with licaminlimab The most frequently reported (>2%) ocula
Slide 27: Drop Comfort Scale & Attributes
Drop Comfort Scale & Attributes Licaminlimab eye drop comfort consistent with artificial tears* Drop Comfort Score Day 43 (Post-CAE) Licaminlimab Vehicle (n = 61) (n = 59) Upon instillation 2.6 1.1 1 minute post instillation 1.8 1.1 2 minutes post instillation 1.4 1.1 Drop Attributes Day 43 (Post-CA
Slide 28: Summary
Summary
Slide 29: Opportunity for Highly Differentiated Product Profile
Opportunity for Highly Differentiated Product Profile Licaminlimab has potential to address key unmet needs and transform the treatment paradigm of DED UNMET NEEDS IN DED1 LICAMINLIMAB New MoA targeting both signs and Meaningful treatment effect in both signs and symptoms with a symptoms potential d
Slide 30: Conclusions and Next Steps
Conclusions and Next Steps RELIEF trial showed positive results on signs in full population with 5x improvements in TNFR1-genotype group Phase 2b RELIEF study in signs along with the previously completed Phase 2 study in symptoms: Provided consistent and meaningful results from two randomized contro
Slide 31: Thank you
Thank you