Oculis Holding Ag · NASDAQ:OCS
Oculis — Investor Presentation (April 2023)
39 slides from Oculis's investor presentation, Apr 14, 2023
Slide 1: Rethinking Ophthalmology Investor Webcast
Exhibit 99.1 Rethinking Ophthalmology INVESTOR WEBCAST April 13, 2023 1
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: Rethinking Ophthalmology Investor Webcast
Rethinking Ophthalmology INVESTOR WEBCAST April 13, 2023 3
Slide 4: Investor webcast agenda
Inventor webcast agenda Opening remarks Sylvia Cheung, CFO Company presentation Dr. Riad Sherif, CEO Sylvia Cheung, CFO Discussions with KoL’s Dr. Pravin Dugel Dr. Arshad Khanani Dr. Eric Donnenfeld Q&A Pall Johannesson, CSO Closing remarks Riad Sherif, CEO 44
Slide 5: Our Purpose
Our Purpose To drive innovation to save sight and improve eye care 5
Slide 6: Unmet needs and substantial rise in visual impairments
Unmet needs and substantial rise in visual impairments Underpinning demand for ophthalmic innovations Driven by three key areas: A growing At least 2.2 billion people Retina $22+bn have a vision impairment, and (1) of these, at least 1 billion Market ~196m (1) people have a vision with age-related ~
Slide 7: Building a world leader in ophthalmology
Building a world leader in ophthalmology Possible Effects of DME Normal Vision Poised to Breakthrough Key unmet deliver innovations medical needs Ophthalmology experienced A leading and Strategic presence in key markets and with a solid differentiated portfolio of maximizing success track record of
Slide 8: Uniquely positioned to build significant value
Uniquely positioned to build significant value st ▪ OCS-01: 1 Retina eye-drop for Diabetic Macular Edema (DME) in Ph3 Targeting critical unmet needs in 3 major st ▪ OCS-02: 1 Biologic eye-drop for Dry Eye Disease (DED) in Ph2b ophthalmology segments (upside potential from biomarker-driven precision
Slide 9: Innovative, diversified and late-stage pipeline
Innovative, diversified and late-stage pipeline Next Catalysts Product Investigational Pre-clinical Phase 1 Phase 2 Phase 3 2023 2024 Candidate(s) Indication(s) Ph3 Stage 1 readout DIABETIC MACULAR EDEMA OCS-01 ® Ph3 readout NDA Optireach INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY technology CYS
Slide 10: Oculis leadership team with successful track record
Oculis leadership team with successful track record Committed to build an industry leader in ophthalmic innovation ✓ Highly experienced leadership team ✓ Expertise in drug development leading to Joanne Chang M.D. Bastian Dehmel M.D. Sylvia Cheung Pall Johannesson Riad Sherif M.D. approvals and launc
Slide 11: OCS-01 in Diabetic Macular Edema (DME)
Possible Effects of DME Normal Vision Possible Effects of DME Normal Vision Possible Effects of DME Normal Vision OCS-01 in OCS-01 in Diabetic Macular Diabetic Macular Edema (DME) Edema (DME) Possible Effects of DME Normal Vision Possible Effects of DME Normal Vision OCS-01 in OCS-01 in Diabetic Mac
Slide 12: DME is a large and growing market with critical unmet needs
DME is a large and growing market with critical unmet needs Growing DME patient Only invasive Late start (1) population size treatments approved of treatment Global DME Patients DME – Treatment rate and (2) (7% of diabetics ) market size in G7 countries (4) (US, EU5 and JP) 2045 53m+ Undiagnosed 202
Slide 13: Current DME treatment paradigm leaves two patient segments undertreated
OCS-01 | Current DME treatment paradigm leaves two patient segments undertreated and losing vision Patient presents with DME with DME DME with moderate to severe DME symptoms 43% 33% 24% mild visual recent onset visual impairment (1) Diagnosed by OCT impairment (2) (2) (2) DME Disease Progression an
Slide 14: First eye drop for DME: positive results in exploratory Phase 3 program
OCS-01 | First eye drop for DME Positive results in exploratory Phase 3 program initiated after Unique product candidate and Phase 2 studies in DME positive Phase 2 results and EoP2 meeting OCS-01 is a unique high-concentration (3) Patient Case (Phase 2 DX211 ) nanoparticle formulation of OCS-01 sho
Slide 15: Data support OCS-01 to address large DME patient pool
OCS-01 | Data support OCS-01 to address large DME patient pool A potential effective and versatile option to treat all DME patients Patient presents with DME with DME DME with moderate to severe DME symptoms 24% 43% 33% mild visual recent onset visual impairment Diagnosed by OCT impairment (1) (1) (
Slide 16: Phase 3 DME study post positive EoP2 FDA meeting
OCS-01 | Phase 3 DME study post positive EoP2 FDA meeting Protocol with loading dose & enriched population to drive probability of success Successful EoP2 meeting with FDA supporting Phase 3 program Primary Endpoints (EoP2 meeting w/FDA): Key Enrollment Criteria: Phase 3 study design: ▪ Mean change
Slide 17: Recap - first retina eye-drop for DME
OCS-01 | Recap - first retina eye-drop for DME • First Eye drop in DME expected to address broad DME population TRANSFORMATIVE (1)(2) • Total addressable US patient population for DME ~1.2M THERAPY • Phase 2 in DME: CMT & BCVA endpoints reached with statistical significance, 144 pts IN PHASE 3 • Pha
Slide 18: OCS-02 in Dry Eye Disease
OCS-02 in Dry Eye Disease 18
Slide 19: DED a large, underpenetrated and growing market
OCS-02 | DED a large, underpenetrated and growing market USD 4bn Market – 13% of patients experience lasting relief after 12 months of treatment Dry Eye Rx drug market Significant market opportunity (1) G7 countries, 2019 Corticosteroids (ophthalmic), (1) • Large and growing market forecasted to rea
Slide 20: First topical biologic candidate for DED
OCS-02 | First topical treatment candidate for DED Clinically proven MoA with potential transformative impact in Ocular Inflammatory Diseases Topical Biologic Candidate Innovative Antibody Fragment Technology Illustration of fragment technology scFv* IgG Fab OCS-02 is an anti-TNFα antibody fragment
Slide 21: Anti-TNFα biologic eye drop advancing into Phase 2b for DED & Uveitis
OCS-02 | Anti-TNFα biologic Eye Drop Advancing into Phase 2b for DED & Uveitis Positive Phase 2 / PoC Advancing into Significant in DED and Uveitis Phase 2b for both indications market opportunity Potential to become the OCS-02 in Phase 2b to DED#1 FIRST precision medicine in Dry Eye evaluate signs
Slide 22: Phase 2a positive results in DED
OCS-02 | Phase 2a positive results in DED Proof-of-Concept Phase 2 trial evaluating symptoms demonstrated statistically (1) significant reduction in symptoms and well-tolerated profile Full study population High responders P=0.02 % Points 20 0 Vehicle OCS-02 18% (12/67 pts) Safety: -4 ▪ No meaningfu
Slide 23: Biomarker identified for high responders
OCS-02 | Biomarker identified for high responders – potential for precision medicine approach Genetic biomarker for OCS-02 response Association between gene variants and global ocular discomfort score at treatment day 29 was Pre-specified exploratory pharmacogenetic analysis focused on tested: the g
Slide 24: Phase 2b study in Dry Eye Disease
OCS-02 | Phase 2b study in Dry Eye Disease A multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of OCS-02 for the treatment of signs and symptoms of DED Phase 2b study design: Objectives: Key enrollment criteria: ▪ Randomized, masked, vehicle-▪ Subje
Slide 25: Recap – first Anti-TNFα eye drop for DED and Uveitis
OCS-02 | Recap – first Anti-TNFα eye drop for DED and Uveitis INNOVATIVE Next gen. ophthalmic anti-TNFα to directly address core inflammation in THERAPY both, DED and Uveitis Total addressable US patient population for DED: ~10M LARGE MARKET Ready to advance Phase 2b with three clinical Phase 2a stu
Slide 26: OCS-05 in Neuro-Ophthalmology: Acute Optic Neuritis
OCS-05 in Neuro-Ophthalmology: Acute Optic Neuritis Normal vision Early glaucoma Advanced glaucoma
Slide 27: OCS-05 Candidate overview
OCS-05 | Candidate overview SGK-2 activator peptidomimetic small molecule with a unique MoA for neuro-ophthalmology Unique & Differentiated MOA Disease modifying drug to protect and OCS-05 targets SGK as part of the neurotrophic factor repair neurons signalling pathways triggering multiple beneficia
Slide 28: New neuro-ophthalmology candidate
OCS-05 | New neuro-ophthalmology candidate Compelling data showing prevention of RGC’s damage in Glaucoma and AON models (3) OCS-05, IVT and topical, shown to prevent RGCs AON model: Short term study (5-day OCS-05 shown to promote improvement of damage (the key element in Glaucoma vision loss) treat
Slide 29: OCS-05 Development status
OCS-05 | Development status Paving the way to multiple indications 1 Oculis New Sponsor Q3 2022 2 Previous and ongoing studies in Europe Acute Optic Neuritis (AON) Phase 1: No drug-related side effects Glaucoma ▪ Randomized, double-blind, placebo-controlled, single and multiple Oculis is considering
Slide 30: Acute Optic Neuritis (AON)
Acute Optic Neuritis (AON) Optic Neuritis trials allows to validate OCS-05 in neuro-ophthalmology 130k patients a year (US/EU) Preventing axonal damage at the Retinal thickness (pRNFL and GCIPL) as optic nerve and RGC loss will preserve surrogate of permanent visual impairment AON mean annual preval
Slide 31: Recap - first SGK neuroprotective candidate in ophthalmology
OCS-05 | Recap - first SGK neuroprotective candidate in ophthalmology • Disease modifying drug with neuroprotective activities in neuro ophthalmology TRANSFORMATIVE • Potential paradigm shift in treating major blinding diseases, acting directly on retinal neurons THERAPY • No treatment to-date • Pot
Slide 32: Summary
Summary 32
Slide 33: Proven track record of efficient capital deployment
Proven track record of efficient capital deployment Building a world leader in ophthalmology Clinical readouts: OCS-01 Optireach® clinical validation in OCS-01 ➢ OCS-01 DME Ph3 Stage 1 DME/retina and Oc Sx➢ OCS-02 DED Ph2b Building a ➢ OCS-01 Oc Sx Ph3 Positive EoP2 with FDA for DME and ➢ OCS-02 Uve
Slide 34: Uniquely positioned to build significant value
Uniquely positioned to build significant value st ▪ OCS-01: 1 Retina eye-drop for Diabetic Macular Edema (DME) in Ph3 st Advanced and Innovative product portfolio ▪ OCS-02: 1 Biologic eye-drop for Dry Eye Disease (DED) in Ph2b (upside potential from biomarker-driven precision medicine approach) st ▪
Slide 35: Investor Webcast – Discussion with KoL’s
Investor Webcast – Discussion with KoL’s 35
Slide 36: Key Opinion Leaders
Key Opinion Leaders Dr. Eric Donnenfeld Dr. Donnenfeld, who is a trustee of Dartmouth Medical School and clinical professor of ophthalmology at New York University. He is a past president of The American Society of Cataract and Refractive Surgery, President of the International Intraocular Implant S
Slide 37: Investor Webcast – Q&A
Investor Webcast – Q&A 37
Slide 38: Thank you
THANK YOU 38
Slide 39: Our Purpose
Our Purpose To drive innovation to save sight and improve eye care 39 39