Oculis Holding Ag · NASDAQ:OCS
Oculis — SPAC Merger (December 2022)
65 slides from Oculis's SPAC merger presentation, Dec 14, 2022
Slide 1: Rethinking Ophthalmology
Exhibit 99.1 Rethinking Ophthalmology
Slide 2: Disclaimer (1 of 2)
Disclaimer (1 of 2) This investor presentation (this “Presentation”) is for informational purposes only to assist interested parties in making their own evaluation with respect to the proposed business combination (the “Business Combination”) between European Biotech Acquisition Corp. (“SPAC”) and O
Slide 3: Disclaimer (2 of 2)
Disclaimer (2 of 2) Industry and Market Data This presentation also contains estimates and other statistical data made by independent parties and by the Company relating to market size and growth and other data about the Company’s industry. This data involves a number of assumptions and limitations,
Slide 4: Today's Agenda
Today’s Agenda Presenter(s) Topic Time Opening remarks & introduction to Oculis and 1 Riad Sherif Eduardo Bravo 09:00AM – 09:15AM European Biotech Acquisition Corp. (EBAC) OCS-01 in diabetic macular edema (DME) and post-ocular surgery § Market opportunity 2 Riad Sherif 09:15AM – 10:00AM § Existing d
Slide 5: Our Purpose
Our Purpose To drive innovation to save sight and improve eye care Strictly private and confidential 5 5 Commercially confidential information
Slide 6: Executive summary: Uniquely positioned to build significant value
Executive summary: Uniquely positioned to build significant value § Advanced pipeline with 2 Phase 3 and 2 Phase 2b indications Advanced and diversified product portfolio § 10+ Innovative and differentiated clinical and preclinical programs st § 1 Retina eye-drop for Diabetic Macular Edema (DME) st
Slide 7: Addressing key unmet medical needs with major innovations
Addressing highly meaningful key unmet medical needs with 3 major innovations ® OCS-01: Optireach enables eye OCS-02: Antibody fragment OCS-05: Promising drops technology enables biologic eye neuroprotective agent in for retinal disease drop clinical trial Regions that bind To address neurological d
Slide 8: Oculis clinical stage candidates pipeline
Oculis clinical stage candidates 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 INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY Ph3 rea
Slide 9: Experienced leadership team with successful track record
Experienced leadership team with successful track record ü Over 200 years of cumulative experience at leading industry and drug development organizations ü Combined experience in drug development leading to approvals and launches with >40 drug products across the world ü Experience in managing and g
Slide 10: EBAC overview
EBAC overview Led by some of Europe’s most experienced healthcare investors Executive team Board (Lead, Manage, Develop) Martin Kleijwegt Mark Wegter Onno van de Stolpe Eduardo Bravo Chairman, Founder and Board member, Independent Board Chief Executive Officer Member Former CEO Managing partner Mana
Slide 11: OCS-01 in Diabetic Macular Edema (DME) & Post Ocular Surgery
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) & Post Ocular Surgery (in High-Risk Patients) Possible Effects of DME Normal Vision Possible Effects of DME
Slide 12: OCS-01: Retina eye drop in Phase 3
OCS-01: Retina eye drop in Phase 3 § Topical, non-invasive, self-administered treatment for DME in Phase 3 Retina eye drop in § Well-differentiated potential treatment for inflammation and pain following ocular surgery in Phase 3 high-risk patients High potential (1)(2) (3)(4) § Total addressable US
Slide 13: Current Eye Delivery Limitations vs Oculis Innovation
Large aggregates Current Eye Delivery Limitations Oculis Innovation about 2-5 μm in diameter High Poor aqueous solubility of lipophilic drugs concentration Complex aggregate and Thermodynamic activity. The dissolved water-soluble gradient nanoparticle drug must possess high thermodynamic approx. 100
Slide 14: SNP Technology Pharmacokinetics
SNP Technology Pharmacokinetics Consistently delivers enhanced pharmacokinetics for front and back of the eye (2) (1) Greater concentration in the aqueous humor Greater concentration in the tear film OCS-01 ® Maxidex Concentration of dexamethasone (μg/ml) in the tear film DorzNP 3% dorzolamide SNP s
Slide 15: 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 DME – Treatment rate and market size Global DME Patients (4) in G7 countries (US, EU5 and JP) (2) (7% of diabetics ) 2045 53m+ Undiagnosed $8b
Slide 16: Utility of invasive treatments is limited by compliance issues
Utility of invasive treatments is limited by compliance issues 14 20/40 or better 20/40 - 20/70 20/70 - 20/200 12. 11.4 12 12 VA improvement correlates with 10.2 § Number of injections; and 10 § Baseline vision 9 8 7.1 6 6 4 2 3.6 3.1 2.7 2.3 0 3 1 2 3 4 5 6 7 8 9 10 11 12 13 -2 -4 0 (2) (2) VIVID/V
Slide 17: 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 18: OCS-01 Phase 2 eye drop for DME
OCS-01 | Phase 3 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 (4) Patient Case (Phase 2 DX211 ) nanoparticle formulation of OCS-01 s
Slide 19: OCS-01 DME DX-211 study design
OCS-01 | DME DX-211 study design Design: Key Enrollment Criteria: Study objective: § Multicenter, randomized, § ETDRS BCVA letter score double-masked, vehicle- between 73 and 24 Test OCS-01 efficacy and safety in controlled § CMT of ≥ 310 μm § 144 subjects all-comer DME patients § OCS-01 compared to
Slide 20: Positive Phase 2 DME study
OCS-01 Positive Phase 2 DME study with 144 patients Statistically significant results in CMT and BCVA Mean CMT (Central Macular Thickness) Mean BCVA (Best Corrected Visual Acuity) (1) (1) change from Baseline at week 12 change from Baseline at week 12 0 4 -15 3 2.62 -20.06 -30 2 1.04 -45 1 -60 0 -56
Slide 21: OCS-01 was well tolerated
OCS-1 was well tolerated Increased IOP consistent with dexamethasone mechanism and always reversible as seen in the trial OCS-01 Vehicle (1) Safety Results (n=99) (n=45) Patients n (%) Patients n (%) ≥1 Ocular treatment-emergent ADR 32 (32.3) 9 (20.0) Increased intraocular pressure (IOP) 21 (21.2) 0
Slide 22: DME Phase 2: Higher response in typical Phase 3 population
OCS-01 | DME Phase 2: Higher response in both (1) endpoints in typical Phase 3 population Mean CMT change among patients with Mean BCVA change among patients BCVA gain of at least 15 letters among baseline BCVA ≤ 65 at Week 12 with baseline BCVA ≤ 65 at week 12 patients with baseline BCVA ≤ 65 at we
Slide 23: Data support OCS-01 to meet two treatment gaps in DME
OCS-01 | Data support OCS-01 to meet two treatment gaps in DME A potential versatile and effective option to treat 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) (1) O
Slide 24: OCS-01 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 for Phase 3 program Primary Endpoints (EoP2 meeting w/FDA) : Key Enrollment Criteria: Phase 3 study design: § Mean change in BCV
Slide 25: OCS-01 in Ocular Surgery provides unique medical profile
OCS-01 in Ocular Surgery provides unique medical profile in high-risk patients Cystoid Macular Edema (CME), the OCS-01 1x/day highly effective and most significant cause of Ocular Surgery Market safe in treating inflammation and pain postoperative vision loss after ocular (5) surgery (1) (2) U.S. Oc
Slide 26: SKYGGN Study: cross-trial comparison vs FDA approved treatments
OCS-01 | SKYGGN (DX-216) Study (1) Cross-trial comparison of OCS-01 SKYGGN vs. FDA approved treatments Active ZERO INFLAMMATION D15 PAIN FREE D4 Source Dosing Ingredient % Drug vs vehicle % Drug vs vehicle Active Arm vs Active Arm vs OCS-01 Delta vs vehicle Delta vs vehicle vehicle vehicle SKYGGN De
Slide 27: Cystoid Macular Edema pilot studies
OCS-01 | Cystoid Macular Edema Pilot studies support CME treatment/prevention potential of OCS-01 (1)(2) Two pilot studies (11 eyes in 8 patients) Case study Fully restored anatomy after 8 weeks treatment for OCS-01 in CME & vitritis in intermediate/ posterior uveitis demonstrated improved Baseline
Slide 28: OCS-01 Phase 2 post ocular surgery results
OCS-01 1x/day showed statistically significant reduction in inflammation and pain post ocular surgery in a Phase 2 study (1) Ocular surgery development DX-216 Phase 2 study design OCS-01 1x/day resulted in § Vehicle-controlled, randomized, multi- ü Positive Phase 2 Skyggn study largely de-risks Phas
Slide 29: OCS-01 Phase 3 study in post-cataract patients
OCS-01 | Phase 3 study in post-cataract patients Phase 3 study evaluating efficacy and safety of OCS-01 once daily for the treatment of inflammation and pain following cataract surgery Primary Objective : Key Enrollment Criteria: Design: To evaluate the efficacy and safety of OCS-01 once § Planning
Slide 30: OCS-01 Recap
OCS-01 Recap | Phase 3 retina eye-drop § Phase 3 Eye drop in DME with unique match with two critical unmet medical needs: early intervention & treated patients with inadequate response Retina eye drop in Phase 3 § A leading Ocular Surgery treatment with 1x/d dosing, combined with potential CME impro
Slide 31: Q&A
Q&A 31
Slide 32: OCS-02 in Dry Eye Disease & Uveitis
OCS-02 in Dry Eye Disease & Uveitis 32
Slide 33: OCS-02 First anti-TNFα eye drop for DED & Uveitis
OCS-02 First anti-TNFα eye drop for DED & Uveitis First biologic eye § Next gen. ophthalmic anti-TNFα to directly address core inflammation in DED & Uveitis drop in DED High potential (1) § Total addressable US patient population for DED: ~10M commercial impact $ Positive Ph2 in both § 3 clinical Ph
Slide 34: DED is a large & growing market opportunity
OCS-02 | DED is a large & growing market opportunity Underpenetrated with very few patients experiencing lasting relief Dry Eye Rx drug market in Significant market opportunity (1) G7 countries in 2019 (1) § Large and growing market forecasted to reach $7.3bn in 2029 Corticosteroids (ophthalmic), 3%
Slide 35: Ocular surface inflammation, a central role in DED
OCS-02 | Ocular surface inflammation, a central role in DED (1)(4) Current understanding of DED has advanced The vicious circle of DED TFOS DEWS II (2020) recognizes the etiological role of ocular (2,3) surface inflammation and damage in DED DED is initiated by desiccating stress and perpetuated by
Slide 36: First topical treatment candidate based on anti-TNFα antibody fragment
OCS-02 | First and only topical treatment candidate based on anti-TNFα antibody fragment Clinically proven MoA with potential transformative impact in ocular diseases of inflammation Innovative Antibody Fragment Technology Topical Biologic Candidate Illustration of fragment technology OCS-02 is an a
Slide 37: Anti-TNFα biologic eye drop addressing large unsatisfied market
OCS-02 | Anti-TNFα biologic eye drop, intended to address large unsatisfied market Positive Phase 2 / PoC Advancing into Significant Market in DED and Uveitis Phase 2b for both indications Opportunity Dry Eye Disease The potential to become the DED#1 FIRST precision medicine in Dry Eye Disease 85 pt
Slide 38: Phase 2a study in DED
OCS-02 | Phase 2a study in DED A multi-center, randomized, double-masked, vehicle-controlled, proof-of-concept study evaluating efficacy of OCS-02 for the treatment of signs and symptoms of DED Objectives: Phase 2a study design: Key Enrollment Criteria: § To assess the safety and tolerability of OCS
Slide 39: Phase 2a positive results in DED
OCS-02 | Phase 2a positive results in DED Proof-of-Concept Phase 2 trial evaluating symptoms demonstrated (1) statistically significant reduction in symptoms and well-tolerated profile Full study population High responders OCS-02 Vehicle P=0.02 % Safety Results Points (n=69) (n=65) 0 Patients n Pati
Slide 40: 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 Pre-specified exploratory pharmacogenetic analysis focused on ocular discomfort score at treatment day 29 was the genes rel
Slide 41: Genetic biomarker correlated with TNFα mRNA expression
OCS-02 | Genetic biomarker correlated with TNFα mRNA expression Enables de-risking of program and potential commercial upside § Significant reduction of anti-inflammatory IL1B IL8 TNFα factors IL1B, IL8, and TNFα was observed in LML636 - IL1B mRNA expression LML636 - IL8 mRNA expression OCS LML -636
Slide 42: Phase 2b study in Chronic Uveitis
OCS-02 | Phase 2b study in Chronic Uveitis A Multi-center, Randomized, Parallel-Group, Single-Masked Study Evaluating the Safety and Efficacy of OCS-02 for the Treatment of Chronic Uveitis in Subjects Treated with Steroids Dosing (treatment arm): Endpoints: Objectives: Key Enrollment Criteria: § Per
Slide 43: Current DED treatment paradigm and unmet needs
OCS-02 | Current DED treatment paradigm and unmet needs DED Progression and Treatment Landscape st nd rd 1 line Behavioral Changes 2 line Treatment 3 line Treatment Artificial Tears / OTC Products Cyclosporin Punctal Plugs LFA-1 inhibitor Current Lid Hygiene Other Corticosteroid Treatment (Scleral c
Slide 44: Uveitis unmet need and market opportunity
OCS-02 | Uveitis unmet need and market opportunity Chronic/recurrent patients have OCS-02 completed positive Phase 2a with Widespread willingness to Rx OCS-02 (7) the greatest unmet medical need topical biologic in Anterior Uveitis given non-steroidal & topical profile Non-Infectious Uveitis Epidemi
Slide 45: Steroid Sparing Non-Infectious Anterior Uveitis Phase 2 results
OCS-02 | Steroid Sparing Non-Infectious Anterior Uveitis Phase 2 results met endpoints with a lasting effect after the end of the treatment Target Profile Steroid sparing treatment for non-infectious anterior uveitis § Address unmet need with no current topical options beyond steroids Value Proposit
Slide 46: Phase 2b study in non-infectious anterior uveitis
OCS-02 | Phase 2b study in non-infectious anterior uveitis Primary Endpoints: Key Enrollment Criteria: Phase 2b study design: § Absence of anterior chamber cells (i.e. score of § Multicenter study§ Non-infectious chronic zero) at Visit 5 (Day 29) anterior uveitis in at § 8-week study in 60-100 patie
Slide 47: OCS-02 Recap
OCS-02 Recap | First anti-TNFα eye drop for DED & Uveitis First biologic eye § Next gen. ophthalmic drug to directly address core inflammation conditions in DED & drop, with new mode of action for Uveitis ocs-02: Anti-inflammatory & anti-necrosis (anti-TNFα) NCE DED § Underpenetrated market only 9%
Slide 48: Q&A
Q&A 48
Slide 49: OCS-05 in Neuroprotection
OCS-05 in Neuroprotection Normal vision Early glaucoma Advanced glaucoma
Slide 50: OCS-05 First SGK2 neuroprotective candidate in ophthalmology
OCS-05 First SGK2 neuroprotective candidate in ophthalmology First SGK neuroprotective § Disease modifying drug which protects and repairs neurons ophthalmic candidate High potential § Potential application in ophthalmology including Glaucoma, Geographic Atrophy, Diabetic commercial impact Retinopat
Slide 51: OCS-05 Candidate Overview
OCS-05 | Candidate Overview SGK-2 activator peptidomimetic small molecule with unique MoA for neuroprotection and potential applications in large ophthalmic disease areas Unique & Differentiated MOA Disease modifying drug to protect and repair neurons OCS-05 targets SGK as part of the neurotrophic f
Slide 52: OCS-05 to meet critical unmet need in Glaucoma
OCS-05 to meet critical unmet need in Glaucoma Large unmet need remains despite availability of effective IOP lowering drugs ̴ 80M people have Glaucoma worldwide – While SOC drugs reduce IOP (a risk factor), Current medications are insufficient: >20% reaching ~110M by 2040 there is no treatment to p
Slide 53: OCS-05 Promotes neuroprotection
OCS-05 | Promotes neuroprotection Compelling data showing neuroprotection in Glaucoma and AON models OCS-05 shown to promote improvement of OCS-05, IVT and topical, shown to prevent (3) RGCs damage (the key element in clinical function (disability due to vision loss) in Glaucoma vision loss) experim
Slide 54: OCS-05 Protects against loss of Retinal Ganglion Cells
OCS-05 | Protects against loss of Retinal Ganglion Cells AON model: Short term study (5-day treatment, assessment at day 6) (1) Visual of RGC Protection Prevention of Retinal Ganglion Cell (RGC) loss Sham control % of Efficacy RGC 250 35.9 64.0 No loss 198 *** 200 ** 178 163 Placebo 144 150 Loss of
Slide 55: ACUITY first-in-patients trial in AON
OCS-05 | ACUITY first-in-patients trial in AON Paving the way to multiple indications ACUITY PoC Study paving the way to multiple indications Acute Optic Neuritis (AON) Glaucoma Ongoing Acuity PoC Geographic Atrophy Discovery Animal models Phase 1 Neuro-Retina Diabetic Retinopathy CNS: Multiple Scle
Slide 56: OCS-05 recap
OCS-05 recap | First SGK neuroprotective candidate in ophthalmology First SGK § Disease modifying drug which protects and repairs neurons neuroprotective § Potential paradigm shift in treating major blinding diseases by acting directly on retinal ophthalmic neurons candidate High potential § Potenti
Slide 57: Q&A
Q&A 57
Slide 58: Summary
Summary 58
Slide 59: Proven track record of efficient capital deployment and milestones
Proven track record of efficient capital deployment and execution of key milestone opportunities OCS-01 Positive EoP2 with FDA for DME OCS-01 OCS-01 and Ocular Sx OCS-05 OCS-02 Optireach® clinical commenced Phase 3 studies Neuroprotective Biologic eye drop Optireach® animal & validation in disease m
Slide 60: EBAC expects to enter into a definitive agreement to merge with Oculis
European Biotech Acquisition Corp. (“EBAC”) expects to enter into a definitive agreement to merge with Oculis EBAC is a compelling SPAC partner for Oculis Transaction Overview (1,2,3,4) ü Supported by Life Sciences Partners, one of • EBAC (NASDAQ: EBAC) to combine with Oculis at a $218 million pro f
Slide 61: Oculis Intellectual Property Rights
Oculis Intellectual Property Rights Strong IP and market exclusivity Patent Categories Data Exclusivity Last to expire Formulation Manufacturing n/a OCS-01 2040 Methods of use 2037 US biosimilar exclusivity for 12 Product (further patents in years and similar in other OCS-02 Methods of use preparati
Slide 62: Transaction overview (2)
Transaction overview (2) PIPE Financing Pro-Forma Ownership 7% • Implied post-money enterprise value of $218 million Seller's Rollover Equity 17% EBAC Public Shareholders (1) • $76 million of committed PIPE financing led by LSP 7 47% PIPE Investors 29% • To fund the continued clinical development of
Slide 63: Financing: Anticipated Use of Net Proceeds
Financing: Anticipated Use of Net Proceeds Overview (1) ~$100m to drive multiple value catalysts Use of Value US Proceeds Driver $m Purpose General & NDA & DME Phase 3 OCS-01 $35§ DME NDA enabling commercial Execution 20% OCS-01 35% Phase 3 Readiness§ OCS-02 technical development OCS-02 $30 In DED a
Slide 64: Recap: Uniquely positioned to build significant value
Recap: Uniquely positioned to build significant value § Advanced pipeline with 2 Phase 3 and 2 Phase 2b indications Advanced and diversified product portfolio § 10+ Innovative and differentiated clinical and preclinical programs st § 1 Retina eye-drop for Diabetic Macular Edema (DME) st § 1 Biologic
Slide 65: Our Purpose
Our Purpose To drive innovation to save sight and improve eye care Strictly private and confidential 65 65 Commercially confidential information