Eyepoint, Inc. · NASDAQ:EYPT
Eyepoint — EyePoint Pharmaceuticals — Investor Presentation (January 2022)
46 slides from Eyepoint's investor presentation, Jan 12, 2022
Slide 1: Delivering Innovation to the Eye
1 | EYEPOINT PHARMACEUTICALS Delivering Innovation to the Eye Investor Presentation January 2022 Exhibit 99.1
Slide 2: Forward-looking statements
Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments
Slide 3: Company Overview
COMPANY OVERVIEW Pipeline leveraging proven Durasert® technology * Compelling pipeline focused on retinal disease EYP-1901 - advancing into phase 2 trials for wet AMD, diabetic retinopathy (DR), and retinal vein occlusion (RVO) after positive phase 1 interim results and positive Type C FDA meeting g
Slide 4: Durasert: Platform Technology
5 | EYEPOINT PHARMACEUTICALS DURASERT® Proven sustained release intravitreal drug delivery PLATFORM TECHNOLOGY 4 | EYEPOINT PHARMACEUTICALS
Slide 5: Durasert: Proven safe, sustained intravitreal delivery
TECHNOLOGY DURASERT® Proven safe, sustained intravitreal delivery Delivered by a simple, single in-office intravitreal injection Continuous, stable release provides consistent and reliable drug delivery over weeks, months, or years Approved Products YUTIQ® (2018, EyePoint) Posterior Segment Uveitis
Slide 6: Retinal disease focused pipeline
6 | EYEPOINT PHARMACEUTICALS Retinal disease focused pipeline
Slide 7: EYP-1901 – IVT delivery of vorolanib using bioerodible Durasert
EYP-1901 – IVT delivery of vorolanib using bioerodible Durasert® as a potential six-month treatment Our goal is nothing short of transforming the treatment of wet AMD, diabetic retinopathy, and retinal vein occlusion PIPELINE 7 | EYEPOINT PHARMACEUTICALS
Slide 8: Real World Reality – Even One Missed Injection Can Mean Loss of Vision
PIPELINE EYP-1901 RETROSPECTIVE STUDY OF 3350 RANIBIZUMAB AND 4300 AFLIBERCEPT TREATMENT-NAIVE EYES WITH WET AMD 8 | EYEPOINT PHARMACEUTICALS Real World Reality – Even One Missed Injection Can Mean Loss of Vision Study evaluated 1,041 pts getting intravitreal anti-VEGF therapies 60% went to schedule
Slide 9: EYP-1901 – A Novel Approach to Wet AMD Therapy
Bioerodible Durasert® : Similar technology used in YUTIQ®, Retisert®, and Vitrasert® Polyimide shell removed (used for 3-year duration) Bioerodible core matrix remains Initial burst from the surface of implant Constant, zero-order kinetic release rate for months EYP-1901 – A Novel Approach to Wet AM
Slide 10: Effective blocking of VEGFR
23 | EYEPOINT PHARMACEUTICALS Effective blocking of VEGFR Prevents Exudation and Loss of Vision PIPELINE EYP-1901 VEGF-B VEGF-C VEGF-D VEGF-A R1 / INFLAMMATION R2 / BLOOD VESSEL LEAKAGE R3 / BLOOD VESSEL GROWTH & LEAKAGE VEGF SIGNALING PATHWAYS VOROLANIB 10 | EYEPOINT PHARMACEUTICALS Approved Anti-V
Slide 11: EYP-1901 – Intellectual Property Overview
EYP-1901 – Intellectual Property Overview 11 USFDA Exclusivity Potential 5 years for new chemical entity or 3 years for new clinical investigation In-Licensed Patents and Applications US patents expiring in 2027 US patent expiring in 2037, and related pending US application Ex-US patents and pending
Slide 12: EYP-1901 phase 1 trial interim results
EYP-1901 phase 1 trial interim results 12 | EYEPOINT PHARMACEUTICALS
Slide 13: 6-month interim data summary: All study objectives successfully met
6-month interim data summary: All study objectives successfully met Positive safety data: No ocular Serious Adverse Events (SAEs) reported No drug-related systemic SAEs reported All ocular AEs were < grade 2; the only grade 3 AE was not drug-related EFFICACY Positive efficacy Data: Stable VA and OCT
Slide 14: DAVIO Phase 1 Study in Wet AMD design
NO mandated EYP 1901 retreatments Criteria for rescue anti-VEGF therapy*: New fluid > 75 microns (OCT) compared to Day-0 2 lines of BCVA secondary to wet AMD compared to Day-0 New macular hemorrhage secondary to wet AMD Enrollment Previously treated wet AMD eyes only No exclusion for presence of flu
Slide 15: Phase 1 DAVIO Study Participants and 6-month Follow-Up
BCVA: best corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; CST: central subfield thickness 15 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study Participants and 6-month Follow-Up
Slide 16: Phase 1 DAVIO Study 6-Month Results: Safety
16 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study 6-Month Results: Safety
Slide 17: Primary Endpoint – Safety at 6 months
No other reported significant adverse events such as: No vitreous floaters No endophthalmitis No retinal detachment No implant migration in the anterior chamber No retinal vasculitis No posterior segment inflammation AC, anterior chamber; AE, adverse event; BCVA, best corrected visual acuity; SAE, s
Slide 18: Summary at 6 Months - Ocular Safety
a. All mild-to-moderate in severity and determined not related to study drug b. Grade 1/Mild AEs of particular interest AC anterior chamber; AE, adverse event; BCVA, best corrected visual acuity; OS, left eye; OU; both eyes 18 | EYEPOINT PHARMACEUTICALS EYP-1901 - Phase 1 DAVIO Study Summary at 6 Mo
Slide 19: 6 Month Results: visual acuity, CST, rescue free rates
19 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study 6 Month Results: visual acuity, CST, rescue free rates, and reduction in treatment burden
Slide 20: Average Visual Acuity Stable 6 Months After Treatment
EYP-1901 – Phase 1 DAVIO Study Average Visual Acuity (VA) Stable 6 Months After Treatment 20 BCVA: best corrected visual acuity Interim data – monitored through 6 months For all 17 eyes at 6 months VA = -2.5 letters
Slide 21: Central Subfield Thickness (CST)
OCT: optical coherence tomography; CST: central subfield thickness Interim data – monitored through 6 months 21 | EYEPOINT PHARMACEUTICALS EYP-1901 - Phase 1 DAVIO Study Central Subfield Thickness (CST) Sustainable Anatomical Control & Efficacy For all 17 eyes at 6 months CST on OCT = - 2.7 microns
Slide 22: Rescue-free Rates: Entire Study group
Interim data – monitored through 6 months 22 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study Rescue-free Rates up to Each Visit: Entire Study group
Slide 23: Rescue-free Rates up to Each Visit
Interim data – monitored through 6 months 23 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study Rescue-free Rates up to Each Visit 8 of 17 eyes rescue-free at 6 months
Slide 24: Details on Patients That Received Rescue Anti-VEGF Therapy
EYP-1901 Phase 1 DAVIO Study Details on Patients (n=9) That Received Rescue Anti-VEGF Therapy Up to six months CST: central subfield thickness; SRF: subretinal fluid; IRF: intra-retinal fluid CST’s NOT Reading Center Confirmed - Interim data – monitored through 6 months
Slide 25: Clinically Significant Reduction in Treatment Burden
SOC Anti-VEGF Injections Before and After Treatment SoC (Anti-VEGF) + EYP1901 ● Anti-VEGF ○ No rescue injection given ☐ Missed visit months 25 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study – 6 Month Results Clinically Significant Reduction in Treatment Burden - 79 % for the entire cohort I
Slide 26: Case 1: Entered Dry, Stayed Dry for 9 Months
Screening Visit: 6 anti-VEGF injections prior to enrollment Initial Diagnosis: 9 months prior to enrollment Screening visits prior to treatment 26 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study Case 1: Entered Dry, Stayed Dry for 9 Months Low dose cohort (EYP-1901 440 µg)
Slide 27: Case 1: Post-Treatment
Month 5 – no rescue 27 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study Case 1: Post-Treatment (No Rescues Through Month 9) Low dose cohort (EYP-1901 440 µg)
Slide 28: Case 2: Rescued at Month 1
Screening Visit (9 prior anti-VEGF injections) Prior to Treatment 28 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study Case 2: Rescued at Month 1 and failure of both SOC and EYP-1901 Low dose cohort (EYP-1901 440 µg) Significant intraretinal fluid
Slide 29: Case 2: Rescued at Month 1 and failure of both SOC and EYP-1901
EYP-1901 Phase 1 DAVIO Study Case 2: Rescued at Month 1 and failure of both SOC and EYP-1901 Low Dose Cohort (EYP-1901 440 µg) Despite early rescue, EYP1901 still reduced treatment burden by 34% Month 1 – Rescue 8 weeks post Eylea rescue #1 12 weeks post EYP1901 5 weeks post Eylea 4 weeks post EYP19
Slide 30: Case 3: Entered the Study With Subretinal Fluid
30 | EYEPOINT PHARMACEUTICALS Screening Visit (8 prior anti-VEGF injections) Prior to treatment EYP-1901 Phase 1 DAVIO Study Case 3: Entered the Study With Subretinal Fluid High dose cohort (EYP-1901 3090 µg)
Slide 31: Case 3: Post-treatment – New Fluid Doesn't Mean Rescue
31 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study Case 3: Post-treatment – New Fluid Doesn’t Mean Rescue ! High dose cohort (EYP-1901 3090 µg) Month 6 – no rescue
Slide 32: 6-Month Summary - All Objectives Successfully Met
Proof of Concept for bioerodible Durasert and vorolanib in wet AMD Positive Safety Data No ocular SAEs reported No drug-related systemic SAEs reported Ocular AEs - majority mild and to be expected EFFICACY Positive Efficacy Data: Stable VA and OCT Median time to rescue: 6 months 76 % rescue-free up
Slide 33: 8 month Update For All 17 Patients
Continued Positive Safety Data No ocular SAEs reported No drug-related systemic SAEs reported Ocular AEs - majority mild and to be expected SAFETY 33 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study 8 month Update For All 17 Patients DURABILITY 7 of 17 (41%) eyes rescue-free through 8-months
Slide 34: January 2022 Update: Reduction in Treatment Burden
SOC Anti-VEGF Injections Before and After Treatment SoC (Anti-VEGF) + EYP1901 ● Anti-VEGF ○ No rescue injection given ☐ Missed visit months 34 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study – January 2022 Update Clinically Significant Reduction in Treatment Burden - 76 % for the entire coho
Slide 35: Phase 2 Plan
Phase 2 Plan 35 | EYEPOINT PHARMACEUTICALS Positive and collaborative Type C meeting held with FDA in December 2021 Obtained guidance on Phase 2 and pivotal studies Phase 2 trial in Wet AMD expected to initiate in Q3 of 2022 Two doses, randomized and controlled (aflibercept) Approximately 144 patien
Slide 36: Retrospective Sub-Group Analysis: 88% Reduction in Treatment Burden
EYP-1901 Phase 1 DAVIO Study Retrospective Sub-Group (N=11) Analysis Based on Entry Criteria and Anticipated Dosing in Phase 2 Wet AMD Study – 88 % reduction in Treatment Burden SoC (Anti-VEGF) + EYP1901 ● Anti-VEGF ○ No rescue injection given ☐ Missed visit months Subgroup Analysis of DAVIO Medium
Slide 37: 2022 and Beyond: Positioned to Transform the Ophthalmology Landscape
2022 and Beyond Positioned to Transform the Ophthalmology Landscape 37 | EYEPOINT PHARMACEUTICALS Paradigm-shifting potential of DURASERT technology now demonstrated with multiple approved drugs and small molecule agents Ability to utilize technology for small molecule agents with different MOAs Abi
Slide 38: Products: FDA approved commercial products
Products FDA approved commercial products 38 | EYEPOINT PHARMACEUTICALS
Slide 39: YUTIQ: Continuous Calm in Uveitis
Approved for the treatment of chronic non-infectious uveitis affecting the back of the eye Commercially launched in U.S. in 2019 Patent protection to August 2027 Constant and stable release of fluocinolone with Durasert helps prevent uveitis flares for up to 3 years LICENSE AGREEMENTS Alimera Scienc
Slide 40: Chronic non-infectious uveitis causes blindness with every flare
PRODUCTS 60K–100K patients are suffering from uveitis in the U.S. The need Flares can cause blindness 30,000 Americans become blind each year because of uveitis Uveitis lasts a lifetime and often affects people in middle age Conventional treatment is burdensome for patients and caregivers The YUTIQ
Slide 41: Continuous 3-year delivery limits uveitis flares
PRODUCTS CONTINUOUS CALM IN UVEITIS Continuous 3-year delivery limits blindness-causing uveitis flares Time to recurrence of uveitis within 36 months YUTIQ MEDIAN TIME TO FIRST RECURRENCE: 1051 DAYS PROBABILITY RECURRENCE 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 0 60 120 180 240 300 360 420 480 5
Slide 42: YUTIQ Customer Demand in Units
PRODUCTS CUSTOMER DEMAND IN UNITS CONTINUOUS CALM IN UVEITIS 42 | EYEPOINT PHARMACEUTICALS Record customer demand* in Q4 2021 *Customer demand is defined as units purchased by Surgery Centers or physicians from the specialty distributors.
Slide 43: DEXYCU: Target the Site
Treatment of inflammation following ocular surgery Effective January 1, 2022 sales and marketing activities to be managed by our commercial alliance partner ImprimisRX EyePoint to retain NDA and continue to record revenue and COGS for DEXYCU sales LICENSE AGREEMENT Rights for China, Hong Kong, Taiwa
Slide 44: DEXYCU Customer Demand in Units
PRODUCTS TARGET THE SITE CUSTOMER DEMAND IN UNITS 44 | EYEPOINT PHARMACEUTICALS Record customer demand* in Q4 2021 *Customer demand is defined as units purchased by Surgery Centers or physicians from the specialty distributors.
Slide 45: Financial Summary
DELIVERING INNOVATION TO THE EYE Financial Summary 45 | EYEPOINT PHARMACEUTICALS ~$210 million of Cash on December 31, 2021 $38.9 million of debt on December 31, 2021 $8.6 million of net product revenues in Q3 2021, a 49% increase over Q3 2020 $24.1 million of net product revenues YTD September 30,
Slide 46: Delivering Innovation to the Eye
1 | EYEPOINT PHARMACEUTICALS Delivering Innovation to the Eye
EyePoint Pharmaceuticals — Investor Presentation (January 2022) on 6ix