Eyepoint, Inc. · NASDAQ:EYPT
Eyepoint — EyePoint Pharmaceuticals — Investor Day (July 2022)
74 slides from Eyepoint's investor day presentation, Jul 18, 2022
Slide 1: Investor Day, University Club, New York City
UNIVERSITY CLUB | NEW YORK CITY | JULY 18, 2022 Exhibit 99.2
Slide 2: Forward-Looking Statements
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 activit
Slide 3: Introductions and Agenda
INTRODUCTIONS AND AGENDA Nancy Lurker| President and Chief Executive Officer
Slide 4: Investor Day: Speakers - Management
George O. Elston 20 years of C-Level experience with strong and established relationships across wall street, buy-side, venture capital and pharma/biotech resulting in transformative company-building and M&A transactions covering a wide range of financing and partnering Investor Day: Speakers - Mana
Slide 5: Investor Day: Speakers - Management
Said Saim, Ph.D. >25 years of pre-formulation, formulation, process development and tech transfer experience resulting in several FDA approvals and >20 patents and 20 publications Dario Paggiarino, MD >20 years of ophthalmic small molecule, biologic, and device clinical development and medical affai
Slide 6: Investor Day: KOL Guest Speakers
Investor Day: KOL Guest Speakers Carl D. Regillo Professor of Ophthalmology, Thomas Jefferson University Chief of the Retina Service, Wills Eye Hospital Founder, Wills Eye Clinical Retina Research Unit in Philadelphia Charles C. Wykoff Director of Research, Retina Consultants of Texas, Chairman of t
Slide 7: Investor Day: Agenda
PRESENTATION SPEAKER Investor Day: Agenda Introductions EyePoint Overview Durasert® and EYP-1901 Overview EYP-1901: Development and Formulation EYP-1901: DAVIO 12-Month Data EYP-1901: Treat to Maintain Nancy Lurker Nancy Lurker Jay Duker, M.D. Said Saim, Ph.D. Carl Regillo, M.D. Jay Duker, M.D. Char
Slide 8: Investor Day: Agenda
PRESENTATION SPEAKER Investor Day: Agenda EYP-1901: Phase 2 Plans YUTIQ Clinical Update Financial Update Q&A Closing Remarks Dario Paggiarino, M.D. Dario Paggiarino, M.D. George Elston All Nancy Lurker
Slide 9: Company Overview
COMPANY OVERVIEW Nancy Lurker| President and Chief Executive Officer
Slide 10: Compelling Pipeline Leverages Proven Durasert Technology
EYP-1901 is key pipeline program Vorolanib, a TKI in bioerodible Durasert Positive safety and efficacy data from Phase 1 DAVIO clinical trial Phase 2 clinical trials in wet AMD and in non-proliferative diabetic retinopathy (NPDR) expected to begin in Q3 2022 Durasert® - proven intravitreal (IVT) dru
Slide 11: Platform Technology Durasert
Jay Duker, M.D. | Chief Operating Officer PLATFORM TECHNOLOGY DURASERT®
Slide 12: Durasert Technology: Safe Sustained Intravitreal Drug Delivery
DURASERT® TECHNOLOGY 12 | INVESTOR PRESENTATION Safe Sustained Intravitreal Drug Delivery Used in four of six FDA approved intravitreal sustained delivery products Delivered by a single in-office intravitreal injection Continuous, stable release of drug Non-Erodible Products YUTIQ® (EyePoint) ILUVIE
Slide 13: EYP-1901 Overview
EYP-1901 OVERVIEW Jay Duker, M.D. | Chief Operating Officer
Slide 14: EYP-1901: Vorolanib in Bioerodible Durasert
EYP-1901 Single IVT injection of up to 3 inserts Bioerodible formulation of Durasert Initial drug burst from surface of insert to rapidly reach therapeutic levels in ocular tissues Zero order kinetics release Vorolanib Receptor-binding tyrosine kinase inhibitor (TKI) Binds receptors of all VEGF grow
Slide 15: EYP-1901 bioerodible formulation of Durasert
EYP-1901 utilizes a bioerodible formulation of Durasert for repeated IVT injections Sustained, zero-order kinetics drug release over 6-9 months in bioerodible High drug load per insert Insert is ~1/5,000 the volume of the vitreous YUTIQ® Non-Erodible Silicone Seal v 3.5 mm EYP-1901 Bioerodible v Up
Slide 16: Strong patents and applications for long term value
EYP-1901, vorolanib and new injector hold strong patents and patent applications for long term value 2006 2012 2018 2024 2007 - 2027 2017 - 2037 2021 - 2041 EYPT FORMULATION APPLICATIONS VOROLANIB CRYSTAL FORM ISSUED PATENT VOROLANIB ISSUED PATENTS 2030 2036 2042 2022 - 2042 EYPT INJECTOR APPLICATIO
Slide 17: Vorolanib Overview
EYP-1901 VOROLANIB OVERVIEW Said Saim, Ph.D. | Chief Technology Officer
Slide 18: Why Vorolanib?
Vorolanib selected after evaluation of over 100 small molecule TKIs Previously studied in Phase 1 and Phase 2 clinical trials as an oral therapy with compelling efficacy data and no ocular toxicity Intracellular binding of all VEGF receptors thereby blocking receptors of all VEGF family of growth fa
Slide 19: Vorolanib designed to reduce off-target binding
sunitinib Vorolanib was specifically designed to reduce off target binding that may lead to an improved safety profile vorolanib TRIETHYLAMINE CHIRAL CENTER AT THE PYRROLIDINE RING CIS/TRANS INDOLINONE WITH PYRROLIDONE GROUP DIMETHYLCARBAMOYL PYRROLIDINE
Slide 20: Vorolanib binds all VEGF receptors
Vorolanib binds receptors of all VEGF growth factors with strong affinity to VEGF receptor 2 - a receptor associated with blood vessel leakage VOROLANIB VOROLANIB VOROLANIB VEGF-A VEGF-B VEGF-C VEGF-D R1 | Inflammation R2 | Blood Vessel Leakage R3 | Blood Vessel Growth & Leakage 20 | INVESTOR PRESEN
Slide 21: Vorolanib Pre-Clinical POC Pharmacology Studies
EYP-1901 VOROLANIB PRE-CLINICAL POC PHARMACOLOGY STUDIES Said Saim, Ph.D. | Chief Technology Officer
Slide 22: Vorolanib reduces new blood vessel formation
NUMBER OF TUBES Control VEGF VEGF + Sunitinib VEGF + Vorolanib 100 80 60 40 20 0 50 nM 100 nM Vorolanib significantly reduces new blood vessel formation in an established cell model Vorolanib inhibited blood vessel tube formation at very low concentrations of 50 to 100 nM (IC50 is 52 nM; equivalent
Slide 23: Vorolanib inhibits VEGFR phosphorylation
Vorolanib concentrations at only 20% of IC50 induced significant inhibition of VEGFR phosphorylation VEGFR-2 PHOSPHORYLATION IN HUVEC CELLS STIMULATED WITH VEGF
Slide 24: Lower vascular leakage in laser CNV animal study
TREATMENT STARTED AT DAY 7 AFTER LASER INJURY | 30 MG/KG/D In a validated laser CNV animal study vorolanib demonstrated significantly lower vascular leakage suggesting activity in wet AMD INTENSITY SCORE DAY 7 vorolanib 1.0 0.8 0.6 0.4 0.2 0.0 Vehicle INTENSITY SCORE DAY 14 vorolanib 1.0 0.8 0.6 0.4
Slide 25: Inhibition of retinal neovascularization in animal study
Vorolanib demonstrated inhibition of retinal neovascularization in an animal study suggesting activity in diabetic retinopathy HIGH EFFICACY (~71% REDUCTION IN NV AREA) Hu Huang, Effects of X-82 on retinal neovascularization (NV) in a murine model of oxygen-induced retinopathy (OIR) (X-82-NCL-033) ;
Slide 26: Neuroprotective properties in retinal detachment model: visual function
Optokinetic tracking in validated retinal detachment mouse model suggests that vorolanib has neuroprotective properties Higher visual acuity function in vorolanib treated mice vs vehicle Significantly higher contrast vision in vorolanib treated mice vs vehicle Visual Acuity Contrast Vision
Slide 27: Neuroprotective properties in retinal detachment model: OCT
OCT in validated retinal detachment mouse model further suggests that vorolanib has neuroprotective properties Preservation of Structure: Significant loss of ONL thickness in vehicle eyes but not in vorolanib eyes suggesting that vorolanib protects photoreceptors
Slide 28: Summary and Key Takeaways: Vorolanib
Summary and Key Takeaways VOROLANIB Binds intracellular domain of receptors Compelling efficacy data as an oral therapy in Phase 1 and 2 clinical trials Levels as low as 20% of IC50 show significant inhibition of VEGFR2 phosphorylation Retinal detachment model indicates potential neuroprotection by
Slide 29: Preclinical PK Data
EYP-1901 PRECLINICAL PK DATA Said Saim, Ph.D. | Chief Technology Officer
Slide 30: YUTIQ zero-order kinetics release over 12 months
YUTIQ provides a benchmark for zero-order kinetics release over 12 months in non-erodible Durasert ASSAY (µG) TIME (DAYS) Near-zero order drug release through 12 Months ASSAY OF EXPLANTS FROM RABBIT VITREOUS OF YUTIQ INSERT 200 180 16014012010080 60 40 20 0 71% 0 30 60 90 120 150 180 210 240 270 300
Slide 31: YUTIQ continuous 3-year delivery and efficacy
YUTIQ demonstrates continuous 3-year delivery and efficacy in non-erodible Durasert 71% PRBABILITY RECURRENCE US Phase 3 Trial 0 60 120 180 240 300 360 420 480 540 600 660 720 780 840 900 960 1020 1080 1140 1200 1260 1.0 0.9 0.80.70.60.50.40.3 0.2 0.10.0 SHAM INJECTION (N=42) YUTIQ INSERT (N=87) 3 Y
Slide 32: EYP-1901 near zero-order drug release in rabbit model
TIME POINT (MONTH) EYP-1901 reflects near zero-order drug release across multiple doses in a rabbit model 71% MEAN REMAINING DOSE (% LABEL CLAIM/EYE) Near zero-order drug release is observed over 8-10 months Inserts are essentially depleted past 8 months, confirming observed pharmacokinetics in ocul
Slide 33: EYP-1901 pharmacokinetic profile in local tissues
TIME POINT (DAY) CONCENTRATION (NG/ML) Pharmacokinetic profile of EYP-1901 in local tissues supports zero-order kinetics release and sustained receptor binding above IC50 in a rabbit model 71% Initial burst followed by steady state levels of vorolanib in all ocular tissues Levels approximately an or
Slide 34: Bioerodible formulation supported by in-vitro dissolution model
EYP-1901 bioerodible formulation supported by in-vitro dissolution model INSERT AT 12 MONTHS AND DAY 0 EYP-1901 IS ~1/5000 OF VITREOUS Enlarged for illustrative purposed
Slide 35: Summary and Key Takeaways: EYP-1901 Preclinical PK and Safety
Summary and Key Takeaways EYP-1901 PRECLINICAL PK AND SAFETY DATA Consistent, zero order release of µgs/day through 9 months Steady state levels in ocular tissues for 8-9 months at levels higher than IC50 for VEGFR2 inhibition Release is dose proportional Inserts are bioeroded over time
Slide 36: Vorolanib Oral Formulation Clinical Trials
EYP-1901 VOROLANIB ORAL FORMULATION CLINICAL TRIALS Jay Duker, M.D. | Chief Operating Officer
Slide 37: Oral vorolanib Phase 1 clinical trial results
Trial Design Open label, 24 weeks, dose escalation, no control, oral delivery N=25 Phase 1: Results BCVA maintained to within 4 letters of baseline or improved in all but 1 participant 60% (15/25) of patients required no supplemental anti-VEGF injection while on oral vorolanib Excluding the low dose
Slide 38: Vorolanib Phase 2 Clinical Trial Results
Vorolanib Phase 2 Clinical Trial Results For subjects followed ≥ 6 months Placebo n=33 50 mg n=34 100 mg n=30 200 mg n=26 Median number of anti-VEGF injections* 9.0 6.1 5.8 4.6 Percent of Patients w/ no supplemental anti-VEGF therapy 2.6 7.5 10.3 20.5 * Normalized for number of months on study. Stud
Slide 39: Well controlled fellow eye conversion to wet AMD
Oral vorolanib clinical trials showed well controlled fellow eye conversion to wet AMD * Study performed by Tyrogenix. Phase 1 trial: No participant among the 25 completers developed new neovascular AMD in the fellow eye* Phase 2 trial: Placebo group (PRN intravitreal Anti-VEGF) 12.5% - (3/24) of su
Slide 40: EYP-1901 Phase 1 DAVIO Clinical Trial 12-Month Results
Carl Regillo, M.D. EYP-1901 PHASE 1 DAVIO CLINICAL TRIAL 12 MONTH RESULTS
Slide 41: Phase 1 DAVIO Clinical Trial protocol
EYP-1901 Phase 1 DAVIO Clinical Trial – “Durasert® and Vorolanib In Ophthalmology” Enrollment Previously treated wet AMD eyes No exclusion for presence of fluid Criteria for Supplemental Anti-VEGF Therapy* New fluid > 75 microns on OCT Loss of ≥ 2 lines of BCVA secondary to wet AMD New macular hemor
Slide 42: DAVIO enrolled patients over four dosages
EYP-1901 Phase 1 DAVIO clinical trial enrolled 17 patients over four different dosages Primary Endpoint: Safety Ocular and non-ocular TEAEs through month-12 Secondary Endpoints Supplemental anti-VEGF therapy through 6-months Change in BCVA from baseline CST as measured by OCT RESULTS: MONTH 12 FULL
Slide 43: DAVIO participant overview
EYP-1901 Phase 1 DAVIO clinical trial participant overview BASELINE CHARACTERISTICS Mean age, range (years) Female (n) Mean BCVA, range (ETDRS letters) Mean CST, range (microns) Median length of time for Wet AMD Diagnosis Mean # of anti-VEGF injections per year prior to enrollment 77.4 13/17 69 lett
Slide 44: Favorable overall safety data at 12 months
EYP-1901 Phase 1 DAVIO clinical trial demonstrated favorable overall safety data at 12-months meeting primary endpoint Ocular AEs of particular interest: No vitreous floaters No endophthalmitis No retinal detachment No implant migration in the anterior chamber No retinal vasculitis No posterior segm
Slide 45: 79% reduction in treatment burden at 6 months
EYP-1901 phase 1 DAVIO clinical trial demonstrated clinically significant reduction in treatment burden of 79% at 6-months DOSE % LOW DOSE (N=3) -70% LOW MID DOSE (N=3) -100% MID DOSE (N=3) -89% HIGH DOSE (N=5) -55% Anti-VEGF SoC (Anti-VEGF)+ EYP1901 Missed visit No rescue injection given REDUCTION
Slide 46: 74% reduction in treatment burden at 12 months
EYP-1901 Phase 1 DAVIO clinical trial continues clinically significant reduction in treatment burden of 74% at 12-months DOSE 12 MOS LOW DOSE (N=3) -66% LOW MID DOSE (N=1) -100% MID DOSE (N=8) -88% HIGH DOSE (N=5) -47% Anti-VEGF SoC (Anti-VEGF)+ EYP1901 Missed visit No rescue injection given REDUCTI
Slide 47: 6-month results: mean BCVA stable
EYP-1901 Phase 1 DAVIO clinical trial results at 6-months: mean BCVA is stable after single treatment 1 2 3 4 5 6 MONTHS CHANGE IN ETRDS LETTERS For all 17 eyes at 6 months | BCVA = -2.5 letters MEAN CHANGE IN BCVA FROM SCREENING VISIT 30 20 10 0 -10 -20 -30 Screen Visit BCVA: best corrected visual
Slide 48: 6-month results: mean CST stable
EYP-1901 Phase 1 DAVIO clinical trial results at 6-months: mean CST is stable after single treatment 1 2 3 4 5 6 MONTHS CST CHANGE IN MICRONS For all 17 eyes at 6 months | CST on OCT = -3.4 microns MEAN CHANGE IN CST FROM SCREENING VISIT 200 100 0 -100 -200 OCT: optical coherence tomography; CST: ce
Slide 49: 12-month results: mean BCVA stable
EYP-1901 Phase 1 DAVIO clinical trial results at 12-months: mean BCVA is stable after single treatment MONTHS CHANGE IN ETRDS LETTERS For all 17 eyes at 12 months | BCVA = -4.1 letters MEAN CHANGE IN BCVA FROM SCREENING VISIT 30 20 10 0 -10 -20 -30 1 2 3 4 5 6 7 8 9 10 11 12 SV BCVA: best corrected
Slide 50: 12-month results: mean CST stable
EYP-1901 Phase 1 DAVIO clinical trial results at 12-months: mean CST is stable after single treatment 200 100 0 -100 -200 MONTHS CHANGE IN ETRDS LETTERS For all 17 eyes at 12 months | CST on OCT = -2.8 microns MEAN CHANGE IN CST FROM SCREENING VISIT 1 2 3 4 5 6 7 8 9 10 11 12 SV OCT: optical coheren
Slide 51: 53% did not require supplemental anti-VEGF at 6 months
EYP-1901 Phase 1 DAVIO clinical trial demonstrated that 53% of patients did not require supplemental anti-VEGF treatment at 6-months SUPPLEMENTAL ANTI-VEGF INJECTION-FREE RATE UP TO EACH VISIT MONTHS
Slide 52: Case study 1: mid-dose patient remained dry
MONTH 8 EYP-1901 Phase 1 DAVIO clinical trial case study, a mid-dose cohort patient remained dry after only one supplemental injection -13 -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 Case 1: SOC Anti-VEGF Injections Before and After Treatment DAY 0 Indicates administration of
Slide 53: Case study 2: high-dose patient remained dry
EYP-1901 Phase 1 DAVIO clinical trial case study 2, a high-dose cohort patient remained dry after single EYP-1901 treatment MONTH 8 SCREENING BCVA 85 CST 232 Case 2: SOC Anti-VEGF Injections Before and After Treatment DAY 0 MONTH 2 MONTH 3 MONTH 4 MONTH 5 MONTH 6 MONTH 7 MONTH 9 MONTH 11 MONTH 10 MO
Slide 54: DAVIO clinical trial met all objectives
EYP-1901 Phase 1 DAVIO clinical trial met all objectives FAVORABLE SAFETY PROFILE Stabilization of mean BCVA and OCT throughout 6 months was achieved 53% supplemental anti-VEGF injection free up to 6-months 79% reduction in treatment burden at 6-months No ocular SAEs reported No drug-related systemi
Slide 55: Treat to Maintain
EYP-1901 TREAT TO MAINTAIN Jay Duker, M.D. | Chief Operating Officer Charlie Wykoff M.D.
Slide 56: Reduction in treatment burden supporting treat to maintain
EYP-1901 demonstrated clinically significant reduction in treatment burden of 79% at 6 months supporting treat to maintain positioning Anti-VEGF SoC (Anti-VEGF)+ EYP1901 Missed visit No rescue injection given About half of eyes in DAVIO could go up to 6 months on EYP-1901 alone Another ~30% received
Slide 57: Positioned as potential Treat-to-Maintain therapy
EYP-1901 positioned as a potential “Treat-to-Maintain” therapy Treat initially with current anti-VEGF standard of care until VA is maximally improved and retina is as dry as possible (induction phase) Maintain with EYP-1901 every six months, supplementing if needed with current anti-VEGF biologic Ba
Slide 58: Discussion on potential clinical use of EYP-1901
Discussion on the potential clinical use of 1901 with Charlie Wykoff, M.D. If you had EYP-1901 available in your practice, how would you introduce it for your patients with wet AMD? What would like to see before you adopt it more broadly? Where do you see the value of a “Treat and Maintain” therapy
Slide 59: EYP-1901 Phase 2 Clinical Trial Plans
Wet AMD | NPDR EYP-1901 PHASE 2 CLINICAL TRIAL PLANS
Slide 60: Wet AMD Phase 2 Trial (DAVIO 2)
Dario Paggiarino, M.D. | Chief Medical Officer WET AMD PHASE 2 TRIAL (DAVIO 2)
Slide 61: DAVIO 2 randomized, double-masked, aflibercept controlled
EYP-1901 DAVIO 2 clinical trial is non-pivotal randomized, double-masked, aflibercept controlled -D14 to -D7 D1 W4 W8 W12 W16 W24 W32 W36 to W56 W20 W28 EYP-1901 2mg low dose (n=48) EYP-1901 3mg high dose (n=48) Aflibercept q8W (n=48) RANDOMIZATION REQUIRED AFLIBERCEPT INJECTION VISIT VISIT SCHEDULE
Slide 62: DAVIO 2 trial design and endpoints
EYP-1901 DAVIO 2 clinical trial design to evaluate two different doses with BCVA as primary endpoint 71% Key I/E Criteria Diagnosed within past 9 months History of response to anti-VEGF History of at least 2 injections in last 6 months OCT exclusion criteria: Central subfield thickness > 400 µm Intr
Slide 63: Criteria for supplemental aflibercept injections
Criteria for supplemental aflibercept injections Starting from Week 12 EYP-1901 DAVIO 2 trial to evaluate supplemental anti-VEGF injections under strict criteria BCVA reduction of > 5 letters from best on study measurement due to wAMD AND Increase in CST of >75 microns on SD-OCT from lowest on study
Slide 64: NPDR Phase 2 Clinical Trial
NPDR PHASE 2 CLINICAL TRIAL Dario Paggiarino, M.D. | Chief Medical Officer
Slide 65: Phase 2 NPDR trial with sham control
EYP-1901 Phase 2 NPDR clinical trial is non-pivotal, randomized double-masked, day-one single injection with sham control EYP-1901 DOSING VISIT SCHEDULED SHAM INJECTION -D21 to –D5 D1 W4 W12 W24 W36 W48 EYP-1901 2mg low dose (n=35) EYP-1901 3mg high dose (n=35) Control Sham (n=35) RANDOMIZATION EYP-
Slide 66: NPDR primary endpoint: 2-step DRSS improvement at week 36
EYP-1901 Phase 2 NPDR clinical trial primary endpoint is improvement of at least 2 DRSS* severity levels at week 36 71% Objectives Evaluate efficacy and safety of a single injection of two doses of EYP-1901 in NPDR Primary Endpoint Improvement of at least 2 DRSS* severity levels at Week 36 01 Second
Slide 67: YUTIQ Clinical Updates
PRODUCTS YUTIQ CLINICAL UPDATES Dario Paggiarino, M.D. | Chief Medical Officer
Slide 68: YUTIQ supported by ongoing CALM study
YUTIQ commercial franchise supported by ongoing CALM study with real-world data Methods Data will be collected on up to 500 patients; 150 enrolled to date Routine standard of care assessments and adverse events will be recorded from routine visits over 5 years Status Next data presentation updates p
Slide 69: YUTIQ supported by Synchronicity phase 4 study
YUTIQ commercial franchise also supported by anticipated Synchronicity phase 4 study First patient dosed in Q2 2022 Initial data anticipated in 2H 2023 The Synchronicity study is evaluating YUTIQ’s ability to attain complete remission of inflammation through control of macular edema
Slide 70: Financial Update
FINANCIAL UPDATE George O. Elston | Chief Financial Officer
Slide 71: Balance Sheet – June 30, 2022
Balance Sheet – June 30, 2022* $171 million of cash and investments $40 million of short and long-term debt Solid cash position and growing revenues FINANCIAL SUMMARY Financial Performance* $11.3 million of net product revenues in Q2 2022, a 30% increase over Q2 2021 Q2 2022 Customer demand ~900 uni
Slide 72: CMS Draft Hospital Outpatient Rule impact on DEXYCU
CMS Draft Hospital Outpatient Rule does not extend the pass- through status of expiring drugs impacting DEXYCU If draft rule is finalized as is, DEXYCU pass-through status will expire on December 31, 2022 CMS clarified their intent to offer on-going pass through to non-opioid pain alternatives CMS c
Slide 73: Q&A
Q&A
Slide 74: Closing Remarks
CLOSING REMARKS