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8-K Filing
EyePoint Pharmaceuticals (EYPT) 8-KOther Events
Filed: 5 Feb 25, 7:05am
Investor Presentation February 2025 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Exhibit 99.2
Legal Disclaimers ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 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 that we intend, expect, plan or believe may occur in the future, are forward-looking statements , including but not limited to statements regarding: our expectations regarding the timing and clinical development of DURAVYU™ in Wet AMD and DME, our expectations regarding the enrollment, dosing and data readouts for the LUGANO trial and the LUCIA trial; our expectations regarding the VERONA trial following our announcement of full topline data; our optimism that that DURAVYU has the potential to change the current treatment paradigm and revolutionize real-world outcomes for patients suffering from serious retinal diseases; our belief that DURAVYU has the potential to maintain a majority of patients with active disease with no supplemental anti-VEGF therapy for six months or longer; and our expectations regarding the timing and clinical development of our other product candidates, including EYP-2301. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the company’s product candidates; changes in the regulatory environment; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; our ability to obtain additional funding to support our clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to our Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission (SEC). More detailed information on these and additional factors that could affect our actual results are described in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
EyePoint: The Leader in Sustained Release Drug Delivery for Retinal Disease ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Most robust dataset in wet AMD and DME among all sustained delivery programs in development Two ongoing global Phase 3 non-inferiority pivotal trials in wet AMD Strong balance sheet with ~$370M in cash and equivalents1; cash runway into 2027 DURAVYU™: patent protected vorolanib featuring new MOA delivered via best-in-class IVT delivery technology, Durasert E™ Only sustained release TKI with active program in DME bolstered by highly positive Phase 2 clinical data 1. As of December 31, 2024. Unaudited estimate, inclusive of net proceeds from October 2024 equity financing. MOA, mechanism of action; wet AMD, wet age-related macular degeneration; DME, diabetic macular edema 1 2 3 4 5
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. wet AMD, wet age-related macular degeneration; DME, diabetic macular edema; PK, pharmacokinetic; GA, geographic atrophy Pipeline Leveraging Durasert E™ Drug Delivery Technology trial underway non-clinical Durasert E™ Programs Indication Discovery Pre-Clin Phase 1 Phase 2 Phase 3 Anticipated Next Milestone DURAVYU™ – (vorolanib intravitreal insert) (f/k/a EYP-1901) Wet AMD DME EYP-2301 – razuprotafib (TIE-2 agonist) serious retinal diseases Enrollment completion in 2H 2025 FDA mtg expected in 2Q 2025 Pre-clin tox and PK data PIVOTAL TRIALS UNDERWAY Positive Six-Month Data Evaluating additional pipeline opportunities
IVT, intravitreal DURASERT E™ TECHNOLOGY Sustained-Release Drug Delivery Standard in-office IVT injection Continuous dosing Zero-order kinetics drug release Bioerodible Durasert E™: Solid injectable insert Drug formulated within a bioerodible matrix Designed to release drug load before matrix fully erodes Favorable safety profile across multiple indications ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Insert is 1/5000 of Vitreous Volume
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. Bakri SJ, et al. PLoS One. 2024;19(6):e0304782 [CC BY 4.0]. TKI tyrosine kinase inhibitor; AMD, age-related macular degeneration; Ang, angiopoietin; FGF(R), fibroblast growth factor (receptor); PDGF(R), platelet-derived growth factor (receptor); PLGF, placental growth factor; TKI, tyrosine kinase inhibitor; TIE2, tyrosine-protein kinase receptor TIE-2; VEGF(R), vascular endothelial growth factor (receptor); VE-PTP, vascular endothelial cell-specific protein tyrosine phosphatase. Vorolanib is a Best-In-Class TKI that Selectively Inhibits all Forms of the VEGF Receptor Potent and highly selective pan-VEGF receptor inhibitor Composition of matter patent into 2037 Acts intracellularly to preventpro-angiogenic signaling Demonstrated neuroprotection Potential antifibrotic Does not inhibit TIE21 Endothelial cell VEGFB VEGFA VEGFC VEGFD VEGFR1 VEGFR2 VEGFR3 TIE2 PDGFR ANG1 ANG2 PDGF Angiogenesis, permeability, leakage, growth, migration, and proliferation Blood vessel stability Proliferation, motility PLGF Pericyte VOROLANIB Pathological angiogenesis and vascular instability underlie wet AMD
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Immediately bioavailable – reaches therapeutic levels within hours Constant dosing – zero-order kinetics release for at least six months Controlled drug release – bioerodible matrix controls drug release; no free-floating drug Contains NO PEG or PLGA Preloaded sterile syringe injector Shipped and stored at ambient temperature DURAVYU: Vorolanib in Bioerodible Durasert E™ DURAVYU™ Bioerodible Insert 94% drug 1/5000 of vitreous volume
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU Demonstrated Positive Efficacy and Favorable Safety Profile Across Multiple Clinical Trials and Indications 1. Data as of January 16, 2025. Preliminary data pending final analysis. Wet AMD, wet age-related macular degeneration; NPDR, non-proliferative diabetic retinopathy; DME, diabetic macular edema; SAEs, serious adverse events; BCVA, best-correct visual acuity; OCT, optical coherence tomography. Clinical Trial Indication Safety Key Efficacy Outcomes DAVIO wet AMD No DURAVYU related ocular or systemic SAEs Stable BCVA and CST 74% reduction in treatment burden DAVIO 2 wet AMD Statistically non-inferior BCVA vs on-label aflibercept >80% reduction in treatment burden Stable anatomy (CST) PAVIA NPDR Stable or prevention of worsening disease severity VERONA1 DME Primary endpoint met Meaningful, immediate and sustained improvement in BCVA and OCT DURAVYU Has Been Evaluated in Over 190 Patients to Date Across Multiple Indications
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 VERONA Clinical Trial in DME – Six-Month Results Immediate Bioavailability and sustained delivery for At Least Six months DME, diabetic macular edema Data as of January 16, 2025. Preliminary data pending final analysis.
Diabetic Macular Edema: Large Market Opportunity with Significant Unmet Need for More Durable Treatments ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. William R. Rowley, Clement Bezold, Yasemin Arikan, et al. Diabetes 2030: Insights from Yesterday, Today and Future Trends. PubMed Central. 2017 PMCID: PMC5278808 PMID: 27124621 . 2. Russel Lazarus. Optometrists Network. Guide to Eye Conditions; Diabetic Macular Edema. 3. DelveInsights DME Market Report -2030. 4. Monique A. Rose, Meri Vukicevic, Konstandina Koklanis. Adherence of patients with diabetic macular oedema to intravitreal injections: A systematic review. PubMed 2020 PMID: 32829485 DOI: 10.1111/ceo.13845. 5. Lee, R., Wong, T.Y. & Sabanayagam, C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye and Vis 2, 17 (2015). https://doi.org/10.1186/s40662-015-0026-2. 6. Nagda D, Mitchell W, Zebardast N. The functional burden of diabetic retinopathy in the United States. Graefes Arch Clin Exp Ophthalmol. 2021;259(10):2977–2986. https://doi.org/10.1007/s00417-021-05210-3. Patients in the US with diabetes by 20301 Global market by 20303 Delayed/missed treatment visits4 54.9M 25% up to 51% $3.9B Develop DME within 10 years2 Vision loss from missed injection5 5-6 letters By 2050, diabetes-related vision loss is expected to cost 500 million US dollars annually6
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DME, diabetic macular edema; VEGF, vascular endothelial growth factor; BCVA, best corrected visual acuity; OCT, optical coherence tomography; CST, central subfield thickness DURAVYU dosing Visit Scheduled aflibercept injection Sham injection DURAVYU 1.3mg (n=10) DURAVYU 2.7mg (n=11) Aflibercept 2mg single injection (n=6) Supplemental Anti-VEGF injection based on prespecified criteria Objectives: Evaluate the safety and efficacy of DURAVYU in patients with active DME (CST >325μm) Collect dose-ranging data to inform Phase 3 clinical trials Primary endpoint: time to supplemental anti-VEGF injection up to week 24 Key Secondary endpoints: safety, change in BCVA vs. aflibercept control and anatomical control (CST) Primary endpoint -D28 to -D7 D1 W4 W8 W12 W16 W20 W24 Phase 2 VERONA Clinical Trial is a Randomized, Open-Label, Aflibercept Controlled Trial as a Potential Treatment for DME
VERONA Clinical Trial Supplement Criteria ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. vs. best on study measurement; 2. as measured by Spectral domain OCT (SD-OCT) BCVA, best corrected visual acuity; PRN, pro re nata; CST, central subfield thickness Starting at Week 4: Reduction in BCVA ≥10 letters due to DME1 Reduction in BCVA of 5-9 letters and >75 microns of new fluid at two consecutive visits1 Increase of ≥100 microns of new fluid vs. Baseline (Day 1)2 Investigator discretion Starting at Week 12 (unique supplementation criteria incorporated due to PRN design of trial): Lack of 10% reduction in CST compared to Baseline (Day 1)
VERONA:Phase 2 Clinical Trial Met Primary and Secondary EndpointsData supports DURAVYU as a Potential Treatment for DME with improvement in vision and anatomy with superior dosing intervals ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU 2.7mg - 24 WEEK EFFICACY Results: Primary endpoint achieved - extended time to first supplemental injection vs. aflibercept control Early and sustained BCVA improvement = +7.1 letters Early and sustained CST improvement = -76 microns 73% supplement-free eyes vs. 50% aflibercept control ~Two-thirds reduction in treatment burden DURAVYU SAFETY Results: No ocular or systemic DURAVYU-related SAEs No cases of: Impaired vision Endophthalmitis Retinal vasculitis (occlusive or non-occlusive) Intraocular inflammation (IOI) Insert migration DME, diabetic macular edema; BCVA, best-corrected visual acuity; CST, central subfield thickness; SAEs, serious adverse events. Data as of January 16, 2025. Preliminary data pending final analysis.
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. VERONA: Single DURAVYU 2.7mg Treatment Demonstrated Clinically Meaningful Improvement in BCVA; Supports Noninferiority in Pivotal Trial BCVA, best-corrected visual acuity; VA, visual acuity Data as of January 16, 2025. Preliminary data pending final analysis. MEAN CHANGE IN BCVA FROM BASELINE +7.1 +7.3 DURAVYU 2.7mg -0.2 Mean Change in BCVA vs Aflibercept +6.9 Early and sustained VA improvement
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. VERONA: DURAVYU 2.7mg Demonstrated Improved and Controlled Anatomy with 74% More Drying than Aflibercept Control CST: central subfield thickness Data as of January 16, 2025. Preliminary data pending final analysis. Source: Independent reading center results available as of the full 24-week data cut. MEAN CHANGE IN CST FROM BASELINE -75.9 um -43.7 um Mean Change in CST vs Aflibercept DURAVYU 2.7mg -32.2 um -71.1 um
VERONA: Eyes Treated with DURAVYU had a Greater Proportion of Supplement-Free Eyes vs. Aflibercept Control up to Six Months ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Data as of January 16, 2025. Preliminary data pending final analysis. 2.7mg DURAVYU reduced treatment burden by over two-thirds Summary of Cumulative Supplement-Free Rates 100% 100% 100% 100%
Phase 2 VERONA Clinical Trial Case Study 1 - 2.7mg Dose Pt - Immediate Drying with Improved Vision After Single DURAVYU Treatment and No Supplementation- Prior treatment = 2x Eylea, 1x Vabysmo in past 12 months ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Day 1 BCVA: 46 Week 4 BCVA: 65 Week 16 BCVA: 67 Week 24 BCVA: 66
Phase 2 VERONA Clinical Trial Case Study 2 - 2.7mg Dose Patient- Continued Drying at Week 24 with Improved VA After Single DURAVYU Treatment and No Supplementation - Prior treatment = 1x Avastin, 5x Vabysmo in past 7 months ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Day 1 BCVA: 73 Week 4 BCVA: 74 Week 16 BCVA: 80 Week 24 BCVA: 80
Continued Favorable Safety and Tolerability Profile in VERONA Clinical Trial ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. SAE, serious adverse event Data as of January 16, 2025. Preliminary data pending final analysis. No reported DURAVYU-related ocular SAEs or systemic SAEs No cases of: Endophthalmitis Retinal vasculitis (occlusive or non-occlusive) Insert migration Intraocular inflammation (IOI) No discontinuations >190 patients treated with DURAVYU to date with no DURAVYU-related SAEs
VERONA: Phase 2 Clinical Trial Highlights ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Data as of January 16, 2025. Preliminary data pending final analysis. Primary endpoint met for both DURAVYU doses Demonstrated immediate clinical bioavailability Achieved clinically meaningful results without a full load of aflibercept Significant improvement in vision paired with a meaningful reduction in treatment burden Significantly better anatomic results with fewer supplemental injections Continued favorable safety and tolerability
Positive Phase 2 VERONA Data Supports Advancement to Phase 3 Pivotal Program – Expected Initiation by End of 2025 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Next Steps: Continue development of Phase 3 clinical protocol – non-inferiority design Discuss Phase 2 results and proposed Phase 3 clinical protocol with regulatory agencies (FDA, EMA) Initiation of pivotal program anticipated by the end of 2025 leveraging the experience from LUGANO and LUCIA wet AMD trials Present results at future medical conferences
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYULUGANO/LUCIAPhase 3 Pivotal Trials in wet AMD NON-INFERIORITY VERSUS AN AFLIBERCEPT CONTROL
Phase 3 Trials are Designed to Enable Global Regulatory Approvals for DURAVYU ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Demonstrate DURAVYU, when administered every six months, achieves similar visual outcomes to on-label aflibercept while reducing treatment burden ~400 patients per trial Two arms 2.7mg DURAVYU aflibercept on-label control DURAVYU dosing every 6-months One-year efficacy and safety endpoint for NDA submission Primary Endpoint: difference in mean change in BCVA from Day 1 to Week 52 and 56 (blended) versus aflibercept control Secondary endpoints: safety, reduction in treatment burden, percent of eyes supplement-free, anatomical stability LUGANO and LUCIA Trials: global, randomized, double-masked, aflibercept controlled Objective Trial Design Endpoints
DURAVYU™ in Wet AMD Phase 3 Pivotal Trial Design ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Screening D1 W4 W8 W12 W16 W24 W32 W84-W92 W20 W28 DURAVYU™ 2.7mg Aflibercept 2mg q8W RANDOMIZATION REQUIRED AFLIBERCEPT INJECTION VISIT VISIT SCHEDULED DURAVYU™ DOSE AFLIBERCEPT q8W 1⁰ ENDPOINT BLEND W52 AND W56; UNMASK W56 SHAM INJECTION FOR MASKING W36 W40 W44 W48 W52 W56 W60-W76 W80 W96 EOS AFLIBERCEPT Q8W Sham injection For Masking Supplemental anti-VEGF injection based on strict criteria AFLIBERCEPT load DURAVYU DURAVYU DURAVYU DURAVYU LUGANO/LUCIA First Patient Dosed Topline Data in 2026
Exceptional Enrollment to Date Driven by Significant Investigator and Patient Enthusiasm ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. June 2024 Final Phase 3 protocols October 2024 First patient in LUGANO trial dosed December 2024 First patient in LUCIA trial dosed 2H 2025 Expected full enrollment of both Phase 3 pivotal trials Top line data for both Phase 3 pivotal trials anticipated in 2026 January 2025 LUGANO trial ~1/3 enrolled; LUCIA exceeding expectations 2026 Topline data for pivotal program
Commercial Manufacturing Facility Opened in October 2024 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. FDA, Federal Drug Administration; EMA, European Medicines Agency; cGMP, current good manufacturing practice Located in Northbridge, MA Built to US FDA and EU EMA standards 40,000sf cGMP manufacturing facility Built to EYPT specifications by landlord preserving upfront cash investment New manufacturing site for commercial production of DURAVYU
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EYP-2301: razuprotafib in Durasert E™ A sustained delivery tie-2 agonist for severe retinal diseases
EYP-2301: Razuprotafib in Durasert E™ is a Patented TIE-2 Agonist as a Potential New MOA for Treating Serious Retinal Diseases ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. Heier et al. Retina, 2021;41:1-19. and Joussen et al. Eye 2021; 35:1305-1316.; 2. Hammes, et. Al – Diabetes.2011 Jan 1; 3. Shen et al. JCI, 2014; 124:4564; 3. Campochiaro et al. Ophthalmology, 2016; 123:1722-1730; 4. Phase 2 TIME 2a clinical trial conducted by Aerpio. 5.Campochiaro et al. PubMed 2016 123(8):1722-1730. DOI: 10.1016/j.ophtha.2016.04.025 EYP-2301 targets vascular endothelial protein tyrosine phosphatase (VE-PTP) activating TIE-2 and downregulating ANG2 to maintain vascular stability in the retina P P EYP-2301 Blood vessel lumen Intracellular space VE-PTP ANG2 Tie-2 activation combined with VEGF inhibition has the potential to enhance efficacy and extend durability1 of treatment Razuprotafib (f/k/a AKB-9778) delivered subcutaneously demonstrated preclinical and clinical proof of concept in posterior segment disease 2,3 In a Phase 2 clinical trial, razuprotafib combined with ranibizumab, was more effective than ranibizumab alone at reducing macular edema with a favorable safety and tolerability profile4,5
On Track for Continued Execution And Well-Funded Through Key Anticipated DURAVYU Milestones ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DME, diabetic macular edema; EOP2, End of Phase 2; wet AMD, wet age-related macular degeneration; SAB, Scientific Advisory Board DURAVYU™ Corporate ✓ Positive EOP2 meeting with FDA for wet AMD April 2024 ✓ PAVIA for NPDR topline data May 2024 ✓ DAVIO 2 12-month data Jue 2024 ✓ Positive interim VERONA data October 2024 ✓ First patient dosed – LUGANO October 2024 ✓ First patient dosed – LUCIA December 2024 ✓ VERONA Phase 2 DME full topline data February 2025 FDA meeting for DME Q2 2025 Anticipated initiation of Phase 3 pivotal program for DME By end of 2025 ✓ Expanded SAB with world-renowned retina specialists April 2024 ✓ R&D Day - NYC June 2024 ✓ Fred Hassan appointed to Board of Directors September 2024 ✓ Northbridge manufacturing facility grand opening October 2024 ✓ Reginald Sanders, MD appointed to Board of Directors January 2025
EyePoint: The Leader in Sustained Release Drug Delivery for Retinal Disease ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Most robust dataset in wet AMD and DME among all sustained delivery programs in development Two ongoing global Phase 3 non-inferiority pivotal trials in wet AMD Strong balance sheet with ~$370M in cash and equivalents1; cash runway into 2027 DURAVYU™: patent protected vorolanib featuring new MOA delivered via best-in-class IVT delivery technology, Durasert E™ Only sustained release TKI with active program in DME bolstered by highly positive Phase 2 clinical data 1. As of December 31, 2024. Unaudited estimate, inclusive of net proceeds from October 2024 equity financing. MOA, mechanism of action; wet AMD, wet age-related macular degeneration; DME, diabetic macular edema 1 2 3 4 5
Investor Presentation February 2025 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved.