Product Development - EyePoint's lead product candidate, DURAVYU™, is currently in Phase 3 trials for wet AMD and DME, with topline data expected in mid-2026[2] - Over 900 patients have been enrolled in the Phase 3 LUGANO and LUCIA trials within 7 months, making it one of the fastest enrolling wet AMD pivotal programs[4] - The Phase 3 wet AMD program has a primary endpoint of noninferiority in best corrected visual acuity (BCVA) at weeks 52 and 56, compared to aflibercept[6] - First patient dosing in the Phase 3 DME trials (COMO and CAPRI) is expected in Q1 2026, with each trial enrolling approximately 240 patients[6] - The independent Data Safety Monitoring Committee recommended the continuation of the Phase 3 program with no protocol modifications[6] Treatment Efficacy - DURAVYU demonstrated an 88% reduction in treatment burden six months after treatment, with over 80% of patients being supplement-free or requiring only one supplemental anti-VEGF injection[10] - DURAVYU's multi-mechanism of action includes a greater than 50% reduction in IL-6 activity, which is significant for treating wet AMD and DME[6] - DURAVYU is positioned as the only sustained release TKI in development for DME, addressing a significant need for new therapeutic options[3] Financial Overview - The company completed a public offering with gross proceeds of $172.5 million in October 2025, with approximately $300 million in cash and investments as of December 31, 2025[6] - EyePoint is preparing for an expeditious NDA filing and FDA review to deliver DURAVYU to patients as soon as possible[3]

Core Insights - EyePoint, Inc. is advancing its lead product candidate, DURAVYU, through pivotal Phase 3 trials for wet age-related macular degeneration (AMD) and diabetic macular edema (DME), with significant milestones expected in 2026 [1][2] Company Updates - DURAVYU is positioned as a unique sustained-release treatment for retinal diseases, with pivotal trials for wet AMD on track for data readout starting mid-2026 and first patient dosing for DME expected in Q1 2026 [1][2] - The company reported a successful year in 2025, focusing on scientific rigor and a patient-centric approach, aiming for expedited NDA filing and FDA review for DURAVYU [2][4] - EyePoint completed enrollment of over 900 patients in the Phase 3 trials for wet AMD, making it one of the fastest enrolling programs in this space [4] Product Details - DURAVYU (vorolanib intravitreal insert) is designed for sustained drug delivery, releasing therapeutic doses for at least six months via a simple in-office injection [8][9] - Vorolanib, a tyrosine kinase inhibitor, has shown no ocular safety signals in previous trials and targets both VEGF-mediated vascular permeability and IL-6 mediated inflammation [9][10] - The Phase 3 trials for wet AMD (LUGANO and LUCIA) are designed to demonstrate noninferiority compared to aflibercept, with primary endpoints focused on visual acuity changes [4][11] Financial Position - EyePoint raised $172.5 million in a public offering in October 2025, with approximately $300 million in cash and investments as of December 31, 2025, providing a cash runway into Q4 2027 [11][12] Upcoming Events - The company will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, highlighting its advancements and future plans [1][11]

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: EyePoint (EYPT) - EyePoint currently holds a Momentum Style Score of A, indicating strong momentum characteristics [2] - The company has a Zacks Rank of 2 (Buy), suggesting it is positioned for potential outperformance in the market [3] Performance Metrics - Over the past week, EYPT shares increased by 9.01%, while the Zacks Medical - Biomedical and Genetics industry declined by 1.33% [5] - In a longer timeframe, EYPT's shares rose by 27.41% over the past month, significantly outperforming the industry's 0.8% [5] - For the last three months, EYPT shares have increased by 25.4%, and over the past year, they have surged by 145.49%, compared to the S&P 500's gains of 2.85% and 17.84%, respectively [6] Trading Volume - EYPT's average 20-day trading volume is 1,226,230 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Outlook - In the past two months, three earnings estimates for EYPT have been revised upwards, while none have been lowered, leading to an increase in the consensus estimate from -$3.06 to -$3.00 [9] - For the next fiscal year, three estimates have also moved upwards with no downward revisions [9] Conclusion - Given the strong performance metrics and positive earnings outlook, EYPT is positioned as a solid momentum pick with a Momentum Score of A and a Zacks Rank of 2 (Buy) [11]

Industry Overview - The biotech sector has shown a strong recovery in 2025, with the Nasdaq Biotechnology Index rising by 33.1% year to date after bottoming out in April 2025 due to potential steep tariffs impacting the pharma and biotech sectors [1][2] - Key drivers of this rally include new drug approvals, a positive pipeline, regulatory updates, and a surge in mergers and acquisitions (M&A) activity, with the FDA approving over 42 drugs so far this year [2][3] M&A Activity - The year has seen a significant increase in M&A activity, driven by the changing landscape and focus on AI-driven drug discovery, as large pharmaceutical and biotech companies seek to expand and diversify their product portfolios amid rising generic competition [3] Regulatory Agreements - The Trump administration has signed agreements with major pharma and biotech companies, including Gilead Sciences, Amgen, Merck, and Novartis, aimed at lowering prescription drug prices for chronic conditions [4] - These companies are expected to collectively invest at least $150 billion in domestic production in the near term, indicating a commitment to innovation in medical treatments [5] Company Highlights EyePoint, Inc. (EYPT) - EYPT focuses on developing innovative therapeutics for serious retinal diseases, with its lead candidate, Duravyu, being evaluated in late-stage studies for wet age-related macular degeneration [7][11] - EYPT's shares have surged by 140.5% in 2025, with a current average target price of $34.18 representing an upside of 100.35% [12] ANI Pharmaceuticals (ANIP) - ANIP is a diversified biopharmaceutical company with a strong focus on rare diseases, particularly through its ACTH-based injection, Cortrophin Gel, which saw sales jump by 70% year over year to $236 million in the first nine months of 2025 [13][14] - The stock has gained 52.9% over the year, with a current average target price of $109.25 representing an upside of 31.9% [16] Tango Therapeutics (TNGX) - Tango Therapeutics is focused on precision oncology, developing treatments based on synthetic lethality for specific tumors, with promising pipeline candidates including PRMT5 inhibitors for various cancers [17][19] - TNGX shares have increased by 163.8% in the past year, with a current average target price of $13.22 representing an upside of 56.26% [21]

Core Insights - EyePoint, Inc. is focused on developing innovative therapeutics for serious retinal diseases and will present at the J.P. Morgan Healthcare Conference on January 13, 2026 [1] Company Overview - EyePoint, Inc. is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients with serious retinal diseases [3] - The company's lead product candidate, DURAVYU, is an investigational sustained delivery treatment combining vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E technology [3] - DURAVYU is currently in Phase 3 pivotal trials for wet age-related macular degeneration, with topline data expected in mid-2026, and first patient dosing in diabetic macular edema trials anticipated in Q1 2026 [3] Product and Development - Vorolanib is exclusively licensed to EyePoint for the localized treatment of ophthalmic diseases outside of specific regions in Asia [5] - DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901, but it remains an investigational product and has not yet received FDA approval [5] Commitment to Community - The company aims to partner with the retina community to enhance patient lives while creating long-term value, having developed four approved drugs over three decades and treated tens of thousands of eyes [4]

Core Insights - EyePoint Pharmaceuticals announced positive recommendations from the independent Data Safety Monitoring Committee (DSMC) for its pivotal Phase 3 trials, LUGANO and LUCIA, evaluating DURAVYU for wet age-related macular degeneration (wet AMD) [1][2][3] - The trials are on track to report topline data in mid-2026, with no changes to the protocol recommended by the DSMC [1][2] - DURAVYU is designed as a sustained-delivery treatment, potentially reducing the treatment burden for patients with wet AMD [5][9] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [11] - The lead product candidate, DURAVYU, combines vorolanib, a selective tyrosine kinase inhibitor, with proprietary Durasert E technology for sustained drug release [11][13] - The company has a history of developing approved drugs and aims to improve patient lives while creating long-term value [12] Clinical Trials - The LUGANO and LUCIA trials are randomized, double-masked, aflibercept-controlled, non-inferiority Phase 3 trials with over 900 patients enrolled [3][9] - The primary endpoint is non-inferiority in best corrected visual acuity (BCVA) change at weeks 52 and 56 compared to baseline [3][9] - Secondary endpoints include safety, treatment burden reduction, and anatomical results measured by optical coherence tomography (OCT) [3][9] Treatment Context - Wet AMD is a leading cause of vision loss in individuals over fifty, requiring continuous treatment to maintain visual function [4] - Current standard-of-care treatments are administered on average every two months, posing a significant burden on patients and healthcare systems [4] - DURAVYU aims to address these challenges by providing a sustained-release option that could reduce the frequency of treatments [5][9] Product Details - DURAVYU is a solid bioerodible insert designed to release a constant therapeutic dose for at least six months [5][6] - Vorolanib, the active ingredient, has shown no ocular safety signals in previous trials and targets multiple pathways involved in retinal diseases [7][8] - The product is positioned to potentially offer a flexible dosing regimen for physicians treating wet AMD [9][10]

Core Viewpoint - EyePoint Pharmaceuticals has granted stock options to new employees as inducement awards outside its 2023 Long-Term Incentive Plan, in compliance with NASDAQ Listing Rule 5635(c)(4) [1][2]. Company Overview - EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3]. - The company's lead product candidate, DURAVYU™, is a sustained delivery treatment combining vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E™ technology [3]. - DURAVYU is currently undergoing evaluation in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with topline data for the LUGANO trial expected in mid-2026 [3]. - The first patient dosing in pivotal Phase 3 clinical trials for diabetic macular edema (DME) is anticipated in the first quarter of 2026 [3]. Stock Options Details - The company granted stock options to purchase up to 31,000 shares of common stock to seven new employees on November 14, 2025 [2]. - The exercise price for the options is set at $11.58 per share, which is the closing price of EyePoint's common stock on the grant date [2]. - The options have a ten-year term and vest over four years, with 25% vesting on the first anniversary and the remainder vesting in equal monthly installments over the following three years [2].

Summary of EyePoint Pharmaceuticals Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals (NasdaqGM:EYPT) - **Focus**: Phase 3 development in sustained drug delivery for wet age-related macular degeneration (AMD) and diabetic macular edema (DME) [1][2] Key Points Industry and Market Position - EyePoint is a leader in sustained drug delivery to the back of the eye, with a focus on wet AMD and DME [2] - The company has a strong balance sheet with approximately $350 million in cash, providing a runway into Q4 2027 [3] Clinical Trials and Pipeline - **Wet AMD Trials**: Two phase 3 trials (LUGANO and LUCIA) are fully enrolled, with top-line data expected mid-2026 [10][22] - **DME Trials**: First patients to be dosed in Q1 2026, with simultaneous readouts expected in Q4 2027 [3][19] - **EYP2301**: A pipeline asset in preclinical stage [3] Technology and Drug Delivery - **DuraCert Technology**: Proven in four FDA-approved products, with a new delivery system (Duravyu) consisting of 94% drug and 6% matrix [4][5] - **Vorolanib**: A multi-mechanism action (MOA) drug that blocks VEGF receptors and inflammation through JAK1, showing sustained drug levels for at least six months [4][6][8] Efficacy and Safety - Previous trials (one phase 1 and three phase 2) demonstrated excellent efficacy and safety, with no ocular or systemic serious adverse events (SAEs) reported [5][6] - Vorolanib showed over 50% reduction in IL-6 activity, indicating potential for better outcomes in DME and wet AMD [9][16] Competitive Landscape - EyePoint's approach may capture significant market share if non-inferiority to existing treatments (Eylea and Lucentis) is demonstrated, with potential for better visual outcomes and reduced treatment burden [26][27] - Other companies, such as Kodiak Sciences and Genentech, are also exploring IL-6 blockage, indicating a competitive environment [16] Commercial Strategy - The company is focused on commercial scale-up and success, with a new facility in Northbridge, Massachusetts, capable of producing hundreds of thousands of inserts annually [24] - Physician enthusiasm for the treatment is high, with expectations that a successful trial could shift retinal practice towards EyePoint's TKI approach [25][26] Regulatory Considerations - The FDA has provided clear guidelines for non-inferiority trials, requiring on-label controls for both wet AMD and DME [34] - EyePoint plans to leverage safety data from wet AMD trials to inform DME trials, potentially reducing the number of patients needed for safety assessments [21][22] Future Outlook - The company is positioned to be first in class and best in class in the two largest retinal indications, with robust phase 1 and phase 2 efficacy and safety data [22] - Full enrollment for DME trials is expected in the second half of next year, with a focus on achieving better visual acuity and reduced treatment burden [22][23] Additional Insights - The company emphasizes the importance of sustained release options for chronic diseases, which may improve patient compliance and outcomes [29] - The potential for neuroprotective and antifibrotic effects from vorolanib could further differentiate EyePoint's offerings in the market [27][28]

Stifel 2025 Healthcare Conference November 12, 2025 Jay Duker, MD President and CEO © 2025 EyePoint. All Rights Reserved. Legal Disclaimers 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 fo ...

Summary of EyePoint Pharmaceuticals FY Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals (NasdaqGM:EYPT) - **Mission**: To improve patients' lives through enhanced treatment of retinal diseases, focusing on drug delivery systems [6][5][4] Key Trials and Developments - **Pivotal Trials**: - Two pivotal trials for wet age-related macular degeneration (AMD): Lugano Trial and Lugia Trial, both fully enrolled with over 400 patients each [6][7] - Expected readout for Lugano Trial in mid-2026 and Lugia Trial shortly thereafter [6] - Phase three trials for diabetic macular edema (DME) named COMO and COPRI, with patient dosing starting in Q1 2026 [7] - **Drug Mechanism**: Vorolanib, the drug in focus, exhibits both anti-VEGF and anti-inflammatory effects by blocking the JAK1 receptor, which is significant for conditions like diabetic macular edema and wet AMD [9] Enrollment and Study Design - **Rapid Enrollment**: The rapid enrollment in the wet AMD trials was attributed to strong phase two data and the patient-centric design of the studies [11][10] - **Patient Population**: The phase three study includes both previously treated and naive patients, with expectations of better outcomes in naive patients [14][13] Safety and Efficacy Expectations - **Safety Profile**: The safety results so far are consistent with prior trials, with no vision loss reported due to the drug insert [21][23] - **Efficacy Goals**: The aim is to be statistically non-inferior to Eylea, with hopes of achieving statistical superiority [20][19] Competitive Landscape - **Market Position**: EyePoint aims to differentiate itself from competitors like Vabysmo and Eylea by offering a different mechanism of action and a six-month dosing schedule [36][37] - **First-to-Market Advantage**: If approved, EyePoint will be the first to market with its sustained-release product, which is expected to be advantageous [38] Market Potential - **DME Market Size**: The DME market is approximately $3 billion in the U.S., representing about 35-40% of the overall market for retinal diseases [49][50] Regulatory and Global Strategy - **Regulatory Readiness**: EyePoint is preparing for a pre-approval inspection by the FDA and has a clear plan for NDA submission based on the results of the ongoing trials [33][31] - **Ex-U.S. Strategy**: The company plans to include European sites in its studies and is preparing for potential launch outside the U.S., with a focus on finding a global partner at the right time [50][51] Conclusion EyePoint Pharmaceuticals is positioned at a pivotal moment with multiple ongoing trials and a strong focus on innovative drug delivery for retinal diseases. The company is optimistic about its upcoming trial results and the potential market impact of its products.