Summary of EyePoint Pharmaceuticals (EYPT) FY Conference - August 13, 2025 Company Overview - **Company**: EyePoint Pharmaceuticals - **Focus**: Development of sustained-release therapies for ocular diseases, specifically targeting wet age-related macular degeneration (AMD) with their drug Duravu Key Points and Arguments Clinical Trials and Drug Development - **Phase Three Trials**: Both Lugano and Lucia trials for Duravu have completed enrollment, including treatment naive and treatment experienced patients, which is expected to positively impact future data readouts [3][4][5] - **Patient Population**: The trials have a 75% treatment naive to 25% previously treated patient ratio, which is considered advantageous for FDA evaluation [8][10][12] - **Safety Profile**: No safety signals were observed in previous trials, and the inclusion of naive patients is not expected to alter safety outcomes [6][42] - **Supplemental Injections**: The criteria for supplemental injections have been simplified based on phase two findings, aiming to reduce the supplemental rate in pivotal trials [13][15][17] Drug Technology - **DuraCert e Technology**: The new bioerodible DuraCert e technology differs from previous DuraCer technology by eliminating the polyamide shell, which is expected to enhance safety and efficacy [20][22][26] - **Drug Composition**: The inserts are now 94% drug and 6% matrix, designed to fully bioerode without leaving harmful residues [27][28][32] Market Expectations and Competitive Landscape - **Regulatory Pathway**: Vorolanib, the active ingredient in Duravu, has been approved in China for kidney cancer but is a new drug entity in the U.S., providing potential advantages in patent protection [44][46] - **Real-World Use**: Duravu is expected to be integrated into existing treatment protocols, potentially allowing for longer intervals between injections compared to current therapies like Eylea and Lucentis [47][49][52] - **Payer Receptiveness**: Payers have shown receptiveness to the idea of a sustained release therapy that reduces treatment burden, which is a significant factor in market adoption [55][56] Financial and Operational Readiness - **Manufacturing Capacity**: EyePoint has established a new manufacturing facility capable of producing hundreds of thousands of inserts annually, with potential expansion to a million inserts [57][59] - **Cash Runway**: The company has sufficient cash to complete pivotal trials and prepare for regulatory approval, with optimism about raising additional funds for commercialization [63][64] Future Outlook - **Data Expectations**: Top-line data from the Lugano trial is expected in mid-2026, with hopes of demonstrating noninferiority or even superiority to Eylea [36][38][62] - **Market Positioning**: The company is optimistic about the potential for rapid uptake of Duravu in the market, especially if pivotal trial results are positive [54][65] Additional Important Information - **Patient Engagement**: Rapid enrollment in trials indicates strong enthusiasm from both doctors and patients for the drug [36] - **Clinical Evidence**: Previous studies suggest that Duravu may provide better visual acuity outcomes compared to existing treatments [41][62]

Financial Data and Key Metrics Changes - For Q2 2025, total net revenue was $5.3 million, down from $9.5 million in Q2 2024, primarily due to lower recognition of deferred revenue related to the YUTIQ product rights [21][22] - Operating expenses increased to $67.6 million from $44 million in the prior year, driven by higher clinical trial costs [22] - Net loss for the quarter was $59.4 million, or $0.85 per share, compared to a net loss of $30.8 million, or $0.58 per share, in the prior year [22] Business Line Data and Key Metrics Changes - The company has transitioned from specialty pharma to a clinical-stage biopharmaceutical company, focusing on the development of Duravu for wet AMD and DME [7][8] - Enrollment for the Phase III trials (Lugano and Lucia) was completed ahead of schedule, with over 800 patients enrolled [8][15] Market Data and Key Metrics Changes - The wet AMD market is valued at $10 billion and is currently dominated by anti-VEGF biologics [9][10] - Duravu aims to address the need for improved durability in treatment, with a proposed six-month dosing interval compared to the average two-month interval for current treatments [14][10] Company Strategy and Development Direction - The company is focused on advancing Duravu as a new treatment paradigm in retinal diseases, with plans for an NDA filing anticipated following positive Phase III data [18][24] - A state-of-the-art cGMP manufacturing facility has been established to support commercial production of Duravu [8][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming top-line data for the Phase III trials, expected in mid-2026, and emphasized the importance of a differentiated product profile for Duravu [16][24] - The company is well-capitalized, with cash and investments totaling $256 million, expected to support operations into 2027 [20][22] Other Important Information - The company has eliminated debt and extended its cash runway, positioning itself favorably for future developments [8][20] - Positive feedback from the retina community was noted, highlighting excitement for the potential of Duravu [88] Q&A Session Summary Question: Can you speak to the overall trial conduct of the pivotal studies in wet AMD? - The company has a strong phase III study experience and is focused on ensuring protocol adherence and patient safety during the trial conduct [28][30] Question: What are the expectations regarding the cadence of safety updates? - Periodic updates on safety will be provided, although a specific cadence has not been established yet [39] Question: Can you elaborate on the rescue criteria for the trials? - The rescue criteria are designed to ensure that only patients who truly need additional treatment are rescued, based on specific clinical indicators [42][44] Question: What is the baseline division between naive and previously treated patients? - The target was a 75-25% ratio of naive to previously treated patients, which was successfully achieved [50] Question: What feedback has been received from the physician community regarding the ASRS? - Positive feedback was received, with physicians expressing excitement about the potential of Duravu and its new mechanism of action [88] Question: Will there be another data safety monitoring committee meeting before the first data readout? - Yes, there will be at least two data safety monitoring committee meetings before the top-line results [99]

Summary of EyePoint Pharmaceuticals (EYPT) FY Conference Call - June 10, 2025 Company Overview - EyePoint Pharmaceuticals is a publicly traded company specializing in sustained release drug delivery for retinal diseases, with its lead asset being Duravu, a small molecule tyrosine kinase receptor inhibitor, which is patent protected [2][4]. Key Developments - EyePoint is currently conducting two pivotal Phase III trials for wet age-related macular degeneration (AMD): the Lugano trial, which is fully enrolled with over 400 patients, and the LUCIA trial, which is expected to be fully enrolled by Q3 2025 [3][23]. - The company has a strong cash position of $318 million, providing a runway into 2027, which is approximately one year post data from the Phase III trials [4]. Product Pipeline - Duravu is being tested for diabetic macular edema (DME) and has shown positive efficacy and safety data in the Phase II VORONA trial [4][28]. - EyePoint is advancing EYP2301, a small molecule TIE II agonist, for serious retinal diseases [5]. Market Opportunity - The current market for DME is approximately $3 billion, with a significant percentage of patients experiencing delayed or missed visits, leading to visual loss [8]. - There is a growing need for durable treatments in both wet AMD and DME due to the aging population and the burden of frequent intravitreal injections [6][7]. Clinical Trial Insights - The DuraVu delivery system offers continuous dosing with zero-order kinetics, allowing for a sustained release of the drug for a minimum of six months [10][13]. - The Phase II trial results for wet AMD showed that the two and three milligram doses of Duravu had similar visual acuity outcomes compared to EYLEA, with a significant reduction in treatment burden of about 80% [18][19]. - In the VORONA trial for DME, the high dose of Duravu demonstrated early improvement in visual acuity and anatomy, achieving a primary endpoint of extended time to rescue compared to aflibercept [28][44]. Regulatory and Manufacturing Updates - EyePoint has received approval from both the FDA and EMA for its trial protocols, indicating a strong regulatory position [23]. - The company has established a new manufacturing facility in Northbridge, Massachusetts, capable of producing over a million inserts annually, which is crucial for supporting future commercial activities [46][47]. Safety and Efficacy - The safety profile of Duravu has been favorable, with no serious adverse events reported in the trials conducted to date [15][28]. - The drug's formulation avoids problematic components like PEG and PLGA, which have been associated with adverse effects in sensitive patients [14]. Future Outlook - EyePoint plans to start pivotal trials for DME in 2026 and aims to submit a New Drug Application (NDA) for Duravu at the end of one year from the start of the Phase III trials [45][48]. - The company is optimistic about the upcoming trial results and their potential impact on the treatment landscape for retinal diseases [48].