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]

Core Insights - EyePoint Pharmaceuticals, Inc. is focused on developing innovative therapeutics for serious retinal diseases, with a commitment to improving patient lives [3][4] - The company will participate in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference on August 13, 2025 [1] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company with a lead product candidate, DURAVYU, which is a sustained delivery treatment for VEGF-mediated retinal diseases [3] - DURAVYU combines vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E technology [3] - The company is currently evaluating DURAVYU in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with topline data expected in 2026 [3] - DURAVYU has also completed a positive Phase 2 clinical trial in diabetic macular edema (DME), with Phase 3 planning underway [3] - Despite existing therapies, patients with wet AMD and DME continue to experience long-term vision loss, with wet AMD being the leading cause of vision loss in individuals aged 50 and older in the U.S. [3] Product and Development - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of specific regions in Asia [5] - DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901, although it has not yet received FDA approval [5]

[Executive Summary & Recent Developments](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Developments) EyePoint Pharmaceuticals reported Q2 2025 results, emphasizing rapid DURAVYU Phase 3 enrollment, manufacturing, and a strong cash runway into 2027 [Q2 2025 Highlights and Corporate Developments](index=1&type=section&id=Q2%202025%20Highlights%20and%20Corporate%20Developments) EyePoint Pharmaceuticals announced its second quarter 2025 financial results and highlighted significant corporate advancements, including rapid Phase 3 enrollment for DURAVYU, initiation of commercial manufacturing, and a strong cash position into 2027 - Completed enrollment in both pivotal Phase 3 trials, LUGANO and LUCIA, for DURAVYU in wet AMD in record time, with over **800 patients enrolled and randomized**[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - Topline LUGANO data is anticipated in mid-2026, with LUCIA data to closely follow in the second half of 2026[3](index=3&type=chunk)[6](index=6&type=chunk) - Initiated DURAVYU registration batches at the Northbridge, MA commercial manufacturing facility, which is now operational and built to meet FDA and EMA standards[2](index=2&type=chunk)[3](index=3&type=chunk)[7](index=7&type=chunk) - Cash, cash equivalents, and marketable securities totaled **$256 million** as of June 30, 2025, providing a cash runway into 2027, extending beyond topline data for both Phase 3 wet AMD trials[2](index=2&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) [Research & Development Updates](index=1&type=section&id=R%26D%20Highlights%20and%20Updates) EyePoint completed Phase 3 enrollment for DURAVYU in wet AMD and advanced its DME program with positive Phase 2 results and FDA discussions [DURAVYU™ Wet AMD Program](index=1&type=section&id=DURAVYU%E2%84%A2%20Wet%20AMD%20Program) EyePoint completed Phase 3 enrollment for DURAVYU in wet AMD, with the LUGANO and LUCIA trials demonstrating unprecedented recruitment rates, consistent interim safety data, and EMA approval of Phase 3 protocols - LUGANO and LUCIA trials each rapidly enrolled in seven months, exceeding observed recruitment rates of comparable historical and ongoing wet AMD clinical trials, underscoring strong physician and patient interest[5](index=5&type=chunk)[6](index=6&type=chunk) - The oversubscribed LUGANO trial randomized **432 patients** in the U.S. with topline data anticipated in mid-2026. LUCIA randomized over **400 patients** in the U.S. and ex-U.S. sites, with topline data anticipated in the second half of 2026[6](index=6&type=chunk) - Interim masked safety data for LUGANO and LUCIA is consistent with previous DURAVYU clinical trials, and an independent Data Safety Monitoring Committee (DSMC) recommended continuation of the program as planned[10](index=10&type=chunk) - Received approval of the Phase 3 protocols for the LUGANO and LUCIA trials by the European Medicines Agency (EMA)[10](index=10&type=chunk) [DURAVYU™ DME Program](index=2&type=section&id=DURAVYU%E2%84%A2%20DME%20Program) The company completed a positive End-of-Phase 2 meeting with the FDA for DURAVYU in Diabetic Macular Edema (DME) and presented promising 24-week topline results from the Phase 2 VERONA study - Completed a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss pivotal Phase 3 clinical trial plans for DURAVYU in DME, with details on the DME pivotal plan to be shared in the second half of 2025[10](index=10&type=chunk) - Presented 24-week topline results from the Phase 2 VERONA study in DME at the Retina World Congress, highlighting DURAVYU's potential to transform the treatment landscape with its best-in-class safety and efficacy profile[10](index=10&type=chunk) - Accepted to present the Phase 2 VERONA 24-week end-of-study results in DME at the Retina Society Annual Meeting in September, underscoring broad treatment potential[10](index=10&type=chunk) [Manufacturing and Operations](index=2&type=section&id=Manufacturing%20and%20Operations) EyePoint initiated commercial manufacturing for DURAVYU at its Northbridge facility, built to FDA and EMA standards to meet anticipated demand [DURAVYU™ Commercial Manufacturing](index=2&type=section&id=DURAVYU%E2%84%A2%20Commercial%20Manufacturing) EyePoint has initiated DURAVYU registration batches at its state-of-the-art, 41,000-square-foot commercial manufacturing facility in Northbridge, Massachusetts, built to meet FDA and EMA standards and support significant anticipated demand - Initiated DURAVYU registration batches in support of a potential NDA filing at EyePoint's commercial manufacturing facility in Northbridge, Massachusetts[7](index=7&type=chunk) - The **41,000-square-foot** facility was built to meet both FDA and EMA standards and will have capacity to support the anticipated significant demand for DURAVYU, if approved[7](index=7&type=chunk) [Financial Performance](index=2&type=section&id=Review%20of%20Results%20for%20the%20Second%20Quarter%20Ended%20June%2030%2C%202025) EyePoint reported a Q2 2025 net revenue of **$5.3 million** and a net loss of **$59.4 million**, projecting a cash runway into 2027 [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) EyePoint reported a total net revenue of **$5.3 million** for Q2 2025, a decrease from **$9.5 million** in Q2 2024, primarily due to lower recognition of deferred revenue, with operating expenses significantly increasing to **$67.6 million**, resulting in a net loss of **$59.4 million**, or **($0.85)** per share Q2 Financial Performance (in thousands) | Financial Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :----------------- | :------------------------------- | :------------------------------- | :----------- | | Total Net Revenue | $5,333 | $9,477 | -43.8% | | License & Royalties| $5,333 | $8,409 | -36.6% | | Operating Expenses | $67,560 | $44,023 | +53.5% | | Net Loss | $(59,426) | $(30,826) | +92.8% | | Net Loss per Share | $(0.85) | $(0.58) | +46.6% | - The decrease in license and royalties revenue was primarily driven by lower recognition of deferred revenue related to the Company's 2023 agreement for the license of YUTIQ® product rights[9](index=9&type=chunk) - The increase in operating expenses was primarily driven by an increase in clinical trial costs related to ongoing DURAVYU™ Phase 3 clinical trials (LUGANO and LUCIA) for wet AMD[10](index=10&type=chunk)[11](index=11&type=chunk) Cash, Cash Equivalents, and Marketable Securities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $71,143 | $99,704 | | Marketable securities | $184,590 | $271,209 | | **Total Cash, Cash Equivalents, and Marketable Securities** | **$255,733** | **$370,913** | [Financial Outlook](index=3&type=section&id=Financial%20Outlook) EyePoint projects that its current cash, cash equivalents, and marketable securities will be sufficient to fund operations into 2027, extending beyond the anticipated topline Phase 3 data for DURAVYU in wet AMD - EyePoint expects its cash, cash equivalents, and marketable securities as of June 30, 2025, totaling **$256 million**, will enable the Company to fund operations into 2027, beyond topline Phase 3 data for DURAVYU in wet AMD expected in 2026[2](index=2&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) [Company Information](index=3&type=section&id=About%20EyePoint) EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases, with DURAVYU™ as its lead candidate [About EyePoint Pharmaceuticals](index=3&type=section&id=About%20EyePoint%20Pharmaceuticals) EyePoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics for serious retinal diseases, with DURAVYU™ as its lead investigational sustained delivery treatment - EyePoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases[14](index=14&type=chunk) - DURAVYU™ is an innovative investigational sustained delivery treatment for VEGF-mediated retinal diseases, combining vorolanib (a selective and patent-protected tyrosine kinase inhibitor) in next-generation bioerodible Durasert E™ technology[14](index=14&type=chunk) - DURAVYU is currently being evaluated in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) with topline data anticipated in 2026, and has completed a positive Phase 2 clinical trial in diabetic macular edema (DME) with Phase 3 pivotal planning underway[14](index=14&type=chunk) - Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan[16](index=16&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section provides a standard disclosure regarding forward-looking statements, outlining the company's expectations for clinical development, regulatory approvals, market positioning, and financial outlook, while detailing various risks and uncertainties that could cause actual results to differ materially from these projections [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) This section presents EyePoint's consolidated balance sheets and statements of operations, detailing financial position and performance for Q2 2025 [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets present EyePoint's financial position as of June 30, 2025, and December 31, 2024, showing a decrease in total assets and stockholders' equity over the six-month period Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $71,143 | $99,704 | | Marketable securities | $184,590 | $271,209 | | Total current assets | $265,251 | $383,306 | | Total assets | $301,147 | $418,465 | | **Liabilities** | | | | Total current liabilities | $33,175 | $49,048 | | Deferred revenue | $0 | $17,784 | | Total liabilities | $55,138 | $81,964 | | **Stockholders' Equity** | | | | Total stockholders' equity | $246,009 | $336,501 | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) The consolidated statements of operations detail EyePoint's revenues and expenses for the three and six months ended June 30, 2025, and 2024, indicating a significant increase in net loss primarily driven by higher research and development expenditures Consolidated Statements of Operations Highlights (in thousands) | Income Statement Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Revenues | $5,333 | $9,477 | $29,786 | $21,161 | | Research and development | $55,498 | $29,822 | $114,072 | $60,011 | | Total operating expenses | $67,560 | $44,023 | $140,850 | $89,028 | | Loss from operations | $(62,227) | $(34,546) | $(111,064) | $(67,867) | | Net loss | $(59,426) | $(30,826) | $(104,621) | $(60,110) | | Net loss per common share | $(0.85) | $(0.58) | $(1.50) | $(1.13) |

Company Overview - EyePoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3] - The company is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts [4] Product Development - EyePoint's lead product candidate, DURAVYU, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases, combining vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E technology [3] - DURAVYU is currently being evaluated in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with topline data expected in 2026 [3] - The product has also completed a positive Phase 2 clinical trial in diabetic macular edema (DME), with Phase 3 pivotal planning underway [3] - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of certain regions in Asia [5] Market Context - Wet AMD is the leading cause of vision loss among individuals aged 50 and older in the United States, indicating a significant unmet medical need [3] - Despite existing therapies, patients with wet AMD and DME continue to experience long-term vision loss [3] Corporate Communication - EyePoint Pharmaceuticals will host a conference call and live webcast on August 6, 2025, to report its second quarter 2025 financial results and highlight recent corporate developments [1]

– Interim analysis by independent Data Safety Monitoring Committee (DSMC) confirmed no changes to Phase 3 protocol and recommended continuation of trial as planned – – LUCIA pivotal Phase 3 trial enrolled and randomized over 400 patients in seven months, demonstrating continued strong enthusiasm for the DURAVYU pivotal program across the global retinal community – – Over 800 patients enrolled across the LUGANO and LUCIA trials of DURAVYU, representing one of the fastest enrolling Phase 3 pivotal programs fo ...

DURAVYU Clinical Trials and Data - DURAVYU pivotal Phase 3 trial in wet AMD, LUGANO is fully enrolled, and LUCIA is 60% enrolled and randomized[3] - VERONA Phase 2 trial in DME showed highly positive efficacy and safety data[3] - DAVIO 2 Phase 2 trial showed 89% reduction in treatment burden with 2mg DURAVYU and 85% with 3mg DURAVYU vs 6 months prior[29] - In the VERONA Phase 2 DME trial, DURAVYU 2.7mg demonstrated an early and sustained BCVA improvement of +7.1 letters and CST improvement of -76 microns[47] - In a sub-group analysis of supplement-free patients in the VERONA trial, DURAVYU 2.7mg showed a mean BCVA change from baseline of +7.3 letters and a CST change of -73.7 um[59] Market and Unmet Needs - Over 80% of Retina Specialists indicate undertreatment in wet AMD is due to patient noncompliance, scheduling limitations, or provider preference for less frequent dosing[8] - A delay in treatment of only 5.34 weeks can result in vision loss[9] - By 2030, the global branded market for DME is projected to reach $3.0 billion[11] - By 2050, diabetes-related vision loss is expected to cost $500 million annually in the US[12] Company Financials and Pipeline - EyePoint Pharmaceuticals had $318 million in cash as of March 31, 2025, providing a runway into 2027 post Phase 3 LUGANO/LUCIA data in 2026[3] - LUCIA full enrollment is anticipated in 3Q 2025[5] - LUGANO topline data is anticipated in mid-2026, with LUCIA topline data following in 2H 2026[35]

DURAVYU Program - DURAVYU, a patent-protected vorolanib product utilizing Durasert E technology, is in Phase 3 trials for wet AMD and has a program in DME supported by Phase 2 data[3] - Phase 2 VERONA trial in DME showed a 73% supplement-free rate in the 2.7mg DURAVYU arm compared to 50% in the aflibercept control group[35] - The VERONA trial's 2.7mg DURAVYU treatment demonstrated a clinically meaningful improvement in BCVA of +7.1 letters[35] - The VERONA trial's 2.7mg DURAVYU treatment demonstrated an early and sustained CST improvement of -76 microns[35] Clinical Trials and Pipeline - EyePoint is conducting two global Phase 3 non-inferiority pivotal trials (LUGANO and LUCIA) in wet AMD[3] - Enrollment completion in the EYP-2301 program for serious retinal diseases is expected in the second half of 2025[6] - LUGANO trial is ~1/3 enrolled, and LUCIA is exceeding expectations as of January 2025, with topline data for both Phase 3 pivotal trials anticipated in 2026[65, 66] Financial Status - EyePoint has a strong balance sheet with approximately $370 million in cash and equivalents as of December 31, 2024, providing a cash runway into 2027[3] Market Opportunity - The global market for DME is projected to reach $3.9 billion by 2030[25]

Core Insights - EyePoint Pharmaceuticals, Inc. has granted non-statutory stock options to new employees as inducement awards outside the 2023 Long-Term Incentive Plan, in compliance with NASDAQ Listing Rule 5635(c)(4) [1][2] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing therapeutics for serious retinal diseases [3] - The company's lead product candidate, DURAVYU™, is an investigational treatment for VEGF-mediated retinal diseases, currently in Phase 3 global clinical trials for wet age-related macular degeneration (wet AMD) and has recently completed a Phase 2 trial for diabetic macular edema (DME) [3][5] - EyePoint utilizes its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery, which has been safely administered in multiple FDA-approved products [4] Stock Option Details - The company granted stock options to purchase a total of 12,500 shares of common stock to three new employees, with an exercise price of $9.03 per share, the closing price on June 13, 2025 [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 next three years, contingent on continued service [2]

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, and has prepared detailed reports on more than 1,000 companies [1]

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].