EyePoint Pharmaceuticals (EYPT) 2025 Conference September 03, 2025 02:45 PM ET Speaker0Thanks for joining our fireside chat with EyePoint Pharmaceuticals. I'm Jennifer Kim, one of the biotech analysts here at Cantor, and I'm excited to have with us George Elston, CFO. George, it's always good to have you. Thanks for being here.Speaker1Thank you, Jennifer, and thanks to Cantor for having EyePoint here today. Excited to talk to you.Speaker0Always. So a lot of exciting things happening at EyePoint right now. M ...

Question-and-Answer SessionSo obviously, a very busy time for the company. and for the wet AMD space. So I think just to start out, why don't you -- Jay, if you could spend just a few minutes just introducing the company, the therapy you're advancing, the key trials, obviously, in Phase III trials in wet AMD, and then we can get into a lot more detail from there.Jay DukerPresident, CEO & Director Sure. Thank you, and thanks, everybody, for coming. EyePoint does drug delivery to the back of the eye. We've ha ...

Summary of EyePoint Pharmaceuticals (EYPT) Conference Call - September 02, 2025 Company Overview - EyePoint Pharmaceuticals specializes in drug delivery systems for ocular diseases, particularly focusing on wet age-related macular degeneration (AMD) [2][3] - The company has developed a fully bioerodable insert containing Verolanib, a small molecule tyrosine kinase inhibitor targeting all VEGF receptors [2] Key Trials and Market Potential - EyePoint is currently conducting two identical Phase 3 trials for wet AMD, with a market size of approximately $10 billion annually in the U.S. [2][3] - Both trials have been fully enrolled, achieving the fastest enrollment rates on record for wet AMD trials, approximately seven months [3][4] - The primary endpoint of the trials is non-inferiority in visual acuity compared to aflibercept (Eylea) [2][20] Enrollment and Trial Design - The company attributes the rapid enrollment to strong Phase 2 data and effective trial design, including a patient-centric approach [3][12] - The trials include rescue criteria for patients losing vision, allowing supplemental injections to prevent long-term vision loss [12][16] Expected Outcomes and Safety - The non-inferiority margin is set at -4.5 letters, with previous Phase 2 data showing a lower limit of around 2.6 letters [21] - Over 190 patients have been treated with no ocular or systemic serious adverse events (SAEs) attributed to the drug or insert [22] - The Data Safety Monitoring Committee has recommended no changes to the trial protocols, indicating no unexpected safety issues [22] Treatment Burden and Commercial Success - A significant reduction in treatment burden is expected, with Phase 2 data indicating an 80% reduction compared to Eylea [22][23] - The company aims for at least a 50% reduction in treatment burden to achieve commercial success [23] Integration into Clinical Practice - The expected administration interval for the new treatment is six months, with potential for some patients to go a full year without additional injections [25][26] - The treatment strategy will likely involve a combination of existing anti-VEGF therapies and the new insert, allowing for individualized patient care [28][49] Manufacturing and Supply Capacity - EyePoint's manufacturing facility in Northbridge, Massachusetts, is capable of producing nearly one million inserts annually, sufficient to meet global demand [41][42] - The facility is being prepared for FDA inspection and potential commercial launch [42] Competitive Positioning - EyePoint believes it is positioned to be the first to file for approval among competitors developing long-acting inserts for wet AMD, with a potential launch by the end of 2027 [34][35] Future Developments - The company plans to initiate pivotal trials for diabetic macular edema (DME) in 2026, following successful Phase 2 results [57][58] - EyePoint is also exploring opportunities in other retinal diseases, although financial considerations have led to the discontinuation of some programs [66] Upcoming Catalysts - Key upcoming events include presentations at eye meetings and updates on safety and demographic data from the Phase 3 trials [68][69] - The company plans to release data from the two Phase 3 trials separately to maximize impact [70] Conclusion - EyePoint Pharmaceuticals is on track to potentially revolutionize the treatment of wet AMD with its innovative drug delivery system, backed by strong trial data and a robust manufacturing strategy [2][34][42]

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]

PART I. FINANCIAL INFORMATION [Item 1. Unaudited Financial Statements](index=3&type=section&id=Item%201%2E%20Unaudited%20Financial%20Statements) [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's financial position as of June 30, 2025, shows a decrease in total assets and stockholders' equity compared to December 31, 2024, primarily driven by a reduction in cash, cash equivalents, and marketable securities | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | 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 | | Total current liabilities | $33,175 | $49,048 | | Total liabilities | $55,138 | $81,964 | | Total stockholders' equity | $246,009 | $336,501 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three and six months ended June 30, 2025, the company reported increased net losses, primarily due to a significant rise in research and development expenses for DURAVYU™ Phase 3 clinical trials, despite fluctuations in revenue streams | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (%) | | :-------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------------------------- | :--------------------------- | :--------- | | Total revenues | $5,333 | $9,477 | -44% | $29,786 | $21,161 | 41% | | Research and development | $55,498 | $29,822 | 86% | $114,072 | $60,011 | 90% | | Net loss | $(59,426) | $(30,826) | 93% | $(104,621) | $(60,110) | 74% | | Net loss per share (Basic & Diluted) | $(0.85) | $(0.58) | 47% | $(1.50) | $(1.13) | 33% | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) The company's accumulated deficit significantly increased for both the three and six months ended June 30, 2025, reflecting the net losses incurred, while common stock shares outstanding increased due to various equity activities | Metric (in thousands except shares) | Balance at April 1, 2025 | Balance at June 30, 2025 | Balance at January 1, 2025 | Balance at June 30, 2025 | | :---------------------------------- | :----------------------- | :----------------------- | :----------------------- | :----------------------- | | Net loss (3 months) | $(59,426) | N/A | N/A | N/A | | Net loss (6 months) | N/A | N/A | $(104,621) | N/A | | Stock-based compensation (3 months) | $6,876 | N/A | N/A | N/A | | Stock-based compensation (6 months) | N/A | N/A | N/A | $14,696 | | Common stock shares outstanding | 68,811,357 (Apr 1, 2025) | 68,889,649 (Jun 30, 2025) | 68,266,005 (Jan 1, 2025) | 68,889,649 (Jun 30, 2025) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, the company experienced a significant increase in cash used in operating activities, partially offset by cash provided by investing activities, primarily from sales and maturities of marketable securities | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash (used in) operating activities | $(115,709) | $(51,349) | | Net cash (used in) provided by investing activities | $87,861 | $(139,589) | | Net cash (used in) provided by financing activities | $(713) | $444 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(28,561) | $(190,494) | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [1. Operations](index=8&type=section&id=1%2E%20Operations) EyePoint Pharmaceuticals is focused on developing innovative therapeutics for retinal diseases, with its lead product candidate DURAVYU™ in Phase 3 clinical trials for wet AMD and advancing towards a Phase 3 program for DME. The company had $255.7 million in cash, cash equivalents, and marketable securities as of June 30, 2025, and expects this to fund operations for at least the next twelve months - **DURAVYU™** is in two global **Phase 3 clinical trials** (**LUGANO** and **LUCIA**) for wet AMD, with enrollment completed for LUGANO and expected completion for LUCIA in **Q3 2025**. Top-line data for both is expected in **H2 2026**[17](index=17&type=chunk)[18](index=18&type=chunk) - **DURAVYU™** completed a positive **Phase 2 clinical trial** in **DME**, meeting primary and secondary endpoints, with an anticipated **Phase 3 start in 2026**[17](index=17&type=chunk)[18](index=18&type=chunk) - The company had **$255.7 million** in cash, cash equivalents, and marketable securities at **June 30, 2025**, which is expected to fund operations for **at least the next twelve months**[19](index=19&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2%2E%20Summary%20of%20Significant%20Accounting%20Policies) The company's significant accounting policies remain unchanged since December 31, 2024. It is currently evaluating the impact of new FASB ASUs 2023-09 (Income Taxes) and 2024-03 (Expense Disaggregation Disclosures), effective for fiscal years beginning after December 15, 2024, and December 15, 2026, respectively - **ASU 2023-09 (Income Taxes)** effective for the Company in **Q1 2025**, impact on disclosures being evaluated[22](index=22&type=chunk) - **ASU 2024-03 (Expense Disaggregation Disclosures)** effective for fiscal years beginning after **December 15, 2026**, impact on disclosures being evaluated[23](index=23&type=chunk) [3. Revenue](index=10&type=section&id=3%2E%20Revenue) Total revenues for the three months ended June 30, 2025, decreased by 44% YoY, primarily due to no product sales and a decrease in license and collaboration revenue. However, for the six months ended June 30, 2025, total revenues increased by 41% YoY, driven by a significant increase in royalty income due to the recognition of deferred SWK royalty revenue | Revenue Type (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (%) | | :-------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------------------------- | :--------------------------- | :--------- | | Product sales, net | $0 | $1,068 | -100% | $715 | $1,726 | -59% | | License and collaboration agreements | $5,333 | $7,782 | -31% | $16,382 | $18,345 | -11% | | Royalty income | $0 | $627 | -100% | $12,689 | $1,090 | 1064% | | Total revenues | $5,333 | $9,477 | -44% | $29,786 | $21,161 | 41% | - The Commercial Supply Agreement (CSA) with ANI **terminated on May 31, 2025**. **Royalty payments from ANI to the Company will begin in 2025** based on U.S. annual net sales exceeding certain thresholds[28](index=28&type=chunk)[27](index=27&type=chunk) - Royalty income for the six months ended June 30, 2025, included the recognition of the remaining **$12.7 million** of **deferred SWK royalty revenue** due to the **termination of the SWK royalty purchase agreement on March 18, 2025**[95](index=95&type=chunk) [4. Prepaid Expenses and Other Current Assets](index=12&type=section&id=4%2E%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid expenses and other current assets decreased from $9.481 million at December 31, 2024, to $6.215 million at June 30, 2025, primarily due to a reduction in prepaid clinical expenses | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Prepaid expenses | $2,860 | $2,339 | | Prepaid clinical expenses | $1,783 | $5,737 | | Other | $1,572 | $1,405 | | Total | $6,215 | $9,481 | [5. Inventory](index=13&type=section&id=5%2E%20Inventory) Total inventory increased from $2.305 million at December 31, 2024, to $2.678 million at June 30, 2025, driven by an increase in work in process | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Raw materials | $1,676 | $1,657 | | Work in process | $1,002 | $648 | | Total inventory | $2,678 | $2,305 | [6. Accrued Expenses](index=13&type=section&id=6%2E%20Accrued%20Expenses) Accrued expenses decreased from $18.103 million at December 31, 2024, to $11.478 million at June 30, 2025, mainly due to lower personnel and clinical trial costs | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Personnel costs | $7,747 | $11,830 | | Clinical trial costs | $1,663 | $4,541 | | Professional and legal fees | $1,236 | $840 | | Sales chargebacks, rebates and other revenue reserves | $79 | $147 | | Other | $753 | $745 | | Total accrued expenses | $11,478 | $18,103 | [7. Leases](index=13&type=section&id=7%2E%20Leases) The company amended its headquarters lease to extend the term and recognized a $0.9 million increase in lease liabilities and ROU assets. The Northbridge manufacturing facility lease, with a 15-year term, commenced in Q2 2024, adding $17.7 million to lease liabilities. Total operating lease liabilities were $23.7 million at June 30, 2025 - Headquarters lease amended, extending term to **May 31, 2028**, resulting in a **$0.9 million increase** in lease liabilities and ROU assets[39](index=39&type=chunk) - Northbridge manufacturing facility lease (41,141 sq ft, **15-year term**) commenced in **Q2 2024**, adding **$17.7 million to lease liabilities** and **$17.9 million to ROU assets**[40](index=40&type=chunk) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total operating lease liabilities | $23,715 | $23,105 | | Total lease expense (6 months) | $2,235 | $1,074 | [8. Stockholders' Equity](index=14&type=section&id=8%2E%20Stockholders%27%20Equity) The company did not sell any shares under its ATM facility during Q2 2025 or Q2 2024. As of June 30, 2025, 1,090,909 Pre-Funded Warrants (PFWs) were outstanding. The 2023 Long-Term Incentive Plan was amended to increase authorized shares by 2,900,000 to a total of 10,400,000 shares - **No shares sold** under the ATM Facility during the three and six months ended June 30, 2025 and 2024[46](index=46&type=chunk) - **1,090,909 Pre-Funded Warrants (PFWs)** were outstanding as of **June 30, 2025**[48](index=48&type=chunk) - The 2023 Long-Term Incentive Plan was amended to **increased authorized shares by 2,900,000 to 10,400,000 shares**, with **4,743,299 shares available** for new awards at June 30, 2025[49](index=49&type=chunk) [9. Share-Based Payment Awards](index=15&type=section&id=9%2E%20Share-Based%20Payment%20Awards) Stock-based compensation expense for the six months ended June 30, 2025, was $14.7 million, a decrease from $21.4 million in the prior year. As of June 30, 2025, there was $28.7 million of unrecognized compensation expense related to outstanding equity awards | Metric (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Stock options granted | 2,366,135 shares | N/A | | RSUs granted | 822,208 units | N/A | | ESPP shares issued | 55,283 shares | N/A | | Total stock-based compensation expense | $14,696 | $21,394 | - Unrecognized compensation expense related to outstanding equity awards was approximately **$28.7 million** at **June 30, 2025**, expected to be recognized over **1.61 years**[57](index=57&type=chunk) [10. Fair Value Measurements](index=17&type=section&id=10%2E%20Fair%20Value%20Measurements) The company's cash equivalents and marketable securities, totaling $245.6 million at June 30, 2025, are classified within Level 1 (money market funds) or Level 2 (commercial paper, U.S. Treasury/Agency securities) based on valuation hierarchy | Asset Type (in thousands) | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :------------------------ | :----------------------- | :--------------------------- | | Money market funds (Level 1) | $60,973 | $95,859 | | Commercial paper (Level 2) | $49,378 | $94,842 | | U.S. Treasury securities (Level 2) | $115,364 | $114,711 | | U.S. Agency securities (Level 2) | $19,848 | $61,656 | | Total | $245,563 | $367,068 | [11. Segment Information](index=19&type=section&id=11%2E%20Segment%20Information) EyePoint Pharmaceuticals operates as a single business segment focused on developing and commercializing ophthalmic products. For the six months ended June 30, 2025, total revenues were $29.8 million, and the net loss was $104.6 million, with DURAVYU™ direct R&D expense being a significant component | Metric (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $29,786 | $21,161 | | DURAVYU™ direct research and development expense | $(79,247) | $(30,086) | | Net loss | $(104,621) | $(60,110) | [12. Contingencies](index=19&type=section&id=12%2E%20Contingencies) The company is involved in routine legal proceedings and is cooperating with a U.S. Department of Justice subpoena received in August 2022 regarding sales, marketing, and promotional practices related to DEXYCU®. The outcome and financial impact of this matter are currently unpredictable - Received a **subpoena from the U.S. Attorney's Office** in **August 2022** related to sales, marketing, and promotional practices for **DEXYCU®**[65](index=65&type=chunk) - The company is cooperating fully, but the duration, scope, or outcome, and potential material impact on financial condition, results of operations, or cash flow, are **currently unpredictable**[65](index=65&type=chunk) [13. Net Loss per Share](index=20&type=section&id=13%2E%20Net%20Loss%20per%20Share) For the six months ended June 30, 2025, the basic and diluted net loss per share was $(1.50). Common stock equivalents totaling 11,055,774 shares were excluded from the diluted EPS calculation as their effect would have been anti-dilutive | Common Stock Equivalents Excluded | As of June 30, 2025 | As of June 30, 2024 | | :-------------------------------- | :------------------ | :------------------ | | Stock options | 9,475,631 | 7,426,691 | | ESPP | 57,876 | 9,102 | | Restricted stock units | 1,522,267 | 1,378,823 | | Total | 11,055,774 | 8,814,616 | [14. Related Party Transactions](index=20&type=section&id=14%2E%20Related%20Party%20Transactions) The company recorded $0.6 million in research and development expense for the six months ended June 30, 2025, related to preclinical and analytical services provided by Altasciences, a company where a current board member also serves - Recorded **$0.6 million in R&D expense** with **Altasciences** for the **six months ended June 30, 2025**[68](index=68&type=chunk) - **Nancy S. Lurker**, a current Vice Chair of the Board, is also a board member of **Altasciences' parent company**[68](index=68&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202%2E%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) [Note Regarding Forward-Looking Statements](index=21&type=section&id=Note%20Regarding%20Forward-Looking%20Statements) This section outlines the company's forward-looking statements, which involve risks and uncertainties, and advises readers that actual results may differ materially due to various factors, including clinical trial outcomes, regulatory approvals, and financial resources - Forward-looking statements include expectations for **DURAVYU™'s potential**, **timing of clinical trials**, regulatory interactions, and **funding needs**[71](index=71&type=chunk) - Risks include uncertainties in **clinical development**, **regulatory approval**, **sufficiency of cash resources**, and **intellectual property protection**[75](index=75&type=chunk) [Our Business](index=23&type=section&id=Our%20Business) [Overview](index=23&type=section&id=Overview) EyePoint Pharmaceuticals is dedicated to developing innovative treatments for serious retinal diseases, utilizing its Durasert E™ technology. Its lead candidate, DURAVYU™, is in Phase 3 trials for wet AMD and has completed Phase 2 for DME, with other pipeline programs like EYP-2301 also in development - **DURAVYU™** is in two global **Phase 3 clinical trials** (LUGANO and LUCIA) for **wet AMD**[76](index=76&type=chunk) - **DURAVYU™** completed a positive **Phase 2 clinical trial** for **diabetic macular edema (DME)**[76](index=76&type=chunk) - Additional pipeline programs include **EYPT-2301**, a promising **TIE-2 agonist**[76](index=76&type=chunk) [Recent Developments](index=23&type=section&id=Recent%20Developments) Enrollment for the pivotal Phase 3 LUCIA clinical trial evaluating DURAVYU™ was completed on July 29, 2025 - **Enrollment completed** in pivotal **Phase 3 LUCIA clinical trial** for **DURAVYU™** on **July 29, 2025**[78](index=78&type=chunk) [R&D Highlights](index=23&type=section&id=R%26D%20Highlights) Enrollment for the pivotal Phase 3 LUGANO clinical trial evaluating DURAVYU™ was completed on May 27, 2025 - **Enrollment completed** in pivotal **Phase 3 LUGANO clinical trial** for **DURAVYU™** on **May 27, 2025**[79](index=79&type=chunk) [Critical Accounting Policies and Estimates](index=23&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies and estimates, including revenue recognition and clinical trial expense recognition, remain consistent with those disclosed in the 2024 Form 10-K, with no material changes noted in this report [Results of Operations](index=24&type=section&id=Results%20of%20Operations) [Three months ended June 30, 2025 Compared to Three months ended June 30, 2024](index=24&type=section&id=Three%20months%20ended%20June%2030%2C%202025%20Compared%20to%20Three%20months%20ended%20June%2030%2C%202024) Total revenues decreased by 44% to $5.3 million, primarily due to no product sales and lower license revenue. Operating expenses increased by 53% to $67.6 million, driven by an 86% surge in R&D costs for DURAVYU™ Phase 3 trials, leading to a 93% increase in net loss to $59.4 million | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (Amount) | Change (%) | | :-------------------------- | :--------------------------- | :--------------------------- | :-------------- | :--------- | | Total revenues | $5,333 | $9,477 | $(4,144) | -44% | | Product sales, net | $0 | $1,068 | $(1,068) | -100% | | License and collaboration agreements | $5,333 | $7,782 | $(2,449) | -31% | | Royalty income | $0 | $627 | $(627) | -100% | | Research and development | $55,498 | $29,822 | $25,676 | 86% | | Net loss | $(59,426) | $(30,826) | $(28,600) | 93% | [Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024](index=26&type=section&id=Six%20Months%20Ended%20June%2030%2C%202025%20Compared%20to%20Six%20Months%20Ended%20June%2030%2C%202024) Total revenues increased by 41% to $29.8 million, largely due to a 1064% increase in royalty income from deferred revenue recognition. Operating expenses rose by 58% to $140.9 million, primarily from a 90% increase in R&D for DURAVYU™ Phase 3 trials, resulting in a 74% higher net loss of $104.6 million | Metric (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (Amount) | Change (%) | | :-------------------------- | :--------------------------- | :--------------------------- | :-------------- | :--------- | | Total revenues | $29,786 | $21,161 | $8,625 | 41% | | Product sales, net | $715 | $1,726 | $(1,011) | -59% | | License and collaboration agreements | $16,382 | $18,345 | $(1,963) | -11% | | Royalty income | $12,689 | $1,090 | $11,599 | 1064% | | Research and development | $114,072 | $60,011 | $54,061 | 90% | | Net loss | $(104,621) | $(60,110) | $(44,511) | 74% | [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) The company had $255.7 million in cash, cash equivalents, and marketable securities at June 30, 2025, which is projected to fund operations into 2027. Operating cash outflows significantly increased to $115.7 million for the six months ended June 30, 2025, primarily due to net loss and changes in deferred revenue - Cash, cash equivalents, and marketable securities totaled **$255.7 million** at **June 30, 2025**, expected to **fund operations into 2027**, beyond the topline data expected in 2026[19](index=19&type=chunk)[103](index=103&type=chunk) - **Net cash used in operating activities** for the six months ended June 30, 2025, was **$115.7 million**, an **increase of $64.4 million** compared to the prior year[107](index=107&type=chunk) - **Net cash provided by investing activities** for the six months ended June 30, 2025, was **$87.9 million**, primarily from **sales of marketable securities**[109](index=109&type=chunk) - Future capital requirements are influenced by **clinical trial progress**, **R&D programs**, and **potential strategic acquisitions**[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=30&type=section&id=Item%203%2E%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, EyePoint Pharmaceuticals is not required to provide quantitative and qualitative disclosures about market risk [Item 4. Controls and Procedures](index=30&type=section&id=Item%204%2E%20Controls%20and%20Procedures) [Evaluation of Disclosure Controls and Procedures](index=30&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025 - Disclosure controls and procedures were evaluated and deemed **effective at the reasonable assurance level** as of **June 30, 2025**[113](index=113&type=chunk) [Changes in Internal Control over Financial Reporting](index=30&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) There were no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2025 - **No material changes** in **internal control over financial reporting** during the **quarter ended June 30, 2025**[114](index=114&type=chunk) PART II: OTHER INFORMATION [Item 1. Legal Proceedings](index=31&type=section&id=Item%201%2E%20Legal%20Proceedings) The company is subject to routine legal proceedings and an ongoing U.S. Department of Justice subpoena concerning sales and marketing practices for DEXYCU®. The outcome and financial impact of the subpoena remain uncertain - **Ongoing U.S. Department of Justice subpoena** regarding sales, marketing, and promotional practices for **DEXYCU®**[117](index=117&type=chunk) - Outcome and financial impact of the subpoena are **currently unpredictable**[117](index=117&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A%2E%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202%2E%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203%2E%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204%2E%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures [Item 5. Other Information](index=31&type=section&id=Item%205%2E%20Other%20Information) Nancy S. Lurker, a director, adopted a Rule 10b5-1 trading arrangement on June 16, 2025, for the sale of 83,351 shares of common stock, effective until June 16, 2026 - **Nancy S. Lurker**, Director, adopted a **Rule 10b5-1 trading arrangement** on **June 16, 2025**, to sell **83,351 shares of common stock**[122](index=122&type=chunk) - The plan's duration is until **June 16, 2026**[122](index=122&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206%2E%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including various corporate documents, equity plans, and certifications SIGNATURES [SIGNATURES](index=33&type=section&id=SIGNATURES) The report was signed by Jay S. Duker, M.D., President and Chief Executive Officer, and George O. Elston, Executive Vice President and Chief Financial Officer, on August 7, 2025

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) |

WATERTOWN, Mass., July 30, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, August 6, 2025 to report its second quarter 2025 financial results and highlight recent corporate developments. To access the live conference call, please register using the aud ...

– 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 ...