Core Insights - EyePoint Pharmaceuticals has initiated its pivotal Phase 3 program for Duravyu (vorolanib intravitreal insert) targeting diabetic macular edema (DME), with first patient dosing expected in Q1 2026 [1] - DME is a significant cause of vision loss in diabetes patients, resulting from fluid leakage into the macula [1] Phase 3 Clinical Program Overview - The FDA has approved a pathway for DME consisting of two identical non-inferiority trials named "COMO" and "CAPRI," with redosing of Duravyu every six months [2] - Each trial will enroll around 240 patients, including both previously treated and treatment-naïve individuals, who will be randomly assigned to either a Duravyu 2.7mg arm or a 2mg aflibercept control arm [2] Primary Endpoint - The primary endpoint of the trials is the change from baseline in best-corrected visual acuity (BCVA) at weeks 52 and 56, compared to the on-label 2mg aflibercept [3] Preclinical Data - New preclinical data indicates that vorolanib inhibits IL-6 mediated inflammation by blocking all Janus Kinase (JAK) receptors, in addition to its known effect on VEGF mediated vascular permeability [4] - IL-6 is a pro-inflammatory cytokine elevated in DME and wet AMD patients, contributing to vascular leakage and inflammation [5] Funding and Financials - EyePoint Pharmaceuticals has priced a public offering of 11 million shares at $12 each, along with pre-funded warrants for an additional 1.5 million shares at $11.999 per warrant, aiming for approximately $150 million in gross proceeds [6] - The proceeds will be utilized to advance the clinical development of Duravyu for wet AMD and DME, support earlier-stage pipeline initiatives, and for general corporate purposes [6] Stock Performance - As of the latest check, EyePoint Pharmaceuticals' stock is down 1.98% at $12.90 [7]

Core Viewpoint - EyePoint Pharmaceuticals, Inc. has announced a public offering of 11 million shares at $12.00 per share, aiming to raise approximately $150 million to support its clinical development and corporate initiatives [1][2]. Group 1: Offering Details - The offering includes 11,000,000 shares of common stock priced at $12.00 each and pre-funded warrants for 1,500,000 shares at $11.999 each, with total gross proceeds expected to be around $150 million before expenses [1]. - The closing of the offering is anticipated on or about October 16, 2025, pending customary closing conditions [1]. - Underwriters have a 30-day option to purchase an additional 1,875,000 shares at the public offering price [1]. Group 2: Use of Proceeds - Net proceeds from the offering will be utilized to advance the clinical development of DURAVYU™ for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as to support earlier stage pipeline initiatives and general corporate purposes [2]. Group 3: Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on innovative therapeutics for serious retinal diseases, with its lead product candidate, DURAVYU™, currently in Phase 3 trials for wet AMD and expected to initiate trials for DME in early 2026 [6][8]. - The company has a history of developing four approved drugs over three decades, treating tens of thousands of patients [7].

WATERTOWN, Mass., Oct. 14, 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 that it has commenced an underwritten public offering of $150 million of shares of its common stock. All of the shares are being offered by EyePoint. In addition, EyePoint intends to grant the underwriters an option for a period of 30 days to purchase up ...

[Legal Disclaimers](index=2&type=section&id=Legal%20Disclaimers) [Summary of Disclaimers](index=2&type=section&id=Legal%20Disclaimers_Summary) This section outlines forward-looking statements, risks, and uncertainties inherent in the presentation, advising readers that actual results may differ materially from projections, referencing SEC filings for more detailed risk factors - The presentation contains forward-looking statements subject to risks and uncertainties, including clinical trial timing, regulatory approvals, manufacturing, and financial resources, as detailed in SEC filings (10-K, 10-Q)[5](index=5&type=chunk) [Company Overview & Pipeline](index=3&type=section&id=A%20Leader%20in%20Sustained%20Release%20Drug%20Delivery%20for%20Retinal%20Disease) [Company Highlights](index=3&type=section&id=A%20Leader%20in%20Sustained%20Release%20Drug%20Delivery%20for%20Retinal%20Disease_Highlights) EyePoint is a leader in sustained-release drug delivery for retinal diseases, with DURAVYU™ in Phase 3 for wet AMD and DME, supported by its Durasert® technology, experienced leadership, and a strong financial position - DURAVYU™ Phase 3 programs are underway for DME and wet AMD, with wet AMD data anticipated in **mid-2026**[7](index=7&type=chunk) - The company utilizes Durasert® delivery technology, which has a strong safety profile across multiple FDA-approved products[7](index=7&type=chunk) Financial Runway | Metric | Value | | :--- | :--- | | Cash & Equivalents (as of 9/30/25) | $200 million+ | | Runway | Into 2027 (beyond Phase 3 wet AMD data) | [Pipeline Programs](index=4&type=section&id=Pipeline%20Pursuing%20Large%20Market%20Opportunities) EyePoint's pipeline focuses on large market opportunities in retinal diseases, primarily with DURAVYU™ (vorolanib) in Phase 3 for wet AMD and DME, and EYP-2301 (razuprotafib) in pre-clinical development for other retinal diseases Durasert E™ Pipeline Programs | Program | Indication | Phase 1 | Phase 2 | Phase 3 | Anticipated Milestones | | :--- | :--- | :--- | :--- | :--- | :--- | | DURAVYU™ (vorolanib) | Wet AMD | | | LUGANO and LUCIA fully enrolled | LUGANO top mid-2026; LUCIA shortly after | | DURAVYU™ (vorolanib) | DME | | | Phase 3 planning underway | Phase 3 FPI | | EYP-2301 (razuprotafib) | Retinal diseases | | | | Tox and PK studies | - Current cash runway extends **into 2027**, covering significant milestones for DURAVYU in wet AMD[10](index=10&type=chunk) [Market Opportunity](index=5&type=section&id=DURAVYU%E2%84%A2%20is%20being%20evaluated%20in%20Wet%20AMD%20and%20DME) DURAVYU™ targets the two largest retinal disease markets, wet AMD and DME, which together represent **80%** of the **$12 billion+** global branded market for vascular retinal diseases - The global branded market for vascular retinal diseases is over **$12 billion**[11](index=11&type=chunk) Vascular Retinal Disease Market Share | Indication | Market Share (Billion $) | | :--- | :--- | | Wet AMD | $7 | | DME | $3 | | RVO | $2 | | NPDR | $0.3 | | **Total** | **$12.3+** | - Wet AMD and DME collectively account for **80%** of the branded market[12](index=12&type=chunk) [Durasert E™ Technology & DURAVYU Overview](index=6&type=section&id=Durasert%20E%E2%84%A2%3A%20The%20Next%20Generation%20in%20Sustained-Release%20Intravitreal%20Drug%20Delivery) [Durasert E™ Technology](index=6&type=section&id=Durasert%20E%E2%84%A2%3A%20The%20Next%20Generation%20in%20Sustained-Release%20Intravitreal%20Drug%20Delivery_Tech) Durasert E™ is a bioerodible, next-generation sustained-release intravitreal drug delivery technology with a proven safety profile, and DURAVYU, utilizing this technology, offers a novel multi-MOA, immediate therapeutic levels, and sustained drug release for six months or longer - Durasert E™ is a bioerodible technology with over **three decades** of innovation and proven safety across **four FDA-approved products**[14](index=14&type=chunk) - DURAVYU (vorolanib) offers a novel mechanism of action, inhibiting signaling from all VEGF isoforms at the receptor level[14](index=14&type=chunk) - DURAVYU achieves therapeutic levels **within hours** and provides consistent daily dosing with receptor inhibition for **≥6 months**[14](index=14&type=chunk) [DURAVYU Clinical Data Summary](index=7&type=section&id=DURAVYU%20Data%20Suggests%20Robust%20Efficacy%20Outcomes%20and%20a%20Strong%20Safety%20Profile%20Across%20Multiple%20Indications) DURAVYU has demonstrated robust efficacy and a strong safety profile across multiple indications in over **190 patients**, meeting primary endpoints in wet AMD and DME with disease control, fewer injections, and no safety signals DURAVYU Clinical Trial Results Summary | Trial | Phase | Indication | Key Outcomes | | :--- | :--- | :--- | :--- | | DAVIO | 1 | Wet AMD | Stable vision and OCT with 74% reduction in treatment burden | | DAVIO 2 | 2 | Wet AMD | Stable vision & strong anatomical control with >80% reduction in treatment burden | | PAVIA | 2 | NPDR | Prevented worsening of disease severity | | VERONA | 2 | DME | Rapid & sustained improvements in vision and anatomical control with fewer injections | - Primary endpoints were met in wet AMD & DME, showing disease control with fewer injections and a favorable safety and tolerability profile with no safety signals[17](index=17&type=chunk) [DURAVYU for Wet AMD](index=8&type=section&id=DURAVYU%20for%20Wet%20AMD) [Phase 3 Pivotal Program](index=9&type=section&id=DURAVYU%20in%20Wet%20AMD%3A%20LUGANO%20and%20LUCIA%3A%20Identical%20Phase%203%20Pivotal%20Trials%20Evaluating%20Non-inferiority%20vs%20On-label%20Aflibercept) The DURAVYU Phase 3 pivotal program for wet AMD, comprising identical LUGANO and LUCIA trials, is fully enrolled and on track, comparing DURAVYU **2.7mg q6M** against on-label aflibercept **2mg q8W**, with topline data for LUGANO expected **mid-2026** - Both LUGANO and LUCIA Phase 3 trials for wet AMD are fully enrolled, with topline **56-week data** for LUGANO expected in **mid-2026**[9](index=9&type=chunk)[22](index=22&type=chunk) - The trial design, informed by Phase 1 DAVIO and Phase 2 DAVIO 2 trials, has written alignment with the FDA, establishing a clear regulatory path[22](index=22&type=chunk) Phase 3 Wet AMD Trial Design (LUGANO & LUCIA) | Feature | Description | | :--- | :--- | | Design | Identical, non-inferiority pivotal trials | | Patients per trial | ~400 | | DURAVYU Dosing | 2.7 mg every 6 months (q6M) | | Comparator | Aflibercept 2 mg every 8 weeks (q8W) | | Primary Endpoint | Blended mean change in BCVA from baseline at Week 52 & Week 56 | | Supplemental Treatment | Anti-VEGF allowed based on strict prespecified criteria | [Commercial Manufacturing](index=11&type=section&id=Commercial%20Manufacturing%20Facility%20to%20Support%20DURAVYU%20through%20Potential%20NDA%20Approval%20and%20Commercial%20Launch) EyePoint has a **41,000 sq ft** commercial manufacturing facility in Northbridge, MA, built to FDA and EMA standards, with DURAVYU registration batches underway to support future NDA filing and commercial launch - A **41,000 sq ft** commercial manufacturing facility in Northbridge, MA, is built to US FDA and EU EMA standards[28](index=28&type=chunk) - DURAVYU registration batches are underway to support future NDA filing[28](index=28&type=chunk) [DURAVYU for DME: Market & Mechanism](index=12&type=section&id=DURAVYU%20for%20DME) [DME Market Opportunity & Unmet Needs](index=13&type=section&id=Diabetic%20Macular%20Edema%3A%20Large%20Market%20Opportunity%20with%20Significant%20Unmet%20Need%20for%20More%20Durable%20Treatments) Diabetic Macular Edema (DME) represents a large and growing market with significant unmet needs for more durable treatments and better inflammation control, as many patients still experience vision loss despite current therapies - **25%** of patients in the US with diabetes are projected to develop DME by **2030**[34](index=34&type=chunk) - The global branded market for DME is projected to reach **$10 billion** by **2030**[34](index=34&type=chunk) - There is an unmet need for effective, durable disease control and inflammation treatment in DME, as current therapies often lead to delayed/missed visits and vision loss[33](index=33&type=chunk)[37](index=37&type=chunk) [DME Pathogenesis: VEGF & Inflammation](index=15&type=section&id=DME%20is%20a%20Multifactorial%20Disease%20Driven%20by%20VEGF%20and%20Inflammation) DME is a multifactorial disease driven by both VEGF and inflammation, particularly IL-6, which plays a prominent role in its pathogenesis, and targeting both appears superior to VEGF blockage alone as IL-6 signaling via JAK kinases (especially JAK1) contributes to vascular leakage and neovascularization - DME is a multifactorial disease where VEGF suppression alone is insufficient; inflammation, particularly increased levels of IL-6, plays a key role[39](index=39&type=chunk)[41](index=41&type=chunk) - Dual inhibition of VEGF and IL-6 is critical for alleviating vascular leakage and inflammation, with IL-6 signaling occurring via activation of JAK kinases, especially JAK1[43](index=43&type=chunk)[45](index=45&type=chunk)[48](index=48&type=chunk) [Vorolanib's Multi-MOA in DME](index=17&type=section&id=DURAVYU%20for%20DME%3A%20Vorolanib%20provides%20multi-MOA%20functionality%20by%20inhibiting%20both%20VEGF%20and%20IL-6%20activation%20of%20inflammation) Vorolanib, the active ingredient in DURAVYU, provides multi-MOA functionality by inhibiting both VEGF and IL-6-mediated inflammation through its binding to JAK1 and other kinases relevant to retinal disease - Vorolanib provides multi-MOA functionality by inhibiting both VEGF and IL-6 activation of inflammation[49](index=49&type=chunk) - Vorolanib binds JAK1, inhibiting IL-6 activity in vitro, and targets multiple kinases of interest in retinal disease, including JAKs, TIE, PDGFR, FLT3, Kit, VEGFRs, and FGFR[50](index=50&type=chunk) [DURAVYU for DME: Clinical Data](index=18&type=section&id=DURAVYU%20in%20DME%3A%20Single%20DURAVYU%202.7mg%20Treatment%20Demonstrated%20Meaningful%20Vision%20and%20Anatomical%20Improvement%20as%20Early%20as%20Week%204) [Phase 2 VERONA Efficacy](index=18&type=section&id=DURAVYU%20in%20DME%3A%20Single%20DURAVYU%202.7mg%20Treatment%20Demonstrated%20Meaningful%20Vision%20and%20Anatomical%20Improvement%20as%20Early%20as%20Week%204_Efficacy) In the Phase 2 VERONA trial, a single **2.7mg** DURAVYU treatment demonstrated meaningful and rapid improvements in vision (BCVA) and anatomical control (CST) as early as **Week 4**, with sustained effects up to **Week 24**, outperforming aflibercept in both metrics VERONA Trial: BCVA Change from Baseline (Week 24) | Treatment | Mean Change in ETDRS Letters | | :--- | :--- | | DURAVYU 2.7mg (n=10, ex-outlier) | +10.1 | | Aflibercept 2mg (n=6) | +7.1 | VERONA Trial: CST Change from Baseline (Week 24) | Treatment | Mean Change in Microns | | :--- | :--- | | DURAVYU 2.7mg (n=10, ex-outlier) | -75.9 | | Aflibercept 2mg (n=6) | -43.7 | [Comparative Efficacy & Treatment Burden](index=19&type=section&id=DURAVYU%20in%20DME%3A%202.7%20mg%20in%20Supplement-Free%20Eyes%20Achieved%20Similar%20BCVA%20Contrasted%20to%20Anti-VEGF%20%2B%20Anti-IL-6%20Dosed%20Monthly) A single **2.7mg** DURAVYU dose, combined with a single aflibercept dose, achieved comparable BCVA improvements to monthly anti-VEGF + anti-IL-6 combination therapy (**12 injections vs. 2 injections**) in supplement-free eyes, significantly reducing treatment burden - In supplement-free eyes, a single DURAVYU **2.7mg** dose (with a single aflibercept dose) achieved comparable BCVA to monthly anti-IL6 (vamikibart) + ranibizumab, significantly reducing the number of injections (**2 vs. 12**)[56](index=56&type=chunk) [Macular Leakage Reduction](index=20&type=section&id=DURAVYU%20in%20DME%3A%20Dose-Dependent%20Reduction%20in%20Macular%20Leakage%20Area%20with%20a%20Single%20DURAVYU%20Injection) A single DURAVYU injection demonstrated a marked and dose-dependent reduction in macular leakage area at **Week 24**, a key biomarker of vascular stability in DME, with the **2.7mg** dose showing the most significant improvement Vascular Leakage Area Change from Baseline to Week 24 | Treatment | Change (mm²) | | :--- | :--- | | DURAVYU 2.7 mg (n=10) | -3.14 | | DURAVYU 1.3 mg (n=11) | -2.02 | | Aflibercept 2.0 mg (n=6) | -0.66 | - Marked reduction in leakage area at **Week 24** after a single DURAVYU **2.7 mg** dose and no supplementation, indicating improved vascular stability[58](index=58&type=chunk) [Patient Case Study](index=21&type=section&id=DURAVYU%20in%20DME%3A%20Continued%20Drying%20at%20Week%2024%20with%20Improved%20BCVA%20After%20a%20Single%20DURAVYU%202.7%20mg%20Dose%20%3A%20No%20Supplementation) A patient case study demonstrated continued fluid drying and improved BCVA (**+8 letters**) at **Week 24** after a single DURAVYU **2.7mg** dose with no supplementation, showing a more favorable response compared to prior VABYSMO treatment - A patient case showed fluid drying and vision improvement (**+8 letters BCVA**) at **Week 24** after a single DURAVYU **2.7mg** dose, with no supplementation, responding more favorably than to VABYSMO[60](index=60&type=chunk)[61](index=61&type=chunk) [DURAVYU for DME: Phase 3 Plans](index=22&type=section&id=DURAVYU%20for%20DME_Phase3) [Phase 3 Clinical Program Design](index=23&type=section&id=DURAVYU%20in%20DME%3A%20Phase%203%20Clinical%20Program%20is%20Designed%20to%20Drive%20Global%20Regulatory%20and%20Commercial%20Success) EyePoint's Phase 3 clinical program for DME, consisting of two global, randomized, double-masked, non-inferiority trials ('COMO' and 'CAPRI'), is designed to demonstrate DURAVYU's efficacy and reduced treatment burden compared to on-label aflibercept, with First Patient In (FPI) anticipated in **Q1 2026** - The Phase 3 DME program includes **two pivotal**, non-inferiority trials ('COMO' and 'CAPRI'), each with **~240 patients**, comparing **2.7mg** DURAVYU every **six months** to on-label aflibercept[65](index=65&type=chunk) - Primary endpoint is the difference in mean change in BCVA from Day 1 to **Week 52 and 56** (blended) versus aflibercept control[65](index=65&type=chunk) - First Patient In (FPI) for the DME Phase 3 trials is anticipated in **Q1 2026**, leveraging existing clinical trial infrastructure from the wet AMD program[66](index=66&type=chunk) [DME Program Summary](index=26&type=section&id=DURAVYU%E2%84%A2%3A%20The%20Only%20TKI%20in%20Development%20for%20DME) DURAVYU is positioned as the only TKI in development for DME, offering dual anti-VEGF and anti-IL-6 inhibition, with positive Phase 2 VERONA results supporting its multi-MOA approach, and Phase 3 pivotal trials expected to commence in **Q1 2026** following FDA alignment - DURAVYU is the **only TKI** in development for DME, providing **dual anti-VEGF and anti-IL-6 inhibition** to alleviate vascular leakage and inflammation[70](index=70&type=chunk) - Positive Phase 2 VERONA trial results showed early and sustained improvements in vision and anatomy, underscoring the potential clinical utility of vorolanib's multi-MOA[70](index=70&type=chunk) - Following a positive End-of-Phase 2 meeting with the FDA, initiation of Phase 3 pivotal trials in DME is expected in **Q1 2026**[70](index=70&type=chunk)

– DURAVYU now in Phase 3 for the two largest, multi-billion-dollar retinal disease markets, wet AMD and DME with first patient dosing in pivotal Phase 3 DME trials anticipated in Q1 2026 – – New preclinical data demonstrates that vorolanib, the active drug in DURAVYU, inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation, key contributors to wet AMD and DME –  – IL-6 finding supports the compelling efficacy data observed in the Phase 2 VERONA DME trial and underscores DURAVYU as a ...

Summary of EyePoint Pharmaceuticals (EYPT) 2025 Conference Call Company Overview - EyePoint Pharmaceuticals focuses on sustained delivery of therapeutics to the eye using DuraCert delivery technology [3][4] - The company has progressed from initial Phase I trials to two global Phase III trials, each enrolling over 400 patients [3][4] Key Developments - EyePoint expects to be the first to read out both Phase III trials in 2026, file for NDA, and launch in 2027 [4][73] - Enrollment for the trials was completed in seven months, significantly faster than the average of twelve months for similar trials [5][6] - The Lugano trial had approximately 80% U.S. patients, while the overall trials will have about 90% U.S. patients, which is favorable for FDA approval [10] Trial Design and Expectations - The Phase III trials are designed to be identical, with no changes made since inception, ensuring consistency in protocol [12][23] - The trials aim for non-inferiority to aflibercept, with a focus on visual acuity as the primary endpoint [25][26] - Redosing every six months is included in the trial design, with a total of four doses over the course of the clinical trial [19][20] Safety and Efficacy - The safety profile remains strong, with no serious adverse events reported in over 190 patients during Phase II [43][44] - The next safety update is expected after the Data Safety Monitoring Committee meeting in November [45] Market Position and Competitive Landscape - The wet AMD market is valued at approximately $14 billion to $15 billion, with EyePoint's DuraVu positioned as a unique treatment option due to its different mechanism of action [58][60] - EyePoint emphasizes that DuraVu is not just another anti-VEGF therapy, but a TKI that blocks intracellular signaling of VEGF [30][60] - The company aims to capture a significant market share by offering a different treatment regimen that includes both DuraVu and existing anti-VEGF therapies [30][62] Regulatory and Commercial Strategy - EyePoint has received protocol approval from both U.S. and EU regulatory agencies, indicating a strong regulatory path [33] - The company plans to launch DuraVu independently in the U.S. while considering partnerships for international markets later [34][35] Financial Outlook - As of Q2, EyePoint reported $256 million in cash, with guidance indicating sufficient funds into 2027 [75][76] - The company has managed cash effectively, with spending aligned with rapid trial enrollment [76] Future Opportunities - EyePoint is also exploring the diabetic macular edema (DME) market, with plans for a smaller trial expected to start in 2026 [52][54] - The DME program is seen as a significant opportunity, with positive feedback from the retina community regarding the potential for improved patient compliance [50][51] Conclusion - EyePoint Pharmaceuticals is on track for significant milestones in the coming years, with a strong focus on execution, safety, and regulatory compliance as it prepares for the launch of DuraVu in the competitive wet AMD market [76]

Company Overview - EyePoint specializes in drug delivery systems for the back of the eye, with four FDA-approved products utilizing its technology [2] - The latest innovation is a fully bioerodible insert containing vorolanib, a small molecule tyrosine kinase inhibitor targeting all VEGF receptors [2] Industry Context - The company is currently conducting two Phase III trials for wet age-related macular degeneration (AMD), which represents the largest market among retinal vascular diseases, valued at approximately $10 billion annually in the United States [3] - Both trials are fully enrolled and are designed to assess noninferiority in visual acuity changes compared to the on-label aflibercept control [3]

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