Financial Data and Key Metrics Changes - For Q4 2025, total net revenue was $0.6 million, a decrease from $11.6 million in Q4 2024, primarily due to the recognition of remaining deferred revenue related to the YUTIQ product rights license [14][15] - Full year 2025 total net revenue was $31 million, down from $43 million in 2024, again attributed to the deferred revenue recognition [16][17] - Operating expenses for Q4 2025 totaled $71 million, up from $57 million in the prior year, driven by ongoing Phase 3 trials for DURAVYU [16] - Full year operating expenses reached $275 million, compared to $189 million in 2024, reflecting increased trial costs [17] - Net loss for Q4 2025 was approximately $68 million or $0.81 per share, compared to a net loss of $41 million or $0.64 per share in Q4 2024 [16] - Full year net loss was $232 million or $3.17 per share, compared to a net loss of $131 million or $2.32 per share in 2024 [17] - Cash and investments as of December 31, 2025, totaled $306 million, down from $371 million at the end of 2024, expected to fund operations into Q4 2027 [17][18] Business Line Data and Key Metrics Changes - DURAVYU is positioned as a leading asset with pivotal Phase 3 trials for wet AMD and DME, with first patient dosing reported [5][10] - The company anticipates top-line data for the wet AMD program in mid-2026 and for the DME program in the second half of 2027 [10][19] Market Data and Key Metrics Changes - The combined global market for wet AMD and DME is estimated at $10 billion and growing, representing a significant opportunity for DURAVYU [11] Company Strategy and Development Direction - The company aims to establish DURAVYU as a durable franchise targeting the largest retinal disease markets, focusing on its unique multi-mechanism of action and favorable safety profile [10][11] - The strategy includes preparing for a potential U.S. launch and expanding commercial readiness with the appointment of a new Chief Commercial Officer [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in DURAVYU's potential, citing strong clinical data and a favorable safety profile, with no safety signals reported in over 190 patients across completed trials [6][27] - The company is optimistic about upcoming milestones and the transformative potential of DURAVYU in the retinal disease market [13][19] Other Important Information - The company is expanding its cGMP manufacturing facility to support commercial supply and regulatory submissions [12] - Management emphasized the importance of a de-risked, clinically rigorous, and patient-centric approach in advancing DURAVYU [19] Q&A Session Summary Question: Can you clarify the rate of ocular AEs seen with DURAVYU, particularly around vitreous floaters and cataracts? - The incidence of cataracts in treated patients was 5.8%, with vitreous floaters reported at 5.2%, consistent with injection studies [25][26] Question: How are you thinking about recent FDA chatter around single study-driven regulatory approvals? - The company welcomes a more rapid approval pathway but does not anticipate altering its current strategy for wet AMD and DME [31][32] Question: Will there be additional looks at masked safety in the wet AMD trials before they read out? - There will be ongoing safety reviews by both internal and independent committees, with the next review scheduled for May [39] Question: What are the expectations for the reduction in treatment burden in the wet AMD studies? - The treatment burden will be measured after the loading doses, with expectations of a 60% reduction in the DURAVYU arm compared to the control [68][70] Question: How do you expect the steps or requirements to affect the adoption of vorolanib? - Initial adoption is expected among patients requiring frequent treatments, with potential expansion based on clinical trial outcomes [90][92]

Financial Data and Key Metrics Changes - The company ended the first quarter with $318.2 million in cash and investments, which is expected to support operations into 2027 [21] - Total net revenue for the quarter was $24.5 million, up from $11.7 million in the same quarter of the previous year [22] - Operating expenses increased to $73.3 million from $45 million year-over-year, primarily due to ongoing Phase III trials for DuraVu [25] - The net loss for the quarter was $45.2 million, or $0.65 per share, compared to a net loss of $29.3 million, or $0.55 per share, in the prior year [25] Business Line Data and Key Metrics Changes - Net product revenue remained consistent at $700,000, with expectations for immaterial levels going forward as the company will stop supplying YUTIQ after May 31, 2025 [22][23] - Revenue from royalties and collaborations increased to $23.7 million from $11 million year-over-year, driven by the recognition of deferred revenue from the outlicense of YUTIQ [24] Market Data and Key Metrics Changes - The DuraVu program is positioned to address a large unmet need in a growing multibillion-dollar market for retinal diseases, particularly wet AMD and diabetic macular edema (DME) [12][18] - DME represents a $3 billion market opportunity by 2030, with DuraVu showing promising results in clinical trials [18] Company Strategy and Development Direction - The company is focused on advancing DuraVu through late-stage clinical development, aiming to be the first to market with a sustained release treatment for wet AMD [9] - The strategic plan includes a potential NDA filing and future commercial launch, with a state-of-the-art manufacturing facility capable of producing over 1 million treatments annually [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting enrollment timelines for the Phase III trials, with over 90% of patients randomized in the Lugano trial and over 50% in the LUCIA trial [8][13] - The company anticipates top-line data from the Phase III trials in the second half of 2026, with a strong belief in the potential of DuraVu as a paradigm-shifting treatment option [19][27] Other Important Information - The company has received strong positive feedback from physicians and patients regarding the DuraVu trials, which is expected to enhance enrollment rates [8][14] - The company is well-positioned regarding potential tariff impacts, as it sources its active pharmaceutical ingredient from a U.S.-based manufacturer [17] Q&A Session Summary Question: Enrollment completion timeline for trials - Management reiterated guidance for full enrollment in the second half of the year, but acknowledged the potential for earlier completion based on current enrollment rates [32] Question: Upcoming FDA meeting for DME - The company plans to propose a clinical plan for a Phase III study comparing their drug to standard care, with the primary endpoint being best corrected visual acuity [34] Question: Rapid enrollment factors - The rapid enrollment is attributed to the patient-centric study design and robust Phase II data, which instills confidence in investigators and patients [38][41] Question: Screen failure rates and patient mix - The company reported better than historical screen failure rates and aims for a mix of approximately 75% treatment-naive patients in the trials [50] Question: Impact of biosimilars on the market - Management believes that DuraVu's unique mechanism of action and sustained delivery will differentiate it from biosimilars and traditional anti-VEGF treatments [75][78] Question: NDA submission strategy - The NDA submission will depend on the last patient in the second pivotal trial, with confidence in being first to file based on current enrollment rates [101] Question: Patient characteristics in trials - The trials are designed to enroll patients with active wet AMD, with a focus on those meeting specific imaging and vision criteria [93]