Financial Data and Key Metrics Changes - The company's cash, cash equivalents, and restricted cash totaled $27.3 million as of June 30, 2025, down from $58.8 million as of December 31, 2024 [23] - Total operating expenses for the three months ended June 30, 2025, were $15.2 million, compared to $16.6 million for the same period in 2024 [23] Business Line Data and Key Metrics Changes - The OCU400 Phase three Limelight clinical trial for retinitis pigmentosa is currently recruiting patients in the United States and Canada, with BLA and MAA filings expected in 2026 [9] - The OCU410 ST clinical trial for Stargardt disease has achieved key milestones, including the first patient dosing and rare pediatric disease designation [12][13] - Preliminary data for OCU410 ST shows a 23% slower lesion growth compared to untreated eyes after a single subretinal injection [15] Market Data and Key Metrics Changes - The OCU400 gene therapy has the potential to address over 100 different mutations associated with retinitis pigmentosa, which currently lacks approved treatment options for approximately 298,000 patients in the US and Europe [11] - Stargardt disease affects around 100,000 individuals in the US and Europe, with no FDA-approved treatment available [12] Company Strategy and Development Direction - The company aims to file three biological licensing applications and market authorization applications in the next three years [7] - A regional partnership for OCU400 has been signed, with plans to close the definitive agreement by September [16] - The proposed reverse merger with OrthoCelix is intended to create a NASDAQ-listed late clinical stage regenerative cell therapy company [17] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the progress of their modified gene therapy platform and the positive response from recent collaborations [7][9] - The company is actively exploring strategic partnerships to enhance funding and minimize shareholder dilution [56] Other Important Information - The Data and Safety Monitoring Board reported no serious adverse events related to OCU400, allowing the study to continue as planned [12] - Leadership changes were made to strengthen the company's internal expertise and critical functions [20][21] Q&A Session Summary Question: Are there any other deals that you might be looking to execute? - The company is continuously looking for potential partnership opportunities, including regional partnerships for all gene therapy programs [28] Question: Can you remind us how many sites are included in the Stargardt Phase three trial? - There are 15 centers activated for the Stargardt trial, and the company does not anticipate challenges in enrolling patients due to the lack of approved products [33][34] Question: Can you talk about the potential interim update for OCU410? - An interim analysis for the geographic atrophy trial is expected in the fourth quarter, providing structural and functional outcomes [43] Question: When will we get feedback from the EMA regarding the pivotal study? - Feedback from the EMA regarding Stargardt is expected by the fourth quarter of this year [46] Question: How does the company plan to bring in additional funds? - The company is working on potential business development opportunities and partnerships to bring in non-dilutive funding [56]