Financial Data and Key Metrics Changes - As of December 31, 2024, the company's cash and cash equivalents totaled approximately $20 million, which is expected to fund operations into the fourth quarter of 2025 [38]. Business Line Data and Key Metrics Changes - The company reported positive results from the Odyssey Phase IIb WET-AMD clinical trial, leading to a successful end-of-Phase II meeting with the FDA regarding the planned Phase III activities for CLSAX [8]. - CLSAX is positioned as a leading maintenance treatment for WET-AMD, with plans to enroll treatment-naive patients to potentially expand its commercial value [21][30]. Market Data and Key Metrics Changes - The wet AMD market represents over $12 billion in annual sales, and the company believes that CLSAX's flexible dosing regimen will provide a competitive advantage [32]. Company Strategy and Development Direction - The company is focused on advancing its small molecule superchoroidal pipeline led by CLSAX for the treatment of wet AMD, with increasing interest from retinal specialists and pharmaceutical companies [40]. - The Phase III trial design aims to reduce variability and maximize commercial potential by targeting treatment-naive patients and employing flexible dosing intervals [21][30]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Phase III program's design and its potential to demonstrate the efficacy of CLSAX, with expectations of minimal to no anti-VEGF rescue needed during the trial [30]. - The company is actively pursuing options to fund the CLSAX Phase III program, including potential partnerships [38]. Other Important Information - The company has made significant progress with its partners in validating the applicability of superchoroidal delivery for various indications, with ongoing or planned Phase III trials in multiple territories [9][10]. Q&A Session Summary Question: How might the amendments to the Phase 3 plan improve results from Phase 2? - Management believes that excluding patients with higher variability will lead to better results in the general population, as those who did not require extra treatment performed well [47][48]. Question: How long is expected to enroll the treatment-naive population? - Enrollment is expected to take around 12 months, based on recent trials [51]. Question: What is the estimated overall cost of the Phase III program? - While specific costs were not disclosed, similar Phase III trials have been around $55 million to $60 million each [58]. Question: What are the powering assumptions in the Phase III trial? - The powering assumptions are based on a 14-letter variability, similar to other studies, with a 4.5% letter margin as suggested by the agency [94]. Question: Can you elaborate on redosing criteria and physician discretion? - Redosing criteria will rely on OCT biomarkers, with a focus on intra-retinal fluid, while rescue criteria will be based on vision loss and worsening anatomy [100][103].

Financial Data and Key Metrics Changes - As of December 31, 2024, the company's cash and cash equivalents totaled approximately $20 million, which is expected to fund operations into the fourth quarter of 2025 [27] - The company is actively pursuing options to fund the CLSAX Phase III program, including potential partnerships with third parties [27] Business Line Data and Key Metrics Changes - The SES microinjector has been used for over 15,000 suprachoroidal injections, indicating strong interest from retinal specialists and pharmaceutical companies [6] - Positive results from the Odysee Phase 2b clinical trial have led to a successful end of Phase II meeting with the FDA regarding CLSAX [6][7] Market Data and Key Metrics Changes - The wet AMD market represents over $12 billion in annual sales, highlighting the commercial potential for CLSAX [22] - The company’s partner Arctic Vision has achieved several regulatory milestones in the Asia Pacific region, with products approved in Australia and Singapore [9] Company Strategy and Development Direction - The company aims to position CLSAX as a leading maintenance treatment for wet AMD, focusing on reducing variability in clinical trial outcomes [11][21] - The Phase III trial design includes two pivotal non-inferiority trials, which are expected to maximize commercial opportunities and reduce regulatory risks [14][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Phase III program's design and its potential to demonstrate the drug's efficacy and safety [39][40] - The company is optimistic about the broad applicability of suprachoroidal delivery in treating serious retinal diseases, with ongoing evaluations for additional small molecule treatments [23][25] Other Important Information - The company is preparing for participation in upcoming healthcare conferences to further engage with stakeholders [27] - The management team emphasized the importance of flexible dosing regimens in the competitive landscape of wet AMD treatments [22] Q&A Session Summary Question: How might the amendments to the planned Phase III improve results from Phase II? - Management believes that moving to a more general patient population will yield better results, as the previous Phase II focused on difficult-to-treat patients [35] Question: How long is expected to enroll the treatment-naive population? - Enrollment is expected to take around twelve months, based on recent trials [38] Question: What is the estimated overall cost of the Phase III program? - While specific costs were not disclosed, similar Phase III trials have been estimated around $55 million to $60 million [46] Question: What is the financing strategy for the Phase III study? - The company is pursuing options to fund the clinical part of the study, including potential partnerships [52] Question: Can you elaborate on the redosing criteria? - Redosing will rely on OCT biomarkers, with a focus on intra-retinal fluid, and will be scientifically justified to reduce variability [75][76]