Clearside Biomedical(CLSD) - 2024 Q4 - Earnings Call Transcript

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]