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Clearside Biomedical(CLSD) - 2024 Q4 - Earnings Call Transcript
CLSDClearside Biomedical(CLSD)2025-03-28 00:31
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Financial Data and Key Metrics Changes - As of December 31, 2024, the company's cash and cash equivalents totaled approximately 20million,whichisexpectedtofundoperationsintothefourthquarterof2025[36]−ThecompanyisactivelypursuingoptionstofundtheCLS−AXPhase3program,includingpotentialpartnershipswiththirdparties[36]BusinessLineDataandKeyMetricsChanges−ThecompanyreportedpositiveresultsfromtheODYSSEYPhase2bwetAMDclinicaltrial,leadingtoasuccessfulendofPhase2meetingwiththeFDAregardingplannedPhase3activitiesforCLS−AX[7][29]−TheSCSMicroinjectorhasbeenusedforover15,000suprachoroidalinjections,indicatingstronginterestfromretinalspecialistsandpharmaceuticalcompanies[6]MarketDataandKeyMetricsChanges−ThewetAMDmarketrepresentsover20 million, which is expected to fund operations into the fourth quarter of 2025 [36] - The company is actively pursuing options to fund the CLS-AX Phase 3 program, including potential partnerships with third parties [36] Business Line Data and Key Metrics Changes - The company reported positive results from the ODYSSEY Phase 2b wet AMD clinical trial, leading to a successful end of Phase 2 meeting with the FDA regarding planned Phase 3 activities for CLS-AX [7][29] - The SCS Microinjector has been used for over 15,000 suprachoroidal injections, indicating strong interest from retinal specialists and pharmaceutical companies [6] Market Data and Key Metrics Changes - The wet AMD market represents over 12 billion in annual sales, with the company positioning CLS-AX as a maintenance treatment to capture a significant share [31] - The company’s partner, Arctic Vision, achieved regulatory milestones in the Asia-Pacific region, with product approvals in Australia and Singapore, and a new drug application under review in China [9] Company Strategy and Development Direction - The company aims to maximize the commercial potential of CLS-AX through a pivotal Phase 3 program designed to reduce regulatory risk and enhance market competitiveness [29][30] - The strategy includes targeting treatment-naive patients to potentially expand the commercial value of CLS-AX [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Phase 3 trial design and its potential to demonstrate the efficacy of CLS-AX, emphasizing the importance of reducing variability in patient selection [29][84] - The company is optimistic about the broad applicability of suprachoroidal delivery in treating serious retinal diseases, with ongoing evaluations of small molecules for geographic atrophy [32] Other Important Information - The company is the only TKI in development with multi-dosing data from its Phase 2b trial and the ability to re-dose before six months, which is seen as a significant differentiator [29] - The company is preparing for participation in upcoming healthcare conferences to further engage with stakeholders [36] Q&A Session Summary Question: How might the amendments to the planned Phase 3 improve results from Phase 2? - Management believes that excluding patients with higher disease variability will lead to better results in the general population [45][46] Question: How long will it take to enroll the treatment-naive population? - Enrollment is expected to take around 12 months, based on recent trials [48] Question: What is the estimated cost of the Phase 3 program? - While specific costs were not disclosed, similar Phase 3 trials have been around 55millionto55 million to 60 million [55] Question: How will the redosing criteria work? - Redosing will rely on OCT biomarkers, with a focus on intraretinal fluid, and will be distinct from rescue criteria [95][100] Question: Will the inclusion criteria impact enrollment speed? - Management anticipates minimal impact on enrollment speed, estimating that less than 10% of patients would be rejected based on the new criteria [84]