Clearside Biomedical(US:CLSD)2023-11-14 00:18Financial Data and Key Metrics Changes - As of September 30, 2023, the company's cash and cash equivalents totaled approximately $29 million, with a new licensing agreement with BioCryst expected to provide $5 million in non-dilutive capital [77][50]. - The company anticipates having sufficient resources to fund operations into the fourth quarter of 2024, which includes the completion of the ODYSSEY trial and the related top-line data announcement [50]. Business Line Data and Key Metrics Changes - The ODYSSEY Phase 2b clinical trial for CLS-AX has completed recruitment, exceeding the target of 60 patients, with randomization expected to be completed by mid-December 2023 [71][80]. - The partnership with BioCryst focuses on developing avoralstat for diabetic macular edema, a significant market opportunity [72]. Market Data and Key Metrics Changes - Bausch & Lomb announced that XIPERE has been granted a permanent Category 1 CPT code in the U.S., which is expected to facilitate better access and adoption of the product [70][75]. - Arctic Vision completed enrollment in its Phase 3 clinical trial for XIPERE in China, which is a critical milestone for the company [70][76]. Company Strategy and Development Direction - The company aims to establish CLS-AX as a best-in-class approach for long-term maintenance therapy for wet AMD, leveraging its suprachoroidal delivery method [45]. - The suprachoroidal approach is seen as a proven method with a clean safety profile, and the company has five collaboration partners targeting this space for various retinal diseases [79]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ODYSSEY trial, highlighting the potential for CLS-AX to provide a treatment duration of four to six months, which could position it favorably in the market [60][92]. - The company is committed to the current trial design of ODYSSEY and has made adjustments based on FDA draft guidelines, including using aflibercept as a comparator [90]. Other Important Information - The company has received positive feedback from the medical community regarding its CLS-AX program, with leading retinal physicians presenting data at major ophthalmic meetings [4]. - The partnership with BioCryst is expected to enhance the company's external development pipeline, particularly in the treatment of diabetic macular edema [39]. Q&A Session Summary Question: What is the status of the ODYSSEY trial recruitment? - The company reported a very healthy recruitment rate, exceeding the target of 60 patients, with good participation across all sites [14][80]. Question: What are the potential inflection points for the REGENXBIO and Aura partnership? - The next significant inflection point is the decision on when to enter Phase 3 trials for REGENXBIO, with positive Phase 2 data encouraging further development [57]. Question: Can you clarify the responsibilities in the BioCryst partnership? - The company will collaborate with BioCryst on IND enabling studies through next year, after which BioCryst will take over the development of avoralstat [58]. Question: What are the expectations for the ODYSSEY trial data? - Management is hopeful for a treatment duration of five to six months and believes that the data will guide future FDA proposals for Phase 3 trials [60][65].