Ocular Therapeutix(OCUL) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended the second quarter with over $390 million in cash and cash equivalents, having raised approximately $97 million through its existing at-the-market facility [28][29] - The company expects a financial runway into 2028, which is well beyond anticipated top-line data readouts for both SOLO-one and SOLAR [29][34] Business Line Data and Key Metrics Changes - The registrational program for expaxly includes the SOLO-one and SOLAR studies, which are designed to address key questions regarding durability and flexibility in treating wet AMD [7][21] - The company reported exceptional retention rates in both SOLO-one and SOLAR trials, reinforcing confidence in the quality of data being generated [31] Market Data and Key Metrics Changes - The company aims to address the critical needs of millions of patients worldwide suffering from wet AMD, where nearly 40% of patients in the U.S. discontinue treatment within the first year [6][30] - The company is preparing to expand its reach towards diabetic eye diseases, having received positive FDA feedback on its proposed trial design for patients with diabetic retinopathy [25][34] Company Strategy and Development Direction - The company is focused on advancing expaxly as a treatment designed to offer best-in-class durability and meaningful efficacy, with the potential to be the first product for wet AMD with a superiority claim [7][30] - Plans include incorporating a long-term open-label extension study for both SOLO trials to generate valuable real-world insights and long-term safety data [15][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the potential for expaxly to redefine treatment standards in retinal diseases, particularly in wet AMD and diabetic eye diseases [30][34] - The company is committed to delivering a long-lasting, flexible, and non-pulsatile solution that could improve long-term visual outcomes for patients [16][34] Other Important Information - The company will host an Investor Day on September 30 in New York City to provide deeper insights into the SOLO trials and its diabetic eye disease strategy [27][34] - The company has strategically modified the rescue criteria for the SOLAR trial to enhance its clinical relevance and adoption potential [19][20] Q&A Session Summary Question: When do you expect to complete randomization of the 555 patients required for the SOLAR trial? - Management stated that enrollment has been completed and trial conduct is going superbly [38] Question: What drove the change in the rescue criteria for the SOLAR study? - The change was made purely for strategic advantage and was not required by the FDA, reflecting confidence based on the data observed [39][40] Question: How do you think removing the 10-letter loss requirement for the rescue criteria will impact the primary endpoint? - Management confirmed that the modification will not impact the primary endpoint and is aimed at making the drug more adoptable [50][56] Question: What is the rationale for starting the open-label extensions now? - The decision was based on logistics and the desire to answer clinically relevant questions regarding the drug's long-term benefits [99] Question: How should investors think about the interplay of the eventual time to market for expaxly with a potential superior label? - Management emphasized that a superiority label would provide a significant competitive advantage, allowing for better patient care and outcomes [96][97]