Q2 2024 Ocular Therapeutix Inc Earnings Call Transcript
Key Points
- FDA has confirmed that the SOL-1 and SOL-R studies are appropriate as registration-enabling studies for AXPAXLI in wet AMD.
- Ocular Therapeutix Inc (OCUL) has approximately $460 million in cash, providing a cash runway into 2028.
- Enrollment in the SOL-1 study is accelerating and exceeding expectations, with 60 sites activated and over 150 patients in various stages of loading and randomization.
- Initiation of the SOL-R study for wet AMD was completed in just 3 months, with the FDA confirming it as a registrational study.
- Positive results from the Phase I HELIOS study in nonproliferative diabetic retinopathy (NPDR) show that no patients developed vision-threatening complications at 48 weeks after a single AXPAXLI implant.
- The company had to make the difficult decision to reduce headcount in areas not aligned with its vision.
- There is still uncertainty regarding the exact timeline for the completion of patient enrollment in the SOL-1 and SOL-R studies.
- The company has not yet had a formal meeting with the FDA regarding the nonproliferative diabetic retinopathy study.
- The SOL-R study's retreatment criteria are still under discussion with the FDA, leading to potential uncertainties.
- The company has not provided specific updates on the number of patients randomized in the SOL-1 study since the Investor Day.
Good morning, and welcome to the Ocular Therapeutix Second Quarter 2024 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded and will be available for replay on the Investor Relations section of the Ocular Therapeutix website. I would now like to turn the call over to Ocular's Vice President of Investor Relations, Bill Slattery. Please go ahead, Mr. Slattery.
Good morning, everyone, and thank you for joining us today. Earlier this morning, we issued a press release outlining our financial results for the second quarter of 2024. To make the best use of your time today, Ocular's Executive Chairman, President and CEO; Dr. Pravin Dugel, will briefly provide a summary of recent business highlights so we can quickly get to your questions. Joining Dr. Dugel for the Q&A portion of the call will be Donald Notman, Chief Financial Officer; Dr. Nadia Waheed, Chief Medical Officer; Dr. Sanjay Nayak, Chief Strategy Officer; and Steve Meyer,
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