OCULAR THERAPEUTIX, INC Q2 FY2024 earnings call

Pravin Dugel outlined several key points: Transformed Ocular into a retina-focused company with the goal of bringing AXPAXLI to market for wet AMD. The FDA advised that SOL-1 and SOL-R studies are appropriate as registration-enabling studies. Achieved four main accomplishments: set a vision and streamlined the organization, accelerated SOL-1 enrollment, initiated SOL-R and confirmed it's a registrational study, and presented HELIOS study results in NPDR showing AXPAXLI favorable. Invested in retina experts, has ~$460M cash, and reduced head count in non-aligned areas. SOL-1 enrollment is accelerating, SOL-R was initiated and enrolled patients, and HELIOS results in NPDR were remarkable.

Cash runway into 2028 to fund SOL-1 and SOL-R top-line results. Enrollment in SOL-1 is accelerating and expected to continue. SOL-R is designed to increase SOL-1 recruitment. Goal is to get AXPAXLI to patients as soon as possible, with flexibility in dosing up to every six months or longer depending on patient needs.

Q: Tazeen Ahmad asked about FDA alignment, SOL-1 recruitment feeding into SOL-R, and dosing frequency.

A: Pravin Dugel responded on FDA alignment, SOL-1 recruitment pace, and dosing flexibility.

Q: Biren Amin asked about SOL-1 timeline and EMA update.

A: Pravin Dugel updated on SOL-1 enrollment timeline and EMA conversations.

Q: Tara Bancroft asked about FDA feedback risk.

A: Pravin Dugel said FDA alignment is in writing, no remaining risk.

Q: Colleen Kusy asked about SPA for SOL-R, trial design changes, and comparator arm.

A: Pravin Dugel discussed SPA uncertainty, trial design alignment, and comparator arm for masking.

Q: Kelly Shi asked about SOL-R enrollment timeline and AXPAXLI in diabetic retinopathy.

A: Pravin Dugel talked about SOL-R enrollment timeline and next steps for DR.

Q: Sean McCutcheon asked about SOL-R comparator arm strategic significance.

A: Pravin Dugel discussed comparator arm for masking and commercial insights.

Q: Yi Chen asked about SOL-R enrollment timeline and loading doses.

A: Pravin Dugel talked about SOL-R enrollment timeline and loading dose application.

Q: Unidentified Analyst asked about SOL-1 recruitment and screen failure rate.

A: Pravin Dugel updated on SOL-1 recruitment numbers and screen failure rate