Ocugen, Inc. Q1 FY2026 earnings call

The first quarter of 2026 was defined by execution. Delivered positive 12-month phase 2 data for ARCA 410 NGA, completed enrollment and dosing in the Guardian 3 trial well ahead of schedule, and continued advancing ARCA 400 towards its rolling BLA submission later this year. The remainder of 2026 is poised to be consequential with multiple meaningful inflection points. Expect interim outcome analysis from Guardian III in the third quarter, regulatory alignment with FDA and EMA on the OCU-410 phase III design in the third quarter, and the initiation of the first BLA submission for OCU-400 also in the third quarter. Each milestone brings closer to delivering on the commitment of three BLAs by 2028. Thanked employees, investigators, patients, and shareholders.

Total operating expenses for the three months ended March 31, 2026 were $19.4 million, including research and development expenses of $11.3 million and general and administrative expenses of $8.1 million. Compared to the three months ended March 31, 2025, total operating expenses were $16 million with research and development expenses of $9.5 million and general and administrative expenses of $6.5 million. Ocugen reported a $0.06 net loss per common share for the three months ended March 31, 2026 compared to a $0.05 net loss per common share for the same period in 2025. Cash, cash equivalents, and restricted cash totaled $32.2 million as of March 31, 2026, compared to $18.9 million as of March 31, 2025. The company received $37.5 million in gross proceeds inclusive of $15 million due to exercise warrants in the first quarter of 2026. With the recent offering, the company is expected to have cash, cash equivalents, and restricted cash of $112.1 million at closing, which includes the Avenue debt payoff and expects to extend cash runway into 2028.

Expect interim outcome analysis from Guardian III in the third quarter, regulatory alignment with FDA and EMA on the OCU-410 phase III design in the third quarter, and the initiation of the first BLA submission for OCU-400 also in the third quarter. With the recent offering, the company expects to extend cash runway into 2028 and have cash, cash equivalents, and restricted cash of $112.1 million at closing, which includes the Avenue debt payoff and is expected to cover GA Phase III spend.

Q: It seems like it's gearing up to be an exciting year for Accu 400 and the Retina 8, this pigmentosa. And with that, could you give us a sense of what's being submitted for the rolling BLA versus the full BLA next year? And How else are you thinking about the pre-commercialization activities going into 2027 launch?

A: The rolling submission will start with non-clinical section module and completing PPQ lots from CMC manufacturing perspective this year. Next year, within weeks after top line results come in, the final clinical module will be submitted. From commercial perspective, working on pricing, government (CMS), identifying centers for excellence where gene therapy can be administered, and sales and marketing plans.

Q: Given how quickly the Stargardt program has been moving, how close together are you expecting an RP and a Stargardt approval could occur? And then are there any additional commercial considerations you're evaluating with the possibility that you will be kind of ramping both of these launches contemporaneously?

A: If everything goes according to plan, they could be within six months of each other. Targeting same Centers for Excellence for Gene Therapy Administration, economies of scale, and setting up for RP will help with Stargardt disease launch.

Q: How much overlap is there between the Limelight and the Guardian studies? Are they largely at the same centers, or if you take them combined, do they reach a broader swath of the overall market?

A: Both represent inherited retinal diseases, almost same centers, but need more centers for commercialization. Current clinical centers are good but not enough for commercial.

Q: My question has to do with the marketing and your mentions of centers for excellence. My understanding was that the product is something that can be administered by any ophthalmologist and anyone who treats patients and is very easy to fit into the current practice. So I was wondering about the centers of excellence and how you're going to launch the product if it's going to be a broad launch or focused on specific areas or treatment centers in the marketplace?

A: It's a vitrectomy, pretty common part of standard of care. Any of 2,500 trained retinal surgeons can do it. But want to make sure centers for excellence are well trained and follow same procedure for consistency and patient safety. Initial launch covers majority of centers, no special training needed.

Q: Headed into the interim for the Stargardt study in the third quarter. Can you remind us, first of all, the powering of that study, like what was assumed, and then what should we all be expecting to see in that readout? And then, what is the range of outcomes based on that data for the study moving forward?

A: Outcome analysis done under DMC guidance. Possible outcomes: no change, on track; or some delay but minimizing risk. Study is 300 patients global, 200 in treatment, 100 in untreated control, powered over 95% for primary endpoint.

Q: On the OCU 400, you know, where you're planning to start the rolling VLA in third quarter, can you confirm your PPQ runs would be completed, you know, in time, like by end of second quarter or so, so that you can initiate your rolling VLA?

A: We're on target to complete PPQ runs this quarter to support the rolling BLA submission.

Q: In terms of expenses, we have seen G&A and R&D expenses go up this quarter, which is understandable. But how should we think about this going forward, especially into 2027, as you're preparing, you know, for commercialization? And relatedly, you know, on the BD side of things, what progress has been made, especially for 410 in terms of ex-US licensing?

A: Part of spend due to timing and exceeding programmatic milestones. Anticipated spend averaging $50 to $60 million per year, cash runway into 2028. Actively evaluating various BD deals for XUS for both OCU 400 and OCU 410ST, with term sheets being looked at.

Q: I have a more general question on easy preservation. It appears to be emerging as an important endpoint. So I wanted to ask in your conversations with the regulators, what would you say their most recent position is on the importance of easy preservation? And two, are there any differences in how U.S. and EU regulators are thinking about easy preservation?

A: Just submitted meeting request to both FDA and EMA. Primary endpoint is lesion (approved in 2 commercial products in US), secondary endpoint is ellipsoid zone which correlates to visual function. Will let markets know after meetings with agencies are completed and aligned.