Ocular Therapeutix, Inc. (NASDAQ:OCUL) Q2 2023 Earnings Call Transcript

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Rabia Ozden: Yeah. Maybe start with DED, because I’m going to ask for a clarification for TKI. They are dry eye programs. We have two programs in dry eye and be, what we have seen, like in Phase 2 — Phase 2 programs in both that we need a proper placebo because our insert, intracanalicular insert, placebo insert worked really well, stayed in actually in the canary course more than we expected. And that’s why our CSI was inconclusive and DED, although we showed a statistically significant sign, the symptom was not statistically significant. And the reason for our review is that the placebo arm did really well. What we are doing now is actually, running a small trial to come up with a more proper placebo, like very short life collagen plaques that they would just, be completely gone, like, in two to three days, two to five days, actually.

And then, like, use that in our pivotal trials. We didn’t want to start a pivotal trial before completely de-risking that issue because, we really, like, in our pivotals, we would like to hit both, sign and symptom. Does that answer your question, Yi, for the dry eye program?

Chaitanya G: Yes. Thank you.

Rabia Ozden: And can you repeat your TKI question?

Chaitanya G: The ideal timeframe for the second pivotal study.

Rabia Ozden: The — I mean, we really would like to start this trial first. And, the — you heard the finance of the trial from Antony. And then as we go along, dependent on our partnering processes or other financing, then we would start the second. For now, we are starting this first trial, and then the second trial, we’re going to inform you when we get that. Antony, do you want to add more to this?

Antony Mattessich: I think it’s important to note that we’re going to learn a lot from the initiation of this trial. We’re going to learn a lot by — see how quickly it can enroll, we’re going to learn a lot from the mask data, to be able to see how patients are doing in the trial, which would give us the confidence and the data to be able to understand when is the right time to pull the trigger on the second trial. But what we’re not going to do is commit to funding that trial until we see how the first trial is moving, until we have the appropriate discussions with other funding sources that could help us expand into a second pivotal. But we would be ready, from a standpoint of [trial material] (ph) to start it very soon after the initial — after initiation of the first pivotal. But we’re not committing to the start time of that second pivotal yet.

Chaitanya G: That makes a lot of sense. Thank you. Thank you so much.

Antony Mattessich: Thank you.

Operator: Thank you. Please hold for our next question. Our next question comes from Caroline Palomeque of Berenberg Capital Markets.

Caroline Palomeque: Hi, good afternoon. I’m just wondering if — thanks for taking my question. Just wondering if you could confirm the guidance on the estimated cost of the two pivotal trials in wet AMD. I know you said the past, it was somewhere between $50 million and $100 million, but then I had also seen some different numbers. Just wondering if you could just comment on that. Thanks.

Antony Mattessich: Thank you. The number we’ve been quoting is approximately $50 million per trial. So $100 million to NDA filing.

Caroline Palomeque: Got it. Thanks.

Operator: I am showing no further questions at this time. This concludes today’s conference. Thank you for participating. You may now disconnect.

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