Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) Q3 2022 Earnings Call Transcript

David Young: We have a couple of roadmaps to go forward on. We are actually getting ready to prepare for — to request the meeting with the FDA to talk through a few things. And we hope to have that in the beginning of next year, sometime the first half of next year in 2023, so we can define the path. Part of what we’re doing in terms of defining the path is defining really what the target population would be. Should we be using biomarkers? Should we be using — what kind of dosing regimen? Is it first-line, second-line, or third-line therapy? All these things are being considered that we feel we need to talk to the FDA first. And so we’ll be doing that in the first half of next year.

Naz Rahman: Got it. Thanks a lot for taking my questions and congrats on all the recent data thus far.

David Young: Thanks, Naz.

Operator: .

Unidentified Analyst: Thank you. Again, congratulations, gentlemen. David, just a very quick question. On the gastroparesis drug, what were your thoughts on the 0.5 milligrams being significant and the 1.0 milligram? Do you have thoughts on that?

David Young: So it’s actually 0.5 milligrams and 0.1 milligram?

Unidentified Analyst: Oh, I misread it. My bad.

David Young: Yeah. So we did not expect the 0.1 milligram. We thought it was a — not likely the 0.1 milligram would be good, and we thought the 0.5 milligram. But we wanted to show that we can find a dose that was not effective. And that was why we chose a 0.1 milligram. There’s a chance the 0.1 milligram could have been effective. But again, we didn’t think it was going to be as good as the 0.5 milligram. And so that’s what we did.

Unidentified Analyst: Great. Thank you.

Operator: Francois Brisebois, Oppenheimer.

Francois Brisebois: Just on the gastroparesis. In terms of what you can share, between the 0.5 milligram and 0.1 milligram, just based on that, any thoughts if the safety is better to — how high can you go here? Is 0.5 milligram probably the max?

David Young: That’s a good question. At least from the tox data that we’ve seen and the other data we’ve seen in healthy volunteers and constipation patients who’ve actually received up to 5 milligrams of the drugs, the safety data says 0.5 milligrams and 1.0 milligrams are equally safe, not really much difference, but we could go higher. We would not want to go to 5 milligrams, 0.5 milligram to 5 milligrams. But we would consider going higher than 0.5 milligram, but not too much higher.

Francois Brisebois: Thank you.

David Young: Thank you.

Operator: Thank you. And there are no further questions in queue at this time. Ladies and gentlemen, this does conclude today’s conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

David Young: Thank you.

Jim Stanker: Bye.

David Young: Good day.