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

And so that’s one reason we targeted that population. They really have an unmet medical need. Metoclopramide works really well there, but again as I said in the talk, the side effects are just too big. We need something else. If you can only give the drug for 12 weeks, because of the side effects. And potentially the side effects are neurological. You get tardive dyskinesia, and you can have tardive dyskinesia for the rest of your life for some patients, just because you take this drug. That’s not good. We need something better, and that’s what we think our drug is.

Francois Brisebois: Okay. And those side effects, is it the cardiovascular side? Is it the nausea that’s especially bad?

David Young: For our drug or for other drugs?

Francois Brisebois: No. Metoclopramide.

David Young: So metoclopramide, it’s the tardive dyskinesia. It’s the CNS problem. That’s what is really bad.

Francois Brisebois: Okay. Okay. Great. And then just lastly, I noticed this wasn’t emphasized, because you just had data on other programs, but I just was looking for an update. I think in the deck, I still see that next year, we might see some data on the 499. So any update there on the difficulty recruiting patients and whatnot?

David Young: Yes. The only thing I can comment right now is that we do expect to have that data in the mid next year for the interim analysis group. And then we hope to be able to enroll all the rest of our patients in the beginning of the year, sometime the first half of the year. So we’ll get the results, the final results for the whole study, near the end of the year. That’s what our hope is. We’re moving slowly, but we’re hoping to do that. We’re trying to initiate and push other approaches to recruit patients. Unfortunately, the problem with this is it’s a very, very small population. The patients that we have been getting, coming in, who think they have ulcerative NL, a lot of them do not have ulcerative NL. A lot of them do not have NL, and a lot of them do not have ulcers. They have lesions, not ulcers. So there’s a little bit of problem of defining in this population what ulcerative NL is.

Francois Brisebois: Is it more difficult for the patients to know what they have? Or even amongst physicians or derms, they’re not sure exactly if it’s an ulcer or not?

David Young: No. It’s actually very easy for the physicians to know. So when we receive calls from patients who say — or sites have received calls from patients who say, oh, I want to come in. I have this ulcerative NL. And then when they come in, they don’t have an ulcer. Or they don’t — if they do biopsy on the lesion, they don’t have NL. That’s what seems to be our problem. So there’s seems to be in the — among dermatologists and an endocrinologists and other physicians who are diagnosing this for the patient, there seems to be a little bit of disconnect between is it really NL? Is it not NL? Is that really an ulcer or is it an erosion? And that’s just unfortunately, miscommunication to the patients about what they really have.

Francois Brisebois: Understood. Okay. Thank you very much.

Operator: Naz Rahman, Maxim Group.