Greetings, and welcome to Processa Pharmaceuticals Third Quarter 2021 Earnings Conference Call and Corporate Update. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce Jim Stanker, Chief Financial Officer. Thank you, sir. You may begin.

Thank you. And welcome to Processa’s third quarter 2021 quarterly results and drug development update conference call. Joining me on the call today are Dr. David Young, our Chief Executive Officer; and Mike Floyd, our Chief Operating Officer. Shortly before this call, we filed our third quarter Form 10-Q. I want to remind everyone that a PowerPoint presentation will accompany Dr. Young’s prepared remarks. To view the PowerPoint slides, please go to the earnings press release and click on the webcast link to follow along. I will start our call by reading the Safe Harbor statement. This statement is made pursuant to the Safe Harbor for forward-looking statements described in the Private Securities Litigation Reform Act of 1995. All statements made on this call, with the exception of historical facts may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. Although, we believe expectations and assumptions reflected in these forward-looking statements are reasonable, we can make no assurances that such expectations will prove to be correct. Actual results may differ materially from those expressed or implied in forward-looking statements due to various risks and uncertainties. For a discussion of such risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in our annual report on Form 10-K, those contained in subsequently filed quarterly reports on Form 10-Q, as well as in other reports we file from time-to-time with the Securities and Exchange Commission. Any forward-looking statements included in this earnings call are made only as of the date of this call. We do not undertake any obligation to update or supplement any forward-looking statements to reflect subsequent knowledge, events or…

Thank you, Jim. Good evening. Thank you for joining us. During my time with you today, I’ll be updating you on our pipeline and briefly discuss what you should be expecting over the next 15 months. I will not be covering all the details on each slide, but the slide will be posted on our website as Jim said previously. Let’s go to our first slide, Slide 3. This slide provides you with a snapshot of the Processa highlights. The first four major bullets are the highlights that I’m sure most of you have already heard or read about. The last three major bullets or the more recent highlights, I will be discussing bullets five and six, our key accomplishments in the third quarter and some milestones to expect over the next 15 months in more depth in subsequent slides. The last bullet represents something that has happened recently, and we are only in the beginning stages of our discussions. Next slide. Slide 4 describes the criteria that we have used to select drugs in our pipeline. Again, this is a slide that many of you have already seen or heard about. Next slide. Now let’s look at a summary of our pipeline, instead of going into the details of each drug using the slide, I’d like to point out that we have four drugs in clinical development, 499, 12852, 3117 and 6422. 6422 which we are rebranding as next-generation capecitabine. We expect these same four drugs to be in Phase 3 in 2023 to 2025 and all four drugs to be FDA approved and commercialized between 2025 and 2028 in four different $1 billion markets. I will only be briefing you on the status of next-generation capecitabine and 499, which are now being clinically evaluated and 12852, which we…

Absolutely. We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Robin Garner with Craig-Hallum. Please go ahead.

Hi, good evening, and thanks for answering my questions. My first question is on 6422. I’m curious if the preclinical data and the clinical data that came before you gave any hint as to that 50x concentration being something that you expected to see from the first two cohorts.

Hi Robin, this is David. That’s a good question. It gave us a hint that there would be – it would be more potent, but we did not think of it to be this more potent. So this is greater than we thought.

Okay. Great. Thank you. And then question for you on 499, for the interim data coming up, how many patients can we expect to see at what doses and what kind of information will we learn from that interim data?

Sure. So the interim data – the interim analysis is supposed to be anywhere from eight to 10 patients. The dose will be the maximum dose of 1.8 grams per day. And it will be – I won’t say, how it’s split, but it will be split between placebo treated patients and then also the PCS499 treated patients. The real key to this is, what is the response of the placebo group. That’s something that FDA has no handle on at all. And so they really wanted us to get a better handle on the placebo group as well, of course, to get some information about the treatment group. But that placebo group is key. If that placebo group, for example, has a response rate of zero, there’s nobody responding even out of the four or five patients. Then FDA looks on that different than if one patient responded. So that placebo response is really driving everything and will drive how we presented to FDA. If we go for a fast track or a breakthrough therapy or whatever else we do in terms of our regulatory submission.

Okay. Thank you very much.

Thank you, Robin.

The next question comes from François Brisebois with Oppenheimer. Please go ahead. François Brisebois: Thanks for taking the questions. I apologize if you hear some barking in the background. So interim data here for PCS499, just to be clear, it’s still – you mentioned, from first half to mid-2022, and then we still feel comfortable to complete the trial and have data of the full data set in 2022 or just to double-check that?

Yes, that’s a good question. Right now, we’re expanding some of our enrollment efforts and we’re going to – in the U.S., for example, we’re going to be looking at a national recruiting of patients. We’re going to be adding travel funds if patients need travel. So we’re doing everything we can to increase the enrollment rate, but again, this is a rare disease. So we’ll just have to see how that goes. The expectation, if sometime mid-2022, we’ll have the analysis, the interim analysis. And when I say mid I’m talking about sometime, May, June, July, something in that range or August something in that range. I just don’t know when, it really will depend when we get at least eight patients. One of the things you have to remember is that, we’re not talking about a very complicated analysis here. We’re talking about how many patients had the ulcers completely closed and how many patients did not have the ulcers completely closed. So it’s not real complicated that, so the analysis itself should not take much time. It’s just, like you said, getting the patients in. Now in terms of the – what’s happening at the end, in terms of the completion of the study and analysis, we still think we can complete and get all the patients in by the enrolled before June of 2022. We still think we can do that, because of the push that we’re putting on right now. So as long as we do that, we’ll be able to, again, get all the patients enrolled, all the patients treated by the end of the year. And at the – at least with a top line analysis, we’ll be able to get that. We won’t have the full – all the secondary endpoints and all the exploratory – and all those won’t be done by the end the year. But hopefully, we’ll at least have the top line results by the end of the year. François Brisebois: Okay, great. And then on the PCS6422, this is pretty fresh data, you talked about the 50 times exposure that Robin just mentioned, and I’m just trying to understand in terms of the safety that maybe we can see here was the dose use or are you not disclosing doses yet of capecitabine. Would you even have expected maybe some Hand-Foot Syndrome? And then to counter that question is, if it’s going the other side, instead of the FBAL, if you’re going more towards the tumor activity. How comfortable are you that a higher exposure, higher potency of PCS6422 wouldn’t necessarily – wouldn’t maybe trigger side effects like neutropenia.

Okay. So let me see if I can remember all the questions. Let me do the last one first. Okay, Franc, we have to evaluate that. We have to evaluate, if in fact, the doses we are – we give, when you shut down DPD is actually going to result in neutropenia or in GI distress or something diarrhea and things like that. Those things have to be evaluated. And that’s why we’re increasing the dose of capecitabine as determined the maximum tolerated dose, when we get those things. I think my gut feeling is that the side effects that will be maximum tolerated dose side effects, the DLT will be those that are related to the nucleotides. That’s what I feel. So it will be the neutropenia. It will be the diarrhea, the GI effects. It will be those things that are related to the nucleotides, where that occurs. I don’t know. But I can tell you right now, given the exposure that we have of 5-FU at the present dose, which was 150 milligrams per day, that was our highest dose in group two. And given the 5-FU levels, the 5-FU levels are good levels. They’re high levels. Are they therapeutic yet? They’re not quite they’re therapeutic, but remember, you can’t compare the therapeutic here, because the AUC for next generation capecitabine, the AUC of 5-FU is only being really eliminated through the nucleotide side and anything through the urine. There’s nothing going on the other side, while the AUC, we talk about for capecitabine by itself, that goes 80% to FBAL and 20% the other way. So you really can’t compare exactly the AUC. That’s not appropriate from a PK/PD point of view, but we’re getting to levels that you would expect in the next one – next higher dose or the dose after that, we’re going to be pretty significant levels going into nucleotides. Now, will that have – what will that do in terms of efficacy? Don’t know. What will that do in terms of safety? Again, I don’t think we’re going to see any HFS, but we will see some side effects from the nucleotides, I think. François Brisebois: Okay.

I don’t know if… François Brisebois: Go ahead.

I don’t know if I answered everything, right? François Brisebois: No, you absolutely did it. And I’m just trying to make sure that in terms of the hypothesis here, is it more that if you give with PCS6422, if you give capecitabine at the old dose, would it be safer or is it potentially just a safer combo, because you would give a smaller dose of capecitabine?

That’s a good question. I can tell you what happens, what would happen. And I think we know this both from preclinical past data, as well as past studies. If you gave PCS6422 completely shutdown DPD and you gave the dose of normal capecitabine, right now, what’s normally get. You would definitely have neutropenia, you would definitely have GI effects. There’s no question, no question. So you would have some serious side effects from the nucleotide side. You would not have the Hand-Foot Syndrome. You will not have the other things going on, but you would definitely have some neutropenia problems. François Brisebois: Okay, great. And then, sorry to – I just this is pretty fresh data. So on the bio – you’ve talked about biomarkers for PCS6422 and I was wondering now that you’re trying to personalize the treatment, as you learn more about DPD de novo formation. Would the biomarker approach there help you to try to personalize this? And then just lastly, I just finished with this. Any reason we did not talk about PCS3117 here.

Okay. So in terms of the biomarkers that you used to – I’m used to using biomarkers in two ways. One way to enrich population or decide what population should receive a certain kind of therapy. So that’s one approach, right. The other approach to choose biomarkers to tell you what direction your efficacy is going to guide you in terms of your dosing. It’s pretty much like therapeutic drug monitoring, like, we did with Gentamicin [indiscernible] digoxin a lot of these other drugs. And so that’s a different approach. Our approach from the biomarker is more the latter. So it’s not going to tell us, this general population should have this kind of regimen, you stick to that regimen. I believe that the biomarkers will help guide us to say, PCS6422 is stop working now and there’s DPD coming in, so we’ve got to either get more PCS6422 or there’s a change of the dose of capecitabine or do something therapeutically. So I think it’s more that way, rather than the biomarker is going to be a general biomarker to tell you what patients should receive it. There’s another way we can do that. That’s already been developed in Europe. And so we may be taking that approach. In terms of PCS3117, we did not present anything in PCS3117, because we’re trying to still figure out the assays for 3117 for the biomarkers. And so that’s taking a little bit more time than we thought, because these – some of these are new assays, they’re assays that we actually have to develop quickly. It’s not an assay that can take weeks and weeks to develop – weeks and weeks to run. It’s something that when we get into clinical study, it has to be turned around fast. So that’s taking a little bit more time planning those out, actually doing all the nitty-gritty work that you have to do in the beginning to get them to the stage we want them to be. And so that’s why we haven’t talked about. There’s really nothing new, except we’re still doing the planning, we’re still doing all the nitty-gritty beginning stuff. François Brisebois: Understood. Thank you very much.

Thanks, Franc.

The next question comes from Aydin Huseynov with Benchmark. Please go ahead.

Hi. Thanks very much for taking my question. So I have one on 499. Just wanting to understand the enrollment process and why do you think it was slower than expected? Also, you mentioned the interim analysis for 2022. So would that mean that the enrollment will be completed by the end of this year?

Okay. So let me answer the first question. The enrollment for the interim analysis will not be completed by the end of this year. We don’t think it will be. It might be, there’s a chance. But we’re giving an extra one or two months to complete that enrollment. So we think it will be – the completion of the interim analysis group will be completed in the first quarter of next year. The enrollment of all patients for the study will be completed around June. That’s our expectation. The reason that this is taking – and the reason we think we can push the enrollment is because we’re taking – we’re being more aggressive in our recruiting. We’re doing the national recruiting. We’re not saying sites, you do recruiting, you talk to all your patients and that’s the only thing you’re going to do. And as you know, when clinical sites, they first talked to all their patients, and then, then after that they go out and look around. But they don’t have a national PR type of approach to getting patients. So we’ve actually are hiring a group to help us do more of a national, more general all dermatologists, all diabetologists, really hit it hard, all types of patient – all types of physicians, let people know about it. And then hopefully then direct them to sites. We get somebody interested, we’ll direct them to a site, go to this site and because we’re going to pay some of their transportation, there it’s easier for them to go to the different sites. So we’re really pushing it hard.

Right, right. Understood. And for the 6422, so given the increased potency and from modeling perspective, do you think that there should be some shorter time for approval for 6422 in the kind of when you pass all the phases, just thinking about when the Phase 3 potential, Phase 3 could be completed and when the drug would be approved?

I sure hope so. I sure hope so. But I can’t answer that right now, that’s a hard one until we talk a little bit more to the FDA. We are going to be pushing that. We believe that the increased potency with a decrease of side effects at least the HFS, the neurotoxin and cardiotoxicity side effects with a decrease in those side effects should stand well with the FDA. So we hope that by presenting this data and future data that we can expedite the development and the approval process for the drug. Yes, we hope so.

And did you have any feedback from medical oncologists who use capecitabine, and just kind of general feedback about the possibility of having next-generation capecitabine, any survey formal and informal? Yes.

Yes. So we’ve talked to – there are oncologists in the studies and there’s oncologists who are consultants and advisors who we talked to. Everybody likes the idea. 100% of them liked the idea. They liked the approach. They’ve said to us that if you can get a next-generation capecitabine that doesn’t have the side effects that capecitabine has like the neurotoxicity, cardiotoxicity those types in HFS type of side effects. That’s great. But there is a balance that you have to realize that that may cause more of the neutropenia, which we talked about earlier, and you have to find that balance. And that’s what we – that’s the purpose of the MTV study. That’s the purpose of all the studies we’re doing. In addition, the physicians and oncologists who are in our study, who have dose these patients are very, very enthused about the drug in what we’re doing. They – when we told them that we were going to be modifying the study, which requires us to put a hold on this study for a little bit, make some changes, have to get new IRB approvals, et cetera, all these kinds of things that have to go on for a study, as well as interact with FDA. Every one of them said to us, who had patients said to us, I can keep my patient on the drug right now, though, right? And we said, yes, yes, that’s fine. That’s not fallible. As long as you think it’s ethically and appropriate to do we have no problems doing that. So if they thought there was something bad with it, whether it’s side effects or there’s no kind of potential efficacy, they would’ve said, okay, fine. And they would have said, we’re not keeping our patients on it. But they didn’t, all of them are interested in if they can keep the patients on it.

Okay. Understood. All right. Thank you very much.

Thanks Aydin.

[Operator Instructions] The next question comes from Julian Harrison with BTIG. Please go ahead.

Congrats on all the reason progress. And thank you for taking my question. On 6422, I’m wondering if you could give us a better sense for what the dosing regimens will probably look like in upcoming cohorts. And is it fair to assume that these new regimens will continue to have favorable [indiscernible] Thanks.

Okay. Thanks, Julian. So I can tell you what we’re doing. I can’t tell you the specific regimens, because again, we’re going to be interacting with FDA on those. But we are going to be increasing the dose – the amount of doses. So the dosing interval would be decreased. So we’ll have more often dosing of 6422. Right now, just to remind everybody, we gave a single dose of 6422 on day one, we waited until day two to start the regimen of capecitabine. And there was no more – and capecitabine was dosed for seven days and there was no more 6422 administered. And then that was repeated in the next cycle. What we’re going to be doing is we’re going to be adding doses of 6422 between day one and within the seven days of dosing capecitabine. So there will be doses of 6422 also after – during the dosing of capecitabine. So that’s the first thing. And again, I can’t get into specifics because we’re still – we’ll have to negotiate and discuss that with the FDA. The second point you asked about is, how does that ratio compare to what was done before? So the ratio that we’re talking about is much lower than the ratio done by anything with GSK. So all that work is – it’s a completely different ratio. It’s much, much lower ratio, so much, much less 6422. Now in terms of the done – paper done by the publications and work done by rev Riviera for example that was lower dose that was given multiple days. In terms of the given dose on a given day, our ratio will still be about the same or little lower but not higher.

Got it. Very helpful. Thanks, again.

This concludes the question-and-answer session. I would like to turn the conference back over to Dr. David Young for any closing remarks.

Thank you. I just wanted to thank all everybody on the call, all the questions and all the attendees. We really appreciate it. We appreciate your support. And hopefully in the next few months, you’ll be hearing more about the things we’re doing, the things we’re trying to do and some interaction with the FDA. We really believe all five of these products are blockbusters and we hope you stay with us and enjoy the ride. Thank you very much. Back to you operator.

Thank you. This concludes today’s conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.