Good day, ladies and gentlemen. Welcome to the Winter Wrap-Up MicroCap Rodeo Virtual Conference. The next presenting company is Processa Pharmaceuticals. I'd now like to turn the floor over to today's host, George Ng, the CEO of Processa Pharmaceuticals. George, over to you. Thank you, Jenny. Again, yeah, I just wanted to thank everybody for taking time to listen to and attend this presentation. My name is George Ng. I'm the CEO of, you know, again, of Processa Pharmaceuticals. We are a company that's developing next-generation chemotherapy drug products. This next slide is just the obligatory forward-looking statement and disclosures. I'd ask that you take a look at them, and please note that we may and will likely be making forward-looking statements as part of this presentation. So first off, in terms of Processa Pharmaceuticals, as I mentioned previously, we are a company that's developing next-generation chemotherapy drug products. And what's unique about this situation and the company is that... And it's not, you know, really a factor for most companies, that is, you know, on one side you have a de-risk strategy for developing a new chemical entity. So you have a new chemical entity too. And in this case, you know, chemotherapy is known. It's used in first-line, second-line treatments. It's been around for, you know, decades. So we don't have a situation here where we're having to prove that chemotherapy works or how it works. So it's a de-risk strategy in, you know, developing drugs. But by the same token, these are not me-too products. These are not generic products. These are, you know, not even 505(b)(2) hybrid products. These are new chemical entities, and we're developing all these drug products on a 505(b)(1), new drug, new chemical entity, you know, approach in terms of regulatory development. And so along with that, you also have all the extra added benefits of, you know, commercially, for example, with new chemical entities, you know, better, reimbursement, its own J-code. Yeah, you know, and even in this case, in our last FDA meeting with the FDA, for example, with you know, next-generation chemotherapy capecitabine, one of our drug products in development, the FDA even you know, on the record, had indicated that that they believe that the drug product that we're developing is a new chemical entity, which bodes well, you know, for the company and for our drug development. And you know, another advantage of Processa Pharmaceuticals, and a factor, is that we have a very experienced management team with decades of you know, regulatory and clinical development you know, using our proprietary regulatory science approach. And you know, in fact, you know, this development team, led by Dr. David Young and Dr. Sian Bigora have had over or at least, you know, 30 regulatory approvals to date using this proprietary regulatory science approach. So proven track record. As so, the development team at Processa has a proven track record as well as a record of success in terms of getting drugs through to, you know, to approval. And then also, we have a pretty robust diverse pipeline. And although all our drug candidates and drug products in development are next-generation chemotherapy drug products, they are each distinct, you know, distinct and unique. And we have three of them that are going through, you know, they're being developed right now. Two of them in clinical development and one that's pre-IND or preclinical, but it's near clinic-ready, you know, right now. You know, as well, the company is going through a bit of a pivot from, you know. Previously, you know, we also had a you know other non-oncology drug products. About a year and a half, you know, ago, you know, the company decided to pivot to to oncology and to focus on oncology. But the advantage of that is that we do have non- next-generation chemotherapy non-oncology assets that we have to out-license and partner out. One, which is a you know GI you know drug product for the treatment of gastroparesis, and then another drug product, which is you know dermatological you know drug product. Both are in, you know, both are, you know, on clinic-- you know, we're in clinical development, so there's clinical data for both of those assets. So this gives us an opportunity to partner these assets out to hopefully bring in non-dilutive capital and also act as catalysts for the company, and we're actively working on that right now. And, we're in the midst of, you know, discussions and negotiations with various companies, you know, on, on these assets. And as you may have seen more recently, we also, you know, the company, you know, we're, moving forward, you, and, and, and I guess what's... You know, we're in a nice position that we have cash runway, you know, to, you know, to 2025. More recently, we effected a reverse split to regain compliance with Nasdaq minimum stock price rules, and so we're back in compliance, and we've already announced that. And then along with that, we also did a raise, so, you know, largely to fund our Phase 2 clinical studies that we're anticipating entering into, you know, around mid-year of this year. So the, on the right side of the slide, you can see sort of a, you know, summary of where we're at, in terms of our cash position. And, you know, the insider ownership number, you know, I believe that that's from the 13.1% has gone up, you know, the, you know, you know, as of a couple weeks ago, a few weeks ago, you know, there were some insider purchases on the, you know, open, you know, market, you know, as well. So, this is a good, good snapshot of the company. Yeah. Moving forward. Okay, here it goes. So this is just a snapshot of senior management. As I explained previously, decades of experience in drug, you know, all areas of, you know, pharmaceuticals and life sciences, from the business side of things, but especially on the development and clinical side of things and regulatory side of things. I just wanna highlight that. Here's the opportunity that we have here in terms of, you know, for Processa. What we know is oncology, obviously, is a big market, in terms of, you know, just, you know, the number of patients. There's more than 200,000 new cancer diagnoses worldwide across multiple indications for each of our next generation chemotherapy drug products in development. And, you know, so chemotherapy is known, right? And it's used, you know, extensively. But the problem is that there are issues with chemotherapy, though, right? And also, our drug products are developed to address those issues, right? And to improve, you know, standard of care. And I'll get into more detail about that, you know, you know, you know, later on in the presentation. And again, you know, we, you know, our development team has a proprietary, regulatory science, you know, approach to, you know, to do drug development. And this aligns well with the FDA's new Project Optimist initiative and the requirement that now, that in oncology, drug companies need to, not just develop. You know, I mean, previously, you know, you know, drug, you know, companies would come up with a maximum tolerated dose, but now what's required is come up with an optimal dose. But we're already doing that, right? So, unlike some companies that may have to go back now and redo certain studies or do additional studies, we are already following this approach. So, you know, so in our instance, for each of our next generation chemotherapy drug products, we don't have to do that. You know, we can just move forward. And then also, another advantage and opportunity is that we are developing our NGCs or next generation chemotherapy drug products, not just as, well, in both as singular agents, you know, as well as in combination. So there are more opportunities there as well. And here's our pipeline. In terms of our NGC pipeline, as I mentioned, previously, we are planning our Phase 2 study in, you know, for NGC-Cap, you know, Cap or capecitabine, you know, drug product. We just finished our Phase 1/ 1b study. And, you know, we're just doing patient follow-up, you know, right now. So a Phase 2 study is being planned. And again, we anticipate, you know, initiating the study in terms of beginning to dose patients right around or right after mid-year of this year. For our NGC-Gem, we finished a Phase 2a study, and right now we're in the process of working with the FDA and meeting with the FDA to come up with the next study design and are working around plans for that. In terms of our NGC-Irinotecan, as I mentioned previously, it is preclinical, you know, right now, but we already have animal data, which I will, you know, discuss in a little bit. We're, you know, we're in the process of, you know, planning for preclinical IND-enabling tox studies, which is the next step in order to get to... And really the last step, you know, in order to get to filing an IND and entering into, you know, clinical studies. So again, how do our oncology assets differ from current chemotherapy? Well, you know, as I mentioned previously, you know, chemotherapy, you know, we know that chemotherapy works in general, but chemotherapy does have its dis, you know, its issues. You know, it's, you know, I mean, chemotherapy tends to have a serious adverse events. High toxicity levels are associated with chemotherapy drugs, as well as, for just some patients, you know, chemotherapy just doesn't work for them, or, you know, they can't tolerate it because of, of the high toxicity levels and adverse events. So they need to go off it or have a lower dose or, or have to receive a lower dose. And then for some patients, they are highly resistant, or they're resistant to, you know, chemotherapy, or they acquire resistance, you know, at a later point. So, you know, and I'll get into a little more detail as we go through each and every, you know, each of the, you know, drug products. But, you know, essentially, we develop our drug products to, in, you know, in a way that we change either the metabolism-... or the distribution of the drugs, you know, and thereby, you know, lower the amount of adverse events, reduce toxicity levels, and/or increase, you know, exposure and efficacy, so in doing so. And so, that's just generally how our drugs are work and are being developed. So in terms of Next Generation Capecitabine, yeah, this is what we know about. And, you know, I'll move over to the next one. But in terms of especially how it works, you know, with Capecitabine, you know, it essentially is 5-FU, and, you know, it's a prodrug of 5-FU. When it enters into your body, it actually metabolizes into two different, you know, metabolites, one anabolite and one catabolite. The anabolite is actually the metabolite that actually has the cancer-killing effect and works. It has side effects, too, you know, associated with it, but it... But that is the metabolite that's responsible for the cancer-killing effect. And as for the catabolite, it's responsible for much of the side effects, you know, including hand-foot syndrome, which is a very serious adverse, you know, event or side effect. But there's no antitumor properties associated with it, so it's not responsible for any of the cancer-killing or antitumor effect. So what we do in our NGC Capecitabine is we actually add a component that actually prevents the catabolite from forming. And so thereby, all the 5-FU, or most of it, then metabolizes over into anabolites. So instead of about 10, 10%-20% of the 5-FU, you know, metabolizing into anabolites, okay, it's now 80%-90%. So you're increasing exposure and increasing efficacy. At the same time, you're, you know, since the catabolite is not being formed, your adverse events are, you know, reduced. There's much lower toxicity, and that's shown, you know, and we've seen it, you know, so far in our, you know, the clinical studies so far, with a much better safety profile. And, you know, part of the reason why this is important is that, for Capecitabine, what we know is that 35%-70% of all patients that are given Capecitabine, and I, and I mentioned 35%-70% because it depends upon the cancer indication. 35%-70% of all patients receiving capecitabine, you know, they can't tolerate it because of the, you know, the high toxicity levels. So they either go off of capecitabine, or they receive a reduced dose that's not optimal. And so, you know, so through our NGC-Cap, we can help address that. And, yeah, so that's sort of how this works. So, you know, and what's also important is that the exposure profile of cancer cells to cancer-killing anabolites is greater than the existing FDA-approved capecitabine, even though the amount of capecitabine administered is 10% of the FDA-approved, you know, capecitabine. So it's just higher exposure, higher efficacy, even at a lower dose, and we've seen that in our earlier studies. And our next drug product involved is Next Generation Gemcitabine. And the way this drug product works is we're actually going through a different, you know, metabolism, you know, system. And the issue with gemcitabine is that about 55%-85% of patients, they're either inherently resistant to gemcitabine, or they acquire resistance. So what we found is, by going through a different, enzyme, you know, metabolism pathway, right? is that for some cancers, we actually, you know, it actually has a higher activity. So, so the idea is that by going through this different pathway, with... but still gemcitabine, that we can, you know, possibly overcome, you know, the resistance, and, you know, in terms of patient resistance to gemcitabine. And, you know, so far, the results have been, you know, somewhat encouraging. I think one of the other benefits of our NGC-Gemcitabine is that it's an oral formulation. So currently, right now, there is no oral form of gemcitabine, and right now, you know, it's given, you know, it's given IV. So this is based upon feedback from key opinion leaders, you know, on our, you know, advisory board, that this is actually they consider this having oral treatment or form a significant benefit. And, you know, in that, for example, if you have a. You know, I mean, right now, in terms of chemotherapy, it's largely given in cocktails or in combination, right, with other you know, you know, in terms of two or more chemotherapy drug products. If you have an all-oral, you know, regimen, you know, dosing regimen, except for, you know, then it makes it easier because then you can just, you know, you know, have everything administered at home without having to come into the clinic, or hospital, right? And you only have to come in for, you know, checkups and, yeah, you know, and only, you know, occasionally, right? But, you know, right now, you know, you can't do that with, you know, the current gemcitabine. And so, for example, a prominent combination is gemcitabine plus capecitabine. There is already oral capecitabine, but there isn't an oral gemcitabine. So if you had an oral gemcitabine, you could do an all-oral, you know, combination. And also, there's an advantage, you know, it's helpful for patients who either live in more, you know, rural areas that make it difficult for them to get to a clinical hospital or those patients in underserved, you know, communities where, you know, clinic and hospital access, you know, is not readily available. So this would help with that. And our next and last next-generation chemotherapy drug product in development is NGC-Irinotecan. And the way this drug product works is that we actually add a transporter LAT that preferentially draws in more of the active ingredient of irinotecan. So it changes the distribution, right, of the drug. As you know, preferentially draws in more of SN-38, which is the active ingredient that's responsible for the anti-tumor cancer-killing effect, but is also responsible, you know, for adverse events too, right? And you know, draws more of that into the tumor cell, preferentially over surrounding healthy cells. And so what that means is that you would. The way this would work is that you'd have, you know, if you're drawing more of the active ingredient into the tumor cell, you'd have higher efficacy, more activity, but then at the same time, you'd also have lower surrounding toxicity. So the healthy cells are not, you know, not affected as much, so you have less off-target effects, right? And so far in, you know, you know, even though this is a preclinical, you know, drug asset, we, you know, we do have some animal data that looks promising, right? So in mice, for example, if you take a look at the left side of the slide, you can see that, our NGC-Irinotecan, it had, in terms of in mice, there were 200 times higher drug in tumor versus surrounding healthy muscle, compared to 15 times with regular, you know, irinotecan. So it much higher amounts are being drawn in with our NGC-Irinotecan than in terms of regular, you know, irinotecan. And, you know, what was also interesting is that in, you know, the, you know, these, you know, animal studies, what also showed was that in terms of, on the right-hand side, as you can see, in terms of efficacy, that this also translates there as well, in that when you had, decreasing doses of regular irinotecan, you could see as well that, that tumor growth inhibition, went down, while ours did not. So even from, you know, even at half the maximum tolerated dose and, one-fourth of the maximum tolerated dose, we still had 100% tumor growth inhibition. So, you know, which bodes nicely for this drug product and why we're excited about it and why we intend to move forward with this drug product into from preclinical to clinical studies. Here's basically a summary of the milestones for the first half of 2024, not to get, you know, too ahead of ourselves. We've already completed 1, which is that we've already had a cohort review committee meeting to determine that the Phase 1b enrollment was completed, so finishing that. Now moving forward with NGC-Capecitabine, you know, that is, we're in the process of working with the FDA on the Phase 2, you know, design, which right now will be in, you know, breast cancer. We plan on submitting, based upon that, a Phase 2 protocol to IND to begin initiating sites. And again, you know, we're anticipating initiating the Phase 2 study by around right after midyear this year. In terms of NGC gemcitabine, you know, we will turn to that after we finish, you know, largely our work in NGC capecitabine, getting that ready. And so we're currently in the process of reaching out and meeting with and working with the FDA on the next study design. As you may recall, we've already finished a Phase 2A. The next study could be a Phase 2b or even possibly a Phase 3. And so, that would be in the second or third quarter, you know, this year. Largely with NGC Gemcitabine, you know, we based upon that, we anticipate submitting the Phase 2b or Phase 3 protocol to IND in the second half of this year. And then with NGC-I rinotecan, as I mentioned previously, what we have left is to conduct IND-enabling tox studies, as well as, you know, some smaller, you know, preclinical studies before we can file our IND. So we're in the process of, you know, preparing for that. We're selecting manufacturing sites or site or sites, you know, or manufacturer to begin manufacturing drug product for those studies. And so, you know, we're actively in the process of doing that right now. And so, you know, I feel that, just, just to summarize, that we're positioned for success. You know, we have, you know, we're transitioning to an, you know, oncology-focused company. So what that means is we have multiple, you know, oncology assets or NGC drug products. It's not, you know, it's not a platform. They're all individually different, but with the same approach, and that, you know, they're being developed. So that offers a somewhat, de-risk, non-binary, you know, portfolio. And then also, we have non-oncology. What that also means is we have non-oncology drug products that, we're in the process of partnering out and, you know, and, and which will hopefully bring in non-dilutive funding for the development of our oncology drug products, right? And then, we have a track record of regulatory and clinical development success, you know, shown by, you know, our team's 30 FDA regulatory approvals to date using our proprietary regulatory science approach that's been developed over, you know, decades. And then, you know, we, you know, addressing, you know, issues of standard of care, right, in chemotherapy. You know, and that's evidenced by, you know, our NGC capecitabine, which we're moving into a Phase 2 study in first-line metastatic breast cancer. And that's based upon encouraging Phase 1b study results, and also based upon feedback and input from the FDA. You know, right now, we have, you know, we're, you know, fortunately, you know, unlike, you know, a lot of companies out there, that we have, you know, we're in pretty strong financial position to support all this, right? So we have, we now post-raise about $11.1 million pro forma cash, right? And a cash runway that will take us all the way to 2025, and will fund, you know, and allow us to start our Phase 2 study in NGC-Capecitabine, you know, which is our lead drug product in development. So, this hopefully bodes well for us, you know, you know, entering into 2024. And, you know, and I just wanted to thank all of you for, you know, listening today, and thank you for all your support. And I'll turn it back to you, Jenny. Thank you very much. Ladies and gentlemen, that does conclude Processa Pharmaceuticals' presentation. You may now disconnect.