This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk04: Greetings, and welcome to Processa Pharmaceuticals' fourth quarter and year-end 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. If you have a question or a comment, please hit star 1 on your touchtone phone. Pressing star 2 will remove you from the queue should your question be answered. 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.
spk09: Thank you and welcome to Processa's fourth quarter and year-end 2021 results and drug development update conference call. Joining me on the call today are our Chief Executive Officer, Dr. David Young, and our Chief Operating Officer, Mike Floyd. Shortly before this call, we filed our 2021 annual report on Form 10-K. 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 investor relations section of the company's website or our 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. 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 circumstances. At this time, I will briefly touch on our published financial results and then turn it over to Dr. Young to provide an update on our drug development activities, which will be followed by Q&A. We continue to manage our cash efficiently, And as of December 31st, 2021, we had a cash balance of 16.5 million. During the year ending on December 31st, 2021, we increased our cash balance by 1.1 million compared to December 31st, 2020. We accomplished this by raising 9.9 million in a private placement in early 2021 offset by 8.7 million in costs we incurred related to our three clinical trials and along with spending for operating and other related costs. We defined overhead as our general and administrative expenses plus the salaries for our development and admin teams. Our cash outlay for overhead expenses for the year ended December 31, 2021 was only $3 million. We accomplished this in part by having the cash portion of our six executive team members totaling only 525,000 for 2021. We are very much focused on directing our cash to activities that move our drug products forward. Given the current uncertainty in the capital markets, we executed a purchase agreement with Lincoln Park Capital LP earlier this month under which we have the right at our sole discretion to sell to Lincoln Park up to $15 million worth of our common stock over the next three years. We put this facility in place as a financing insurance policy to ensure the continued development of our pipeline. We are under no obligation to sell any shares under the agreement. For the year ending December 31st, 2021, we reported a net loss of 11.4 million or 75 cents per share compared to a net loss of 14.4 million or $2.54 per share for the same period of 2020. The primary reduction in our net loss was due to a decline in licensing activities in 2021 versus 2020. During 2021, we licensed PCS-3117 from OccuFire for cash and stock totaling $567,000. Compare this to a total expense of $8.7 million we incurred related to licensing PCS-12852 from Yuhan Pharmaceuticals, PCS-6422 from Illion Oncology, and PCS-11T from Apisense. Adjusting for in-process research and development acquisition costs, our net loss increased by 5.1 million for the year ended December 31st, 2021, compared to the comparable period in 2020. This increase in our acquisition related net loss relates to clinical trial costs we incurred as we progress with our clinical trials. We anticipate our costs will continue to increase as we continue these trials and continue development activities for the other drug products in our pipeline. During the year ended December 31st, 2021, we incurred research and development expenses totaling 6.9 million compared to 3.2 million for the same period in 2020. The increase in our R&D costs of 3.7 million in 2021 was primarily due to costs we incurred related to our active clinical trials. During the year ended December 31st, 2021, our general and administrative expenses totaled $4.7 million compared to $3.3 million for the same period in 2020. The increase related primarily to increases in professional and other consulting fees as well as non-cash stock-based compensation. Allocated between our R&D and G&A costs is 3.4 million of non-cash compensation costs. As of December 31st, 2021, we had 15.7 million common shares issued and outstanding. Along with a current shareholder, yesterday we purchased shares of our stock from one of our licensees. We consider this to be in the best interest of our shareholders. That concludes my remarks. I'll turn the call over to our CEO, David Young. David, please go ahead.
spk07: Thank you, Jim. Good evening. Thank you for joining us. During my time with you today, I plan to highlight what we've accomplished in 2021 in our drug development program and briefly share what you should be expecting over the next 12 months. I will not be covering all the details on each slide, but the slides are posted on our website if you want to study them more. Let's go to our first slide, slide three. This slide provides you with a snapshot of Processa High Life. As you know, Processa is a drug development company focused on improving the quality of life and or survival of patients who have an unmet medical need condition. These are patients who either have no treatment option or need a better treatment option. Each of our five drugs within our pipeline addresses a different unmet medical need with a potential market size for each drug being greater than a billion dollars. This means that Procesa is giving each of our investors, which includes the Procesa staff, five independent opportunities or shots on goal to have a blockbuster drug. In addition, we not only have five potential blockbusters, but we are simultaneously developing all five drugs, all at different stages, but all are now going through our development process. This process is the regulatory science approach that we started to develop 30 years ago when we worked on two FDA contracts determining the best way to answer a number of FDA clinical and scientific regulatory questions. Our contracts led to the development of a number of FDA guidances. We now have multiple near-term milestones on our five drugs that we expect to achieve from March to August and at the end of the year. I'll discuss these milestones as I briefly review each drug within our pipeline. Next slide. To remind everyone, slide four describes the criteria that we have used to select the five drugs in our pipeline. Since I've already spoken to some of this slide, I would only like to point out one other key item on the slide. The second criteria in the red box states efficacy evidence. This means that there is some clinical evidence of efficacy in the targeted population for each of the five drugs or for a drug with very similar pharmacology. If you look at other biotech companies, how many of the companies can say that they have five potential $1 billion drugs in the pipeline and all five have some positive evidence of efficacy in the targeted population? Next slide. Now let's look at a summary of our pipeline. The status of each drug and the key milestones we expect to achieve in 2022 are presented on the slide. Instead of going into the details of each drug using this slide, I'd like to point out that we have three drugs in clinical development, 6422, 6422 which we are now rebanding the next-generation capcitabine, 499, and 12852, and a fourth drug, 3117, that will be ready for clinical development by the end of the year. In 2022, we should hit key milestones for all four of these drugs. Although in later slides I do provide some background information on each of the five drugs, I will be emphasizing the 2021 achievements and the 2022 value-added milestones for each drug. Next slide. Let's first review the next-generation capcitabine, which should have some data readout mid-2022. Next slide. Next-generation capcitabine, which we previously designated as 6422, is a chemotherapy treatment that includes 6422 chemotherapy modifier to capcitabine. administered with capcitabine, capcitabine being one of the cornerstone chemotherapy drugs used in cancer, and the oral prodrug form of 5-FU. As you can see from the diagram, looking at the right side of the metabolic scheme for 5-FU, 5-FU is metabolized through DPD enzyme to a metabolite called FBAL, which has no therapeutic effect but can cause side effects, and these side effects can be dose-limiting. 6422 irreversibly inhibits existing DPD in the body, shutting down the right side of 5-FU metabolism to F-ball. The shutdown of the right side results in 5-FU metabolism shifting to the left side, the side that forms 5-FU nucleotides, which kills cancer cells, but also kills normal cells being synthesized like neutrophils. This shift, however, does not last forever because the no DPD is formed over time and if no 6422 is present, the new de novo DPD can metabolize 5-FU death ball. We demonstrated in 2021 the next generation of capcitabine with a single dose of 6422 inhibited DPD activity for 24 to 48 hours after 6422 administration, resulting in the capcitabine potency being 50 times greater than the present FDA approved capcitabine. However, the increased potency appeared to only last for 24 to 48 hours and did not last for all seven days of kepsidamine dosing. Next slide. We have clinical and preclinical evidence that if we can decrease the metabolism of 5-FU to FBAL to less than 10% compared to the typical 80% for all seven days of kepsidamine dosing, while still minimizing the exposure to 6422, The efficacy safety profile for next-generation capcitabine should be much better than presently approved capcitabine. To achieve this, we need to better understand the timeline of DPD inhibition and de novo formation to determine a regimen of 6422 that would provide minimal exposure and still maintain less than 10% metabolism at death ball. Next slide. Given the DPD activity findings after a single dose of 6422, We've modified the Phase 1B protocol to also, one, better understand the timeline of DTD inhibition and de novo formation, and two, evaluate the possibility of using an individualized, personalized treatment approach for next-generation capsaicin. The modified protocol was submitted to FDA in February, and we are working to restart the modified Phase 1B trial. Sites are being reactivated, and we are adding one to two more sites. Sites with IRB approval have begun to identify patients, and we expect to restart dosing patients in the second quarter of 22. We expect to have preliminary results on the DPD timeline by mid-2022 and have the preliminary determination of an MTD for next-generation capcitabine by the end of the year. The overall timeline for initiation of a pivotal registration trial is still 2023 to 2024 and an NDA submission in 2027 to 2028. Next slide. Let me quickly review 499, our Phase IIb drug, for which we have FDA orphan designation for the treatment of necrobiosis lipoidica, and there is presently no approved treatment or even a standard of care for this condition. Next slide. As seen in these two pictures, necrobiosis lipoidica, or NL, presents in patients as non-ulcerated NL and ulcerated NL. The literature reports approximately 22,000 to 55,000 ulcerative NL patients in the U.S. with painful ulcers occurring naturally or from contact trauma to the lesion. However, the numbers may be significantly less, but this should not alter the potential $1 billion market. It is important to note that natural complete healing or wound closure of moderate to severe ulcers during the first one to two years after onset incurs in less than 5% of these patients. Next slide. Currently, there is no FDA-approved treatment for NL, or also ulcerative NL. There's no standard of care, and all drugs used off-label are inadequate because of dose-limiting side effects, which prevents the drugs to be given at a high enough dose to see significant efficacy in a trial. This includes a drug called petoxyfilin, or as I often call it, PTF. PTX does work in closing ulcers of some patients, but side effects limit the dose that can be administered, which then limits the efficacy. 499 is the deuterated analog of a metabolite of PTX. 499 qualitatively has the same metabolites as PTX, but quantitatively has different amounts of the metabolites, resulting in a better safety profile. Next slide. In addition, In our Phase IIa NL trial, complete wound closure was achieved in the only two patients who presented with ulcers. Next slide. So what have we accomplished in 2021 for 499? We've enrolled three patients in our blinded Phase IIb randomized placebo-controlled trial with the preliminary findings in some of these patients showing complete wound closure and improvement in the NL lesion overall. At this time, we do not know if these patients received 499 or a placebo, and the results are only preliminary. We have had a number of patients interested in enrolling, but not willing to travel because of COVID. Many ulcers and NL patients have other medical conditions such as diabetes, and having lived with ulcers for years, they don't want to travel. With the COVID risk, these patients are willing to continue tolerating the ulcer even a little longer rather than potentially be exposed to COVID and the travel to the sites. In fact, a couple of patients who expressed interest in the study actually died from COVID before they came into the screening process. To improve the enrollment, we have also initiated a number of remedial efforts at the end of last year. We've closed four sites in Europe that were not recruiting well, and we are replacing these sites with new sites in the U.S., or possibly ex-U.S. Since the purpose of this Phase 2B trial is to obtain additional information on the response to 499 and placebo, we are also evaluating if these questions can be answered with fewer patients in the interim and final analysis. The interim analysis group of patients should be enrolled by 6-30-2022, with the interim results expected in December of 2022. Complete enrollment of the trial is expected by the end of the year. We still plan to meet with the FDA after the study is completed and begin a phase three trial at the end of 2023. Next slide. The next drug to discuss is PCS12852. Next slide. Let me remind you that the drug increases the gastric emptying rate, which can have a significant effect on the symptoms of gastroparesis. 12A52 has already been shown to have a significant effect on gastric emptying in patients with constipation. In our phase 2A trial, we expect to see the same type of improvement in the gastric emptying rate in gastroparesis patients. Next slide. At the present time, there is only one FDA-approved drug for the treatment of gastroparesis, and that drug has serious side effects, a black box warning, and can only be used for 12 weeks. even though most patients have chronic gastroparesis. Next slide. We are presently activating clinical sites for this trial and expect our first patient to be dosed in the second quarter of 2022. We expect the trial to complete enrollment in 2022 with top-line final results available December of 2022 or January 23, and the Phase IIb trial to begin in 2023. Next slide. The last two drugs are cancer drugs and they are 3117 and 11T. Next slide. The next three slides briefly describe the status of these programs and the next milestones. A summary of these drugs is one, both are cancer drugs with a market potential each of over $1 billion. Two, for both drugs, the active moiety has already been shown to be clinically efficacious in cancer patients. Three, The potential benefit risk associated with these drugs allows us to target a population of cancer patients who need alternative treatments. And lastly, we are presently defining the development programs and the roadmaps to approval for both of these drugs. The last group of slides are the pipeline background slides that have been presented before in some form. I'll not discuss these slides, but they are in the deck to provide more information on each drug. This concludes my remarks. I will now ask the operator to open the phone lines for Q&A. Operator, can you please poll for questions?
spk04: Thank you. Ladies and gentlemen, if you have a question or a comment, please press star 1 on your touchtone phone. Pressing star 2 will remove you from the queue should your question be answered. And lastly, while posing your question, please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. Once again, that's star 1 if you have a question or a comment.
spk03: Okay, the first question is coming from Frank Brisbois from Oppenheimer.
spk04: Your line is live.
spk05: Hey, guys. Thanks for taking the question. So first of all, on 499, can you just help us understand? It seems like in the literature it was higher on the 499 side in terms of the prevalence. But what are your basis for thinking it might be smaller? And do you have any estimates there? Is that literature is just more based on enrollment of the trial? Is it any help there would be helpful?
spk07: Thanks for the question, Frank. This is David. We don't have any other literature that supports a lower number. So all the literature, though it's, you know, 10 to 20 years old or more, supports the number of 22,000 to 55,000. However, given the enrollment and given the open ulcers, one would think you would see more patients. So because we haven't, we're just thinking maybe it isn't. We don't know that for sure, but we're thinking possibly it isn't. So regardless, though, what we've done is we've initiated, as I said in the discussion, in the talk, a few remedial type of things to increase our enrollment, We have an advertising campaign campaign directly to patients. We have a MD referral program that we're talking to sending emails to physicians to see if they have patients. We help pay for travel. We're doing a lot of things to to increase the numbers. But right now, seeing we're not even getting a lot of interest, that just kind of tells us either this is a very small, smaller group than we thought, or they're just all over the place and they're not well identified.
spk05: Okay. And in terms of, you know, the flexibility related to pricing to make sure the opportunity is still as big, is this something where you think that understanding, you know, having a better feel for the prevalence is necessary to get that kind of flexibility on the pricing? Or, you know, how are you guys thinking about the potential flexibility if we're not too sure how many patients are out there?
spk07: Yeah, that's a good question. I think more important than the prevalence in terms of pricing is the seriousness of the condition. So one of the things that FDA has done in our communications with FDA is they have noted to us that this is a serious condition. That in itself puts a little different hurdle there in terms of pricing. Because it is defined by FDA as a serious condition, then that gives us a little bit more flexibility of what we can do. All right. What we believe is when we first did our analysis of the pricing, our analysis said we could price anywhere from $30,000 to $50,000 a year for these patients if this was classified as a serious condition. And that was actually on the low side. The person who did the analysis actually came back and said it could be higher than $50,000 if it really is, depending how serious it is. What we did in our analysis is we said, okay, let's just take the 30,000 though. Let's ignore the number. Let's just say, let's take the lowest number, 30,000. Let's look at our population. That's where we came up with a market opportunity of about a billion dollars. All right. Just imagine if you decrease the prevalence by half, but you're increasing from 30 to 60, you're still getting $30,000 a year to $60,000 a year. You're still going to get the same number. So that's kind of where we're coming from. In addition, what we did in our analysis to determine the potential market is we looked at and we did not assume that 80 to 90% of the patients who have the ulcers would be taking it. We assumed less than 50, about 50% would be taking it. Given the seriousness of the condition and given how we're talking when we talk to the patients who have received it, we find that actually a number of these patients said, I would take this. There's no question. I'm going to take it given I have these ulcers and it goes away. So I think there's some assumptions that we made in the beginning that will be not as valid. And I think more patients will take it. I think of higher prices there because of the seriousness of the disease itself.
spk05: Okay. All right. That's very helpful. And then I think I saw there was an 8K recently in terms of the March corporate deck. And I think I had seen three in pre-screening. I might be wrong here, but Is it only two in prescreening now? And can you share what might have happened? Did I hear that a couple of patients now might have died from COVID? Is that maybe what happened here or any cause?
spk07: Well, we did have a couple of patients die from COVID before they came into screening. So they were in prescreening. They notified us they were interested in being in the study. They passed away before they actually got screened. And so we contacted them back, or the site contacted them back. They found out they passed away of COVID. We originally, back in earlier March, we had three patients in the pre-screening, not screening. These were patients who we looked at their ulcers. We said their ulcers, it does look like ulcers rather than just a surface type of wound. but it looked like a deeper ulcer. So we said, okay, you should be in the study, and you could now go through screening. One of those patients said, I don't want to do it now. And so they're gone. And so we still have the two other patients that we're trying to get into screening. Again, the trouble is they're just not willing to come in right now. Now things may get better because of the COVID situation, but then again with the new variant, who knows what's going to happen after that? Just don't know.
spk05: Okay, okay, great. And then on the 6422 side in mid-year, just remind us what kind of data you're looking for for the DPD, better understanding of the DPD synthesis or inhibition.
spk07: Yeah, so we expect in mid-year to have enough patients to get a better idea of the timeline of DPD inhibition and the timeline of DPD de novo formation. So we'll not only see the inhibition when the 6422 is around. We'll see that. But when there's no more 6422 around, we'll see how fast and what the curve looks like for DPD new formation to occur and know the timeline for different patients. With that timeline, we'll be able to better predict when we should give another dose of 6422. So we'll have what I'll call enzyme kinetics or kinetics of the formation of DPD enzyme will have the kinetics for that, which will allow us to better predict when to give the next dose of 6422 to have a better regimen. So it's not actually the final regimen yet, but by the mid-year we'll know the timeline or the course of DPD inhibition and de novo formation.
spk03: Okay, thank you. That's it for me. Thanks, Frank. Okay, the next question is coming from Robin Garner from Craig Hallam.
spk04: Your line is live.
spk02: Thank you. Quick question for you for 6422. You mentioned a 10% estimate for the amount of 5-FU metabolized to FBAL as being the right threshold for establishing a strong efficacy signal. What is that based on? Is that based on the human kind of PK data that had been collected or biomarker data, or is this from earlier research? Can you just expand on that data point specifically?
spk07: Sure. Thanks for the question, Robin. This is actually based on preclinical studies done previously, as well as clinical studies done previously. And so, you know, that estimate is not based on what we that 1B studied that we did cohort 1 and cohort 2. That's not what it's based on. It's based on previous data we have from clinical results as well as from preclinical results.
spk02: Okay, thank you. And in terms of 499, are there any criteria that are just establishing themselves as being too exclusive in terms of the patients that you are enrolling? Are people coming close or is this purely a COVID issue and how else will you be able to just ramp up enrollment?
spk07: Yeah, that's a good question. We asked the exact same question. So what we did is we went actually back to all the patients who were in pre-screening and we looked at all the patients who were screened and pre-screened and we tried to see if there was some reason why the patients didn't qualify. All right. And when we were looking at that, we actually could not find any reason. One reason people might think is, well, your ulcer size is too strict. The ulcer has to be too big or it has to be too many or something like that. Well, in fact, those who failed screening did not fail because of ulcer size. They failed because of other reasons. All right. Other reasons were, for example, they had an erosion, not a actual ulcer. So erosion is just on the top of the skin. And so that doesn't qualify because you need to have an open wound. Or their diabetes was uncontrolled, or they had a heart condition. So all these other reasons is why they did not qualify. Besides the actual ulcer size and ulcer number, we did look at things like cardiovascular, i.e., inclusion-exclusion criteria. We did look at the diabetic inclusion-exclusion criteria. So we looked at all of them to see if there was any sign that we were excluding too many patients. And the answer was there wasn't. There wasn't anything there. Most of the patients never made it to screening. So we had a number of patients going to prescreen. The patients who went to prescreen, those who did not make it to screening or did not make it through screening, mainly did it because they weren't ulcers. It was an erosion. It was on the top layer of the skin. That's all. It wasn't an open wound. And so that's why they didn't make it. That's how most of the patients were.
spk02: Okay, thank you. And then perhaps just as a follow-up, this doesn't seem to underlie the total number of patients that have severe ulcers caused by NL. So does this... cause any concern from a commercial perspective in terms of reaching patients once this is hopefully approved?
spk07: It doesn't to us. And the reason is one of the things that we found out even in the first study, the 2A study, is that a patient who even doesn't have a lesion, let's say they don't have an ulcer, all right, but they get kicked or they have a contact trauma, which causes an ulcer, that ulcer goes away quickly. So even though we are not looking for a label of prevention, there is a potential for this drug to quickly heal ulcers that occur because of contact ulcers. So even very small ulcers, it can quickly heal. So we believe that even though the label is going to be in our indication will be for ulcerative NL, We believe, and the physicians on our KOLs tell us, is that they might prescribe it for patients who might have an ulcer, even though they don't have an ulcer, to prevent an ulcer. Those who are more prone to potentially get an ulcer because of their lifestyle, because of whatever other reasons. So even though we're only looking at 22,000 to 55,000 patients with ulcers, there's a lot of other patients there who may need this. per our KOLs, they say, they say this, as well as there are patients in our study, in our first 2A study, who had, you know, non-ulcerated lesions, just a lesion, and their lesions got better, right? So our physicians had said, whether you have it for ulcerated or non-ulcerated, we're going to be using it much broader.
spk01: Okay, thank you for clarifying that. That's the end of my questions. Thanks so much.
spk03: Thanks, Robin. Thank you. I'd now like to turn the floor back to David Young for any remaining remarks.
spk07: I just want to thank everybody for joining us today. This is, 2021 has been a rough year for everybody in terms of COVID, but hopefully you see that we have been able to move the programs forward. Again, 499, not as much as we would want to, but we are doing things to expedite that program to move it forward. And as you can see from our catalysts and our milestones this year, we have a lot of milestones that we see will be occurring. And it's important to remember, it's not one milestone in one drug. Again, it's five drugs. We'll have multiple milestones in each of the drugs over the next 12 months. And we hope that that will really increase the value of the company and advance every program for us as we go forward. Thank you again for joining us.
spk03: Excuse me, David. Do you have time for one more question? Sure, I do.
spk04: Okay. We have a question coming from Julian Harrison from BTIG. Hi, Julian.
spk06: Oh, hi. Thanks very much, and congrats on all the recent progress. I have two questions. So first, on your next-generation capecitabine program, I'm wondering if hand-foot syndrome and cardiotoxicity, or lack thereof, I should say, could be informative or further support whether or not you're in the target therapeutic window for these next few cohorts, aside from DPD inhibition itself. And then second, when you're establishing the MTD for your regimen here later this year, just curious if that will involve just increasing the dose of N-olurosil itself or potentially capecitabine as well. Thanks.
spk07: Okay, so let me deal with the first one. It's possible that the neurotoxin, Cardiotox, if we see it, could tell us something about the therapeutic window for 642 and Capsidabine. The problem is that we don't really expect to see it. And so even though we are monitoring that, and we would expect that at some point or time that will occur, Our expectation is that the maximum tolerated dose safety signal will not be a cardiotox, neurotox signal. It'll be more neutropenia, GI effects, and things like that. So I don't see, at this time, I don't see neurotox or cardiotox actually playing a role in us stopping the dose or decreasing the maximum tolerated dose achievement for capsaicin. I don't see that right now. We're monitoring it, though, just in case. But that's a good idea. I mean, that's one reason we're monitoring it, because it could set the therapeutic window for us. So that's the first question. The second question, let's see, what was the second question again? Yeah, sure.
spk06: So later this year, when you're establishing the maximum tolerated dose, potentially, I'm just curious if that will likely just involve NLUrasil being increased or potentially capecitabine as well?
spk07: Yeah, no, actually, so what we believe, is that if we can decide on how DPD is inhibited, the kinetics of inhibition of DPD and the kinetics of de novo formation of DPD over time for different regimens, because we're doing it for multiple regimens of 6422, that will give us enough information to better understand mathematically how this occurs through a model. So we'll be able to look at a potential model that will guide us. So we believe we'll be able to develop a 6422 regimen that will be used for every cohort after we do this slight modification. And so every cohort after this will be just a change in capcitabine. So we'll be having kind of after this next six or nine patients, we'll have a standardized dosing regimen one or two that we could use if necessary to inhibit the DPD for almost any dose of capcitabine. That's what we plan to do.
spk08: But Julian, just to add on to what David was saying, there's going to be a fixed dose of the 6422 component, and there may be different dosing regimens of the 6422 part of it. And then we're escalating the capcitabine as we go. So what this next stage is going to do is going to tell us what the appropriate timing and dosing regimen is for the 6422 portion.
spk07: Got it. Yeah, so the MTD is really the MTD of capcitabine, not the MTD of 6422.
spk06: Right, right. Thank you very much. Thank you, Julian.
spk04: Okay. We have no further questions in queue.
spk07: Okay. Thank you very much, everybody. I appreciate it.
spk04: Thank you. Thank you. Thank you, 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.
Disclaimer