Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) Q4 2021 Earnings Conference Call March 30, 2022 4:30 PM ET
Company Participants
Jim Stanker – Chief Financial Officer
David Young – Chief Executive Officer
Conference Call Participants
Frank Brisebois – Oppenheimer
Robin Garner – Craig-Hallum
Julian Harrison – BTIG
Operator
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. [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.
Jim Stanker
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 31, 2021, we had a cash balance of $16.5 million.
During the year ending on December 31, 2021, we increased our cash balance by $1.1 million, compared to December 31, 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 define 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 31, 2021, we reported a net loss of $11.4 million or $0.75 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 PCS3117 from Ocuphire for cash and stock totaling $567,000. Compare this to a total expense of $8.7 million we incurred related to licensing PCS12852 from Yuhan Pharmaceuticals, PCS6422 from Elion Oncology and PCS11T from Aposense. Adjusting for in-process research and development acquisition costs, our net loss increased by $5.1 million for the year ended December 31, 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 31, 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 31, 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 31, 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.
David Young
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 programs 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 3. This slide provides you with a snapshot of the Processa highlights. 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 $1 billion. This means that Processa is giving each of our investors, which includes the Processa 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 4 describes the criteria that we have used to select the five drugs in our pipeline. Since I’ve already spoken to some of these slides, I would only like to point out one other key item on this 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 drug 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 rebranding the next-generation capecitabine, 499 and 12852. And the 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 that 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 capecitabine, which should have some data readout mid-2022.
Next slide. Next-generation capcitabine, which we previously designated at 6422, is a chemotherapy treatment that includes 6422 chemotherapy modifier to capecitabine, administered with cepcitabine. Capecitabine 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 and line to a metabolite called FBAL, which has no therapeutic effect that 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 to the metabolite to FBAL. The shutdown of the side results in 5-FU metabolism shifting to the left side, the side that forms 5-FU nucleotide, which kills cancer cells but also kills normal cells being synthesized like neutrophils. This shift, however, does not last forever because they know DPD is formed over time. And if no 6422 is present, the new de novo DPD can metabolize 5-FU to FBAL.
We demonstrated into 2021, the next-generation capecitabine with a single dose of 6422 inhibited DPD activity for 24 to 48 hours after 6422 administration, resulting in capecitabine potency being 50x greater than the present FDA-approved capecitabine. However, the increased potency appeared to only last for 24 to 48 hours and did not last for all seven days of capecitabine dosing.
Next slide. We have clinical and preclinical evidence that if we can decrease the metabolism of 5-FU to FBAL for less than 10% compared to the typical 80% for all seven days of capecitabine dosing, while still minimizing the exposure to 6422. The efficacy safety profile for next-generation capecitabine should be much better than presently approved capecitabine. 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% metabolized to FBAL.
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 time line of DPD inhibition and de novo formation. And two, evaluate the possibility of using an individualized, personalized treatment approach for next-generation Capecitabine.
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. We expect to restart dosing patients in the second quarter of 2022. We expect that 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 PCS499, our Phase 2b 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 as 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 in ulcerative NL patients in the U.S. with painful ulcers occurring naturally or from contract from 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 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 pentoxifylline or as I often call it PTX. PTX does work in closing the ulcers of some patients, but side effects limit the dose that can be administered, which then limits the efficacy. PCS499 is the duterated analog of a metabolite of PTX.
PCS499 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 2a 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 PCS499? We’ve enrolled three patients in our blinded Phase 2b 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 receive PCS499 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 ulcerative NL patients have other medical conditions such as diabetes and having lived with ulcers for years that we don’t want to travel. The combined risk, these patients are willing to continue tolerating the ulcer even a little longer rather than potentially be exposed to COVID in the travel 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 PCS499 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 began a Phase 3 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. PCS12852 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 constipation. 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 2023 and the Phase 2b trial to begin in 2023.
Next slide. The last two drugs are cancer drugs, and they are PCS3117 and PCS11T. 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 the market potential each of over $1 billion; two, for both drugs, the active media 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 program and the road map 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?
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] The first question is coming from Frank Brisebois from Oppenheimer. Your line is live.
Frank Brisebois
Hey guys. Thanks for taking the questions. 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. 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.
David Young
Thanks for the question, Frank. This is David. We don’t have any other literature that supports a lower number. So the literature, though it’s 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 directly to patients. We have an MD referral program that we’re talking to – sending e-mails to physicians to see if they have patients. We think our paper traveled. We’re doing a lot of things 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 smaller group than we thought or they’re just all over the place, and they’re not well identified.
Frank Brisebois
Okay. And in terms of the flexibility related to pricing to make sure the opportunity is still as big. Is this something where you think that understanding – having a better feel for the prevalence is necessary to get that kind of flexibility on the pricing? Or what – how are you guys thinking about the potential flexibility if we’re not too sure how many patients are out there?
David Young
Yes, that’s a good question. I think more important than the number of 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?
Now 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. When we did – in our analysis is we said, okay, let’s just take the $30,000. Let’s ignore the number, but let’s take the lowest number, $30,000. Let’s look at our population, that’s where we came up with the market opportunity of about $1 billion. All right.
Just imagine, if you decrease the prevalence by half, but you’re increasing from $30,000 to $60,000, 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 will 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.
Frank Brisebois
Okay. All right. That’s very helpful. And then I think I saw – there was an 8-K recently in terms of the March corporate deck. And I think I had seen three in prescreening, 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 color?
David Young
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 and – or the site contact at the back, they found out they passed the wave of COVID. We had – we originally – back in earlier March, we had three patients in the prescreening, not screening. These were patients who are – who we looked at their ulcers.
We said their ulcers look – it does look like ulcers rather than just a surface type of wound, but it looks 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, I just don’t know.
Frank Brisebois
Okay. Okay. Great. And then on the 6422 side in midyear, just remind us what kind of data you’re looking for the DPD better understanding of the DPD inhibition [ph].
David Young
Yes. So we expect the midyear to have enough patients to get a better idea of the time line of DPD inhibition and the time line of DPD de novo formation. So we’ll not only see the inhibition with the DPD 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 some, what I’ll call enzyme kinetic or kinetics of the formation of DPD enzyme will have the kinetics for that and which will allow us to better predict when to give the next dose 6422 to have a better regimen. So it’s not actually the final regimen yet, but by the midyear, we’ll know the timeline or the course of DPD inhibition and de novo formation.
Frank Brisebois
Okay. Thank you. That’s it from me.
David Young
Thanks, Frank.
Operator
Okay. The next question is coming from Robin Garner from Craig-Hallum. Your line is live.
Robin Garner
Thank you. A quick question for you for 6422. You mentioned a 10% estimate for the amount of 5-FU metabolized to as being the right threshold for establishing a strong efficacy signal. What is that based on? Is that based on the human, the 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?
David Young
Sure. Thanks for the question, Robin. This is actually based on preclinical studies done previously as well as clinical studies done previously. And so – that estimate is not based on what we that 1b study that we did [indiscernible]. 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.
Robin Garner
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? Like are people coming close? Or is this purely a COVID issue? And how else will you be able to just ramp up enrollment?
David Young
Yes, that’s a good question. We have the exact same question. So what we did is we went actually back to all the patients who were in prescreening and we looked at all the patients who were screened and prescreened. And we tried to see if there was some reason why the patients didn’t qualify, right? And when we were looking at that, we actually could not find any reason. One reason people might think as well, your ulcer size is too strict. It’s too – 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, right? The other reasons were, for example, they had an erosion not an 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 they had, 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.
Robin Garner
Okay. Thank you. And then perhaps just as a follow-up. This doesn’t seem to underline the total number of patients that have severe ulcers caused by NL. So does this cause any terms from a cultural perspective in terms of reaching patients and once this is hopefully approved?
David Young
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 where 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 users, it could quickly heal. So we believe that even though the label is going to be – and 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 else 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 non-ulcerated lesions, just the 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?
Robin Garner
Okay. Thank you for clarifying that. That’s the end of my questions. Thanks so much.
David Young
Thanks, Robin.
Operator
Thank you. I’d now like to turn the floor back to David Young for any remaining remarks.
David Young
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.
Operator
Excuse me, David; do you have time for one more question?
David Young
Sure, I do.
Operator
Okay. We have a question coming from Julian Harrison from BTIG. Your line is open.
David Young
Hi, Julian?
Julian Harrison
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 the 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 Eniluracil itself or potentially Capecitabine as well? Thanks.
David Young
Okay. So let me deal with the first one. It’s possible that the neurotox and cardiotox, if we see it, could tell us something about the therapeutic window for 6422 and Capecitabine. The problem is that we don’t early 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 cardiotoxic, neurotoxic signal. It will be more neutropenia, GI effects and things like that.
So I don’t see – at this time, I don’t see neurotoxic, cardiotoxic actually playing a role in us stopping the dose or decreasing the maximum tolerated dose achievement for Capecitabine. 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?
Julian Harrison
Yes, sure. So later this year, when you’re establishing the maximum tolerated dose potentially. I’m just curious that likely this involve Eniluracil being increased or potentially Capecitabine as well?
David Young
Yes. No, actually, so what we believe is that if we can decide on how DPD is inhibited, that 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, okay? 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 the slight modification.
And so every cohort after this will be just the change in Capecitabine. So we’ll be having a kind of after this next six or nine patients, we’ll have a standardized dosing regimens, one or two that we could use, if necessary, for to inhibit the DPD, for almost any dose of Capecitabine. That’s what we plan to do.
Julian Harrison
Thanks, David. That’s really helpful…
Jim Stanker
So just to add on to what David was saying is 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 Capecitabine 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.
David Young
Yes. So the MTD is really the MTD of Capecitabine not the MTD of 6422.
Julian Harrison
Right. Thank you very much.
David Young
Thank you, Julian.
Operator
Okay. We have no further questions in queue.
David Young
Okay. Thank you very much, everybody. I appreciate it.
Jim Stanker
Thank you.
Operator
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.
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