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spk07: Greetings and welcome to Processa Pharmaceutical's 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. To join the question queue, you may press star then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. 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.
spk05: 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 10Q, 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 circumstances. At this time, I will briefly touch on our published financial results, 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 September 30th, 2021, we had a balance of $19.1 million. During the nine months ended September 30th, 2021, we increased our cash balance by $3.7 million when compared to December 31, 2020. We accomplished this by raising $9.9 million in a private placement and spending $6.2 million for clinical trials, operating, and other related costs. While our operating cash flow for the nine months ending September 30, 2021 was $6.2 million, we only spent $2.5 million on what we define as overhead. Overhead includes our general and administrative expenses, as well as salaries for all employees, including our development team. For the third quarter of 2021, we reported a net loss of $3 million, or 19 cents per share, compared to a net loss of 3.1 million, or 55 cents a share, for the same period of 2020. The quarter ended September 30, 2020, included an expense of $2 million related to our licensing of 12-852 from the Yuhan Corporation. Adjusting for in-process research and development acquisition costs, our net loss increased by $1.9 million for the third quarter of 2021 compared to the comparable period for 2020. The increase in our acquisition adjusted net loss relates to increased costs we incurred as we progress with our clinical trials for PCS-499 in ulcerative necrobiosis lipoidica and PCS-6422 in advanced gastrointestinal refractory tract tumors. And we begin our Phase II trial in PCS-12852 in gastroparesis. We anticipate our costs will continue to increase for the rest of the year. as we continue to enroll patients in these trials and continue development activities for the other drugs in our pipeline. Our net cash used in operating activities for the nine months ended September 30, 2021, also increased by $5.1 million to $6 million when compared to $867,000 for the same period in 2020. The increase was due to cost we incurred in our clinical trials for PCS-499, PCS-6422, and PCS-12852, including advanced payments to our CROs and a $200,000 payment related to our licensing of PCS-3117. In February 2021, we closed a $10.2 million gross proceeds private offering of common stock from which we received net proceeds of $9.9 million after deducting offering-related costs. Following that offering, and as of today, we have 15.7 million common shares issued and outstanding. During the third quarter of 2021, we incurred research and development expenses totaling $1.7 million compared to $533,000 for the same period in 2020. The increase in our R&D costs of $1.2 million in 2021 was primarily due to costs we incurred related to our active clinical trials. During the third quarter of 2021, our general and administrative expenses totaled $1.3 million compared to $424,000 for the same period in 2020. The increase related primarily to increases in professional and other consulting fees, as well as non- non-cash stock-based compensation. Allocated between R&D and G&A is $2.3 million of non-cash compensation costs. That concludes my remarks. I'll turn the call over to our CEO, David Young. David, please go ahead.
spk04: 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 slides will be posted on our website, as Jim said previously. Let's go to our first slide, slide three. This slide provides you with a snapshot of the process of 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 are 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 beginning in the beginning stages of our discussions. Next slide. Slide four 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 this 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 capcitabine. We expect these same four drugs to be in Phase III 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 capcitabine and 499, which are now being clinically evaluated, and 12852, which we expect to be in patients in the first half of 22. Let's first look at next-generation capcitabine since the interim results are hot off the press. Next slide. Next-generation capcitabine, which we previously designated as 6422, is a chemotherapy treatment that includes 6422, a chemotherapy modifier, administered with capcitabine, currently 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 currently metabolized through the DPD enzyme to a metabolite called FBAL, which has no therapeutic effect and can cause side effects. 6422 irreversibly inhibits existing DPD in the body, shutting down the right side of 5-FU metabolism to FBAL. The shutdown of the right side results in 5-FU metabolism shifting to the left side, the side that forms 5-FU nucleotide, which kills cancer cells but also normal cells being synthesized, such as neutrophils. This shift, however, does not last forever because de novo DPD is formed over time, and if no 6422 is present, the new DPD can metabolize 5-FU to F-ball. We would expect that as long as next-generation capcitabine inhibits DPD, less F-ball is in the body than current capcitabine, and next-generation capcitabine is more potent as determined by a greater 5-FU systemic exposure per milligram of capcitabine dose. So what did our interim phase 1B results with only one dose of 6422 and seven days of capcitabine telus? 24 to 48 hours after administering a single dose of 6422, less than 10% of 5-FU was metabolized to FBAL compared to 80% reported for FDA-approved capcitabine. And the potency of next-generation capcitabine as determined by the 5FU systemic exposure per milligram of capcitabine administered, was at least 50 times greater than reported for current FDA-approved capcitabine. And in some patients, it was even 100 times greater. We also determined from this interim analysis that the improved metabolism profile and increased potency is transient and did not last for seven days after a single dose of 6422. Next slide. We believe that the change in 5FU metabolism over the seven days occurs because existing DPD is inhibited for 24 to 48 hours after a dose of 6422. New DPD is then formed, and no 6422 exists to irreversibly inhibit the new DPD. Therefore, we are modifying the Phase 1B protocol to better understand the timeline of DPD inhibition and de novo formation. so we can select regimens of 6422 that will inhibit DPD as long as capcitabine is administered. By achieving this, we not only expect next generation capcitabine to be more potent than current capcitabine, but we also expect to have a product that can provide a better benefit-risk profile important to FDA and to patients. The information from the modified protocol will be extremely valuable. and may allow us to treat cancer patients using a personalized or precision medicine approach, which likely would result in next-generation capcitabine taking over all the existing capcitabine markets, as well as some of the 5FU markets for multiple types of cancer. I would like to point out that we also are evaluating other regulatory submissions that could expedite the development of next-generation capcitabine. And even though we've had to call an audible after seeing the interim data, The timeline to initiate Phase III and the timeline for approval has not changed. Next slide. Let me quickly review 499, our Phase IIb drug, for which we have FDA orphan designation. NL is an unmet medical need condition that initially appears to be a dermatological condition, but is a condition that affects the skin and tissues below the skin. NL can last for months to years with complications such as infections, amputation of the limb, and cancer. Ulcers occur in about 30% of the patients, and conclusive diagnosis can only be accomplished through a biopsy, where the histological presentation is different than other ulcers, such as diabetic ulcers. Ulcerative NL is a serious condition with no approved drugs. The prevalence of ulcerative NL is 22,000 to 65,000 patients in the U.S., with the U.S. potential market of approximately $1 billion. The NL ulcers can occur naturally over the clinical course, or they can occur from contact trauma to the lesion because the skin becomes more fragile and brittle. More importantly, natural complete healing of moderate to severe ulcers during the first one to two years after onset occurs in less than 5% of these patients. As I said before, there is no FDA-approved treatment for NL, no standard of care, and all drugs used off-label are inadequate. because of dose-limiting side effects, which prevent the drugs to be given at a high enough dose to see significant efficacy in a formal trial. This includes a drug called pentoxyfilin, or as I often call it, PTX. PTX does work in closing the ulcers in some patients, but side effects limit the dose that can be administered. 499 is the deuterated analog of a metabolite of PTX. In our FACE-2A NL trial, complete wound closure was achieved in the only two patients who presented with ulcers. And each patient had contact trauma ulcers while on the drug. And those ulcers also closed within one month. Next slide. In our Phase IIb randomized placebo-controlled trial, three patients have enrolled, one patient is in screening, and one patient failed screening. A total of 20 patients are to be enrolled. The interim analysis expected in mid-2022 of both placebo and treated patients, is critical to guiding us in our development program as well as future regulatory submissions to expedite the development and approval of 499 in ulcerative NL. We expect to complete our Phase 2B study in 2022 and initiate our Phase 3 trial in 2023. Next slide. The last drug that I'll cover in this update is 12852, a very potent and specific 5-HT4 agonist. You may recall that this drug is being developed for the treatment of gastroparesis. There's only one drug approved for gastroparesis, metoclopramide, while other drugs are used unsuccessfully off-label. All these drugs have side effects that significantly limit their use. Given the high specificity and potency for the 5-HT4 receptor, The side effect profile appears to be significantly better for 12A52 than all of the drugs used for gastroparesis, which would make 12A52 the drug of choice in this $1 billion market. To date, we have received a study to proceed letter from the FDA for our Phase 2A trial. The trial is a placebo-controlled randomized dose response trial evaluating the gastric emptying rate and symptoms in gastroparesis patients. The study is expected to enroll its first patient in the first half of 22 with final analysis in the second half of 2022 or the beginning of 2023. Next slide. Over the next six to nine months, we expect for next-generation capcitabine to interact with the FDA regarding a modification to the Phase 1B protocol, to modify the Phase 1B protocol in order to evaluate the timeline for DPD inhibition and DPD de novo formation. to restart the Phase 1B trial enrolling patients mid first half of 22, to complete an interim analysis on the timeline of DPD inhibition. And for 499, we expect to complete enrollment of patients for interim analysis and possibly complete the interim analysis. And for 12852, we expect to begin enrollment of the Phase 2A trial. Also, since we are now evaluating if we qualify for regulatory submissions, to expedite development and approval, for example, fast-track and breakthrough therapy, we expect to have at least one additional regulatory submission for one of our pipeline drugs within the next six to nine months. Next slide. This table is just a repeat of the first table to remind you where we are now and what we expect to achieve in 2022 and beyond. I hope this earnings call has given everyone a better understanding of what we've accomplished over the last three months as well as what we expect to accomplish over the next 6 to 15 months. This concludes my remarks. I'll now pass it to the operator to open the phone lines for Q&A. Operator, can you please poll for questions?
spk07: Absolutely. We will now begin the question and answer session. To join the question queue, you may press star, then 1 on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star, then two. We will pause for a moment as callers join the queue. The first question comes from Robin Garner with Craig Hallam. Please go ahead.
spk08: 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.
spk04: Hi, Robin. This is David. That's a good question. It gave us a hint that it would be more potent, but we did not think it would be this more potent. So this is greater than we thought.
spk08: Okay, great. Thank you. And then a 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?
spk04: Sure. So the interim data, the interim analysis is supposed to be anywhere from 8 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 499-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 present it to FDA if we go for a fast track or a breakthrough therapy or whatever else we do in terms of our regulatory submission.
spk01: Okay. Thank you very much. Thank you, Robin.
spk07: The next question comes from Francois Brisbois with Oppenheimer. Please go ahead.
spk03: Hi. Thanks for taking the question. I apologize if you hear some barking in the background. So interim data here for 499, just to be clear, is still, you mentioned, you know, from first half to mid-2022 and then we still feel comfortable to complete the trial, you know, and have data of the full data set in 22, or just to double-check that?
spk04: Yeah, that's a good question. You know, 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, you know, we'll just have to see how that goes. The expectation is 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. So the analysis itself should not take much time. It's just like you said, getting the patients in. Now, in terms of 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 least for the top line analysis, we'll be able to get that. We won't have the full all the secondary endpoints and all the, you know, exploratory endpoints, all those won't be done by the end of the year. But hopefully we'll at least have the top line result by the end of the year.
spk03: Okay, great. And then on the 6422, you know, this is pretty fresh data. You talk about the 50 times exposure that Robin just mentioned. And I'm just trying to understand, in terms of the safety aspect, that maybe we can see here, was the dose use or are you not disclosing doses yet of capcitabine? Would you even have expected maybe some hand-foot syndrome? And then, you know, to counter that question is, if it's going the other side, you know, instead of the F-ball, if you're going more towards the tumor activity, how comfortable are you that a higher exposure, higher potency of 6422 wouldn't necessarily, wouldn't maybe trigger side effects like neutropenia.
spk04: Okay. So, let me see if I can remember all the questions here. Let me do the last one first. Okay, Frank. You know, we have to evaluate that. We have to evaluate if, in fact, the doses we give when you shut down DPD is actually going to result in neutropenia. or in GI distress or diarrhea and things like that. Those things have to be evaluated. And that's why we're increasing the dose of capcitabine to determine 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 DLTs, 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 capcitabine, 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 capcitabine by itself that goes 80% to FBAL and 20% the other way. So you really can't compare exactly the AUCs. That's not appropriate from a PKPD point of view. But we're getting to levels that you would expect in the next one, the 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.
spk01: Okay. Go ahead. I don't know if I answered everything, Frank.
spk03: No, no, you absolutely did. And I'm just trying to make sure that in terms of the hypothesis here, is it more that if you give, you know, with 6422, if you give quipcitabine at the old dose, would it be safer or is it potentially just a safer combo because you would give a smaller dose of capcitabine?
spk04: That's a good question. I can tell you what happens, what would happen. And I think we know this, you know, both from preclinical past data as well as past studies. If you gave 6422, completely shut down DPD, and you gave the dose of normal capcitabine, right now what you 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 Hines-Flood syndrome. You would not have the other things going on. But you would definitely have some neutropenia problems.
spk03: Okay, great. And then, sorry to, I just, it's pretty fresh data. So, on the bio, you've talked about biomarkers for 6422. 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'll just finish with this. Any reason we did not talk about 3117 here? And that's it.
spk02: Okay.
spk03: Okay.
spk04: So in terms of the biomarkers, 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. Okay, so that's one approach, right? The other approach is to use biomarkers to tell you what direction your efficacy is going, you know, to guide you in terms of your dosing. It's pretty much like therapeutic drug monitoring like we did with genomycin, zeothelin, digoxin, you know, 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, you know, 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, oh, you know, 6422 has stopped working now and there's DPD coming in. So we've got to either give more 6422 or we have to change the dose of capsaicin 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 patient 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 3117, we did not present anything in 3117 because, you know, 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 some of these are new assays There are assays that we actually have to develop quickly. It's not an assay that, you know, can take weeks and weeks to develop, weeks and weeks to run. It's something that when we get into clinical studies, it has to be turned around fast. So that's taking a little more time, planning those out, you know, 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 what 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.
spk01: Understood. Thank you very much. Thanks, Frank.
spk07: The next question comes from Aiden Husanoff with Benchmark. Please go ahead. Hi.
spk06: Thank you very much for taking my questions. So I have one on 499. Just wanted to understand... the enrollment process and why do you think it was slower than expected? Also, you mentioned the interim analysis that they need 2022. So would that mean that the enrollment will be completed by the end of this year?
spk04: 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 it an extra one or two months to complete that enrollment. So we think the completion of the interim analysis group will be completed in the first quarter of next year. All right. 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 recruitings. We're doing the national recruiting. You know, we're not saying, site, 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 talk to all their patients. And 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 approach. You know, all dermatologists, all dermatologists, you know, really hit it hard, all types of patients, all types of physicians, let people know about it, and then hopefully then direct them to a site. If we get somebody interested, we'll direct them to a site. Go to this site. And because we're going to pay some of the transportation, it's easier for them to go to different sites. So we're really pushing it hard.
spk06: 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, you know, when the phase three potential phase three could be completed and when the drug would be approved?
spk04: I sure hope so. I sure hope so. But I can't answer that right now. That's a hard one until we We talk a little bit more to the FDA. We are going to be pushing that. We believe that the increased potency with the decrease of side effects, at least the HFS and neurotoxin, cardiotoxicity side effects, with the 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.
spk06: And did you have any feedback from medical oncologists who use capsaicin and just kind of general feedback about the possibility of having next-generation capsaicin? Any survey, formal or informal?
spk04: Yeah, so we've talked to – there are oncologists in the studies, and there's oncologists who are consultants and advisors who we talk to. Everybody likes the idea. 100% of them like the idea. They like the approach. They've said to us that if you can get a next-generation capcitabine that doesn't have the side effects that capcitabine has, like the neurotoxicity, cardiac toxicity, those type and 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 the purpose of the MTD 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 dosed these patients and are very, very enthused about the drug and what we're doing, when we told them that we were going to be modifying the study, which requires us to put a hold on the study for a little bit, um make some changes you know have to get new irb approvals etc all these kind 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 yeah yeah that's fine uh that's not a problem as long as you think it's it's ethically and it's 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 have said, okay, fine, and they would have said, we're not keeping our patients on it. But they didn't.
spk01: All of them are interested in, if they can, keep the patients on it. Okay, understood. All right, thank you very much. Thanks, Aiden.
spk07: Once again, if you have a question, please press star, then 1. The next question comes from Julian Harrison with BTIG. Please go ahead.
spk02: Hey, congrats on all the recent 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 NLU or SIL to 5FU ratios? Thanks.
spk04: 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, dosing, 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 capcitabine. And there was no more, and then capsidamine was dosed for seven days, and there was no more 6422 administered. Okay. 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 capsidamine. So there will be doses of 6422 also after, during the dosing of capsidamine. So that's the first thing. And again, I can't get into the specifics because we're still left to negotiate and discuss that with the FDA. The second point you asked about is, you know, 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 a completely different ratio. It's a much, much lower ratio. So, much, much less 6422, right? Now, in terms of the paper done by the publications and work done by Riviera, for example, that was lower dose. That was given multiple days. You know, in terms of the given dose on a given day, our ratio will still be about the same or a little lower, but not higher.
spk01: Got it. Very helpful. Thanks again.
spk07: This concludes the question and answer session. I would like to turn the conference back over to Dr. David Young for any closing remarks.
spk04: Thank you. I just wanted to thank 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 interactions 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.
spk07: Thank you. This concludes today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.
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