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spk05: Good morning and welcome to the DELCAD Systems second quarter fiscal 2022 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask a question. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to David Hoffman, General Counsel of DELCAS System. Please go ahead.
spk00: Thank you. And once again, welcome to DELCAS System's second quarter 2022 earnings call. With me on the call are Gerard Michel, Chief Executive Officer, Dr. Johnny John, Senior Vice President of Medical Affairs and Clinical Development, Kevin Muir, Vice President of Commercial Operations, John Papora, Chief Operating Officer, and Anthony Diaz, Vice President of Finance. I'd like to begin the 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 Exchange Act of 1934. Although the company believes that expectations and assumptions reflected in these forward-looking statements are reasonable, it makes no assurance that such expectations will prove to have been 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, which could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in the company's annual report on Form 10-K, those contained in subsequently filed quarterly reports on Form 10-Q, as well as in other reports that the company files 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. Now, I would like to turn the call over to Gerard and Michelle. Gerard, please proceed.
spk15: Thank you, everyone, for joining today. Belcab has had a very productive second quarter of 2022 and year-to-date. For both the Hepzido kit, the company's investigational product candidate with the United States, and ChemoSat, the company's marketed product in Europe. In the U.S., we continue to move forward towards the resubmission of a new drug application for the Hesato kit late this quarter. As previously reported, in late April, we completed a pre-NDA meeting with FDA, and based on that interaction and subsequent meeting minutes provided by FDA, which incorporated feedback and recommendations, we see no barriers to a resubmission of the NDA with the current data in hand. For purposes of the NDA submission, all queries have been resolved and are considered complete, and the focus trial database has been locked. While the database is locked for purposes of the submission, I want to remind listeners that certain time-to-event endpoints, such as overall survival, will continue to mature through mid-2023. DELCAP expects to provide FDA with routine periodic updates of the additional data in future submissions. Within 30 days after the resubmission, we expect the FDA will confirm receipt of the submission, and if they agree the submission is sufficiently complete to warrant review, which we fully expect they will, establish a producer date six months from the submission date. While we do not know whether the FDA will convene an advisory committee, we are preparing for one and look forward to the opportunity to highlight the status of efficacy and safety. The foundation of the NDA resubmission is the focus trial results. for which Dr. Jonathan Zager, Global Lead Investigator, provided an update during ASCO's annual meeting in June. I won't take the time to review those data here, since I have covered that many times in various forums, and the updated data was largely consistent with the early data release. I will simply reiterate that we believe the totality of the efficacy data demonstrates that Hepsado produces clinically meaningful benefits to patients suffering from liver-dominant metastatic acromelanomas and that its safety profile is in line with other traditional cytotoxics. Taken together, we believe the data supports a very positive benefit-risk profile for patients. In an effort to ensure suitable patients have access to the Hensato kit during the NDA preparation and FDA review, we have started opening expanded access program, or EAP, sites. The first site opened has completed three treatments to date and has another three treatments scheduled for this month. The pace of treatments will increase as more patients are referred to the treating site. A second site has started to screen patients but may not start treating until October due to clinical trial coordinator staffing issues. We will be judicious in our pace of opening EAP sites to ensure the treating sites are well qualified and prepared. Although investigators at clinical trial sites are interested in participating, clinical staffing turnover and shortages that have occurred over the last year at many of the clinical sites make it imperative to that we are certain that a well-trained team is in place before we allow treatments to go forward. To this end, we have recently hired a dedicated medical device procedural trainer who will work with potential EAP site treatments. The procedural trainer will also complete the development of Roblox training program needed for commercial launch and lead our overall training effort. Based on the ongoing usage of Chemoset in Europe, during the second quarter, additional European office publications supported of Chemosat, and by extension, Hepcet or Kit, were published. I'll cover just two of them now. At ASCO, researchers from the Leiden University Medical Center in the Netherlands presented additional data on the Yango and Chopin trial. The goal of this investigator-initiated combined Phase 1B randomized Phase 2 trial is to study the safety and potential synergistic effects of systemic immunotherapy, ipilimumab plus nivolumab, or ipinivo, when combined with DELF-CAS proprietary liver-targeted treatment in metastatic uveal melanoma patients. The primary objective of Phase B was to determine the safety and toxicity of the combined products, and last summer at the 2021 cardiovascular interventional radiological society of Europe conference, the investigators reported that there were no dose-limiting toxicities and that the Phase 2 randomized course to the trial comparing PHP alone to PHP with the epinephrine had commenced. In total, 79 to 88 patients will be treated in Phases 1B and 2 combined, and we understand that to date, 28 patients have been enrolled. While the primary purpose of the first phase of the trial was safety, efficacy results on seven patients treated with combination PHP with ipinevo were reported this past quarter at ASCO, and the results were noteworthy. The poster reported an objective response rate of 85.7% and a disease control rate of 100%. At a median follow-up time of 20.2 months, four patients have an ongoing response according to RESIST criteria. The presentation reported a median progression-free survival of 22.4 months, and all patients were still alive. If similar results are seen in the current larger randomized phase two portion of the trial, and the combination continues to be well-tolerated, it could represent a significant improvement over current standard of care, including PHP alone. It is important to take a moment to explain why this investigator-initiated trial is of great interest to DELCAP. Combination therapy is a rational approach, since while liver failure due to hepatic mets is the leading direct cause of deaths for metastatic ocular melanoma patients, as many other types of cancer cells, such as colorectal, extrahepatic mets do occur, and treatment with PHP alone cannot effectively treat these, while systemic immunotherapy has very limited efficacy on liver mets. Logically, companion therapies may lead to better control of both hepatic and extrahepatic disease. Beyond these additive effects, there are compelling reasons to believe the combination could have synergistic effects. First, tumor license induced by PHP treatment could provoke antigen release that may lead to enhanced antigen presentation and increased efficacy of immunotherapy. Secondly, a related but distinct possible synergic effect is based on the unique role the liver plays in the systemic immune system. The liver, continuously exposed to food and microbial antigens from the intestine, avoids autoimmune damage through the use of specialized mechanisms of immune tolerance. An extensive body of published literature supports that the liver is an immune-privileged environment and functions as a systemic immune-modulating organ, possibly enhancing tolerance due to tumor antigens outside of the liver. It is well documented that patients with liver mets derive limited benefit from immunotherapy, possibly due to these effects. In pre-clinical models, the elimination of hepatic, of immune cells resident in the liver has been shown to reverse the immunosuppressive effect of hepatic catastrophes. This may be relevant to the HPSADAR kit and chemosat, given high doses of melatonin in the liver may be reducing the local and systemic immunosuppressive effect of hepatic catastrophes, by depleting the various immune cells in the liver responsible for these effects. We look forward to further data coming out of Leiden, both in terms of patient outcomes as well as other analyses which may help elucidate whether a chemo site is actually improving the efficacy of immunotherapy by the elimination or reduction of the immunosuppressive effect of hepatic metastases. While the results will be important in terms of treatment of metastatic doctor melanoma patients, they could have relevance across multiple tumor types where hepatic metastases are present and immunotherapy is an accepted treatment. Last week, a retrospective analysis of patients treated with PHP at three European centers was published in the journal Cardiovascular Interventional Radiology. The study included 101 patients who were treated with a total of 212 PHP procedures between 2014 and 2019. After a medium follow-up time of 15 months, a complete response was reported in five patients, partial response in 55, and stable disease in 30. resulting in an overall response rate of 59.4% and a disease control rate of 89.1%. The median progression-free survival was 9 months, and overall survival was 20 months. The study also found statistically significant differences in overall survival between patients who had complete response, partial response, or stable disease and progressive disease. For example, patients with complete response or partial response, the median overall survival was 27 months. For patients with stable disease, the median overall survival was 21 months, and for patients with progressive disease, the median overall survival was eight months. This correlation between response status and overall survival is critical, since response rates do not always correlate with survival. As overall response rate is the primary endpoint of the focus trial, from a regulatory perspective, any supportive data showing a correlation between overall response rate and survival is helpful. As we have previously reported, we did see the same correlation in the FOCUS trial, and we intend to share the details of that specific analysis at an upcoming medical conference. For the safety analysis in this publication, the most common adverse events for hematological toxicities were grade 1 and 2 and self-limiting in the majority of patients and consistent with previous reports on PHP. Other adverse events were thromboembolic in nature. The adverse events reported in this retrospective study are consistent with other publications and the focus trial results. Turning to the commercial progress of Chemosat in Europe, the second quarter was the first full quarter since we resumed direct responsibility on March 1 for sales, marketing, and distribution activities. Q2 unit volumes were down approximately 10% from Q2 of 2021. but essentially flat if one takes into account that almost all patients being treated with chemo set in the Netherlands are being enrolled and treated in the Chopin trial. In terms of unit performances over Q1 2022, growth was over 75%, but the first quarter and second quarter unit volumes may have been impacted due to the business transition from MEAC back to DELCAP on March 1. While we expect meaningful growth going forward, I would not expect that level of quarter-on-quarter growth. on a regular basis. We are satisfied with this performance since we have a very limited team in place at the moment with only a single account manager in all of Europe. Clearly, the current business is primarily being driven by investigator word of mouth, and we are confident we can drive uptake as we build our commercial infrastructure. Revenue comparisons at this time are not relevant given in prior quarters revenue is comprised of product sales and MEDEC and a share of growth profits. Our primary focus in Europe at the moment is hiring an account representative in Germany to increase referrals, utilizing our medical affairs personnel to foster increased support in larger markets such as Italy and France, where we do not yet have much active commercial business, and developing the submission packages for national coverage in major markets. We anticipate submitting for national coverage in the United Kingdom, Austria, and the Netherlands by the end of this year. In 2023, we'll submit for national coverage in France, Italy, the Scandinavian markets, and other select smaller markets in the EU. We already have reimbursement in Germany under the ZE scheme, but we need to work to increase awareness and subsequent referrals to the trading centers. While it will likely take several years to obtain national coverage in the majority of major markets, we are confident that Europe will become a meaningful revenue contributor to the business, with EU revenues likely growing along with U.S. commercial launch at Pesado, if approved next year. I want to note that given the difficult capital market situation, we have decided to manage the European business on a cash flow neutral basis to maintain adequate capital to support the U.S. submission and launch. At the moment, the European business is self-sustaining, and we continue to continue to be so as revenues grow and are reinvested in the European business. While we continue to plan on expanding the PHP platform to other indications, like many companies in this difficult capital markets environment, we need to prioritize the shorter-term, higher-return activities, which is clearly the submission of the NDA and preparation for a potential U.S. launch. We continue to hold advisory boards to obtain feedback on and review proposed clinical trial protocols, including atriohepatologic carcinoma and colorectal, as well as discuss IITs in various areas, including other combination immunotherapy trials. Although we believe, based on feedback and protocol proposals, that there is real interest from the investigators to expand the usage of Hepsado and ChemoSaf. The timing of the trials may be delayed to ensure the activities most critical to the success of the business are adequately funded. We are confident we can access the capital necessary to fund the business and want to do so in a manner that minimizes dilution to our existing shareholders. Hence, our decision last month to raise $5 million in what was effectively a straight common deal priced at markets versus a larger raise, which may have involved much less favorable terms. I look forward to taking questions, but first we'll turn the call over to Tony to review the financials. Tony?
spk09: Thank you, Gerard. Product revenues for the three-month ended June 30th, 2022 was approximately $797,000 compared to $398,000 from the prior year quarter from the sales of Chemostat in Europe. Since the second quarter of 2022 was the first full quarter of direct sales, It is not comparable to the second quarter of 2021 in which we generated product revenues for the European distributor on a revenue share arrangement. Research and development expenses for the quarter increased to $5.5 million compared to $3.5 million in the prior year quarter, primarily due to high professional service costs relating to the preparation for our NDA submission by the end of the third quarter of 2022. Selling general administrative expenses for the quarter was approximately $4.1 million compared to $3.3 million in the prior year quarter. The increase was primarily due to pre-launch costs related to the commercialization of Rosado. Interest expense increased to $665,000 from $40,000 a year ago due to the interest expense and amortization related to the debt financing that we entered into on August 6, 2021 with Avenue. On June 30, 2022, the company had cash, cash equivalents, and restricted cash totaling $14.4 million as compared to cash, cash equivalents, and restricted cash totaling $27 million on December 31, 2021. During the six months ended June 30, 2022 and 2021, we used $12.4 million and $11.7 million respectively of cash in our operating activities. July 20, 2022, we closed the private placement for $5 million issuance and sale of 690,954 shares of common stock and 566,751 pre-funded warrants to purchase common stock to certain investors. Each share of common stock was sold at a price of $3.98, and the pre-funded warrants were sold at a price of $3.97 per funded warrant. The pre-funded warrants have an exercise price of a penny. per share of common stock and are exercisable immediately. We received those proceeds from the private placement of approximately $5 million before deducting offering expenses. That concludes my financial remarks. I ask the operators to open the phone lines for Q&A. Can you please check for questions?
spk06: We will now begin the question and answer session.
spk05: To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press more than two. At this time, we will pause momentarily to assemble our roster.
spk06: And our first question will come from Scott Henry of Roth Capital.
spk05: Please go ahead.
spk11: Thank you and good morning. I did have a couple questions. I guess for starters, since we just went through the financials, you know, with the top off from the private placement, do you think that gives you the runway to get to an FDA response? I think it would be close, but I was just curious your thoughts.
spk15: I think It would be that we could do it by making some very difficult choices, and I think we'd probably be prudent to probably do something a little prior to that.
spk11: Okay. Thank you. That's helpful. And then staying on the financial side, I just wanted to check. So under the direct sales in Europe now, does other revenue that we've seen in prior quarters, does that go away? And at the same time, should we think of the 797 as a base going forward? And as well, the gross margins, are they what we would expect to see under the new model?
spk15: Yeah, in terms of viewing that as the base, yes. And again, the prior quarters were a mix of supply sales and gross profit split. In terms of gross margins, yeah, we should just look at that as kind of the proper percentage going forward.
spk03: Tony, chime in if I've got anything wrong there. I guess I got it right, so. Perfect, thank you.
spk11: And, you know, I know we've, I just wanted to ask the question, I know we've always expected a six-month FDA review Is there any risk to the FDA wanting a longer review or how comfortable are you in the six-month review assumption?
spk15: Well, you know, I can give you the puts and takes on that. You know, the net is we're comfortable they should be able to get through this because it really is one trial. And it's not a huge trial that they have to evaluate. So that really is in many ways a simple story for them to go through. I can't, you know, we all know the FDA is busy. We all know that pushback reviews. So I really can't comment on whether, you know, this division is more likely than not, et cetera, to do that. But, you know, again, it's a single trial they have to review, which really, you know, helps us dramatically in terms of, you know, the workload they have to go through. And then we're really endeavoring to write this NDA in a way to facilitate their review. And there are certain ways to do that, just to make the links together well in terms of story, et cetera. So I would say there's a very good chance. As reviews go, this is a very light one for them. But I can't, you know, on their behalf, I can't say I guarantee they'll get through it in six months. But I think they certainly should be able to.
spk11: Okay, great. Thank you for the callers. Final question, just with regards to the expanded access program, how should we think about that as a means to prepare the market such that when you do get approval, the expanded access program is in place and they're really centers that you convert into revenue-producing centers? Is there a way to quantify how much of an impact that could be, at least in that that initial year from the expanded access centers?
spk15: Well, yeah, I think one way that, I mean, I can give you, you know, the inputs to a model, excuse me, the framework of a model. And, you know, I want to be careful not to give some specific numbers. I mean, I'd like to strive towards having at least five open eyes. That depends. The headwinds to that are one, frankly, you know, the This expanded access protocol cost us about as much as a Phase III does in terms of individual sites and patient costs. So, again, in a different capital market situation, we've kind of pulled that back a bit. I'd like to strive to get to five. The second thing we've determined is that, you know, there's been a lot of staffing issues and a bit of turnover at a lot of clinical sites we have. And we have always been, but it's really brought a fine point to it. We want to be very careful to make sure everyone on the team is well trained. So we're being judicious in opening these up. We're not just saying, hey, you were part of the trial. We're making sure everybody in that room has gone through the appropriate training and having the exact same path the characters are realizing is not quite as feasible as we had hoped, given the dynamics I mentioned before. So that'll limit the pace at which we bring them on board. Again, we're going to target five. We'll see what happens. But we'll now want to make sure every one that's opened is doing it properly. In terms of how to use it for a commercial kind of mindset, I mean, I think One way to think of it is, let's say a site could do, on average, one to two patients a week. Let's say they got one IR suite a week or so. And if you thought of six to ten patients at a site a month, based on that, and then you thought through pricing, if you wanted to price it comparable to IPINIVO to... You know, you're looking at a price of at least 75K. You can start understanding with that framework what a site might be worth and what type of revenue you might generate out of the blocks. And, again, that's really dependent on the EAP sites we have up and running when we get launched. And I just mentioned the dynamics behind that as well. So hopefully that framework will allow you to kind of put together a spreadsheet, but I'll let you come up with your own assumptions in terms of number of patients a month, how many EAPs, pricing. I don't want to be nailed down precisely on those things, aside from saying we're going to try to target to get to five, and we'll see if we can do that.
spk11: Okay, great.
spk03: Thank you for taking the questions.
spk06: The next question comes from Marie Sebald of BTIG.
spk04: Please go ahead. Thank you. Good morning, Gerard and Tony, and congrats on the progress. I wanted to check here, now that we're in the final weeks before the resubmission, what else needs to get done? Are you just in the final writing stage, or are there any other tasks to check off the list?
spk15: Pretty much the final writing stages. If you go through this, you're occasionally additional analyses that you want to run. But, you know, Johnny, why don't you talk through kind of where you're at in terms of pulling together the critical modules, Module 5, and then clinical sections of Module 2.
spk13: Sure. Thank you, Gerard. Yes, as Gerard said, the database has been locked, and we have all the data in hand. We are putting it through all the programming that was programmed earlier to get the outputs and the analysis. In terms of documents, there's a variety of documents that go into the different modules, and they're all being worked on concurrently as we go week by week, and this includes the clinical summary report, the summary of clinical efficacy, the summary of clinical safety. We have a PK manual and a PK analysis, a pop PK analysis that we're also conducting. We're also putting together the REMS program that's required for the submission. So a variety of different tasks are in play at the same time, and that's where we currently stand.
spk04: Okay, great. Very helpful. And then I wanted to go back to the retrospective study that was published and press released last week. Certainly some very impressive data coming out of that. And I wanted to hear how you'll be using that sort of commercially in the U.S. with your direct sales team, as well as whether it will be part of any of your submissions to support reimbursement in those various countries you discussed.
spk15: Yeah, so it's certainly, if it's published, you know, we'll be able to use it in detail, which is helpful as long as it's consistent with the label, which it will be. So, yeah, we'll leverage any literature we can that's consistent with the label that's published. And if it's not consistent with the label and the doctors are interested, of course, the medical affairs teams can talk about it as well. Any data we have, you know, will be, It's just supportive, but we'll also put it in front of the FDA. And then lastly, in terms of national coverage submissions, again, all of that data that's published is very helpful and supportive. I think a critical component that's also going to be in the NDA is the quality of life study. One of those came out, I think it was Germany, I didn't mention on this call. But then we have another one I think that's based predominantly on patients out of Leiden, that we're going to use to support the UK submission, national coverage submission, as well as a variety of others. So all the literature is helpful for national coverage, and then we have some specialized quality of life retrospective analyses, or prospects, excuse me, that we will include in the national coverage submissions.
spk06: Okay, thank you so much. The next question will come from Bill Mahan of Canaccord Genuity.
spk05: Please go ahead.
spk08: Hi, good morning and thank you. So just looking forward to launch preparation. Is there anything, any other programs or efforts that you need to undertake other than getting the EAP sites up and running? And are any of those kind of on hold or being rationed as you look to be good stewards of capital?
spk15: I'd say we're probably slowing down a few things, but given this is such a focused prescribing population, it doesn't have much of an impact. But, Kevin, why don't you just give a brief overview of some of the major activities that are taking place right now in terms of commercial products?
spk14: Thank you, Gerard. Currently, we are working on our branding from a marketing aspect. as well as our market access. We are putting together a patient access assistance program, and those will be kicked off in Q4, the end of Q4, and should be in place by the time for approval in the April timeframe. So they should be ready for approval, considering the six-month timeframe we've been talking about.
spk15: I think, Kevin, some of the more important things you're doing as well are looking very carefully in terms of the codes that will be used to make sure that the hospitals are appropriately reimbursed for actually conducting the procedure. We've mapped out codes that are similar. They may end up using miscellaneous codes, but what's helpful with the codes that are most similar to what we're doing now do reimburse well the procedure but that's very helpful that we can point to something that has a decent price to it in terms of the procedure even if we end up using a miscellaneous so we're going through those necessary mapping processes as well so that we have a full kind of reimbursement kit to assist the hospitals with when we launch okay and i know you said you're in the final writing stages of the nda but just to to
spk08: be a little more specific. Do you have all of the data or assurances you need from any third parties and everything is in-house, or is there anything else that's out of your hands that you're relying on someone else for to keep to your timeline?
spk15: Yeah, I think we have virtually everything. I think the top PK model is not in hand days away from being in hand, so that's That's good. I should be on top of that, but that's one where I don't know exactly past that. But there's no data gaps or anything like that that we need. Everything is pretty much at hand. Really what it is now is just taking this all and getting all the writing done, which we are relying to a tremendous degree on outside medical writers. I can't hazard a guess on how many are involved, but it's probably well over a dozen people running up the various modules assisting us. But in terms of data becoming dating, that's not going to occur.
spk08: Okay. And then on the takeover of the EU commercialization, has there been any just kind of qualitative learnings from you having switched to a direct sales approach? model in terms of receptivity of doctors, any challenges that you've identified?
spk15: Yeah, what we found out in, well, first of all, I think a lot of the treating centers hadn't seen anyone, any representative for a very, very long time for the product. So that was not necessarily a surprise to us, but It confirmed what we suspected. The second thing is where we have run surveys, for example, we ran one in Germany. The docs who were aware of the treatment and using it were very, very favorable. The issue really is that broad knowledge of different referring centers about effectiveness of the treatment, the process to do referrals, et cetera, and that's where they need to increase. In Germany. In the UK, you know, there are opportunities to get regional funding while we're waiting for NICE. There haven't been really any dramatic attempts to access that. So now we're starting that as well. So we've heard nothing that gives us pause to say, hey, you know, there really is negativity about this product. It really has either been, you know, crickets or alternatively, you know, just not a lot of support since they got it. got the product, so we are really confident we can drive uptake. Now, there's only a limit on how much you can do when patients are primarily paying out of pocket in much of Europe when they use it, but we'll access regional funding in the short term and then try to get national coverage in the longer term to drive uptake.
spk02: Thank you very much.
spk06: The next question comes from Yale Jen of Laidlaw & Co.
spk05: Please go ahead.
spk10: Good morning, and thanks for taking the questions. My first question is that what's the inventory preparation at this point preparing for the launch? And then I have some follow-ups.
spk08: Sure.
spk03: John, do you want to take that one?
spk12: Sure, Gerard. Thank you. Hello, Yael. Thank you for your question. So, inventory preparations, as you know, we have, this is a sterile product. So, we're keeping a watchful eye on X3 dating of all of the various that contribute to HEPZOTO kits. So, we're judiciously monitoring all of that and amassing launch quantities, certainly at the appropriate time. We see no issues with pulling together inventory for initial launch, both on the drug and device component side.
spk15: Yeah, I think it's important to note, John, is you're keeping a careful eye on lead times.
spk12: So given the supply chain issues that we've sort of been working through during the conduct of the focus trial, we have certainly seen monitored all of the supply chain issues that could uh become a rate limiting factor and have built that into our inventory bills and calculations so as of this moment we don't see uh that to be any rate limiting issues on any component okay great that's very helpful and uh in terms of the potential adcom meeting if that happens uh what
spk10: Any comments on what sort of preparation you guys may have at this point? Because this could be a very quick thing in the first quarter of next year.
spk15: Sure. Johnny, you want to talk a little bit about the prep we're planning on and, you know, the third party we might bring in? You don't need to name the name, but our efforts there.
spk13: Yeah, sure. Thank you, Gerard. So, yeah, we have, you know, we're not getting a clear indication if we will be in front of an advisory committee, but we are starting the preparations for that. And in turn, we will, as George said, be, you know, interacting with a third-party vendor that is a specialist in preparing, you know, sponsors for this type of event. Internally, we will put together, you know, different slide decks about our data and efficacy and specifically about addressing any concerns that we think may come up during the FDA review, and then highlight the safety and efficacy, of course, that we saw in our analysis, and that'll be part of the submission. So this is a large amount of preparation and slide preparation with contingencies for questions that may come up during this event if it does take place. occur over several months, starting as soon as possible and going into the early part of next year.
spk10: I'm sorry. Should we anticipate feedback from the FDA 30 days after you file for the resubmission of the NDA? They will give you a hint as to whether that could happen?
spk15: John, before I chime in if I'm incorrect here, but I don't think they're really going to give as much of a hint until, you know, the end of the year, the earliest January, more likely. But, John, do you have any other thoughts on that?
spk12: Yeah, sure, Gerard. The first 30 days is simply a cursory review to determine if the filing warrants a substantive review. So once FDA starts the substantive review, we could potentially be in receipt of any information requests that they so desire from that point forward.
spk15: Right, but I'm saying, hey, you're going to have an advisory panel meeting. Generally, you don't know until they give you notification, I believe.
spk12: That's correct. They will tell you that we plan to take your product to an advisory committee, but, again, they have to cut through certain amounts of data and a certain amount of time has to pass by. It's not actually defined. If we do have an advisory committee, it'll probably be in month five of the review.
spk10: Okay, great. And maybe the last question here is that you mentioned about the checkpoint combo study and that you will have the third data readout. Do we have any sense what time that data readout might be?
spk15: Johnny, what is the latest you're hearing out of LIDEN that you can share?
spk13: Yeah, so the next readout they have scheduled is approximately after 40 patients, as we had mentioned during our remarks that we're currently at around 28. The 28th patient has been treated. So we have been, you know, discussing the next potential readout because we also would like very much to see some additional analysis. But currently, you know, they are looking at around the 40th patient, when the 40th patient is treated, which is in about 12 additional patients that have to be treated.
spk10: Okay, great. That's very helpful.
spk03: Again, congrats on all the progress so far.
spk02: Thank you.
spk06: Once again, if you would like to ask a question, please press star, then 1.
spk05: And our next question will come from Suyam Pakula Ramakant of HC Rainwright. Please go ahead.
spk01: Thank you. I hope you're able to hear me well because it's been choppy. The whole call has been choppy for me. We can hear you, Arthur. Very good. Most of my questions have been asked. I just have one question on the EAP program. I know you said that in earnest the program may not have patients enrolled until October. So if that's the case, and then when you are about to commercialize Hepsado in the U.S., would there be enough data from that program so that you can use it use the data for commercialization process.
spk15: I think, I mean, at that moment from that particular study, it probably wouldn't be much, but any amount is helpful when it eventually gets published. But I think, you know, if you look at the steady stream of data that's coming out of Europe for chemosat, which is effectively the same product, I think that will be very supportive in terms of the U.S. law.
spk01: Okay, perfect. I'll stop here and then I'll talk to you folks later.
spk03: Thank you very much. All right, thanks, Arte.
spk06: This concludes our question and answer session.
spk05: I would like to turn the conference back over to Gerard Michel for any closing remarks.
spk15: Yeah, I just want to thank everyone for their continued support. This is really an exciting time for the company. After a very long journey, we're on the cusp of resubmitting the NDA, confirming a PDUCA date 30 days after that, participating in a possible on-campus drug advisory committee, and if the NDA is approved, commencing a U.S. launch. And in parallel, we're building a commercial team in Europe while submitting for national coverage in major markets. Importantly, more clinical data will likely be generated by the Japan trial the relevance of which could extend well beyond metastatic oculomelanoma. So, look, I look forward to continuing to update all of you on future calls, and have a great day.
spk06: The conference is now concluded. Thank you for attending today's presentation, and you may now disconnect.
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