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spk06: Good day, ladies and gentlemen, and welcome to the Delcath fourth quarter 2021 earnings call. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, David Hoffman, Delcath General Counsel. Sir, the floor is yours.
spk04: Thank you. And once again, welcome to DelCast Systems' fourth quarter 2021 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 Pappora, 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 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 or a discussion of such risks and uncertainties which could cause actual results to differ from those expressed or implied in the forward-looking statement, 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 Michel. Gerard, please proceed.
spk08: Thank you, everyone, for joining today. We have had a very productive four months since our last earnings call. Since that call, we've released additional secondary and exploratory efficacy endpoints from the phase three focus study. hosted a comprehensive virtual investor update meeting, made important strides towards filing our NDA for the treatment of metastatic ocular melanoma, and continued our discussions with medical oncologists regarding further development and additional indications. Starting with focus study data, we believe the totality of the efficacy data we released last year provides strong support for the clinical benefit of Hipsado for patients with metastatic ocular melanoma. The 31.4% objective response rate in the intent to treat population, including a 6.9% complete response rate, meaningfully exceeds response rates reported in published studies in this difficult-to-treat disease. Notably, it far exceeds the 5.5% objective response rate from the meta-analysis of immune oncology agents, which we used to power the study. Importantly, the responses seen in the trial are durable. with a clinically meaningful duration of response of 14 months. And the categories of response ranging from progression of disease to complete response correlate with increased median overall survival. The overall survival of 20.5 months in this patient population compares favorably to published studies in metastatic doctor melanoma. As we have previously reported, supportive, predefined exploratory analyses were conducted comparing patients in the hep-sato arm versus a best alternative care or BAC arm. As a reminder, the BAC arm was comprised of 42 patients originally randomized in the FOCUS trial prior to its amendment in consultation with FDA through a single arm pivotal study in 2018. These predefined exploratory analyses between the BAC arm and Hopsado show statistically significant treatment advantages and objective response rate, disease control rate, and progression-free survival. Specifically, in patients who received one or more treatments, objective response rate was almost triple BAC at 35.2% versus 12.5%, almost double the disease control rate at 73.6% versus 37.5%, and almost triple the progression-free survival at nine months versus 3.1 months. Further, while survival data has not fully matured, a six-month median overall survival trend in favor of Lepsado is observed In an important post-hoc analysis, survival at 12 months in the evaluable patients was 75% in the hips out of arm versus 47% for BAC, a statistically significant and clinically meaningful difference. Per the statistical plan, a predefined exploratory survival analysis versus BAC will be conducted at 24 months after last patient, last treatment, which occurred in May of last year. We will provide future overall survival analysis updates as patient follow-up continues and the capillary viral analysis matures. In the hepato-safety population, the most commonly reported treatment emergent serious adverse events were anemia, 29.7% of patients, thrombocytopenia, 26.4% of patients, and neutropenia, 19.8% of patients, which were well manageable and transient. 5.3% of patients experienced a treatment of emergency serious cardiac adverse events. All of those events resolved with no ongoing complications. There were no treatment related deaths in the trial. This adverse event profile is similar to many commonly prescribed cytotoxic agents. We are excited to share these and other data with the FDA and are on track to submit the class two resubmission to the agency in mid-year. I'm glad to be able to announce that we're close to having 1% of the patient data monitored. We have requested a pre-NDA meeting with the FDA and are scheduled to meet with the agency in late April. Last year, an outside firm completed a mock audit of our Queensbury, New York medical device manufacturing facility in anticipation of the submission and of an eventual FDA pre-approval inspection. While we recently achieved a medical device regulation or MDR certification from our notified body for chemosat under the new European medical devices regulation, We recognize that an FDA pre-approval inspection has a distinct set of standards and therefore hired this outside firm to conduct the mock audit. I am pleased to announce that based on the findings from the audit and our ongoing activities, we are confident that we will be well prepared for the anticipated FDA inspection, hopefully sometime in late summer or fall. We announced last month that we were resuming direct responsibility for sales, marketing, and distribution activities of Chemostat in all of Europe. Since December 2018, Mediac, a privately held company based in Germany, has been the licensee for ChemoSat in the EU, the UK, Norway, and Switzerland. We resumed direct sales, marketing, and distribution earlier this month and currently have four customer-facing employees in sales, marketing, and medical affairs working with healthcare providers in the UK, Germany, and Netherlands and anticipate hiring several more this year to further support healthcare providers and patients in those markets as well as expand use throughout broader Europe. Importantly, we anticipate our first submissions for national coverage will occur by the end of the year, including in the United Kingdom. In December, we hosted a distinguished panel of 12 U.S. and European physicians who discussed their respective experience with Hepsado in the FOCUS trial, commercial experience with Chemostat in Europe, and the unmet need in the treatment of liver metastases and the possible role of Chemostat and Hepsado, if approved, to treat those patients. We were able to gather this large group of distinguished experts for three reasons. First, the compelling nature of the FOCUS trial results for Hepsados treatment of metastatic octomelanoma patients. Second, the existence of approximately 10 years of real-world experience in the EU demonstrated the utility of the PHP platform. And finally, the large unmet need for improved treatments for patients with hepatic-dominant disease. If you haven't had a chance to watch the December 2nd Virtual Investor Update presentation, I recommend you take the time to get a treating physician's view on Hep Ceto and ChemoSat, as well as their perspective on the need for better treatments for patients suffering from liver-dominant cancers. Related to the real-world experience shared during that Virtual Update presentation by some of the European KOLs, last month we were pleased to see results from a single institution retrospective study published in the journal Melanoma Research. The study was conducted by University Hospital Southampton NHS Foundation Trust in England on the use of chemosat for the treatment of patients with liver-dominant metastatic uveal melanoma and was authored by Dr. Sachin Modi and his colleagues. The study evaluated the safety and efficacy of chemosat in 81 patients with liver-dominant metastatic uveal melanoma treated with chemosat between 2012 and 2020. Approximately half of the patients had received other treatments, either systemic or liver-directed, before chemosat treatment, similar to the FOCUS trial that included first-line patients and patients who had failed prior lines of therapy. 250 PHP procedures were performed in 81 patients with a median of three per patient. The analysis demonstrated a hepatic disease control rate of 88.9%, a hepatic response rate of 66.7%, which included a hepatic complete response rate of 12.3%, and an overall response rate of 60.5%. After a median follow-up of 12.9 months, median overall progression-free survival and median overall survival were 8.4 and 14.9 months, respectively. Treatment of emergent adverse events of grade three or four occurred in 27.7% of the patients. The most common grade three or four hematological toxicities where anemia observed in 13.3% of patients and thrombocytopenia observed in 12% of patients. There were no fatal treatment-related adverse events. The authors concluded that ChemoSaf provides excellent response rates and progression-free survival compared with other available treatments and noted that combination therapy with systemic agents may be viable to further advance overall survival. These results are consistent with numerous other publications out of Europe and as the growing body of published research documenting the efficacy of our PrimaSat system in the European commercial setting. Shifting gears, we also strengthened our leadership team with two appointments in early 2022. We announced Anthony Diaz as our new Vice President of Finance. Tony brings over 20 years of experience leading finance and operational teams of pharmaceutical, medical device, and technology companies. Tony will oversee all financial aspects of the company, including financial planning and analysis, financial reporting, accounting and control, tax and treasury. We also announced David Hoffman as General Counsel and Corporate Secretary. David will also serve as DELCAP's Chief Compliance Officer. He brings over 20 years of experience advising biotechnology companies with a focus on the commercialization of therapies. Most recently, he served as Associate General Counsel and Chief Compliance Officer at Barrasoft Corporation. where he was responsible for legal and compliance matters in support of the launching growth of products in the advanced cell therapy and biologic space. David has considerable expertise in pharmaceutical law and regulation, business development, commercial business transactions, IT, and compliance. Both hires bolster our management team at a critical juncture as we approach commercialization in the US and resume direct commercial operations in the EU. Regarding US commercialization, A key goal is to have 10 expanded access sites open by the time of launch and to ensure that the mix of sites are appropriately located to enable reasonable access regardless of a patient's location. To date, well over 10 sites have expressed interest in participating, and we should have two sites in a position to start accepting patients within a month. In addition, we are actively developing key documentation to support reimbursement, such as a value dossier and an NTAP submission. as well as holding advisory boards and treating physicians to better understand the patient journey. Finally, we continue to plan on expanding the PHP platform into other indications. An important part of that is garnering further input from both medical oncologists and interventional oncologists to ensure that there is broad interest in sites and any trial can recruit patients. As hopefully was evident from the virtual investor update presentation, there is real interest in investigating the U.S. the use of PSV platform in a variety of other cancers, specifically both intrahepatic cholangiocarcinoma and colorectal carcinoma. We have scheduled a series of further advisory boards to review proposed protocols for each indication, after which we will start formal discussions with sites and prepare any required regulatory submissions. Given our first priority remains submitting the NDA and launching in the U.S., DELCAP is primarily focused on those regulatory and commercial bills. However, these expanded indications are still a core part of our strategy and our efforts will continue in parallel. In summary, fiscal year 2021 and nearly a quarter into 2022, we've taken important steps towards commercialization of our PHP system in our initial indication and expansion into new areas. We have brought in key personnel and continue to be supported by a growing body of data as demonstrated by our positive phase two results and the study at Southampton. Ahead of refiling our NDA plan for mid-2022, we're excited to conduct a pre-NDA meeting in coming weeks. 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, and I'm happy to be joining the company during this exciting time. Product revenue for the three months ended December 31st, 2021 was approximately $246,000. compared to $379,000 for the prior year quarter from sales of Chemostat in Europe. Other income for the quarter was $1.9 million compared to $129,000 in the prior year quarter, with an increase primarily due to the acceleration of deferred revenue caused by the termination of the MEDEC license agreement. Research and development expenses for the quarter was $3.6 million compared to $2.7 million in the prior year quarter. Selling general administrative expenses for the quarter were approximately $3 million compared to $4.5 million in the prior year quarter. Total operating expenses for the quarter was $6.6 million compared with $7.3 million in the prior year quarter. Expenses for the quarter included approximately $1.6 million stock option expense compared to $3.5 million in the prior year quarter. The company recorded a net loss for three months ended December 31st, 2021 of 5.3 million compared to a net loss of $7 million for the same period in 2020. On December 31st, 2021, the company had cash, cash equivalents and restricted cash totaling $27 million as compared to cash, cash equivalents and restricted cash totaling $28.7 million on December 31st, 2020. During the three months ended December 31st, 2021 and December 31st, 2020, we used $6.4 million and $5 million respectively of cash in our operating activities. During the fourth quarter of 2021, we raised approximately $4 million pursuant to the ATM offering, predominantly from a single trade. That concludes my financial remarks, and I ask the operator to open the phone lines for Q&A. Can you please check for questions?
spk06: Certainly. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. Your first question for today is coming from Marie Seibel. Please announce your affiliation, then pose your question. Hi, thank you for taking the questions.
spk05: This is Marie Tebow from BTIG. Congrats on the progress over the last several months. I'm glad to meet a few other members of the team. I just wanted to hear what we might hear out of this pre-NBA meeting you have coming up at the end of April, if there's potential for any surprises or any changes to the timeline.
spk08: I don't think there's much potential for any surprises. These meetings are fairly, I wouldn't say ministerial, but it really is trying to get confirmation from the FDA that the body of data we have is adequate for them to review, which it should be. There are a couple of questions in terms of in what way would you like to see the data John, do you want to chime in a bit? Certainly there won't be any surprises. We want to give a little more detail on the purpose of these meetings and what we need to hear from them.
spk02: Sure, Gerard. Thank you. So we don't expect surprises. We do have a vast body of data coming off of the prior complete response letter that we are answering, as well as data on the safety and efficacy side from the FOCUS trial. This is really the first display of of our data set in totality along with our complete response letter responses that FDA will see all in one place. So, we're asking for their guidance on how they would like to see all of that compiled into the NDA resubmission. Plus, as Gerard said, asking some technical questions about the presentation of those data.
spk05: Okay. That's very helpful. Thank you for that. I'll ask my follow-up here on Europe. I'm curious to hear a little bit more about how the transition to the direct sales force is going. You mentioned some hiring, as well as the progress you're making on the reimbursement efforts there. I know that you mentioned you expect to submit for some national coverage at the end of the year. And thanks for taking the question.
spk08: Sure. So the transition was fairly smooth, I think, for two reasons. One is, I think, Both parties, MEDEC and ourselves, obviously wanted to make sure that there was no disruption in the supply of product to the institutions and for the patients. And my hat's off for MEDEC for being very professional in the transition. Second is there was not a lot of promotion ongoing that we were aware of. We're very much aware of in terms of trying to open many new sites. We're very much aware, given our continued role in medical affairs, we're very much aware of where the treating physicians were, even to some cases when patients were being scheduled. So it wasn't very difficult for us to pick it up. In terms of putting more customer-facing people in Europe, pretty much once you have a site up and running, really there's not a lot of support that's necessary. We do like to check in just to make sure that the procedures are being done according to the protocol that we think is best for the patient. So we like to be available, but there isn't a lot to be done. Really, new reps will really do one of two things. One is try to find sites that are surveilling these patients and get them referred to the treating sites. And the second thing will be in opening new sites. So I don't see a great disruption to kind of the base, the very modest base business that's there. What will occur with us being out there now is gonna be, it'll take a bit of time, but I think a resumption in growth that we saw in the business through the end of 2018, then it dropped and plateaued. Now in terms of national coverage submissions, We're targeting to try to get something in for chemoset this year in the UK. We're leveraging a lot of the work we're doing in the US for the value dossier that's also required or helpful in the US, a little less required but more helpful there. A big part of that in terms of describing treatment, alternative treatment regimes, literature search and stuff is common between Europe and European submissions in the US. So we're leveraging that. But the only one that I'm confident that we're going to get in or mostly confident we're going to get into the UK, we'll look at trying to get others in. Every country has their different calendar and process. We're going to try to get the one in that's due in the fall in the UK. So we're working hard towards that.
spk05: All right. Good luck with that. Thanks for taking my question.
spk08: Thank you.
spk06: Your next question for today is coming from Yale Jen. Please announce your affiliation, then pose your question.
spk11: Good morning. This is Yale from Laylaw and Company. I just want to follow up the earlier question a little bit in terms of in Europe. What should we anticipate potentially from the revenue perspective compared to this year, last year, and the last few years? Do we anticipate... you know, if successful, more meaningful increase, or there will be a learning period before things start to take off?
spk08: I think it'll take several quarters, i.e. the balance of this year, before we see a meaningful infection. I would hope by the fourth quarter we'd start seeing a difference. I think, as you know, that the biggest, the two biggest drivers to, there were three drivers really to increase revenue. One is increasing patient referrals, and that'll take some bodies on the ground and finding where those patients are being surveilled. The second is opening new sites, both within countries, but more importantly in other countries, and that clearly will take some time. Then the third is the reimbursement submissions for national coverage, and those have their own clock. So it will take time, but I think we will see multiples. If we execute appropriately and put the right focus on it, which as a single product company, we will. I think even before national reimbursement comes in, well before that, we'll see, you know, an uptick in revenue. But I think, you know, the fourth quarter is, I think, the time we'll start seeing a meaningful increase in volume and revenue.
spk11: Okay, that's very helpful. Maybe, are you guys going to build a head office in Europe, or those sales will be dispersed in their respective territories?
spk08: Oh, we have a... we have an office right now in Galway that does some packaging in Ireland. So that's, you know, technically on paper, our head office, but we're not going to open up a, you know, a head office with, you know, a fair amount of people located in it. I think this will be a virtual, you know, kind of a virtual business in Europe outside of the manufacturing facility. It seems to be the way the world works at the moment.
spk11: Okay, great. Maybe the last question here is that what do you consider to be the gating factor at this point before you are ready to file in mid-year this year? And thanks.
spk08: I think it really is the medical writing is really the gating factor. Hands down, it's a tremendous amount of information put together, whether or not it's the results of the FOCUS trial or It was a rather long list on the CRL side, you know, to document all that, but it really is the internal medical writing. You know, John, anything else you want to add to that or do you agree it's pretty much the medical writing?
spk02: Yeah, it's the consolidation, Gerard, of an enormous amount of data in the way the NDA requires, but also, as you pointed out, some of the questions in the complete response letter require data analysis of that data set in the NDA. So it's a huge amount of data, and medical writing is quite challenging, yes.
spk08: There's a bit of clean up. There's still a bit of monitoring going on at the sites, but very little. That's no longer gating. It really is just getting it out the door, which most companies, you know, the standard is about four months between data locks. And we don't technically have data lock, final data lock yet because we're monitoring a few more patients. But most companies, it's about four months between data lock and being able to get an NDA in. We're going to try to do it in about two months. Okay.
spk11: And so, therefore, no data remains to be collected or unclear at this point. Is that right?
spk08: Yeah, there's nothing to be collected. You know, we're shooting for 100% monitoring. If monitoring ends up becoming gating again and we're at 99.2, we'll go with 99.2, which is Um, you know, per the industry, that's just fine. I mean, many times things go out without a totally a hundred percent, but we'll be close to it. Okay, great.
spk11: Uh, thanks a lot and best luck.
spk08: Thank you.
spk06: Your next question for today is coming from Scott Henry. Please announce your affiliation, then pose your question.
spk10: Thank you. And good morning. I'm from Roth capital. Just a couple questions. First, you talked about being in 10 expanded access centers at the time of U.S. launch. What is the total number of U.S. centers we should think about that account for the bulk of procedures here? Kevin, do you want to handle that?
spk03: Sure, Gerard. I don't want to put a specific number on it, but it's not a very large number. This is a rare disease with a limited number of patients for uveal melanoma. When we look at 10 accounts or 10 hospitals that we want to enroll in the EAP, we estimate that that's – and those are world-renowned centers on top of that. So those are going to be the larger hospitals that are covering or treating most of the patients with uveal melanoma. We would estimate that that would represent roughly half of the hospitals in the United States that are treating uveal melanoma. Does that answer your question?
spk08: That does. If we did the 80-20 rule, I think it would be something along the lines of 20 centers probably account for about 80% of the treatments. The data is never totally clear. What we'll end up doing is trying to steer patients to our initial 10 centers. This is a fairly tight, well-informed patient community, as is often the case with these ultra, ultra orphan diseases. We'll make sure that it's well known where our centers are. We're going to try to offer what I'll call white glove service. so patients know how to get to where we are, know how to get a hotel book, et cetera, so they can get to A to B and they're not feeling like they're lost to figure it out on their own.
spk10: Okay, great. Thank you for the color. And then, Gerard, you gave us a lot of data in the prepared remarks. Just for clarity, is there any new data or perhaps any data sliced in a different way that you would highlight or should we think about this as similar to the recent presentation?
spk08: Yeah, I think it just was a reprisal of the data, you know, we've already gone through in the past, and then plus I added some of the Southampton publication data that recently came out.
spk10: Okay, great. Thanks for clarifying that. And then I guess the other question, as we start to see investigators publish data And we start to see other areas where this could be used, Tepzato. How do you think about off-label usage upon approval? Obviously, it's not something you market, but just how should we think about that? Do you expect it to happen in isolated situations and to what magnitude?
spk08: Yeah, that's a... A good question and also a very difficult one, one must answer carefully. Obviously, we will not promote this, but doctors also are free to read case study reports or alternatively cohort reports and such. Probably, there is a modest amount of data out there in ICC. And we expect there may very well likely be case studies published in other tumor types. So I expect doctors will try this. It really is going to be to the extent to which they wish to push the payers or alternatively the extent to which patients are willing to pay out of pocket. But there is a modest amount of data. I expect there will be more data coming out of Europe in the coming year or two in other indications. Um, and I think in, in very difficult disease treat diseases where, um, importantly, there aren't really well-established guidelines. Um, I think ICC foot fits into that category, which is about two to three times the size of. I like their melanoma. I think that's one where we might pick up some, some off label usage.
spk10: Okay, great. And, uh, finally just, uh, Shifting to the income statement, a couple of things jumped out at me and fourth quarter. First, you've got this big bolus of other revenue in fourth quarter 21. What exactly was that, and how should we think about that line going forward?
spk08: Tony?
spk09: Yes, we had a prepaid amount that we had with MEDAC that was being amortized over, I think, seven years. And as a result of the termination, we accelerated some of that deferred revenue. in the fourth quarter. So it was something that was prepaid that we were deferring. Okay, and that's a one-time event? It will be a one-time event, yes. Okay, perfect.
spk10: And then also SG&A, around $4 million in Q3, around $3 million in Q4. Which quarter do you think is more reflective of what we should think about for SG&A?
spk08: I think... Probably the higher quarter going forward given increased hires and increased activity getting ready for commercialization.
spk10: Okay, great. Thank you for taking all the questions.
spk06: Your next question is coming from Swayam Pakula, Ramakant. Your line is live.
spk01: Thank you. This is RK from Hitsy Wainwright. Good morning, Gerard and Tony. Most of my questions have been asked, but in general, I'm just trying to understand what's the market for chemosat in Europe, and how are you trying to ensure better market penetration than what MEDAC had done in the last few years?
spk08: Yeah, I think... The potential for Europe, given its much larger population offset by a lower price point, is probably about, let's call it $100 million in all of Europe for ocular melanoma. To increase penetration, we need to do really three things. One is, for the markets we are in, start getting patients referred to those treating sites So that means that we need to find out where those patients are that have been diagnosed who are going in on a regular basis, getting CAT scans or MRIs, looking for liver mets. We need to make sure the physicians who are surveilling them know about these treatment settings, know about the data, and get them referred to those sites. The second thing is opening new sites. Whether or not it's, for example, in Germany, we probably could use more sites, I think, in the south part of Germany. But as importantly, or more importantly, opening sites in other markets. uh france and italy uh you know obviously are two large markets in spain that jumped to mark the mind um so we need to garner interest uh with medical oncologists in those sites and interventional oncologists um and open and open sites and then the third thing after that would be obviously be um getting national coverage uh that in itself is um you know take some time And it's difficult to do that in any market unless you have real support from the treating physicians. So you need to try to get in there prior to national coverage, build support, and then put in your submission. So those are the necessary steps and kind of in that order that we'll take on. It'll be a multi-year effort. But I think by the time we're starting to see the meaningful revenue uptake in the U.S., I think Europe is probably going to lag a bit, again, because of the national reimbursement requirements to really get revenue going. But we will definitely get there. I think the other point that Noah's mentioned that I think it's important to keep in mind is having European rights from a strategic perspective, I think is very valuable. As this company evolves and grows, I think it'll be a lot more attractive from other dimensions. if we do maintain global rights, or at least, importantly, rights in the Europe and the U.S. So we're glad to have that all back in our camp.
spk01: Yes, that's for sure, Gerard. In terms of national coverage, probably you said this, but I didn't catch it. Is there any coverage at all in any geography? I know you said you're looking into the U.K. in the immediate future.
spk08: There is coverage in Germany under a process called ZEDI. What happens there is the hospital every year has to actually request funding for approved products that don't have national coverage. They can make a special request, and they do that sort of in a basket every year. That definitely is a bit of a cap on how much business you can get, because not only do you need to get it new hospital often interested in it you'll also need to get you know their financial office on board to actually put in the request every year before they use the product there are ways to simplify that for example getting a set price would be the next step and we're working on that right now so if we have a set price it removes one negotiating knob they have to deal with but it makes it a bit easier for them but yeah there is some coverage right now in Germany It's not, you know, kind of write it down. You get paid type coverage, but it is coverage. And, you know, we're going to push hard. Germany is one place we're going to try to open up additional sites as well as try to get more referring patients because there is some coverage there now.
spk01: Thank you. Thank you, Gerard. Talk to you soon.
spk08: Take care, RK. Thank you.
spk06: Your next question is coming from Arlinda Lee. Please announce your affiliation, then pose your question.
spk07: Hey, good morning, everybody. It's Ben Shin calling in for Arlinda Lee of the County Court of Genuity. Congrats on all the progress, gents. I got a question for Gerard. For HEPCETO and Chemoset, can you remind us what the legal intellectual property protection runway is? And how does that compare to the practical competitive barriers to entry and I got a couple follow ups.
spk08: Sure, Ben. Your voice. There is it still on various components of the product, but I'll be, you know, blunt and say, Look, I think anybody can engineer around that IP over the course of a year, year and a half. There's no way to get the type of filter we use. There's no way to get a 100% airtight set of IP around carbon absorption of small molecules. We do have patents in terms of the specific design. And what that would do would be require someone to find a way to come up with a filter that does the same thing, which they could do. but it would have to be, by definition, different than our system. If it gets different than our system, they're going to have to rerun preclinical, in vitro and in vivo preclinical studies. They're going to need to do phase one, twos. Then they're going to have to rerun everything, a pivotal trial in whatever patient population they choose, let's say ocular melanoma. They're going to have to run that all over again. They're going to have to run that trial when we're out there already treating patients. So, you know, that's a seven-year-plus process to go from zero to on the market. And that is essentially the IP protection we have, which ironically is very similar to the IP protection that occurred at my last company, that's VeriCell, where they had old-school 1980s cell therapy technology going by leaps and bounds. And what keeps competitors out of the market there is you can't do exactly what they do. You'd have to recreate it, and you'd have to prove to the FDA that it is the same. So similar to that company, you know, there is no 505B2. There's no 510K. This is a drug-device combination ANDA-type process to get a B2 on the market. You'd have to start from ground zero and replicate everything. And while replicating it, make sure you don't do anything, you know, that we have IP on.
spk07: Wow, great. That's great. Thanks. Switching to the NDA refiling, given the six-month review time and given that we're going to have a bunch of holidays within that second half, how soon will you know if there is going to be an adcom, if any?
spk08: John, when will we know if there's going to be an adcom or not? We have talked about this, but John, why don't you handle that?
spk02: Well, sure, Gerard. With a six-month review clock from the PDUCA requirements, one would anticipate an adcom in month five so that would give them the opportunity to get everything complete. You would know FDA would tell us probably within a month or two of their receipt of the resubmission if, in fact, an adcom was in the offering. To get that and then plan for it in month five is probably reasonable. I mean, a six-month review clock is short, and if we did have one, it would probably be in month five. And we hear you about the holidays sprinkled amongst the out months there. It's going to be interesting.
spk07: Knock on wood. Hopefully everything goes to plan here. My last question is regarding the European experience, and we've got quite a bit of, I guess, experience and data there and a number of patients. How helpful will that be for the FDA in support of this NDA refiling?
spk08: John, what's your perspective on that?
spk02: So when you say real-world experience, Ben, is that true? Yes. You know, the point about real-world experience is that, of course, it's not – It's not contributing to the meaningful safety data set. We do have supportive evidence from various European centers either through a registry or other single center institution work that we'll use as supportive evidence for the NDA. But it wouldn't be part of what FDA would consider part of the safety database. While it's important in that it's supportive, it wouldn't be considered as part of the focused trial data. It's a different quality of data.
spk08: Yeah, I think another way to look at this is if there was a strong theme through the published literature that there were significant safety issues with the current product, with the Gen 2 filter. it would be problematic. The FDA would read that, and they will read these papers. The theme is not such. The theme is one of a safe product for a devastating disease. So I think technically it's not part of the safety database, the publications, but I'd be hard-pressed to think that they wouldn't take note of it. So I think it's very helpful it's there, but we can't pound the table and point to it. We have to just make sure they're aware of them and let them read it without us making too much noise about it.
spk07: Gotcha. That's a very helpful color. Thank you very much for taking my questions. All right. Thank you, Ben.
spk06: There are no further questions in queue. I would like to turn the floor back over to Gerard for any closing comments.
spk08: Yeah, I just want to say that I appreciate everyone taking the time and your support. This is a very exciting time for us here at the company, and we very much look forward to giving you further updates as the year progresses. Everyone have a great day. Thank you.
spk06: Thank you, ladies and gentlemen. This does conclude today's event. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.
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