Good morning, welcome to the Delcath Systems Business Update 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 questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to David Hoffman, Delcath General Counsel. Please go ahead. Thank you. Once again, welcome to Delcath Systems Business Update Call to discuss the recent FDA approval of HEPZATO KIT or HEPZATO. With me on the call are Gerard Michel, Chief Executive Officer, Dr. Johnny John, Senior Vice President of Medical Affairs, Dr. Vojislav Vukovic, Chief Medical Officer, Kevin Muir, General Manager of U.S. Interventional Oncology, John Purpura, Chief Operating Officer, and Sandra Pennell, Senior 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 Act, 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 statement, please see the 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 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. Thank you, everyone, for joining us. Yesterday, the FDA approved HEPZATO KIT, a drug device combination product designed to administer high-dose melphalan to the liver while controlling systemic exposure and associated side effects for adult patients with uveal melanoma with unresectable hepatic metastases. The NDA approval represents the culmination of years of work by investigators and employees. We'd like to thank the FDA for their collegial and collaborative efforts through the review period of the HEPZATO NDA, resulting in approval by the PDUFA date. I also want to thank our 25 investigators, including Dr. Zager, our Global Lead Investigator. While there are many Delcath employees that have worked tirelessly over a decade or more, I want to make special mention to Dr. Johnny John and John Purpura. Both joined the company well over 10 years ago and stuck with the business through some very hard times, driven by a sincere belief in the potential of the therapy. It is not an exaggeration to say the company would likely not be here if it wasn't for their support. In addition to our latest set of healthcare-dedicated funds that started supporting us earlier this year, there are numerous retail investors and small funds that carried the business for many years. I want to thank them for their support and importantly, their trust, as we navigated some difficult issues over the years. This is truly a remarkable milestone and transformative moment for Delcath and most importantly, for patients with unresectable hepatic metastatic Uveal Melanoma. With HEPZATO's approval, patients in the United States now have 2 approval-approved therapies, KIMMTRAK and now HEPZATO KIT. Importantly, the two treatments have very different mechanisms of action, and it is hoped that after a patient progresses on one of these therapies, the other may offer some additional benefit for the subset of patients for whom both products are appropriate. This is not the case of another me-too therapy being approved. This is a significant win for patients. It is important to note that the FOCUS trial, which supported the registration, included both treatment-naive and previously treated patients and had no HLA-A*02:01 restrictions. As we had expected, our label indication is consistent with this patient population, which means our US patient TAM is the approximately 800 patients we have been discussing for years. Also, as expected, the approval comes with a REMS requirement. Much of what is in the REMS from a training perspective, we have been practicing in Europe for years, with some additional formal record keeping and reporting practices. We do not believe this will hinder peak penetration, although it may add one or two months to some startup times at two sites. Commercial supply likely won't be available until late in the fourth quarter, a change in expectations from earlier this summer. We had planned to produce certain product packaging items and labeling items at risk. Given the compressed timeframe of the review, discussions with the agency regarding elements of the packaging continued up until the last few days before the PDUFA date. Given the complexity of the product, we have over 25 distinct labeling items. For example, the outer cardboard carton with printed labeling, the longest lead time and unusually containing a minimal amount of information, was not finalized until a week or so ago. The net effect is we lost approximately six to eight weeks of lead time. We hope to have to produce certain packaging items prior to the August vacations in Europe, where the printing vendor is located. We'll need to get in the queue when the August vacations end. However, given our unique commercialization model, where we need to help create and train multiple multidisciplinary treatment teams at multiple cancer centers, as well as help establish patient referral patterns, we believe that the cumulative revenue loss in the 1st quarters of commercialization will be modest, since we'll be using the existing EAP treatment teams to train additional centers and reaching out to oncologists to discuss the option of referring their appropriate patients to these treating centers. When commercial supply become way available later this year, we will start at a higher level of volume and greater growth rate than if we came out of the gates just now. Both Vojo and Kevin will add more detail on the EAP and commercialization plans later in the call. At this point, we're not ready to give any detailed level of dollar revenue guidance regarding our projections. I will state that our initial percentage penetration into our TAM will likely be slower than KIMMTRAK, but we expect penetration into our larger TAM should eventually match at least their current penetration. We believe KIMMTRAK has reached a penetration of approximately 40% of their target addressable market in just over one year. Our rate of penetration into our TAM will be somewhat slower due to the nature of our product, but we do believe a similar percentage penetration into the larger TAM can be achieved after two years on the market. As a result of the March 2023 PIPE, the approval of HEPZATO effectively triggers a $35 million financing, which, combined with another $25 million triggered upon reaching $10 million quarterly revenue, we believe should be sufficient to fund the business, including additional development activities and other indications, without the need to sell additional equity. While our immediate attention will be the successful launch of HEPZATO KIT, we can now more seriously enter into conversations with investigators about additional indications. Metastatic uveal melanoma represents well under 5% of the patient population, whose cancers become liver-dominant. In June of this year, we hired Vojo Vukovic as our Chief Medical Officer. Dr. Vukovic is an experienced drug development executive with a distinguished career in cancer research and clinical and global clinical development. His experience spans early to late-stage oncology clinical projects and global medical affairs programs across multiple anticancer modalities and tumor types. Given Vojo's extensive experience in oncology drug development and medical affairs, he's well-positioned to make a major contribution as we prepare for the launch of HEPZATO and continue to advance our interventional oncology platform into other indications. As expected, we have a large set of new investors on this call, and many are likely not as familiar with Delcath Systems, the Delcath Systems story, as our core set of investors and covering analysts. I'm going to hand the call over to Dr. Johnny John, Delcath Systems' Senior Vice President, Medical Affairs, and ask him to give a brief description of uveal melanoma, our treatment, and the clinical results which supported our approval. Vojo will share some details on the EAP and REMS program. Kevin Muir, our General Manager of US Interventional Oncology, will describe our launch plans, Sandra Pennell, Senior Vice President of Finance, will give a brief recap of the multi-tranche financial transaction we entered into earlier this year. Johnny? Thanks, Gerard. Ocular melanoma is a very rare form of cancer that affects melanocytes in the eye, with approximately 5% of all melanomas being ocular. We estimate the U.S. incidence of primary ocular melanoma to be approximately 2,000 cases per year. While surgical or radiation therapy of the primary tumor is generally successful, approximately half of all patients with ocular melanoma will develop metastatic disease, primarily due to the inability to treat early micrometastases of the primary tumor. The metastases occur predominantly in the liver, with 90% of all metastatic disease patients having some level of hepatic disease, and less commonly in the lungs and bones. In 50% of metastatic UM cases, the liver is the only site of metastases, and most people with metastatic uveal melanoma eventually die from liver failure. Until now, there was only one approved therapy for metastatic uveal melanoma, Immunocore's KIMMTRAK, which is approved for the approximately 45% of metastatic UM patients with a specific HLA genotype. Historically, based on meta-analysis of survival in metastatic UM across a variety of treatments, including chemotherapy, systemic immunotherapy, and liver-directed therapy, median survival is generally 10-13 months across all therapies, and 14-16 months for liver-directed therapy. Multiple studies and analyses support that early and effective management of liver disease can improve survival for those diagnosed with metastatic uveal melanoma, and liver-directed therapy is a core part of existing NCCN guidelines for treatment of metastatic uveal melanoma patients. It is important to note that the HEPZATO KIT is already included as one of several liver-directed therapies to treat metastatic uveal melanoma in the NCCN 2023 guidelines, giving HEPZATO KIT clear visibility in the medical community. HEPZATO KIT is a very different form of liver-directed therapy. HEPZATO is the first approved product to treat the whole liver, and it is targeting both imageable and non-imageable metastases in the liver. HEPZATO KIT is used to perform a Percutaneous Hepatic Perfusion procedure, during which the entire liver is subject to chemosaturation, in which a very high dose of melphalan is administered, while proprietary filters remove greater than 85% of the total administered dose from blood that leaves the liver. In contrast to the most commonly used liver-directed therapies to treat metastatic UM patients, Transarterial Chemoembolization, or TACE, and Y-90 radioembolization, or SIRT, HEPZATO KIT can treat the entire liver. It does not damage the vasculature. It is repeatable up to six cycles per our label, with an average of four treatments in the FOCUS trial, and it is not limited by hepatotoxicity. TACE is not a whole-liver therapy, and by its inherent mechanism of action, it can lead to permanent occlusion of hepatic arteries, limiting feasibility of future liver-directed therapy. SIRT irradiates both the tumor lesions and healthy hepatic parenchyma. Concerns over cumulative radiation exposure to the liver and lungs can lead to limiting the dosage or the number of treatments. This is especially true in patients with diffuse disease or high tumor burden, who require a whole-liver treatment, as these patients are at greater risk of liver function impairment and radiation-induced liver damage. Whole-liver Y-90 delivery at the recommended dose typically precludes additional Y-90 treatments. Given the well-established importance of controlling liver metastases in metastatic UM patients and the unique profile of HEPZATO KIT compared to existing locoregional treatment options, we believe that HEPZATO KIT should become the locoregional therapy of choice for appropriate metastatic uveal melanoma patients. The FDA approval of HEPZATO KIT is based on the results from the pivotal FOCUS trial. The indication for HEPZATO KIT is adult patients with uveal melanoma who have unresectable liver metastases that affect less than 50% of the liver. Those patients have either no metastases outside of liver or have metastases limited to the bone, lymph nodes, subcutaneous tissue, or lung that are amenable to resection or radiation. Importantly, the use of HEPZATO KIT is not restricted to patients with certain genetic profiles, and patients can undergo up to six treatments. We believe this patient population represents approximately 80% of the estimated 1,000 cases of incidence of metastatic uveal melanoma patients in the U.S. The FOCUS study provides strong evidence of the clinical benefit of HEPZATO KIT for patients with metastatic uveal melanoma. There are two points I would like to emphasize. First, the efficacy was determined both in patients with tumor lesions in the liver only, as well as in patients with liver and extrahepatic disease. Secondly, the FOCUS study patient population included both treatment-naive as well as previously treated metastatic uveal melanoma patients, resulting in a broad label. The HEPZATO KIT label includes ORR, or objective response rate, and DoR as efficacy endpoints. In the FOCUS study, the 36.3% ORR, including a 7.7% complete response rate, meaningfully exceeds response rates reported in the literature and is difficult to treat disease. A meta-analysis of metastatic uveal melanoma studies with immune checkpoint inhibitors, which was used to estimate the required sample size for the single-arm FOCUS study, showed an ORR of 5.5% for these immunotherapy treatments. In several recently published articles reporting results for immunotherapy treatment, ipilimumab, nivolumab, and/or pembrolizumab in patients with metastatic uveal melanoma, the ORRs and CRs were also substantially lower than what was observed in the FOCUS study. In addition, an analysis of survival by response category in the FOCUS study showed a significant correlation between response category and survival, supporting that ORR is a clinically meaningful endpoint for this treatment modality. Overall survival is not reported in our label, as the FOCUS study was a single-arm trial and overall survival was an exploratory endpoint. As previously reported, the median OS was 20.5 months in a mixed population of treatment-naive and previously treated patients. While we want to be cautious about comparisons across different clinical studies, we note that in the FOCUS study, the one year survival rate was 80%, which is similar to the 73% one year survival rate observed in the Keytruda arm of the Keytruda study. Given these are two completely different types of therapy, these comparisons are best thought of as evidence that each therapy has a role in treating patients within their labeled indication. Almost all, if not all, patients eventually progress, and if the metastatic disease is caught early enough, the HLA-A*02:01-positive patients will hopefully benefit from both products. With regard to safety, overall in the FOCUS study, treatment with the HEPZATO KIT was well-tolerated. The HEPZATO KIT prescribing information has a boxed warning, which includes 3 sections: toxicity related to the procedure, the REMS program, and myelosuppression. Serious adverse events associated with HEPZATO KIT and the associated PHP procedures, such as hemorrhage, hepatocellular injury, and thromboembolic events, occurred in less than 5% of treated patients and did not result in long-term sequelae or treatment-related deaths in the FOCUS study. In agreement with the FDA, Delcath Systems is implementing a Risk Evaluation and Mitigation Strategy program, commonly known as REMS. The objective of the REMS is to ensure consistent conduct of the PHP procedure and to ensure that the HEPZATO KIT is only used by treatment teams with the appropriate training. PHP procedure or treatment teams consist of an anesthesiologist, an Interventional Radiologist, and a perfusionist. We have trained over 20 PHP procedure teams in Europe over the past 10 years and are comfortable with the REMS training requirements. The third element of the box warning is myelosuppression, including thrombocytopenia, anemia, and neutropenia, which were commonly observed in the FOCUS study patients. Myelosuppression is a well-known and predictable side effect of melphalan and is routinely managed with standard supportive care measures. This box warning was expected because generic melphalan's PI, or package insert, includes this specific box warning. I'll now hand it back to Gerard for his additional comments. Thank you, Johnny. Let's move on to the discussion of our commercial plans. I'll start by describing key stakeholders and key activities of our commercial plan. HEPZATO KIT is a combination product that is administered at a hospital by a PHP procedure team. Patients undergo the PHP procedure with HEPZATO KIT are referred by medical oncologists. Both treatment teams and oncologists are our primary stakeholders. To engage the treatment teams, we need to work with the hospitals, enroll them in the REMS program, and provide training. We also need to engage medical oncologists and ensure they understand the value of HEPZATO KIT and refer the metastatic ocular melanoma patients to the treatment teams. Our commercial group has two dedicated teams. One will focus on the hospital treatment team stakeholders, and the other commercial team will focus on medical oncologists. Our medical team will collaborate with and support the two commercial teams. Now Vojo, please address our plans and activities within the EAP and REMS. Thank you, Gerard. Let me start by saying a couple of words on why I chose to join Delcath Systems. Over the course of my career, I had the opportunity to work with several biotech and pharmaceutical companies on the development and commercialization of numerous oncology drugs. While we rightfully celebrate success of each new approved drug for cancer patients, the reality is that very few new drugs improve patient outcomes in a truly substantial and meaningful way. I believe HEPZATO KIT is one of such rare products that has the potential to meaningfully change patient outcomes. This unique drug device combination has tremendous potential to address a huge unmet medical need, the treatment of unresectable liver metastases, which affect tens of thousands of patients per year in the U.S. Of course, that's a very fragmented and diverse patient population, and there's much work required to determine which patients could most benefit from HEPZATO. I look forward to discussing these opportunities on future calls, but for the moment, we are focused on the immediate opportunity, which we intend to successfully capitalize on, the launch and commercialization of HEPZATO KIT in metastatic uveal melanoma patients. It's important to recognize that there's no established roadmap to commercialize a product like HEPZATO KIT. It's a novel process, and it involves mobilizing and training a PHP procedure team composed of an interventional radiologist, an anesthesiologist, and a perfusionist, and at the same time, engaging medical and surgical oncologists who are managing metastatic uveal melanoma patients. Our medical team will focus on providing information to treating physicians on the HEPZATO KIT and the PHP procedure, thus enabling them to choose the best treatment options for the patients. It's clearly a more demanding and engaging objective when compared to the launch of other oncology products. With that said, new clinical practice patterns have been created before, and we have a plan as to how to bring HEPZATO KIT to patients. A critical and obvious first step is to identify major cancer centers interested in conducting the PHP procedure commercially and selecting those that we believe can be active soon after commercial supply is available. After HEPZATO KIT launch, PHP procedure team training will be the gating item in getting a new commercial site ready to treat patients under our REMS plan. The training is required for the three members of the PHP procedure team. Beyond didactic training, which can be accomplished quickly, the training involves both a preceptorship and a proctored PHP procedure case. The preceptorship takes place at an existing treatment site, where the new PHP procedure team observes a procedure conducted by an experienced team. Currently, preceptorships can occur at our active Expanded Access Program sites that include Moffitt Cancer Center, Duke University, and University of Tennessee here in the US. We can also offer preceptorships in Southampton, Leiden, and Hanover in Europe. The final training step is for the new PHP procedure team to conduct the procedure at their own site under the guidance of a proctor team. We currently have available proctors from Moffitt, University of Tennessee, the Angeles Clinic, Southampton, Hamburg, Hanover, and Leiden. We have a list of 10 targeted sites we would like to have actively treating patients within six months of launch. Three of these 10 sites are active expanded access program sites, which can both currently treat patients and also serve as sites for preceptorship training of new sites. Additional five sites are currently in the process to join the expanded access program. Keep in mind that the expanded access program is a clinical trial, and that the budget negotiations, institutional protocol review, and IRB approvals involved can take up to a year. It's difficult to predict which of these will become active prior to the availability of commercial product. The advantage of adding new sites to the expanded access program, even if just for a month prior to launch, is that we can offer HEPZATO KIT to a greater number of patients prior to launch, and these sites will be ready to treat commercial patients after launch. In addition, these sites can offer preceptorship and also potential proctorships. An additional six centers have confirmed interest in being a HEPZATO KIT treating site after launch, but are not interested in joining the Expanded Access Program. Finally, we plan to approach at least 15 additional sites as soon as we scale up the number of active sites and thus expand our training capacity. Second, critical work stream is to reach out to medical oncologists at cancer centers with high volumes of metastatic uveal melanoma patients. Up until now, we have built an extensive network of Interventional Radiologists and Surgical Oncologists through the FOCUS trial. Now, we will start reaching out to medical oncologists who are directly involved with metastatic uveal melanoma patient treatment decisions. With the HEPZATO KIT approval in hand and with additional resources, Kevin, Johnny, and I can partner to start aggressively pursuing this outreach. I will now hand over the call to Kevin to give more detail on our commercialization plans. Kevin? Thank you, Vojo. As Vojo mentioned, to successfully commercialize the HEPZATO KIT, we will need to create a new practice pattern involving a new type of treatment team and a new patient referral pattern. While this is a greater challenge than just introducing another infusion therapy oral drug, I am confident that we can accomplish this task. I have the benefit of having done this before with BTG, now Boston Scientific TheraSphere, as well as the advantage of having multiple TheraSphere veterans here with me. For example, Zac MacLean, our newly hired Director of Sales and Strategy, will lead our sales team. Zac has spent the past 10 years with BTG Boston Scientific's Y-90 product in various sales and sales leadership positions and has a total of 20 years in the interventional oncology market. Vojo touched upon the importance of contacting medical oncologists to share the HEPZATO clinical data and give them the information they need to select patients for whom a HEPZATO referral is appropriate. Patient referrals are critical, even in this period prior to commercial launch, because both preceptorships and proctored cases cannot occur without patients. Recall that the majority of our US investigators in the FOCUS trial were surgical oncologists, and we have learned through the FOCUS trial in the early days of EAP that these treating teams do not actively solicit patients for referrals. We need to drive referrals by engaging with oncologists, and frankly, we were hindered up until now because of limited headcount. With the additional financing now available with the approval, we can rapidly expand our customer-facing teams and increase our level of engagement with treating oncologists. We will build a commercial organization with two complementary goals: partnering with treatment sites as well as driving referrals. Regional business managers partnering with treatment sites will focus on supporting the treatment teams, managing any back or formulary approvals needed, and soliciting referrals from within the treatment site. The commercial team will also be staffed with individuals who will focus on calling on oncologists outside of existing treatment sites. They will create the referrals necessary for the treatment team to have a steady stream of patients, as well as identify and qualify possible new treatment sites. I can offer some detail on the 10 targeted sites Vojo has discussed. Beyond the three active sites, Duke, Tennessee, and Moffitt, we have identified and qualified sites that have oncology support and are treating at least 10 metastatic uveal melanoma patients at this time. These include Stanford University, the University of Miami, two Mayo Clinic sites, HonorHealth, Ohio State, and Thomas Jefferson University. As Vojo has described, training new sites will in turn create new preceptor sites and new proctor teams, allowing for the steady expansion of treatment sites. Starting with our three EAP sites, we anticipate on having 10 treatment sites within six months of commercial supply and 15 centers by the end of 2024, and 25-30 sites by the end of 2025. Based on our experience with Delcath's CE marked CHEMOSAT product in the EU, after sufficient training and experience with HEPZATO, we expect an average-sized hospital will be able to perform one treatment per week and eventually up to two patients per week, assuming adequate patient demand. As Johnny mentioned, HEPZATO can be used to treat metastatic uveal melanoma patients regardless of HLA genotype. This includes the 45% of metastatic uveal melanoma patients eligible for KIMMTRAK, as well as the 55% of melanoma or metastatic uveal melanoma patients who, until HEPZATO approval, had no approved treatment options. It is important to note that patients enrolled in our EAP and FOCUS trial sites have included first-line sand alone treatment, first-line treatment for those who are intending to get KIMMTRAK as a second-line treatment, and as a third-line palliative treatment. According to the NCCN guidelines for uveal melanoma, if the metastatic disease is confined to the liver, regional therapy should be considered first. The guidelines also mention that since KIMMTRAK's response rates are low, symptomatic HLA-A*02:01-positive patients may be better palliated by liver-directed treatment first. We continue to explore the pricing of HEPZATO and plan to remain competitive, and ensure reimbursement. HEPZATO is approved for up to six treatments, with an average of four treatments per patient in the FOCUS trial. As mentioned earlier, we expect to be able to launch and provide commercial treatment late in the fourth quarter. The launch time is later than previously anticipated, we will now be launching with a greater number of trained treatment centers and a more established referral pattern. In closing, the commercial team we are building is staffed with veterans who have created new practice patterns before, our path forward is clear, given there is an obvious need for our product. I couldn't be more excited to get out in the field with my colleagues and meet with oncologists, potential training, potential treatment teams, and to get HEPZATO off the ground. I will now hand the call over to Sandra to share some details on our financial position. Sandra? Thank you, Kevin. We ended the prior quarter with $14.6 million in cash, and the cash used in operations was approximately $9.6 million in the second quarter and $13.9 million for the first six months of the year. As previously reported, on March 29, 2023, the company closed a tranche PIPE deal with healthcare-focused institutional investors, as well as existing investors that provided $25 million in upfront funding. Related to that deal, the HEPZATO KIT approval effectively triggers a $35 million financing within 20 days of the approval date. Specifically, the March PIPE deal included warrants exercisable into 70.7 million shares of common stock equivalent at a strike price of $4.50 per share. Those will expire 21 days after approval. Similarly, another 4.1 million shares of common stock equivalent are issuable at a strike price of $6 per share, representing $25 million in additional growth proceeds. These warrants will expire within 21 days of the company achieving $10 million in quarterly revenue. We are confident the $35 million in proceeds we expect to receive within three weeks, combined with our cash on our balance sheet, will be more than adequate to allow our revenue ramp to achieve $10 million in quarterly revenue, which will trigger the additional $25 million without the need to raise additional capital outside of this tranched financing. We believe that the second $25 million tranche should be sufficient to fund the company until it becomes cash flow positive. That concludes our business update, I'd ask the operator to open the phone after Gerard. Open the phones for questions, yeah. Open the phones for questions. Thank you. We will now begin the question-and-answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble the roster. Our first question will come from Marie Thibault of BTIG. Please go ahead. Hi, good morning. Thanks for taking the questions, and, and congrats to the whole team. Really, really happy to see this for you. Wanted to start here, and, and see if I could get a little more detail on how the team is planning to sort of message or position against KIMMTRAK. Maybe against isn't the right verb to use there because it sounds like it could be complementary. Certainly seems like a, a, a good opportunity in those patients, you know, those patients who don't have the right allele profile. But just tell us a little bit more about the awareness oncologists have of HEPZATO KIT at this point, sort of the willingness or interest in, in finding a, another treatment or using another treatment. Sure. I'm gonna just start off there, and Kevin can add some more color. We really don't view these as necessarily competitive. There will be times where a doctor, you know, has to decide what's most appropriate for first line. Patients generally die of liver failure from this disease, so at some point, you really do need to do a liver-directed therapy. It is part of guidelines, but we don't control systemic growth. All patients progress at some point. I think the question for the docs will be, you know, which do they start first with? I think in some cases it makes more sense to probably, they will decide it makes more sense to start with KIMMTRAK and others with us. When patients progress, hopefully, they will have been caught early enough that patients can get both. In terms of awareness, I'll be frank, there isn't a tremendous-- I think oncologists are aware of the product. We have not been out there, talking to them aggressively with, with MSLs because we really haven't had any to date. Most of our treating teams or our, our KOLs have been surg oncs, and some IRs in this country, and that's just a function of where this product came from. You pull the calendar back over 10 years, this was derived from a surgical procedure, intrahepatic perfusion, where surg oncs were taking the lead, and they naturally had the most interest in the first trial that was run over 10 years ago, and a lot of those continued their interest. That's not to say oncologists aren't aware of the product, but we're gonna have to get in front of them and show the data. You know, whenever we do have calls, KOL calls, they are very impressed with the data. They're very excited to get their hands on it. They're wondering, you know, where are the treatment teams? How do I get things started? There's a bit of work to do there. Kevin, do you want to add any color to that? Sure. In speaking with a number of medical oncologists out there, one thing they will always go to is, if they can, liver-directed therapy would be their first-line choice. Their goals, quite simple, are to stabilize the existing disease and preserve existing liver function. To kind of freeze the disease or stop the disease in its tracks and allow the patient to live with the liver that they have. We've seen this in practice, in both the FOCUS trial and specifically the EAP, where we've been used as simply as a first-line treatment. But we've also seen it, since the approval of KIMMTRAK, where some physicians have used KIMMTRAK first to do what I just said, stabilize the disease, preserve the list, existing liver function prior to administering KIMMTRAK. There are physicians out there that are, that are treating that way, and, it's our hope that when we get out and educate them, we would, we would get a lot more centers to treat exactly just that way. Vojo, I will see. Do you want to add any color to that as well? Yeah, sure. I'll, I'll provide a couple of numbers, so it's easier to calculate the patient populations. I mean, starting with frontline, the HLA profile, which is indicated for KIMMTRAK, is approximately 40%- 45% of patients. These are the only patients who can receive this product. The second number that you can consider is basically the percentage of patients who have liver-only disease. That's certainly, these are patients who are prime time candidates for liver-directed therapies. Then, as Gerard mentioned earlier, there's also a lot of patients where the disease is dominant in the liver. That means, as a physician, you have to first make sure that the liver is stabilized because that's what's really life-threatening to the patient. Taking everything into account, I think it's probably fair to say that about 60%-70% of patients in frontline would be best served with the liver-directed therapy and we're the only approved option. Second line, obviously, everybody else who hasn't received it in frontline. These are, I think, some numbers that are helpful when you think about the market opportunity. Yeah, extremely helpful. Thank you for all that detail. Much appreciated. I guess my follow-up here would be to try to understand the reimbursement process a little bit better. There's a slide there in your deck, gives a pretty wide range of reimbursement possibilities. How should we be thinking about, you know, what the most realistic level of reimbursement might be and, and what the workload is, is, you know, for the doctors that the hospitals in securing some of that reimbursement? Thanks again for taking the questions, and congrats once more. Kevin, you want to touch on reimbursement, please? Sure. We, we really get into inpatient or outpatient. Most of the patients that were in the FOCUS Trial, if treated commercially, would have been considered outpatient. We feel comfortable that the majority of the patients that we treat will be outpatient. That being said, we're taking steps to make this procedure reimbursable to the hospital on the inpatient side. This October, we will be helping them with outlier payments by applying for the NTAP, which is a New Technology Add-on Payment. That's for CMS patients. At these sites, PPS-exempt NCI cancer centers, most of them will have their own contracts with private payers that will give them good reimbursement for inpatient procedures. For outpatient procedures, shortly, we will be, with the news of this approval, we will be, applying for TPT, to get our transitional pass-through status. That will cover, the drug. We have done a number of CPT mapping exercises, and we believe that although there will not be a specific CPT code for, the Percutaneous Hepatic Perfusion procedure that HEPZATO KIT will be used in, that there are more than enough existing codes to make this, just, a well-paying or a, or covered within the hospital, and the physicians will get adequate fees for their time in the, during, their time spent during the procedure. Yeah, you know, at a, at a higher level, Kevin covered this, but to make it crystal clear, I mean, for most of these patients, the drug will be a pass-through expense for the hospitals. I think as everyone knows, CMS Medicare, for physician administered outpatient drugs, picks up the cost and adds 6% for the hospital. We don't see. In terms of private payers, for these ultra-orphan type products, again, we're thinking our towns, but in our patients, they generally, it's just not an area of focus for them. They generally have a tendency to follow what CMS does. You know, I, I think one thing these hospitals that we're going to go to do well is they know how to get reimbursed. These are not, you know, community oncology infusion centers. These are major, major cancer centers that, frankly, this is part of what they do for a living, is making sure they maximize their, their reimbursement. KIMMTRAK has, had been very successful. Admittedly, a very different product. It's not a procedure, but you have to go into the hospital, be watched during the infusion. I don't, I don't believe, I mean, I don't know this firsthand, but I don't believe they've had a lot of reimbursement issues, and we don't expect that. Similarly, we don't expect having any reimbursement issues ourselves, given the nature of the product. Very good. Thank you so much. Congrats again. Next question comes from William Maughan of Canaccord Genuity. Please go ahead. Good morning, I, I'd definitely like to add my congratulations here. Just wanted to ask about the EAP going forward now about, you know, three or four months out from launch, potentially looking at some, some turnover in that program. Just wondering how you're thinking about continuing to enroll and, and, and essentially ramp patients on, on drug before commercial availability, balancing, you know, giving free drug versus having sort of a captive audience once you launch, you know, to, to convert to commercial pay. Then I, I also wanted to ask, to ask about the ramp of centers. I think it, you said something like 15 by year-end 2024, 35 by year-end 2025. Just wanted to get a sense of, of the staging of those, of those hospitals, how you plan on adding those and, and, you know, I guess, is there any sort of, I mean, diminishing returns at the end of that? For example, you know, are the first 15 or 20 going to be high prescribers and then, and then sort of the next, tranche, a little less active? Or, just how are you seeing sort of, bucketing by hospital volume? Thank you. Yeah, Bill, let me break that into three portions. One is, you know, rationale for the EAP this close to launch. Two, how we're gonna expand the EAP and expand patient flow. Three, how is Kevin going to, once we have commercial launch, how is he going to prioritize, you know, additional centers beyond the 10 we've already prioritized? In terms of the rationale for the EAP, first and foremost, we don't have commercial supply, but we have clinical supply. Just given the way the regulations work, we're allowed to over sticker, you know, commercially available melphalan, say, it's for clinical supply and ship it out to centers and treat patients. We can't sell that stuff. That has a whole different set of labels, and that's gonna take, you're gonna say, "What could take so long about printing labels and getting some cardboard boxes put together?" Anything that's highly regulated, it takes a while. It's gonna be a bit of time till we have commercial product, you know, we can legally sell. We want these patients to be treated. We don't want any patient who could possibly get this product not to be treated, so we're gonna try to get them, you know, into the EAP and treat them. Those patients could very well become paying customers if between their third and fourth dose, we have commercial supply. Really, the first reason to do this is to make sure patients have access to product. The second thing is we can't expand and get more sites trained unless we have patients flowing through the EAP. This is, this is what's gonna allow us. Our hope is with the approval, there'll be a little bit of resurgence of interest in getting the EAP. Frankly, you know, Kevin's hired two people in the last few weeks. Boy, he's got some folks he's, he's bringing on board. We're actually gonna get start getting people out there in front of oncologists, which we frankly haven't been doing much of due to just trying to make the money last. We'll start helping oncologists figure out how to refer their patients to these sites. We've heard stories of oncologists calling our EAP sites and frankly, referring their patients and something else happening because we don't have good established referral to referral patterns. That's what we need to do now. Now, in terms of, you know, expanding the EAPs, Vojo, why don't you tell them, you know, again, how we're gonna get expand this number. Kevin, you can show. Turn to how are you gonna prioritize sites to choose? Yeah. To really simplify the explanation, I think analogy of a snowball rolling down the hill is a good one. Currently, we have three active sites which can treat patients, and they can also train the procedure experts that will conduct the procedure at the other sites. If you keep these first three sites going, we will not only treat patients, but we will also train up the other sites so we can actually open them, first within the EAP, and then when commercial supply is available, all sites will be switched over from EAP to commercial treatment sites. That's really, that's really the plan. It's all based on patient referrals, the procedures being conducted, new procedure team members being trained, and that gives us the possibility to open up new sites. We'll conduct 3 or 4 cycles, like geometric progression, 2, 4, 8, 16, and so on. Until we hit the number of sites that we believe is the right number of sites considering the size of indication, that's where Kevin can provide some, some more detail. Thanks, Vojo. On the, on the starting the kind of the back half of next year and through 2025, we would expect to have enough sites trained, as, as we talked about during the presentation. The gating items for opening accounts in a lot of ways is, is training, just having the appropriate amount of preceptor and proctorships available. You know, mid-next year, we should get, get behind that problem, or ahead of that problem, sorry. As we prioritize the sites that, that we choose, you know, one of the first things we'll look at is the current use of liver-directed therapy. Do the sites have a desire to use liver-directed therapy first? On top of that, do they really have a desire to truly treat the whole liver? That's what we talk about with With HEPZATO KIT is the ability to truly treat the entire liver and sparing any healthy brain amount. These are key things when we, when we talk to physicians. Then we go to the, the desire to use the product, as I mentioned, and the desire to train. There are some training requirements that will be outside of a physician preference or or a physician preference device or a infused drug. There has to be motivation on the part of the team, and that's part of our qualification process when we look at these sites. You know, I believe firmly that if we can get to that 25-30 sites, we'll have the majority of the sites in the U.S. that, that treat metastatic uveal melanoma patients. We'll have a nice regional base of accounts that patients who aren't-- who don't live next to a facility to get meta, HEPZATO KIT, they can travel to 1 pretty easily. Yeah, I think, you know, I think 1 of the key drivers really is how many patients do they currently treat, just to pick the obvious 1. I would say that the, the top 10 we're choosing right now are probably within the top 20 in terms of patient volume. We're fairly confident that I think if you take the top 30 sites in terms of current treatment volume, we'll probably have 25 or so of those at the end of year after next. It's, you know, number of patients, but having an oncologist that is interested is key. That's kind of what's missing in the equation to date, given our KOL basis of surg oncs. Yeah, just one more comment. I mean, until now, just to remind you, there were no approved liver-directed treatments. I mean, the medical profession, as evidenced in the NCCN guidelines, recognizes the significance of this treatment approach over systemic treatment, yet nothing is approved. If it's not there, if you don't build it, nobody will come. I think this new dynamic will kick in, and that all current centers that are treating uveal melanoma patients across the nation will eventually have to adopt a liver-directed treatment approach. Some of them are doing it voluntarily because they believe it's the right thing to do, but now with an approved drug, it's a very different dynamic. Thank you for the commentary, and, and again, congratulations. Thanks, Doc. Next question comes from Scott Henry of ROTH Capital Partners. Please go ahead. Thank you. good morning, and, and congratulations. really big day for the company. I just had a couple questions. first, you know, as far as the... I don't, I don't know if, you know, registration of the, of the center is the correct term, but, the EAPs, do they automatically become registered to be commercial, sellers or, or providers, or, or is there a process they have to conduct at that point? The only process that's involved, because EAP is technically a clinical study, in the process of conversion from the EAP clinical study status to a commercial status, we just have to close out the clinical study at that site. There's a formal process that takes a couple of weeks' time. I think there's also... These, all of these centers that will be part of the EAP will have conducted the required number of- Yeah ... didactic, didactic training, the preceptorship, the proctorship. Really, it will be paperwork at that point to, to get them formally registered within, within the within the REMS. It'll be a paper exercise for the EAP sites. Okay, great. I believe it's slide 23, you indicate 9 centers that are targets for launch. Would your goal to have all 9 of those, certified or registered to be commercial by the launch in late Q4? No, because what will be ready for launch at, when we have commercial supply, will just be the EAP centers. The commercial centers, they cannot conduct a treatment with clinical trial material. They only conduct a treatment with clinical supply. Those who do not choose to become part of the EAP or frankly, just can't work through the bureaucracy to get the IRB approval and everything else, what we will want to do is have them have completed their didactic training. We will want them to have completed their preceptorship, i.e., have gotten on an airplane and watched a procedure. What they will need then is a patient to treat at their own site and with a proctoring team to be with them. That would be the final step if you were not part of the EAP, but you did do the previous two steps I mentioned. The, you know, ideally, and what we're trying to do is get these commercial sites that have a strong interest, or the EAP sites, or the pending EAP sites, to follow one of their patients to one of the three treating sites, do the preceptorship, watching that, their patient getting treated, and then hopefully the next treatment can be a proctored one at their own site as, as a commercial member or an EAP, if they get done on time. That's a lot to drive. Hopefully, that would... You could follow that. Okay, now that's helpful. I know you've given us a lot of this information already, but it's, it's kind of nice to walk through it a second time. Yeah. At the time of commercial launch, how many centers do you expect to have an EAP program that you could transfer over? I mean, we know we have 3. I think 4 to 6. Downside, only one more comes in under the, you know, over the finish line before we launch. Upside, we get it up to six. Then, we would hope to have 10 commercial sites up and running within six months of launch. Then after that, we would hope to have 15 centers at the end of next year, calendar year, and then 25-30 at the end of 2025. I think I'm counting the years correctly in my fingers here. Yeah, at the end of 2025. Okay. I, I, I think you mentioned, you know, 1 treatment per week at the start, working itself up to two treatments per week for a center. I think it'll probably at launch, it'll be closer to, you know, one per month, working its way up to one per week at the end of next year. Then, I think it could, for some of those centers, it could become two per week. But I think one, somewhere between one and two, and now, you know, the future is a bit hazy when we get that far out, but it's somewhere between one to two a week would be the goal, with between, you know, let's call it 25 to plus centers again, end of year after next. When you set these targets, do you consider that a capacity limitation or, or a demand limitation? Meaning people need to get familiar with it before they put more patients in it, or, or is it strictly, you know, capacity-wise, they're just coming up to speed. How, you know, what is the gating factor there, supply or demand? Well, immediately right now, gating factor is oncologists knowing where to, how to refer a patient to one of the three sites. They just don't know that. That's probably the, the immediate one. It will then become the number of sites available. That's going to be the next guiding item, which is going to be driven by how many have gone through preceptorships and proctorships. We're asking docs to get treating teams to get on an airplane. You know, three people watch a procedure, and then we need to get generally a proctored case will require two proctors, we believe. We believe an anesthesiologist and an IR. We got to get those scheduled. That is not as simple as it sounds. Now, Once it's done, it's done, and we have a treating site. That would be the next limitation. Then the third limitation, quite frankly, is, you know, who knows truly, you know, we're estimating an 800 person TAM. If you listen to Immunocore, the market's twice as big as we're saying. I, I don't think that's the case. Then within our 800 patient, yeah, our 800 TAM, patient TAM, we're saying it's about 80% of the, our estimated 1,000 patients with metastatic uveal melanoma. Maybe it's really only 60% of that really fits within our TAM. Maybe it's twice that amount. So that's where we get a little fuzzy because, you know, these small disease states, it's pretty tough to be very precise. Okay. You know, we know there's hundreds of millions of dollars worth of business here, but I can't really put a cap on it. Okay. As we try to get our arms around this process, so it sounds like all three members of the team have to be certified and, and, and go through those two steps. Now, when they go back to their center, do they certify other members of the team? Yeah. Do those individuals also have to go through the process if a different, you know... Yeah, if we go to our- Oncologist If we go to our, our two most established centers, in Europe, Leiden, that they primarily do clinical work, but, or Southampton, which is mostly self-pay. Both of those centers have multiple IRs trained, multiple anesthesiologists trained, multiple perfusionists trained. That's one of the things we need to do. In our established three centers, we want to expand out those teams. Within a center, we wanna have, you know, more than one specialist for each role available, both to treat a patient as well as to get on an airplane and be a proctor. All right, great. Thank you again for taking the questions, and congratulations to the whole team. Thanks so much, Scott. The next question comes from Yale Jen of Laidlaw & Co. Please go ahead. Good morning, I add my congrats to you guys as well. Nice job done. My first question is that in terms of marketing, you have 2 teams, 1 for the interventional oncologist, and secondly, is for medical oncologist. My question is that in terms of a medical oncologist, getting the referral, what's your current goal in terms of how many patients, how many physicians try to reach? What's the timeline, what do you see the challenges there at this moment? Then I have a follow-up. Yeah, I think, our first focus will be reaching the medical oncologist at the treating, at the EAP sites that we currently have. Each one of those have several medical oncologists. I'll be honest, not every single one of them are well-versed that, you know, to building two, you know, building a block down, they have somebody doing this procedure. Again, that's a factor of just the lack of resources we've had. The next target will be sites that are interested to be part of the EAP or interested in becoming a commercial site that those 10 or so sites we mentioned. We'll have the teams calling on those oncologists there, and each one of those have at least two to three oncologists that might make sense to call on. Thereafter, the target will be the sites that are part of the 20-25 that we want to eventually become commercial. That second set will be driven largely by the ends. Who's got the most patients? We have the data. You know, longitudinal data is, is, is pretty good nowadays, so we know who's treating how many patients. The targets, I, you know, I could say the average, you know, rep's gonna have maybe 25 or 30 oncology targets, maybe a little higher than that, with a big doc maybe having 10 of these patients or 15, a lot of the docs just having 1 or 2. They're, they're clustered around certain centers, it's surprising how many oncologists there are with just n equals 2 or 3 of these patients. They're clustered around, you know, a number of high-volume centers. Kevin, does that sound about right in terms of 30 oncologists per rep or so? Yeah. Um... Yes, Gerard, you know, when you look at the, when you look at the. We can confirm this with some claims data. There's kind of 2 scenarios in these hospitals. 1, there's 1 uveal melanoma specialist, 1 medical oncologist that has focused his practice, at least in part, on uveal melanoma. There's the other scenario where there isn't a specific uveal melanoma specialist, where the medical oncologist just treats everyone. They treat their own patients. They don't refer them on to the uveal melanoma specialist. When you look at what we're looking at, there's probably 30 sites that we think we're gonna open, as we mentioned, by the end of 2025. If you look at the, again, the claims data that we use to target and qualify accounts, there's probably 90 to 100 accounts that have a, any kind of volume of uveal melanoma outside of 1 or 2. We would-- when we break the territory up, depending on the type of scenario that I described earlier, 30 to 30-ish medical oncologist per rep is a good number. Then we're talking about roughly 4 reps in that type. 4 reps. That, that would cover, you know, 100 or so hospitals. The second part of your question, you know, is, you know, the IRs are gonna be a little more condensed. They're gonna be at the treatment sites, as you rightly called out, we will need to train multiple IRs within the, within the institution. It gives us flexibility for treatment times, vacations, and it allows us to increase our volume. The oncology rep team, they'll be, they'll be calling on a lot more centers and a lot more docs than the hospital-focused team that will be calling on and supporting the treating teams at specific centers, if that helps. Okay, great. That's very helpful. Maybe just to tag on this question a little bit more, which is that, what about the oncologists who are not associated with the, these, sites? I understand that's a very large number or very sparse. Was there any plan in terms of tackling those and how to prioritize that, in terms of that endeavor? I'll just say, you know, one thing we've noticed when looking at the longitudinal data is it seems like most of these patients, somewhere along the line, make a stop at the top, top 20 or so centers. It's, it's, you know, if you look at Thomas Jefferson University is a good example. You know, if you don't understand how to look at the data, you'd think they treat every single patient that has this disease or close to it. But in reality, what a lot of people do is they make a stop at these centers. So these, these patients do have a head tendency to make a stop at 1 of these centers of excellence. So that isn't gonna be a gating item, we think, when we talk to the oncologists who have 1 or 2 of these patients. It means, you know, and nowadays, a lot of this stuff is done virtually, but it's gonna mean a lot more, you know, virtual calls or, you know, airplane rides for the oncology team, the medical oncology team, versus the, the team, the team focused on the hospital treating centers. Yeah. I'll just add one thing. I mean, this disease starts as a local tumor in the eye, and that type of treatment, the surgery or radiation therapy, which are the most common treatments, that's done at a specialized center. That's not done in the community. All these patients with uveal melanoma, they will go to a large center, and they will be becoming part of the follow-up. If and when they metastasize, and half of them do, if the chemotherapy, systemic chemotherapy, which is the old option for treatment, that was the only option available, that you can give anywhere. You don't have to travel 200 miles to get an infusion of some chemotherapy medication. You can do it at your local community practice two miles down the road. On the other hand, if you have specialized treatments, like, for example, KIMMTRAK or, or liver-directed therapies and HEPZATO, that's delivered at large treatment centers. I think as Gerard mentioned, virtually all of these patients will be referred either a primary physician to a large specialized center. It would become basically a, a question of patient choice. Is somebody willing to make the effort to get specialized treatment or not? Not, not every patient is motivated to do that. We will, we will have these referral patterns, and then, of course, we'll work through other channels, to the patient-directed channels, for example, patient advocates, to make them aware of this treatment being available. Information will be coming to patients from two different channels. We believe that, these measures will, really help us, maximize the number of patients who are eligible and able and willing to take, get this treatment. Okay, great. Maybe just one follow-up question here. Which I understand that, you will not reveal the actual pricing for the drug, at least for the time being. But just curious, what was the general thought or principle at this moment in terms of how to think about that? Would that be on par with the KIMMTRAK or something else, you can comment on? Thanks and congrats. Yeah, comparing the 2 price products from a pricing perspective is a bit of an apples and oranges. That they can go on. The patient could be on KIMMTRAK for two years. You know, we're capped at 6 treatments. We can get a good handle on whether a patient's getting a response on our product after 2 doses. They have to treat through progression 'cause of pseudoprogression. Then you can look at it on an annual basis. A lot of different ways to cut it. I will say it'll be in the same order of magnitude, the same ballpark, given the difference in, you know, the types of treatments they are, weekly versus up to 6. You know, some ways you calculate it, you know, the number we pick may come out a little higher. Other ways, it may come out a bit lower. Let's just say it's in the, in the roughly the same ballpark is what we're thinking. Okay, great. That's very helpful. Again, congrats, it's a long journey. All right. The next question comes from Swayampakula Ramakanth of H.C. Wainwright. Please go ahead. Thank you. Good morning, Gerard and team. Congratulations. Thanks. Most of my questions have been answered, but I got few. Thinking about the NCCN guideline that's already out there, how do you plan to utilize that in your commercialization? Also, how much of it can be used during detailing as well? From how much... I think it's perfectly fine to tell doctors from a promotional perspective, "Hey, you know, Percutaneous Hepatic Perfusion is on guidelines as one of the locoregional therapies." I think it's also perfectly fine to tell docs that, for patients who are liver-dominant and already symptomatic, or have liver-only disease, you know, locoregional therapy is, is recommended. Lastly, I think, you know, we talked to oncologists and Interventional Radiologists. We can clearly state we are the only locoregional therapy on guidelines. I mean, approved, that is, on guidelines. Yeah, I think we'll, we'll fully leverage that. I think it'll be incredibly helpful, not only for uptake but also, for, you know, reimbursement purposes. I don't foresee a lot of headwinds with commercial payers, but the fact that we have this in our hip pocket is incredibly helpful. Yeah. Then thinking about, KIMMTRAK, and, you know, you're, you're saying that it, at this point, it looks like it's, capturing nearly 40% of its time. Are some of these- I'll just interrupt for a second, Swayampakula Ramakanth. That's Gerard's calculation. You know, Immunocore may beg to differ. They think, I think they think the market is larger. I don't for a moment mean to dispute it because it's very helpful. Yeah. Yeah, that's Gerard's calculation. That's not, that's not around the point of the question. Yeah. That's just an introductory remark. Yeah. How would, how... In terms of utilizing those centers that have already used KIMMTRAK, are, are using KIMMTRAK at this point, you know, since these physicians and centers are familiar, not only with the indication but also with, you know, therapies for those, for that indication, would those points of contact be your initial places, you know, to reach out in terms of commercializing HEPZATO KIT? Yeah, yeah, without a doubt. I mean, anybody who's treating a lot of these patients is using KIMMTRAK. They will naturally be on our list of, of, of oncologists to call upon. Now, they, KIMMTRAK's at well over 100, I think I saw 140 centers they said they were in, like. 187. Thank you, 187. That's far more centers than we're planning on going to. Most of these patients have to drive, these patients have to drive weekly to get this infused therapy. You know, we're gonna be every six to eight weeks. I suspect it's gonna be closer to the eight week timeline for our patients. Whether or not it's a long, you know, a flight and a hotel room, first every two months versus a weekly drive infusion. You know, who knows which is more preferable? It depends on the patient. I don't think one's tremendously better than the other. We will be calling those on those oncologists, but we'll be trying to get them if they're not already at a treating center, we're going to try to get them to refer their patient to another oncologist at a treating center. What we need to do is make sure that the doctor receiving the referrals, it's, I, it's best if they are an oncologist. What we've learned. It's very difficult, and again, we've learned this both through the FOCUS trial, as we've kind of done an analysis of how things went, as well as the early days of the EAP. What we've learned is it's difficult to get oncologists to refer to a totally different center if they're referring to another, to an IR. They're much more comfortable referring to another oncologist. Those are the referral networks that we have to build up. Okay. The last question from me is, in terms of, what you have observed during the clinical trials, how long do you think it takes for a surgical team to get trained so that they can use this procedure on a regular basis? Yeah, so I think for the REMS program dictates that they attend, you know, they do the didactic training, which is a couple of hours. They go and attend a case, so that's going to be an airplane trip. You know, it's going to be a day out of their schedule to see a case somewhere else. Then they need to treat a patient. I wouldn't necessarily say that takes time. That's where they're going to do that anyway, but they need to treat a patient under a proctorship, having an experienced treating team there with them. It's less of a time issue, it's more of a getting schedules to align issue. That's why if we talk about the snowball effect that Voya was talking about, the more potential we have for preceptorships and proctors in terms of fits into a, a team schedule, the, the better off we'll do. The only other, you know, time aspect to that is, you know, there'll be paperwork and that sort of thing. Any REMS program is, you know, it's a government-enforced program. By definition, it's going to be a little more, little more bureaucratic, but that's part of what our rep has to do. We're going to have hospital support there for, you know, working through the REMS program and getting the documentation done. We're also going to hire some clinical support specialist types. We have that in Europe, who will actually attend cases after these docs are trained, just to be there in case there's an issue, answer any questions, help troubleshoot. Again, that's not time out of the doctor's schedule to be trained, but it's important to know that kind of their training will be ongoing as they do more and more of these with some, you know, some Delcath support or some support by another expert on the phone if necessary, because we'll build networks of that as well. Okay, perfect. Thank you again, and congratulations, and talk to you guys soon. Thanks a lot, Mark. This concludes our question and answer session. I would like to turn the conference back over to Gerard Michel, CEO, for any closing remarks. Closing, I want to once again thank the multiple stakeholders who had a role in making this approval a reality. Employees, investigators, and the treating teams at the, at the sites, patients, FDA, and, and investors all played an important role. You know, we look forward to launching next quarter in the interim, building out the EAPs and referral networks, and then longer term, accelerating our efforts to expand the availability of this product to broader indications. Again, thank you very much, everyone, for your time this morning. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.