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spk01: Good morning and welcome to Selectar's Bioscience 2023 year-end earnings call. Today's call is being recorded. Before we begin, I would like to remind everyone that statements made during this call relating to Selectar's expected future performance, future business prospects, or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties that could differ materially from those forecast due to the impact of many factors beyond the control of SelectR. The company assumes no obligation to update, supplement, or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the cautionary notes set forth in today's press release, which is available on the investor relations portion of the company's website, as well as the risk factors set forth in Selecta's annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Selecta. Mr. Caruso, please go ahead.
spk05: Thank you, Mark, and good morning, everyone. It is my pleasure to be here with you to report our year-end results and provide a corporate update. With me today are Dr. Andrei Shustov, Senior Vice President, Medical, Jarrett Longkorff, Chief Operating Officer, Shane Leah, Chief Commercial Officer, and Chad Colleen, our Chief Financial Officer. I will begin today with a brief overview of the meaningful accomplishments the company has achieved these past 12 months. I will then review our WM plans, after which I will turn the call over to our team for a more in-depth update. You will first hear from Dr. Shustoff, who will provide a review of our successful WM trial results and discuss Hypophysine I-131 clinical development programming. Regarding the WM pivotal study, I am pleased to report that we remain on track for a Q2 announcement of our updated top line data from our Clover Rand study. Jarrett will provide an update on our regulatory plans and NDA filing. Shane will review our commercial readiness plans and announce the hiring of additional commercial talent to support the potential launch of WM, followed by Jarrett providing an update on our lead alpha emitter, phospholipid radioconjugate, or PRC, and briefly discuss why our alpha emitters provide unique mechanism of action qualities which differentiate our PRCs from existing alpha emitters in development. As you are aware, it is an exhilarating time for radiotherapy companies, and certainly a renaissance for radiotherapeutics. With the next radiotherapeutic approval, potentially Iapopasine I-151, Coupled with our unique delivery platform providing differentiated radioisotope offerings, we are confident in our market position and excited about the future of SelectARC. Chad will then discuss our financial results, and we will open the call for Q&A. Please allow me to now provide an overview of key accomplishments. As part of a private placement of up to $103 million, the company has received just under $69 million to date. In addition, approximately $34 million in warrants will be available for conversion upon approval of our WM-NDA. Achieved further validation of Iopopocene I-131 and our PDC delivery platform to treat solid and hematologic tumors, including those located across the blood-brain barrier. Initiated and enrolled the first patient in our Phase Ib clinical study of iapophysine in pediatric high-grade gliomas. Announced a new licensing agreement covering pediatric cancers with the Wisconsin Alumni Research Foundation for intellectual property that was the result of collaborative research conducted at the University of Wisconsin-Madison with iapopacin. We further expanded our PDC and radiotherapeutic intellectual property portfolio, which was recognized by global data, citing SelectARP as the leading pharmaceutical company as measured by patent grants and applications for radiopharmaceuticals. We also announced promising preclinical data for three Separate alpha emitters, including our proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR121255, and actinium-labeled phospholipid ether in pancreatic cancer models. In preparation for the potential commercial launch of iapofasine, we announced the first of many anticipated strategic partnerships with leading physician-led community-based oncology networks, such as Florida Cancer Specialists and American Oncology Network, or AON, to advance the treatment of WM in the community and support communication between physicians, patients, and industry partners. And, of course, we announced positive top-line data in the Clover-WAM pivotal study evaluating Iofocucine I-131 for the treatment of relapsed refractory Waldenstrom's macroglogulamia. We remain on target to provide an update on our WM top line data during the second quarter. Currently, we are in process of completing the work for our NDA filing and plan to submit our filing to the FDA in the second half of this year. Assuming we are granted priority review associated with our fast track designation, we could expect a six month review period from the date of submission. In parallel, we remain focused on constructing highly efficient commercialization capabilities for Iopopasin. As Shane will review, the WM market is highly concentrated, highly scalable, ideal for a nimble biotech company like ours to build a focused and productive commercial infrastructure. Let me now turn the call over to Andre to further review the WM trial and our clinical development program. Andre?
spk06: Thank you, Jim, and good morning, everyone. I would like to start with a very brief review of the study design, study patient characteristics, and top-line efficacy and safety data from our Global WAMP pivotal trial that we revealed earlier this year. As a reminder, Global WAMP was a global, open-label, single-arm study examining hypoxin I131 in relapsed and refractory WM patients who received at least two prior lines of therapy, including those patients who failed or had suboptimal response to a BTKI, the only FDA-approved class of treatment for this cancer. Study patients received a total of four doses of ipophysin over two cycles without maintenance or a treatment and were evaluated continuously for response for up to 12 months from the initial dose. Patients eligible for the trial had to have histologically and serologically confirmed diagnosis of Waldenstrom macroglogonemia and ECOG performance status of 0 to 2 and have received at least two lines of prior therapy, which practically included treatment with a BTK inhibitor. The study also included WM patients with central nervous system involvement known as Benil syndrome. and patients with lymphoplasmocytic lymphoma without full features of WM. Patients enrolled in ClovoM were the most heavily pretreated and the most refractory WM patient population ever reported in clinical trials. This statement is supported by key patient characteristics, including number of prior therapies, which is four, Proportion refractory to BTKI and rituximab, which is 50% and 40% respectively. Proportion refractory to both BTKI and anti-CD20 therapy, which is 26.7%. Proportion with medium and high IPSS-WM score, which is 42%. And five to six-fold enrichment with MITEI-88 wild-type genotype. Topline data from the Cloverweb trial reported on 41 consecutive evaluable patients, or approximately 75% of the total MITT efficacy population, demonstrated a 61% major response rate, a 75.6% overall response rate, and a 100% disease control rate. Further, the data showed a 7.3% complete response rate with a median duration of response and median progression pre-survival not reached at the time of data cutoff date and a median follow-up of eight months. We saw a high rate of responses across all key WM genotypes, including those that have been shown to control resistance to currently available improved therapies. Responses were durable, with median duration of response not reached, and 76% of patients remaining progression-free at a median follow-up at eight months, and the longest continuous response of over 30 months. Importantly, durability of these responses without the need for continuous therapy or retreatment suggests that ipophysin could be potentially disease-modifying new therapy with novel and unique mechanisms of action. Our safety results were also very positive with 0% treatment related discontinuations, 0% treatment related deaths, and 0% clinically significant bleeding. We saw predictable and manageable onset and recovery of cytopenias in all patients. We did not observe any treatment related cardiovascular, renal, or hepatic adverse events. In summary, Global WEM was the largest study in relapsed refractory post-BTKI patients to date and the first WEM study to evaluate dual refractory patient population. We believe that to achieve a 61% major response rate in 41 evaluable patients with a median of four prior lines of therapy is nothing short of remarkable, especially with results that show a favorable safety profile and a four-dose truly fixed-duration course of treatment. We believe that these results demonstrate that ipofasin is a promising therapy for patients in high clinical need, one that is easy to administer as an IV infusion in an outpatient community oncology practice with a tolerable side effect profile and very encouraging efficacy results in some of the most difficult to treat relapsed refractory patients ever studied. We look forward to providing our updated study results, which will include data from all 55 efficacy-available patients enrolled in the study sometime in the next quarter. In addition to impressive results from Cloverwem's study, we've also reported promising activity of ipophysin and other hematologic malignancies and solid tumors. This includes exciting results in a primary CNS lymphoma patient with attainment of complete remission, and stabilization of disease in a pediatric patient with a refractory high-grade brain tumor. These findings further validate our previous observation of iapophysin's ability to cross the blood-brain barrier and deliver an antineoplastic payload to a variety of tumors in a sanctuary site. Further, a recent report from the University of Wisconsin-Madison demonstrated the ability of ipophysin to safely combine with external beam radiotherapy in relapsed carcinoma of head and neck, with 64% of patients attaining a complete remission and one-year overall survival of 67%. We believe that these findings may be broadly applicable to a variety of SALT tumors. In summary, Data demonstrating iapophysin's ability to induce deep responses, including complete responses in a variety of relapsing refractory, hematologic, and solid tumors while exhibiting a consistently low toxicity profile with good tolerability may translate into durable and clinically meaningful benefits to a diverse patient population in urgent need for novel therapies. I will conclude. by emphasizing that we are pleased with the results highlighted above and are looking forward to sharing updates from our ongoing studies in multiple myeloma, primary CNS lymphoma, and pediatric high-grade gliomas later this year. We will continue to evaluate product development and commercialization opportunities to craft the future focused clinical development of hypofysin, including frontline treatment of WM, a WM-retreatment study to include a third cycle, as well as studies in other indications, including marginal zone lymphomas, mycosis fungoides, and primary amyloid doses. With that, I will now turn the call to a dear colleague of mine, Jared Longport, for an overview of our regulatory plans. Jared.
spk09: Thank you, Andre. With the successful completion of the Clover-WAM study, we remain focused on the completion of our NDA which we plan to submit to the Food and Drug Administration in the second half of this year. We continue to work closely with the agency, and since announcing top line results, we have received helpful advice and direction on various elements for all of our modules required for the following. We are working diligently to ensure our submission is robust and provides the supporting components the agency has requested. At the time of submission, we will request priority review associated with our Fast Track designation, and assuming it is accepted, we would expect an approximate six-month review period from the date of submission for our NDA, which is, if accepted, will provide approval of iApofacine in the first half of 2025. With this potential commercial launch timing in mind, we are refining our manufacturing and logistics process to ensure uninterrupted supply of iApofacine I-131. Based upon our understanding of the difficulties experienced by others associated with the manufacturing and supply of targeted radiotherapies, we developed and executed a plan that we believe will mitigate or eliminate these risks. The frequent challenges that have been experienced by others include the inability to source isotope, issues or failures at the finished product manufacturing plant, and or insufficient shelf life, all resulting in an interruption in supply and an inability to treat patients. As discussed previously, rather than building and maintaining a single Selectar-operated manufacturing facility, which would limit total potential supply and run the risk of a site closure interrupting commercial supply, we have strategically established contract manufacturing partners that provide a multi-layered, overlapping, redundant, finished product supply chain network. This allows us to have multiple facilities providing hypoxine for the global marketplace It ensures that an issue at one facility does not completely stop production and supply and allows for an easy increase in total production capacity. In fact, because of this strategy, we can far exceed the projected supply requirements for all proposed indications with our existing North American-based supply partners. As an example, we currently have a capacity to provide greater than 200 doses per week and can scale to nearly 1,000 without an increase in infrastructure. Importantly, we will look to expand our contract manufacturing footprint later this year with the addition of a facility in Europe. This approach will increase our total supply and will provide easier and more rapid distribution in Europe and Asia. As a reminder, currently from North America, we supply globally within 48 to 72 hours. The addition of the facility in Europe will reduce this timing for specific regions. In addition to the redundancy, At the finished product level, we have also established similar redundancies in the supply of the isotope and production of our carrier model. This approach ensures availability to the necessary quantities of I-131 and our PLE, reducing or eliminating potential risks to that portion of our supply chain. We believe this approach results in a seamless, secure supply via focusing I-131. Combining this with our 17-day shelf-life providing an off-the-shelf, fully finished, ready-to-use product with no on-site compounding required provides a product with unique convenience and flexibility for patients and physicians that has historically been lacking with targeted radiotherapies. Now let me turn the call over to Shane, who will provide an update on our commercial preparation.
spk07: Thank you, Jared, and good morning, everyone. Our team is significantly advancing our capabilities in preparation for a potential commercial launch by Apophisene and WM. Importantly, we continue to execute and make progress on our commercialization strategy for Iopofacine with the goal of ensuring a successful launch upon FDA approval. We are very encouraged by the findings from our two most recent market research projects, which include an evaluation of Iopofacine's product profile and an evaluation of the WM patient journey. The hematologist review of Iopofacine's product profile for WM was seen as very promising and impressive, with a high rating for intent to prescribe. Key findings from our patient journey work also show patient active participation in treatment choice and important treatment drivers, which includes a need for new options and fixed therapy. We are building a high, successful, large team that's very concentrated in nature with lots of experience and have recently filled all of the critical commercial leadership roles with two new senior hires to our commercial team. Our new VP of Marketing, Allison Bautista, brings over 20 years of industry experience and has an exceptional track record in new product launch leadership, notably leading the ReblaZil launch for beta thalassemia and myelodysplastic syndrome at BMS and the Zivo launch for desmoid tumors at SpringWorks. Our newly appointed VP of Market Access, Eric Gustafson, brings over 30 years of industry experience across broad commercial roles with deep experience in market access. His most recent role was leading the integrated access and value team to commercialize two-part T cell therapies at BMS. The ability to attract and staff highly competent and experienced talent uniquely positions SelectR for a successful launch. We also continue to build out our data capabilities to drive our understanding of the market. As Jim noted earlier, WM is a very attractive market for a company of our size. It's a concentrated market with a high unmet need, limited competition, and has high value capture. Our third party claims and epi data show the total US WM market to be approximately 2.1 billion, with an approximate prevalence of 26,000 patients. The third line plus segment represents approximately 4,700 patients, and the total number of patients in second line or greater is approximately 11,564 patients. We estimate the relapsed refractory market to be valued at approximately $1 billion. In our next slide, it illustrates our claims data, which demonstrate there is no established standard of care in WM. Greater than 60% of patients receive non-FDA-approved drugs, and over half, or 52%, of patients who receive a BTKI in second line are re-challenged with again as third-line therapy. This is mainly because there are limited treatment options in this relapsed refractory setting, as there has been no FDA-approved new mechanism of action in nearly a decade. We believe iapofasine, with its novel mechanism of action, has the potential to capture significant share in this market. In summary, the WM market has high unmet need with an addressable market of about 11,600 relapsed refractory patients, 4,700 beyond second-line therapy, and an annual third-line incidence of nearly 1,000 patients. It is a highly concentrated market with 10% of the treatment centers representing about 70% of the WM opportunity and 80% of the patients located in 15 states. There is limited competition in this market with no established standard of care, and greater than 60% of patients receiving non-FDA-approved treatment across all lines of therapy. Finally, with its efficacy, safety profile, and fixed dosing regimen, iapofasine represents a strong value proposition for physicians and payers and will provide a meaningful benefit for WM patients. In conclusion, the commercial team is continuing to advance both capabilities and launch preparations to ensure a successful iapofasine launch. We look forward to providing additional updates. I will now turn the call back over to Jared Longcore to highlight our Alpha Admitter program. Jared. Thank you, Shane.
spk09: While our focus is on the successful submission of ipopacine's NDA and preparing for a potential launch in WM, our radio conjugate franchise offers a very robust and diverse pipeline of opportunities. In addition to the broad applicability of ipopacine, and other relapsed refractory disease settings beyond WM, as described by Andre earlier, we continue to demonstrate the potential of our phospholipid radio conjugate pipeline with isotopes other than iodine-131. Due to the nature of our PDC platform, we have the unique ability to rapidly switch isotopes and leverage a particular isotope's physical properties and match that with the biological properties of a specific tumor to create an optimized semi-personal radiotherapeutic option. We have validated by demonstrating in xenograft models our ability to deliver effective doses of actinium-225, lead-212, and astatine-211 in various tumor types. We are rapidly advancing our actinium program, CLR121-225, through IND-enabling studies with the plan to initiate a Phase I study in pancreatic cancer late this year or early next year. Our programs are differentiated from other targeted alpha therapy programs, or TATs, by overcoming some of the challenges associated with the limited linear energy length provided by alpha emitters. A challenge with TATs is that the energy from the molecules only penetrates a single cell. Therefore, the targeting ligand must achieve uptake in nearly 100% of the tumor cells to be efficacious. For most other alpha-emitter programs, this is restricting them to pursuing tumor types that remain small. For example, small metastatic sites or small, slow-growing neuroendocrine tumors. But due to our ability with our PDCs to provide a uniform delivery to the tumor, we can achieve robust activity in large, bulky, rapidly-growing tumors like seen in our lymphoma clinical study and in the preclinical models of pancreatic, breast, and lung cancer that we've tested. We believe that this technological advantage will allow us to develop an extensive portfolio of TATs, TAT programs, and expand the utilization of this highly effective treatment modality to a number of broad, to a number broad array of tumor types. I will now turn the call over to Chad to review our financials. Chad?
spk08: Thank you, Jared. As shown in our 10-K filed earlier today, cash and cash equivalence balance as of December 31, 2023 was $9.6 million, compared to $19.9 million as of December 31, 2022. Net cash used in operating activities during the year was approximately $36.4 million. It's important to note the September 2023 finance and design included a tranche of warrants and an expiration of 10 trading days after the company released positive top-line data, which we did on January 8th. As a result of the data release, the investors who held the warrants exercised them in their entirety, generating aggregate additional funding of $44.1 million or $42.8 million net of fees. As Jim noted earlier, September 2023 financing represents up to $103 million in funding and has generated nearly $69 million for the company to date. The company believes its cash on hand, inclusive of the funds from the exercised warrants in January, is adequate to fund budgeted operations into the fourth quarter of 2024. R&D expense for the year was approximately $28.2 million, compared to $19.2 million last year. The overall increase in R&D expense is primarily a result of three initiatives. Our continued focus on and investment in establishing a multi-source supply chain capability with redundant capacity in every aspect to ensure product supply cannot be disrupted, the substantial increase in pivotal study patient enrollment culminating in the top-line data announcement, and the initiation of a pediatric high-grade flea illness study. G&A expense for 2023 was $10.7 million, compared to $9.5 million last year. The increase in G&A costs was composed of an increase in personnel-related costs, which were partially offset by reduced professional fees. Net loss attributable to common stockholders for the year was $38.0 million, or $3.11 per share, as compared to $28.6 million, or $4.05 per share last year. I will now turn the call to Jim for closing remarks.
spk05: Jim? Okay. Thank you, Chad. I hope that all of you agree that SelectR's accomplishments over the course of the year have been substantial. We also believe 2024 sets up very nicely for us and will represent yet another transformational year with further advancements and real growth as a company. With that, I would like to now open the call for our question and answer session. Operator?
spk01: Thank you. If you wish to ask a question, please dial star 1 on your telephone keypads now to enter the queue. Once your name is announced, you can ask your question. If you find it's answered before it's your turn to speak, you can dial star 2 to cancel. Our first question comes from the line of Jonathan Ashcroft at Roth MKM. Please go ahead. Your line is open.
spk02: Thank you, guys. Good morning, and congrats on all the obvious progress. Given that progress, are you getting any serious acquisition inquiries? Because the drug seems to be rather isotopically modular and targeted to lipids that really don't seem like they're going to change that much. So it sounds like something somebody would want to own and apply broadly.
spk05: So, Jonathan, thank you for pulling punches on your first question. We appreciate it. Now, listen, I mean, as we were chatting at your conference, and thanks again for the opportunity to participate there, when you take a look at the landscape in radiotherapeutics in general with, you know, almost predominantly the two available agents on the market currently, Lutathera and Fluvicto, both being beta emitters as an aside. And of the eight products that currently are in pivotal studies, eight radio-acuteic products that are in pivotal studies, three are in the kind of net area and three are in prostate, really fragmenting that space now, right? As these alpha emitters continue to develop, what you'll discover and what you know is that they're really focused on those particular areas. And, you know, Jared or Andre can do a much better job than I to talk to why that is the case and the differentiation between our delivery platform and our capacity to be very effective against larger bulk tumors relative to some of these other antibody drug conjugate, these ligand approaches that limit the capacity to smaller tumors. tumor types like neuroendocrine and prostate. So having said that, we believe not only can we differentiate with our radioisotope program in general from all others currently available, we also, we believe, are potentially the next-to-market approved agent with hypothesin, which has demonstrated utility beyond hematologic malignancies in our first-to-market indication, which would be WM, which we believe, and as Shane discussed, and hopefully have an opportunity to provide broader background on, is just an excellent opportunity for us as a company for top line revenue there, as well as the capacity to really help patients with high clinical need, as Andre appropriately discussed. So having said all that, I think that positions us very nicely. The other element here, Jonathan is obviously our intellectual property portfolio. As other companies have more recently come into the space, we have been planning and have been methodically expanding our intellectual property waterfront over the course of five, six, seven years. And that also favorably positions us as well as our PDC platform very nicely inclusive of all of our radiotherapeutic assets. So I think, you know, without directly answering your question based on, you know, where we sit as a company, we really like what we've built. We believe the last 12 months have been transformative and we've demonstrated real growth and we look forward to over the next, you know, six, 12, 18 months to experience similar growth. And we do believe the NDA submission, and acceptance as substantially complete, and our first approval in WM will be yet another game changer for the organization from a valuation perspective.
spk02: Okay. You know, is Clover shut, or are you seeing any higher enrollment in liquid tumors after you came out with this data in January? I can't remember if Clover always seemed to me to be this open-ended, you know, highly inclusive trial of yours that I just can't recall if it's closed formally or if it can take additional patients.
spk05: As you recall, there were three arms associated with our Clover Wham study. We had the WM pivotal portion, and then we had two additional elements, the phase 2A and And I could have Andre or Jarrett talk to the multiple myeloma arm and how we were dialing in on post-BCMA data to further enrich our data set, which would allow us, we believe, with a formidable opportunity and package just to secure NCC and compendia guidelines. So once approved with WM, this would allow those clinicians that believe Iopopacin could benefit some later line multiple myeloma patients, the opportunity to do that. So we continue to enroll there. And then, of course, we have the phase 2A primary central nervous system lymphoma arm as we continue to explore the really unique benefits of our delivery vehicle and Iopopacin in particular to cross the blood-brain barrier. And as Andre will tell you, penetrate and demonstrate effectiveness in these sanctuary sites. So with that, I don't know if Jared or Andre have any additional to add to that. Thank you, Jim.
spk06: And Jonathan, thank you for your question. Jim answered the majority, I think, of your request. I will just reconfirm, reiterate that Global WAM has emerged as an expansion from the – just to say basket to a study that included our cohorts in non-Hodgkin lymphoma, primary CNS lymphoma, and multiple myeloma. The Clover web study is fully involved, and we are in the process of preparing the NDA submission this year, as you know. We continue to enroll in multiple myeloma cohort to enrich high-risk population, and we'll be evaluating our data in the second half of this year to further guide us into where to take this program from regulatory standpoint. We also enroll in patients into primary CNS lymphoma cohort to further distill the signal of activity first demonstrated by CR in the patient with refractory disease across blood-brain barrier. So those are ongoing studies that we will be reporting updates in the second half of the year.
spk02: Okay, and all these patients will get four doses, like in the WM trial, unless toxicity dictates otherwise, is that accurate?
spk06: So, as you probably know, the protocol, the 2A study contains several cohorts with different dosing schedules. The currently open cohorts will pursue the schedule that we have reported in the global WEMS study.
spk02: Okay, and just two quick boring questions. With a pop in SG&A in the fourth quarter, can you help us out? What does SG&A look like for 2024?
spk08: Total expense, I guess for SG&A alone, I'm going to defer that a little bit until we actually look at that breakdown a little bit more. I don't think you're going to see much of a change in the trend as we go into 24 from what you saw in fourth quarter to your point. We won't see that really change dramatically until we get later in the year.
spk05: And so what I'll add to that, Jonathan, yeah, what I'll add to that, Jonathan, as you kind of think about how we would invest in the WN space, Shane is building out a very targeted organization and where you would typically see, I think, an OPEX for a commercial, especially launch and early years, when you're really driving trial use and adoption, this kind of $50 to $70 million OPEX, I believe Shane has a targeted, very targeted, focused strategic plan that we really like, leveraged with smart data. And Shane, I believe that's in and around a $25 million OPEX.
spk02: Correct. Thank you very much, guys. All right. Thank you, Jonathan.
spk01: Thank you. Our next question comes from the line of Jeff Jones at Oppenheimer. Please go ahead. Your line is open.
spk04: Thanks. Thank you, Operator. And congrats on the great year, guys, and all the progress you've made. I guess starting off on following on what Jonathan was asking on sort of the operational G&A program, can you speak to how – what your – thinking about in terms of the commercial organization at launch or sales rep, MSL structure?
spk05: Sure. I'm going to turn that over to Shane and his team that have done just a really nice job from a preparation perspective. As you know, Jeff, I've spent a lot of years in commercialization space and marketing in both large multinational pharmaceutical companies as well as small biotech And Shane has done as good or better of a job than I have historically observed in the past. So I'll give him an opportunity to kind of talk through some of his thinking.
spk07: Yeah, thanks, Jim, and thanks for the question. When we look at the build of our go-to-market model, it's really focused on two things, right? One is what are we doing to influence brand choice, building of awareness, leveraging the key attributes for iOpophysine, And the second piece of it's more operational in nature is we think about how do we target our efforts in the right locations, especially since this market is very concentrated. And the other key piece of this is focused around the radiotherapy enablement process. So looking at the... opportunity, we want to make sure that it's one which is very targeted in nature and one which is also scalable. And I believe that we have the opportunity to do that since it is a concentrated market. So when you look at the go-to-market model, we'll have roles which will help to support the pull-through of those two key things. First, having proper marketing capabilities, proper data capabilities to help drive choice and decision-making. We will have a team which will be dedicated to the site activation and radiotherapeutic enablement process in these very targeted accounts. And we'll have a traditional sales role, which will be focused on driving trial and use and building awareness. Also supporting those teams will be a focus group of MSLs to support medical information inquiries and provide further enrichment and education around iapophysine And we also have a dedicated team that will be supporting all of our market access initiatives. We want to ensure that in our focused approach, we leave no patient behind because there is significant unmet need in this space. And we believe with Iopofacine's profile, we have a unique opportunity here to capture share in all of these key segments. of the market, which we've illustrated as part of the share basket slide that you saw today.
spk04: Thanks, Shane. Could you speak to how you're looking at Europe, both from a regulatory and commercial perspective?
spk09: Absolutely, Jeff. For those that may not recognize my voice, this is Jared. So let me start from a regulatory perspective, as I think many folks are aware. Last year, we did receive prime designation in Europe. The prime designation for Europe is essentially the equivalent of the breakthrough designation here in the US. It does provide you with increased engagement with the agency. It provides you with a more rapid pathway to launch, and it provides actually encourages the cross communication between those two agencies. So EMA and FDA actually behind the scenes start to align and get their sort of requirements in harmonization with one another for the same product. With that said, so that sort of tees that up. Our timeline or our expectation is that we will push forward here rapidly with EMA to rapidly follow a approval in the U.S. It won't be at the exact same time as the U.S. launch, but we're in discussions right now to determine exactly what that timeline will look like in a fourth European launch. Now, with that said, we as Selectar do not plan to be the party to commercialize in Europe. What we are looking to do and what we have a number of ongoing discussions with various partners is is to have a partner take over the commercialization and functionality of the product in Europe. We will continue to control the sort of supply chain and make sure that they receive product as necessary, but they will be the drivers for the commercialization.
spk04: Great. Thank you, Jared. I guess last question for me, and you spoke to it a little bit, really providing some interesting data on the diversity of therapies used by line in these patients. So any update on your thinking about the label, the indication you would propose to the agency being at third line plus BTKI refractory, et cetera? Yeah.
spk09: So from a regulatory perspective, you know, I'll say that, You know, based off the clinical data that we've seen to date, as Andre took you through, the one, yes, we're a later line, but more importantly, the refractoriness of these patients, the level of treatments that they have received, we do believe that we have a very strong position and a strong opportunity to pursue a simplistic sort of second line or later positioning, or as one might say, a relapse refractory treatment. patient population. So really targeting in on that sort of 11,000-ish patient population. We do believe that we have a very high probability of success on that, again, because of the number of patients that we've had that have been exposed, not just the only approved class of therapy, but essentially all other therapeutic options, and for which they've shown high levels of refractoriness, unlike what's been tested historically. So we do believe that there's a strong opportunity there.
spk03: Great. Really appreciate the additional clarity, guys. I'll step back into the queue.
spk05: All right. Thanks much, Jeff.
spk01: Thank you. And currently there are no further questions in the queue at this time, so I'll hand the floor back to Mr. Caruso for the closing remarks.
spk05: All right. Terrific. Thank you, Mark. Appreciate your facilitation of this call today. And obviously I would like to thank everyone for joining us as well. We look forward to speaking with you in the near term. Have a good day.
spk01: Thank you. This now concludes our call. Thank you all very much for attending. You may now disconnect.
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