Earnings Call Transcript - CLRB Q4 2023

Operator, Operator

Good morning. And welcome to Cellectar Biosciences 2023 Yearend 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 Cellectar’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 forecasts due to the impact of many factors beyond the control of Cellectar. The company assumes no obligation to update, supplement, or otherwise change 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 risk factors set forth in Cellectar’s annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in forward-looking statements. At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Cellectar. Mr. Caruso, please go ahead.

Jim Caruso, CEO

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; Jarrod Longcor, Chief Operating Officer; Shane Lea, Chief Commercial Officer; and Chad Kolean, our Chief Financial Officer. I will begin today with a brief overview of the meaningful accomplishments the company has achieved over the 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. Shustov. He will provide a review of our successful WM trial results and discuss Iopofosine I-131 clinical development programming. Regarding PWM 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-WaM study. Jarrod 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 Jarrod, providing an update on our lead alpha-emitter, phospholipid radio conjugate or PRC, and briefly discuss why our alpha-emitters provide unique mechanism of action qualities that 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 radio therapeutics. With the next radiotherapeutic approval potentially being Iopofosine I-131, coupled with our unique delivery platform providing differentiated radioisotope offerings, we are confident in our market position and excited about the future of Cellectar. 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. We achieved further validation of Iopofosine I-131 and PDC delivery platform to treat solid and hematologic tumors, including those located across the blood-brain barrier. We initiated and enrolled the first patient in our Phase 1b clinical study of Iopofosine in pediatric high-grade gliomas, and announced a new licensing agreement covering pediatric cancers with the Wisconsin Alumni Research Foundation for intellectual property that resulted from collaborative research conducted at the University of Wisconsin-Madison with Iopofosine. We further expanded our PDC and radiotherapeutic intellectual property portfolio, which was recognized by global data, citing Cellectar as the leading pharmaceutical company in terms of patent grants and applications for radio pharmaceuticals. We also announced promising preclinical data for three separate alpha-emitters, including our proprietary novel alpha-emitting phospholipid, radiotherapeutic conjugate CLR-121255, and actinium-labeled phospholipid ether in pancreatic cancer models. In preparation for the potential commercial launch of Iopofosine, we announced the first of many anticipated strategic partnerships with leading physician-led, community-based oncology networks such as Florida Cancer Specialists, and the 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 CLOVER-WaM pivotal study evaluating Iopofosine I-131 for the treatment of relapsed refractory Waldenstrom macroglobulinemia. We remain on target to provide an update on our WM top-line data during the second quarter. Currently, we are in the process of completing the work for our NDA filing and plan to submit it 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 Iopofosine. As Shane will review, the WM market is highly concentrated, highly scalable, and ideal for a nimble biotech company like ours to build a focused and productive commercial infrastructure. Let me now turn the call over to Andrei, to further review the WM trial and our clinical development program. Andrei?

Andrei Shustov, Senior Vice President, Medical

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 CLOVER-WaM pivotal trials that were revealed earlier this year. As a reminder, CLOVER-WaM was a global open label single arm study examining Iopofosine I-131 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 BTKi, the only FDA approved class of treatment for this cancer. Study patients received a total of four doses of Iopofosine in over two cycles without maintenance treatment and were evaluated continuously for response for up to 12 months from the initial dose. Patients eligible for the trial had to have a histologically and serologically confirmed diagnosis of Waldenstrom macroglobulinemia and ECOG performance status from zero to two, and have received at least two lines of therapy, which preferred treatment included a BTK inhibitor. The study also included WM patients with central nervous system involvement, known as Bing-Neel Syndrome, and patients with lymphoplasmacytic lymphoma without full features of WM. Patients enrolled in CLOVER-WaM were the most heavily pre-treated and refractory WM patient population ever reported in clinical trials. This statement is supported by key patient characteristics, including the number of prior therapies, the proportion refractory to BTKi and Rituximab, which is 50% and 40% respectively, and the proportion refractory to both the BTKi and anti-CD-20 therapy, which is 26.7%. Additionally, the proportion with medium and high IPSSWM scores is 42% and there is a five to six-fold enrichment with MYD88 vial type genotype. Top-line data from the CLOVER-WaM trial reported on 41 consecutive evaluable patients, where 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 show a 7.3% complete response rate, with a median duration of response and median progression-free survival not reached at the time of our update with 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 confer resistance to currently available improved therapies. The responses were durable, with a median duration of response not reached and 76% of patients remaining progression-free at a median follow-up of eight months, and the longest continuous response observed within 30 months. Importantly, the durability of these responses without the need for continuous therapy or retreatment suggest that Iopofosine could be a potentially disease-modifying new therapy with a novel and unique mechanism of action. Our safety results were also very positive, with zero percent treatment-related discontinuations, zero percent treatment-related deaths, and zero percent of clinically significant bleeding. We observed 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, CLOVER-WaM was the largest study in relapsed refractory post-BTKi patients to date, and the first step study to evaluate a 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 showed a favorable safety profile and a four-dose fixed duration course of treatment. We believe that these results demonstrate that Iopofosine is a promising therapy for patients with high clinical needs, 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 CLOVER-WaM study, we've also reported promising activity of Iopofosine in other hematologic malignancies and solid tumors. This includes exciting results in primary CNS lymphoma patients with attainment of complete remission and stabilization of disease in pediatric patients with refractory high-grade brain tumors. These findings further validate our previous observation of Iopofosine’s ability to cross the blood-brain barrier and deliver an antineoplastic payload to various tumors in sanctuary sites. Furthermore, a recent report from the University of Wisconsin-Madison demonstrated the ability of Iopofosine to safely combine with external beam radiotherapy in relapsed carcinoma head and neck, with 64% of patients achieving complete remission and one-year overall survival of 67%. We believe that these findings may be broadly applicable to a variety of solid tumors. In summary, data demonstrating Iopofosine’s ability to induce deep responses, including complete responses across a variety of relapsed and refractory hematologic and solid tumors, while exhibiting consistently low toxicity profiles and good tolerability, may translate into durable and clinically meaningful benefits for a diverse patient population in urgent need of novel therapies. I will conclude by emphasizing that we are pleased with the results highlighted above. I look 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 validate product development and commercialization opportunities to shape the future-focused clinical development of Iopofosine, including frontline treatment of WM, WM treatment studies to include a third cycle, as well as studies in other indications, including marginal zone lymphomas, mycosis fungoides, and primary amyloidosis. With that, I will now turn the call to my colleague, Jarrod Longcor, for an overview of our regulatory plans.

Jarrod Longcor, Chief Operating Officer

Thank you, Andrei. 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 our top line results, we have received helpful advice and direction on various elements of all of our modules required for submission. 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. Assuming it is accepted, we expect an approximate six-month review period from the date of submission for our NDA, which, if accepted, will provide approval of Iopofosine in the first half of 2025. With this potential commercial launch timing in mind, we are refining our manufacturing and logistics processes to ensure an uninterrupted supply of Iopofosine I-131. Based on our understanding of the difficulties experienced by others associated with the manufacturing and supply of targeted radiotherapy, we have developed and executed a plan that we believe will mitigate or eliminate these risks. The frequent challenges associated with others include an inability to source isotopes, issues or failures at the finished product manufacturing plant, 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 Cellectar 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-layer overlapping redundant finished product supply chain. This allows us to have multiple facilities providing Iopofosine for the global marketplace and ensures that an issue at one facility does not completely stop production and supply, while allowing 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 base supply partners. As an example, we currently have a capacity of 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 carry amount. This approach ensures availability of 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, focusing on I-131. Combining this with our 17-day shelf life, we provide an off-the-shelf, fully finished ready to use product with no onsite compounding required, making it convenient and flexible 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 commercial preparation.

Shane Lea, Chief Commercial Officer

Thank you, Jarrod. And good morning, everyone. Our team is significantly advancing our capabilities in preparation for the potential commercial launch of Iopofosine and WM. Importantly, we continue to execute and make progress on our commercialization strategy for Iopofosine, with a goal of ensuring a successful launch upon FDA approval. We are very encouraged by the findings from our two most recent market research projects, including an evaluation of Iopofosine’s product profile, and an evaluation of the WM patient journey. The hematologist's review of Iopofosine’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 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 large and successful team that is very concentrated in nature, with lots of experience. We have recently filled all of the critical commercial leadership roles, including two new senior hires to our commercial team. Our new VP of Marketing, Alison Bautista, brings over 20 years of industry experience and has an exceptional track record in new product launch leadership, notably leading the REBLOZYL launch for beta-thalassemia and myelodysplastic syndrome at BMS, and the Ogsiveo 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 CAR-T cell therapies at BMS. The ability to attract and staff highly competent and experienced talent uniquely positions Cellectar 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, as a concentrated market with a high unmet need, limited competition, and high value capture. Our third-party claims and epidemiological data show the total U.S. 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. Our claims data demonstrate that there is no established standard of care in WM. Greater than 60% of patients received non-FDA approved drugs, and over half or 52% of patients who receive a BTKi in the second line are rechallenged with 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 Iopofosine, with this novel mechanism of action, has the potential to capture significant share in this market. In summary, the WM market has a 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. This 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, Iopofosine represents a strong value proposition for physicians and payers, providing a meaningful benefit for WM patients. In conclusion, the commercial team is continuing to advance both capabilities and launch preparations to ensure a successful Iopofosine launch. We look forward to providing additional updates, and I will now turn the call back over to Jarrod Longcor to highlight our Alpha Emitter program.

Jarrod Longcor, Chief Operating Officer

Thank you, Shane. While our focus is on the successful submission of Iopofosine NDA and preparing for the potential launch of WM, our radio conjugate franchise offers a very robust and diverse pipeline of opportunities. In addition to the broad applicability of Iopofosine in other relapsed/refractory disease settings beyond WM, as described by Andrei earlier, we continue to demonstrate the potential of our phospholipid radio conjugate pipeline with isotopes other than I-131. Due to the nature of our PDC platform, we have the unique ability to rapidly switch isotopes and leverage the physical properties of a particular isotope, matching it with the biological properties of a specific tumor to create an optimized semi-personal radio therapeutic option. We have validated our ability in Xenograft models to deliver effective doses of Actinium-225 and Astatine-211 in various tumor types. We are rapidly advancing our Actinium program, CLR-121225, through IND-enabling studies with the plan to initiate a Phase 1 study in pancreatic cancer late this year or early next year. Our programs differentiate from other targeted alpha therapy programs (TATs), 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 restricts them to small tumor types, such as small metastatic sites or small growing neuroendocrine tumors. However, due to our ability with PDCs to provide uniform delivery to tumors, we can achieve robust activity in large, bulky, rapidly growing tumors, as seen in our lymphoma clinical study and in preclinical models of pancreatic, breast, and lung cancer that we tested. We believe this technological advantage will allow us to develop an extensive portfolio of TATs programs and expand the utilization of this highly effective treatment to a broad array of tumor types. I will now turn the call over to Chad to review our financials.

Chad Kolean, Chief Financial Officer

Thank you, Jarrod. As shown in our 10-K filed earlier today, our cash and cash equivalents 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 $32.4 million. It's important to note that the September 2023 financing design included a tranche of warrants with an expiration of 10 trading days after the company released positive top line data, which we did on January 8. As a result of the data release, the investors who hold their 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 cash on hand, inclusive of the funds from the exercised warrants in January, is adequate to fund ongoing 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, including our continued focus on and investment in establishing a multi-source supply chain capability with redundant capacity 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 the pediatric high-grade glioma study. G&A expense for 2023 was $10.7 million compared to $9.5 million last year. The increase in G&A costs resulted from a rise in personnel-related costs, which were partially offset by reduced professional fees. Net loss attributable to common stockholders for the year was $38 million or $3.11 per share, compared to $28.6 million or $4.05 per share last year. I will now turn the call to Jim for closing remarks.

Jim Caruso, CEO

Okay. Thank you, Chad. I hope that all of you agree that Cellectar'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?

Operator, Operator

Thank you. Our first question comes from Jonathan Aschoff at ROTH MKM. Please go ahead. Your line is open.

Jonathan Aschoff, Analyst

Thank you, guys. Good morning. And congrats on all the evident 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.

Jim Caruso, CEO

So Jonathan, thank you for pulling punches on your first question. I 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 radio therapeutics in general, with almost predominantly the two available agents on the market currently, Lutathera and Pluvicto, both being beta emitters. As an aside, of the eight products currently in pivotal studies, three are in the net area and three are in prostate, really fragmenting that space now, right, as the alpha emitters continue to develop. What you'll discover is that they're really focused on those particular areas. And Jarrod or Andrei can do a much better job than I to explain 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 conjugates, and these ligand approaches that limit the capacity to smaller 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, but we also believe we are potentially the next to market with Iopofosine, which has demonstrated utility beyond hematologic malignancies in our first-to-market indication, which would be WM, where we believe – and as Shane discussed – is an excellent opportunity for us as a company for top-line revenue and really helps patients with high clinical needs, as Andrei 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 systematically expanding our intellectual property over the course of 5-6-7 years, which also favorably positions us as well as our PDC platform. So I think without directly answering your question, based on 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. We look forward to the next 6-12-18 months to experience similar growth. We do believe the NDA submission and acceptance is substantially complete, and our first approval in WM will be yet another game changer for the organization from a valuation perspective.

Jonathan Aschoff, Analyst

Okay. 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 seems to me to be this open-ended highly inclusive trial of yours that I just can't recall if it's closed formally or if it can take additional patients.

Jim Caruso, CEO

As you recall, there were three arms associated with our CLOVER-WaM study. We had the WM pivotal portion, and then we had two additional elements, the Phase 2a, and I could have Andrei or Jarrod talk to the multiple myeloma arm and how we were dialing in on post-BCMA data to further enrich our data set, which we believe will provide a formidable opportunity that could secure NCCN Compendia guidelines. So once approved with WM, this would allow those clinicians that believe Iopofosine could benefit some later line multiple myeloma patients. So we continue to enroll there. And of course, we have the Phase 2a primary central nervous system lymphoma arm as we continue to explore the unique benefits of our delivery vehicle and Iopofosine, in particular, to cross the blood-brain barrier. And as Andrei will tell you, penetrate and demonstrate effectiveness in these sanctuary sites. So with that, I don't know if Jarrod or Andrei have anything additional to that.

Andrei Shustov, Senior Vice President, Medical

Thank you, Jim. And Jonathan, thank you for your question. Jim answered the majority of your inquiry. I will just reconfirm, reiterate that CLOVER-WaM has emerged as an expansion from the basket 2A study that included cohorts in non-Hodgkin lymphoma, primary CNS lymphoma, and multiple myeloma. The CLOVER-WaM study is fully enrolled, and we are in the process of preparing the NDA submission this year. As you know, we continue to enroll in the multiple myeloma cohort to enrich the high-risk population and will be validating our data in the second half of this year to further guide us into where to take this program from a regulatory standpoint. We're also enrolling patients into the primary CNS lymphoma cohort to further distill a signal of activity, first demonstrated by CMR in the patient with refractory disease across the blood-brain barrier. So those are ongoing studies that we will be reporting updates on in the second half of the year.

Jonathan Aschoff, Analyst

Okay. And all these patients will get 4 doses like in the WM trial unless toxicity dictates otherwise. Is that accurate?

Andrei Shustov, Senior Vice President, Medical

Yes, the protocol for the 2A study contains several cohorts with different dosing schedules. The currently open cohorts will pursue the schedule that we reported in the CLOVER-WaM study.

Jonathan Aschoff, Analyst

Okay. And just two quick boring questions. With the top and SG&A in the fourth quarter, what does SG&A look like for 2024?

Chad Kolean, Chief Financial Officer

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 the fourth quarter. We won't see that change dramatically until we get later in the year.

Jim Caruso, CEO

What I'll add to that, Jonathan, as you think about how we would invest in the WM space. Shane is building out a very targeted organization, and where you would typically see an OpEx for a commercial specialty launch in early years, when you're really driving trial use and adoption, this kind of ranges from $50 million to $70 million. I believe Shane has a targeted, focused strategic plan that we really like, leveraging smart data. I believe that's in and around $25 million.

Shane Lea, Chief Commercial Officer

Correct.

Jonathan Aschoff, Analyst

Thank you very much, guys.

Jim Caruso, CEO

All right. Thank you, Jonathan.

Operator, Operator

Thank you. Our next question comes from the line of Jeff Jones at Oppenheimer. Please go ahead. Your line is open.

Jeff Jones, Analyst

Thank you, operator. Congratulations on the fantastic year and all the progress you've achieved. To start off, following up on Jonathan's question regarding the operational G&A program, could you share your thoughts on the structure of the sales rep and MSL organization for the launch?

Jim Caruso, CEO

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 the commercialization space and marketing in both large multinational pharmaceutical companies as well as small biotech. Shane has done as good or better of a job than I have historically observed in the past. So I'll let him talk through some of his thinking.

Shane Lea, Chief Commercial Officer

Thank you, 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: one is influencing brand choice, building awareness, leveraging the key attributes for Iopofosine, and the second piece is more operational in nature as we consider how to target our efforts in the right locations, especially since this market is very concentrated. We want to ensure that it's one which is targeted in nature and one which is also scalable. 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 that will help support the pull-through of those two key things. First, having proper marketing capabilities and data capabilities to help drive choice and decision-making. We will have a team dedicated to the site activation and radiotherapeutic enablement process in these very targeted accounts. Alongside this will be traditional sales roles focused on driving trial use and building awareness. Supporting those teams will be a focus group in sales to handle medical information inquiries and further enrich education around Iopofosine. We will also have a dedicated team supporting all of our market access initiatives, ensuring that we leave no patient behind, given the significant unmet need in this space. We believe with Iopofosine’s profile, there is a unique opportunity here to capture share across all key segments of the market.

Jeff Jones, Analyst

Thanks, Shane. Could you speak to how you're looking at Europe, both from a regulatory and commercial perspective?

Jarrod Longcor, Chief Operating Officer

Absolutely, Jeff. For those who may not recognize my voice, this is Jarrod. So let me start from a regulatory perspective. As I think many folks are aware, last year, we received PRIME designation in Europe. The PRIME designation for Europe is essentially the equivalent of the breakthrough designation here in the U.S.; it provides you with increased engagement with the agency, a more rapid pathway to launch, and it also encourages cross-communication between the EMA and FDA for the same product. With that said, our expectation is to push forward rapidly with the EMA to follow approval in the U.S. It won't be at the exact same time as the U.S. launch, but we are currently in discussions to determine exactly what that timeline will look like for the European launch. Now, Cellectar does not plan to be the party to commercialize in Europe. What we are looking to do, and have a number of ongoing discussions with various partners, is to have a partner take over the commercialization and functionality of the product in Europe. We will continue to control the supply chain and ensure they receive product as necessary, but they will be the drivers for commercialization.

Jeff Jones, Analyst

Great. Thank you, Jarrod. I guess the last question for me, you spoke to it a little bit suggesting some interesting data on the diversity of therapies used by line in these patients. So any update on your thinking about the label indication you would propose to the agency, being at third line plus BTKi refractory, et cetera?

Jim Caruso, CEO

Yeah. So from a regulatory perspective, I'll say that based on the clinical data we've seen to date, we believe we have a strong position and a strong opportunity to pursue a straightforward second line or later positioning for the relapse/refractory patient population. So we are really targeting that approximately 11,000 patient population. We do believe that we have a very high probability of success on that because of the number of patients that have been exposed not just to the only approved class of therapy but essentially all of their therapeutic options and for whom they have shown high levels of refractoriness, unlike what's been tested historically. And so we do believe that there's a strong opportunity there.

Jeff Jones, Analyst

Great. Really appreciate the additional clarity, guys. I’ll step back into the queue.

Jim Caruso, CEO

All right. Thanks so much, Jeff.

Operator, Operator

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.

Jim Caruso, CEO

All right. Terrific. Thank you, Mark. I appreciate your facilitation of this call today. 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.

Operator, Operator

This now concludes our call. Thank you all very much for attending. You may now disconnect.