Q4 2023 Cellectar Biosciences Inc Earnings Call
Participants
James Caruso; President, Chief Executive Officer, Director; Cellectar Biosciences Inc
Andrei Shustov; Senior Vice President - Medical; Cellectar Biosciences Inc
Jarrod Longcor; Chief Operating Officer; Cellectar Biosciences Inc
Shane Lea; Chief Commercial Officer; Cellectar Biosciences Inc
Chad Kolean; Chief Financial Officer; Cellectar Biosciences Inc
Presentation
Operator
Good morning, and welcome to Cellectar Biosciences 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 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 least from those forecast due to the impact of many factors beyond the control of Cellectar. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events, or otherwise.
Participants are directed to the cautionary note 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 Cellectar'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 Cellectar. Mr. Caruso, please go ahead.
James Caruso
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 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 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. Shustov who will provide a review of our successful WM trial results and discuss iopofosine I 131 clinical development program.
Regarding the WM pivotal study, I am pleased to report that we remain on track for a Q2 announcement of our updated topline 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 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 iopofosine I 131. And 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 achieved further validation of ioko pursuing. I went 31 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 I am focusing in pediatric high-grade almost announced a new licensing agreement covering pediatric cancers with the Wisconsin Alumni Research Research Foundation for intellectual property.
That was the result of collaborative research conducted at the University of Wisconsin Madison with ioko percent. We further expanded our PDC. and radiotherapeutic intellectual property portfolio, which was recognized by global data siting, select our 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, CLR. one two one two five five, and actinium enables phospholipid either in pancreatic cancer models in preparation for the potential commercial launch.
By focusing, 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 win pivotal study evaluating, I am focusing I went 31 for the treatment of relapsed refractory Waldenstrom's macroglobulinemia. We remain on target to provide an update on our W. and 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 via focusing 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 Andrei to further review the WM trial and our clinical development program. Andrei?
Andrei Shustov
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 WM pivotal trials that were revealed earlier this year. As a reminder, mobile web was a global open-label single-arm study examining our office in Taiwan, 31 in relapsed and refractory DLBCL 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 hypothesis over two cycles without maintenance or retreatment and were evaluated continuously for response for up to 12 months from the initial dose patients eligible for the trial have to have histologically and serologic with confirmed diagnosis of Waldenstrom macroglobulinemia and e-com performance status of zero to two and have received at least two lines of prior therapy, which preferably included treatment with a BTK inhibitor.
The study also included WM patients with central nervous system development, known as being Neil syndrome and patients with lymphoblastic lymphoma. Without full features of WMZ patients enrolled in global well 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 a number of prior therapies, which is for proportion refractory to BTKI. and rituximab, which is 50% and 40% respectively, proportion refractory to both BTKI. anti-CD20 therapy, which is 26.7% proportion with medium and high IPSSWM. score, which is 42% and five to six fold enrichment with mighty 88 wild type genotype top-line data from the global WHIM trial reported on 41 consecutive evaluable patients or approximately 75% of the total MITT.
Efficacy population demonstrated a 61% major response rate and 75.6% overall response rate and a 100% disease control rate will further that data show. The 7.3% complete response rate with a median duration of response and median progression-free survival is 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 confer resistance to currently available approved therapies. Responses were durable with 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 of over 30 months. Importantly, durability of these responses without the need for continuous therapy or retreatment suggested hypothesis could be potentially disease modifying to therapy with novel and unique mechanism 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 observed any treatment related cardiovascular, renal or hepatic adverse events.
In summary, global, when was the largest study in relapsed refractory post VTKI. patients to date and the first RPM 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 showed a favorable safety profile and a four dose truly fixed duration course of treatment.
We believe that these results demonstrated I have often seen as a promising therapy for patients in high clinical need, one that is easy to administer as an IV infusion in the 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 evaluable patients enrolled in the study sometime in the next quarter.
In addition to impressive results from closure one study. We've also reported promising activity of IR office and in other hematologic malignancies and solid tumors. This includes exciting result in primary CNS lymphoma patient with attainment of complete remission and stabilization of disease in pediatric patients with refractory high-grade brain tumor. These findings further validate our previous observation of IR office and its ability to cross the blood-brain barrier and deliver an anti neoplastic payload to a variety of tumors in a sanctuary sites. Further, a recent order from the University of Wisconsin Madison demonstrated the ability of IO offices to safely combined with external beam radiotherapy in relapse carcinoma, head and neck, with 64% of patients attaining a complete remission and one year overall survival of 6% to 7%. We believe that these findings may be broadly applicable to a variety of solid tumors.
In summary, data demonstrating the office and its ability to induce deep responses, including complete responses in a variety of relapsed and refractory hematologic and solid tumors, while exhibiting consistently low toxicity profiles with good tolerability may translate into durable and clinically meaningful benefits to a diverse patient population.
An 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 five offices, including front-line treatment of WM Adelphia retreatment study to include a third cycle as well as studies in other indications, including marginal zone lymphomas, mycosis fungoides and primary Andalay dose.
With that, I will now turn the call to a dear colleague of mine, Jarrod Longcor, for an overview of our regulatory plans. Jarrod?
Jarrod Longcor
Thank you, Andre. With the successful completion of the global web 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 of all of our modules required for the filing. 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 by publishing 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 IPOCI. one 31. Based upon our understanding of the difficulties experienced by others associated with the manufacturing and supply of targeted radiotherapy needs. We developed and executed a plan that we believe will mitigate or eliminate these risks.
Frequent challenges that have been experienced by others include the inability to source isotope issues or failures at finished product manufacturing plants 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 select our 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 multilayer overlapping redundant finished product supply chain.
This allows us to have multiple facilities providing I have overseen for Cold Lake global marketplace and ensures that an issue at one facility does not put the 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 platforms. As an example, we currently have the 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 focus 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 model.
This process ensures availability to the necessary quantities by one 31 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 iconic one 31. Combine this with our 17 day shelf life, providing it off the shelf fully finished, ready to use product with no on-site compounding required provided product with unique convenience and flexibility for patients and physicians that has historically been lacking with targeted radiotherapy.
Now let me turn the call over to Shane who will provide an update on commercial preparation.
Shane Lea
Thank you, Jarrod, and good morning, everyone. Our team is significantly advancing our capabilities in preparation for potential commercial launch, bioprocessing and WM. Importantly, we continue to execute and make progress on our commercialization strategy for I have both seen 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 hypotheses product profile and an evaluation of WM. patient journey, hematologist review of our overseas 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 therapies.
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, 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 and at BMS and the Xevo launch for Des Moines tumors at SpringWorks, our newly appointed VP of Market Access, Eric stops and brings over 30 years 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 to CAR T cell therapies at BMS. The ability to attract and staff highly competent and experienced talent uniquely positions selector for a successful launch. We also continue to build out our data capabilities to drive our understanding market. As Jim noted earlier, WM as 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 IP data show the total USW. and market to be approximately 2.1 billion with an approximate prevalence of 26,000 patients. The third-line plus segment represents approximately 47 hundred patients and the total number of patients in second line or greater is approximately 11,500, 64 patients. We estimate the relapsed refractory market to be valued at approximately $1 billion and our next slide 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 BTK and second line are rechallenged with scan 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 bioprocessing with its novel mechanism of action has the potential to capture significant share in this market.
In summary, the WI. market has high unmet need with an addressable market of about 11,600 relapsed refractory patients, 47 hundred beyond second line therapy and an annual third-line incidence of nearly 1,000 patients 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, I have overseen represents a strong value proposition for physicians and payers and will providing 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?
Jarrod Longcor
Thank you, Shane. While our focus is on the successful submission of hypotheses, NDA and preparing for potential launch of WMR. radio conjugate franchise offers a very robust and diverse pipeline of opportunities. In addition to the broad applicability of IPO proceeds and other relapse refractory disease settings beyond WM., as described by Andre. Earlier, we continued to demonstrate the potential of our Fossil lipid radio conjugate pipeline with isotopes other than IT one 31 due to the nature of our PDC. platform, we have the unique ability to rapidly switch isotopes and leverage a particular isotopes physical properties and match that with the biological properties of a specific tumor to create and optimize semi personal radio therapeutic options we have validated by demonstrating in xenograft models, our ability to deliver effective doses of actinium to 25 led to 12 and asked the team to 11 in various tumor types.
We are rapidly advancing our actinium program, CLR. one two one two two five through IND-enabling studies with the plan to initiate a Phase one study in pancreatic cancer late this year or early next year. Our programs are differentiated from other targeted alpha therapy programs or tests by overcoming some of the challenges associated with the limited limited linear energy length provided by house of meters. Our challenge with that 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 restrict them to pursuing tumor types that remains small. For example, small metastatic sites or small, slow growing neuro endocrine 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 patents, TAP programs and expand the utilization of this highly effective treatment modality to a number of broad it to a number of broad array of tumor types.
I will now turn the call over to Chad to review our financials. Chad?
Chad Kolean
Thank you, Jared. As shown in our 10 K filed earlier today for cash and cash equivalents balance as of December 31st, 2023, was $9.6 million compared to $19.9 million as of December 31st, 2022. Net cash used in operating activities during the year was approximately 32.4 million. That's important to note September 2023 financing 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 eighth, 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 for 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, company believes that cash on hand inclusive of the funds from the exercised warrants and Jim is adequate to fund operations into the fourth quarter of 2020 for 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 the pivotal study, patient enrollment, culminating in the hub top-line data announcement and the initiation of the pediatric.
I basically understand. 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 $4.5 per share last year.
I will now turn the call to Jim for closing remarks. Jim?
James Caruso
Okay. Thank you, Chad, and I hope that all of you agree that select DOORS 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?
Question and Answer Session
Operator
(Operator Instructions) Jonathan Aschoff at ROTH and KM. Please go ahead, your line is open.
Thank you, guys. Good morning and congrats on all the obvious progress. Given that progress on, are you getting any serious acquisition inquiries because you know the drugs you see rather topically 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 it why broad?
James Caruso
So Jonathan, thank you for pulling punches on your first question. We appreciate it. Not 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 and with almost predominantly the two available agents on the market currently Lutathera and to that though on both being beta emitters as an aside and of the eight products that currently are in a pivotal studies, a video to generic products that are in pivotal studies, three are in the kind of debt net area and three are in prostate, really fragmenting that space now, right? As they 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 that, why that is the case and the differentiation between our delivery platform and our capacity to be very effective against larger, both tumors relative to some of these other antibody drug conjugate. These ligands approaches that limit and the capacity to smaller tumor types like neuro, endocrine, endocrine and prostate.
So having said that, we believe not only can we differentiate with our radio isotope program in general from all others currently available. We also, we believe, are potentially the next market approved agent with a post the same, which has damaged 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 to provide broader background.
Dan is a just an excellent opportunity for us as a Company from top line revenue there as well as the capacity to really help patients with high clinical need as André 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 and 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. And we look forward to over the next six, 12, 18 months to experience similar growth and we do believe the NDA submission and acceptance is substantially complete and our first approval in WM will be a yet another game changer for the organization from a valuation perspective.
Okay. On, you know, is a Clover shot or are you seeing any higher enrollment in liquid tumors after you came out with this data in January?
I can't remember is click Clover always seem to me to be just open-ended know, highly inclusive trial of yours that I just can't. I just can't recall if it's closed formally or if it can take additional patients.
James Caruso
As you recall, there were three arms associated with them with our Clover wind study. We had the WM pivotal portion and then we had two additional elements to Phase IIa and I could have Andrea generic talk to the multiple myeloma arm and how we were dialing in on post PCMA. data to further enrich our data set, which would allow us, we believe, with a formidable opportunity and package deals on just to secure NCC and compendia guidelines. So once approved with WN., this would allow those clinicians that believe and I have probably seen 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 two, a primary central nervous system lymphoma arm as we continue to explore really unique benefits of our delivery vehicle. And I are focusing in particular to cross the blood-brain barrier and as Andre will tell you, penetrate and demonstrate effectiveness in these Sanctuary sites so that I don't know if Jan Erik or Andre, have an additional add to that. Thank you.
Andrei Shustov
Jim 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 so just about to say basket to a study that included our cohorts and non-Hodgkin lymphoma, primary CNS lymphoma and multiple myeloma. The global study is fully enrolled. And now we are in the process of preparing the NDA submission this year. As you know, we've continued to evolve in multiple myeloma cohort to get breached 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. And from a regulatory standpoint, we're also enrolling patients into product into primary CNS lymphoma cohort to further. That is still the signal of activity, first demonstrated by CR. in the patient with refractory disease as a cross blood-brain barrier. So those are ongoing studies that we will be reporting updates in the second half of the year.
Okay. And all these patients will get four doses like in the WM. trial unless toxicity dictates otherwise Is that accurate.
Andrei Shustov
And so they are, as you probably know, the protocol and the two A. study contains several cohorts with different dosing schedules as the currently open cohorts will we'll pursue the schedule that we have reported a global web stack.
Okay. And just two quick boring questions on with the pop in SG&A in the fourth quarter, what can you help us out what does SG&A look like for 2024 and total expense, I guess, for SG&A alone?
Chad Kolean
I'm going to I'm going to I'm going to defer that a little bit until we actually look at that breakdown, I hope in our I don't think you're going to see much of a change in the trend as we go into 18 on 24 from what you saw in Q4 to your point?
James Caruso
I don't see that really change dramatically until we get later and so that what I'll add to that, Jonathan?
Yes, what I'll add to that, Jonathan, as you kind of think about how we would invest and in the IWN. space chain is building out a very targeted organization and where you would typically see, I think in our OpEx for a commercial specialty launch or an early years when you're really driving trial use and adoption, this kind of 50 to $70 million OpEx. I believe chain has a targeted very targeted focused strategic plan that we really like leverage with smart data and chain. I believe that's in and around that 25 million credit credit arm.
Thank you very much.
Jarrod Longcor
All right.
James Caruso
Thank you, Jonathan.
Jarrod Longcor
Thank you.
Operator
Our next question comes from the line of Jeff Jones at Oppenheimer. Please go ahead.
Your line is open.
Thank you, operator, and congrats on the great year, guys and all the progress you've made on. 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 you're thinking about in terms of the commercial organization at launch for a sales rep MSL structure?
James Caruso
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 virtualization space in marketing in both large multinational pharmaceutical companies as well as small biotech and chain has done as good or better of a job that the and I have historically observed in the past. So I'll let that give him an opportunity to kind of talk through some of these things.
Yes.
Shane Lea
Thanks, Jim, and thanks for the question. And when we look at the build of our go-to-market model, it's really focused on two things, right? So one is what are we doing to influence brand choice, building awareness, leveraging the key attributes, Brian, both the scene and the second piece of it's more operational in nature as 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 radio therapy enablement process. So I'm looking at the math 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. And first, having a 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 focused group of MSLs to support medical information inquiries and provide further enrichment and education around I/O processing. And we also have a dedicated team that will be supporting all of our market access initiatives. We want to ensure that our focused approach. We leave no patient behind because there is significant unmet need in this space. And we believe with our purchasing 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.
Akshay, on, could you speak to how you're looking at Europe, both from a regulatory and commercial perspective?
Jarrod Longcor
Absolutely, Jeff, for those that may not recognize my voice.
This is Gerard. So from a Brett, 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 like 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 communications 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 price. And with that that said. So that's sort of piece that up our time line or our expectation is that we will push forward here rapidly with the eight with EMR part to rapidly follow a approval in the US. It won't be at the exact same time as the US launch, but we're in discussions right now to determine exactly what that time line will look like are in it for European launch. Now with that said, we as select, are 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 to have a partner take over the commercialization and functionality of the product in Europe. We will do 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.
Great.
Thank you, Jerry. I guess last question for me, and you spoke to it a little bit and really providing some interesting data on the diversity of therapies used by line on 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?
Jarrod Longcor
Yes. So from a from a from a regulatory perspective, I'll say that based off the clinical data that we've seen to date as Andre as Andre took you through the one.
Yes, we're later-line, but more importantly, the refractoriness of these patients, the level of treatments that they have received. We do believe that this we have a very strong position and a strong opportunity to pursue a simplistic sort of second-line or later positioning, whereas one might say a relapse refractory patient population. So really targeting in on that sort of 11,000 ish based problems. But 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 of their therapeutic options and for which they've shown high levels of refractoriness, unlike what's been tested historically. And so we do believe that there's a strong opportunity.
Great, really appreciate the additional clarity, guys. I'll step back into the queue.
James Caruso
Thanks much, Jeff.
Operator
Thank you. And currently, there are no further questions the queue at this time. So I'll hand the floor back to Mr. Caruso for the closing remarks to.
James Caruso
Alright, terrific. Thank you, Mark. Appreciate your facilitation of this call today. And obviously, I would like to thank everyone for joining us as well, and we look forward to speaking with you in the near term. Have a good day.
Operator
Thank you. This now concludes our call. Thank you all very much for attending. You may now disconnect.
