Cellectar Biosciences Q4 2023 Earnings Call Transcript

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Provided by Quartr
March 27, 2024

There are 8 speakers on the call.

Operator

Good morning, and welcome to Selecta'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 Selecta'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 Selecta. 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.

Operator

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 Selectar. Mr. Caruso, please go ahead.

Speaker 1

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 Doctor. Andre Shusthof, Senior Vice President, Medical Jarrett Longcorp, Chief Operating Officer Shane Leah, Chief Commercial Officer and Chad Collin, our Chief Financial Officer. I will begin today with a brief overview of the meaningful accomplishments the company has achieved these past 12 months.

Speaker 1

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 Doctor. Shustoff, who will provide a review of our successful WM trial results and discuss Ibuprofen I-one hundred and thirty one clinical development programming. Regarding the VWM 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 ramp study. Jared will provide update on our regulatory plans and NDA filing.

Speaker 1

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 radio 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 IAP focusing I-one hundred and fifty one. And coupled with our unique delivery platform providing differentiated radioisotope offerings, we are confident in our market position and excited about the future of Selectar.

Speaker 1

Chad will then discuss financial results and we will open the call for Q and A. Please allow me to now provide an overview of key accomplishments. As part of a private placement of up to $103,000,000 the company has received under $69,000,000 to date. In addition, approximately $34,000,000 in warrants will be available for conversion upon approval of our WM NDA. Achieved further validation of Ibuprofen I-1 hundred and thirty one and our PDC delivery platform to treat solid and hematologic tumors, including those located across the blood brain barrier, initiated and enrolled the 1st patient in our Phase 1b clinical study of iapofacine 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 iapopacine.

Speaker 1

We further expanded our PDC and radiotherapeutic intellectual property portfolio, which was recognized by Global Data citing Selectar as the leading pharmaceutical company as measured by patent grants and applications for radiopharmaceuticals. We also announced promising preclinical data for 3 separate alpha emitters including our proprietary novel alpha emitting phospholipid radiotherapeutic conjugate CLR-twelve fifty five and actinium labeled phospholipid ether in pancreatic cancer models. In preparation for the potential commercial launch of Ibupofacin, we announced the first of many anticipated strategic partnerships with leading physician led community based oncology networks such as Florida Cancer Specialist 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 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 6 month review period from the date of submission.

Speaker 1

In parallel, we remain focused on constructing highly efficient commercialization capabilities for iapoposene. 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?

Speaker 2

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 WAM pivotal trial that we revealed earlier this year. As a reminder, VOLO-one was a global open label single arm study examining iapoface in I-one hundred and thirty one in relapsed and refractory WM patients who received at least 2 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 4 doses of hypofersen over 2 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 had to have histologically and serologically confirmed diagnosis of Waldenstrom macroglaucomemia and ECOG performance status of 0 to 2 and have received at least two lines of prior therapy, which preferably included treatment with a BTK inhibitor.

Speaker 2

The study also included WM patients with central nervous system involvement known as Bind Niall Syndrome and patients with lymphoplasmacytic lymphoma without full features of WM. Patients enrolled in CLOVER WAM 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 4 proportion refractory to BTKI and rituximab, which is 50% 40%, respectively proportion refractory to both BTKI and anti CD20 therapy, which is 26.7 percent, proportion with medium and high IPSSWM score, which is 42% and 5 to 6 fold enrichment with MITEI88 wild type genotype. Top line data from the CLOVO WAM 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 100% disease control rate. Further, the data showed a 7.3% complete response rate with a median duration of response and median progression free survival not breached at the time of data cutoff date and a median follow-up of 8 months.

Speaker 2

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. Responses were durable, with median duration of response not reached and 76% of patients remaining progression free at a median follow-up at 8 months and the longest continuous response of over 30 months. Importantly, durability of these responses without the need for continuous therapy or retreatment suggest that ipofersen could be potentially disease modifying new 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.

Speaker 2

We did not observe any treatment related cardiovascular, renal or hepatic adverse events. In summary, GLOBAL WEM was the largest study in relapsedrefractory post BTKI patients to date and the 1st WMD 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 4 prior lines of therapy is nothing short of remarkable, especially with results that showed a favorable safety profile and a 4 dose truly fixed duration course of treatment. We believe that these results demonstrate that ipofacin 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 relapsedrefractory 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.

Speaker 2

In addition to impressive results from CLOVM study, we've also reported promising activity of iapofacin in 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 hypofersen's ability to cross the blood brain barrier and deliver an antineoplastic payload to a variety of tumors in the sanctuary sites. Further, a recent report from the University of Wisconsin Madison demonstrated the ability of iapofacin to safely combine with external beam radiotherapy in relapsed carcinoma of head and neck with 64% of patients obtaining a complete remission and 1 year oral survival of 67%. We believe that these findings may be broadly applicable to a variety of solid tumors.

Speaker 2

In summary, data demonstrating hypofersen's ability to induce deep responses, including complete responses at a variety of relapse and refractory, hematologic and solid tumors, while exhibiting consistently low toxicity profile with good tolerability, may translate into durable and clinically meaningful benefits to a diverse patient population and 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 iapofacin, including frontline treatment of WM, a WM retreatment study to include a 3rd cycle as well as studies in other indications, including marginal zone lymphomas, mycosis funboitiz and primary MLA doses. With that, I will now turn the call to a dear colleague of mine, Jared Longcourt, for an overview of our regulatory plans. Jared?

Speaker 3

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 6 month review period from the date of submission for our NDA, which is if accepted, will provide approval by in mind, we are refining our manufacturing and logistics process to ensure uninterrupted supply of Ibuprocyne I-one hundred and thirty one.

Speaker 3

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 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 multilayered overlapping redundant finished product supply chain network. This allows us to have multiple facilities providing iofovacine 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.

Speaker 3

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.

Speaker 3

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-one hundred and thirty one 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-one

Speaker 4

hundred

Speaker 3

and thirty one. 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.

Speaker 4

Thank you, Jared, and good morning, everyone. Our team is significantly advancing our capabilities in preparation for potential commercial launch of bifocalcin and WM. Importantly, we continue to execute and make progress on our commercialization strategy for Ibupofacin with the goal of ensuring a successful launch upon FDA approval. We are very encouraged by the findings from our 2 most recent market research projects, which include an evaluation of Ibuprofen's product profile and an evaluation of the WM patient journey. The hematologist review of Ibupofacene's product profile for WM seen as very promising and impressive with a high rating for intent to prescribe.

Speaker 4

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 2 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 Revlisil launch for beta thalassemia and myelodysplastic syndrome at BMS and the Xevo launch for desmoid tumors at SpringWorks. Our newly appointed VP of Market Access, Eric Gustafsson brings over 30 years of industry experience across broad commercial roles with deep experience in market access. His most recent role is leading the integrated access and value team to commercialize 2 Part T cell therapies at BMS.

Speaker 4

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 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 U.

Speaker 4

S. WM market to be approximately 2,100,000,000 with an approximate prevalence of 26,000 patients. The 3rd 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 $1,000,000,000 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 received non FDA approved drugs and over half or 52 percent of patients who receive a BTKI in second line are re challenged with TPN as third line therapy.

Speaker 4

This is mainly because there are limited treatment options in this relapsedrefractory setting as there has been no FDA approved new mechanism of action in nearly a decade. We believe iofofacin with 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's 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.

Speaker 4

Finally, with its efficacy, safety profile and fixed dosing regimen, iapofacine 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 Ibuprofen launch. We look forward to providing additional updates. I will now turn the call back over to Jared Longcourt to highlight our alpha emitter program. Jared?

Speaker 4

Thank you, Shane.

Speaker 3

While our focus is on the successful submission of iapofacin's NDA and preparing for potential launch of WM, our radio conjugate franchise offers a very robust and diverse pipeline of opportunities. In addition to the broad applicability of ipopacene and other relapsedrefractory disease settings beyond WM as described by Andre earlier, we continue to demonstrate the potential of our phospholipid radiconjugate pipeline with isotopes other than iodine-1 hundred and thirty one. 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 an optimized semipersonal radiotherapeutic option. We have validated by demonstrating in xenograft models our ability to deliver effective doses of actinium-two twenty five, lead-two twelve and astatine-two eleven in various tumor types. We are rapidly advancing our actinium program, CLR-one hundred and twenty one-two twenty five, through IND enabling studies with the plan to initiate a Phase I study in pancreatic cancer late this year or early next year.

Speaker 3

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 has restricted 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.

Speaker 3

We believe that this technological advantage will allow us to develop an extensive portfolio of TAP programs and expand the utilization of this highly effective treatment modality to a number of broad array of tumor types. I will now turn the call over to Chad to review our financials. Chad?

Speaker 5

Thank you, Jared. As shown in our 10 ks filed earlier today,

Speaker 2

our

Speaker 5

cash and cash equivalents balance as of December 31, 2023 was $9,600,000 compared to $19,900,000 as of December 31, 2022. Net cash used in operating activities during the year was approximately $32,400,000

Speaker 4

It's important to note,

Speaker 5

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 held the warrants exercised them in their entirety, generating aggregate additional funding of $44,100,000 or $42,800,000 net of fees. As Jim noted earlier, September 2023 financing represents up to $103,000,000 in funding and has generated nearly $69,000,000 for the company to date. Company believes its cash on hand, inclusive of the funds from the exercised warrants in January, is adequate to fund budgeted operations into the Q4 of 2024. R and D expense for the year was approximately $28,200,000 compared to $19,200,000 last year.

Speaker 5

The overall increase in R and D expense is primarily a result of 3 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 the pediatric high grade glioma study. G and A expense for 2023 was $10,700,000 compared to $9,500,000 last year. The increase in G and 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 $38,000,000 or $3.11 per share as compared to 28 point $6,000,000 or $4.05 per share last year.

Speaker 1

I will now turn the call to Jim for closing remarks. Jim? Okay. Thank you, Chad. I hope that all of you agree that Selector's accomplishments over the course of the year have been substantial.

Speaker 1

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

Thank Our first question comes from the line of Jonathan Ashcroft at ROTH MKM. Please go ahead. Your line is open.

Speaker 6

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.

Speaker 1

So Jonathan, thank you for pulling punches on your first question. We appreciate it. 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 almost predominantly the 2 available agents on the market currently, Lutathera and Pluvicto, both being beta emitters as an aside. And of the 8 products that currently are in pivotal studies, 8 radiotherapeutic products that are pivotal studies, 3 are in the kind of debt area and 3 are in prostate.

Speaker 1

Really fragmenting that space now, right, as they as these alpha emitters continue to develop, but you'll discover and what you know is that they're really focused on those particular areas. And 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 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 hypofecine, 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 a 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.

Speaker 1

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 5, 6, 7 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, 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 6, 12, 18 months to experience similar growth.

Speaker 1

And we do believe WM will be a yet another game changer for the organization from a valuation perspective.

Speaker 6

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 CLOVERO seemed 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?

Speaker 1

As you recall, there were 3 arms associated with our CLOVER WAM study. We had the WM pivotal portion and then we had 2 additional elements, the Phase 2a and I could have Andre or Jared talk to the multiple myeloma arm and 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, iaproposine 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 iapofacin in particular to cross the blood brain barrier and as Andre will tell you, penetrate and demonstrate effectiveness in these sanctuary sites.

Speaker 1

So with that, I don't know if Jared or Andre have any additional

Speaker 2

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 to say basket 2a study that included our cohorts in non Hodgkin lymphoma, primary CNS lymphoma and multiple myeloma. The CLOEM 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 will be evaluating our data in the second half of this year to further guide us into where to take this program from regulatory standpoint.

Speaker 2

We're also enrolling 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.

Speaker 6

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

Speaker 2

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 CLO WEM study.

Speaker 6

Okay. And just two quick boring questions. With the pop in SG and A in the Q4, what can you help us out? What does SG and A look like for 2024?

Speaker 5

Total expense, I guess, for SG and 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 Q4 to your point. We won't see that really change dramatically until we get later in the year.

Speaker 1

And so what I'll add to that, Jonathan, as you kind of think about how we would invest in the WM space, Shane is building out a very targeted organization and where you would typically see, I think, an OpEx for a commercial, especially launch in early years when you're really driving trial use and adoption, this kind of $50,000,000 to $70,000,000 OpEx, I believe Shane has a targeted very targeted focused strategic plan that we really like, leverage with smart data. And Shane, I believe that's in and around a $25,000,000 Correct.

Speaker 6

Thank you very much guys.

Speaker 5

All right. Thank you, Jonathan.

Operator

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

Speaker 7

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 and 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?

Speaker 1

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. And Shane has done as good or better of a job than I have historically observed in the past. So I'll let give him an opportunity to kind of talk through some of his thinking.

Speaker 4

Yes. Thanks, Jim, and thanks for the question. When we look at the build of our go to market model, it's really focused on 2 things, right? So one is, what are we doing to influence brand choice, building of awareness, leveraging the key attributes for Ibuprofenacin. 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.

Speaker 4

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 1 which is very targeted in nature and 1 which is also scalable. And I believe that we have the opportunity to do that 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 2 key things. First, having proper marketing capabilities, proper data capabilities to help drive choice and decision making.

Speaker 4

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, Iopofacine. 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.

Speaker 4

And we believe with iofofacin'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.

Speaker 7

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

Speaker 3

Absolutely, Jeff. For those that may not recognize my voice, this is Jared.

Speaker 2

So from a

Speaker 3

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 U. S. Does provide you with increased engagement with the agency.

Speaker 3

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 time line or our expectation is that we will push forward here rapidly with EMA to rapidly follow a approval in the U. S.

Speaker 3

It won't be at the exact same time as a U. S. Launch, but we're in discussions right now to determine exactly what that timeline will look like in a full European launch. Now with that said, we as Selecta 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.

Speaker 3

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.

Speaker 7

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 3rd line plus BTKI refractory, etcetera?

Speaker 3

Yes. So from a regulatory perspective, I'll say that based off the clinical data that we've seen to date, as Andre took you through, the Juan, yes, we're later aligned, 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 relapsed refractory patient population. So really targeting in on that sort of 11000 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 refractory ness, unlike what's been tested historically. So we do believe that there's a strong opportunity there.

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.

Speaker 1

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. And we look forward to speaking with you in the near term.

Speaker 1

Have a good day.

Operator

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

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Cellectar Biosciences Q4 2023
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