Cellectar Biosciences (NASDAQ:CLRB) reported on its year-end financials and strategic advancements during its 2023 Yearend Earnings Call. The company highlighted the successful private placement of $69 million, part of a potential $103 million, and provided updates on their clinical and regulatory progress.
Cellectar emphasized its plans to submit a New Drug Application for Iopofosine I-131 in the second half of the year, with approval anticipated in the first half of 2025. The company also noted a strong cash position, expecting to fund operations into Q4 of 2024, and shared its strategy for capturing a significant share of the Waldenström macroglobulinemia market.
Key Takeaways
- Cellectar Biosciences has raised $69 million through private placement, with total potential funding reaching $103 million.
- The company has validated its Iopofosine I-131 and PDC delivery platform and initiated a Phase 1b study for pediatric high-grade gliomas.
- Positive top-line data from the CLOVER-WaM study has been announced, and an NDA submission to the FDA is planned for the second half of the year.
- Cellectar has established manufacturing partnerships and plans to expand its footprint to Europe.
- Investors exercised warrants, contributing an additional $44.1 million to the funding, which, along with the current cash balance of $9.6 million, is expected to fund operations until Q4 of 2024.
- Research and Development expenses were approximately $28.2 million, while General and Administrative expenses totaled $10.7 million.
- The net loss for the year was $38 million, equating to $3.11 per share.
Company Outlook
- Cellectar Biosciences is preparing for the potential commercial launch of Iopofosine, having filled essential leadership roles.
- Plans are in place to partner with a European company for commercialization after approval.
- The company aims to influence brand choice and operational efficiency at launch.
Bearish Highlights
- The net loss attributable to common stockholders for 2023 was reported at $38 million, or $3.11 per share.
Bullish Highlights
- Iopofosine has the potential to capture a significant market share in the Waldenström macroglobulinemia sector, with high unmet need and limited competition.
- The PRIME designation in Europe could lead to a faster pathway to launch and increased engagement with regulatory agencies.
Misses
- There were no specific "misses" reported in the provided summary.
Q&A Highlights
- The company received PRIME designation in Europe, facilitating a more rapid pathway to launch and increased regulatory engagement.
- Cellectar does not plan to commercialize in Europe independently but is in discussions with potential partners.
- The proposed label indication for Iopofosine is for the relapse/refractory patient population in the second line or later.
Cellectar Biosciences is positioning itself to make significant strides in the treatment of various cancers, with a focus on pediatric high-grade gliomas and Waldenström macroglobulinemia.
The company's strategic initiatives and robust funding efforts indicate a strong commitment to advancing their product pipeline and ensuring a sustainable future. While the net loss for the year is notable, the potential for market capture and the strategic partnerships in Europe may provide a promising outlook for Cellectar Biosciences and its stakeholders.
InvestingPro Insights
Cellectar Biosciences (CLRB) has been navigating a challenging financial landscape, as evidenced by their year-end financials. According to InvestingPro data, the company holds a market capitalization of $117.24 million, reflecting investor sentiment towards its potential growth.
Despite a strong cash position, the company's price-to-earnings (P/E) ratio stands at -1.08, with an adjusted P/E for the last twelve months as of Q3 2023 at -3.11. This indicates that the market has concerns about the company's current profitability.
InvestingPro Tips highlight several key facets of Cellectar's financial health and stock performance. The company is recognized for holding more cash than debt, which aligns with their reported robust cash position to fund operations into Q4 of 2024.
Still, it is important to note that Cellectar is quickly burning through its cash reserves and suffers from weak gross profit margins. Analysts are not optimistic about profitability in the near term, as they do not anticipate the company will be profitable this year.
On the upside, Cellectar has experienced a high return over the last year with a 142.33% price total return, along with a strong return over the last three months at 39.81%. This might reflect investor confidence in the company's strategic advancements and clinical progress. Still, it's important to recognize that the company does not pay dividends, which can be a drawback for income-focused investors.
For readers looking to dive deeper into Cellectar's financial and stock performance, InvestingPro provides additional insights. There are 9 more InvestingPro Tips available, offering a comprehensive analysis that can help investors make informed decisions. To access these tips, investors can visit https://www.investing.com/pro/CLRB and use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Full transcript - Cellectar Biosciences Inc (CLRB) Q4 2023:
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 believe from those forecasts due to the impact of many factors beyond the control of Cellectar. The company assumes no obligation to update supplements, or supplements any further 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: 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 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. 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 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 announced 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 radio therapeutics. With the next radiotherapeutic approval potentially, 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, 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. Initiated and enrolled the first patient in our Phase 1b clinical study Iopofosine 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 Iopofosine. We further expanded our PDC and radiotherapeutic intellectual property portfolio which was recognized by global data citing Cellectar as the leading pharmaceutical company, as measured by 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 Iopofosine, we announced the first of many anticipated strategic partnerships with leading physician-led unity-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 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 process of completing the work for our NDA filing and plan to submit our filing to the FDA in the second half of this year. Assuming we are granted priority review associated with our fast track designation, we could expect a six-month review period from the date of submission. In parallel, we remain focused on constructing highly efficient commercialization capabilities for Iopofosine. 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 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 the please do 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 or a treatment, 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 serologically confirmed diagnosis of Waldenstrom macroglobulinemia and ECOG performance status from zero to two, and have received at least two lines of cryotherapy, which preferably included treatment with 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 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 for proportion refractory to BTKi and Rituximab the map which is 50% and 40% respectively, proportion refractory to both the BTKi and anti-CD-20 therapy, which is 26.7% proportion with medium and high IPSSWM score, which is 42% and five to six-fold enrichment with MYD88 vial type genotype. Top-line data from the CLOVER-WaM trial reported on 41 consecutive evaluable patients are 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 show the 7.3% complete response rate, with a median duration of response, and median progression free survival not breached at the time of [Indiscernible] update 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 concurrently available improved therapies. Responses with durable with median duration of response not reached and 76% of patients remaining progression free and at a median follow up at eight months, and the longest continuous response of all within 30 months. Importantly, durability of this responses without the need for continuous therapy, or retreatment, suggest that Iopofosine could be potentially disease modifying new therapy with 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 saw predictable and manageable onset and recovery of cytopenias in all patients. We did not observe any treatment related cardiovascular, renal or hepatic adverse events. In summary, CLOVER-WaM was the largest study in relapsed refractory post-BTKi patients to date, and the first step we study to evaluate your 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 4 dose truly fixed duration course of treatment. We believe that this results demonstrated Iopofosine is a promising therapy for patients and 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 patient with attainment of complete remission, and stabilization of disease and in pediatric patients with a refractory high grade brain tumor. These findings further validate our previous observation of Iopofosine’s ability to cross the blood brain barrier and deliver an antineoplastic payload to variety of tumors in the sanctuary sites. Further, a recent report from the University of Wisconsin-Madison demonstrated the ability of Iopofosine 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 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 and 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 to a diverse patient population in urgent need for novel therapies. I will conclude by emphasizing that we're pleased with the results highlighted above. And I'm 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 validate product development and commercialization opportunities to craft the future focused clinical development of Iopofosine, including frontline treatment of WM, WM treatment study 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 a dear colleague of mine, Jarrod Longcor, for an overview of our regulatory class, Jarrod.
Jarrod Longcor: 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 top line results, we have received helpful advice and direction on various elements of all of our modules required for the following. We are working diligently to ensure our submission is robust and provides the supporting components the agency has requested. At the time of submission, we will request priority review associated with our fast track designation. And assuming it is accepted, we would expect an approximate six-month review period from the date of submission for our NDA which is, if accepted, will provide approval of Iopofosine 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 Iopofosine I-131. Based upon our understanding of the difficulties experienced by others, associated with the manufacturing and supply of targeted radiotherapy, we develop 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 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 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 that 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 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 base supply partners. As an example, we currently have a capacity by 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 to the necessary quantities of I-131 and our PLE reducing or eliminating potential risks to that portion of our supply chain. We believe this approach results in a seamless secure supply, by focusing I-131. Combining this with our 17 days shelf life, providing an off the shelf fully finished ready to use product with no onsite compounding required provides a product with unique convenience and flexibility for patients and physicians that has historically been lacking with targeted radio therapies. 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 Iopofosine and WaM. 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, which include an evaluation of Iopofosine’s product profile, and an evaluation of the WM patient journey. The hematologist review of Iopofosine’s product profile for WM was seen as very promising and impressive with the 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 fix therapy. We are building a high, successful, large team that's very concentrated in nature, with lots of experience. And have recently filled all of the critical commercial leadership roles with two new senior hires to our commercial team. Our new VP of Marketing, Alison Bautista brings over 20 years of industry experience and has an exceptional track record and 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 2 CAR-T cell therapies at BMS. The ability to attract and staff highly competent and experienced talent uniquely positioned 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 has high value capture. Our third-party claim and epidata 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. In our next slide, it illustrates our claims data, which demonstrate there is no established standard of care in WM. Greater than 60% patients received non-FDA approved drugs and over half or 52% of patients who receive a BTKi in second line or rechallenged with then 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 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 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 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 Iopofosine NDA and preparing for a 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 and 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 a particular isotopes physical properties and match that with the biological properties of a specific tumor to create an optimized semi-personal radio therapeutic option. We have validated by demonstrating in Xenograft models, our ability to deliver effective doses of Actinium-225 led to 12 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 are differentiated from other targeted alpha therapy programs TATs, by overcoming some of the challenges associated with the limited linear energy length provided by alpha emitters. A challenge with TATs is that the energy from the molecules only penetrates a single cell. Therefore, the targeting ligand must achieve uptake in nearly 100% of the tumor cells to be efficacious. For most other alpha emitter programs, this is restricting them to pursuing tumor types that remain small. For example, small metastatic sites or small 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 tested. We believe that this technological advantage will allow us to develop an extensive portfolio of TATs programs and expand the utilization of this highly effective treatment done to a number of broad -- to a number broad array of tumor types. I will now turn the call over to Chad to review our financials. Chad?
Chad Kolean: 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 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. Company believes cash on hand, inclusive of the funds from the exercised warrants in January is adequate to fund diluted 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 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 is pivotal study patient enrollment culminating in the top-line data announcement and the initiation of the pediatric high-grade [indiscernible]. G&A expense for 2023 was $10.7 million compared to $9.5 million last year. The increase in G&A cost is 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 million or $3.11 per share as compared to $28.6 million or $4.05 per share last night. I will now turn the call to Jim for closing remarks. Jim?
Jim Caruso: 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: Thank you. [Operator Instructions] Our first question comes from the line of Jonathan Aschoff at ROTH MKM. Please go ahead. Your line is open.
Jonathan Aschoff: 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.
Jim Caruso: So Jonathan, thank you for pulling punches on your first question. 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. And of the eight products that currently are in pivotal studies, eight therapeutic products that are in pivotal studies, three are in kind of net area and three are in prostate, really fragmenting that space now, right, as the -- 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 Jarrod or Andrei 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 Iopofosine which has demonstrated utility beyond hematologic malignancies in our first-to-market indication, which would be WM, which we believe and as Shane discussed and hopefully have an opportunity to provide broader background on is just an excellent opportunity for us as a company from for top line revenue there as well as the capacity to really help patients with high clinical need 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 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 radio therapeutic 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. And we do believe the NDA submission and acceptance has substantially complete and our first approval in WM will be yet another game changer for the organization from a valuation perspective.
Jonathan Aschoff: 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: 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 would allow us, we believe, with a formidable opportunity and package just to 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, 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 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 any additional to that.
Andrei Shustov: Thank you, Jim. And Jonathan, thank you for your question. Jim answered the majority, I think, of your request. I will just reconfirm, reiterate that CLOVER-WaM has emerged as an expansion from the -- so just to say the basket 2A study that included cohorts and 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 multiple myeloma cohort to enrich 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 primary CNS lymphoma cohort to further distill a signal of activity, first demonstrated by CMR 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.
Jonathan Aschoff: Okay. And all these patients will get 4 doses like in the WM trial unless toxicity dictates otherwise. Is that accurate?
Andrei Shustov: So the -- 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 CLOVER-WaM study.
Jonathan Aschoff: Okay. And just two quick boring questions. With the top and SG&A in the fourth quarter, what -- can you help us out, what does SG&A look like for 2024?
Chad Kolean: 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, to your point. We won't see that really change dramatically until we get later in the year.
Jim Caruso: And so what I'll add to that Jonathan -- yeah, what I'll add to that, Jonathan, as you kind of think about how we would invest in the WM space. Shane is building out a very targeted organization and where you would typically see, I think, an OpEx for a commercial specialty launch in early years when you're really driving trial use and adoption this kind of $50 million to $70 million 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 million.
Shane Lea: Correct.
Jonathan Aschoff: Thank you very much, guys.
Jim Caruso: 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.
Jeff Jones: Thank you, operator. And congrats on the great year guys and all the progress you've made. I guess, starting off on -- following on what Jonathan was asking on sort of the operational G&A program. Can you speak to how -- what's your thinking about in terms of the commercial organization at launch for sales rep MSL structure?
Jim 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 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 that I have historically observed in the past. So I'll let give him an opportunity to kind of talk through some of his thinking.
Shane Lea: Yeah. Thanks, Jim, and thanks for the question. When we look at the build of our go-to-market model, it's really focused on two things, right? One is what are we doing to influence brand choice, building awareness, leveraging the key attributes for Iopofosine and the second piece of it is 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 radiotherapy enablement process. So looking at the opportunity. We want to make sure that it's one which is very targeted in nature and one which is also scalable. And I believe that we have the opportunity to do that since it is a concentrated market. So when you look at the go-to-market model, we'll have roles, which will help to support the pull-through of those two key things. First, having proper marketing capabilities, proper data capabilities to help drive choice and decision making. We will have a team, 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 in the sales to support medical information inquiries and provide further enrichment and education around Iopofosine. And we also have a dedicated team that will be supporting all of our market access initiatives. We want to ensure that in our focused approach, we leave no patient behind because there is significant unmet need in this space. And we believe with Iopofosine’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 shared basket slide that you saw today.
Jeff Jones: Thanks, Shane. 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 Jarrod. So from a -- 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., it does provide you with increased engagement with the agency, it provides you with a more rapid pathway to launch, and it provides actually encourages the cross communication between those two agencies. So EMA and FDA actually behind the scenes start to align and get their sort of requirements in harmonization with one another for the same product. With that said, so that sort of feeds that up. Our timeline or our expectation is that we will push forward here rapidly with the EMA to rapidly follow approval in the U.S. It won't be at the exact same time as the U.S. launch, but we're in discussions right now to determine exactly what that timeline will look like in for European launch. Now with that said, we, as Cellectar 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 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.
Jeff Jones: Great. Thank you, Jarrod. 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 indication you would propose to the agency being at third line plus BTKi refractory, et cetera?
Jim Caruso: Yeah. So from a regulatory perspective, I'll say that based off the clinical data that we've seen to date, as Andrei took you through, the one, yeah, 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 for as one might say a relapse/refractory patient population. So really targeting in on that sort of 11,000-ish patient population. We do believe that we have a very high probability of success on that, again, because of the number of patients that we've had that have been exposed not just the only approved class of therapy, but essentially all 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 there.
Jeff Jones: Great. Really appreciate the additional clarity, guys. I’ll step back in to the queue.
Jim Caruso: All right. Thanks so much, Jeff.
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: 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. Have a good day.
Operator: This now concludes our call. Thank you all very much for attending. You may now disconnect.
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