Q4 2023 Cellectar Biosciences Inc Earnings Call
Unknown Executive: Good morning, and welcome to Cellectar's Bioscience 2023 year end earnings call. Today's call is being recorded.
Good morning, and welcome to select House Bioscience, 'twenty 'twenty free at year end.
Speaker Change: This call today's call is being recorded before we begin I would like to remind everyone that statements made during this call relating to select songs 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.
Unknown Executive: Before we begin, I would like to remind everyone that statements made during this call relating to Selectar's expected 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.
Speaker Change: Fine.
Speaker Change: 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.
Speaker Change: From those forecast due to the impact of many factors beyond the control of select all the.
Unknown Executive: The company assumes no obligation to update, supplement, or supplement any forward-looking statements, whether as a result of new information, future events, or other. Participants are directed to the cautionary notes set forth in today's press, which is available on the Investor Relations portion of the company's website, as well as the risk factors set forth in Selectar's annual... Reports filed with the SEC for factors that could cause actual results to differ materially from those At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Cellectar. Please go ahead.
Speaker Change: The company assumes no obligation to update supplements all supplement any funds that 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.
Speaker Change: As the risk factors set forth in <unk> annual report.
Speaker Change: <unk> 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 select saw MS. Krewson. Please go ahead.
James V. 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, who will provide a review of our successful WM trial results and discuss Ipofacin 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 top-line data from our Clover RAND study. Jarrod will provide an update on our regulatory plans and NDA files.
James V. Caruso: Thank you Mark and good morning to everyone. It is my pleasure to be here with you to report our yearend results and provide a corporate update with me today are Dr. Andrzej <unk> Senior Vice President Medical Jarrett long core Chief operating Officer, Shane Lea Chief.
James V. Caruso: <unk> Officer, and Chad Cohen, our Chief Financial Officer.
James V. Caruso: I will begin today with a brief overview of the meaningful accomplishments. The company has achieved these past 12 months.
James V. Caruso: I will then review our Wm plans after which I will turn the call over to our team for a more in depth update.
Dr.: You will first hear from Dr. <unk>, who will provide a review of our successful Wm trial results and discuss I, focusing I 131 clinical development programming.
Dr. <unk>: Regarding our PWM pivotal study.
Dr. <unk>: I am pleased to report that we remain on track for a Q2 announcements of our updated topline data from our <unk> study.
Dr. <unk>: Jarrett will provide an update on our regulatory plans and NDA filing.
James V. Caruso: 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 discussing why our alpha emitters provide unique mechanisms 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 potential radiotherapeutic approval, Iopocrazine I-151. And coupled with our unique delivery platform providing differentiated radioisotope offerings, we are confident in our market position and excited about the future of Celectar. 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.
Dr. <unk>: Shane will review, our commercial readiness plans and announced the hiring of additional commercial talent to support the potential launch of Wm.
Dr. <unk>: <unk> Bye Jarrett, 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 <unk> from existing alpha emitters and develop.
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 <unk> 551.
Dr. <unk>: Coupled with our unique delivery platform, providing differentiated radioisotope offerings, we are confident in our market position and excited about the future of select car.
Dr. <unk>: Chad will then discuss our financial results and we will open the call for Q&A.
Dr. <unk>: Please allow me to now provide an overview of key accomplishments.
Dr. <unk>: 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.
James V. Caruso: In addition, approximately $34 million in warrants will be available for conversion upon approval of our WMNDA, achieved further validation of Iopropacin I-131 and our PDC delivery platform to treat solid and hematologic tumors, including those located across the blood-brain barrier, initiated and enrolled the first patient in our Phase 1b clinical study of iopophycine in pediatric high-grade glioma, announced a 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 three separate alpha emitters, including our proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR121255, and actinium-labeled phospholipid ether in pancreatic cancer models.
Dr. <unk>: Achieved further validation of <unk> I went 31, and our PDC delivery platform to treat solid and hematologic tumors, including those located across the blood brain barrier.
Dr. <unk>: Initiated and enroll the first patient in our phase <unk> clinical study of <unk> in pediatric high grade Gliomas.
Dr. <unk>: 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 ire Pope has changed.
Dr. <unk>: We further expanded our PDC in Radiotherapeutic intellectual property portfolio, which was recognized by global data, citing select our.
Dr. <unk>: Z, leading pharmaceutical company as measured by patent grants and applications for Radiopharmaceuticals.
Dr. <unk>: We also announced promising preclinical data for three separate alpha emitters, including our proprietary novel Alpha emitting phospholipid Radiotherapeutic conjugate CLR 121255, and actinium enabled phospholipid ether in pancreatic cancer models.
Dr. <unk>: Yeah.
James V. Caruso: In preparation for the potential commercial launch of iupofazine, 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 Wham Pivotal Study, evaluating Iopocrazine I-131 for the treatment of relapsed refractory Waldenstrom's macroglobulin. We remain on target to provide an update on our WM top-line data during the second quarter. Currently, we are in the process of completing the work for our NDA filing and plan to submit 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.
Dr. <unk>: In preparation for the potential commercial launch of <unk>, 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 <unk> to advance the treatment.
Dr. <unk>: Of Wm, and the community and support communication between physicians patients and industry partners and of course, we announced positive top line data and the Clover Wham pivotal study evaluating <unk> <unk> 31.
Dr. <unk>: Treatment of relapse refractory Walden strong macro globule EMEA.
Dr. <unk>: We remain on target to provide an update on our Wm topline 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.
Dr. <unk>: 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.
Andrei Shustov: In parallel, we remain focused on constructing highly efficient commercialization capabilities for Iopophycin. As Shane will review, the WM market is highly concentrated and 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 discuss the WM trial and our clinical development program.
Dr. <unk>: In parallel we remain focused on constructing highly efficient commercialization capabilities for eye of pulp machine 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.
Dr. <unk>: Structure.
Dr. <unk>: Let me now turn the call over to Andre to further review the Wm trial, and our clinical development program Andre.
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 WAMP pivotal trial that were revealed earlier this year. As a reminder, Global WEMP was a global, open-label, single-arm study examining iapopatin I-131 in relapsing refractory WM patients who received at least two prior lines of therapy, Study patients received a total of four doses of ipofacin 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 had to have histologically and serologically confirmed diagnosis of Waldenstrom macroglobulinemia and ECOP performance status of 0 to 2 and have received at least two lines of prior therapy, which preferably included treatment with a B The study also included WM patients with central nervous system involvement, known as Binkneal syndrome, and patients with lymphoplasmic lymphoma without the full features of WM.
Thank you, Jim and good morning, everyone I.
Andre: I would like to start with very brief review of the study design study patient characteristics and top line efficacy and safety data from our global Wham to pivotal trial that were revealed earlier this year.
Andre: As a reminder, <unk> was a global open label single arm study examining our profits in <unk> 21 in relapsed and refractory <unk> patients who received at least two prior lines of therapy, including those patients who failed or had suboptimal response to <unk>.
Speaker Change: Hi, all.
Speaker Change: Only FDA proved class of treatment for this cancer.
Speaker Change: Study patients received a total of four doses of <unk> over two cycles.
Speaker Change: Without maintenance or retreat and were evaluated continuously for response for up to 12 months from the initial dose.
Speaker Change: Patients eligible for the trial had to have histologically and serologic with confirmed diagnosis of Walden from macro block of anemia, and ikat performance status of zero to two and have received at least two lines of prior therapy, which preferably included treatment with a <unk>.
Speaker Change: TK inhibitor.
Speaker Change: The study also included Wm patients with central nervous system involvement known as <unk> syndrome, and patients with linked for plasma Citic lymphoma without full features of Wm.
Andrei Shustov: Patients Enrolled in Global Wealth. Word, the most heavily pre-treated and the most refractory WM patient population ever reported in clinical trials. This statement is supported by key patient characteristics, including the number of prior therapies, which is four, and the proportion refractory to BTKI and rituximab, which is 50% and 40%, respectively. Proportion refractory to both BTKI and anti-CD20 therapy, which is 26.7%; proportion with medium and high IPSS WM score, which is 42%; and five to six-fold enrichment with MIDI 88 wild type genotype.
Speaker Change: Okay.
Speaker Change: Patients enrolled in <unk> work.
Speaker Change: The most heavily pretreated and in most refractory wm patient population ever reported in clinical trials.
Speaker Change: This statement is supported by key patient characteristics in.
Speaker Change: A number of private Eric switches for.
Speaker Change: Portion refractory to Teekay, <unk>, App, which is 50% and 40% respectively proportion refractory to both be Teekay, I and anti CD <unk> therapy, which is 26, 7%.
Speaker Change: Portion with medium and high Ips SWM score, which is 42% and five to six fold enrichment with Mighty 88 Wild type genotype.
Andrei Shustov: Top-line data from the Clover Web trial, reported on 41 consecutive evaluable patients for approximately 75% of the total MITT efficacy population, demonstrated a 61% major response rate, at 75.6% overall response rate and 100% disease control rate. Furthermore, the data showed a 7.3% complete response rate with a median duration of response and median progression pre-survival not reached at the time of data cutoff date and a median follow- We saw a high rate of responses across all key WM genotypes, including those that have been shown to control resistance to currently available improved therapy. 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.
Speaker Change: Topline data from the <unk> trial reported on 41 consecutive evaluable patients or approximately 75% of the total M ITT efficacy population.
Speaker Change: Demonstrated a 61% major response rate at.
Speaker Change: At 75, 6% overall response rate and a 100% disease control rate.
Speaker Change: Further the data showed a seven 3% complete response rate with a median duration of response and median progression free survival not reached at the time of data cutoff date, and a median follow up of eight months.
Speaker Change: We saw a high rate of responses across all key <unk> genotypes, including those that have been shown to confer resistance to currently available improved therapies.
Speaker Change: Responses were durable with median duration of response not reached 76% of patients remained progression free at a median follow up at eight months and the longest continuous response of over 30 months.
Andrei Shustov: Importantly, durability of these responses, without the need for continuous therapy or retreatment, suggests that iapophicin could be a potentially disease-multiplying new therapy with novel and unique mechanisms of action. Our safety results were also very positive, with 0% treatment-related discontinuations. 0% treatment-related deaths and 0% clinically significant bleeding. We saw predictable and manageable onset and recovery of cytopenias in all patients. We did not observe any treatment-related cardiovascular, renal, or hepatic adverse events.
Speaker Change: Importantly, durability of this responses without the need for continuous therapy or treatment suggests that <unk> could be potentially disease modifying to therapy with novel and unique mechanism of action.
Speaker Change: Our safety results were also very positive with zero percent treatment related discontinuation.
Speaker Change: So a percent treatment related deaths and zero percent clinic with significant bleeding risk.
Speaker Change: We saw a predictable and manageable onset and Rick Congress of Cytopenia is in all patients.
Speaker Change: We did not observed any treatment related cardiovascular renal or hepatic or adverse events.
Andrei Shustov: Summary. Clova-Wem was the largest study in relapsed refractory post-VTKI patients to date and the first WM study to evaluate a dual refractory patient population. We believe that to achieve a 61% major response rate in 41 evaluable patients with a median of four prior lines of therapy is nothing short of remarkable, especially with results that show a favorable safety profile and a four-dose, truly fixed-duration course of treatment. We believe that these results demonstrate that iapophicin is a promising therapy for patients in high clinical need who want this easy-to-administer as an IV infusion 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 Cloverweb's study, we've also reported promising activity of iapophicin 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 hybrid brain tumor.
Speaker Change: In summary.
Speaker Change: Global <unk> was the largest study in relapsed refractory post <unk> patients to date and the first step the <unk> study to evaluate dual refractory patient population.
Speaker Change: We believe that to achieve a 61% major response rate in 41 of Alico patients with a median of four prior lines of therapy.
Speaker Change: Is nothing short of remarkable, especially with results that showed a favorable safety profile and a four dose truly fixed duration course of treatment.
Speaker Change: We believe that these results demonstrate that <unk> is a promising therapy for patients and high clinical need.
Speaker Change: While it is easy to administer 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.
Speaker Change: 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 Change: In addition to impressive results from cohort. One study. We also reported promising activity of <unk> office and in other hematologic malignancies and solid tumors.
Speaker Change: This includes exciting results in a primary CNS lymphoma patient with attainment of complete remission.
Speaker Change: And stabilization of disease in pediatric patients with refractory high grade brain tumor.
Andrei Shustov: These findings further validate our previous observation of hypothesin's ability to cross the blood-brain barrier and deliver an antineoplastic payload to a variety of tumors in a sanctuary site. Furthermore, a recent report from the University of Wisconsin-Madison demonstrated the ability of iapophicin to safely combine with external beam radiotherapy in relapsed carcinoma of the head and neck, with 64% of patients attaining We believe that these findings may be broadly applicable to a variety of salt tumors.
Speaker Change: These findings further validate our previous observation office since ability to cross the blood brain barrier and deliver an antineoplastic payload to a variety of tumors and the sanctuary sites.
Speaker Change: Further.
Speaker Change: A recent report from the University of Wisconsin, Madison demonstrated the ability of <unk> office into safely combined with external beam radiotherapy in relapsed carcinoma head and neck with 64% of patients attaining a complete remission and one year overall survival of 67%.
We believe that this findings may be broadly applicable to a variety of solid tumors.
Jarrod Longcor: Summary. Data demonstrating iapophysin's ability to induce deep responses, including complete responses, in a variety of relapsing refractory, hematologic, and solid tumors, while exhibiting a consistently low toxicity profile with good tolerability may translate into durable and clinically meaningful benefits for a diverse patient population in urgent need of novel therapies. I will conclude by emphasizing that we are pleased with the results highlighted above 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 iapophicin, including frontline treatment of WM, a WM retreatment study to With that, I will now turn the call over to a dear colleague of mine, Jarrod Longcor, for an overview of our regulatory plans. Thank you, Andrei.
Speaker Change: In summary.
Data, demonstrating <unk> ability to induce deep responses, including complete responses to a variety of relapsed and refractory hematologic and solid tumors.
Speaker Change: All exhibiting consistently low toxicity profile with good tolerability may translate into durable and clinically meaningful benefits to a diverse patient population an urgent need for novel therapies.
Speaker Change: I will conclude by emphasizing that we are 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 gratefully almost later this year.
Speaker Change: We'll continue to evaluate product development and commercialization opportunities to craft the future focus clinical development of fire offices, including frontline treatment of Wm.
Speaker Change: We haven't heard treatment study to include a third cycle as well as studies in other indications, including marginal zone lymphoma, Mycosis, <unk> and primary MLA doses.
Speaker Change: With that I will now turn the call Judaea colleague of mine Jarrett long quarter for an overview of our regulatory glass Jarrett.
Jarrett: Thank you Andre.
Jarrod Longcor: With the successful completion of the Clover Wham 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.
Jarrett: With the successful completion of the <unk> 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.
Jarrett: We continue to work closely with the agency and since announcing topline results. We have received helpful advice and direction on various elements of it.
Jarrett: All of our modules required for the following.
Jarrett: We are working diligently to ensure our submission is robust and provides a supporting components. The agency has requested.
Jarrod Longcor: At the time of submission, we will request a priority review associated with our FASTRAC designation, and assuming it is accepted, we would expect an approximate six-month review period from the date of submission for our NDA, which, if accepted, will provide approval via posting in the first half of 2025. With this potential commercial launch timing in mind, we are refining our manufacturing and logistics process to ensure an uninterrupted supply of Ipofaxine I-131 Based upon our understanding of the difficulties experienced by others associated with the manufacturing and supply of targeted radiotherapies, we developed and executed a plan that we believe will mitigate or eliminate these risks. The frequent challenges that have been experienced by others include the inability to source isotopes, 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.
Jarrett: 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 would provide approval by publishing in the first half of 2025.
Jarrett: With this potential commercial launch timing in mind, we are refining our manufacturing and logistics process to ensure uninterrupted supply of <unk> hundred 31.
Jarrett: Based upon our understanding of the difficulties experienced by others associated with the manufacturing and supply of targeted radio therapies, 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.
Jarrett: At finished product manufacturing plant.
Jarrett: And for insufficient shelf life, all resulting in an interruption in supply and an inability to treat patients.
Jarrod Longcor: As discussed previously, rather than building and maintaining a single Selectar-operated manufacturing facility, which would limit total potential supply and run the risk of a site closure interrupting commercial supply, we have strategically established contract manufacturing partners that provide a multi-layered, overlapping, redundant, finished product supply chain network. This allows us to have multiple facilities providing ibuprofen for the global market. 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.
Jarrett: 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 multi layered overlapping redundant finished product supply.
Jarrett: Chain.
Jarrett: This allows us to have multiple facilities, providing <unk> for the call.
Jarrett: Global marketplace and ensures that an issue at one facility does not completely stopped production and supply and allows for an easy increase in total production capacity in fact because of this strategy, we can far exceed the projected supply requirements for all proposed indications with our existing North American based supply partners as an example.
Jarrod Longcor: 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 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.
Jarrett: We currently have the capacity to provide greater than 200 doses per week and can scale to nearly 1000 without an increase in it infrastructure and 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 quota supply and will provide easier.
Jarrett: 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.
Jarrod Longcor: 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 of the necessary quantities of I-131 and our PLE, reducing or eliminating potential risks to that portion of our supply chain. We believe this approach results in a seamless, secure supply via Focusene I-131.
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 them out. This approach ensures availability to the necessary quantities of I, 131, and our PLE, reducing or eliminating potential risks to that portion of our supply chain.
We believe this approach results in a seamless secure supply via focusing I wanted 131 <unk>.
Shane Lea: 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 radiotherapy. Now, I will turn the call over to Shane, who will provide an update on our commercial preparation. Thank you, Jarrod, and good morning, everyone.
Jarrett: Binds us with our 17 day 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 pay.
Shane: I had an update on our commercial preparation thank.
Shane: Thank you Jared and good morning, everyone. Our team is significantly advancing our capabilities in preparation for potential commercial launch of <unk> in Wm.
Shane Lea: Our team is significantly advancing our capabilities in preparation for a potential commercial launch via Pothicine and WM. Additionally, we continue to execute and make progress on our commercialization strategy for Iopophycine 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 included an evaluation of Iopophycine's product profile and an evaluation of the WM patient journey. The hematologist's review of iupofacin's product profile for WM was seen as very promising and impressive, with a high rating for intent to prescribe. Key findings from our patient journey work also show patient active participation in treatment choice and important treatment drivers, which include a need for new options and fixed therapies. We are building a high
Shane: Importantly, we continued to execute and make progress on our commercialization strategy for <unk> with the goal of ensuring a successful launch upon FDA approval.
Jared: We are very encouraged by the findings from our two most recent market research projects, which include an evaluation of <unk> product profile.
Jared: And an evaluation of the Wm patient journey.
Jared: Hematologist review of <unk> product profile for Wm was seen as very promising and impressive with a high rating for intent to prescribe.
Jared: Key findings from our patient journey work also show a patient active participation and treatment choice and important treatment drivers, which includes a need for new options and fixed therapy.
Jared: We are building a high.
Shane Lea: A successful, large team that's very concentrated in nature, with lots of experience, and we have recently filled all of the critical commercial leadership roles with two new senior hires to our commercial team. Our new VP of Marketing, Allison Bautista, brings over 20 years of industry experience and has an exceptional track record in new product launch leadership, notably leading the Reblazil launch for beta thalassemia and myelodysplastic syndrome at BMS and the Xevo launch for Desmoid Tumors at SpringWorks. Our newly appointed VP of Market Access, Eric Gustafson, brings over 30 years of industry experience across broad commercial roles with deep experience in market access. His most recent role was leading the Integrated Access and Value Team to commercialize two-part T-cell therapies at BMI. The ability to attract staff, highly competent, and experienced talent uniquely positioned Celectar for a successful launch.
Jared: Successful large team that's very concentrated in nature.
Jared: Lots of experience and have recently filled all of the critical commercial leadership roles with two new senior hires to our commercial team.
Jared: Our new VP of marketing Allison Bautista brings over 20 years of industry experience and has an exceptional track record and new product launch leadership, notably leading the <unk> launch for beta thalassemia and Myelodysplastic syndrome.
Jared: Yes.
Jared: And yet vivo launched for desert tumors at spring works.
Jared: Our newly appointed VP of market access Eric Gustafsson brings over 30 years of industry experience across broad commercial roles with deep experience and market access. His most recent role as leading the integrated access and value team to commercialize two car T cell therapies at BMS.
Jared: The ability to attract and staff highly competent and experienced talent uniquely position select are for a successful launch.
Shane Lea: 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 high value capture.
Jared: 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.
Jared: A concentrated market with a high unmet need limited competition and has high value capture.
Shane Lea: Our third-party claims and epi data show the total U.S. WM market to be approximately $2.1 billion, with an approximate prevalence of 26,000 patients. The third line plus segment represents approximately 4,700 patients, and the total number of patients in second line or greater is approximately 11,564 patients. We estimate the relapsed refractory market to be valued at approximately $1 billion. On our next slide, we'll... It illustrates our claims data, which demonstrate that there is no established standard of care in WM.
Jared: Yeah.
Jared: Our third party claims and <unk> data showed that total U S. W in market to be approximately $2 1 billion.
Jared: With an approximate prevalence of 26000 patients. The third line plus segment represents approximately 4700 patients and the total number of patients in second line or greater is approximately 11564 patients we estimate the relapsed refractory market to be valued at approximately $1 billion.
Jared: And our next slide.
Jared: Illustrates our claims data, which demonstrate there is no established standard of care and Wm.
Shane Lea: Greater than 60% of patients receive non-FDA-approved drugs, and over half, or 52%, of patients who receive a BTKI in second line are re-challenged within this 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 I have prophesied, a novel mechanism of action has the potential to capture significant share in this market. In summary, the WM market has high unmet need with an addressable market of about 11,600 relapsed refractory patients, 4,700 beyond second-line therapy, and an annual third-line incidence of nearly 1,000 patients. It is a highly concentrated market, with 10% of the treatment centers representing about 70% of the WM opportunity, There is limited competition in this market, with no established standard of care and greater than 60% of patients receiving non-FD approved treatment across all lines of therapy. Finally, with its efficacy, safety profile, and fixed dosing regimen, iupofacine represents a strong value proposition for physicians and payers and will provide a meaningful benefit for WM patients.
Jared: Greater than 60% of patients received non FDA approved drugs and over half or 52% of patients who receive a beta Cai in second line or re challenged 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 <unk> with its novel mechanism of action has the potential to capture significant share in this market.
Jared: In summary, the Wm market has high unmet need with an addressable market of about 11600 relapsed refractory patients 4700 beyond second line therapy, and an annual third line incidence of nearly 1000 patients as.
Jared: As 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's 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 <unk>.
Jared: Therapy.
Jared: Finally, with its efficacy safety profile and fixed dosing regimen I am focusing 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.
Jarrod Longcor: In conclusion, the commercial team is continuing to advance both capabilities and launch preparations to ensure a successful Iapofacene 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. Thank you, Shane. While our focus is on the successful submission of IAPOFACINE's NDA and preparing for a potential launch in WM, our Radio Conjugate franchise offers a very robust and diverse pipeline of opportunities. In addition to the broad applicability of ipococine and other relapsed refractory disease settings beyond WM, as described by Andrei earlier, we continue to demonstrate the potential of our phospholipid radioconjugate pipeline with isotopes other than iodine-131. Due to the nature of our PDC platform, we have the unique ability to rapidly switch isotopes and leverage a particular isotope We have validated by demonstrating in xenograft models our ability to deliver effective doses of actinium-225, lead-212, and astatine-211 to various tumor types.
Jared: <unk> launch.
Speaker Change: We look forward to providing additional updates and I will now turn the call back over to Jerry Law Court to highlight our Alpha program.
Speaker Change: Thank you Shane.
Speaker Change: While our focus is on the successful submission of IPO proceeds NDA and preparing for potential launch of Wm, a radio conjugate franchise offers a very robust and diverse pipeline of opportunities. In addition to the broad applicability of <unk> and other relapsed refractory disease that is beyond Wm as described by.
Speaker Change: Andre earlier, we continued to demonstrate the potential of our phospholipid radio conjugate pipeline with isotopes other than <unk> 131 due.
Speaker Change: 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.
Speaker Change: In xenograft models, our ability to deliver effective doses of actinium $2 25 led to 12 and ask the team to 11 in various tumor types.
Jarrod Longcor: We are rapidly advancing our Actinium program, CLR121-225, through IND-enabling studies, with the plan to initiate a Phase I study in pancreatic cancer late this year or early next year. Our programs are differentiated from other targeted alpha therapy programs, or TATs, by overcoming some of the challenges associated with the limited linear energy length provided. A challenge with TATs is that the energy from the molecules only penetrates a single Therefore, the targeting ligand must achieve uptake in nearly 100% of the tumor cells to be efficacious. For most other alpha-emitter programs, this is restricting them to pursuing tumor types that remain small. For example, small metastatic sites or small, slow-growing neuroendocrine tumors.
Speaker Change: We are rapidly advancing our actinium program CLR 121225.
Through IND, enabling studies with the plan to initiate a phase one study in pancreatic cancer late this year early next year, our programs with differentiated from other targeted alpha therapy programs or tats by overcoming some of the challenges associated with the linear limited linear energy length provided by Alpha.
Speaker Change: <unk> a challenge with <unk> is that the energy from the molecules only penetrate the single cell. Therefore, the targeting ligand must achieve uptake in nearly 100% of the tumor cells to be applications for most other alpha emitter programs. This is restrict them to pursue a tumor types that remains small.
Speaker Change: For example, small metastatic sites or small slow growing neuroendocrine tumors, but due to our ability with our pdc's to provide a uniform delivery to the tumor we can achieve robust activity and large bulky rapidly growing tumors like seen in our lymphoma clinical study and in the preclinical.
Jarrod Longcor: 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, as seen in our lymphoma clinical study and in the preclinical models of pancreatic, breast, and lung cancer that we've tested. We believe that this technological advantage will allow us to develop an extensive portfolio of TATs. TAP programs and expand the utilization of this highly effective treatment modality to a number of broad, broad array of tumor types. I will now turn the call over to Chad to review our financials. 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.
Speaker Change: 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 pets.
Speaker Change: Tap programs and expand the utilization of this highly effective treatment modality to a number abroad to.
Speaker Change: So a number of broad array of tumor types.
Speaker Change: I will now turn the call over to Chad to review our financials Chad.
Chad J. Kolean: Thank you Jared.
Chad J. Kolean: As shown in our 10-K filed earlier today, our cash and cash equivalents balance as of December 31, 2023 was $9 6 million carats.
Chad J. Kolean: <unk> $2019 9 million as of December 31, 2022.
Net cash used in operating activities during the year was approximately $34 million.
It's important to note that the.
Chad J. Kolean: September 23 financing design included a tranche of warrants with an exploration of 10 trading days. After the company released positive top line data, which we did on January eight.
Chad J. Kolean: It's important to know that September 2023 finance and 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 released. The investors who held the warrants exercised them in their entirety.
Chad J. Kolean: As a result of the data release, the investors, who held the warrants exercised them in their entirety.
Chad J. Kolean: Generating aggregate additional funding of $44 1 million.
Chad J. Kolean: $442 8 million net of fees.
Chad J. Kolean: As Jim noted earlier September 2023, refinancing represents up to $103 million in funding and has generated nearly $69 million for the company to date.
Chad J. Kolean: Generating aggregate additional funding of $44.1 million or $42.8 million net of, As Jim noted earlier, September 2023 financing represents up to $103 million in funding and has generated nearly $69 million for the company. The company believes its cash on hand, inclusive of the funds from the exercised warrants in January, is adequate to fund budgeted operations into the fourth quarter of 2024. R&D expenses for the year were approximately $28.2 million, compared to $19.2 million last year.
Chad J. Kolean: The company believes that the cash on hand inclusive of the funds from the exercise of warrants and James.
Chad J. Kolean: This is adequate to fund budgeted operations into the fourth quarter of 2020.
Chad J. Kolean: R&D expense for the year was approximately $28 2 million compared to $19 2 million last year.
Chad J. Kolean: 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.
Chad J. Kolean: The substantial increase of pivotal study patients.
Chad J. Kolean: Enrollment, culminating in the topline data announcement.
Chad J. Kolean: And the initiation of the pediatric hi, gratefully almost.
Chad J. Kolean: The overall increase in R&D expenses is primarily a result of three initiatives. Our continued focus on, and investment in, establishing a multi-source supply chain capability with redundant capacity in every aspect to ensure product supply cannot be disrupted. The Substantial Increase in Pivotal Study Patient Enrollment Culminating in the Top-Line Data Analysis and the initiation of the pediatric high-grade glioma. GNA expense for 2023 was $10.7 million compared to $9.5 million last year. The increase in DNA costs was composed of an increase in personnel-related costs, which were partially offset by reduced professional costs. The net loss attributable to common stockholders for the year was $38.0 million, or $3.11 per share, as compared to $28.6 million, or $4.05 per share less.
Chad J. Kolean: G&A expense for 2023 was $10 7 million compared to $9 5 million last year.
Chad J. Kolean: The increase in G&A costs was composed of an increase in personnel related costs, which were partially offset by reduced professional fees.
Chad J. Kolean: Net loss attributable to common stockholders for the year was $38 zero million or $3 11 per share as compared to $28 6 million or $4 <unk> per share last year.
Chad J. Kolean: I will now turn the call to Jim for closing remarks, Jim Okay. Thank you Chad.
Jim: 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.
James V. Caruso: I will now turn the call over to Jim for his closing remarks. Jim? Okay. Thank you, Chad. I hope that all of you agree that Celectar'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 it comes. With that, I would now like to open the call for our question and answer session. Operator.
Jim: With that I would like to now open the call for our question and answer session.
Jim: Operator.
Speaker Change: Thank you if you wish to ask a question. Please star one on your telephone keypad smelter and so the key once your name is pronounced you can ask your question. If you find it's almost with before <unk> start to to cancel.
Speaker Change: Our first question comes from the line of Jonathan Aschoff.
Unknown Executive: Thank you. If you wish to ask a question, please dial star 1 on your telephone keypad now to enter the... Once your name has been announced, you can ask your question. If you find it's answered before it's your turn to speak, you can dial star 2 to cancel.
Jonathan Matthew Aschoff: Ross. Please go ahead your line is open.
Thank you guys good morning, and congrats on all the obvious progress given that progress.
Jonathan Matthew Aschoff: Are you getting any serious acquisition inquiries because.
Jonathan Matthew Aschoff: The drug seems to be rather Isa topically modular and targeted to lipids that really don't seem like they are going to change that much.
Jonathan Matthew Aschoff: Our first question comes from the line of Jonathan Aschoff at Roth MKM. Please go ahead; your line is open. Thank you guys. Good morning, and congrats on all the obvious progress. You know, given that progress, are you getting any serious acquisition inquiries? Because, you know, 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.
Jonathan Matthew Aschoff: It sounds like something somebody would want to own and apply broadly.
Speaker Change: So Jonathan Thank you for pulling punches on your first question.
Speaker Change: We appreciate.
Speaker Change: Listen I mean, as we were chatting at your conference and thanks again for the opportunity to participate there.
Speaker Change: When you take a look at the landscape and radio therapeutics in general.
James V. Caruso: So Jonathan, thank you for pulling punches on your first question; we appreciate it. Now, listen, I mean, as we were chatting at your conference, and thanks again for the opportunity to participate there. When you take a look at the landscape in radiotherapeutics in general, with, you know, almost predominantly the two available agents on the market currently, glutathera and fluvicto, both being beta emitters, as an aside, and of the eight products that are currently in pivotal studies, eight radiotherapeutic products that are in pivotal studies, three are in the kind of net area, and three are in the prostate. Really fragmenting that space now, right? As these alpha emitters continue to develop, what you'll discover and what you know is that they're really focused on those particular areas.
Speaker Change: With.
Speaker Change: Almost predominantly the two.
Speaker Change: Available agents on the market currently Ah lunar thorough and pubic, though both being beta emitters as an aside and of the eight products that currently are in pivotal studies eight radio therapeutic products that are in pivotal studies three are in the kind of debt.
Speaker Change: Net area and three are in prostate really fragmenting that space now right as they as these alpha emitters continue to develop but youll discover and what you know is that they're really focused on those particular areas.
Speaker Change: And Jared or Andre can do a much better job than I to talk to why that is the case and that 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.
James V. Caruso: And, you know, 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 hypothesine, which has demonstrated utility, you know, beyond hematologic malignancies in our first-to-market indication, which would be WM, which we believe, and as Shane discussed, and hopefully have an opportunity to provide broader background on, is just an excellent opportunity for us as a company for top-line revenue there, as well as the capacity to really help patients with high clinical need, as Andrei appropriately discussed.
The capacity to smaller tumor types like neuroendocrine 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 our.
Speaker Change: Potentially the next to market approved agent with a potent Shane which has damaged demonstrated utility beyond hematologic malignancies, and our first to market indication, which would be wm, which we believe and ashamed discussed and hopefully have an opportunity to.
Speaker Change: To provide broader background dawn is a just an excellent opportunity.
Speaker Change: For us as a company from for topline revenue there as well as the capacity to really help patients with high clinical need as Andre appropriately discussed so having said all of that.
Speaker Change: I think that positions us very nicely the other element here.
James V. Caruso: So having said all that, you know, I think that positions us very nicely. The other element here, Jonathan, is obviously our intellectual property portfolio. You know, as other companies have more recently come into the space, we have been planning and 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, 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, you know, six, 12, 18 months, experiencing similar growth, and we do believe the NDA submission and acceptance is substantially complete, and our first approval in WM will be yet another game-changer for the organization from a valuation perspective. OK, you know, is Clover shut, or are you seeing any higher enrollment in liquid tumor in January. I can't remember if Clover always seemed to me to be this open-ended.
Speaker Change: Jonathan is obviously, our intellectual property portfolio.
Speaker Change: As other companies have more recently come into the space, we have been planning and have been methodically expanding our intellectual property waterfront over.
Speaker Change: Over the course, so 567 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.
Speaker Change: Without directly answering your question based on where.
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 612 18 months to experience similar growth and we do believe the NDA submission.
Speaker Change: And acceptance is substantially complete and our first approval in Wm.
Speaker Change: B a yet another game changer for the organization from a valuation perspective.
Speaker Change: Okay.
Clover shut.
Speaker Change: Or are you seeing any higher enrollment in liquid tumors. After you came out with this data.
Speaker Change: In January I can't remember, if <unk> always seemed to me to be just open ended.
James V. Caruso: You know, that highly inclusive trial of yours that I just can't think of. I just can't recall if it's closed formally or if it can take additional pace. As you recall, there were three arms associated with our Clover WHAM study. We had the WM pivotal portion, and then we had two additional elements, the Phase 2a, and 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, a formidable opportunity and package to secure NCCN compendia guidelines. So once approved with WM, this would allow those clinicians that believe So we continued to enroll there.
Speaker Change: Highly inclusive.
Trial of yours that I, just can't I, just can't recall, if its close to formally or if it could take additional patients.
Speaker Change: As you recall there were three arms associated with.
Speaker Change: With our <unk> study, we had the Wm pivotal portion and then we had two additional elements of the phase Iia.
Speaker Change: Could have Andrea Jarrett talk to the multiple myeloma arm and how we were dialing in on post bcm a data at the.
Andrea Jarrett: Further enrich our dataset, which would allow us we believe with a formidable.
Andrea Jarrett: <unk> and package.
Secure NCC and compendium guidelines, so once approved with Wm.
Andrea Jarrett: It would allow those clinicians that belief.
Andrea Jarrett: <unk>, 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 Iia.
James V. Caruso: 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 iopropocene 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 questions.
<unk> central nervous system lymphoma arm as we continue to explore the real unique benefits of our delivery vehicle and I appropriately and in particular to cross the blood brain barrier and as Andre will tell you.
Andrea Jarrett: Penetrates and demonstrate effectiveness in these sanctuary sites, so that I don't know if jarrett or Andre.
Andrea Jarrett: Sure.
Andre: Thank you, Jim and Jonathan and Thank you for your question Jim answered the majority I think of your request Diebold, just reconfirmed reiterate that.
James V. Caruso: 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 global WAM has emerged as an expansion from the so-called basket to a study that included our cohorts and non-Hodgkin lymphoma, primary CNS lymphoma, and multiple myeloma.
Speaker Change: <unk> has emerged as an expansion from <unk>. So.
Speaker Change: Just.
Speaker Change: To say basket to a study that included our cohorts and non Hodgkin lymphoma.
Speaker Change: I'm very CNS lymphoma, and multiple myeloma. The <unk> study is fully enrolled and we are.
Andrei Shustov: The global WAM 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 the multiple myeloma cohort to enrich the high-risk population, and we'll be evaluating our data in the second half of this year to further guide us into where to take this program from a regulatory standpoint. We're also enrolling patients into a primary CNS lymphoma cohort to further distill the signal of activity first demonstrated by CR in the patient with refractory disease across the blood brain barrier.
Speaker Change: We are in the process of preparing the.
Speaker Change: NDA submission this year as you know we've continued to enroll in multiple myeloma cohort two in breached high risk population and we will be validating our data in the second half of this year to further guide us into at where to take this program.
Speaker Change: From a regulatory standpoint, we are also enrolling patients into into proprietary CNS lymphoma cohort to further distilled a signal of activity first demonstrated by <unk> in the patients with refractory disease.
Speaker Change: Cross the blood brain barrier. So those are ongoing studies that we will be reporting updates in the second half of the year.
Andrei Shustov: So those are ongoing studies that we will be recording updates on 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?
Speaker Change: Okay and all these patients will get four doses like in the Wm trial, unless toxicity dictates otherwise is that accurate.
Speaker Change: So they.
Andrei Shustov: As you probably know, the 2A study contains several cohorts with different dosing schedules. The currently open cohorts will follow the schedule that we have reported in the Global WOM study. Okay, and just two quick boring questions.
Speaker Change: As you probably know the protocol.
Speaker Change: <unk> contains several cohorts with different dosing schedules.
Speaker Change: Currently open cohorts.
Speaker Change: Pursue.
Speaker Change: Schedule.
Speaker Change: We have reported in <unk>.
Speaker Change: Okay, and just two quick boring questions with.
Jonathan Matthew Aschoff: With a pop in SG&A in the fourth quarter, what can you help us out? What does SG&A look like for 2020? Ah, Total Expense. I guess it's for SPNA alone. [inaudible] I'm gonna, I'm gonna, 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 the fourth quarter from what you saw in the fourth quarter.
Speaker Change: With a pop in SG&A in the fourth quarter, what can you help us out what does SG&A look like for 2024.
Okay.
Speaker Change: Total expense.
Speaker Change: I guess for SG&A alone.
Speaker Change: Yes.
Speaker Change: I'm going to I'm going to I'm going to defer that.
Speaker Change: A little bit until we actually.
Speaker Change: Look at that breakdown, a little bit more I don't think youre going to see much of a change in the trend as we go into.
Speaker Change: 24 from what you saw in the fourth quarter to your point.
Speaker Change: We won't see that really change dramatically until we get later in the year.
Speaker Change: So what I'll add to that Jonathan Yeah, what I'll add to that Jonathan as you kind of think about.
James V. Caruso: We won't see that really change dramatically until later in the year. 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 and early years, when you're really driving trial use and adoption, this kind of $50 to $70 million OPEX. I believe Shane has a very targeted, focused, strategic plan that we really like, leveraged with smart data, and Shane, I believe that's in and around a $25 million OPEX. Thank you very much.
Jonathan Matthew Aschoff: How we would invest.
Jonathan Matthew Aschoff: In the <unk> space Shane is building out a very targeted.
Speaker Change: 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 million to $70 million Opex I believe Shane has.
Speaker Change: A targeted very targeted focused.
Speaker Change: Strategic plan that we really like leverage with smart data and Shane I believe that's in and around that $25 million correct correct.
Speaker Change: Yes.
Jonathan Matthew Aschoff: All right, thank you, Jonathan. Thank you. Our next question comes from the line of Jeff Jones at Oppenheimer. Please go ahead, your line is open.
Speaker Change: Thank you very much guys.
Speaker Change: Alright, Thank you Jonathan.
Speaker Change: Thank you.
Comes from the line.
Speaker Change: I'll have Jeff Jones of Oppenheimer. Please go ahead your line is open.
Jeffrey Michael Jones: Thanks. Thank you, operator. And congrats on a great year, guys, and all the progress you've made. I guess, starting off by following on what Jonathan was asking about sort of the operational GNA program. Can you speak to how what you're thinking about in terms of The Commercial Organization at Launch, Sales Rep, MSL Structure? Sure, I'm going to turn that over to Shane and his team, who have done 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 as I have historically observed in the past. So I'll give him an opportunity to kind of talk through some of his thinking.
Jeffrey Michael Jones: Thank you operator, and congrats on the great year, guys and all the progress you've made.
Speaker Change: I guess.
Jeffrey Michael Jones: Starting off on.
Jeffrey Michael Jones: Following on what Jonathan was asking on sort of the operational G&A program.
Jeffrey Michael Jones: Can you speak to how what's your thinking about in terms of.
Jeffrey Michael Jones: The commercial organization that launch where our sales were up.
Jeffrey Michael Jones: MSL structure.
Jeffrey Michael Jones: 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.
Jeffrey Michael Jones: <unk> space and marketing in both large multinational pharmaceutical companies as well as small biotech and Shane has done.
Good or better of a job.
Shane: And then I have historically observed in the past so I'll, let him give him an opportunity to kind of talk through some of his thinking yes. Thanks, Thanks, Jim and thanks for the question.
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, build awareness, and leverage the key attributes of ibuprofen?
When we look at the buildup of our go to market model, It's really focused on two things right. One is.
Jim: What are we doing to influence brand choice building of awareness leveraging the key attributes Brian <unk> 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.
Shane Lea: And the second piece of it is more operational in nature as we think about how we should 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... We want to make sure that it's one that 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 that will help to support the pull-through of those two key things. First, having proper marketing capabilities and proper data capabilities to help drive choice and decision making.
Jim: The radio therapy enablement process so.
Jim: Looking at the.
Jim: <unk>, 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.
Jim: So when you look at the go to market model will 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 <unk>.
Jim: Joyce and decision making.
Shane Lea: We will have a team that will be dedicated to the site activation and radio therapeutic enablement process in these very targeted accounts. And we'll have a traditional sales role that will be focused on driving trial and use and building awareness. Also supporting those teams will be a focus group of Medical Specialists to support medical information inquiries and to provide further enrichment and education around Iopofacin.
We will have a team which will be dedicated to the site activation in radiotherapeutic enablement process in these very targeted accounts.
Jim: And we will have a traditional sales role, which will be focused on driving trial and use in building awareness also supporting those teams will be a focus group and myself.
Jim: To support medical information inquiries and provide further enrichment education around <unk>.
Jim: <unk>.
Shane Lea: 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 Iopofacin'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.
Jim: And we also have a dedicated team that will be supporting all of our market access initiatives, we want to ensure that and our focused approach we leave no patient behind because there is significant unmet need in this space and we believe with <unk> profile, we have a unique.
Jim: Opportunity here to capture share.
Jim: And all of these key segments of the market, which we've illustrated as part of the share basket slide that you saw today.
Okay.
Jarrod Longcor: Thanks, Shane. Could you speak to how you're looking at Europe, both from a regulatory and commercial perspective? Absolutely, Jeff. For those that may not recognize my voice, this is Jarrod.
Speaker Change: Thanks Shane.
Shane: Could you speak to how you're looking at Europe.
Shane: Both from a regulatory and commercial perspective.
Shane: Absolutely Jeff.
Shane: For those that May not recognize my voice this is jarrett.
Jarrod Longcor: So let me start from a regulatory perspective. As I think many folks are aware, last year we did receive prime designation in Europe. The prime designation for Europe is essentially the equivalent of the breakthrough designation here in the U.S. It does provide you with increased engagement with the agency. It provides you with a more rapid pathway to launch, and it actually encourages cross-communication between those two agencies. So EMA and FDA actually 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 ties that up.
Jarrett: So let me start from a regulatory perspective as I think many folks are aware.
Jarrett: Last year, we did received prime designation in Europe, the Prime designation for Europe is essentially equivalent.
Jarrett: Like the breakthrough designation here in the U S. It does provide you with increased engagement with the agency and provide you with a more rapid.
Jarrett: Pathway to launch and it provides actually encourages the cros communication between those two agencies, so EMA and FDA actually behind the scenes start to align and get.
Jarrett: Yet there are still growth requirements in harmonization with one another for the same product.
Jarrett: With that but that said, so thats sort of piece that up our timeline or our expectation is that we will push forward here rapidly with the eight with EMA.
Jarrod Longcor: Our timeline, or our expectation, is that we will push forward here rapidly with 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 for the European launch. Now with that said, we at Cellectar do not plan to be the party to commercialize in Europe. What we are looking to do, and what we have had a number of ongoing discussions with various partners, is to have a partner take over the commercialization and functionality of the product in Europe.
Jarrett: To rapidly follow a approval in the U S. 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.
Jarrett: <unk> European launch now with that said, we at select or 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.
Jarrett: 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.
Jarrod Longcor: 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. 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 Lyme in these patients. So any update on your thinking about the label, the indication you would propose to the agency being at third line plus BTKI refractory, et cetera? Yeah, so from a regulatory perspective, you know, I'll say that, you know, based off the clinical data that we've seen to date as Andrei took you through, the one, yes, we're a later line, but more importantly, the refractoriness of these patients, the level of treatments that they have received, we do believe that we have a very strong position and a strong opportunity to pursue a simplistic sort of second line or later positioning, or as one might say, a relapse refractory patient population.
Jarrett: And make sure that they receive product as necessary, but they will be the drivers for the commercialization.
Speaker Change: Great. Thank you Terri.
Speaker Change: I guess last question for me.
Speaker Change: You spoke to it a little bit.
Speaker Change: Really providing some interesting data on the diversity of therapy used by line.
Speaker Change: In these patients so any update on your thinking about the label indication you would propose to the agency being at third line, plus <unk> refractory et cetera.
Speaker Change: Yeah, so from a from a from a regulatory perspective.
Speaker Change: Say that base.
Speaker Change: Based off the clinical data that we've seen to date as Andre as Andre took you through the one yes were later line, but more importantly, the refractory ness of these patients to a 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.
Speaker Change: 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 populations. We do believe that we have a very high probability of success on that again because of the the number of patients that we've had that have been exposed.
Jarrod Longcor: 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 to 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.
Speaker Change: Not just the only approved class of therapy, but essentially all other therapeutic options and for which they have shown high levels of refractoriness. Unlike what's been tested historically, so we do believe that there is a strong opportunity there.
Jarrod Longcor: So we do believe that there's a strong opportunity. Great. I really appreciate the additional clarity, guys. I'll step back into the queue.
Great really appreciate the additional clarity guys I'll step back into the queue.
Unknown Executive: All right. Thanks much, Jeff. 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. All right, terrific. Thank you, Mark. I 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 future. Have a good day. Thank you. This now concludes our call. Thank you all very much for attending. You may now go.
Alright, thanks, so much Jeff.
Speaker Change: Thank you and currently there are no further questions.
Speaker Change: And then the queue at this time, so I'll hand, the floor back to Mr. Caruso for closing remarks.
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.
Caruso: Yeah.
Speaker Change: Thank you. This now concludes all cool. Thank you all very much for attending you may now disconnect.