NASDAQ:CLRB Cellectar Biosciences Q1 2024 Earnings Report $0.30 +0.02 (+5.58%) Closing price 04/17/2025 04:00 PM EasternExtended Trading$0.30 +0.00 (+0.67%) As of 04/17/2025 06:18 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Cellectar Biosciences EPS ResultsActual EPS-$0.40Consensus EPS -$0.50Beat/MissBeat by +$0.10One Year Ago EPSN/ACellectar Biosciences Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ACellectar Biosciences Announcement DetailsQuarterQ1 2024Date5/14/2024TimeN/AConference Call DateTuesday, May 14, 2024Conference Call Time8:30AM ETUpcoming EarningsCellectar Biosciences' Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Cellectar Biosciences Q1 2024 Earnings Call TranscriptProvided by QuartrMay 14, 2024 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Good morning, and welcome to Selector Biosciences 2024 Year End Earnings Call. Today's call is being recorded. Before we begin, I would like to remind everyone that statements made during this call relating to Selector's expected future performance, future business prospects or future events or plans are forward looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties that could differ materially from those forecast due to the impact of many factors beyond the company, the control of Selector. The company assumes no obligation to update or supplement any forward looking statements whether as a result of new information, future events or otherwise. Operator00:00:51Participants are directed to the cautionary notes set forth in today's press release, which is available on the Investor Relations portion of the company's website as well as the risk factors set forth in Selector's annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward looking statements. At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Selector. Mr. Caruso, please go ahead. Speaker 100:01:24Thank you, operator, and good morning, everyone. It is my pleasure to be here with you to report our Q1 results and provide a corporate update. With me today are Doctor. Andrey Shustoff, Senior Vice President, Medical Jared Vancourt, Chief Operating Officer Shane Leah, Chief Commercial Officer and Chad Killeen, our Chief Financial Officer. As you know, we recently completed our 2023 annual earnings call in which we reviewed a highly productive year for the company, including the announcement of detailed top line data from our WM pivotal study and reiterated guidance for a data update in Q2. Speaker 100:02:08I'm pleased to report that we remain on track for a Q2 data announcement for the fully enrolled study patient population. We plan to press release this data in June and review in greater detail on a key opinion leader call scheduled for the same day. We look forward to sharing the study data and the subsequent KOL call. Currently, we are in process of completing our NDA 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 would expect a 6 month review period from the date of the NDA submission. Speaker 100:02:55The focus of today's earnings call is to have a more in-depth commercial discussion regarding the attractiveness of the WM market, including the existing high unmet need, the lack of competitive investment and scalable nature, among other factors, all likely to facilitate rapid capture of iapofacine I-one hundred and thirty one market share. In addition, we will review our efficient and cost effective product manufacturing infrastructure and distribution plan in preparation for the potential marketing of our lead radiotherapeutic. To further orient you to today's agenda, I will provide a brief overview of the meaningful accomplishments of the company over the past Q1. I will then transition the call to Chad to discuss our financial results. Shane will review the commercial topics followed by Jared's manufacturing and distribution network update. Speaker 100:03:54We will then open the call for queue and day. As you are likely aware and as I have previously stated, it is an exciting time for companies with radiotherapeutic pipelines and those few companies with late stage and or near term approvable assets. With the next radiotherapeutic approval potentially ipoficine I-one hundred and thirty one along with our unique PLA delivery platform providing a differentiated radioisotope offering or offerings, including alpha emitting agents, we are confident in our position and excited about the future of Selectar. With that as background, I will now provide an overview of our key Q1 accomplishments. Of course, we announced positive top line data in the CLOVER WAM pivotal study, evaluating iapopacin I-one hundred and thirty one for the treatment of relapsedrefractory Waldenstrom's macroglobulemia and as cited, we'll provide the data update on full patient enrollment in June. Speaker 100:04:58As part of a private placement of up to $103,000,000 the company received approximately $44,000,000 in January with the potential to secure another $34,000,000 in warrants available for conversion at a $4.77 strike price upon approval of our WM NDA. Importantly, to support launch preparation and the potential marketing by pofuscene, we announced another strategic partnership with Aon or the American Oncology Network, a physician led community based cutting edge oncology platform that is currently managing the treatment of approximately 650 WM patients. The partnership's objective is to collectively advance the treatment of WM in the community setting through a better understanding of the WM landscape and to ensure patient access to iapofacine I-one hundred and thirty one for the many communities that AAON serves. Announced promising preclinical data for 3 unique internally developed alpha emitters, including our proprietary novel alpha emitting phospholipid therapeutic conjugate, CLR-one hundred and twenty one-two fifty five and actinium labeled phospholipid ether in pancreatic cancer models. We are evaluating CLR-one hundred and twenty one-two twenty five in additional preclinical models such as ovarian and triple negative breast cancer and plan to initiate a Phase I study in one of these solid tumor cancers no later than Q1 2025. Speaker 100:06:40Reported a complete central nervous system clearance in relapsedrefractory Waldenstrom's macroglobulemia, providing further validation for iofofacin I-one hundred and thirty one to treat solid and hematologic tumors, including those located across the blood brain barrier initiated and enrolled the first patient in our Phase Ib clinical study biopofacin I-one hundred and thirty one in pediatric high grade gliomas or PHGG. Based on investigator excitement and iapofacine's demonstrated activity in solid tumors across the blood brain barrier, we are excited about the value iapofacine may provide in this treatment setting, one in which patients are restricted to few treatment options. As previously announced, we look forward to providing an update on this study in the second half of twenty twenty four. Reported a high rate of complete remission in an investigator initiated Phase I study of Ibuprofen in combination with external beam radiotherapy in another challenging solid tumor, recurrent head and neck cancer. The complete remission rate was 64%, and overall response rate was 73% in a highly refractory patient population. Speaker 100:08:03Durability of clinical activity was also impressive, achieving 67% overall survival and 42% progression free survival at 1 year. Let me now turn the call over to Chad to review the company's financials. Speaker 200:08:21Thank you, Jim. Our cash and cash equivalents balance as of March 31, 2024 was $40,000,000 compared to $9,600,000 as of December 31, 2023. The exercise of the tranche A warrants from the September 2023 financing combined with the exercise of 547,000 warrants issued in October 2022 generated net proceeds of 43,900,000 dollars Net cash used in operating activities during the quarter was approximately $13,400,000 Company believes its cash on hand is adequate to fund budgeted operations into the Q4 of 2024. R and D expense for the quarter was approximately $7,400,000 compared to $6,700,000 in the Q1 of 2023. As we continue our preparations for an expected product launch for IPL-one hundred and thirty one in 2025, the company has invested extensively to ensure that we have the ability to deliver product in the event of a disruption in one of our suppliers, which we have solutioned by the establishment of a multi source supply chain that has redundancies at every step from radioisotope suppliers to material producers and final conjugated product providers. Speaker 200:09:43Those costs were partially offset by reduced spending related to our pivotal trial AWML that we have completed trial enrollment. G and A expense for the Q1 of 2024 was $4,600,000 as compared to $2,100,000 last year for the same period. The substantial increase in G and A is also primarily driven by the expectation of a product launch in 2025. With the development of the infrastructure and information necessary to support a fully commercialized product including personnel and marketing costs. There is a $9,900,000 non cash charge that relates to the impact of the accounting for the warrants on the P and L. Speaker 200:10:30The accounting rules for the warrants requires the company to revalue them at every reporting date. Also upon settlement, the tranche A warrants that were exercised in the quarter were required to be revalued as of that settlement date. The value was determined to be $4,800,000 which represents the intrinsic value of the warrants at the time of exercise. The difference between the stated preferred conversion price to common of $3.185 $3.185 and the price of the stock at the time. This is booked as an expense and then that amount is immediately reclassified to equity as is shown in the statement of stockholders equity in the 10 Q we just filed this morning. Speaker 200:11:16In addition to the impact of the settlement of the tranche A warrants, the remaining tranche B warrants were revalued as of the end of the period, which resulted in an increase to the liability of $5,100,000 This expense is primarily driven by the increase in the stock price. Combined, these two components composed the loss on valuation of warrants on the P and L. The net loss attributable to common stockholders for the quarter ended March 31, 2024 was $21,400,000 or $0.74 per share compared to $8,600,000 or $0.76 per share last year. With that, I will now turn the call over to Shane Lee for a commercial overview. Shane? Speaker 300:12:07Thank you, Chad. Commercial team is advancing our preparation for potential commercial launch of iapofacine and WM. Importantly, we continue to execute and make progress supporting our commercial strategy for Ibupofacin, the goal of ensuring a successful launch upon FDA approval. We are very encouraged by the findings from our most recent research projects, which included an evaluation of iofofacene's product profile, an evaluation of WM patient journey and segmentation research with radiation oncologists and nuclear medicine physicians. Biofofacene's product profile for WM was given exceptionally high rate for intent to prescribe with hematologists. Speaker 300:12:48Key findings from our patient journey work also show patient active participation in treatment choice and important treatment drivers, which includes a need for new options and fixed therapy. We have also engaged radiation oncologists and nuclear medicine physicians since they are key stakeholders for radiotherapy utilization. The radiation oncologist and nuclear medicine physicians review of iofofacene's profile was very positive. They were enthusiastic with iofofacene's simplicity of use versus existing radiotherapeutics. Iofacene's features such as no required dosimetry, short infusion time, long storage life and ease of administration were regarded as significant differentiators by this key stakeholder group. Speaker 300:13:36Interactions with these key stakeholders further supports our belief that iofofacene is a best in class next generation radiotherapeutic that if approved will secure significant utilization in both the hospital and community outpatient setting. We are selectively building a successful and experienced commercial team that will support the framework for our go to market model in WM with a goal of establishing market leadership. We will be utilizing claims data to drive decision making will support radiotherapy site activation, brand awareness and ensure that the first treatment experience with iofocusing is the right experience for both patient and provider. We have initiated additional market research projects that will further support product positioning, value payer messaging and pricing strategy. We continue to build out data capabilities to further understand the WM market supporting a highly efficient and cost effective commercial model. Speaker 300:14:35We believe WM is a very attractive market with no real market leadership, is a concentrated market with a high unmet need, limited competition and provides an opportunity to capture significant share with active promotion utilizing FDA approval. Turning to slide 3. Our 3rd party claims and FDA data show the total USWM market to be approximately $2,100,000,000 with the current relapsed refractory market valued at $1,000,000,000 iofofacin has 2 very compelling opportunities to capture patient share, assuming marketing approval. The first opportunity to capture patient share exists in the current lapse refractory market, which is burdened by high unmet need. Nearly 50% of patients in the 3rd line or greater setting are retreated with the same or simpler treatment from an earlier line due to lack of options. Speaker 300:15:28Greater than 60% of these therapies are not FDA approved and cannot be promoted. Iofofacin can be readily positioned to capture share in the existing relapsed refractory market. 2nd, we believe the 3rd line or greater market, which is approximately 4,700 patients could expand to 5,700 patients. This is the second opportunity for iapofacine. Approximately 1,000 patients have exhausted the prevalent treatment options. Speaker 300:15:55As a result, patients remain either ineligible or intolerant of current market treatments. This market expansion opportunity could allow fast patient capture by our focusing as a novel WM treatment. On Slide 4, our claims data demonstrate there is no established standard of care in WM. As previously stated, greater than 60% of patients receive non FDA approved drugs and over half, 52 percent of patients who receive a BTKI in the second line are rechallenged a BTKI, again, as third line therapy. This is mainly a function of limited treatment options in the relapsedrefractory setting, as there has been no FDA approved new mechanism of action in nearly a decade. Speaker 300:16:39Iofofacene with its novel mechanism of action and strong clinical profile along with CELLECTVAR's active promotion of iofofacene can capture significant share in this market. Slide 5, market claims data confirms and significant recycling of existing therapies. According to claims data, 10% of third line patients received the chemotherapeutic drug bendamustine and approximately 40% of these patients are re challenged with that chemotherapy in later lives. Approximately 1600 patients receive rituximab in the 3rd line or greater setting and more than 50% are retreated with rituximab after prior exposure. There is only one class of approved drugs and only 2 FDA approved therapies in this class, which includes ibrutinib and zanubrutinib. Speaker 300:17:293rd party claims data also validates approximately 50% of BTKI patients retry BTKIs in the 3rd line or greater segment. As previously stated, nearly 50% of 4,700 patients in the 3rd line or greater setting have been retreated after prior exposure to that same therapy. The consistent recycling of therapies is due to the lack of treatment options. Market characteristics for existing therapies underscores the unmet need and nearly all are not actively promoted. According to market research, WMP opinion leadership and treaters expressing need for a novel mechanism of action, fixed course of therapy and better efficacy outcomes. Speaker 300:18:11We believe can cost over $1,000,000 This provides significant optionality for iapofacin premium pricing. As noted earlier, we have initiated our pricing work that will provide the optimal recommended price. Lastly, Slide 6 is a high level illustration of our approach to execution. The WM market is highly concentrated with approximately 80% of diagnosed patients in 15 states. 75% of second line or greater patients are treated in only 199 accounts. Speaker 300:18:51This concentrated nature of the market supports a commercial strategy that will leverage geographic and account segmentation to optimize share of voice with the right customer at the right time to drive awareness and quickly capture patient share. In conclusion, our commercial planning efforts are advancing with the objective of executing a successful launch and establishing ipofacene as a market share leader in WM. We look forward to providing additional updates. I will now turn the call over to Jared Loncore to highlight our manufacturing and distribution. Jared? Speaker 400:19:24Thank you, Shane. Historically targeted radiotherapeutics have faced significant supply and manufacturing challenges, primarily due to limited finished product manufacturing locations, constrained availability of isotopes, the isotope half life and limited shelf life of the finished product, resulting in manufacturing and patient treatment bottlenecks. Additionally, targeted radiotherapies have been expensive to manufacture with significant challenges and scalability to match market demand. At Selector, we've implemented multiple strategies to avoid many, if not all of these pitfalls. Unlike other models, we've adopted a flexible modular manufacturing strategy. Speaker 400:20:02This approach offers scalability and addresses various challenges in traditional manufacturing methods. Instead of relying on a single select our operated manufacturing facility, our modular approach utilizes a network of overlapping suppliers and contractors. This tactic reduces the overall footprint operating cost of 1 or multiple manufacturing facilities, significantly lowering fixed capital expenditure. Furthermore, by validating multiple suppliers for every component of our product, we have mitigated issues related to constrained source of isotope, the targeting ligands and limited finished product manufacturing capabilities. Our modular approach enables rapid increases in supply to meet market demands. Speaker 400:20:48Currently, we can supply over 200 doses per week of iofocusing I-one hundred and thirty one with the capability to quickly scale up to over 1,000 patient doses per week without expanding our existing infrastructure. This means we can effectively serve the needs of nearly 20,000 patients per year without additional investment. Additionally, our modular supply chain allows for further expansion of the market as the market grows. With capacity to nearly double current supply and plans in place for over a 50% increase in supplies with the addition of at least one more facility. Securing our supply chain was the first step in our plan to improve the availability of iofocusing. Speaker 400:21:32In addition, we have invested in optimizing production processes, enhancing yield and reducing costs. Exploring alternative production methods has increased flexibility and scalability. These efforts have resulted in a more robust process, improved product quality, increased production capacity and a novel formulation providing a industry leading 17 day shelf life. These developments have also generated new intellectual property and technologies applicable to future radiotherapeutic programs like our Actinium or Alpha emitter program. Our modular production strategy extends to our logistics chain and physician provider network, aiming to provide the most flexible and accessible options for patients and physicians. Speaker 400:22:19While regulatory restrictions by the NRC and FDA dictate where patients can access targeted radiotherapies, we have designed a system to provide broad access. We are committed to working closely with both community focused oncology networks and hospital systems to ensure availability of eye focusing I-one hundred and thirty one for their patients. You can expect to learn more about the strategic approaches during our upcoming June data release and KOL call. I will now turn the call over to Jim for closing remarks. Jim? Speaker 100:22:51Thank you, Jarrett. As you can see, the Q1 of 2024 has been highly productive. In terms of WM, continue to assemble our NDA submission, judiciously construct a talented and highly efficient commercial infrastructure and further refine an already advanced manufacturing infrastructure and distribution model. Of course, we also look forward to sharing our WM pivotal study data in June. I would also like to highlight the utility of our PLE delivery platform as further demonstrated by ongoing internal and collaborative R and D with a variety of oncology payloads, including small molecules, peptides and oligos. Speaker 100:23:40We plan to rapidly advance our lead alpha emitter asset CLR112125 and actinium based phospholipid radio conjugate or PRC into a solid tumor Phase 1 study no later than Q1 of 2,005. And of course, we remain optimistic regarding the potential of ipofacin I-one hundred and thirty one in pediatric high grade gliomas and will provide an update on our Phase Ib study in the second half of twenty twenty four. With that, I would now like to open the call up for our Q and A session. Operator00:24:21Thank you. Ladies and gentlemen, we will now begin the question and answer session. Your first question is from the line of Ahu Demir from Ladenburg Thalmann. Please go ahead. Speaker 500:24:51Good morning, everyone. Thanks for all the color that you provided. A couple of follow-up questions on the commercial side. Can you give us a sense on, number 1, the FDA filing timeline, where you are at and what is the timeline that you are looking at? And number 2 portion of the question is, have you hired any sales members? Speaker 500:25:15What will be the first part that given the commercial effort? And the third part of the question is on the pricing. Could you provide a little bit more color on the pricing? What should we take as a base? Speaker 100:25:28All right. Terrific, Adho. First of all, thank you for your participation in the call today. Very much appreciated. In terms of the regulatory filing timeline, our guidance remains consistent with the second half of this year. Speaker 100:25:42As you know, based on our FDA fast track designation and the market itself and FDA precedent in terms of how they recently treated like assets, we have a high degree of comfort that what we see for 6 month, approximately a 6 month review, sometimes the FDA may go a little bit longer and leak into 7 months or so, but we believe that's a 6 month review and have a high degree of comfort around that. Before prior to transitioning over to Shane to kind of review briefly how selectively we've been approaching the attraction of recruitment and hiring of highly talented commercial I will say that we're being very, very judicious in terms of how we think about the commercial opportunity. And based on the scale of nature of the market, we can be highly targeted and greater detail. And then relative to pricing, we believe we have the opportunity to premium price in this market. There's a number of benchmarks that support that as well as quite frankly our early market research and pricing work. Speaker 100:27:04So with that, I'll turn it over to Shane Speaker 300:27:06for the Speaker 100:27:07Q and A. Speaker 300:27:08Thanks, Jim. I'll address the question around the sales. So as stated earlier, we're leveraging segmentation in our approach. We want to be very smart in terms of a very targeted approach to take advantage of the opportunity. And so we're still in the process of refining and understanding exactly where we're going to target our efforts. Speaker 300:27:31We feel very confident that we're going to be able to place in a highly talented sales team that will be able to drive awareness and eventually trial use and adoption. So again, we feel very, very good about that. Again, all of our decision making is being driven by data, so that it's a very targeted and we're leveraging our efforts most effectively. And we're allowed to do that based on the concentrated nature of this market, which is a unique opportunity. The second thing I'll add just to echo the comments Jim, again, we have orphan drug designation, rare disease like WM is very good for us in terms of optionality around premium pricing, especially with policy provisions that are in place. Speaker 300:28:15We feel confident looking at other analogs in the marketplace, both for continuous therapy and other radiotherapeutics that we'll be able to place a price that will be effective and support high value for the organization. Speaker 100:28:30Yes. And then in terms of your question relative to contract sales organization or the type of commercial model that we would employ, everything is on the table at this particular point in time. We're evaluating the most cost effective and most productive approaches. Typically with a CSO model, you would hire your own leadership internally and then farm out the sales specialist or other radiotherapeutic nuclear radonck specialist via a CSO. We're evaluating the cost associated with both and capacity to drive trial use and adoption with Ibofacin, a variety of different commercial models. Speaker 100:29:23So it will be cost efficient. We will secure the best talent and we're as I mentioned earlier, we're highly comfortable and confident in our capacity to field a highly productive commercial organization. Speaker 500:29:41Thank you for taking my question. Speaker 100:29:44Of course. Thank you. Operator00:29:56Your next question is from the line of Jeff Jones from Oppenheimer. Your line is now open. Speaker 600:30:02Good morning, guys, and thanks for taking the call. One follow-up question on pricing and a couple on the Waldenstrom's trial data. On pricing, you mentioned some of the analogs you're looking at. Could you share perhaps what some of those examples are? And then on the Waldenstrom data that we're anticipating in now in June, What should we be expecting from that update, for example, the number of additional patients will be that you think you're going to share data on? Speaker 600:30:46And also from the prior data set, there were 3 patients with near CRs. Can you comment on what the hurdle is for those to convert and if any of those have converted since the January update. Speaker 100:31:04All right, Jeff. Thank you. Of course. Thank you, Jeff. Again, appreciate your participation in today's call and for the three questions that we'll triage here. Speaker 100:31:16I will say based on the clinical data, and I'll have Andre talk to that initially in terms of what we're going to provide. Speaker 300:31:24At this point, Speaker 100:31:25we are likely not going to provide any color relative to the updated information. But to your point, it will be consistent in terms of that data that we previously shared. And Andre is closer to this than anyone as he consolidates our data at this point in time. So I'll turn it over to Andre to provide his color and thank you. Thank you, Jim. Speaker 100:31:50And Jeff, good morning. Thank you for Speaker 700:31:52your question. We're certainly looking forward to confirming the exciting results we've put in the coalfic domain in January, specifically the rate of responses, overall response, major response, deep responses as well as durability in the form of duration of response. We are determining based on current data cleaning the right timing to do time dependent variable analysis. As you probably recall, we enrolled sizable fraction of patients at the very back end of the study in the 3rd Q4 of 2023. So these patients were some of them treated in 2024. Speaker 700:32:39So to avoid doing very early censoring, we've pushed out the time dependent there on how to like duration of response to the back end of the Q1, but we are planning to update that. So to answer more directly the first part of your question, we will be reporting on response rate, including types of responses and durability of response at the time of our announcement. Speaker 100:33:11So as you recall, Jeff, we had 41 patients that we had reviewed with the top line data. Now we'll have the full enrollment in the mid-fifty range. I can give you color on that. And so it's a significant increase in number of patients. And as I think Andre appropriately mentioned, we'll have a better line of sight, on durability certainly for those patients that were enrolled earlier in the study. Speaker 100:33:42Relative to pricing, we clearly have an opportunity to premium price in this space based on our market research, initial pricing work as well as in discussions with advisory boards built around pharmacy benefit managers from large third party payers. I think it's also fair to say approximately 70% to 75% of these patients will be reimbursed via Medicare. So that gives us a lot of optionality and flexibility well. But looking at pricing benchmarks, I'll turn that over to Shane to provide some color. Speaker 200:34:23Yes. Speaker 300:34:24Thanks, Jim. So as stated earlier, we're also in the process of really drilling into our value messaging and pricing work. But as we're looking at certain pricing analogs, certainly we're looking at a wide range of products, which I think best represents rare disease treatment categorization. So for example, CAR T, AZEDRA for gliochromocytoma, as well as BTKI therapy in WM, looking at its costs from a total cost of care perspective. Speaker 100:35:02Yes. So, Jeff, we believe we can put together a really nice health value message around the pharmacoeconomic kind of story here based on the durability, the 4 limited infusions and then the durability of that treatment, as well as, as you recall, patients will no longer require therapy for an extended period of time, which means no adverse events, unlike other therapies that are continuous, where clinicians share with us, they're constantly it's a constant battle to manage the adverse events associated with some of these products that are taken more consistently. Speaker 600:35:49Great. Really appreciate that additional color, guys. Speaker 100:35:53Our pleasure, Jeff. Thank you. Operator00:35:57Your next question is from the line of Jonathan Aschoff from ROTH. Your line is now open. Speaker 800:36:04Good morning, guys. I guess, hopefully, a lesson to ask is, what can you share about ex U. S. Negotiations? Maybe what those potential partners might be waiting for before getting any more deep into those kind of discussions? Speaker 100:36:23It's a great question, Jonathan. Obviously, there's consistency I will say this, there's consistency among third parties that we are collaborating with on our delivery platform and those that are interested in promoting this product ex U. S. And we're taking both a regional approach as well as a more larger kind of global approach to this. And so I'll turn it over to Jared, who's been our providing oversight leadership in this area. Speaker 400:37:00Yes. Hi, Jonathan. What I would say is, we continue to advance those dialogues. We're in deep discussions with a number of parties in different regions, as Jim alluded to. And we continue to evaluate additional regional partnerships for certain components. Speaker 400:37:16And then as Jim said, we also are engaged in dialogues with folks that are, what I'd say is more, well, global sort of strategy. So we are consistently advancing both in parallel, advancing both lines of thinking and both opportunities and trying our best not to let one run too far in advance of the other. Speaker 800:37:42And can you tell me if you're getting any from the clawback provisions that you had said that you insisted would be doable at a low price for you? Do they not want those at all or at the kind of limited premium that we acquired that you mentioned earlier? Speaker 400:38:01Yes. If I'm following where your question is going, yes. If we do a partnership for a particular region, yes, we were we are incorporating into those the ability to pull back the asset if we were to structure a larger, broader deal with certain, obviously, premiums on investment by the partner. Okay. Speaker 800:38:23And then although you were asked twice before on this call about pricing, did you or did you not list any specific drugs that you were comparing yourself to when you used the word premium pricing? Speaker 100:38:39I believe we stated the CAR T. Speaker 300:38:42Yes, yes. I think so. As stated mentioned the various CAR T therapies, a range of different analogs that we're looking at for these treatments. AZEDRA is another one for pheochromocytoma is one which we're looking at. And as mentioned before, with earnings calls previous, we're looking also at BTKI therapy, the total cost of care for these continuous therapies. Speaker 100:39:11Yes. So BTKI is typically, let's just say approximately $1,000,000 I think AZEDRA was $600,000 and then your CAR Ts are pretty much between that range. Operator00:39:34At this time, there are no further questions in the queue. I will now turn the call over to Jim Caruso for closing remarks. Please go ahead. Speaker 100:39:43Okay. Thank you, operator. Certainly, we'd like to thank everyone for joining us today. Appreciate the questions, and we look forward to speaking with you in the near term. Thanks again. Speaker 100:39:53Have a good day. Operator00:39:55Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallCellectar Biosciences Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Cellectar Biosciences Earnings HeadlinesCellectar Biosciences (NASDAQ:CLRB) Shares Cross Below Two Hundred Day Moving Average - Here's What HappenedApril 19 at 3:43 AM | americanbankingnews.comCellectar Biosciences (NASDAQ:CLRB) Coverage Initiated at StockNews.comApril 13, 2025 | americanbankingnews.comReal Americans Don’t Wait on Wall Street’s Next MoveWhat's happening in the markets right now should concern every freedom-loving American who's worked hard and saved smart. Your 401(k) doesn't deserve to be dragged through the mud by tariffs, trade wars, reckless spending, and political standoffs. And you don't have to stand by while Wall Street plays roulette with your future.April 19, 2025 | Premier Gold Co (Ad)Reviewing Sarepta Therapeutics (NASDAQ:SRPT) & Cellectar Biosciences (NASDAQ:CLRB)April 12, 2025 | americanbankingnews.comCellectar Biosciences Inc. (CLRB) Q4 2024 Earnings Call TranscriptMarch 15, 2025 | seekingalpha.comOppenheimer Keeps Their Hold Rating on Cellectar Biosciences (CLRB)March 14, 2025 | markets.businessinsider.comSee More Cellectar Biosciences Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Cellectar Biosciences? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Cellectar Biosciences and other key companies, straight to your email. Email Address About Cellectar BiosciencesCellectar Biosciences (NASDAQ:CLRB), a clinical biopharmaceutical company, focuses on the discovery, development, and commercialization of drugs for the treatment of cancer. Its lead phospholipid drug conjugate (PDC) candidate is CLR 131 (iopofosine I-131), which is in Phase 2 clinical study for patients with B-cell malignancies; Phase 2a clinical study for patients with relapsed or refractory (r/r) Waldenstrom's macroglobulinemia cohort, r/r multiple myeloma (MM) cohort, and r/r non-Hodgkin's lymphoma cohort; Phase 1 clinical study for r/r pediatric patients with select solid tumors, lymphomas, and malignant brain tumors; and Phase 1 clinical study for r/r head and neck cancer. The company also develops CLR 1900, a PDC chemotherapeutic program that is in the preclinical development stage to treat solid tumors. It has collaborative with Orano Med to develop CLR 12120 Series; and LegoChemBio. The company was founded in 2002 and is headquartered in Florham Park, New Jersey.View Cellectar Biosciences ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Archer Aviation Unveils NYC Network Ahead of Key Earnings Report3 Reasons to Like the Look of Amazon Ahead of EarningsTesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? 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There are 9 speakers on the call. Operator00:00:00Good morning, and welcome to Selector Biosciences 2024 Year End Earnings Call. Today's call is being recorded. Before we begin, I would like to remind everyone that statements made during this call relating to Selector's expected future performance, future business prospects or future events or plans are forward looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties that could differ materially from those forecast due to the impact of many factors beyond the company, the control of Selector. The company assumes no obligation to update or supplement any forward looking statements whether as a result of new information, future events or otherwise. Operator00:00:51Participants are directed to the cautionary notes set forth in today's press release, which is available on the Investor Relations portion of the company's website as well as the risk factors set forth in Selector's annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward looking statements. At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Selector. Mr. Caruso, please go ahead. Speaker 100:01:24Thank you, operator, and good morning, everyone. It is my pleasure to be here with you to report our Q1 results and provide a corporate update. With me today are Doctor. Andrey Shustoff, Senior Vice President, Medical Jared Vancourt, Chief Operating Officer Shane Leah, Chief Commercial Officer and Chad Killeen, our Chief Financial Officer. As you know, we recently completed our 2023 annual earnings call in which we reviewed a highly productive year for the company, including the announcement of detailed top line data from our WM pivotal study and reiterated guidance for a data update in Q2. Speaker 100:02:08I'm pleased to report that we remain on track for a Q2 data announcement for the fully enrolled study patient population. We plan to press release this data in June and review in greater detail on a key opinion leader call scheduled for the same day. We look forward to sharing the study data and the subsequent KOL call. Currently, we are in process of completing our NDA 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 would expect a 6 month review period from the date of the NDA submission. Speaker 100:02:55The focus of today's earnings call is to have a more in-depth commercial discussion regarding the attractiveness of the WM market, including the existing high unmet need, the lack of competitive investment and scalable nature, among other factors, all likely to facilitate rapid capture of iapofacine I-one hundred and thirty one market share. In addition, we will review our efficient and cost effective product manufacturing infrastructure and distribution plan in preparation for the potential marketing of our lead radiotherapeutic. To further orient you to today's agenda, I will provide a brief overview of the meaningful accomplishments of the company over the past Q1. I will then transition the call to Chad to discuss our financial results. Shane will review the commercial topics followed by Jared's manufacturing and distribution network update. Speaker 100:03:54We will then open the call for queue and day. As you are likely aware and as I have previously stated, it is an exciting time for companies with radiotherapeutic pipelines and those few companies with late stage and or near term approvable assets. With the next radiotherapeutic approval potentially ipoficine I-one hundred and thirty one along with our unique PLA delivery platform providing a differentiated radioisotope offering or offerings, including alpha emitting agents, we are confident in our position and excited about the future of Selectar. With that as background, I will now provide an overview of our key Q1 accomplishments. Of course, we announced positive top line data in the CLOVER WAM pivotal study, evaluating iapopacin I-one hundred and thirty one for the treatment of relapsedrefractory Waldenstrom's macroglobulemia and as cited, we'll provide the data update on full patient enrollment in June. Speaker 100:04:58As part of a private placement of up to $103,000,000 the company received approximately $44,000,000 in January with the potential to secure another $34,000,000 in warrants available for conversion at a $4.77 strike price upon approval of our WM NDA. Importantly, to support launch preparation and the potential marketing by pofuscene, we announced another strategic partnership with Aon or the American Oncology Network, a physician led community based cutting edge oncology platform that is currently managing the treatment of approximately 650 WM patients. The partnership's objective is to collectively advance the treatment of WM in the community setting through a better understanding of the WM landscape and to ensure patient access to iapofacine I-one hundred and thirty one for the many communities that AAON serves. Announced promising preclinical data for 3 unique internally developed alpha emitters, including our proprietary novel alpha emitting phospholipid therapeutic conjugate, CLR-one hundred and twenty one-two fifty five and actinium labeled phospholipid ether in pancreatic cancer models. We are evaluating CLR-one hundred and twenty one-two twenty five in additional preclinical models such as ovarian and triple negative breast cancer and plan to initiate a Phase I study in one of these solid tumor cancers no later than Q1 2025. Speaker 100:06:40Reported a complete central nervous system clearance in relapsedrefractory Waldenstrom's macroglobulemia, providing further validation for iofofacin I-one hundred and thirty one to treat solid and hematologic tumors, including those located across the blood brain barrier initiated and enrolled the first patient in our Phase Ib clinical study biopofacin I-one hundred and thirty one in pediatric high grade gliomas or PHGG. Based on investigator excitement and iapofacine's demonstrated activity in solid tumors across the blood brain barrier, we are excited about the value iapofacine may provide in this treatment setting, one in which patients are restricted to few treatment options. As previously announced, we look forward to providing an update on this study in the second half of twenty twenty four. Reported a high rate of complete remission in an investigator initiated Phase I study of Ibuprofen in combination with external beam radiotherapy in another challenging solid tumor, recurrent head and neck cancer. The complete remission rate was 64%, and overall response rate was 73% in a highly refractory patient population. Speaker 100:08:03Durability of clinical activity was also impressive, achieving 67% overall survival and 42% progression free survival at 1 year. Let me now turn the call over to Chad to review the company's financials. Speaker 200:08:21Thank you, Jim. Our cash and cash equivalents balance as of March 31, 2024 was $40,000,000 compared to $9,600,000 as of December 31, 2023. The exercise of the tranche A warrants from the September 2023 financing combined with the exercise of 547,000 warrants issued in October 2022 generated net proceeds of 43,900,000 dollars Net cash used in operating activities during the quarter was approximately $13,400,000 Company believes its cash on hand is adequate to fund budgeted operations into the Q4 of 2024. R and D expense for the quarter was approximately $7,400,000 compared to $6,700,000 in the Q1 of 2023. As we continue our preparations for an expected product launch for IPL-one hundred and thirty one in 2025, the company has invested extensively to ensure that we have the ability to deliver product in the event of a disruption in one of our suppliers, which we have solutioned by the establishment of a multi source supply chain that has redundancies at every step from radioisotope suppliers to material producers and final conjugated product providers. Speaker 200:09:43Those costs were partially offset by reduced spending related to our pivotal trial AWML that we have completed trial enrollment. G and A expense for the Q1 of 2024 was $4,600,000 as compared to $2,100,000 last year for the same period. The substantial increase in G and A is also primarily driven by the expectation of a product launch in 2025. With the development of the infrastructure and information necessary to support a fully commercialized product including personnel and marketing costs. There is a $9,900,000 non cash charge that relates to the impact of the accounting for the warrants on the P and L. Speaker 200:10:30The accounting rules for the warrants requires the company to revalue them at every reporting date. Also upon settlement, the tranche A warrants that were exercised in the quarter were required to be revalued as of that settlement date. The value was determined to be $4,800,000 which represents the intrinsic value of the warrants at the time of exercise. The difference between the stated preferred conversion price to common of $3.185 $3.185 and the price of the stock at the time. This is booked as an expense and then that amount is immediately reclassified to equity as is shown in the statement of stockholders equity in the 10 Q we just filed this morning. Speaker 200:11:16In addition to the impact of the settlement of the tranche A warrants, the remaining tranche B warrants were revalued as of the end of the period, which resulted in an increase to the liability of $5,100,000 This expense is primarily driven by the increase in the stock price. Combined, these two components composed the loss on valuation of warrants on the P and L. The net loss attributable to common stockholders for the quarter ended March 31, 2024 was $21,400,000 or $0.74 per share compared to $8,600,000 or $0.76 per share last year. With that, I will now turn the call over to Shane Lee for a commercial overview. Shane? Speaker 300:12:07Thank you, Chad. Commercial team is advancing our preparation for potential commercial launch of iapofacine and WM. Importantly, we continue to execute and make progress supporting our commercial strategy for Ibupofacin, the goal of ensuring a successful launch upon FDA approval. We are very encouraged by the findings from our most recent research projects, which included an evaluation of iofofacene's product profile, an evaluation of WM patient journey and segmentation research with radiation oncologists and nuclear medicine physicians. Biofofacene's product profile for WM was given exceptionally high rate for intent to prescribe with hematologists. Speaker 300:12:48Key findings from our patient journey work also show patient active participation in treatment choice and important treatment drivers, which includes a need for new options and fixed therapy. We have also engaged radiation oncologists and nuclear medicine physicians since they are key stakeholders for radiotherapy utilization. The radiation oncologist and nuclear medicine physicians review of iofofacene's profile was very positive. They were enthusiastic with iofofacene's simplicity of use versus existing radiotherapeutics. Iofacene's features such as no required dosimetry, short infusion time, long storage life and ease of administration were regarded as significant differentiators by this key stakeholder group. Speaker 300:13:36Interactions with these key stakeholders further supports our belief that iofofacene is a best in class next generation radiotherapeutic that if approved will secure significant utilization in both the hospital and community outpatient setting. We are selectively building a successful and experienced commercial team that will support the framework for our go to market model in WM with a goal of establishing market leadership. We will be utilizing claims data to drive decision making will support radiotherapy site activation, brand awareness and ensure that the first treatment experience with iofocusing is the right experience for both patient and provider. We have initiated additional market research projects that will further support product positioning, value payer messaging and pricing strategy. We continue to build out data capabilities to further understand the WM market supporting a highly efficient and cost effective commercial model. Speaker 300:14:35We believe WM is a very attractive market with no real market leadership, is a concentrated market with a high unmet need, limited competition and provides an opportunity to capture significant share with active promotion utilizing FDA approval. Turning to slide 3. Our 3rd party claims and FDA data show the total USWM market to be approximately $2,100,000,000 with the current relapsed refractory market valued at $1,000,000,000 iofofacin has 2 very compelling opportunities to capture patient share, assuming marketing approval. The first opportunity to capture patient share exists in the current lapse refractory market, which is burdened by high unmet need. Nearly 50% of patients in the 3rd line or greater setting are retreated with the same or simpler treatment from an earlier line due to lack of options. Speaker 300:15:28Greater than 60% of these therapies are not FDA approved and cannot be promoted. Iofofacin can be readily positioned to capture share in the existing relapsed refractory market. 2nd, we believe the 3rd line or greater market, which is approximately 4,700 patients could expand to 5,700 patients. This is the second opportunity for iapofacine. Approximately 1,000 patients have exhausted the prevalent treatment options. Speaker 300:15:55As a result, patients remain either ineligible or intolerant of current market treatments. This market expansion opportunity could allow fast patient capture by our focusing as a novel WM treatment. On Slide 4, our claims data demonstrate there is no established standard of care in WM. As previously stated, greater than 60% of patients receive non FDA approved drugs and over half, 52 percent of patients who receive a BTKI in the second line are rechallenged a BTKI, again, as third line therapy. This is mainly a function of limited treatment options in the relapsedrefractory setting, as there has been no FDA approved new mechanism of action in nearly a decade. Speaker 300:16:39Iofofacene with its novel mechanism of action and strong clinical profile along with CELLECTVAR's active promotion of iofofacene can capture significant share in this market. Slide 5, market claims data confirms and significant recycling of existing therapies. According to claims data, 10% of third line patients received the chemotherapeutic drug bendamustine and approximately 40% of these patients are re challenged with that chemotherapy in later lives. Approximately 1600 patients receive rituximab in the 3rd line or greater setting and more than 50% are retreated with rituximab after prior exposure. There is only one class of approved drugs and only 2 FDA approved therapies in this class, which includes ibrutinib and zanubrutinib. Speaker 300:17:293rd party claims data also validates approximately 50% of BTKI patients retry BTKIs in the 3rd line or greater segment. As previously stated, nearly 50% of 4,700 patients in the 3rd line or greater setting have been retreated after prior exposure to that same therapy. The consistent recycling of therapies is due to the lack of treatment options. Market characteristics for existing therapies underscores the unmet need and nearly all are not actively promoted. According to market research, WMP opinion leadership and treaters expressing need for a novel mechanism of action, fixed course of therapy and better efficacy outcomes. Speaker 300:18:11We believe can cost over $1,000,000 This provides significant optionality for iapofacin premium pricing. As noted earlier, we have initiated our pricing work that will provide the optimal recommended price. Lastly, Slide 6 is a high level illustration of our approach to execution. The WM market is highly concentrated with approximately 80% of diagnosed patients in 15 states. 75% of second line or greater patients are treated in only 199 accounts. Speaker 300:18:51This concentrated nature of the market supports a commercial strategy that will leverage geographic and account segmentation to optimize share of voice with the right customer at the right time to drive awareness and quickly capture patient share. In conclusion, our commercial planning efforts are advancing with the objective of executing a successful launch and establishing ipofacene as a market share leader in WM. We look forward to providing additional updates. I will now turn the call over to Jared Loncore to highlight our manufacturing and distribution. Jared? Speaker 400:19:24Thank you, Shane. Historically targeted radiotherapeutics have faced significant supply and manufacturing challenges, primarily due to limited finished product manufacturing locations, constrained availability of isotopes, the isotope half life and limited shelf life of the finished product, resulting in manufacturing and patient treatment bottlenecks. Additionally, targeted radiotherapies have been expensive to manufacture with significant challenges and scalability to match market demand. At Selector, we've implemented multiple strategies to avoid many, if not all of these pitfalls. Unlike other models, we've adopted a flexible modular manufacturing strategy. Speaker 400:20:02This approach offers scalability and addresses various challenges in traditional manufacturing methods. Instead of relying on a single select our operated manufacturing facility, our modular approach utilizes a network of overlapping suppliers and contractors. This tactic reduces the overall footprint operating cost of 1 or multiple manufacturing facilities, significantly lowering fixed capital expenditure. Furthermore, by validating multiple suppliers for every component of our product, we have mitigated issues related to constrained source of isotope, the targeting ligands and limited finished product manufacturing capabilities. Our modular approach enables rapid increases in supply to meet market demands. Speaker 400:20:48Currently, we can supply over 200 doses per week of iofocusing I-one hundred and thirty one with the capability to quickly scale up to over 1,000 patient doses per week without expanding our existing infrastructure. This means we can effectively serve the needs of nearly 20,000 patients per year without additional investment. Additionally, our modular supply chain allows for further expansion of the market as the market grows. With capacity to nearly double current supply and plans in place for over a 50% increase in supplies with the addition of at least one more facility. Securing our supply chain was the first step in our plan to improve the availability of iofocusing. Speaker 400:21:32In addition, we have invested in optimizing production processes, enhancing yield and reducing costs. Exploring alternative production methods has increased flexibility and scalability. These efforts have resulted in a more robust process, improved product quality, increased production capacity and a novel formulation providing a industry leading 17 day shelf life. These developments have also generated new intellectual property and technologies applicable to future radiotherapeutic programs like our Actinium or Alpha emitter program. Our modular production strategy extends to our logistics chain and physician provider network, aiming to provide the most flexible and accessible options for patients and physicians. Speaker 400:22:19While regulatory restrictions by the NRC and FDA dictate where patients can access targeted radiotherapies, we have designed a system to provide broad access. We are committed to working closely with both community focused oncology networks and hospital systems to ensure availability of eye focusing I-one hundred and thirty one for their patients. You can expect to learn more about the strategic approaches during our upcoming June data release and KOL call. I will now turn the call over to Jim for closing remarks. Jim? Speaker 100:22:51Thank you, Jarrett. As you can see, the Q1 of 2024 has been highly productive. In terms of WM, continue to assemble our NDA submission, judiciously construct a talented and highly efficient commercial infrastructure and further refine an already advanced manufacturing infrastructure and distribution model. Of course, we also look forward to sharing our WM pivotal study data in June. I would also like to highlight the utility of our PLE delivery platform as further demonstrated by ongoing internal and collaborative R and D with a variety of oncology payloads, including small molecules, peptides and oligos. Speaker 100:23:40We plan to rapidly advance our lead alpha emitter asset CLR112125 and actinium based phospholipid radio conjugate or PRC into a solid tumor Phase 1 study no later than Q1 of 2,005. And of course, we remain optimistic regarding the potential of ipofacin I-one hundred and thirty one in pediatric high grade gliomas and will provide an update on our Phase Ib study in the second half of twenty twenty four. With that, I would now like to open the call up for our Q and A session. Operator00:24:21Thank you. Ladies and gentlemen, we will now begin the question and answer session. Your first question is from the line of Ahu Demir from Ladenburg Thalmann. Please go ahead. Speaker 500:24:51Good morning, everyone. Thanks for all the color that you provided. A couple of follow-up questions on the commercial side. Can you give us a sense on, number 1, the FDA filing timeline, where you are at and what is the timeline that you are looking at? And number 2 portion of the question is, have you hired any sales members? Speaker 500:25:15What will be the first part that given the commercial effort? And the third part of the question is on the pricing. Could you provide a little bit more color on the pricing? What should we take as a base? Speaker 100:25:28All right. Terrific, Adho. First of all, thank you for your participation in the call today. Very much appreciated. In terms of the regulatory filing timeline, our guidance remains consistent with the second half of this year. Speaker 100:25:42As you know, based on our FDA fast track designation and the market itself and FDA precedent in terms of how they recently treated like assets, we have a high degree of comfort that what we see for 6 month, approximately a 6 month review, sometimes the FDA may go a little bit longer and leak into 7 months or so, but we believe that's a 6 month review and have a high degree of comfort around that. Before prior to transitioning over to Shane to kind of review briefly how selectively we've been approaching the attraction of recruitment and hiring of highly talented commercial I will say that we're being very, very judicious in terms of how we think about the commercial opportunity. And based on the scale of nature of the market, we can be highly targeted and greater detail. And then relative to pricing, we believe we have the opportunity to premium price in this market. There's a number of benchmarks that support that as well as quite frankly our early market research and pricing work. Speaker 100:27:04So with that, I'll turn it over to Shane Speaker 300:27:06for the Speaker 100:27:07Q and A. Speaker 300:27:08Thanks, Jim. I'll address the question around the sales. So as stated earlier, we're leveraging segmentation in our approach. We want to be very smart in terms of a very targeted approach to take advantage of the opportunity. And so we're still in the process of refining and understanding exactly where we're going to target our efforts. Speaker 300:27:31We feel very confident that we're going to be able to place in a highly talented sales team that will be able to drive awareness and eventually trial use and adoption. So again, we feel very, very good about that. Again, all of our decision making is being driven by data, so that it's a very targeted and we're leveraging our efforts most effectively. And we're allowed to do that based on the concentrated nature of this market, which is a unique opportunity. The second thing I'll add just to echo the comments Jim, again, we have orphan drug designation, rare disease like WM is very good for us in terms of optionality around premium pricing, especially with policy provisions that are in place. Speaker 300:28:15We feel confident looking at other analogs in the marketplace, both for continuous therapy and other radiotherapeutics that we'll be able to place a price that will be effective and support high value for the organization. Speaker 100:28:30Yes. And then in terms of your question relative to contract sales organization or the type of commercial model that we would employ, everything is on the table at this particular point in time. We're evaluating the most cost effective and most productive approaches. Typically with a CSO model, you would hire your own leadership internally and then farm out the sales specialist or other radiotherapeutic nuclear radonck specialist via a CSO. We're evaluating the cost associated with both and capacity to drive trial use and adoption with Ibofacin, a variety of different commercial models. Speaker 100:29:23So it will be cost efficient. We will secure the best talent and we're as I mentioned earlier, we're highly comfortable and confident in our capacity to field a highly productive commercial organization. Speaker 500:29:41Thank you for taking my question. Speaker 100:29:44Of course. Thank you. Operator00:29:56Your next question is from the line of Jeff Jones from Oppenheimer. Your line is now open. Speaker 600:30:02Good morning, guys, and thanks for taking the call. One follow-up question on pricing and a couple on the Waldenstrom's trial data. On pricing, you mentioned some of the analogs you're looking at. Could you share perhaps what some of those examples are? And then on the Waldenstrom data that we're anticipating in now in June, What should we be expecting from that update, for example, the number of additional patients will be that you think you're going to share data on? Speaker 600:30:46And also from the prior data set, there were 3 patients with near CRs. Can you comment on what the hurdle is for those to convert and if any of those have converted since the January update. Speaker 100:31:04All right, Jeff. Thank you. Of course. Thank you, Jeff. Again, appreciate your participation in today's call and for the three questions that we'll triage here. Speaker 100:31:16I will say based on the clinical data, and I'll have Andre talk to that initially in terms of what we're going to provide. Speaker 300:31:24At this point, Speaker 100:31:25we are likely not going to provide any color relative to the updated information. But to your point, it will be consistent in terms of that data that we previously shared. And Andre is closer to this than anyone as he consolidates our data at this point in time. So I'll turn it over to Andre to provide his color and thank you. Thank you, Jim. Speaker 100:31:50And Jeff, good morning. Thank you for Speaker 700:31:52your question. We're certainly looking forward to confirming the exciting results we've put in the coalfic domain in January, specifically the rate of responses, overall response, major response, deep responses as well as durability in the form of duration of response. We are determining based on current data cleaning the right timing to do time dependent variable analysis. As you probably recall, we enrolled sizable fraction of patients at the very back end of the study in the 3rd Q4 of 2023. So these patients were some of them treated in 2024. Speaker 700:32:39So to avoid doing very early censoring, we've pushed out the time dependent there on how to like duration of response to the back end of the Q1, but we are planning to update that. So to answer more directly the first part of your question, we will be reporting on response rate, including types of responses and durability of response at the time of our announcement. Speaker 100:33:11So as you recall, Jeff, we had 41 patients that we had reviewed with the top line data. Now we'll have the full enrollment in the mid-fifty range. I can give you color on that. And so it's a significant increase in number of patients. And as I think Andre appropriately mentioned, we'll have a better line of sight, on durability certainly for those patients that were enrolled earlier in the study. Speaker 100:33:42Relative to pricing, we clearly have an opportunity to premium price in this space based on our market research, initial pricing work as well as in discussions with advisory boards built around pharmacy benefit managers from large third party payers. I think it's also fair to say approximately 70% to 75% of these patients will be reimbursed via Medicare. So that gives us a lot of optionality and flexibility well. But looking at pricing benchmarks, I'll turn that over to Shane to provide some color. Speaker 200:34:23Yes. Speaker 300:34:24Thanks, Jim. So as stated earlier, we're also in the process of really drilling into our value messaging and pricing work. But as we're looking at certain pricing analogs, certainly we're looking at a wide range of products, which I think best represents rare disease treatment categorization. So for example, CAR T, AZEDRA for gliochromocytoma, as well as BTKI therapy in WM, looking at its costs from a total cost of care perspective. Speaker 100:35:02Yes. So, Jeff, we believe we can put together a really nice health value message around the pharmacoeconomic kind of story here based on the durability, the 4 limited infusions and then the durability of that treatment, as well as, as you recall, patients will no longer require therapy for an extended period of time, which means no adverse events, unlike other therapies that are continuous, where clinicians share with us, they're constantly it's a constant battle to manage the adverse events associated with some of these products that are taken more consistently. Speaker 600:35:49Great. Really appreciate that additional color, guys. Speaker 100:35:53Our pleasure, Jeff. Thank you. Operator00:35:57Your next question is from the line of Jonathan Aschoff from ROTH. Your line is now open. Speaker 800:36:04Good morning, guys. I guess, hopefully, a lesson to ask is, what can you share about ex U. S. Negotiations? Maybe what those potential partners might be waiting for before getting any more deep into those kind of discussions? Speaker 100:36:23It's a great question, Jonathan. Obviously, there's consistency I will say this, there's consistency among third parties that we are collaborating with on our delivery platform and those that are interested in promoting this product ex U. S. And we're taking both a regional approach as well as a more larger kind of global approach to this. And so I'll turn it over to Jared, who's been our providing oversight leadership in this area. Speaker 400:37:00Yes. Hi, Jonathan. What I would say is, we continue to advance those dialogues. We're in deep discussions with a number of parties in different regions, as Jim alluded to. And we continue to evaluate additional regional partnerships for certain components. Speaker 400:37:16And then as Jim said, we also are engaged in dialogues with folks that are, what I'd say is more, well, global sort of strategy. So we are consistently advancing both in parallel, advancing both lines of thinking and both opportunities and trying our best not to let one run too far in advance of the other. Speaker 800:37:42And can you tell me if you're getting any from the clawback provisions that you had said that you insisted would be doable at a low price for you? Do they not want those at all or at the kind of limited premium that we acquired that you mentioned earlier? Speaker 400:38:01Yes. If I'm following where your question is going, yes. If we do a partnership for a particular region, yes, we were we are incorporating into those the ability to pull back the asset if we were to structure a larger, broader deal with certain, obviously, premiums on investment by the partner. Okay. Speaker 800:38:23And then although you were asked twice before on this call about pricing, did you or did you not list any specific drugs that you were comparing yourself to when you used the word premium pricing? Speaker 100:38:39I believe we stated the CAR T. Speaker 300:38:42Yes, yes. I think so. As stated mentioned the various CAR T therapies, a range of different analogs that we're looking at for these treatments. AZEDRA is another one for pheochromocytoma is one which we're looking at. And as mentioned before, with earnings calls previous, we're looking also at BTKI therapy, the total cost of care for these continuous therapies. Speaker 100:39:11Yes. So BTKI is typically, let's just say approximately $1,000,000 I think AZEDRA was $600,000 and then your CAR Ts are pretty much between that range. Operator00:39:34At this time, there are no further questions in the queue. I will now turn the call over to Jim Caruso for closing remarks. Please go ahead. Speaker 100:39:43Okay. Thank you, operator. Certainly, we'd like to thank everyone for joining us today. Appreciate the questions, and we look forward to speaking with you in the near term. Thanks again. Speaker 100:39:53Have a good day. Operator00:39:55Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.Read morePowered by