NASDAQ:CLRB Cellectar Biosciences Q2 2026 Earnings Report $2.58 +0.10 (+3.87%) As of 10:46 AM Eastern This is a fair market value price provided by Massive. Learn more. ProfileEarnings HistoryForecast Cellectar Biosciences EPS ResultsActual EPS-$0.57Consensus EPS -$0.59Beat/MissBeat by +$0.02One Year Ago EPSN/ACellectar Biosciences Revenue ResultsActual RevenueN/AExpected Revenue$12.00 millionBeat/MissN/AYoY Revenue GrowthN/ACellectar Biosciences Announcement DetailsQuarterQ2 2026Date8/13/2026TimeBefore Market OpensConference Call DateThursday, August 13, 2026Conference Call Time8:30AM ETUpcoming EarningsCellectar Biosciences' Q3 2026 earnings is estimated for Thursday, October 29, 2026, based on past reporting schedulesConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Cellectar Biosciences Q2 2026 Earnings Call TranscriptProvided by QuartrAugust 13, 2026ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: Cellectar reported encouraging 12-month CLOVER-WaM results for iopofosine I-131, including a 62% major response rate, 17.8-month median duration of response, and deeper responses over time in heavily pretreated Waldenström macroglobulinemia patients. Positive Sentiment: Site activation has begun for the planned Phase III confirmatory study, with first patient enrollment expected in late 2026 or early 2027 and an accelerated-approval submission targeted for March–April 2027, subject to having sufficient sites and enrollment underway. Positive Sentiment: The company’s $35 million upfront financing, with up to $105 million in milestone-linked proceeds, increased cash and equivalents to approximately $34 million and is intended to fund the WM program through potential commercialization. Neutral Sentiment: Cellectar is expanding beyond WM through its phospholipid drug-conjugate platform, including the Phase Ib CLR 125 program in triple-negative breast cancer and earlier-stage alpha-emitting CLR 225; initial CLR 125 dosimetry, safety, and efficacy data are expected later this year or early next year. Negative Sentiment: Second-quarter R&D expenses rose to $4.6 million from $2.4 million year over year, while the company recorded a $6.9 million net loss; future funding also depends partly on warrant exercises tied to clinical and regulatory milestones and stock-price conditions. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCellectar Biosciences Q2 202600:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good morning, ladies and gentlemen. Thank you for standing by, and welcome. At this time, all participants are in listen-only mode, and following the presentation, we will conduct a question-and-answer session. Please be advised that today's call may be recorded. I would now like to hand the call over to Anne Marie Fields, Managing Director of Precision AQ. Please go ahead. Anne Marie FieldsManaging Director at Precision AQ00:00:23Thank you, operator. Good morning, and welcome to Cellectar Biosciences' second quarter 2026 financial results and business update conference call. Joining us today from Cellectar are James Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Kolean, CFO, for a financial review of the quarter. Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Cellectar issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of Cellectar's corporate website. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Anne Marie FieldsManaging Director at Precision AQ00:01:14Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 13, 2026. The company undertakes no obligation to revise or update any firm forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line to your questions. I'll now turn the call over to James Caruso. Jim? James CarusoPresident and CEO at Cellectar Biosciences00:01:59Thank you, Anne Marie, and thank you all for joining us this morning. The second quarter marked an especially productive period for Cellectar as we continued making meaningful progress across every area of our business, including clinical development, regulatory action, pipeline advancement, platform expansion, and strengthening of our financials. Our near-term priority remains clear. Advancing iopofosine I-131 for patients with relaxed or refractory Waldenström macroglobulinemia, or WM. Particularly those patients whose disease has progressed following earlier lines of treatment, including BTK inhibitor therapy. We believe this represents a significant unmet medical need and an attractive opportunity to bring a differentiated treatment option to patients who currently face limited therapeutic alternatives. During the quarter, we took several important steps to move this strategy forward. First, we reported the full 12-month follow-up results from the CLOVER WaM study. James CarusoPresident and CEO at Cellectar Biosciences00:03:12These data further reinforced both the depth and durability of response achieved with iopofosine and demonstrated that the study successfully met both its primary and secondary endpoints. Taken together, we believe the totality of evidence generated to date continues to support iopofosine's potential to become an important treatment option for WM patients. Second, we continued to build an increasingly compelling clinical data set for iopofosine. We presented new data at ASCO 2026 from the CLOVER WaM study highlighting outcomes in patients treated immediately following BTKI therapy, a challenging patient population. These results demonstrated a 79.2% major response rate, an 87.5% overall response rate, a 100% clinical benefit rate, and encouraging durability with a median duration of response of 16 months. Most importantly, we have now initiated site activation activities for our planned confirmatory phase III study. James CarusoPresident and CEO at Cellectar Biosciences00:04:34This represents a critical milestone in our regulatory strategy. Once necessary site activation and ongoing patient enrollment is achieved, we expect to be in a position to submit our new drug application under the FDA's Accelerated Approval Program in mid-2027. Based upon the breakthrough designation awarded to iopofosine I-131 for relapsed refractory WM, an approximate six-month review is anticipated. To support these efforts, we were pleased to complete an oversubscribed financing in May that has the potential to provide up to $140 million in capital, including $35 million upfront and up to $105 million tied to future milestones. This financing significantly strengthens our balance sheet and provides the resources needed to execute our WM strategy, advance our regulatory initiatives, and continue investing in our broader radiopharmaceutical pipeline. James CarusoPresident and CEO at Cellectar Biosciences00:05:51Beyond WM, we continue to advance the broader opportunity represented by our Phospholipid Drug Conjugate or PDC platform. The PDC platform is a highly differentiated targeting technology designed to selectively deliver therapeutic payloads to cancer cells, including primary tumors, metastatic lesions, and cancer stem cells. Importantly, the platform is highly versatile and can be combined with a variety of payloads and isotopes, including beta-emitting, Auger-emitting, and alpha-emitting radiotherapeutics. We believe the success we are seeing with iopofosine is validating the platform and creating a strong foundation for future pipeline expansion. Today, in addition to discussing our progress with iopofosine, we will also review advancements in CLR 125, our Auger-emitting program in solid tumors, and discuss how we plan to leverage the platform to build a next-generation radiopharmaceutical franchise. With that overview, I'll turn the call over to Chad for the financial review. Chad KoleanCFO at Cellectar Biosciences00:07:14Thank you, Jim, and good morning, everyone. First, I will spend a couple of minutes on the financing that Jim mentioned. As he stated, the transaction provided the company with the current and anticipated future funding to support our strategy to obtain approval for iopofosine I-131. The company received $35 million gross upfront, or approximately $31.7 million net, for common shares and pre-funded warrants. Additionally, we issued three tranches of approximately 13.2 million warrants each, all of which are currently exercisable with a strike price of $2.65. Chad KoleanCFO at Cellectar Biosciences00:07:56Furthermore, these warrants are callable for cash by the company if the respective milestone and related criteria are met. Each tranche of warrants, A, B, and C, has a milestone associated with it. The tranche A warrants, which expire on July 7, 2027, have a milestone of first patient enrolled in the confirmatory study for iopofosine I-131 in Waldenström macroglobulinemia, or WM, patients. Chad KoleanCFO at Cellectar Biosciences00:08:25The tranche B warrants, which expire July 7, 2028, have the milestone of the FDA's acceptance of a new drug application for iopofosine. The tranche C warrants, which expire July 7, 2031, have the milestone of approval by the FDA of iopofosine for marketing. In addition to achieving the milestones, two additional criteria must be met for the warrants to be callable. First, the volume-weighted average price, or VWAP, for the company stock must be at least $3.45 for 20 consecutive trading days. Second, the trading liquidity based upon the VWAP must average a minimum of $500,000 for those same 20 trading days. The milestone timing is designed to provide the necessary funding through the anticipated study initiation, submission to FDA, and approval. We believe this structure, provided it occurs as designed, supports the company's capital needs through initial commercialization of iopofosine. Chad KoleanCFO at Cellectar Biosciences00:09:38Now for our financial results for the period ended June 30, 2026. We ended the second quarter with cash and cash equivalents of approximately $34.0 million, compared to $13.2 million as of December 31, 2025, which reflects the cash generated from the initial portion of the May financing. Turning now to our operating results. Research and development expenses for the three months ended June 30, 2026, were approximately $4.6 million, compared to approximately $2.4 million for the three months ended June 30, 2025. The overall increase in R&D largely reflected increased clinical study activity to support our CLR 125 study in triple-negative breast cancer and initiation of the confirmatory study of iopofosine I-131 in WM. General and administrative expenses for the three months ended June 30, 2026, were $2.6 million, compared to $3.6 million for the same period in 2025. Chad KoleanCFO at Cellectar Biosciences00:10:50The decrease in G&A was driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs. Net loss for the three months ended June 30, 2026, was $6.9 million, or $0.57 per share, compared with $5.4 million, or $3.39 per share, during the three months ended June 30, 2025. The enhanced strength of our balance sheet enables our ability to effectively advance our clinical and regulatory programs. Now I will turn the call over to Jarrod to discuss the regulatory and clinical advancements we have been making during the first half of 2026. Jarrod LongcorCOO at Cellectar Biosciences00:11:38Thank you, Chad, and good morning, everyone. As Jim noted, we continue to make meaningful progress across our clinical, regulatory, and development initiatives and believe Cellectar is entering an important phase of execution with multiple value-driving milestones ahead. Our primary focus remains advancing iopofosine I-131 to potential registration in WM, where we have generated a compelling body of clinical evidence and established a clear regulatory path forward. We have been encouraged by the consistency of the data emerging from the CLOVER WaM study, which continues to demonstrate meaningful and durable responses in a patient population with significant unmet medical need. During the quarter, we expanded that clinical evidence base with two important data updates. First, we presented new analyses at ASCO highlighting outcomes in patients treated immediately following BTK inhibitor therapy, a particularly challenging setting where treatment options remain limited. Jarrod LongcorCOO at Cellectar Biosciences00:12:40As Jim mentioned a few minutes ago, we demonstrated an approximately 80% major response rate and 16 months of durability in these patients. We also reported the full 12-month follow-up data set from the CLOVER WaM study on all patients, which further reinforced the durability with a median durability of 17.8 months and approximately 62% of patients achieving a major response, and the depth of the response observed of iopofosine increasing over time, with the very good partial response and complete response rate increasing to 14.5% in these late-line, highly refractory patients. Importantly, we are now translating these clinical achievements into regulatory and operational execution. We have initiated site activation activities for our planned phase III confirmatory trial and expect the first sites to open in the coming months, a key milestone in the development strategy. Jarrod LongcorCOO at Cellectar Biosciences00:13:37This study is designed to support long-term registration requirements while also enabling us to submit our planned Accelerated Approval pathway filing in the U.S. in 2027. We view the initiation of patient dosing in this trial as a significant upcoming catalyst and believe that could occur late this year or early next year, and is an important step toward bringing iopofosine to patients who urgently need new treatment options. Beyond WM, we continue to broaden the opportunity for both iopofosine and our proprietary Phospholipid Drug Conjugate, or PDC platform. Our recently published multiple myeloma data in a peer-reviewed journal, Cancers, further support the differentiated mechanism of action of iopofosine and highlight its potential applicability across a range of B-cell malignancies, including WM, multiple myeloma, diffuse large B-cell lymphoma, or DLBCL, and other difficult-to-treat hematologic cancers where new therapeutic options are urgently needed. Jarrod LongcorCOO at Cellectar Biosciences00:14:43At the same time, we are advancing the next generation of our radiopharmaceutical pipeline. We recently enrolled and dosed the first patients in our phase Ib trial of CLR 125 in triple-negative breast cancer and remain on track to report initial dosimetry, safety, and efficacy data later this year or early next year. Taken together, we believe these accomplishments underscore the growing validation of our platform, the strength of our development strategy, and a significant opportunity ahead. In tandem, we continue to advance what we believe is one of the most innovative, differentiated, and versatile targeting platforms in radiopharmaceutical development today. Our proprietary PDC platform was designed to selectively target cancer cells through a mechanism that is independent of specific tumor mutation or surface antigens. Jarrod LongcorCOO at Cellectar Biosciences00:15:33We believe this enables near-universal tumor targeting across hematologic malignancies as well as solid tumors, while providing a flexible delivery vehicle for multiple therapeutic payloads. The platform has already generated clinical validation through iopofosine and serves as the foundation of our next-generation pipeline, including CLR 125, our Auger-emitting radiotherapeutic program, and CLR 225, our alpha-emitting program. We believe these programs represent significant long-term value creation opportunities and demonstrate the range of the platform across multiple cancer indications. One of the unique strengths of the PDC platform is its flexibility. By leveraging the similar targeting backbone with different therapeutic payloads, we have the potential to develop multiple product candidates addressing a range of tumor types while capitalizing on the extensive knowledge we've already accumulated regarding tumor uptake, biodistribution, and safety. To provide additional insight into this opportunity, we'll be hosting an educational webinar on August 18th. Jarrod LongcorCOO at Cellectar Biosciences00:16:39During this event, members of our management team will discuss the scientific foundation of the PDC platform, its differentiated targeting capabilities, the progress we have made across clinical programs, and the significant future opportunities we see for the platform. We encourage you all to join us for what we believe will be an informative and engaging discussion about long-term potential of Cellectar's technology and pipeline. Overall, we are pleased with the progress made across our clinical, regulatory, and pipeline initiatives during the first half of the year. We believe we are well-positioned for the next stage of development and remain focused on executing against the milestones ahead. With that, I'll turn the call back to Jim for closing remarks. James CarusoPresident and CEO at Cellectar Biosciences00:17:19Okay. Thank you, Jarrod. As we look ahead, we believe Cellectar is entering an important and exciting, as well as transformational period. Our immediate focus is executing on the next steps required to advance iopofosine in WM. With compelling clinical data, active site initiation efforts already underway, and a clear regulatory path forward, we are working toward the start of our confirmatory phase III study, which we view as a critical catalyst and an important step toward our planned Accelerated Approval submission, which remains on target for the first half of the year in the U.S. At the same time, we are well-positioned financially following the oversubscribed financing completed earlier this year, which provides us with the resources necessary to execute our near-term objectives. Importantly, as Jarrod just reviewed, we believe the opportunity extends far beyond a single product. James CarusoPresident and CEO at Cellectar Biosciences00:18:26The progress we are making with iopofosine continues to validate the underlying strength of our PDC platform and further reinforces our confidence in expanding the feed technology across additional radiopharmaceutical programs, including our Auger-emitting and alpha-emitting product candidates for solid tumors. To this end, I encourage listeners to participate in our educational webinar on August 18th. Our vision is to build a leading radiopharmaceutical company founded on versatile, clinically validated delivery platform capable of generating multiple product opportunities across both hematologic and solid tumor indications. With strong momentum across our regulatory, clinical, and corporate initiatives, we look forward to sharing additional milestones throughout the remainder of 2026 and into 2027. I would like to thank our employees, as always, investigators, most importantly, patients, our stockholders, and partners for their continued support and commitment to our mission. Operator, we're now prepared to take questions. Operator00:19:47Thank you. Ladies and gentlemen, we'll now begin the question-and-answer session. Should you have a question, please press the star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Kevin DeGeeter from Ladenburg. Please go ahead. Kevin DeGeeterAnalyst at Ladenburg00:20:15Hey, great. Thanks, guys. Appreciate the update. Exciting time. A couple of questions from us. First off, on the phase III WM program, can you just walk us through, with a little bit more granularity, the rate-limiting steps to first patient enrolled? I think you've mentioned site activation, presumably IRB, but any other factors that may drive your guidance to be earlier, 4Q versus 1Q 2027? Can you just clarify what triggers potential FDA submission? Is it a specific number of patients enrolled? A more qualitative criteria? Just a little bit more granularity there would be helpful. Thank you. James CarusoPresident and CEO at Cellectar Biosciences00:21:06All right. Terrific. First of all, Kevin, thank you for your participation today in support of the company. It's very much appreciated. That is a significant question, and as you would expect, there's enormous amount of work that goes into initiating the confirmatory study, especially one of this size. We're very pleased with the progress that we've made to date, and we're particularly happy with the response from not only those academic catchment centers that treat a significant portion of the relapsed refractory WM population, but also from community networks, integrated oncology delivery networks that typically treat these patients or diagnose these patients, as well as treat out in the general community, certainly in the first handful of lines of therapy prior to referring to one of these institutions that are world-renowned for the treatment of highly refractory WM. James CarusoPresident and CEO at Cellectar Biosciences00:22:16So we're looking at all customer segments, even quite frankly, community-based institutions that also see a significant amount of patients. By way of background, 15 states in the U.S. essentially control 80% of the population for WM, so it is highly targeted, and in and around those geographic communities, all of these segments, the integrated oncology delivery networks, community-based hospitals, as well as those academic centers, provide treatment for this patient population. The net, having said that, we're very pleased with where we currently sit. We're on target from a timing perspective. I'll have Jarrod talk to the details of your questions, but we still view that kind of March-April timeframe as our submission for accelerated approval with our friends at the FDA. Jarrod? Jarrod LongcorCOO at Cellectar Biosciences00:23:17Sure. As you mentioned, there's a number of steps that go into the, obviously, the startup process. Just to sort of lay out a few. Generally, the way the process actually starts is at, and I'll just sort of give probably way too much granularity here, but at the time of beginning the process, where you start is the contracting with the CRO and getting the documentation in place with the CRO. That means not just the contract, but it's all the supporting documentation. So all of the necessary investigator letters, all of the necessary documents for the operation of the study and the SOPs, and making sure everything lines up. Jarrod LongcorCOO at Cellectar Biosciences00:24:04After that, then you move into the next phase, which is really site identification, where you identify which sites you want to target, which countries you want to go to, and so on and so forth from that. That then goes into what is called a feasibility step, where you submit to those various sites and investigators a feasibility questionnaire where they, again, request. They get basically a protocol synopsis. Jarrod LongcorCOO at Cellectar Biosciences00:24:28They review it, they determine if they are interested in participating, and they provide you with a sense of how many patients they might enroll and in what time frame. After that, you move into what is called the qualification phase, which is, obviously, with the radiopharmaceutical. It is not like taking an oral antibiotic per se. In this case, you have got to have an infusion suite. You have got to be able to handle and license for handling I-131. Jarrod LongcorCOO at Cellectar Biosciences00:24:54You have to go through all of that process, and you have to collect all that documentation as well. Then you move through, and as you said, you get into the IRB phase. The IRB phase comes. Site contracting comes. That can sometimes go in parallel, sometimes not. That depends, depending, as Jim said, we got a lot of interest from both community centers as well as academic centers. When you think about community centers, we can use a central IRB that allows them to approve more rapidly and move more rapidly. However, some of the more academic centers tend to have a local IRB in addition to that central IRB, so there is an extra IRB review process. Jarrod LongcorCOO at Cellectar Biosciences00:25:30In addition to that, many of the academic centers also have an internal committee that have to review the protocol with the final full protocol and statistical analysis plan, where they then vote to participate and go from that step to the next step, which would then be the contracting. After that, you have to train the centers and begin all that process, and then you do the true site initiation, which allows them to open and begin screening for patients, and then first patient in. Jarrod LongcorCOO at Cellectar Biosciences00:25:57All of that execution and operational stuff is going on in the background, and as we said in our prepared remarks, we have initiated much of that, and we are on track to have what we believe our first sites open in a handful of months here, over the next coming months, with the potential first patient in late this year or early next year. As it relates to then the FDA submission and what is the gating aspect for that. The gating aspect, by FDA's definition is the study has to be initiated and quote, unquote, "ongoing." So initiated at the time of submission, ongoing at the time of regulatory action, the definition of which is not defined by the FDA. They will not provide any clear, direct guidance on that subject. So you are left to sort of estimate what you think that might mean. Jarrod LongcorCOO at Cellectar Biosciences00:26:52We know what they are asking is basically that companies are executing diligently against the confirmatory studies for acceptance of their Accelerated Approval Program application, and diligently continue to execute that by the time they are doing regulatory action. Our interpretation of that is that we want to have a number of sites open, somewhere perhaps 10 to 20 sites open at the time of submission. We want to be in a position that we have got a couple patients enrolled, preferably at the time of submission, and then having somewhere between 5% or more patients enrolled by the time there is regulatory action. That is six to eight months after the submission goes in. Does that help? Kevin DeGeeterAnalyst at Ladenburg00:27:42It does. Incredibly granular. Thank you for that. Separately, on CLR 125, interesting asset. Just talk to us about what the initial learning around, I guess, the dose symmetry data and potential timeline. I think you called out milestones, but not specific timeline for data update on that exciting program. Jarrod LongcorCOO at Cellectar Biosciences00:28:10Yeah. I am going to stay very vague on what we know about the dose symmetries and so forth. I think the reason for that is to be transparent. We do expect to be able to provide some data later this year. We are looking at the San Antonio Breast Cancer Conference, obviously, as one potential opportunity to present data as it relates to that program, as well as other opportunities as may warrant to provide a data update around the program. What I can say is we know we have got very good uptake into the tumor. We have distribution that looks as one would predict based off of what we know about the targeting ligand and what we have known from iopofosine, and we see that it is very much predictable and in line what we would have expected. Jarrod LongcorCOO at Cellectar Biosciences00:29:05What we are doing from there is really, as one would expect in a phase Ib dose-finding study, is optimizing and looking at how we optimize the dose, ideally, for patients. Kevin DeGeeterAnalyst at Ladenburg00:29:20Perfect. Thanks for taking my questions. I'll get back in queue. Operator00:29:24Thank you. Your next question comes from Kemp Dolliver from Brookline Capital Markets. Please go ahead. Kemp DolliverAnalyst at Brookline Capital Markets00:29:33Hi. Thank you, and good morning. Couple questions. You have started to manufacture supply for your trials. Are you manufacturing any commercial supply for iopofosine I-131 at this point, or plan to do so shortly? Jarrod LongcorCOO at Cellectar Biosciences00:30:00Yeah. Thanks for the question, Kemp. What I would say to you is, I'm going to say it as a yes, but I'm going to put a qualifier in there, and that qualifier is obviously, we can't manufacture the isotope or the finished product because those are essentially what I'll call near-term, just-in-time or nearly just-in-time productions. But the targeting ligand, we do have significant stability data on that, and what we do is we produce that now. We've been producing that essentially at commercial scale for the last several years, and to give you a sense, we've got more than five-years' stability on the ligand. We generally produce that at large scale and then use that as necessary as we produce and generate the drugs. Jarrod LongcorCOO at Cellectar Biosciences00:30:48As I said, we have our commercial, and I'll say for the finished product, we have our commercial infrastructure built out and ready to go. Obviously, when we get a commercial approval, should we get a commercial approval, let me say it that way, we would then obviously be in a position to relatively quickly turn on that production process and ship drug through our existing logistics chain and production process. James CarusoPresident and CEO at Cellectar Biosciences00:31:21Yeah, we have the capacity to scale significantly in terms of patient lives, and we could stack very quickly. In fact, what's our max capacity from a patient perspective? It was well beyond any of our potential patient treatment and/or revenue models. It was very substantial. Close to 1,000, was it? Jarrod LongcorCOO at Cellectar Biosciences00:31:49Yeah. I'd say right now, we would easily be able to hit essentially about 100 patients per week, kind of scale with finished products. Jarrod LongcorCOO at Cellectar Biosciences00:31:58Because, as I'm sure you know, Kemp, the way these things are set up is the production of each unit is essentially done in an individual hot cell. You can obviously, as I'll call them, you daisy chain the hot cells together. In our case, our production runs actually give us considerably more material than we need. So even just two or three hot cells would provide us more than sufficient supply to hit that sort of 100-ish patient range. Kemp DolliverAnalyst at Brookline Capital Markets00:32:36That's great. Thanks. That leads into the next question, is how quickly you can launch after receiving the Accelerated Approval. James CarusoPresident and CEO at Cellectar Biosciences00:32:48That would be a function of levels of investment and when we determine when to pull particular levers. It's typically a 12-month period at a minimum to fully lock and load for commercial execution. Really, I think in this particular case, because of the scalable nature of the space, as I cited earlier, 15 states essentially control 80% of the WM lives. When you look at the actual customers triaging those patients, that number gets even more scalable and smaller. It's just one of the attractive reasons this space is, from a commercial perspective, a whiteboard, if you will. There's limited competitive tension in the space. The BTKIs are the only approved class of medications. They're predominantly used in first line, in second line and beyond. Kemp DolliverAnalyst at Brookline Capital Markets00:34:10Did I lose you? Hello? Operator00:34:13Hi, Jarrod. I think you went- There we go. James CarusoPresident and CEO at Cellectar Biosciences00:34:23A bunch of inbound inquiries relative to the availability of the drug. Getting back to your original question, we could scale up quickly because it is a targeted environment, but ultimately, the time to fully lock and load and mobilize is really a function of when you pull the trigger on certain levels of investment. Having said that, we are deliberating appropriate to advance this environment. Because there is limited to no competitive tension there or medical marketing commercial machinery in the space, it is pretty wide open. For a small company like ours, it could potentially be a consideration to commercialize on our own because of the limited amount of oncology spend that would be required to really drive trial use and adoption. James CarusoPresident and CEO at Cellectar Biosciences00:35:27However, having said that, we are also discussing with third-party partners that would take that on, as well as world-class, extremely large and efficient commercial organizations that we can also partner with to drive this for us. All three typical commercial options are on the table for us. We are evaluating all of them. We believe we could move very quickly in terms of establishing trial use and adoption in the space for limited funds in comparison to other spaces like breast or et cetera, in terms of the cost of doing business. Kemp DolliverAnalyst at Brookline Capital Markets00:36:17Great. My last question is more for broader industry view, but you do have some toehold in actinium-225, at least not in the clinic yet, but something of interest to you. What is your sense of the availability of actinium-225 now versus, say, a year ago? Jarrod LongcorCOO at Cellectar Biosciences00:36:44Great question, Kemp. I love the fact that it just allows me to just wander off and pontificate for a few hours. I appreciate that opportunity. What I would say is, yeah, a year ago, everybody was considerably concerned about the supply chain for actinium. I do not think that it has fully resolved, but I do think, as we have been advancing here and as I think people were expecting, we have gotten new suppliers in place. I think groups like SpectronRx are now up and consistently supplying actinium in addition to the group ITM and Eckert & Ziegler, and then you now have NorthStar online. I think you have got a number of other groups, Ionetix and a few others that are coming online in the near future, Nucleus, and so forth. Jarrod LongcorCOO at Cellectar Biosciences00:37:40Where we sit today to where we are going, I think the supply chain for the sourcing of actinium is opening up a bit. Now, I do expect that as programs advance and the need for larger quantities of actinium for certain programs increases, we may continue to see future constriction and opportunity. As you know, our strategy here on all of our components for production has been to multi-source every piece of the component. So everything from our targeting ligand to each radioisotope we work to work on, then each finished product that gets made, we multi-source all of that through various contractors in what I will call our collaborative outsourcing model. Jarrod LongcorCOO at Cellectar Biosciences00:38:34As you probably may or may not be aware, historically what we have done, and what we have done particularly around actinium, is we put in place our ready supply agreements with a number of parties. I think we are at four at this juncture, in order to make sure that we can access and get the supply necessary for our program, both near-term and long-term. Kemp DolliverAnalyst at Brookline Capital Markets00:38:59All right. Thank you. Operator00:39:02Thank you. No further questions at this time. I will turn it back over to Jim for closing remarks. James CarusoPresident and CEO at Cellectar Biosciences00:39:09Well, terrific. Thank you to everyone who participated in our call today. It is very much appreciated. In particular, our analysts for asking very thoughtful and provoking questions. Operator, with that, we will conclude our call. Operator00:39:27Ladies and gentlemen, this does conclude your call for today. We thank you very much for your participation, and you may now disconnect. Have a great day, everyone.Read moreParticipantsExecutivesJames CarusoPresident and CEOChad KoleanCFOJarrod LongcorCOOAnalystsAnne Marie FieldsManaging Director at Precision AQKevin DeGeeterAnalyst at LadenburgKemp DolliverAnalyst at Brookline Capital MarketsPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Cellectar Biosciences Earnings HeadlinesCellectar targets mid-2027 accelerated approval NDA for iopofosine in WM, backed by up to $140M financing3 hours ago | seekingalpha.comCellectar Biosciences, Inc. (CLRB) Q2 2026 Earnings Call TranscriptAugust 13 at 8:11 PM | seekingalpha.comThe world’s least risky AI stock?Whitney Tilson, senior editor at Stansberry Research, has identified a company he calls the world's safest AI stock, one most investors have never heard of. The firm sits at the intersection of AI, energy, and defense, and one of America's most famous investors reportedly put roughly half his fund into it. In recent years it has returned more than Apple, Amazon, and the S&P 500 combined. Tilson has released a free presentation naming the company and its ticker symbol, no payment or email required.August 14 at 1:00 AM | Stansberry Research (Ad)Cellectar Biosciences Reports Q2 2026 Results and Advances Phase 3 Iopofosine I 131 Program in Waldenström MacroglobulinemiaAugust 13 at 7:31 AM | quiverquant.comQCellectar Biosciences Reports Second Quarter 2026 Financial Results and Provides Corporate UpdatesAugust 13 at 7:15 AM | globenewswire.comAnalysts Set Cellectar Biosciences, Inc. (NASDAQ:CLRB) Price Target at $11.00August 13 at 2:59 AM | americanbankingnews.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) is a clinical‐stage biopharmaceutical company focused on the development of targeted cancer therapies and imaging agents. The company’s proprietary phospholipid drug conjugate (PDC) technology platform is designed to selectively deliver therapeutic and diagnostic payloads to malignant cells while sparing healthy tissue. Through its PDC approach, Cellectar aims to improve the efficacy and safety profile of traditional treatments like chemotherapy and radiotherapy. Its lead therapeutic candidate, CLR 131, is a radioisotope‐labeled PDC being evaluated in Phase II clinical trials for relapsed or refractory B‐cell malignancies, including multiple myeloma and non‐Hodgkin lymphoma. In addition to its therapeutic pipeline, Cellectar has developed CLR 1501 and CLR 1502, fluorescent and near‐infrared imaging probes that enhance intraoperative tumor detection and surgical guidance. These imaging agents are intended to help surgeons distinguish cancerous tissue from healthy tissue in real time. Founded in 2007 and headquartered in Madison, Wisconsin, Cellectar Biosciences conducts its research and development primarily in the United States. Preclinical and clinical studies have demonstrated the selective uptake and prolonged retention of its PDC compounds in tumor cells, supporting the potential of its platform across a range of oncologic indications. The company collaborates with academic centers and contract research organizations to advance its clinical programs. Under the leadership of President and Chief Executive Officer Will Berry, Cellectar Biosciences is advancing its pipeline and engaging with regulatory agencies to support future product commercialization. The company continues to explore strategic partnerships and funding opportunities to further develop its PDC technology for both therapeutic and diagnostic applications in oncology.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 Latest Articles Cerebras Sells Off After Earnings: Is This a Market Disconnection?Nebius Just Exploded 34% on Blowout Earnings—Is It Time to Buy?SpaceX’s First Earnings Report Only Made Wall Street More DividedFranco-Nevada Earnings: Gold Is Rallying, But Does the Stock Even Care?Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not DemandLumentum Just Delivered the AI Growth Investors WantedCoreWeave's $129 Billion AI Backlog Changes the Bull Case Upcoming Earnings BHP Group (8/17/2026)Palo Alto Networks (8/17/2026)Home Depot (8/18/2026)Medtronic (8/18/2026)Keysight Technologies (8/18/2026)Lowe's Companies (8/19/2026)TJX Companies (8/19/2026)Target (8/19/2026)Analog Devices (8/19/2026)NetEase (8/20/2026) Unlock superior investment research and tools. 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PresentationSkip to Participants Operator00:00:00Good morning, ladies and gentlemen. Thank you for standing by, and welcome. At this time, all participants are in listen-only mode, and following the presentation, we will conduct a question-and-answer session. Please be advised that today's call may be recorded. I would now like to hand the call over to Anne Marie Fields, Managing Director of Precision AQ. Please go ahead. Anne Marie FieldsManaging Director at Precision AQ00:00:23Thank you, operator. Good morning, and welcome to Cellectar Biosciences' second quarter 2026 financial results and business update conference call. Joining us today from Cellectar are James Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Kolean, CFO, for a financial review of the quarter. Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Cellectar issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of Cellectar's corporate website. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Anne Marie FieldsManaging Director at Precision AQ00:01:14Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 13, 2026. The company undertakes no obligation to revise or update any firm forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line to your questions. I'll now turn the call over to James Caruso. Jim? James CarusoPresident and CEO at Cellectar Biosciences00:01:59Thank you, Anne Marie, and thank you all for joining us this morning. The second quarter marked an especially productive period for Cellectar as we continued making meaningful progress across every area of our business, including clinical development, regulatory action, pipeline advancement, platform expansion, and strengthening of our financials. Our near-term priority remains clear. Advancing iopofosine I-131 for patients with relaxed or refractory Waldenström macroglobulinemia, or WM. Particularly those patients whose disease has progressed following earlier lines of treatment, including BTK inhibitor therapy. We believe this represents a significant unmet medical need and an attractive opportunity to bring a differentiated treatment option to patients who currently face limited therapeutic alternatives. During the quarter, we took several important steps to move this strategy forward. First, we reported the full 12-month follow-up results from the CLOVER WaM study. James CarusoPresident and CEO at Cellectar Biosciences00:03:12These data further reinforced both the depth and durability of response achieved with iopofosine and demonstrated that the study successfully met both its primary and secondary endpoints. Taken together, we believe the totality of evidence generated to date continues to support iopofosine's potential to become an important treatment option for WM patients. Second, we continued to build an increasingly compelling clinical data set for iopofosine. We presented new data at ASCO 2026 from the CLOVER WaM study highlighting outcomes in patients treated immediately following BTKI therapy, a challenging patient population. These results demonstrated a 79.2% major response rate, an 87.5% overall response rate, a 100% clinical benefit rate, and encouraging durability with a median duration of response of 16 months. Most importantly, we have now initiated site activation activities for our planned confirmatory phase III study. James CarusoPresident and CEO at Cellectar Biosciences00:04:34This represents a critical milestone in our regulatory strategy. Once necessary site activation and ongoing patient enrollment is achieved, we expect to be in a position to submit our new drug application under the FDA's Accelerated Approval Program in mid-2027. Based upon the breakthrough designation awarded to iopofosine I-131 for relapsed refractory WM, an approximate six-month review is anticipated. To support these efforts, we were pleased to complete an oversubscribed financing in May that has the potential to provide up to $140 million in capital, including $35 million upfront and up to $105 million tied to future milestones. This financing significantly strengthens our balance sheet and provides the resources needed to execute our WM strategy, advance our regulatory initiatives, and continue investing in our broader radiopharmaceutical pipeline. James CarusoPresident and CEO at Cellectar Biosciences00:05:51Beyond WM, we continue to advance the broader opportunity represented by our Phospholipid Drug Conjugate or PDC platform. The PDC platform is a highly differentiated targeting technology designed to selectively deliver therapeutic payloads to cancer cells, including primary tumors, metastatic lesions, and cancer stem cells. Importantly, the platform is highly versatile and can be combined with a variety of payloads and isotopes, including beta-emitting, Auger-emitting, and alpha-emitting radiotherapeutics. We believe the success we are seeing with iopofosine is validating the platform and creating a strong foundation for future pipeline expansion. Today, in addition to discussing our progress with iopofosine, we will also review advancements in CLR 125, our Auger-emitting program in solid tumors, and discuss how we plan to leverage the platform to build a next-generation radiopharmaceutical franchise. With that overview, I'll turn the call over to Chad for the financial review. Chad KoleanCFO at Cellectar Biosciences00:07:14Thank you, Jim, and good morning, everyone. First, I will spend a couple of minutes on the financing that Jim mentioned. As he stated, the transaction provided the company with the current and anticipated future funding to support our strategy to obtain approval for iopofosine I-131. The company received $35 million gross upfront, or approximately $31.7 million net, for common shares and pre-funded warrants. Additionally, we issued three tranches of approximately 13.2 million warrants each, all of which are currently exercisable with a strike price of $2.65. Chad KoleanCFO at Cellectar Biosciences00:07:56Furthermore, these warrants are callable for cash by the company if the respective milestone and related criteria are met. Each tranche of warrants, A, B, and C, has a milestone associated with it. The tranche A warrants, which expire on July 7, 2027, have a milestone of first patient enrolled in the confirmatory study for iopofosine I-131 in Waldenström macroglobulinemia, or WM, patients. Chad KoleanCFO at Cellectar Biosciences00:08:25The tranche B warrants, which expire July 7, 2028, have the milestone of the FDA's acceptance of a new drug application for iopofosine. The tranche C warrants, which expire July 7, 2031, have the milestone of approval by the FDA of iopofosine for marketing. In addition to achieving the milestones, two additional criteria must be met for the warrants to be callable. First, the volume-weighted average price, or VWAP, for the company stock must be at least $3.45 for 20 consecutive trading days. Second, the trading liquidity based upon the VWAP must average a minimum of $500,000 for those same 20 trading days. The milestone timing is designed to provide the necessary funding through the anticipated study initiation, submission to FDA, and approval. We believe this structure, provided it occurs as designed, supports the company's capital needs through initial commercialization of iopofosine. Chad KoleanCFO at Cellectar Biosciences00:09:38Now for our financial results for the period ended June 30, 2026. We ended the second quarter with cash and cash equivalents of approximately $34.0 million, compared to $13.2 million as of December 31, 2025, which reflects the cash generated from the initial portion of the May financing. Turning now to our operating results. Research and development expenses for the three months ended June 30, 2026, were approximately $4.6 million, compared to approximately $2.4 million for the three months ended June 30, 2025. The overall increase in R&D largely reflected increased clinical study activity to support our CLR 125 study in triple-negative breast cancer and initiation of the confirmatory study of iopofosine I-131 in WM. General and administrative expenses for the three months ended June 30, 2026, were $2.6 million, compared to $3.6 million for the same period in 2025. Chad KoleanCFO at Cellectar Biosciences00:10:50The decrease in G&A was driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs. Net loss for the three months ended June 30, 2026, was $6.9 million, or $0.57 per share, compared with $5.4 million, or $3.39 per share, during the three months ended June 30, 2025. The enhanced strength of our balance sheet enables our ability to effectively advance our clinical and regulatory programs. Now I will turn the call over to Jarrod to discuss the regulatory and clinical advancements we have been making during the first half of 2026. Jarrod LongcorCOO at Cellectar Biosciences00:11:38Thank you, Chad, and good morning, everyone. As Jim noted, we continue to make meaningful progress across our clinical, regulatory, and development initiatives and believe Cellectar is entering an important phase of execution with multiple value-driving milestones ahead. Our primary focus remains advancing iopofosine I-131 to potential registration in WM, where we have generated a compelling body of clinical evidence and established a clear regulatory path forward. We have been encouraged by the consistency of the data emerging from the CLOVER WaM study, which continues to demonstrate meaningful and durable responses in a patient population with significant unmet medical need. During the quarter, we expanded that clinical evidence base with two important data updates. First, we presented new analyses at ASCO highlighting outcomes in patients treated immediately following BTK inhibitor therapy, a particularly challenging setting where treatment options remain limited. Jarrod LongcorCOO at Cellectar Biosciences00:12:40As Jim mentioned a few minutes ago, we demonstrated an approximately 80% major response rate and 16 months of durability in these patients. We also reported the full 12-month follow-up data set from the CLOVER WaM study on all patients, which further reinforced the durability with a median durability of 17.8 months and approximately 62% of patients achieving a major response, and the depth of the response observed of iopofosine increasing over time, with the very good partial response and complete response rate increasing to 14.5% in these late-line, highly refractory patients. Importantly, we are now translating these clinical achievements into regulatory and operational execution. We have initiated site activation activities for our planned phase III confirmatory trial and expect the first sites to open in the coming months, a key milestone in the development strategy. Jarrod LongcorCOO at Cellectar Biosciences00:13:37This study is designed to support long-term registration requirements while also enabling us to submit our planned Accelerated Approval pathway filing in the U.S. in 2027. We view the initiation of patient dosing in this trial as a significant upcoming catalyst and believe that could occur late this year or early next year, and is an important step toward bringing iopofosine to patients who urgently need new treatment options. Beyond WM, we continue to broaden the opportunity for both iopofosine and our proprietary Phospholipid Drug Conjugate, or PDC platform. Our recently published multiple myeloma data in a peer-reviewed journal, Cancers, further support the differentiated mechanism of action of iopofosine and highlight its potential applicability across a range of B-cell malignancies, including WM, multiple myeloma, diffuse large B-cell lymphoma, or DLBCL, and other difficult-to-treat hematologic cancers where new therapeutic options are urgently needed. Jarrod LongcorCOO at Cellectar Biosciences00:14:43At the same time, we are advancing the next generation of our radiopharmaceutical pipeline. We recently enrolled and dosed the first patients in our phase Ib trial of CLR 125 in triple-negative breast cancer and remain on track to report initial dosimetry, safety, and efficacy data later this year or early next year. Taken together, we believe these accomplishments underscore the growing validation of our platform, the strength of our development strategy, and a significant opportunity ahead. In tandem, we continue to advance what we believe is one of the most innovative, differentiated, and versatile targeting platforms in radiopharmaceutical development today. Our proprietary PDC platform was designed to selectively target cancer cells through a mechanism that is independent of specific tumor mutation or surface antigens. Jarrod LongcorCOO at Cellectar Biosciences00:15:33We believe this enables near-universal tumor targeting across hematologic malignancies as well as solid tumors, while providing a flexible delivery vehicle for multiple therapeutic payloads. The platform has already generated clinical validation through iopofosine and serves as the foundation of our next-generation pipeline, including CLR 125, our Auger-emitting radiotherapeutic program, and CLR 225, our alpha-emitting program. We believe these programs represent significant long-term value creation opportunities and demonstrate the range of the platform across multiple cancer indications. One of the unique strengths of the PDC platform is its flexibility. By leveraging the similar targeting backbone with different therapeutic payloads, we have the potential to develop multiple product candidates addressing a range of tumor types while capitalizing on the extensive knowledge we've already accumulated regarding tumor uptake, biodistribution, and safety. To provide additional insight into this opportunity, we'll be hosting an educational webinar on August 18th. Jarrod LongcorCOO at Cellectar Biosciences00:16:39During this event, members of our management team will discuss the scientific foundation of the PDC platform, its differentiated targeting capabilities, the progress we have made across clinical programs, and the significant future opportunities we see for the platform. We encourage you all to join us for what we believe will be an informative and engaging discussion about long-term potential of Cellectar's technology and pipeline. Overall, we are pleased with the progress made across our clinical, regulatory, and pipeline initiatives during the first half of the year. We believe we are well-positioned for the next stage of development and remain focused on executing against the milestones ahead. With that, I'll turn the call back to Jim for closing remarks. James CarusoPresident and CEO at Cellectar Biosciences00:17:19Okay. Thank you, Jarrod. As we look ahead, we believe Cellectar is entering an important and exciting, as well as transformational period. Our immediate focus is executing on the next steps required to advance iopofosine in WM. With compelling clinical data, active site initiation efforts already underway, and a clear regulatory path forward, we are working toward the start of our confirmatory phase III study, which we view as a critical catalyst and an important step toward our planned Accelerated Approval submission, which remains on target for the first half of the year in the U.S. At the same time, we are well-positioned financially following the oversubscribed financing completed earlier this year, which provides us with the resources necessary to execute our near-term objectives. Importantly, as Jarrod just reviewed, we believe the opportunity extends far beyond a single product. James CarusoPresident and CEO at Cellectar Biosciences00:18:26The progress we are making with iopofosine continues to validate the underlying strength of our PDC platform and further reinforces our confidence in expanding the feed technology across additional radiopharmaceutical programs, including our Auger-emitting and alpha-emitting product candidates for solid tumors. To this end, I encourage listeners to participate in our educational webinar on August 18th. Our vision is to build a leading radiopharmaceutical company founded on versatile, clinically validated delivery platform capable of generating multiple product opportunities across both hematologic and solid tumor indications. With strong momentum across our regulatory, clinical, and corporate initiatives, we look forward to sharing additional milestones throughout the remainder of 2026 and into 2027. I would like to thank our employees, as always, investigators, most importantly, patients, our stockholders, and partners for their continued support and commitment to our mission. Operator, we're now prepared to take questions. Operator00:19:47Thank you. Ladies and gentlemen, we'll now begin the question-and-answer session. Should you have a question, please press the star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Kevin DeGeeter from Ladenburg. Please go ahead. Kevin DeGeeterAnalyst at Ladenburg00:20:15Hey, great. Thanks, guys. Appreciate the update. Exciting time. A couple of questions from us. First off, on the phase III WM program, can you just walk us through, with a little bit more granularity, the rate-limiting steps to first patient enrolled? I think you've mentioned site activation, presumably IRB, but any other factors that may drive your guidance to be earlier, 4Q versus 1Q 2027? Can you just clarify what triggers potential FDA submission? Is it a specific number of patients enrolled? A more qualitative criteria? Just a little bit more granularity there would be helpful. Thank you. James CarusoPresident and CEO at Cellectar Biosciences00:21:06All right. Terrific. First of all, Kevin, thank you for your participation today in support of the company. It's very much appreciated. That is a significant question, and as you would expect, there's enormous amount of work that goes into initiating the confirmatory study, especially one of this size. We're very pleased with the progress that we've made to date, and we're particularly happy with the response from not only those academic catchment centers that treat a significant portion of the relapsed refractory WM population, but also from community networks, integrated oncology delivery networks that typically treat these patients or diagnose these patients, as well as treat out in the general community, certainly in the first handful of lines of therapy prior to referring to one of these institutions that are world-renowned for the treatment of highly refractory WM. James CarusoPresident and CEO at Cellectar Biosciences00:22:16So we're looking at all customer segments, even quite frankly, community-based institutions that also see a significant amount of patients. By way of background, 15 states in the U.S. essentially control 80% of the population for WM, so it is highly targeted, and in and around those geographic communities, all of these segments, the integrated oncology delivery networks, community-based hospitals, as well as those academic centers, provide treatment for this patient population. The net, having said that, we're very pleased with where we currently sit. We're on target from a timing perspective. I'll have Jarrod talk to the details of your questions, but we still view that kind of March-April timeframe as our submission for accelerated approval with our friends at the FDA. Jarrod? Jarrod LongcorCOO at Cellectar Biosciences00:23:17Sure. As you mentioned, there's a number of steps that go into the, obviously, the startup process. Just to sort of lay out a few. Generally, the way the process actually starts is at, and I'll just sort of give probably way too much granularity here, but at the time of beginning the process, where you start is the contracting with the CRO and getting the documentation in place with the CRO. That means not just the contract, but it's all the supporting documentation. So all of the necessary investigator letters, all of the necessary documents for the operation of the study and the SOPs, and making sure everything lines up. Jarrod LongcorCOO at Cellectar Biosciences00:24:04After that, then you move into the next phase, which is really site identification, where you identify which sites you want to target, which countries you want to go to, and so on and so forth from that. That then goes into what is called a feasibility step, where you submit to those various sites and investigators a feasibility questionnaire where they, again, request. They get basically a protocol synopsis. Jarrod LongcorCOO at Cellectar Biosciences00:24:28They review it, they determine if they are interested in participating, and they provide you with a sense of how many patients they might enroll and in what time frame. After that, you move into what is called the qualification phase, which is, obviously, with the radiopharmaceutical. It is not like taking an oral antibiotic per se. In this case, you have got to have an infusion suite. You have got to be able to handle and license for handling I-131. Jarrod LongcorCOO at Cellectar Biosciences00:24:54You have to go through all of that process, and you have to collect all that documentation as well. Then you move through, and as you said, you get into the IRB phase. The IRB phase comes. Site contracting comes. That can sometimes go in parallel, sometimes not. That depends, depending, as Jim said, we got a lot of interest from both community centers as well as academic centers. When you think about community centers, we can use a central IRB that allows them to approve more rapidly and move more rapidly. However, some of the more academic centers tend to have a local IRB in addition to that central IRB, so there is an extra IRB review process. Jarrod LongcorCOO at Cellectar Biosciences00:25:30In addition to that, many of the academic centers also have an internal committee that have to review the protocol with the final full protocol and statistical analysis plan, where they then vote to participate and go from that step to the next step, which would then be the contracting. After that, you have to train the centers and begin all that process, and then you do the true site initiation, which allows them to open and begin screening for patients, and then first patient in. Jarrod LongcorCOO at Cellectar Biosciences00:25:57All of that execution and operational stuff is going on in the background, and as we said in our prepared remarks, we have initiated much of that, and we are on track to have what we believe our first sites open in a handful of months here, over the next coming months, with the potential first patient in late this year or early next year. As it relates to then the FDA submission and what is the gating aspect for that. The gating aspect, by FDA's definition is the study has to be initiated and quote, unquote, "ongoing." So initiated at the time of submission, ongoing at the time of regulatory action, the definition of which is not defined by the FDA. They will not provide any clear, direct guidance on that subject. So you are left to sort of estimate what you think that might mean. Jarrod LongcorCOO at Cellectar Biosciences00:26:52We know what they are asking is basically that companies are executing diligently against the confirmatory studies for acceptance of their Accelerated Approval Program application, and diligently continue to execute that by the time they are doing regulatory action. Our interpretation of that is that we want to have a number of sites open, somewhere perhaps 10 to 20 sites open at the time of submission. We want to be in a position that we have got a couple patients enrolled, preferably at the time of submission, and then having somewhere between 5% or more patients enrolled by the time there is regulatory action. That is six to eight months after the submission goes in. Does that help? Kevin DeGeeterAnalyst at Ladenburg00:27:42It does. Incredibly granular. Thank you for that. Separately, on CLR 125, interesting asset. Just talk to us about what the initial learning around, I guess, the dose symmetry data and potential timeline. I think you called out milestones, but not specific timeline for data update on that exciting program. Jarrod LongcorCOO at Cellectar Biosciences00:28:10Yeah. I am going to stay very vague on what we know about the dose symmetries and so forth. I think the reason for that is to be transparent. We do expect to be able to provide some data later this year. We are looking at the San Antonio Breast Cancer Conference, obviously, as one potential opportunity to present data as it relates to that program, as well as other opportunities as may warrant to provide a data update around the program. What I can say is we know we have got very good uptake into the tumor. We have distribution that looks as one would predict based off of what we know about the targeting ligand and what we have known from iopofosine, and we see that it is very much predictable and in line what we would have expected. Jarrod LongcorCOO at Cellectar Biosciences00:29:05What we are doing from there is really, as one would expect in a phase Ib dose-finding study, is optimizing and looking at how we optimize the dose, ideally, for patients. Kevin DeGeeterAnalyst at Ladenburg00:29:20Perfect. Thanks for taking my questions. I'll get back in queue. Operator00:29:24Thank you. Your next question comes from Kemp Dolliver from Brookline Capital Markets. Please go ahead. Kemp DolliverAnalyst at Brookline Capital Markets00:29:33Hi. Thank you, and good morning. Couple questions. You have started to manufacture supply for your trials. Are you manufacturing any commercial supply for iopofosine I-131 at this point, or plan to do so shortly? Jarrod LongcorCOO at Cellectar Biosciences00:30:00Yeah. Thanks for the question, Kemp. What I would say to you is, I'm going to say it as a yes, but I'm going to put a qualifier in there, and that qualifier is obviously, we can't manufacture the isotope or the finished product because those are essentially what I'll call near-term, just-in-time or nearly just-in-time productions. But the targeting ligand, we do have significant stability data on that, and what we do is we produce that now. We've been producing that essentially at commercial scale for the last several years, and to give you a sense, we've got more than five-years' stability on the ligand. We generally produce that at large scale and then use that as necessary as we produce and generate the drugs. Jarrod LongcorCOO at Cellectar Biosciences00:30:48As I said, we have our commercial, and I'll say for the finished product, we have our commercial infrastructure built out and ready to go. Obviously, when we get a commercial approval, should we get a commercial approval, let me say it that way, we would then obviously be in a position to relatively quickly turn on that production process and ship drug through our existing logistics chain and production process. James CarusoPresident and CEO at Cellectar Biosciences00:31:21Yeah, we have the capacity to scale significantly in terms of patient lives, and we could stack very quickly. In fact, what's our max capacity from a patient perspective? It was well beyond any of our potential patient treatment and/or revenue models. It was very substantial. Close to 1,000, was it? Jarrod LongcorCOO at Cellectar Biosciences00:31:49Yeah. I'd say right now, we would easily be able to hit essentially about 100 patients per week, kind of scale with finished products. Jarrod LongcorCOO at Cellectar Biosciences00:31:58Because, as I'm sure you know, Kemp, the way these things are set up is the production of each unit is essentially done in an individual hot cell. You can obviously, as I'll call them, you daisy chain the hot cells together. In our case, our production runs actually give us considerably more material than we need. So even just two or three hot cells would provide us more than sufficient supply to hit that sort of 100-ish patient range. Kemp DolliverAnalyst at Brookline Capital Markets00:32:36That's great. Thanks. That leads into the next question, is how quickly you can launch after receiving the Accelerated Approval. James CarusoPresident and CEO at Cellectar Biosciences00:32:48That would be a function of levels of investment and when we determine when to pull particular levers. It's typically a 12-month period at a minimum to fully lock and load for commercial execution. Really, I think in this particular case, because of the scalable nature of the space, as I cited earlier, 15 states essentially control 80% of the WM lives. When you look at the actual customers triaging those patients, that number gets even more scalable and smaller. It's just one of the attractive reasons this space is, from a commercial perspective, a whiteboard, if you will. There's limited competitive tension in the space. The BTKIs are the only approved class of medications. They're predominantly used in first line, in second line and beyond. Kemp DolliverAnalyst at Brookline Capital Markets00:34:10Did I lose you? Hello? Operator00:34:13Hi, Jarrod. I think you went- There we go. James CarusoPresident and CEO at Cellectar Biosciences00:34:23A bunch of inbound inquiries relative to the availability of the drug. Getting back to your original question, we could scale up quickly because it is a targeted environment, but ultimately, the time to fully lock and load and mobilize is really a function of when you pull the trigger on certain levels of investment. Having said that, we are deliberating appropriate to advance this environment. Because there is limited to no competitive tension there or medical marketing commercial machinery in the space, it is pretty wide open. For a small company like ours, it could potentially be a consideration to commercialize on our own because of the limited amount of oncology spend that would be required to really drive trial use and adoption. James CarusoPresident and CEO at Cellectar Biosciences00:35:27However, having said that, we are also discussing with third-party partners that would take that on, as well as world-class, extremely large and efficient commercial organizations that we can also partner with to drive this for us. All three typical commercial options are on the table for us. We are evaluating all of them. We believe we could move very quickly in terms of establishing trial use and adoption in the space for limited funds in comparison to other spaces like breast or et cetera, in terms of the cost of doing business. Kemp DolliverAnalyst at Brookline Capital Markets00:36:17Great. My last question is more for broader industry view, but you do have some toehold in actinium-225, at least not in the clinic yet, but something of interest to you. What is your sense of the availability of actinium-225 now versus, say, a year ago? Jarrod LongcorCOO at Cellectar Biosciences00:36:44Great question, Kemp. I love the fact that it just allows me to just wander off and pontificate for a few hours. I appreciate that opportunity. What I would say is, yeah, a year ago, everybody was considerably concerned about the supply chain for actinium. I do not think that it has fully resolved, but I do think, as we have been advancing here and as I think people were expecting, we have gotten new suppliers in place. I think groups like SpectronRx are now up and consistently supplying actinium in addition to the group ITM and Eckert & Ziegler, and then you now have NorthStar online. I think you have got a number of other groups, Ionetix and a few others that are coming online in the near future, Nucleus, and so forth. Jarrod LongcorCOO at Cellectar Biosciences00:37:40Where we sit today to where we are going, I think the supply chain for the sourcing of actinium is opening up a bit. Now, I do expect that as programs advance and the need for larger quantities of actinium for certain programs increases, we may continue to see future constriction and opportunity. As you know, our strategy here on all of our components for production has been to multi-source every piece of the component. So everything from our targeting ligand to each radioisotope we work to work on, then each finished product that gets made, we multi-source all of that through various contractors in what I will call our collaborative outsourcing model. Jarrod LongcorCOO at Cellectar Biosciences00:38:34As you probably may or may not be aware, historically what we have done, and what we have done particularly around actinium, is we put in place our ready supply agreements with a number of parties. I think we are at four at this juncture, in order to make sure that we can access and get the supply necessary for our program, both near-term and long-term. Kemp DolliverAnalyst at Brookline Capital Markets00:38:59All right. Thank you. Operator00:39:02Thank you. No further questions at this time. I will turn it back over to Jim for closing remarks. James CarusoPresident and CEO at Cellectar Biosciences00:39:09Well, terrific. Thank you to everyone who participated in our call today. It is very much appreciated. In particular, our analysts for asking very thoughtful and provoking questions. Operator, with that, we will conclude our call. Operator00:39:27Ladies and gentlemen, this does conclude your call for today. We thank you very much for your participation, and you may now disconnect. Have a great day, everyone.Read moreParticipantsExecutivesJames CarusoPresident and CEOChad KoleanCFOJarrod LongcorCOOAnalystsAnne Marie FieldsManaging Director at Precision AQKevin DeGeeterAnalyst at LadenburgKemp DolliverAnalyst at Brookline Capital MarketsPowered by