CLRB

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 8:30 a.m. ET President and Chief Executive Officer - James Caruso Executive Vice President and Chief Financial Officer - Chad Kolean Chief Operating Officer - Jarrod Longcor Operator: Good morning, ladies and gentlemen. Thank you for standing by, and welcome. [Operator Instructions] Please be advised that today's call may be recorded. I will now hand the call over to Anne Marie Fields, Managing Director of Precision AQ. Please go ahead. Anne Marie Fields: Thank 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 Jim 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. Actual 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 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 Jim Caruso. Jim? James Caruso: Thank 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 relapsed or refractory, Waldenstrom's 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. These 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 continue 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, and 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. This 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 6-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. Beyond 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 Kolean: Thank 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 prefunded warrants. Additionally, we issued three tranches of approximately 13.2 million warrants each, all of which are currently exercisable at a strike price of $2.65. Furthermore, 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 Waldenstrom Macroglobulinemia, or WM, patients. The 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 a 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's stock must be at least $3.45 for 20 consecutive trading days. Second, the trading liquidity based upon a 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. Now, 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 3 months ended June 30, 2026, were approximately $4.6 million compared to approximately $2.4 million for the 3 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 3 months ended June 30, 2026, were $2.6 million compared to $3.6 million for the same period in 2025. The decrease in G&A was driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs. Net loss for the 3 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 3 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've been making during the first half of 2026. Jarrod Longcor: Thank 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 global 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 BTKi inhibitor therapy, a particularly challenging setting where treatment options remain limited. And as 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 with iopofosine increasing over time with a 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. This study is designed to support long-term registration requirements while also enabling us to submit our planned accelerated approval pathway filing in the United States 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 the 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. At the same time, we are advancing the next generation of our radiopharmaceutical pipeline, which 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. We 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 18. During 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 Caruso: Okay. 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 United States. 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. The progress we are making with iopofosine continues to validate the underlying strength of our PDC platform and further reinforces our confidence in expanding the 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 18. 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. Operator: [Operator Instructions] And your first question comes from Kevin DeGeeter from Ladenburg. Kevin DeGeeter: Appreciate the update. Exciting time. A couple of questions from myself. First off, on the Phase III WM program. Can you just walk us through a little bit more granularity, the rate-limiting steps to first patient enrolled? I think you've mentioned your site activation, presumably IRB, but kind of any other factors that may drive kind of your guidance to be, earlier kind of 4Q versus 1Q '27? And then 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. James Caruso: All 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 an enormous amount of work that goes into initiating the confirmatory study, especially one of this size. And 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. So 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 United States 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. So 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 on that kind of March-April time frame as our submission for accelerated approval with our friends at the FDA. Jarrod? Jarrod Longcor: Sure. So, as you mentioned, there's a number of steps that go into the -- obviously, the start-up process, just sort of lay out a few, I mean, generally, the way the process actually starts is that, and I'll just sort of give probably way too much granularity here, but at the time of beginning the process, right, where you start is the contracting with the CRO and getting the documentation in place with the CRO. And 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. After 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's 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, they review it, they determine if they're interested in participating, and they provide you with a sense of how many patients they may or may not -- how many patients they might enroll in what time frame. After that, you move into what's called the qualification phase, which is obviously, with the radiopharmaceutical, it's not like taking an oral antibiotic per se, right? In this case, you've got to have an infusion suite, you got to be able to handle and licensed for handling I 131. And so you 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. And that depends -- depending, as Jim said, we've 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's an extra IRB review process. In 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 site -- the true site initiation, which allows them to open and begin screening for patients, and then first patient in. That's sort of all 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, early next year. As it relates to then the FDA submission and what's the gating aspect for that, that is -- the gating aspect by FDA's definition is the site has to be their site. The study has to be initiated and "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 be. We know what they're asking is basically that companies are executing diligently against the confirmatory studies for acceptance of their accelerated approval 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. And we want to be in a position that we've gotten a couple of patients enrolled, preferably at the time of submission, and then having somewhere between 5% or more patients enrolled by the time there's regulatory action, that's 6 to 8 months after the submission goes in. Does that help? Kevin DeGeeter: It does. Incredibly granular. And then just separately, on CLR 125, interesting asset. Just kind of talk to us about kind of what the initial learning around, I guess, the dosimetry data and potential time line. I think you kind of called out milestones, but not a specific time line for data update on that exciting program. Jarrod Longcor: Yes. So I'm going to stay very vague on the -- what we know about the dosimetry and so forth. And I think the reason for that is we, 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, has an opportunity, 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've got very good uptake into the tumor. We have distribution that looks as one would predict based on what we know about the targeting ligand and what we've known from iopofosine. And we see that, that it is very much predictable and in line with what we would have expected. And so what we're 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. Operator: And your next question comes from Kemp Dolliver from Brookline Capital Markets. Brian Kemp Dolliver: A couple of questions. So you have started to manufacture -- your supply for your trials. Are you manufacturing any commercial supply for iopofosine I 131 at this point or plan to do so shortly? Jarrod Longcor: Yes. So -- 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, our -- we've got more than 5 years stability on the ligand. So we generally produce that at large scale and then use that as necessary as we produce it and generate the drugs. As I said, we have our commercial, and I'll say it 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 Caruso: Yes. 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 went well beyond any of our potential patient treatment and/or our revenue models. It was very substantial. Close to 1,000... Jarrod Longcor: Yes. We're at about -- I'd say right now, we would easily be able to hit essentially about a 100 patients per week kind of scale with finished products, because as you -- 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. And so even just two or three hot cells would provide us more than sufficient supply to hit that sort of 100-ish patient range. Brian Kemp Dolliver: That's great. And that leads into the next question is, how quickly you can launch after receiving the accelerated approval? James Caruso: So that would be a function of levels of investment and when we determine when to pull particular levers. So it's typically a 12-month period at a minimum to fully lock and load for commercial execution. And 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. But when you look at the actual customers triaging those patients, that number gets even more scalable and smaller. It's 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. BTKis are the only approved class of medications. They're predominantly used in first line and second line and beyond. A bunch of inbound inquiries relative to the availability of the drug. So getting back to your original question, we could scale up quickly because it's 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. Now having said that, we also have -- where we are [Technical Difficulty] digital environment. Because there's limited to no competitive tension there, or [Technical Difficulty] medical marketing, commercial machinery in the space, it's pretty wide open. And so for a small company like ours, it could potentially be a consideration to commercialize on our own because a limited amount of oncology spend that would be required to really drive trial use and adoption. However, having said that, we're 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. So all three typical commercial options are on the table for us. We're evaluating all of them. And 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, et cetera, in terms of the cost of doing business. Brian Kemp Dolliver: Great. And my last question is more for the 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. And so what's your sense of the availability of actinium-225 now versus, say, a year ago? Jarrod Longcor: Great question, Kemp. And I love the fact that it just allows me to just wander off and pontificate for a few hours. I appreciate that opportunity. So what I would say is, yes, a year ago, I would say -- actinium, everybody was considerably concerned about the supply chain for actinium. I don't think that it has fully resolved, but I do think as we have been advancing here and as I think people were expecting, we've gotten new suppliers in place. I think groups like SpectronRx are now up and consistently supplying actinium in addition to the group ITM, Eckert & Ziegler, and then you now have Northstar online. I think you've got a number of other groups, Ionetix and a few others that are coming online in the near future, Nucleus and so forth. And so I think, where we sit today to where we're going, I think the supply chain is 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. And as you know, our strategy here on all of our components for production has been to multisource every piece of the component. So everything from our targeting ligand to each radioisotope we work to work on and then each finished product that gets made, we multisource all of that through various contractors. And in our, what I'll call our collaborative outsourcing model. And as you probably may or may not be aware, historically, what we've done, and what we've done particularly around actinium, is we put in place our ready supply agreements with a number of parties. I think we're at 4 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. Operator: And with no further questions at this time, I will turn it back over to Jim for closing remarks. James Caruso: Well, terrific. Thank you to everyone who participated in our call today. It's very much appreciated. In particular, our analysts for asking very thoughtful and provoking questions. And operator, with that, we'll conclude our call. Operator: Ladies 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. 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This article first appeared on GuruFocus. Cash and Cash Equivalents: $34.0 million as of June 30, 2026, compared to $13.2 million as of December 31, 2025. R&D Expenses: $4.6 million for Q2 2026, up from $2.4 million in Q2 2025. G&A Expenses: $2.6 million for Q2 2026, down from $3.6 million in Q2 2025. Net Loss: $6.9 million, or $0.57 per share, for Q2 2026, compared to $5.4 million, or $3.39 per share, in Q2 2025. Financing: Completed oversubscribed financing in May with $35 million gross upfront (approximately $31.7 million net) and up to $105 million tied to future milestones. Warning! GuruFocus has detected 1 Warning Sign with CLRB. Is CLRB fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Cellectar Biosciences Inc (NASDAQ:CLRB) reported strong clinical data from the CLOVER WaM study, with a 79.2% major response rate and 87.5% overall response rate in patients treated immediately after BTKi therapy, and a median duration of response of 16 months. The company completed an oversubscribed financing in May, securing up to $140 million in potential capital, including $35 million upfront, to support its regulatory and clinical programs. Cellectar Biosciences Inc (NASDAQ:CLRB) has initiated site activation for its confirmatory Phase 3 study of iopofosine I 131 in Waldenstrom macroglobulinemia, with first patient dosing expected late 2026 or early 2027. The company is on track to submit a New Drug Application (NDA) for accelerated approval of iopofosine I 131 in mid-2027, with a potential six-month FDA review due to Breakthrough Therapy designation. Cellectar Biosciences Inc (NASDAQ:CLRB) is advancing its versatile PDC platform, with CLR 125 (Auger-emitting) and CLR 225 (alpha-emitting) programs, and has dosed the first patients in the Phase 1b trial for triple-negative breast cancer. The company has a robust commercial supply chain, with the ability to produce up to 100 patients' worth of finished product per week, and has multi-sourced key components like actinium-225 to mitigate supply risks. Cellectar Biosciences Inc (NASDAQ:CLRB) reported a net loss of $6.9 million for Q2 2026, with R&D expenses nearly doubling year-over-year to $4.6 million due to increased clinical activity. The company's cash position of $34.0 million is relatively low, and it relies on future milestone-based warrant exercises (up to $105 million) to fund operations, which are contingent on achieving specific clinical and regulatory milestones. The confirmatory Phase 3 study initiation is still in early stages, with first patient dosing not expected until late 2026 or early 2027, and the FDA submission is dependent on having 10-20 sites open and a few patients enrolled, which may be challenging to achieve. The company faces uncertainty regarding the FDA's definition of 'ongoing' for the confirmatory study, which could impact the timing of the accelerated approval submission and potential approval. Cellectar Biosciences Inc (NASDAQ:CLRB) has not yet provided specific data updates for CLR 125, and initial dosimetry, safety, and efficacy data are not expected until late 2026 or early 2027, leaving a gap in pipeline visibility. The company's commercial strategy for iopofosine is still undecided, with options including self-commercialization or partnering, which could lead to delays or additional costs in the launch process. Q: What are the gating steps to first patient enrollment in the Phase 3 WM confirmatory study, and what specifically triggers the FDA submission for accelerated approval?A: Jarrod Longcor, COO, detailed the extensive site activation process, including CRO contracting, site identification, feasibility questionnaires, qualification for radiopharmaceutical handling, IRB approvals (central for community sites, local for academic centers), and training. He clarified that the FDA requires the study to be "initiated" at submission and "ongoing" at regulatory action. The company's interpretation is to have 10-20 sites open and a couple of patients enrolled at submission, with 5% or more enrolled by the time of regulatory action, targeting a March-April 2027 submission. Q: Can you provide more granularity on the timeline for initial data from the CLR 125 Phase 1b trial in Triple Negative Breast Cancer?A: Jarrod Longcor, COO, stated that while he would remain vague on specific dosimetry trends, the company expects to provide data later this year. He identified the San Antonio Breast Cancer Conference as a potential venue for presenting initial dosimetry, safety, and efficacy data, noting that tumor uptake and biodistribution are in line with predictions based on the targeting ligand. Q: Are you manufacturing commercial supply for iopofosine I 131, and how quickly could you launch after receiving accelerated approval?A: Jarrod Longcor, COO, confirmed the company produces the targeting ligand at commercial scale with over five years of stability data, while the finished product is produced just-in-time. He noted the commercial infrastructure is built out and can scale to approximately 100 patients per week. For launch, he indicated a 12-month minimum to fully "lock and load" for commercial execution, but the targeted WM market (15 states control 80% of patients) allows for a rapid, cost-effective launch, with options including self-commercialization or partnering. Q: What is your sense of the availability of actinium-225 now versus a year ago, and how does that impact your CLR 225 program?A: Jarrod Longcor, COO, noted that while supply chain concerns persist, the landscape has improved with new suppliers like SpectronRx, ITM, Eckert & Ziegler, and Northstar coming online. He emphasized the company's strategy of multi-sourcing every component, including having ready supply agreements with four parties for actinium, to ensure access for both near-term and long-term program needs. Q: What were the key financial results for the second quarter of 2026, and how does the recent financing support the company's strategy?A: Chad Kolean, CFO, reported cash and cash equivalents of $34.0 million as of June 30, 2026, up from $13.2 million at year-end 2025, reflecting the $35 million gross upfront from the May financing. R&D expenses increased to $4.6 million (from $2.4 million) due to CLR 125 study activity and confirmatory study initiation, while G&A decreased to $2.6 million (from $3.6 million). Net loss was $6.9 million, or $0.57 per share. The financing includes up to $105 million in milestone-based warrants tied to study initiation, NDA acceptance, and FDA approval. Q: What were the key clinical data updates presented at ASCO 2026 and in the full 12-month follow-up from the CLOVER WaM study?A: Jim Caruso, CEO, highlighted data from patients treated immediately following BTKi therapy, showing a 79.2% major response rate, 87.5% overall response rate, and 100% clinical benefit rate with a median duration of response of 16 months. Jarrod Longcor, COO, added that the full 12-month follow-up data showed a median durability of 17.8 months, with approximately 62% of patients achieving a major response and VGPR/CR rates increasing to 14.5%. Q: What is the status of the site activation for the Phase 3 confirmatory study, and what is the expected timeline for first patient dosing?A: Jim Caruso, CEO, stated that site activation activities have been initiated, with strong interest from both academic centers and community oncology networks. Jarrod Longcor, COO, confirmed the company is on track to open first sites in the coming months, with potential first patient dosing late this year or early next year, which is viewed as a significant upcoming catalyst. Q: How does the PDC platform support the broader pipeline beyond iopofosine, and what are the next steps for CLR 125 and CLR 225?A: Jarrod Longcor, COO, explained that the PDC platform is highly versatile, capable of delivering beta, Auger, and alpha-emitting radiotherapeutics. CLR 125 (Auger-emitting) has enrolled and dosed first patients in a Phase 1b trial for Triple Negative Breast Cancer, with initial data expected late 2026 or early 2027. CLR 225 (alpha-emitting) is in preclinical development. The company plans to host an educational webinar on August 18 to discuss the platform's scientific foundation and future opportunities. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Prioritizing iopofosine I 131 for relapsed/refractory Waldenstrom's macroglobulinemia (WM), targeting a high unmet need in patients failing BTK inhibitor therapy. Performance attribution for the quarter is driven by 12-month CLOVER-WaM data showing a 17.8-month median durability and increasing depth of response over time. Strategic positioning focuses on the Phospholipid Drug Conjugate (PDC) platform's versatility to deliver various isotopes (beta, Auger, alpha) across hematologic and solid tumors. Operational focus has shifted to site activation for the Phase III confirmatory study, a prerequisite for the planned accelerated approval regulatory pathway. Capital allocation was bolstered by a $140 million financing structure designed to fund the company through anticipated commercialization milestones. Market environment for WM is characterized as highly concentrated, with 15 states containing 80% of the patient population, allowing for a lean commercial footprint. Targeting New Drug Application (NDA) submission for iopofosine in WM by mid-2027 under the FDA's accelerated approval program. Anticipating a 6-month regulatory review period following submission, supported by the drug's breakthrough therapy designation. Expectations for first patient dosing in the Phase III confirmatory trial are set for late 2026 or early 2027. Initial dosimetry, safety, and efficacy data for CLR 125 in triple-negative breast cancer are projected for late 2026 or early 2027. Commercial strategy assumes a 12-month 'lock and load' period for execution, with options for self-commercialization or strategic partnerships under evaluation. The May financing includes $105 million in milestone-linked warrants, contingent on clinical enrollment, NDA acceptance, and FDA approval. Warrant callability is subject to stock price and liquidity thresholds, specifically a $3.45 VWAP and $500,000 average daily trading volume over 20 days. R&D expense increase to $4.6 million reflects intensified clinical activity for CLR 125 and the initiation of the iopofosine confirmatory study. Supply chain strategy for Actinium-225 involves multi-sourcing through four separate agreements to mitigate potential future isotope scarcity. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that the FDA requires the confirmatory study to be 'initiated and ongoing' at the time of submission and regulatory action. The company interprets this as having 10 to 20 sites open at submission and approximately 5% or more patients enrolled by the time of regulatory action. Site activation involves complex steps including I 131 licensing, infusion suite qualification, and local IRB reviews at academic centers. The targeting ligand is already produced at commercial scale with over 5 years of stability data, while finished product is 'just-in-time' due to isotope decay. Current infrastructure can scale to approximately 100 patients per week using existing hot cell capacity, exceeding current revenue models. The logistics chain is already established to ship drug through existing production processes immediately upon potential approval. Management noted that while the Actinium supply chain is opening up with new suppliers, future constriction is possible as more programs enter the clinic. Cellectar utilizes a 'collaborative outsourcing model' to multisource every component, from the targeting ligand to the radioisotope.

Site Activation Initiated for Confirmatory Phase 3 Study of Iopofosine I 131 with New Drug Application Submission Planned for mid-2027 under the FDA’s Accelerated Approval Program Presented Data from CLOVER WaM Trial of Iopofosine I 131 in relapsed/refractory Waldenström Macroglobulinemia (r/r WM) at the American Society of Clinical Oncology 2026 Annual Meeting Initiated Enrollment and Dosed First Patients in Phase 1b Clinical Trial of CLR 125 in Triple Negative Breast Cancer Announced Publication of Phase 1 Data in Peer-Reviewed Journal Cancers Company to Hold Webcast and Conference Call at 8:30 AM ET Today FLORHAM PARK, N.J., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced financial results for the quarter ended June 30, 2026, and provided a corporate update. “Our second quarter marked another period of significant execution as we continued to advance multiple programs across our oncology pipeline while laying the foundation for several important near-term catalysts,” said James Caruso, president and chief executive officer of Cellectar. “Most notably, we progressed our regulatory strategy for iopofosine I 131 in Waldenström macroglobulinemia, including initiation of site activation activities for our confirmatory Phase 3 trial, which is an important first step toward our accelerated approval application in the U.S., which we plan to submit in mid-2027. The compelling data we continue to generate from the Phase 2b CLOVER WaM study reinforce our belief that iopofosine has the potential to address a critical unmet need for WM patients, including those previously treated with BTK inhibitors and prior to off-label salvage therapies.” “At the same time, we continued to expand the clinical validation of our proprietary PDC platform, achieving key enrollment and dosing milestones in our CLR 125 Phase 1b trial in triple-negative breast cancer and advancing our broader radiopharmaceutical portfolio. Supported by a strengthened balance sheet and a clear operational roadmap, we are entering the second half of 2026 with strong momentum, multiple anticipated data and development milestones, and a steadfast commitment to creating long-term value for patients and stockholders.” Second Quarter 2026 and Recent Corporate Highlights Iopofosine I 131, the company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope) CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumor Phospholipid Drug Conjugate (PDC) Platform Corporate 2026 Financial Highlights Cash and Cash Equivalents: As of June 30, 2026, the company had cash and cash equivalents of $34.0 million, compared to $13.2 million as of December 31, 2025, which reflects net proceeds of approximately $31.7 million from the May 2026 offering. The company believes its cash balance as of June 30, 2026, is adequate to fund its budgeted operations into the second quarter of 2027. Research and Development Expenses: R&D 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 initiation of the WM confirmatory iopofosine I 131 and CLR 125 Triple Negative Breast Cancer studies drove the increase. General and Administrative Expenses: G&A expenses for the three months ended June 30, 2026, were approximately $2.6 million, compared to approximately $3.6 million for the same period in 2025. The decrease was primarily a result of reduced commercialization efforts, professional fees, and lower personnel costs. Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2026, was $6.9 million, or $0.57 per share, compared to $5.4 million, or $3.39 per share, for the three months ended June 30, 2025. Conference Call & Webcast DetailsCellectar management will host a conference call and webcast today, August 13, 2026, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the “Events & Presentations” section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the company’s website for approximately 90 days. About Cellectar Biosciences, Inc.Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes iopofosine I 131, which is a PDC designed to provide targeted delivery of iodine-131 (radioisotope). Iopofosine I 131 has been tested in Phase 2b trials as a treatment for relapsed or refractory Waldenström Macroglobulinemia (WM), in relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma. The CLOVER-2 Phase 1b study is evaluating iopofosine I 131 in pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIority MEdicines (PRIME) designation. Cellectar is also developing CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal cancer, and is currently being evaluated in a Phase 1b study for TNBC, which will determine the recommended dose for the subsequent Phase 2 trial. CLR 125 has been well tolerated in vivo and has demonstrated strong preclinical data showing reduction or inhibition of solid tumor growth. In addition to these assets, the Cellectar team is developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors in indications with significant unmet need, such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. For more information, please visit https://www.cellectar.com/or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook. Forward Looking Statements Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2025, and our Form 10-Q for the quarterly period ended March 31, 2026. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. INVESTORS:Anne Marie FieldsPrecision [email protected]

FLORHAM PARK, N.J., July 30, 2026 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the Company will report financial results for the second quarter ended June 30, 2026, and provide a corporate update on August 13, 2026, at 8:30 a.m. Eastern Time. A replay of the corporate presentation will be available on the Events section of the Company’s Investor Relations website. About Cellectar Biosciences, Inc.Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes iopofosine I 131, which is a PDC designed to provide targeted delivery of iodine-131 (radioisotope). Iopofosine I 131 has been tested in Phase 2b trials as a treatment for relapsed or refractory Waldenström Macroglobulinemia (WM), in relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma. The CLOVER-2 Phase 1b study is evaluating iopofosine I 131 in pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIority MEdicines (PRIME) designation. Cellectar is also developing CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal cancer, and is currently being evaluated in a Phase 1b study for TNBC, which will determine the recommended dose for the subsequent Phase 2 trial. CLR 125 has been well tolerated in vivo and has demonstrated strong preclinical data showing reduction or inhibition of solid tumor growth. In addition to these assets, the Cellectar team is developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors in indications with significant unmet need, such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. For more information, please visit https://www.cellectar.com/ or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook. Investor Contact:Anne Marie FieldsPrecision [email protected]

This article first appeared on GuruFocus. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Cellectar Biosciences Inc (NASDAQ:CLRB) reported positive 12-month follow-on data from the Phase IIb Clover-WAM study, demonstrating durable and consistent responses in heavily pretreated WM patients. The company plans to file for accelerated FDA approval and initiate a Phase III confirmatory trial for iapopicine, indicating strong confidence in its clinical profile. Cellectar Biosciences Inc (NASDAQ:CLRB) completed an oversubscribed financing round of up to $140 million, significantly strengthening its balance sheet. The company is advancing its broader pipeline, including the Phase 1B trial of CLR125 for triple-negative breast cancer, showcasing its commitment to expanding its radiopharmaceutical portfolio. The company has aligned with the FDA on the comparator arm for the Phase III study, demonstrating proactive regulatory engagement. Cellectar Biosciences Inc (NASDAQ:CLRB) reported a net loss of $5.7 million for the first quarter of 2026, indicating ongoing financial challenges. Research and development expenses decreased slightly, but the company still faces significant costs associated with clinical trials and manufacturing. The company's cash and cash equivalents decreased to $8.3 million by the end of the first quarter, highlighting the need for continued financial management. The Phase III confirmatory trial for iapopicine is not expected to initiate until late 2026, potentially delaying market entry and revenue generation. The company faces uncertainties related to the successful achievement of milestones tied to the $140 million financing, which could impact future funding. Warning! GuruFocus has detected 1 Warning Sign with CLRB. Is CLRB fairly valued? Test your thesis with our free DCF calculator. Q: For the Clover-WAM study, did most patients transition directly from a BTK inhibitor to the study drug, or were there other therapies in between? A: Jim Caruso, President and CEO, explained that over 50% of patients transitioned directly from a BTK inhibitor to the study drug. Jared Loncourt, COO, added that the most common alternative transition was from rituximab, either as monotherapy or in combination with chemotherapy. Q: What is the likely comparator arm for the Phase III program, and how should we think about the potential range of progression-free survival (PFS) for the control arm? A: Jared Loncourt, COO, stated that the comparator arm will be rituximab, cyclophosphamide, and dexamethasone (RCD). He noted that PFS for the control arm in a post-BTKI setting is expected to range from 5.8 to 8.1 months, with the refractory population closer to 5.8 months. Q: Can you provide details on the powering of the Phase III study and expectations for progression-free survival? A: Jared Loncourt, COO, explained that the study is powered with 100 patients in each arm, assuming an eight-month PFS for the comparator arm and a 12-month PFS for the iapopacine arm. The expectation is that the iapopacine arm will achieve a PFS closer to 15 months, based on Phase II results. Q: What is the timeline for a potential NDA submission under accelerated approval for WM? A: Jim Caruso, President and CEO, indicated that the study is expected to initiate at the end of 2026. Following a few months of patient enrollment, the NDA submission will occur, with potential FDA approval in the second half of 2027, leveraging the breakthrough designation for a six-month review window. Q: How does the recent financing impact the company's financial position and strategic plans? A: Chad Colleen, CFO, highlighted that the oversubscribed financing of up to $140 million strengthens the balance sheet, enabling the company to fund operations through the second quarter of 2027. This includes the initiation of the Phase III trial and potential commercialization efforts. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. The company achieved a transformational inflection point following positive 12-month data from the Phase IIb CLOVER-WaM study, meeting both primary and secondary endpoints. Performance was driven by iopofosine I 131's ability to produce durable responses in a heavily pretreated Waldenstrom Macroglobulinemia (WM) population, including those refractory to BTK inhibitors. Management attributes the study's success to the targeted phospholipid drug conjugate platform, which maintained a 98.2% disease control rate in a population with limited approved options. Strategic positioning focuses on addressing the 'post-BTKi' treatment gap, where approximately 60,000 to 80,000 patients in the U.S. and EU currently lack FDA-approved therapies after progressing on standard care. Operational focus has shifted from clinical validation to late-stage execution, supported by an oversubscribed $140 million financing agreement. R&D expenses decreased to $3 million as CLOVER-WaM follow-up activities wound down, though this was partially offset by increased manufacturing investment for iopofosine and CLR125. Management plans to initiate a randomized Phase III confirmatory study in late Q4 2026, utilizing progression-free survival (PFS) as the primary endpoint. The NDA submission for accelerated approval is contingent upon the initiation and enrollment of the Phase III study, with a target submission window in early 2027. The company anticipates a potential FDA approval action in the second half of 2027, leveraging its existing Breakthrough Therapy Designation for an expedited 6-month review. Current cash reserves, bolstered by the recent financing, are projected to fund operations and the Phase III trial into the second quarter of 2027. Future capital access is structured around three $35 million tranches tied to specific milestones: Phase III enrollment, NDA acceptance, and final FDA approval. The $140 million financing includes $105 million in milestone-based warrants that are callable only if the stock maintains a price above $3.45 with specific volume requirements. Dosing has commenced in a Phase Ib trial for CLR125, targeting relapsed/refractory triple-negative breast cancer (TNBC), an aggressive subtype representing 12% of U.S. breast cancer cases. The TNBC study utilizes dosimetry assessments to predict safety and therapeutic activity across three distinct dose levels and regimens. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Over 50% of patients entered the study immediately after failing BTK inhibitor therapy, while others transitioned from rituximab monotherapy or chemo-combinations. Management emphasized that this represents a highly refractory population with a median of four prior lines of therapy. The company has aligned with the FDA to use RCD (rituximab, cyclophosphamide, dexamethasone) as the comparator arm for the Phase III study. Management expects the control arm to show a PFS of approximately 5.8 to 8.1 months based on historical salvage therapy data in post-BTKi patients. The study is powered assuming a 12-month PFS for iopofosine, though Phase II data showed a PFS exceeding 15 months, suggesting the trial is conservatively powered for success. The NDA will be filed once the Phase III study is 'up and running' and enrolling, likely 2-3 months after the late 2026 initiation. Breakthrough Designation is expected to shorten the FDA review period to 6 months from the time of submission.

Image source: The Motley Fool. Thursday, May 14, 2026 at 8:30 a.m. ET President and CEO — James Caruso Chief Financial Officer — Chad Kolean Chief Operating Officer — Jarrod Longcor Investor Relations — Anne Marie Fields Need a quote from a Motley Fool analyst? Email [email protected] Anne Marie Fields: Thank you, Vanessa. Good morning, and welcome to Cellectar Biosciences First Quarter 2026 Financial Results and Business Update Conference Call. Joining us today from Cellectar are Jim Caruso, President and CEO; who will provide an overview of the company's progress before turning the call over to Chad Cohen, 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. Actual 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 the SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 14, 2026. The company undertakes no obligation to revise or update any 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 for your questions. Now let me turn the call over to Jim Caruso. Jim? James Caruso: Thank you, Anne Marie, and thank you to all for joining us today. The first quarter of 2026 marked a transformational period for Cellectar. Defined by rigorous execution across our clinical, regulatory and financial strategies. We entered the year with momentum. And over the past quarter, that momentum has meaningfully accelerated. Earlier this month, we reported positive 12-month follow-on data from the Phase IIb CLOVER WaM study evaluating iopofosine I 131 in patients with relapsed or refractory Waldenstrom Macroglobulinemia or WM. These data demonstrated durable and consistent responses across one of the most heavily pretreated and refractory WM populations studied to date, including patients who were both exposed to and refractory to BTKi inhibitors. Importantly, iopofosine met both the primary and secondary endpoints of the study. Reinforcing our confidence in its clinical profile and its potential to address a profound unmet need in WM, particularly for patients who have been previously prescribed to BTKi and are now searching for treatment answers with off-label salvage therapies. These results take on even greater significance when viewed in the broader disease context. WM is a rare and curable lymphoma affecting a prevalent patient population of approximately 60,000 to 80,000 patients in the U.S. and EU alone with a rapidly growing population of patients progressing after BTKi therapy with no FDA-approved therapies beyond BTKIs. For these patients, therapeutic options are limited, outcomes are suboptimal and the need for new durable treatments is urgent. With the full 12-month data set now in hand, along with a deep and mature body of clinical evidence, we are advancing our plans to file for accelerated approval with the FDA and to initiate a randomized Phase III confirmatory trial. We believe iopofosine is well positioned to meet regulatory expectations and to become a foundational therapy in the WM treatment landscape. Running in parallel with this clinical momentum, we announced an oversubscribed financing of up to $140 million, led by high-quality long-term health care investors. This capital materially strengthens our balance sheet and provides the resources necessary to advance iopofosine through our planned Phase III confirmatory study and potential commercialization as well as support the continued advancement of triple-negative breast cancer study as part of our broader radiopharmaceutical pipeline. Taken together, the strength of our iopofosine data and the successful financing represent a clear inflection point for Cellectar. They enable us to move forward decisively from a clinical validation to late-stage execution. With that overview, I'll now turn the call over to Chad to walk through our financial results. Chad Kolean: Thank you, Jim, and good morning, everyone. I'll address our financial results for the period ended March 31, 2026, and the recently completed financing that allows us to accelerate our development of iopofosine I 131. We ended the first quarter with cash and cash equivalents of approximately $8.3 million compared to $13.2 million at the end of 2025. This does not include the results of the financing, which I will address in a moment. Our research and development expenses for the 3 months ended March 31, 2026, were approximately $3 million compared to approximately $3.4 million for the 3 months ended March 31, 2025. R&D costs declined as the follow-up activities for patients of CLOVER WaM Phase IIb clinical study declined and preclinical product development was reduced. These reductions were partially offset by increased manufacturing spend for both iopofosine and CLR125. General and administrative expenses for the 3 months ended March 31, 2026, were $2.8 million compared to $3 million for the same period in 2025. The modest decrease in G&A was driven primarily by reduced personnel costs. Net loss for the 3 months ended March 31, 2026, was $5.7 million or $1.33 per share compared with $6.6 million or $4.30 per share during the 3 months ended March 31, 2025. Importantly, as Jim stated earlier. Earlier this month, we completed an oversubscribed financing for up to $140 million, consisting of an upfront amount of $35 million and up to $105 million in milestone-based capital. As a result, we believe our current cash position enables us to fund planned operations, particularly the initiation of our confirmatory Phase III trial of iopofosine in patients with WM into the second quarter of 2027. The structure of the milestone-based warrants is designed to provide additional funding at key points in the development of iopofosine. Three tranches of warrants, one tied to each of three milestones were issued for each security the investors purchased upfront. The first milestone is the initiation of the confirmatory study as demonstrated by the enrollment of the first patient in the study. The second milestone is the acceptance of an NDA submission by the FDA. And the third milestone is the approval of iopofosine by the FDA. Upon the attainment of each milestone, provided our common stock trades above $3.45 with volume exceeding $500,000 per day for 20 consecutive days, the company can call the warrants for cash. The warrants for each milestone represent potential additional funding of $35 million. So the aggregate potential for the 3 milestones is $105 million and when combined with the upfront of $35 million represents the $140 million of total potential funding. The warrants are all exercisable upon approval of the transaction by the stockholders. Which will be part of our Annual Stockholders' Meeting agenda. Completion of this offering puts us in a position of financial strength and strategic flexibility, allowing the organization to remain focused on disciplined execution and value creation. Now I will turn the call over to Jarrod for an operational update, including plans for our promising pipeline of radiopharmaceuticals. Jarrod Longcor: Thank you, Chad, and good morning, everyone. As Jim highlighted, the 12-month CLOVER-WaM results represent a significant milestone for iopofosine for patients living with WM. For some background, patients enrolled in the CLOVER-WaM had a median of four prior lines of therapy with refractory rates from 77% to 75% and 60% in BTKi, rituximab chemotherapy exposed patients, respectively. Additionally, 58% of patients exposed to both BTKi and rituximab were dual class refractory. Despite this being one of the most heavily pretreated and refractory WM patient populations to date, iopofosine produced robust and durable responses, underscoring the strength of the targeted phospholipid drug conjugate platform. Notably, the primary and secondary endpoints were both achieved in the protocol study population (N=55) with an overall response rate of 83.6% and the primary endpoint of major response rate or MRR, improving to 61.8%. The secondary endpoint of duration of response, or DOR, achieved a median of 17.8 months. Importantly, greater than 30% of responders maintained their responses beyond 36 months. The median progression-free survival was 13.5 months and the (VGPR/CR) rate was 14.5%. The disease control rate remained stable at 98.2%. In addition, the data demonstrated consistent efficacy in both BTKi exposed and BTKi refractory patients. These results compare favorably with available therapies in the post-BTKi setting, where outcomes remain limited and durability is often modest. Moreover, iopofosine's fixed dose regimen and manageable safety profile may also provide offer practical advantages for patients and providers. Importantly, these outcomes incorporate key elements that align with the previously described regulatory expectations for iopofosine's eligibility for accelerated approval. We were delighted to have the immediately post-BTKi subgroup analysis from the CLOVER WaM trial selected for presentation at the upcoming ASCO conference, which brings together the world's leading oncologists. The safety and efficacy of iopofosine observed to date in this subgroup are highly encouraging and underscore its potential to address a significant unmet need for patients who progressed after BTKi therapy. We believe these findings further support the potential for iopofosine to emerge as a differentiated therapeutic option in the post-BTKi setting and as early as the second line of treatment in WM. With the strength and maturity of the total data set, we are advancing with a randomized controlled Phase III confirmatory study, evaluating progression-free survival as the primary endpoint. We anticipate initiating the study in the late fourth quarter of 2026. Beyond iopofosine, we were delighted to advance our broader pipeline with the recent dosing of the first patients in the Phase Ib trial of CLR125, our OJ emitting radio conjugate in relapsed/refractory triple-negative breast cancer or TNBC. TNBC is an aggressive subtype of breast cancer characterized by the absence of estrogen receptors, progesterone receptors and HER2 protein expression. This lack of common therapeutic targets make TNBC particularly challenging to treat with limited options beyond chemotherapy. TNBC tends to grow and spread more quickly than other breast cancer types and disproportionately affects younger women and those of African descent. In the U.S., approximately 12% of breast cancer diagnoses are triple-negative breast cancer. CLR125 with its demonstrated selective tumor uptake, promising activity in preclinical models of TNBC gives us confidence in its potential to be an effective treatment for TNBC. The Phase Ib clinical trial is an open-label dose-finding study in patients with relapsed/refractory TNBC. It will evaluate three dose levels and dosing regimens of CLR125. 32.75 millicuries administered over four cycles or 62.5 millicuries per meter squared over three cycles or 95 millicuries per meter squared over 2 cycles, with approximately 15 patients enrolled per treatment arm with an expansion arm of an additional 15 patients for the recommended Phase II dose. The study utilizes dosimetry assessments to characterize tumor uptake and distribution, which supports the prediction of safety and therapeutic activity. Clinical endpoints include safety, tolerability as well as preliminary efficacy measures, including tumor response per RECIST criteria and progression-free survival. The study is well underway and our first patients already treated, and we look forward to sharing biodistribution, dosimetry and early clinical efficacy insights as the year progresses. Overall, 2026 is shaping up to be a year of substantial execution and progress across the organization, and we remain focused on advancing each program with scientific rigor and regulatory discipline. With that overview of our clinical progress and plans moving forward, I'll turn the call back to Jim for closing remarks. James Caruso: All right. Thank you, Jarrod. As we look ahead, Cellectar enters the next phase of 2026 with clarity of purpose, strong momentum and the financial resources to execute. The combination of compelling 12-month iopofosine data and a significantly strengthened balance sheet positions us to advance with the initiation of our Phase III confirmatory study and subsequent accelerated approval application. The WM patient community remains at the heart of our commitment. We continue to hear from and remain motivated by individuals and families affected by WM, particularly those patients with limited treatment options or those that are no longer treatment seekers because of poor or no remaining treatment options. The product profile presented by iopofosine reinforce our belief that this therapy has the potential to be truly meaningful and potentially life-changing for these patients in need. At the same time, we remain disciplined towards of capital, focused on creating long-term shareholder value by advancing differentiated assets, engaging constructively with regulators and executing against clearly defined milestones. I want to take this opportunity to thank the entire Cellectar team for their continued dedication and sense of urgency. And I thank our investors for their continued support and conviction. We are committed to delivering on both our mission for patients and our responsibility to shareholders. With that, operator, we are happy to open the call for questions. Operator: [Operator Instructions] And we have our first question from Kevin DeGeeter with Ladenburg Thalmann. Kevin DeGeeter: My first question is on CLOVER WaM and specifically for the BTK experienced patients. did most patients go directly from a BTK inhibitor to study drug in CLOVER WaM or for the patients that did get lines of therapy between a BTK and coming on study drug, what were the most common therapies they received immediately prior to study drug? James Caruso: Kevin, this is Jim. First of all, thank you for your participation in the call today. And your question is spot on. It's significant on a number of different levels, and I'll ask Jarrod Longcor to address it. Jarrod Longcor: Kevin, briefly, I don't have the number -- the exact number in my head at the moment, but I can say that it was over 50% of patients in the study, who immediately came off BTKi before getting treatment with iopofosine. Most common -- in addition to that as the most common sort of transition, the other would be coming directly off of rituximab either monotherapy or in combination with chemotherapy. Kevin DeGeeter: Really helpful. And then with regard to the Phase III program, thanks for the additional color. Can you comment on what the likely comparator arm for the Phase III program will be or at least -- or I think the question I'm ultimately interested is how one might think about potential range of PFS for the control arm population in a potential Phase III population? James Caruso: Excellent question, Kevin. We've had -- we've engaged our friends at the FDA a number of different times on this. So we've settled in and are aligned on the comparator arm in the study. I could have Jarrod talk to that and provide some additional color. Jarrod Longcor: Yes. So it is a great question. So what we believe the -- or what we've aligned on with the agency on the comparator arm is rituximab, cyclophosphamide, dexamethasone or RCD. It is commonly used in a post-BTKi patient population that tends to have significant adverse events associated with any of the other treatments and provides a comparable sort of outcome to some of the other treatment scenarios. So it makes a good choice. I will say since you sort of asked the question about how to think about these compounds and how they might behave because obviously, in the literature, what you will find is that RCD, the last time it was significantly sort of challenged or experienced in various studies was pre-BTKi being in the marketplace. And so what you best bet is to look at an article that came out from a group, I'll call it Anna Frustaci out of Italy, where they demonstrated that with any rituximab combination and essentially any salvage therapy, progression-free survival in those patients varied anywhere from about 5.8 to 8.1 months in a post-BTKi exposed patient population and refractory for the earlier numbers. So the 5.8 was a refractory patient population, which in our case, with the pivotal study or the confirmatory study that we're designing, which is essentially an immediate post-BTKi patient population following the frontline therapy. What we expect to see is the vast majority of those patients to be refractory to the BTKis' when they enter into the clinical study. James Caruso: And the refractory to BTKi population in that salvage therapy, including these RCD combinations were approximately 5.8 months, correct? Jarrod Longcor: Correct. James Caruso: And out of the Phase II CLOVER WaM, our progression-free survival with iopofosine. Jarrod Longcor: It was over 15 months. James Caruso: In that same patient population. I think the other element there, Kevin, if you could take a moment and just talk to the powering of the study, the 100 in each arm and based on that differential, your level of confidence relative to how the study was powered. Jarrod Longcor: Yes. So to Jim's point on the powering, what we did was we assumed for the comparator arm, essentially a hazard ratio that corresponds to an 8-month progression-free survival. And for the iopofosine arm, we used a hazard ratio that assumed no greater than a 12-month progression-free survival. So obviously, as Jim just said, our expectation is really that the -- with the vast majority of the patients being BTKi refractory, we're going to see something likely closer to 6 months of progression-free survival of the per arm. And if the patients behave as they did in the CLOVER WaM study, we would expect something closer to 15 months in the iopofosine arm, thereby essentially overpowering the study by a number of patients in order to ensure success. Kevin DeGeeter: Makes a lot of sense. And if I could just sneak in one more. I think just one of the questions that might be on investors' minds is just how you're thinking about the potential timing for an NDA submission under accelerated approval for WM. James Caruso: It's pretty straightforward from our perspective. I mean, we're planning to initiate the study, as Jarrod had cited at the very back end of this year. Once we have the study up and running, enrolling patients, and that may be a couple of 2, 3 months. At that point, we would submit our new drug application. Please keep in mind that in May of last year, we received our breakthrough designation, which essentially obligates the FDA to -- for a 6-month window prior to regulatory action. So if you initiate at the very back end of this year, wait a couple of 2 or 3 months and then have the FDA action within 6 months of that submission. You're in the second half of 2027 with a potential approval. Operator: [Operator Instructions] There are no further questions at this time. I will now turn the call over to Jim Caruso for final remarks. James Caruso: All right. Thank you, operator. I appreciate your assistance today. And certainly, thank you to all conference participants for both your time and continued interest in Cellectar. Have a good day. Operator: And thank you, ladies and gentlemen. This concludes today's conference call. Thank you for your participation. You may now disconnect. Before you buy stock in Cellectar Biosciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Cellectar Biosciences wasn’t one of them. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Cellectar (CLRB) Q1 2026 Earnings Transcript was originally published by The Motley Fool

Announced Positive 12-month Follow-on Data for Iopofosine I 131 in relapsed/refractory Waldenström Macroglobulinemia (r/r WM) Completed Financing of up to $140 Million to Support Initiation of Confirmatory Study of Iopofosine I 131 in r/r WM and Subsequent U.S. FDA Filing for Accelerated Approval Efficacy Results from r/r WM Patients in CLOVER-WaM Phase 2b Study Treated with Iopofosine I 131 Immediately Following BTK Inhibitor Therapy Selected for Presentation at ASCO 2026 Dosed First Patients in Phase 1b Dose Finding Study for CLR 125 in Triple Negative Breast Cancer with Early Dosimetry, Safety and Efficacy Data Expected Mid-year 2026 Company to Hold Webcast and Conference Call at 8:30 AM ET Today FLORHAM PARK, N.J., May 14, 2026 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced financial results for the quarter ended March 31, 2026, and provided a corporate update. “The first part of 2026 was a pivotal period for Cellectar as we executed across our pipeline and capital strategies to position the company for value creation,” said James Caruso, president and chief executive officer of Cellectar. “With the support of industry-leading healthcare focused investors, we successfully completed a financing of up to $140 million, providing the necessary resources to advance iopofosine through key U.S. regulatory milestones and potential commercialization. The recently reported positive 12-month follow-on data from our CLOVER WaM study reinforce our confidence that iopofosine can provide meaningful patient benefits and meet regulatory expectations, supporting our plans to initiate a Phase 3 confirmatory study and file for accelerated approval with the FDA,” Mr. Caruso continued. “In parallel, we expanded our radio-conjugate pipeline with the enrollment of the first patients in our Phase 1b study of CLR 125 in triple negative breast cancer, a challenging solid tumor cancer with a substantial unmet medical need. Together, these advances underscore the strength of our radiopharmaceutical platform and potential to deliver meaningful new treatment options to patients battling a variety of difficult-to-treat cancers,” concluded Mr. Caruso. First Quarter 2026 and Recent Corporate Highlights Iopofosine I 131, the company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope) Reported positive 12-month follow-up data from all patients in the Phase 2b CLOVER WaM study evaluating iopofosine I 131 in relapsed/refractory Waldenström Macroglobulinemia, which demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients. The minimum 12-month follow-up data aligns with the expectations set by the U.S. Food and Drug Administration (FDA) and positions the company for accelerated approval submission and the initiation of the confirmatory study. Notably, the primary and secondary endpoints were both achieved in the protocol study population (n=55), with 61.8% achieving a major response rate (MRR) and a median duration of response (DoR) of 17.8 months. Additional data points included: Overall response rate (ORR): 83.6% Median progression-free survival (PFS): 13.5 months Very good partial response/complete response rate (VGPR/CR): 14.5% Disease control rate (DCR):98.2 Selected to present data from the CLOVER WaM study of iopofosine I 131 in r/r WM patients at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO) taking place May 29 - June 2, 2026. The poster presentation will highlight efficacy results from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy. Details of the poster presentation are as follows: Title: “Iopofosine I-131 after BTK inhibitors in Waldenström macroglobulinemia: CLOVER-WaM subgroup efficacy and safety” Poster: 592 Date/Time: June 1, 2026, 9:00 AM – 12:00pm CDT Presenter: Jarrod Longcor Advancing plans to initiate a Phase 3 confirmatory trial of iopofosine I 131 as a treatment for WM and file for accelerated approval with the U.S. FDA in alignment with the FDA requirements. This Phase 3 study will be a comparator, randomized controlled study with approximately 100 WM patients per arm, with full patient enrollment projected within 18-24 months of the first patient admitted to the study. Continuing to work with the European Medicines Agency (EMA) to file for a Conditional Marketing Approval (CMA) for iopofosine I 131 as a treatment option for post-BTKi refractory patients with WM. CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors Announced the enrollment of the first patient in the Phase 1b trial evaluating CLR 125 in refractory triple negative breast cancer (TNBC). The Company anticipates activating additional study sites throughout the second quarter and will provide dosimetry, safety and efficacy updates in the second quarter and throughout the balance of 2026. Corporate In May 2026, the Company entered into a securities purchase agreement with certain institutional investors to issue and sell an aggregate of approximately $35 million upfront and up to $105 million of milestone-based securities in a registered direct offering of common stock and a concurrent private placement of common stock, pre-funded warrants and milestone-based warrants. The oversubscribed financing was led by Nantahala Capital, with participation from Balyasny Asset Management, Caligan Partners, Janus Henderson Investors, SilverArc Capital Management and other dedicated healthcare funds. In connection with the Offering, Andrew Gu of Nantahala Capital Management, LLC will join Cellectar’s Board of Directors. 2026 Financial Highlights Cash and Cash Equivalents: As of March 31, 2026, the company had cash and cash equivalents of $8.3 million, compared to $13.2 million as of December 31, 2025, which does not reflect net proceeds of approximately $31 million from the May 2026 offering. The company believes its cash balance as of March 31, 2026, along with funds from the May 2026 financing, are adequate to fund its budgeted operations into the second quarter of 2027, including the initiation costs for the iopofosine I 131 confirmatory study in WM. Research and Development Expenses: R&D expenses for the three months ended March 31, 2026, were approximately $3.0 million, compared to approximately $3.4 million for the three months ended March 31, 2025. The overall decrease was primarily a result of reduced clinical and preclinical study costs, partially offset by increased spending for product manufacturing processes. General and Administrative Expenses: G&A expenses for the three months ended March 31, 2026, were approximately $2.8 million, compared to approximately $3.0 million for the same period in 2025. The decrease was primarily a result of reduced personnel costs. Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2026, was $5.7 million, or $1.33 per share, compared to $6.6 million, or $4.30 per share, in the three months ended March 31, 2025. Conference Call & Webcast Details Cellectar management will host a conference call and webcast today, May 14, 2026, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the “Events & Presentations” section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days. About Cellectar Biosciences, Inc. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes iopofosine I 131, which is a PDC designed to provide targeted delivery of iodine-131 (radioisotope). Iopofosine I 131 has been tested in Phase 2b trials as a treatment for relapsed or refractory Waldenström Macroglobulinemia (WM), in relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma. The CLOVER-2 Phase 1b study is evaluating iopofosine I 131 in pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIority MEdicines (PRIME) designation. Cellectar is also developing CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal cancer, and is currently being evaluated in a Phase 1b study for TNBC, which will determine the recommended dose for the subsequent Phase 2 trial. CLR 125 has been well tolerated in vivo and has demonstrated strong preclinical data showing reduction or inhibition of solid tumor growth. In addition to these assets, the Cellectar team is developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors in indications with significant unmet need, such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. For more information, please visit https://www.cellectar.com/or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook. Forward Looking Statements Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the quarterly period ended March 31, 2026. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. INVESTORS: Anne Marie Fields Precision AQ 212-362-1200 [email protected] +++ TABLES TO FOLLOW +++

FLORHAM PARK, N.J., May 11, 2026 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the Company will report financial results for the first quarter ended March 31, 2026, and provide a corporate update on May 14, 2026, at 8:30 a.m. Eastern Time. A replay of the corporate presentation will be available on the Events section of the Company’s Investor Relations website. About Cellectar Biosciences, Inc. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes iopofosine I 131, which is a PDC designed to provide targeted delivery of iodine-131 (radioisotope). Iopofosine I 131 has been tested in Phase 2b trials as a treatment for relapsed or refractory Waldenström Macroglobulinemia (WM), in relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma. The CLOVER-2 Phase 1b study is evaluating iopofosine I 131 in pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIority MEdicines (PRIME) designation. Cellectar is also developing CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal cancer, and is currently being evaluated in a Phase 1b study for TNBC, which will determine the recommended dose for the subsequent Phase 2 trial. CLR 125 has been well tolerated in vivo and has demonstrated strong preclinical data showing reduction or inhibition of solid tumor growth. In addition to these assets, the Cellectar team is developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors in indications with significant unmet need, such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. For more information, please visit https://www.cellectar.com/ or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook. Investor Contact: Anne Marie Fields Precision AQ 212-362-1200 [email protected]