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Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference call over to Anne Marie Fields, Managing Director at Precision AQ. Please go ahead.

Thank you, Vanessa. Good morning, welcome to Cellectar Biosciences first quarter 2026 financial results and business update conference call. Joining us today from Cellectar are James Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Kolean, CFO, for a financial review of the quarter. Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Cellectar issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of Cellectar's corporate website. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 James Caruso. James.

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. Over the past quarter, that momentum has meaningfully accelerated. Earlier this month, we reported positive 12-month follow-on data from the phase II-B CLOVER-WaM study evaluating iopofosine I-131 in patients with relapsed or refractory Waldenström's 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 a 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 incurable lymphoma affecting a prevalent patient population of approximately 60,000-80,000 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 healthcare 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.

Thank you, James, 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 R&D expenses for the three months ended March 31, 2026, were approximately $3 million, compared to approximately $3.4 million for the three months ended March 31, 2025. R&D costs declined as the follow-up activities for patients of the CLOVER-WaM phase II-B clinical study declined and preclinical product development was reduced.

These reductions are partially offset by increased manufacturing spend for both iopofosine and CLR 125. General and administrative expenses for the three months ending 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 three 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 three months ended March 31, 2025. Importantly, as James stated 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 plant operations, particularly the initiation of our confirmatory phase III trial by 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. The aggregate potential for the three 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.

Thank you, Chad. Good morning, everyone. As James 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 4 prior-line therapy, with refractory rates from 77%-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, equaling an N of 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 offer practical advantages for patients and providers. Importantly, these outcomes incorporate key elements that align with 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 progress 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 control 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 I-B trial of CLR 125, our Auger-emitting radioconjugate in relapse 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. CLR 125, 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 I-B clinical trial is an open label dose-finding study in patients with relapsed refractory TNBC. It will evaluate 3 dose levels and dosing regimens of CLR 125. 32.75 millicuries administered over 4 cycles or 62.5 millicuries per meter squared over 3 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 are 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 James for closing remarks.

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 stewards 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. 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.

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you're using a speakerphone, please lift the handset first before pressing any keys. We have our first question from Kevin DeGeeter with Ladenburg Thalmann.

Hey, good morning, guys. Thanks for taking my question. My first question is on CLOVER-WaM and specifically for the BTK experienced patients. Did most patients go, you know, directly from a BTK inhibitor to, you know, study drug in CLOVER-WaM or, for the patients that, you know, did get lines of therapy between a BTK and coming on study drug, you know, what were the most common therapies they received immediately prior to study drug?

Hi, Kevin. This is James. First of all, thank you for your participation in the call today. Your question is spot on. It's significant on a number of different levels, and I'll ask Jarrod Longcor to address it.

Yeah. Hi, 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. you know, in addition to that, as the most common sort of transition, the other would be coming directly off rituximab, either monotherapy or in combination with chemotherapy.

No, really helpful.

Right.

Then with regard to the, you know, 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 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?

You know, excellent question, Kevin. We've had, we've engaged our friends at the FDA a number of different times on this. 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.

Yeah. It is a great question. 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. 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.

What you best bet is to look at an article that came out from a group, I'll call it Anna Bustocchi out of Italy, where they demonstrated that with any rituximab combination, essentially any salvage therapy, progression-free survival in those patients varied anywhere from about 5.8-8.1 months in a post-BTKI exposed patient population and refractory for the earlier number. 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 immediately post-BTKI patient population following 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.

The refractory to BTKI population, in that salvage therapy, including these RCD combinations, were approximately 5.8 months, correct?

Correct.

Out of the phase II CLOVER-WaM, our progression-free survival with iopofosine-

Was over 15 months.

In that same patient population?

I think the other element there, Kevin.

Yep.

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.

Yeah. To James point on the power, what we did was we assumed for the comparator arm, essentially a hazard ratio that corresponds to an 8-month progression-free survival. For the iopofosine arm, we used a hazard ratio that assumed no greater than a 12-month progression-free survival. Obviously, as James just said, our expectation is really that the, with the vast majority of the patients being BTKI refractory, we're gonna see something likely closer to 6 months of progression-free survival with the comparator arm. 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.

Makes a lot of sense. 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 a potential timing for an NDA submission under accelerated, you know, approval, for WM.

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, 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. If you initiate at the very back end of this year and wait a couple, 2, 3 months and then have the FDA action within 6 months of that, the submission, you know you're in the second half of 2027 with a potential approval.

Great. Thanks for taking my questions.

All right, Kevin. Thank you.

Thank you. As a reminder, if you would like to ask a question, please press star then one. There are no further questions at this time. I will now turn the call over to James Caruso for final remarks.

All right. Thank you, operator. 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.

Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for your participation. You may now disconnect.

Ladies and gentlemen, thank you for standing by, and welcome. At this time, all participants are in listen-only mode. Following the presentation, there will be a question-and-answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference call over to Anne Marie Fields, Managing Director at PrecisionIQ. Please go ahead.

Thank you, operator. Good morning, and welcome to Cellectar Biosciences, Inc.’s fourth quarter and full-year 2025 Financial Results and Business Update Conference Call. Joining us today from Cellectar Biosciences, Inc. 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 and the year. 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 Biosciences, Inc. issued a release earlier this morning detailing the contents of today's call. A copy can be found on the investor page of Cellectar Biosciences, Inc.’s corporate website. I want to remind callers that the information discussed on the call today is covered under the Safe Harbor provision 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 information that is accurate only as of the date of this live broadcast, 03/04/2026. The company undertakes no obligation to revise or update any forward-looking statement 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. We will begin the call with prepared remarks and then open the line for your questions. Let me now turn the call over to Jim Caruso.

Thank you, Anne Marie, and thank you all for joining us this morning as we review Cellectar Biosciences, Inc.’s progress throughout the year. 2025 was a productive and strategically meaningful year for Cellectar Biosciences, Inc. Across the organization, we executed with focus and discipline, advancing our lead asset, Iapocin, I-131, strengthening our regulatory position in both Europe and the U.S., and progressing our next-generation radiotherapeutic programs supported by our proprietary phospholipid drug conjugate platform. Let me begin with iapocene I-131, our late-stage in Waldenstrom's macroglobulinemia, or WM. As discussed in this morning's press release, we ended the year with regulatory alignment in Europe. Following guidance from the EMA's Scientific Advice Working Party, or SAWP, we remain on track to submit a conditional marketing authorization application in 2026, positioning iapopacine for potential approval in European commercialization as early as 2027. This EU regulatory clarity together with iaupopasim's PRIME designation underscores both the strength of the CLOVER-WaM dataset and the significant unmet medical need. As the full twelve-month follow-up data become available in early 2026, we are even more convicted on our plans to pursue an NDA under the accelerated approval pathway. These assumptions are supported by hypopacine's FDA Breakthrough Therapy designation for WM, and by our agency dialogue. In addition, we continue engagement and partnering conversations to support the program globally. Beyond iapofacine, we also made important progress across our broader PDC-based radiotherapeutic pipeline. We initiated the Phase 1b study of CLR125 in triple-negative breast cancer, or TNBC. CLR125 is an iodine-125 Auger-emitting agent designed for highly precise tumor targeting, and its initiation represents a key milestone for this second asset. The dose-finding study is ongoing, and we expect early interim data in mid-2026. We also strengthened the infrastructure supporting our alpha-emitting program, CLR225, through new supply partnerships with ITM Technologies and Ionectics, providing commercial-scale access to 225 and astatine-211 for future clinical development. Importantly, 2025 also marked significant expansion of our global intellectual property estate with new patents issued across Europe, Asia Pacific, the Middle East, as well as the Americas. These patents bolster the protection of ibuprofen I-131, CLR125, and the broader PDC platform. Finally, we raised approximately $15.2 million over the course of the year, extending our cash runway and enabling ongoing advancement of our pipeline, which positions us to achieve a number of value-creating milestones throughout the year. With that brief overview, I will now turn the call over to Chad to review our financial results. Chad?

Thank you, Jim, and good morning, everyone. I will address our financial results for the year ended 12/31/2025. We ended the year with cash and cash equivalents of $13.2 million, as compared to $23.3 million as of 12/31/2024. In the fourth quarter, we raised $5.8 million and now expect that our cash on hand is adequate to fund budgeted operations into 2026. Turning to our results from operations, research and development expenses for the three months ended 12/31/2025 were approximately $11.5 million, compared to approximately $26.6 million for the year ended 12/31/2024. The overall decrease in research and development was largely driven by the conclusion of patient enrollment and declining patient follow-up for our CLOVER-WaM clinical study, modestly offset by increased activity in our preclinical development project costs. General and administrative expenses for the year ended 12/31/2025 were $11.5 million, compared to $25.6 million for the same period in 2024. The decrease in SG&A was primarily driven by deemphasizing pre-commercialization efforts and related personnel cost reductions. Other income was approximately $1.1 million for fiscal 2025, while in 2024, other income was $7.3 million. These amounts are non-cash and largely a result of the impact of issuing and marking to market certain warrants. The warrants we issued in 2025 were classified as permanent equity upon issuance, reducing the impact on the statement of operations in comparison to fiscal 2024. Net loss for the full year ended 12/31/2025 was $21.8 million, or $8.35 per basic and diluted share, compared with $44.6 million, or $36.52 per basic share and $41.89 per diluted share during 2024. Now I will turn the call over to Jarrod for an operational update, including plans for our pipeline of radiopharmaceuticals.

Thank you, Chad, and good morning, everyone. As Jim highlighted, our regulatory and clinical progress in 2025 positions us well for important advances across our pipeline programs and for a milestone-rich 2026. Starting with iapobicine I-131, our EMA and FDA have provided us with clear, actionable regulatory paths. In Europe, we are planning to submit this conditional marketing authorization application later this year. In the U.S., we continue to make strong progress in our regulatory engagement as we work with the FDA on the accelerated approval pathway and the design of our confirmatory Phase 3 trial to support full registration. As requested by the FDA in November 2024, we have now collected twelve months of follow-up on all patients and, based upon further review of the data, agree that a confirmatory study evaluating iapocene I-131 in a post-BTKi treated patient population in the second-line setting is appropriate. Importantly, this earlier line more than doubles the potential addressable population in the U.S. As mentioned, we have been analyzing the more mature CLOVER-WaM dataset, including the full twelve-month follow-up for all patients, and are very encouraged that the results continue to demonstrate robust and durable clinical benefit over time in this salvage treatment setting where there are no approved drugs. In addition, new subgroup analyses, particularly within defined high-need patient segments, are emerging as especially promising. We look forward to sharing these findings with regulators as part of our ongoing discussions. Taken together, we believe the strength and consistency of these data provide a robust foundation for our U.S. and EU registration strategy. Over the remainder of the year, we intend to present our findings, including a minimum of twelve-month follow-up on all patients, updates on response data, duration of response, progression-free survival, and detailed outcomes in various patient subsets at major medical meetings. We expect these results to be highly compelling to both the clinical community and regulatory decision makers. Beyond WM, ibuprofen continues to show potential across multiple oncology indications. Prior data sets in multiple myeloma and diffuse large B-cell lymphoma demonstrated strong activity in these hematologic malignancies, and recently, I presented data at the AACR Special Conference on Pediatric Cancer from a study of iapopacine in relapsed/refractory pediatric high-grade glioma that showed IFOP seemed to provide meaningful improvements in progression-free survival and overall survival and to be well tolerated with a consistent safety profile. Iapofacine remains an asset with tremendous global market opportunity, and its success supports other assets in our radiopharmaceutical pipeline, including CLR125 and CLR225, and further validates our proprietary phospholipid delivery mechanism. Turning now to CLR125, our Auger-emitting asset for solid tumors, which has the potential to provide extreme precision targeted radiotherapy due to the short-distance Auger emission travel, meaning the isotope must be delivered within the cell and near to the nucleus. As Jim noted earlier, we initiated a Phase 1b dose-finding study in TNBC at two sites, and we will be adding additional sites in the second quarter. This study is evaluating three dosing regimens with an expansion arm planned once the recommended Phase 2 dose is determined. We anticipate a steady cadence of results throughout 2026, including early, interim dosimetry, safety, and preliminary efficacy data. For CLR225, our alpha-emitting asset, we completed IND-enabling work and are ready to initiate a Phase 1 trial pending available funding and continued strategic alignment with corporate objectives. Preclinical studies in pancreatic cancer models have shown compelling tumor inhibition at multiple dose levels, further demonstrating the potential of targeted alpha therapy within our platform. Across the pipeline, our expanded global patent estate provides long-term protection for ibuprofen, CLR125, and dosing regimens central to our PDC technology. Combined with strengthened isotope supply partnerships, we believe we are well positioned to build sustainable value. 2025 was a year of significant regulatory, clinical, and operational advancement, and we look forward to continuing this momentum throughout 2026. Jim, I will turn it back to you for closing remarks.

All right. Thanks, Jarrod, for that overview. As you have heard today, 2025 was a year defined by meaningful progress across the entirety of our radiotherapeutic pipeline, with strong execution across the organization. We advanced iapoficine toward key regulatory submissions that would accelerate its market approval and get this much-needed therapy to patients. We initiated the CLR125 Phase 1b trial for triple-negative breast cancer, expanded our intellectual property, strengthened supply chain infrastructure, and extended our cash runway. We are entering 2026 with clear vision, strong momentum, and a pipeline supported by robust science and regulatory engagement. We expect multiple value-creating milestones in the months and year ahead, and remain focused on delivering transformative therapies to patients with difficult-to-treat cancers. I want to extend my gratitude to our outstanding Cellectar Biosciences, Inc. team whose commitment and hard work continue to drive our programs and the company forward. We remain deeply committed to the WM community and are grateful for their strong support and encouragement as we work to bring hypophasine to patients. We will now open for questions. Operator, we are ready to open the call for questions.

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the queuing process, please press the star followed by the number two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Aydin Huseynov with Ladenburg. Please go ahead.

Hi. Good morning, Cellectar Biosciences, Inc. team, and congratulations for the progress in 2025 and so far in 2026. A couple of questions I have regarding apofacine. So you are planning to submit in the third quarter for EMA. I am just curious to understand, can you use the same package that you will submit to EMA? Can you use exactly the same package for the FDA submission as well? And how long after you start the Phase 3 trial can you actually initiate that process of submission with the FDA?

Sure. Aydin, first of all, thank you for participating in the call. As always, we appreciate that and your coverage of the company. Let me start, and then we will turn it over to Jarrod to provide some additional details relative to your question. As you may recall, we have already built out substantial portions of our NDA application, and although the format with the EMA is different, there are a lot of similarities in terms of the requested data. So a lot of the work that we have already done in preparation for our NDA submission, we can also apply to the EMA. Jarrod has been providing oversight on this process and I will turn it over to him to provide greater detail.

Good morning. Great question. So the very short answer is yes. The data itself is essentially the same, and so it is all, obviously, it is all the CLOVER-WaM data. There will be some different, what I will call subset analyses, that the EMA may have requested that might be a bit different than what the FDA might request. So we are executing on that. And as Jim said, the standard packages are a little different, the ordering and how things come together for the EMA versus the FDA. The actual NDA is a little different from the CMA package development, but otherwise, it is all the same. So, as you said, that is pretty much largely taken care of at this point. And then your second part of your question was, I think, how long to submitting in the U.S. post the initiation of the confirmatory study? Is that correct?

Yes. Yes.

Okay. So the way we are doing that, just to share, back when we met with the agency in November 2024, where they basically outlined for us a handful of criteria that were necessary for us to achieve in order to be able to submit for the accelerated approval, part of what they shared was that, for an accelerated approval, a study must be initiated at the time of submission and ongoing, meaning enrolling patients, at the time of regulatory action. So what we have taken, or the way we are approaching this, is about a month or two post the initiation of the study, having a handful of sites open, we would then submit the NDA to the FDA. That should allow us to have enrolled one or two patients essentially at that point, and then, over the intervening six months, because we now have Breakthrough—remembering that we got Breakthrough designation in May 2025—we are now eligible and have the guaranteed six-month review under the accelerated approval pathway, and so we would then expect that that feedback would come in six months, and we would want to make sure that we had about 10% of the patients enrolled.

So, Jarrod, to summarize that, within seven to nine months of initiation of the study, assuming we submitted the NDA a month or two post initiation, we would have a response from the FDA regarding the accelerated approval. And I think, Aydin, it is also important to point out that at that point in time they are not reviewing any data out of the confirmatory study. It is just a function of the study being initiated, is ongoing, and patients are successfully being enrolled.

Understood and very helpful. And for the Phase 3 confirmatory study design, I mean, it seems like the design is okay with both U.S. and EU to get the full approval. But just for modeling purposes, you are getting into an earlier line of therapy, second line for BTK, and comparing this to rituximab and standard of care. I am trying to understand what it is that we should model in terms of the differences in PFS on evapofolcin versus the standard of care, and, you know, just to get a better sense in terms of what to expect down the road.

Absolutely. And another great question. So, until recently, it was very difficult to give a definitive answer here because nobody had really evaluated any salvage therapy in a post-BTKi exposed patient population. However, earlier this year, or late last year, I guess early 2025—I have to remember we are in 2026 now—a group out of Italy, where the lead author's name was Fristauchi, produced data looking at seventy-eight post-BTKi patients, irrespective of what salvage therapy they got. So these patients received rituximab, chemo, combinations like RCD, or rituximab-bendamustine. They also received subsets of them also received pirtobrutinib, so a noncovalent BTKi. They also received proteasome inhibitors. They received venetoclax or BCL-2 inhibitors. So they basically got every alternative salvage therapy. In all cases, these patients, as a median, their PFS was eight months if they were a second-line patient, irrespective. And what you see is when it was RCD or any of the rituximab combinations, it was sub-eight months as progression-free survival. And so you can clearly model that number because it was a significant patient population, approximately seventy-eight patients again.

I think, thank you, Jarrod. Very helpful. And I think I can provide some additional color relative to our data. Obviously, I cannot report because we have not publicly disclosed the updated twelve-month data, but it will include what we believe to be some very robust durability elements associated with the twelve-month data. So we are really excited about the data package. If everyone was impressed with our clinical data, Aydin, that we have put in play to date, I think the subsequent data based on the twelve-month follow-up is going to be viewed as very, very exciting. And the other element here, and you brought this up, is significant. As you recall, in the CLOVER-WaM study, on average, we were the fifth line of therapy, which means four lines of therapy prior to the utilization of ibuprofen on average. However, under Jarrod's leadership, the team has done substantial analysis, and we have really been able to segment, based on the latest data cut that occurred in December 2025, these patients and the variety of subsets, but also importantly, where they sat in terms of the number of prior treatments. And we will tell you that, as you would expect, as you advance further upstream, the data is more and more impressive. And, as you cited, second line in the U.S. the patient population is double that of third line plus. So it really not only does it create opportunities for clinicians to provide their patients with a meaningful treatment option, there are also going to be a lot more of them in the U.S. and globally benefiting from this treatment.

And just historically, so that we do not lose that, currently, right now in the United States, and it is increasing in Europe, the BTKis are being predominantly prescribed in the first-line setting. Whether that is in combination with rituximab or as monotherapy, since the ibrutinib-rituximab study came out showing that potential in the first-line setting, most of the U.S. physicians have transitioned into a BTKi in the first-line setting in some form or fashion, which means the second-line setting is a BTKi patient population today.

Thank you. Very helpful. And looking at your prior major response rate, they were already high, in our eighties, and you are going to move to the earlier line of therapy. And, typically, the responses increase in earlier lines of therapy. So just curious to understand your sort of benchmark in the earlier line of therapy, and whether this Phase 3 trial design will have some sort of top-line major response rates first before we see the PFS, maybe at some point one year after we start the trial.

So the primary endpoint for the confirmatory study is progression-free survival. Obviously, a secondary endpoint is going to be major response rates or response rates as a whole, and, obviously, major response rate is one of them. What I would say is we will not be announcing data from a confirmatory study during enrollment because, obviously, that can result in bias being introduced into the study, and especially in a comparative study. And that would be problematic and would actually negatively impact the review eventually for full approval.

And so, Aydin, I will add to that. You know, and it is going in a potentially different direction. Based on the primary endpoint, progression-free survival, in that confirmatory study, you can take a look at the Fristauchi data, and you will get a sense as to the progression-free survival there. And so this study is powered in such a way, as we introduce our PFS and durability performance for this drug out of the CLOVER-WaM study, I think it will very quickly determine that, the way the study is powered for the confirmatory study, we are setting ourselves up for a high probability of success, assuming the PFS remains consistent with all of the literature and data that we have seen. And best case there for PFS, as Jarrod discussed, was 8.1 months. So we feel very, very comfortable with PFS being the primary endpoint based on the literature.

Thank you. Very helpful. And the last question I have regarding the current environment in post-BTK in U.S. and EU, what do you feel in terms of the enrollment speed and level of interest of PIs and among patients to be participating in this trial once you start it.

I can say directly that, having spoken with every one of the PIs that were in the CLOVER-WaM study, the interest from the physician side is extremely high. I can say in a number of cases, when I have talked with them recently, they have all felt that the delay from a regulatory standpoint in getting to this point is largely unwarranted and that this drug absolutely has a spot in the marketplace and a significant need to fill. And so I think that that is important from that perspective. I think, again, as patients, this is a very active patient population. They are very engaged as a community and in looking at new therapies. I think as patients and these physicians get a look at the new data that is coming out later this year, as we were talking about, so over the remainder of this year, I think everybody is going to be very excited about the ability to participate and have the impact that ibuprofen can have for them and their disease in this setting.

And I would add that, in addition to the thought leadership that are very excited about this because they are on the cutting edge, they understand and observe the performance of existing salvage therapies, especially just post first line. And as I think Jarrod cited earlier, BTKis are used predominantly now either as a monotherapy or in combination with rituximab in first line. So you are already, for many of these patients, in a salvage therapy mode in the second line. But interesting here, Aydin, in addition to key thought leadership around the globe really appreciative of the feature benefits that this product provides their patients as early as second line, this also tested extremely well with community-based physicians. So we really see this transitioning out of a controlled clinical environment at these world-class institutions or WM catchment centers. Because of the ease of administration and, quite frankly, the lack of artistry required here relative to other drugs—the four simple doses—our community-based physicians are as excited as the thought leaders as well. So I think all constituents, including nuclear medicine and radiation oncology that have a seat at the table in terms of the utilization of this drug, all constituents are really excited about the opportunity to bring this patient to the many patients that will benefit from treatment.

Thank you. Super helpful, and congratulations with the progress so far, and we will be looking forward to seeing your twelve-month data later this year. Thanks so much.

Thank you, Aydin.

Thank you. The next question comes from Edward Andrew Tenthoff with Piper Sandler. Please go ahead.

Great. Thank you, guys, for taking my question, and congrats—my congratulations too on the very hard work and steady progress. You guys deserve a persistence award for sure. I wanted to follow up, two questions if I may. So firstly, and I apologize if I missed this, but what would be the plans to distribute in Europe, and can you walk us through a sense of what that second line now in Europe—would it be second line too, or there it is actually a little different where you would be getting approved? And what does that patient population look like? Thank you very much.

Thank you, Ted. Great to have you on the call. Appreciate your interest, your continued interest in the company. You have been very supportive, so we are appreciative of that. I will have Jarrod launch into this, and then I can fill in any blanks or provide additional color.

Great, and thank you, Ted. From a distribution plan, the idea here is that, obviously, Cellectar Biosciences, Inc. itself, we will not really commercialize it ourselves in Europe. We are in discussions with various parties that we would partner with to actually do the commercialization in Europe on our behalf, in one way or another. So we are looking at partnership as the main thing. Just to give you a sense, we have set up our distribution of a radiotherapeutic in a global sense. I will remind you that the CLOVER-WaM study was run as a global study where we had approximately 25 sites in Europe. We had a handful of sites also in Asia and Australia. And so we have set up a logistical chain that allows us to ship and cover the globe easily with this product. And I will remind you, for folks that may have forgotten, that we have a unique competitive advantage in the marketplace that is often overlooked, which is our shelf lifetime. Most radiotherapies have a shelf life of about three to seven days max. Ours is 21 days. That allows us—and it is not cold chain; it is at room temperature. It allows us to more easily distribute this product globally and make sure that it is conveniently handled by the physicians and by the patients. So that sets up the distribution. Now, the second part of your question was really about, in Europe, where would the approval be, and what is the size of the market? So in general, just to give you a sense, the size of the European market is generally about 10,000 or so patients in total greater than the U.S. I would say that when we look at the second-line setting, the U.S. market is just a bit south of 12,000 patients. In Europe, its second-line setting is generally a bit over 12,000, approaching 13,000 patients, is what we have come to learn. And so it is a meaningful patient subset. Now, the conditional marketing authorization would actually be a later line utilization, so it would be a third line or later post-BTKi patient population. That is largely because still in Europe, they are transitioning. They are using BTKis more in a first-line setting, but they are more evenly split right now between first-line and second-line utilization of BTKi. So the median would likely be a third-line or later sort of position. Upon the confirmatory study, I think we would be shifting to a second-line setting in Europe.

Great. That is very, very helpful color. Appreciate it. Thank you.

Alright. Thanks so much, Ted.

At this time, Jim will address questions sent electronically. Please go ahead.

Alright. So if there are no other questions, I have some that are in the inbox. Jarrod, you up for another question, or—alright. I think I will decipher this one. What is the benefit of the twelve-month data cited in the press release versus your December 2024 data?

Good question. So what I would say is that, reminding folks that in the December 2024 data, most of the patients that we had enrolled at that point did not have twelve months of follow-up data on them. They were still essentially shortly post their treatment segment and therefore did not have the twelve months. Since that time, we have all patients with at least twelve months of follow-up, and while the data presented at ASH was very good in 2024, I think, as Jim alluded to earlier, this follow-up data is even better. And what I mean by that is there are improvements in the response rates, there are improvements in durability, there are improvements in progression-free survival. So across the board, we are seeing depth and durability of the responses going out and looking stronger than they did in December 2024.

Jarrod, could you elaborate on the benefit relative to the regulatory pathway with the FDA in the U.S. on the twelve-month data.

So, in November 2024, the FDA laid out essentially a pathway for accelerated approval that really had two key components to it. One was that we needed to have twelve months of follow-up on all patients, which obviously we now have, which allows us to then take that next step. And the next step was really that we needed to have an ongoing confirmatory study in an earlier line of patients, so as to not be between our study and commercially available product. At the time, we were a little worried about moving to a second-line setting because we did not really have data that would say whether we would be better or worse in that line of setting or the same. Now, with the analysis and the twelve-month follow-up data, we now know exactly that we performed better in an earlier line of setting, as one might expect, but with the confidence now we have the data sets that show and validate that approach. And I think sets us up very nicely for both the confirmatory study, but then also the accelerated approval and moving forward.

Alright. We have one more here. It is a layup, which means I will handle it. Will this data include durability, such as PFS and DOR? So PFS, progression-free survival, and DOR, duration of response, the answer is yes. Beyond the response data such as major response, complete responses, very good partial responses, the overall response rate metric, and clinical benefit rate, we will be providing progression-free survival and duration of response, not only in the broader population, but in important subsets like post-BTKi and refractory BTKi patient populations where this drug is, or appears to be, naturally falling post-BTKi based on the regulatory path both in the EU and here in the U.S. So with that, I will turn it back over to the operator.

Thank you. We have reached the end of the question-and-answer session. Let me turn the call over to Jim Caruso, President and CEO, for closing remarks. Please go ahead.

All right. Thank you, operator. Thank you, everyone who participated in today's call. We appreciate your time. Have a good day.

Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.