Cellectar BioSciences, Inc. Aktie

Ladies and gentlemen, thank you for standing by, and welcome. [Operator Instructions] 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, 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?

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.

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.

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.

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 Instructions] And we have our first question from Kevin DeGeeter with Ladenburg Thalmann.

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?

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.

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.

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?

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.

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.

And the refractory to BTKi population in that salvage therapy, including these RCD combinations were approximately 5.8 months, correct?

Correct.

And out of the Phase II CLOVER WaM, our progression-free survival with iopofosine.

It was over 15 months.

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.

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.

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.

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 Instructions] There are no further questions at this time.

I will now turn the call over to Jim Caruso for final remarks.

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.

And 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. [Operator Instructions] 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, operator. Good morning, and welcome to Cellectar Biosciences Fourth Quarter and Full Year 2025 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 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 issued a release earlier this morning detailing the contents 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 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, March 4, 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. 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. Jim?

Thank you, Anne Marie, and thank you all for joining us this morning as we review Cellectar's progress throughout the year.

2025 was a productive and strategically meaningful year for Cellectar. Across the organization, we executed with focus and discipline, advancing our lead asset, iopofosine 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 iopofosine I 131, our late-stage asset in Waldenström'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 Scientific Advice Working Party or SAWP. We remain on track to submit a conditional marketing authorization application in the third quarter of 2026, positioning iopofosine for potential approval and European commercialization as early as 2027. This EU regulatory clarity, together with iopofosine's prime designation underscores both the strength of the CLOVER WaM data set and the significant unmet medical need.

As the full 12-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 iopofosine's FDA breakthrough designation for WM and by our agency dialogue. In addition, we continue engagement and partnering conversations to support the program globally.

Beyond iopofosine, we also made important progress across our broader PDC-based radiotherapeutic pipeline. We initiated the Phase Ib study of CLR 125 and in triple-negative breast cancer or TNBC. CLR 125 is an iodine 125 Auger-emitting agent designed for highly precise tumor targeting and its inhibition represents a key -- initiation represents a key milestone for the 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, CLR 225 through new supply partnerships with ITM Technologies and Ionetix providing commercial scale access to Actinium-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 iopofosine I 131, CLR-125 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'll turn the call over to Chad to review our financial results. Chad?

Thank you, Jim, and good morning, everyone. I'll address our financial results for the year ended December 31, 2025.

We ended the year with cash and cash equivalents of $13.2 million as compared to $23.3 million as of December 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 third quarter of 2026.

Turning to our results from operations. Research and development expenses for the 3 months ended December 31, 2025, were approximately $11.5 million compared to approximately $26.6 million for the year ended December 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 December 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 noncash 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 December 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 iopofosine I 131, our interactions with the EMA and FDA have provided us with clear, actionable regulatory paths. In Europe, we are planning to submit this conditional market 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 III trial to support full registration.

As requested by the FDA in November of 2024, we have now collected 12 months of follow-up on all patients. And based upon further review of the data, agree that a confirmatory study evaluating iopofosine 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 data set, including the full 12-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 analysis, 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 12-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, iopofosine 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 iopofosine in relapsed/refractory pediatric high-grade glioma that showed iopofosine to provide meaningful improvements in progression-free survival and overall survival and to be well tolerated with a consistent safety profile.

Iopofosine remains an asset with tremendous global market opportunity and its success supports other assets in our radiopharmaceutical pipeline, including CLR-125 and CLR-225 and further validates our proprietary phospholipid ether delivery mechanism.

Turning now to CLR-125, 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 Ib dose-finding study in TNBC at 2 sites, and we'll be adding additional sites in the second quarter. This study is evaluating 3 dosing regimens with an expansion arm plan once the recommended Phase II dose is determined. We anticipate a steady cadence of results throughout 2026, including early interim dosemetry, safety and preliminary efficacy data.

For CLR-225, our alpha-emitting asset, we completed IND-enabling work and are ready to initiate a Phase I 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 iopofosine, CLR-125 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'll turn it back to you for closing remarks.

All right. Thanks, Jarrod, for that overview. As you've 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 iopofosine toward key regulatory submissions that would accelerate its market approval and get this much needed therapy to patients. We initiated the CLR-125 Phase Ib trial for triple-negative breast cancer, expanded our intellectual property, strengthened supply chain, infrastructure and extended our cash runway. We're 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 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 iopofosine to patients.

Operator, we're ready to open the call for questions.

[Operator Instructions] Your first question comes from Aydin Huseynov with Ladenburg.

Congratulations with the progress in '25 and so far in '26. A couple of questions I have regarding iopofosine. So you're planning to submit in the third quarter for EMA. I'm 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 III trial, you can 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'll turn it over to Jarrod to provide some additional details relative to your question.

As you may recall, we've 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've already done in preparation for our NDA submission, we could also apply to the EMA. Jarrod has been providing oversight on this process, and I'll turn it over to him to provide greater detail.

Yes, great question. So the very short answer is, yes, the data itself is essentially the same. And so it's all -- obviously, it's all the CLOVER WaM data. There will be some different, what I'll call, subset analyses that the EMA may have requested that might be a bit different than what the FDA might request. So we're executing on that. And as Jim said, there is just 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're doing that, just to share what -- 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've taken or the way we're approaching this is about -- we're thinking perhaps 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 1 or 2 patients essentially at that point. And then over the intervening 6 months because we now have -- remembering that we got breakthrough designation in May of 2025, we are now eligible and have the guaranteed 6-month review under the accelerated approval pathway. And so we would then expect that, that feedback would come in 6 months, and we would want to make sure that we had about 10% of the patients enrolled.

So Jarrod, to summarize that within 7 to 9 months of initiation of the study, we would -- assuming we submitted the NDA in a month or two post initiation, we would have a response from the FDA regarding the accelerated approval. And I think, Aydin, it's also important to point out that at that point in time, they're not reviewing any data out of the confirmatory studies, just a function of the study being initiated is ongoing, and patients are successfully being enrolled.

Understood. Very helpful. And for the Phase III confirmatory study design, I mean, it seems like it is -- the design is okay with both U.S. and EU to get the full approval. But just for modeling purposes, I mean, you're getting into earlier line of therapy, second line post BTK and comparing this to rituximab and standard of care. Trying to understand what it is that we should model in terms of the differences in PFS on iopofosine versus the standard of care. And just to get a better sense in terms of what to expect down the road?

Absolutely. And another great question. Until recently, it was very difficult to give a definitive answer here because nobody has 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 got to remember we're in 2026 now. A group out of Italy, where the lead author whose name was Frustaci, they produced data looking at 78 post-BTKi patients irrespective of what salvage therapy they got. So these patients received rituximab, chemo combinations, so 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 8 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-8 months as progression-free survival. And so you can clearly model that number because it was -- it's a significant patient population, approximately 78 patients again.

Yes. I think in -- thank you, Jarrod. Very helpful. And I think I can provide some additional color relative to our data. Obviously, I can't report because we haven't publicly disclosed the updated 12-month data, but it will include what we believe to be some very robust durability elements associated with the 12-month data. So we're really excited about the data package. If you -- and everyone was impressed with our clinical data, Aydin, that we have put in play to date. I think the subsequent data based on the 12-month follow-up is going to be viewed as very, very exciting. And the other element here, and you brought this up, it's significant. As you recall, in the CLOVER WaM study, on average, we were the fifth line of therapy, which means 4 lines of therapy prior to the utilization of iopofosine on average. However, under Jarrod's leadership, the team has done substantial analysis, and we've really been able to segment based on the latest data cut that occurred in December of 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 the -- 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. is 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's also going to be a lot more of them in the U.S. benefit and globally benefiting from this treatment.

And just historically, so that we don't lose that. Currently right now in the United States and it's increasing in Europe, the BTKis are being predominantly prescribed in the first-line setting, whether that's in combination with rituximab or monotherapy, since the ibrutinib-rituximab study came out showing its potential in the first-line setting, most of the U.S. physicians have transitioned into BTKi in the first-line setting in some form or fashion, which means a second-line setting is a post-BTKi based population today.

Very helpful. And looking at your prior major response rate, they were already high enough 80s and you're going to move to the earlier line of therapy. And typically, the responses increase in early lines of therapy. So just curious to understand your sort of benchmark in the earlier line of therapy. And whether the Phase III trial design will have some sort of top line visual response rates first before we see the TFS maybe at some point, 1 year after we start the trial.

Yes. So the primary endpoint for the confirmatory study is progression-free survival. Obviously, we will be -- 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 won't be announcing data from a confirmatory study during enrollment because obviously, that can result in bias being introduced into the study. Even -- and especially in a comparator study, and that would be problematic and would actually negatively impact the review eventually for full approval.

And so Aydin, I'll add to that going in a potentially different direction, were based on the primary endpoint of progression-free survival in that confirmatory study, you can take a look at the Frustaci data and you'll get a sense as to the progression-free survival there. And so this is -- 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 you'll very quickly determine that the way the study is powered for the confirmatory study. It's -- we're setting ourselves up for a high probability of success, assuming the PFS remains consistent with all of the literature and data that we've seen and best case there for PFS is Jarrod discussed was 8.1 months. So we feel very, very comfortable with PFS being the primary endpoint based on the literature.

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 started?

Yes. So 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've all felt the delay from a regulatory standpoint and getting to this point is largely unwarranted and that this drug absolutely has a spot in the marketplace and a significant need to fill. So I think that's important from that perspective. I think, again, as patients -- this is a very active patient population. They're very engaged as a community and 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 iopofosine can have for them and their disease in this setting.

Yes. And I would add that in addition to the thought leadership that are very excited about this because they're on the cutting edge. They understand and observe the performance of existing salvage therapies, especially just post first line. And as I think Jarrod stated earlier, BTKIs are used predominantly now either as a monotherapy or a 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 future 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 oncology drugs, the 4 simple doses. Our community-based physicians are as excited as the thought leaders as well. So I think all constituents, including nuclear medicine, radiation oncology that have a seat at the table in terms of the utilization of this drug, everyone, all constituents are really excited about the opportunity to bring these patients to the many patients that will benefit from this treatment.

Super helpful. And congratulations with the progress so far, and we'll be looking forward to seeing your 12-month data later this year.

The next question comes from Ted Tenthoff with Piper Sandler.

Great. Congrats -- my congratulations to -- on the very hard work and steady progress. You guys deserve a persistence award for sure. Wanted to follow up, 2 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 is actually a little different where you would be getting approved? And what does that patient population look like?

Sure. Thank you, Ted. Great to have you on the call. I appreciate your interest, your continued interest in the company, and you've been very supportive. So we're appreciative of that. I'll have Jarrod launch into this, and then I can fill in any blanks or provide additional color.

Yes. So -- and thank you, Ted. So from a distribution plan, the idea here is that, obviously, Cellectar 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're 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. So I'll remind you that the CLOVER WaM study was run as a global study, where we had approximately 25 sites in Europe. We had some sites -- a handful of sites also in Asia and Australia. And so we've set up a logistical chain that allows us to ship and cover the globe easily with this product. And I will remind you that for folks that may have forgotten that we have a unique competitive advantage in the marketplace that is often overlooked, which is our time -- shelf life time. Most radiotherapies have a shelf life of about 3 to 7 days max, ours is 21 days. That allows us, and it's not cold chain. That's at room temperature. It allows us to more easily distribute this product globally and make sure that it's 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've come to learn. And so it's a meaningful patient subset. Now the conditional market authorization would actually be a later line utilization. So it would be a third line or later post-BTKi patient population. That's largely because still in Europe they are transitioning. They're using BTKis more in a first-line setting, but they're 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 it would -- we would be shifting to a second-line setting in Europe.

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

So if there's no other questions, we have some that are in the inbox. Jarrod, you up for another question or two? All right. I think I'll decipher this one, what is the benefit of the 12-month data cited in the press release versus your December 2024 data?

Yes. Good question. So what I would say is that reminding folks that the December 2024 data, most of the patients that we had enrolled at that point did not have 12 months of follow-up data on them. They were still essentially shortly post their treatment segment and therefore did not have 12 months. Since that time, we have all patients with at least 12 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 that is -- what I mean by that is there are improvements in the response rates, there's improvements in durability. There are improvements in progression-free survival. So across the board, we're 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 12-month data?

Yes. So again, in November 2024, the FDA laid out essentially a pathway for accelerated approval that really had 2 key components to it. One was that we needed to have 12 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 competing between our study and commercially available product. At the time, we were a little worried about moving to a second-line setting because we didn't 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 12-month follow-up data, we now know exactly that we perform better in an early line setting as one might expect. But with the confidence now we have the data sets that show and validate that approach. And I think it sets us up very nicely for both the confirmatory study, but then also the execution of the accelerated approval moving forward.

All right. We have 1 more here. It's a layup, which means I'll 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 an important subset like post-BTKi and refractory BTKi patient populations where this drug appears to be naturally falling post-BTKi based on the regulatory pathways, both in the EU and here in the U.S.

So with that, I'll 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 to 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.

Good morning, ladies and gentlemen, and welcome to the Cellectar Biosciences' Third Quarter 2025 Earnings Call. [Operator Instructions] This call is being recorded on Thursday, November 13, 2025. I would now like to turn the conference over to [Technical Difficulty].

Thank you, operator. Good morning, and welcome to Cellectar Biosciences' Third Quarter 2025 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, November 13, 2025.

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'll begin the call with prepared remarks and then open the call to your questions.

I'll now turn the call over to Jim Caruso. Jim?

Thank you, Anne Marie, and thanks to all participants for joining us this morning as we review Cellectar's progress in the third quarter of 2025. I'm pleased to share that we have made significant strides throughout the quarter, marking a period of strong operational execution on key corporate priorities, including the strengthening of our balance sheet, making significant advancements with our global regulatory strategy for iopofosine I 131 Waldenstrom’s macroglobulinemia or WM, and advancing our clinical and preclinical programs. These achievements underscore our commitment to innovation in oncology and position Cellectar as a company with transformative potential as we head into the final stretch of the year and prepare for an impactful 2026.

Let me begin with our lead asset, iopofosine I 131, which continues to show strong promise as a first-in-class radio conjugate therapy for patients with WM. The third quarter brought exciting developments that further validate its potential and may accelerate its path to market. We've been closely collaborating with the EMA to align on a clear regulatory strategy. Importantly, following a thorough review by the EMA's scientific working party, we received confirmation of our eligibility to file for conditional marketing approval in the EU based upon the CLOVER-WaM study, a major milestone that could bring iopofosine to patients as early as 2027.

This endorsement not only reflects the strength of our data and the urgency of the unmet need, but also carries a high probability of success with 80% of such filings ultimately receiving approval. Confirmation of our eligibility to file for a conditional marketing authorization in the EMA gives us further confidence in our regulatory strategy with the U.S. FDA.

As previously reported, the FDA requested 12-month follow-up data on all patients from the CLOVER-WaM study. With the 12-month follow-up data now available, we plan to submit an NDA under the accelerated approval pathway upon initiation of a confirmatory Phase III trial. As you may be aware, in the second quarter of this year, iopofosine was granted breakthrough designation for WM by the FDA. Data from a recent Jefferies research report showed that 79% of oncology drugs, which have been granted breakthrough designation are successfully awarded accelerated approval by the FDA.

The momentum provided by the success of our global regulatory strategy in Europe and our strengthened regulatory position in the U.S. significantly enhance the value of iopofosine, potentially reducing time to commercialization and making it an increasingly attractive opportunity for strategic collaborations. To support these efforts, we are in active discussions with potential partners, both regional and global, who share our vision for iopofosine. These partnerships are designed to provide iopofosine I 131 to patients as quickly as possible to secure nondilutive capital and commercial expertise while preserving long-term value for our shareholders.

With our bolus of positive clinical data, a favorable safety profile, expedited review designations in the U.S. and Europe as well as a compelling commercial market potential, we believe iopofosine I 131 represents an attractive candidate for potential collaborations or partners seeking impactful innovation and oncology assets with accelerated pathways to the global market.

We remain equally excited about the progress from our next-generation radiopharmaceutical pipeline, including our recently initiated Phase Ib study of CLR 125, our Iiodine-125 Auger-emitting agent, which targets solid tumors, such as triple-negative breast cancer; and CLR 225, our actinium alpha-emitting radio conjugate targeting several other solid tumors with significant unmet need, including pancreatic cancer.

We have also been extremely active in showcasing data from these programs at medical meetings throughout the quarter, including posters and oral presentations at the American Association for Cancer Research and Special Conferences in Cancer Research. We encourage everyone to visit the Posters and Publications section of our investor website to view our presentations.

Operationally, we have raised approximately $12.7 million in recent financings to help strengthen our balance sheet and have also engaged in selective supply and trial support agreements with partners to secure the necessary supply of actinium-225 and to complete our Phase I study for CLR 125 for the treatment of triple-negative breast cancer.

In summary, we are closing out 2025 with strong momentum and entering the new year with a clear regulatory path for iopofosine in Europe and the U.S. and maintain the promise of a unique and robust pipeline addressing challenging solid tumor cancers with significant unmet medical need. As a result, we have several near-term milestones to look forward to that we believe place Cellectar in a position of rapid growth. We are energized by the opportunities ahead and remain deeply committed to delivering innovative life-extending therapies to patients with cancers.

With that overview, I'll now turn the call over to Chad Kolean, our Chief Financial Officer, for a review of our financials. Chad?

Thank you, Jim, and good morning, everyone. Here are my comments on our financial results for the third quarter ended September 30, 2025. We ended the quarter with cash and cash equivalents of $12.6 million, which is compared to $23.3 million as of December 31, 2024. In July 2025, we raised a net of $5.8 million through the issuance of common stock, prefunded warrants and new common warrants. And following the close of the third quarter, we raised an additional $5 million net through investors exercise of certain outstanding warrants and the issuance of new common warrants and now expect that our cash on hand is adequate to fund budgeted operations into the third quarter of 2026.

Turning to our results from operations. Research and development expenses for the 3 months ended September 30, 2025, were approximately $2.5 million compared to approximately $5.5 million for the 3 months ended September 30, 2024. The overall decrease in research and development was a result of lower costs related to CLOVER-WaM study, where the patient follow-up effort continues to decline as patients are moving off study. Additionally, manufacturing costs have declined as in the third quarter of 2024, we were investing more heavily in establishing a second manufacturing source for iopofosine, an effort that is now complete.

General and administrative expenses for the 3 months ended September 30, 2025, were $2.3 million compared to $7.8 million for the same period in 2024. The decrease in G&A was primarily driven by a reduction in pre-commercialization and market assessment efforts and lower personnel costs. Net loss for the 3 months ended September 30, 2025, was $4.4 million or $1.41 per basic and diluted common share as compared with $14.7 million or $11.18 per basic and $12.13 per diluted common share during the 3 months ended September 30, 2024.

With that, let me turn the call over to Jarrod for a regulatory and operational update.

Thank you, Chad, and good morning, everyone. As Jim just reviewed, we believe iopofosine I 131 has a high probability of approval in the EU and pending the initiation of the confirmatory study, its approval in the U.S. We have had extensive communications with both the EMA and the U.S. FDA throughout 2025 and look forward to continuing these interactions through the approval process. As a reminder, this is a program that has received EMA prime designation; FDA breakthrough therapy designation for the treatment of WM; 5 rare pediatric disease designations, including most recently one for relapsed/refractory pediatric high-grade glioma; as well as multiple FDA and EMA orphan drug designations.

These rare pediatric disease designations provide eligibility to receive a priority review voucher, which can be used to expedite the review process for future new drug applications or biological licensing applications for any drug or can be sold or transferred to another party. All of these updates have positioned iopofosine as a major value creator heading into the fourth quarter and early 2026 and underscores its potential in strategic collaborations.

Now let's turn to our 2 exciting earlier-stage radio conjugates, CLR 125, our lead Auger-emitter; and CLR 225, our alpha-emitting actinium-based compound. CLR 125 may provide the greatest precision in targeted radiotherapy as the Auger emissions only travel a few nanometers, meaning the isotope has to be delivered within the cell and near the nucleus or the DNA. Our phospholipid ether delivery mechanism provides this necessary targeting to the tumor entry into the cell and transport to the nucleus as validated through clinical studies.

It has been demonstrated that CLR 125 provides significant tumor uptake and depending on the dose results in tumor volume reduction or growth inhibition with no toxicities being noted, including no hematologic toxicities at any of the doses tested across multiple challenging animal models, including triple-negative breast cancer or TNBC and metastatic breast cancer.

The Phase Ib study of CLR 125 in relapsed triple-negative breast cancer will utilize dosimetry to determine tumor versus normal tissue uptake and will evaluate the activity of 3 distinct doses of CLR 125: a dose of 32.75 millicuries per dose for 4 cycles versus 62.5 millicuries per dose for 3 cycles versus 95 millicuries per dose for 2 cycles with 4 doses per cycle in approximately 15 patients per arm with a planned expansion arm in the proposed Phase II dose. The primary endpoint for the study will be to determine the recommended Phase II dose and dosing regimen, and we will also evaluate safety and tolerability as well as initial response assessments for RECIST as well as progression-free survival in patients. We expect to start dosing patients imminently and could have multiple patients dosed by the end of the year.

For the Phase Ib study, we will be partnering with Evestia Clinical for full CRO services with the Mayo Clinic network serving as a treatment center for the trial and Dr. Pooja Advani acting as our lead investigator. The initiation of this trial will be a significant milestone for Cellectar as it brings us closer to being able to evaluate the safety and optimal dosing of CLR 125. We expect to have a dosimetry data and efficacy data throughout 2026.

Moving to CLR 225, our lead alpha-emitting radio conjugate product candidate, which also has shown excellent biodistribution and uptake into solid tumors preclinically with demonstrated activity across multiple solid tumor animal models, including challenging to treat pancreatic and refractory colorectal cancers, CLR 225 has been observed to be well tolerated in these experiments, which we highlighted in our presentation at the AACR Advances in Pancreatic Cancer Research Conference held in Boston in September.

Pending the necessary financing, our Phase I trial for CLR 225 is designed to comprehensively evaluate the compound's biodistribution, safety and tolerability in patients with pancreatic adenocarcinoma. The study will commence with the dosimetry phase aimed at determining the absorb dose in both normal and tumor tissues. Following dosimetry, the study will progress to a dose escalation phase, systematically evaluating increasing doses of CLR 225 to establish the maximum tolerated dose. We believe this approach gives us an opportunity to demonstrate proof of concept for our innovative combination of phospholipid ether or POE technology with alpha emitters, potentially showcasing its radio conjugates' unique ability to safely treat large bulky solid tumors like pancreatic cancer.

We also recently announced a partnership with ITM, wherein they will provide actinium-225 to help support our alpha labeled phospholipid ether radiopharmaceutical candidates, CLR 225. Actinium-225 is a powerful alpha-emitting isotope used in targeted cancer therapies and both -- and is a rare and in limited supply isotope. This collaboration further underscores our strategic approach to a diversified supply chain to ensure the supply of key resources and thereby guaranteeing patient access to these therapies.

All of these updates and more reinforce our position as a premier radiopharmaceutical company to watch as we look towards the end of the year. This is incredible value to be found in the iopofosine story that will aid in spurring the development of CLR 125 and CLR 225 with alignment from U.S. and European agencies. We feel more confident than ever in the position of our programs.

With that overview, let me turn the call back to Jim for closing remarks. Jim?

All right. Thank you, Jarrod. This has been a very successful quarter for our team. We've maintained consistent dialogue with the appropriate global regulatory authorities and feel that iopofosine now maintains its strongest position to marketing approval and commercialization. With our earlier-stage assets, CLR 125 and CLR 225, we have made significant progress advancing these radio conjugates and have recently initiated the Phase Ib study for CLR 125 in triple-negative breast cancer.

Additionally, we've strengthened our balance sheet with runway out to the third quarter of 2026 and are positioned to execute across multiple near-term priorities, including filing for iopofosine conditional marketing approval in the EU, initiation of our CLR 125 Phase Ib clinical trial with important dosimetry and early efficacy data readouts over the first half of 2026.

We continue to advance our plans to file for accelerated approval of iopofosine in the U.S. pending funding required to initiate the Phase III confirmatory study. We remain committed to achieving these key milestones and confident that these achievements will create value over time. We look forward to finishing the year and believe we are in a strong position to bring iopofosine I 131 and our pipeline of radiopharmaceutical therapies to the patients who continue to battle cancers with high unmet need.

With that, operator, we are ready to open the call to questions.

[Operator Instructions]

Your first question comes from Aydin Huseynov, Ladenburg.

Congratulations with the significant progress with the EMA application. I've got a couple of questions. For the EMA strategy and the decision from Scientific Advice Working Party, could you help us better understand the specific data that we're considering before making a recommendation? Because it sounds like they're allowing you to do it post-BTKi, which could be second line. And in your trial, your prior lines, I think the median prior lines were 4 lines. So could you help us better understand what they were looking for?

Aydin, this is Jim. First of all, thanks for your participation in the call today and certainly appreciate your question. As you are likely aware, we put together a very comprehensive data package for our friends across the pond. And as you appropriately identified, we have recently received additional data from CLOVER-WaM relative to post-BTKi, which gives us a high degree of confidence of our capacity to move iopofosine further upstream. And as you suggest, post-BTKi could be as early as the second line. But with that as an opening comment, I'll turn this over to Jarrod to provide some additional detail relative to the package itself and the consumption of that data from the EMA. Jarrod?

Yes. Thanks, Jim. And thank you, Aydin. Great question. So let me sort of try to unpack that a little bit for you. There are a couple of elements. One, the EU prescribing pattern is a bit different than in the U.S. In the U.S. sentiment, as you just outlined, BTKIs now are generally used in the first-line setting, either in monotherapy or in combination, but predominantly in the first-line setting anymore, which would mean a post-BTKi population or post-BKKi approval in the United States is representative of a second line.

However, in Europe, at this time, the post-BTKi ICE population would still be a third-line setting. Generally in Europe, they start with a rituximab combination and continue to follow that with BTKi at this juncture. They are starting to shift to earlier utilization of BTKi, but that hasn't taken over in the vast majority of the 28 member countries at this juncture. So based on that, what the EMA evaluated, what the SAWP evaluated was the totality of our data, so all patient population, but they did focus in on that in their opinion. In Europe at this juncture, the greatest unmet need that would warrant a conditional market authorization is a post-BTKi patient population.

As Jim just alluded to, when we look at that patient population, we have a vast majority of our patients in our CLOVER-WaM study are post-BTKi. And of those, many of them -- obviously, the majority of them responded well to the treatment, did very well. So we do have statistical significance there. And when we look even deeper into that into varying subsets of that where we look at combination of refractoriness across those patients, what you see is a continued high response rate and even in some sets a much higher response rate than that of the general population.

And based on that, the agency, the EMA, the SAWP felt that the drug warranted or should apply for conditional market approval focusing in on that post-BTKi patient population at this time. I'll stop there.

And Aydin, as I think you brought to our attention a handful of months back, approximately 80% of all drugs that apply for conditional marketing authorization that have received eligibility to apply for a conditional marketing authorization are granted the CNA.

Right. Yes, that's great news. And given that -- I know you don't have to run any trial, you just need to submit. And for the FDA, you only need to initiate a Phase III trial. So how much resources do you think you need just to initiate a trial in the U.S. and whether your current balance sheet would be enough? Just to start off, it's only 200 patients, 24 months. And so can you just start the trial and finish it once you have more resources?

Yes. That's a very good question, Aydin. Based on our assessment, the total overall cost of the study in totality, including multiple years of follow-up is approximately $40 million. Importantly, we're estimating approximately $15 million to full patient enrollment and it's $10 million to initiate the trial. I'll have Jarrod in a moment talk to detail around expectations by the FDA for accelerated approval.

But the net here is essentially, it's trial initiation, which would allow us to submit the NDA and then have a study which is ongoing, enrolling patients at the time of the FDA assessment of our accelerated approval. And as you know, with Breakthrough Designation and Fast Track, that's approximately 6 months further downstream. Based on the high level of interest in iopofosine by both patients suffering from WM as well as thought leadership in the area, we would expect the study to enroll very, very quickly.

But Jarrod, I think it's fair to say, based on our assessment, approximately $15 million or so to full patient enrollment?

Let me correct that. It's about $28 million to full patient enrollment. It's about $15 million to the point at which we would have sufficient enrollment for the agency to act on an accelerated approval application. So Aydin, if I back you up a little bit, as Jim said, to initiate the study itself because of CRO cost and the start-up costs, that's approximately about $10 million of the $40 million that Jim outlined as the total cost.

Then what happens is, obviously, you get the study started. The requirement, as you alluded to, is initiation of a confirmatory study. Assuming that would happen, then the agency also has the obligation or the statement in the regulations now that the study must be considered ongoing, which they have been updated as some level of enrollment. They have not specified what level of enrollment. We are estimating that somewhere between 10% and 25% of patient enrollment will probably be satisfactory. In our calculation, that is somewhere between 20 and 50 patients. In order to achieve that, we think it would take about $15 million, including the $10 million start-up to achieve that number.

And then obviously, as Jim said, $28 million to get the full enrollment and then $40-ish million to see out the rest of the study, including all of the long-term follow-up. We do believe that if we were to have enough funding to really launch the study and get to that first metric, I think, of having the agency respond to the submission, we would be -- we would absolutely want to initiate and go.

No, I appreciate the question, Aydin. And Jarrod, thank you for the clarification on that. And as a recent -- and I cited in my opening comments, a recent assessment by Jefferies research report identified those oncology drugs with -- that have been awarded breakthrough designation, there's a 79% approval rating for accelerated approvals. And net, both with the EU at approximately 80% likelihood of success. And based on this Jefferies report with the BTD for iopofosine in the U.S., approximately 79%. So we view those as certainly reasonable statistics that stack up in the favor of iopofosine.

Right, right. And given that -- it appears that you will be first launching in Europe, then in the U.S. and given all these MFN discussions. So could you help us understand the pricing potential for iopofosine in Europe and U.S. And also whether you would consider different brands maybe given potentially different labels for EMA and FDA? Just curious to hear your thoughts on this.

Yes, I'll open. We anticipate submitting our application for the CMA in the middle of 2026, if you estimate an approximately 12-month review by our friends across the pond, that's an approximately middle of 2027 marketing or commercial launch ex U.S. And to your point, it's not only Europe, it's 30 major countries, except for China, Japan and the U.S. that would be -- have the capacity to market iopofosine. So it's a significant market size comparable certainly to that of the U.S. when you look at incidence and prevalence numbers for WM.

Now taking a step back before we address the pricing question, and we're not going to give you specific numbers, but we'll give you -- it's clearly a premium-priced opportunity. But as you cited earlier, with the approximate $10 million to initiate our Phase III confirmatory study in the U.S., and with that, as Jarrod cited, approximately 6 months or so to get to the necessary patient enrollment that we would believe would satisfy the FDA's requirement for an accelerated -- for the granting of an accelerated approval, you could actually have a horse race depending on when that study was initiated.

So if, in fact, the study is initiated in the first quarter or second quarter of next year, within 6 months, you're obviously submitting your application to our friends at the FDA. And because of Breakthrough and Fast Track, et cetera, it would be an approximate 6-month review. So in reality, you could have access to the U.S. market and approval in the U.S. market prior to that of the EMA. And so from a pricing perspective, that would certainly make pricing both in the U.S. and ex U.S. a little bit easier.

Jarrod, without providing price points, if you could provide any additional detail for Aydin and our call participants, I think that would be helpful.

Absolutely. And I'm going to go in 2 directions -- or take this in 2 steps again. As you mentioned, Aydin, the Most Favored Nation discussion has resulted in some interesting outcomes. I think as I'm sure you are aware that for pharmaceutical pricing nature that some companies -- some of the larger companies have taken a position of rather than decreasing prices in the U.S., they've taken a strategy of a more flat universal price globally and thereby negotiating harder in Europe and other places for higher prices. And I think that, that is a trend that is going to likely continue. There will likely be some downtick in the U.S. price in order to sort of get them more mirrored, but that there's significant increases in Europe.

Now as it relates to iopofosine directly, obviously, one of the processes that we have to go through is now to work through the HTA process, which was recently -- earlier this year announced, particularly for oncology drugs that this has to be done sort of in parallel with our CMA. That process, I can't -- as Jim sort of alluded to, we're not in a position at this time yet to give specificity on pricing. We have given what we believe and based off our pricing estimates for what we would expect in the U.S. Traditionally, in Europe, those prices can be anywhere from similar to 50-ish percent of that as a whole, but that really comes down to that discussion.

The HTA requirement is for -- even if you do not have a comparator in your clinical study or in your initial -- in our case, in the initial study for CMA, what it would require is that we would do research to evaluate the potential clinical benefit of iopofosine I 131 over comparative drugs. I think the key takeaway on that is that, obviously, based off of the regulatory, the SAWP and in general, the EMA process, the Prime and everything else, there is a significant unmet medical need that this drug is needing. And in their own words, that is essentially driven by the fact that these patients do not have treatment options available to them.

So there is a justification for negotiating higher percentages under that, the more -- the greater the value to the patient and the patient outcomes, the greater the price point can be. And so our expectation is based on the research we have historically done, recognizing that there is no direct comparator that one could utilize that we are in a position of strength to negotiate -- or with a partner, negotiate a stronger price point in Europe.

Yes. Super helpful. Super helpful. And for modeling purposes, it sounds like 2027 is the launch year for both U.S. and EU, which makes it sort of a global launch perspective. Congratulations for the significant progress this quarter.

Yes. Thank you, Aydin. Appreciate your participation. Appreciate the questions.

Our next question comes from Jeff Jones, Oppenheimer.

Congrats on the progress and the regulatory wins so far. So great progress. The -- can you comment at all on how the partnering discussions have evolved since the EU regulatory update and how you're thinking about partnering, be it U.S., Europe or globally?

Jeff, thank you for the question. Much appreciated. Hope you're doing well on your end. Obviously, when we anticipated a positive outcome with our friends across the pond and did the necessary work on the costs associated with our clinical trial, our confirmatory study for the U.S., it became apparent to us to slow play corporate development discussions until we had the blessing certainly from the EMA on our capacity to file.

Obviously, that becomes now iopofosine is a near-term oncology asset in a very robust ex-U.S. market at a minimum. And then when we also -- based on our further communications with the FDA, we're able to really drill down in terms of line of sight and this $10 million to $15 million for upfront-ish to the necessary patients enrolled, as Jarrod cited earlier, in order for us to receive an answer from our friends at the FDA.

We felt as if we would be in a much better position with both of those. And so we kind of, over the early part of the year here or middle part of the year, really slow played our discussions. It also allowed a handful of other companies to kind of get up to speed on their diligence. So we have a number of companies all in -- in and around the same spot in terms of their understanding of where we currently sit, certainly from a regulatory perspective.

And also, quite frankly, the latest data that we've mined from our clinical trial is also very, very supportive of our regulatory approach. So Jarrod has been overseeing and has done a great job in terms of communication on the corporate development side and making certain that we were in a position of strength to optimize the potential value for our stockholders with iopofosine on a number of different fronts. And I'll turn this over to him to provide some additional detail. Jarrod?

Sure. And I'll confess -- Jeff, it's great to talk to you. But I'll confess that I'm not sure that I can add much more detail. Jim did a great job there, explaining exactly where we sit. I would say that we -- obviously, as you get closer and closer to a regulatory approval, the interest and activity heats up, especially when you start to be able to position this sort of as we just talked about with Aydin with the conditional market approval in Europe, the potential to negotiate from a position of strength on pricing through the HTA process, the potential to -- the potential and our approach to manufacture and cost of goods, all of those things puts us in a very positive light in most -- various partners and opportunities. And so we've seen, as Jim said, an increase in that.

I think the second part of your question, which Mike I can dig into a little bit more, which is the strategy. I think we've talked about this before, and we continue to be in this situation. We have ongoing discussions with parties who, I would say, are either globally focused or are focused on the 2 predominant regions right now for radiopharm, which is the U.S. and Europe. We do have various regional conversations ongoing that are advancing rapidly. So those are -- those might be part of those territories or all of those territories. Said another way, it could be solely Europe, could be solely U.S., could be other territories outside of that.

But as Jim alluded to, we have quite a number of parties right now who have either completed or nearly completed their diligence, who have supplied and move forward into the next phases of partnering, and we continue to try to drive that to maximize both the return for the organization and to ensure, as Jim said in his opening remarks, ensure that the drug is developed in such a way that it does get the patient actual benefit.

Great. Really appreciate it, Jarrod. And apologies if I missed this on the call. With respect to 225 and the pancreatic program, I know you're moving -- you're actively moving 125 ahead and that trial is taking off. Any gating items on 225 to begin that trial? Or is that something you would move ahead with absent additional financing? Or is that one pending?

Yes. I believe the team, Jeff, has put us on the precipice of a Phase I ready study there with the pancreatic cancer and 225. It is a function essentially of financing as the gating issue there. Jarrod, any additional color you'd like to provide?

No, I would agree with you. I think that financing is the gating element. And as Jim said, we are -- we currently sit in a position to essentially initiate the study as soon as the capital is in hand, so to speak. We have the CRO, we have the submissions, we have sites. We have everything ready to run for that study. And as you can see, part of the reason we have announced the various supply agreements is because -- particularly around actinium is because what we've done is make sure that we have a consistent supply of actinium so that we are not delayed in any way, shape or form as it relates to actinium sourcing and that supply gets us from where we sit today based off our forecasting all the way through into commercialization on the actinium program. And that's exactly why we've done that. So there are no hiccups or delays on that front as we've seen with other parties.

And so we expect, again, pending the capital, we expect to initiate that Phase I, and I'll call it Phase Ia study. It really -- it is a dose escalation safety study with the dosimetry component. So at the end of the day, what we'd be looking at is clear safety and understanding of the uptake and distribution of the molecule, which we don't expect to be very different than what we've seen historically.

No, Jeff, I was just going to make a comment -- no worries. I was just going to make a comment on how significant we view the -- as an example, the triple-negative breast cancer study. It's a solid tumor. As Jarrod cited, we believe our drug, our conjugate will behave in a very similar manner to what we've observed with other isotopes as well, 124, 125 as well as 131.

And so this is really, I think, for the company and for validation of our platform, very significant. And Jarrod, perhaps you could just expand a little bit for our audience the imaging and dosimetry data that we expect to collect very early on in this study that we believe will be further validating our platform and in particular, our capacity to be very effective in challenging solid tumors.

Sure. And so we're -- I'm going to blend this because it's the same, whether I'm talking about the actinium program in pancreatic cancer with CLR 225 or the triple-negative breast cancer program with CLR 125. In both cases, we're utilizing dosimetry. And for folks that may not be as familiar with the radiopharmaceutical, radiotherapeutic -- targeted radiotherapeutic strategies here, the benefit of dosimetry is unlike other therapies where we take blood samples and we've used that to sort of calculate and guesstimate the amount of uptake into the tumor and their -- and also into other healthy tissues.

In this case, what we're able to do is actually image in the transit of the drug with inside the human body, and we're able to identify exactly where it is at different time points. Utilizing that data, we're then able to calculate both the absorbed dose in the healthy tissue and be able to know when we might achieve a level that would be sort of toxic. And on the other side, we're able to calculate the absorbed dose into the tumor and thereby calculate the expected dose and dosing regimen necessary to be an active therapy in that tumor type.

And utilizing that data, you could get what's called a therapeutic window and you get the opportunity, that is the difference between your therapy dose and when you start to see toxicity. And we expect, as we have seen with iopofosine, that this therapeutic window will be significantly wide enough. Interestingly enough, in the CLR 225 program, back to pancreatic piece for a moment, one of the great challenges in pancreatic cancer is not just the nature of the tumor and the late stage in which patients are diagnosed, but it's also there is, what they call interstitial pressure in the tumor, which prevents most drugs from actually being able to penetrate the tumor because there's fluid pressure pushing back against anything entering.

Interestingly enough, as what we saw when we did this in the [indiscernible] studies. Our phospholipid ethers, again, give us a unique ability to actually penetrate through that and actually get inside the tumor and get deep inside the tumor, which is one of the reasons why we think, particularly in pancreatic cancer, we have a competitive advantage over other programs in that tumor specific. Obviously, in triple-negative breast cancer with the CLR 125, we've seen similar sort of results, but that comes at it from a different perspective, particularly because you have limited targets now in breast cancer and being able to overcome that with our targeting mechanism that is based off [indiscernible].

[Operator Instructions]

Our next question comes from Jonathan Aschoff by ROTH.

Congrats on the regulatory progress. I was curious, just because the full approval is based on PFS, can you remind us where you are in CLOVER-WaM follow-up and where that PFS last came out or at least what it at least is and how that compares to standard of care for WM?

Of course, Jonathan. Thanks for your participation. We have not updated our data since January of last year relative to PFS. And at that point in time, it was very robust and well beyond what you normally would see with salvage therapies in the lines of therapy that we were treating. So Jarrod, if you want to provide some detail there, I think it would be helpful for Jonathan and our audience.

Yes, Jarrod, please to do that. I had 11.4 months after 8 months, but you last said you had follow-up beyond 12 months. I just didn't get any further PFS with that additional follow-up. So I'm kind of just trying to reconcile where it is.

Yes, absolutely. Thank you for confirming what I was about to say. What I was about to say is it was 11.4 months with 8 months of follow-up. We now have 12 months of follow-up on all patients. That is correct. That is -- that was one of the criteria that the FDA for submission for accelerated approval had requested. We now have that.

As you might -- as I'm sure you are aware, basically, where we are in the process, we have not announced additional data. We do not wish -- we're not in a position -- I don't want to say we do not wish, we're not in a position to announce additional data at this juncture, largely in part because we are now in a process of trying to submit this for FDA regulation, and we don't want to be caught in a situation where the FDA may view us as being promotional as it relates to this data prior to a submission.

So at this juncture, the most recent data is that data from January of last year, and that won't be updated in the near term -- or I'll say in the near term, based off of the requirements and discussions with them.

Okay. And by the way, the order for pancreatic is file the IND, get funding, start the trial, correct?

Sort of. So -- sorry, Jim, if I jumped in there too fast. The pancreatic cancer study is one that we're not running in the U.S. So it will be filing and we have filed ex U.S. with the appropriate authority to execute the study and have that acceptance already. So we're in a position now where it is await the capital and then initiate the trial.

No worries. And the only additional information that I'll provide in regards to the PFS question, Jonathan, is that when we did multiple advisory boards with global thought leadership for Waldenstrom’s macroglobulinemia, and what came across very, very clearly was in the patient population. And just for all participants, this was -- iopofosine being used essentially as fifth-line therapy for this patient population.

One, the response rate that we achieved was that 60% range was considered outstanding. And more importantly, they gave us insight that 4 to 6 months of PFS for that patient population would be an excellent outcome. And as you cited yourself with our initial cut of data, we're at approximately 1 year of PFS. So almost doubling or greater the expectation of thought leadership in WM in terms of what would be considered an excellent result for patients.

Okay. There are no further questions at this time. I will now turn the call over to Jim Caruso. Please continue.

Terrific. Thank you, operator. This concludes our call for today. Certainly appreciate the great questions from our analysts and for your participation as well as all participants. Of course, this will be up on our website, and a transcript will be following this call. Thank you all very much.

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. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to Anne Marie Fields, Managing Director at Precision AQ. Please go ahead.

Thank you, operator. Good morning, and welcome to Cellectar Biosciences Second Quarter 2025 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 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 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 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 14, 2025. 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'll begin with prepared remarks and then open the line for your questions. I'll now turn the call over to? Jim Caruso. Jim?

Thank you, Anne-Marie, and thank you all for joining us this morning as we review the progress Cellectar has made throughout the first half of 2025. First half of 2025 has been a period of strong execution and strategic progress for Cellectar. We've made significant strides across our development pipeline, regulatory strategy corporate development initiatives and fundraising efforts, collectively positioning us for a strong conclusion to 2025.

Let me begin with our lead asset, I am focusing I-131, which continues to demonstrate its potential as a first-in-class radio conjugate therapy for patients with Waldenstrom's Macroglobulemia or WM. As we reported in this morning's press release, we have shifted our regulatory strategy and now plan to submit a new drug application or NDA with the FDA under an accelerated approval pathway for iopofosine I 131 as a treatment for WM, subject to sufficient funding and having a confirmatory study underway.

The CLOVER-WaM study will serve as the primary basis for the demonstration of efficacy. Our confidence in this new strategy is supported by a number of key elements that we will discuss later in the call. Importantly, we also believe this new regulatory path aligns with the FDA's commitment to expediting treatments for rare diseases such as WM.

In parallel, we are advancing our regulatory strategy for iopofosine I 131 in Europe, where the product candidate has been granted prime designation which is the FDA equivalent of breakthrough designation, which is designed to provide early regulatory support to accelerate the development of innovative medicines addressing unmet medical needs for patients in Europe.

Last quarter, we submitted a filing seeking guidance from the EMA on conditional approval of iopofosine I 131 and as a treatment for WM based on the CLOVER-WaM Phase II data. We believe the results from the study should be sufficiently compelling to support the conditional marketing authorization strategy. Since then, we've entered the scientific advice process with the EMA and anticipate a response late in the third quarter or very early in the fourth quarter.

These dual regulatory tracks reflect our commitment to bringing iopofosine to patients globally as efficiently as possible. To support our vision for iopofosine and these efforts, we are in active discussions with the potential partners, both regional and global. We would expect these partnerships, if completed, to provide nondilutive capital, additional human resources and subject matter expertise while preserving long-term value for our shareholders.

With robust clinical data and a well-understood safety profile, potential expedited program designations in both the U.S. and Europe and a compelling commercial market potential. We believe iopofosine I 131 represents an attractive candidate for potential partners seeking impactful innovation and accelerated development pathways.

Beyond iopofosine, we are equally excited about the progress in our next-generation radiopharmaceutical pipeline. We remain on track to initiate a Phase I trial for CLR 125 in late 2025 or early 2026. CLR 125, our iodine-125 Auger-emitting agent is advancing towards clinical evaluation in triple-negative breast cancer, and we've already submitted the Phase I protocol to the FDA.

Meanwhile, we are prepared to advance CLR 225, our actinium radio conjugate into a Phase I study as a potential solid tumor treatment, such as pancreatic cancer, of course, contingent upon sufficient company funding. Jarrod will provide further detail on both of these promising programs.

Operationally, we've strengthened our foundation with a long-term isotope supply agreement and raised nearly $10 million in recent financings. These funds will support our clinical programs and regulatory milestones while enabling continued progress on strategic initiatives.

In summary, Cellectar is entering the second half of 2025 with positive momentum a potentially streamlined regulatory path for iopofosine and a series of interesting and novel Phase I ready as well as early-stage assets. We are energized by the opportunities ahead and remain deeply committed to delivering innovative, life-extending therapies to patients with cancer. Thank you for your continued support. I'll now turn the call over to Chad Kolean, our CFO, for a review of our financials. Chad?

Thank you, Jim, and good morning, everyone. I will address our financial results for the quarter ended June 30, 2025, beginning with our cash position. We ended the quarter with cash and cash equivalents of $11 million which includes $2.3 million in net funds raised from the June financing, compares to $23.3 million as of December 31, 2024. Right after the close of the second quarter, we completed a financing that raised an additional $5.8 million net and expect that our cash on hand is adequate to fund budgeted operations into the second quarter of 2026.

Turning to our results from operations. Research and development expenses for the 3 months ended June 30, 2025, and were approximately $2.4 million compared to approximately $7.3 million for the 3 months ended June 30, 2024. The overall decrease in research and development was largely the result of our having concluded both patient enrollment and a significant portion of the necessary follow-up for our CLOVER-WaM Phase II clinical study in WM and a reduction in personnel costs.

General and administrative expenses for the 3 months ended June 30, 2025, were $3.6 million compared to $6.4 million for the same period in 2024. The decrease in general and administrative was primarily driven by a reduction in pre-commercialization efforts and personnel costs.

Other income and expense for the quarter was a gain of approximately $0.6 million for the quarter as compared to $12.8 million in the same period in the prior year. Most of this activity in other income is noncash in nature and relates to either the issuance exercise or changes in the valuation of warrants. These noncash changes are having a significant impact on earnings, nonoperating only, but do not impact cash burn or runway.

Net loss for the 3 months ended June 30, 2025, was $5.4 million or $3.39 per basic and diluted share, compared with $0.9 million or $0.77 per basic and $5.43 per diluted share during the 3 months ended June 30, 2024. As I just mentioned, the significant differences in the net loss and earnings per share are the result of the noncash impact of warrant activity.

With that financial overview, let me turn the call over to Jarrod for an operational update, including plans for our pipeline of radiopharmaceuticals.

Thank you, Chad, and good morning, everyone. Earlier this year, iopofosine i-131 was granted FDA breakthrough therapy designation for the treatment of WM. I will now focus on the FDA strategy for iopofosine based on these outcomes. Following the breakthrough designation and an analysis of data from the Phase IIb CLOVER-WaM study, including a subset analysis of patients being treated with iopofosine immediately following treatment with a Bruton Tyrosine Kinase inhibitor or BTKi treatment failures and the completion of a minimum of 12-month follow-up on all patients as requested by the FDA.

Cellectar has decided to shift our regulatory strategy to pursue accelerated approval for iopofosine I 131 using the CLOVER-WaM study data. During our discussions with the FDA late last year, it was clear that if we wanted to pursue an accelerated approval using the CLOVER-WaM study data, we would need to move to an earlier line of treatment for confirmatory study and would also need to include a minimum of 12 months of follow-up from time of response for all patients in our NDA package.

The subset analysis that has been conducted demonstrates the potential for iopofosine to be highly effective in an earlier line of therapy, i.e., post-BTKi failure, which is now commonly used in the first-line setting. This, combined with the now minimum of 12 months of data on all patients allow us to advance this regulatory strategy contingent upon sufficient funding and a confirmatory study being underway at the time of regulatory action, which would be expected approximately 8 months post submission or 6 months post filing given the breakthrough designation.

I will now provide an update on our 2 exciting Phase I-ready radio conjugates. The first is CLR 121125 or CLR 125, our lead Auger-emitting compound. Our second and alpha-emitting actinium-based compound, CLR121225 or referred to as CLR225. Our Auger-emitting radio conjugate product candidate, CLR125, potentially represents the highest level of precision in targeted radiotherapy with its emissions traveling only a few nanometers.

With our delivery mechanism providing the necessary targeting to the tumor, entry into the cell and transport to the nucleus as validated through preclinical studies, we have seen CLR125 demonstrate significant tumor uptake and activity with enhanced tolerability across multiple challenging animal models, including triple-negative breast cancer or TNBC and metastatic breast cancer.

Building on these promising preclinical results with CLR125, we have submitted a Phase Ib dose-finding study protocol to the FDA for the treatment of triple-negative breast cancer, including metastatic disease and are now able to initiate the study pending Institutional Review Board or IRB sign-off.

The proposed Phase Ib dose-finding study in relapsed TNBC will utilize dosimetry to determine tumor versus normal tissue uptake and evaluate the activity of 3 distinct doses of CLR125, 32.75 millicuries per dose for 4 cycles versus 62.5 millicuries per dose for 3 cycles and 95 millicuries per dose for 2 cycles with 4 doses per cycle in 15 patients per arm with a planned expansion arm.

The primary endpoint of the study will be to determine the recommended Phase II dose and dosing regimen and will also evaluate safety and tolerability as well as initial response assessments per RECIST as well as progression-free survival in patients. Our confidence in CLR-125 is grounded in its molecular similarity to iopofosine I-131, designed to provide targeted delivery of iodine radioisotopes for which we have evidence supporting proof of concept and tolerability from the CLOVER-WaM Phase IIb clinical trial.

Leveraging dosimetry imaging to measure drug delivered directly to the tumors is expected to provide CLR 125 proof of concept of the therapeutic window and appropriate dosing. Initiating this Phase Ib study in late 2025 or early 2026 will mark a significant milestone and an important step towards evaluating the safety and optimal dosing of CLR 125 in patients, ultimately providing a potential new treatment option for those patients afflicted by this challenging disease.

Looking now to CLR-225, our lead alpha-emitting radio conjugate product candidate. To date, it has shown excellent biodistribution and uptake into solid tumors and demonstrated activity across multiple solid tumor animal models, including 4 distinct refractory pancreatic cancer models. CLR-225 has been observed to be well tolerated in these experiments. The Phase I trial for CLR-225 is designed to comprehensively evaluate the compound's biodistribution, safety and tolerability in patients with pancreatic adenocarcinoma.

The study will commence with a dosimetry phase aimed at determining the absorbed dose in both normal and tumor tissues. The initial assessment will provide valuable insights into the compound's biodistribution and potential therapeutic window, laying the foundation for subsequent phases of the trial and future development.

Following dosimetry, the study will progress to a dose escalation phase systematically evaluating increasing doses of CLR-225 to establish the maximum tolerated dose. This approach offers an opportunity to demonstrate proof of concept for our innovative combination of phospholipid ether or PLE technology with alpha emitters, potentially showcasing its radio conjugates unique ability to safely treat large bulky solid tumors.

It is important to note that the initiation of this trial is dependent on the company obtaining the necessary funding. With that overview, let me turn the call back to Jim for closing remarks. Jim?

Thanks, Jarrod. As we reflect on the first half of 2025, I'm incredibly proud of the progress our team has made across every dimension of our business from clinical development and regulatory strategy to operational excellence. We've laid a strong foundation for what we believe will be an important growth opportunity for Cellectar.

With breakthrough therapy and prime designations in hand for iopofosine and what we believe is compelling clinical data, we have defined a clear regulatory strategy for accelerated approval in the U.S. and remain engaged with the EMA regarding advice on a conditional marketing authorization approval in Europe, for which we anticipate a decision late in the third or early in the fourth quarter of 2025.

At the same time, our next-generation pipeline assets are advancing rapidly. CLR125 and CLR225 represent exciting opportunities to expand our impact into solid tumors. As we look ahead, our focus remains clear to deliver transformative radiopharmaceutical therapies to patients with cancer efficiently globally and with purpose. We are grateful for the continued support of our investors, our collaborators and most importantly, the patients and families who inspire our work every day.

Thank you again for joining us this morning. We look forward to sharing more updates as we continue to execute on our mission and advance toward key milestones in the months ahead. Operator, we are ready to open the call for questions.

[Operator Instructions] We now have our first question, and this comes from Fanyi Zhong from Oppenheimer.

This is Fanyi on for Jeff. A couple of questions. First, for WM program, where do you stand with the EU on the path to approval? And then for 125 programs, for the preclinical biodistribution data on these molecules, what are the off-target sites of the greatest concern with that platform?

Thank you, Fanyi. So let me see if I captured the first question correctly. feel free to correct me or guide me if I don't answer it fully. But iopofosine I 131, as we look to the approval pathway, and I'll say for the FDA, obviously, we have continuing discussions for conditional market authorization in the coming weeks with the EMA. But for the FDA, where we sit now is finalization of a protocol for an accelerated approval confirmatory study and where we sit with regard to the submission for the NDA. I think as we've referred to in the past, we have largely completed most of the NDA package.

We now -- now that we have the 12-month follow-up data that we're referring to and independent review committee's review of the data, confirming the response rates and durability of those responses, we are now finalizing the clinical portion of the data package with the idea that pending sufficient capital, we'd be in a position to submit later this year or at the latest early next year.

The only other thing I'll add to that, Jarrod's thorough response is as we thought about the shift in regulatory strategy here with our friends at the FDA, it was important to note, and as Jarrod highlighted in his overview a few moments ago, was that we now have 12 months of follow-up on all patients that we were required to for this study, which was a prerequisite to apply for this more, let's call it, a traditional accelerated approval pathway.

And then additionally, with that traditional accelerated approval pathway, the company was obligated to advance iopofosine up into earlier lines of therapy. And at that point in time, we did not have data to support that transition to earlier lines of therapy. Based on an analysis of the data that we currently have, the company remains highly confident that post BTKi failures regardless of line of therapy that this drug would perform very, very well.

So that gives us now confidence to advance further upstream into second line. And as you're likely aware, there's been a significant transition to the utilization of a combination with ibrutinib and a BTKI, let's say, ibrutinib in the first line of therapy. And as that number continues to increase, that second line now becomes available for post BTK treatment such as iopofosine.

I think I will also mention that we did receive breakthrough designation from the FDA in late May, which is also factored into this as well. So we have -- we go into this with an approach with a higher degree of confidence based on the data that we have from the Phase II CLOVER-WaM study.

And then Fanyi, and I think your second question then was on the biodistribution of CLR125?

Yes.

So I'll summarize because it takes too long to go through all of it, but let me just say this. Fundamentally, what we see is approximately 25% to 30% of the infused drug when you look -- when you evaluate it into the tumor. When you look across all other tissues, off-target tissues, so to speak, what we see is approximately less than -- and I'll say approximately less than 5% of the activity in any single tissue. As one might expect, probably the most common tissue that you tend to see accumulation in is the liver. But again, it's well below 5% or around 5%, I should say, for that, so well below a concerning level.

And post this call, based on the news that we've released this morning, we'll be updating our corporate presentation on the website. And there is a significant amount of new data relative to our preclinical work with a series of radioisotopes, which includes CLR125 and the Auger-emitting work.

[Operator Instructions] And the next question comes from Ted Tenthoff from Piper Sandler.

Congratulations. This is a really meaningful update this series of events from breakthrough designation to the 12-month data and then the commitment and decision to move into the second-line confirmatory trial, all positioning for an NDA for accelerated approval, really exciting stuff. When it comes down to the timing, when do you think you would submit this NDA? And you mentioned the need to have the confirmatory trial underway by decision, which I assume means potential approval. So how much has it cost to kind of submit and get iopofosine I-131 approved?

That's a great question, Ted. I'll open with some of the financials related to this, and then we could have Jarrod walk us through some of the nuance associated with the accelerated approval pathway. It's similar to what you just described.

But our estimate on the study is approximately $40 million to $45 million. And I believe we're in this kind of $20 million to $25 million range for full enrollment and to secure the necessary data and then back-ended beyond full enrollment and initial data is the follow-up costs associated with the follow-up of the study. So as you think about it, we would require approximately $20 million, $25 million to complete study enrollment, get it up rolling, finalize enrollment and see some early top line data. And then the remainder of that $40 million, $45 million would be a function of follow-up.

Yes. So Ted, I'll add to that with regard to some of the extra details. And one of them would be, as we think about it, and I think this links to your question, the timing, right? So the requirement by the guidance and by the FDA is that at the time of submission, the study needs to be initiated. Now the definition of initiated is not defined. I know -- as industry, we generally think of that as first patient enrolled. But for the FDA, they have made it clear that they don't have necessarily the exact same definition.

To your point, then by the time of regulatory action, which is assumed to be an approval timing point, would be that, that would -- at that point, you would have enrollment ongoing, as they call it. And again, there is not a specific number of patients that would need to be enrolled by that time point.

Our interpretation and based on what the guidance -- what the FDA has said to us and going back to your portion of your question, in order to initiate the study, you can think that somewhere between, as Jim laid out, the total cost, somewhere between 25% to 30% of the money needs to be utilized is actually spent with the CRO at the time of initiation, so somewhere in the $10 million to $12 million-ish range to get the study up and operating.

That said, we've already prepped for all this. As you might imagine, we've already have a CRO prepared to initiate. We have the quote, we have the contracts. So we've sort of outlined all of this ahead of time. So we're ready to run either if we were funded or with a partner to execute this in a rapid fire sort of method.

Which is why when you asked the question about our exact timing, it might be later this year or early next year because we didn't want to have that study initiated prior to the submission, just we probably check a little extra box just so that we have time in a rare disease setting like this to have enough sufficient enrollment by the time that 6-month window based off the fast track and breakthrough designation, which gives us that accelerated review time line.

I would also add, Ted, thank you, Jarrod. I would also add that we would anticipate study enrollment to be very rapid based on the availability of our Phase II CLOVER-WaM data out in the public domain, the WM patient population is highly communicative among each other. They're very aware of the data.

And we would anticipate that as a result of that and the outstanding performance of our drug, both from a response perspective as well as durability just based on the 4 single infusions over approximately 70 days is going to be very, very attractive for these patients and we've already received significant feedback.

I think the other element here that's important from a rapid enrollment perspective is the thought leadership is very aware of this drug. And most of the sites that we used, especially those that enrolled very quickly and in large numbers have already expressed interest in participating in the confirmatory trial. Jarrod, anything else to add about that?

Yes. Thank you, Jim. I would add the one piece I would add to what Jim has outlined there for rapid enrollment is also the concept, as you also noted, Ted, which is moving to an earlier line of treatment. Jim sort of outlined before, this post-BTKi patient population with so many, nearly 50% and growing of patients receiving rituximab and ibrutinib in the first-line setting or BTKi in that first-line setting, it offers a significantly larger patient population to pull from to enroll into the study. And that as well, we believe will add to the speed and quickness of the study getting completed. So we do think that the overall time line for completion and getting to the primary endpoint of the study will be much more -- much quicker.

[Operator Instructions] No further questions that came through. I'll now turn the call over back to James Caruso for closing remarks. Please go ahead, sir.

Thank you, operator, and thanks again for joining us this morning. We certainly look forward to sharing more updates as we continue to execute on our mission and advance towards these key milestones that we discussed this morning in the months ahead.

Thank you. This concludes our conference call for today. Thank you all for participating. You may now disconnect.