Cellectar Biosciences, Inc. (CLRB) Q2 2025 Earnings Report, Transcript and Summary

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.