Cellectar Biosciences - Earnings Call - Q2 2025

Executive Summary

• EPS beat: Q2 2025 diluted EPS was ($3.39) vs S&P Global consensus of ($3.70), a $0.31 beat; revenue remained $0 as expected for a pre-commercial company. Values retrieved from S&P Global.*
• Operating discipline: Total OpEx fell 56% YoY to $6.04M on lower R&D and G&A, with net loss improving sequentially to ($5.45M) from ($6.60M) in Q1 2025.
• Regulatory catalysts: Management shifted to pursue an FDA NDA under the accelerated approval pathway for iopofosine I-131 in WM, contingent on sufficient funding and having the confirmatory study underway; EMA decision on potential CMA filing expected late Q3/early Q4 2025.
• Liquidity extended: Cash was $11.0M at 6/30/25; with July’s financing (~$5.8M net) management believes runway extends into Q2 2026, creating time to finalize partnerships to fund the WM program.

What Went Well and What Went Wrong

What Went Well

• Breakthrough Therapy Designation (BTD) for iopofosine I-131 in WM strengthens the expedited U.S. regulatory path and supports the accelerated approval strategy.
• Clearer regulatory plan and timing: Company now plans to file an NDA for accelerated approval, subject to funding and confirmatory study initiation; EMA advice process underway with a decision expected late Q3/early Q4 2025.
• Cost control and runway: OpEx decreased sharply YoY; cash plus July raise provides runway into Q2 2026, supporting ongoing regulatory engagement and pipeline steps (CLR125 Phase 1b TNBC).

Quote

• “We are encouraged by the recent FDA Breakthrough Therapy Designation…our regulatory strategy aligns with the FDA’s…mission to accelerate the delivery of lifesaving medicines to patients battling rare diseases, such as WM.” — CEO James Caruso.

What Went Wrong

• Funding prerequisite remains: Management explicitly tied NDA filing and confirmatory trial start to sufficient funding or collaborations; execution risk until capital secured.
• Non-cash warrant volatility obscures P&L: CFO flagged that warrant revaluation creates significant non-cash swings in earnings, complicating comparability and not affecting cash burn/runway.
• Capital structure optics: Company executed a 1-for-30 reverse split in June to maintain Nasdaq compliance, a signal of valuation pressure and market access challenges.

Transcript

Speaker 6

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

Speaker 5

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 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 and in our SEC filing. 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?

Speaker 2

Thank you, Ann-Marie, and thank you all for joining us this morning as we review the progress Cellectar Biosciences has made throughout the first half of 2025. The first half of 2025 has been a period of strong execution and strategic progress for Cellectar Biosciences. 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, iopofosine I-131, which continues to demonstrate its potential as a first-in-class radioconjugate therapy for patients with Waldenstrom's macroglobulinemia, 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 CloverWAM 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 therapy 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 for iopofosine I-131 as a treatment for WM based on the CloverWAM Phase IIb 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 potential partners, both regional and global. We would expect these partnerships, if completed, to provide non-dilutive 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 OG-emitting agent, is advancing toward 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-based alpha-emitting agent, 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 Biosciences 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?

Speaker 4

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 and 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 three months ended June 30, 2025 were approximately $2.4 million, compared to approximately $7.3 million for the three 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 CloverWAM Phase II clinical study in WM and a reduction in personnel costs. General and administrative expenses for the three 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 non-cash in nature and relates to either the issuance, exercise, or changes in the valuation of warrants.

These non-cash changes are having a significant impact on earnings, non-operating only, but do not impact cash burn or runway. Net loss for the three 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 three months ended June 30, 2024. As I just mentioned, the significant differences in the net loss and earned per share are other results of the non-cash 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.

Speaker 3

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 CloverWAM 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 CloverWAM 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 CloverWAM study data, we would need to move to an earlier line of treatment or 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, allows 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 eight months post-submission or six months post-filing, given the breakthrough designation. I will now provide an update on our two exciting Phase I ready radioconjugates. The first is CLR-125, our lead OG-emitting compound. Our second, an alpha-emitting actinium-based compound, CLR-225. Our OG-emitting radioconjugate product candidate, CLR-125, 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 CLR-125 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 CLR-125, 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 three distinct doses of CLR-125: 32.75 millicuries per dose for four cycles versus 62.5 millicuries per dose for three cycles and 95 millicuries per dose for two cycles, with four 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 we'll 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 CloverWAM Phase IIb clinical trial.

Leveraging dosimetry imaging to measure drug delivery directed 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 radioconjugate product candidate, to date it has shown excellent biodistribution and uptake in two solid tumors and demonstrated activity across multiple solid tumor animal models, including four 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 radioconjugate's 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?

Speaker 2

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 Biosciences. 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. CLR-125 and CLR-225 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.

Speaker 6

Yes, sir. Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you wish to ask a question, please press star and one on your telephone keypad and wait for your name to be announced. Once again, star and one if you wish to ask a question. Please stand by while we compile the Q&A roster. Thank you for waiting. We now have our first question. This comes from Fanyi Zhong from Oppenheimer & Co. Inc. Your line is now open. Please go ahead.

Speaker 1

Thanks for taking the question. This is Fanyi for Jeff. A couple of questions. First, for the WM program, where do you stand on alignment with the EU on the path to approval? For the 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.

Speaker 3

Thank you, Fanyi. Let me see if I captured the first question correctly. Feel free to correct me or guide me if I don't answer fully. For iopofosine I-131, as we look to the approval pathway, and I'll say for the FDA, obviously, we have continuing discussions for conditional marketing authorization in the coming weeks with the EMA. For the FDA, where we sit now is finalization of a protocol for an accelerated approval confirmatory study. 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.

Now that we have the 12-month follow-up data that we're referring to and independent review committees' 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.

Speaker 2

The only other thing I'll add to that, Jarrod's thorough response, is as you know, as we thought about this 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, 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. Additionally, with that traditional accelerated approval pathway, the company was obligated to advance iopofosine up into earlier lines of therapy. 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, this drug would perform very, very well. That gives us now confidence to advance further upstream into second line. 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. As that number continues to increase, that second line now becomes available for post-BTKI treatments such as iopofosine. I think I will also mention that we did receive breakthrough therapy designation from the FDA in late May, which is also factored into this as well. We go into this with an approach with a higher degree of confidence based on the data that we have from the Phase IIb CloverWAM study.

Speaker 3

Fanyi, I think your second question was on the biodistribution of CLR-125?

Speaker 1

Yes.

Speaker 3

Yeah. I'll summarize because it'd take too long to go through all of it. 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, all 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. Again, it's well below 5% or around 5%, I should say, for that. It's well below a concerning level.

Speaker 2

Following this call, based on the news that we've released this morning, we'll be updating our corporate presentation on the website. There is a significant amount of new data relative to our preclinical work with a series of radioisotopes, which includes CLR-125 and the OG-emitting work.

Speaker 1

Great. Very helpful. Thank you.

Speaker 3

Thank you.

Speaker 6

Thank you. Once again, for those who want to ask a question, please press star and one on your telephone keypad. Star and one for question. The next question comes from Edward Andrew Tenthoff from Piper Sandler & Co. Your line is now open. Please go ahead.

Speaker 0

Great. Thank you, guys, and congratulations. This is a really meaningful update. This series of events from breakthrough therapy 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? You mentioned the need to have the confirmatory trial underway by decision, which I assume means potential approval. How much does it cost to kind of submit and get iopofosine I-131 approved? Thanks.

Speaker 2

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

Speaker 3

Yeah. Ted, I'll add to that with regard to some of the extra details. One of them would be, as we think about it, and I think this links to your question, the timing, right? 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. For the FDA, they have made it clear that they don't have necessarily the exact same definition. To your point, by the time of regulatory action, which is assumed to be an approval timing point, at that point, you would have enrollment ongoing, as they call it. 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, 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. Somewhere in this $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 had a CRO prepared to initiate. We have the quote. We have the contracts. We've outlined all of this ahead of time.

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, early next year, because we want to have that study initiated prior to the submission. We'd 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 six-month window, based off the fast track and breakthrough designation, which gets us that accelerated review timeline.

Speaker 2

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 IIb CloverWAM data out in the public domain. The WM patient population is highly communicative among each other. They're very aware of the data. 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 four single infusions over approximately 70 days, it is going to be very, very attractive for these patients. 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.

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 to that?

Speaker 3

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 treatments. 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. That as well, we believe, will add to the speed and quickness of this study getting completed. We do think that the overall timeline for completion and getting to the primary endpoint in the study will be much quicker.

Speaker 0

Great. Excellent. Very, very helpful. Really important update. Thanks, guys.

Speaker 2

All right. Thank you, Ted.

Speaker 6

Thank you. Once again, for those who want to ask a question, please press star and one on your telephone keypad. Star and one for questions. No further questions that came through. I'll now turn the call over back to Jim Caruso for closing remarks. Please go ahead, sir.

Speaker 2

Thank you, Operator. Thank you 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 and the months ahead.

Speaker 6

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