Cellectar Biosciences Inc (CLRB) 2025 Q3 法說會逐字稿

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 Anne Marie Fields.

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 US 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 US 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 US 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 US 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 three months ended September 30, 2025, were approximately $2.5 million compared to approximately $5.5 million for the three 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 three 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 three 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 three 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 US 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; five 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 two 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 three 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 US 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)

Aydin Huseynov, Ladenburg.

Hi, good morning, guys. 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 four 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?

Yeah. 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 US. In the US 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. Yeah, 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 US 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?

Yeah. 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 US, 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 US and given all these MFN discussions. So could you help us understand the pricing potential for iopofosine in Europe and US. 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.

Yeah, 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 US. And to your point, it's not only Europe, it's 30 major countries, except for China, Japan and the US that would be have the capacity to market iopofosine. So it's a significant market size comparable certainly to that of the US 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 US, 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 US market prior to that of the EMA. And so from a pricing perspective, that would certainly make pricing both in the US and ex US 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 two directions or take this in two 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 US, 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 US 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 US. 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 negotiat or with a partner, negotiate a stronger price point in Europe.

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

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

Jeff Jones, Oppenheimer.

Good morning guys, and 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 US, 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 US, 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-US 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 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 two predominant regions right now for radiopharm, which is the US 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 US, 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?

Yeah. 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 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 metabolic.

Greatly. Appreciated. Thank you, Gerd.

(Operator Instructions)

Jonathan Aschoff, ROTH.

Hi guys, good morning. 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.

Yeah, 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.

Yeah, 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 US. So it will be filing and we have filed ex US 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 one 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.