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

Thank you operator. Good morning, and welcome to Cellectar Biosciences' Fourth Quarter and Full Year 2024 Financial Results and Business Update Conference Call. Joining us today from Cellectar are Jim Caruso, President and CEO, who will provide an overview of the company's progress; before turning the call over to Chad Kolean, CFO, for a financial review of the quarter and the year. Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Cellectar issued a 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's accurate only as of the date of this live broadcast, March 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 will begin the call 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 to all for joining us this morning as we share Cellectar's recent regulatory progress with iopofosine, our ongoing preparations to advance our Alpha and Auger radioisotopes solid tumor programs, and forward-looking plans to address the Company's NASDAQ status and future funding including evaluation of non-dilutive funding opportunities. 2024 can be described as a bittersweet year for Cellectar, starting with the announcement of excellent clinical results from our CLOVER-WaM study of iapopacine I131 for the treatment of relapsed/refractory Waldenstrom's macroglobulinemia, or WN, and concluding with disappointing regulatory news, which delays the submission of the new drug application, or NDA, for conditional approval under the accelerated approval process. In the CLOVER-WaM study, iapopacine demonstrated an impressive 98.2% clinical benefit rate, 83.6% overall response rate and a major response rate of 58.2%. These clinical outcomes are particularly meaningful for this challenging to treat relapsed/refractory elderly patient population. For these patients, limited reduction in tumor burden or achievement of disease stability can provide clinical benefit with improved symptoms and extended progression free-survival and time to next treatment. We remain confident in the potential value iapopacine will provide to patients suffering from this incurable disease. Unfortunately, we experienced a regulatory setback with our plans to file an NDA in the first half of 2025, which adversely impacted our stock price towards the end of last year. As the clinical data demonstrates, iapopacine offers potential to be a meaningful treatment for all relapsed/refractory WM patients. As such, in alignment with the FDA, we recrafted the path to market through the accelerated approval process pathway. Our comprehensive product market research, market sizing and commercial analysis underscores iapopacine's significant market potential in the relapsed/refractory setting. This potential is driven by iapopacine's novel mechanism of action, its distinctive product profile and size…

Thank you, Jim. In 2024 we executed multiple financial transactions that strengthened Cellectar’s balance sheet, including investors exercise a warrant in January generating $44.1 million and an inducement financing in July which included the exercise of existing warrants and the purchase of new warrants for $19.4 million in proceeds. As we communicated last October, we refiled our historical financial statements for fiscal years 2023 and 2022, an action that was precipitated by a re-evaluation of the accounting for warrants issued prior to 2023. As a reminder at the time of issuance, the warrants were classified as equity-based upon internal and external assessment. As supported by our existing accounting firm at that time and a global professional services firm, which provided an expert third party evaluation, a subsequent internal review determined that these warrants should have been classified as liabilities, which necessitated the revision to our historical reporting. Importantly, the restatement had no impact on historical cash or cash burn reported and the changes to earnings were all non-operating and non-cash. Now turning to our financial results in the fourth quarter and full year ended December 31, 2024, we ended the year with cash and cash equivalents of $23.3 million, as compared to $9.6 million as of December 31, 2023. Based upon the delay in iopofosine’s NDA submission and lack of regulatory clarity, we implemented a cost savings strategic restructuring which reduced headcount by approximately 60%, we expect restructuring to drive savings of approximately $7.5 million annually and to extend our cash runway into the fourth quarter of 2025. Moving to the operating results, research and development expenses for the full year 2024 were approximately $26.1 million compared with $27.3 million in the prior year. The decrease was largely driven by the timing of expenditures for our WM Phase 2 study…

Thank you, Chad and good morning, everyone. I will begin by providing a regulatory update on iopofosine for the treatment of WM. Following our November 2024 FDA meeting, we sought to obtain additional clarity on the agency's preferred study design to support an accelerated approval. We formally submitted an end of Phase 2 meeting request in early January, providing a study protocol designed to align with the FDA’s clinical development feedback. The formal meeting was held on March 6 and I am pleased to report that we successfully achieved a crucial milestone for the future development of iopofosine I 131, establishing a clear regulatory pathway for our promising drug. We view the outcome as a significant win and believe it sets a clear path to the NDA submission and market approval for iopofosine in WM patients. The path requires the completion of a confirmatory randomized controlled study of iopofosine I 131 versus a comparator arm, which will provide the study investigators a choice between one of two NCCN approved treatment options. This trial is expected to enroll approximately 100 patients per arm. Both the FDA and Cellectar have agreed upon the major protocol elements and the requirements for accelerated and full approval. The approval process is anticipated to proceed in two stages. The additional accelerated approval is based upon major response rate. Subsequently, full approval is contingent upon achieving progression-free survival. We anticipate that the study to enroll – will enroll rapidly and to achieve full enrollment within approximately 24 months of the first patient treatment. The total cost is between $40 million and $45 million. We estimate that approximately $30 million will be required to achieve full enrollment, which facilitates the NDA submission for conditional approval. The approximately $15 million balance remaining would be required for the determination of…

Thank you, Jarrod. As you can see, we are off to a very good start in 2025 by rapidly securing clarity on the FDA’s requirements for a conditional approval under the accelerated approval pathway. To state the obvious, this is a significant achievement and asset value enhancer. As I previously reported, we are in advanced discussions with multiple companies regarding the licensing rights for iopofosine. The regulatory strategy established with the FDA provides a clear and cost efficient regulatory pathway forward for iopofosine with what we believe to be limited clinical and execution risk. In essence, the regulatory clarity has significantly enhanced the value of iopofosine. Non-dilutive cash associated with these potential deals would be highly beneficial for the company. In addition, we will be prepared to initiate Phase 1 studies for both the alpha actinium-based radioconjugate in pancreatic cancer and the Auger-emitter for triple negative breast cancer in the first half of 2025. The initiation of these respective studies are to be determined. Our current cash position extends into the fourth quarter of 2025, which we believe provides ample time to evaluate and advance non-dilutive licensing deals and potential funding vehicles and in parallel assess time for the initiation of our Phase 1 assets. Before opening the call to your questions, I would like to thank our dedicated and talented Cellectar team who continue to work with tremendous determination to move these important programs and the company forward. We remain committed to the WM community and sincerely appreciate the abundance of support and continued encouragement to advance iopofosine to market. Together, we continue to push the boundaries of what is possible in oncology and we look forward to the future with optimism and hopes. Operator, we are ready to open the call to questions.

Thank you. Ladies and gentlemen, we will now conduct a question-and-answer session. [Operator Instructions] Our first question comes from the line of Jeff Jones from Oppenheimer. Your line is open.

Hi, thanks for the update. This is Shiny [ph] on for Jeff. A clarity question for NDA is acceptance for iopofosine I 131. Does the NDA section require the NR data from the confirmatory study or just the CLOVER-WaM? And I have follow up. Thanks.

Sorry, let me you were breaking up there pretty bad. So I'm not 100% sure I captured everything that to you are trying question. Was the question for the NDA submission, does it require data from the new from a new study or is it just from the CLOVER-WaM study?

Yes, I mean the NDA acceptance require the MRR data from the confirmatory study or just the CLOVER study?

Yes. The accelerated approval will require data from the additional study as well.

Gotcha. Thanks. So can you share the timeline for patients to achieve and be evaluated for an MRR response under the [indiscernible] study design?

Certainly. Hi, this is, Jim. Before I turn that question over to Jarrod. We do anticipate rapid enrollment in this study based on our obviously the drug's performance in the Phase 2 where we achieved outstanding clinical results and quite frankly a very impressive adverse event profile as well. WM community was very disappointed that there would be a delay to market for iopofosine. There's clearly high unmet medical need there and the patients have really reached out and have rallied around this drug and the company and we're very appreciative of that. In addition, the thought leadership also disappointed that they're not going to have this drug available in the very near term for their patients. Having said that, it's very clear that the healthcare community would rally around the clinical study and we expect enrollment quite frankly very quickly. And from first patient in we've crafted some time and events that we believe are conservative. And I'll turn this over to Jarrod to provide some detail around this.

Yes, as Jim said, we took a conservative sort of approach to building our timelines here. And from that perspective we look at it from first patient enrolled, aka first patient dose that it would be approximately 24 months to full enrollment and then with the two major response rate being approximately 30 days that it would basically be one more month to achieve the necessary outcomes for major response rate.

Great, very helpful, thank you. And what would be the comparator be or any color on the comparator? Thanks.

We're particularly excited about, how we've crafted this with the FDA and the FDA support in terms of the comparator arm. And this is one of the reasons why we believe we have and our thought leaders and advisory council believe we have very limited clinical risk here. Jarrod?

Yes. I would add to that. We believe or we know that at least one of the comparators, as we mentioned it will be two comparators. It’s investigator choice study design. So they get instead of one of the nine NCCN guideline options, they get two options to choose from. Both of those based off of utility. None of it’s based off of efficacy because no one’s tested in this late line study group before. Obviously, the most relevant data comes from the iNNOVATE study using rituximab monotherapy which we are using here again as one of the choices. Just to give you a sense in that iNNOVATE study, if you look at the major response rate rituximab monotherapy it was 22% with progression free survival of – median progression free survival around six months. And so we think that again based off of our data that we stack up very nicely against that. The other arm will be – we’re finalizing that choice and I believe it will be a rituximab combination treatment where the expectation is it will perform very similar to the rituximab monotherapy.

And for clarity, both treatments will sum to 100 patients.

Great, thanks. If you don’t mind, I have a one follow-up. For financial runway of cash to fourth quarter this year, does this include the work to complete IND filings for CLR 121225 and 125 [ph]? And what about the studies themselves and what the estimated cost of those Phase 1 studies? Thank you so much.

Sure. What – yes, go right ahead, Chad.

So the answer to your question is yes, that runway does include the cost for the IND filings and the cost is relatively modest to get the Phase 1 trials running. And that is also encompassed in the cash runway that we presented earlier.

And the cost associated with each of those studies is in the ballpark of about $4.5 million.

Great. Thank you so much.

Thank you.

Our next question comes from the line of Jonathan Aschoff from ROTH. Your line is open.

Hi, good morning. Thanks. Congrats on the progress. And I was just curious, the comparator arm is pretty much going to be 50/50, one group taking rituximab and the other one taking something else among those nine NCCN drugs, is that correct?

No, that is not correct, Jonathan. So they only get to choose one. There’s only two choices, right? One will be rituximab, one will be the other arm that we’re agreeing to with the FDA, we have to provide them with utilization data on our other choice. That’s what they want to see. How that breaks down…

Sounds like what I said…

It’s – no, it’s not though. It’s not a 50/50, right? The physicians get to choose. It could be 90% rituximab monotherapy and 10% the other arm. We don’t know. We don’t have any control over that. So it’s 100% an investigator choice between two options.

That’s helpful. Do you wish to allow us to understand at all the range of deal types you're entertaining for 131 to get that trial started?

Yes. We're – obviously we're very fortunate, right. We have a Phase 3 ready oncology asset in an area with high unmet medical need, with a substantial market both here and abroad, with the opportunity for orphan drug pricing and in a space with very, very limited treatment options. And likely one of the next one or two radiotherapeutics that would be approved in this space in an area that's growing in a high degree of interest. So I mean, as you would expect there would be a lot of interest in an asset of that nature. I also believe, as I cited in my remarks that the clarity on the regulatory side has been very well received. And I believe those entities that are doing the asset also view this as very, very limited clinical risk. And so you have a pretty much a clear pathway to approval with very low risk of not achieving the necessary results versus the comparator arms that Jarrod just cited earlier. So those deals could take on a number of different looks. I'll have Jarrod talk to some, you know, broadly or in generally some of the types of deals that we would entertain.

Yes. So to your point, Jonathan, and I think we've talked about this in the past. We're entertaining everything from global partnerships where someone would take over obviously the global rights and we would continue to collaborate with them on execution, but that they would be predominantly responsible for everything and then they'd be responsible for the commercialization of the compound afterwards. All the way down to regional rights where it might be a European partner or an Asia partner and we would still maintain the U.S. rights and proceed. From that perspective, we do have a number of, as Jim alluded to, we have a number of parties and we have parties in each of those buckets that have – that are progressing through the process. And really we're looking to really make a decision here on which offers the best outcome for the company and for our investors.

And from a global licensing perspective, just for some clarity, Jonathan, from a global licensing perspective that would include a typical upfront payment, series of milestones and royalties back to our company. And then the entity that we assign those rights to would also be fully responsible for the economics associated with the – with the pivotal study and the responsibility for the execution of it. As Jarrod mentioned, based on our relationships that have been established and our experience in executing the Phase 2 and with those known contacts with those institutions and community based systems that will drive the majority of those both here and ex-U.S., that'll be some additional value that we would bring to add [ph]. Additionally and importantly, all of the CMC related costs and manufacturing costs would also be responsibility of a third party. We would, obviously, because of our experience here and what we believe best-in-class radiotherapeutic manufacturing, we would be responsible for the manufacturing of the drug.

Okay, thanks. Lastly, why pancreatic for 225? Is that based mostly on market need or was there some clearly differential preclinical efficacy signal?

Yes. So yes actually, John, easy answer is yes, both actually. So clearly the market need is significant there and patients are in severe need of a new treatment paradigm, particularly for PDAC or pancreatic ductal adenocarcinoma. The addition to that is every preclinical model that we've tested of PDAC. The actinium program has done an incredible job of being highly effective in every animal model. And we've reproduced that now quite a few times and have demonstrated that. And it also shows a very consistent uptake and dose response. So, it's an opportunity to really take advantage of both the delivery platform to get after a complex, difficult to treat high unmet need and at the same time have a good understanding of where the likely therapeutic activity will be and the therapeutic window based off the safety profile.

One of the attractive natures of both of these Phase 1s is that, Jarrod will orchestrate this in such a way where we'll receive dosimetry data on patients so we will very rapidly see the amount of drug that's targeted to the tumor and also, within six, nine patients or so have a really good understanding of safety associated with this as well. So, it's not a long pathway to evaluation. We believe both of these tumor types are – there's clearly high unmet medical needs in very large markets and also high unmet medical need. And on the radiotherapeutic side of the equation, these solid tumor programs for these large bulky tumors are very rare. Based on the technology associated with delivery of these radioisotopes, and we believe, based on proof-of-concept with iopofosine and a significant amount of preclinical work, and obviously all the work we've done on the imaging and diagnostic side of the equation that our targeting platform is unique and will be able to deliver the isotope, regardless of the isotope, to the tumor high uptake as well as the associated safety that we observe with iopofosine.

Thanks a lot. I'm glad you guys are having the inbound.

All right. Jonathan, thank you. We'll see you next week at your conference. Thank you for the invitation.

Got it. Bye.

[Operator Instructions] There are no further question at this time. Mr. Caruso, please go ahead.

Sure. Thank you, operator. And thank you, everyone. This does conclude our call for today. Obviously take this opportunity to disconnect and please have an enjoyable day. Thank you.

Ladies and gentlemen, this concludes the conference call for today. Thank you for participating. Please disconnect your lines.