Good morning, and welcome to Cellectar Biosciences Second Quarter 2024 Financial Results Call. Today’s call is being recorded. Before we begin, I would like to remind everyone that statements made during this call relating to Cellectar’s expected future performance, future business prospects or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties that could differ materially from those forecast due to the impact of many factors beyond the control of Cellectar. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events or otherwise. Participants are directed to the cautionary notes set forth in today’s press release which is available on the Investor Relations portion of the company’s website as well as the risk factors set forth in Cellectar’s annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Cellectar. Mr. Caruso, please go ahead.

Thank you, operator, and good morning, everyone. It is my pleasure to be here with you to provide a corporate update for our second quarter of 2024. With me today are Dr. Andrei Shustov, Senior Vice President, Medical; Jarrod Longcor, Chief Operating Officer; Shane Lea, Chief Commercial Officer; and Chad Kolean, Chief Financial Officer. I will begin today with a brief recap of our progress over the past quarter and discuss anticipated near-term milestones. I will then ask Chad to provide an update on our financials. Andrei will follow with additional insights regarding our CLOVER-WaM pivotal study, followed by Jarrod, who will provide an operations update on the regulatory front and manufacturing. Finally, Shane will review our commercial progress. We will then open the call for Q&A. As you are likely aware, on July 23, we announced our full data results from our pivotal trial in WM, which are truly impressive and maintain the potential to meaningfully improve upon the current standard of care in WM. Andrei will talk to the quality of the data in an extremely challenging patient population. However, I’d like to emphasize to everyone that the patients in the clinical trial were by far the most refractory ever studied in this indication with iopofosine I 131 representing the fifth medium line treatment. It is, therefore, impressive to observe comparable results obtained in CLOVER WaM to those reported in first and second line with other treatments. Of course, our near-term organizational focus remains lock on iopofosine’s WM regulatory and commercial objectives. Iopofosine has also demonstrated utility in other hematologic indications such as relapsed/refractory multiple myeloma and DLBCL. And clinical development is ongoing in our Phase 1b for pediatric high-grade gliomas. As you may recall, we initiated and enrolled the first patient in this Phase 1b study earlier…

Thank you, Jim. Our cash and cash equivalents balance as of June 30, 2024, $25.9 million compared to $9.6 million as of December 31, 2023. To note that at the end of the first quarter, we had a cash balance of $40 million, resulting in the net cash used in operating activities during the second quarter being approximately $14.1 million. In addition to the cash on hand at the end of June, in July, nearly all of the investors from the September 2023 financing exercised their Tranche B warrants at a reduced as-converted common stock price of $2.52 per share. Those investors who exercised their Tranche B warrants also received new warrants as part of the transaction, which generated gross upward proceeds of approximately $19.4 million before customary expenses and fees. The company believes its cash on hand, inclusive of the July warrant exercise proceeds. It’s adequate to fund budgeted operations into the second quarter of 2025. The three warrant tranches issued last month provide potential additional funding based upon their respective expiration dates, which occur with a first tranche of approximately $17 million after we received a PDUFA date in the FDA. A second tranche of approximately $32.9 million after we receive approval of iopofosine I 131 from the FDA. And a third tranche of approximately $23.5 million after the first quarter in which we generate $10 million in revenue from iopofosine I 131. Assuming our discussions with the FDA go as planned, this funding would get Cellectar to the point where we will be cash flow positive. Turning back to the second quarter, R&D expense was approximately $8.2 million, compared to $6.3 million in the second quarter of 2023. The increase is largely driven by the timing of expenditures for our WM pivotal trial to support patients’ final…

Thank you, Chad, and good morning, everyone. Recently, we provided an update on the top line results from our pivotal CLOVER WaM study that is fully enrolled with all living patients who have completed study treatment remaining in long-term follow-up. There are 65 patients in the safety data set defined as all patients receiving at least one dose of iopofosine I 131, and there are 55 patients who met the criteria for inclusion in the efficacy valuable set defined as all patients who have received at least 60 millicurie total administered dose and have undergone at least one response assessment. The response rates and safety data discussed today are as of May 31, 2024 data cutoff date. As a reminder, CLOVER WaM is a global single-arm Phase 2b study examining iopofosine I 131 in relapsed and refractory patients who have received at least two prior lines of therapy, including those patients who failed or has suboptimal response to BTKi, the only FDA-approved class of treatment for this cancer. Study patients received a total of four doses of iopofosine I 131 over two cycles without maintenance or retreatment and were evaluated for response at regular protocol-defined intervals using standard IWWM criteria. As Jim stated, patients enrolled in CLOVER WaM were the most heavily pretreated and the most refractory WM patient population ever reported in clinical trials. Please allow me to review a few key patient and disease characteristics. The median age was 70 years with August enroll patients aged 88 years. The median number of prior therapies was four with a range from two to 14. 71% of patients were previously treated with BTKi, 91% were treated with rituximab, and 84% received prior multi-agent chemotherapy. Over 90% of patients were refractory to at least one class of drugs with refractories to…

Thank you, Andrei. As Andrei described, our clinical data from the CLOVER WaM study continues to be quite impressive and improves with time. We remain actively engaged in the review "cleaning and prepping" of the CLOVER WaM pivotal study data for the near-term NDA submission. As you are aware, the NDA submission process requires relentless attention to detail and is a time-consuming project. For your background, the thousands of patient data points collected over the course of the study must be validated and verified. This is a process called data cleaning, which also includes identifying and correcting any data entry errors. Once this process is complete, the database is locked and the final study data sets can be produced for the NDA. This information is required for the completion of the clinical study report and the clinical sections of the NDA submission. We are expediting this process by performing several of these activities in parallel. For example, as a subset of the data is clean and finalized, we use this data to complete required sections in both the clinical study report and the NDA rather than waiting for the entirety of the data to be finalized. This allows us to shorten the traditional time line of approximately six to eight months of final study results to submit a submission around to four to six months to that submission time line. In addition to these activities, we continue to work closely with the FDA to ensure our submission meets all requirements planned remaining FDA interactions prior to the final submission include the determination of the potential need for a confirmatory study. And should the FDA require one agreement on the design of the confirmatory study and the pre-NDA meeting with submission plan for Q4 2024. Shifting now to the supply chain.…

Thank you, Jarrod. Good morning, everyone. I'm excited to share our commercial planning progress regarding the product launch of iopofosine, Waldenstrom's macroglobulinemia or WM. We continue to make significant advances in our commercial capabilities and understanding of the WM market dynamics, which along with the highly scalable nature of the market will allow our team to capture the WM opportunity with a focused and efficient commercialization model. As previously noted, WM is a rare type of non-Hodgkin's lymphoma with a prevalence of approximately 26,000 patients in the U.S. Of these, about 80% are currently receiving active treatment. The market is highly concentrated with 80% of the opportunity located in just 15 states. We plan to pursue a relapse or refractory indication, which has an estimated population of approximately 11,500 patients. We have also built conservative plans with a base case indication assumption for the third line plus setting which represents an addressable population of 5,700 patients who could benefit from iopofosine therapy. Of these, approximately 4,700 patients are currently receiving third-line plus therapy and approximately 1,000 patients have exhausted all treatment options, leaving them an acute need for new therapy. Additionally, there are approximately 2,200 new third line plus patients each year, which means that 2,200 additional patients advanced into the third line plus treatment setting annually. Our base case assumption provides a significant iopofosine market opportunity in terms of the total addressable population in the likelihood of orphan drug pricing. Importantly, there is a significant unmet need in the third line plus setting with only approximately 10% of third line plus patients achieving a major response and the duration of response for these one in 10 patients is approximately six months. Moreover, 60% of the drugs utilized in this setting are not FDA approved, which means limited competitive promotional…

Thank you, Shane. It certainly remains an exciting time for us at Cellectar with a potential approval for iopofosine I 131 on the horizon, coupled with our unique delivery platform providing differentiated radioisotope offerings. We are confident in our market position and excited about our future. We look forward to our meaningful milestones in the second half of this year, positioning us for further advancements and real growth as a company. With that, I would now like to open the call for Q&A. Operator?

Thank you. [Operator Instructions] And your first question comes from Jonathan Aschoff of ROTH. Please go ahead. Your line is open.

Thank you. Good morning, guys. I think I might have missed a couple of numbers you were throwing out there. Do you have a new major response rate of 58 point something?

That is correct, Jonathan. With the latest data cut it's now 58.2%. And I think Andrei can talk to one of the reasons why we see consistent improvement over time with iopofosine for these patients.

And that's based on what? Jim, or you can say that it's based on what...

Yes, the patient end.

So we have – Jonathan, good morning, Andrei here. So we have 55 patients in the efficacy evaluable set, and as Jim pointed out after the most recent data cutoff, we just registered another late response effectively brings the MRR rate to 58.2%. We also expect that we might see additional major responses based on our prior observations that we demonstrated or reported in January that responses can occur as late as six months after receiving therapy. So we will not be surprised, and we actually anticipate that if I have additional major responses as follow-up continues.

Okay. That's very helpful. Chad, can you help us out a little closer on even if it's just the bottom result for the quarter, meaning the net income? And can you help us out on a share count and whether that's a time point or a weighted average?

So I can't provide a net income at this point, Jonathan, because the restatement has to be brought all the way forward, the evaluation needs to be done on a quarter-by-quarter basis to do that. That's why we didn't provide it in the comments, unfortunately. We simply need to work through that before we can essentially publish that information; so my apologies there. We did obviously provide operating expenses, but the non-operating components need to be further definitized.

And how about the share count?

So on the share front, I will – I think the expectation is we're going to get an 8-K published on that because I want to essentially publish the entire cap table. And so that is forthcoming. You should have that in the very near future.

Okay. That's helpful. This is also something I may have missed. But when will your HGG data come out your next data set for that? And how is about starting the timing for Phase 1 for the alpha-emitter actinium?

Sure. I'll have Andrei talk to the pediatric high grade glioma study, and then Jarrod can address our work with our actinium-based program.

Thanks again, Jonathan. We started enrollment in the HGG study at the very beginning of this year with patients already enrolled in the study and a few patients being screened as we anticipate that will provide initial look initial results from that study by the end of the year.

Okay. And starting Phase 1.

Yes. Great question, Jonathan. So real fast, what I'd say is we sit in a unique advantage in that our phospholipid ether delivery targeting mode is validated based on the iopofosine data as a validated targeting ligand. And we have a unique advantage in that that allows us to accelerate our time lines into clinical trials and completion of IND-enabling studies. I think as we mentioned before, we expect to complete the IND-enabling studies here in the fourth quarter of this year and either late this year or early next year, initiate that Phase I study with the actinium program.

And Jarrod, we haven't talked about it very much, but could you share a little bit about the OG program and...

Yes, absolutely. So obviously, as Jim just alluded to, Jonathan, we've got – as we've talked about, we've validated with a number of different isotopes or different emitting isotopes. And as Jim just said, we also have the advantage of being able to use OG emitting isostopes quite readily. And we do have a program that has been in the background for a little while that we're moving forward with that we would expect that we could quickly initiate Phase 1 study in that arena as well shortly on the heels of the actinium spending capital.

Okay. That answers my question. Thank you guys.

All right. Thank you, Jonathan.

And your next question comes from Jeff Jones of Oppenheimer. Please go ahead. Your line is open.

Hi, guys and thanks for taking the question. A couple from me. Andrei, you gave a really long and really detailed update on the data, and obviously, key update there was the increase in the MRR. Were there any other changes that we – that I might have missed from the prior data set that was described in July?

Thank you, Jeff. I don't think you missed anything. This is the single most impactful update even though it's just one additional response, it brings us closer to our previously reported number within margin of error. So the current MRR effectively is 58.2%. And we expect that we might have in the next few months additional responses converting from minor to major responses as we model at the beginning of the year. But where we sit now is 58.2% and that's the most impactful update from a month ago.

Great. Thank you. In terms of the NDA filing, one of the major reasons folks have been getting refusal to files or rejections have been on the CMC side. So you talked about a lot about the importance of supply chain and how you build redundancy in your supply chain. But can you speak to the level of confidence in the NDA filing in the CMC section, perhaps what you've done in terms of quality audits and preparations for FDA inspections?

Yes, absolutely. So that's a great question, Jeff. And there's a lot to unpack in that. So I'll try to unpack as much as I can in a little bit of time here. But so as it comes to our confidence, we are highly confident for a number of reasons, not least of which we've done – we've been producing iopofosine at these facilities for a while now, particularly one of those facilities we've been producing and have not missed a single batch in over three years. As I exemplified, we've replicated that process, and the second facility have produced multiple batches now, a number of batches at that facility without any hitches as well. So we're very confident in the robustness of the ability to do the tech transfer and of both manufacturing facilities to actually produce the material as defined and with inside the criteria as necessary for release [ph]. In addition to that, again, we've done that from the beginning to the end of sort of things. And like anything, we use a design sort of approach with our manufacturing that allows us to get controlled by design sort of quality by design sort of approach. So we're always looking to optimize and enhance that a little by little. So that's part of it. The other piece that I think we’ve done is when we started this process, we actually – and I’m going to get in a little bit too much detail probably, but we took this outside of our hands and we actually had an outside group come in and do a GAAP analysis on our entire manufacturing process from beginning to end to identify any potential gaps in any historical areas that we would need to backfill for questions we might want to answer to make sure our submission was as robust as possible and we did that. One of those folks was actually a gentleman who used to work at the FDA and had actually established a lot of their radiopharmaceutical manufacturing criteria. So we were taking a very robust look at that, and we’ve gone through that, and we continue to sort of reassess it. Now as you enunciated the last piece is the audits, as I’ll call them, whether that be pre-FDA audits or regular audits. We do our own regular audits, both by our team and by external teams every couple of years with all of the sites. So we’ve done that. And right now, we’ve done it with everybody leading into the FDA submission. To your point, we are with every one of our manufacturers right now. We do have on the books, the plan to do pre-FDA, pre-NDA evaluations so that when they do get audited, we will have already gone through there again just to make sure and tighten the screw so that everything is above board and appropriate, so to speak.

Perfect. Thank you very much for that, Jarrod. And then one very quick clarification. For the actinium-based program in solid tumors, the carrier there is the same as iopofosine, correct? Or is it a modification?

There is a modification, but what I would say is that it’s about 90-ish percent, 95%, depending on what chemists you asked, the same. There are slight tweaks.

Okay. So in essence, the targeting agent is the same.

Exactly.

Got it. Great. Thanks, guys.

All right. Thank you, Jeff. We appreciate your questions and obviously your continued interest and support of the company. Thank you.

Thank you. And your next question comes from Ahu Demir of Ladenburg Thalmann. Please go ahead. Your line is open.

Good morning. This is [indiscernible] for Ahu Demir. Thank you for taking our questions. We also have a question regarding the NDA applications. So for the application, what population are you targeting? Will be three line clients [ph] patients treated with the BTK inhibitor before it will be double or triple refractory patients? And are there any additional analysis that the company plans to do prior to the submission? Thank you.

Okay. I think prior to handing it over to Jarrod and Andrei for their perspective and optics here, as we originally designed the study, it was for a third line or greater originally post-BTKi based on the patient population and roll that supported that, it’s essentially a relapsed/refractory patient population. And so it is our belief that we have an opportunity as we continue to engage with the FDA that our data package would be supportive of a relapsed/refractory indication or essentially second line and beyond. And so I can have Jarrod and/or Andrei provide both the regulatory and some of our clinical thinking around that.

Yes. I think from a regulatory perspective, if you look at the patient population, as Jim said and as Andrei defined or described to you in the – when you look at base characteristics, you can clearly see that this is a highly relapsed/refractory patient population, whether you want to cut it from post BTKi, which essentially is BTKis are predominantly being used to refine these days kind of element to whether you just want to say, let’s just look at the refractory. I think the key element there is, as Andrei stated, the data shows that irrespective of the patient population, the drug works consistently and robustly in all of these patients. And because of that, when the agency – or any agency evaluates the drug based off of that and they start to do subanalysis, what you see is there’s really no change in the patient population or the response rates. And that means that you’re likely to get a broader label and label like what Jim just described in relapsed/refractory. I’ll turn it over to Andrei for any other thoughts.

Thank you, Jarrod. I would thank you for this question. It’s a very important question that we are discussing internally, and I’m completely aligned from a clinical perspective with my colleagues that our data is supportive of broad applicability in clinic iopofosine in WM patients, as described in our call, population in CLOVER WaM contained patients post chemo, post-BTKi, post-ritux exposed to couples of those classes, all of those classes, different genomic profiles. So the data is highly applicable clinically to entire WM population and clinically, again, supports the proposed label that Jarrod discussed, and more importantly, applicability once and if iopofosine is approved, applicability to a broad variety of patients with relapsed/refractory WM.

That's very helpful. Thank you.

Of course, thank you.

Thank you. And your next question comes from Ted Tenthoff of Piper Sandler. Please go ahead. Your line is open.

Great. Thank you very much and thanks for the update. Following up on some of the questions with respect to the NDA, I’m curious, what are the major segments that still need to be done? You’ve got into some good detail on the CMC portion is clinical and everything else all ready to go. Just giving a sense for what still needs to be done? Thank you.

Absolutely, Ted. And this is – yes, essentially, all modules are nearly complete. And when I say that, so CMC is complete, preclinical is complete, I think module two is essentially complete. Module one will be finished when we have the full sort of – what sort of table contents completed based off of the clinical piece. So right now, where we sit is really wrapping up the final pieces of the clinical. And when I say that, what I mean is all of the other clinical components have been – are essentially there and done. It’s really just the addition of the final data reports and essentially the CSR out of the CLOVER WaM study. So as those – as that data comes in and gets put into the NDA, that essentially will wrap it up. And that’s exactly – as I tried to describe in the conversation earlier, that’s where that detail comes in that process of going from final – going from having the data to finalizing the data and having a locked database and all the analytics completed.

Sure. And then would you guys anticipate having a panel for this. I know it will probably take some time. But what are your thoughts on that? Thank you.

And when you – Ted, just so that I understand, when you mean a panel, are you thinking of an ODAC?

Yes, advisory committee, correct.

Yes. So obviously, that’s something we will come to. Eventually, I wouldn’t be surprised if there is an ODAC request or a desire by the agency to have an ODAC as you may be aware, many of the radiopharmaceuticals have not actually had an ODAC. They’ve gone through without that. However, we’re not – we’re flexible with that. I don’t know, Andrei, if there’s anything else you’d like to add?

Yes. Thank you, Jarrod, and thank you, Ted. A great question, and we, again, keep discussing this continuously internally our efficacy data looks from our perspective, really impressive and great tolerability and safety data is also impressive. Having said that, it depends on the composition of FDA panel that reviews it and how comfortable they are experienced with disease they’re looking at, whether they need additional advice from the panel. I think it’s a tossup at this point from a clinical perspective. We will continue to prepare for it. We are putting groundwork assuming that it might be necessary to go through, we will be ready.

Great. Sounds good. Thank you so much.

All right. Thank you, Ted. Appreciate your questions.

Thank you. And at this time, there are no further questions in the queue. I will now turn the call over to Jim Caruso for closing remarks.

All right. Thank you, operator. I would like to thank certainly our analysts and everyone for joining us today. We look forward to speaking with you, hopefully, in the near term. Thank you.

Thank you, everyone. This concludes today’s conference call. You may now disconnect.