Good morning, and welcome to Cellectar Biosciences 2024 Year-End (sic) [ First Quarter ] Earnings 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 company -- 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 report our Q1 results and provide a corporate update. With me today are Dr. Andrei Shustov, Senior Vice President, Medical; Jarrod Longcor, Chief Operating Officer; Shane Lea, Chief Commercial Officer; and Chad Kolean, our Chief Financial Officer. As you know, we recently completed our 2023 annual earnings call in which we reviewed a highly productive year for the company, including the announcement of detailed top line data from our WM pivotal study and reiterated guidance for a data update in Q2. I'm pleased to report that we remain on track for a Q2 data announcement for the fully enrolled study patient population. We plan to press release this data in June and review in greater detail on a key opinion leader call scheduled for the same day. We look forward to sharing the study data and the subsequent KOL call. Currently, we are in process of completing our NDA and plan to submit our filing to the FDA in the second half of this year. Assuming we are granted priority review associated with our Fast Track designation, we would expect a 6-month review period from the date of the NDA submission. The focus of today's earnings call is to have a more in-depth commercial discussion regarding the attractiveness of the WM market, including the existing high unmet need, the lack of competitive investment and scalable nature, among other factors all likely to facilitate rapid capture of iopofosine I 131 market share. In addition, we will review our efficient and cost-effective product manufacturing infrastructure and distribution plan in preparation for the potential marketing of our lead radiotherapeutic. To further orient you to today's agenda, I will provide a brief overview of the meaningful accomplishments…

Thank you, Jim. Our cash and cash equivalents balance as of March 31, 2024, was $40.0 million compared to $9.6 million as of December 31, 2023. The exercise of the tranche A warrants from the September 2023 financing, combined with the exercise of 547,000 warrants issued in October 2022, generated net proceeds of $43.9 million. Net cash used in operating activities during the quarter was approximately $13.4 million. The company believes its cash on hand is adequate to fund budgeted operations into the fourth quarter of 2024. R&D expense for the quarter was approximately $7.4 million, compared to $6.7 million in the first quarter of 2023. As we continue our preparations for an expected product launch for iopofosine I 131 in 2025, the company has invested extensively to ensure that we have the ability to deliver product in the event of a disruption at one of our suppliers, which we have solution by the establishment of multi-source supply chain that has redundancies at every step from radioisotope suppliers to material producers and final conjugated product providers. Those costs were partially offset by reduced spending relating to our pivotal trial in WM now that we have completed trial enrollment. G&A expense for the first quarter of 2024 was $4.6 million as compared to $2.1 million last year for the same period. The substantial increase in G&A was also primarily driven by the expectation of a product launch in 2025 with the development of the infrastructure and information necessary to support a fully commercialized product, including personnel and marketing costs. There is a $9.9 million noncash charge that relates to the impact of the accounting for the warrants on the P&L. The accounting rules for the warrants required the company to revalue them at every reporting date. Also, upon settlement, the tranche…

Thank you, Chad. Commercial team is advancing our preparation for the potential commercial launch of iopofosine in WM. Importantly, we continue to execute and make progress supporting our commercialization strategy for iopofosine, the goal of ensuring a successful launch upon FDA approval. We are very encouraged by the findings from our most recent market research projects, which included an evaluation of iopofosine's product profile and evaluation of WM patient journey and segmentation research with radiation oncologists and nuclear medicine physicians. Iopofosine's product profile for WM was given an exceptionally high rate for intent to prescribe with hematologists. Key findings from our patient journey work also showed patient active participation in treatment choice and important treatment drivers, which includes a need for new options and fixed therapies. We have also engaged radiation oncologists and nuclear medicine physicians since they are key stakeholders for radiotherapy utilization. Radiation oncologists and nuclear medicine physicians review of iopofosine's profile was very positive. They were enthusiastic with iopofosine's simplicity of use versus existing radiotherapeutics. Iopofosine's features such as no required dosimetry, short infusion time, long storage life and ease of administration were regarded as significant differentiators by this key stakeholder group. Interactions with these key stakeholders further supports our belief that iopofosine is a best-in-class next-generation radiotherapeutic that, if approved, will secure significant utilization in both the hospital and community outpatient setting. We are selectively building a successful and experienced commercial team that will support the framework for our go-to-market model in WM with a goal of establishing market leadership. We will be utilizing claims data to drive decision-making that will support radiotherapy site activation, brand awareness and ensure that the first treatment experience with iopofosine is the right experience for both patients and providers. We have initiated additional market research projects that will further support…

Thanks, Shane. Historically, targeted radiotherapeutics have faced significant supply and manufacturing challenges, primarily due to limited finished product manufacturing locations, constrained availability of isotopes, the isotope half life and limited shelf life of the finished product, resulting in manufacturing and patient treatment bottlenecks. Additionally, targeted radiotherapies have been expensive to manufacture with significant challenges and scalability to match market demand. At Cellectar, we've implemented multiple strategies to avoid many, if not all, of these pitfalls. Unlike other models, we've adopted a flexible modular manufacturing strategy. This approach offers scalability and addresses various challenges in traditional manufacturing methods. Instead of relying on a single Cellectar-operated manufacturing facility, our modular approach utilizes a network of overlapping suppliers and contractors. This tactic reduces the overall footprint and operating costs of one or multiple manufacturing facilities, significantly lowering fixed capital expenditure. Furthermore, by validating multiple suppliers of every component of our product, we have mitigated issues related to constrained source of isotope, the targeting ligands and limited finished product manufacturing capabilities. Our modular approach enables rapid increases in supply to meet market demands. Currently, we can supply over 200 doses per week of iopofosine I 131 with the capability to quickly scale up to over 1,000 patient doses per week without expanding our existing infrastructure. This means we can effectively serve the needs of nearly 20,000 patients per year without additional investment. Additionally, our modular supply chain allows for further expansion of this market as the market grows with capacity to nearly double current supplies and plans to place -- plans in place for over a 50% increase in supplies with the addition of at least one more facility. Securing our supply chain was the first step in our plan to improve the availability of iopofosine. In addition, we have invested in optimizing production processes, enhancing yield and reducing costs. Exploring alternative production methods has increased flexibility and scalability. These efforts have resulted in a more robust process, improved product quality, increased production capacity and a novel formulation providing an industry-leading 17-day shelf life. These developments have also generated new intellectual property and technologies applicable to future radiotherapeutic programs like our actinium or alpha-emitter program. Our modular production strategy extends to our logistics chain and physician provider network, aiming to provide the most flexible and accessible options for patients and physicians. While regulatory restrictions by the NRC and FDA dictate where patients can access targeted radiotherapies, we have designed a system to provide broad access. We are committed to working closely with both community-focused oncology networks and hospital systems to ensure availability of iopofosine I 131 for their patients. You can expect to learn more about the strategic approaches during our upcoming June data release and KOL call. I will now turn the call over to Jim for closing remarks. Jim?

Thank you, Jarrod. As you can see, the first quarter of 2024 has been highly productive. In terms of WM, we continue to assemble our NDA submission, judiciously construct a talented and highly efficient commercial infrastructure and further refine an already advanced manufacturing infrastructure and distribution model. Of course, we also look forward to sharing our WM pivotal study data in June. I would also like to highlight the utility of our PLE delivery platform as further demonstrated by ongoing internal and collaborative R&D with a variety of oncology payloads, including small molecules, peptides and oligos. We plan to rapidly advance our lead alpha-emitter asset, CLR 121225, and actinium-based phospholipid radio conjugate or PRC into a solid tumor Phase I study no later than Q1 of 2025. And of course, we remain optimistic regarding the potential of iopofosine I 131 in pediatric high-grade gliomas, and we'll provide an update on our Phase Ib study in the second half of 2024. With that, I would now like to open the call up for our Q&A session.

[Operator Instructions] Your first question is from the line of Ahu Demir from Ladenburg Thalmann.

A couple of follow-up questions on the commercial side. Can you give us a sense on, number one, the FDA filing timeline where you are at? And what is the timeline that you are looking at? And number two portion of the question is have you hired any sales members? What will be the first target given the commercial efforts? And the third part of the question is on the pricing. Could you provide a little bit more color on the pricing? What should we take as a base?

All right. Terrific, Ahu. First of all, thank you for your participation in the call today. Very much appreciated. In terms of the regulatory filing timeline, our guidance remains consistent with the second half of this year. As you know, based on our FDA Fast Track designation and the market itself and FDA precedent in terms of how they recently treated like assets, we have a high degree of comfort that -- on what we see for 6 months -- approximately a 6-month review. Sometimes the FDA may go a little bit longer and leak into 7 months or so, but we believe that's a 6-month review and have a high degree of comfort around that. Before -- prior to transitioning over to Shane to kind of review briefly how selectively we've been approaching the attraction of recruitment and hiring of highly talented commercial folks, I will say that we're being very, very judicious in terms of how we think about the commercial opportunity. And based on the scalable nature of the market, we can be highly targeted. And limited investment goes a real long way here. So we'll have Shane talk to that in greater detail. And then relative to pricing, we believe we have the opportunity to premium price in this market. There's a number of benchmarks that support that as well as, quite frankly, our early market research and pricing work. So with that, I'll turn it over to Shane for...

Yes. Thanks, Jim. I'll address the question around the sales. So as stated earlier, we're leveraging segmentation in our approach. We want to be very smart in terms of a very targeted approach to take advantage of the opportunity. And so we're still in the process of refining and understanding exactly where we're going to target our efforts. We feel very confident that we're going to be able to place in a highly talented sales team that will be able to drive awareness and eventually trial use and adoption. So again, we feel very, very good about that. Again, all of our decision-making is being driven by data so that it's very targeted, and we're leveraging our efforts most effectively. And we're allowed to do that based on the concentrated nature of this market, which is a unique opportunity. The second thing I'll add, just to echo the comments from Jim, again, we have orphan drug designation, rare disease like WM is very good for us in terms of optionality around premium pricing, especially with policy provisions that are in place. We feel confident looking at other analogs in the marketplace, both continuous therapy and other radiotherapeutics that we'll be able to place a price that will be effective and support high value for the organization.

Yes. And then in terms of your question relative to contract sales organization or the type of commercial model that we would employ, everything is on the table at this particular point in time. We're evaluating the most cost-effective and most productive approaches. Typically with a CSO model, you would hire your own leadership internally and then farm out the sales specialist or other radiotherapeutic nuclear Rad-Onc specialists via a CSO. We're evaluating the costs associated with both and capacity to drive trial use and adoption with iopofosine, a variety of different commercial models. So it will be cost efficient. We will secure best talent. And we're -- as I've mentioned earlier, we're highly comfortable and confident in our capacity to field a highly productive commercial organization.

[Operator Instructions] Your next question is from the line of Jeff Jones from Oppenheimer.

One follow-up question on pricing and a couple on the Waldenstrom's trial data. On pricing, you mentioned some of the analogs you're looking at. Could you share perhaps what some of those examples are? And then on the Waldenstrom's data that we're anticipating in -- now in June, what should we be expecting from that update? For example, the number of additional patients will be that you think you're going to share data on. And also from the prior data set, there were 3 patients with near CRs. Can you comment on what the hurdle is for those to convert and if any of those have converted since the January update?

All right, Jeff. Of course. Thank you, Jeff. Again, appreciate your participation in today's call and for the 3 questions that we'll triage here. I will say based on the clinical data, and I'll have Andrei talk to that initially in terms of what we're going to provide. At this point, we are likely not going to provide any color relative to the updated information. But to your point, it will be consistent in terms of that data that we previously shared. And Andrei is closer to this than anyone as he consolidates our data at this point in time. So I'll turn it over to Andrei to provide his color and thinking.

Thank you, Jim, and Jeff, thank you for your questions. We're certainly looking forward to confirming the exciting results we've put in the public domain in January, specifically, the rate of responses, overall response, major response, deep responses as well as durability in the form of duration of response. We are determining based on current data cleaning, the right timing to do time-dependent empirical analysis. As you probably recall, we enrolled a sizable fraction of patients at the very back end of the study in the third and fourth quarter of 2023. So these patients were -- some of them treated in 2024. So to avoid doing very early censoring, we got pushed out the time-dependent empirical analysis like duration of response to the back end of the first quarter, but we are planning to update that. So to answer more directly the first part of your question, we will be reporting on response rate, including types of responses and durability of response at the time of our announcement.

Yes. So as you recall, Jeff, we had 41 patients that we had reviewed with the top line data. Now we'll have the full enrollment in the mid-50 range. I can give you color on that. And so it's a significant increase in number of patients. And as I think Andrei appropriately mentioned, we'll have a better line of sight on durability certainly for those patients that were enrolled earlier in the study. Relative to pricing, we clearly have an opportunity to premium price in this space based on our market research, initial pricing work as well as in discussions with advisory boards built around pharmacy benefit managers from large third-party payers. I think it's also fair to say approximately 70% to 75% of these patients will be reimbursed via Medicare. So that gives us a lot of optionality and flexibility as well. But looking at pricing benchmarks, I'll turn that over to Shane to provide some color.

Yes. Thanks, Jim. So as stated earlier, we're also in the process of really drilling into our value messaging and pricing work. But as we're looking at certain pricing analogs, certainly, we're looking at a wide range of products, which I think best represents a rare disease treatment categorization. So for example, CAR T, Azedra for pheochromocytoma as well as BTKi therapy in WM looking at its cost from a total cost of care perspective.

Yes. So Jeff, we believe we can put together a really nice healthy value message around the pharmacoeconomic kind of story here based on the durability, the 4 limited infusions and then the durability of that treatment as well as, as you recall, patients will no longer require therapy for an extended period of time, which means no adverse events unlike other therapies that are continuous where clinicians share with us they're constantly -- it's a constant battle to manage the adverse events associated with some of these products that are taken more consistently.

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

I guess [indiscernible] to ask is what can you share about ex U.S. negotiations? Maybe what those potential partners might be waiting for before getting any more deep into those kind of discussions?

It's a great question, Jonathan. Obviously, there's consistency -- I will say this, there's consistency among third parties that we are collaborating with on our delivery platform and those that are interested in promoting this product ex U.S. And we're taking both a regional approach as well as a more larger kind of global approach to this. And so I'll turn it over to Jarrod, who's been our -- providing oversight leadership in this area.

Yes, Jonathan. What I would say is we continue to advance those dialogues. We're in deep discussions with a number of parties in different regions, as Jim alluded to. And we continue to evaluate additional regional partnerships for certain components. And then as Jim said, we also are engaged in dialogues with folks that are, what I'd say is, more, well, global sort of strategy. And so we are consistently advancing both -- in parallel events in both lines of thinking and both opportunities and trying our best not to let one run too far in advance of the other.

And can you tell me if you're getting any clawback provisions that you had said that you insisted would be doable at a low price for you? Do they not want those at all or at the kind of limited premium that we acquired that you mentioned earlier?

Yes. If I'm following where your question is going, yes. If we do a partnership for a particular region, yes, we are incorporating into those the ability to pull back the asset if we were to structure a larger, broader deal with certain, obviously, premiums on investment by the partner.

Okay. And then although you're asked twice before on this call about pricing, did you or did you not list any specific drugs that you are comparing yourself to when you use the word premium pricing?

I believe we stated the CAR T.

Yes. Yes. I think so. As stated -- mentioned, the various CAR T therapies. There's a range of different analogs that we're looking at for these treatments. Azedra is another one for pheochromocytoma as one which we're looking at. And as mentioned before, with earnings calls previous, we're looking also at BTKi therapy, the total cost of care for these continuous therapies.

Yes. So BTKi is typically, let's just say, approximately $1 million. I think Azedra was $600,000, and then your CAR Ts are pretty much between that range.

At this time, there are no further questions in the queue. I will now turn the call over to Jim Caruso for closing remarks. Please go ahead.

Okay. Thank you, operator. Certainly, we'd like to thank everyone for joining us today. Appreciate the questions, and we look forward to speaking with you in the near term. Thanks again. Have a good day.

Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.