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, Joelle. Good morning, and welcome to Cellectar Biosciences Third Quarter 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. Following this, Andrei Shustov, Senior Vice President, Medical, will provide an update on the CLOVER WaM development program; and Shane Lea, Chief Commercial Officer will review the market opportunity in WM along with the company's plans for expected commercial launch. Finally, 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 18, 2024. We undertake 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. With that, let me turn the call over to Jim Caruso. Jim?

Thank you, Anne Marie, and thank you all for joining us this morning. The exceptionally positive data reported from our CLOVER WaM study represents a game changing outcome for Cellectar and an event that we can accurately characterize as transformational for the future of the company. We remain focused on the NDA submission for focusing I 131 in Waldenstrom’s and our planned product launch in the second half of 2025. To date, we have made meaningful progress toward commercial readiness and have analyzed the WM market and the role of all associated constituents such as patients, payers and providers. Importantly, we have efficiently advanced our platform technology through potential high value yielding targeted investment and research collaborations, creating the option to initiate near-term Phase 1 and 2 clinical study opportunities based on business conditions and cash position. The CLOVER WaM study outcomes demonstrating an impressive 56.4% major response rate, a clinically relevant 80% overall response rate and 98.2% clinical benefit rate are particularly compelling when you consider that CLOVER WaM was conducted in the most heavily pre-treated WM patient population ever evaluated in a clinical study. As such, it was not surprising to have been selected for an oral presentation at the upcoming American Society of Hematology's Annual Meeting, or ASH. ASH is the healthcare industry's most prestigious Hematology Congress and provides an exceptional platform to share new data from our WM pivotal study. These outcomes will be showcased in a podium presentation by Dr. Sikander Ailawadhi, Professor of Medicine, Division of Hematology, Oncology, Departments of Medicine and Cancer Biology at the Mayo Clinic, and the Principal Investigator for the CLOVER-WaM study. These compelling data in hand, we have engaged the FDA, are constructing our NDA, and remain focused on submitting the application. Based on ongoing discussions with the FDA,…

Thank you, Jim, and good morning, everyone. Recently, we filed amended financial statements for fiscal years 2023 and 2022, an action that was precipitated by a reevaluation of the accounting for the warrants and preferred stock we issued prior to 2023. At the time they were issued, these warrants and preferred stock were classified as permanent equity based on our assessment and supported by third-party expert evaluations. In August, the company determined that the equity classification should be changed to liability classification for the warrants and to temporary or mezzanine equity for the preferred stock, necessitating the revision in our historical reporting. It is important to note that the restatement did not impact cash or cash burn, and the changes to historical earnings were all non-operating and non-cash, with the exception of a minor reclassification of R&D expenses to G&A. Turning to our financial results for the period ended September 30, 2024. We ended the quarter with cash and cash equivalents of $34.3 million, compared to $9.6 million as of December 31, 2023. Our cash on hand at the end of September includes the funds raised in July 2024 from investor exercises of Tranche B warrants and purchase of new warrants that have the potential to raise up to an additional $73.3 million. All major investors from the September 2023 financing exercise their Tranche B warrants at a reduced as converted common stock price of $2.52 per share, which was the closing price on the date of exercise. Those investors also received new warrants as part of the transaction, generating gross proceeds of $19.4 million and net proceeds after customary fees and expenses of $17.5 million. We expect that cash on hand is adequate to fund budgeted operations into the second quarter of 2025. The three warrant tranches issued in…

Thank you, Chad, and good morning, everyone. Our lead asset iopofosine I 131 is a small molecule phospholipid radio conjugate, or PRC designed to provide targeted delivery of Iodine-131 directly to cancer cells, while limiting exposure to healthy cells. We believe iopofosine has a profile that differentiates it from many traditional on-market and in-development treatments as demonstrated by the pivotal study results from CLOVER-WaM. Iopofosine has received both fast track and orphan drug designation for WM from the FDA. In July, we provided an update on the top line results from our CLOVER-WaM pivotal study evaluating iopofosine I 131 in Waldenstrom's macroglobulinemia. CLOVER-WaM is a global single arm Phase 2b study examining iopofosine I 131 in relapsed and refractory WM patients who received at least two prior lines of therapy, including those patients who failed or had some optimal response to BTKi, the only FDA approved class of treatment for this cancer. Patients enrolled in CLOVER-WaM were the most heavily pre-treated and the most refractory WM patient population ever reported in clinical studies. The study is fully enrolled with all living patients who have completed study treatment remaining in long term follow-up. Based on the demonstrated CLOVER-WaM study results, we believe iopofosine has the potential to become the first-in-class and best-in-class radiotherapeutic agent to address the high clinical need for relapsed/refractory WM patients. In October, we were delighted to share this initial compelling results in an oral presentation at a prestigious 12th International Workshop on Waldenstrom's macroglobulinemia, or IWWM. WM experts from around the globe had the opportunity to review and discuss the CLOVER-WaM data and provide insights on the future utilization of iopofosine assuming FDA and EMA approvals. In addition, an iopofosine case study report was presented by Jorge Castillo MD, Associate Professor of Medicine, Harvard Medical School, and…

Thanks, Andrei, and good morning, everyone. As both Andrei and Jim mentioned, we are excited to have a strong presence at this year's ASH, beginning with the oral session highlighting the CLOVER-WaM outcomes and including a series of outreach initiatives with KOLs and key community doctors to enhance the visibility for iopofosine I 131 and Cellectar. In addition, we will optimize our presence at ASH with an interactive booth on the exhibit floor where conference participants can learn more about iopofosine I 131, the CLOVER-WaM outcomes, and our novel platform science. Selecting iopofosine I 131 pivotal data as an oral presentation at such an important conference is an efficient opportunity to enhance visibility of iopofosine's novel profile. Turning now to the market opportunity for iopofosine I 131 and WM, let's begin with a review of the prevalence of WM, which in the U.S. is approximately 26,000 patients, with 1,500 to 1,900 patients being diagnosed annually. Of those, approximately 11,500 patients require treatment in the relapsed/refractory setting, and there are an estimated 4,700 patients requiring third-line or greater therapy. There are approximately 1,000 patients who have exhausted current treatment options by third-line because of progression in eligibility or intolerance to those existing therapies. Therefore, the total addressable market for third-line or greater therapy is approximately 5,700 patients. It is important to note that there are no FDA approved treatment options for patients progressing on BTKi therapy. BTKi therapies do not demonstrate complete response rates and require continuous treatment. Furthermore, 50% of third-line or greater patients are treated with the same or similar treatments from prior failed lines of therapy. Greater than 60% of treatments utilized are non-FDA approved therapies. Clearly, there is an established unmet need for new FDA approved treatments such as iopofosine I 131 that could provide a novel…

Thank you, Shane, and good morning to everyone. As we think about the regulatory pathway for iopofosine I 131, we believe it is important to put our data in context with other approved programs. Our major response rates for the CLOVER-WaM's study was 56.4% in a later line of treatment, with the patients having a median of four prior lines, highly refractory and over 70% post BTKi. Ibrutinib, Ibrutinib's WM NDA submission had a 61.9% major response rate in an earlier line of treatment, where patients had two prior lines, and who were not considered refractory to any treatment and were BTKi-naive. We remain engaged with the FDA and our focused on the tasks required to complete our submission. The agency has acknowledged the strength of our data. Based on recent discussions regarding a potential confirmatory study, we shared with the FDA a post full enrollment data cut, which included the primary endpoint and secondary endpoints of the study. The goal was to provide the FDA a comprehensive overview of results and supporting data to facilitate a discussion on next steps, considering iopofosine's significant response rates and durability observed in this patient population. To allow the agency sufficient time to evaluate the data, the meeting was pushed from October to November. Cellectar has maintained internal submission time lines; however, we must remain flexible with the FDA, FDA review timing and requests. As a result of this delay and subsequent impact on our submission requirements, we are revising our anticipated time line for NDA submission from late December 2024 to late first quarter or second quarter of 2025. As mentioned earlier, the FDA is now recommending a confirmatory study. We are in active discussions exploring potential study designs, including a single-arm study like CLOVER-WaM, which would align with the recommendations from…

Thank you, Jarrod. As you can see, we remain sharply focused on building value and on the cusp of achieving a series of transformational drugs driving near and long-term growth for Cellectar. We maintain a compelling value proposition with iopofosine I 131 with solid clinical data and a differentiated product profile to support its potential accelerated approval in WM, a disease with great unmet need, limited approved treatment options and a significant revenue opportunity. We are preparing for a successful WM product launch for a highly scalable market, presenting minimum existing competitive share of voice, with an expected launch of iopofosine for the end of 2025. And we possess a unique PLE-based delivery platform which provides drug development optionality and currently maintain the option to advance two unique radiotherapeutic assets into the clinic for the treatment of large market solid tumors as company and market dynamics dictate. We believe the achievements we've made in 2024 are paving the way to drive growth in 2025 and beyond and look forward to keeping you apprised of our progress. I want to take a moment to thank the dedicated and talented team here at Cellectar who are working smart and hard to support iopofosine's marketing approval and projected launch while advancing our promising pipeline of radiopharmaceuticals. I also want to thank you, our stockholders and partners, on this journey for your continued support and encouragement as together we are changing the course of cancer treatment for patients with few, if any, viable treatment options. With that, operator, let's open the call for questions.

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

Good morning, guys and congrats on the quarter. Just following up on the commentary on FDA's interest in confirmatory studies. They have, in some cases, required that confirmatory studies commenced prior to approval. Do you think that is a potential risk here? And in addition, as we think about confirmatory studies going on during the launch, how do you think that impacts product uptake and adoption?

Sure, Jeff. That's a very fair question. In regards to an ongoing confirmatory study prior to our capacity to submit the application, we don't believe that's the case based on direct written correspondence from the agency. And I'll turn it over to Jarrod to provide more specifics relative to that portion of your question.

Yeah. So, hi, Jeff. What Jim is referring to is, we have great correspondence from the agency that basically says what they're seeking prior to submission of our NDA is that we would have agreement around a confirmatory study, but not that the requirement as yet is not for it to be ongoing.

And then relative to the second part of your question, Jeff, in terms of potential impact on trial use and adoption of iopofosine I 131 commercially. Obviously, we would not anticipate the N for confirmatory study to be significant. And of course, we would, Jarrod, Andrei and the team would align with the EMA in terms of what the study protocol would look like and we would anticipate a significant portion of the N regardless of the size, the patients being evaluated ex-U.S. top five, top seven EU, and some of the other sites that participated pretty actively in the CLOVER-WaM study.

Okay. Great. And I guess just one financial question for you guys. You gave cash runway guidance, assuming the full exercise of the $73 million worth of outstanding warrants, where does that take you roughly as you prepare for launch?

So I think that if you look at the time line, there will be a need to raise funds as an interim step, we believe, just given the fact that we expect the first tranche of the warrants would not really fall into the timing for exercise until we have a need to add additional cash to the coffers, as you would say. So there is an interim raise that will be required. But beyond that, once you get into the exercise of those warrants, it should provide additional funding that we believe will get us through the process, at least that's the expectation based on the current budgeted pathway.

And Jeff, so if you take a look at, if we anticipate, for the sake of palliative care (ph) an April 1 submission, with a 75 day PDUFA, that hits June 15, and that's the activation of the first tranche of warrants. So we would have a quarter bridge, and we would evaluate and continue to evaluate a number of different options that we have relative to raising funds, whether that's in the form of a traditional financing or the evaluation of some of the corporate development activities that we're currently evaluating and are ongoing that Jarrod spoke to during his prepared statements. So we view a number of different options available to us to establish and strike that bridge. I think the other piece here that's significant is the $73 million overall will satisfy our needs from a commercial launch perspective as well. And as we've talked to in the past, because of the scalable nature of the Waldenstrom's market, we view a targeted sales organization with an OpEx in and around this kind of $20 million, $25 million a year range as being more than sufficient to drive trial use and adoption. And that, I think, is important to note, because typically in oncology spaces, you're looking at more along the lines of a $50 million to $70 million a year expenditure for the effective commercialization. As you recall, not only is the space scalable, there's limited to no multinational pharmaceutical machinery in the space. There's not a lot of spend, share of mind from a thought leadership perspective is highly available for us. And without this share of mind and competitive detailing that you typically see in some of these more highly competitive spaces, a limited investment in commercial medical marketing really yields as high value yielding in terms of increase in trial, use and adoption.

Great. Really appreciate the clarity, guys. I’ll hop back into the queue.

Thanks so much, Jeff.

[Operator Instructions] There are no further questions at this time. I will now turn the call over to Jim for closing remarks.

Okay. Thank you, operator. Again, thank you for all of you joining us today. And we look forward to keeping you apprised of our progress. Enjoy the day. Thank you.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.