Cellectar Biosciences, Inc.

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 PrecisionAQ. Please go ahead.

Thank you, Operator. Good morning and welcome to Selectar Bioscience's fourth quarter and full year 2024 financial results and business update conference call. Joining us today from Selectar are Jim Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Coley, CFO, for a financial review of the quarter and the year. Following this, Jared Loncore, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Selectar issued a press release earlier this morning detailing the contents of today's call. A copy can be found on the investor page of Selectar'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 filing. 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'll 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 Selectar's recent regulatory progress with iFocusing, our ongoing preparations to advance our alpha and OG radioisotope solid tumor programs, and forward-looking plans to address the company's NASDAQ status and future funding, including evaluation of non-available funding opportunities. 2024 can be described as a bittersweet year for SelectR, starting with the announcement of excellent clinical results from our Clover-WAM study of Iopococine I131 for the treatment of relapsed refractory Waldenstrom's macroglobulinemia, or WM, 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, iaprofising 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 pre-survival and time to next treatment. We remain confident in the potential value I am focusing will provide 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 toward the end of last year. As the clinical data demonstrates, hypophysine offers potential to be a meaningful treatment for all relapsed refractory WM patients. As such, and aligned it 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 iapofasin's significant market potential in the relaxed refractory setting. This potential is driven by iapofasin's novel mechanism of action, its distinctive product profile, and size of the relaxed refractory market. In addition to clinical benefits and the product profile, other key attributes include a fixed dosing regimen, a unique 17-day shelf life, orphan drug pricing, and its ability to address a high unmet clinical need in a landscape with limited approved treatment options. These factors collectively position Iapocasin as a promising therapeutic candidate in this challenging market segment and SelectR remains committed to bringing this potentially life-saving drug to patients likely to benefit from this treatment. To this end, we recently held a very productive meeting with the FDA to finalize the regulatory pathway for ibuprofen and WM. I am pleased to share that we have achieved alignment of the design of a phase three study required for market approval. Later in this call, Jared will discuss the study design the cost efficiency, and projected timelines to advance iapofasine toward commercialization. Given the strong enthusiasm surrounding iapofasine among patients, key opinion leaders in WM, and the broader healthcare community, we are confident that the study will achieve rapid enrollment. This moment underscores the high level of interest in iapofasine as a potential therapy for this challenging disease. and reflects its significant promise in addressing unmet clinical needs. Based upon the quality of the Clover WAMP data, limited perceived clinical risk to approval, and a robust global market opportunity, we continue to evaluate inbound inquiries regarding a range of collaborations and licensing deals, which is our preferred non-by-Luda funding approach. In addition to our late-stage iopopacin program in WN, we remain bullish on our solid tumor-focused radioisotope programs, which include our alpha emitter for pancreatic cancer and the OG emitter for evaluation in triple negative breast cancer, both of which highlight the novel utility of our delivery platform. As mentioned earlier, the delay in our MDA submission for iopopacin adversely impacted the company's stock and market capitalization. We believe we can organically increase our stock price to satisfy the NASDAQ requirement based upon driving milestones such as regulatory clarity for IFO proceeding WM, acquisition of non-dilutive funding, technology validation through third-party collaborations, and progress with our Phase I-ready radioisotope assets, along with the removal of any perceived financial overhead. Now let me turn the call over to Chad for additional color on this topic and a detailed review of our financial results. Chad?