Cellectar Biosciences, Inc.

Good morning and welcome to SelectHAR Biosciences 2024 Year-End 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 SelectHAR'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 forecasts due to the impact of many factors beyond the control of Selectar. 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 Selectar'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 Selectar.

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. Andre Schustoff, Senior Vice President, Medical, Jared Longcore, Chief Operating Officer, Shane Leah, Chief Commercial Officer, and Chad Colleen, 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 am 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 six-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 iApofacine 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 of the company over the past first quarter. I will then transition the call to Chad to discuss our financial results. Shane will review the commercial topics, followed by Jared's manufacturing and distribution network update. We will then open the call for Q&A. As you are likely aware, and as I have previously stated, it is an exciting time for companies with radiotherapeutic pipelines to and those few companies with late-stage and or near-term approvable assets. With the next radiotherapeutic approval, potentially, ipofasine I-131, along with our unique PLA delivery platform providing a differentiated radioisotope offering or offerings, including alpha-emitting agents, we're confident in our position and excited about the future of SelectArc. With that as background, I will now provide a full review of our key Q1 accomplishments. Of course, we announced positive top-line data in the Clover-WAM pivotal study, evaluating Iopopocene I131 for the treatment of relapsed refractory Waldenstrom's macroglobulemia, and as cited, we'll provide the data update on full patient enrollment in June. As part of a private placement of up to $103 million, the company received approximately $44 million in January, with the potential to secure another $34 million in warrants available for conversion at a $4.77 strike price upon approval of our WMNDA. Importantly, to support launch preparation and the potential marketing via Pophosene, we announced another strategic partnership with AON, or the American Oncology Network, a physician-led, community-based, cutting-edge oncology platform that is currently managing the treatment of approximately 650 WM patients. The partnership's objective is to collectively advance the treatment of WM in the community setting through a better understanding of the WM landscape and to ensure patient access to Iopophasine I-131 for the many communities that AON serves. Announce promising preclinical data for three unique internally developed alpha emitters, including our proprietary novel alpha-emitting phospholipid therapeutic conjugate, CLR121255, and actinium-labeled phospholipid ether in pancreatic cancer models. We are evaluating CLR121, 225, and additional preclinical models, such as ovarian and triple negative breast cancer, and plan to initiate a phase one study in one of these solid tumor cancers no later than Q1 2025. Reported a complete central nervous system clearance in relapsed refractory Waldenstrom's macroglobulinemia. providing further validation for apophysine I131 to treat solid and hematologic tumors, including those located across the blood-brain barrier. Initiated and enrolled the first patient in our Phase 1B clinical study by apophysine I131 in pediatric high-grade gliomas, or PHGG. Based on investigator excitement and iapophysin's demonstrated activity in solid tumors across the blood-brain barrier, we are excited about the value iapophysin may provide in this treatment setting, one in which patients are restricted to few treatment options. As previously announced, we look forward to providing an update on this study in the second half of 2024. Reported a high rate of complete remission and an investigator-initiated Phase I study of iapophysine in combination with external beam radiotherapy in another challenging solid tumor, recurrent head and neck cancer. The complete remission rate was 64%, and overall response rate was 73% in a highly refractory patient population. Durability of clinical activity was also impressive, achieving 67% overall survival and 42% progression-free survival at one year. Let me now turn the call over to Chad to review the company's financials.