Cellectar Biosciences, Inc.

Good morning and welcome to Selectar's Bioscience 2023 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 Selectar'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 SelectR. The company assumes no obligation to update, supplement, 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 Selecta'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 Selecta. Mr. Caruso, please go ahead.

Thank you, Mark, and good morning, everyone. It is my pleasure to be here with you to report our year-end results and provide a corporate update. With me today are Dr. Andrei Shustov, Senior Vice President, Medical, Jarrett Longkorff, Chief Operating Officer, Shane Leah, Chief Commercial Officer, and Chad Colleen, our Chief Financial Officer. I will begin today with a brief overview of the meaningful accomplishments the company has achieved these past 12 months. I will then review our WM plans, after which I will turn the call over to our team for a more in-depth update. You will first hear from Dr. Shustoff, who will provide a review of our successful WM trial results and discuss Hypophysine I-131 clinical development programming. Regarding the WM pivotal study, I am pleased to report that we remain on track for a Q2 announcement of our updated top line data from our Clover Rand study. Jarrett will provide an update on our regulatory plans and NDA filing. Shane will review our commercial readiness plans and announce the hiring of additional commercial talent to support the potential launch of WM, followed by Jarrett providing an update on our lead alpha emitter, phospholipid radioconjugate, or PRC, and briefly discuss why our alpha emitters provide unique mechanism of action qualities which differentiate our PRCs from existing alpha emitters in development. As you are aware, it is an exhilarating time for radiotherapy companies, and certainly a renaissance for radiotherapeutics. With the next radiotherapeutic approval, potentially Iapopasine I-151, Coupled with our unique delivery platform providing differentiated radioisotope offerings, we are confident in our market position and excited about the future of SelectARC. Chad will then discuss our financial results, and we will open the call for Q&A. Please allow me to now provide an overview of key accomplishments. As part of a private placement of up to $103 million, the company has received just under $69 million to date. In addition, approximately $34 million in warrants will be available for conversion upon approval of our WM-NDA. Achieved further validation of Iopopocene I-131 and our PDC delivery platform to treat solid and hematologic tumors, including those located across the blood-brain barrier. Initiated and enrolled the first patient in our Phase Ib clinical study of iapophysine in pediatric high-grade gliomas. Announced a new licensing agreement covering pediatric cancers with the Wisconsin Alumni Research Foundation for intellectual property that was the result of collaborative research conducted at the University of Wisconsin-Madison with iapopacin. We further expanded our PDC and radiotherapeutic intellectual property portfolio, which was recognized by global data, citing SelectARP as the leading pharmaceutical company as measured by patent grants and applications for radiopharmaceuticals. We also announced promising preclinical data for three Separate alpha emitters, including our proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR121255, and actinium-labeled phospholipid ether in pancreatic cancer models. In preparation for the potential commercial launch of iapofasine, we announced the first of many anticipated strategic partnerships with leading physician-led community-based oncology networks, such as Florida Cancer Specialists and American Oncology Network, or AON, to advance the treatment of WM in the community and support communication between physicians, patients, and industry partners. And, of course, we announced positive top-line data in the Clover-WAM pivotal study evaluating Iofocucine I-131 for the treatment of relapsed refractory Waldenstrom's macroglogulamia. We remain on target to provide an update on our WM top line data during the second quarter. Currently, we are in process of completing the work for our NDA filing 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 could expect a six month review period from the date of submission. In parallel, we remain focused on constructing highly efficient commercialization capabilities for Iopopasin. As Shane will review, the WM market is highly concentrated, highly scalable, ideal for a nimble biotech company like ours to build a focused and productive commercial infrastructure. Let me now turn the call over to Andre to further review the WM trial and our clinical development program. Andre?

Thank you, Jim, and good morning, everyone. I would like to start with a very brief review of the study design, study patient characteristics, and top-line efficacy and safety data from our Global WAMP pivotal trial that we revealed earlier this year. As a reminder, Global WAMP was a global, open-label, single-arm study examining hypoxin I131 in relapsed and refractory WM patients who received at least two prior lines of therapy, including those patients who failed or had suboptimal response to a BTKI, the only FDA-approved class of treatment for this cancer. Study patients received a total of four doses of ipophysin over two cycles without maintenance or a treatment and were evaluated continuously for response for up to 12 months from the initial dose. Patients eligible for the trial had to have histologically and serologically confirmed diagnosis of Waldenstrom macroglogonemia and ECOG performance status of 0 to 2 and have received at least two lines of prior therapy, which practically included treatment with a BTK inhibitor. The study also included WM patients with central nervous system involvement known as Benil syndrome. and patients with lymphoplasmocytic lymphoma without full features of WM. Patients enrolled in ClovoM were the most heavily pretreated and the most refractory WM patient population ever reported in clinical trials. This statement is supported by key patient characteristics, including number of prior therapies, which is four, Proportion refractory to BTKI and rituximab, which is 50% and 40% respectively. Proportion refractory to both BTKI and anti-CD20 therapy, which is 26.7%. Proportion with medium and high IPSS-WM score, which is 42%. And five to six-fold enrichment with MITEI-88 wild-type genotype. Topline data from the Cloverweb trial reported on 41 consecutive evaluable patients, or approximately 75% of the total MITT efficacy population, demonstrated a 61% major response rate, a 75.6% overall response rate, and a 100% disease control rate. Further, the data showed a 7.3% complete response rate with a median duration of response and median progression pre-survival not reached at the time of data cutoff date and a median follow-up of eight months. We saw a high rate of responses across all key WM genotypes, including those that have been shown to control resistance to currently available improved therapies. Responses were durable, with median duration of response not reached, and 76% of patients remaining progression-free at a median follow-up at eight months, and the longest continuous response of over 30 months. Importantly, durability of these responses without the need for continuous therapy or retreatment suggests that ipophysin could be potentially disease-modifying new therapy with novel and unique mechanisms of action. Our safety results were also very positive with 0% treatment related discontinuations, 0% treatment related deaths, and 0% clinically significant bleeding. We saw predictable and manageable onset and recovery of cytopenias in all patients. We did not observe any treatment related cardiovascular, renal, or hepatic adverse events. In summary, Global WEM was the largest study in relapsed refractory post-BTKI patients to date and the first WEM study to evaluate dual refractory patient population. We believe that to achieve a 61% major response rate in 41 evaluable patients with a median of four prior lines of therapy is nothing short of remarkable, especially with results that show a favorable safety profile and a four-dose truly fixed-duration course of treatment. We believe that these results demonstrate that ipofasin is a promising therapy for patients in high clinical need, one that is easy to administer as an IV infusion in an outpatient community oncology practice with a tolerable side effect profile and very encouraging efficacy results in some of the most difficult to treat relapsed refractory patients ever studied. We look forward to providing our updated study results, which will include data from all 55 efficacy-available patients enrolled in the study sometime in the next quarter. In addition to impressive results from Cloverwem's study, we've also reported promising activity of ipophysin and other hematologic malignancies and solid tumors. This includes exciting results in a primary CNS lymphoma patient with attainment of complete remission, and stabilization of disease in a pediatric patient with a refractory high-grade brain tumor. These findings further validate our previous observation of iapophysin's ability to cross the blood-brain barrier and deliver an antineoplastic payload to a variety of tumors in a sanctuary site. Further, a recent report from the University of Wisconsin-Madison demonstrated the ability of ipophysin to safely combine with external beam radiotherapy in relapsed carcinoma of head and neck, with 64% of patients attaining a complete remission and one-year overall survival of 67%. We believe that these findings may be broadly applicable to a variety of SALT tumors. In summary, Data demonstrating iapophysin's ability to induce deep responses, including complete responses in a variety of relapsing refractory, hematologic, and solid tumors while exhibiting a consistently low toxicity profile with good tolerability may translate into durable and clinically meaningful benefits to a diverse patient population in urgent need for novel therapies. I will conclude. by emphasizing that we are pleased with the results highlighted above and are looking forward to sharing updates from our ongoing studies in multiple myeloma, primary CNS lymphoma, and pediatric high-grade gliomas later this year. We will continue to evaluate product development and commercialization opportunities to craft the future focused clinical development of hypofysin, including frontline treatment of WM, a WM-retreatment study to include a third cycle, as well as studies in other indications, including marginal zone lymphomas, mycosis fungoides, and primary amyloid doses. With that, I will now turn the call to a dear colleague of mine, Jared Longport, for an overview of our regulatory plans. Jared.