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 Precision AQ. Please go ahead.

Thank you, Joelle. Good morning and welcome to Selectar Biosciences' third quarter 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 Coleyan, 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 Leah, Chief Commercial Officer, We'll review the market opportunity in WM along with the company's plans for expected commercial launch. Finally, Jared Loncar, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. SelectArt issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of SelectArt'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 SelectR and an event that we can accurately characterize as transformational for the future of the company. We remain focused on the NDA submission for iFocusing I-131 in Walton Strongs 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 I and II clinical study opportunities based on business conditions and cash position. The Clover WAN 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 pretreated 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. Sikandar Alawade, Professor of Medicine, Division of Hematology Oncology, Departments of Medicine and Cancer Biology, at the Mayo Clinic and the principal investigator for the Clover Wham study. With 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, we have very recently determined that, unfortunately, our NDA submission will be pushed from December of this year to likely the back end of the first quarter of 2025 and potentially into Q2. That said, given our accelerated approval designation, which provides review and determination within approximately six months of filing, we maintain our timeline for potential market approval and the launch in the second half of 2025. We will provide additional regulatory pathway clarity in today's prepared statements and as requested in the Q&A session. Our sales, marketing, and operation teams continue to construct and execute our commercial plan and will be prepared for the U.S. market launch. We have made substantial progress, most recently securing our second Iopopocene I-131 fit and finish manufacturing source, which provides additional production capacity and product supply redundancy at large. Long-term, we view expansion of iFocucine I-131 to other indolent lymphomas as smart, cost-effective, and low-risk investments with the potential to meaningfully increase the overall top-line revenue opportunity. Our collaboration with the City of Hope evaluating iFocucine and mycosis fungoides is an example of this approach. We also strongly believe that radiotherapeutics will continue to increase in importance for the treatment of cancer with both the pharmaceutical industry and oncology-focused provider networks continuing to aggressively invest in infrastructure necessary to support anticipated growth in demand for novel radiotherapeutics. Our pipeline includes preclinically validated phospholipid radiotherapeutic alpha and OG isotope conjugates for the treatment of solid tumors and offer significant potential to catalyze and drive company value in the next phase of growth beyond IFO. Now, let me turn the call over to Chad Colleen for review of our potentials.