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5/14/2025
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 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. Thank you, Operator. Good morning, and welcome to Select Our Biosciences first quarter 2025. 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 Collian, CFO, for a financial review of the quarter and the year. Following this, Jared Longar, 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 content of today's calls. Copy can be found on the investor page of SelectR'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 the company's SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 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 will begin the call with prepared remarks and then open the line for your questions. I will now turn the call over to Jim Caruso. Jim?
Thank you, Hillary, and thank you all for joining us this morning as we review the progress SelectR has made throughout the first quarter of 2025. We entered 2025 with a continued focus on our PDC platform, our radio conjugate pipeline, and finalizing the requirements from the FDA and EMA, or European Medicines Agency, regarding ibuprofen I-131 for the treatment of Waldenstrom's macroglobulemia, or WM. We rapidly scheduled and completed a productive meeting with the U.S. Food and Drug Administration regarding the accelerated approval regulatory path for ibuprofen I-131 and WM. The results from the Phase II Clover-WAM clinical trial of Iopophicin I-131 as a treatment for relapsed refractory WM demonstrated the drug's unique efficacy and safety product profile, which we believe represents a significant opportunity as a promising therapeutic candidate in a relapsed refractory market where no approved drugs currently exist. In parallel, we are seeking guidance from the EMA on conditional approval for ipofasine I-131 as a treatment for WM based on the Cloverfam Phase II study. We believe the compelling results from this study support the conditional marketing authorization strategy and will make available this critically needed new medicine to WM patients in Europe more rapidly. In addition to our iapofasine program in WM, we continue to progress 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. Jared will speak further to these programs later in the call. As we explore strategic alternatives for the company, we have engaged Oppenheimer as an exclusive financial advisor to assist us. These alternatives may include, but are not limited to, mergers, acquisitions, partnerships, joint ventures, licensing arrangements, or other non-dilutive transactions. Now, let me turn the call over to Chad for a review of our financial results. Chad?
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