8/14/2025

speaker
Operator
Conference Operator

Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Anne-Marie Fields, Managing Director at PrecisionAQ. Please go ahead.

speaker
Anne-Marie Fields
Managing Director, PrecisionAQ

Thank you, Operator. Good morning, and welcome to Selectar Bioscience's second 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 Coley and CFO for a financial review of the quarter. Following this, Jared Lancourt, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical pipeline of radiopharmaceuticals. Selectar issued a press release earlier this morning detailing the content 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 and in our FEC filing. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 14, 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 with prepared remarks and then open the line for your questions. I'll now turn the call over to Jim Caruso. Jim?

speaker
Jim Caruso
President and Chief Executive Officer

Thank you, Anne-Marie, and thank you all for joining us this morning as we review the progress SelectArt has made throughout the first half of 2025. The first half of 2025 has been a period of strong execution. and strategic progress for SelectR. We've made significant strides across our development pipeline, regulatory strategy, corporate development initiatives, and fundraising efforts, collectively positioning us for a strong conclusion to 2025. Let me begin with our lead asset, iApofacine I-131, which continues to demonstrate its potential as a first-in-class radioconjugate therapy for patients with Waldenstrom's macroglobulemia, or WM. As we reported in this morning's press release, we have shifted our regulatory strategy and now plan to submit a new drug application, or NDA, with the FDA under an accelerated approval pathway for iapofasine I-131 as a treatment for WM, subject to sufficient funding and having a confirmatory study underway. The Clover Wham study will serve as the primary basis for the demonstration of efficacy. Our confidence in this new strategy is supported by a number of key elements that we will discuss later in the call. Importantly, we also believe this new regulatory path aligns with the FDA's commitment to expediting treatments for rare diseases such as WM. In parallel, we are advancing our regulatory strategy for apopecine I-131 in Europe, where the product candidate has been granted prime designation, which is the FDA equivalent of breakthrough designation, which is designed to provide early regulatory support to accelerate the development of innovative medicines addressing unmet medical needs for patients in Europe. Last quarter, we submitted a filing seeking guidance from the EMA on conditional approval for iapofasine I-131 as a treatment for WM based on the Clover-WAM Phase II data. We believe the results from the study should be sufficiently compelling to support the conditional marketing authorization strategy. Since then, we've entered the scientific advice process with the EMA, and anticipate a response late in the third quarter or very early in the fourth quarter. These dual regulatory tracks reflect our commitment to bringing Iopopocene to patients globally as efficiently as possible. To support our vision for Iopopocene and these efforts, we are in active discussions with the potential partners, both regional and global. We would expect these partnerships, if completed, to provide non-dilutive capital, additional human resources, and subject matter expertise while preserving long-term value for our shareholders. With robust clinical data and a well-understood safety profile, potential expedited program designations in both the U.S. and Europe, and a compelling commercial market potential, we believe Iapofasin I-131 represents an attractive candidate for potential partners seeking impactful innovation and accelerated development pathways. Beyond iapofasine, we are equally excited about the progress in our next-generation radiopharmaceutical pipeline. We remain on track to initiate a Phase I trial for CLR125 in late 2025 or early 2026. CLR125, our iodine 125 OG emitting agent, is advancing toward clinical evaluation in triple negative breast cancer, and we've already submitted the phase one protocol to the FDA. Meanwhile, we are prepared to advance CLR225, our actinium radio conjugate, into a phase one study as a potential solid tumor treatment, such as pancreatic cancer. course, contingent upon sufficient company funding. Jarrett will provide further detail on both of these promising programs. Operationally, we've strengthened our foundation with a long-term isotope supply agreement and raised nearly $10 million in recent financings. These funds will support our clinical programs and regulatory milestones while enabling continued progress on strategic initiatives. In summary, SelectR is entering the second half of 2025 with positive momentum, a potentially streamlined regulatory path for iapophysine, and a series of interesting and novel phase one ready, as well as early stage assets. We are energized by the opportunities ahead and remain deeply committed to delivering innovative, life-extending therapies to patients with cancer. Thank you for your continued support. I'll now turn the call over to Chad Collian, our CFO, for a review of our financials. Chad?

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