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8/13/2026
. . . . . . . . . . . . . . . . . . . . Good morning, ladies and gentlemen. Thank you for standing by and welcome. At this time, all participants are in listening mode, and following the presentation, we will conduct a question and answer session. Please be advised that today's call may be recorded. I would now like to hand the call over to Anne Marie Fields, Managing Director of PrecisionAQ. Please go ahead.
Thank you, operator. Good morning, and welcome to Selectar Biosciences' second quarter 2026 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 Kolean, CFO, for a financial review of the quarter. Following this, Jarrod Longcor, 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 call. Copy can be found on the investor page of the 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 press release 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 13, 2026. 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 to your questions. I'll now turn the call over to Jim Caruso. Jim?
Thank you, Anne-Marie, and thank you all for joining us this morning. The second quarter marked an especially productive period for SelectArc as we continued making meaningful progress across every area of our business, including clinical development, regulatory action, pipeline advancement, platform expansion, and strengthening of our financials. Our near-term priority remains clear. Advancing Iopopacin I-131 for patients with relaxed or refractory Waldenstrom's macroglobulinemia, or WM, particularly those patients whose disease has progressed following earlier lines of treatment, including BTK inhibitor therapy. We believe this represents significant unmet medical need and an attractive opportunity to bring a differentiated treatment option to patients who currently face limited therapeutic alternatives. During the quarter, we took several important steps to move this strategy forward. First, we reported the full 12-month follow-up results from the Clover-WHAM study. These data further reinforced both the depth and durability of response achieved with Iopococine and demonstrated that the study successfully met both its primary and secondary endpoints. Taken together, We believe the totality of evidence generated to date continues to support iapococine's potential to become an important treatment option for WM patients. Second, we continue to build an increasingly compelling clinical data set for iapococine. We presented new data at ASCO 2026 from the Clover-WAM study highlighting outcomes in patients treated immediately following BTKI therapy, a challenging patient population. These results demonstrated a 79.2% major response rate, an 87.5% overall response rate, and 100% clinical benefit rate, and encouraging durability with a median duration of response of 16 months. Most importantly, we have now initiated site activation activities for our planned confirmatory phase three study. This represents a critical milestone in our regulatory strategy. Once necessary site activation and ongoing patient enrollment is achieved, we expect to be in a position to submit our new drug application under the FDA's accelerated approval program in mid-2027. Based upon the breakthrough designation awarded to Iopopocene I-131 for relapsed refractory WM, an approximate six-month review is anticipated. To support these efforts, we were pleased to complete an oversubscribed financing in May that has the potential to provide up to $140 million in capital including $35 million upfront and up to $105 million tied to future milestones. This financing significantly strengthens our balance sheet and provides the resources needed to execute our WM strategy, advance our regulatory initiatives, and continue investing in our broader radiopharmaceutical pipeline. Beyond WM, We continue to advance the broader opportunity represented by our phospholipid drug conjugate or PDC platform. The PDC platform is a highly differentiated targeting technology designed to selectively deliver therapeutic payloads to cancer cells, including primary tumors, metastatic lesions, and cancer stem cells. Importantly, the platform is highly versatile. and can be combined with a variety of payloads and isotopes, including beta-emitting, ogi-emitting, and alpha-emitting radiotherapeutics. We believe the success we are seeing with Iopopasine is validating the platform and creating a strong foundation for future pipeline expansion. Today, in addition to discussing our progress with Iopopasine, we will also review advanced advancements in CLR125, our OGIE emitting program in solid tumors, and discuss how we plan to leverage the platform to build a next-generation radiopharmaceutical franchise.
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