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 a call over to Anne-Marie Fields, Managing Director of Precision AQ. 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 Colleen, CFO, for a financial review of the quarter. Following this, Jared Longcore, 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 Selectar's corporate website. I want to remind callers that the information discussed on the call today is covered under the safe harbor provision 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, 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 calling webcasts 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.

Thank you, Anne-Marie, and thank you all for joining us this morning. The second quarter marked an especially productive period for SelectArk 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 I-apophysine I-131 for patients with Waldenstrom's macroglobulimia for WM, particularly those patients whose disease has progressed following earlier lines of treatment, 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 quality. We took several important steps, 12-month follow-up results. These data further reinforced the durability of response achieved with iapofasine and demonstrated that the study's success is primary and secondary. And together, we believe the totality of evidence generated to date continues to become an important treatment option for WM patients. We continue to build an increasingly compelling clinical data set for iapophysy. We presented new data at ASCO 2026 from the Clover WAM study highlighting outcomes in patients treated immediately following BTC. 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 Importantly, we have now initiated site activation activities for our planned confirmatory phase 3 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 I-131 for relapsed refractory WM, an approximate six-month review is anticipated. 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 up front, 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, validating the platform, and creating a strong foundation for future pipeline today. In addition to discussing our progress with iapophysine, we will also review advancements in CLR125, our OG-emitting program, and solid tumors. We plan to leverage the platform to build a next generation. I'll turn the call over to Chad for the financial review.

Thank you, Jim, and good morning, everyone.

First, I will spend a couple of minutes on the financing that Jim mentioned. As he stated, the transaction provided the company with the current and anticipated future funding to support our strategy to obtain approval for IFOFC and I-131. The company received $35 million gross up front, or approximately $31.7 million net. for common shares and pre-funded warrants. Additionally, we issued three tranches of approximately 13.2 million warrants each, all of which are currently exercisable with a strike price of $2.65. Furthermore, these warrants are callable for cash by the company if the respective milestone and related criteria are met. Each tranche of warrants, A, B, and C, has a milestone associated with it. The tranche A warrants, which expire on July 7, 2027, have a milestone of first patient enrolled in the confirmatory study for ibuprofesine I-131 and Waldstrom maculopathy anemia, or WM, patients. The tranche B warrants, which expire July 7, 2028, have the milestone of the FDA's acceptance of a new drug application for iapovicine. The tranche C warrants, which expire July 7, 2031, have the milestone of approval by the FDA of iapovicine for marketing. In addition to achieving the milestones, two additional criteria must be met for the warrants to be callable. First, the volume weighted average price, or VWAP, for the company's stock must be at least $3.45 for 20 consecutive trading days. Second, the trading liquidity based upon VWAP must average a minimum of $500,000 for those same 20 trading days. The milestone timing is designed to provide the necessary funding through the anticipated study initiation, submission to FDA, and approval. We believe this structure, provided it occurs as designed, supports the company's capital needs through initial commercialization of Iapophacine. Now for our financial results for the period ended June 30, 2026. We ended the second quarter with cash and cash equivalents of approximately $34.0 million, compared to $13.2 million as of December 31, 2025, which reflects the cash generated from the initial portion of the May financing. Turning now to our operating results, research and development expenses for the three months ended June 30, 2026 were approximately $4.6 million compared to approximately $2.4 million for the three months ended June 30, 2025. The overall The general increase in R&D largely reflected increased clinical study activity to support our CLR125 study in triple-negative breast cancer and initiation of the confirmatory study of IPHC9131 in WF. General and administrative expenses for the three months ended June 30, 2026, were $2.6 million compared to $3.6 million for the same period in 2025. The decrease in G&A was driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs. Net loss for the three months ended June 30, 2026, was $6.9 million, or $0.57 per share, compared with $5.4 million, or $3.39 per share, during the three months ended June 30, 2025. Five, the enhanced strength of our balance sheet enables our ability to effectively advance our clinical and regulatory programs. Now I will turn the call over to Jared to discuss the regulatory and clinical advancements we've been making during the first half of 2026.

Thank you, Chad, and good morning, everyone. As Jim noted, we continue to make meaningful progress across our clinical, regulatory, and development initiatives and believe SelectArt is entering an important phase of execution with multiple value-driving milestones ahead. Our primary focus remains advancing I-Povescine I-131 to potential registration in WM, where we have generated a compelling body of clinical evidence and established a clear regulatory path forward. We have been encouraged by the consistency of the data emerging from the Clover Wham study, which continues to demonstrate meaningful and durable responses in a patient population with significant unmet medical need. During the quarter, we expanded that clinical evidence base with two important data updates. We presented new analyses in patients treated immediately following BTKI inhibitor therapy, a particularly challenging setting where treatment options remain limited. And as Jim mentioned a few minutes ago, we demonstrated an approximately 80% major response rate and 16 months of durability in these patients. We also reported the full 12-month follow-up data set from the Clover-WAM study on all patients, which further reinforced the durability with a median durability of 17.8 months and approximately, and the depth of the response observed of ibophysine increasing over time with a very good partial response and complete response rate increasing to 14.5% in these late-line, highly refractory. Importantly, we are now translating these clinical achievements into regulatory and operational execution. We have initiated site activation activities for our planned Phase III confirmatory trial and expect the first sites to open in the coming months. A key milestone in this study is designed to support long-term registration requirements while also enabling us to submit our planned accelerated approval pathway filing in the United States. We view the initiation of PAPE early next year. Beyond WM, we continue to broaden the opportunity for both ibuprofacine and our proprietary phospholipid drug conjugate, or PDC. Our recently published multiple myeloma data in a peer-reviewed journal, Cancers, further support the differentiated mechanism of action of ibuprofacine and highlight its potential applicability across a range of B-cell malignancies and other difficult-to-treat hematologic cancers. At the same time, we are advancing the next generation of our radio-pharmaceutical pipeline, We recently enrolled and dosed the first patients in our Phase I-B trial of CLR-125 and triple-negative breast cancer and remain on track to report initial dose symmetry, safety, and efficacy data later this year or early next year. Taken together, we believe these accomplishments underscore the growing validation of our platform, the strength of our development strategy, and the significant opportunity ahead. In tandem, we continue to advance what we believe is one of the most innovative, differentiated, and versatile targeting platforms in radiopharmaceutical development today. Our proprietary PDC platform was designed to selectively target cancer cells through a mechanism that is independent of specific tumor mutation or surface antigens. We believe this enables near-universal tumor targeting across hematologic malignancies as well as solid tumors while providing a flexible delivery vehicle for multiple therapeutic pay levels. The platform has already generated clinical validation through Ipovacine and serves as the foundation of our CLR-225. We believe these programs represent significant long-term value creation opportunities and demonstrate the range of the platform. One of the unique strengths of the PDC platform is its flexibility by leveraging the similar to already accumulated regarding tumor uptake, biodistribution, and safety. To provide additional insight into this opportunity, we'll be hosting an educational webinar on August 18. During this event, members of our management team will discuss the scientific foundation of the PDC platform, its differentiated targeting capabilities, the progress we have made across clinical programs, and the significant future. We encourage you all to join us for what we believe will be technology and pipeline. Overall, we are pleased with the progress made across our clinical, regulatory, and pipeline initiatives during the first half of the year. We believe we are well positioned for the next focus on executing against. With that, I'll turn the call back to Jim for closing.

Okay. Thank you, Jared. As we look ahead, we believe SelectR is entering an important and exciting as well as transformational period. Our immediate focus is executing on the next steps required to advance iapopacine in WM. With compelling clinical data, active site initiation efforts already underway, and a clear regulatory path forward, we are working toward the start of our confirmatory Phase III study, which we view as a critical catalyst and an important step toward our planned accelerated approval submission, which remains on target for the first half of the year in the United States. At the same time, we are well-positioned financially, following the oversubscribed financing completed earlier this year, which provides us with the resources necessary. Importantly, as Jared just reviewed, we believe the opportunity extends far beyond a single product. The progress we are making with iapofacine continues to validate the underlying strength of our PDC platform and further reinforces our confidence in expanding the technology across additional radiopharmaceutical programs. emitting. To this end, I encourage listeners to participate in a webinar. Our vision is to build a leading radiopharmaceutical company founded on a clinically validated delivery platform capable of generating multiple product opportunities across both hematologic and solid tumor. With strong momentum across our regulatory, clinical, and corporate initiatives, we look forward to sharing additional milestones throughout the remainder of 2020. I would like to thank our employees, as always investigators, most importantly patients, our stockholders, and partners for their continued support and commitment. Operator, we're now prepared to take questions.

Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press the star followed by the one under touchstone phone. you will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. And if you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. And your first question comes from Kevin DeGieter from Leidenberg. Please go ahead.

Hey, great. Yeah, thanks, guys. Appreciate the update. Exciting time. A couple of questions from us. First off, on the Phase 3 WM program, Can you just walk us through with a little bit more granularity, the rate limiting steps to first patient enrolled? I think you've mentioned site activation, presumably IRB, but kind of any other factors that may drive kind of your guidance to be earlier, kind of 4Q versus 1Q27?

And then can you just clarify kind of what triggers? um potential fda submission is it a specific number of patients enrolled a more qualitative criteria just um just a little bit more granularity there would be helpful thank you all right terrific first of all kevin thank you for your participation today in support of the company it's very much appreciated that is a significant question and as you would expect there's enormous amount of work that goes into initiating the confirmatory study especially one of this size and we're very pleased with the progress that we've made to date and we're particularly happy with the response from not only those academic catchment centers that treat a significant portion of the relapse refractory WM population community networks integrated oncology delivery networks that typically treat these patients or diagnose these patients as well as treat out in the general community, certainly in the first handful of lines of therapy prior to referring to one of these world-renowned for the treatment of highly refractory. So we're looking at all customer segments, even, quite frankly, community-based institutions that also see a significant amount of patients by way of background. In states and the United States, essentially control 80% of the population for WM. So it is highly targeted. And in and around those geographic communities, the Integrated Oncology Delivery Networks community-based hospitals, as well as those academic centers, provide treatment for this. So the net, having said that, we're very pleased with the timing perspective. of March.

There's a number of generally the way the process actually starts is that at the time of with the CRO and getting the documentation contract, but it's all the supporting documentation, investigator letters, all of the necessary documents for the operation of the study and the SOPs and making sure everything lines up. So after that, then you move into the next phase, which is really site identification where you identify which sites you want to target, which countries you want to go to, and so on and so forth from that. That then goes into what's called a feasibility step where you submit to those various sites and investigators a feasibility questionnaire where they, again, request, you know, they get basically a protocol synopsis. They review it. They determine if they're interested in participating, and they provide you with a sense of how many patients they may or may not. Now, after that, you move into what's called the qualification phase, which is, you know, obviously with a radiopharmaceutical, it's not like taking an oral antibiotic, per se, You know, in this case, you've got to have an infusion suite. You've got to be able to handle a license for handling I-131. And so you have to go through all of that process, and you have to collect all that documentation as well. Then you move through, and as you said, you get into the IRB phase. The IRB phase comes, site contracting comes. that can sometimes go in parallel, sometimes not. And that depends, depending, as Jim said, we've got a lot of interest from both community centers as well as academic centers. When you think about community centers, we can use a central IRB. That allows them to improve more rapidly and move more rapidly. However, some of the more academic centers tend to have a local IRB in addition to that central IRB, so there's an extra IRB review process. In addition to that, many of the academic centers also have an internal committee They have to review the protocol with the final full, where they then vote to participate and go from that step to the next step, which would then be the contracting. After that, you have to train the centers and begin all that process, and then you do site initiate, the true site initiation, which allows them to open and begin screening for patients, and then first patient in. All of that execution and operational stuff is going on in the background, and as we said in in our prepared remarks you know we have initiated much of that and we are on track months here over the next coming months with the potential first patient in late this year early next year as it relates to then the FDA submission and and what's the gating aspect for that that is you know the gating aspect by FDA's definition is the site has to be their site the study has to be initiated and quote unquote ongoing so initiated at the time of submission ongoing at the time of regulatory action, the definition of which is not defined by the FDA. They will not provide any clear, direct guidance on that subject. So you are left to sort of estimate what you think that might mean. We know what they're asking is basically that companies are executing diligently. Studies diligently continue to execute that by the time they are doing regulatory action. Our interpretation of that is that we want to have a number of sites open somewhere, perhaps 10 to 20 sites open at the time of submission, and we want to be in a position that we've gotten a couple, somewhere between that six to eight months after the submission goes in. Does that help?

It does. Incredibly granular. Thank you for that. And then just separately, on CLR-125, you know, interesting asset, just kind of, you know, talk to us about kind of what the initial, you know, learning around, I guess, the dose symmetry data and potential timeline. I think you kind of called out milestones, but not, you know, specific timeline for, you know, data update on that exciting program.

Yeah. So I'm going to stay very vague on what we know about the dosimeters and so forth. And I think the reason for that is, to be transparent, we do expect to be able to provide some data later this year. We are looking at, you know, the San Antonio Breast Cancer Conference obviously as an opportunity, one potential opportunity to present data as it relates to that program, as well as other opportunities as may warrant to provide a data update around the program. What I can say is we know we've got very good uptake into the tumor. We have distribution that looks, you know, as one would predict based off of what we know about the targeting ligand and what we've known from iapophacine. And we see that it is very much predictable and in line what we would have expected. And so what we're doing from there is really, you know, as one would expect in a phase 1 B dose finding study is optimizing and looking at how we optimize the dose ideally for patients.

Perfect. Thanks for taking my questions.

Thank you. And your next question comes from Kemp Alvier from Brookline Capital Market. Please go ahead.

Thank you. And good morning. A couple questions. So, you have started to manufacture, you know, supply for your trials. Are you manufacturing any commercial supply for Ipofacene 131 at this point or plan to do so shortly?

Yeah, so thanks for the question, Kemp. What I would say to you is I'm going to say it as a yes. Obviously, we can't manufacture the isotope or the finished product because those are essentially what I'll call near-term just-in-time or nearly just-in-time. But the targeting line, again, we do have significant stability data on that. And what we do is we produce that now. We've been producing that essentially at commercial scale for the last several years. And to give you a sense, we've got more than five years stability. We generally produce that at large scale and then use that as necessary. As I said, we have our commercial, and I'll say for the finished product, we have our commercial infrastructure out and ready to go. Obviously, when we get a commercial approval, should we get a commercial approval, let me say it that way, we would then obviously be in a position to relatively quick production process through our existing logistics chain.

Yeah, we have the capacity to scale significantly in terms of patient lives, and we could stack our max capacity. It was well beyond any of our potential treatment and our revenue model.

I'd say right now we would easily be a product. The production of each unit is essentially done in an individual hot cell. So you can obviously, as I'll call them, you daisy chain the hot cells together. In our case, you know, our production runs actually give us considerably more material than we need. So even just.

That's great. Thanks. And that leads into the next question is how quickly you can launch after receiving the accelerated approval.

That would be a function of investment. and when we determine, you know, when to pull particular levers. So it's typically, you know, a 12-month period at a minimum to fully lock and load for commercial execution. And really, you know, I think in this particular case, because of the scalable nature of the space, you know, as I cited earlier, you know, 15 states essentially control 80% of the WM lives. But when you look at the actual customers triaging those patients, you know, that number gets, you know, even more scalable and smaller. So it's one of the attractive reasons this space is, you know, from a commercial perspective, a whiteboard, if you will. There's limited competitive tension in the space. You know, BTKIs are the only approved class of medications. They're predominantly used in first line and second line and beyond.

Hello, Hugh. Hi, Jared. There we go.

A bunch of inbound inquiries, you know, relative to the availability of the drug. So getting back to your original question, we could scale up quickly because it's a targeted environment. But ultimately, the time to fully lock and load and mobilize, you know, is really a function of when you pull the trigger on certain levels of investment. Now, having said that, we also have, you know, we are, because there's limited to no competitive tension there or, you know, multiple marketing, commercial machinery in the space, it's pretty wide open. And so for a small company like ours, it could potentially be a consideration to commercialize on our own because of the limited amount of oncology spend that would be required to really drive trial use and adoption. However, having said that, we're also discussing with third-party partners that would take that on, as well as world-efficient commercial organizations that we can also partner with to drive this for us. So all three, you know, typical, you know, commercial options are on the table for us. We're evaluating all of them, and we believe we could move very quickly in terms of establishing trial use and adoption in the space for limited funds in comparison to other spaces like breast or et cetera in terms of the cost of doing business.

Great. And my last question is more for a broader industry view, but you do have some toehold in actinium-225, at least not in the clinic yet, but something of interest to you. And so what's your sense of the availability of actinium-225 now versus, say, a year ago?

Great question, Kevin. It allows me to just want... I appreciate that opportunity. So what I would say is, yeah, a year ago, I would say, you know, Actinium, everybody was considerably concerned about the supply chain for Actinium. I don't think that it has fully resolved, but I do think as, you know, as we have been advancing here and as I think people were expecting, we've gotten new suppliers in place. You know, I think groups like SpectronRx are now up and consistently supplying Actinium in addition to the group ITM and Eckerd Ziegler. And then you now have Northstar online. I think you've got a number of other groups, Ionetics and a few others that are coming online in the near future, Nucleus and so forth. And so I think, you know, where we sit today to where we're going, I think the supply chain is for the sourcing of actinium is opening up a bit. Now, I do expect that, you know, as programs advance and the need for larger quantities of actinium for certain programs increases, we may continue to see future constriction and opportunity. And as you know, you know, our strategy here on all of our components for production has been to multi-source every piece of the component. So everything from our targeting ligand to each radioisotope we work to work on and then each finished product that gets made, we multi-source all of that through various contractors and in our what I'll call our collaborative outsourcing model. And as you probably may or may not be aware, historically what we've done, and what we've done particularly around Actinium, is we put in place our ready supply agreements with a number of parties. I think we're at four at this show that we can access and get both near term and long term.

All right.

Thank you.

Thank you. And then no further questions at this time.

I will turn it back over to Jim for closing remarks. well terrific thank you to everyone who participated in our call today it's very much appreciated in particular our analysts for asking very thoughtful and provoking questions an operator with that will conclude our call ladies and gentlemen this does conclude your call for today we thank you very much for your participation and you may now disconnect have a great day everyone