Cellectar Biosciences, Inc. (CLRB) Earnings Call Transcript & Summary

Thank you. 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 Select Our 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 Lancourt, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopulmonary care. the goals. 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. by the cautionary statements contained in today's press release and in our FEC 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 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 SelectArt 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. near-term priority remains clear, advancing Iopopacin I-131 for patients with relaxed or refractory Wolvenstrom's macroglobulemia for WN. particularly those patients whose disease has progressed following earlier lines of 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-WAM study. These data further reinforced both the depth and durability of response achieved with iapocasin 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 Iopopocene's potential to become an important treatment option for WM patients. Second, we can continued to build an increasingly compelling clinical data set for ayopoposy. 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 needed. 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 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, OGIE-emitting, and alpha-emitting radiotherapeutics. We believe the success we are seeing with iapocasin is validating the platform and creating a strong foundation for future pipeline expansion. Today, in addition to discussing our progress with iaprofosine, we will also review advancements in CLR125, our OGIE-emitting program in solid tumors, and discuss how we plan to leverage the platform to build a next-generation program. radiopharmaceutical brand shops. With that overview, 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 IFO for CNI 131. The company received $35 million gross upfront 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 apophysin I-131 in Waldens from macrobobby anemia, or WM, patient. The Tranche B warrants, which expire July 7, 2028, have the milestone of the FDA's acceptance of a new drug application for ifo-facil. The tranche C warrants, which expired July 7, 2031, had a milestone of approval by the FDA of Iapovacine 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 IFO facilities. Now, for our financial results for the period ended June 30, 2026. end of 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 increase in R&D largely reflected increased clinical study activity to support our CLR1-25 study in triple negative breast cancer. and initiation of the confirmatory study of iPhone PC9131 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. 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 SelectAR is entering an important phase of execution with multiple value-driving milestones ahead. Our primary focus remains advancing ipoviscine 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 global 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. First, we presented new analyses at ASCO, highlighting outcomes 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 15 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 62% of patients achieving a major response, and the depth of the response observed of apophysine increasing over time, with a very good partial response and complete response rate increasing to 14.5% in these late line highly refractory patients. Importantly, we are now translating these clinical achievements into regulatory and operational execution. We have initiated site activation activities for our planned phase three confirmatory trial and expect the first sites to open in the coming months, a key milestone in the development strategy. This study is designed to support long-term registration requirements while also enabling us to submit our plant accelerated approval pathway filing in the United States in 2027. We view the initiation of patient dosing in this trial as a significant upcoming catalyst and believe that could occur late this year or early this year. next year and is an important step toward bringing hypopasine to patients who urgently need new treatment options. Beyond WM, we continue to broaden the opportunity for both iPopacy and our proprietary phospholipid drug conjugate or PDC platform. Our recently published multiple myeloma data in a peer-reviewed journal, Cancers, further support the differentiated mechanism of action of iapococine and highlight its potential applicability across a range of B-cell malignancies, including WM, multiple myeloma, diffuse large B-cell lymphoma, or DLBCL, and other different types of myeloma. difficult to treat hematologic cancers where new therapeutic options are urgently needed. At the same time, we are advancing the next generation of our radiopharmaceutical pipeline, which recently enrolled and dosed the first patients in our Phase 1B trial of COR125 and triple negative breast cancer, and remain on track to report initial dosimetry, safety, and efficacy data later this year or later this year. early next year. Taken together, we believe these accomplishments underscore the growing validation of our platform, the strength of our development strategy, and a 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 tumor therapeutic payloads. The platform has already generated clinical validation through iapovacine and serves as the foundation of our next generation pipeline, including CLR-125, our OJ emitting radiotherapeutic program, and CLR-225, our alpha emitting program. We've We believe these programs represent significant long-term value creation opportunities and demonstrate the range of the platform across multiple cancer indications. One of the unique strengths of the PDC platform is its flexibility. By leveraging the similar targeting backbone with different therapeutic payloads, we have the potential to develop multiple product candidates addressing a range of tumor types while capitalizing on the extensive knowledge we've already accumulated regarding tumor uptake, biodistribution, and supply chain. 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 opportunities we see for clinical platform. We encourage you all to join us for what we believe will be an informative and engaging discussion about long-term potential of Selectar's 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 stage of development and remain focused on executing against the milestones ahead. With that, I'll turn the call back to Jim for closing remarks. 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 iapopasine 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 3 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 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 to execute our near-term objectives. Importantly, as Jared just reviewed, we believe the opportunity extends far beyond a single product. The progress we are making with Iopococine continues to validate the underlying strength of our PDC platform and further reinforces our confidence in expanding the technology across additional radiopharmaceutical programs, including our OG emitting and alpha emitting product candidates for solid tumors. To this end, I encourage listeners to participate in our educational webinar on August 18th. Our vision is to build a leading radiopharmaceutical company founded on versatile, clinically validated delivery platform capable of generating multiple product opportunities across both hematologic and solid tumor indications. With strong momentum across our regulatory, clinical, and corporate initiatives, we look forward to sharing additional milestones throughout the remainder of 2026 and into 2027. I would like to thank our employees, as always, investigators, most importantly patients, and partners for their continued support and commitment to our mission.

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 touched on phone. You will hear a prompt that your hand has been raised. If 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.

Hey, great. Yes, 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 great limiting steps to first-person care? patient enrolled. I think you've mentioned your site activation, presumably IRB, but kind of any other factors that may drive kind of your guidance to be you know earlier kind of poor Q versus 1q 27 and then Please clarify what triggers potential FDA submission. Is it a specific number of patients enrolled, a more qualitative criteria, just a little bit more granularity there would be helpful.

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 an 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 excited happy with the response from not only those academic catchment centers that treat a significant portion of the relapsed refractory WM population, but also from community networks integrated on complex networks. technology 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 institutions, you know that are world renowned for the treatment of highly refractory WM. 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. 15 states in the United States essentially control 80% of the population for WM. So it is highly targeted. And in and around those geographic communities, all of these segments, the integrated oncology delivery networks, community-based hospitals, as well as those academic centers, provide treatment for this patient population. So the NET, having said that, we're very pleased with where we currently sit. We're on target from a timing perspective. I'll have Jarrett talk to the details of your questions, but we still view that kind of March-April timeframe as our submission.

for accelerated approval with our friends at the FDA. Sure. So, as you mentioned, you know, there's a number of steps that go into the, obviously, the startup process, just to sort of lay out a few. I mean, sure. Generally, the way the process actually starts is that, you know, and I'll just sort of give probably way too much granularity here, but, you know, at the time of beginning the process, right, where you start is the contracting with the CRO and getting the documentation in place with the CRO. And that means not just the contract, but it's all the supporting documentation. documentation, so all of the necessary investigator letters, all of the necessary for the operation of the study and the SOPs and making sure everything lines up. 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 can They again request, 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, how many patients they might enroll in and what time frame. After that, you move into what's called the qualification phase, which is obviously with the radiopharmaceutical, it's not like taking an oral, antibiotic per se, right? 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 approve 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 that have to review the protocol with the final full protocol and statistical analysis plan 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 the true site initiation, which allows them to open and begin screening for patients, and then first patient in. That's sort of all of that execution. and operational stuff is going on in the background. And as we said in our prepared remarks, we have initiated much of that, and we are on track to have what we believe are first sites open in a handful of months here over the next coming months with a potential first patient in late this year, early next year. as it relates to then the FDA submission 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, or 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 be. We know what they're asking is basically that companies are executing diligently against the confirmatory studies or acceptance of their accelerated approval application, and 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 patients enrolled, preferably at the time of submission, and then having somewhere between 5% or more patients enrolled by the time there's regulatory action. That's 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 learning around, I guess, the dose symmetry data and potential timeline. I think you kind of called out milestones, but not specific timeline for.

data update on that exciting program. Yes, so I'm going to stay very vague on the, what we know about the dosambertriance and so forth, and I think the reason for that is we, to be transparent, we do expect to be able to provide some data later this year. We are looking at the San Antonio Breast Cancer Conference obviously as an opportunity, one potential opportunity 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 as one would predict based off of what we know about the targeting ligand and what we've known from iapopacin, and we see that that 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 1B dose-finding study, is optimizing and looking at how we optimize the dose ideally for patients.

Perfect. Thanks for taking my questions. I'll get back into it. Thank you.

And your next question comes from Kemp Alvea from Brookline Capital Market. Please go ahead.