Full Transcript: Cellectar Biosciences Q1 2026 Earnings Call

Cellectar Biosciences (NASDAQ:CLRB) reported first-quarter financial results on Thursday. The transcript from the company's first-quarter earnings call has been provided below. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. The full earnings call is available at https://viavid.webcasts.com/starthere.jsp?ei=1761593&tp_key=32a3ce62a5 Summary Cellectar Biosciences reported positive 12-month follow-up data from their Phase 2B Clover WHAM study, demonstrating strong responses in heavily pretreated Waldenstrom's macroglobulinemia (WM) patients. The company plans to file for accelerated FDA approval and initiate a Phase 3 confirmatory trial for their lead candidate Iapocene I131. Cellectar Biosciences completed an oversubscribed financing round of up to $140 million, strengthening their balance sheet and supporting future trials and potential commercialization. Financially, the company ended Q1 2026 with $8.3 million in cash and reported a net loss of $5.7 million, showing reduced R&D and G&A expenses compared to the previous year. The company advanced its broader pipeline by dosing the first patients in a Phase 1b trial of CLR125 for triple-negative breast cancer, showcasing their ongoing commitment to expanding their radiopharmaceutical offerings. Full Transcript 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, there will be a question and answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference call over to Ann Marie Fields, managing director at Precision8Q. Please go ahead. Ann Marie Fields (Managing Director) Thank you. Vanessa, good morning and welcome To Cellectar Biosciences First 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 Lancour, 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 call. A copy can be found on the investor page of our 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 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 14, 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 for your questions. Now let me turn the call over to Jim Caruso. Jim Caruso (President and CEO) Jim thank you Ann Marie and thank you to all for joining us today. The first quarter of 2026 marked a transformational period for Cellectar defined by rigorous execution across our clinical, regulatory and financial strategies. We entered the year with momentum and over the past quarter that momentum has meaningfully accelerated. Earlier this month we reported positive 12 month follow on data from the Phase 2B Clover WHAM study evaluating Iopofacine I131 in patients with relapsed or refractory Waldenstrom's macroglobulinemia or WM (Waldenstrom's macroglobulinemia). These data demonstrated durable and consistent responses across one of the most heavily pretreated refractory WM (Waldenstrom's macroglobulinemia) populations studied to date, including patients who were both exposed to and refractory to BTKI inhibitors. Importantly, iapopolpacine met both the primary and secondary endpoints of the study, reinforcing our confidence in its clinical profile and its potential to address a profound unmet need in wm, particularly for patients who have been previously prescribed the BTKI and are now searching for treatment answers with off label salvage therapies. These results take on even greater significance when viewed in the broader disease context. WM (Waldenstrom's macroglobulinemia) is a rare incurable lymphoma affecting a prevalent patient population of approximately 60 to 80,000 patients, the US and EU alone with a rapidly growing population of patients progressing after BTKI therapy with no FDA approved therapies beyond BTKIs. For these patients, therapeutic options are limited, outcomes are sub optimal and the need for new durable treatments is urgent. With the full 12 month data set now in hand, along with a deep and mature body of clinical evidence, we are advancing our plans to file for accelerated approval with the FDA and to initiate a randomized Phase three confirmatory trial. We believe iapofacine is well positioned to meet regulatory expectations and to become a foundational therapy in the WM (Waldenstrom's macroglobulinemia) treatment landscape. Running in parallel with this clinical momentum, we announced an oversubscribed financing of up to $140 million led by high quality long term health care investors. This capital materially strengthens our balance sheet and provides the resources necessary to advance IAPocene through our planned Phase 3 confirmatory study and potential commercialization as well as support the continued advancement of Triple Negative Breast Cancer study as part of our broader radiopharmaceutical pipeline. Taken together, the strength of our Iopofacine data and the successful financing represent a clear inflection point for Cellectar. They enable us to move forward decisively from a clinical validation to late stage execution. With that overview, I'll now turn the call over to Chad to walk through our financial results. Chad Colleen (Chief Financial Officer) Thank you Jim and good morning everyone. I will address our financial results for the period ended March 31, 2026 and the recently completed financing that allows us to accelerate our development via Iopofacine I131. We ended the first quarter with cash and cash equivalents of approximately 8.3 million compared to 13.2 million at the end of 2025. This does not include the results of the financing, which I will address in a moment. Our research and development expenses for the three months ended March 31, 2026 were approximately 3 million compared to approximately 3.4 million for the three months ended March 31st, 2025 R&D costs declined as the follow up activities for patients of the Focalam Phase IIb clinical study declined and preclinical product development was reduced. These reductions are partially offset by increased manufacturing spend for Both Iopofacine and CLR. General and administrative expenses for the three months ended March 31, 2026 were 2.8 compared to 3 million for the same period in 2025. The modest decrease in GNA was driven primarily by reduced personnel costs. Net loss for the three months ended March 31, 2026 was 5.7 million or $1.33 per share, compared with 6.6 million or $4.30 per share during the three months ended March 31, 2025. Importantly, as Jim stated earlier, earlier this month we completed an oversubscribed financing for up to $140 million consisting of an upfront amount of $35 million and up to $105 million in milestone based capital. As a result, we believe our current cash position enables us to fund planned operations, particularly the initiation of of Our confirmatory phase 3 trial of iopofacine in patients with WM into the second quarter of 2027. The structure of the milestone based warrants is designed to provide additional funding at key points in the development of IPOPHase. Three tranches of warrants, one tied to each of three milestones, were issued for each security the investors purchased up front. The first milestone is the initiation of the confirmatory study as demonstrated by the enrollment of the first patient in the study. The second milestone is the acceptance of an NDA submission by the fda and the third milestone is the approval of Iopofacine by the fda. Upon the attainment of each milestone, provided our common stock trades above $3.45 with volume exceeding $500,000 per day for 20 consecutive days, the company can call the warrants for cash. The warrants for each milestone represent potential additional funding of $35 million, so the aggregate potential for the three milestones is 105 million and when combined with the upfront of 35 million represents the 140 million of total potential funding. Warrants are all exercisable upon approval or of the transaction by the stockholders, which will be part of our annual stockholders meeting agenda. Completion of this offering puts us in a position of financial strength and strategic flexibility, allowing the organization to remain focused on disciplined execution and value creation. Now I will turn the call over to Jared for an operational update including plans for for our promising pipeline of Jared Lancour (Chief Operating Officer) radiopharmaceuticals thank you Chad and good morning everyone. As Jim highlighted the 12 month Clover WHAM results represent a significant milestone for ioprovacine for patients living with wm. For some background, patients enrolled in the Clova WHAM had a median of four prior lines of therapy with refractory rates from 77 to 75 and 60% in BTKI rituximab chemotherapy exposed patients respectively. Additionally, 58% of patients exposed to both BTKI and rituximab were dual class refractory, despite this being one of the most heavily pretreated and refractory WM patient populations to date. Iopofacine produced robust and durable responses underscoring the strength of the targeted phospholipid drug conjugate platform. Notably, the primary and secondary endpoints were both achieved in the protocol study population equaling an N of 55 with an overall response rate of 83.6% and the primary endpoint of major response rate or MNRR improving to 61.8%. The secondary endpoint of duration of response or duration of response achieved a median of 17.8 months. Importantly, greater than 30% of responders maintained their responses beyond 36 months. The median progression free survival was 13.5 months and the BGPR/CR rate was 14.5%. The disease control rate (DCR) remained stable at 98.2%. In addition, the data demonstrated consistent efficacy in both BTKI exposed and BTKI refractory patients. These results compare favorably with available therapies in the post BTKI setting where outcomes remain limited and durability is often modest. Moreover, iapocene's fixed dose regimen and manageable safety profile may also offer practical advantages for patients and providers. Importantly, these outcomes incorporate key elements that align with previously described regulatory expectations. Iopofacine's eligibility for accelerated approval we were delighted to have the immediately post BTKI subgroup analysis from the Clover WHAM trial selected for presentation at the upcoming ASCO conference which brings together the world's leading oncologists. The safety and efficacy of Iopofacine observed to date in this subgroup are highly encouraging and underscore its potential to address a significant unmet need for patients progressed after BTKI therapy. We believe these findings further support the potential for ifocene to emerge as a differentiated therapeutic option in the post PTKI setting and as early as the second line of treatment in wm. With the strength maturity of the total data set we are advancing for the randomized control phase 3 confirmatory study evaluating progression free survival as the primary endpoint. We anticipate initiating the study in the late fourth quarter of 2026. Beyond I proposing we were delighted to advance our broader pipeline with the recent dosing of the first patients in the phase 1b trial of CLR 125. Our auger emitting radio conjugate and relapse refractory triple negative breast cancer, or tnpc. TMPC is an aggressive subtype of breast cancer characterized by the absence of estrogen receptors, progesterone receptors and HER2 protein expression. This lack of common therapeutic targets make TNPC particularly challenging to treat with limited options beyond chemotherapy. TNPC tends to grow and spread more quickly than other breast cancer types and disproportionately affects younger women and those of African descent. In the US approximately 12% of breast cancer diagnoses are triple negative breast cancer. CLR 125, with its demonstrated selective tumor uptake promising activity in preclinical models of tnbc, gives us confidence in its potential to be an effective treatment for TNBC. The Phase 1b clinical trial is an open label dose finding study in patients with relapse refractory TNBC. It will evaluate three dose levels and dosing regimens of CLR 125 32.75 millikeuries administered over four cycles or 62.5 milli curies per meter squared over three cycles or 95 milliquries per meter squared over two cycles, with approximately 15 patients enrolled per treatment arm, with an expansion arm of an additional 15 patients for the recommended phase 2 dose. The study utilizes dosimetry assessments to characterize tumor uptake distribution which supports the prediction of safety and therapeutic activity. Clinical endpoints include safety tolerability as well as preliminary efficacy measures including tumor response per resist criteria and progression free survival. The study is well underway and our first patients are already treated and we look forward to sharing biodistribution, dosimetry and early clinical efficacy insights as the year progresses. Overall, 2026 is shaping up to be a year of substantial execution and progress across the organization and we remain focused on advancing each program with scientific rigor and regulatory discipline. With that overview of our clinical progress and plans moving forward, I'll turn the call back to Jim for closing remarks. Jim Caruso (President and CEO) All right, thank you Jared. As we look ahead, Cellectar enters the next phase of 2026 with clarity of purpose, strong momentum and the financial resources to execute. The combination of compelling 12 month Iopofacine data and a significantly strengthened balance sheet positions us to advance with the initiation of our phase 3 confirmatory study and subsequent accelerated approval application. The WM patient community remains at the heart of our commitment. We continue to hear from and remain motivated by individuals and families affected by wm, particularly those patients with limited treatment options or those that are no longer treatment seekers because of poor or no remaining treatment options. The product profile presented by Iopofacine reinforce our belief that this therapy has the potential to be truly meaningful and potentially life changing for these patients in need. At the same time, we remain disciplined stewards of capital focused on creating long term shareholder value by advancing differentiated assets, engaging constructively with regulators and executing against clearly defined milestones. I want to take this opportunity to thank the entire select our team for their continued dedication and sense of urgency and I thank our investors for their continued support and conviction. We are committed to delivering on both our mission for patients and our responsibility to shareholders. With that operator, we are happy to open the call for questions. OPERATOR Thank you ladies and gentlemen. We will now begin the question and answer session. Should you have a question, please press the star followed by the one. On your touchtone 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're using a speakerphone, please lift the handset first before pressing any keys. And we have our first question from Kevin DeGeeter with Lanenberg Dalman. Kevin DeGeeter (Equity Analyst) Hey, good morning guys. Thanks for taking my question. My first question is on Clover WHAM. And specifically for the BTKI experienced patients, did most patients go directly from a BTKI inhibitor to study drug in Clover WHAM. Or for the patients that did get lines of therapy between a BTKI and coming on study drug, what were the most common therapies they received immediately prior to study drug? Jim Caruso (President and CEO) Hi Kevin, this is Jim. First of all, thank you for your participation in the call today. And your question is spot on. It's significant on a number of different levels and I'll ask Jared Lancour to address it. Jared Lancour (Chief Operating Officer) Yeah. Hi Kevin. Briefly, I don't have the number, the exact number in my head at the moment, but I can say that it was over 50% of patients in the study immediately came off BTKI before getting treatment with most common, you know, in addition to that as the most common sort of transition, the other would be coming directly off rituximab, either monotherapy or in combination with chemotherapy. Kevin DeGeeter (Equity Analyst) No really helpful. And then with and then with regard to the, you know, phase three program. Thanks for the additional color. Can you comment on what the likely comparator arm for the phase three program will be or at least or. I think the question I'm ultimately interested in is how one might think about potential range of PFS for the control arm population in a potential phase 3 population. Jim Caruso (President and CEO) Excellent question, Kevin. We've engaged our friends at the FDA a number of different times on this. So we've settled in and are aligned on the comparator arm in the study. I could have Jared talk to that and provide some additional color. Jared Lancour (Chief Operating Officer) Yeah, so it is a great question. So what we believe the. Or what we've aligned on with the agency on the comparator arm is rituximab, cyclophosphamide, dexamethasone or rcd. It is commonly used in a post BTKI patient population that tends to have significant adverse events associated with any of the other treatments and provides a comparable sort of outcome to some of the other treatment scenarios. So it makes a good choice. I will say, since you sort of asked the question about how to think about these compounds and how they might behave, because obviously in the literature what you will find is that rcd, the last time it was significantly sort of challenged or experienced in various studies was pre BTKI being in the marketplace. And so what you best bet is to look at an article that came out from a group, I'll call it Anna Forstauchi out of Italy, where they demonstrated that with any rituximab combination, essentially any salvage therapy, progression free survival in those patients varied anywhere from about 5.8 to 8.1 months in a post BTKI exposed patient population and refractory for the earlier number. So the 5.8 was a refractory patient population, which in our case with the phase 3 study or the confirmatory study that we're designing, which is essentially an immediate post BTKI patient population following frontline therapy. What we expect to see is the vast majority of those patients to be refractory to the BTKIs when they enter Jim Caruso (President and CEO) into the clinical study and the refractory to BTKI population in that salvage therapy, including these RCD combinations, whereas approximately 5.8 months. Correct. Correct. And out of the phase two clover wham. Our progression free survival with iapopacine was over 15 months in that same patient population. I think the other element there, Kevin, if you could take a moment and just talk through the powering of the study, the 100 in each arm and based on that differential level of confidence relative to how the study was powered. Jared Lancour (Chief Operating Officer) Yeah. So to Jim's point on the power, what we did was we assumed for the comparator arm essentially a hazard ratio that corresponds to an 8 month progression free survival. And for the iapomacine arm we used a hazard ratio that assumed no greater than a 12 month progression free survival. So obviously as Jim has said our expectation is really that the with the vast majority of patients being BTKI refractory we're going to see something likely closer to six months of progression free survival of the pareter arm. And if the patients behave as they did in the Clover Wham study we would expect something closer to 15 months in the Iapobacine arm. Thereby essentially overpowering the study by a number of patients in order to ensure success. Kevin DeGeeter (Equity Analyst) Makes a lot of sense. And if I could just sneak in one more. I think just one of the questions that might be on investors minds is just how you're thinking about a potential timing for an NDA submission under accelerated approval for wn. Jim Caruso (President and CEO) It's pretty straightforward from our perspective. I mean we're planning to initiate the study as Jared had cited at the very back end of this year once we have the study up and running, enrolling patients and that may be a couple, two, three months. At that point we would submit our new drug application. Please keep in mind that in May of last year we received our breakthrough designation which essentially obligates the FDA to for a six month window prior to regulatory action. So if you initiate at the very back end of this year, wait a couple, two, three months and then have the FDA action within six months of that submission, you know you're in the second half of 2027 with a potential approval. Kevin DeGeeter (Equity Analyst) Great. Thanks for taking my questions. Jim Caruso (President and CEO) All right Kevin, thank you and thank you. OPERATOR As a reminder, if you would like to ask a question please press star then one. There are no further questions at this time. I will now turn the call over to Jim Caruso for final remarks. Jim Caruso (President and CEO) All right, thank you operator. Appreciate your assistance today and certainly thank you to all conference participants for both your time and continued interest in Selectar. Have a good day and thank you. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.