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 Anne-Marie Fields, Managing Director at Precision 8Q. Please go ahead.
Thank you, Vanessa. Good morning and welcome to Selectar 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 Longcore, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline at Radio Pharmaceuticals. Selectart issued a press release earlier this morning detailing the contact of the state's A copy can be found on the investor page of Selectart'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 and in the SEC final. 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 call over to Jim Caruso.
Thank you, Anne-Marie, and thank you to all for joining us today. The first quarter of 2026 marked a transformational period for SelectAR, 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 Iapopocin I-131 in patients with relapsed or refractory Waldenstrom's macroglobulimia, or WM. These data demonstrated durable and consistent responses across one of the most heavily pretreated and refractory WM populations studied to date, including patients who were both exposed to and refractory to BTKI inhibitors. Importantly, ibuprofacine 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 to 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. WN is a rare incurable lymphoma affecting a prevalent patient population of approximately 60,000 to 80,000 patients in the U.S. 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 self-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 iaprofacine is well positioned to meet regulatory expectations and to become a foundational therapy in the WM 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 healthcare investors. This capital materially strengthens our balance sheet and provides the resources necessary to advance iapophysine through our planned page three 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 iapofasine data and the successful financing represent a clear inflection point for SelectArt. 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.
Thank you, Jim. I'll address our financial results for the period ended March 31, 2026 and the recently completed financing that allows us to accelerate our development by both the CNI-131. 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 home. 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 31, 2025. R&D costs declined. There's the follow-up activities for patients of the full program phase 2B clinical study declined, and preclinical product development was reduced. These reductions are partially offset by increased manufacturing spend for both have both seen 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 G&A 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 cents per share during the three months ended March 31, 2025. Importantly, as Jim stated earlier, he 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 our confirmatory phase 3 trial of ibuprofesine 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 ibuprofesine. 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 Ipofacine 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. The warrants are all exercisable upon approval 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 our promising pipeline of radiopharmaceuticals.
Thank you, Chad, and good morning, everyone. As Jim highlighted, the 12-month Clover WHAM results represent a significant milestone for iapobosine for patients living with WM. For some background, patients enrolled in the Clover WHAM had a median of four prior line 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, hiapoposine 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 MRR, improving to 61.8%. The Secondary Endpoint of Duration of Response, or DOR, 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 remains stable at 98.2%. In addition, the data demonstrated consistent efficacy in both BTKI exposed and BTKI for frack-free patients. These results compare favorably with available therapies in the post-BTKI setting, where outcomes remain limited and durability is often modest. Moreover, iapoposine's fixed-dose regimen and manageable safety profile may also be offer practical advantages for patients and providers. Importantly, these outcomes incorporate key elements that align with previously described regulatory expectations for Ipococene's eligibility for accelerated We were delighted to have the immediately post-BTKI subgroup analysis from the Clover-WAM trial selected for presentation at the upcoming ASCO conference, which brings together the world's leading oncologists. The safety and efficacy of ibuproxine observed to date in this subgroup are highly encouraging and underscore its potential to address a significant unmet need for patients who progressed after BDKI therapy. We believe these findings further support the potential for ibuproxine to emerge as a differentiated therapeutic option in the post-BDKI setting and as early as the second line of treatment in WM. With the strength and maturity of the total data set, we are advancing with randomized control phase three confirmatory study evaluating progression-free survival as the primary endpoint. We anticipate initiating the study in the late fourth quarter of 2026. Beyond Ipropocene, we were delighted to advance our broader pipeline with the recent dosing of the first patients in the phase 1B trial of CLR125, our OJ-emitting radioconjugate, in relapse refractory triple-negative breast cancer, or TMDC. TMDC is an aggressive subtype of breast cancer characterized by the absence of estrogen receptors with limited options beyond chemo therapy. TMDC tends to grow and spread more quickly than other breast cancer types and disproportionately affects younger women and those of African descent. In the U.S., approximately 12% of breast cancer diagnoses are triple-negative breast cancer. CLR125, with its demonstrated selective tumor uptake, promising activity, and preclinical models of TNVC gives us confidence in its potential to be an effective treatment for TNVC. The Phase 1B clinical trial is an open-label dose-finding study in patients with relapse refractory TNVC. It will evaluate three-dose levels and dosing regimens of CLR125. 32.75 millicuries administered over four cycles, or 62.5 millicuries per meter squared over three cycles, or 95 millicuries 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 two dose. The study utilizes dosimetry assessments to characterize tumor uptake and 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 bio-distribution, 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.
All right. Thank you, Jared. As we look ahead, Selectar enters the next phase of 2026 with clarity of purpose, strong momentum, and the financial resources to execute. The combination of compelling 12-month iapophysine 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 Iapofasene reinforced 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 SelectR 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 touch-tone 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 a handset first before pressing any keys. And we have our first question from Kevin DeGieter with Lannaberg-Dellman.
Hey, good morning, guys. Thanks for taking my question. My first question is on Clover Wham and specifically for the BTK experienced patients. Did most patients go directly from a BTK inhibitor to study drug in Clover Wham or for the patients that did get lines of therapy between a BTK and coming on study drug? What were the most common therapies they received immediately prior to study drug?
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 Longcore to address it.
Hi, Kevin. Briefly, I don't have the exact number in my head at the moment, but I can say that it was over 50% of patients in the study who immediately came off B2KI before getting treatment with IFOX. In addition to that, as the most common sort of transition, the other would be coming directly off rituximab, either monotherapy or in combination for chemotherapy.
That really helped, Paul. And then with regard to the Phase III program, thanks for the additional color. Can you comment on what the likely comparator arm for the Phase III 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 three population.
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 this study.
I could have Jared talk to that and provide some additional color 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 BDKI patient population that tends to have significant adverse events associated with any of the other treatments and scenarios, so it makes a good choice. I will say, since you said so, what Salve-G out of Italy, where they demonstrate a Tuximab combination and essentially any, which in our case, a population following the frontline therapy, the expect to see is the vast majority of those patients to be refractory to the BT.
The refractory to BTKI population in that salvage therapy, including these RCD combinations, were as approximately 5.8 months, correct? Correct. And out of the Phase 2 Clover-WAM, our progression-free survival with iapophacin 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 to 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.
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 eight-month progression-free survival. And for the iapoposine arm, we used a hazard ratio that assumed no greater than a 12-month progression-free survival. So obviously, as Jim just said, our expectation is really that with the vast majority of the patients being BDKI refractory, we're going to see something likely closer to six months of progression-free survival of the parator arm. And if the patients behave as they did in the Clover-WAM study, we would expect something closer to 15 months in the iapopocene arm, thereby essentially overpowering the study.
It 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 WM.
Yeah, that'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 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're in the second half of 2027 with a potential approval.
Great. Thanks for taking my questions.
All right, Kevin. Thank you.
Operator
And thank you. 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.
All right. Thank you, Operator. I appreciate your assistance today, and certainly thank you to all conference participants for both your time and continued interest in SelectArk. Have a good day.
Operator
And thank you, ladies and gentlemen. This concludes today's conference call. Thank you for your participation. You may now disconnect.