Q4 2025 Cellectar Biosciences Inc Earnings Call

March 4, 2026

Operator: Ladies and gentlemen, thank you for standing by, and welcome. At this time, all participants are in 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 AQ. Please go ahead.

Speaker #2: I would now like to hand the conference call over to Anne Marie Fields, Managing Director at Precision AQ. Please go ahead. Thank you, Operator.

Anne Marie Fields: Thank you, operator. Good morning, and welcome to Cellectar Biosciences Q4 and full year 2025 Financial Results and Business Update Conference Call. Joining us today from Cellectar are Jim Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Kolean, CFO, for a financial review of the quarter and the year. Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Cellectar issued a press release earlier this morning detailing the contents of today's call. A copy can be found on the investor page of Cellectar'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.

Speaker #2: Good morning, and welcome to Cellectar Biosciences' fourth quarter and full year 2025 financial results and business update conference call. Joining us today from Cellectar are Jim Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Kolean.

Speaker #2: CFO for a financial review of the quarter and the year. Following this, Chad Jarrod Longcore, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals.

Speaker #2: Selectar issued a release earlier this morning detailing the contents of today's call. A copy can be found on the investor page of Selectar's corporate website.

Speaker #2: 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.

Anne Marie Fields: 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 information that is accurate only as of the date of this live broadcast, 04 March 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. We'll begin the call with prepared remarks and then open the line for your questions. Let me now turn the call over to Jim Caruso. Jim?

Speaker #2: 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.

Speaker #2: 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 information that is accurate only as of the date of this live broadcast, March 4, 2026.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Let me now turn the call over to Jim Caruso. Jim?

James Caruso: Thank you, Anne Marie, thank you all for joining us this morning as we review Cellectar's progress throughout the year. 2025 was a productive and strategically meaningful year for Cellectar. Across the organization, we executed with focus and discipline, advancing our lead asset, Iopofosine I 131, strengthening our regulatory position in both Europe and the US, and progressing our next-generation radiotherapeutic programs supported by our proprietary Phospholipid Drug Conjugate platform. Let me begin with Iopofosine I 131, our late-stage asset in Waldenstrom's macroglobulinemia or WM. As discussed in this morning's press release, we ended the year with regulatory alignment in Europe. Following guidance from the EMA's Scientific Advice Working Party, or SAWP, we remain on track to submit a Conditional Marketing Authorisation application in Q3 2026, positioning Iopofosine for potential approval and European commercialization as early as 2027.

Speaker #3: Thank you, Anne Marie, and thank you all for joining us this morning as we review Selectar's progress throughout the year. 2025 was a productive and strategically meaningful year for Selectar.

Speaker #3: Across the organization, we executed with focus and discipline advancing our lead asset, iopoficine I-131, strengthening our regulatory position in both Europe and the US, and progressing our next-generation radiotherapeutic programs supported by our proprietary phospholipid drug conjugate platform.

Speaker #3: Let me begin with iopoficine I-131, our late-stage asset in Waldenstrom's macroglobulemia or WM. As discussed in this morning's press release, we ended the year with regulatory alignment in Europe.

Speaker #3: Following guidance from the EMA's Scientific Advice Working Party, or SOP, we remain on track to submit a conditional marketing authorization application in the third quarter of 2026.

Speaker #3: Positioning iopoficine for potential approval in European commercialization as early as 2027. This EU regulatory clarity together with iopoficine's prime designation underscores both the strength of the Clover-WAM M dataset and the significant unmet medical need.

James Caruso: This EU regulatory clarity, together with Iopofosine's PRIME designation, underscores both the strength of the CLOVER-WaM dataset and the significant unmet medical need. As the full 12-month follow-up data become available in early 2026, we are even more convicted on our plans to pursue an NDA under the accelerated approval pathway. These assumptions are supported by Iopofosine's FDA Breakthrough Designation for WM and by our agency dialogue. In addition, we continue engagement in partnering conversations to support the program globally. Beyond Iopofosine, we also made important progress across our broader PDC-based radiotherapeutic pipeline. We initiated the phase 1B study of CLR 125 in triple-negative breast cancer or TNBC. CLR 125 is an Iodine-125 Auger-emitting agent designed for highly precise tumor targeting, and its initiation represents a key milestone for this second asset.

Speaker #3: As the full 12-month follow-up data become available in early 2026, we are even more convicted in our plans to pursue an NDA under the Accelerated Approval Pathway.

Speaker #3: These assumptions are supported by iopoficine's FDA breakthrough designation for WM and by our agency dialogue. In addition, we continue engagement and partnering conversations to support the program globally.

Speaker #3: Beyond iopoficine, we also made important progress across our broader PDC-based radiotherapeutic pipeline. We initiated the Phase 1b study of CLR125 in triple-negative breast cancer, or TNBC.

Speaker #3: CLR125 is an iodine-125 OJ-emitting agent designed for highly precise tumor targeting. And its inhibition represents a key initiation, a key milestone for this second asset.

James Caruso: The dose-finding study is ongoing, and we expect early interim data in mid-2026. We also strengthened the infrastructure supporting our alpha-emitting program, CLR 225, through new supply partnerships with ITM Technologies and Ionetix, providing commercial scale access to Actinium-225 and Astatine-211 for future clinical development. Importantly, 2025 also marked significant expansion of our global intellectual property estate with new patents issued across Europe, Asia Pacific, the Middle East, as well as the Americas. These patents bolster the protection of Iopofosine I 131, CLR 125, and the broader PDC platform. Finally, we raised approximately $15.2 million over the course of the year, extending our cash runway and enabling ongoing advancement of our pipeline, which positions us to achieve a number of value-creating milestones throughout the year.

Speaker #3: The dose-finding study is ongoing, and we expect early interim data in mid-2026. We also strengthened the infrastructure supporting our alpha-emitting program, CLR225, through new supply partnerships with ITM Technologies and Ionextix, providing commercial-scale access to Actinium 225 and acetine 211 for future clinical development.

Speaker #3: Importantly, 2025 also marks significant expansion of our global intellectual property estate, with new patents issued across Europe, Asia-Pacific, the Middle East, as well as the Americas.

Speaker #3: These patents bolster the protection of iopoficine I-131, CLR125, and the broader PDC platform. Finally, we raised approximately $15.2 million over the course of the year, extending our cash runway and enabling ongoing advancement of our pipeline.

Speaker #3: Which positions us to achieve a number of value-creating milestones throughout the year. With that brief overview, I'll turn the call over to Chad to review our financial results.

James Caruso: With that brief overview, I'll turn the call over to Chad to review our financial results. Chad?

Chad Kolean: Thank you, Jim, and good morning, everyone. I'll address our financial results for the year ended 31 December 2025. We ended the year with cash and cash equivalents of $13.2 million as compared to $23.3 million as of 31 December 2024. In Q4, we raised $5.8 million and now expect that our cash on hand is adequate to fund budgeted operations into Q3 2026. Turning to our results from operations. Research and development expenses for the three months ended 31 December 2025, were approximately $11.5 million, compared to approximately $26.6 million for the year ended 31 December 2024.

Speaker #3: Chad?

Speaker #4: Thank you, Jim. And good morning, everyone. I'll address our financial results for the year ended December 31, 2025. We ended the year with cash and cash equivalents of $13.2 million.

Speaker #4: As compared to 23.3 million as of December 31, 2024. In the fourth quarter, we raised $5.8 million and now expect that our cash on hand is adequate to fund budgeted operations into the third quarter of 2026.

Speaker #4: Turning to our results from operations, research and development expenses for the three months ended December 31, 2025, were approximately $11.5 million. Compared to approximately 26.6 million for the year ended December 31, 2024.

Chad Kolean: The overall decrease in research and development was largely driven by the conclusion of patient enrollment and declining patient follow-up for our CLOVER-WaM clinical study, modestly offset by increased activity in our preclinical development project costs. General and administrative expenses for the year ended 31 December 2025 were $11.5 million, compared to $25.6 million for the same period in 2024. The decrease in SG&A was primarily driven by de-emphasizing pre-commercialization efforts and related personnel cost reductions. Other income was approximately $1.1 million for fiscal 2025, while in 2024 other income was $7.3 million. These amounts are non-cash and largely a result of the impact of issuing and marking to market certain warrants.

Speaker #4: The overall decrease in research and development was largely driven by the conclusion of patient enrollment and declining patient follow-up for our Clover-WAM clinical study, modestly offset by increased activity in our preclinical development project costs.

Speaker #4: General and administrative expenses for the year ended December 31, 2025, were $11.5 million, compared to $25.6 million for the same period in 2024. The decrease in SGNA was primarily driven by de-emphasizing pre-commercialization efforts and related personnel cost reductions.

Speaker #4: Other income was approximately $1.1 million for fiscal 2025, while in 2024, other income was $7.3 million. These amounts are non-cash and largely a result of the impact of issuing and marking-to-market certain warrants.

Chad Kolean: The warrants we issued in 2025 were classified as permanent equity upon issuance. Reducing the impact on the statement of operations in comparison to fiscal 2024. Net loss for the full year ended 31 December 2025 was $21.8 million, or $8.35 per basic and diluted share, compared with $44.6 million, or $36.52 per basic share, and $41.89 per diluted share during 2024. Now I will turn the call over to Jared for an operational update, including plans for our pipeline of radiopharmaceuticals.

Chad Kolean: The warrants we issued in 2025 were classified as permanent equity upon issuance. Reducing the impact on the statement of operations in comparison to fiscal 2024. Net loss for the full year ended 31 December 2025 was $21.8 million, or $8.35 per basic and diluted share, compared with $44.6 million, or $36.52 per basic share, and $41.89 per diluted share during 2024. Now I will turn the call over to Jarrod for an operational update, including plans for our pipeline of radiopharmaceuticals.

Speaker #4: The warrants we issued in 2025 were classified as permanent equity upon issuance. Reducing the impact on the statement of operations in comparison to fiscal 2024.

Speaker #4: Net loss for the full year ended December 31, 2025, was $21.8 million, or $8.35 per basic and diluted share. Compared with 44.6 million, or $36.52 per basic share, and $41.89 per diluted share, during 2024.

Speaker #4: Now I will turn the call over to Jared for an operational update, including plans for our pipeline of radiopharmaceuticals.

Jarrod Longcor: Thank you, Chad, and good morning, everyone. As Jim highlighted, our regulatory and clinical progress in 2025 positions us well for important advances across our pipeline programs and for a milestone-rich 2026. Starting with Iopofosine I 131, our interactions with the EMA and FDA have provided us with clear, actionable regulatory paths. In Europe, we are planning to submit this Conditional Marketing Authorisation application later this year. In the US, we continue to make strong progress in our regulatory engagement as we work with the FDA on the accelerated approval pathway and the design of our confirmatory phase 3 trial to support full registration.

Speaker #5: Thank you, Chad. And good morning, everyone. As Jim highlighted, our regulatory and clinical progress in 2025 positions us well for important advances across our pipeline programs, and for a milestone-rich 2026.

Speaker #5: Starting with iopoficine I-131, our interactions with the EMA and FDA have provided us with clear, actionable regulatory paths, and Europe, we are planning to submit the conditional market authorization application later this year.

Speaker #5: In the U.S., we continue to make strong progress in our regulatory engagement as we work with the FDA on the accelerated approval pathway and the design of our confirmatory Phase 3 trials to support full registration.

Jarrod Longcor: As requested by the FDA in November 2024, we have now collected 12 months of follow-up on all patients, and based upon further review of the data, agree that a confirmatory study evaluating Iopofosine I 131 in a post-BTKI-treated patient population in the second-line setting is appropriate. Importantly, this earlier line more than doubles the potential addressable population in the US. As mentioned, we have been analyzing the more mature CLOVER-WaM dataset, including the full 12-month follow-up for all patients, and are very encouraged that the results continue to demonstrate robust and durable clinical benefit over time in this salvage treatment setting where there are no approved drugs. In addition, new subgroup analysis, particularly within defined high-need patient segments, are emerging as especially promising. We look forward to sharing these findings with regulators as part of our ongoing discussions.

Speaker #5: As requested by the FDA in November of 2024, we have now collected 12 months of follow-up on all patients and based upon further review of the data agree that a confirmatory study evaluating iopoficine I-131 in a post-BTKI treated patient population in the second-line setting is appropriately.

Speaker #5: Importantly, this earlier line more than doubles the potential addressable population in the US. As mentioned, we have been analyzing the more mature Clover-WAM dataset, including the full 12-month follow-up for all patients, and are very encouraged that the results continue to demonstrate robust and durable clinical benefit over time in this salvage treatment setting where there are no approved drugs.

Speaker #5: In addition, new subgroup analysis, particularly within defined high-need patient segments, are emerging as especially promising, we look forward to sharing these findings with regulators as part of our ongoing discussions.

Jarrod Longcor: Taken together, we believe the strength and consistency of these data provide a robust foundation for our US and EU registration strategy. Over the remainder of the year, we intend to present our findings, including a minimum of 12-month follow-up on all patients, updates on response data, duration of response, progression-free survival, and detailed outcomes in various patient subsets at major medical meetings. We expect these results to be highly compelling to both the clinical community and regulatory decision-makers. Beyond WM, Iopofosine continues to show potential across multiple oncology indications. Prior datasets in multiple myeloma and diffuse large B-cell lymphoma demonstrated strong activity in these hematologic malignancies.

Speaker #5: Taken together, we believe the strength and consistency of these data provide a robust foundation for our US and EU registration strategy. Over the remainder of the year, we intend to present our findings including a minimum of 12-month follow-up on all patients, updates on response data, duration of response, progression-free survival, and detailed outcomes in various patient subsets at major medical meetings.

Speaker #5: We expect these results to be highly compelling to both the clinical community and regulatory decision-makers. Beyond WN, iopoficine continues to show potential across multiple oncology indications, prior datasets and multiple myeloma, and diffuse large B-cell lymphoma demonstrated strong activity in these hematologic malignancies, and recently I presented data at the AACR special conference on pediatric cancer from a study of iopoficine in relapsed refractory pediatric high-grade glioma, that showed iopoficine to provide meaningful improvements in progression-free survival and overall survival and to be well tolerated with a consistent safety profile.

Jarrod Longcor: Recently, I presented data at the AACR Special Conference on Pediatric Cancer from a study of Iopofosine in relapse refractory pediatric high-grade glioma that showed Iopofosine to provide meaningful improvements in progression-free survival and overall survival, and to be well-tolerated with a consistent safety profile. Iopofosine remains an asset with tremendous global market opportunity, and its success supports other assets in our radiopharmaceutical pipeline, including CLR 125 and CLR 225, and further validates our proprietary phospholipid ether delivery mechanism. Turning now to CLR 125, our Auger-emitting asset for solid tumors, which has the potential to provide extreme precision-targeted radiotherapy due to the short distance Auger emission travel, meaning the isotope must be delivered within the cell and near to the nucleus.

Speaker #5: Iopoficine remains an asset with tremendous global market opportunity, and its success supports other assets in our radiopharmaceutical pipeline, including CLR 125 and CLR 225, and further validates our proprietary phospholipid ether delivery mechanism.

Speaker #5: Turning now to CLR125, our OJ-emitting asset for solid tumors, which has the potential to provide extremely precise, targeted radiotherapy due to the short distance OJ emissions travel—meaning the isotope must be delivered within the cell and near to the nucleus.

Jarrod Longcor: As Jim noted earlier, we initiated a phase 1B dose-finding study in TNBC at two sites and will be adding additional sites in Q2. This study is evaluating three dosing regimens with an expansion arm plan once the recommended phase 2 dose is determined. We anticipate a steady cadence of results throughout 2026, including early interim dosimetry, safety, and preliminary efficacy data. For CLR 225, our alpha-emitting asset, we completed IND-enabling work and are ready to initiate a phase 1 trial pending available funding and continued strategic alignment with corporate objectives. Preclinical studies in pancreatic cancer models have shown compelling tumor inhibition at multiple dose levels, further demonstrating the potential of targeted alpha therapy within our platform. Across the pipeline, our expanded global patent estate provides long-term protection for Iopofosine, CLR 125, and dosing regimens set central to our PDC technology.

Speaker #5: As Jim noted earlier, we initiated a Phase 1B dose-finding study and TNBC at two sites, and will be adding additional sites in the second quarter.

Speaker #5: This study is evaluating three dosing regimens, with an expansion arm planned once the recommended Phase 2 dose is determined. We anticipate a steady cadence of results throughout 2026, including early interim dosimetry, safety, and preliminary efficacy data.

Speaker #5: For CLR225, our ALPHA emitting asset, we completed IND-enabling work and are ready to initiate a Phase 1 trial pending available funding and continued strategic alignment with corporate objectives.

Speaker #5: Pre-clinical studies in pancreatic cancer models have shown compelling tumor inhibition at multiple dose levels, further demonstrating the potential of targeted ALPHA therapy within our platform.

Speaker #5: Across the pipeline, our expanded global patent estate provides long-term protection for iopoficine, CLR125, and dosing regimens central to our PDC technology. Combined with strengthened isotope supply partnerships, we believe we are well positioned to build sustainable value.

Jarrod Longcor: Combined with strengthened isotope supply partnerships, we believe we are well-positioned to build sustainable value. 2025 was a year of significant regulatory, clinical, and operational advancement. We look forward to continuing this momentum throughout 2026. Jim, I'll turn it back to you for closing remarks.

Speaker #5: 2025 was a year of significant regulatory, clinical, and operational advancement, and we look forward to continuing this momentum throughout 2026. Jim, I'll turn it back to you for closing remarks.

Chad Kolean: All right. Thanks, Jared, for that overview. As you've heard today, 2025 was a year defined by meaningful progress across the entirety of our radiotherapeutic pipeline with strong execution across the organization. We advanced Iopofosine toward key regulatory submissions that would accelerate its market approval and get this much-needed therapy to patients.

James Caruso: All right. Thanks, Jarrod, for that overview. As you've heard today, 2025 was a year defined by meaningful progress across the entirety of our radiotherapeutic pipeline with strong execution across the organization. We advanced Iopofosine toward key regulatory submissions that would accelerate its market approval and get this much-needed therapy to patients.

Speaker #4: All right. Thanks, Jared, for that overview. As you've heard today, 2025 was a year defined by meaningful progress across the entirety of our radiotherapeutic pipeline, with strong execution across the organization.

Speaker #4: We advanced iopoficine toward key regulatory submissions that would accelerate its market approval and get this much-needed therapy to patients. We initiated the CLR125 Phase 1B trial for triple-negative breast cancer, expanded our intellectual property, strengthened supply chain infrastructure, and extended our cash runway.

James Caruso: We initiated the CLR 125 Phase 1b trial for triple-negative breast cancer, expanded our intellectual property, strengthened supply chain infrastructure, and extended our cash runway. We're entering 2026 with clear vision, strong momentum, and a pipeline supported by robust science and regulatory engagement. We expect multiple value-creating milestones in the months and year ahead, and remain focused on delivering transformative therapies to patients with difficult-to-treat cancers. I want to extend my gratitude to our outstanding Cellectar team, whose commitment and hard work continue to drive our programs and the company forward. We remain deeply committed to the WM community and are grateful for their strong support and encouragement as we work to bring Iopofosine to patients. Operator, we're ready to open the call for questions.

Speaker #4: We're entering 2026 with clear vision, strong momentum, and a pipeline supported by robust science and regulatory engagement. We expect multiple value-creating milestones in the months and year ahead, and remain focused on delivering transformative therapies to patients with difficult-to-treat cancers.

Speaker #4: I want to extend my gratitude to our outstanding select our team, whose commitment and hard work continue to drive our programs and the company forward.

Speaker #4: We remain deeply committed to the WN community and are grateful for their strong support and encouragement as we work to bring iopoficine to patients.

Speaker #4: Operator, we're ready 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 number 1 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 number 2. If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Aydin Huseynov with Ladenburg Thalmann. Please go ahead.

Speaker #6: 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 number 1 on your touch-tone phone.

Speaker #6: 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 number 2.

Speaker #6: If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Aydin Ozanov with Leidenburg.

Speaker #6: Please go ahead.

Aydin Huseynov: Hi. Good morning, Cellectar team, and congratulations on the progress in 2025 and so far in 2026. Couple of questions I have regarding Iopofosine. You're planning to submit in Q3 for EMA. I'm just curious to understand, can you use the same package that you will submit to EMA, can you use exactly the same package for the FDA submission as well? How long after you start the Phase III trial you can actually initiate that process of submission with the FDA?

Speaker #7: Hi. Good morning. Cellectar team and congratulations with the progress in 25 and so far in 26. A couple of questions I have regarding iopoficine.

Speaker #7: So you're planning to submit in the third quarter for EMA. I'm just curious to understand, can you use the same package that you will submit to EMA?

Speaker #7: Can you use exactly the same package for the FDA submission as well, and how long after you start the Phase 3 trial can you actually initiate that process of submission with the FDA?

James Caruso: Sure. Aydin, first of all, thank you for participating in the call. As always, we appreciate that and your coverage of the company. Let me start, and then we'll turn it over to Jared to provide some additional details relative to your question. As you may recall, we've already built out substantial portions of our NDA application. Although the format with the EMA is different, there are, you know, a lot of similarities in terms of the requested data. A lot of the work that we've already done in preparation for our NDA submission, we can also apply to the EMA. Jared has been providing oversight on this process, and I'll turn it over to him to provide greater detail.

James Caruso: Sure. Aydin, first of all, thank you for participating in the call. As always, we appreciate that and your coverage of the company. Let me start, and then we'll turn it over to Jarrod to provide some additional details relative to your question. As you may recall, we've already built out substantial portions of our NDA application. Although the format with the EMA is different, there are, you know, a lot of similarities in terms of the requested data. A lot of the work that we've already done in preparation for our NDA submission, we can also apply to the EMA. Jarrod has been providing oversight on this process, and I'll turn it over to him to provide greater detail.

Speaker #4: Sure. Aydin, first of all, thank you for participating in the call. As always, we appreciate that and your coverage of the company. Let me start, and then we'll turn it over to Jared to provide some additional details.

Speaker #4: Relative to your question, as you may recall, we've already built out substantial portions of our NDA application. And although the format with the EMA is different, there are a lot of similarities in terms of the requested data.

Speaker #4: So a lot of the work that we've already done in preparation for our NDA submission, we can also apply to the EMA. Jared has been providing oversight on this process, and I'll turn it over to him to provide greater detail.

Jarrod Longcor: Good morning, Aydin. Yeah, great question. The very short answer is yes, the data itself is essentially the same. Obviously, it's all the CLOVER-WaM data. There will be some different, what I'll call subset analyses that the EMA may have requested that might be a bit different than what the FDA might request. You know, we're executing on that. As James Caruso said, you know, there is just the standard packages are a little different, you know, the ordering and how things come together for the EMA versus the FDA. The actual NDA is a little different from the CMA package development, but otherwise it is all the same. As you said, that is pretty much largely taken care of at this point.

Speaker #5: Yeah, good morning, Aydin. Great question. So the very short answer is yes, the data itself is essentially the same. And so obviously, it's all the Clover-WaM data.

Speaker #5: There will be some different what I'll call subset analyses that the EMA may have requested that might be a bit different than what the FDA might request.

Speaker #5: So we're executing on that. And as Jim said, there is just the standard packages are a little different. The ordering and how things come together for the EMA versus the FDA.

Speaker #5: The actual NDA is a little different from the CMA package development, but otherwise, it is all the same. So, as you said, that is pretty much largely taken care of at this point.

Jarrod Longcor: Your second part of your question was, I think, how long to submitting in the US post the initiation of the confirmatory study. Is that correct?

Speaker #5: And then your second part of your question was, I think, how long to submitting in the US post-initiation of the confirmatory study. Is that correct?

Aydin Huseynov: Yes. Yes.

Jarrod Longcor: Okay. Yeah. The way we're doing that, just to share what, you know, back when we met with the agency in November 2024, where they basically outlined for us a handful of criteria that were necessary for us to achieve in order to be able to submit for the accelerated approval. Part of what they shared was that, you know, for an accelerated approval, a study must be initiated at the time of submission and ongoing, meaning enrolling patients at the time of regulatory action. What we have taken or the way we're approaching this is about, you know, we're thinking perhaps a month or 2 post the initiation of the study, having a handful of sites open, we would then submit the NDA to the FDA.

Speaker #7: Yes. Yes.

Speaker #5: Okay. Yeah. So the way we're doing that, just to share, back when we met with the agency, in November 2024, where they basically outlined for us a handful of criteria that were necessary for us to achieve, in order to be able to submit for the accelerated approval, part of what they shared was that for an accelerated approval, a study must be initiated at the time of submission, and ongoing, meaning enrolling patients, at the time of regulatory action.

Speaker #5: So what we've taken, or the way we're approaching this, is about we're thinking perhaps a month or two post the initiation of the study, having a handful of sites open, we would then submit the NDA to the FDA.

Jarrod Longcor: That should allow us to have enrolled one or two patients essentially at that point. You know, over the intervening six months. You know, remembering that we got Breakthrough designation in May 2025, we are now eligible and have the guaranteed six-month review under the accelerated approval pathway. We would then expect that that feedback would come in six months, and we would want to make sure that we had, you know, about 10% of the patients enrolled.

Speaker #5: That should allow us to have enrolled one or two patients, essentially, at that point. And then, over the intervening six months—because we now have, remembering that we got breakthrough designation in May of 2025—we are now eligible and have the guaranteed six-month review under the accelerated approval pathway.

Speaker #5: And so we would then expect that that feedback would come in six months, and we would want to make sure that we had about 10% of the patients enrolled.

James Caruso: Jarrod, to summarize that, within seven to nine months of initiation of the study, we would, you know, assuming we submit the NDA in a month or two post initiation, we would have a response from the FDA regarding the accelerated approval. I think, Aydin, it's also important to point out that at that point in time, they're not reviewing any data out of the confirmatory studies. Just a function of the study being initiated, is ongoing, and patients are successfully being enrolled.

James Caruso: Jared, to summarize that, within seven to nine months of initiation of the study, we would, you know, assuming we submit the NDA in a month or two post initiation, we would have a response from the FDA regarding the accelerated approval. I think, Aydin, it's also important to point out that at that point in time, they're not reviewing any data out of the confirmatory studies. Just a function of the study being initiated, is ongoing, and patients are successfully being enrolled.

Speaker #4: So Jared, to summarize that, within seven to nine months of initiation of the study, we would assuming we submitted the NDA in a month or two post-initiation, we would have a response from the FDA regarding the accelerated approval.

Speaker #4: And I think, Aydin, it's also important to point out that at that point in time, they're not reviewing any data out of the confirmatory study.

Speaker #4: It's just a function of the study being initiated, is ongoing, and patients are successfully being enrolled.

Aydin Huseynov: Understood and very helpful. For the phase III confirmatory study design, I mean, it seems like it is, the design is okay with both US and EU to get the full approval. Just for modeling purposes, I mean, you're getting into earlier line of therapy, second line, post-BTK, and comparing this to Rituximab, and standard of care. Trying to understand what it is that we should model in terms of the differences in PFS, in Iopofosine versus the standard of care. You know, just to get a better sense and in terms of what to expect down the road.

Speaker #7: Understood. And very helpful. And for the Phase 3 confirmatory study design, I mean, it seems like the design is okay with both the US and EU to get the full approval.

Speaker #7: But just for modeling purposes—I mean, you're getting into early line of therapy, second line post-BTK, and comparing this to rituximab and standard of care. I'm trying to understand what it is that we should model in terms of the differences in TFS on yobufosin versus the standard of care.

Speaker #7: And just to get a better sense in terms of what to expect down the road.

Jarrod Longcor: Absolutely. Another great question. You know, until recently, it was very difficult to give a definitive answer here because nobody has really evaluated any salvage therapy in a post-BTKI exposed patient population. However, earlier this year or late last year, I guess, early 2025, I got to remember we're in 2026 now. A group out of Italy, where the lead author's name was Ristaucci, they produced data looking at 78 post-BTKI patients, irrespective of what salvage therapy they got. These patients received Rituximab chemo combinations, so like RCD, or Rituximab bendamustine. They also received, subsets of them also received Pirtobrutinib, so a non-covalent BTKI. They also received proteasome inhibitors. They received Venetoclax or BCL-2s inhibitors. You know, they basically got every alternative salvage therapy.

Speaker #5: Absolutely. And another great question. So until recently, it was very difficult to give a definitive answer here because nobody had really evaluated any salvage therapy in a post-BTKI exposed patient population.

Speaker #5: However, earlier this year or late last year, I guess early 2025, I got to remember we're in 2026 now, a group out of Italy where the lead author's name was Verstaucci, they produced data looking at 78 post-BTKI patients, irrespective of what salvage therapy they got.

Speaker #5: So they were these patients received rituximab, chemo, combinations, so like RCD, or rituximab bendamustine, they also received subsets of them also received peridobrutinib, so a non-covalent BTKI, they also received proteasome inhibitors, they received venetoclax or BCL2s, inhibitors, so they basically got every alternative salvage therapy.

Jarrod Longcor: In all cases, these patients, you know, as a median, their PFS was 8 months if they were a second-line patient, irrespective. What you see is when it was RCD or any of the Rituximab combinations, it was sub 8 months as progression-free survival. You can clearly model that number because it was, you know, it's a significant patient population, approximately 78 patients again.

Speaker #5: In all cases, these patients as a median, their PFS was eight months if they were a second-line patient. Irrespective. And what you see is when it was RCD or any of the rituximab combinations, it was sub-eight months as progression-free survival.

Speaker #5: And so you can clearly model that number because it was a significant patient population of approximately 78 patients again.

James Caruso: Yeah, I think, you know, thank you, Jarrod. Very helpful. I think I can provide, you know, some additional color relative to our data. Obviously I can't report because we haven't publicly disclosed the updated 12-month data, but it will include what we believe to be some very robust durability elements associated with the 12-month data. We're really excited about the data package. If you and everyone was impressed with our clinical data, Aydin, you know, that we have put in play to date, I think the subsequent data based on the 12-month follow-up is gonna be viewed as very, very exciting. The other element here, and you brought this up, it's significant.

Speaker #4: Yeah. I think in a thank you, Jared. Very helpful. And I think I can provide some additional color relative to our data. Obviously, I can't report because we haven't publicly disclosed the updated 12-month data, but it will include what we believe to be some very robust durability elements associated with the 12-month data.

Speaker #4: So, we're really excited about the data package. If you and everyone were impressed with our clinical data, Aydin, that we have put in play to date, I think the subsequent data, based on the 12-month follow-up, is going to be viewed as very, very exciting.

Speaker #4: And the other element here, and you brought this up, it's significant, as you recall, in the CloverWAM study, on average, we were the fifth line of therapy.

James Caruso: As you recall in the CLOVER-WaM study, on average, we were the 5th line of therapy, which means 4 lines of therapy prior to the utilization of Iopofosine on average. However, under Jarrod's leadership, the team has done substantial analysis, and we've really been able to segment based on the latest data cut that occurred in December 2025, these patients and, you know, the variety of subsets, but also importantly, where they sat in terms of the number of prior treatments. We will tell you that, you know, as you would expect, as you advance further upstream, the data is more and more impressive. As you cited, 2nd line in the US is, the patient population is double that of 3rd line plus.

Speaker #4: Which means four lines of therapy prior to the utilization of iopovacin, on average. However, under Jared's leadership, the team has done substantial analysis and we've really been able to segment based on the latest data cut that occurred in December of 2025, these patients and the variety of subsets, but also importantly, where they sat in terms of the number of prior treatments.

Speaker #4: And we will tell you that the as you would expect, as you advance further upstream, the data is more and more impressive. And as you cite it, second line in the US is the patient population is double that of third line plus.

James Caruso: It really not only does it, you know, create opportunities for clinicians to provide their patients with a meaningful treatment option, there's also going to be a lot more of them in the US benefit and globally benefiting from this treatment.

Speaker #4: So it really not only does it create opportunities for clinicians to provide their patients with a meaningful treatment option, there's also going to be a lot more of them.

Speaker #4: In the US, patients benefit and globally benefit from this treatment.

Jarrod Longcor: Just, you know, historically, so that we don't lose that. Currently right now in the United States and it's increasing in Europe, the BTKIs are being predominantly prescribed in the first line setting, whether that's in combination with Rituximab or as monotherapy. Since the Ibrutinib Rituximab study came out showing its potential in the first line setting, most of the US physicians have transitioned into a BTKI in the first line setting in some form or fashion, which means a second line setting is a post-BTKI patient population today.

Speaker #5: And just historically, so that we don't lose that, currently right now in the United States, and it's increasing in Europe, the BTKIs are being predominantly prescribed in the first-line setting.

Speaker #5: Whether that's in combination with rituximab or as monotherapy, since the ibrutinib-rituximab study came out showing that it's potential in the first-line setting, most of the US physicians have BTKI in the first-line setting in some form or fashion, which means a second-line setting is a post-BTKI patient population today.

Aydin Huseynov: Thank you. Very helpful. Looking at your prior major response rate, there were already high enough 80s, you know, you're gonna move to the earlier line of therapy and typically the responses increase in the earlier lines of therapy. Just curious to, you know, understand, you know, your sort of benchmark in the earlier line of therapy and whether the phase 3 trial design will have some sort of top line major response rate first before we see the PFS, maybe at some point 1 year after we start the trial.

Speaker #7: Thank you. Very helpful. And looking at your prior major response rate, there were already high enough 80s and you're going to move to the early line of therapy and typically the responses increase in early lines of therapy.

Speaker #7: So just curious to understand your sort of therapy and whether these phase three trial design will have some sort of top-line major response rate first before we see the TFS.

Speaker #7: Maybe at some point, one year after you start the trial.

Jarrod Longcor: You know, the primary endpoint for the confirmatory study is progression-free survival. Obviously, you know, a secondary endpoint is going to be major response rates or response rates as a whole, and obviously major response rate is one of them. What I would say is we won't be announcing data from a confirmatory study during enrollment because obviously that can result in bias being introduced into the study even, you know, and especially in a comparative study and that would be problematic and would actually negatively impact the review eventually for full approval.

Speaker #5: Yeah. So the primary endpoint for the confirmatory study is progression-free survival. Obviously, a secondary endpoint is going to be major response rates, or response rates as a whole, and obviously major response rate is one of them.

Speaker #5: What I would say is, we won't be announcing data from a confirmatory study during enrollment because, obviously, that can result in bias being introduced into the study.

Speaker #5: Even and especially in a comparative study. And that would be problematic and would actually negatively impact the review eventually for full approval.

James Caruso: Aydin, I'll add to that, you know, and going in a, you know, potentially different direction where, you know, based on the primary endpoint of progression-free survival in that confirmatory study, you know, you can take a look at the Trastuzumab data and you'll get a sense as to the progression-free survival there. This study is powered in such a way as we introduce our PFS and durability performance for this drug out of the CLOVER-WaM study. I think it'll, you'll very quickly determine that the way the study is powered for the confirmatory study, it's, we're setting ourselves up for a high probability of success, assuming the PFS remains consistent with all of the literature and data that we've seen.

Speaker #4: And so Aydin, I'll add to that. And going in a potentially different direction, based on the primary endpoint of progression-free survival in that confirmatory study, you can take a look at the Forstowci data and you'll get a sense as to the progression-free survival there and so this is this study is powered in such a way as we introduce our PFS and durability performance for this drug out of the CloverWAM study I think you'll very quickly determine that the way the study is powered for the confirmatory study, we're setting ourselves up for a high probability of success assuming the PFS remains consistent with all of the literature and data that we've seen and best case there for PFS is Jared discussed was 8.1 months.

James Caruso: Best case there for PFS, as Jared discussed, was 8.1 months. We feel very comfortable, you know, with PFS being the primary endpoint based on the literature.

Speaker #4: So we feel very, very comfortable with PFS being the primary endpoint based on the literature.

Aydin Huseynov: Thank you. Very helpful. The last question I have, regarding the current environment in post-BTK in US and EU, what do you feel in terms of the enrollment speed and level of interest of PIs and among patients, to be participating in this trial once you start it?

Speaker #7: Thank you. Very helpful. And the last question I have regarding the current environment in post-BTK in US and EU, what do you feel in terms of the enrollment speed and level of interest of PIs and among patients to be participating in this trial once you

Jarrod Longcor: Yeah. You know, I can say directly that having spoken with every one of the PIs that were in the CLOVER-WaM study, the interest from the physician side is extremely high. I can say in a number of cases when I have talked with them recently, they've all felt that, you know, the delay from a regulatory standpoint in getting to this point is largely unwarranted and that this drug, it absolutely has a spot in the marketplace and a significant need to fill. I think that's important from that perspective. I think, again, as patients, this is a very active patient population. They're very engaged as a community and in looking at new therapies.

Speaker #5: Yeah. So I can say directly that having spoken with every one of the PIs that were in the CloverWAM study, the interest from the physician side is extremely high.

Speaker #5: I can say in a number of cases when I have talked with them recently, they have all felt that the delay from a regulatory standpoint in getting to this point is largely unwarranted and that this drug absolutely has a spot in the marketplace and a significant need to fill.

Speaker #5: And so I think that's important from that perspective. I think again, as patients this is a very active patient population. They're very engaged. As a community and in looking at new therapies, I think as patients and these physicians get a look at the new data that is coming out later this year as we were talking about, so over the remainder of this year, I think everybody is going to be very excited about the ability to participate and have the impact that I hope seen can have for them and their disease in this setting.

Jarrod Longcor: I think as patients and these physicians get a look at the new data that is coming out, later this year as we were talking about, so over the remainder of this year, I think everybody is going to be very excited about the ability to participate and have the impact that Iopofosine can have for them and their disease in this setting.

James Caruso: Yeah. I would add that in addition to the thought leadership that are very excited about this because they're on the cutting edge, they understand and observe the performance of existing salvage therapies, especially just post first line. As I think Jared cited earlier, BTKis are used predominantly now either as a monotherapy or a combination with Rituximab in first line. You're already for many of these patients in a salvage therapy mode in the second line. Interesting here, Aidin, in addition to key thought leadership around the globe, really appreciative of the future benefits that this product provides their patients, as early as second line. This also tested extremely well with community-based physicians.

James Caruso: Yeah. I would add that in addition to the thought leadership that are very excited about this because they're on the cutting edge, they understand and observe the performance of existing salvage therapies, especially just post first line. As I think Jarrod cited earlier, BTKis are used predominantly now either as a monotherapy or a combination with Rituximab in first line. You're already for many of these patients in a salvage therapy mode in the second line. Interesting here, Aidin, in addition to key thought leadership around the globe, really appreciative of the future benefits that this product provides their patients, as early as second line. This also tested extremely well with community-based physicians.

Speaker #4: Yeah. And I would add that, in addition to the thought leadership, they are very excited about this because they're on the cutting edge. They understand and observe the performance of existing salvage therapies.

Speaker #4: Especially just post-first line. And as I think Jared cited earlier, BTKIs are used predominantly now either as a monotherapy or a combination with rituximab in first line.

Speaker #4: So you're already, for many of these patients, in a salvage therapy mode in the second line. But what's interesting here, Aydin, in addition to key thought leadership around the globe—really appreciative of the feature benefits that this product provides their patients as early as second line—this also tested extremely well with community-based physicians.

James Caruso: We really see this transitioning out of, you know, a controlled clinical environment at these world-class institutions or WM catchment centers because of the ease of administration, and quite frankly, the lack of artistry required here relative to other oncology drugs, the four simple doses. Our community-based physicians are as excited as the thought leaders as well. I think all constituents, including nuclear medicine, radiation oncology, that have a seat at the table in terms of the utilization of this drug, everyone, all constituents are really excited about the opportunity to bring this patients to the many patients that will benefit from this treatment.

Speaker #4: So we really see this transitioning out of a controlled clinical environment at these world-class institutions or WM catchment centers because of the ease of administration and quite frankly, the lack of artistry required here relative to other oncology drugs.

Speaker #4: The four simple doses are—community-based physicians are as excited as the thought leaders as well. So, I think all constituents, including nuclear medicine, radiation, oncology, that have a seat at the table in terms of the utilization of this drug—everyone, all constituents—are really excited about the opportunity to bring this to the many patients that will benefit from its treatment.

Aydin Huseynov: Thank you. Super helpful and congratulations, with the progress so far, and we'll be looking forward to seeing your 12-month data later this year. Thanks so much.

Speaker #7: Thank you. Super helpful and congratulations with the progress so far and we'll be looking forward to seeing your 12-month data later this year. Thanks so much.

James Caruso: Thank you, Aydin.

Operator: Thank you. The next question comes from Ted Tenthoff with Piper Sandler. Please go ahead.

Speaker #4: Thank you, Aydin.

Speaker #1: Thank you. The next question comes from Ted Stankhoff with Piper Sandler. Please go ahead.

Ted Tenthoff: Great. Thank you guys for taking my question, and my congratulations, too, on the very hard work and steady progress. You guys deserve a persistence award for sure. Wanted to follow up two questions, if I may. Firstly, and I apologize if I missed this, but what would be the plans to distribute in Europe? Can you walk us through a sense of what that second line... Now, in Europe, would it be second line 2, or there it's actually a little different where you would be getting approved? What does that patient population look like? Thank you very much.

Speaker #8: Great. Thank you, guys, for taking my question, and congrats—my congratulations, too—on the very hard work and steady progress. You guys deserve a persistence award, for sure.

Speaker #8: One of the follow-up two questions if I may. So firstly, and I apologize if I missed this, but what would be the plans to distribute in Europe?

Speaker #8: And can you walk us through a sense of what that second line now in Europe would it be second line two or there it's actually a little different where you would be getting approved?

Speaker #8: And what does that patient population look like? Thank you very much.

James Caruso: Sure. Thank you, Ted. Great to have you on the call. Appreciate, you know, your interest, your continued interest in the company, and you've been very supportive. We're appreciative of that. I'll have Jared launch into this, and then I can fill in any blanks or provide additional color.

James Caruso: Sure. Thank you, Ted. Great to have you on the call. Appreciate, you know, your interest, your continued interest in the company, and you've been very supportive. We're appreciative of that. I'll have Jarrod launch into this, and then I can fill in any blanks or provide additional color.

Speaker #5: Sure. Thank you, Ted. Great to have you on the call. Appreciate your interest and your continued interest in the company and you've been very supportive.

Speaker #5: So we're appreciative of that. I'll have Jared launch into this and then I can fill in any blanks or provide additional color.

Jarrod Longcor: Yeah.

James Caruso: Great.

Jarrod Longcor: Thank you, Ted. From a distribution plan, the idea here is that, you know, obviously Cellectar itself, we will not really commercialize it ourselves in Europe. We are in discussions with various parties that we would partner with to actually do the commercialization in Europe on our behalf in one way or another. We're looking at partnership as the main thing. Just to give you a sense, we have set up our distribution of a radiotherapeutic in a global sense. I'll remind you that the CLOVER-WaM study was run as a global study where we had approximately 25 sites in Europe. We had some sites, a handful of sites also in Asia and Australia.

Speaker #2: Yeah. So and thank you, Ted. So from a distribution plan, the idea here is that obviously SelectR itself, we will not really commercialize it ourselves in Europe.

Speaker #2: We are in discussions with various parties that we would partner with to actually do the commercialization in Europe on our behalf, in one way or another.

Speaker #2: So we're looking at partnership as the main thing. Just to give you a sense, we have set up our distribution of a radiotherapeutic in a global sense.

Speaker #2: So I'll remind you that the CloverWAM study was run as a global study. Where we had approximately 25 sites in Europe. We had some sites a handful of sites also in Asia and Australia.

Jarrod Longcor: We've set up a logistical chain that allows us to ship and cover the globe easily with this product. I will remind you that for folks that may have forgotten, that we have a unique competitive advantage in the marketplace that is often overlooked, which is our time or shelf lifetime. Most radiotherapies have a shelf life of about 3 to 7 days max. Ours is 21 days. That allows us, and it's not cold chain, that's at room temperature, it allows us to more easily distribute this product globally and make sure that it's conveniently handled by the physicians and by the patients. That sets up the distribution. Now the second part of your question was really about in Europe, where would the approval be, and what is the size of the market?

Speaker #2: And so, we've set up a logistical chain that allows us to ship and cover the globe easily with this product. And I will remind you, for folks that may have forgotten, that we have a unique competitive advantage in the marketplace that is often overlooked, which is our shelf life time.

Speaker #2: Most radiotherapies have a shelf life of about three to seven days max. Ours is 21 days. That allows us and it's not cold chain.

Speaker #2: That's at room temperature. It allows us to more easily distribute this product globally and make sure that it's conveniently handled by the physicians and by the patients.

Speaker #2: So that sets up the distribution. Now, the second part of your question was really about, in Europe, where would the approval be, and what is the size of the market?

Jarrod Longcor: In general, just to give you a sense, the size of the European market is generally about 10,000 or so patients in total, greater than the US. I would say that when we look at the second line setting, the US market is just a bit south of 12,000 patients. In Europe, its second line setting is generally a bit over 12,000, approaching 13,000 patients, is what we've come to learn. It's a meaningful patient subset. Now, the Conditional Marketing Authorisation would actually be a later line utilization, so it would be a third line or later post-BTKI patient population. That's largely because still in Europe, they are transitioning. They're using BTKIs more in a first-line setting, but they're more evenly split right now between first-line and second-line utilization of BTKI.

Speaker #2: So in general, just to give you a sense, the size of the European market is generally about 10,000 or so patients in total greater than the US.

Speaker #2: I would say that when we look at the second-line setting, the US market is just a bit south of 12,000 patients. In Europe, its second-line setting is generally a bit over 12,000, approaching 13,000 patients.

Speaker #2: Is what we've come to learn. And so it's a meaningful patient subset. Now the conditional market authorization would actually be a later line utilization.

Speaker #2: So it would be a third line or later post-BTKI patient population. That's largely because still in Europe, they are transitioning. They're using BTKIs more in a first line setting, but they're more evenly split right now between first line and second line utilization of BTKI.

Jarrod Longcor: The median would likely be a third line or later sort of position. Upon the confirmatory study, I think we would be shifting to a second line setting in Europe.

Speaker #2: So the median would likely be a third line or later sort of position. Upon the confirmatory study, I think we would be shifting to a second line setting in Europe.

Ted Tenthoff: Great. That is very, very helpful color. Appreciate it.

Speaker #8: Great. That is very, very helpful color. Appreciate it.

Jarrod Longcor: Thank you.

James Caruso: All right. Thanks so much, Ted.

Speaker #5: Thank you.

Speaker #4: All right. Thanks so much, Ted.

Operator: Thank you. At this time, Jim will address questions sent electronically. Please go ahead.

Speaker #1: Thank you. At this time, Jim will address questions sent electronically. Please go ahead.

James Caruso: All right. if there's no other questions, we have some that are in the inbox. Jared, you up for?

Speaker #4: All right. So if there's no other questions we have, some that are in the inbox, Jared, you up for another question or two?

Jarrod Longcor: Please

James Caruso: ... another question or two? All right. I think I'll decipher this one. What is the benefit of the 12-month data cited in the press release versus your December 2024 data?

Speaker #5: Please.

Speaker #4: All right. I think I'll decipher this one. What is the benefit of the 12-month data cited in the press release versus your December 2024 data?

Jarrod Longcor: Yeah. Good question. What I would say is that, you know, reminding folks that the December 2024 data, most of the patients that we had enrolled at that point did not have 12 months of follow-up data on them. They were still, you know, essentially shortly post their treatment segment and therefore did not have the 12 months. Since that time, we have all patients with at least 12 months of follow-up. While the data presented at ASH was very good in 2024, I think as Jim alluded to earlier, this follow-up data is even better. That is... What I mean by that is there are improvements in the response rates, there is improvements in durability, there are improvements in progression-free survival.

Speaker #2: Yeah. Good question. So what I would say is that reminding folks that the December 2024 data most of the patients that we had enrolled at that point did not have 12 months of follow-up data on them.

Speaker #2: They were still essentially shortly post their treatment segment and therefore did not have the 12 months. Since that time, we have all patients with at least 12 months of follow-up.

Speaker #2: And while the data presented at ASH was very good in 2024, I think as Jim alluded to earlier, this follow-up data is even better.

Speaker #2: And that is what I mean by that is there are improvements in the response rates. There's improvements in durability. There are improvements in progression-free survival.

Jarrod Longcor: Across the board, we're seeing depth and durability of the responses going out and looking stronger than they did in December 2024.

Speaker #2: So across the board, we're seeing depth and durability of the responses going out and looking stronger than they did in December of 2024.

James Caruso: Jared, could you elaborate on the benefit relative to the regulatory pathway with the FDA in the US on the 12-month data?

Speaker #4: Jared, could you elaborate on the benefit relative to the regulatory pathway with the FDA in the US on the 12-month data?

Jarrod Longcor: Yeah. Again, in November 2024, the FDA laid out essentially a pathway for accelerated approval that really had two key components to it. One was that we needed to have 12 months of follow-up on all patients, which obviously we now have, which allows us to then take that next step. The next step was really that we needed to have an ongoing confirmatory study in an earlier line of patients so as to not be competing between our study and commercially available product. At the time, we were a little worried about moving to a second-line setting 'cause we didn't really have data that would say whether we would be better or worse in that line of setting or the same.

Speaker #2: Yeah. So again, in November 2024, the FDA laid out essentially a pathway for accelerated approval that really had two key components to it. One, was that we needed to have 12 months of follow-up on all patients, which obviously we now have, which allows us to then take that next step.

Speaker #2: And the next step was really that we needed to have an ongoing confirmatory study in an earlier line of patients so as to not be competing between our study and commercially available product.

Speaker #2: At the time, we were a little worried about moving to a second line setting because we didn't really have data that would say whether we would be better or worse in that line of setting or the same.

Jarrod Longcor: Now, with the analysis and the 12-month follow-up data, we now know exactly that we perform better in an earlier line of early line setting, as one might expect, with the confidence now we have the datasets that show and validate that approach. I think sets us up very nicely for both the confirmatory study, also the execution of the accelerated approval and moving forward.

Speaker #2: Now with the analysis and the 12-month follow-up data, we now know exactly that we perform better in an earlier line of setting as one might expect, but with the confidence now we have the data sets that show and validate that approach.

Speaker #2: And I think sets us up very nicely for both the confirmatory study, but then also the execution of the accelerated approval and moving forward.

James Caruso: All right, we have one more here. It's a layup, which means I'll handle it. Will this data include durability, such as PFS and DOR? PFS, progression-free survival, and DOR, duration of response. The answer is yes. Beyond the response data such as major response, complete responses, very good partial responses, the overall response rate metric and clinical benefit rate, we will be providing progression-free survival and duration of response, you know, not only in the broader population, but in important subsets like post-BTKI and refractory BTKI patient populations where this drug is, you know, well appears to be naturally, you know, falling post-BTKI based on the regulatory pathways both in the EU and here in the US. With that, I'll turn it back over to the operator.

Speaker #4: All right. We have one more here. It's a layup, which means I'll handle it. Will this data include durability such as PFS and DOR?

Speaker #4: So, PFS—progression-free survival—and DOR—duration of response? The answer is yes. Beyond the response data, such as major response, complete responses, very good partial responses, partial responses, the overall response rate metric, and clinical benefit rate, we will be providing progression-free survival and duration of response not only in the broader population, but in important subsets like post-BTKI and refractory BTKI patient populations, where this drug will appear to be naturally falling post-BTKI based on the regulatory pathways, both in the EU and here in the US.

Speaker #4: So with that, I'll turn it back over to the operator.

Operator: Thank you. We have reached the end of the question and answer session. Let me turn the call over to James Caruso, President and CEO, for closing remarks. Please go ahead.

Speaker #1: Thank you. We have reached the end of the question and answer session. Let me turn the call over to Jim Caruso, president and CEO for Closing Remarks.

James Caruso: All right. Thank you, operator. Thank you to everyone who participated in today's call. We appreciate your time. Have a good day.

Speaker #1: Please go ahead.

Speaker #4: All right. Thank you, operator. Thank you, to everyone who participated in today's call. We appreciate your time. Have a good day.

Operator: Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

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