Q2 2026 Cellectar Biosciences Inc Earnings Call

August 13, 2026

Speaker #1: Good morning, ladies and gentlemen. Thank you for standing by, and welcome. At this time, all participants are in listen-only mode. Following the presentation, we will conduct a question-and-answer session.

Operator: Thank you for standing by, and welcome. At this time, all participants are in listen-only mode, and following the presentation, we will conduct a question and answer session. Please be advised that today's call may be recorded. I would now like to hand the call over to Anne Marie Fields, Managing Director of Precision AQ. Please go ahead.

Speaker #1: Please be advised that today's call may be recorded. I would now like to hand the call over to Anne Marie Fields, Managing Director of Precision AQ.

Speaker #1: Please go ahead.

Speaker #2: Thank you, operator. Good morning, and welcome to Cellectar Biosciences' second quarter 2026 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.

Anne Marie Fields: Thank you, operator. Good morning, and welcome to Cellectar Biosciences' Q2 2026 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. 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 content 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. I caution listeners that management will be making forward-looking statements.

Speaker #2: Before turning the call over to Chad Kolean, CFO, for a financial review of the quarter, Jarrod Longcor, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals.

Speaker #2: Cellectar issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of Cellectar'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.

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.

Anne Marie Fields: Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, 13 August 2026. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line to your questions. I will now turn the call over to Jim Caruso. Jim?

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 contents of this conference call contain time-sensitive information that is accurate only as of the date of this live broadcast, August 13, 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 calling webcast.

Speaker #2: As a reminder, this conference calling webcast is being recorded and archived. We will begin the call with prepared remarks and then open the line to your questions.

Speaker #2: I'll now turn the call over to Jim Caruso. Jim?

Speaker #3: Thank you, Anne Marie, and thank you all for joining us this morning. The second quarter marked an especially productive period for Cellectar. As we continued making meaningful progress across every area of our business, including clinical development, regulatory action, pipeline advancement, platform expansion, and strengthening of our financials.

James Caruso: Thank you, Anne Marie, and thank you all for joining us this morning. The Q2 marked an especially productive period for Cellectar as we continued making meaningful progress across every area of our business, including clinical development, regulatory action, pipeline advancement, platform expansion, and strengthening of our financials. Our near-term priority remains clear, advancing iopofosine I 131 for patients with relapsed or refractory Waldenstrom's macroglobulinemia, or WM, particularly those patients whose disease has progressed following earlier lines of treatment, including BTK inhibitor therapy. We believe this represents a significant unmet medical need and an attractive opportunity to bring a differentiated treatment option to patients who currently face limited therapeutic alternatives. During the quarter, we took several important steps to move this strategy forward. First, we reported the full 12-month follow-up results from the CLOVER-WaM study.

Jim Caruso: Thank you, Anne Marie, and thank you all for joining us this morning. The Q2 marked an especially productive period for Cellectar as we continued making meaningful progress across every area of our business, including clinical development, regulatory action, pipeline advancement, platform expansion, and strengthening of our financials. Our near-term priority remains clear, advancing iopofosine I 131 for patients with relapsed or refractory Waldenstrom's macroglobulinemia, or WM, particularly those patients whose disease has progressed following earlier lines of treatment, including BTK inhibitor therapy. We believe this represents a significant unmet medical need and an attractive opportunity to bring a differentiated treatment option to patients who currently face limited therapeutic alternatives. During the quarter, we took several important steps to move this strategy forward. First, we reported the full 12-month follow-up results from the CLOVER-WaM study.

Speaker #3: Our near-term priority remains clear: advancing iopofosine I-131 for patients with relapsed or refractory Waldenstrom's macroglobulinemia, or WM, particularly those patients whose disease has progressed following earlier lines of treatment, including BTK inhibitor therapy.

Speaker #3: We believe this represents a significant unmet medical need and an attractive opportunity to bring a differentiated treatment option to patients who currently face limited therapeutic alternatives.

Speaker #3: During the quarter, we took several important steps to move this strategy forward. First, we reported the full 12-month follow-up results from the CLOVER-WaM study.

Speaker #3: These data further reinforced both the depth and durability of response achieved with iopophysine and demonstrated that the study successfully met both its primary and secondary endpoints.

James Caruso: These data further reinforced both the depth and durability of response achieved with iopofosine and demonstrated that the study successfully met both its primary and secondary endpoints. Taken together, we believe the totality of evidence generated to date continues to support iopofosine's potential to become an important treatment option for WM patients. Second, we continued to build an increasingly compelling clinical data set for iopofosine. We presented new data at ASCO 2026 from the CLOVER-WaM study highlighting outcomes in patients treated immediately following BTKI therapy, a challenging patient population. These results demonstrated a 79.2% major response rate, an 87.5% overall response rate, a 100% clinical benefit rate, and encouraging durability with a median duration of response of 16 months. Most importantly, we have now initiated site activation activities for our planned confirmatory phase III study. This represents a critical milestone in our regulatory strategy.

Jim Caruso: These data further reinforced both the depth and durability of response achieved with iopofosine and demonstrated that the study successfully met both its primary and secondary endpoints. Taken together, we believe the totality of evidence generated to date continues to support iopofosine's potential to become an important treatment option for WM patients. Second, we continued to build an increasingly compelling clinical data set for iopofosine. We presented new data at ASCO 2026 from the CLOVER-WaM study highlighting outcomes in patients treated immediately following BTKI therapy, a challenging patient population. These results demonstrated a 79.2% major response rate, an 87.5% overall response rate, a 100% clinical benefit rate, and encouraging durability with a median duration of response of 16 months. Most importantly, we have now initiated site activation activities for our planned confirmatory phase III study. This represents a critical milestone in our regulatory strategy.

Speaker #3: Taken together, we believe the totality of evidence generated to date continues to support iapophysine's potential to become an important treatment option for WM patients.

Speaker #3: Second, we continue to build an increasingly compelling clinical dataset for iopofosine. We presented new data at ASCO 2026 from the CLOVER-WaM study, highlighting outcomes in patients treated immediately following BPI therapy.

Speaker #3: A challenging patient population. These results demonstrated a 79.2% major response rate and 87.5% overall response rate and 100% clinical benefit rate. And encouraging durability with a median duration of response of 16 months.

Speaker #3: Most importantly, we have now initiated site activation activities for our planned confirmatory phase three study. This represents a critical milestone in our regulatory strategy.

Speaker #3: Once necessary, site activation and ongoing patient enrollment is achieved, we expect to be in a position to submit our new drug application under the FDA's Accelerated Approval Program in mid-2027.

James Caruso: Once necessary site activation and ongoing patient enrollment is achieved, we expect to be in a position to submit our new drug application under the FDA's Accelerated Approval Program in mid-2027. Based upon the breakthrough designation awarded to iopofosine I 131 for relapsed refractory WM, an approximate 6-month review is anticipated. To support these efforts, we were pleased to complete an oversubscribed financing in May that has the potential to provide up to $140 million in capital, including $35 million upfront and up to $105 million tied to future milestones. This financing significantly strengthens our balance sheet and provides the resources needed to execute our WM strategy, advance our regulatory initiatives, and continue investing in our broader radiopharmaceutical pipeline. Beyond WM, we continue to advance the broader opportunity represented by our phospholipid drug conjugate, or PDC platform.

Jim Caruso: Once necessary site activation and ongoing patient enrollment is achieved, we expect to be in a position to submit our new drug application under the FDA's Accelerated Approval Program in mid-2027. Based upon the breakthrough designation awarded to iopofosine I 131 for relapsed refractory WM, an approximate 6-month review is anticipated. To support these efforts, we were pleased to complete an oversubscribed financing in May that has the potential to provide up to $140 million in capital, including $35 million upfront and up to $105 million tied to future milestones. This financing significantly strengthens our balance sheet and provides the resources needed to execute our WM strategy, advance our regulatory initiatives, and continue investing in our broader radiopharmaceutical pipeline. Beyond WM, we continue to advance the broader opportunity represented by our phospholipid drug conjugate, or PDC platform.

Speaker #3: Based upon the breakthrough designation awarded to iapophysine I-131 for relapse, refractory WM, and approximate six-month review, is anticipated. To support these efforts, we were pleased to complete an oversubscribe financing in May that has the potential to provide up to $140 million in capital including $35 million upfront and up to $105 million tied to future milestones.

Speaker #3: This financing significantly strengthens our balance sheet and provides the resources needed to execute our WM strategy, advance our regulatory initiatives, and continue investing in our broader radiopharmaceutical pipeline.

Speaker #3: Beyond WM, we continue to advance the broader opportunity represented by our phospholipid drug conjugate, or PDC, platform. The PDC platform is a highly differentiated targeting technology designed to selectively deliver therapeutic payloads to cancer cells, including primary tumors, metastatic lesions, and cancer stem cells.

James Caruso: The PDC platform is a highly differentiated targeting technology designed to selectively deliver therapeutic payloads to cancer cells, including primary tumors, metastatic lesions, and cancer stem cells. Importantly, the platform is highly versatile and can be combined with a variety of payloads and isotopes, including beta emitting, Auger-emitting, and alpha emitting radiotherapeutics. We believe the success we are seeing with iopofosine is validating the platform and creating a strong foundation for future pipeline expansion. Today, in addition to discussing our progress with iopofosine, we will also review advancements in CLR 125, our Auger-emitting program in solid tumors, and discuss how we plan to leverage the platform to build a next-generation radiopharmaceutical franchise. With that overview, I'll turn the call over to Chad for the financial review.

Jim Caruso: The PDC platform is a highly differentiated targeting technology designed to selectively deliver therapeutic payloads to cancer cells, including primary tumors, metastatic lesions, and cancer stem cells. Importantly, the platform is highly versatile and can be combined with a variety of payloads and isotopes, including beta emitting, Auger-emitting, and alpha emitting radiotherapeutics. We believe the success we are seeing with iopofosine is validating the platform and creating a strong foundation for future pipeline expansion. Today, in addition to discussing our progress with iopofosine, we will also review advancements in CLR 125, our Auger-emitting program in solid tumors, and discuss how we plan to leverage the platform to build a next-generation radiopharmaceutical franchise. With that overview, I'll turn the call over to Chad for the financial review.

Speaker #3: Importantly, the platform is highly versatile and can be combined with a variety of payloads and isotopes, including beta-emitting, Auger-emitting, and alpha-emitting radiotherapeutics. We believe the success we are seeing with iopofosine is validating the platform and creating a strong foundation for future pipeline expansion.

Speaker #3: Today, in addition to discussing our progress with iopofosine, we will also review recent advancements in CLR 125, our OJ-emitting program, and solid tumors, and discuss how we plan to leverage the platform to build a next-generation radiopharmaceutical franchise.

Speaker #3: With that overview, I'll turn the call over to Chad for the financial review.

Speaker #4: Thank you, Jim. And good morning, everyone. First, I will spend a couple of minutes on the financing that Jim mentioned. As he stated, the transaction provided the company with the current and anticipated future funding to support our strategy to obtain approval for iopofosine I-131.

Chad Kolean: Thank you, Jim, and good morning, everyone. First, I will spend a couple of minutes on the financing that Jim mentioned. As he stated, the transaction provided the company with the current and anticipated future funding to support our strategy to obtain approval for iopofosine I 131. The company received $35 million gross upfront, or approximately $31.7 million net for common shares and pre-funded warrants. Additionally, we issued 3 tranches of approximately 13.2 million warrants each, all of which are currently exercisable with a strike price of $2.65. Furthermore, these warrants are callable for cash by the company if the respective milestone and related criteria are met. Each tranche of warrants, A, B, and C, has a milestone associated with it. The tranche A warrants, which expire on 7 July 2027, have a milestone of first patient enrolled in the confirmatory study for iopofosine I 131 in Waldenstrom's macroglobulinemia, or WM, patients.

Speaker #4: The company received $35 million gross upfront or approximately $31.7 million net for common shares and pre-funded warrants. Additionally, we issued three tranches of approximately $13.2 million warrants each, all of which are currently exercisable with a strike price of $2.65.

Chad Kolean: Additionally, we issued 3 tranches of approximately 13.2 million warrants each, all of which are currently exercisable with a strike price of $2.65. Furthermore, these warrants are callable for cash by the company if the respective milestone and related criteria are met. Each tranche of warrants, A, B, and C, has a milestone associated with it. The tranche A warrants, which expire on 7 July 2027, have a milestone of first patient enrolled in the confirmatory study for iopofosine I 131 in Waldenstrom's macroglobulinemia, or WM, patients.

Speaker #4: Furthermore, these warrants are callable for cash by the company if the respective milestone and related criteria are met. Each tranche of warrants—A, B, and C—has a milestone associated with it.

Speaker #4: The tranche A warrants, which expire on July 7, 2027, have a milestone of first patient enrolled in the confirmatory study for iapophysine I-131 and Waldenstrom macroglobulinemia, or WM, patients.

Speaker #4: The tranche B warrants, which expire July 7, 2028, have the milestone of the FDA's acceptance of a New Drug Application for iapophysine. The tranche C warrants, which expire July 7, 2031, have the milestone of approval by the FDA of iapophysine for marketing.

Chad Kolean: The tranche B warrants, which expire 7 July 2028, have a milestone of the FDA's acceptance of a new drug application for iopofosine. The tranche C warrants, which expire 7 July 2031, have a milestone of approval by the FDA of iopofosine for marketing. In addition to achieving the milestones, two additional criteria must be met for the warrants to be callable. First, the volume-weighted average price, or VWAP, for the company's stock must be at least $3.45 for 20 consecutive trading days. Second, the trading liquidity based upon the VWAP must average a minimum of $500,000 for those same 20 trading days. The milestone timing is designed to provide the necessary funding through the anticipated study initiation, submission to FDA, and approval. We believe this structure, provided it occurs as designed, supports the company's capital needs through initial commercialization of iopofosine.

Speaker #4: In addition to achieving the milestones, two additional criteria must be met for the warrants to be callable. First, the volume-weighted average price, or VWAP, for the company's stock must be at least $3.45 for 20 consecutive trading days.

Speaker #4: Second, the trading liquidity based upon the VWAP must average a minimum of $500,000 for those same 20 trading days. The milestone timing is designed to provide the necessary funding through the anticipated study initiation submission to FDA and approval.

Speaker #4: We believe this structure, as designed, supports the company's capital needs through the initial commercialization of iopofosine. Now for our financial results for the period ended June 30, 2026.

Chad Kolean: Now for our financial results for the period ended 30 June 2026. We ended the Q2 with cash and cash equivalents of approximately $34.0 million, compared to $13.2 million as of 31 December 2025, which reflects the cash generated from the initial portion of the May financing. Turning now to our operating results. Research and development expenses for the three months ended 30 June 2026, were approximately $4.6 million, compared to approximately $2.4 million for the three months ended 30 June 2025. The overall increase in R&D largely reflected increased clinical study activity to support our CLR 125 study in triple-negative breast cancer and initiation of the confirmatory study of iopofosine I 131 in WM. General and administrative expenses for the three months ended 30 June 2026 were $2.6 million, compared to $3.6 million for the same period in 2025.

Speaker #4: We ended the second quarter with cash and cash equivalents of approximately $34.0 million compared to $13.2 million as of December 31, 2025, which reflects the cash generated from the initial portion of the May financing.

Speaker #4: Turning now to our operating results, research and development expenses for the three months ended June 30, 2026, were approximately $4.6 million, compared to approximately $2.4 million for the three months ended June 30, 2025.

Speaker #4: The overall increase in R&D largely reflected increased clinical study activity to support our CLR125 study in triple-negative breast cancer, and initiation of the confirmatory study of iapophysine I-131 in WM.

Speaker #4: General and administrative expenses for the three months ended June 30, 2026, were $2.6 million, compared to $3.6 million for the same period in 2025.

Speaker #4: The decrease in GNA was driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs. Net loss for the three months ended June 30, 2026 was $6.9 million, or $57 per share.

Chad Kolean: The decrease in G&A was driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs. Net loss for the three months ended 30 June 2026, was $6.9 million, or $0.57 per share, compared with $5.4 million, or $3.39 per share during the three months ended 30 June 2025. The enhanced strength of our balance sheet enables our ability to effectively advance our clinical and regulatory programs. Now I will turn the call over to Jarrod to discuss the regulatory and clinical advancements we have been making during the H1 of 2026.

Speaker #4: Compared with $5.4 million, or $3.39 per share, during the three months ended June 30, 2025. The enhanced strength of our balance sheet enables our ability to effectively advance our clinical and regulatory programs.

Speaker #4: Now I will turn the call over to Jared to discuss the regulatory and clinical advancements we have been making during the first half of 2026.

Speaker #3: Thank you, Chad, and good morning, everyone. As Jim noted, we continue to make meaningful progress across our clinical, regulatory, and development initiatives and believe SELECTAR is entering an important phase of execution with multiple value-driving milestones ahead.

Jarrod Longcor: Thank you, Chad, and good morning, everyone. As Jim noted, we continue to make meaningful progress across our clinical, regulatory, and development initiatives and believe Cellectar is entering an important phase of execution with multiple value-driving milestones ahead. Our primary focus remains advancing iopofosine I 131 to potential registration in WM, where we have generated a compelling body of clinical evidence and established a clear regulatory path forward. We have been encouraged by the consistency of the data emerging from the CLOVER-WaM study, which continues to demonstrate meaningful and durable responses in a patient population with significant unmet medical need. During the quarter, we expanded that clinical evidence base with two important data updates. First, we presented new analyses at ASCO highlighting outcomes in patients treated immediately following BTK inhibitor therapy, a particularly challenging setting where treatment options remain limited.

Speaker #3: Our primary focus remains advancing iapophysine I-131 to potential registration in WM. Where we have generated a compelling body of clinical evidence and established a clear regulatory path forward.

Speaker #3: We have been encouraged by the consistency of the data emerging from the CLOVER-WaM study, which continues to demonstrate meaningful and durable responses in a patient population with significant unmet medical need.

Speaker #3: During the quarter, we expanded that clinical evidence base with two important data updates. First, we presented new analyses at ASCO, highlighting outcomes in patients treated immediately following BTKI inhibitor therapy of particularly challenging setting where treatment options remain limited.

Speaker #3: And as Jim mentioned a few minutes ago, we demonstrated an approximately 80% major response rate and 16 months of durability in these patients. We also reported the full 12-month follow-up dataset from the CLOVER-WaM study on all patients, which further reinforced the durability with a median durability of 17.8 months and approximately 62% of patients achieving a major response, and the depth of the response observed of iopofosine increasing over time, with the very good partial response and complete response rate increasing to 14.5% in these late-line, highly refractory patients.

Jarrod Longcor: As Jim mentioned a few minutes ago, we demonstrated an approximately 80% major response rate and 16 months of durability in these patients. We also reported the full 12-month follow-up data set from the CLOVER-WaM study on all patients, which further reinforced the durability with a median durability of 17.8 months and approximately 62% of patients achieving a major response, and the depth of the response observed of iopofosine increasing over time, with the very good partial response and complete response rate increasing to 14.5% in these late-line, highly refractory patients. Importantly, we are now translating these clinical achievements into regulatory and operational execution. We have initiated site activation activities for our planned phase III confirmatory trial and expect the first sites to open in the coming months, a key milestone in the development strategy.

Speaker #3: Importantly, we are now translating these clinical achievements into regulatory and operational execution. We have initiated site activation activities for our planned Phase 3 confirmatory trial and expect the first sites to open in the coming months, a key milestone in the development strategy.

Speaker #3: This study is designed to support long-term registration requirements while also enabling us to submit our planned accelerated approval pathway filing in the United States in 2027.

Jarrod Longcor: This study is designed to support long-term registration requirements while also enabling us to submit our planned accelerated approval pathway filing in the United States in 2027. We view the initiation of patient dosing in this trial as a significant upcoming catalyst and believe that could occur late this year or early next year and is an important step toward bringing iopofosine to patients who urgently need new treatment options. Beyond WM, we continue to broaden the opportunity for both iopofosine and our proprietary phospholipid drug conjugate, or PDC platform. Our recently published multiple myeloma data in a peer-reviewed journal, Cancers, further support the differentiated mechanism of action of iopofosine and highlight its potential applicability across a range of B-cell malignancies, including WM, multiple myeloma, diffuse large B-cell lymphoma, or DLBCL, and other difficult-to-treat hematologic cancers where new therapeutic options are urgently needed.

Speaker #3: We view the initiation of patient dosing in this trial as a significant upcoming catalyst and believe that could occur late this year or early next year and is an important step toward bringing iapophysine to patients who urgently need new treatment options.

Speaker #3: Beyond WM, we continue to broaden the opportunity for both iopofosine and our proprietary platform. Our recently published multiple myeloma data in the peer-reviewed journal Cancers further support the differentiated mechanism of action of iopofosine and highlight its potential applicability across a range of B-cell malignancies, including WM, multiple myeloma, diverse diffuse large B-cell lymphoma, or DLBCL, and other difficult-to-treat hematologic cancers where new therapeutic options are urgently needed.

Speaker #3: At the same time, we are advancing the next generation of our radiopharmaceutical pipeline. We recently enrolled and dosed the first patients in our Phase 1b trial of CLR 125 in triple-negative breast cancer and remain on track to report initial dosimetry, safety, and efficacy data later this year or early next year.

Jarrod Longcor: At the same time, we are advancing the next generation of our radiopharmaceutical pipeline. We recently enrolled and dosed the first patients in our phase I-B trial of CLR-125 in triple-negative breast cancer and remain on track to report initial dosimetry, safety, and efficacy data later this year or early next year. Taken together, we believe these accomplishments underscore the growing validation of our platform, the strength of our development strategy, and a significant opportunity ahead. In tandem, we continue to advance what we believe is one of the most innovative, differentiated, and versatile targeting platforms in radiopharmaceutical development today. Our proprietary PDC platform was designed to selectively target cancer cells through a mechanism that is independent of specific tumor mutation or surface antigens. We believe this enables near universal tumor targeting across hematologic malignancies as well as solid tumors, while providing a flexible delivery vehicle for multiple therapeutic payloads.

Speaker #3: Taken together, we believe these accomplishments underscore the growing validation of our platform, the strength of our development strategy, and the significant opportunity ahead. In tandem, we continue to advance what we believe is one of the most innovative differentiated and versatile targeting platforms in radiopharmaceutical development today.

Speaker #3: Our proprietary PDC platform was designed to selectively target cancer cells through a mechanism that is independent of specific tumor mutation or surface antigens. We believe this enables near-universal tumor targeting across hematologic malignancies as well as solid tumors while providing a flexible delivery vehicle for multiple therapeutic payloads.

Speaker #3: The platform has already generated clinical validation through iopofosine and serves as a valid foundation for our next-generation pipeline, including CLR 125, our OJ-emitting radiotherapeutic program, and CLR 225, our alpha-emitting program.

Jarrod Longcor: The platform has already generated clinical validation through iopofosine and serves as the foundation of our next-generation pipeline, including CLR-125, our Auger-emitting radiotherapeutic program, and CLR-225, our alpha-emitting program. We believe these programs represent significant long-term value creation opportunities and demonstrate the range of the platform across multiple cancer indications. One of the unique strengths of the PDC platform is its flexibility. By leveraging the similar targeting backbone with different therapeutic payloads, we have the potential to develop multiple product candidates addressing a range of tumor types while capitalizing on the extensive knowledge we've already accumulated regarding tumor uptake, biodistribution, and safety. To provide additional insight into this opportunity, we will be hosting an educational webinar on 18 August.

Speaker #3: We believe these programs represent significant long-term value creation opportunities and demonstrate the range of the platform across multiple cancer indications. One of the unique strengths of the PDC platform is its flexibility.

Speaker #3: By leveraging the similar targeting backbone with different therapeutic payloads, we have the potential to develop multiple product candidates addressing a range of tumor types while capitalizing on the extensive knowledge we've already accumulated regarding tumor uptake by our distribution and safety.

Speaker #3: To provide additional insight into this opportunity, we'll be hosting an educational webinar on August 18. During this event, members of our management team will discuss the scientific foundation of the PDC platform, its differentiated targeting capabilities, the progress we have made across clinical programs, and the significant future opportunities we see for the platform.

Jarrod Longcor: During this event, members of our management team will discuss the scientific foundation of the PDC platform, its differentiated targeting capabilities, the progress we have made across clinical programs, and the significant future opportunities we see for the platform. We encourage you all to join us for what we believe will be an informative and engaging discussion about long-term potential of Cellectar's technology and pipeline. Overall, we are pleased with the progress made across our clinical, regulatory, and pipeline initiatives during the H1 of the year. We believe we are well-positioned for the next stage of development and remain focused on executing against the milestones ahead. With that, I'll turn the call back to Jim for closing remarks.

Speaker #3: We encourage you all to join us for what we believe will be an informative and engaging discussion about the long-term potential of Cellectar's technology and pipeline.

Speaker #3: Overall, we are pleased with the progress made across our clinical, regulatory, and pipeline initiatives during the first half of the year. We believe we are well-positioned for the next stage of development and remain focused on executing against the milestones ahead.

Speaker #3: With that, I'll turn the call back to Jim for closing remarks.

Speaker #1: Okay. Thank you, Jarrod. As we look ahead, we believe SELECTAR is entering an important and exciting as well as transformational period. Our immediate focus is executing on the next steps required to advance iapophysine in WM.

James Caruso: Okay. Thank you, Jarrod. As we look ahead, we believe Cellectar is entering an important and exciting, as well as transformational period. Our immediate focus is executing on the next steps required to advance iopofosine in WM. With compelling clinical data, active site initiation efforts already underway, and a clear regulatory path forward, we are working toward the start of our confirmatory phase III study, which we view as a critical catalyst and an important step toward our planned accelerated approval submission, which remains on target for the H1 of the year in the United States. At the same time, we are well-positioned financially following the oversubscribed financing completed earlier this year, which provides us with the resources necessary to execute our near-term objectives. Importantly, as Jarrod just reviewed, we believe the opportunity extends far beyond a single product.

Jim Caruso: Okay. Thank you, Jarrod. As we look ahead, we believe Cellectar is entering an important and exciting, as well as transformational period. Our immediate focus is executing on the next steps required to advance iopofosine in WM. With compelling clinical data, active site initiation efforts already underway, and a clear regulatory path forward, we are working toward the start of our confirmatory phase III study, which we view as a critical catalyst and an important step toward our planned accelerated approval submission, which remains on target for the H1 of the year in the United States. At the same time, we are well-positioned financially following the oversubscribed financing completed earlier this year, which provides us with the resources necessary to execute our near-term objectives. Importantly, as Jarrod just reviewed, we believe the opportunity extends far beyond a single product.

Speaker #1: With compelling clinical data, active site initiation efforts already underway, and a clear regulatory path forward, we are working toward the start of our confirmatory Phase 3 study.

Speaker #1: Which we view as a critical catalyst and an important step toward our planned accelerated approval submission, which remains on target for the first half of the year, in the United States.

Speaker #1: At the same time, we are well positioned financially following the oversubscribed financing completed earlier this year, which provides us with the resources necessary to execute our near-term objectives.

Speaker #1: Importantly, as Jarrod just reviewed, we believe the opportunity extends far beyond a single product. The progress we are making with iopofosine continues to validate the underlying strength of our PDC platform and further reinforces our confidence in expanding the technology across additional radiopharmaceutical programs, including our beta-emitting and alpha-emitting product candidates for solid tumors.

James Caruso: The progress we are making with iopofosine continues to validate the underlying strength of our PDC platform and further reinforces our confidence in expanding the feed technology across additional radiopharmaceutical programs, including our Auger-emitting and alpha-emitting product candidates for solid tumors. To this end, I encourage listeners to participate in our educational webinar on 18 August. Our vision is to build a leading radiopharmaceutical company founded on versatile, clinically validated delivery platform capable of generating multiple product opportunities across both hematologic and solid tumor indications. With strong momentum across our regulatory, clinical, and corporate initiatives, we look forward to sharing additional milestones throughout the remainder of 2026 and into 2027. I would like to thank our employees, as always, investigators, most importantly, patients, our stockholders, and partners for their continued support and commitment to our mission. Operator, we're now prepared to take questions.

Jim Caruso: The progress we are making with iopofosine continues to validate the underlying strength of our PDC platform and further reinforces our confidence in expanding the feed technology across additional radiopharmaceutical programs, including our Auger-emitting and alpha-emitting product candidates for solid tumors. To this end, I encourage listeners to participate in our educational webinar on 18 August. Our vision is to build a leading radiopharmaceutical company founded on versatile, clinically validated delivery platform capable of generating multiple product opportunities across both hematologic and solid tumor indications. With strong momentum across our regulatory, clinical, and corporate initiatives, we look forward to sharing additional milestones throughout the remainder of 2026 and into 2027. I would like to thank our employees, as always, investigators, most importantly, patients, our stockholders, and partners for their continued support and commitment to our mission. Operator, we're now prepared to take questions.

Speaker #1: To this end, I encourage listeners to participate in our educational webinar on August 18. Our vision is to build a leading radiopharmaceutical company founded on a versatile, clinically validated delivery platform capable of generating multiple product opportunities across both hematologic and solid tumor indications.

Speaker #1: With strong momentum across our programs, we look forward to sharing additional milestones throughout the remainder of 2026 and into 2027. I would like to thank our employees, as always, investigators, most importantly patients, our stockholders, and partners for their continued support and commitment to our mission.

Speaker #1: Operator, we're now prepared to take questions.

Speaker #2: Thank you. Ladies and gentlemen, we'll now begin the question-and-answer session. Should you have a question, please press the star followed by the one on your touch-tone phone.

Operator: Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press the star followed by the 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 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 Kevin DeGeeter from Ladenburg. Please go ahead.

Speaker #2: 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.

Speaker #2: And if you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. And your first question comes from Kevin DeGieter from Ladenburg.

Speaker #2: Please go ahead.

Speaker #4: Hey, Greg. Yeah, thanks, Scott. I just appreciate the update. Exciting time. A couple of questions from us. First off, on the Phase 3 WM program, can you just walk us through it a little bit more—granularity, the rate-limiting steps to first patient enrolled? I think you've mentioned site activation, presumably IRB, but are there any other factors that may drive your guidance to be earlier, kind of fourth quarter versus first quarter '27?

Kevin DeGeeter: Hey, great. Thanks, guys. Appreciate the update. Exciting time. A couple of questions from us. First off, on the phase III WM program, can you just walk us through with a little bit more granularity the rate-limiting steps to first patient enrolled? I think you've mentioned site activation, presumably IRB, but any other factors that may drive your guidance to be earlier, kind of Q4 versus Q1 2027? Can you just clarify what triggers potential FDA submission? Is it a specific number of patients enrolled? A more qualitative criteria? Just a little bit more granularity there would be helpful. Thank you.

Speaker #4: And then can you just clarify kind of what triggers potential FDA submission? Is it a specific number of patients enrolled? A more qualitative criteria?

Speaker #4: Just a little bit more granularity there would be helpful. Thank you.

Speaker #1: All right, terrific. First of all, Kevin, thank you for your participation today and your support of the company; it's very much appreciated. That is a significant question.

James Caruso: All right. Terrific. First of all, Kevin, thank you for your participation today in support of the company. It's very much appreciated. That is a significant question, and as you would expect, there's enormous amount of work that goes into initiating the confirmatory study, especially one of this size. We're very pleased with the progress that we've made to date, and we're particularly happy with the response from not only those academic catchment centers that treat a significant portion of the relapsed refractory WM population, but also from community networks, integrated oncology delivery networks that typically treat these patients or diagnose these patients, as well as treat out in the general community, certainly in the first handful of lines of therapy prior to referring to one of these institutions that are world-renowned for the treatment of highly refractory WM.

Jim Caruso: All right. Terrific. First of all, Kevin, thank you for your participation today in support of the company. It's very much appreciated. That is a significant question, and as you would expect, there's enormous amount of work that goes into initiating the confirmatory study, especially one of this size. We're very pleased with the progress that we've made to date, and we're particularly happy with the response from not only those academic catchment centers that treat a significant portion of the relapsed refractory WM population, but also from community networks, integrated oncology delivery networks that typically treat these patients or diagnose these patients, as well as treat out in the general community, certainly in the first handful of lines of therapy prior to referring to one of these institutions that are world-renowned for the treatment of highly refractory WM.

Speaker #1: And as you would expect, there's enormous amount of work that goes into initiating the confirmatory study. Especially one of this size. And we're very pleased with the progress that we've made to date, and we're particularly happy with the response from not only those academic catchment centers that treat a significant portion of the relapse refractory WM population, but also from community networks integrated oncology delivery networks that typically treat these patients or diagnose these patients as well as treat out in the general community certainly in the first handful of lines of therapy prior to referring to one of these institutions that are world-renowned for the treatment of highly refractory WM.

Speaker #1: So, we're looking at all customer segments, even, quite frankly, community-based institutions that also see a significant number of patients. By way of background, 15 states in the United States essentially control 80% of the population for WM.

James Caruso: So we're looking at all customer segments, even quite frankly, community-based institutions that also see a significant amount of patients. By way of background, 15 states in the United States essentially control 80% of the population for WM, so it is highly targeted, and in and around those geographic communities, all of these segments, the integrated oncology delivery networks, community-based hospitals, as well as those academic centers, provide treatment for this patient population. So having said that, we're very pleased with where we currently sit. We're on target from a timing perspective. I'll have Jarrod talk to the details of your questions, but we still view that kind of March, April timeframe as our submission for accelerated approval with our friends at the FDA. Jarrod?

Jim Caruso: So we're looking at all customer segments, even quite frankly, community-based institutions that also see a significant amount of patients. By way of background, 15 states in the United States essentially control 80% of the population for WM, so it is highly targeted, and in and around those geographic communities, all of these segments, the integrated oncology delivery networks, community-based hospitals, as well as those academic centers, provide treatment for this patient population. So having said that, we're very pleased with where we currently sit. We're on target from a timing perspective. I'll have Jarrod talk to the details of your questions, but we still view that kind of March, April timeframe as our submission for accelerated approval with our friends at the FDA. Jarrod?

Speaker #1: So it is highly targeted. And in and around those geographic communities, all of these segments, the integrated oncology delivery networks, community-based hospitals as well as those academic centers provide treatment for this patient population.

Speaker #1: So the net having said that, we're very pleased with where we currently sit. We're on target from a timing perspective. I'll have Jarrod talk to the details of your questions, but we still view that kind of March, April timeframe as our submission for accelerated approval with our friends at the FDA.

Speaker #1: Jarrod?

Speaker #3: Sure. So, as you mentioned, there are a number of steps that go into, obviously, the startup process. And just to sort of lay out a few, I mean, generally, the way the process actually starts is—and I'll just sort of give probably way too much granularity here—but at the time of beginning the process, right, where you start is the contracting with the CRO.

Jarrod Longcor: Sure. As you mentioned, there's a number of steps that go into, obviously, the startup process and just sort of lay out a few. Generally, the way the process actually starts is at, and I'll just sort of give probably way too much granularity here. But, at the time of beginning the process, right, where you start is the contracting with the CRO and getting the documentation in place with the CRO. That means not just the contract, but it's all the supporting documentation. So all of the necessary investigator letters, all of the necessary documents for the operation of the study and the SOPs, and making sure everything lines up.

Speaker #3: And getting the documentation in place with the CRO—and that means not just the contract, but all the supporting documentation. So, all of the necessary investigator letters, all of the necessary documents for the operation of the study, and the SOPs. Making sure everything lines up.

Speaker #3: So after that, you move into the next phase, which is really site identification, where you identify which sites you want to target and which countries you want to go to.

Jarrod Longcor: After that, then you move into the next phase, which is really site identification, where you identify which sites you want to target, what countries you want to go to, and so on and so forth from that. That then goes into what is called a feasibility step, where you submit to those various sites and investigators a feasibility questionnaire where they, again, request, they get basically a protocol synopsis. They review it, they determine if they are interested in participating, and they provide you with a sense of how many patients they might enroll and in what time frame. After that, you move into what is called the qualification phase, which is, obviously with the radiopharmaceutical, it is not like taking an oral antibiotic per se, right? In this case, you have to have an infusion suite. You have to be able to handle and license for handling I-131.

Speaker #3: And so on and so forth from that. That then goes into what's called a feasibility step, where you submit to those various sites and investigators a feasibility questionnaire where they, again, request—they get basically a protocol synopsis.

Speaker #3: They review it. They determine if they're interested in participating. And they provide you with a sense of how many patients they may or may not how many patients they might enroll in and what timeframe.

Speaker #3: After that, you move into what's called the qualification phase, which is obviously, with the radiopharmaceutical, it's not like taking an oral antibiotic per se, right?

Speaker #3: In this case, you've got to have an infusion suite. You've got to be able to handle and license for handling I-131. And so you have to go through all of that process, and you have to collect all that documentation as well.

Jarrod Longcor: You have to go through all of that process, and you have to collect all that documentation as well. Then you move through, and as you said, you get into the IRB phase. The IRB phase comes, site contracting comes. That can sometimes go in parallel, sometimes not. That depends, depending, as Jim said, we have a lot of interest from both community centers as well as academic centers. When you think about the community centers, we can use a central IRB that allows them to approve more rapidly and move more rapidly. However, some of the more academic centers tend to have a local IRB in addition to that central IRB, so there is an extra IRB review process.

Speaker #3: Then you move through and, as you said, you get into the IRB phase. The IRB phase comes, site contracting comes—that can sometimes go in parallel, sometimes not.

Speaker #3: And that depends. Depending, as Jim said, we've got a lot of interest from both community centers as well as academic centers. When you think about the community centers, we can use a central IRB.

Speaker #3: That allows them to approve more rapidly and move more rapidly. However, some of the more academic centers tend to have a local IRB in addition to that central IRB.

Speaker #3: So there's an extra IRB review process in addition to that. Many of the academic centers also have an internal committee that has to review the protocol with the final, full protocol and statistical analysis plan, where they then vote to participate and go from that step to the next step, which would then be in the contracting.

Jarrod Longcor: In addition to that, many of the academic centers also have an internal committee that have to review the protocol with the final full protocol and statistical analysis plan, where they then vote to participate and go from that step to the next step, which would then be the contracting. After that, you have to train the centers and begin all that process, and then you do the true site initiation, which allows them to open and begin screening for patients, and then first patient in. All of that execution and operational stuff is going on in the background. As we said in our prepared remarks, we have initiated much of that, and we are on track to have what we believe our first sites open in a handful of months here, over the next coming months, with the potential first patient in late this year, early next year.

Speaker #3: After that, you have to train the centers and begin all that process. And then you do the true site initiation, which allows them to open and begin screening for patients.

Speaker #3: And then first patient in. And that's sort of all of that execution and operational stuff is going on in the background. And as we said in our prepared remarks, we have initiated much of that, and we are on track to have what we believe our first sites open and a handful of months here over the next coming months with the potential first patient in late this year, early next year.

Speaker #3: As it relates to then the FDA submission and what's the gating aspect for that? That is the gating aspect by FDA is definition is the site has to be or the study has to be initiated and quote-unquote "ongoing." So initiated at the time of submission, ongoing at the time of regulatory action.

Jarrod Longcor: As it relates to then the FDA submission and what is the gating aspect for that, the gating aspect by FDA's definition is the study has to be initiated and quote, unquote, "ongoing." So initiated at the time of submission, ongoing at the time of regulatory action, the definition of which is not defined by the FDA. They will not provide any clear, direct guidance on that subject. So you are left to sort of estimate what you think that might mean. We know what they are asking is basically that companies are executing diligently against the confirmatory studies for acceptance of their accelerated approval application and diligently continue to execute that by the time they are doing regulatory action.

Speaker #3: The definition of which is not defined by the FDA. They will not provide any clear, direct guidance on that subject, so you are left to sort of estimate what you think that might mean.

Speaker #3: We know what they're asking is basically that companies are executing diligently against the confirmatory studies or acceptance of their accelerated approval application, and diligently continue to execute that by the time they are doing regulatory action.

Speaker #3: Our interpretation of that is that we want to have a number of sites open—somewhere, perhaps 10 to 20 sites open at the time of submission.

Jarrod Longcor: Our interpretation of that is that we want to have a number of sites open, somewhere perhaps 10 to 20 sites open at the time of submission, and we want to be in a position that we have a couple patients enrolled, preferably at the time of submission, and then having somewhere between 5% or more patients enrolled by the time there is regulatory action. That is 6 to 8 months after the submission goes in. Does that help?

Speaker #3: And we want to be in a position that we've gotten a couple of patients enrolled, preferably at the time of submission. And then having somewhere between 5% or more of patients enrolled by the time there's regulatory action—that's six to eight months after the submission goes in.

Speaker #3: Does that help?

Speaker #2: That does. Incredibly granular. Thank you for that. And then just separately, on CLR 125, interesting asset. Just kind of talk to us about kind of what the initial learning around, I guess, the dose symmetry data and potential timeline.

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

Speaker #2: I think you kind of called out milestones, but not a specific timeline for data update on that exciting program.

Speaker #3: Yeah. So I'm going to stay very vague on the what we know about the dose symmetry and so forth. And I think the reason for that is we to be transparent, we do expect to be able to provide some data later this year.

Jarrod Longcor: Yeah. I am going to stay very vague on what we know about the dose symmetries and so forth, and I think the reason for that is to be transparent, we do expect to be able to provide some data later this year. We are looking at the San Antonio Breast Cancer Symposium, obviously as an opportunity, one potential opportunity to present data as it relates to that program, as well as other opportunities as may warrant to provide a data update around the program. What I can say is we know we have very good uptake into the tumor. We have distribution that looks as one would predict based off of what we know about the targeting ligand and what we have known from iopofosine, and we see that it is very much predictable and in line what we would have expected.

Speaker #3: We are looking at the San Antonio Breast Cancer Conference, obviously, as a potential opportunity to present data as it relates to that program, as well as other opportunities, as may warrant, to provide a data update around the program.

Speaker #3: What I can say is we know we've got very good uptake into the tumor. We have distribution that looks as one would predict, based off what we know about the targeting ligand and what we've known from iopofosine.

Speaker #3: And we see that that it is very much predictable and in line what we would have expected. And so what we're doing from there is really as one would expect in a phase one B dose finding study is optimizing and looking at how we optimize the dose ideally for patients.

Jarrod Longcor: What we are doing from there is really, as one would expect in a phase I-B dose-finding study, is optimizing and looking at how we optimize the dose, ideally for patients.

Speaker #2: Perfect. Thanks for taking my questions. I'll get back to you.

Kevin DeGeeter: Perfect. Thanks for taking my questions. I will get back in queue.

Speaker #1: Thank you. And your next question comes from Camp Alvea from Brookline Capital Markets. Please go ahead.

Operator: Thank you. Your next question comes from Kemp Alvia from Brookline Capital Markets. Please go ahead.

Speaker #2: All right. Thank you. And good morning. A couple of questions. So you have started to manufacture supply for your trials. Are you manufacturing any commercial supply for iapofosine 131 at this point or plan to do so shortly?

Kemp Alvia: Hi. Thank you, and good morning. Couple questions. You have started to manufacture supply for your trials. Are you manufacturing any commercial supply for iopofosine I 131 at this point, or plan to do so shortly?

Kemp Dolliver: Hi. Thank you, and good morning. Couple questions. You have started to manufacture supply for your trials. Are you manufacturing any commercial supply for iopofosine I 131 at this point, or plan to do so shortly?

Speaker #3: Yeah, so thanks for the question, Camp. What I would say to you is I'm going to say it's a yes, but I'm going to put a qualifier in there.

Jarrod Longcor: Yeah. Thanks for the question, Kemp. What I would say to you is, I am going to say it as a yes, but I am going to put a qualifier in there, and that qualifier is, obviously, we cannot manufacture the isotope or the finished product because those are essentially what I will call near term, just-in-time, or nearly just-in-time productions. But the targeting ligand, we do have significant stability data on that. What we do is we produce that now. We have been producing that essentially at commercial scale for the last several years. To give you a sense, we have got more than five years stability on the ligand. We generally produce that at large scale and then use that as necessary as we produce and generate the drugs.

Speaker #3: And that qualifier is, obviously, we can't manufacture the isotope or the finished product, because those are essentially what I'll call near-term, just-in-time—or nearly just-in-time—productions.

Speaker #3: But the targeting ligand—we do have significant stability data on that. And what we do is we produce that now. We've been producing that essentially at commercial scale.

Speaker #3: For the last several years. And to give you a sense, we've got more than five years stability on the ligand. So we generally produce that at large scale and then use that as necessary as we produce and generate the drugs.

Speaker #3: As I said, we have our commercial and I'll say for the finished product, we have our commercial infrastructure built out and ready to go.

Jarrod Longcor: As I said, we have our commercial, and I will say for the finished product, we have our commercial infrastructure built out and ready to go. Obviously, when we get a commercial approval, should we get a commercial approval, let me say it that way, we would then obviously be in a position to relatively quickly turn on that production process and ship drug through our existing logistics chain and production process.

Jim Caruso: As I said, we have our commercial, and I will say for the finished product, we have our commercial infrastructure built out and ready to go. Obviously, when we get a commercial approval, should we get a commercial approval, let me say it that way, we would then obviously be in a position to relatively quickly turn on that production process and ship drug through our existing logistics chain and production process.

Speaker #3: Obviously, when we get a commercial approval, should we get a commercial approval? Let me say it that way. We would to relatively quickly turn on that production process and ship drug through our existing logistics chain and production process.

Speaker #4: Yeah, we have the capacity to scale significantly in terms of patient lives, and we could scale very quickly. In fact, what's our max capacity from a patient perspective?

James Caruso: Yeah, we have the capacity to scale significantly in terms of patient lives, and we could stack very quickly. In fact, what is our max capacity from a patient perspective? It was well beyond any of our potential patient treatment and/or revenue models. It was very substantial. Close to 1,000, was it?

Jarrod Longcor: Yeah, we have the capacity to scale significantly in terms of patient lives, and we could stack very quickly. In fact, what is our max capacity from a patient perspective? It was well beyond any of our potential patient treatment and/or revenue models. It was very substantial. Close to 1,000, was it?

Speaker #4: It was well beyond any of our potential patient treatment and/or revenue models. It was very substantial close to 1,000 was it?

Speaker #3: Yeah. We're at about, I'd say right now, we would easily be able to hit essentially about 100 patients per week kind of scale with finished products.

Jarrod Longcor: Yeah. I would say right now, we would easily be able to hit essentially about 100 patients per week kind of scale with finished product.

Speaker #3: Because, as I'm sure you know, Camp, the way these things are set up is that the production of each unit is essentially done in an individual hot cell.

Jarrod Longcor: Because, as I am sure you know, Kemp, the way these things are set up is the production of each unit is essentially done in an individual hot cell. You can obviously, as I will call them, you daisy chain the hot cells together. In our case, our production runs actually give us considerably more material than we need. So even just two or three hot cells would provide us more than sufficient supply to hit that sort of 100-ish patient range.

Speaker #3: You can obviously, as I'll call them, daisy chain the hot cells together. In our case, our production runs actually give us considerably more material than we need.

Speaker #3: And so even just two or three hot cells would provide us more than sufficient supply to hit that sort of 100-ish patient range.

Speaker #2: That's great. Thanks. And that leads into the next question is how quickly you can launch after receiving the accelerated approval.

Kemp Alvia: That is great. Thanks. That leads into the next question, how quickly you can launch after receiving the accelerated approval.

Kemp Dolliver: That is great. Thanks. That leads into the next question, how quickly you can launch after receiving the accelerated approval.

Speaker #4: So that would be a function of levels of investment. And when we determine when to pull particular levers. So it's typically a 12-month period at a minimum.

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

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

Speaker #4: To fully lock and load for commercial execution. And really, I think in this particular case, because of the scalable nature of the space, as I cited earlier, 15 states essentially control 80% of the WM lives.

Speaker #4: But when you look at the actual customers triaging those patients, that number gets even more scalable and smaller. It's one of the attractive reasons this space is from a commercial perspective, a whiteboard, if you will.

Speaker #4: There's limited competitive tension in the space. BTKIs are the only approved class of medications. They're predominantly used in first line and second line and beyond.

Speaker #2: Can I lose you? Hello?

Kemp Alvia: Did I lose you? Hello?

Kemp Dolliver: Did I lose you? Hello?

Speaker #1: Hi, Jarrod. I think your line is there we go.

Operator: Hi, Jarrod. I think you went. There we go.

James Caruso: A bunch of inbound inquiries relative to the availability of the drug. Getting back to your original question, we could scale up quickly because it is a targeted environment, but ultimately, the time to fully lock and load and mobilize is really a function of when you pull the trigger on certain levels of investment. Now, having said that, we are deliberating appropriate to advance this particular environment. Because there is limited to no competitive tension there or medical marketing commercial machinery in the space, it is pretty wide open. For a small company like ours, it could potentially be a consideration to commercialize on our own because of the limited amount of oncology spend that would be required to really drive trial use and adoption.

Jim Caruso: A bunch of inbound inquiries relative to the availability of the drug. Getting back to your original question, we could scale up quickly because it is a targeted environment, but ultimately, the time to fully lock and load and mobilize is really a function of when you pull the trigger on certain levels of investment. Now, having said that, we are deliberating appropriate to advance this particular environment. Because there is limited to no competitive tension there or medical marketing commercial machinery in the space, it is pretty wide open. For a small company like ours, it could potentially be a consideration to commercialize on our own because of the limited amount of oncology spend that would be required to really drive trial use and adoption.

Speaker #4: A bunch of inbound inquiries. Relative to the availability of the drug. So getting back to your original question, we could scale up quickly because it's a targeted environment.

Speaker #4: But ultimately, the time to fully lock and load and mobilize is really a function of when you pull the trigger on certain levels of investment.

Speaker #4: Now, having said that, we also have we are. Appropriate to advance this digital environment. Because there's limited to know competitive tension there or emotional competition, medical marketing, commercial machinery in the space, it's pretty wide open.

Speaker #4: And so for a small company like ours, it could potentially be a consideration to commercialize on our own, because at a limited amount of oncology spend, that would be required to really drive trial use and adoption.

Speaker #4: However, having said that, we're also discussing with third-party partners that would take that on, as well as world-class, extremely large and efficient commercial organizations that we can also partner with to drive this for us.

James Caruso: However, having said that, we are also discussing with third-party partners that would take that on, as well as world-class, extremely large and efficient commercial organizations that we can also partner with to drive this for us. All three typical commercial options are on the table for us. We are evaluating all of them. We believe we could move very quickly in terms of establishing trial use and adoption in the space for limited funds in comparison to other spaces like breast, et cetera, in terms of the cost of doing business.

Jim Caruso: However, having said that, we are also discussing with third-party partners that would take that on, as well as world-class, extremely large and efficient commercial organizations that we can also partner with to drive this for us. All three typical commercial options are on the table for us. We are evaluating all of them. We believe we could move very quickly in terms of establishing trial use and adoption in the space for limited funds in comparison to other spaces like breast, et cetera, in terms of the cost of doing business.

Speaker #4: So all three typical commercial options are on the table for us. We're evaluating all of them. And we believe we could move very quickly in terms of establishing trial use and adoption in the space.

Speaker #4: For limited funds, in comparison to other spaces like breast, or etc., in terms of the cost of doing business.

Speaker #2: Great. And my last question is more for a broader industry view, but you do have some toehold in Actinium-225—at least not in the clinic yet, but it's something of interest to you.

Kemp Alvia: Great. My last question is more for broader industry view, but you do have some toehold in actinium-225, at least not in the clinic yet, but something of interest to you. What is your sense of the availability of actinium-225 now versus, say, a year ago?

Kemp Dolliver: Great. My last question is more for broader industry view, but you do have some toehold in actinium-225, at least not in the clinic yet, but something of interest to you. What is your sense of the availability of actinium-225 now versus, say, a year ago?

Speaker #2: And so, what's your sense of the availability of Actinium-225 now versus, say, a year ago?

Speaker #3: Great question, Camp, and I love the fact that it just allows me to wander off and pontificate for a few hours. I appreciate that opportunity.

Jarrod Longcor: Great question, Kim. I love the fact that it just allows me to just wander off and pontificate for a few hours. I appreciate that opportunity. What I would say is, a year ago, everybody was considerably concerned about the supply chain for actinium. I do not think that it has fully resolved, but I do think as we have been advancing here, and as I think people were expecting, we have gotten new suppliers in place. I think groups like SpectronRx are now up and consistently supplying actinium in addition to the group ITM and Eckert & Ziegler. Then you now have NorthStar online. I think you have got a number of other groups, Ionetix and a few others that are coming online in the near future, Nucleus RadioPharma, and so forth.

Speaker #3: So what I would say is, yeah, a year ago with Actinium, everybody was considerably concerned about the supply chain for Actinium. I don't think that it has fully resolved, but I do think as we have been advancing here, and as I think people were expecting, we've gotten new suppliers in place.

Speaker #3: I think groups like Spectron RX are now up and consistently supplying Actinium in addition to the group ITM and Eckert Ziegler. And then you now have North Star Online.

Speaker #3: I think you've got a number of other groups—Ionetics and a few others—that are coming online in the near future, Nucleus, and so forth.

Speaker #3: And so I think where we sit today to where we're going I think the supply chain is for the sourcing of Actinium is opening up a bit.

Jarrod Longcor: I think where we sit today to where we are going, I think the supply chain for the sourcing of actinium is opening up a bit. I do expect that as programs advance and the need for larger quantities of actinium for certain programs increases, we may continue to see future constriction and opportunity. As you know, our strategy here on all of our components for production has been to multi-source every piece of the component. Everything from our targeting ligand to each radioisotope we work to work on, then each finished product that gets made, we multi-source all of that through various contractors and in what I will call our collaborative outsourcing model.

Speaker #3: Now, I do expect that as programs advance, and the need for larger quantities of actinium for certain programs increases, we may continue to see future constriction and opportunity.

Speaker #3: And as you know, our strategy here on all of our components for production has been to multi-source every piece of the component. So everything from our targeting ligand to each radioisotope we work to work on.

Speaker #3: And then each finished product that gets made, we multi-source all of that through various contractors, and in our—what I'll call our collaborative outsourcing model.

Speaker #3: And as you probably may or may not be aware, historically what we've done, and what we've done particularly around Actinium, is we put in place our ready supply agreements with a number of parties.

Jarrod Longcor: As you probably may or may not be aware, historically what we have done and what we have done particularly around actinium, is we put in place our ready supply agreements with a number of parties, I think we are at four at this juncture, in order to make sure that we can access and get the supply necessary for our program, both near-term and long-term.

Speaker #3: I think we're at four at this juncture in order to make sure that we can access and get the supply necessary for our program, both near-term and long-term.

Speaker #2: All right. Thank you.

Kemp Alvia: All right. Thank you.

Kemp Dolliver: All right. Thank you.

Speaker #1: Thank you. There are no further questions at this time. I will turn it back over to Jim for closing remarks.

Operator: Thank you. No further questions at this time. I will turn it back over to Jim for closing remarks.

Speaker #4: Well, terrific. Thank you to everyone who participated in our call today; it’s very much appreciated. In particular, I’d like to thank our analysts for asking very thoughtful and thought-provoking questions.

James Caruso: Well, terrific. Thank you to everyone who participated in our call today. It is very much appreciated, in particular, our analysts for asking very thoughtful and provoking questions. Operator, with that, we will conclude our call.

Jim Caruso: Well, terrific. Thank you to everyone who participated in our call today. It is very much appreciated, in particular, our analysts for asking very thoughtful and provoking questions. Operator, with that, we will conclude our call.

Speaker #4: And operator, with that, we'll conclude our call.

Speaker #1: Ladies and gentlemen, this does conclude your call for today. We thank you very much for your participation, and you may now disconnect. Have a great day, everyone.

Operator: Ladies and gentlemen, this does conclude your call for today. We thank you very much for your participation, and you may now disconnect. Have a great day, everyone.