Cuộc họp công bố kết quả kinh doanh Quý 2/2026 của Cellectar Biosciences (CLRB): Khởi động Giai đoạn III và Kế hoạch NDA năm 2027

Điểm tin chính

• Cellectar Biosciences đã kết thúc quý 2/2026 với 34,0 triệu USD tiền mặt và các khoản tương đương tiền, tăng từ mức 13,2 triệu USD tại ngày 31/12/2025, sau đợt huy động vốn vào tháng 5.
• Chi phí nghiên cứu và phát triển quý 2 đã tăng lên 4,6 triệu USD từ mức 2,4 triệu USD cùng kỳ năm ngoái, chủ yếu do thử nghiệm CLR 125 trong điều trị ung thư vú thể tam âm và công tác khởi động nghiên cứu xác nhận iopofosine I 131.
• Ở các bệnh nhân CLOVER-WaM được điều trị ngay sau liệu pháp chế ngự BTK, iopofosine I 131 đạt tỷ lệ đáp ứng chính 79,2%, tỷ lệ đáp ứng toàn bộ 87,5%, tỷ lệ lợi ích lâm sàng 100% và thời gian đáp ứng trung bình là 16 tháng.
• Hoạt động kích hoạt trung tâm nghiên cứu đã bắt đầu cho nghiên cứu xác nhận Giai đoạn III trên bệnh nhân mắc bệnh tăng xơ macroglobulinemia Waldenstrom tái phát hoặc kháng trị. Ban lãnh đạo cho biết việc dùng thuốc cho bệnh nhân đầu tiên có thể diễn ra vào cuối năm 2026 hoặc đầu năm 2027.
• Công ty đang hướng tới việc nộp hồ sơ NDA xin phê duyệt cấp tốc vào khoảng tháng 3 - tháng 4 năm 2027. Ban lãnh đạo dự kiến thời gian xem xét của FDA là khoảng 6 tháng dựa trên chứng nhận liệu pháp đột phá của phương pháp này, tùy thuộc vào tiến độ thử nghiệm và sự chấp thuận của cơ quan quản lý.
• Cellectar đã nhận được 35 triệu USD tổng số tiền, tương đương khoảng 31,7 triệu USD ròng, trả trước từ đợt huy động vốn vượt mức đăng ký có thể cung cấp tới 140 triệu USD, bao gồm tới 105 triệu USD từ các chứng quyền gắn liền với cột mốc phát triển.

Dữ liệu tài chính chính

Đợt huy động vốn bao gồm ba đợt chứng quyền, mỗi đợt khoảng 13,2 triệu chứng quyền, có giá thực hiện là 2,65 USD. Các cột mốc bao gồm việc tuyển bệnh nhân đầu tiên trong nghiên cứu xác nhận, sự chấp thuận hồ sơ NDA iopofosine của FDA và phê duyệt lưu hành từ FDA. Việc thu hồi chứng quyền nhận tiền mặt cũng yêu cầu giá VWAP cổ phiếu đạt ít nhất 3,45 USD và thanh khoản giao dịch trung bình dựa trên VWAP đạt ít nhất 500.000 USD, cả hai đều áp dụng trong 20 ngày giao dịch liên tiếp.

Kết quả Kinh doanh và Hoạt động

Iopofosine I 131 trong điều trị bệnh tăng xơ macroglobulinemia Waldenstrom

Ưu tiên ngắn hạn của Cellectar vẫn là iopofosine I 131 đối với bệnh tăng xơ macroglobulinemia Waldenstrom tái phát hoặc kháng trị, đặc biệt là sau khi đã điều trị bằng thuốc ức chế BTK trước đó.

Theo dõi đầy đủ trong 12 tháng của nghiên cứu CLOVER-WaM cho thấy thời gian đáp ứng trung bình là 17,8 tháng, với khoảng 62% tổng số bệnh nhân đạt đáp ứng chính. Tỷ lệ đáp ứng một phần rất tốt và đáp ứng hoàn toàn tăng lên 14,5% theo thời gian ở nhóm bệnh nhân giai đoạn muộn, kháng trị cao. Công ty cho biết nghiên cứu đã đạt các tiêu chí đánh giá chính và phụ.

Đối với những bệnh nhân được điều trị ngay sau liệu pháp chế ngự BTK, phân tích tại ASCO 2026 cho thấy tỷ lệ đáp ứng chính là 79,2%, tỷ lệ đáp ứng toàn bộ là 87,5% và tỷ lệ lợi ích lâm sàng là 100%. Thời gian đáp ứng trung bình là 16 tháng.

Công ty đã bắt đầu các hoạt động kích hoạt trung tâm nghiên cứu Giai đoạn III. Ban lãnh đạo cho biết nghiên cứu này nhằm hỗ trợ các yêu cầu đăng ký dài hạn, đồng thời tạo điều kiện thuận lợi cho việc nộp hồ sơ xin phê duyệt cấp tốc dự kiến vào năm 2027.

CLR 125 và nền tảng PDC

Cellectar đã tuyển dụng và dùng thuốc cho những bệnh nhân đầu tiên trong thử nghiệm Giai đoạn Ib đối với CLR 125 trong điều trị ung thư vú thể tam âm. Ban lãnh đạo cho biết các quan sát ban đầu cho thấy mức độ hấp thu và phân bố vào khối u diễn ra mạnh mẽ, phù hợp với kỳ vọng từ ligand hướng mục tiêu và kinh nghiệm iopofosine trước đó. Nghiên cứu đang tập trung vào việc tối ưu hóa liều lượng.

Dữ liệu ban đầu về liều lượng bức xạ, tính an toàn và hiệu quả dự kiến sẽ có vào cuối năm 2026 hoặc đầu năm 2027. Ban lãnh đạo xác định Hội nghị Ung thư Vú San Antonio là một trong những địa điểm tiềm năng để trình bày báo cáo cập nhật.

Nền tảng phức hợp phospholipid-thuốc (PDC) của công ty cũng hỗ trợ CLR 225, chương trình phát xạ hạt alpha của hãng. Cellectar cho biết nền tảng này được thiết kế để phân phối các tải trọng phóng xạ khác nhau bằng cách sử dụng một khung hướng mục tiêu chung trên các bệnh ung thư máu và khối u đặc.

Triển vọng từ Ban lãnh đạo

Ban lãnh đạo dự kiến các trung tâm nghiên cứu Giai đoạn III đầu tiên sẽ mở cửa trong những tháng tới, với việc dùng thuốc cho bệnh nhân đầu tiên có thể diễn ra vào cuối năm 2026 hoặc đầu năm 2027.

Đối với việc nộp hồ sơ xin phê duyệt cấp tốc, diễn giải hiện tại của công ty là cần mở khoảng 10 đến 20 trung tâm và tuyển một vài bệnh nhân vào thời điểm nộp hồ sơ. Công ty muốn đạt ít nhất 5% bệnh nhân được tuyển tại thời điểm FDA đưa ra quyết định quản lý, ước tính từ 6 đến 8 tháng sau khi nộp. Các ngưỡng này là diễn giải của Cellectar chứ không phải là tiêu chí cố định từ FDA.

Công ty tiếp tục hướng tới việc nộp hồ sơ NDA vào khoảng tháng 3 - tháng 4 năm 2027. Thời điểm này vẫn phụ thuộc vào việc nghiên cứu xác nhận được bắt đầu và tiếp tục triển khai.

Rủi ro và Các điểm cần theo dõi

• FDA vẫn chưa xác định rõ ràng thế nào là một nghiên cứu xác nhận "đang diễn ra" phục vụ cho việc nộp hồ sơ xin phê duyệt cấp tốc và hành động quản lý. Do đó, Cellectar phải đưa ra các đánh giá vận hành liên quan đến việc kích hoạt trung tâm và đăng ký bệnh nhân.
• Khởi động Giai đoạn III đòi hỏi phải xác định trung tâm, đánh giá tính khả thi, cấp chứng nhận xử lý dược chất phóng xạ, phê duyệt của hội đồng đạo đức nghiên cứu, ký kết hợp đồng và đào tạo. Các trung tâm học thuật có thể yêu cầu thêm các đánh giá tại địa phương.
• Khoản tài trợ tương lai lên tới 105 triệu USD phụ thuộc vào các cột mốc lâm sàng và quản lý, cũng như điều kiện về giá cổ phiếu và thanh khoản giao dịch.
• Ban lãnh đạo cho biết khả năng cung ứng actinium-225 đã cải thiện khi có thêm nhiều nhà cung cấp gia nhập thị trường, nhưng những hạn chế về nguồn cung trong tương lai có thể xuất hiện trở lại khi các chương trình cạnh tranh yêu cầu số lượng lớn hơn.
• Thời điểm ra mắt thương mại sẽ phụ thuộc vào các quyết định đầu tư và sự phê duyệt của FDA. Ban lãnh đạo cho biết quá trình chuẩn bị thương mại hóa đầy đủ thường mất ít nhất 12 tháng.

Điểm nổi bật trong phần Q&A với chuyên viên phân tích

Tuyển dụng bệnh nhân Giai đoạn III và các yêu cầu đối với NDA: Ban lãnh đạo đã nêu rõ các bước cần thiết trước khi tuyển bệnh nhân đầu tiên, bao gồm tài liệu CRO, tính khả thi của trung tâm, chứng nhận xử lý I 131, đánh giá của cơ quan quản lý, hợp đồng và đào tạo nhân sự. Cellectar đang tập trung vào các mạng lưới điều trị phân bố tập trung theo khu vực địa lý, đồng thời lưu ý rằng 15 bang ở Mỹ chiếm khoảng 80% dân số mắc bệnh WM.

Các phát hiện ban đầu về CLR 125: Ban lãnh đạo từ chối cung cấp kết quả chi tiết về liều lượng bức xạ trước báo cáo cập nhật chính thức nhưng cho biết mức độ hấp thu vào khối u diễn ra mạnh mẽ và phân bố sinh học phù hợp với kỳ vọng. Tối ưu hóa liều lượng vẫn là mục tiêu chính của Giai đoạn Ib.

Mức độ sẵn sàng sản xuất: Cellectar cho biết ligand hướng mục tiêu có dữ liệu về độ ổn định hơn 5 năm và đã được sản xuất ở quy mô thương mại trong nhiều năm. Cơ sở hạ tầng thành phẩm hiện tại của công ty có thể hỗ trợ khoảng 100 bệnh nhân mỗi tuần, theo ban lãnh đạo, nếu nhận được sự phê duyệt.

Các lựa chọn thương mại hóa: Công ty đang xem xét việc tự thương mại hóa, hợp tác thương mại hóa với bên thứ ba hoặc các tổ chức thương mại lớn hơn. Ban lãnh đạo tin rằng thị trường điều trị WM tập trung có thể cho phép việc triển khai tương đối nhanh chóng với mức chi tiêu hạn chế so với các chỉ định ung thư rộng hơn.

Nguồn cung ứng Actinium-225: Cellectar cho biết họ đã có thỏa thuận nguồn cung với khoảng 4 đối tác và tuân thủ chiến lược đa dạng hóa nguồn cung đối với ligand hướng mục tiêu, đồng vị phóng xạ và thành phẩm.

Toàn văn Biên bản Cuộc họp Báo cáo Kết quả Kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome. [Operator Instructions] Please be advised that today's call may be recorded.

I will now hand the call over to Anne Marie Fields, Managing Director of Precision AQ. Please go ahead.

Anne Marie Fields

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 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. 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, August 13, 2026. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line to your questions.

I'll now turn the call over to Jim Caruso. Jim?

James Caruso

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.

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. 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 continue 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, and 100% clinical benefit rate, and encouraging durability with a median duration of response of 16 months.

Most importantly, we have now initiated site activation activities for our planned confirmatory Phase III study. This represents a critical milestone in our regulatory strategy. Once necessary site activation and ongoing patient enrollment is achieved, we expect to be in a position to submit our new drug application under the FDA's accelerated approval program in mid-2027. Based upon the breakthrough designation awarded to 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.

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.

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 prefunded warrants. Additionally, we issued three tranches of approximately 13.2 million warrants each, all of which are currently exercisable at a strike price of $2.65. Furthermore, these warrants are callable for cash by the company if the respective milestone and related criteria are met.

Each tranche of warrants, A, B, and C, has a milestone associated with it. The Tranche A warrants, which expire on July 7, 2027, have a milestone of first patient enrolled in the confirmatory study for iopofosine I 131 in Waldenstrom Macroglobulinemia, or WM, patients. The Tranche B warrants, which expire July 7, 2028, have the milestone of the FDA's acceptance of a new drug application for iopofosine. The Tranche C warrants, which expire July 7, 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 a 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.

Now, for our financial results for the period ended June 30, 2026. 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.

Turning now to our operating results. Research and development expenses for the 3 months ended June 30, 2026, were approximately $4.6 million compared to approximately $2.4 million for the 3 months ended June 30, 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 3 months ended June 30, 2026, were $2.6 million compared to $3.6 million for the same period in 2025. The decrease in G&A was driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs.

Net loss for the 3 months ended June 30, 2026, was $6.9 million, or $0.57 per share, compared with $5.4 million, or $3.39 per share, during the 3 months ended June 30, 2025. The enhanced strength of our balance sheet enables our ability to effectively advance our clinical and regulatory programs.

Now I will turn the call over to Jarrod to discuss the regulatory and clinical advancements we've been making during the first half of 2026.

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 global 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 BTKi inhibitor therapy, a particularly challenging setting where treatment options remain limited. And as Jim mentioned a few minutes ago, we demonstrated an approximately 80% major response rate 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 with iopofosine increasing over time with a very good partial response and complete response rate increasing to 14.5% in these late-line highly refractory patients.

Importantly, we are now translating these clinical achievements into regulatory and operational execution. We have initiated site activation activities for our planned Phase III confirmatory trial and expect the first sites to open in the coming months, a key milestone in the development strategy. This study is designed to support long-term registration requirements while also enabling us to submit our 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 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, diffuse large B-cell lymphoma, or DLBCL, and other difficult-to-treat hematologic cancers where new therapeutic options are urgently needed.

At the same time, we are advancing the next generation of our radiopharmaceutical pipeline, which recently enrolled and dosed the first patients in our Phase Ib 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.

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'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. 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 first half of the year. We believe we are well positioned for the next stage of development and remain focused on executing against the milestones ahead.

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

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 first half 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.

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 Auger-emitting and alpha-emitting product candidates for solid tumors. 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 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.

Operator

[Operator Instructions] And your first question comes from Kevin DeGeeter from Ladenburg.

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Kevin DeGeeter

Appreciate the update. Exciting time. A couple of questions from myself. First off, on the Phase III WM program. Can you just walk us through a little bit more granularity, the rate-limiting steps to first patient enrolled? I think you've mentioned your site activation, presumably IRB, but kind of any other factors that may drive kind of your guidance to be, earlier kind of 4Q versus 1Q '27? And then 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.

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 an enormous amount of work that goes into initiating the confirmatory study, especially one of this size. And we're very pleased with the progress that we've made to date, and we're particularly 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.

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

Jarrod Longcor

Sure. So, as you mentioned, there's a number of steps that go into the -- obviously, the start-up process, just sort of lay out a few, I mean, generally, the way the process actually starts is that, 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. And 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.

After that, then you move into the next phase, which is really site identification, where you identify -- which sites you want to target, which countries you want to go to, and so on and so forth from that. That then goes into what's called a feasibility step where you submit to those various sites and investigators a feasibility questionnaire where they again, request -- they get basically a protocol synopsis, they review it, they determine if they're interested in participating, and they provide you with a sense of how many patients they may or may not -- how many patients they might enroll in what time frame.

After that, you move into what's called the qualification phase, which is obviously, with the radiopharmaceutical, it's not like taking an oral antibiotic per se, right? In this case, you've got to have an infusion suite, you got to be able to handle and licensed for handling I 131. And so you have to go through all of that process and you have to collect all that documentation as well. Then you move through and, as you said, you get into the IRB phase. The IRB phase comes, site contracting comes that can sometimes go in parallel, sometimes not. And that depends -- depending, as Jim said, we've got a lot of interest from both community centers as well as academic centers.

When you think about community centers, we can use a central IRB, that allows them to approve more rapidly and move more rapidly. However, some of the more academic centers tend to have a local IRB in addition to that central IRB, so there's an extra IRB review process. In addition to that, many of the academic centers also have an internal committee that have to review the protocol with the final full protocol and statistical analysis plan, where they then vote to participate and go from that step to the next step, which would then be the contracting.

After that, you have to train the centers and begin all that process, and then you do site -- the true site initiation, which allows them to open and begin screening for patients, and then first patient in. That's sort of all of that execution and operational stuff is going on in the background. And as we said in our prepared remarks, we have initiated much of that, and we are on track to have what we believe 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.

As it relates to then the FDA submission and what's the gating aspect for that, that is -- the gating aspect by FDA's definition is the site has to be their site. The study has to be initiated and "ongoing." So initiated at the time of submission, ongoing at the time of regulatory action, the definition of which is not defined by the FDA. They will not provide any clear direct guidance on that subject. So you are left to sort of estimate what you think that might be.

We know what they're asking is basically that companies are executing diligently against the confirmatory studies for acceptance of their accelerated approval application, and diligently continue to execute that by the time they are doing regulatory action. Our interpretation of that is that we want to have a number of sites open somewhere -- perhaps 10 to 20 sites open at the time of submission. And we want to be in a position that we've gotten a couple of patients enrolled, preferably at the time of submission, and then having somewhere between 5% or more patients enrolled by the time there's regulatory action, that's 6 to 8 months after the submission goes in. Does that help?

Kevin DeGeeter

It does. Incredibly granular. 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 dosimetry data and potential time line. I think you kind of called out milestones, but not a specific time line for data update on that exciting program.

Jarrod Longcor

Yes. So I'm going to stay very vague on the -- what we know about the dosimetry and so forth. And I think the reason for that is we, to be transparent, we do expect to be able to provide some data later this year. We are looking at the San Antonio Breast Cancer Conference, obviously, has 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've got very good uptake into the tumor. We have distribution that looks as one would predict based on what we know about the targeting ligand and what we've known from iopofosine. And we see that, that it is very much predictable and in line with what we would have expected. And so what we're doing from there is really, as one would expect in a Phase Ib dose-finding study, is optimizing and looking at how we optimize the dose ideally for patients.

Operator

And your next question comes from Kemp Dolliver from Brookline Capital Markets.

Brian Kemp Dolliver

A couple of questions. So you have started to manufacture -- your supply for your trials. Are you manufacturing any commercial supply for iopofosine I 131 at this point or plan to do so shortly?

Jarrod Longcor

Yes. So -- thanks for the question, Kemp. What I would say to you is -- I'm going to say it as a yes, but I'm going to put a qualifier in there. 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. 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 for the last several years. And to give you a sense, our -- we've got more than 5 years stability on the ligand. So we generally produce that at large scale and then use that as necessary as we produce it and generate the drugs.

As I said, we have our commercial, and I'll say it 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.

James Caruso

Yes. We have the capacity to scale significantly in terms of patient lives and we could stack very quickly. In fact, what's our max capacity from a patient perspective. It went well beyond any of our potential patient treatment and/or our revenue models. It was very substantial. Close to 1,000...

Jarrod Longcor

Yes. We're at about -- I'd say right now, we would easily be able to hit essentially about a 100 patients per week kind of scale with finished products, because as you -- as I'm 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'll call them, you daisy chain the hot cells together. In our case, our production runs actually give us considerably more material than we need. 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.

Brian Kemp Dolliver

That's great. And that leads into the next question is, how quickly you can launch after receiving the accelerated approval?

James Caruso

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 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. 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. 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.

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. 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 also have -- where we are [Technical Difficulty]

digital environment. Because there's limited to no competitive tension there, or [Technical Difficulty]

medical marketing, commercial machinery in the space, it's pretty wide open.

And so for a small company like ours, it could potentially be a consideration to commercialize on our own because a limited amount of oncology spend that would be required to really drive trial use and adoption. 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. 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 for limited funds in comparison to other spaces like breast, et cetera, in terms of the cost of doing business.

Brian Kemp Dolliver

Great. And my last question is more for the 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. And so what's your sense of the availability of actinium-225 now versus, say, a year ago?

Jarrod Longcor

Great question, Kemp. And I love the fact that it just allows me to just wander off and pontificate for a few hours. I appreciate that opportunity. So what I would say is, yes, a year ago, I would say -- 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. I think groups like SpectronRx are now up and consistently supplying actinium in addition to the group ITM, Eckert & Ziegler, and then you now have Northstar online. I think you've got a number of other groups, Ionetix and a few others that are coming online in the near future, Nucleus and so forth.

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. 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. And as you know, our strategy here on all of our components for production has been to multisource every piece of the component. So everything from our targeting ligand to each radioisotope we work to work on and then each finished product that gets made, we multisource all of that through various contractors. And in our, what I'll call our collaborative outsourcing model.

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. I think we're at 4 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.

Operator

And with no further questions at this time, I will turn it back over to Jim for closing remarks.

James Caruso

Well, terrific. Thank you to everyone who participated in our call today. It's very much appreciated. In particular, our analysts for asking very thoughtful and provoking questions. And operator, with that, we'll conclude our call.

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.