Cellectar Biosciences Inc (CLRB) 2026 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question-and-answer session. Please be advised that today's conference call may be recorded.

各位女士、先生，感謝您稍候並歡迎參與。此時，所有與會者皆為僅聆聽模式。簡報結束後，將進行問答環節。敬請留意，今日的電話會議可能會被錄音。

I would now like to hand the conference call over to Anne-Marie Fields, Managing Director at Precision AQ. Please go ahead.

現在我想將電話會議交給 Precision AQ 董事總經理 Anne-Marie Fields。請開始。

Thank you, Vanessa. Good morning, and welcome to Cellectar Biosciences first 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 Cohen, 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.

謝謝你，Vanessa。各位早安，歡迎參加 Cellectar Biosciences 2026 年第一季財務結果與業務更新電話會議。今天與我們一同出席的 Cellectar 團隊成員包括總裁暨執行長 Jim Caruso；他將先概述公司進展，之後把電話交給財務長 Chad Cohen；進行本季財務回顧。接著，營運長 Jarrod Longcor 將就公司進展與其具前景之放射性藥物臨床開發產品線的計畫提供更新。Cellectar 今早稍早已發布新聞稿，詳述今日電話會議內容。

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 the SEC filings.

新聞稿可於 Cellectar 公司官網的投資人頁面查閱。我想提醒來電者，今日電話會議所討論之資訊受《私人證券訴訟改革法案》之「安全港」條款保障。我提醒聽眾，管理層將發表前瞻性陳述。由於與業務相關之風險與不確定性，實際結果可能與我們前瞻性陳述中所述或所暗示者有重大差異。這些前瞻性陳述在其整體上均受今日新聞稿及向 SEC 提交文件中所載之警示性聲明所限制。

The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 14, 2026. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line for your questions.

本次電話會議內容包含具時效性之資訊，僅於本次直播日期（2026 年 5 月 14 日）為準且屬正確。公司不承擔任何義務在本次電話會議與網路直播日期之後，因事件或情況變化而修訂或更新任何前瞻性陳述。提醒各位，本次電話會議與網路直播正在錄音並將存檔。我們將先進行預先準備的發言，之後開放提問。

Now let me turn the call over to Jim Caruso. Jim?

現在讓我把電話交給 Jim Caruso。Jim？

Thank you, Anne Marie, and thank you to all for joining us today. The first quarter of 2026 marked a transformational period for Cellectar. Defined by rigorous execution across our clinical, regulatory and financial strategies. We entered the year with momentum. And over the past quarter, that momentum has meaningfully accelerated.

謝謝你，Anne Marie，也感謝各位今天加入我們。2026 年第一季對 Cellectar 而言是具有轉型意義的時期。其特徵在於我們在臨床、法規與財務策略上的嚴謹執行。我們以動能進入新的一年。而在過去一季，這股動能已明顯加速。

Earlier this month, we reported positive 12-month follow-on data from the Phase IIb CLOVER WaM study evaluating iopofosine I 131 in patients with relapsed or refractory Waldenstrom Macroglobulinemia or WM. These data demonstrated durable and consistent responses across one of the most heavily pretreated and refractory WM populations studied to date, including patients who were both exposed to and refractory to BTKi inhibitors.

本月稍早，我們公布了 CLOVER WaM 第二期 b 臨床研究的 12 個月追蹤正面數據；該研究評估 iopofosine I 131 用於復發或難治性華氏巨球蛋白血症（Waldenstrom Macroglobulinemia，WM）患者。這些數據顯示，在迄今研究中接受過最重度既往治療且最難治的 WM 族群之一，反應具有持久性且一致，包括曾接受 BTKi 抑制劑治療且對其產生難治性的患者。

Importantly, iopofosine met both the primary and secondary endpoints of the study. Reinforcing our confidence in its clinical profile and its potential to address a profound unmet need in WM, particularly for patients who have been previously prescribed to BTKi and are now searching for treatment answers with off-label salvage therapies. These results take on even greater significance when viewed in the broader disease context.

重要的是，iopofosine 同時達成研究的主要與次要終點。這進一步強化我們對其臨床特性以及其在 WM 領域滿足重大未被滿足醫療需求之潛力的信心，特別是對於先前已使用 BTKi、如今正透過適應症外的挽救性治療尋找答案的患者。若從更廣泛的疾病背景來看，這些結果更具重要意義。

WM is a rare and curable lymphoma affecting a prevalent patient population of approximately 60,000 to 80,000 patients in the US and EU alone with a rapidly growing population of patients progressing after BTKi therapy with no FDA-approved therapies beyond BTKIs. For these patients, therapeutic options are limited, outcomes are suboptimal and the need for new durable treatments is urgent.

WM 是一種罕見且可治癒的淋巴瘤；僅在美國與歐盟即影響約 6 萬至 8 萬名患者，且在 BTKi 治療後病情進展的患者人數正快速增加，而在 BTKi 之外目前尚無 FDA 核准的治療。對這些患者而言，可用治療選項有限、療效結果不理想，對新的、具持久性的治療之需求十分迫切。

With the full 12-month data set now in hand, along with a deep and mature body of clinical evidence, we are advancing our plans to file for accelerated approval with the FDA and to initiate a randomized Phase III confirmatory trial. We believe iopofosine is well positioned to meet regulatory expectations and to become a foundational therapy in the WM treatment landscape.

目前我們已掌握完整的 12 個月數據集，並累積了深厚且成熟的臨床證據體系，因此正推進向 FDA 申請加速核准的計畫，並啟動一項隨機分派的第三期確認性試驗。我們相信 iopofosine 具備良好條件可符合監管期待，並有望成為 WM 治療版圖中的基礎性療法。

Running in parallel with this clinical momentum, we announced an oversubscribed financing of up to $140 million, led by high-quality long-term health care investors.

在此臨床動能同步推進之際，我們宣布完成一項超額認購的融資，總額最高可達 1.4 億美元，由高品質的長期醫療保健投資人領投。

This capital materially strengthens our balance sheet and provides the resources necessary to advance iopofosine through our planned Phase III confirmatory study and potential commercialization as well as support the continued advancement of triple-negative breast cancer study as part of our broader radiopharmaceutical pipeline. Taken together, the strength of our iopofosine data and the successful financing represent a clear inflection point for Cellectar. They enable us to move forward decisively from a clinical validation to late-stage execution.

這筆資金將實質強化我們的資產負債表，並提供推進 iopofosine 進入規劃中的第三期確認性研究與潛在商業化所需資源，同時也支持三陰性乳癌研究的持續推進，作為我們更廣泛放射性藥物產品線的一部分。綜合而言，iopofosine 數據的強勁表現與成功完成融資，代表 Cellectar 的明確轉折點。它們使我們得以果斷地從臨床驗證邁向後期階段的執行。

With that overview, I'll now turn the call over to Chad to walk through our financial results.

以上為概述，接下來我把電話交給 Chad，請他說明我們的財務結果。

Thank you, Jim, and good morning, everyone. I'll address our financial results for the period ended March 31, 2026, and the recently completed financing that allows us to accelerate our development of iopofosine I 131. We ended the first quarter with cash and cash equivalents of approximately $8.3 million compared to $13.2 million at the end of 2025.

謝謝你，Jim，各位早安。我將說明截至 2026 年 3 月 31 日止期間的財務結果，以及近期完成、使我們得以加速 iopofosine I 131 開發的融資。第一季結束時，我們的現金及約當現金約為 830 萬美元，較 2025 年底的 1,320 萬美元下降。

This does not include the results of the financing, which I will address in a moment. Our research and development expenses for the three months ended March 31, 2026, were approximately $3 million compared to approximately $3.4 million for the three months ended March 31, 2025.

此數字尚未包含該次融資的結果，我稍後會說明。截至 2026 年 3 月 31 日止三個月，我們的研發費用約為 300 萬美元，相較於截至 2025 年 3 月 31 日止三個月約 340 萬美元。

R&D costs declined as the follow-up activities for patients of CLOVER WaM Phase IIb clinical study declined and preclinical product development was reduced. These reductions were partially offset by increased manufacturing spend for both iopofosine and CLR125. General and administrative expenses for the three months ended March 31, 2026, were $2.8 million compared to $3 million for the same period in 2025. The modest decrease in G&A was driven primarily by reduced personnel costs. Net loss for the three months ended March 31, 2026, was $5.7 million or $1.33 per share compared with $6.6 million or $4.30 per share during the 3 months ended March 31, 2025.

研發成本下降，主要因 CLOVER WaM 第二期 b 臨床研究患者的追蹤活動減少，以及前臨床產品開發縮減。上述降幅部分被 iopofosine 與 CLR125 的製造支出增加所抵銷。截至 2026 年 3 月 31 日止三個月，一般及行政費用為 280 萬美元，較 2025 年同期的 300 萬美元下降。G&A 的小幅下降主要由人事成本降低所致。截至 2026 年 3 月 31 日止三個月，淨損為 570 萬美元或每股 1.33 美元，相較於截至 2025 年 3 月 31 日止三個月的 660 萬美元或每股 4.30 美元。

Importantly, as Jim stated earlier. Earlier this month, we completed an oversubscribed financing for up to $140 million, consisting of an upfront amount of $35 million and up to $105 million in milestone-based capital. As a result, we believe our current cash position enables us to fund planned operations, particularly the initiation of our confirmatory Phase III trial of iopofosine in patients with WM into the second quarter of 2027. The structure of the milestone-based warrants is designed to provide additional funding at key points in the development of iopofosine. Three tranches of warrants, one tied to each of three milestones were issued for each security the investors purchased upfront.

重要的是，如 Jim 先前所述。本月稍早，我們完成一項超額認購的融資，總額最高可達 1.4 億美元，包括 3,500 萬美元的預付款，以及最高 1.05 億美元以里程碑為基礎的資金。因此，我們相信目前的現金部位足以支應規劃中的營運資金需求，特別是推進在 WM 患者中進行 iopofosine 第三期確認性試驗的啟動，並可支應至 2027 年第二季。這種以里程碑為基礎的認股權證結構，旨在於 iopofosine 開發的關鍵節點提供額外資金。針對投資人預先購買的每一項證券，我們發行了三個批次的認股權證，分別與三項里程碑各自連結。

The first milestone is the initiation of the confirmatory study as demonstrated by the enrollment of the first patient in the study. The second milestone is the acceptance of an NDA submission by the FDA. And the third milestone is the approval of iopofosine by the FDA. Upon the attainment of each milestone, provided our common stock trades above $3.45 with volume exceeding $500,000 per day for 20 consecutive days, the company can call the warrants for cash. The warrants for each milestone represent potential additional funding of $35 million.

第一個里程碑是啟動確認性研究，其標誌為該研究納入第一位受試者。第二個里程碑是 FDA 受理 NDA 申請。第三個里程碑是 FDA 核准 iopofosine。在達成各項里程碑時，前提是本公司普通股股價高於 3.45 美元且每日成交量超過 50 萬美元並連續 20 個交易日，公司即可要求以現金方式贖回認股權證。每個里程碑所對應的認股權證代表潛在額外融資 3,500 萬美元。

So the aggregate potential for the 3 milestones is $105 million and when combined with the upfront of $35 million represents the $140 million of total potential funding.

因此，三個里程碑合計的潛在金額為 1.05 億美元，若再加上 3,500 萬美元的預付款，總潛在資金為 1.4 億美元。

The warrants are all exercisable upon approval of the transaction by the stockholders. Which will be part of our Annual Stockholders' Meeting agenda. Completion of this offering puts us in a position of financial strength and strategic flexibility, allowing the organization to remain focused on disciplined execution and value creation.

所有認股權證均可在股東核准該交易後行使。該事項將列入我們年度股東大會議程。完成本次發行使我們具備財務實力與策略彈性，讓組織得以持續專注於嚴謹執行與價值創造。

Now I will turn the call over to Jarrod for an operational update, including plans for our promising pipeline of radiopharmaceuticals.

現在我把電話交給 Jarrod，請他提供營運更新，包括我們前景看好的放射性藥物產品線之規劃。

Thank you, Chad, and good morning, everyone. As Jim highlighted, the 12-month CLOVER-WaM results represent a significant milestone for iopofosine for patients living with WM. For some background, patients enrolled in the CLOVER-WaM had a median of four prior lines of therapy with refractory rates from 77% to 75% and 60% in BTKi, rituximab chemotherapy exposed patients, respectively.

謝謝你，Chad，各位早安。如 Jim 所強調，CLOVER-WaM 的 12 個月結果對於 WM 患者的 iopofosine 而言是一項重要里程碑。補充背景，納入 CLOVER-WaM 的患者先前治療線數中位數為 4 線；在曾接受 BTKi、利妥昔單抗合併化療暴露的患者中，難治比例分別為 77% 至 75% 以及 60%。

Additionally, 58% of patients exposed to both BTKi and rituximab were dual class refractory. Despite this being one of the most heavily pretreated and refractory WM patient populations to date, iopofosine produced robust and durable responses, underscoring the strength of the targeted phospholipid drug conjugate platform.

此外，同時暴露於 BTKi 與利妥昔單抗的患者中，有 58% 為雙類別難治。儘管這是迄今治療最為充分且難治程度最高的 WM 患者族群之一，iopofosine 仍產生強勁且持久的反應，凸顯標靶磷脂藥物偶聯平台的優勢。

Notably, the primary and secondary endpoints were both achieved in the protocol study population (N=55) with an overall response rate of 83.6% and the primary endpoint of major response rate or MRR, improving to 61.8%. The secondary endpoint of duration of response, or DOR, achieved a median of 17.8 months. Importantly, greater than 30% of responders maintained their responses beyond 36 months.

值得注意的是，在方案規定的研究族群（N=55）中，主要與次要終點皆達成：總反應率為 83.6%，而主要終點重大反應率（MRR）提升至 61.8%。次要終點反應持續時間（DOR）之中位數為 17.8 個月。重要的是，超過 30% 的反應者其反應維持超過 36 個月。

The median progression-free survival was 13.5 months and the (VGPR/CR) rate was 14.5%. The disease control rate remained stable at 98.2%. In addition, the data demonstrated consistent efficacy in both BTKi exposed and BTKi refractory patients. These results compare favorably with available therapies in the post-BTKi setting, where outcomes remain limited and durability is often modest.

無進展存活期（PFS）中位數為 13.5 個月，且（VGPR/CR）比率為 14.5%。疾病控制率維持穩定在 98.2%。此外，數據顯示在曾暴露於 BTKi 與 BTKi 難治患者中皆具有一致療效。在 BTKi 後治療情境中，現有療法的療效仍受限且持久性往往有限；相較之下，這些結果具備有利的比較優勢。

Moreover, iopofosine's fixed dose regimen and manageable safety profile may also provide offer practical advantages for patients and providers. Importantly, these outcomes incorporate key elements that align with the previously described regulatory expectations for iopofosine's eligibility for accelerated approval. We were delighted to have the immediately post-BTKi subgroup analysis from the CLOVER WaM trial selected for presentation at the upcoming ASCO conference, which brings together the world's leading oncologists.

此外，iopofosine 的固定劑量療程與可管理的安全性特徵，也可能為患者與醫療提供者帶來實務上的優勢。重要的是，這些結果涵蓋關鍵要素，與先前所述 iopofosine 取得加速核准資格的監管期待相一致。我們很高興 CLOVER WaM 試驗中「緊接 BTKi 後」亞組分析獲選於即將召開的 ASCO 年會發表，該會議匯聚全球頂尖腫瘤科醫師。

The safety and efficacy of iopofosine observed to date in this subgroup are highly encouraging and underscore its potential to address a significant unmet need for patients who progressed after BTKi therapy. We believe these findings further support the potential for iopofosine to emerge as a differentiated therapeutic option in the post-BTKi setting and as early as the second line of treatment in WM.

迄今在此亞組觀察到的 iopofosine 安全性與療效令人高度振奮，並凸顯其有潛力滿足 BTKi 治療後仍進展患者的重大未被滿足醫療需求。我們相信，這些發現進一步支持 iopofosine 有望在 BTKi 後治療情境中成為具差異化的治療選項，並可望最早於 WM 的第二線治療中使用。

With the strength and maturity of the total data set, we are advancing with a randomized controlled Phase III confirmatory study, evaluating progression-free survival as the primary endpoint. We anticipate initiating the study in the late fourth quarter of 2026.

憑藉整體數據集的強度與成熟度，我們正推進一項隨機對照的第三期確認性研究，以無進展存活期作為主要終點。我們預期於 2026 年第四季末啟動該研究。

Beyond iopofosine, we were delighted to advance our broader pipeline with the recent dosing of the first patients in the Phase Ib trial of CLR125, our OJ emitting radio conjugate in relapsed/refractory triple-negative breast cancer or TNBC. TNBC is an aggressive subtype of breast cancer characterized by the absence of estrogen receptors, progesterone receptors and HER2 protein expression. This lack of common therapeutic targets make TNBC particularly challenging to treat with limited options beyond chemotherapy.

除 iopofosine 之外，我們也很高興推進更廣泛的產品線：近期已在 CLR125 的 Ib 期試驗中完成首批患者給藥；CLR125 為我們的 OJ 發射型放射性偶聯物，適用於復發／難治性三陰性乳癌（TNBC）。TNBC 是一種侵襲性乳癌亞型，其特徵為缺乏雌激素受體、黃體素受體及 HER2 蛋白表現。由於缺乏常見治療標的，使 TNBC 特別難以治療，除化療外可用選項有限。

TNBC tends to grow and spread more quickly than other breast cancer types and disproportionately affects younger women and those of African descent. In the US approximately 12% of breast cancer diagnoses are triple-negative breast cancer. CLR125 with its demonstrated selective tumor uptake, promising activity in preclinical models of TNBC gives us confidence in its potential to be an effective treatment for TNBC. The Phase Ib clinical trial is an open-label dose-finding study in patients with relapsed/refractory TNBC. It will evaluate three dose levels and dosing regimens of CLR125.

TNBC 相較其他乳癌類型更容易快速生長與擴散，且對年輕女性及非洲裔族群影響比例較高。在美國，約 12% 的乳癌診斷為三陰性乳癌。CLR125 已證實具選擇性腫瘤攝取，且在 TNBC 的臨床前模型中展現具前景的活性，讓我們對其成為有效 TNBC 治療的潛力充滿信心。Ib 期臨床試驗為開放標籤的劑量探索研究，對象為復發／難治性 TNBC 患者。該試驗將評估 CLR125 的三個劑量水準與給藥方案。

32.75 millicuries administered over four cycles or 62.5 millicuries per meter squared over three cycles or 95 millicuries per meter squared over two cycles, with approximately 15 patients enrolled per treatment arm with an expansion arm of an additional 15 patients for the recommended Phase II dose.

分別為：32.75 millicuries 於四個療程給藥；或每平方公尺 62.5 millicuries 於三個療程給藥；或每平方公尺 95 millicuries 於兩個療程給藥；每個治療組別約納入 15 名患者，並設有擴增組再增加 15 名患者，以確定建議的第二期劑量。

The study utilizes dosimetry assessments to characterize tumor uptake and distribution, which supports the prediction of safety and therapeutic activity. Clinical endpoints include safety, tolerability as well as preliminary efficacy measures, including tumor response per RECIST criteria and progression-free survival.

本研究採用劑量測定（dosimetry）評估以描繪腫瘤攝取與分布特性，支持對安全性與治療活性的預測。臨床終點包括安全性、耐受性，以及初步療效指標，包括依 RECIST 標準評估的腫瘤反應與無進展存活期。

The study is well underway and our first patients already treated, and we look forward to sharing biodistribution, dosimetry and early clinical efficacy insights as the year progresses. Overall, 2026 is shaping up to be a year of substantial execution and progress across the organization, and we remain focused on advancing each program with scientific rigor and regulatory discipline.

研究進展順利，我們的首批患者已完成治療；隨著今年推進，我們期待分享生體分布、劑量測定與早期臨床療效的洞見。整體而言，2026 年正逐步成為公司在各面向大幅執行與推進的一年；我們仍專注以科學嚴謹性與監管紀律推動各項計畫。

With that overview of our clinical progress and plans moving forward, I'll turn the call back to Jim for closing remarks.

以上為我們臨床進展與後續規劃的概述，接下來我把電話交回 Jim 作結語。

All right. Thank you, Jarrod. As we look ahead, Cellectar enters the next phase of 2026 with clarity of purpose, strong momentum and the financial resources to execute. The combination of compelling 12-month iopofosine data and a significantly strengthened balance sheet positions us to advance with the initiation of our Phase III confirmatory study and subsequent accelerated approval application. The WM patient community remains at the heart of our commitment.

好的。謝謝你，Jarrod。展望未來，Cellectar 以明確目標、強勁動能與可執行的財務資源，進入 2026 年下一階段。具說服力的 iopofosine 12 個月數據，加上大幅強化的資產負債表，使我們得以推進第三期確認性研究的啟動，以及後續的加速核准申請。WM 患者社群始終是我們承諾的核心。

We continue to hear from and remain motivated by individuals and families affected by WM, particularly those patients with limited treatment options or those that are no longer treatment seekers because of poor or no remaining treatment options. The product profile presented by iopofosine reinforce our belief that this therapy has the potential to be truly meaningful and potentially life-changing for these patients in need.

我們持續聽到 WM 受影響的個人與家庭的聲音，並因此受到激勵；尤其是那些治療選項有限的患者，或因剩餘治療選項不佳或已無選項而不再尋求治療的患者。iopofosine 所呈現的產品特性強化了我們的信念：此療法有潛力對這些有需求的患者帶來真正有意義、甚至可能改變生命的影響。

At the same time, we remain disciplined towards of capital, focused on creating long-term shareholder value by advancing differentiated assets, engaging constructively with regulators and executing against clearly defined milestones. I want to take this opportunity to thank the entire Cellectar team for their continued dedication and sense of urgency. And I thank our investors for their continued support and conviction. We are committed to delivering on both our mission for patients and our responsibility to shareholders.

同時，我們在資本運用上保持紀律，專注於透過推進具差異化的資產、與監管機關進行建設性互動，並依明確界定的里程碑執行，以創造長期股東價值。我想藉此機會感謝整個 Cellectar 團隊持續的投入與緊迫感。也感謝投資人持續的支持與信念。我們致力於同時履行對患者的使命，以及對股東的責任。

With that, operator, we are happy to open the call for questions.

那麼，接線員，我們很高興現在開放電話會議進行提問。

(Operator Instructions)

(接線員指示)

Kevin DeGeeter, Ladenburg Thalmann.

Kevin DeGeeter，Ladenburg Thalmann。

Hey, good morning, guys. Thanks for taking my question. My first question is on CLOVER WaM and specifically for the BTK experienced patients. did most patients go directly from a BTK inhibitor to study drug in CLOVER WaM or for the patients that did get lines of therapy between a BTK and coming on study drug, what were the most common therapies they received immediately prior to study drug?

嗨，早安，各位。謝謝讓我提問。我的第一個問題是關於 CLOVER WaM，特別是針對有 BTK 治療經驗的患者。CLOVER WaM 中大多數患者是否是從 BTK 抑制劑直接轉到研究用藥？或者對於在 BTK 與進入研究用藥之間還接受過其他治療線的患者，他們在研究用藥前最常見的立即前序治療是什麼？

Hi, Kevin, this is Jim. First of all, thank you for your participation in the call today. And your question is spot on. It's significant on a number of different levels, and I'll ask Jarrod Longcor to address it.

嗨，Kevin，我是 Jim。首先，感謝你今天參與這通電話會議。你的問題切中要點。它在多個層面都很重要，我會請 Jarrod Longcor 來回答。

Hi, Kevin, briefly, I don't have the number -- the exact number in my head at the moment, but I can say that it was over 50% of patients in the study, who immediately came off BTKi before getting treatment with iopofosine. Most common -- in addition to that as the most common sort of transition, the other would be coming directly off of rituximab either monotherapy or in combination with chemotherapy.

嗨，Kevin，簡單說，我現在腦中沒有確切數字，但我可以說，研究中有超過 50% 的患者是在接受 iopofosine 治療前，剛從 BTKi 停藥後立即進入的。最常見的——除了這種最常見的轉換之外，另一種則是直接從利妥昔單抗（rituximab）停藥後進入，可能是單藥治療或與化療合併。

That was Really helpful. And then with regard to the Phase III program, thanks for the additional color. Can you comment on what the likely comparator arm for the Phase III program will be or at least -- or I think the question I'm ultimately interested is how one might think about potential range of PFS for the control arm population in a potential Phase III population?

這非常有幫助。另外，關於第三期計畫，謝謝你補充更多細節。你能否評論一下第三期計畫可能的對照組會是什麼？或者至少——我最終想了解的是，在潛在的第三期族群中，對照組人群的 PFS 可能落在什麼範圍？

No, excellent question, Kevin. We've had -- we've engaged our friends at the FDA a number of different times on this. So we've settled in and are aligned on the comparator arm in the study. I could have Jarrod talk to that and provide some additional color.

不，這是個很棒的問題，Kevin。我們已經——就這點與 FDA 的朋友多次溝通。因此我們已經確定並與其在研究的對照組上達成一致。我可以請 Jarrod 談談並提供更多說明。

Yeah, so it is a great question. So what we believe the -- or what we've aligned on with the agency on the comparator arm is rituximab, cyclophosphamide, dexamethasone or RCD. It is commonly used in a post-BTKi patient population that tends to have significant adverse events associated with any of the other treatments and provides a comparable sort of outcome to some of the other treatment scenarios. So it makes a good choice.

是的，這確實是個好問題。我們認為——或者說我們與主管機關就對照組達成一致的是利妥昔單抗、環磷醯胺、地塞米松，也就是 RCD。它常用於 BTKi 後的患者族群，這些患者通常對其他治療伴隨顯著不良事件，而 RCD 能提供與其他治療情境相當的結果。所以它是個很好的選擇。

I will say since you sort of asked the question about how to think about these compounds and how they might behave because obviously, in the literature, what you will find is that RCD, the last time it was significantly sort of challenged or experienced in various studies was pre-BTKi being in the marketplace.

我也想說，既然你問到如何看待這些藥物以及它們可能的表現，因為很明顯，在文獻中你會看到，RCD 上一次在各種研究中被大量檢驗或使用，是在 BTKi 尚未上市之前。

And so what you best bet is to look at an article that came out from a group, I'll call it Anna Frustaci out of Italy, where they demonstrated that with any rituximab combination and essentially any salvage therapy, progression-free survival in those patients varied anywhere from about 5.8 to 8.1 months in a post-BTKi exposed patient population and refractory for the earlier numbers.

因此，你最好的參考是義大利一個團隊（我稱之為 Anna Frustaci 團隊）發表的一篇文章，他們顯示在 BTKi 暴露後的患者族群中，任何利妥昔單抗合併方案以及基本上任何救援治療，其無進展存活期大約介於 5.8 到 8.1 個月；而較早的數字則是在難治族群中。

So the 5.8 was a refractory patient population, which in our case, with the pivotal study or the confirmatory study that we're designing, which is essentially an immediate post-BTKi patient population following the frontline therapy. What we expect to see is the vast majority of those patients to be refractory to the BTKis' when they enter into the clinical study.

所以 5.8 個月是難治患者族群；而在我們正在設計的關鍵性研究或確認性研究中，基本上是第一線治療後、緊接著 BTKi 之後的患者族群。我們預期，這些患者在進入臨床研究時，絕大多數都會對 BTKi 呈現難治。

And the refractory to BTKi population in that salvage therapy, including these RCD combinations were approximately 5.8 months, correct?

而在那個救援治療中，對 BTKi 難治的族群，包括這些 RCD 合併方案，其無進展存活期大約是 5.8 個月，對嗎？

Correct.

對。

And out of the Phase II CLOVER WaM, our progression-free survival with iopofosine.

而在第二期 CLOVER WaM 中，我們使用 iopofosine 的無進展存活期。

It was over 15 months.

超過 15 個月。

In that same patient population. I think the other element there, Kevin, if you could take a moment and just talk to the powering of the study, the 100 in each arm and based on that differential, your level of confidence relative to how the study was powered.

在同樣的患者族群中。我想另一個要素是，Kevin，如果你能花點時間談談研究的統計把握度（power），每組 100 人，並基於這個差異，你對研究設計把握度的信心程度。

Yeah, so to Jim's point on the powering, what we did was we assumed for the comparator arm, essentially a hazard ratio that corresponds to an eight-month progression-free survival. And for the iopofosine arm, we used a hazard ratio that assumed no greater than a 12-month progression-free survival.

是的，針對 Jim 提到的把握度，我們的做法是：對照組方面，我們假設的風險比（hazard ratio）相當於 8 個月的無進展存活期。而在 iopofosine 組，我們使用的風險比假設其無進展存活期不低於 12 個月。

So obviously, as Jim just said, our expectation is really that the -- with the vast majority of the patients being BTKi refractory, we're going to see something likely closer to six months of progression-free survival of the per arm. And if the patients behave as they did in the CLOVER WaM study, we would expect something closer to 15 months in the iopofosine arm, thereby essentially overpowering the study by a number of patients in order to ensure success.

所以很明顯，正如 Jim 剛才所說，我們的預期是——由於絕大多數患者對 BTKi 為難治，我們可能會看到每組的無進展存活期更接近 6 個月。而如果患者的表現與 CLOVER WaM 研究相同，我們預期 iopofosine 組會更接近 15 個月，因此我們等於以更多的受試者數量讓研究「超額」具備把握度，以確保成功。

Makes a lot of sense. And if I could just sneak in one more. I think just one of the questions that might be on investors' minds is just how you're thinking about the potential timing for an NDA submission under accelerated approval for WM.

非常合理。如果我可以再補問一個。我想投資人心中可能有個問題是，你們如何看待 WM 在加速核准途徑下提交 NDA 的可能時間點？

It's pretty straightforward from our perspective. I mean, we're planning to initiate the study, as Jarrod had cited at the very back end of this year. Once we have the study up and running, enrolling patients, and that may be a couple of two, three months. At that point, we would submit our new drug application.

從我們的角度來看相當直接。我的意思是，我們計畫在今年年底、如 Jarrod 在最後提到的那樣啟動研究。一旦研究啟動並開始收案，可能需要兩三個月。到那時，我們就會提交新藥申請（NDA）。

Please keep in mind that in May of last year, we received our breakthrough designation, which essentially obligates the FDA to -- for a six-month window prior to regulatory action. So if you initiate at the very back end of this year, wait a couple of two or three months and then have the FDA action within 6 months of that submission. You're in the second half of 2027 with a potential approval.

請記得，我們在去年 5 月獲得突破性療法認定（breakthrough designation），這基本上要求 FDA 在採取監管行動前提供一個為期 6 個月的窗口期。因此，如果你在今年年底啟動，等兩三個月後提交，然後 FDA 在提交後 6 個月內採取行動。那麼潛在核准時間點會落在 2027 年下半年。

Great. Thanks for taking my questions.

很好。謝謝回答我的問題。

All right, Kevin. Thank you.

好的，Kevin。謝謝你。

(Operator Instructions)

(接線員指示)

There are no further questions at this time.I will now turn the call over to Jim Caruso for final remarks.

目前沒有其他問題。我現在把電話交回給 Jim Caruso 作結語。

All right. Thank you, operator. I appreciate your assistance today. And certainly, thank you to all conference participants for both your time and continued interest in Cellectar. Have a good day.

好的。謝謝你，接線員。感謝你今天的協助。也誠摯感謝所有與會者撥冗參與，以及持續關注 Cellectar。祝各位有美好的一天。

And thank you, ladies and gentlemen. This concludes today's conference call. Thank you for your participation. You may now disconnect.

也謝謝各位女士先生。今天的電話會議到此結束。感謝各位的參與。您現在可以掛線。