Cellectar Biosciences Inc (CLRB) 2026 Q2 法說會逐字稿

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

各位女士、先生，早安。感謝您耐心等候並歡迎加入。(接線員指示) 請注意，今天的電話會議可能會被錄音。

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

現在我想將電話交給 Precision AQ 董事總經理 Anne Marie Fields。請開始。

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 radiopharmaceutical.

謝謝，接線員。各位早安，歡迎參加 Cellectar Biosciences 2026 年第二季財務業績與業務更新電話會議。今天與會的 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 Kolean 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 issued a press release earlier this morning detailing the contents of today's call. A copy can be found on the Investor page of Cellectar's corporate website. I want to remind callers that the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. 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.

Cellectar 今早稍早已發布新聞稿，詳述今日電話會議內容。副本可於 Cellectar 公司網站的投資人頁面查閱。提醒各位來電者，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，管理層將作出前瞻性陳述。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。

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 after 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 calling webcast.

上述前瞻性陳述在其整體上均受今日新聞稿及我們向 SEC 提交文件中所載之警示性聲明所限制。本次電話會議內容包含具時效性的資訊，僅在本次直播日期（2026 年 8 月 13 日）當日為準確。公司不承擔任何義務在本次電話會議網路直播日期之後，因事件或情況變化而修訂或更新任何前瞻性陳述。

As a reminder, this conference calling 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?

提醒各位，本次電話會議網路直播將被錄音並存檔。我們將先進行預先準備的發言，之後開放提問。現在我把電話交給 Jim Caruso。Jim？

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.

謝謝你，Anne Marie，也感謝各位今天早上加入我們。第二季對 Cellectar 而言是一段特別高產的期間；我們在業務各個面向持續取得具意義的進展，包括臨床開發、法規推進、產品線推進、平台擴展，以及強化財務狀況。

Our near-term priority remains clear: advancing iopofosine I 131 for patients with relapsed or refractory Waldenström macroglobulinemia or WM, particularly those patients whose disease has progressed following earlier lines of treatment, including BTK inhibitor therapy. We believe this represents significant unmet medical need and an attractive opportunity to bring a differentiated treatment option to patients who currently face limited therapeutic alternatives.

我們的近期優先事項仍然明確：推進 iopofosine I 131 用於復發或難治性華氏巨球蛋白血症（Waldenström macroglobulinemia，WM）患者，特別是那些在先前治療線（包括 BTK 抑制劑治療）後疾病仍進展的患者。我們認為這代表重大的未被滿足醫療需求，也是一個具吸引力的機會，能為目前治療選擇有限的患者帶來具差異化的治療方案。

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.

在本季期間，我們採取了數項重要步驟以推進此一策略。首先，我們公布了 CLOVER WaM 研究完整的 12 個月追蹤結果。這些數據進一步強化了 iopofosine 所達成反應的深度與持久性，並顯示該研究成功達成其主要與次要終點。綜合而言，我們相信迄今所產生的整體證據持續支持 iopofosine 有潛力成為 WM 患者的重要治療選項。

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.

第二，我們持續建立更具說服力的 iopofosine 臨床數據集。我們在 ASCO 2026 發表了 CLOVER WaM 研究的新數據，重點呈現於 BTKi 治療後立即接受治療之患者的結果，該族群屬於治療具挑戰性的患者群。結果顯示主要反應率為 79.2%、總反應率為 87.5%、臨床獲益率為 100%，且持久性令人鼓舞，中位反應持續時間為 16 個月。

Most importantly, we have now initiated site activation activities for our planned confirmatory Phase 3 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 six-month review is anticipated.

最重要的是，我們現已啟動規劃中的確認性第三期研究之試驗中心啟用（site activation）相關作業。這是我們法規策略中的關鍵里程碑。一旦完成必要的試驗中心啟用並達成持續的病患收案，我們預期可在 2027 年年中依 FDA 加速核准計畫提交新藥申請（NDA）。基於 iopofosine I 131 針對復發/難治性 WM 所獲得的突破性療法認定，預期審查期約為六個月。

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.

為支持上述工作，我們很高興於 5 月完成一項超額認購的融資，該融資有潛力提供最高達 1.4 億美元資金，包括 3,500 萬美元的前期款，以及最高達 1.05 億美元與未來里程碑連動的資金。此融資顯著強化我們的資產負債表，並提供執行 WM 策略、推進法規計畫，以及持續投資於更廣泛放射性藥物產品線所需的資源。

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.

除 WM 之外，我們也持續推進由磷脂藥物偶聯（Phospholipid Drug Conjugate，PDC）平台所代表的更廣泛機會。PDC 平台是一項高度差異化的標靶技術，旨在選擇性地將治療性載荷遞送至癌細胞，包括原發腫瘤、轉移病灶以及癌症幹細胞。

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.

重要的是，該平台具高度多樣性，可與多種載荷與同位素結合，包括 β 放射（beta-emitting）、奧傑放射（Auger-emitting）以及 α 放射（alpha-emitting）的放射治療藥物。我們相信 iopofosine 所展現的成功正在驗證此平台，並為未來產品線擴展奠定堅實基礎。

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.

今天，除了討論 iopofosine 的進展外，我們也將回顧 CLR 125（我們在實體腫瘤的奧傑放射計畫）的進展，並說明我們計畫如何運用該平台打造下一代放射性藥物事業版圖。

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

以上為概述，接下來我把電話交給 Chad 進行財務回顧。

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.

謝謝你，Jim，各位早安。首先，我將花幾分鐘談談 Jim 提到的融資。如他所述，該交易為公司提供目前及預期未來的資金，以支持我們取得 iopofosine I 131 核准的策略。公司就普通股與預付認股權證（pre-funded warrants）收到 3,500 萬美元的總額前期款，或約 3,170 萬美元的淨額。

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. Furthermore, these warrants are callable for cash by the company if the respective milestone and related criteria are met.

此外，我們發行了三個批次（tranches）的認股權證，每一批約 1,320 萬美元；目前均可行使，行使價為 2.65 美元。此外，若達成各自的里程碑及相關條件，公司可要求以現金方式贖回（call）這些認股權證。

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 and Waldenström macroglobulinemia or WM patients.

每一批次的認股權證（A、B 與 C）皆對應一項里程碑。A 批次認股權證將於 2027 年 7 月 7 日到期，其里程碑為在 iopofosine I 131 針對華氏巨球蛋白血症（WM）患者之確認性研究中完成首位病患收案。

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 the milestone of approval by the FDA of iopofosine for marketing.

B 批次認股權證將於 2028 年 7 月 7 日到期，其里程碑為 FDA 受理 iopofosine 的新藥申請（NDA）。C 批次認股權證將於 2031 年 7 月 7 日到期，其里程碑為 FDA 核准 iopofosine 上市。

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 VWAP must average a minimum of $500,000 for those same 20 trading days.

除達成里程碑外，認股權證要能被公司召回（callable）還必須符合另外兩項條件。第一，公司股票的成交量加權平均價（VWAP）必須連續 20 個交易日至少為 3.45 美元。第二，以 VWAP 為基礎的交易流動性在同樣這 20 個交易日內，平均必須至少達到 50 萬美元。

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.

里程碑的時間安排旨在於預期的研究啟動、向 FDA 提交，以及核准等階段提供所需資金。我們相信，若此結構能如設計般實現，將可支持公司在 iopofosine 初期商業化之前的資本需求。

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.

接下來說明截至 2026 年 6 月 30 日期間的財務結果。我們第二季期末的現金及約當現金約為 3,400 萬美元，相較於 2025 年 12 月 31 日的 1,320 萬美元增加，反映出 5 月融資初始部分所帶來的現金流入。

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. 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.

接著看營運結果，截至 2026 年 6 月 30 日止三個月的研發費用約為 460 萬美元，較截至 2025 年 6 月 30 日止三個月約 240 萬美元增加。研發費用整體增加主要反映臨床研究活動提升，以支持我們在三陰性乳癌的 CLR 125 研究，以及啟動 iopofosine I 131 於 WM 的確認性研究。

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. The decrease in G&A was driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs.

截至 2026 年 6 月 30 日止三個月的一般及行政費用為 260 萬美元，較 2025 年同期的 360 萬美元下降。G&A 的下降主要由專業服務費用降低、商業化前期工作減少，以及人事成本下降所致。

Net loss for the three 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 three months ended June 30, 2025. The enhanced strength of our balance sheet enables our ability to effectively advance our clinical and regulatory programs.

截至 2026 年 6 月 30 日止三個月的淨損為 690 萬美元（每股 0.57 美元），相較於截至 2025 年 6 月 30 日止三個月的淨損 540 萬美元（每股 3.39 美元）。資產負債表的強化使我們能更有效地推進臨床與法規計畫。

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

接下來我將把電話會議交給 Jarrod，請他說明我們在 2026 年上半年於法規與臨床方面所取得的進展。

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.

謝謝你，Chad，各位早安。如 Jim 所提到的，我們在臨床、法規與開發計畫上持續取得實質進展，並相信 Cellectar 正進入一個重要的執行階段，前方有多個可驅動價值的里程碑。

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.

我們的首要重點仍是推進 iopofosine I 131 在 WM 的潛在註冊申請；在此適應症上，我們已累積具說服力的臨床證據，並建立清晰的法規推進路徑。我們對 CLOVER WaM 研究所持續產出的數據一致性感到鼓舞，該研究在具有重大未被滿足醫療需求的病患族群中，持續展現具意義且持久的反應。

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.

在本季期間，我們透過兩項重要的數據更新擴充了臨床證據基礎。第一，我們在 ASCO 發表新的分析，重點呈現於 BTKi 抑制劑治療後立即接受治療之病患的結果；這是一個特別具挑戰性的情境，治療選項仍然有限。

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.

正如 Jim 幾分鐘前提到的，我們在這些病患中顯示約 80% 的主要反應率，以及 16 個月的持久性。我們也回報 CLOVER WaM 研究所有病患完整的 12 個月追蹤數據集，進一步強化其持久性：中位持久性為 17.8 個月，且約 62% 的病患達到主要反應。

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.

此外，觀察到 iopofosine 的反應深度會隨時間增加；在這些後線、對治療高度難治的病患中，「非常好的部分緩解」與「完全緩解」率提升至 14.5%。重要的是，我們現在正把這些臨床成果轉化為法規與營運層面的執行。

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. 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.

我們已啟動規劃中的第 3 期確認性試驗之試驗中心啟用（site activation）相關工作，並預期首批試驗中心將在未來數月開放，這是開發策略中的關鍵里程碑。此研究旨在支持長期註冊需求，同時也使我們能在 2027 年於美國提交規劃中的加速核准途徑申請。

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.

我們將此試驗開始對病患給藥視為一項重要的近期催化劑，並相信可能在今年年底或明年年初發生；這是將 iopofosine 帶給迫切需要新治療選項之病患的重要一步。

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.

除 WM 之外，我們也持續擴大 iopofosine 以及我們專有的磷脂藥物偶聯（Phospholipid Drug Conjugate，PDC）平台的機會。我們近期在同儕審查期刊《Cancers》發表的多發性骨髓瘤數據，進一步支持 iopofosine 具差異化的作用機制，並凸顯其在多種 B 細胞惡性腫瘤中的潛在適用性，包括 WM、多發性骨髓瘤、瀰漫性大 B 細胞淋巴瘤（DLBCL），以及其他難以治療、亟需新療法的血液腫瘤。

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 1b trial of CLR 125 and Triple Negative Breast Cancer and remain on track to record 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.

同時，我們也在推進下一代放射藥物產品線；近期已在 CLR 125 針對三陰性乳癌的第 1b 期試驗中完成首批病患入組並給藥，並仍按計畫於今年稍晚或明年年初取得初步的劑量測定（dosimetry）、安全性與療效數據。綜合而言，我們相信這些成果凸顯了我們平台日益獲得驗證、開發策略的強度，以及前方龐大的機會。

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.

與此同時，我們持續推進我們認為是當今放射藥物開發領域中最具創新性、差異化且多用途的標靶平台之一。我們專有的 PDC 平台旨在透過一種不依賴特定腫瘤突變或表面抗原的機制，選擇性地標靶癌細胞。

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.

我們相信，這使其能在血液惡性腫瘤以及實體腫瘤中實現近乎普遍的腫瘤標靶，同時提供可搭載多種治療載荷（payload）的彈性遞送載體。該平台已透過 iopofosine 取得臨床驗證，並作為我們下一代產品線的基礎，包括 CLR 125、我們的奧傑電子（Auger）放射治療計畫，以及 CLR 225（α 粒子發射）計畫。

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.

我們相信這些計畫代表顯著的長期價值創造機會，並展現該平台在多種癌症適應症上的廣泛性。PDC 平台的一項獨特優勢是其彈性。透過以相似的標靶骨幹搭配不同的治療載荷，我們有潛力開發多個產品候選藥物以涵蓋多種腫瘤類型，同時運用我們在腫瘤攝取、生物分布與安全性方面已累積的豐富知識。

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 as Cellectar's technology and pipeline.

為了就此機會提供更多洞見，我們將於8月18日舉辦一場教育性網路研討會。在本次活動中，我們的管理團隊成員將討論PDC平台的科學基礎、其差異化的標靶能力、我們在各項臨床計畫上取得的進展，以及我們所看到該平台未來的重大機會。我們鼓勵各位一同參與；我們相信，隨著Cellectar的技術與產品線推進，這將是一場關於長期潛力、內容充實且引人入勝的討論。

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.

整體而言，我們對今年上半年在臨床、法規與產品線推進等各項計畫所取得的進展感到滿意。我們相信公司已為下一階段的發展做好充分準備，並將持續專注於落實接下來的各項里程碑。

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

接下來，我把電話交回給Jim作結語。

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.

好的。謝謝你，Jarrod。展望未來，我們相信Cellectar正進入一個重要、令人振奮且具轉型意義的時期。我們當前的重點是執行推進iopofosine用於WM的下一步所需工作。

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

憑藉具說服力的臨床數據、已在進行中的試驗中心啟動工作，以及清晰的法規推進路徑，我們正朝著啟動確認性第3期研究邁進；我們視其為關鍵催化劑，也是朝向我們規劃的加速核准申請的重要一步，而該申請在美國仍維持於今年上半年按計畫推進。

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.

同時，隨著我們今年稍早完成超額認購的融資，我們在財務上也處於有利位置，這為我們提供了執行短期目標所需的資源。重要的是，正如Jarrod剛才回顧的，我們相信這個機會遠不止於單一產品。

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.

我們在iopofosine方面取得的進展，持續驗證了PDC平台的根本優勢，並進一步強化我們將該技術擴展至更多放射性藥物計畫的信心，其中包括針對實體腫瘤的Auger放射與α放射產品候選藥物。

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.

為此，我鼓勵各位聽眾參與我們於8月18日舉辦的教育性網路研討會。我們的願景是打造一家領先的放射性藥物公司，以多用途、經臨床驗證的遞送平台為基礎，能在血液腫瘤與實體腫瘤適應症上創造多項產品機會。

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.

在法規、臨床與公司層面各項計畫皆具強勁動能之下，我們期待在2026年剩餘期間以及進入2027年後，持續分享更多里程碑進展。我也要一如既往地感謝我們的員工、研究人員，最重要的是病患，以及我們的股東與合作夥伴，感謝各位持續支持並投入我們的使命。

Operator, we're now prepared to take questions.

接線員，我們現在準備開始回答問題。

(Operator Instructions) Kevin DeGeeter, Ladenburg.

(接線員指示) Kevin DeGeeter，Ladenburg。

Exciting time. A couple of questions from us. First off, on the Phase 3 WM program, can you just walk us through a little bit more granularity, the great limiting steps to first patient enrolled? I think you've mentioned just site activation, presumably the IRB, but kind of any other factors that may drive kind of your guidance to be earlier kind of 4Q versus 1Q, '27?

令人振奮的時刻。我們有幾個問題。首先，關於WM的第3期計畫，你能否更細緻地帶我們了解一下，從現在到第一位病患入組之前的主要限制步驟有哪些？我想你們提到過試驗中心啟動，推測也包括IRB，但還有沒有其他因素會影響你們的指引，讓時間點偏向較早的第4季，而不是2027年第一季？

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. Thank you.

另外，你能否釐清一下，觸發可能向FDA提交申請的條件是什麼？是達到特定的入組人數，還是較偏質性的標準？如果能再提供更細的說明會很有幫助。謝謝。

All right. Terrific. First of all, Kevin, thank you for your participation today in support of the company. It's very much appreciated.

好的。非常好。首先，Kevin，感謝你今天參與並支持公司。我們非常感激。

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 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.

這是一個重要的問題；正如你所預期，啟動確認性研究需要投入大量工作，尤其是像這樣規模的研究。我們對目前為止取得的進展感到非常滿意，並且對回應感到特別高興：不僅來自那些治療相當比例復發／難治性WM族群的學術醫療中心服務區（catchment centers），也來自社區網絡與整合式腫瘤照護網絡；這些機構通常在一般社區中診斷並治療這些病患。

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.

當然，在轉介至這些在治療高度難治性WM方面享譽全球的機構之前，病患往往會先在前幾線治療中於其他機構接受照護。因此我們正在評估所有客戶區隔，坦白說也包括同樣能接觸到大量病患的社區型機構。

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.

補充背景說明，在美國有15個州基本上涵蓋了WM人口的80%，因此這是一個高度聚焦的市場。而在這些地理社群內及其周邊，上述各個區隔——整合式腫瘤照護網絡、社區型醫院以及學術中心——共同為這些病患族群提供治療。

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. Jarrod?

總之，基於上述情況，我們對目前所處的位置感到非常滿意。就時程而言，我們仍按計畫推進。我會請Jarrod說明你問題中的細節，但我們仍將大約3月、4月的時間點視為與FDA的夥伴進行加速核准申請提交的目標。Jarrod？

Sure, so as you mentioned, there's a number of steps that go into the, obviously, the start-up process, just to 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.

好的，如你所提到，啟動流程中包含許多步驟；我先概述幾個。一般而言，流程真正開始的方式是——我可能會提供過多細節——在啟動之初，你首先要與CRO簽約，並把與CRO相關的文件建置到位。

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, what countries you want to go to, and so on and so forth from that.

這不僅是合約本身，還包括所有支援性文件。也就是所有必要的研究者函件、研究運作所需的各項文件與SOP，並確保一切相互一致。之後，你會進入下一階段，也就是試驗中心辨識：確認你要鎖定哪些中心、要進入哪些國家等等。

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 and what timeframe.

接著會進入所謂的可行性（feasibility）步驟：你向各試驗中心與研究者提交可行性問卷；他們會收到基本的試驗方案摘要，進行審閱，判斷是否有意願參與，並提供他們可能入組的病患數量以及可能的時間框架。

After that, you move into what's called the qualification page, which is obviously with the radiopharmaceutical. It's not like taking an oral antibiotic per se, right? In this case, you got to have an infusion suite, you got to be able to handle a 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.

之後，你會進入所謂的資格審查階段（qualification），這在放射性藥物上尤其重要。這不像口服抗生素那樣簡單，對吧？在這種情況下，你必須具備輸注治療空間，並且能夠取得與處理I 131相關的執照。因此你必須完成整個流程，並同時蒐集所有相關文件。

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.

接著你就往下推進，如你所說，會進入 IRB 階段。IRB 階段到來後，場址合約簽訂也會開始；有時可以並行進行，有時不行。而這取決於情況；正如 Jim 所說，我們同時獲得了社區中心以及學術中心的高度興趣。

When you think about community centers, we can use a central IRB. That allows them to improve 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.

談到社區中心時，我們可以使用中央 IRB。這讓他們能更快改善並更快推進。不過，一些較偏學術的中心除了中央 IRB 之外，往往還會有本地 IRB，因此會多一道 IRB 審查流程。

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.

除此之外，許多學術中心也有內部委員會，必須以最終完整版方案與統計分析計畫來審查該試驗方案，之後他們會投票決定是否參與，並從那一步進到下一步，也就是合約簽訂。之後，你必須訓練各中心並啟動整個流程，接著進行真正的場址啟動（site initiation），讓他們得以開站並開始篩選病人，然後迎來首位受試者入組（first patient in）。

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 or early next year.

所有這些執行與營運面的工作都在背景同步進行；正如我們在事先準備的發言中所說，我們已啟動其中許多工作，並且正按計畫推進。我們相信在接下來幾個月內的幾個月時間裡，首批場址將會開站；而首位受試者入組的時間點，可能在今年稍晚或明年初。

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 -- 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.

至於 FDA 送件以及其關鍵門檻（gating aspect）是什麼，依 FDA 的定義，關鍵門檻是——場址必須——研究必須已啟動，且用他們的話說是「正在進行中」。也就是：送件時已啟動、監管處置（regulatory action）時仍在進行中；但 FDA 並未定義「正在進行中」的具體含義。

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'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.

他們不會就此主題提供任何清楚、直接的指引。因此你只能自行估算你認為那可能代表什麼。我們知道他們基本上是在要求：公司在申請加速核准（accelerated approval）時，必須對確認性試驗（confirmatory studies）的執行保持勤勉，並且在他們做出監管處置時仍持續勤勉執行。

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 got a couple 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 six to eight months after the submission goes in.

我們對此的解讀是：在送件時，我們希望有一定數量的場址已開站——可能是 10 到 20 個場址開站；並且最好在送件時就已經有幾位病人完成入組。接著在監管處置時（也就是送件後 6 到 8 個月），希望入組人數達到約 5% 或以上。

Does that help?

這樣有幫助嗎？

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

非常細緻。謝謝你說得這麼清楚。另外，關於 CLR 125，這是一個很有意思的資產；請跟我們談談初步的學習——我想是關於劑量對稱性（dose symmetry）數據——以及可能的時間線。我知道你提到了里程碑，但對這個令人振奮的專案，尚未給出具體的數據更新時間點。

Yeah. So I'm going to stay very vague on what we know about the December trends 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 Conference obviously as an opportunity -- one potential opportunity to present data as it relates to that program, as well as other opportunities as maybe warrant to provide a data update around the program.

好的。所以我會對我們所掌握的 12 月趨勢等等保持相當模糊。原因是——坦白說——我們確實預期能在今年稍晚提供一些數據。我們正在關注聖安東尼奧乳癌研討會（San Antonio Breast Cancer Conference），顯然那是一個機會——其中一個可能的機會——來發表與該專案相關的數據；同時也會視情況在其他場合提供該專案的數據更新。

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 of what we know about the targeting ligand and what we've known from iopofosine.

我能說的是，我們知道腫瘤的攝取（uptake）非常好。我們看到的分佈情況，符合基於我們對靶向配體（targeting ligand）的了解，以及我們從 iopofosine 所掌握的資訊所做出的預期。

And we see 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 1b dose finding study is, optimizing and looking at how we optimize the dose ideally for patients.

而且我們看到它非常可預測，並且與我們原本的預期一致。因此接下來我們要做的，正如你對一項第 1b 期劑量探索研究（Phase 1b dose finding study）所預期的那樣，就是進行最佳化，並研究如何為病人理想地最佳化劑量。

Kemp Dolliver, Brookline Capital Markets.

Kemp Dolliver，Brookline Capital Markets。

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

有幾個問題。你們已經開始為試驗製造供應量。目前你們是否正在為 iopofosine 131 製造任何商業供應量，或計畫在短期內這麼做？

Yeah, so thanks for the question. 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, but those are essentially what I'll call near-term just-in-time or nearly just-in-time productions.

是的，謝謝你的問題。我會說答案是「是」，但我會加上一個但書。這個但書是：很明顯，我們無法製造同位素或最終成品；那些基本上屬於我所稱的短期即時（just-in-time）或近乎即時（nearly just-in-time）的生產。

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, 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.

但就靶向配體而言，我們有相當多的穩定性數據，而我們現在就會生產它。過去幾年我們基本上一直以商業規模在生產。讓你有個概念，我們的配體穩定性已超過五年。因此我們通常會以大規模生產，然後在需要時使用——也就是在我們製造並產出藥品時使用。

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. 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.

如我所說，我們的商業——我指的是最終成品——商業化基礎設施已建置完成並可隨時啟用。當然，一旦我們獲得商業核准——如果我們獲得商業核准，我換個方式說——我們就能在相對短的時間內啟動該生產流程，並透過既有的物流鏈與生產流程出貨藥品。

Yeah, 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 was well beyond any of our potential patient treatment and or revenue models. It was very substantial, close to 1,000 patients, was it?

是的，我們有能力在病人治療量方面大幅擴產，而且可以非常快速地擴增。事實上，從病人角度來看，我們的最大產能是多少？那遠遠超過我們任何可能的病人治療量和／或營收模型。規模非常可觀，接近 1,000 名病人，是嗎？

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 because 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.

是的，我們大約在——我會說以目前來看，我們很容易就能達到大約每週 100 名病人的最終成品供應規模；因為如你所知 Kemp，這些系統的設置方式是，每一個單位的生產基本上是在一個獨立的熱室（hot cell）中完成。

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.

當然，你可以把這些熱室——我姑且這麼稱呼——串接起來（daisy chain）。以我們的情況而言，我們的生產批次實際上能產出遠多於我們所需的材料。因此即使只用兩到三個熱室，也能提供綽綽有餘的供應量，以達到那種約 100 名病人的規模。

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

太好了。謝謝。接著下一個問題是，在收到加速核准後，你們能多快啟動上市？

So that would be a function of levels of investment and when we determine when to pull particular lever. 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.

這會取決於投資規模，以及我們決定何時啟動特定槓桿。因此，通常至少需要 12 個月，才能為商業化執行做好全面準備。而且我認為在這個特定案例中，由於這個領域具備可擴展性，如我先前提到的，基本上 15 個州就掌控了 80% 的 WM 患者人數。

But when you look at the actual customers triaging those patients, that number gets even more scalable and smaller, which is 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 -- (technical difficulty)

但當你看實際在分流（triage）這些病患的客戶時，這個數字會更具可擴展性、也更小，這也是從商業角度來看這個領域很有吸引力的原因之一，可以說是一塊「白板」。這個領域的競爭張力有限。BTKi 是唯一獲核准的一類藥物。它們主要用於一線、二線及後線治療--（技術問題）

Hi, Jarrod. I think your line is -- there we go.

嗨，Jarrod。我想你的線路是——好了。

A bunch of inbound inquiries relative to the availability of the draw. 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.

有很多關於抽籤（draw）可用性的來電詢問。回到你原本的問題，因為這是一個目標明確的環境，我們可以很快擴大規模。但最終，要完全就緒並動員起來所需的時間，確實取決於你何時針對某些投資層級扣下扳機。

Now, having said that, we also have -- we are delivering appropriate (technical difficulty) 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 of the limited amount of oncology spend that would be required to really drive trial use and adoption.

話雖如此，我們也有——我們正在提供適當的（技術問題）環境，因為那裡競爭張力有限甚至幾乎沒有，或（技術問題）在該領域的醫療行銷商業化機器也不多，基本上相當開放。因此，對像我們這樣的小公司而言，由於真正推動試用與採用所需的腫瘤科支出有限，可能會考慮自行商業化。

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 or et cetera, in terms of the cost of doing business.

不過話說回來，我們也在與第三方合作夥伴討論由他們承接，同時也在與世界級、規模極大且效率極高的商業化組織洽談合作，由他們來推動。因此，三種典型的商業化選項我們都在考慮。我們正在評估全部選項，並且相信相較於乳癌等其他領域，就營運成本而言，我們可以用相對有限的資金，在這個領域非常快速地建立試用與採用。

Great. And 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. And so what's your sense of the availability of actinium-225 now versus, say, a year ago?

很好。我最後一個問題比較偏向產業的宏觀觀點，不過你們在錒-225（actinium-225）方面確實有一些切入點，至少目前還沒進入臨床，但你們對此有興趣。那麼，你對現在錒-225 的供應可得性，相較於例如一年前，有什麼看法？

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, yeah, 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.

好問題，Kemp。我也很喜歡這個問題，因為它讓我可以離題一下、講上幾個小時。謝謝你給我這個機會。我會這麼說：是的，一年前我會說——關於錒，大家對錒的供應鏈都相當擔憂。我不認為這已經完全解決，但我確實認為，隨著我們在這裡推進、也如同大家所預期的，我們已經引入了新的供應商。

I think groups like SpectronRx are now up and consistently supplying actinium in addition to the group ITM and 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.

我認為像 SpectronRx 這樣的團隊現在已經上線並且穩定供應錒，此外還有 ITM 與 Eckert & Ziegler。然後現在 Northstar 也已上線。我想還有一些其他團隊，例如 Ionetix 以及其他幾家，近期也會上線，像是 Nucleus 等等。

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.

因此，我認為從我們今天所處的位置到未來的走向，錒的供應鏈——也就是錒的來源——正在稍微打開一些。不過我確實預期，隨著各項計畫推進，以及某些計畫對更大量錒的需求增加，我們未來可能仍會看到供應收緊與相應的機會。

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 on and then each finished product that gets maybe multi-sourced, all of that through various contractors and in our, what I'll call our collaborative outsourcing model.

而且如你所知，我們在所有生產要素上的策略，一直是對每一個組件都採取多來源供應。因此，從我們的標靶配體到我們使用的每一種放射性同位素，再到每一個最終產品（可能也會多來源供應），這些都透過不同承包商，並在我們所謂的協作式外包模式下完成。

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 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.

而且你可能知道也可能不知道，歷史上我們所做的——特別是在錒方面——是與多方簽訂現成供應協議，我想目前大約有四家，以確保我們能取得並獲得我們計畫所需的供應量，涵蓋短期與長期。

Thank you. And there are no further questions at this time. I will turn it back over to Jim for closing remarks.

謝謝。目前沒有其他問題。我將把時間交回給 Jim 做結語。

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.

很好。感謝今天參與我們電話會議的各位。我們非常感激。特別感謝各位分析師提出非常周到且發人深省的問題。主持人，那麼我們就到此結束本次電話會議。

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.

各位女士先生，本日電話會議到此結束。非常感謝各位的參與，現在可以掛線。祝各位今天愉快。