Clovis Oncology Inc (CLVS) 2022 Q1 法說會逐字稿

Good morning, and welcome to the Clovis Oncology First Quarter 2022 Operating Results Conference Call. (Operator Instructions)

早安，歡迎參加克洛維斯腫瘤學 2022 年第一季營運績效電話會議。 （操作員說明）

I would now like to turn the call over to Anna Sussman, Vice President of Investor Relations and Corporate Communications for Clovis. Please go ahead.

我現在想將電話轉給克洛維斯投資者關係和企業傳播副總裁安娜·蘇斯曼 (Anna Sussman)。請繼續。

Thank you. Good morning, everyone. Welcome to the Clovis Oncology First Quarter 2022 Conference Call. Thank you for joining us. You've likely seen this morning's news release, and if not, it's available on our website at clovisoncology.com. As a reminder, this conference call is being recorded and webcast. Remarks may be accessed live on our website during the call and will be available in our archives for the next several weeks.

謝謝。大家，早安。歡迎參加克洛維斯腫瘤學 2022 年第一季電話會議。感謝您加入我們。您可能已經看過今天早上的新聞稿，如果沒有，可以在我們的網站 clovisoncology.com 上找到。謹此提醒，本次電話會議正在錄製並進行網路直播。通話期間您可以在我們的網站上即時存取評論，並將在接下來的幾週內在我們的檔案中提供。

Today's agenda includes the following: Pat Mahaffy, our President and CEO, will discuss the first quarter and recent highlights, including a summary of the recent ATHENA-MONO top line data readout and the anticipated upcoming clinical milestones for Rubraca. Dr. Thomas Harding, our Chief Scientific Officer, will present an update of our FAP-2286 and targeted radionuclide therapy development programs, including upcoming clinical data presentations for FAP-2286 and in the year. Dan Newell, our Chief Financial Officer, will cover the financial results for the quarter. Patrick will make a few closing remarks, and then we'll open the call for Q&A, during which time, Pat, Tom and Dan will be available to answer questions. Lindsey Rolfe, our Chief Medical Officer, is unable to attend this morning's call and Q&A session, but I'm happy to arrange follow-up calls if indeed needed.

今天的議程包括以下內容：我們的總裁兼執行長 Pat Mahaffy 將討論第一季度和近期亮點，包括最近ATHENA-MONO 頂線數據讀數的摘要以及Rubraca 預期即將到來的臨床里程碑。我們的首席科學官 Thomas Harding 博士將介紹我們的 FAP-2286 和靶向放射性核素治療開發計劃的最新情況，包括即將發布的 FAP-2286 和今年的臨床數據演示。我們的財務長 Dan Newell 將報告本季的財務表現。派崔克將做一些總結發言，然後我們將開始問答環節，在此期間，派特、湯姆和丹將回答問題。我們的首席醫療官 Lindsey Rolfe 無法參加今天早上的電話會議和問答環節，但如果確實需要，我很樂意安排後續電話會議。

Before we begin, please note that during today's conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans. All these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Our actual results could differ materially due to a number of factors, including the extent and duration of the effects of the COVID-19 pandemic and the timing and extent of recovery from it. Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made, and Clovis undertakes no obligation to update or revise any forward-looking statements.

在開始之前，請注意，在今天的電話會議上，我們可能會做出聯邦證券法含義內的前瞻性聲明，包括有關我們的財務前景和預期業務計劃的聲明。所有這些陳述都存在風險和不確定性，可能導致實際結果與前瞻性陳述中描述的結果有重大差異。由於多種因素的影響，我們的實際結果可能會存在重大差異，包括 COVID-19 大流行影響的程度和持續時間以及從中恢復的時間和程度。請參閱我們最近向 SEC 提交的文件，以全面審查與我們業務相關的風險和不確定性。前瞻性陳述僅代表截至其作出之日的情況，克洛維斯不承擔更新或修改任何前瞻性陳述的義務。

Additionally, please note that we'll be discussing cash burn, a non-GAAP financial measure, during today's conference call. Required disclosures related to this are in today's news release, which can be found on our website.

此外，請注意，我們將在今天的電話會議上討論現金消耗，這是一項非公認會計準則財務指標。與此相關的必要披露資訊包含在今天的新聞稿中，您可以在我們的網站上找到該新聞稿。

I will now turn the call over to Pat Mahaffy.

我現在將把電話轉給帕特·馬哈菲。

Thanks, Anna. Good morning, everybody. I appreciate your time. I'll start the call with a review of Rubraca sales for the quarter. Sales in Q1 2022 were $34.2 million, 5% lower than the prior quarter and 10% lower year-over-year compared to Q1 2021. As seen over the previous quarters, this year-over-year decline is primarily due to continued fewer diagnoses ii to our patient stats in the U.S., primarily caused by the ongoing COVID-19 pandemic. As noted by one of our competitors, ovarian cancer diagnoses are down approximately 29% from pre-pandemic levels. And in Q4 2021, the most recent data available, new patient stats for PARP inhibitors across all indications were down 19% compared to Q1 2021 and down 26% compared to Q1 2020. Clearly, and as reflected in their sales, the impact of COVID-19 has been borne by our competitors as well as us, and we do believe this impact will moderate over the course of this year as the pandemic hopefully received. Most importantly, it is tragic that so many patients with this disease will only be diagnosed when their disease is ever more difficult to treat.

謝謝，安娜。大家早安。我很感激你的時間。我將首先回顧本季 Rubraca 的銷售情況。 2022 年第一季的銷售額為3,420 萬美元，比上一季下降5%，與2021 年第一季相比同比下降10%。從前幾季可以看出，同比下降主要是由於診斷數量持續減少ii 我們在美國的患者統計數據，主要是由持續的 COVID-19 大流行造成的。正如我們的一位競爭對手所指出的，卵巢癌的診斷率比疫情前的水平下降了約 29%。根據最新的可用數據，2021 年第四季度，所有適應症的PARP 抑制劑的新患者統計數據與2021 年第一季相比下降了19%，與2020 年第一季相比下降了26%。顯然，正如其銷售額所反映的那樣，新冠肺炎的影響-19 已經由我們的競爭對手和我們共同承擔，我們相信這種影響將在今年隨著疫情的蔓延而減弱。最重要的是，可悲的是，許多患有這種疾病的患者只有在疾病變得更難治療時才被診斷出來。

We do expect the need for maintenance treatment of advanced ovarian cancer patients to increase as patient visits and diagnoses eventually grow. In addition to Rubraca's use in the recurrent maintenance treatment setting, based on ATHENA-MONO and potentially our other Phase III readouts anticipated in the next 12 months, we see significant label expansion opportunities for Rubraca to address both ovarian and prostate cancer patient populations. Of course, the highlight for the first quarter was the release of top line results from ATHENA-MONO, the monotherapy portion of our Phase III ATHENA study of Rubraca as first-line maintenance treatment for ovarian cancer, results of which exceeded our expectations. We believe these data demonstrate the benefit that Rubraca can provide as an important new treatment option for women with advanced ovarian cancer in the frontline maintenance setting.

我們確實預計，隨著患者就診和診斷的最終增加，晚期卵巢癌患者維持治療的需求也會增加。除了Rubraca 在定期維持治療環境中的使用之外，根據ATHENA-MONO 以及我們預計在未來12 個月內可能出現的其他III 期數據，我們看到Rubraca 在治療卵巢癌和前列腺癌患者群體方面具有重大的標籤擴展機會。當然，第一季的亮點是 ATHENA-MONO 的頂線結果發布，這是我們將 Rubraca 作為卵巢癌一線維持治療的 III 期 ATHENA 研究的單一療法部分，其結果超出了我們的預期。我們相信這些數據證明了 Rubraca 作為一種重要的新治療選擇，可以為第一線維持環境中患有晚期卵巢癌的女性提供益處。

I'll discuss the ATHENA-MONO top line results to be presented next month at ASCO as well as the upcoming data readouts for the 2 Rubraca Phase III label expansion study shortly. For FAP-2286, the Phase I portion of LuMIERE continues to enroll, and we remain committed to maintaining our lead in the clinical development of an FAP-targeted radionuclide therapeutic candidate. We and our investigators remain extremely enthusiastic about this program and look forward to presenting initial Phase I LuMIERE data in an oral presentation at the Society of Nuclear Medicine and Molecular Imaging, or SNMMI at (inaudible) 2022 (inaudible) tumor types during the fourth quarter of this year. Tom will speak about developments for the program shortly, but first, I'll stand in for Lindsay to describe the ATHENA-MONO top line data and upcoming clinical milestones for Rubraca.

我將討論下個月在 ASCO 上公佈的 ATHENA-MONO 頂線結果，以及即將公佈的 2 Rubraca III 期標籤擴展研究的數據。對於 FAP-2286，LuMIERE 的 I 期部分繼續入組，我們仍然致力於保持我們在 FAP 靶向放射性核素治療候選藥物的臨床開發方面的領先地位。我們和我們的研究人員對該計劃仍然非常熱衷，並期待在第四季度在核醫學和分子成像協會 (SNMMI) 的口頭報告中介紹 2022 年（聽不清楚）腫瘤類型的初始 I 期 LuMIERE 數據今年的。 Tom 很快就會談論該計畫的進展，但首先，我將代表 Lindsay 描述 ATHENA-MONO 的主要數據和 Rubraca 即將到來的臨床里程碑。

ATHENA, to remind you, is a Phase III 1,000-patient study in first-line newly diagnosed advanced ovarian cancer maintenance. With ATHENA, we believe we are uniquely positioned to evaluate Rebraca in terms of 2 independent outcomes: monotherapy versus placebo in the first-line maintenance setting as well as any potential advantage of the combination of Rubraca plus OPDIVO over Rubraca alone in the same first-line indication. As we detailed the results on our previous call, I'll briefly review the data today.

提醒您一下，ATHENA 是一項針對新診斷的晚期卵巢癌一線維持治療的 1,000 名患者的 III 期研究。透過ATHENA，我們相信我們處於獨特的地位，可以根據2 個獨立的結果來評估Rebraca：在一線維持治療中單一療法與安慰劑的比較，以及在同一一線中Rubraca 加OPDIVO 組合相對於單獨使用Rubraca 的任何潛在優勢。線路指示。正如我們在之前的電話會議中詳細介紹了結果一樣，我今天將簡要回顧一下數據。

ATHENA-MONO have enrolled 538 women with high-grade ovarian fallopian tube or primary peritoneal cancer. The primary efficacy analysis evaluated 2 prospectively defined molecular subgroups in a step down manner: HRD positive, inclusive of BRCA mutated tumors; and second, all patients randomized or intent to treat in the ATHENA-MONO study. As a reminder, the study is evaluating newly diagnosed patients with advanced ovarian cancer following successful first-line treatment with platinum-based chemotherapy.

ATHENA-MONO 招募了 538 名患有高惡性度卵巢輸卵管癌或原發性腹膜癌的女性。主要療效分析以逐步遞減的方式評估了 2 個前瞻性定義的分子亞群：HRD 陽性，包括 BRCA 突變腫瘤；其次，所有患者在 ATHENA-MONO 研究中隨機分組或有意接受治療。提醒一下，研究正在評估新診斷的晚期卵巢癌患者在成功接受鉑類化療第一線治療後的情況。

The ATHENA-MONO comparison, which is evaluating Rubraca monotherapy versus placebo, successfully achieved the primary endpoint of improved PFS by investigator assessment in both populations in the primary efficacy analysis, HRD positive and the intent to treat. The HRD-positive subgroup includes those patients whose tumors had homologous recombination deficiency, including deleterious BRCA mutations. In addition, benefit in progression-free survival was also seen in the exploratory subgroups of patients with BRCA-mutant tumors, BRCA wild-type HRD positive or negative tumors and those whose biomarker status could not be determined.

ATHENA-MONO 比較評估了 Rubraca 單藥療法與安慰劑的療效，透過研究者對兩個人群的主要療效分析、HRD 陽性和治療意圖進行評估，成功實現了改善 PFS 的主要終點。 HRD 陽性亞組包括腫瘤有同源重組缺陷（包括有害的 BRCA 突變）的患者。此外，在 BRCA 突變腫瘤、BRCA 野生型 HRD 陽性或陰性腫瘤以及生物標記狀態無法確定的患者的探索性亞組中也看到了無進展生存期的益處。

Moving on to the detail of the primary efficacy analysis, beginning with the HRD-positive patient population. In the HRD population, which included 234 patients, Rubraca showed a statistically significant improvement in investigator-assessed progression-free survival over placebo. The hazard ratio was 0.47. The median PFS for the HRD-positive patient population treated with Rucaparib was 28.7 months versus 11.3 months for placebo with a p-value of 0.0004. And the second step of the primary efficacy analysis, the intent-to-treat population, which included all 530 patients randomized, Rubraca also showed a statistically significant improvement over placebo. Hazard ratio here was 0.52. The median progression-free survival for all patients enrolled in ATHENA-MONO when treated with Rucaparib was 20.2 months versus 9.2 months for placebo with a p-value of less than 0.0001.

接下來詳細介紹主要療效分析，從 HRD 陽性患者族群開始。在包括 234 名患者的 HRD 族群中，與安慰劑相比，Rubraca 在研究者評估的無惡化存活期方面顯示出統計學上顯著的改善。風險比為0.47。使用 Rucaparib 治療的 HRD 陽性患者群體的中位 PFS 為 28.7 個月，而安慰劑組為 11.3 個月，p 值為 0.0004。主要療效分析的第二步，即意圖治療族群（包括隨機分組的所有 530 名患者），Rubraca 也顯示出比安慰劑有統計上顯著的改善。這裡的風險比是 0.52。所有參加 ATHENA-MONO 的患者接受 Rucaparib 治療時的中位無惡化存活期為 20.2 個月，而安慰劑組為 9.2 個月，p 值小於 0.0001。

Moving to the exploratory subgroups. The progression-free survival endpoint in the exploratory subgroup of patients with BRCA-mutated tumors demonstrated a hazard ratio of 0.4. The median PFS for the 91 patients treated with Rucaparib was not yet reached versus 14.7 months for the 24 who received placebo. In the subgroup of BRCA wild-type HRD-negative patients, the progression-free survival endpoint demonstrated a hazard ratio of 0.65. The median PFS for the 189 patients treated with Rucaparib was 12.1 months versus 9.1 months for the 49 patients who received placebo. In the subgroup of BRCA wild type, but HRD-positive patients, the PFS endpoint demonstrated a hazard ratio of 0.58. The median PFS for the 94 patients treated with Rubraca was 20.3 months versus 9.2 months for the 25 patients who received placebo.

轉向探索性團體。 BRCA 突變腫瘤患者探索性亞群的無惡化存活終點顯示風險比為 0.4。接受 Rucaparib 治療的 91 名患者的中位 PFS 尚未達到，而接受安慰劑的 24 名患者的中位 PFS 為 14.7 個月。在 BRCA 野生型 HRD 陰性患者亞群中，無惡化存活終點的風險比為 0.65。接受 Rucaparib 治療的 189 名患者的中位無惡化存活期 (PFS) 為 12.1 個月，而接受安慰劑的 49 名患者的中位無惡化存活期 (PFS) 為 9.1 個月。在 BRCA 野生型但 HRD 陽性患者亞群中，PFS 終點的風險比為 0.58。接受 Rubraca 治療的 94 名患者的中位無惡化存活期 (PFS) 為 20.3 個月，而接受安慰劑的 25 名患者的中位無惡化存活期 (PFS) 為 9.2 個月。

And finally, in the subgroup of patients whose biomarker status could not be determined, the PFS endpoint demonstrated at a hazard ratio of 0.39. The median PFS for the 53 patients treated with Rubraca was 17.5 months versus 8.9 months for the 13 patients who received placebo. The safety of Rubraca observed in ATHENA-MONO was consistent with both the current U.S. and European labels. The most common treatment-emergent grade 3 or higher adverse events and 5% or more patients in the Rubraca arm or anemia or decreased hemoglobin of 28.7%, neutropenia, 14.6%, ALT/ASP increased 10.6% and thrombocytopenia 7.1%. The rate of treatment-emergent myelodysplastic syndrome or acute myeloid leukemia in the Rubraca arm was 0.2% and no patient on the placebo arm experienced treatment-emergent MDS or AML.

最後，在無法確定生物標記狀態的患者亞群中，PFS 終點的風險比為 0.39。接受 Rubraca 治療的 53 名患者的中位 PFS 為 17.5 個月，而接受安慰劑的 13 名患者的中位 PFS 為 8.9 個月。在 ATHENA-MONO 中觀察到的 Rubraca 安全性與當前美國和歐洲標籤一致。最常見的治療中出現的3 級或以上不良事件，Rubraca 組中5% 或更多的患者出現貧血或血紅蛋白降低（28.7%）、中性粒細胞減少（14.6%）、ALT/ASP 增加10.6% （10.6%）和血小板減少（7.1%）。 Rubraca 組中治療引起的骨髓增生異常綜合症或急性髓性白血病的發生率為 0.2%，安慰劑組中沒有患者出現治療引起的 MDS 或 AML。

We presently intend to submit an sNDA to the FDA and subject to EMA discussions, a type 2 variation to the EMA for a first-line maintenance treatment indication for women with advanced ovarian cancer who have responded to first-line platinum-based chemotherapy. We are now engaged in discussions with FDA on the scope and timing of our submission, and we expect that the regulatory agencies will review the overall results as well as results by the individual subgroups I described in making their assessment. We will provide additional data from the ATHENA-MONO trial of the 2022 ASCO Annual Meeting on June 6th in Chicago, which will include Kaplan-Meier curves in key secondary endpoints, including progression-free survival by blinded independent centralized review and other analyses.

我們目前打算向 FDA 提交 sNDA 並接受 EMA 討論，這是 EMA 的 2 型變體，用於對一線鉑類化療有反應的晚期卵巢癌女性的一線維持治療適應症。我們現在正在與 FDA 就我們提交的範圍和時間進行討論，我們希望監管機構將審查總體結果以及我在評估中描述的各個亞組的結果。我們將提供6 月6 日在芝加哥舉行的2022 年ASCO 年會上的ATHENA-MONO 試驗的更多數據，其中包括關鍵次要終點的Kaplan-Meier 曲線，包括通過盲法獨立集中審查和其他分析得出的無惡化存活期。

Looking ahead to other Phase III readouts for Rubraca, data from ATHENA-COMBO, the combination of Rubraca plus OPDIVO versus Rubraca monotherapy are expected in the first quarter of 2023, as previously announced. Beyond the opportunity for monotherapy Rubraca in front-line ovarian cancer, the ATHENA-COMBO study represents the potential to introduce an anti-PD-1 containing regimen for the first time to a broad population of ovarian cancer patients. Continuing with upcoming milestones, top line data from the TRITON3 trial are now expected in the third quarter of 2022 rather than second quarter of '22 based on a slower-than-expected event count. TRITON3 is a Phase III study evaluating Rubraca versus physician's choice of chemotherapy or second-line androgen deprivation therapy in patients with castrate-resistant prostate cancer with BRCA or ATM mutations.

展望 Rubraca 的其他 III 期數據，來自 ATHENA-COMBO 的數據、Rubraca 加 OPDIVO 組合與 Rubraca 單藥療法的數據預計將於 2023 年第一季度公佈，正如之前宣布的那樣。除了 Rubraca 單藥治療第一線卵巢癌的機會之外，ATHENA-COMBO 研究也代表了首次向廣大卵巢癌患者引入含有抗 PD-1 療法的潛力。繼續即將到來的里程碑，由於事件計數慢於預期，TRITON3 試驗的頂線數據目前預計將在 2022 年第三季而不是 22 年第二季獲得。 TRITON3 是一項 III 期研究，評估 Rubraca 與醫生選擇的化療或二線雄性激素剝奪療法對患有 BRCA 或 ATM 突變的去勢抵抗性前列腺癌患者的影響。

This trial is expected to serve as a confirmatory study for Rubraca's current approval in metastatic castrate-resistant prostate cancer as well as a potential second-line label expansion. ATHENA and TRITON3 each provide the potential to reach larger patient populations in earlier lines of therapy for both ovarian and prostate cancers. As is obvious in our industry, the timing for the data readouts for ATHENA-COMBO and TRITON3 are contingent upon the occurrence of the protocol-specified progression-free survival events and timing estimates are based on event-based projections.

該試驗預計將作為 Rubraca 目前批准用於轉移性去勢抵抗性前列腺癌以及潛在的二線標籤擴展的驗證性研究。 ATHENA 和 TRITON3 都有可能在卵巢癌和前列腺癌的早期治療中接觸到更多的患者群體。正如我們行業中顯而易見的那樣，ATHENA-COMBO 和 TRITON3 的數據讀出時間取決於方案指定的無進展生存事件的發生，並且時間估計基於基於事件的預測。

One last mention related to Rubraca. You may recall that we announced top line ARIEL4 data in December 2020, which compared Rubraca with chemotherapy in patients with ovarian fallopian tube or peritoneal cancer with a BRCA mutation, whose cancer has come back after chemotherapy. The trial, which was a post-marketing commitment, met its primary endpoint of progression-free survival with no new safety signals identified. Overall survival is a secondary endpoint of the study. At that time, we shared that there appeared to be a survival advantage for the chemotherapy arm compared to Rubraca. While we announced these data in December 2020 and submitted these data to EMA and FDA last summer, in the last few weeks, the EMA has begun an Article 20 procedure to review the ARIEL4 data set specifically to evaluate the risk benefit of Rubraca in the treatment indication. EMA explicitly states that there are no new safety concerns with medicine, and this review does not, repeat does not include the use of Rubraca as maintenance treatment following chemotherapy in the second-line setting.

最後要提到的是Rubraca。您可能還記得，我們​​在 2020 年 12 月公佈了 ARIEL4 的一線數據，該數據將 Rubraca 與化療對患有 BRCA 突變的卵巢輸卵管癌或腹膜癌患者（化療後癌症復發）進行了比較。該試驗是一項上市後承諾，達到了無惡化存活期的主要終點，沒有發現新的安全訊號。總存活期是研究的次要終點。當時，我們分享說，與 Rubraca 相比，化療組似乎具有生存優勢。雖然我們在2020 年12 月公佈了這些數據，並於去年夏天向EMA 和FDA 提交了這些數據，但在過去幾週內，EMA 已開始按照第20 條程序審查ARIEL4 數據集，專門評估Rubraca 在治療中的風險益處指示。 EMA 明確指出，藥物不存在新的安全問題，本篇回顧也沒有重複，不包括在二線環境中使用 Rubraca 作為化療後的維持治療。

While the Article 20 procedure is ongoing, EMA has asked physicians not to start new patients on the third line treatment indication. We will distribute a DHCP letter to this effect in Europe within the next couple of weeks. We expect this ongoing review to last 3 to 6 months. While the procedure may ultimately lead to limitations on the later line treatment indication in Europe, this represents a very, very small fraction of our sales in Europe and in fact, is only reimbursed in Germany and the Netherlands. The final overall survival data from ARIEL4 are now available and are summarized as follows: in the intent-to-treat population, the hazard ratio was 1.313 with a nominal P-value of 0.0507. In the platinum-resistant subgroup, the hazard ratio is 1.5 with a nominal P-value of 0.0251. In the platinum-sensitive subgroup, the hazard ratio was 1.07, with a nominal P-value of 0.745.

在第 20 條程序正在進行期間，EMA 已要求醫生不要讓新患者接受第三線治療適應症。我們將在接下來的幾週內在歐洲分發一封 DHCP 信函來說明這一點。我們預計這項持續審查將持續 3 至 6 個月。雖然該程序最終可能會導致歐洲後期治療適應症受到限制，但這僅占我們在歐洲銷售額的非常小一部分，事實上，僅在德國和荷蘭報銷。 ARIEL4 的最終總體存活數據現已提供，總結如下：在意圖治療族群中，風險比為 1.313，名目 P 值為 0.0507。在鉑抗藥性亞組中，風險比為 1.5，名目 P 值為 0.0251。在鉑敏感亞組中，風險比為 1.07，名目 P 值為 0.745。

To our knowledge, ARIEL4 is the only randomized Phase III trial of a PARP inhibitor in the advanced treatment setting that has included both platinum-resistant and platinum-sensitive cohorts. The randomized Phase III trial of olaparib SOLO-3, which included platinum-sensitive patients only, also reported a hazard ratio of 1.07, which is exactly the same as the hazard ratio of the platinum-sensitive subgroup in ARIEL4.

據我們所知，ARIEL4 是唯一一項在晚期治療環境中進行 PARP 抑制劑隨機 III 期試驗，其中包括鉑類抗藥性和鉑類敏感隊列。奧拉帕尼 SOLO-3 的隨機 III 期試驗（僅納入鉑類敏感患者）也報告風險比為 1.07，與 ARIEL4 中鉑類敏感亞組的風險比完全相同。

In ARIEL4, patients randomized to chemotherapy were allowed to cross over and receive Rucaparib at the time of disease progression. 69% of the chemotherapy patients, in fact, did cross over and overall 90% of all ARIEL4 participants received Rucaparib within the clinical trial. Therefore, these data are not easy to interpret and highlight the complexity of overall survival analysis in clinical trials where crossover is a mandated or available component within the study. We will present the final ARIEL4 overall survival data at a medical meeting later this year and anticipate a dialogue with FDA as well related to these results.

在 ARIEL4 中，隨機接受化療的患者在疾病進展時被允許交叉接受 Rucaparib 治療。事實上，69% 的化療患者確實發生了交叉，在臨床試驗中，所有 ARIEL4 參與者中總共有 90% 接受了 Rucaparib。因此，這些數據不容易解釋並凸顯了臨床試驗中總體存活分析的複雜性，其中交叉是研究中的強製或可用組成部分。我們將在今年稍後的一次醫學會議上公佈最終的 ARIEL4 總體生存數據，並預計與 FDA 就這些結果進行對話。

All right. Let me turn it over to Tom, our Chief -- Tom Harding, our Chief Scientific Officer, to discuss the FAP-2286 and targeted radionuclide therapeutic development program.

好的。讓我把它交給我們的首席科學家 Tom Harding，我們的首席科學官，討論 FAP-2286 和靶向放射性核素治療開發計劃。

Thanks, Pat. Hello. It's a pleasure to speak with you again today. FAP-2286, our lead targeted radiotherapeutic compound license as part of our ongoing collaboration with 3B Pharmaceuticals is the first peptide targeted radiotherapy candidate or PTRT targeting fibroblast activation protein, also known as FAP in clinical development. FAP is highly expressed on cancer associated fibroblasts, or CAFs, which represent one of the most abundant cell components in tumors and are found in the majority of solid tumors. CAFs play a critical role in tumor initiation, progression, metastasis and therapeutic resistance. For example, recent studies have demonstrated FAP expressing CAFs a potent immunosuppressive activity that can promote tumor progression and confer resistance to immune-based therapies, such as PD-1 or PD-L1 blockade.

謝謝，帕特。你好。很高興今天再次與您交談。 FAP-2286 是我們與3B Pharmaceuticals 持續合作的一部分的主要靶向放射治療化合物許可，是第一個肽靶向放射治療候選藥物或PTRT 靶向成纖維細胞激活蛋白，在臨床開發中也稱為FAP 。 FAP 在癌症相關成纖維細胞 (CAF) 上高度表達，CAF 是腫瘤中最豐富的細胞成分之一，存在於大多數實體瘤中。 CAF 在腫瘤發生、進展、轉移和治療抗藥性中發揮關鍵作用。例如，最近的研究表明，表達 FAP 的 CAF 具有強大的免疫抑制活性，可以促進腫瘤進展並賦予對基於免疫的療法（例如 PD-1 或​​ PD-L1 阻斷）的抵抗力。

Previously, we have presented nonclinical data describing a high expression level of FAP across 9 of 16 solid tumor types screened using immunohistochemistry. High FAP expression was observed in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon bladder, sarcoma, squamous non-small cell lung as well as squamous head and neck cancers. In these tumor types, high FAP expression was detected in both primary metastatic tumor samples and was independent of tumor stage and grade. The analysis also demonstrated that in most tumor types, FAP expression was predominantly localized to cancer-associated fibroblasts surrounding the tumor cells and integrated as the tumor microenvironment. In addition, in cancers of mesenchymal origin, including sarcoma and mesothelioma, FAP expression was observed in tumor cells in addition to CAFs.

先前，我們已經提供了非臨床數據，描述了使用免疫組織化學篩選的 16 種實體瘤類型中的 9 種中 FAP 的高表達量。在胰腺導管腺癌、原發灶不明的癌症、唾液腺癌、間皮瘤、結腸膀胱癌、肉瘤、鱗狀非小細胞肺癌以及鱗狀頭頸癌中觀察到高FAP表達。在這些腫瘤類型中，在原發性轉移性腫瘤樣本中均檢測到高 FAP 表達，且與腫瘤分期和分級無關。分析還表明，在大多數腫瘤類型中，FAP 表達主要定位於腫瘤細胞周圍的癌症相關成纖維細胞，並整合為腫瘤微環境。此外，在間質來源的癌症中，包括肉瘤和間皮瘤，除了 CAF 之外，在腫瘤細胞中也觀察到了 FAP 表現。

These data support the investigation of FAP-2286 in multiple tumor types in the planned Phase II expansion cohorts of LuMIERE. Additional presentations of non-clinical data are anticipated at medical oncology and nuclear medicine meetings over the next few quarters. As interest in FAP as a target increases and the field grows larger, we are pleased to be in the first mover position with FAP-2286, the first peptide-targeted radionuclide therapeutic targeting FAP to enter into the clinic. Clinically, we are focused on FAP-2286 monotherapy development in our ongoing LuMIERE Phase I/II study. However, as we've discussed previously, pre-clinically, we continue to evaluate a number of FAP-2286 drug combinations. Given the role of FAP expressing CAF and mediating resistance gene-based therapies, such as PD-1 and PD-L1 blockade, combination with these agents is a priority. We are evaluating in non-clinical studies, the efficacy and mechanism of action of FAP-2286 and the PD-1 blocking monoclonal antibody in syngeneic mouse tumor models.

這些數據支持在 LuMIERE 計劃的 II 期擴展隊列中對 FAP-2286 在多種腫瘤類型中的研究。預計未來幾季的腫瘤內科和核醫會議將介紹更多非臨床數據。隨著人們對FAP 作為靶點的興趣不斷增加以及該領域不斷擴大，我們很高興能夠憑藉FAP-2286 處於先行者地位，FAP-2286 是第一個進入臨床的針對FAP 的肽靶向放射性核素治療藥物。臨床上，我們正​​在進行的 LuMIERE I/II 期研究專注於 FAP-2286 單藥療法的開發。然而，正如我們之前所討論的，在臨床前，我們繼續評估一些 FAP-2286 藥物組合。鑑於表達 CAF 的 FAP 和介導基於抗藥性基因的療法（例如 PD-1 和 PD-L1 阻斷）的作用，與這些藥物的組合是當務之急。我們正在非臨床研究中評估 FAP-2286 和 PD-1 阻斷單株抗體在同基因小鼠腫瘤模型中的功效和作用機制。

In addition to immune checkpoint inhibitors, there are a number of publications reporting non-clinical data that support the combination of targeted radiotherapy with PARP inhibitors to augment efficacy. This makes sense since radiotherapies work by causing DNA damage by radioactive emission. If this damage is not repaired, the cell will eventually die. One of the critical proteins for repairing radiation-induced damage is PARP and its inhibition augments efficacy in combination with multiple targeted radiotherapy agents. We are currently evaluating the combination of FAP-2286 with our PARP inhibitor Rucaparib in preclinical models.

除了免疫檢查點抑制劑之外，還有許多出版物報告了支持標靶放射治療與 PARP 抑制劑聯合使用以增強療效的非臨床數據。這是有道理的，因為放射療法的作用是透過放射性發射造成 DNA 損傷。如果這種損傷得不到修復，細胞最終就會死亡。 PARP 是修復輻射引起的損傷的關鍵蛋白質之一，其抑製作用可增強與多種標靶放射治療藥物合併使用的療效。我們目前正在臨床前模型中評估 FAP-2286 與我們的 PARP 抑制劑 Rucaparib 的組合。

Lastly, radiation is known to synergize with the number of agents that are currently approved as the standard of care in specific cancer indications. For example, Gemcitabine used as a first-line chemotherapy in pancreatic cancer and other carcinomas is a well-known radio sensitizer and could have utility in combination with FAP-2286. We are currently performing a high Truescreen of approved oncology drugs in combination with radiation to identify promising combinations for 2026 development. We look forward to reporting the results of our ongoing non-clinical work upcoming scientific meetings. At the end our commitment to developing a lutetium-based compound, we've also begun exploring an alpha particle admitting compound. To this end, in March, we initiated a development, manufacturing and services agreement with Evergreen Theragnostics to develop actinium-225 labeled FAP-2286.

最後，眾所周知，放射治療與目前被批准作為特定癌症適應症護理標準的多種藥物具有協同作用。例如，用作胰腺癌和其他癌症一線化療的吉西他濱是一種眾所周知的放射增敏劑，可與 FAP-2286 聯合使用。我們目前正在對已批准的腫瘤藥物與放射治療相結合進行高 Truescreen，以確定 2026 年開發的有希望的組合。我們期待在即將舉行的科學會議上報告我們正在進行的非臨床工作的結果。在我們致力於開發镥基化合物之後，我們也開始探索一種接納α粒子的化合物。為此，我們在 3 月啟動了與 Evergreen Theragnostics 的開發、製造和服務協議，以開發標記為 FAP-2286 的 Actinium-225。

As part of our commitment to this emerging field, we have developed educational materials, including a microsite and introductory video that will provide more information about targeted radiotherapy, FAP-2286 and Clovis' targeted radionuclide development program. To learn more about this, please visit targetedradiotherapy.com.

作為我們對這一新興領域的承諾的一部分，我們開發了教育材料，包括微型網站和介紹性視頻，其中將提供有關靶向放射治療、FAP-2286 和克洛維斯靶向放射性核素開發計劃的更多資訊。要了解更多信息，請訪問 Targetedradiotherapy.com。

Lastly, before I turn to the clinical update and upcoming milestones for FAP-2286, we are collaborating with 3B Pharmaceuticals on a discovery program directed at 3 additional targets for targeted radionuclide therapeutic development to which we will have global rights. In our ongoing Phase I/II LuMIERE study, FAP-2286, is used both as an imaging agent and a therapeutic agent, a concept often described as a theragnostic.

最後，在我談到FAP-2286 的臨床更新和即將到來的里程碑之前，我們正在與3B Pharmaceuticals 合作開展一項發現計劃，該計劃針對靶向放射性核素治療開發的另外3 個靶點，我們將擁有這些靶點的全球權利。在我們正在進行的 I/II 期 LuMIERE 研究中，FAP-2286 既用作顯影劑又用作治療劑，這一概念通常被描述為治療診斷。

For the imaging agent, FAP-2286 is attached the isotope Gallium 68 to allow positron emission tomography or PET imaging and select the patients for inclusion into the study. For the therapeutic agent, FAP-2286 is attached to the (inaudible) lutenium-177, and [admit] a beta particle ionizing radiation that cause DNA damage and cell death. The Phase I portion of the LuMIERE study continues to enroll patients, and the third dose call is planned to initiate this week. Following the Phase I evaluation of the safety of FAP-2286 and the determination of a recommended Phase II dose expansion cohorts are planned in multiple tumor types and are expected to begin in the fourth quarter of 2022.

對於顯影劑，FAP-2286 附有同位素鎵 68，以進行正子斷層掃描或 PET 成像，並選擇納入研究的患者。對於治療劑，FAP-2286 附著在（聽不清楚）镥-177 上，並[承認] β 粒子電離輻射會導致 DNA 損傷和細胞死亡。 LuMIERE 研究的 I 期部分繼續招募患者，第三次劑量調用計劃於本週啟動。在對 FAP-2286 的安全性進行 I 期評估並確定建議的 II 期劑量擴展隊列後，計劃在多種腫瘤類型中進行劑量擴展，預計於 2022 年第四季度開始。

In addition to our own program, a separate investigator-sponsored imaging study with FAP-2286 is underway at UCSF and is being led by Dr. Thomas Hope, who is also the principal investigator of the LuMIERE study. The imaging-only study is evaluating FAP expression in multiple tumor types and is currently enrolling patients. Results from this study, along with the preclinical data we are generating, are expected to help confirm selection of tumor types of the Phase II expansion cohorts within LuMIERE. We are looking forward to several medical meeting presentations in June for FAP-2286.

除了我們自己的計畫外，加州大學舊金山分校正在進行一項由研究者資助的 FAP-2286 影像研究，該研究由 Thomas Hope 博士領導，他也是 LuMIERE 研究的首席研究員。這項純成像研究正在評估多種腫瘤類型中的 FAP 表達，目前正在招募患者。這項研究的結果以及我們正在產生的臨床前數據預計將有助於確認 LuMIERE 內 II 期擴展隊列的腫瘤類型選擇。我們期待 6 月針對 FAP-2286 的多次醫學會議演示。

Dr. Hope's imaging data will be the subject of a poster presentation at ASCO in Chicago on Sunday, June 5. And a week later will be the SNMMI Annual Meeting in Vancouver, on which we will have 2 oral presentations on FAP-2286 on Tuesday, June 14. The first presentation of Phase I data from LuMIERE, which has been accepted to all presentation and Dr. Hope's imaging data, which would also be the subject of an oral presentation at that meeting. It's an exciting time for this program, and we look forward to sharing these updates and others throughout 2022.

Hope 博士的影像資料將成為 6 月 5 日星期日在芝加哥舉行的 ASCO 上海報展示的主題。一週後將在溫哥華舉行的 SNMMI 年會上，我們將在周二就 FAP-2286 進行 2 次口頭報告，6月14 日。LuMIERE 的第一階段數據的首次演示，該數據已被所有演示和Hope 博士的成像數據所接受，這也將成為該次會議上口頭演示的主題。對於該計劃來說，這是一個激動人心的時刻，我們期待在 2022 年分享這些更新和其他內容。

And with that, I'll turn the call over to Dan to discuss first quarter financial results.

接下來，我將把電話轉給丹，討論第一季的財務表現。

Thanks, Tom, and hello, everyone. We reported net product revenues for BRCA of $34.2 million for Q1 2022, which included U.S. product revenues of $24.5 million and ex U.S. product revenues of $9.7 million, respectively. This represents a sequential 5% decrease from Q4 2021 and a 10% decrease year-over-year compared to Q1 2021 net product revenues of $38.1 million, which included U.S. net product revenues of $31.7 million and ex U.S. net product revenues of $6.4 million. Gross to net adjustments totaled 28.5% globally in Q1 2022 compared to 30.6% in Q4 2021. GTN was lower in both the U.S. and Europe. This metric fluctuates quarter-to-quarter, it's difficult to estimate on future revenues, but the high 20 percentile level seems likely, depending on the revenue and distribution mix for the U.S. and Europe. Research and development expenses totaled $42.3 million for Q1 2022, down 20% compared to $52.8 million for the comparable periods in 2021. We expect R&D expenses in 2022 to be comparable to 2021.

謝謝，湯姆，大家好。我們報告的 2022 年第一季 BRCA 產品淨收入為 3,420 萬美元，其中分別包括 2,450 萬美元的美國產品收入和 970 萬美元的美國產品收入。這比2021 年第四季季減5%，與2021 年第一季3,810 萬美元的產品淨收入相比，年減10%，其中包括美國淨產品收入3,170 萬美元及美國除外的淨產品收入640萬美元。 2022 年第一季度，全球毛淨調整總額為 28.5%，而 2021 年第四季為 30.6%。美國和歐洲的 GTN 均較低。該指標按季度波動，很難估計未來的收入，但 20 個百分點的高水準似乎有可能，具體取決於美國和歐洲的收入和分銷組合。 2022 年第一季的研發費用總計 4,230 萬美元，比 2021 年同期的 5,280 萬美元下降 20%。我們預計 2022 年的研發費用將與 2021 年相當。

Selling, general and administrative expenses totaled $29.2 million for Q1 2022 and down 2% compared to $29.9 million for the comparable period in 2021 due to overall cost reduction efforts. We also expect SG&A expenses in 2022 to be comparable to 2021. We reported a net loss for Q1 2022 of $60.2 million or $0.44 per share compared to a net loss for Q1 2021 of $66.3 million or $0.64 per share. Net loss for Q1 2022 included share-based compensation expense of $6.6 million compared to $4 million for the comparable period of 2021.

由於整體成本削減措施，2022 年第一季的銷售、一般和管理費用總計 2,920 萬美元，比 2021 年同期的 2,990 萬美元下降了 2%。我們也預期2022 年的銷售管理、行政管理費用將與2021 年相當。我們報告2022 年第一季的淨虧損為6,020 萬美元，即每股0.44 美元，而2021 年第一季的淨虧損為6,630萬美元，即每股0.64 美元。 2022 年第一季的淨虧損包括 660 萬美元的股權激勵費用，而 2021 年同期的淨虧損為 400 萬美元。

Turning now to a discussion of cash and debt, Clovis had $122.2 million in cash and equivalents as of March 31, 2022. During Q1 2022, the company raised $28.6 million in net proceeds through its at-the-market equity offering program. Clovis remains focused on its liquidity position and is committed to raising additional capital in the near term in order to fund its operating plan for the next 12 months and beyond. As of March 31, 2022, the company had drawn $156.4 million under the Sixth Street Partners, LLC, ATHENA clinical trial financing and had up to $18.6 million available to draw under the agreement to fund the expenses of the ATHENA trial. Net cash used in operating activities was $58.5 million for Q1 2022, down 5% from the $61.9 million reported in Q1 2021. Cash burn in Q1 2022 was $49.3 million, up 2% from $48.1 million in Q1 2021. As the cost for the ATHENA trial are reducing, SSP funding was $4.6 million lower in Q1 2022 versus Q1 2021. Q1 is also typically a higher cash burn quarter during a fiscal year.

現在轉向現金和債務的討論，截至2022 年3 月31 日，克洛維斯擁有1.222 億美元的現金和等價物。在2022 年第一季度，該公司透過其市場股票發行計劃籌集了2,860 萬美元的淨收益。 Clovis 仍關注其流動性狀況，並致力於在短期內籌集更多資金，為其未來 12 個月及以後的營運計劃提供資金。截至 2022 年 3 月 31 日，該公司已根據 Sixth Street Partners, LLC 的 ATHENA 臨床試驗融資提取了 1.564 億美元，並根據協議可提取最多 1860 萬美元，用於資助 ATHENA 試驗的費用。 2022 年第一季報告的6,190 萬美元下降5%。2022 年第一季的現金消耗為4,930 萬美元，比2021 年第一季度的4810 萬美元增長2%。試驗正在減少，2022 年第一季的 SSP 資金比 2021 年第一季減少了 460 萬美元。第一季通常也是一個財年中現金消耗較高的季度。

Now I'll turn it back over to Pat.

現在我會把它轉回給帕特。

Thanks, Dan. In summary, we entered 2022 knowing that it would be the most significant year for clinical data readouts in our history, and we're very pleased with the results from the ATHENA-MONO study of Rubraca. The first of those readouts performed as well as it did. Importantly, we believe that the positive results from ATHENA-MONO, which we will highlight at ASCO next month, demonstrate the benefit that Rubraca can provide as an important treatment option for women with advanced ovarian cancer in the frontline maintenance setting. Looking ahead, we continue to anticipate 2 additional Phase III readouts for Rubraca, TRITON3 in the second-line prostate cancer treatment setting for selected patients during the third quarter of this year and ATHENA-COMBO in combination with OPDIVO in the first-line ovarian cancer maintenance treatment setting in the first quarter of 2023.

謝謝，丹。總之，進入 2022 年，我們知道這將是我們歷史上臨床數據讀出最重要的一年，我們對 Rubraca 的 ATHENA-MONO 研究結果非常滿意。第一個讀數表現良好。重要的是，我們相信 ATHENA-MONO 的積極結果（我們將在下個月的 ASCO 上強調）證明了 Rubraca 可以為一線維護環境中的晚期卵巢癌女性提供重要的治療選擇。展望未來，我們繼續預計今年第三季將有 2 個額外的 III 期試驗結果公佈，Rubraca、TRITON3 用於特定患者的二線前列腺癌治療，以及 ATHENA-COMBO 與 OPDIVO 聯合用於一線卵巢癌2023 年第一季維持治療設置。

Importantly, for our first targeted radiotherapy candidate, FAP-2286, we look forward to presenting initial data from the Phase I portion of LuMIERE study at the SNMMI annual meeting next month and initiating the Phase II portion of the study during the fourth quarter. These anticipated pipeline events and our commitment to improving our balance sheet support our efforts to execute our 3 core strategies: expand the Rebraca label to drive revenue growth, emerge as a leader in targeted radionuclide therapy and achieve longer-term financial stability.

重要的是，對於我們的第一個標靶放射治療候選藥物FAP-2286，我們期待在下個月的SNMMI 年會上展示LuMIERE 研究I 期部分的初步數據，並在第四季度啟動該研究的II期部分。這些預期的管道事件以及我們對改善資產負債表的承諾支持我們執行 3 個核心策略的努力：擴大 Rebraca 標籤以推動收入成長，成為標靶放射性核種治療的領導者並實現長期財務穩定。

With that, happy to answer any questions -- we are all happy to answer any questions you might have.

因此，很樂意回答任何問題——我們都很樂意回答您可能有的任何問題。

(Operator Instructions) Your first question comes from Paul Choi from Goldman Sachs.

（操作員說明）您的第一個問題來自高盛的 Paul Choi。

This is Charlie on for Paul. Thank you for taking our questions. So looking forward to all of these events coming up this year, particularly with the 2286 readout in June. And I was just wondering if you could maybe frame expectation in terms of like what sort of data, what sort of plots we can expect in this oral presentation? And maybe if you could set perhaps a clinical bar even in terms of response rates for the patients that would be included. And then furthermore, regarding additional radiopharma assets with the 3B collaboration, I'm just wondering if we're still on track to maybe hear more about those additional discovery assets in the latter half of this year. Thank you so much.

這是查理替保羅發言。感謝您接受我們的提問。因此，期待今年所有這些事件的發生，尤其是 6 月的 2286 讀數。我只是想知道你是否可以根據我們在這次口頭演講中可以期待什麼樣的數據、什麼樣的圖表來建立期望？也許你可以設定一個臨床標準，甚至在所包含的患者的反應率方面也是如此。此外，關於與 3B 合作的其他放射性製藥資產，我只是想知道我們是否仍有望在今年下半年聽到更多有關這些額外發現資產的資訊。太感謝了。

I'll start with the presentation in June, and then Tom can answer the question about the discovery programs. This will be the first presentation of data from an ongoing Phase I trial. We are just now beginning this week, in fact, to enroll patients in the third dose cohort of the planned 4 dose cohorts. So the data that will be presented will include an update on patients treated in the first and second cohorts of the study. It will focus primarily as it is a Phase I trial on safety and tolerability. There will be other features given that is a targeted nuclear radionuclide, which will include tumor specificity, tumor uptake and the duration of time that the targeted radionuclide 2286 is retained in the tumor environment. So what we have talked about is that to drive ultimate activity for this class, you have to get to the tumor, you have to stay in the tumor and you have to avoid off-target tissues. And we'll be providing an early look at how we perform against that metric. But I'll remind you, it's a relatively small number of patients.

我將從六月的演講開始，然後湯姆可以回答有關發現計劃的問題。這將是正在進行的第一階段試驗數據的首次展示。事實上，我們本週才剛開始將患者納入計畫的 4 個劑量組中的第三個劑量組。因此，將提供的數據將包括在該研究的第一組和第二組中接受治療的患者的最新情況。它將主要關注安全性和耐受性的第一階段試驗。還存在作為靶向核放射性核素的其他特徵，其將包括腫瘤特異性、腫瘤攝取以及靶向放射性核素2286保留在腫瘤環境中的持續時間。所以我們討論的是，為了驅動這類的最終活性，你必須到達腫瘤，你必須留在腫瘤中，你必須避免脫靶組織。我們將儘早了解我們在該指標上的表現。但我要提醒你的是，患者數量相對較少。

As to efficacy, we'll report on any -- of course, on any disease impact from the trial. But I will remind everybody, these are 2 low-dose cohorts. And so I think your expectation should be that there will be much more focus, if not so focused on safety and tolerability and the other attributes I described. At the second meeting where we anticipate presenting data, which is in October in Barcelona at a European equivalent meeting, that's where I think we could most realistically expect to see evidence of [antitumor] effect. Tom, anything you'd add to that or -- and also on the discovery programs?

至於功效，我們將報告試驗對任何疾病的影響。但我要提醒大家，這是兩個低劑量組。因此，我認為您的期望應該是，即使不是那麼關注安全性、耐受性以及我所描述的其他屬性，也會有更多的關注。在第二次會議上，我們預計將展示數據，即 10 月在巴塞隆納舉行的歐洲同等會議上，我認為我們最現實地期望看到[抗腫瘤]效果的證據。湯姆，您有什麼要補充的嗎？還有關於發現計劃的嗎？

Thanks for the question. Nothing to add to the clinical LuMIERE study readouts. Just on the discovery component, so we have signed a deal with 3B Pharmaceuticals for 3 discovery candidates, and I am pleased to say that we are on track to be able to talk about one of those [programmings] actually elevating to pre-clinical lead candidate selection at the end of this year. So I look forward to telling you more about that program when the time comes. But it's a completely novel peptide target ready nuclei therapy against the cancer target.

謝謝你的提問。臨床 LuMIERE 研究讀數中無需添加任何內容。就發現部分而言，我們已經與 3B Pharmaceuticals 簽署了 3 個發現候選藥物的協議，我很高興地說，我們有望討論其中一個實際上提升到臨床前領先地位的[程序]今年年底進行候選人遴選。因此，我期待在時機成熟時向您介紹有關該計劃的更多資訊。但這是一種針對癌症標靶的全新勝肽標靶核療法。

And there are no further questions at this time. I will turn the call back over to the presenters for closing remarks.

目前沒有其他問題。我會將電話轉回給主持人進行閉幕致詞。

Thank you. Thanks, everyone. It's a busy morning of analyst call -- or excuse me, earnings calls, we understand from our analysts. So thank you each for your time today. If you have any follow-up questions, you can reach me at (303) 625-5022. This call can be accessed via a replay of our webcast at clovisoncology.com, beginning in about one hour and will be available for 30 days. We appreciate your interest and time. Thank you and have a good day.

謝謝。感謝大家。這是一個忙碌的上午分析師電話會議——或者對不起，是財報電話會議，我們從分析師那裡了解到。謝謝大家今天抽出時間。如果您有任何後續問題，可以撥打 (303) 625-5022 與我聯絡。您可以透過 clovisoncology.com 上的網路廣播重播來觀看此電話會議，該電話會議將在大約一小時後開始，持續 30 天。我們感謝您的興趣和時間。謝謝你，有美好的一天。

This concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連線。