TRACON Pharmaceuticals Inc (TCON) 2023 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the TRACON Pharmaceuticals Second Quarter 2023 Earnings Conference Call. (Operator Instructions) During today's call, we will be making certain forward-looking statements, including statements regarding expected timing of clinical trials and results of regulatory activities, financing opportunities, future expenses and cash runway, our development plans and strategy and with the recovery of the award from our arbitration with I-Mab, these statements are subject to various risks that are described in our filings made with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2022, and subsequent quarterly reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements and unless required by applicable law, we disclaim any obligation to update such statements.

女士們、先生們，美好的一天，歡迎參加 TRACON Pharmaceuticals 2023 年第二季度收益電話會議。 （操作員指示）在今天的電話會議中，我們將做出某些前瞻性聲明，包括有關臨床試驗的預期時間和監管活動結果、融資機會、未來費用和現金跑道、我們的發展計劃和戰略以及復甦的聲明根據我們與天境生物的仲裁裁決，這些聲明面臨我們向美國證券交易委員會提交的文件中描述的各種風險，包括我們截至 2022 年 12 月 31 日的 10-K 表格年度報告，以及隨後的10-Q 表季度報告。請您注意不要過分依賴這些前瞻性陳述，除非適用法律要求，否則我們不承擔更新此類陳述的義務。

Now I would like to turn the call over to Dr. Charles Theuer, President and CEO of TRACON Pharmaceuticals. Dr. Theuer.

現在我想將電話轉給 TRACON Pharmaceuticals 總裁兼首席執行官 Charles Theuer 博士。特伊爾博士。

Good afternoon, and thank you for joining TRACON's Second Quarter 2023 Financial Results and Business Update Call. I will begin with an update on our pipeline and then review our recent activities. Following that, Scott Brown, our Chief Financial Officer, will discuss our financial results for the 3 and 6 months ended June 30, 2023. Finally, we will conclude by taking your questions. I'll begin with an update on our continued progress with the ongoing ENVASARC pivotal trial.

下午好，感謝您參加 TRACON 的 2023 年第二季度財務業績和業務更新電話會議。我將首先介紹我們的管道的最新情況，然後回顧我們最近的活動。隨後，我們的首席財務官 Scott Brown 將討論我們截至 2023 年 6 月 30 日的 3 個月和 6 個月的財務業績。最後，我們將回答大家的問題。我將首先介紹我們正在進行的 ENVASARC 關鍵試驗的最新進展。

In June, the data monitoring committee reviewed interim safety and efficacy data for more than 80 patients equally randomized into cohort C of single-agent ENVA treatment, a cohort D of ENVA given in combination YERVOY. Patients in Cohort C, who had at least 2 on-study CT scans continue to demonstrate a double-digit objective response rate assessed by investigator and blinded independent central review. ENVA was generally well tolerated without a single greater than grade 2 drug-related adverse events. The combination of ENVA with YERVOY did not demonstrate synergy when compared to single-agent ENVA reatment, and we, therefore, terminated enrollment in Cohort D.

6 月，數據監測委員會審查了 80 多名患者的中期安全性和有效性數據，這些患者均等地隨機分配到單藥 ENVA 治療的 C 組和 ENVA 聯合 YERVOY 治療的 D 組中。 C 組患者至少進行了 2 次研究中 CT 掃描，繼續表現出由研究者和盲法獨立中央審查評估的兩位數客觀緩解率。 ENVA 通常具有良好的耐受性，沒有發生任何 2 級以上的藥物相關不良事件。與單藥 ENVA 治療相比，ENVA 與 YERVOY 的組合併未表現出協同作用，因此我們終止了隊列 D 的入組。

This decision has resulted in a reduction in trial costs and acceleration of the time line to final ENVASARC data. We expect full accrual of the 80 patients into Cohort C of treatment with single-agent ENVA in the fourth quarter and final data, including duration of response by mid-2024.

這一決定降低了試驗成本並加快了獲得最終 ENVASARC 數據的時間。我們預計 80 名患者將在第四季度完全納入單藥 ENVA 治療隊列 C，並獲得最終數據，包括到 2024 年中期的緩解持續時間。

In addition, a protocol-mandated DMC review will be conducted and reported after the 46 patients treated with ENVA has completed a minimum of 12 weeks of efficacy evaluations. We expect the DMC review to occur this quarter as the ENVASARC trial has enrolled 180 patients to date, including 56 of the 80 expected patients in Cohort C of single-agent ENVA treatment. This DMC review includes a futility threshold that has already been achieved based on responses seen to date.

此外，在接受 ENVA 治療的 46 名患者完成至少 12 週的療效評估後，將進行方案規定的 DMC 審查並報告。我們預計 DMC 審查將於本季度進行，因為 ENVASARC 試驗迄今為止已招募了 180 名患者，其中包括單藥 ENVA 治療隊列 C 中 80 名預期患者中的 56 名患者。此次 DMC 審查包括根據迄今為止看到的答复已經達到的無效閾值。

As a reminder, the primary endpoint in ENVASARC is objective response rate by RECIST, confirmed by blinded independent central review, with 9 out of 80 objective responses or an 11.25% objective response rate defines the level response that satisfies the primary endpoint of the study. To statistically exceed the 4% objective response rate of Votrient, the only FDA-approved treatment for patients with refractory UPS or MFS. Therefore, a double-digit response rate at the time of interim analysis is meaningful, indicating that we are on track to achieve the primary endpoint of the study.

提醒一下，ENVASARC 的主要終點是 RECIST 的客觀緩解率，經盲法獨立中央審查確認，80 個客觀緩解中有 9 個或 11.25% 的客觀緩解率定義了滿足研究主要終點的水平緩解。統計上超過 Votrient 4% 的客觀緩解率，Votrient 是 FDA 批准的唯一治療難治性 UPS 或 MFS 患者的治療方法。因此，中期分析時兩位數的緩解率是有意義的，表明我們正在實現研究的主要終點。

Notably, Votrient is a drug with a black box warning for fatal liver toxicity. Our goal in ENVASARC, therefore, is to demonstrate that ENVA has the potential to be both safer and more efficacious than Votrient. Based on data from trials of other checkpoint inhibitors in refractory UPS or MFS, we are targeting a 15% response rate for single-agent ENVA. Furthermore, we plan to approach the FDA to discuss the BLA filing strategy as soon as we determine 9 responses. As a reminder, we have received Fast Track designation for ENVA in the sarcoma subtypes of UPS and MFS that have progressed on 1 or 2 prior lines of therapy and received orphan drug designation in soft tissue sarcoma based on activity observed in ENVASARC. These designations provide important advantages that might expedite regulatory review and commercialization of ENVA. ENVASARC is designed to provide safety and efficacy data for the approval of ENVA in the refractory sarcoma subtypes of UPS and MFS. We also have a strategy for the approval of ENVA in frontline sarcoma.

值得注意的是，Votrient 是一種帶有致命肝毒性黑框警告的藥物。因此，我們 ENVASARC 的目標是證明 ENVA 有潛力比 Votrient 更安全、更有效。根據其他檢查點抑製劑在難治性 UPS 或 MFS 中的試驗數據，我們的目標是單藥 ENVA 的緩解率為 15%。此外，我們計劃在確定 9 項答復後立即與 FDA 聯繫，討論 BLA 備案策略。提醒一下，我們已獲得ENVA 在UPS 和MFS 肉瘤亞型中的快速通道指定，這些亞型在先前的1 或2 線治療中取得了進展，並根據ENVASARC 中觀察到的活性獲得了軟組織肉瘤的孤兒藥指定。這些指定提供了重要的優勢，可以加快 ENVA 的監管審查和商業化。 ENVASARC 旨在為 ENVA 治療難治性肉瘤亞型 UPS 和 MFS 的批准提供安全性和有效性數據。我們還有一個批准 ENVA 用於一線肉瘤治療的策略。

Based on expected synergy between ENVA and YERVOY, we licensed YH001 of potential best-in-class (inaudible) antibody from (inaudible) in October 2021 and began a Phase I/II clinical trial evaluating a triplet that included YH001, ENVA (inaudible) chemotherapy for the treatment of frontline sarcoma.

基於ENVA 和YERVOY 之間的預期協同作用，我們於2021 年10 月獲得了潛在同類最佳（聽不清）抗體YH001 的許可，並開始了I/II 期臨床試驗，評估包括YH001、ENVA（聽不清）的三聯體用於治療前線肉瘤的化療。

However, given the lack of synergy observed in ENVASARC between ENVA and the CTLA-4 antibody YERVOY and available data from patients treated with ENVA and YH001, we have decided to end enrollment into the trial as originally designed. We now plan to initiate a modified trial of ENVA and doxorubicin in the frontline setting of common sarcoma subtypes, including UPS and MFS, following completion of enrollment in the pivotal ENVASARC trial. The goal that modified trial will be to determine the subtypes of sarcoma that best respond to the combination of ENVA and doxorubicin. Assuming positive results in the ENVASARC pivotal trial and potential accelerated approval of ENVA, we expect the FDA will require a randomized trial to demonstrate a survival benefit.

然而，鑑於在 ENVASARC 中觀察到 ENVA 和 CTLA-4 抗體 YERVOY 之間缺乏協同作用，以及接受 ENVA 和 YH001 治療的患者的可用數據，我們決定終止最初設計的試驗招募。我們現在計劃在關鍵 ENVASARC 試驗完成入組後，在常見肉瘤亞型（包括 UPS 和 MFS）的一線環境中啟動 ENVA 和阿黴素的改良試驗。修改試驗的目標是確定對 ENVA 和阿黴素聯合治療反應最佳的肉瘤亞型。假設 ENVASARC 關鍵試驗取得積極結果並且 ENVA 可能會加速批准，我們預計 FDA 將要求進行隨機試驗來證明生存獲益。

We now expect this potential Phase III post-approval trial will compare single-agent doxorubicin to doxorubicin with ENVA with progression-free survival as the endpoint. This trial would be expected to enroll patients with UPS and MFS as well as other sarcoma subtypes shown to respond to therapy with ENVA and doxorubicin. We expect to discuss the design of a frontline trial with the FDA at the time of our expected pre-BLA meeting to review the expected submission of data from ENVASARC for potential accelerated approval of ENVA in refractory sarcoma.

我們現在預計這項潛在的 III 期批准後試驗將比較單藥阿黴素與 ENVA 的阿黴素，以無進展生存期為終點。該試驗預計將招募 UPS 和 MFS 以及其他肉瘤亞型患者，這些患者對 ENVA 和阿黴素治療有反應。我們預計將在預計舉行的 BLA 前會議上與 FDA 討論一線試驗的設計，以審查 ENVASARC 預計提交的數據，以加速批准 ENVA 治療難治性肉瘤。

It is important to understand the sales potential in sarcoma (inaudible) pricing is not solely the forecasted $200 million in peak annual ENVA revenues anticipated upon approval in refractory UPS and MFS. Our clinical development strategy is designed to create the opportunity for ENVA to broadly benefit patients with sarcoma in the frontline, adjuvant and neoadjuvant settings by seeking supplemental BLA approvals. We will now turn to our DNA damage repair inhibitor, TRC102, that is supported through a cooperative research and development agreement with the National Cancer Institute. The NCI sponsoring an ongoing randomized Phase II trial assessing TRC102 in stage III non-squamous non-small cell lung cancer in combination with chemo radiation. The 2-arm trial will enroll 78 patients to assess the benefit of adding TRC102 to current standard of care treatment of pemetrexed-cisplatin radiation therapy followed by consolidated durvalumab maintenance treatment. The primary endpoint of the trial is progression-free survival and the trial is designed to detect an improvement in PFS at 1 year from 56% to 75%.

重要的是要了解肉瘤（聽不清）定價的銷售潛力不僅僅是在難治性 UPS 和 MFS 獲得批准後預期的 ENVA 年度收入峰值 2 億美元。我們的臨床開發戰略旨在通過尋求補充 BLA 批准，為 ENVA 創造機會，使一線、輔助和新輔助環境中的肉瘤患者廣泛受益。我們現在將轉向我們的 DNA 損傷修復抑製劑 TRC102，該抑製劑通過與國家癌症研究所的合作研究和開發協議得到支持。 NCI 贊助一項正在進行的隨機 II 期試驗，評估 TRC102 聯合化療治療 III 期非鱗狀非小細胞肺癌的效果。這項 2 組試驗將招募 78 名患者，以評估將 TRC102 添加到當前培美曲塞-順鉑放射治療的標準護理治療中，然後進行鞏固的 durvalumab 維持治療的益處。該試驗的主要終點是無進展生存期，該試驗旨在檢測 1 年時 PFS 從 56% 改善至 75%。

The nine sites are open for enrollment in the U.S. and final results are expected in 2025. Next, I will provide an update on the collection of our arbitration award from I-Mab. On April 24, we were informed the Tribunal ruled in our favor for certain claims and rendered award to TRACON in the aggregate amount of approximately $23 million, among other findings that Tribunal declared the TJ4309 trial complete, which entitled TRACON to $9 million and also awarded legal fees and costs to TRACON.

這九個站點在美國開放註冊，最終結果預計將於 2025 年公佈。接下來，我將提供天境生物收取仲裁裁決的最新情況。 4 月24 日，我們獲悉，仲裁庭對某些索賠作出了有利於我們的裁決，並向TRACON 授予了總計約2300 萬美元的賠償金，除其他裁決外，仲裁庭宣布TJ4309 審判已完成，該裁決使TRACON 有權獲得900 萬美元的賠償，並判給TRACON TRACON 的法律費用和成本。

In July, we collected $22 million from I-Mab in satisfaction of the International Chamber of Commerce Award to TRACON announced in April. $10.5 million of the collected amount was used to repay our litigation financing facility in full, and net proceeds collected to date of $7.1 million are expected to fund the company's operations as currently planned into the first half of 2024.

7 月，我們從天境生物籌集了 2200 萬美元，以表彰 TRACON 於 4 月獲得的國際商會獎。募集金額中的 1050 萬美元用於全額償還我們的訴訟融資融資，迄今為止募集的淨收益為 710 萬美元，預計將為公司目前計劃到 2024 年上半年的運營提供資金。

An additional $4.4 million of the arbitration award remains in a client trust account administered by our law firm at this time, the disbursement of which is predicated on discussions as to the amount of success-based deferred legal fees the firm is due. Following these discussions, disbursement of all or a portion of that amount is expected later this year. We expect to further extend our runway by securing non-dilutive capital through leveraging our CRO-independent product development platform that we believe positions us as one of the most efficient clinical development organizations. As an example of our efficiency, our fully burdened per patient cost for dosing patients in the ENVASARC trial is less than $90,000 per patient.

目前，另外 440 萬美元的仲裁裁決仍保留在我們律師事務所管理的客戶信託賬戶​​中，該賬戶的支付取決於對公司應支付的基於成功的遞延法律費用金額的討論。經過這些討論，預計將在今年晚些時候支付全部或部分金額。我們希望通過利用我們獨立於 CRO 的產品開發平台來確保非稀釋資本，從而進一步擴展我們的跑道，我們相信該平台使我們成為最高效的臨床開發組織之一。作為我們效率的一個例子，在 ENVASARC 試驗中，我們為每位患者提供劑量的完全負擔成本低於每位患者 90,000 美元。

This compares favorably with typical CRO bid estimates of $300,000 per patient that may be even more expensive if change order charges are considered. In addition, by managing all regulatory filings internally, we believe we significantly shortened trial duration by expecting the approval of protocol amendments and consent forms. We also emphasize quality through the use of a team of reliable site monitors, who are highly experienced with relevant oncology response criteria to ensure accurate data reporting. These attributes of our product development platform have been the basis for capital infusions from partners like Johnson & Johnson, who have collaborated with us to run trials of their drug candidates.

這與每位患者 300,000 美元的典型 CRO 出價估算相比毫不遜色，如果考慮變更單費用，該出價可能會更高。此外，通過內部管理所有監管備案，我們相信通過預期方案修正案和同意書的批准，我們顯著縮短了試驗持續時間。我們還通過使用可靠的現場監控團隊來強調質量，他們在相關腫瘤學反應標準方面經驗豐富，以確保准確的數據報告。我們產品開發平台的這些屬性是強生等合作夥伴注資的基礎，這些合作夥伴與我們合作對其候選藥物進行試驗。

Our current focus is (inaudible) in one of two ways. First, by replacing (inaudible) to lower their anticipated costs, but still generate a substantial profit for TRACON. And two, to teach our operational capabilities to a company with an emerging pipeline who plans to conduct multiple trials. This offering would include our platform of advanced clinical trial management, data management and safety reporting that will enable our collaborator to conduct trials at a cost of less than 1/3 of what they may otherwise pay to a CRO. Leveraging our cost-efficient CRO-independent product development platform to generate non-dilutive capital for the end of this year is a top priority for the company.

我們當前的重點是（聽不清）以下兩種方式之一。首先，通過更換（聽不清）來降低預期成本，但仍然為 TRACON 帶來可觀的利潤。第二，向一家擁有新興管道併計劃進行多項試驗的公司傳授我們的運營能力。該產品將包括我們先進的臨床試驗管理、數據管理和安全報告平台，使我們的合作者能夠以不到他們向 CRO 支付的費用 1/3 的成本進行試驗。利用我們具有成本效益的獨立於 CRO 的產品開發平台，在今年年底產生非稀釋性資本是公司的首要任務。

In that regard, please note the corrected press release, and let me reiterate, we expect to generate non-dilutive capital before end of this year by leveraging our CRO-independent product development platform.

在這方面，請注意更正後的新聞稿，並讓我重申，我們預計在今年年底前通過利用我們獨立於 CRO 的產品開發平台產生非稀釋資本。

At this time, Scott will provide an update on our financials.

此時，斯科特將提供我們財務狀況的最新信息。

Thank you, Charles, and good afternoon, everyone. Collaboration revenue was $9 million for the 3 and 6 months ended June 30, 2023 compared to 0 for the comparable periods of 2022. The increase in revenue was from the prespecified $9 million termination fee for the TJ4309 license in conjunction with the arbitration outcome. TRACON's research and development expenses were $3.5 million and $8.5 million for the 3 and 6 months ended June 30, 2023 compared to $2.9 million and $5.9 million for the comparable periods of 2022. The increase was related to ENVA drug purchased in the first quarter of 2023 as well as higher enrollment in ENVASARC. General and administrative expenses were $1.9 million and $4.3 million for the 3 and 6 months ended June 30, 2023 compared to $3.3 million and $9.8 million for the comparable periods of 2022. The decrease was due to lower legal expenses. We incurred a success fee of $4.4 million in the 3 and 6 months ended June 30, 2023, related to legal fees for the arbitration and collection of the award in July.

謝謝查爾斯，大家下午好。截至2023 年6 月30 日的3 個月和6 個月的合作收入為900 萬美元，而2022 年同期為0。收入的增加來自於與仲裁結果相關的TJ4309 許可的預先指定的900 萬美元終止費。截至2023年6月30日的3個月和6個月，TRACON的研發費用分別為350萬美元和850萬美元，而2022年同期為290萬美元和590萬美元。這一增長與2023年第一季度購買的ENVA藥物有關ENVASARC 的入學率也更高。截至2023 年6 月30 日的3 個月和6 個月，一般和行政費用分別為190 萬美元和430 萬美元，而2022 年同期為330 萬美元和980 萬美元。減少的原因是法律費用減少。截至 2023 年 6 月 30 日的三個月和六個月，我們產生了 440 萬美元的成功費用，與 7 月份仲裁和收取裁決的法律費用有關。

As Charles mentioned, this amount remains in our client trust account administered by our law firm, the disbursement of which is predicated on discussions as to the amount of success-based deferred legal fees the firm is due. Following these discussions, disbursement of all or a portion of that amount is expected later this year. Our net loss was $6.3 million and $14.8 million for the 3 and 6 months ended June 30, 2023 compared to $6.2 million and $15.7 million for the comparable periods of 2022.

正如查爾斯所提到的，這筆金額保留在我們律師事務所管理的客戶信託賬戶​​中，該賬戶的支付取決於對公司應支付的基於成功的遞延法律費用金額的討論。經過這些討論，預計將在今年晚些時候支付全部或部分金額。截至2023年6月30日的3個月和6個月，我們的淨虧損分別為630萬美元和1480萬美元，而2022年同期的淨虧損為620萬美元和1570萬美元。

We will record a gain of $13 million related to the collection of the arbitration award in the third quarter of this year (inaudible) recognized in the 3 and 6 months ended June 30, 2023, it would have resulted in net income of $6.7 million for the 3-month period and a net loss of $1.8 million in the 6-month period on a pro forma basis. Turning to the balance sheet. At June 30, 2023, our cash, cash equivalents and restricted cash totaled $1.9 million compared to $17.5 million at December 31, 2022. As Charles mentioned, we collected the arbitration award in July and net proceeds to date are approximately $7.1 million. which had this been collected prior to June 30, 2023, would have resulted in ending cash of $9 million on a pro forma basis.

我們將記錄與今年第三季度收取仲裁裁決相關的1300 萬美元收益（聽不清），並在截至2023 年6 月30 日的3 個月和6 個月內確認，這將帶來670 萬美元的淨利潤按備考計算，3 個月期間的淨虧損為 180 萬美元，6 個月期間的淨虧損為 180 萬美元。轉向資產負債表。截至2023 年6 月30 日，我們的現金、現金等價物和限制性現金總計為190 萬美元，而2022 年12 月31 日為1,750 萬美元。正如Charles 提到的，我們於7 月份收到了仲裁裁決，迄今為止的淨收益約為710 萬美元。如果在 2023 年 6 月 30 日之前收取，預計期末現金將達到 900 萬美元。

With the award collected, we expect our current capital resources to fund the company into early 2024. With that, I will turn the call back over to Charles.

獲得獎項後，我們預計目前的資本資源將為公司提供資金到 2024 年初。之後，我會將電話轉回給 Charles。

Thank you, Scott. As you've heard, our corporate strategy is proceeding as planned. Allow me to recap 2 key expected events. First, in the third quarter, we expect to report the second and final mandated DMC interim efficacy assessment in ENVASARC that includes the first 46 patients dosed with 600 milligrams of ENVA. The interim efficacy assessment includes a futility threshold that has already been achieved based on responses seen to date. Second, this year, we also expect to further leverage our unique product development platform to enable companies to benefit from our capabilities and realize for themselves the substantial clinical trial time and cost savings we enjoy at TRACON, while allowing TRACON to generate non-dilutive capital.

謝謝你，斯科特。正如您所聽說的，我們的企業戰略正在按計劃進行。請允許我回顧一下 2 個關鍵的預期事件。首先，我們預計在第三季度報告 ENVASARC 的第二次也是最後一次強制 DMC 中期療效評估，其中包括首批 46 名服用 600 毫克 ENVA 的患者。中期療效評估包括根據迄今為止所看到的反應已經達到的無效閾值。其次，今年我們還期望進一步利用我們獨特的產品開發平台，使公司能夠從我們的能力中受益，並為自己實現我們在 TRACON 享受的大量臨床試驗時間和成本節省，同時允許 TRACON 產生非稀釋資本。

Thank you for your time and attention, and we are now available to answer your questions.

感謝您的時間和關注，我們現在可以回答您的問題。

(Operator Instructions) And our first question comes from Joel Beatty from Baird.

（操作員說明）我們的第一個問題來自貝爾德 (Baird) 的喬爾·比蒂 (Joel Beatty)。

First question is on the comment that the futility threshold for the second interim efficacy assessment has already been met. Can you elaborate on exactly what that means? I mean does that mean at an earlier point in time, you saw the percent response needed to hit that assessment or there's -- you actually kind of hit the numerator that you were looking to see as if the denominator headwind 46?

第一個問題是關於第二次中期療效評估的無效閾值已經達到的評論。您能具體解釋一下這意味著什麼嗎？我的意思是，這是否意味著在較早的時間點，您看到了達到該評估所需的百分比響應，或者您實際上達到了您想要看到的分子，就像分母逆風 46 一樣？

Yes, Joel, thanks for the question. So with respect to the futility threshold at the 46-patient evaluation, we need at least 3 responses in order to meet the threshold facility bar. And we had disclosed even at the DMC review in June that based on the data at that time, which continues to be the case, we've exceeded that threshold.

是的，喬爾，謝謝你的提問。因此，對於 46 名患者評估的無效閾值，我們至少需要 3 個響應才能滿足閾值設施欄。我們甚至在 6 月份的 DMC 審查中就透露，根據當時的數據（情況仍然如此），我們已經超過了該閾值。

Terrific. And then are those all confirmed responses?

了不起。那麼這些都是已確認的回應嗎？

Yes. We disclosed at the June meeting that we had seen confirmed responses both by investigator and central review that generated a double-digit response rate.

是的。我們在六月的會議上透露，我們已經看到研究者和中央審查的確認答复，產生了兩位數的答复率。

Terrific. And then thinking ahead to the final analysis, is that something that you anticipate announcing kind of at the end of the trial? Or could you announce it at an earlier point in time once, I believe it's 9 responses have been seen?

了不起。然後提前思考最終分析，您是否預計在審判結束時宣布這一點？或者你能不能早點宣布一次，我相信已經看到了9條回復了？

No, great question, John. I'm glad you brought this up. So we had been very, I think, general about response rate, saying, we've seen double-digit response rates, both at the DMC meeting. I believe that was in December and then also in June. Because we didn't want to (inaudible) potential accrual -- or we didn't want to bias patients who may be assigned in a randomized trial to one versus another where if there were a differential response rate and report that response rate and a patient doesn't get a sign to that preferred arm as well, they might drop out of the study.

不，很好的問題，約翰。我很高興你提出這個問題。因此，我認為，我們對回复率的態度非常籠統，我們在 DMC 會議上都看到了兩位數的回复率。我相信那是在十二月，然後也是在六月。因為我們不想（聽不清）潛在的應計結果，或者我們不想讓可能被分配到隨機試驗中的患者產生偏見，如果存在差異反應率，並報告反應率和患者也沒有得到首選手臂的信號，他們可能會退出研究。

As you know, now we're dosing a single-arm trial based on the single arm being the Cohort C of single-agent ENVA. So with respect to moving forward, but I don't feel like we're restricted with respect to disclosing exact response rates. So going forward, you expect us to disclose exact response rates because we don't have to, if we will protect the integrity of the randomization given we're no longer enrolling the cohort of ENVA plus YERVOY.

如您所知，現在我們正在進行一項單臂試驗，該試驗的單臂是單藥 ENVA 的 C 組。因此，關於前進，但我不認為我們在披露確切的回复率方面受到限制。因此，展望未來，您希望我們披露確切的響應率，因為如果我們不再招募 ENVA 加 YERVOY 隊列，我們​​就可以保護隨機化的完整性，因此我們不必這樣做。

So to answer your question, do you expect us to report data moving forward on a more routine basis with explicit response rates that heretofore we were unable to report.

因此，為了回答您的問題，您是否希望我們以更常規的方式報告前進的數據，並提供迄今為止我們無法報告的明確答复率。

(Operator Instructions) And our next question comes from Ed White from H.C. Wainwright.

（操作員說明）我們的下一個問題來自 H.C. 的 Ed White。溫賴特。

Just a couple of questions for Scott. How should we be thinking of research and development costs going forward now that the combo arm of this study will not be -- has been discontinued. Are there some costs that we'll see in the third quarter for sort of ramping down the trial, so we should see more of an impact in the fourth quarter? Or how should we be thinking of that?

請教斯科特幾個問題。既然這項研究的組合臂已經停止，我們應該如何考慮未來的研發成本。我們會在第三季度看到一些因減少試驗而產生的成本，所以我們應該會在第四季度看到更多的影響嗎？或者我們應該如何思考這一點？

Yes. Thanks for the question, Ed. Yes, I mean we'll see some impact in the third quarter and the fourth quarter, but not too much. I mean I would expect them to go down slightly. But not that much considering our per patient cost is so low.

是的。謝謝你的提問，艾德。是的，我的意思是我們會在第三季度和第四季度看到一些影響，但不會太大。我的意思是我預計它們會略有下降。但考慮到我們每名患者的成本如此之低，這一點並不算多。

Okay. And then another question on expenses. How should we be thinking of general and administrative costs going forward now that the arbitration is over? Is this sort of the run rate that we saw this quarter? Should we think that that's going to continue like that? Or any guidance you can give us there would be appreciated.

好的。然後是關於費用的另一個問題。仲裁結束後，我們應該如何考慮未來的一般費用和行政費用？這是我們本季度看到的運行率嗎？我們是否應該認為這種情況會繼續下去？或者您能給我們任何指導，我們將不勝感激。

Yes. No, I would expect this amount that we had in Q2 to be our cost going forward. It should be right around there, barring anything else until we do ramp up commercial activities once we file for a potential approval of ENVA.

是的。不，我預計第二季度的這筆金額將成為我們未來的成本。它應該就在那裡，除非我們在申請 ENVA 的潛在批准後開始開展商業活動，否則就不會發生任何其他事情。

And I am showing no further questions. I would now like to turn the call back over to Dr. Theuer for closing remarks.

我沒有提出任何進一步的問題。現在，我想將電話轉回給 Theuer 博士，讓其致閉幕詞。

Thank you for your time and attention, and we look forward to updating you next quarter. Have a great day.

感謝您的時間和關注，我們期待下個季度為您提供最新信息。祝你有美好的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。