Bioatla Inc (BCAB) 2023 Q2 法說會逐字稿

Greetings, and welcome to the BioAtla second-quarter 2023 earnings call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 BioAtla 2023 年第二季財報電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Mr. Bruce Mackle with LifeSci Advisors. Thank you, Bruce. You may begin.

現在我很高興向您介紹主持人，LifeSci Advisors 的 Bruce Mackle 先生。謝謝你，布魯斯。你可以開始了。

Thank you, operator, and good afternoon, everyone. With me today on the phone from BioAtla are Dr. Jay Short, Chairman, CEO and Co-Founder; and Richard Waldron, Chief Financial Officer. Following today's call, Dr. Eric Sievers, Chief Medical Officer; and Sheri Lydick, Chief Commercial Officer, will join Jay and Rick for a short Q&A.

謝謝接線員，大家下午好。今天與我通電話的是 BioAtla 董事長、執行長兼聯合創辦人 Jay Short 博士；和財務長理查德·沃爾德倫。在今天的電話會議之後，首席醫療官 Eric Sievers 博士表示：首席商務官 Sheri Lydick 將與 Jay 和 Rick 一起進行簡短的問答。

Earlier this afternoon, BioAtla released financial results and a business update for the second quarter ended June 30, 2023. A copy of the press release and corporate presentation are available on the company's website.

今天下午早些時候，BioAtla 發布了截至 2023 年 6 月 30 日的第二季度財務業績和業務更新。新聞稿和公司簡報的副本可在公司網站上取得。

Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements including, but not limited to, statements regarding BioAtla's business plans and prospects, potential selective licensing, collaborations, and other strategic partnerships, whether its clinical trials will be potentially registrational, achievements of milestones, results, conduct, progress, and timing of its research and development programs and clinical trials, expectations with respect to enrollment and dosing in its clinical trials, plans and expectations regarding future data updates, clinical trials, regulatory meetings, and regulatory submissions, the potential regulatory approval path for its product candidates, expectations about the sufficiency of its cash and cash equivalents, and expected R&D and G&A expenses.

在我們開始之前，我想提醒大家，本次電話會議期間發表的聲明將包括前瞻性聲明，包括但不限於有關BioAtla 的業務計劃和前景、潛在的選擇性許可、合作和其他戰略夥伴關係的聲明，其臨床試驗是否可能註冊、其研發計劃和臨床試驗的里程碑、結果、實施、進展和時間安排、對其臨床試驗中的入組和劑量的期望、對未來數據更新的計劃和期望、臨床試驗、監管會議和監管提交、候選產品的潛在監管批准路徑、對其現金和現金等價物充足性的預期，以及預期的研發和一般管理費用。

These statements are subject to various risks, assumptions and uncertainties. They can cause actual results to differ materially and are described in the filings made with the SEC, including the most quarterly report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 1, 2023, and BioAtla disclaims any obligation to update such statements to reflect future information, events, or circumstances except as required by law.

這些陳述受到各種風險、假設和不確定性的影響。它們可能會導致實際結果出現重大差異，並在向 SEC 提交的文件中進行了描述，包括 10-Q 表中的大多數季度報告。請您注意不要過度依賴這些前瞻性陳述，這些陳述僅截至今天，即 2023 年 8 月 1 日，BioAtla 不承擔任何更新此類陳述以反映未來資訊、事件或情況的義務，除非法律要求。

With that, I'd like to turn the call over to Jay Short. Jay?

說到這裡，我想把電話轉給傑伊·肖特。傑伊？

Thank you, Bruce, and thanks to everyone for joining us for our second-quarter 2023 BioAtla earnings call. BioAtla is the inventor and leader in the development of novel therapies using a proprietary conditionally active biologics, CABs platform with improved selectivity for attacking tumor cells while avoiding healthy cells, thereby addressing urgent unmet needs in oncology to improve patients' lives.

謝謝 Bruce，也謝謝大家參加我們的 2023 年第二季 BioAtla 財報電話會議。 BioAtla 是開發新療法的發明者和領導者，該療法使用專有的條件活性生物製劑、CAB 平台，該平台提高了攻擊腫瘤細胞的選擇性，同時避開了健康細胞，從而解決了腫瘤學中未滿足的迫切需求，以改善患者的生活。

We made significant progress last year across our multiple ongoing Phase 2 trials for our two latest stage, first-in-class CAB-ADC product candidates, BA3011 and BA3021, targeting solid tumor types with high unmet medical needs. As we are now a little over halfway through 2023, we continue our positive trajectory and remain on track to achieve our recently guided milestones outlined on the first-quarter call in May.

去年，我們在兩項最新階段的一流 CAB-ADC 產品候選產品 BA3011 和 BA3021 的多項正在進行的 2 期試驗中取得了重大進展，這些試驗針對的是醫療需求未得到滿足的實體瘤類型。現在 2023 年已過半，我們將繼續保持積極的發展軌跡，並繼續實現 5 月第一季電話會議中概述的近期指導里程碑。

We remain focused on further advancing the development of our innovative clinical programs, leveraging the broad applicability of our CAB technology across several clinical stage antibody types, including CAB-AXL and CAB-ROR2 ADCs, CAB-CTLA4 immuno-oncology naked antibody, and our first dual CAB bispecific EpCAM CD3 T cell engager. Additional details related to what I'm going to provide are available on our website as part of our updated company presentation that may be helpful to you.

我們仍然專注於進一步推進我們創新臨床項目的開發，利用我們的CAB 技術在多種臨床階段抗體類型中的廣泛適用性，包括CAB-AXL 和CAB-ROR2 ADC、CAB-CTLA4 免疫腫瘤學裸抗體以及我們的第一個雙 CAB 雙特異性 EpCAM CD3 T 細胞接合器。與我將要提供的內容相關的其他詳細資訊可以在我們的網站上找到，作為我們更新的公司簡報的一部分，可能對您有所幫助。

We remain excited about our lead asset BA3011 for multiple indications. Previously, we shared the encouraging partial interim data on our BA3011 Phase 2, part one sarcoma study and our BA3011 Phase 2, part one non-small cell lung cancer study. We also shared additional insights of how we have applied the learnings from our differentiated safety data and exposure response analysis as well as our UPS-related FDA interactions to study more frequent dose intensity regimens more broadly across our AXL ADC and our ROR2 ADC programs.

我們對多種適應症的主導資產 BA3011 仍然感到興奮。先前，我們分享了 BA3011 第 2 期第一部分肉瘤研究和 BA3011 第 2 期第一部分非小細胞肺癌研究令人鼓舞的部分中期數據。我們也分享了更多見解，說明我們如何應用從差異化安全數據和暴露反應分析以及UPS 相關FDA 互動中學到的知識，在我們的AXL ADC 和ROR2 ADC 計畫中更廣泛地研究更頻繁的劑量強度方案。

The goal is selling more frequent dose intensity regimens across programs is to provide data to allow us to set study parameters that maximize the company's likelihood of success for our Phase 2 potentially registrational studies. A summary of our current dose regimens can be found in the updated corporate presentation on our website.

目標是跨專案銷售更頻繁的劑量強度方案，以便提供數據，使我們能夠設定研究參數，最大限度地提高公司第二階段潛在註冊研究成功的可能性。我們目前劑量方案的摘要可以在我們網站上更新的公司介紹中找到。

Let's now move to our clinical, operational, and financial updates for the second-quarter 2023. First, we are advancing BA3011 in our ongoing sarcoma Phase 2 studies, including a potentially registrational study in UPS. Without specific treatments approved for UPS, there's a significant commercial opportunity as a stand-alone indication. We have shown strong execution and promising results with continued anti-tumor activity, lack of disease progression, and a differentiated safety profile with BA3011 in UPS to date.

現在讓我們來看看 2023 年第二季度的臨床、營運和財務更新。首先，我們正在正在進行的肉瘤 2 期研究中推進 BA3011，包括 UPS 的一項潛在註冊研究。如果沒有針對 UPS 批准的特定治療方法，作為獨立適應症存在巨大的商業機會。迄今為止，我們在 UPS 中使用 BA3011 表現出了強大的執行力和有希望的結果，具有持續的抗腫瘤活性、沒有疾病進展以及差異化的安全性。

Based on these results, together with the continued differentiated safety profile and encouraging feedback from the FDA around the study design, last year, we initiated part two of the potentially registrational portion of the trial. The first 40 patients are being randomized one-to-one between the more frequent dose intensity regimens.

基於這些結果，再加上持續差異化的安全性以及 FDA 圍繞研究設計提供的令人鼓舞的回饋，去年我們啟動了該試驗的潛在註冊部分的第二部分。前 40 名患者將一對一隨機分配到更頻繁的劑量強度治療方案。

Following the first 40 patients, we plan to enroll an additional 40 patients at the selected dose to complete the study. The primary efficacy endpoint, ORR will be based on approximately 60 patients treated at the selected dosing regimen. As an update, we achieved first patient in and are actively enrolling patients.

繼前 40 名患者之後，我們計劃以選定的劑量招募另外 40 名患者來完成研究。主要療效終點 ORR 將基於按所選給藥方案治療的約 60 名患者。作為更新，我們已經迎來了第一位患者，並且正在積極招募患者。

In addition to UPS, we have completed enrollment of the Phase 2, part one leiomyosarcoma cohort using the 3Q4W dosing regimen and are on track with an anticipated data readout on 10 to 15 patients in the second half of this year. Further, the remaining bone sarcoma cohorts in Phase 2, part one are on track to finish enrolling in the second half of 2023.

除了 UPS 之外，我們還使用 3Q4W 給藥方案完成了 2 期第一部分平滑肌肉瘤隊列的入組，預計今年下半年將有 10 至 15 名患者的數據讀出。此外，第二階段第一部分中剩餘的骨肉瘤隊列預計在 2023 年下半年完成入組。

With regards to safety profile across all sarcoma subtypes, there are no new safety signals to report. BA3011 continues to be generally well tolerated with the Phase 2 safety profile across all doses consistent with the profile we observed in Phase 1.

關於所有肉瘤亞型的安全性，沒有新的安全訊號需要報告。 BA3011 整體上仍具有良好的耐受性，所有劑量的 2 期安全性概況與我們在 1 期觀察到的概況一致。

Regarding our BA3011 Phase 2 study in AXL-positive multi-refractory non-small cell lung cancer, we continue to be encouraged about the data from the Q2W dosing regimen, while we anticipate data from the more frequent dose intensive regimens. Currently, the standard treatment options in patients who progressed on immune checkpoint inhibitors have suboptimal overall response rates of approximately 10% to 20% and four-month PFS rates.

關於我們針對 AXL 陽性多難治性非小細胞肺癌的 BA3011 2 期研究，我們繼續對 Q2W 給藥方案的數據感到鼓舞，同時我們預計來自更頻繁的劑量密集方案的數據。目前，使用免疫檢查點抑制劑取得進展的患者的標準治療方案的整體緩解率和四個月的 PFS 率均未達到最佳水平，約為 10% 至 20%。

Part one of the Phase 2 study in non-small cell lung cancer is ongoing in AXL-positive patients who have previously experienced failure of either PD-1, PD-L1, EGFR, or ALK inhibitors and continues to enroll patients. Anticipated data for all dosing regimens assisting with the study design for the potentially registrational portion of the trial remains on track for the second half of this year.

非小細胞肺癌 2 期研究的第一部分正在 AXL 陽性患者中進行，這些患者之前曾經歷過 PD-1、PD-L1、EGFR 或 ALK 抑制劑的失敗，並繼續招募患者。協助試驗的潛在註冊部分的研究設計的所有給藥方案的預期數據仍在今年下半年按計劃進行。

We have submitted a meeting request to the FDA for potentially registrational BA3011 Phase 2, part two non-small cell lung cancer study design and anticipate feedback in the second half of this year and as a result remain on track to initiate the Phase 2, part two study in non-small cell lung cancer also in the second half of this year, maintaining our overall timeline for development of the non-small cell lung cancer indication.

我們已向 FDA 提交了可能註冊 BA3011 第 2 階段第二部分非小細胞肺癌研究設計的會議請求，並預計在今年下半年得到反饋，因此仍有望啟動第 2 階段第 2 部分兩項針對非小細胞肺癌的研究也在今年下半年進行，維持了我們開發非小細胞肺癌適應症的整體時間表。

We continue to believe BA3011 has the potential to become a significant commercial asset for BioAtla and an even greater importance, a first-in-class treatment for a significant number of patients who failed at least one prior line of therapy, thus addressing a significant unmet medical need.

我們仍然相信 BA3011 有潛力成為 BioAtla 的一項重要商業資產，更重要的是，它是對大量先前至少一種治療失敗的患者的一流治療方法，從而解決了一個重大未滿足的問題醫療需求。

Regarding the ongoing multi-center investigator-initiated IIT Phase 2 clinical trial in patients with platinum-resistant ovarian cancer, the trial is fully enrolled and remains on track for the interim data readout consisting of 10 patients in the second half of this year.

關於正在進行的多中心研究者發起的針對鉑類抗藥性卵巢癌患者的IIT 2 期臨床試驗，該試驗已全部入組，並仍在按計劃於今年下半年公佈由10 名患者組成的中期數據。

Now turning to our second CAB-ADC asset, BA3021, a CAB-ROR2 ADC, currently, BA3021 is a subject of Phase 2 trials in the treatment four different indications. We conducted a similar exposure-response analysis of ROR2-positive tumors to inform the more frequent dose-intensive regimen of 3Q4W in our Phase 2 ROR2-positive non-small cell lung cancer study.

現在轉向我們的第二個 CAB-ADC 資產 BA3021，它是一種 CAB-ROR2 ADC，目前，BA3021 是治療四種不同適應症的 2 期試驗的主題。我們對 ROR2 陽性腫瘤進行了類似的暴露反應分析，以便為我們的 2 期 ROR2 陽性非小細胞肺癌研究中更頻繁的 3Q4W 劑量密集方案提供資訊。

Based on this analysis, which is a similar strategy to our UPS Phase 2 part 2 BA3011 study I mentioned earlier, we are screening and enrolling patients. Based on the activity to date, we believe that we remain on track to obtain data this year to permit clinical trial prioritization across our portfolio.

基於此分析（與我之前提到的 UPS 第 2 階段第 2 部分 BA3011 研究類似的策略），我們正在篩選和招募患者。根據迄今為止的活動，我們相信今年我們仍有望獲得數據，以便在我們的投資組合中確定臨床試驗的優先順序。

Regarding the melanoma Phase 2 trial in patients who have previously experienced failure of PD-1 therapy, we are continuing to screen patients with a validated IHC liquid biopsy assay. As we stated last quarter, we have successfully identified ROR2-positive tumors using the liquid biopsy assay, which is allowing us to enroll ROR2-positive patients. And we are on track to dose patients in the second half of this year.

關於先前經歷過 PD-1 治療失敗的患者進行的黑色素瘤 2 期試驗，我們正在繼續使用經過驗證的 IHC 液體活檢檢測來篩選患者。正如我們上季度所說，我們已經使用液體活檢成功鑑定了 ROR2 陽性腫瘤，這使我們能夠招募 ROR2 陽性患者。我們預計在今年下半年為患者提供劑量。

In addition, our Phase 2 head and neck study is ongoing in patients who have previously experienced failure of PD-1 therapy alone or in combination with platinum therapy. Earlier this year, we announced achievement of first patient in for this study. Since that time, multiple patients have been dosed, and we continue to enroll patients.

此外，我們的 2 期頭頸研究正在針對先前經歷過單獨 PD-1 治療或與鉑類治療聯合治療失敗的患者進行。今年早些時候，我們宣布了第一位患者在這項研究中所取得的成就。從那時起，已有多名患者接受了給藥，我們仍在繼續招募患者。

Regarding the ongoing multi-center investigator-initiated Phase 2 clinical trial in patients with platinum resistant ovarian cancer, the trial is fully enrolled and remains on track for the interim data readout consisting of 10 patients in the second half of this year.

關於正在進行的多中心研究者發起的針對鉑類抗藥性卵巢癌患者的 2 期臨床試驗，該試驗已全部入組，並預計在今年下半年公佈由 10 名患者組成的中期數據。

Now turning to our Phase 1/2 trial for our CAB-CTLA-4 antibody, BA3071, as a reminder, the Phase 1/2 trial is being conducted in tumors known to be responsive to CTLA-4 treatment. And we are continuing to evaluate safety and tolerability of BA3071 in monotherapy and in combination with nivolumab. The trial is progressing as planned.

現在轉向我們的 CAB-CTLA-4 抗體 BA3071 的 1/2 期試驗，提醒一下，該 1/2 期試驗正在已知對 CTLA-4 治療有反應的腫瘤中進行。我們正在繼續評估 BA3071 單藥治療以及與納武單抗聯合治療的安全性和耐受性。審判正在按計劃進行。

Last quarter, we shared that we started treating patients in the fifth cohort at 350 milligrams or 5 mg/kg as monotherapy and in combination with 3 mg/kg nivolumab. As part of today's update, I'm happy to report that the DLT observation period was cleared for the fifth cohort, and no DLTs were reported. We are currently enrolling patients in the sixth cohort at 700 milligrams or 10 mg/kg as the monotherapy or in combination with 3 mg/kg of nivolumab and remain on track to our Phase 1 data readout anticipated the second half of this year.

上個季度，我們分享了我們開始以 350 毫克或 5 毫克/公斤的單一療法並與 3 毫克/公斤納武單抗聯合治療第五隊列中的患者。作為今天更新的一部分，我很高興地報告第五組的 DLT 觀察期已清除，並且沒有報告 DLT。我們目前正在第六隊列中招募患者，以 700 毫克或 10 毫克/公斤作為單一療法或與 3 毫克/公斤納武單抗聯合治療，並繼續按計劃在今年下半年公佈 1 期數據。

We also remain on track to initiate BA371 (sic - BA3071) Phase 2 study also in the second half of this year. We believe there are significant unmet medical needs with sizable commercial opportunities across multiple tumor types where CTLA-4 can deliver efficacy with a manageable safety and tolerability profile that allows patients to stay on therapy for longer and thus achieve the full benefit of this important immunotherapy.

我們也將繼續在今年下半年啟動 BA371（原文如此 - BA3071）2 期研究。我們相信，在多種腫瘤類型中，存在大量未滿足的醫療需求和巨大的商業機會，其中CTLA-4 可以提供療效，並具有可管理的安全性和耐受性，使患者能夠更長時間地接受治療，從而實現這項重要免疫療法的全部益處。

Next on to our potentially first-in-class dual CAB bispecific T cell engager antibody CAB-EpCAM and CAB-CD3 or BA3182, as mentioned during last quarter's call, we received FDA clearance of our IND for the treatment of advanced adenocarcinoma. We are now actively enrolling patients in this Phase 1 study with the full data readout remaining on track for next year.

如上季電話會議中所提到的，繼我們潛在的一流雙 CAB 雙特異性 T 細胞接合抗體 CAB-EpCAM 和 CAB-CD3 或 BA3182 之後，我們的 IND 已獲得 FDA 批准用於治療晚期腺癌。我們現在正在積極招募患者參與這項第一階段研究，完整的數據讀出仍將在明年進行。

Similar to our other three clinical-stage CAB assets, this antibody has shown significant promise in in vivo preclinical studies, demonstrating an over 100-fold improvement in therapeutic index relative to the non-CAB variance due to the combined selectivity of the dual CAB design. We believe that our dual CAB design has the potential to address the tremendous unmet need across several of the most common subtypes of adenocarcinoma, including colon, lung, breast, pancreas, and prostate.

與我們的其他三個臨床階段 CAB 資產類似，該抗體在體內臨床前研究中顯示出巨大的前景，由於雙 CAB 設計的組合選擇性，治療指數相對於非 CAB 變異數提高了 100 倍以上。我們相信，我們的雙 CAB 設計有潛力解決幾種最常見的腺癌亞型（包括結腸癌、肺癌、乳腺癌、胰腺癌和前列腺癌）尚未滿足的巨大需求。

Finally, we continue to pursue opportunities to share our progress with the medical and scientific communities with an additional two Trial in Progress abstracts, one for BA3011 and another for BA3021, which were accepted for poster presentations at the upcoming World Conference on Lung Cancer this September. This brings the total confirmed medical meeting presentation talent to 11 since the beginning of the year. Additional abstracts have been submitted for several upcoming meetings as well.

最後，我們繼續尋求機會與醫學界和科學界分享我們的進展，並提供另外兩份正在進行的試驗摘要，一份針對BA3011，另一份針對BA3021，這些摘要已在今年9 月即將舉行的世界肺癌大會上被接受用於海報展示。這使得自年初以來已確認的醫療會議演講人才總數達到 11 人。也為即將舉行的幾次會議提交了額外的摘要。

With that, I would now like to turn the call over to Rick to review the second-quarter 2023 financials. Rick?

現在，我想將電話轉給 Rick，讓他審查 2023 年第二季的財務狀況。瑞克？

Thank you, Jay. As of June 30, 2023, we had $168.7 million in cash and cash equivalents compared to $215.5 million as of December 31, 2022. We expect current cash and cash equivalents will be sufficient to fund planned operations, including all ongoing CAB product development programs into 2025. As a reminder, we control all CAB product market rights in the US, Europe, and Japan.

謝謝你，傑伊。截至2023 年6 月30 日，我們擁有1.687 億美元的現金和現金等價物，而截至2022 年12 月31 日為2.155 億美元。我們預計當前的現金和現金等價物將足以為計劃運營提供資金，包括所有正在進行的CAB 產品開發計劃2025 年。提醒一下，我們控制著美國、歐洲和日本的所有 CAB 產品市場權利。

Our business strategy includes advancing commercial preparations in key global markets while exploring opportunities to extend our cash runway by generating upfront cash through the selective licensing of product rights in certain territories or collaborations with other biopharmaceutical companies that could also provide to us development milestones and royalties upon regulatory approval and commercialization and create additional value for stockholders.

我們的業務策略包括推進全球主要市場的商業準備工作，同時探索擴大我們現金跑道的機會，透過在某些地區選擇性地許可產品權利或與其他生物製藥公司合作來產生預付現金，這些公司也可以向我們提供開發里程碑和特許權使用費。監管部門的批准和商業化，並為股東創造額外價值。

For the second quarter ended June 30, 2023, we reported a net loss of $35.8 million compared to a net loss of $28.9 million in the same period of 2022. Research and development expenses were $31 million for the second quarter ended June 30, 2023, compared to $20.7 million for the same period in 2022. The increase of $10.3 million was primarily driven by our preclinical and clinical product development efforts. We expect our R&D expenses to remain variable from quarter to quarter and generally increase as we continue to invest in R&D activities to advance our product candidates and our clinical programs.

截至2023年6月30日的第二季度，我們的淨虧損為3,580萬美元，而2022年同期的淨虧損為2,890萬美元。截至2023年6月30日的第二季度的研發費用為3,100萬美元，相較之下，2022 年同期為 2,070 萬美元。增加 1,030 萬美元主要是由我們的臨床前和臨床產品開發工作所推動的。我們預計我們的研發費用將在每個季度保持變化，並且隨著我們繼續投資於研發活動以推進我們的產品候選者和臨床項目，整體上將會增加。

General and administrative expenses were $6.2 million for the quarter ended June 30, 2023, compared to $8.3 million for the same quarter in 2022. The $2.1 million change was attributable to a decrease in various administrative expenses for the 2023 period. We expect our G&A expenses to moderately increase to support development of our product candidates, advance our intellectual property portfolio, support focused pre-commercialization activities for our asset BA3011, and satisfy requirements as a public company.

截至 2023 年 6 月 30 日的季度，一般及管理費用為 620 萬美元，而 2022 年同期為 830 萬美元。210 萬美元的變化是由於 2023 年期間各種管理費用減少。我們預計我們的一般管理費用將適度增加，以支持我們的候選產品的開發，推進我們的知識產權組合，支持我們的資產 BA3011 的重點預商業化活動，並滿足作為上市公司的要求。

Net cash used in operating activities for the six months ended June 30, 2023, was $46.7 million compared to net cash used in operating activities of $42.1 million for the same period in 2022. The increase in net cash used in operating activities for the first six months of 2023 is primarily due to an increase in research and development expenses related to our program development efforts as compared to the first six months of 2022.

截至2023 年6 月30 日的六個月經營活動使用的現金淨額為4,670 萬美元，而2022 年同期經營活動使用的現金淨額為4,210 萬美元。前六個月經營活動使用的現金淨額增加與 2022 年前六個月相比，2023 年的成長主要是由於與我們的專案開發工作相關的研發費用增加。

And now, back to Jay.

現在，回到傑伊。

Thank you, Rick. We are pleased with the progress we have made to date and cumulative results that continue to support both the preliminary efficacy and safety from our differentiated proprietary CAB platform. We are encouraged with the compelling clinical profile that is emerging in treatment refractory UPS and non-small cell lung cancer and are eager to start evaluating data from our Phase 2 studies with the addition of the more frequent dose-intensive regimens.

謝謝你，瑞克。我們對迄今為止所取得的進展和累積結果感到高興，這些結果繼續支持我們差異化的專有 CAB 平台的初步功效和安全性。我們對難治性 UPS 和非小細胞肺癌治療中出現的令人信服的臨床資料感到鼓舞，並渴望開始評估我們的 2 期研究數據，並增加更頻繁的劑量密集型治療方案。

We're also excited by the continued clinical execution of our other promising CAB assets, in particular, our BA3071 CAB-CTLA-4 clearing the fifth cohort with no DLTs observed and are well positioned to reach several value-creating milestones and key inflection points by year end. BioAtla remains confident about the future with the goal of pursuing indications of high unmet medical needs that we feel will have significant impact for patients and our shareholders worldwide.

我們也對我們其他有前途的CAB 資產的持續臨床執行感到興奮，特別是我們的BA3071 CAB-CTLA-4 清除了第五個隊列，沒有觀察到DLT，並且處於有利地位，可以實現幾個創造價值的里程碑和關鍵拐點到年底。 BioAtla 對未來仍充滿信心，目標是追求未滿足的醫療需求的跡象，我們認為這將對全球患者和我們的股東產生重大影響。

With that, we will turn it back to the operator to take your questions.

這樣，我們會將其轉回給接線員以回答您的問題。

(Operator Instructions) Kelly Shi, Jefferies.

（操作員說明）Kelly Shi，Jefferies。

Hi, this is Dave on from Jefferies. Thank you for taking our questions. I have a question on the request that you submitted to FDA. Can you talk a little bit more what kind of data have you provided to do the FDA? And does it include enough data to make a decision on RP2D?

大家好，我是 Jefferies 的戴夫。感謝您接受我們的提問。我對您向 FDA 提交的請求有疑問。您能多談談您向 FDA 提供了哪些數據嗎？它是否包含足夠的數據來做出 RP2D 決策？

Yeah. I mean, I think what we've really approached the FDA with is questions related to a study design and basically both with respect to whether it's a randomized trial, single-arm trial. And we provided a basic update of things that we have to date.

是的。我的意思是，我認為我們真正向 FDA 提出的問題是與研究設計相關的問題，基本上都是關於它是否是隨機試驗、單臂試驗的問題。我們提供了迄今為止的基本更新。

And maybe, Eric, you might want to add a little bit more on that.

也許，艾瑞克，你可能想補充一點。

Sure. Your question was about whether we've provided data regarding a recommended Phase 2 dose, I believe. And presently, we've submitted questions to the agency, just as Jay had mentioned, about the overall study design, randomization, on some of those features. We anticipate preparing more information regarding our dosing regimens in the briefing program.

當然。我相信，你的問題是我們是否提供了有關建議的第二階段劑量的數據。目前，正如傑伊所提到的那樣，我們已向該機構提交了有關總體研究設計、隨機化和其中一些特徵的問題。我們預計在簡報中準備更多有關我們的給藥方案的資訊。

Right. And one more thing, how many our patient data do you expect to include in the follow up? And do you have any internal model to move forward for ORR or PFS?

正確的。還有一件事，您希望在後續行動中包含多少我們的患者資料？您是否有任何內部模型可以推進 ORR 或 PFS？

Eric, you want to start with that one?

艾瑞克，你想從那個開始嗎？

Sure. We are evaluating patient as shown in our corporate deck at multiple dose levels, including more dose-intensive regimens. And I anticipate we'll have a full-some analysis of those data by the end of the year that we can provide to the agency as a part of the Project Optimus.

當然。我們正在對患者進行多種劑量水平的評估，包括更多劑量密集型治療方案，如我們的公司平台所示。我預計我們將在今年年底前對這些數據進行全面的分析，並將其作為 Optimus 計畫的一部分提供給該機構。

And I would add that we're testing basically three different doses, the every-other-week and then the 2Q3W as well as the 3Q4W. And so we'll have a little bit more data on the Q2W, but we believe we'll have sufficient data for all of the doses for our go-forward decision, how we're going to approach it.

我想補充一點，我們基本上正在測試三種不同的劑量，每隔一周一次，然後是第二季第三週以及第三季第四季度。因此，我們將獲得更多關於第二季度的數據，但我們相信我們將擁有所有劑量的足夠數據，以便我們可以做出未來的決定，以及我們將如何處理它。

Great. Thank you for taking our question.

偉大的。感謝您提出我們的問題。

Brian Cheng, JP Morgan.

布萊恩鄭，摩根大通。

Hey, guys. Thanks for taking my questions this morning or this afternoon. Just a couple from us, maybe first on 3021, given the number of potential opportunities here for the molecule, how do you think about the factors to consider when making a prioritization decision? What is your latest thoughts on collaboration or partnership that could potentially build in this consideration?

大家好。感謝您今天早上或今天下午回答我的問題。就我們而言，也許首先是 3021，考慮到該分子的潛在機會數量，您如何考慮在做出優先級決定時需要考慮的因素？您對可能在此考慮中建立的合作或夥伴關係的最新想法是什麼？

Yeah. When we're making these kinds of decisions, Brian, I think we're going to be looking across the entire portfolio. We have to weigh the AXL indications, the fact that we're in the lung AXL and also in ROR2 lung. How many lung indications should we take forward at the same time?

是的。布萊恩，當我們做出這種決定時，我認為我們將審視整個投資組合。我們必須權衡 AXL 適應症，事實上我們在肺 AXL 中，也在 ROR2 肺。我們應該同時提出多少肺部適應症？

We'll be evaluating that, and that's going to be related to data and also where things are safety wise. I think we're across the board feeling very comfortable across all the indications. So I think -- I know personally, I'm very interested to see how the head and neck reads out. We're still accumulating data, likewise in lung, and of course, on both at the AXL and ROR2, we're seeing -- we expect to see -- on track to see ovarian cancer data as well.

我們將對此進行評估，這將與資料以及安全性方面的情況相關。我認為我們對所有跡像都感到非常舒適。所以我認為——我個人知道，我非常有興趣了解頭部和頸部的讀數。我們仍在累積數據，同樣在肺部，當然，在 AXL 和 ROR2 上，我們正​​在看到——我們期望看到——也有望看到卵巢癌數據。

And by the way, just as a footnote at the time of -- right up on the script, we hadn't dosed the melanoma patient yet, but at least we crossed that line today. And so I think that's truly going, and that's going to give us a nice picture there as well, which we expected, but it's nice to see it maybe a little ahead.

順便說一句，正如劇本上的腳註一樣，我們還沒有給黑色素瘤患者服用藥物，但至少今天我們跨越了這條線。所以我認為這確實是在進行，這也將為我們帶來一幅美好的畫面，這是我們所期望的，但很高興看到它可能會提前一點。

So overall, I'd say we have more indications and more drug opportunities that most companies have. So you've got an opportunity to really pick the best ones to advance. And that also gives us some freedom for partnering as well.

總的來說，我想說我們比大多數公司擁有更多的適應症和更多的藥物機會。所以你有機會真正挑選出最好的人來升遷。這也給了我們一些合作的自由。

And I don't know, that's maybe a high-level response. And maybe I don't know, Sheri, you want to add anything else to it, but don't feel obligated.

我不知道，這可能是高層的回應。也許我不知道，Sheri，你想添加任何其他內容，但不要覺得有義務。

No, I think you covered it, Jay. Thank you.

不，我想你已經涵蓋了，傑伊。謝謝。

Yeah. Maybe just one more on 3071, any color on clinical activity so far with the fifth cohort dosing? And just how should we think about the potential indications for the Phase 2 dose-expansion cohort?

是的。也許只是 3071 的一個，到目前為止第五組給藥的臨床活動有任何顏色嗎？我們應該如何考慮 2 期劑量擴展隊列的潛在適應症？

Yeah. I mean, safety wise, we're very happy with that. We're also very encouraged without getting into any specifics, but with the data readouts that we're seeing already. And so I would say that as we said in the script, we're excited about that asset, and we continue to be.

是的。我的意思是，從安全角度來看，我們對此非常滿意。我們也很受鼓舞，雖然沒有透露任何細節，但我們已經看到了數據讀數。所以我想說，正如我們在劇本中所說，我們對這項資產感到興奮，我們將繼續如此。

And I think you'll recall that we're testing this across eight different indications, all known to have some responsiveness to CTLA-4. And so we've done a fair bit of analysis on which ones we are likely to take forward. But I think we're going to see how the next cohort reads out and tighten that view. But I think at this point, I certainly wouldn't be ruling out any indications.

我想您會記得，我們​​正在針對八種不同的適應症進行測試，所有這些適應症都對 CTLA-4 有一定的反應。因此，我們對可能推進哪些項目進行了相當多的分析。但我認為我們將看看下一批人如何宣讀並加強這一觀點。但我認為在這一點上，我當然不會排除任何跡象。

However, there will be some, I think, that have a great opportunity. And I would prefer not to list them now because this is an evolving asset. And I really like the data we're seeing with the combination with PD-1 at 3 mg/kg and clearly the 5 mg/kg. And we already have dosed the patients after at this next level, so it's ongoing.

然而，我認為，有些人會有很好的機會。我不想現在就列出它們，因為這是一項不斷發展的資產。我真的很喜歡我們在 3 mg/kg 和顯然 5 mg/kg 的 PD-1 組合中看到的數據。我們已經在下一級別之後給患者服用了藥物，所以它仍在繼續。

Great. Thanks for taking my question.

偉大的。感謝您提出我的問題。

I should add, Brian, that one nice thing about CTLA-4 is that it also opens up the door for future combination therapies and just like in analogous way that PD-1 has done with so many different other therapies. So one can't help but sit back and think about those possibilities in addition to just combining with PD-1.

Brian，我應該補充一點，CTLA-4 的一個好處是，它也為未來的聯合療法打開了大門，就像 PD-1 與許多不同其他療法的類似方式一樣。因此，除了與 PD-1 結合之外，我們不禁要坐下來思考這些可能性。

Kaveri Pohlman, BTIG.

卡維裡·波爾曼，BTIG。

Yeah. Good evening, and thanks (technical difficulty) Phase 2 trial, it's a relatively small sample size. Any color on when do you think you'll be able to complete the frequent dosing study? And will you be reporting efficacy data from these cohorts after a selection of the right schedule or that won't be allowed as some patients will be part of the pivotal trial?

是的。晚上好，感謝（技術難度）第二階段試驗，這是一個相對較小的樣本量。您認為什麼時候能夠完成頻繁給藥研究？在選擇正確的時間表後，您是否會報告這些隊列的療效數據，或者由於某些患者將成為關鍵試驗的一部分而不允許這樣做？

Well, if we're talking about lung, we do anticipate -- well, we'll have the data, enough data for the more frequent dosing to make our plan for going forward into a registrational study this half of this year. We are and have identified a medical meeting where we intend to provide an update on our data, both for the every-other-week dosing as well as in the more frequent dosing.

好吧，如果我們談論的是肺，我們確實預計——好吧，我們將擁有數據，足夠的數據用於更頻繁的給藥，以便制定我們在今年上半年進行註冊研究的計劃。我們正在並且已經確定了一次醫療會議，我們打算在會議上提供我們的數據更新，包括每隔一周的給藥以及更頻繁的給藥。

We're going to report on that meeting after we formally get accepted at the at that meeting. But we believe that's on track for communication this year. That's with the AXL in lung. The UPS, of course, is the registrational or potentially registrational now, and again, we'll not be reporting on that until later next year once we get further down the line on that.

在我們被該會議正式接受後，我們將對該會議進行報告。但我們相信今年的溝通將步入正軌。這是肺部的 AXL。當然，UPS 現在是註冊的或可能是註冊的，而且，我們要等到明年晚些時候，一旦我們進一步了解這一點，我們才會對此進行報告。

And then the ovarian studies, we intend to report out on those both for the AXL ROR2. And we're certainly hopeful that we'll have sufficient data from the ROR2 asset to allow us to affect the prioritization across our portfolio, both from the standpoint of what we want to take forward and what we might want to partner, et cetera. I'm not sure that we're going to report out efficacy data on ROR2 this year, but we'll certainly have some sense of the prioritization.

然後是卵巢研究，我們打算報告 AXL ROR2 的這兩項研究。我們當然希望我們能夠從 ROR2 資產中獲得足夠的數據，以便我們能夠影響整個投資組合的優先級，無論是從我們想要推進的內容還是我們可能想要合作的內容等角度來看。我不確定今年我們是否會報告 ROR2 的功效數據，但我們肯定會對優先順序有一定的了解。

And of course, CTLA-4, I think also we're going to be -- we'll be giving updates, routine updates on as we progress through Phase 1 about, I think, as we'll also guide a little bit on where we're going ahead with the Phase 2 study as well. The actual readout on that is probably -- most of our plan, as we've reported earlier in the year, is to align with medical meetings for our readout. But we've tried to bring in as many of those as we can into this year.

當然，CTLA-4，我認為我們也會——隨著我們在第一階段的進展，我們將提供更新、例行更新，我認為，我們還將提供一些指導我們也將繼續進行第二階段研究。正如我們在今年早些時候報導的那樣，實際的讀數可能是——我們的大部分計劃是與醫療會議的讀數保持一致。但我們已盡力在今年引入盡可能多的內容。

Got it. That's very helpful. And then I believe for ovarian cancer results, you mentioned that you have completed the enrollment. But can you tell us how long these patients have been on treatment? And will you be able to provide any results on durability?

知道了。這非常有幫助。然後我相信對於卵巢癌結果，您提到您已經完成了入組。但您能告訴我們這些患者接受治療多久了嗎？您能提供有關耐久性的結果嗎？

Well, these have started some time ago, and I'll maybe allow Eric to give better feedback on the timeline. But I'd just remind everyone, these are IIT studies so the actual -- we're waiting on the data ourselves. So we're hope -- we know it is not too far off in the future. We've been told by our Phase 2 studies; we know they're fully enrolled. So we should have a nice snapshot.

嗯，這些已經開始一段時間了，我也許會讓艾瑞克就時間表提供更好的回饋。但我想提醒大家，這些都是 IIT 研究，所以實際情況是我們自己在等待數據。所以我們希望——我們知道這在未來並不遙遠。我們的第二階段研究告訴我們；我們知道他們已經全部註冊。所以我們應該要有一張漂亮的快照。

But Eric, maybe you want to get a sense when things started, keeping in mind that all the patients have come on board at different times. So it's hard to give a specific number. But Eric, you want to add some more color to it?

但是艾瑞克，也許你想了解事情何時開始，並記住所有患者都是在不同時間加入的。所以很難給一個具體的數字。但是艾瑞克，你想為它添加更多的色彩嗎？

Jay, I think you've characterized it really well on. We started working with the Canadian clinical trials group back in 2020 about this. Then we had a mature protocol and started enrolling patients at different times in the two different protocols -- I mean, the two different regimens, one for the ROR2 asset and the other for AXL. We are looking forward to seeing these data as well.

傑伊，我認為你已經很好地描述了它。我們早在 2020 年就開始與加拿大臨床試驗小組合作。然後我們有了一個成熟的方案，並開始在不同時間用兩種不同的方案招募患者——我的意思是，兩種不同的方案，一種用於 ROR2 資產，另一種用於 AXL。我們也期待看到這些數據。

Well, I think we're going to get some insight on durability. Obviously, the latter patients in that study will have a little less than the earlier ones, but that's the way it works.

嗯，我想我們會對耐久性有一些了解。顯然，研究中的後期患者會比早期患者少一點，但這就是它的工作原理。

Got it. And maybe last one, besides exploring the dosing schedule, do you also plan to continue to explore AXL expression score for each tumor type to confirm the patient population that responds best to the treatment? And any changes you expect or need to make in terms of your companion diagnostic tests?

知道了。也許最後一個，除了探索給藥方案之外，您是否還計劃繼續探索每種腫瘤類型的 AXL 表達評分，以確認對治療反應最佳的患者群體？您期望或需要在伴隨診斷測試方面做出任何改變嗎？

I think the companion diagnostics path forward was in good shape. I would just say, though, we are -- I think we reported out earlier in the year that we had at least one PR at the 1% TmPS score level in lung. So we are exploring a bit further and without getting into too many details at this point. But yes, that's certainly on our mind, and we're evaluating things.

我認為伴隨診斷的前進道路狀況良好。不過，我只想說，我們 - 我想我們在今年早些時候報告說，我們至少有一次肺部 TmPS 評分水平達到 1% 的 PR。因此，我們正在進一步探索，目前尚未涉及太多細節。但是，是的，這確實在我們的考慮之中，並且我們正在評估事情。

Excellent. Thanks for taking my questions.

出色的。感謝您回答我的問題。

Arthur He, HC Wainwright.

亞瑟‧何 (Arthur He)，HC 溫賴特 (HC Wainwright)。

Hi. Good afternoon, Jay, Rick, Eric, and Sheri. Thanks for taking my questions. I had a -- as for the on the 3071 data update, so could you just tell us at the current the 5 mg/kilo in combo, what's the average cycles of the 3071 being dosed?

你好。下午好，傑伊、瑞克、艾瑞克和雪莉。感謝您回答我的問題。我有一個 - 至於 3071 數據更新，那麼您能否告訴我們，目前 5 毫克/公斤的組合，3071 的平均給藥週期是多少？

It can be very low because I think we reported out that we were just dosing down in our May timeframe, something like that, and the May, June area. I think also at some of the conferences, we may have mentioned in June. So you can only expect it to be a couple -- a few months. But I think in general, we're encouraged with what we're seeing.

它可能非常低，因為我認為我們報告說我們只是在 5 月的時間範圍內減少劑量，類似的情況，以及 5 月、6 月區域。我想在一些會議上，我們可能也提到了六月的情況。所以你只能期待幾個月——幾個月。但我認為總的來說，我們對所看到的情況感到鼓舞。

Okay. Thanks for that. And I just --

好的。感謝那。我只是——

By the way, Arthur, I should add, though, but we have earlier dose levels that just happened to be earlier. Several of those have gone on for quite some time, well over the three to four cycles that have normally attainable.

順便說一句，亞瑟，我應該補充一點，但我們有更早的劑量水平，只是碰巧更早。其中一些已經持續了相當長的一段時間，遠遠超過了通常可以達到的三到四個週期。

I see. I see. Yes. And just for the 10 mg/kilo, is it still in the monotherapy dosing stage, or it's already reached the combo dosing?

我懂了。我懂了。是的。就10毫克/公斤來說，它還處於單一治療劑量階段，還是已經達到了組合劑量？

I think it's -- we don't have a precise -- I know one has made it, but I don't have much more information, and I don't know the status, but -- so that's about all I'm going to give right now. Let's just see how it plays out here.

我認為——我們沒有一個精確的——我知道有人成功了，但我沒有更多的信息，我也不知道狀態，但是——所以這就是我所知道的。現在就要給予。讓我們看看這裡的表現如何。

Sure. No worries. And my second question is on the EpCAM program. So congrats on the progress. And so for the data update we expect for the next year, could you first give some update on the enrollment status for the study? And regarding the updated -- or what kind of dataset we could expect? Thank you.

當然。不用擔心。我的第二個問題是關於 EpCAM 程序。所以恭喜你取得了進展。因此，對於我們預計明年的數據更新，您能否首先提供有關該研究的註冊狀態的一些最新資訊？關於更新後的資料集，或者我們可以期待什麼樣的資料集？謝謝。

Well, there are elements active across many centers, which we had to roll out across. And so we're happy that that's rolling, and I think it fits our timeline. And we should be able to -- I don't know when we're going to get the first update on that. I would certainly be -- we're just basically would be a little bit similar to how we're handling CTLA-4, but I don't think we would give too much insight on the early doses because they're probably less relevant.

嗯，許多中心都有活躍的元素，我們必須在這些中心進行推廣。所以我們很高興它正在滾動，我認為它符合我們的時間表。我們應該能夠——我不知道我們什麼時候才能得到第一個更新。我當然會——我們基本上會與我們處理 CTLA-4 的方式有點相似，但我認為我們不會對早期劑量提供太多了解，因為它們可能不太相關。

But as we start to march up toward, I would say, EC50, where we start seeing efficacy expectations, and I think looking at the data more (technical difficulty). But clearly, we're on track for next year as everything looks right now, and that's an exciting asset, no question.

但當我們開始邁向 EC50 時，我們開始看到功效預期，我認為更多地關注數據（技術難度）。但顯然，我們明年將步入正軌，因為目前一切看起來都很好，毫無疑問，這是一項令人興奮的資產。

Awesome. Thank you. Thank you for taking my question, and congrats on the progress.

驚人的。謝謝。感謝您提出我的問題，並祝賀我的進展。

Thank you.

謝謝。

Tony Buter, EF Hutton.

托尼·巴特，EF·赫頓。

Thanks very much. Jay, two questions on 3071, please. One is, at 700 mg Q3W, do you -- will you have enough durability in the three to six patients that actually tells you that you need to move forward with whatever two-ish or three-ish cohorts you wish to move forward with? That's question one.

非常感謝。 Jay，有兩個關於 3071 的問題。一是，在 700 mg Q3W 劑量下，您是否能夠對三到六名患者有足夠的持久性，這實際上告訴您需要繼續推進您希望繼續推進的任何兩個或三個左右的隊列？這是問題一。

Number two is, though you said you've done a lot of work on each of those seven cohorts, the notion that any one may be better than another, I guess would you -- are you limited to two is really what I'm saying, which is what you state in your corporate presentation? Thank you.

第二點是，儘管你說你已經在這七個隊列中的每一個上做了很多工作，但我想你會認為任何一個都可能比另一個更好——你是否僅限於兩個，這確實是我的想法您在公司演示中所說的是什麼？謝謝。

What do you mean limited to two? Two combinations?

限制兩個是什麼意思？兩種組合？

Selected to two for potential Phase 2 dose-expansion framework (multiple speakers) --

為潛在的第 2 階段劑量擴展框架選擇了兩位（多名發言者）--

Oh, yeah. No, no, no --

哦耶。不不不 -

For example, in RCC or whatever. Okay. Yeah.

例如，在 RCC 或其他什麼地方。好的。是的。

Yeah. I think we have a a lively discussion around that exact point, Tony. I'm kind of glad you asked it. I think the reason we set up beyond that two was because we're confident we're doing two. I don't mean that -- and I don't mean that to say we're not going to -- couldn't do more than two. But for now, I say two looks pretty solid, and there could be a decent argument to consider more.

是的。我認為我們圍繞這一點進行了熱烈的討論，托尼。我很高興你問這個問題。我認為我們之所以設置這兩項之外的原因是因為我們有信心我們正在做兩項。我並不是說——我也不是說我們不會——不能做超過兩個。但就目前而言，我認為兩個看起來相當可靠，並且可能有一個不錯的論點來考慮更多。

I think with respect to what dose we end up with and durability, I think that remains to be seen, but one's got to love the fact that you're at 5 mg/kg with a plus 3 mg/kg on the PD-1 side, and you haven't got a DLT. And now, we're able to at least dose the people. And we'll just see where patients and where it goes at the 10 mg/kg with 3 mg/kg on PD-1.

我認為關於我們最終的劑量和持久性，我認為這還有待觀察，但人們一定會喜歡這樣一個事實：PD-1 的劑量為 5 毫克/公斤，加上 3 毫克/公斤一邊，而你還沒有DLT。現在，我們至少能夠給人們注射藥物。我們將看看 PD-1 10 mg/kg 和 3 mg/kg 的患者和情況。

This is close to uncharted territory. Adjust for PK and adjust for a few other things, we really like where this asset is going. And I think it's going to -- I'm hopeful it will highlight what I think is a powerful advantage of CAB technology.

這接近未知領域。調整 PK 並調整其他一些事情，我們真的很喜歡這個資產的發展方向。我認為它將會——我希望它能夠突出我認為 CAB 技術的強大優勢。

Within that statement -- and thank you for -- with the two. But the real notion is, is there added -- is there any reason to assume even though you may for the sake of discussion, we don't know. And notion to say that 2x 3071 dose that 350 mg/kg to 700 mg/kg, let's say, really gives you added efficacy despite the fact that there's side-effect profile?

在這句話中——並感謝你們——與兩人一起。但真正的想法是，是否有任何理由可以假設，即使您可能為了討論而假設，我們也不知道。比方說，2x 3071 劑量為 350 mg/kg 至 700 mg/kg，儘管有副作用，但確實可以增加療效嗎？

Well, I think we know from other -- yeah, I think you know from past studies with other CTLA-4s, if you could -- two things: if you could potentially increase the dose or, and/or if you can keep patients on more cycles, you do translate to better outcomes if you can manage the safety. And I think there's a fair bit of literature around that.

好吧，我想我們從其他 - 是的，我想你從過去對其他 CTLA-4 的研究中知道，如果可以的話 - 兩件事：是否可以增加劑量或和/或是否可以保留患者在更多的循環中，如果您能夠管理好安全性，您確實會獲得更好的結果。我認為有很多相關的文獻。

That's not quite as much the case with PD-1. And with CTLA-4, there is support for that, and that actually was the original objective. Could we, number one, get to a higher dose in combination with PD-1? That's one question. The second question was, could we get beyond three to four cycles in the combination therapy with CTLA-4 and PD-1. And the third question is, could we do both?

PD-1 的情況則不然。對於 CTLA-4，這一點得到了支持，這實際上就是最初的目標。第一，我們能否獲得更高劑量的 PD-1 合併用藥？這是一個問題。第二個問題是，CTLA-4 和 PD-1 的合併治療能否超過三到四個週期。第三個問題是，我們可以兩者都做嗎？

And that's what we're on the precipice of answering, and I think we've already answered a portion of it with the 5 mg plus 3 mg that we cleared. And of course, we'd like to see a readout for a few more months on. So all of these things going forward here are additive, but we're at a point in the right timeframe to look at it. And I think we're going to have a great -- encouraging answer, I'm hopeful, later this year.

這就是我們即將回答的問題，我認為我們已經用我們清除的 5 毫克加 3 毫克回答了其中的一部分。當然，我們希望看到幾個月後的數據。因此，這裡發生的所有這些事情都是附加的，但我們正處於正確的時間範圍內來看待它。我認為我們將在今年晚些時候得到一個令人鼓舞的答案，我充滿希望。

Been very helpful. Thanks so much.

非常有幫助。非常感謝。

Reni Benjamin, JMP Securities.

雷尼·本傑明，JMP 證券。

Hey, guys. Thanks for taking the questions. You mentioned that you identified ROR2-positive tumors using liquid biopsy. Can you talk a little bit about how many patients were identified? And what does this tell you about the proportion of ROR2 patients in the real world versus epidemiological studies and the numbers we get from that?

大家好。感謝您提出問題。您提到您使用液體活檢發現了 ROR2 陽性腫瘤。您能談談有多少患者確診嗎？這對現實世界中 ROR2 患者的比例與流行病學研究以及我們從中獲得的數字有何啟示？

Yeah, it's kind of interesting. In melanoma, you'll recall that we saw approximately 7% positivity rate for ROR2 in melanoma using an IHC assay, immunohistochemical assay. As we transition to the liquid biopsy, we haven't given a definitive number, but I can tell you it's certainly double-digit positivity rates.

是的，這有點有趣。在黑色素瘤中，您可能還記得，我們​​使用 IHC 測定（免疫組織化學測定）在黑色素瘤中發現 ROR2 的陽性率約為 7%。當我們轉向液體活檢時，我們還沒有給出明確的數字，但我可以告訴你，陽性率肯定是兩位數。

So it's clear that the liquid biopsy, because we've done a lot of validation around this assay, has -- seems to be more sensitive, being able to pick up patients that ROR2 positive, but at a lower and probably a more sensitive level. So we're seeing more patients. So that's an advantage that goes beyond the fact that it's much easier to perform that assay.

因此很明顯，液體活檢，因為我們已經圍繞該檢測進行了大量驗證，似乎更敏感，能夠挑選出 ROR2 陽性的患者，但靈敏度較低，可能更敏感。 。所以我們看到了更多的病人。因此，這是一個優勢，不僅僅是執行該測定更容易的事實。

So I think the lesson here is that every assay has a certain sensitivity. And of course, the only patients that we had studied -- we had one patient in -- evaluable patient in Phase 1. We had one valuable patient come across in the Phase 2 study, partly only one and one that were evaluable because of the low positivity rate.

所以我認為這裡的教訓是每種檢測都有一定的靈敏度。當然，我們研究的唯一患者——我們有一名患者——在第一階段可評估。我們在第二階段研究中遇到了一名有價值的患者，部分只有一名和一名可評估的患者，因為陽性率低。

Well, if you can start to move the positivity rate up, then you're going to get a lot more patients wanting to come on board to do the study. It's a lot easier to take a blood draw than it is to go and get a tumor biopsy from the patient. The question remaining is, what is that threshold that allows you to see that activity? But with ADCs, there's a lot of history say that there could be a wide range of reaction.

好吧，如果你能開始提高陽性率，那麼就會有更多的患者想要參與這項研究。抽血比對患者進行腫瘤活檢要容易得多。剩下的問題是，允許您查看該活動的閾值是多少？但對於 ADC，有許多歷史記錄表明可能會出現廣泛的反應。

And so like in our head and neck, we saw something in the teens. It was TmPS score in the teens that we saw a PR right our first dose. So long story short, this liquid biopsy is allowing us to see a larger number of patients from a positivity standpoint.

就像我們的頭部和頸部一樣，我們在青少年時期看到了一些東西。正是在青少年時期的 TmPS 評分，我們在第一劑藥物中看到了 PR。長話短說，這種液體活檢使我們能夠從積極的角度看到更多的患者。

The next question we're hoping to answer is that do we maintain a strong response rate in this group? And we should be able to answer that in the near future.

我們希望回答的下一個問題是，我們是否在該群體中保持較高的回覆率？我們應該能夠在不久的將來回答這個問題。

Got it. And I think I've asked you this before, but now that you're dosing the melanoma patients, do you kind of wait to see how this reads out before you're testing the other indications with this liquid biopsy? Or do you kind of -- I think in the past you may have said that with these other indications, you have quite a robust ROR2 expression. And so we don't really need to use the assay.

知道了。我想我之前已經問過你這個問題了，但現在你正在給黑色素瘤患者服用藥物，在用液體活檢測試其他適應症之前，你是否會等待看看結果如何？或者你認為——我想你過去可能說過，透過這些其他跡象，你有一個相當強大的 ROR2 表達。所以我們真的不需要使用該檢測。

Well, we -- yeah, I think rolling it out -- we definitely are working at the research level to make sure we have it covered in these other areas, including AXL, if we needed. However, to roll it out with the expense that you might want to put behind a companion or need to put behind the companion diagnostic, no.

嗯，我們——是的，我認為將其推出——我們肯定正在研究層面開展工作，以確保我們將其覆蓋到其他領域，包括 AXL，如果我們需要的話。然而，要推出它，您可能想要將其置於伴侶或需要置於伴侶診斷之後，但事實並非如此。

We wouldn't do that until we got more confirmation beyond what we have at the moment. Because we're -- keep in mind, we're also wanting to manage our capital, and we're forecasting to get into 2025. And that means you've got to be prudent on how we do things.

在我們得到比目前更多的確認之前，我們不會這樣做。因為我們 - 請記住，我們也希望管理我們的資本，我們預計將進入 2025 年。這意味著您必須謹慎對待我們的做事方式。

Got it. One final one for me, the Phase 2 investigator-sponsored ovarian study in platinum-resistant ovarian cancer, you're getting the 10 patients. What kind of data do you need to see?

知道了。對我來說最後一項是由研究者資助的鉑耐藥性卵巢癌卵巢研究的 2 期研究，共有 10 名患者。您需要查看什麼樣的數據？

Or what would like to hit that so that, I don't know, it would be kind of brought back in-house and developed under a corporate IND versus giving it as an IST? Or is this something -- is this an indication that you would really just like to be seen -- developed by somebody else, even if it's an academic partner?

或者什麼想要實現這一點，以便，我不知道，它會被帶回內部並在公司 IND 下開發，而不是作為 IST 提供？或者這是由其他人開發的東西——這是否表明您真的只是希望被看到——即使是學術合作夥伴？

Well, we've had corporate, we've had companies ask us about the ovarian cancer. So there's interest out there. And what the exact cutoff is, is interesting because it depends on how that whole field is emerging a little bit. But I think the bar is fairly low at the moment in terms of what you need to see to advance this.

嗯，我們有公司，有公司詢問我們有關卵巢癌的問題。所以人們對此很感興趣。確切的界限是什麼，很有趣，因為它取決於整個領域的發展。但我認為目前就推進這一目標所需的內容而言，門檻相當低。

But I think how we'll take that forward is going to be linked to the data. What that exact cutoff will be -- is still being debated. But beyond that, it's hard to answer at this particular second. We have our own thoughts.

但我認為我們如何推動這一進程將與數據連結起來。確切的截止點是什麼——仍在爭論中。但除此之外，在這特定時刻很難回答。我們有自己的想法。

I mean, I would say I'll just throw out, I think 20% still quite viable if you're seeing responses, keep in mind, though, a lot of these drugs get approved on PFS and not ORR. So I just -- we have to keep all -- as well as overall survival. So we have to keep all of these various aspects in mind.

我的意思是，我會說我會放棄，如果你看到反應，我認為 20% 仍然相當可行，但請記住，很多這些藥物在 PFS 上獲得批准，而不是在 ORR 上獲得批准。所以我只是 - 我們必須保留所有 - 以及整體生存。因此，我們必須牢記所有這些不同的方面。

But we'll keep an eye on it, and we will look at it as an upside. And it's a study that we wouldn't have been able to fund ourselves at that time, and it's in combination with PD-L1. So it's going to be an interesting readout one way or the other.

但我們會密切關注它，並將其視為一個積極的一面。這是一項我們當時無法資助自己的研究，而且它與 PD-L1 結合。所以無論如何，這都會是一個有趣的讀​​數。

Got it. Thanks for taking the questions.

知道了。感謝您提出問題。

Thank you. We have reached the end of our question-and-answer session. And with that, I would like to turn the floor back over to CEO, Dr. Jay Short for closing comments.

謝謝。我們的問答環節已經結束。說到這裡，我想把發言權交還給執行長傑伊·肖特 (Jay Short) 博士，讓他發表結束語。

Well, I just appreciate everyone's attendance, and we've got a very active fall here coming up. And we're really looking forward to speaking with everyone at meetings and other venues as we go forward. But thank you for your attention today.

嗯，我非常感謝大家的出席，我們即將迎來一個非常活躍的秋季活動。我們非常期待在會議和其他場所與大家交流。但感謝您今天的關注。

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for you participation.

謝謝。今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。