Bioatla Inc (BCAB) 2023 Q1 法說會逐字稿

Greetings, and welcome to the BioAtla, Inc. first-quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) And as reminder, this conference is being recorded.

您好，歡迎參加 BioAtla, Inc. 2023 年第一季度收益電話會議。此時，所有參與者都處於只聽模式。正式演講之後將舉行簡短的問答環節。 （操作員說明）謹此提醒，本次會議正在錄製中。

And it is now my pleasure to introduce to you Bruce Mackle from LifeSci Advisors. Thank you, Bruce. You may begin.

現在我很高興向您介紹來自 LifeSci Advisors 的 Bruce Mackle。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, Richard Waldron, Chief of Clinical Development and Operations; Dr. Eric Sievers, Chief Medical Officer; and Sheri Lydick, Senior Vice President, Commercial Strategy 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、首席執行官兼聯合創始人 Jay Short 博士；和首席財務官理查德·沃爾德倫。在今天的電話會議之後，臨床開發和運營主管 Richard Waldron 表示： Eric Sievers 博士，首席醫療官；商業戰略高級副總裁 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 first quarter ended March 31, 2023. A copy of the press release is available on the company's website.

今天下午早些時候，BioAtla 發布了截至 2023 年 3 月 31 日的第一季度的財務業績和業務更新。該新聞稿的副本可在該公司網站上獲取。

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 our clinical trials will be potentially registrational, results, conduct, progress, and timing of our research and development programs and clinical trials, expectations with respect to enrollment and dosing in our clinical trials, plans regarding future data updates, clinical trials, regulatory meetings, and regulatory submissions, the potential regulatory approval path for our product candidates, expectations about the sufficiency of our 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，我們的臨床試驗是否可能進行註冊、我們的研發計劃和臨床試驗的結果、實施、進展和時間安排、對我們臨床試驗的註冊和劑量的期望、有關未來數據更新的計劃、臨床試驗、監管會議和監管提交的文件、我們候選產品的潛在監管批准路徑、對我們現金和現金等價物充足性的預期以及預期的研發和一般行政費用。

These statements are subject to various risks, assumptions, and uncertainties that can cause actual results to differ materially and are described in the filings made with the SEC including the most recent quarterly report on Form 10Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, May 11, 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，可能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，包括最新的 10Q 表格季度報告。請您注意不要過分依賴這些前瞻性陳述，這些陳述僅截至今天，即 2023 年 5 月 11 日，BioAtla 不承擔任何更新此類陳述以反映未來信息、事件或情況的義務，除非另有要求。法律。

And 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 first-quarter 2023 BioAtla's earnings call. Before I provide an update on our first-quarter progress, I would like to reiterate a few key points made on our last quarter call in March.

謝謝 Bruce，也感謝大家參加我們 2023 年第一季度 BioAtla 的財報電話會議。在提供第一季度進展的最新信息之前，我想重申 3 月份上一季度電話會議中提出的幾個要點。

As a reminder, BioAtla is the inventor and leader of the development of novel therapies using a proprietary conditionally active biologics, CAB, platform with improved selectivity for attacking tumor cells while avoiding healthy cells to address urgent unmet needs in oncology in order to improve patients' lives. 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.

需要提醒的是，BioAtla 是使用專有的條件活性生物製劑 CAB 平台開發新療法的發明者和領導者，該平台提高了攻擊腫瘤細胞的選擇性，同時避免健康細胞，以滿足腫瘤學中未滿足的迫切需求，從而改善患者的健康狀況。生活。去年，我們針對兩種最新階段的一流 CAB-ADC 產品候選產品 BA3011 和 BA3021 進行多項 2 期試驗，取得了重大進展，針對醫療需求未得到滿足的實體瘤類型。

As we are now a little over one full quarter into 2023, we continue our positive trajectory and are on track to achieve our recently guided milestones. 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, targeted CAB CTLA-4 and 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.

現在距離 2023 年已經過去一個多季度了，我們將繼續保持積極的發展軌跡，並有望實現我們最近指導的里程碑。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的廣泛適用性，包括 CAB-AXL 和 CAB-ROR2-ADC、靶向 CAB CTLA-4 和免疫腫瘤學 -裸露抗體，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信息可以在我們的網站上找到，作為我們更新的公司演示文稿的一部分，可能對您有所幫助。

We have shared promising clinical responses to date that are so far meeting and, in several cases, exceeding our interim study targeted responses. Last quarter, I shared our strategic shift from providing incremental data updates on small sample sizes to releasing more mature data sets across our programs. As a reminder, our goal is to provide sufficient data to allow us to set study parameters that maximize the company's likelihood of success for our Phase 2 potentially registrational studies.

迄今為止，我們已經分享了有希望的臨床反應，這些反應迄今為止達到了，並且在某些情況下超過了我們中期研究的目標反應。上個季度，我分享了我們的戰略轉變，從提供小樣本增量數據更新到在我們的項目中發布更成熟的數據集。提醒一下，我們的目標是提供足夠的數據，以便我們設定研究參數，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。

Additionally, last quarter, I discussed the rationale for including the more frequent dose-intensive regimens. A summary of these current dose regimens can be found in our updated corporate presentation on our website. Based on our exposure-response analyses as well as our UPS-related FDA interactions, we aim to maximize the differentiated benefit-risk profile of our CAB-ADCs in our Phase 2 part 1 trials for potential further improvement in antitumor activity while having similar or even improved safety profile.

此外，上個季度，我討論了採用更頻繁的劑量密集治療方案的理由。這些當前劑量方案的摘要可以在我們網站上更新的公司演示中找到。根據我們的暴露-反應分析以及與 UPS 相關的 FDA 互動，我們的目標是在第 2 期第 1 部分試驗中最大限度地提高 CAB-ADC 的差異化效益-風險狀況，以進一步提高抗腫瘤活性，同時具有類似或甚至提高了安全性。

We continue to be excited about our lead asset BA3011 for multiple indications. Previously, we shared the encouraging partial interim data on our BA3011 Phase 2, part 1 sarcoma study and our BA3011 Phase 2 part 1 non-small cell lung cancer study.

我們繼續對我們的主導資產 BA3011 的多種適應症感到興奮。此前，我們分享了 BA3011 第 2 期第 1 部分肉瘤研究和 BA3011 第 2 期第 1 部分非小細胞肺癌研究的令人鼓舞的部分中期數據。

Let's now move to our clinical, operational, and financial updates for the first-quarter 2023. First, I will reiterate our BA3011 Phase 2 sarcoma study and our overall sarcoma strategy. We are advancing BA3011 in ongoing sarcoma Phase 2 studies, including a potentially registrational study in UPS.

現在讓我們來看看 2023 年第一季度的臨床、運營和財務更新。首先，我將重申我們的 BA3011 2 期肉瘤研究和我們的整體肉瘤策略。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。

As a recap of the unmet need in UPS, it is one of the largest and most aggressive sarcoma subtypes with high recurrence rates representing nearly 15% of all soft tissue sarcomas. Without specific treatments approved for UPS, there is a significant commercial opportunity as a standalone indication.

回顧 UPS 中未滿足的需求，它是最大、最具侵襲性的肉瘤亞型之一，具有高複發率，佔所有軟組織肉瘤的近 15%。如果沒有批准針對 UPS 的特定治療方法，則作為獨立適應症存在巨大的商業機會。

We have shown strong execution and promising results with continued antitumor activity, lack of disease progression, and a differentiated safety profile of BA3011 in UPS today. Additionally, we have observed an overall objective response rate or ORR of 50%, median progression-free survival or PFS of over 11 months, and a duration of response exceeding eight months.

如今，BA3011 在 UPS 中表現出強大的執行力和有希望的結果，具有持續的抗腫瘤活性、無疾病進展以及差異化的安全性。此外，我們觀察到總體客觀緩解率或 ORR 為 50%，中位無進展生存期或 PFS 超過 11 個月，緩解持續時間超過 8 個月。

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 2 of the potentially registrational portion of the trial. The first 40 patients with the TmPS greater than or equal to 50% are being randomized one to one between the 3Q4W or two 2Q3W dosing 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反饋，去年我們啟動了該試驗的潛在註冊部分的第 2 部分。前 40 名 TmPS 大於或等於 50% 的患者將被一對一隨機分配到第 3 季度第 4 週或兩個第 2 季度第 3 週給藥方案之間。

Following this, we plan to enroll an additional 40 patients at the selective dose to complete the study. Overall, the primary efficacy endpoint ORR will be based on approximately 60 patients treated at the selected dosing regimen.

此後，我們計劃以選擇性劑量招募另外 40 名患者來完成研究。總體而言，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。

UPS represents a solid early indication of BioAtla as we plan for the transition into a commercial stage company. In addition to UPS, we continue to enroll in the leiomyosarcoma cohort using the 3Q4W dosing regimen and are on track with anticipated data readout in the second half of this year.

UPS 代表了 BioAtla 的可靠早期跡象，因為我們計劃轉型為商業階段公司。除了 UPS 之外，我們還繼續使用 3Q4W 給藥方案入組平滑肌肉瘤隊列，並有望在今年下半年公佈預期數據。

With regards to the safety profile across sarcoma subtypes, BA3011 continues to be generally well tolerated with a Phase 2 safety profile across all doses consistent with the profile we observed in Phase 1. We also see real value in potentially expanding our sarcoma footprint over time to include other sarcoma subtypes. Ultimately, we believe BA3011 has the potential to treat over 25,000 sarcoma patients per year and generate up to $2 billion in revenue worldwide in this area of high unmet need.

就肉瘤亞型的安全性而言，BA3011 總體上仍具有良好的耐受性，所有劑量的 2 期安全性與我們在 1 期觀察到的安全性一致。我們還看到了隨著時間的推移擴大我們的肉瘤足蹟的真正價值。包括其他肉瘤亞型。最終，我們相信 BA3011 有潛力每年治療超過 25,000 名肉瘤患者，並在這一需求未得到滿足的領域在全球範圍內創造高達 20 億美元的收入。

Regarding our BA3011 Phase 2 study in AXL-positive multi-refractory non-small cell lung cancer, we continue to be enthusiastic about the data we presented earlier this year with the Q2W dosing regimen. Currently, the competitive landscape is scant for treatment options in patients who progress on immune checkpoint inhibitors, particularly in the second line and beyond settings. These patients have suboptimal overall ORRs of approximately 10% to 20% and PFS rates of four months.

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，我們仍然對今年早些時候提供的 Q2W 給藥方案的數據充滿熱情。目前，對於使用免疫檢查點抑製劑取得進展的患者，特別是在二線及其他治療領域，治療方案的競爭格局很少。這些患者的總體 ORR 約為 10% 至 20% 左右，PFS 率為四個月。

As a reminder, part 1 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. So far in this study, we have reported preliminary efficacy with an ORR of 44% as monotherapy in a PD-1 failure population that have seen on average three prior lines of therapy.

提醒一下，非小細胞肺癌 2 期研究的第 1 部分正在針對先前經歷過 PD-1、PD-L1、EGFR 或 ALK 抑製劑失敗的 AXL 陽性患者進行。到目前為止，在這項研究中，我們報告了在平均接受過三種先前療法的 PD-1 失敗人群中，單一療法的 ORR 為 44% 的初步療效。

This response rate is highly competitive and exceeded our targeted response for moving forward to the Phase 2, potentially registrational part of the study. We continue to believe BA3011 will be highly commercially relevant with a response well above those observed with a multi-refractory patient population, particularly in view of treating patients in earlier lines in Phase 2 part 2.

這一答复率極具競爭力，超出了我們進入第二階段（該研究可能註冊的部分）的目標答复。我們仍然相信 BA3011 將具有高度的商業相關性，其反應遠高於在多難治性患者群體中觀察到的反應，特別是考慮到在第 2 階段第 2 部分的早期線中治療患者。

In addition, part 1 of the Phase 2 study continues to enroll using the more frequent dose intensity regimen with anticipated data readout for all dosing regimens on track for the second half of this year. We remain on track to submit a meeting request to the FDA for the potentially registrational BA3011 Phase 2 part 2 non-small cell lung cancer study design in the first half of this year, with feedback anticipated in the second half of this year, allowing us to initiate the Phase 2 part 2 study in non-small cell lung cancer in the second half of this year, maintaining our overall timeline for development of the non-small cell lung cancer indication.

此外，2 期研究的第 1 部分繼續使用更頻繁的劑量強度方案進行招募，並預計今年下半年所有給藥方案的數據讀出。我們仍有望在今年上半年向 FDA 提交關於可能註冊的 BA3011 第 2 期第 2 部分非小細胞肺癌研究設計的會議請求，預計在今年下半年得到反饋，使我們能夠今年下半年啟動非小細胞肺癌第2階段第2部分研究，維持我們開發非小細胞肺癌適應症的總體時間表。

As we have previously mentioned, approximately 35% of patients in the second-line plus indication of non-small cell lung cancer express AXL. We estimate annually that there are over 100,000 AXL-positive addressable patients worldwide with the potential to add approximately $2.5 billion to $3 billion in worldwide revenue at peak.

正如我們之前提到的，大約 35% 接受二線及適應症的非小細胞肺癌患者表達 AXL。我們每年估計，全球有超過 100,000 名 AXL 陽性可尋址患者，在高峰期有可能增加約 25 億至 30 億美元的全球收入。

Considering only the sarcoma non-small cell lung cancer indications, we continue to believe that BA3011 has the potential to become a significant commercial asset for BioAtla. Of even greater importance is that BA3011 has the potential to be the best-in-class treatment for a significant number of patients who failed multiple lines of therapy, thus filling a significant unmet medical need.

僅考慮肉瘤非小細胞肺癌適應症，我們仍然相信 BA3011 有潛力成為 BioAtla 的重要商業資產。更重要的是，BA3011有潛力成為大量多線治療失敗患者的同類最佳治療藥物，從而滿足大量未滿足的醫療需求。

To round out our CAB-ADC BA3011 program, we are supporting an ongoing multicenter investigator-initiated or IIT Phase 2 clinical trial in patients with platinum resistant ovarian cancer. The trial is on track, and we anticipate interim data consisting of 10 patients in the second half of this year.

為了完善我們的 CAB-ADC BA3011 項目，我們正在支持一項正在進行的多中心研究者發起的或 IIT 2 期臨床試驗，對像是鉑類耐藥卵巢癌患者。該試驗正在按計劃進行，我們預計將在今年下半年獲得包含 10 名患者的中期數據。

Now, turning to our second lead CAB-ADC product candidate, BA3021, a CAB-ROR2-ADC. Currently, BA3021 is the subject of Phase 2 trials in the treatment of four indications. As a reminder, no other company has a therapy in the clinic targeting ROR2, so we have the potential to have a first-in-class treatment for solid tumors.

現在，轉向我們的第二個主要 CAB-ADC 候選產品 BA3021，即 CAB-ROR2-ADC。目前，BA3021正在進行治療四種適應症的二期試驗。需要提醒的是，沒有其他公司在臨床上有針對 ROR2 的療法，因此我們有潛力針對實體瘤提供一流的治療方法。

We conducted a similar exposure-response analyses of ROR2-positive tumors to form the more frequent dose-intensity regimen in our Phase 2 ROR2-positive non-small cell lung cancer study. Based on this analysis, which utilizes a similar strategy to our UPS Phase 2 part 2 BA3011 study I mentioned earlier, we are continuing to enroll patients in the more frequent dose intensive regimen of 3Q4W as planned, with interim data readout on track for the second half of this year.

我們對 ROR2 陽性腫瘤進行了類似的暴露反應分析，以在我們的 2 期 ROR2 陽性非小細胞肺癌研究中形成更頻繁的劑量強度方案。基於此分析，該分析採用了與我之前提到的 UPS 第 2 期第 2 部分 BA3011 研究類似的策略，我們將繼續按計劃將患者納入更頻繁的 3Q4W 劑量密集治療方案，第二次中期數據讀出將按計劃進行。今年一半。

Regarding the melanoma Phase 2 trial in patients who have previously experienced failure of PD-1 therapy, following an additional complete response in an evaluable patient identified using our IHC assay, we are screening patients with the validated liquid biopsy. Although we haven't enrolled additional patients to date, we have successfully identified ROR2-positive tumors using the liquid biopsy assay, which is now allowing us to enroll ROR2-positive patients. We anticipate an increased enrollment in the second half of this year.

關於對先前經歷過 PD-1 治療失敗的患者進行的黑色素瘤 2 期試驗，在使用我們的 IHC 檢測確定的可評估患者中獲得額外的完全緩解後，我們正在通過經過驗證的液體活檢篩選患者。儘管迄今為止我們還沒有招募更多患者，但我們已經使用液體活檢測定成功鑑定了 ROR2 陽性腫瘤，這使得我們現在能夠招募 ROR2 陽性患者。我們預計今年下半年的入學人數將會增加。

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. Last quarter, we announced achievement of first patient in for this study. Since last quarter, we continued to enroll patients, and the observed ROR2-positivity rate is high, over 50%, and in line with our expectations.

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。上個季度，我們宣布了這項研究的第一位患者的成就。自上季度以來，我們持續入組患者，觀察到的ROR2陽性率很高，超過50%，符合我們的預期。

To round out our CAB-ADC BA3021 program, we are also supporting the Phase 2 IIT study with BA3021 in patients with platinum resistant ovarian cancer. The trial is on track, and we anticipate interim data consisting of 10 patients in the second half of this year.

為了完善我們的 CAB-ADC BA3021 項目，我們還支持針對鉑類耐藥卵巢癌患者進行的 BA3021 2 期 IIT 研究。該試驗正在按計劃進行，我們預計將在今年下半年獲得包含 10 名患者的中期數據。

Now, I'd like to talk briefly about 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 will evaluate safety and tolerability of BA3071 in monotherapy and in combination with nivolumab. The trial is progressing as planned.

現在，我想簡單談談我們的 CAB-CTLA-4 抗體 BA3071 的 1/2 期試驗。提醒一下，1/2 期試驗正在已知對 CTLA-4 治療有反應的腫瘤中進行，我們將評估 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, I shared that the DLT observation period was cleared for the fourth cohort at a dose of 210 mgs for 3 mgs/kg in combination with 3 mgs/kg of nivolumab. No DLTs were recorded. As part of today's update, we are treating patients in the fifth cohort at 350 mgs or 5 mgs/kg as a monotherapy or in combination with 3 mgs/kg of nivolumab and are on track for a Phase 1 data readout in the second half of this year. We also remain on track for the initiation of our BA3071 Phase 2 study to commence in the second half of this year.

上個季度，我分享了第四個隊列的 DLT 觀察期已清除，劑量為 210 毫克/千克，劑量為 3 毫克/千克，與 3 毫克/千克納武單抗組合。沒有記錄 DLT。作為今天更新的一部分，我們正在以 350 mgs 或 5 mgs/kg 作為單一療法或與 3 mgs/kg 納武單抗聯合治療第五隊列中的患者，並有望在 2019 年下半年公佈 1 期數據。今年。我們還將繼續按計劃於今年下半年啟動 BA3071 第 2 期研究。

Finally, on to our potentially first-in-class dual-CAB bispecific T-cell engager antibody, CAB-EpCAM, CAB-CD3 or BA3182. In the first quarter, we received FDA clearance of our IND for the treatment of advanced adenocarcinoma. We anticipate first patient in for the Phase 1 study in the current quarter with the complete Phase 1 data readout anticipated next year.

最後，介紹我們潛在的一流雙 CAB 雙特異性 T 細胞接合抗體 CAB-EpCAM、CAB-CD3 或 BA3182。第一季度，我們的治療晚期腺癌的 IND 獲得 FDA 批准。我們預計第一名患者將在本季度參加第一階段研究，並預計明年公佈完整的第一階段數據。

Similar to our other three clinical-stage CAB product candidates, this antibody holds much promise in view of the 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 that dual-CAB design. Several of the most common subtypes of adenocarcinoma that have tremendous unmet need that we can potentially address include colon, lung, breast, pancreas, and prostate.

與我們的其他三種臨床階段 CAB 產品候選產品類似，該抗體在體內臨床前研究中具有很大的前景，由於其組合選擇性，相對於非 CAB 方差，治療指數提高了 100 倍以上雙CAB設計。幾種最常見的腺癌亞型有巨大的未滿足需求，我們可以潛在地解決這些亞型，包括結腸癌、肺癌、乳腺癌、胰腺癌和前列腺癌。

BioAtla also continues to progress several candidates through IND-enabling studies, including CAB bispecifics and next-generation ADC antibodies. And we still anticipate IND submissions for additional candidates potentially in 2023 and through 2024.

BioAtla 還繼續通過 IND 支持研究來開發幾種候選藥物，包括 CAB 雙特異性抗體和下一代 ADC 抗體。我們仍然預計 2023 年至 2024 年可能會提交更多候選藥物的 IND 申請。

With respect to important ongoing communications, the company has nine accepted recent and upcoming poster presentations since March, including at the ESMO Sarcoma and Rare Cancers Congress, the European Lung Cancer Congress, AACR, and ASCO, the latter of which will include an online publication of the abstract related to exposure-response analyses of BA3011. Additional abstracts have been submitted for several upcoming meetings, and these will be updated as they are accepted.

關於重要的持續溝通，自 3 月份以來，該公司已接受了九次最近和即將到來的海報展示，包括在 ESMO 肉瘤和罕見癌症大會、歐洲肺癌大會、AACR 和 ASCO 上，後者將包括一份在線出版物與 BA3011 的暴露反應分析相關的摘要。已為即將舉行的幾次會議提交了其他摘要，這些摘要將在被接受後進行更新。

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

現在，我想將電話轉給 Rick，讓他審查 2023 年第一季度的財務狀況。瑞克？

Thank you, Jay. As of March 31, 2023, we had $192.7 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.

謝謝你，傑伊。截至 2023 年 3 月 31 日，我們擁有 1.927 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。

As a reminder, we control all CAB product market rights in the US, Europe, and Japan. 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.

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。我們的業務戰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，通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 first quarter ended March 31, 2023, we reported a net loss of $27.5 million compared to a net loss of $24.3 million in the same period of 2022. Research and development expenses were $21.7 million for the first quarter ended March 31, 2023, compared to $16.9 million for the same period in 2022. The increase of $4.8 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3月31日的第一季度，我們的淨虧損為2750萬美元，而2022年同期的淨虧損為2430萬美元。截至2023年3月31日的第一季度的研發費用為2170萬美元，相比之下，2022 年同期為 1690 萬美元。增加 480 萬美元主要是由我們的臨床前和臨床產品開發工作推動的。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，總體上會增加。

General and administrative expenses were $7.2 million for the first quarter ended March 31, 2023, compared to $7.4 million for the same period in 2022. The $0.2 million change was attributable to a decrease in various 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 product candidate, BA3011, and satisfy requirements as a public company.

截至 2023 年 3 月 31 日的第一季度的一般和管理費用為 720 萬美元，而 2022 年同期為 740 萬美元。20 萬美元的變化是由於 2023 年期間各種費用減少。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，支持我們的候選產品 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 three months ended March 31, 2023, was $22.7 million compared to net cash used in operating activities of $25.1 million for the same period in 2022. The decrease in net cash used in operating activities for the first three months of 2023 is primarily due to an increase in accounts payable and accrued expenses in the 2023 period compared to a decrease in accounts payable in the same period in 2022. And now, back to Jay.

截至 2023 年 3 月 31 日的三個月經營活動使用的現金淨額為 2,270 萬美元，而 2022 年同期經營活動使用的現金淨額為 2,510 萬美元。前三個月經營活動使用的現金淨額減少2023 年同期的應付賬款和應計費用增加，而 2022 年同期應付賬款減少。現在，回到傑伊。

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

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數據感到興奮，並渴望繼續推進 2 期研究，增加更頻繁的劑量密集方案，並提供預期的臨床更新。今年下半年。

We also remain encouraged by the continued execution of our other promising CAB assets in multiple cancer indications, and we are well poised to reach several value-creating milestones and key inflection points in the next several months. BioAtla remains confident about the future, with the goal of pursuing indications of high unmet medical need that we feel will have significant impact for patients and our shareholders worldwide.

我們還對我們在多種癌症適應症中繼續執行其他有前景的 CAB 資產感到鼓舞，並且我們準備在未來幾個月內實現幾個創造價值的里程碑和關鍵拐點。 BioAtla 對未來仍然充滿信心，目標是尋找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) Brian Cheng, JP Morgan.

（操作員指令）Brian Cheng，摩根大通。

Good afternoon, guys. Thanks for taking my question. A couple from me. Looking ahead into the data update in a second half this year, I assume that you have multiple interim data across a number of programs in the second half? How should we think about the cadence of each of this data update? And I have a couple of follow-ups. Thank you.

下午好，伙計們。感謝您提出我的問題。我的一對。展望今年下半年的數據更新，我假設你們下半年有多個項目的多個中期數據？我們應該如何考慮每次數據更新的節奏？我還有一些後續行動。謝謝。

Yeah. This is Jay, and thanks for your question, Brian. I think we'll expect to see the -- this is a best guess at this point, but I'm expecting to see the ovarian readouts earlier than, let's say, the lung readouts. I would expect the AXL to be ahead of ROR2, and I think that those are some of the key ones.

是的。我是傑伊，謝謝你的提問，布萊恩。我認為我們期望看到——這是目前最好的猜測，但我期望看到卵巢讀數早於肺部讀數。我預計 AXL 會領先於 ROR2，我認為這些都是關鍵因素。

And then we'll, of course, be giving progress reports on -- general progress reports in terms of -- in the area of sarcoma in terms of UPS, leiomyosarcoma. And of course, CTLA-4, we'll also be somewhere in there as well. And there's kind of a couple of updates, right? One may be completing the Phase 1 like in CTLA-4 and then a follow up a little later saying kicking off the Phase 2 study.

然後，當然，我們將提供有關 UPS、平滑肌肉瘤等肉瘤領域的一般進展報告的進展報告。當然，CTLA-4，我們也會在那裡。還有一些更新，對吧？人們可能會像 CTLA-4 一樣完成第一階段，然後稍後跟進說開始第二階段研究。

So that's our intent. Same would happen with the AXL lung. Here's our data, hopefully tied in with a meeting or conference, and then followed by kicking off the -- describing the FDA feedback and kicking off the Phase 2 portion of the last part 2 Phase 2 portion of that. So hopefully, that gives you a sense of it, Brian.

這就是我們的意圖。 AXL 肺也會發生同樣的情況。這是我們的數據，希望與一次會議或大會聯繫起來，然後開始描述 FDA 的反饋並開始最後一部分第 2 階段第 2 部分的第 2 階段部分。希望這能讓你有所體會，布萊恩。

Great. That was helpful. And for your AXL program in non-small cell, what's your latest thoughts on the trial design for the potentially pivotal Phase 2 part 2? And I think to more extent, I guess, have you decided on whether to focus on non-squamous versus squamous, whether you'll evaluate combo or single agents? And then the second part of that question is that if the part 1 data with the more frequent regimen looks better in the second half, will you have to revisit the trial protocol with the FDA? Thank you.

偉大的。這很有幫助。對於非小型基站的 AXL 項目，您對潛在關鍵的第 2 階段第 2 部分的試驗設計有何最新想法？我想，在更大程度上，我想，您是否決定是否關注非鱗狀細胞和鱗狀細胞，是否會評估組合藥物或單一藥物？然後該問題的第二部分是，如果更頻繁的治療方案的第 1 部分數據在下半年看起來更好，您是否需要重新審視 FDA 的試驗方案？謝謝。

So first off, I can just say that we've decided to focus on the non-squamous going forward, even though I think there's more to learn on the squamous side, but I think we're going to focus on the non-squamous. But I'm going to actually ask Philippe to potentially answer this one. Philippe? The rest of the questions in this section.

首先，我可以說我們決定未來重點關注非鱗狀細胞，儘管我認為鱗狀細胞方面還有更多東西需要學習，但我認為我們將重點關注非鱗狀細胞。但我實際上會請菲利普回答這個問題。菲利普？本節的其餘問題。

Yes. Thank you, Jay. So in terms of study design, I think clearly, this will be the focus of the conversation with the FDA around the end of this quarter. We haven't landed -- based on their feedback, we'll decide which -- whether to go with a single arm or our primary endpoints or go with a randomized study against a comparator, probably docetaxel. And it might still be an ORR endpoint, but it could also be a PFS endpoint.

是的。謝謝你，傑伊。因此，就研究設計而言，我清楚地認為，這將是本季度末左右與 FDA 對話的焦點。我們還沒有確定——根據他們的反饋，我們將決定是採用單臂還是我們的主要終點，還是進行針對比較劑（可能是多西紫杉醇）的隨機研究。它可能仍然是 ORR 端點，但也可能是 PFS 端點。

So we'll make that decision post meeting with the FDA. Currently, we're focusing on the monotherapy, but we'll be getting more data for the combo later on in this year. So we'll be able to make a decision whether to go with combo as well which will only focus on the monotherapy arm.

因此，我們將在與 FDA 會面後做出決定。目前，我們專注於單一療法，但我們將在今年晚些時候獲得更多有關組合療法的數據。因此，我們將能夠決定是否也採用組合療法，而組合療法僅專注於單一療法。

And then with your last question about 3Q4W, should we -- would we have to rediscuss it with FDA? No, that would not be required. The dose selection is left to the sponsor to decide which dose or doses to move forward with. So should we see a better benefit-risk profile than the 3Q4W arm, we could just replace the 3QW with the 3Q4W dosing regimen.

然後，關於您關於 3Q4W 的最後一個問題，我們是否應該與 FDA 重新討論？不，不需要那樣。劑量選擇由申辦者決定繼續使用哪一個或多個劑量。因此，如果我們看到比 3Q4W 組更好的獲益-風險狀況，我們可以用 3Q4W 給藥方案取代 3QW。

Okay. If I can squeeze one more in on CAB-CTLA-4, that would be great. How does the 350 dose that you're dosing now with the CAB-CTLA-4 correlate to the target engagement that you're seeing with the currently approved CTLA-4 agents that you are seeing out in the market space? Thank you.

好的。如果我能在 CAB-CTLA-4 上再擠一粒，那就太好了。您現在使用 CAB-CTLA-4 服用的 350 劑量與您在市場上看到的當前批准的 CTLA-4 藥物的目標參與度有何關聯？謝謝。

Well, we've done a lot of work with ipilimumab, and so we do a lot of comparisons. So we believe that our antibody is most comparable to ipi when you start to think about these doses. Of course, there will be nuances in PK and so forth, but for the most part -- because of the different antibodies and the different sequence. But their origin was very similar in all of our comparisons. So I think that's a nice general guideline with the caveat of some PK alignment at the end of the study.

嗯，我們對伊匹單抗做了很多工作，所以我們做了很多比較。因此，當您開始考慮這些劑量時，我們相信我們的抗體與 IPI 最具可比性。當然，PK 等方面會有細微差別，但大多數情況是因為不同的抗體和不同的序列。但在我們所有的比較中，它們的起源都非常相似。所以我認為這是一個很好的一般指南，但在研究結束時需要注意一些 PK 對齊。

Great. Thanks for taking my questions, Jay.

偉大的。謝謝你回答我的問題，傑伊。

Yeah.

是的。

Kelly Shi, Jefferies.

施凱莉，杰弗里斯。

Hi, everyone. This is Dave from Jefferies. Kelly is traveling to Asia, so I'm here on behalf of her. Just one quick question for me. In last update in March, you mentioned there were six patients enrolled in LMS cohort. Just wondering how many new patients are added since then? And when do you expect to complete 10 to 15 patient enrollment and any comment on pace of enrollment? Thanks.

大家好。我是來自 Jefferies 的戴夫。凱莉要去亞洲旅行，所以我代表她來到這裡。只是問我一個簡單的問題。在 3 月份的最後一次更新中，您提到有 6 名患者參加了 LMS 隊列。只是想知道自那時以來增加了多少新患者？您預計什麼時候完成 10 到 15 名患者的登記？對登記速度有什麼評論嗎？謝謝。

Yeah. I don't think we -- I don't have an update on additional patients, but we believe that's really going to be available in the second half and will be completed there. So there's no indication that we have, that it won't be timely in terms of being able to report out on that in the fall. But I don't know, Philippe, if you have any other nuance on it?

是的。我不認為我們——我沒有關於更多患者的最新情況，但我們相信這確實會在下半年提供，並將在那裡完成。因此，沒有跡象表明我們在秋季報告這一情況並不及時。但我不知道，菲利普，你對此還有什麼其他的細微差別嗎？

We're on schedule, 10 to 15 patients in the second half. Currently, based on the pace of enrollment, it might be more, closer to 15 than 10, but we're on target.

我們按計劃進行，下半年有 10 到 15 名患者。目前，根據招生速度，可能會更多，接近 15 人而不是 10 人，但我們已經達到了目標。

Okay. Thank you for taking my question.

好的。感謝您回答我的問題。

Kaveri Pohlman, BTIG.

卡維里·波爾曼，BTIG。

Yeah. Good evening, and thanks for taking my questions. For non-small cell lung cancer, can you tell us what's the bar for durability here? What would be clinically meaningful to see in these late-line patients from the data you're collecting?

是的。晚上好，感謝您回答我的問題。對於非小細胞肺癌，您能告訴我們持久性的標準是什麼嗎？從您收集的數據中可以看出這些晚期患者有什麼臨床意義？

Yeah. No, that's a good question. And Philippe, I think, since we've discussed this before, you should grab that one.

是的。不，這是個好問題。菲利普，我想，既然我們之前討論過這個問題，你應該抓住那個。

Yes, I can. What would be meaningful in any patients that have failed? Remember, the patients that we're dosing are patients that failed not only PD-1, but they failed generally the first round of chemo and then docetaxel or gemcitabine after that. So they are highly refractory. Durability of response anywhere above four months would be positive. As we said before, we are targeting six months plus, and the latest data we had recorded led us to believe that we'll be able to achieve that.

我可以。對於失敗的患者來說什麼是有意義的？請記住，我們給藥的患者不僅是 PD-1 失敗的患者，而且通常是第一輪化療失敗，然後是多西他賽或吉西他濱失敗。因此它們非常難熔。任何超過四個月的響應的持久性都是積極的。正如我們之前所說，我們的目標是六個月以上，我們記錄的最新數據讓我們相信我們能夠實現這一目標。

Got it. That's helpful. And I believe you just mentioned that you're moving forward with non-squamous. I was just wondering, I believe squamous type is treated with taxane-based regimen in the first line. Does that make it less susceptible to respond to MMA in late line?

知道了。這很有幫助。我相信您剛剛提到您正在推進非鱗狀細胞癌。我只是想知道，我相信鱗狀細胞癌是用基於紫杉烷的療法作為第一線治療的。這是否會降低後期對 MMA 的反應？

I don't think that's the case. I think it's just we're not moving with squamous because we were not able to enroll new squamous patients. So we don't know how these patients would respond at this point. So we'll need to generate that data before we start enrolling squamous patient or decide to go further with squamous patients.

我認為情況並非如此。我認為這只是我們沒有轉向鱗狀細胞癌，因為我們無法招募新的鱗狀細胞癌患者。所以我們不知道這些患者此時會如何反應。因此，在開始招募鱗狀患者或決定進一步招募鱗狀患者之前，我們需要生成這些數據。

Yeah, there's just a lot more non-squamous patients coming into the study.

是的，有更多的非鱗狀細胞癌患者參與了這項研究。

Got it. And maybe one last one on the other sarcoma types that you have besides UPS and LMS. Do you plan to test more frequent regimen or they're just the way you're doing core UPS and LMS before you decide to move forward?

知道了。也許最後一篇是關於除了 UPS 和 LMS 之外的其他肉瘤類型。您是否計劃測試更頻繁的方案，或者它們只是您在決定繼續之前進行核心 UPS 和 LMS 的方式？

Well, I think we're going to wait on the leiomyo data because there are strategies around that. Obviously, we also want to drive UPS as it is, move that down the line. And we'll be doing -- I think we had mentioned this in the March call that we'll be looking across -- I mean, we have an awful lot of indications, a lot of Phase 2 studies going on, so we'll be prioritizing at that time which ones we'll prioritize over others in the fall.

好吧，我認為我們將等待 leiomyo 數據，因為有相關策略。顯然，我們也希望按原樣驅動 UPS，並將其向下推進。我們將要做的——我想我們在三月份的電話會議中已經提到過這一點，我們將進行研究——我的意思是，我們有大量的跡象，正在進行大量的第二階段研究，所以我們'那時我們將優先考慮哪些是我們在秋季優先考慮的。

And so -- but we do believe ultimately, there will be several other sarcoma types to add. And a couple of them are still getting data, leiomyo as well as some of the bone sarcomas, but others have already passed our criteria. But when we will actually load those other ones, I think that's yet to be determined because we have some very large indications and great opportunities. I mean, sarcomas also, but I think we have to have balance which ones to go first, and we'll be looking at that carefully in the fall.

所以，但我們確實相信最終還會添加其他幾種肉瘤類型。其中一些仍在獲取數據，leiomyo 以及一些骨肉瘤，但其他一些已經通過了我們的標準。但當我們真正加載其他那些時，我認為這尚未確定，因為我們有一些非常大的跡象和巨大的機會。我的意思是，還有肉瘤，但我認為我們必須平衡先處理哪些腫瘤，我們將在秋天仔細研究這一點。

That's helpful. Thank you.

這很有幫助。謝謝。

(Operator Instructions) Reni Benjamin, JMP Securities.

（操作員指令）Reni Benjamin，JMP 證券。

Hey. Good afternoon, guys. Thanks for taking the questions. Maybe just to start off, can you just take us through your latest thoughts on the liquid biopsy assay, it's potential use across all the programs? I know right now it appears to be confined to the ROR2, but is this something that can be further expanded? And as we think about this, how does this get, I guess, further fine-tuned and ready for commercialization as part of the development program?

嘿。下午好，伙計們。感謝您提出問題。也許首先，您能否向我們介紹一下您對液體活檢檢測的最新想法，它在所有程序中的潛在用途？我知道現在它似乎僅限於 ROR2，但這是否可以進一步擴展？當我們思考這個問題時，我想，作為開發計劃的一部分，如何進一步微調並為商業化做好準備？

Philippe or Eric, if you just want to handle that one?

菲利普或埃里克，如果你只想處理那個？

Yeah. I'll start, and then if Eric wants to add more, please do so. So it's not confined to ROR2. We have developed a liquid biopsy for AXL non-small cell lung as well. And we are currently generating data. So every patient that we're enrolling in the current study, we're testing them obviously for IHC because that's the entry criteria.

是的。我先開始，然後如果埃里克想添加更多內容，請這樣做。所以它不限於ROR2。我們還開發了用於 AXL 非小細胞肺的液體活檢。我們目前正在生成數據。因此，我們正在對參與當前研究的每一位患者進行 IHC 測試，因為這是進入標準。

But we'll soon be testing them for the CTC or the liquid biopsy. So we'll be able to correlate the IHC data to the CTC data once we've enrolled other patients. But we have all the results from this first part of the study.

但我們很快就會對它們進行 CTC 或液體活檢測試。因此，一旦我們招募了其他患者，我們就能夠將 IHC 數據與 CTC 數據關聯起來。但我們已經獲得了研究第一部分的所有結果。

So it's ongoing for ROR2 and AXL, and we're just waiting to generate more data in melanoma because we had some difficulty enrolling as we've discussed before. We prioritized that and are now using this assay in melanoma, and we've been able to identify patients that were both positive within the CTC assay.

因此，ROR2 和 AXL 的研究正在進行中，我們只是在等待生成更多關於黑色素瘤的數據，因為正如我們之前討論的那樣，我們在註冊方面遇到了一些困難。我們優先考慮這一點，現在正在黑色素瘤中使用這種檢測，並且我們已經能夠識別出在 CTC 檢測中均呈陽性的患者。

So right now, in the future, our assumption is we're going with IHC. But should CTC continue to perform, we could switch to liquid biopsy data.

所以現在，在未來，我們的假設是我們將使用 IHC。但如果 CTC 繼續表現，我們可以轉向液體活檢數據。

Got it. Okay. And I think you have several readouts coming out in the second half. You mentioned about 10 patients' worth for the ovarian, 10 to 15 patients' worth for LMS. Can you give us a sense just based on current enrollment trends how many patients' worth of data we might see from the anticipated readout for non-small cell lung and anything else I might be missing that's not coming at the top of my head right now?

知道了。好的。我認為下半年會發布一些數據。您提到大約 10 名患者的卵巢價值，10 至 15 名患者的 LMS 價值。您能否根據當前的入組趨勢讓我們了解一下，我們可以從非小細胞肺的預期讀數中看到多少患者的數據，以及我可能錯過的任何其他我現在還沒有想到的數據？

Yeah. Philippe, you may go ahead on the AXL lung. You want to give an update on that one? Estimate.

是的。 Philippe，您可以繼續使用 AXL 肺。您想提供最新情況嗎？估計。

Yeah. So on lung, the target is to have approximately 20 patients mono -- Q2W, 20 patients combo with Q2W and then 20 patients 3Q4W, and 20 patients with the 2Q3W dosing regimen. So that's the target that we've set for ourselves. We've already enrolled the Q2W cohorts. We are currently enrolling the 3Q4 and the 2Q3 cohorts. So that's our target for AXL non-small cell lung cancer.

是的。因此，在肺部方面，目標是讓大約 20 名患者採用單 Q2W 給藥方案，20 名患者採用 Q2W 聯合給藥方案，然後 20 名患者採用 3Q4W 給藥方案，以及 20 名患者採用 2Q3W 給藥方案。這就是我們為自己設定的目標。我們已經註冊了 Q2W 隊列。我們目前正在招募第 3 季度和第 2 季度的隊列。這就是我們 AXL 非小細胞肺癌的目標。

Yeah. And whether we hit exactly 20 on the on the more frequent dose-intensive regimens, I think we'll get a good feeling even if we're a few -- happen to be a few patients, shy of that. But certainly, Philippe has described what we're targeting.

是的。無論我們在更頻繁的劑量密集治療方案中是否達到了 20 次，我想我們都會有良好的感覺，即使我們是少數——碰巧是少數患者，對此感到羞恥。但可以肯定的是，菲利普已經描述了我們的目標。

And that was for BA3011, if I'm thinking about it right. What about BA3021?

如果我沒記錯的話，那是針對 BA3011 的。 BA3021呢？

Yes --

是的 -

Yeah. I think we're going to behind that a little bit, but in terms of the more frequent dose intensive but hopefully enough to give us a nice sense of things and certainly how we at the end of the year would like to go in with our discussions, future discussions with the FDA with regard to BA3021. Philippe, you want to add to that?

是的。我認為我們會稍微落後一點，但就更頻繁的劑量密集而言，但希望足以讓我們對事情有一個很好的認識，當然我們在年底希望如何與我們的討論，未來與 FDA 關於 BA3021 的討論。菲利普，你想補充一下嗎？

Yes. So our target is 20 Q2W monotherapy, 20 Q2W combo, and 20 3Q4W. These are the number of patients we're looking to have by the end of the year. Also, obviously, it is approximately, so it might be shy of a couple of patient there or maybe above in some of the cohorts, the 20 patients target, but the current target is 20.

是的。因此，我們的目標是 20 個 Q2W 單療法、20 個 Q2W 組合療法和 20 個 3Q4W。這些是我們預計到今年年底的患者人數。而且，顯然，這個數字是大約的，因此可能會低於那裡的幾個患者，或者可能高於某些隊列中 20 名患者的目標，但當前的目標是 20 名。

Got it. Thanks, guys.

知道了。多謝你們。

And I would also add, depending when we read these out, with ROR2, it's more of an issue potentially than it is for AXL to hit those. The question is if we're getting that data in December, are we're just going to push that into early conference in January? Or do we try to give a sense ot one of the upcoming meetings or also at our earnings for third quarter?

我還要補充一點，根據我們何時讀出這些內容，對於 ROR2，這比 AXL 遇到的問題更可能是一個問題。問題是，如果我們在 12 月獲得該數據，我們是否會將其推遲到 1 月份的早期會議中？或者我們是否試圖對即將舉行的會議或我們第三季度的收益進行了解？

I mean all of those things have yet to be decided. It's just a little early in the year to have that kind of precision. So please keep that in mind.

我的意思是所有這些事情都還沒有決定。現在達到這樣的精確度還為時過早。所以請記住這一點。

Got it. Thank you very much.

知道了。非常感謝。

Arthur He, HC Wainwright.

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

Hi. Good afternoon, Jay and Rick. This is Arthur from HC Wainwright, and thanks for taking my question. So I just wanted to follow-up on the 3011 and the 3021, the data update in lung cancer. So when you look at those data, besides the safety and the presumably ORR, what other criteria are you looking to for you to make the decision choose the optimal dosing for the pivotal study potentially?

你好。下午好，傑伊和瑞克。我是 HC Wainwright 的 Arthur，感謝您提出我的問題。所以我只是想跟進3011和3021，肺癌的數據更新。因此，當您查看這些數據時，除了安全性和大概的 ORR 之外，您還需要哪些其他標準來做出決定，為關鍵研究選擇最佳劑量？

Well, I think ultimately, you've got to have a duration of response. And so we're already -- and Philippe already mentioned what we're targeting there of six months or greater. And I think that's something that we care about, and we'll be looking at. And I think that's the other key feature.

嗯，我認為最終，你必須有一段反應時間。所以我們已經——菲利普已經提到了我們六個月或更長時間的目標。我認為這是我們關心的事情，我們將會關注。我認為這是另一個關鍵特徵。

Obviously, I think in these PD-1 failure groups, and especially with AXL, you got 35% of the patients who are positive, we really could open up some efficacy for patients that really don't have any other choices. Even potentially with some of the new therapies that could be coming -- arriving in 2024, we think we're still in a very strong position to -- there with what we are looking for and what we've seen -- been encouraged with the data that we have already obtained to date.

顯然，我認為在這些 PD-1 失敗組中，尤其是 AXL，有 35% 的患者呈陽性，我們確實可以為確實沒有任何其他選擇的患者提供一些療效。即使有可能會在 2024 年出現一些新療法，我們認為我們仍然處於非常有利的地位，因為我們正在尋找和我們已經看到的東西，因此受到鼓勵我們迄今為止已經獲得的數據。

Okay. Great. Thanks for that. And for the 3071 program, when we're looking for the data from the initial dose escalation part, so how -- could we get the idea about for the RP2D for both monotherapy and the combo when we see the data?

好的。偉大的。感謝那。對於 3071 計劃，當我們尋找初始劑量遞增部分的數據時，當我們看到數據時，我們如何才能了解 RP2D 的單一療法和組合療法？

And another question is for the expansion study, are you planning to go straight for the combo study or you're going to including mono and combo together?

另一個問題是關於擴展研究，您打算直接進行組合研究還是將單聲道和組合包括在一起？

Yeah. Philippe, go ahead.

是的。菲利普，繼續吧。

Yeah. So yes, I mean, our focus is mostly combination, okay? Because that's how ipilimumab is being used or is generally used in combination with a PD-1. So that's our primary focus. But that being said, we are looking at immunotherapy data as well.

是的。所以是的，我的意思是，我們的重點主要是組合，好嗎？因為這就是 ipilimumab 的使用方式，或者通常與 PD-1 聯合使用。這是我們的首要關注點。但話雖這麼說，我們也在研究免疫治療數據。

In terms of dose selection, we will be looking at efficacy and safety in patients that we've treated, but we'll also be looking at certain markers or efficacy as well as the PK characteristics of the dose we're looking at. So it's a novel assessment of the data that will lead us to choose one or two doses to go forward. We reserve the right again to go with mono and combo, but our primary focus will be combo for the expansion data.

在劑量選擇方面，我們將關注我們治療過的患者的療效和安全性，但我們也會關注某些標誌物或功效以及我們正在研究的劑量的 PK 特徵。因此，這是對數據的新穎評估，將引導我們選擇一兩個劑量繼續前進。我們再次保留使用單聲道和組合的權利，但我們的主要重點將是擴展數據的組合。

Got you. Thanks, Philippe. And my last question is on the ovarian cancer study. Could you remind us the inclusion and exclusion criteria for that study? And if you see good data from the more intensive dosing regimen from the either the lung cancer and sarcoma, is there a way to do the dose optimization as well for the ovarian cancer study? Thanks.

明白你了。謝謝，菲利普。我的最後一個問題是關於卵巢癌研究。您能否提醒我們該研究的納入和排除標準？如果您從肺癌和肉瘤的更密集給藥方案中看到良好的數據，是否有辦法對卵巢癌研究進行劑量優化？謝謝。

Yes. So these are platinum-failure patients, and it's in combination with a PD-1 inhibitor. If we see that the dose -- the more intensive dosing regimen is well tolerated and generate more efficacy in the indication we're looking at currently, we'll be translating that to the other indications as well.

是的。這些是鉑類藥物失敗的患者，並且與 PD-1 抑製劑聯合使用。如果我們發現劑量——更密集的給藥方案具有良好的耐受性，並且在我們目前正在研究的適應症中產生更多的療效，我們也會將其轉化為其他適應症。

So in the case of ovarian, we would be able to move forward with the study that would most likely be a registration study with the higher dosing regimen. We might decide to take two doses forward, but we wouldn't have a problem taking forward the more intensive dosing regimen.

因此，就卵巢而言，我們將能夠繼續進行這項研究，該研究很可能是採用更高劑量方案的註冊研究。我們可能決定繼續服用兩劑，但繼續進行更密集的給藥方案不會有問題。

Okay. Thanks. Thanks for taking my question, and congrats on the progress this quarter.

好的。謝謝。感謝您提出我的問題，並祝賀本季度取得的進展。

Thank you.

謝謝。

Thank you.

謝謝。

And at this time, there are no further questions. Now, let's turn the floor back over to Jay for any closing comments.

而此時，已經沒有其他問題了。現在，讓我們把發言權交還給傑伊，聽聽他的總結意見。

Well, I want to thank everyone for their time and attention today, and we're really looking forward to a lot of readouts coming up in the next couple of quarters. So thank you.

好吧，我要感謝大家今天的時間和關注，我們真的很期待在接下來的幾個季度裡出現大量的讀數。所以謝謝。

And thank you, everyone. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.

謝謝大家。今天的會議到此結束。此時您可以斷開線路。感謝您的參與，祝您有美好的一天。