Bioatla Inc (BCAB) 2024 Q2 法說會逐字稿

Good day, everyone. And welcome to today’s BioAtla second quarter 2024 earnings call. (Operator Instructions)

大家好。歡迎參加今天的 BioAtla 2024 年第二季財報電話會議。（操作員說明）

It is now my pleasure to turn the conference over to Bruce Mackle of LifeSci Advisors.

現在我很高興將會議交給 LifeSci Advisors 的 Bruce Mackle。

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 Eric in 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 Eric 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, 2024. 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 2024 年 6 月 30 日的第二季財務表現和業務更新。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 and whether its clinical trials will support registration, plans to form collaborations and other strategic partnerships for selected assets, achievement 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 to fund operations, and expectations regarding R&D expense and cash burn.

在我們開始之前，我想提醒大家，本次電話會議期間所做的陳述將包括前瞻性陳述，包括但不限於有關 BioAtla 的業務計劃和前景以及其臨床試驗是否支持的陳述註冊、為選定資產建立合作和其他策略夥伴關係的計劃、里程碑的實現、研發計劃和臨床試驗的結果、實施、進展和時間表、對其臨床試驗中的註冊和劑量的期望、計劃和對未來數據更新、臨床試驗、監管會議和監管提交的預期、候選產品潛在的監管批准路徑、對資金運營所需現金和現金等價物充足性的預期，以及對研發費用和現金消耗的預期。

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 10-Q.

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 10-Q 表季度報告。

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 8, 2024, and BioAtla disclaims any obligation to update such statements to reflect future information, events or circumstances, except as required by law.

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 2024 年 8 月 8 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 Dr. Jay Short. Jay?

說到這裡，我想把電話轉給傑·肖特醫生。傑伊？

Thank you, Bruce, and thanks to everyone for joining us for our second quarter 2024 BioAtla earnings call. Additional details related to what we will share today are available in today’s press release and our updated company presentation, which are available on our website. Also, the presentation and webcasts of our R&D Day held two weeks ago, featuring three renowned KOLs, are also available on our website.

謝謝 Bruce，也謝謝大家參加我們的 2024 年第二季 BioAtla 財報電話會議。與我們今天分享的內容相關的更多詳細資訊可在今天的新聞稿和我們更新的公司簡報中找到，這些內容可在我們的網站上找到。此外，兩週前舉行的由三位知名 KOL 主持的研發日的演示和網路廣播也可在我們的網站上觀看。

We continue to make considerable progress across all of our ongoing clinical programs, beginning with our CAB-ROR2-ADC ozuriftamab vedotin being evaluated as a monotherapy in highly treatment refractory head and neck cancer patients with a median of three prior lines of treatment. We shared last quarter that among the 29 evaluable patients, 11 responses were documented at the combined 2Q3W and Q2W dose regimens, with six responses now confirmed.

我們在所有正在進行的臨床計畫中繼續取得重大進展，首先是我們的 CAB-ROR2-ADC ozuriftamab vedotin 被評估為單一療法，用於治療高度難治性頭頸癌患者，之前接受過三種治療。上季我們分享了在 29 名可評估患者中，第 2 季第 3 週和第 2 週聯合用藥方案記錄了 11 例緩解，目前已確認 6 例緩解。

We have an abstract accepted as a poster presentation at the upcoming ESMO conference, and look forward to sharing the updated data in September. Additionally, we continue to see a manageable safety profile with no new safety signals to-date. Given the strength of the data, we recently received a Fast Track designation from the FDA, which represents an important recognition of the potential of a ozuriftamab vedotin to potentially fill a significant unmet need in refractory head and neck cancer.

我們在即將舉行的 ESMO 會議上接受了一份摘要作為海報展示，並期待在 9 月分享更新的數據。此外，我們繼續看到可控的安全狀況，迄今為止沒有新的安全訊號。鑑於數據的強度，我們最近獲得了 FDA 的快速通道指定，這代表了對 ozuriftamab vedotin 潛在滿足難治性頭頸癌的重大未滿足需求的潛力的重要認可。

The encouraging clinical profile supports rapidly advancing into a potentially registrational trial, evaluating monotherapy treatment versus investigator’s choice in the second-line and beyond setting. And we are on track to meet with the FDA later this year to discuss further.

令人鼓舞的臨床概況支持快速推進一項潛在的註冊試驗，評估單一療法與研究者在二線及其他領域的選擇。我們預計將在今年稍後與 FDA 會面，進一步討論。

Moving now to our CAB CTLA-4 antibody, evalstotug. As presented during our R&D Day, we have treated 40 patients across multiple doses of evalstotug and we continue to observe low incidence and severity of immune-related adverse events in the combined safety from our Phase 1 and Phase 2 studies.

現在轉向我們的 CAB CTLA-4 抗體 evalstotug。正如我們在研發日期間所介紹的，我們已經使用多次劑量的evalstotug 治療了40 名患者，並且我們繼續觀察到，在我們的1 期和2 期研究的綜合安全性中，免疫相關不良事件的發生率較低且嚴重程度較低。

Specifically, a relatively low rate of grade 2 immune-related adverse events were observed in only four out of 40 patients with no grade 4 or 5 related treatment emergent adverse events. The incidence and severity of immune-related AEs were consistent across both Phase 1 and Phase 2 studies.

具體而言，在 40 名沒有出現 4 級或 5 級相關治療突發不良事件的患者中，只有 4 名患者出現相對較低的 2 級免疫相關不良事件發生率。免疫相關 AE 的發生率和嚴重程度在第 1 期和第 2 期研究中是一致的。

With regards to efficacy from our Phase 1 study, we previously reported confirmed responses for three of eight treatment refractory patients using the 350 milligram dose in combination with a PD-1 antibody, including one complete response with one additional partial response that according to the attending physician showed no evidence of disease and may eventually be ruled as second complete response.

關於我們1 期研究的療效，我們先前報告了使用350 毫克劑量與PD-1 抗體聯合使用8 名治療難治性患者中的3 名的確認緩解，包括根據主治醫師的說法，其中一項完全緩解和一項額外的部分緩解醫生沒有顯示出疾病的證據，最終可能被判定為第二次完全緩解。

No dose interruptions occurred in patients treated with greater than or equal to 350 milligrams of evalstotug, and multiple patients have remained on therapy for more than one year without progression. These data are consistent with the anticipated benefits of our conditionally binding technology.

使用大於或等於 350 毫克 evalstotug 治療的患者沒有發生劑量中斷，且多名患者已繼續治療一年以上而沒有進展。這些數據與我們的條件綁定技術的預期效益一致。

Initial data from our Phase 2 monotherapy study across 14 different treatment refractory solid tumor types at 350 milligrams or 700 milligrams showed 10 patients with stable disease and multiple patients experienced prolonged progression-free survival for greater than 10 months.

我們針對14 種不同治療難治性實體瘤（350 毫克或700 毫克）的2 期單一療法研究的初步數據顯示，10 名患者病情穩定，多名患者經歷了超過10 個月的延長無進展生存期。

We look forward to presenting the data at several upcoming medical conferences, including an oral presentation at the Society for Melanoma Research Congress in October, and a poster presentation at the Society for Immunotherapy of Cancer in November.

我們期待在即將舉行的幾個醫學會議上展示這些數據，包括 10 月在黑色素瘤研究協會大會上的口頭報告，以及 11 月在癌症免疫治療協會上的海報報告。

We continue to enroll in the Phase 2 first-line melanoma study, followed by mutated non-small cell lung cancer using a combination of evalstotug and PD-1 antibody. We are on track for an initial data readout of melanoma later this year.

我們繼續參與 2 期一線黑色素瘤研究，隨後使用 evalstotug 和 PD-1 抗體組合進行突變非小細胞肺癌研究。我們預計在今年稍後獲得黑色素瘤的初步數據。

Based on our evolving data, we continue to believe evalstotug has the potential to be the best-in-class CTLA-4 antibody that holds the promise to be used as often as a PD-1 antibody and potentially expand the indications where combined immune checkpoint inhibition can be effective.

根據我們不斷發展的數據，我們仍然相信 evalstotug 有潛力成為同類最佳的 CTLA-4 抗體，預計將與 PD-1 抗體一樣頻繁使用，並有可能擴大聯合免疫檢查點的適應症抑制可以有效。

We are now designing a blinded randomized pivotal trial employing evalstotug plus PD-1 antibody for newly diagnosed metastatic or unresectable melanoma patients and anticipate FDA guidance in the second half of this year.

我們現在正在設計一項盲法隨機關鍵試驗，採用 evalstotug 聯合 PD-1 抗體治療新診斷的轉移性或不可切除的黑色素瘤患者，並預計 FDA 在今年下半年提供指導。

Now on to our CAB-AXL-ADC set, mecbotamab vedotin. As part of our Phase 2 trial, on patients with non-small cell lung cancer, we have completed an additional expansion cohort of 33 patients to evaluate actual expression, dose, subtype and safety.

現在介紹我們的 CAB-AXL-ADC 套裝，mecbotamab vedotin。作為我們針對非小細胞肺癌患者的 2 期試驗的一部分，我們已經完成了由 33 名患者組成的額外擴展隊列，以評估實際表達、劑量、亞型和安全性。

In our subgroup analysis, we observed that actual expression of greater than or equal to 1% is correlated with clinical benefit in heavily pretreated patients with a median of three prior lines of therapy. We further evaluated the genotype status in this heavily pretreated patient population with tumors expressing multiple KRAS mutation variants, including G12A, G12C, and G12V.

在我們的亞組分析中，我們觀察到，大於或等於 1% 的實際表達與中位接受過三種先前治療的重度預處理患者的臨床益處相關。我們進一步評估了這個經過大量治療的患者群體的基因型狀態，這些患者的腫瘤表達多種 KRAS 突變變異體，包括 G12A、G12C 和 G12V。

Among the 18 evaluable patients with known KRAS mutations, we observed five responders, including one responder whose tumor expressed a mutated KRAS G12C variant and has experienced prior failure of sotorasib.

在 18 名已知 KRAS 突變的可評估患者中，我們觀察到 5 名緩解者，其中一名緩解者的腫瘤表達突變的 KRAS G12C 變異體，並且之前曾經歷過 sotorasib 失敗。

In addition, we have a patient with a complete response that has been maintained now for over two years, demonstrating encouraging clinical benefit in this emerging opportunity in patients with mutated KRAS variants. Importantly, our initial findings support a trend for improved overall survival among patients with tumors expressing mutated KRAS variants compared to the KRAS wild-type genotype.

此外，我們還有一名患者獲得了完全緩解，並且已經維持了兩年多，這表明這一新興機會對 KRAS 突變患者俱有令人鼓舞的臨床益處。重要的是，我們的初步研究結果支持了與 KRAS 野生型基因型相比，表達突變 KRAS 變異體的腫瘤患者的整體存活率有所提高的趨勢。

Furthermore, a manageable safety profile continues with no new safety signals identified in this patient population. We continue to assess KRAS expression across the Phase 2 dataset and look forward to providing an update and additional details regarding a potential path forward later this year.

此外，在該患者群體中沒有發現新的安全訊號，安全狀況仍處於可控狀態。我們將繼續評估第 2 階段資料集的 KRAS 表達，並期待在今年稍後提供有關潛在前進路徑的更新和更多詳細資訊。

Regarding our Phase 2 potentially registrational trial, an undifferentiated pleomorphic sarcoma, UPS, we are evaluating the initial 20-patient dataset and will provide an update on the remaining portion of the registrational trial later this year.

關於我們的 2 期潛在註冊試驗（一種未分化多形性肉瘤，UPS），我們正在評估最初的 20 名患者數據集，並將在今年稍後提供註冊試驗剩餘部分的更新。

Now in our Phase 1/2 Dose Escalation Study for CAB-EpCAM x CAB-CD3 T-cell engager, the study is progressing and ongoing. We remain on track for a Phase 1 data readout in the second half of this year. The T-cell engager space offers tremendous opportunity for more effective therapies, and in particular, our CAB-enabled EpCAM T-cell engager has the potential to treat patients with a wide range of metastatic tumors, including cancers of colon, lung, breast, pancreas, prostate, among others.

現在，在我們針對 CAB-EpCAM x CAB-CD3 T 細胞接合劑的 1/2 期劑量遞增研究中，該研究正在取得進展並正在進行中。我們仍有望在今年下半年公佈第一階段的數據。T 細胞接合器空間為更有效的治療提供了巨大的機會，特別是，我們支持 CAB 的 EpCAM T 細胞接合器有潛力治療患有多種轉移性腫瘤的患者，包括結腸癌、肺癌、乳腺癌、胰臟、前列腺等。

Finally, we are in meaningful discussions regarding potential strategic partnerships with multiple companies evaluating selected preclinical and clinical assets. The current stage of these discussions support our belief that we remain on track for establishing one or more collaborations this year, including for one of our Phase 2 clinical assets.

最後，我們正在與多家公司就潛在的策略夥伴關係進行有意義的討論，以評估選定的臨床前和臨床資產。目前階段的這些討論支持了我們的信念，即我們今年仍有望建立一項或多項合作，包括我們的一項 2 期臨床資產。

With that, I would now like to turn the call over to Rick to review the second quarter 2024 financials. Eric?

現在，我想將電話轉給 Rick，讓他審查 2024 年第二季的財務狀況。艾瑞克？

Thank you, Jay. Research and development expenses were $16.2 million for the quarter ended June 30, 2024, compared to $31 million for the same quarter in 2023. The decrease of $14.8 million was primarily due to completion of preclinical development for our Nectin-4 ADC, which received IND clearance in May 2024, and the impact of prioritization of our clinical programs in 2023, resulting in less expense for our preclinical programs in 2024.

謝謝你，傑伊。截至 2024 年 6 月 30 日的季度，研發費用為 1,620 萬美元，而 2023 年同一季度的研發費用為 3,100 萬美元。減少 1,480 萬美元主要是由於我們的 Nectin-4 ADC 臨床前開發完成，該藥物於 2024 年 5 月獲得 IND 批准，以及我們 2023 年臨床項目優先順序的影響，導致 2024 年我們臨床前項目的費用減少。

Our clinical program expense decreased due to completion of Phase 2 enrollment for our ongoing ADC trials for mecbotamab vedotin and ozuriftamab vedotin. We expect our R&D expenses to continue to decrease in the near-term as we complete our planned Phase 2 clinical trials and meet with the FDA to discuss potentially registrational trials for our Phase 2 programs.

由於我們正在進行的 mecbotamab vedotin 和 ozuriftamab vedotin ADC 試驗的第 2 期註冊完成，我們的臨床項目費用減少。我們預計，隨著我們完成計劃的二期臨床試驗並與 FDA 會面討論二期項目的潛在註冊試驗，我們的研發費用在短期內將繼續減少。

General and administrative expenses were $5.8 million for the quarter ended June 30, 2024, compared to $6.2 million for the same quarter in 2023. The $0.5 million decrease is primarily due to lower stock-based compensation expense.

截至 2024 年 6 月 30 日的季度，一般及管理費用為 580 萬美元，而 2023 年同一季度為 620 萬美元。減少 50 萬美元主要是因為股票補償費用減少。

Net loss for the quarter ended June 30, 2024 was $21.1 million, compared to a net loss of $35.8 million for the same quarter in 2023. Net cash used in operating activities for the sixth month ended June 30, 2024, was $50 million, compared to net cash used in operating activity of $46.7 million for the same period in 2023.

截至 2024 年 6 月 30 日的季度淨虧損為 2,110 萬美元，而 2023 年同一季度的淨虧損為 3,580 萬美元。截至 2024 年 6 月 30 日的第六個月經營活動使用的現金淨額為 5,000 萬美元，而 2023 年同期經營活動使用的現金淨額為 4,670 萬美元。

Our cash use for the quarter ended June 30, 2024, was $19 million, compared to $30.8 million during the quarter ended March 31, 2024. In line with our operating plan, we expect a further reduction in overall cash utilization in the third quarter of 2024.

截至 2024 年 6 月 30 日的季度，我們的現金使用量為 1,900 萬美元，而截至 2024 年 3 月 31 日的季度，我們的現金使用量為 3,080 萬美元。根據我們的營運計劃，我們預計 2024 年第三季的整體現金利用率將進一步減少。

Cash and cash equivalents as of June 30, 2024 were $61.7 million, compared to $111.5 million as of December 31, 2023. We expect current cash and cash equivalents will be sufficient to fund planned operations, including our prioritized CAB programs, through the third quarter of 2025, which is sufficient to deliver clinical readouts in multiple indications, position our programs for one or more potentially registration trials, and enhance our position in advancing strategic collaboration discussions.

截至 2024 年 6 月 30 日，現金及現金等價物為 6,170 萬美元，而截至 2023 年 12 月 31 日，現金及現金等價物為 1.115 億美元。我們預計，到2025 年第三季度，目前的現金和現金等價物將足以為計劃運營提供資金，包括我們的優先CAB 項目，這足以提供多種適應症的臨床讀數，使我們的項目能夠進行一項或多項潛在的註冊試驗，並增強我們在推動策略合作討論方面的地位。

And now, back to Jay.

現在，回到傑伊。

Thank you, Eric. We are pleased with the considerable progress we have made to-date and our cumulative results across our CAB pipeline targeting solid tumors. We continue to focus on finalizing the data readouts and reports for our CAB-AXL, CAB-ROR2 and CAB CTLA-4 assets, and look forward to presenting ROR2 and CTLA-4 data at upcoming medical meetings, as well as keeping you updated on our business activities.

謝謝你，埃里克。我們對迄今為止的巨大進展以及針對實體腫瘤的 CAB 管道的累積成果感到高興。我們將繼續專注於最終確定 CAB-AXL、CAB-ROR2 和 CAB CTLA-4 資產的數據讀數和報告，並期待在即將舉行的醫療會議上展示 ROR2 和 CTLA-4 數據，並讓您隨時了解最新動態我們的商業活動。

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

這樣，我們會將其轉回給運營商以回答您的問題。

(Operator Instructions) Brian Cheng, JPMorgan.

（操作員指令）Brian Cheng，摩根大通。

Hey, guys. Good afternoon. Thanks for taking our questions. Maybe just first on AXL and UPS, can you confirm if you have met with the FDA on the remaining portion for in the registrational study? If so, what is the initial feedback from the agency? And just furthermore, can you give us a bit more color on the patient compliance and safety profile that you saw in the initial conversations? And a quick follow-up. Thank you.

嘿，夥計們。午安.感謝您回答我們的問題。也許首先是關於 AXL 和 UPS，您能否確認您是否已就註冊研究的剩餘部分與 FDA 會面？如果是這樣，該機構的初步回饋是什麼？此外，您能給我們更多關於您在最初對話中看到的患者依從性和安全性概況的資訊嗎？並快速跟進。謝謝。

Eric, this one sounds like it's for you.

艾瑞克，這個聽起來像是給你的。

Great. Thanks, Brian. So as we’ve previously disclosed, we had a conversation with the FDA about mecbotamab vedotin in undifferentiated pleomorphic sarcoma. And we discussed Project Optimus requirements. We discussed treating at two different dose levels. We discussed the potential bar for accelerated approval with a single-arm trial data set.

偉大的。謝謝，布萊恩。正如我們先前所揭露的，我們與 FDA 就 mecbotamab vedotin 在未分化多形性肉瘤中的應用進行了對話。我們也討論了 Optimus 專案的要求。我們討論了兩種不同劑量等級的治療。我們討論了單臂試驗資料集加速核准的潛在障礙。

We have not met with the agency yet with regard to our recent enrollment of the additional patients and we would plan to review our data and then update on this later in the second half of the year.

我們尚未就最近招募更多患者的事宜與該機構會面，我們計劃審查我們的數據，然後在今年下半年對此進行更新。

And Brian, I think you had additional questions about overall safety. Is that right?

布萊恩，我認為您對整體安全還有其他疑問。是這樣嗎？

Yeah. And I guess just from the initial 20 patients, I think, if you can provide any color on the patient compliance and any initial read on efficacy and safety, that would be very helpful?

是的。我想，僅從最初的 20 名患者來看，如果您能提供有關患者依從性的任何信息以及有關療效和安全性的任何初步解讀，那會非常有幫助嗎？

Sure. -- Go ahead Jay.

當然。 ——傑伊，繼續吧。

On the efficacy -- we’re not able -- I was just going to say on the efficacy, we are not -- because it’s part of the potentially registrational trial, we’re not able to update publicly on that. But on the safety, I think, in general, Eric, at a high level, you certainly could update that.

關於功效——我們無法——我只是想說關於功效，我們不能——因為它是潛在註冊試驗的一部分，我們無法公開更新那。但在安全方面，我認為，總的來說，埃里克，在高水平上，你當然可以更新這一點。

Yeah. I’m happy to do so. Certainly no new safety findings have been identified with the ADC. And we did decide that giving the drug every, on the 3-2-4 regimen was, we didn’t see much patient compliance with that coming in so frequently to clinics. So we really focused on the days one and eight regimen of a three-week cycle.

是的。我很高興這樣做。當然，ADC 尚未發現新的安全性發現。我們確實決定按照 3-2-4 方案每次給藥，但我們沒有看到如此頻繁地來到診所的患者對此的依從性。因此，我們真正關注的是三週週期的第一天和第八天的治療方案。

Okay. Maybe just lastly, just on the partnership or BD fund. Can you just talk about your level of confidence, whether you’ll be able to lock in a potential deal in the back half of this year? And as you think about the potential partnerships that are on the table, which potential assets do you think would make the most sense to partner off based on the current data? Thank you.

好的。也許最後，只是關於合夥企業或 BD 基金。您能談談您對今年下半年是否能夠鎖定潛在交易的信心嗎？當您考慮擺在桌面上的潛在合作夥伴關係時，您認為根據當前數據，哪些潛在資產最適合合作？謝謝。

So I’m fairly confident that we’re going to be successful in establishing partnerships, one or more, in this remaining portion of the year. I think we -- as I mentioned in the script, we also may see a partnership as part of that in the preclinical assets.

因此，我相當有信心，在今年剩餘的時間裡，我們將成功建立一個或多個合作夥伴關係。我認為，正如我在腳本中提到的，我們也可能將合作夥伴關係視為臨床前資產的一部分。

When it comes to the, I think the ADCs are certainly getting the most limelight in discussions. And so I think it’s a little difficult to predict for sure which one would partner first, but I’d say both are potential candidates. We like them both. So I think we remain on -- we feel we remain on track for that as best one can forecast and the discussions are clearly at a meaningful level. And so we’re very encouraged, Brian.

談到這一點，我認為 ADC 無疑是討論中最引人注目的。因此，我認為很難確定哪一個會首先合作，但我想說兩者都是潛在的候選人。我們都喜歡他們。因此，我認為我們仍將繼續前進——我們認為我們仍將按照人們所能預測的那樣走上正軌，而且討論顯然處於有意義的水平。所以我們非常受鼓舞，布萊恩。

Okay, Thank you.

好的，謝謝。

Tony Butler, Rodman & Renshaw

東尼巴特勒、羅德曼和倫肖

Hi. This is [Toshida] on for Tony. Question is about the AXL-ADC. I seem to recall that the patient with the complete response received the combination. Now, as it pertains to the combination, I wonder if you can characterize what you see since the last data update when it comes to, let’s say, seeing a potential deepening of response or patients who are not quite there when it comes to having a response, getting close to that negative 30% mark over time?

你好。這是托尼的[Toshida]。問題是關於 AXL-ADC 的。我似乎記得完全緩解的患者接受了該組合。現在，就組合而言，我想知道您是否可以描述自上次數據更新以來您所看到的情況，比如說，看到潛在的反應加深或患者在出現反應時尚未完全到位隨著時間的推移，是否會得到回應，接近30% 的負值？

So it’s Eric Sievers again. And so if I can clarify, I think you’re asking about our relatively mature data set now with mecbotamab vedotin in non-small cell lung cancer. And you commented on the CR patient that we’ve reported previously. And then I think the second part of your question was asking about whether we’ve seen deepening of some of these responses over time.

又是埃里克·西弗斯。因此，如果我可以澄清一下，我認為您是在詢問我們目前相對成熟的 mecbotamab vedotin 在非小細胞肺癌中的數據集。您對我們之前曾報道過的 CR 患者發表了評論。然後我認為你問題的第二部分是問我們是否看到這些反應隨著時間的推移而加深。

I think I probably best to refer everyone to Slide 45 in our updated corporate deck where we are characterizing the confirmed responses across the KRAS mutation variants. Interestingly, one of our responses is a CR patient.

我想我可能最好向大家推薦我們更新的公司幻燈片中的第 45 張幻燈片，其中我們正在描述跨 KRAS 突變變體的已確認反應。有趣的是，我們的回應之一是 CR 患者。

And then also direct folks to Slide 46, which is a preliminary analysis suggesting a difference in outcome amongst patients expressing the mutated KRAS versus wild-type KRAS genotype. So we’re continuing to witness the data evolving over time.

然後也引導人們查看投影片 46，這是一項初步分析，顯示表達突變 KRAS 與野生型 KRAS 基因型的患者的結果存在差異。因此，我們將繼續見證資料隨時間的演變。

This is our current data set that we’ve made public and look forward to continuing to evolve -- to evaluate the evolving KRAS story. I want to indicate that 21 of the patients still have a pending genotype and we’re categorizing them as either wild-type or mutant so we can further this preliminary finding.

這是我們目前已公開的數據集，並期待繼續發展——以評估不斷發展的 KRAS 故事。我想指出的是，其中 21 名患者仍有待確定的基因型，我們將他們歸類為野生型或突變型，以便我們可以進一步推進這一初步發現。

I understand and thank you for that. Furthermore, how would you characterize responses and our clinical activity that the disease control duration longer than and fewer than 16 weeks with the combination of mecbotamab vedotin and nivolumab in patients whose KRAS mutation status is either unknown or wild-type?

我理解並為此感謝你。此外，對於 KRAS 突變狀態未知或野生型的患者，使用 mecbotamab vedotin 和 nivolumab 聯合治療，疾病控制持續時間長於或短於 16 週，您如何描述反應和我們的臨床活動？

So looking at Slide 45, we’re seeing a duration of response of 4.8 months for those with the mutated KRAS. I think that the survival curves give a suggestion of a somewhat lower PFS amongst the patients with a wild-type KRAS and we’ve not performed a formal analysis of the 21 individuals that are unknown. So I look forward to a future data presentation in the Medical Congress where that will be disclosed.

因此，請查看幻燈片 45，我們發現 KRAS 突變患者的反應持續時間為 4.8 個月。我認為生存曲線顯示攜帶野生型 KRAS 的患者的 PFS 較低，而且我們尚未對這 21 名未知個體進行正式分析。因此，我期待未來在醫學大會上公佈數據。

I do think it’s a fairly competitive profile given the fact this is effectively a fourth-line, median fourth-line set of patients.

我確實認為這是一個相當有競爭力的概況，因為這實際上是四線、中位四線患者組。

Thank you.

謝謝。

(Operator Instructions) Arthur He, H.C. Wainwright.

（操作員指令） Arthur He, H.C.溫賴特。

Hey. Good afternoon, guys. Thanks for taking my question. So I have a couple quick ones. So for the AXL program, regarding the UPS study, if I understand correctly, you have the additional 20 patient data. And as of now, you’re just going to pick, waiting for the data to take to FDA. In the meantime, are you still enrolling patients in the program?

嘿。下午好，夥計們。感謝您提出我的問題。所以我有幾個快速的。因此，對於 AXL 計劃，關於 UPS 研究，如果我理解正確的話，您還有額外的 20 名患者數據。截至目前，您只需進行選擇，等待資料提交給 FDA。同時，你們還在招募病患參加計畫嗎？

We are not enrolling patients at the moment. We’re waiting for the three total scans and evaluating the data as it comes in, and then we’ll proceed from there.

我們目前不招募患者。我們正在等待三個完整的掃描並評估傳入的數據，然後我們將從那裡繼續。

Thanks, Jay. And for the non-small cell lung cancer study in the future, my take is you probably got to taking the KRAS status as well as the AXL status together to select the patient, or you might go for either one?

謝謝，傑伊。對於未來的非小細胞肺癌研究，我的看法是，你可能必須同時考慮 KRAS 狀態和 AXL 狀態來選擇患者，或者你可能會選擇其中一個？

I think, it could be either one, but I think right now we see a nice correlation on mKRAS. It just happens to be that AXL is highly correlated with that. So it’s not necessarily required that you have that AXL expression. We clearly see benefit with our drug with AXL expression. So when we finish the next 21 patients analysis, obviously we’ll be comparing that and coming forward with how we think it best be carried out.

我認為，可能是其中之一，但我認為現在我們在 mKRAS 上看到了很好的相關性。恰好 AXL 與此高度相關。因此，不一定需要具有 AXL 表達式。我們清楚地看到我們的 AXL 表達藥物的益處。因此，當我們完成接下來的 21 名患者分析時，顯然我們將對其進行比較，並提出我們認為最好的實施方式。

Gotcha.

明白了。

Can I add to that too? Because Arthur, I think that it’s a great question. And as Jay said, these are evolving data. We’re looking at the 21 patients to see how they sort out between mutated and wild type. But it’s conceivable that if the KRAS findings are further supported with additional data, that given that that’s a standard assessment, the genotype of lung cancer patients is very standard for defining the appropriate treatment options, that this would enable a pretty straightforward approach for defining a population experiencing pronounced clinical benefit. Again, illustrated in Slide 46 with the difference of survival that we’re seeing. Now that could be biologic differences between those two subgroups of patients. It also could be due to the drug.

我也可以補充一下嗎？因為亞瑟，我認為這是一個很好的問題。正如傑伊所說，這些都是不斷變化的數據。我們正在觀察 21 名患者，看看他們如何區分突變型和野生型。但可以想像的是，如果KRAS 的發現得到更多數據的進一步支持，鑑於這是一個標準評估，肺癌患者的基因型對於定義適當的治療方案來說是非常標準的，這將能夠實現一個相當好的結果。再一次，如投影片 46 所示，我們看到了生存的差異。現在這可能是這兩個亞組患者之間的生物學差異。也可能是藥物的原因。

Thanks for the color, Eric. And I had another one for the CTLA-4 study. Just curious, do you guys still plan to enroll more patients for the monotherapy at the 700-milligram dose level or that’s pretty much the 19 -- I guess the 19 patients is every patient that you plan for the monotherapy study?

謝謝你的顏色，艾瑞克。我還有另一份用於 CTLA-4 研究。只是好奇，你們是否仍計劃招募更多患者接受 700 毫克劑量水平的單一療法，或者幾乎是 19 名患者——我猜這 19 名患者是你們計劃進行單一療法研究的所有患者？

I’m happy to take that. So we do not plan to further characterize monotherapy safety. I want to emphasize that the Phase 2 monotherapy approach was a way to very efficiently and rapidly confirm our hypothesis that we were seeing a lower rate of immune-related adverse events compared with marketed CTLA-4 antibodies.

我很高興接受這一點。因此，我們不打算進一步表徵單一療法的安全性。我想強調的是，2 期單一療法是一種非常有效、快速證實我們假設的方法，即與市售 CTLA-4 抗體相比，我們看到的免疫相關不良事件發生率較低。

We believe that we are indeed seeing a substantially lower rate of immune-mediated adverse events. And so our focus is now combining with people with PD-1 antibody approaches and further evaluating drug activity and safety in newly diagnosed metastatic or unresectable melanoma, as well as patients with lung cancer with specified mutations.

我們相信，我們確實看到免疫介導的不良事件發生率大幅降低。因此，我們現在的重點是與採用 PD-1 抗體方法的人結合，進一步評估新診斷的轉移性或不可切除的黑色素瘤以及具有特定突變的肺癌患者的藥物活性和安全性。

Gotcha, thanks for taking my question.

明白了，感謝您提出我的問題。

Thank you.

謝謝。

(Operator Instructions) I'm showing no further questions at this time. I will now turn the program back over to Jay Short for closing remarks.

（操作員說明）我目前沒有提出任何進一步的問題。我現在將把節目交還給傑伊·肖特（Jay Short）做結束語。

Thanks everyone for attending today and we look forward to seeing everyone at ESMO in September, as well as in our additional conferences coming up in the near future. Thank you and we’ll also intend to report out on our business developments as they occur. Thank you.

感謝大家今天出席，我們期待在 9 月在 ESMO 以及不久的將來舉行的其他會議上見到大家。謝謝您，我們也將及時報告我們的業務發展。謝謝。

This does conclude today's program. Thank you for your participation. You may disconnect at any time.

今天的節目到此結束。感謝您的參與。您可以隨時斷開連線。