Bioatla Inc (BCAB) 2023 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the BioAtla third-quarter 2023 earnings call. (Operator Instructions) Please be advised that today's call is being recorded on Tuesday, November 7, 2023.

女士們、先生們，下午好，歡迎參加 BioAtla 2023 年第三季財報電話會議。 （操作員說明）請注意，今天的通話錄音時間為 2023 年 11 月 7 日星期二。

I would now like to turn the conference over to Bruce Mackle of LifeSci Advisors. Please go ahead.

我現在想將會議轉交給 LifeSci Advisors 的 Bruce Mackle。請繼續。

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 Rick 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；和首席財務官里克·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 third quarter ended September 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 9 月 30 日的第三季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 and whether its clinical trials will support registration; plans to form collaborations and other strategic partnerships for selected assets; 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; plans to prioritize and focus development on selected assets and indications; and expected R&D and G&A expenses.

在開始之前，我想提醒大家，本次電話會議中的陳述將包括前瞻性陳述，包括但不限於有關 BioAtla 的商業計劃和前景以及其臨床試驗是否支持註冊的陳述；計劃為選定的資產建立合作和其他策略夥伴關係；其研發計劃和臨床試驗的結果、實施、進展和時間表；對臨床試驗入組和劑量的期望、計劃以及對未來數據更新、臨床試驗、監管會議和監管提交的期望；其候選產品的潛在監管核准途徑；對現金及現金等價物充足性的預期；計劃優先考慮並集中開發選定的資產和適應症；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 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, November 7, 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 10-Q 表季度報告。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（2023 年 11 月 7 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 third-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 critical unmet needs in oncology to improve patients' lives.

謝謝 Bruce，也謝謝大家參加我們的 2023 年第三季 BioAtla 財報電話會議。 BioAtla 是使用專有條件活性生物製劑CAB 平台開發新型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，同時避開了健康細胞，從而解決了腫瘤學中未滿足的關鍵需求，以改善患者的生活。

As we approach the end of 2023, we have obtained data to support several value inflection points across our CAB portfolio and continue to focus on further advancing the development of our prioritized CAB programs. We believe that forming one or more strategic collaborations with major pharmaceutical partners can accelerate development of selected assets and maximize their market opportunities. We also believe that our more focused and strategic approach better positions us to enhance value for shareholders. Additional details related to what I'm going to provide are available in today's press release and our revised company presentation, both of which are available on our website.

隨著 2023 年底的臨近，我們已獲得數據來支持我們的 CAB 投資組合中的幾個價值拐點，並繼續專注於進一步推進我們優先 CAB 項目的開發。我們相信，與主要製藥合作夥伴形成一項或多項策略合作可以加速選定資產的開發並最大化其市場機會。我們也相信，我們更專注和更具策略性的方法可以更好地為股東提高價值。與我將要提供的內容相關的更多詳細資訊可以在今天的新聞稿和我們修訂後的公司簡報中找到，兩者都可以在我們的網站上找到。

I will now provide some new updates since our second-quarter call in August, beginning with our CAB-AXL-ADC BA3011. Regarding our BA3011 Phase 2 study in non-small cell lung cancer, we have consistently observed multiple clinical responses in AXL-positive treatment refractory lung cancer populations. Among patients receiving BA3011 monotherapy who previously experienced PD-1 treatment failure and were evaluable for efficacy at 12 weeks. The observed objective response rate was 27.8%. In patients with EGFR wild-type non-squamous lung cancer, who previously experienced PD-1 treatment failure, 33.3% of the patients had a partial response to BA3011 monotherapy.

我現在將提供自 8 月第二季電話會議以來的一些新更新，從我們的 CAB-AXL-ADC BA3011 開始。關於我們針對非小細胞肺癌的 BA3011 2 期研究，我們持續觀察到 AXL 陽性難治性肺癌族群的多種臨床反應。接受 BA3011 單藥治療且先前經歷過 PD-1 治療失敗且可在 12 週時評估療效的患者。觀察到的客觀緩解率為27.8%。在先前經歷過 PD-1 治療失敗的 EGFR 野生型非鱗狀肺癌患者中，33.3% 的患者對 BA3011 單藥治療有部分緩解。

Of note, AXL expression in lung cancer defines a particularly poor prognostic group. Also, these patients had experienced the failure of a median of three prior lines of therapy. So we believe that observing multiple responses in this treatment refractory poor prognostic group is clinically meaningful and relevant. In addition to the consistent differentiated safety profile, we continue to observe clinical benefit in patients, including multiple PRs and TmPS score of 1%. We are exploring the potential clinical benefits in actual TmPS negative patients, which is important for understanding the market potential of BA3011 in lung cancer.

值得注意的是，肺癌中的 AXL 表現定義了一個預後特別差的群體。此外，這些患者之前曾經歷過中位數三種治療的失敗。因此，我們相信，觀察此治療難治性預後不良組的多重反應具有臨床意義和相關性。除了一致的差異化安全性外，我們還繼續觀察患者的臨床效益，包括多次 PR 和 1% 的 TmPS 評分。我們正在探索實際 TmPS 陰性患者的潛在臨床益處，這對於了解 BA3011 在肺癌中的市場潛力非常重要。

Earlier this quarter, we also received verbal FDA feedback that we believe is supportive of a registrational path forward for BA3011 in lung cancer. We anticipate receiving formal written feedback later this month and plan to share more details and interim Phase 2 data to be presented at the IASLC Conference and our KOL event in early December.

本季度早些時候，我們也收到了 FDA 的口頭回饋，我們認為這些回饋支持 BA3011 在肺癌領域的註冊路徑。我們預計本月稍後會收到正式的書面回饋，並計劃在 12 月初的 IASLC 會議和 KOL 活動上分享更多詳細資訊和中期第 2 階段數據。

Our Phase 2 potentially registrational study for undifferentiated pleomorphic sarcoma or UPS is ongoing and we continue to enroll the 2Q3W dosing regimen for up to 20 patients. We have decided not to further advance the 3Q4W dosing regimen across any cohorts in either the BA3011 or the BA3021 studies due to suboptimal compliance with this dosing regimen, which is consistent with a lack of meaningful difference in efficacy observed with BA3011 in leiomyosarcoma.

我們針對未分化多形性肉瘤或 UPS 的 2 期潛在註冊研究正在進行中，我們將繼續招募最多 20 名患者的 2Q3W 給藥方案。我們決定不再在BA3011 或BA3021 研究的任何隊列中進一步推進3Q4W 給藥方案，因為該給藥方案的依從性不佳，這與BA3011 在平滑肌肉瘤中觀察到的療效缺乏有意義的差異是一致的。

In regards to other bone and soft tissue sarcoma cohorts, we are pleased to have hit our internal Go criteria for several sarcoma subtypes, including synovial sarcoma, liposarcoma, and osteosarcoma. As a reminder, our internal Go criteria is defined as achieving greater than or equal to one complete response slash partial response or a progression-free survival rate of greater than or equal to 40% at 12 weeks. All cohorts are now completed, and we plan to submit available data to a medical meeting in 2024.

至於其他骨骼和軟組織肉瘤隊列，我們很高興達到了幾種肉瘤亞型的內部 Go 標準，包括滑膜肉瘤、脂肪肉瘤和骨肉瘤。提醒一下，我們的內部 Go 標準定義為在 12 週時達到大於或等於一次完全緩解、部分緩解或無惡化存活率大於或等於 40%。所有隊列現已完成，我們計劃向 2024 年的醫學會議提交可用數據。

As previously communicated, our highest priority is to deliver innovative life changing therapies to cancer patients with significant unmet medical needs. We have now observed multiple clinical responses in several treatment refractory solid tumor populations with our CAB-AXL-ADC asset, BA3011. We have also recently received feedback from the FDA on the BA3011 lung cancer registrational study design. Taken together, we continue to believe that BA3011 is an active agent in treatment refractory tumors and has the potential to become a first-in-class treatment for a significant number of patients who experienced a failure of at least one prior line of therapy.

如同先前所傳達的，我們的首要任務是為醫療需求未被滿足的癌症患者提供創新的改變生活的療法。現在，我們已經利用我們的 CAB-AXL-ADC 資產 BA3011 在多個難治性實體腫瘤族群中觀察到了多種臨床反應。我們最近也收到 FDA 關於 BA3011 肺癌註冊研究設計的回饋。總而言之，我們仍然相信 BA3011 是治療難治性腫瘤的活性藥物，並且有潛力成為大量先前至少一種治療失敗的患者的一流治療藥物。

Now turning to our second CAB-ADC asset, BA3021, a CAB-ROR2-ADC. For our ongoing Phase 2 trials, we have completed enrollment of approximately 20 patients at the Q2W dosing regimen in both lung cancer and melanoma, and anticipate to complete enrollment of up to 20 patients at the 2Q3W dosing regimen in head and neck cancer before year end. In treatment refractory patient populations, there are encouraging early responses in the Phase 2 melanoma study at the Q2W dosing regimen that are consistent with our Phase 1 expansion study.

現在轉向我們的第二個 CAB-ADC 資產 BA3021，即 CAB-ROR2-ADC。對於我們正在進行的 2 期試驗，我們已經完成了大約 20 名肺癌和黑色素瘤 Q2W 給藥方案患者的入組，並預計在年底前完成頭頸癌 2Q3W 給藥方案最多 20 名患者的入組。在治療難治性患者族群中，Q2W 給藥方案的 2 期黑色素瘤研究中出現了令人鼓舞的早期反應，這與我們的 1 期擴展研究一致。

In particular, among the eight evaluable monotherapy patients to date with reported first scan across Phase 1 and Phase 2 clinical studies, we have observed four responses. Two stable disease, one of which was a 17% tumor volume reduction in uveal melanoma, and two with progressive disease. Notably, we have now observed a PR in a ROR2 TmPS negative patient, which is likely to expand the applicable patient populations. We are continuing to collect data in the ongoing study and the remainder of patients from the targeted melanoma cohort will have had the opportunity to have first scan by year end.

特別是，在迄今為止報告的 1 期和 2 期臨床研究中首次掃描的 8 名可評估的單一療法患者中，我們觀察到了 4 名緩解。兩種疾病穩定，其中一種是葡萄膜黑色素瘤腫瘤體積減少 17%，另兩種疾病進展。值得注意的是，我們現在已經在 ROR2 TmPS 陰性患者中觀察到 PR，這可能會擴大適用的患者群體。我們正在繼續收集正在進行的研究中的數據，目標黑色素瘤隊列中的其餘患者將有機會在年底前進行第一次掃描。

There are also encouraging early responses in head and neck cancer at 2Q3W, also with a new PR observed in a ROR2 TmPS negative patients, which makes two out of two responses at the 2Q3W dose across Phase 1 and Phase 2. We are on track to complete all dosing regimens enrollment by year end, and we'll continue to collect data on the ongoing study.

在第3 週第2 季的頭頸癌中也出現了令人鼓舞的早期反應，並且在ROR2 TmPS 陰性患者中觀察到了新的PR，這使得第1 期和第2 期的第2 季度劑量的兩個反應中的兩個出現。在年底前完成所有給藥方案的登記，我們將繼續收集正在進行的研究的數據。

Similar to melanoma indication, recruitment has been assisted by enrolling target agnostic patients, followed by a retrospective target expression analysis, both of which resulted in quicker enrollment and the opportunity to target a larger melanoma patient population. In the case of head and neck cancer, ROR2 is expressed in a significant portion of these patients and therefore, is also not anticipated to benefit from a biomarker assay, particularly in view of the observed 2Q3W PR in a ROR2 TmPS negative patients, which maximize the potential applicable patient population.

與黑色素瘤適應症類似，透過招募目標不可知的患者，然後進行回顧性目標表達分析來協助招募，這兩種方法都可以加快招募速度，並有機會針對更大的黑色素瘤患者群體。就頭頸癌而言，ROR2 在這些患者的很大一部分中表達，因此預計也不會從生物標記測定中受益，特別是考慮到在 ROR2 TmPS 陰性患者中觀察到的 2Q3W PR，這最大化了潛在適用的患者族群。

The ROR2 positive lung cancer patients at Q2W, while we observed clinical benefit in terms of substantial stable disease and tumor volume reduction, there are no responses to date, and thus, we did not meet our internal criteria from advancing at this dose. Further in view of these results and our supportive AXL lung cancer data, we currently do not plan to internally explore the more frequent 2Q3W dose for this indication.

在第二週的 ROR2 陽性肺癌患者中，雖然我們觀察到疾病實質穩定和腫瘤體積減少方面的臨床益處，但迄今為止沒有任何反應，因此，我們沒有達到以該劑量進行進展的內部標準。進一步考慮到這些結果和我們支持的 AXL 肺癌數據，我們目前不打算在內部探索針對該適應症的更頻繁的 2Q3W 劑量。

Regarding the ovarian IIT interim analysis of 10 patients in each of the BA3011 and BA3021 Q2W cohorts demonstrated modest disease control, but did not meet our internal criteria for advancing at this dose. We currently do not plan to internally explore additional dosing regimens at this time for this indication.

關於 BA3011 和 BA3021 Q2W 隊列中各 10 名患者的卵巢 IIT 中期分析顯示，疾病得到適度控制，但不符合我們在此劑量下進展的內部標準。我們目前不打算在內部探索針對此適應症的其他給藥方案。

Now on to our other promising CAB assets. Beginning with our CAB CTLA-4 antibody, BA3071, which is applicable in areas of high unmet need and treatment refractory patients, represents a sizable commercial opportunity. We have encouraging Phase 1 observations to date, and we continue to follow these patients progress. In contrast to approved in earlier stage CTLA-4 blocking antibodies, BA3071 is designed to be conditionally and reversible reactive in the tumor micro-environment. We believe this unique design enables our CAB-CTLA-4 antibody to have the potential to deliver efficacy with a manageable safety and tolerability profile.

現在談談我們其他有前途的 CAB 資產。從我們的 CAB CTLA-4 抗體開始，BA3071 適用於需求高度未滿足和難治性患者的領域，代表著巨大的商業機會。到目前為止，我們已經取得了令人鼓舞的第一階段觀察結果，我們將繼續追蹤這些患者的進展。與早期核准的 CTLA-4 阻斷抗體相比，BA3071 被設計為在腫瘤微環境中具有條件性和可逆性反應。我們相信，這種獨特的設計使我們的 CAB-CTLA-4 抗體有潛力以可控的安全性和耐受性發揮功效。

In particular, the safety profile with less immune-related adverse events across multiple tumor types may allow patients to stay on therapy for longer and achieve clinical benefit from this important immunotherapy. The Phase 1, 2 trial was being conducted in tumors known to be responsive to CTL4 for treatment and we are continuing to evaluate safety and tolerability of BA3071 in monotherapy and in combination with nivolumab.

特別是，多種腫瘤類型中免疫相關不良事件較少的安全性可能允許患者接受更長時間的治療，並從這種重要的免疫療法中獲得臨床益處。 1,2 期試驗正在已知對 CTL4 治療有反應的腫瘤中進行，我們正在繼續評估 BA3071 在單一療法以及與納武單抗聯合治療中的安全性和耐受性。

As part of today's brief update, I'm happy to report that we have initiated the Phase 2 expansion cohort enrollment and remain on track for the Phase 1 data readout, which will be highlighted at our upcoming R&D Day on December 13.

作為今天簡短更新的一部分，我很高興地報告，我們已經啟動了第2 階段的擴展隊列註冊，並繼續按計劃進行第1 階段的數據讀出，這將在即將到來的12 月13 日研發日上重點介紹。

Next onto our potentially first-in-class dual CAB bispecific T-cell engager antibody CAB, EpCAM CAB-CD3 or BA3182. We previously announced FDA clearance of our IND for the treatment of advanced adenocarcinoma, and last quarter we announced that the Phase 1 study was actively enrolling patients. Study is progressing nicely through the dose escalation part of the Phase 1 study, and we anticipate completion of the Phase 1 study with a full data readout remaining on track for next year. We believe that our dual CAB design has potential to address tremendous unmet need across multiple tumor types with the most common subtypes of adenocarcinoma, including colon, lung, breast, pancreas, and prostate.

接下來是我們潛在的一流雙 CAB 雙特異性 T 細胞接合抗體 CAB、EpCAM CAB-CD3 或 BA3182。我們先前宣布 FDA 批准了我們用於治療晚期腺癌的 IND，上季我們宣布 1 期研究正在積極招募患者。第一階段研究的劑量遞增部分的研究進展順利，我們預計第一階段研究將完成，完整的數據讀出仍將在明年按計劃進行。我們相信，我們的雙重 CAB 設計有潛力解決多種腫瘤類型（包括最常見的腺癌亞型，包括結腸癌、肺癌、乳腺癌、胰腺癌和前列腺癌）的巨大未滿足需求。

I'd like to round out today's talk with a corporate update. First, in addition to our leadership team, recently Dr. Bin Zhang joined by BioAtla as Senior Vice President, Head of Clinical Development and Operations. Bin brings over 20 years of experience in clinical practice, early and late-stage drug development, and asset management with a focus on oncology drug development. Prior to joining BioAtla, he held leadership roles with increasing responsibilities, including at Bristol-Myers Squibb, Ipsen Bioscience, and most recently as Senior Vice President and Head of Clinical Development at Pyxis Oncology, where he oversee clinical development activities of all oncology assets. His regulatory interaction experience, coupled with his known track record of leading cross functional teams will be instrumental as we advance clinical development efforts and strategic collaborations. We are thrilled to have Bin onboard with BioAtla.

我想以公司最新情況來結束今天的演講。首先，除了我們的領導團隊之外，張斌博士最近加入 BioAtla 擔任高級副總裁、臨床開發和營運主管。 Bin 在臨床實踐、早期和後期藥物開發以及資產管理方面擁有 20 多年的經驗，並專注於腫瘤藥物開發。在加入 BioAtla 之前，他曾在 Bristol-Myers Squibb、Ipsen Bioscience 等公司擔任領導職務，職責也不斷增加，最近擔任 Pyxis Oncology 的高級副總裁兼臨床開發主管，負責監督所有腫瘤學資產的臨床開發活動。他的監管互動經驗，加上他領導跨職能團隊的知名記錄，將有助於我們推動臨床開發工作和策略合作。我們很高興 Bin 加入 BioAtla。

And finally, I'm pleased to report our progress with the medical and scientific communities with an additional abstract on BA3011, alone or in combination with nivolumab in patients with lung cancer, which was accepted for presentation at the upcoming IASLC Conference this December. We also look forward to sharing these data and additional details around our CAB-AXL-ADC asset at our upcoming KOL event on December 4. Moreover, we will present our Phase 1 CAB-CTLA4, BA3071 study data at our upcoming R&D Day on December 13.

最後，我很高興地向醫學界和科學界報告我們的進展，並附上關於BA3011 單獨或與納武單抗聯合治療肺癌患者的附加摘要，該摘要已被接受在今年12 月即將舉行的IASLC會議上發表。我們也期待在12 月4 日即將舉行的KOL 活動中分享這些數據以及有關我們的CAB-AXL-ADC 資產的其他詳細資訊。此外，我們將在12 月即將到來的研發日上展示我們的1 期CAB-CTLA4、BA3071 研究資料13.

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

現在，我想將電話轉給 Rick，讓他審查 2023 年第三季的財務狀況。瑞克？

Thank you, Jay. Cash and cash equivalents as of September 30, 2023 were $141.3 million compared to $215.5 million as of December 31, 2022. We now expect current cash and cash equivalents will be sufficient to fund planned operations, including prioritized CAB programs into the second half of 2025.

謝謝你，傑伊。截至2023 年9 月30 日的現金和現金等價物為1.413 億美元，而截至2022 年12 月31 日為2.155 億美元。我們現在預計當前現金和現金等價物將足以為計劃運營提供資金，包括2025 年下半年的優先CAB 計畫。

Research and development expenses for $28.4 million for the quarter ended September 30, 2023, compared to $19.8 million for the same period in 2022. The increase of $8.6 million was primarily driven by a $6.3 million increase in our clinical product development expenses, primarily related to the launch of our AXL UPS, potentially registrational trial and a $1.8 million increase in additional product development expenses. We expect our R&D expenses to remain variable from quarter to quarter as we continue to advance our clinical programs, then decreasing after we complete enrollment and focus development on selective high potential indications.

截至 2023 年 9 月 30 日的季度研發費用為 2,840 萬美元，而 2022 年同期為 1,980 萬美元。增加 860 萬美元主要是由於我們的臨床產品開發費用增加了 630 萬美元，主要與我們的AXL UPS的推出、可能的註冊試驗以及額外產品開發費用增加180 萬美元。我們預計，隨著我們繼續推進臨床項目，我們的研發費用將在每個季度保持變化，然後在我們完成入組並將開發重點放在選擇性高潛力適應症上後減少。

General and administrative expenses for $6.6 million for the quarter ended September 30, 2023, compared to $6.3 million from the same quarter in 2022. The $0.3 million change was attributable to an increase in professional services and consulting expenses for the 2023 period. We expect our G&A expenses to remain flat to moderately increasing to support development of our prioritized CAB programs.

截至 2023 年 9 月 30 日的季度的一般和管理費用為 660 萬美元，而 2022 年同期為 630 萬美元。30 萬美元的變化是由於 2023 年期間專業服務和諮詢費用的增加。我們預計我們的一般管理費用將保持平穩或適度增長，以支持我們優先 CAB 計劃的發展。

Net loss for the third quarter ended September 30, 2023 was $33.3 million compared to a net loss of $25.8 million for the same quarter in 2022. Net cash used in operating activities for the nine months ended September 30, 2023 was $74.1 million compared to net cash used in operating activities of $66.1 million for the same period in 2022. The increase in net cash used in operating activities for the first nine 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 nine months of 2022.

截至2023 年9 月30 日的第三季淨虧損為3,330 萬美元，而2022 年同一季度的淨虧損為2,580 萬美元。截至2023 年9 月30 日的九個月，經營活動使用的淨現金為7,410 萬美元，而2022 年同期的淨虧損為7,410 萬美元。2022年同期經營活動使用的現金為6610萬美元。2023年前9個月經營活動使用的現金淨額增加主要是由於與我們的項目與開發工作相關的研發費用增加到 2022 年前九個月。

And now, back to Jay.

現在，回到傑伊。

Thank you, Rick. BioAtla is dedicated to deliver innovative ideas, life-changing therapies to cancer patients. We observed that the CAB platform continues to demonstrate compelling clinical efficacy and safety across multiple therapeutic targets and formats in the most challenging cancer cases. As a result, we believe that there are mutually compelling opportunities for forming one or more strategic collaborations with major pharmaceutical partners that both accelerate and maximize the therapeutics opportunity. In addition, to advancing collaboration discussions, we will continue to advance selected CAB assets that can address significant unmet medical needs in order to maximize shareholder value.

謝謝你，瑞克。 BioAtla 致力於為癌症患者提供創新理念和改變生活的療法。我們觀察到，CAB 平台在最具挑戰性的癌症病例中，在多個治療標靶和形式上繼續表現出令人信服的臨床療效和安全性。因此，我們相信，與主要製藥合作夥伴形成一項或多項策略合作存在相互吸引的機會，從而加速並最大化治療機會。此外，為了推進合作討論，我們將繼續推進選定的 CAB 資產，這些資產可以解決重大的未滿足的醫療需求，從而實現股東價值最大化。

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, JPMorgan.

（操作員指令）Brian Cheng，摩根大通。

Hi, guys. Thanks for taking my question this afternoon. Given the responses that you saw here in and out of the AXL in EGFR wild-type and the PD-1 treatment failure patients, to the extent that you can, can you give us a sense of the verbal feedback that you receive on the registrational path forward from the agency? And what are the expectations that we could get in terms of the path for -- at the December event?

嗨，大家好。感謝您今天下午提出我的問題。鑑於您在 EGFR 野生型和 PD-1 治療失敗患者的 AXL 內外看到的反應，您能否在可能的範圍內向我們提供您在註冊時收到的口頭反饋？該機構的前進道路？在 12 月的活動中，我們對路徑有何期望？

I'll start and maybe Eric can add if he has anything to add. So they gave us some very clear and actionable items, both either second or third line therapies. And so, we're just waiting for the written confirmation of the verbal communication. And since we have that, we expect that a little later this month and we'll be communicating that in far more detail in December. But hopefully that's helpful, and we think it's very promising.

我先開始，如果艾瑞克有什麼要補充的話，也許他可以補充。因此，他們給了我們一些非常明確且可操作的項目，無論是二線還是三線療法。因此，我們只是等待口頭溝通的書面確認。既然我們已經有了這個，我們預計在本月晚些時候，我們將在 12 月更詳細地傳達這一點。但希望這會有所幫助，而且我們認為它非常有前途。

Okay. And then related to the IASLC Conference presentation next month, can you talk about what we should expect in terms of the level of details regarding to response and can you also comment on the durability of the response that you have seen so far in non-small cell?

好的。然後，關於下個月的 IASLC 會議演講，您能談談我們在響應的詳細程度方面應該期待什麼嗎？您能否評論一下您迄今為止在非小型領域看到的響應的持久性？細胞？

Eric, do you want to lead off on this one?

艾瑞克，你想主持這場嗎？

Sure. I think we'll be having a pretty standard poster presentation of the datasets, including spider plots, swimmers plots, so you can anticipate that. Jay?

當然。我認為我們將會有一個非常標準的數據集海報展示，包括蜘蛛圖、游泳者圖，所以你可以預見這一點。傑伊？

Also, to add more, we also have monotherapy, obviously, is our focus. We will provide the data on the combo, the updated data on the combination therapy, and also our initial look on a more frequent dosing data up to 10 patients for that as well, maybe more. We'll see how that goes in the next few weeks. And we'll also remember the day after have a KOL event with an expert in lung cancer and also has been treating patients in some of their direct experience.

另外，補充一點，我們也有單一療法，顯然，這是我們的重點。我們將提供組合數據、聯合治療的更新數據，以及我們對最多 10 名患者（甚至可能更多）的更頻繁給藥數據的初步觀察。我們將在接下來的幾週內看看情況如何。我們也會記得與一位肺癌專家一起參加 KOL 活動的第二天，並且還根據他們的一些直接經驗治療了患者。

Great. Thank you for taking my questions.

偉大的。感謝您回答我的問題。

Kaveri Pohlman, BTIG.

卡維裡·波爾曼，BTIG。

Thank you for taking my question. For non-small cell lung cancer, Trodelvy has a Phase 3 EVOKE-01 trial ongoing and in their most recent press release, Seagen also announced that they will be initiating a Phase 3 trial for their integrin beta-6 targeting ADC. So I was just wondering if you could tell us how you're thinking about the competition here? And what level of target expression overlap do you expect to see between Trop-2, beta-6, and AXL?

感謝您回答我的問題。對於非小細胞肺癌，Trodelvy 正在進行一項 3 期 EVOKE-01 試驗，在最近的新聞稿中，Seagen 也宣布他們將啟動針對整合素 beta-6 靶向 ADC 的 3 期試驗。所以我想知道您是否可以告訴我們您如何看待這裡的競爭？您預期 Trop-2、beta-6 和 AXL 之間的目標表達重疊程度是多少？

I'll start off and then maybe Eric or Sheri could add to this. First off, I think you can look at both pieces of data, we've seen now multiple responses at 1% TmPS levels. We're now seeing a strong correlation in responses and stable disease to the level of AXL expression. And this is, I think, observed by a number of different ADC groups, at least in groups with ADC cell lung cancer. We're also reporting responses in ROR2 as well, from ROR2 negative patients. So we're in the process right now of evaluating the frequency and the actual negative patients based on IHC assay. And I think I'll just remind everyone that (inaudible) has its own sensitivity. Just because you don't see AXL by that kind of assay doesn't mean you have no AXL expression, it's just at a much lower level.

我先開始，然後埃里克或謝裡可能會補充這一點。首先，我認為您可以查看這兩條數據，我們現在已經看到 1% TmPS 水平的多個回應。我們現在發現反應和疾病穩定與 AXL 表現量有很強的相關性。我認為，許多不同的 ADC 組都觀察到了這一點，至少在 ADC 細胞肺癌組中是如此。我們也報告了 ROR2 陰性患者的 ROR2 反應。因此，我們現在正在根據 IHC 檢測評估頻率和實際陰性患者。我想我只是提醒每個人（聽不清楚）都有自己的敏感性。僅僅因為您透過這種檢測沒有看到 AXL，並不意味著您沒有 AXL 表達，只是表達水平低得多。

So we think that this has a chance of broadening the actual market opportunity here. It also -- because of the AXL being a poor prognostic indicator, meaning that patients have a very difficult time and these may be some of the most difficult patients to treat, remembering that all of our entire study, all the patients had a median of three prior lines of treatment and they were AXL positive. So there's a real -- there's some significant likelihood that we're going to see responses below the 1%, and we're going to find that out and add that to the datasets, which could have a substantial impact on the market opportunity of our drug. So we think a cross-trial comparison is a little difficult when you -- when the others haven't gone into an AXL positive data set. And so we'll look more broadly and I think we'll have more data on that as we go forward.

因此，我們認為這有可能擴大這裡的實際市場機會。此外，由於AXL 是一個較差的預後指標，這意味著患者會經歷一段非常困難的時期，這些患者可能是最難治療的患者之一，請記住，在我們整個研究中，所有患者的中位數為先前接受過三種治療，且均為 AXL 陽性。因此，我們很可能會看到低於 1% 的反應，我們將找出這一點並將其添加到資料集中，這可能會對以下領域的市場機會產生重大影響：我們的藥物。因此，我們認為當其他人尚未進入 AXL 陽性資料集時，交叉試驗比較有點困難。因此，我們將進行更廣泛的研究，我認為隨著我們的前進，我們將獲得更多這方面的數據。

Sheri or Eric will add. If not, that answers your question.

雪莉或埃里克會補充。如果沒有，那就回答了你的問題。

Yeah, Jay. I think you characterize that very well. Thank you.

是的，傑伊。我認為你很好地描述了這一點。謝謝。

Okay, thank you. And just if you could provide any more details about the assay you're using for AXL expression assessment and how are you thinking about its use? Oh sorry, how are you thinking about it used like when moving from early-stage to pivotal trial?

好的謝謝。如果您能提供有關您用於 AXL 表達評估的檢測的更多詳細信息，以及您如何考慮其使用？哦，抱歉，您如何看待從早期階段轉向關鍵試驗時使用它？

Well I think it's an immunohistochemical assay using an antibody against AXL is not our therapeutic antibody, that's one that was specifically selected for detecting AXL expression on cancer cells. And of course, we've been looking -- a lot of people are used to the H score. We look at the level or the amount expression on each cell versus the number -- the amount on the member -- number cells that have expression of the membrane. And so it has an inherent sensitivity. So the fact that we're seeing responses at such a low AXL expression level is hinting that AXL may well be behaving like we're seeing in ROR2 and that others are seeing with some of their ADCs.

嗯，我認為這是一種使用抗 AXL 抗體的免疫組織化學測定，不是我們的治療性抗體，而是專門選擇用於檢測癌細胞上 AXL 表達的抗體。當然，我們一直在尋找——很多人都習慣了 H 分數。我們觀察每個細胞的表達量或數量與具有膜表達的細胞數量（成員上的數量）。因此它具有固有的敏感性。因此，我們看到 AXL 表達水平如此低的反應這一事實暗示，AXL 的行為很可能就像我們在 ROR2 中看到的以及其他人在他們的一些 ADC 中看到的那樣。

It's quite possible that we'll let the data speak for itself, but it's quite possible that we won't need a companion diagnostic going forward. But as of this moment, we believe we validated at the level of 1% or greater with the TmPS score in these patients -- refractory patients with three prior lines of therapy and show that we have a path forward here with ease, and that's uncertain. So we think we would do even better in second line. But for the moment, we're going to look to see if we can have similar or even potentially greater impact in ones that are less than 1%, given that poor prognostic indication of AXL expression -- with AXL expression.

我們很可能會讓數據自己說話，但很可能我們未來不需要伴隨診斷。但截至目前，我們相信，我們在這些患者（接受過三種先前治療的難治性患者）中驗證了TmPS 評分達到1% 或更高的水平，並表明我們可以輕鬆地向前邁進，但這是不確定的。所以我們認為我們在第二線會做得更好。但目前，考慮到 AXL 表達的不良預後指示（AXL 表達），我們將看看是否可以對小於 1% 的患者產生類似甚至可能更大的影響。

So what's nice about this strategy is that the recruitment now is uncoupled from having to require for at least to finish off this analysis, we can admit all patients to our study and do a retrospective analysis. This allows us to look at those patients with less than 1% as well as some of a few additional ones with 1% or greater. I'm going to add that data very quickly to our current datasets and as we go forward with some of our partnering discussions.

所以這個策略的好處在於，現在的招募不再需要至少完成這個分析，我們可以讓所有患者參與我們的研究並進行回顧性分析。這使我們能夠關注那些低於 1% 的患者以及一些其他一些 1% 或更高的患者。當我們繼續進行一些合作討論時，我很快就會將該資料添加到我們目前的資料集中。

Thank you. That's very helpful.

謝謝。這非常有幫助。

Kelly Shi, Jefferies.

施凱莉，傑弗里斯。

Hi, this is Dave, on for Kelly, and I have a question on 3021. Do you plan to share a non-small cell lung cancer data that you generated? And if you can share any insight that you can draw from the data such as patient baseline or expression, which contributed to lower responses. Also for CTLA-4, can you set the expectation on data details which a sufficient number of dose levels we should expect at R&D Day? Thank you.

大家好，我是戴夫（Kelly），我有一個關於 3021 的問題。您打算分享您產生的非小細胞肺癌數據嗎？如果您可以分享您可以從數據中得出的任何見解，例如患者基線或表達，這會導致較低的反應。另外，對於 CTLA-4，您能否設定對數據細節的預期，即我們在研發日應預期的足夠數量的劑量水平？謝謝。

Yeah. We will definitely share the data on non-small cell lung cancer data. We're going to link that to a meeting. We may also include data from the more frequent dosing with some of the other indications like head and neck cancer and melanoma. So be looking for an upcoming meeting on that.

是的。我們一定會分享非小細胞肺癌的數據。我們將把它與一個會議聯繫起來。我們也可能包括一些其他適應症（如頭頸癌和黑色素瘤）較常給藥的數據。因此，請期待即將召開的有關該問題的會議。

It's still quite possible to -- because we saw responses in lung, I'll remind everyone in Phase 1. But what we've basically shown that we're not driving responses with the Q2W level. We're also seeing responses with 2Q3W in head and neck, but we there's potential to go to a higher dose. But as part of our prioritization process, which has to factor in a very encouraging data out of the AXL lung data, and we decided that it was best to prioritize AXL lung for that particular indication while we continue to advance melanoma and head and neck, especially given the very high unmet need in those particular indications. So we will get it, and we'll have quite a bit more data that we'll be putting together for that release.

這仍然是很有可能的——因為我們看到了肺部的反應，我會在第一階段提醒大家。但我們基本上已經表明，我們並沒有以 Q2W 水平來驅動反應。我們也看到 2Q3W 頭頸部的反應，但我們有可能使用更高的劑量。但作為我們優先排序過程的一部分，必須考慮到 AXL 肺部數據中非常令人鼓舞的數據，我們決定在繼續推進黑色素瘤和頭頸瘤治療的同時，最好優先考慮 AXL 肺部用於該特定適應症，特別是考慮到這些特定適應症的未滿足需求非常高。所以我們會得到它，並且我們將有更多的數據，我們將為該版本整理在一起。

With respect to CTLA-4, we will -- we're on track to give quite a bit of detail on our Phase 1 dose escalation, and we'll be giving you an update on the Phase 2 results. That suffices to say that the fact that we've already kicked off Phase 2 and that we have our first patient in in Phase 2 that we think that it's heading in a very good direction. And I'll remind you that we've been studying patients that are known to be responsive to CTLA-4 with a basket of eight different indications, and that include things like melanoma and non-small cell lung cancer. So we'll be discussing all of that in December. And so, I would just invite everyone on December 13 for the R&D Day, so we can give you a lot more detail around those studies.

關於 CTLA-4，我們將——我們將提供有關第一階段劑量遞增的相當多的細節，並且我們將向您提供有關第二階段結果的最新資訊。這足以說明，我們已經啟動了第二階段，我們在第二階段迎來了第一位患者，我們認為它正在朝著一個非常好的方向發展。我要提醒您的是，我們一直在研究已知對 CTLA-4 有反應的患者，這些患者有八種不同的適應症，其中包括黑色素瘤和非小細胞肺癌等。所以我們將在 12 月討論所有這些。因此，我會在 12 月 13 日邀請大家參加研發日，這樣我們就可以為您提供有關這些研究的更多詳細資訊。

Thank you for taking our question.

感謝您提出我們的問題。

Arthur He, H.C. Wainwright.

何亞瑟，H.C.溫賴特。

Hey, good afternoon, Jay, Rick, Sheri, and Eric. Thanks for taking my question. I just wanted to push the envelope a little bit further on the 3011. These 33.3%, that is also including both the Q2W and the more intensive dose regiment or it will --

嘿，下午好，傑伊、瑞克、雪莉和艾瑞克。感謝您提出我的問題。我只是想在 3011 上進一步挑戰極限。這 33.3%，也包括 Q2W 和更密集的劑量方案，否則它會——

No, the (multiple speakers) On the Q2W, we haven't reported out on any more frequent dosing yet.

不，（多個發言者）在 Q2W 上，我們尚未報告任何更頻繁的劑量。

Okay, thanks for that. And then regarding to the (inaudible) program, for the ROR2 neck and melanoma patient in which shows response, is that patient is in the Phase 2 study or it's a from a Phase 1 study. Could you remind that.

好的，謝謝。然後關於（聽不清楚）計劃，對於顯示出反應的 ROR2 頸部和黑色素瘤患者，該患者是處於 2 期研究還是來自 1 期研究。你能提醒一下嗎？

For head and neck, you mean?

你是說頭部和頸部嗎？

No, for the melanoma, I believe.

不，我相信是黑色素瘤。

For melanoma, we have two -- we have one response from Phase 1, that's included, and we have three responses from Phase 2.

對於黑色素瘤，我們有兩個——我們有一個來自第一階段的反應，包括在內，我們有三個來自第二階段的反應。

Okay. And so far, you said you completed enrollment. So how many total patients we could expect the next data update.

好的。到目前為止，您說您已完成註冊。那我們預期下一次數據更新時總共有多少患者。

Well I don't know what the value -- evaluable patients will be, but we had targeted 20 patients. So we'll see where we go on that. And we've reported on eight evaluable patients today where we saw four responses out of eight, two with a stable disease, and two with progressive disease. So, quite encouraging at this stage.

嗯，我不知道可評估患者的價值是什麼，但我們的目標是 20 名患者。所以我們會看看我們的進展如何。今天我們報告了八名可評估的患者，八名患者中有四名有反應，其中兩名病情穩定，兩名病情進展。所以，現階段非常令人鼓舞。

Got you. So my last question is for the 3182, your bispecific candidate for the EpCAM. Could you give us some more color about the enrollment status for that trial?

明白你了。我的最後一個問題是針對 3182，它是 EpCAM 的雙特異性候選者。您能給我們更多關於該試驗的註冊狀態的資訊嗎？

I think it's going well. It takes about a month, plus or minus a week, to get from patient to patient. I think we're on track here and continue to dose escalate. I think it's early, but all good so far. This is a particularly interesting drug and I get why -- I would be asking the same question as you are because these are one of the pan cancer opportunities with very high selectivity, with a very potent mechanism that is enabled by CABS with this T-cell recruiting capability. And so, we're very eager to push it along. It's going to move quickly, and we'll have a lot more to talk about it and we have -- only seeing positive things so far.

我認為進展順利。從一個病人到另一個病人大約需要一個月，加減一週。我認為我們已經步入正軌並繼續加大劑量。我認為現在還早，但到目前為止一切都很好。這是一種特別有趣的藥物，我明白為什麼——我會問和你同樣的問題，因為這些是具有非常高選擇性的泛癌機會之一，具有由CABS 和這種T 啟用的非常有效的機制。細胞招募能力。因此，我們非常渴望推動它的發展。它會迅速進展，我們將有更多的內容來討論它，而且到目前為止我們只看到了積極的事情。

Awesome. Thanks for taking all my questions and congrats on the program. Talk to you soon.

驚人的。感謝您回答我的所有問題並祝賀該計劃。以後再聊。

Thank you. Look forward to it.

謝謝。對此期待。

Thank you. And there are no further questions at this time. I would like to turn it back to Jay Short for closing remarks.

謝謝。目前沒有其他問題。我想請傑伊·肖特（Jay Short）發表結束語。

Thank you, everyone, for your attendance. We're really looking forward to continuing our discussions, especially with medical experts in early December, it's only a few weeks away, and we're looking forward to speaking with many of you at that time. Take care now and all the best.

謝謝大家的出席。我們真的很期待繼續我們的討論，特別是在 12 月初與醫學專家進行討論，只剩下幾週的時間，我們期待著那時與你們中的許多人交談。現在保重，祝一切順利。

Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

謝謝各位主持人。女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。