Compugen Ltd (CGEN) 2024 Q2 法說會逐字稿

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's second quarter 2024 Results conference call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available in the Investors section of Compugen's website, www.cgen.com. As a reminder, today's call is being recorded.

女士們、先生們，謝謝你們今天加入我們。歡迎參加 Compugen 2024 年第二季業績電話會議。此時，所有參與者都處於只聽模式。本次電話會議的音訊網路廣播可在 Compugen 網站 www.cgen.com 的投資者部分取得。提醒一下，今天的通話正在錄音。

I would now like to introduce Yvonne Naughton, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.

現在我想介紹投資人關係和企業傳播主管 Yvonne Naughton。伊馮，請繼續。

Thank you, [Yoni], and thank you all for joining us on the call today. Joining me from Compugen for the prepared remarks are Dr. Anat Cohen-Dayag, President and Chief Executive Officer; and Alberto Sessa, Chief Financial Officer. Dr. Michelle Mahler, Chief Medical Officer; and Dr. Eran Ophir, Chief Scientific Officer will join us for the Q&A.

謝謝你，[Yoni]，也謝謝大家今天加入我們的電話會議。來自 Compugen 的總裁兼執行長 Anat Cohen-Dayag 博士與我一起發表了準備好的演講。和財務長阿爾貝托·塞薩。米歇爾·馬勒博士，首席醫療官；首席科學官 Eran Ophir 博士將與我們一起參加問答。

Before we begin, we would like to remind you that during this call, the company may make projections or forward-looking statements regarding future events, business outlook, development efforts and their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programs, financial and accounting related matters as well as statements regarding our cash position.

在我們開始之前，我們想提醒您，在這次電話會議中，公司可能會對未來事件、業務前景、開發工作及其潛在結果、公司的發現平台、預期進展和計劃、結果做出預測或前瞻性陳述我們的計劃、財務和會計相關事項的時間表以及有關我們現金狀況的報表。

We wish to caution you that such statements reflect only the company's current beliefs, expectations and assumptions, but actual results, performance or achievements of the company may differ materially.

我們希望提醒您，此類陳述僅反映公司當前的信念、期望和假設，但公司的實際結果、績效或成就可能存在重大差異。

These statements are subject to known and unknown risks and uncertainties and we refer you to the SEC filings for more details on these risks including the company's most recent annual report on Form 20-F. The company undertakes no obligation to update projections and forward-looking statements in the future. And with that, I'll now turn the call over to Anat.

這些聲明受到已知和未知的風險和不確定性的影響，我們建議您參閱 SEC 文件以了解有關這些風險的更多詳細信息，包括公司最新的 20-F 表格年度報告。該公司不承擔更新未來預測和前瞻性陳述的義務。現在，我將把電話轉給阿納特。

Thank you, Yvonne, and thank you, everyone, for joining us on our second quarter 2024 call. I'm delighted to start this call by congratulating our team for the excellent execution on the high-quality COM503 IND submission resulting in FDA clearance for initiation of a Phase I trial. COM503 is our differentiated approach to harness cytokine biology to treat cancer. And I'll come back to this later in the call.

謝謝 Yvonne，也謝謝大家加入我們的 2024 年第二季電話會議。我很高興在這次電話會議開始時祝賀我們的團隊出色地執行了高品質的 COM503 IND 提交，最終獲得 FDA 批准啟動 I 期試驗。COM503 是我們利用細胞激素生物學治療癌症的差異化方法。我稍後會在電話會議中再討論這一點。

There have been many developments in the TIGIT landscape in the last few months and more are expected by the end of this year. Therefore, I thought it is appropriate to begin by sharing with you how we think about the field. We believe that Compugen is uniquely positioned and differentiated in the pursuit of the DNAM-1 axis as part of our COM701, COM902, triple combination.

過去幾個月，TIGIT 領域取得了許多進展，預計到今年年底還會有更多進展。因此，我認為首先與您分享我們對該領域的看法是合適的。我們相信，Compugen 在追求 DNAM-1 軸（作為我們 COM701、COM902 三重組合的一部分）方面具有獨特的定位和差異化。

I will then cover the progress we have made in the second quarter of this year and move to our planned milestones through the rest of 2024. Starting with the TIGIT competitive landscape, what have we learned so far?

然後，我將介紹我們在今年第二季度取得的進展，並在 2024 年剩餘時間內實現我們計劃的里程碑。從TIGIT競爭格局開始，到目前為止我們學到了什麼？

First, the benefit of adding TIGIT blockade to PD-1 compared to PD-1 demonstrated in several Phase II randomized clinical trials and TIGIT blockade added a six-month survival benefit in a Phase III interim analysis. Second, the benefit of TIGIT blockade was observed mostly in PD-L1 high patient population.

首先，與PD-1 相比，在PD-1 中添加TIGIT 阻斷的益處在多項II 期隨機臨床試驗中得到證明，並且TIGIT 阻斷在III 期中期分析中增加了6 個月的生存獲益。其次，TIGIT 阻斷的益處主要在 PD-L1 高患者族群中觀察到。

Third, the nature of the TIGIT antibody matters. The use of an Fc-enabled antibody may not be tolerable in patients with early-stage of disease due to potential immune- mediated safety concerns. And finally, a third component may be needed to be added to TIGIT and PD-1 blockade to maximize the effect.

第三，TIGIT 抗體的性質很重要。由於潛在的免疫介導的安全問題，早期疾病患者可能無法耐受使用 Fc 抗體。最後，可能需要在 TIGIT 和 PD-1 阻斷中添加第三種成分，以最大限度地發揮效果。

Some companies are adding chemo or ADC, which may be an option for patients who can tolerate this combination. Compugen's data consistently suggests that PVRIG co-blockade provides added benefit. We believe an advantage of this choice is the favorable safety profile of IO combination and the prolonged immune benefits that one might expect to achieve.

一些公司正在添加化療或 ADC，這對於能夠耐受這種組合的患者來說可能是一種選擇。Compugen 的數據一致表明，PVRIG 共同封鎖提供了額外的好處。我們相信這種選擇的一個優點是 IO 組合的良好安全性以及人們可能期望實現的長期免疫益處。

We therefore believe that the success of the next anti-TIGIT studies will be determined by several factors. Firstly, the clinical strategy employed, which includes choice of patient population and combinations used; and secondly, the choice of an anti-TIGIT, Fc inactive versus active.

因此，我們相信接下來的抗TIGIT研究的成功將由幾個因素決定。首先，採用的臨床策略，包括病患群體的選擇和使用的組合；其次，抗 TIGIT、Fc 無活性與活性的選擇。

Now elaborating more on why the clinical strategy matters. Led by our innovative research of the PVRIG pathway as part of the DNAM axis. Compugen's hypothesis has always been the blocking TIGIT plus PD-1 alone may not be sufficient. And that a third component, PVRIG may be needed to optimize the potential of TIGIT and PD-1 blockade in certain tumor types and patient population.

現在更多地闡述為什麼臨床策略很重要。由我們對作為 DNAM 軸一部分的 PVRIG 途徑的創新研究領導。Compugen 的假設一直是，單獨阻斷 TIGIT 加 PD-1 可能還不夠。可能需要第三個成分 PVRIG 來優化 TIGIT 和 PD-1 阻斷在某些腫瘤類型和患者群體中的潛力。

Compugen's data suggests that unlike anti-TIGIT, anti-PVRIG may function across PD-L1 expression levels and may also extend the response to the PD-1 TIGIT to nonresponsive tumor types and patient populations. We're, therefore, currently pursuing a triple combination strategy, blocking PVRIG, TIGIT, and PD-1 and we pursue this drug combination in tumor types and patient populations that are not responsive to PD-1.

Compugen 的數據表明，與抗 TIGIT 不同，抗 PVRIG 可能在整個 PD-L1 表達水平上發揮作用，並且還可能將對 PD-1 TIGIT 的反應擴展到無反應的腫瘤類型和患者群體。因此，我們目前正在尋求三重組合策略，阻斷 PVRIG、TIGIT 和 PD-1，並且我們在對 PD-1 無反應的腫瘤類型和患者群體中尋求這種藥物組合。

This strategy helped us to directly prove a COM701 PVRIG-driven effect of a triple combo even though we employ small single-arm studies. By assessing the non-responsive tumor type, our data will not be attributed to a PD-1 effect, but we also recognize that the signals that we may see in these very hard to treat tumor types will not be very high. Of course, this triple combination is also expected to add benefit in inflamed PD-1 responsive settings.

即使我們採用小型單臂研究，該策略也幫助我們直接證明了 COM701 PVRIG 驅動的三重組合的效果。透過評估無反應的腫瘤類型，我們的數據不會歸因於 PD-1 效應，但我們也認識到，我們在這些非常難以治療的腫瘤類型中可能看到的訊號不會很高。當然，這種三重組合也有望為發炎的 PD-1 反應環境帶來益處。

In addition, our partner, AstraZeneca is advancing development of rilvegostomig, their PD-1 TIGIT bispecific, providing a peak revenue target of greater than $5 billion, reflecting the potential of these assets. As the TIGIT components of rilvegostomig is derived from Compugen's COM902, this is a potential significant revenue-generating opportunity for Compugen.

此外，我們的合作夥伴阿斯特捷利康正在推進其 PD-1 TIGIT 雙特異性藥物 rilvegostomig 的開發，提供超過 50 億美元的峰值收入目標，反映了這些資產的潛力。由於 rilvegostomig 的 TIGIT 元件源自 Compugen 的 COM902，因此這對 Compugen 來說是一個潛在的重大創收機會。

Elaborating more on the choice of anti-TIGIT, not all anti-TIGITs are the same. Our COM902 anti-TIGIT antibody is an IgG4 antibody, and so it is Fc reduced chosen with efficacy and safety in mind. We have always said that the Fc activity of the antibody should be disabled.

詳細闡述抗TIGIT的選擇，並非所有抗TIGIT都是一樣的。我們的 COM902 抗 TIGIT 抗體是 IgG4 抗體，因此在選擇 Fc 還原時考慮功效和安全性。我們一直說抗體的Fc活性應該被禁用。

The reason for this is simple. TIGIT is highly expressed on CD8+ T cell and NK cells, cells that are key for anti-tumor activity. And you, therefore, want to avoid depleting them. In addition, Fc-silent anti-TIGIT avoids peripheral Treg depletion that can lead to immune-related adverse effects. Notably, recent data may suggest that an Fc anti-TIGIT antibody may not be tolerable in patients with early stage of disease due to immune-mediated safety concerns.

原因很簡單。TIGIT 在 CD8+ T 細胞和 NK 細胞上高度表達，這些細胞是抗腫瘤活性的關鍵細胞。因此，您希望避免耗盡它們。此外，Fc 沉默抗 TIGIT 可避免週邊 Treg 耗竭，進而導致免疫相關的不良反應。值得注意的是，最近的數據可能表明，由於免疫介導的安全性問題，Fc 抗 TIGIT 抗體在疾病早期患者中可能無法耐受。

Moving now to the progress we have made in the second quarter of the year, continuing our track record in delivering our plans, we again executed on our promises. Firstly, we're delighted that the FDA has cleared the R&D application to initiate a Phase I trial for COM503, our potential first-in-class high-affinity anti-IL -18 binding protein antibody licensed to Gilead.

現在談談我們在今年第二季度取得的進展，繼續我們在交付計劃方面的記錄，我們再次履行了我們的承諾。首先，我們很高興 FDA 已批准啟動 COM503 的 I 期試驗的研發申請，COM503 是我們授權給吉利德的潛在一流高親和力抗 IL -18 結合蛋白抗體。

IND clearance, which triggered a right to a $30 million milestone payment from Gilead further strengthens our balance sheet with an expected cash runway into 2027. We are well advanced in our planning and are currently on track to initiate the Phase I trial for COM503 in solid tumors in the fourth quarter of 2024.

IND 批准觸發了吉利德獲得 3000 萬美元里程碑付款的權利，進一步增強了我們的資產負債表，預計現金跑道將持續到 2027 年。我們的規劃進展順利，目前預計在 2024 年第四季啟動 COM503 在實體腫瘤中的 I 期試驗。

Advancing COM503 to Phase I adds to the multiple clinical programs discovered through our predictive computational discovery platform where we unlock the science and advance to clinical trials.

將 COM503 推進到第一階段增加了透過我們的預測計算發現平台發現的多個臨床項目，我們在該平台上解鎖科學並推進臨床試驗。

Secondly, we are on track to report data from our COM701, COM902 and pembrolizumab, triple combination proof-of-concept study in patients with platinum resistant ovarian cancer in the fourth quarter of this year, and I will come back to this shortly.

其次，我們即將在今年第四季報告 COM701、COM902 和 pembrolizumab 的數據，這是針對鉑類抗藥性卵巢癌患者的三重概念驗證研究，我很快就會回到這一點。

Finally, in the second quarter of 2024, we were excited to see that our partner, AstraZeneca, announced the further advancement of the development of rilvegostomig, their PD-1 TIGIT bispecific, where the TIGIT component is derived from Compugen's COM902 into its third Phase III trial, DESTINY-BTC, which will assess rilvegostomig and the ADC in HER2 for the standard-of-care chemotherapy and the anti-PDL1 durvalumab for first-line locally advanced or metastatic HER2 expressing biliary tract cancer.

最後，在 2024 年第二季度，我們很高興看到我們的合作夥伴阿斯特捷利康宣布進一步推進其 PD-1 TIGIT 雙特異性藥物 rilvegostomig 的開發，其中 TIGIT 成分源自 Compugen 的 COM902，進入第三階段III 試驗DESTINY-BTC，將評估rilvegostomig 和HER2 中的ADC 用於標準護理化療以及抗PDL1 durvalumab 用於一線局部晚期或轉移性HER2 表達膽道癌的情況。

As a reminder, the other Phase III trials initiated by AstraZeneca are in lung cancer as part of an IO ADC regimen and in adjuvant biliary tract cancer. We believe these advancements reinforce our partnering strategy designed to expand the opportunity for our pipeline programs, including COM902.

提醒一下，阿斯特捷利康發起的其他 III 期試驗是作為 IO ADC 方案一部分的肺癌試驗和輔助膽道癌試驗。我們相信這些進步加強了我們的合作策略，旨在擴大我們的管道項目（包括 COM902）的機會。

This brings us closer to potential additional milestone payments in an aggregate amount of up to $200 million and future mid-single-digit tiered royalties presenting together a significant potential revenue source for our company.

這使我們更接近潛在的額外里程碑付款，總金額高達 2 億美元，未來中個位數的分級特許權使用費將為我們公司帶來重要的潛在收入來源。

To-date, we have received around $40 million in upfront payments and milestone payments. Moving on now to what is planned for the rest of the year. And coming back to the presentation of our data in platinum-resistant ovarian cancer, which is on track for the fourth quarter of 2024, and our plan to present the data at a medical conference.

迄今為止，我們已收到約 4000 萬美元的預付款和里程碑付款。現在繼續討論今年剩餘時間的計劃。回到我們在鉑金抗藥性卵巢癌的數據介紹，該數據預計將於 2024 年第四季公佈，以及我們計劃在一次醫學會議上介紹這些數據。

We believe that the totality of the data we have reported to-date in platinum-resistant ovarian cancer patients is encouraging. In the prior cohort of patients, our investigators were excited to report durable shrinking or stabilization of tumors in some of the patients who had previously progressed on all available treatment options.

我們相信，迄今為止我們在鉑類抗藥性卵巢癌患者中報告的全部數據令人鼓舞。在先前的患者群組中，我們的研究人員很高興地報告，一些先前在所有可用治療方案中均取得進展的患者的腫瘤持續縮小或穩定。

We presented a 20% overall response rate with some patients responding for over 16 months, which is favorable, considering the median duration of response for chemotherapy is around 3 to 4 months and ADC is around 6.9 months. Responses were also achieved in the hard to treat high-grade serous adenocarcinoma patients, along with a favorable safety profile.

我們提出了 20% 的整體緩解率，有些患者的緩解時間超過 16 個月，考慮到化療的中位緩解持續時間約為 3 至 4 個月，ADC 約為 6.9 個月，這是有利的。在難以治療的高級別漿液性腺癌患者中也取得了緩解，並且安全性良好。

To remind you, ovarian cancer was pre-identified using our computational capabilities even before we treated patients as high-priority target indications for PVRIG blockade. Of note, we also previously presented data showing COM701 monotherapy activity in a patient with ovarian cancer whose tumor microenvironment was immune desert. This patient had a partial response of more than 18 months.

提醒您的是，甚至在我們將患者作為 PVRIG 阻斷的高優先目標適應症進行治療之前，就已經使用我們的計算能力預先識別了卵巢癌。值得注意的是，我們先前也提供了顯示 COM701 單藥治療在腫瘤微環境處於免疫荒漠的卵巢癌患者中的活性的數據。該患者的部分緩解時間超過 18 個月。

In the fourth quarter, we plan to present the baseline characteristics, safety, overall response rate, disease control rate, initial biomarker data if any and preliminary data on duration of responses for our COM701, COM902, and pembrolizumab combination.

在第四季度，我們計劃提供 COM701、COM902 和 pembrolizumab 組合的基線特徵、安全性、整體緩解率、疾病控制率、初始生物標記數據（如果有）以及緩解持續時間的初步數據。

In relation to baseline characteristics, these platinum-resistant ovarian cancer patients were heavily pretreated, exhausting all other treatment options and the number of patients where ADC experienced reflecting the changing treatment landscape and the hard to treat patient population.

就基線特徵而言，這些鉑類抗藥性卵巢癌患者接受了大量的預處理，耗盡了所有其他治療方案，ADC 經歷的患者數量反映了不斷變化的治療環境和難以治療的患者群體。

Given that the only other treatment option for this patient who had been chemotherapy, we believe that is the most relevant benchmark. As we have previously communicated, our goal is to assess whether we can demonstrate a similar clinical benefit to what we observed in the prior cohort.

鑑於該患者唯一的其他治療選擇是化療，我們認為這是最相關的基準。正如我們之前所傳達的，我們的目標是評估我們是否能夠表現出與我們在先前隊列中觀察到的類似的臨床益處。

We believe repeating it in a larger total number of patients will confirm COM701 combinations are active. There is a significant unmet medical need for women with ovarian cancer, who could benefit from alternative potentially safe, efficacious, and durable treatment options. We intend to share our plans or next steps for our COM701 combination at the time of data presentation.

我們相信，在更多的患者中重複試驗將證實 COM701 組合具有活性。患有卵巢癌的女性存在著巨大的未滿足的醫療需求，她們可以從潛在安全、有效和持久的替代治療方案中受益。我們打算在數據展示時分享我們的 COM701 組合的計劃或後續步驟。

Finally, in the second half of this year, our partner, AstraZeneca anticipates data from Phase I/II ARTEMIDE-01 trial and the poster presentation from Phase II GEMINI-gastric trial, which was accepted at ESMO 2024.

最後，我們的合作夥伴阿斯特捷利康預計將在今年下半年獲得 I/II 期 ARTEMIDE-01 試驗的數據以及 II 期 GEMINI-胃試驗的海報演示，該試驗已在 ESMO 2024 上被接受。

With that, I will hand over to Alberto for the financial update.

接下來，我將把財務最新情況交給阿爾貝托。

Thank you, Anat. I'm happy to summarize our financial results. I will start with our cash balance. As of June 30, 2024, we had approximately $92.3 million in cash and cash related compared with approximately $51.1 million as of December 31, 2023. We recognize the importance of cash efficiency and we are disciplined in how we deploy our cash resources while making sure we focus on reaching key milestones.

謝謝你，阿納特。我很高興總結我們的財務表現。我將從我們的現金餘額開始。截至 2024 年 6 月 30 日，我們擁有約 9,230 萬美元的現金及現金相關資產，而截至 2023 年 12 月 31 日約為 5,110 萬美元。我們認識到現金效率的重要性，並且我們在如何部署現金資源方面遵守紀律，同時確保我們專注於實現關鍵里程碑。

With a cash runway expected to fund our operations into 2027, taking into account the expected milestone payment of $30 million from Gilead which we are now eligible to receive following the successful IND clearance for COM503 last month. The company has no debt.

考慮到吉利德預計將支付3000 萬美元的里程碑付款，我們預計將有現金跑道為我們到2027 年的運營提供資金，繼上個月成功獲得COM503 的IND 批准後，我們現在有資格獲得這筆付款。公司沒有負債。

Revenue for Q2 2024 were approximately $6.7 million compared with no revenue for the comparable period in 2023. The revenues reflect recognition of a portion of the upfront payments from the license agreement with Gilead and the milestone payment from AstraZeneca on the dosing of the first patient in their second Phase III trial with rilvegostomig in non-small cell lung cancer.

2024 年第二季的營收約為 670 萬美元，而 2023 年同期沒有收入。這些收入反映了對與吉利德許可協議的部分預付款的確認，以及阿斯特捷利康在第二個 rilvegostomig 治療非小細胞肺癌的 III 期試驗中對第一位患者給藥的里程碑付款。

Expenses for the second quarter of 2024 were in line with our plans. R&D expenses for the second quarter of 2024 were $6.2 million compared to $7.8 million in the second quarter of 2023. Our G&A expenses for the second quarter of 2024 were $2.2 million compared to $2.4 million in the second quarter of 2023.

2024 年第二季的費用符合我們的計劃。2024 年第二季的研發費用為 620 萬美元，而 2023 年第二季的研發費用為 780 萬美元。我們 2024 年第二季的一般管理費用為 220 萬美元，而 2023 年第二季為 240 萬美元。

For the second quarter of 2024, net loss was $2.1 million or $0.02 per basic and diluted share compared to a net loss of $9.3 million or $0.11 per basic and diluted share in the second quarter of 2023.

2024 年第二季的淨虧損為 210 萬美元，即每股基本股和稀釋股 0.02 美元，而 2023 年第二季的淨虧損為 930 萬美元，即每股基本股和稀釋股 0.11 美元。

With that I will hand back to Anat to summarize.

接下來我將交回給阿納特進行總結。

Thank you, Alberto. To summarize, Compugen is a clinical-stage immuno-oncology type discovery pioneer. We're differentiated by our validated discovery platform which is powered by the mix of human expertise with AI and machine learning to fuel our first-in-class pipeline.

謝謝你，阿爾貝托。總而言之，Compugen 是臨床階段免疫腫瘤學類型發現的先驅。我們的優勢在於我們經過驗證的發現平台，該平台由人類專業知識與人工智慧和機器學習相結合，為我們一流的管道提供動力。

There has been many developments in the TIGIT landscape with more data readouts expected this year. And we believe we stand out as differentiated, both in terms of our clinical strategy and our differentiated programs, including our potential best-in-class anti-TIGIT COM902 and first-in-class anti-PVRIG COM701.

TIGIT 領域取得了許多進展，預計今年將有更多數據讀出。我們相信，我們在臨床策略和差異化計畫方面都脫穎而出，包括我們潛在的一流抗 TIGIT COM902 和一流抗 PVRIG COM701。

Also our partner AstraZeneca is advancing the development of rilvegostomig, the TIGIT PD-1 bispecific, the TIGIT component of which is derived from COM902. AstraZeneca has set a target for more than $5 billion in nonrisk-adjusted peak revenue reflecting the potential of these assets and the potential significant revenue-generating opportunity for Compugen.

此外，我們的合作夥伴阿斯特捷利康正在推進 rilvegostomig 的開發，這是一種 TIGIT PD-1 雙特異性藥物，其 TIGIT 成分源自 COM902。阿斯特捷利康設定了超過 50 億美元的非風險調整高峰收入目標，反映了這些資產的潛力以及 Compugen 潛在的重大創收機會。

Our achievement in successfully gaining FDA IND clearance for COM503 is a clear reflection for our continuous ability to execute. We're on track to deliver data from our COM701, COM902, pembro triple combination study in patients with platinum-resistant ovarian cancer at the end of the year, a disease where there is a significant unmet medical need to alternative treatment options.

我們 COM503 成功獲得 FDA IND 批准的成就清楚地反映了我們持續的執行能力。我們預計在今年底提供針對鉑金抗藥性卵巢癌患者的 COM701、COM902、pembro 三重組合研究的數據，這種疾病對替代治療方案的醫療需求尚未得到滿足。

With the pipeline that is being advanced internally and by our partners, this is an exciting time for Compugen and we believe that we have the fundamentals in place to bring value to our shareholders and cancer patients. I would like to thank all Compugen colleagues for their collaborative spirit and daily dedication resulting in a well-executed second quarter of the year and setting us up for future success.

隨著內部和我們的合作夥伴正在推進的管道，這對 Compugen 來說是一個激動人心的時刻，我們相信我們已經具備了為股東和癌症患者帶來價值的基礎。我要感謝所有 Compugen 同事的協作精神和日常奉獻精神，使今年第二季度表現出色，並為我們未來的成功奠定了基礎。

Finally, I would like to say a special word of thanks to Alberto as this is his last conference call with Compugen and welcome David who has already joined us and will take over from Alberto on August 15, after a transition period.

最後，我要特別感謝 Alberto，因為這是他與 Compugen 的最後一次電話會議，並歡迎 David，他已經加入我們，並將在過渡期後於 8 月 15 日接替 Alberto。

With that I will turn the call over to the operator for questions.

然後我會將電話轉給接線員詢問問題。

Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] Stephen Willey of Stifel.

謝謝。女士們、先生們，現在我們將開始問答環節。[操作員說明] Stifel 的 Stephen Willey。

Yeah, good morning. Thanks for taking the questions. Anat, is there anything that you can say about your confidence in the totality of clinical evidence that you have in hand when you make a decision on the triplet regimen in ovarian? You have data from one heavily pretreated dose expansion cohort that was generated with a different TIGIT antibody, soon you have data from a slightly less pretreated expansion cohort generated with COM902. Just curious about your thoughts here in the totality of evidence that you'll have in hand. And then I just have a follow-up.

是的，早安。感謝您提出問題。Anat，當您決定卵巢三重體方案時，您對現有的全部臨床證據有信心嗎？您擁有使用不同 TIGIT 抗體產生的經過嚴格預處理的劑量擴展隊列的數據，很快您就可以獲得使用 COM902 產生的預處理程度稍低的擴展隊列的數據。只是對你手邊掌握的全部證據的想法感到好奇。然後我有一個後續行動。

Sure. Thank you, Steve. And I'm happy to elaborate on this. First, I'll just say that the totality of the data that we have is pointing to COM701-driven effect and monotherapy effect over response rate that is added to that is combined durability, safety profiles and clearly from our perspective, as I was saying in the prepared remarks, the need is there for safe, efficacious, and durable treatment. And we believe that if we can repeat the clinical benefit that we have seen up until now, there is a need. Now, with respect to the differences in the studies, I can say the following. I believe that since we use the TIGIT antibody, that is Fc-disabled, even though it was not COM902, we believe this will be comparable. We do think that we have a best-in-class potential best-in-class TIGIT antibody, but we believe that the data may be comparable. We use nivo as compared to pembro. So we believe that this triplet that we use now may have the chance to at least repeat the advantage that we saw. And with respect to the differences in the treatment, I want to say that at the end of the day, the patient characteristics are more or less the same and we believe that we would be able to compare between the two different cohorts.

當然。謝謝你，史蒂夫。我很高興詳細說明這一點。首先，我只想說，我們擁有的全部數據都指向 COM701 驅動的效應和單一療法對回應率的影響，加上綜合耐久性、安全性，從我們的角度來看，正如我所說在準備好的發言中，需要安全、有效和持久的治療。我們相信，如果我們能夠重複迄今為止所看到的臨床益處，那就有必要。現在，針對研究中的差異，我可以說以下幾點。我相信，由於我們使用 TIGIT 抗體，即 Fc 禁用的抗體，即使它不是 COM902，我們相信這將具有可比性。我們確實認為我們擁有同類最佳的潛在最佳 TIGIT 抗體，但我們相信數據可能具有可比性。與 pembro 相比，我們使用 nivo。因此，我們相信我們現在使用的這個三元組可能有機會至少重複我們看到的優勢。關於治療的差異，我想說，歸根結底，患者的特徵或多或少是相同的，我們相信我們能夠在兩個不同的隊列之間進行比較。

Okay. That's helpful. And then I might have missed this, but did I interpret your commentary, I guess, regarding the update at the end of the year to suggest that you may not have biomarker data to present in conjunction with the safety and efficacy data?

好的。這很有幫助。然後我可能錯過了這一點，但我想我是否解釋了您關於年底更新的評論，表明您可能沒有生物標誌物數據與安全性和有效性數據一起呈現？

We did not say whether we really have or not. What we said is that we'll present data if we have the data. And I think it's fair to say and we're saying that we had the initial data. It looks supportive of patient with clinical benefits. We also stated few times that we recognized the challenges in generating biomarkers in IO and mainly with small number of patients. We are assessing the biomarkers, the expression level and we share what we have at the time that we have it.

我們沒有說我們是否真的有。我們所說的是，如果我們有數據，我們就會提供數據。我認為可以公平地說，我們是說我們擁有初始數據。它看起來對患者有臨床益處。我們也多次表示，我們認識到在 IO 中（主要是針對少數患者）生成生物標記的挑戰。我們正在評估生物標記、表達水平，並分享我們當時擁有的資訊。

Okay. And so in terms of being able to articulate a potential path forward here before the end of the year in conjunction with data, should we then expect that you will be communicating either the use of or the absence of a patient selection and enrichment strategy in terms of accepts?

好的。因此，就能夠在今年年底之前結合數據來闡明潛在的前進道路而言，我們是否應該期望您將使用或不使用患者選擇和豐富策略來溝通的接受？

So in general we were preparing ourselves to two scenarios from the get-go. Obviously, we had initial biomarker data and enrichment strategy, on the table, but we also recognize the fact, as I said, that this is very challenging and we may not have enough supporting data and we had to prepare ourselves to a situation where there is no enrichment strategy, but I will say that we will always be data-driven. As we've been up until today and will continue to do so, we will focus pending the data. We will focus where we believe we have the competitive edge where we can give our triplet combo the best chance to impact the appropriate patient population and we'll take everything into consideration. So we're not saying no. We're not saying yes. We're assessing. And we see what we have and we take the steps accordingly.

因此，總的來說，我們從一開始就為兩種情況做好了準備。顯然，我們已經有了初步的生物標記數據和富集策略，但我們也認識到一個事實，正如我所說，這是非常具有挑戰性的，我們可能沒有足夠的支持數據，我們必須做好準備以應對以下情況：不是豐富策略，但我會說我們將永遠是數據驅動的。正如我們迄今為止並將繼續這樣做的那樣，我們將重點關注數據。我們將重點關注我們認為具有競爭優勢的領域，我們可以為我們的三聯體組合提供影響適當患者群體的最佳機會，並且我們將考慮一切。所以我們並不是說不。我們並不是說「是」。我們正在評估。我們看到我們擁有什麼，並採取相應的步驟。

Okay. Thanks for taking the questions.

好的。感謝您提出問題。

Asthika Goonewardene of SunTrust.

SunTrust 的 Asthika Goonewardene。

Hi. Good morning, guys. Thanks for taking my questions. I'll clarify, I'm from Truist. No longer SunTrust. I just want to dig into this on the platinum-resistant ovarian cancer data that's coming up. I think you mentioned in your prepared comments that you have patients who have seen prior ADC. And I wanted to maybe contrast between the previous data set. What proportion of patients are you expecting to have prior ADCs is going to be considering more than the previous data set? And how do you expect exposure to the ADC, particularly , they're actually seeing payload to alter the patient's T cells? Is there any opportunity for this patient to be conditioned the way that they might actually respond better or worse to immunotherapy such as PVRIG and TIGIT et cetera? And then I have a follow-up.

你好。早安，夥計們。感謝您回答我的問題。我會澄清一下，我來自 Truist。不再是 SunTrust。我只是想深入研究即將出現的鉑金抗藥性卵巢癌數據。我想您在準備好的評論中提到您的患者曾經看過 ADC。我想也許可以對比之前的數據集。您預計有多少比例的患者會考慮比之前的資料集更多的先前 ADC？您如何期望接觸 ADC，特別是他們實際上看到了改變患者 T 細胞的有效負載？該患者是否有機會接受調節，使其實際上對 PVRIG 和 TIGIT 等免疫療法的反應更好或更差？然後我有一個後續行動。

Sure. Thank you, Asthika. Michelle, do you want to take this one?

當然。謝謝你，阿斯提卡。米歇爾，你想買這個嗎？

Yeah, sure. So I can't comment on the exact amount of patients who received ADCs at this point since we're not ready to disclose the data. However, what I can say is when you look at the different timing of when the studies were enrolled, the one study enrolled before, a good amount of patients enrolled before the ADC is ready to come forward and before they recently got approved, whereas the current study is ongoing. So we naturally have captured a certain amount of patients that have previously seen ADCs. I can hypothesize with you on what we think may occur once patients are exposed to ADCs and that there is potential for cell death with increased antigen presentation. However, at this point in time, I can't share any data with you. And I think the other thing to be aware is it's all the totality of the data and coming back to the ADCs in terms of the prior lines of treatment also matter in terms of how patients are in terms of the overall condition and the immunogenicity of the response to them.

是的，當然。因此，我目前無法評論接受 ADC 的患者的確切數量，因為我們還沒有準備好披露數據。然而，我可以說的是，當你觀察研究註冊的不同時間時，之前註冊的一項研究，在 ADC 準備好提出之前以及最近獲得批准之前註冊了大量患者，而目前的研究正在進行中。所以我們自然而然地捕獲了一定數量的曾經見過ADC的患者。我可以與您一起假設，一旦患者接觸 ADC，我們認為可能會發生什麼，並且隨著抗原呈現的增加，細胞可能會死亡。但是，目前我無法與您分享任何數據。我認為另一件需要注意的事情是，這是所有數據的整體，並且回到 ADC 的先前治療方案，對於患者的整體狀況和免疫原性也很重要。

Got it. Thanks.

知道了。謝謝。

Yes. Thank you, Michelle. Sorry, Asthika, I'll just add that mechanistically, why it makes sense, I want to emphasize that we enrolled somewhat more than 20 patients and with smaller number, it is going to be hard to get any specifics with respect to ABC plus IO in our study, but I believe that the potential is there.

是的。謝謝你，米歇爾。抱歉，Asthika，我只是機械地補充一下，為什麼這是有道理的，我想強調的是，我們招募了 20 多名患者，而且人數較少，很難獲得有關 ABC 加 IO 的任何細節在我們的研究中，但我相信潛力是存在的。

Anat, do you think you'll actually report the two data points? I mean would that be sort of a breakout like a subgroup analysis of patients who've seen prior ADC versus not? Is that do you have enough numbers to really do that?

Anat，您認為您真的會報告這兩個數據點嗎？我的意思是，這是否會像對之前接受過 ADC 治療和未接受過 ADC 治療的患者進行亞組分析一樣進行突破？你們有足夠的人數來真正做到這一點嗎？

I think that in 20 patients cohort, doing any subgroup analysis, that was my point of the remark. I don't think that the numbers we support specific conclusions based on this.

我認為，在 20 名患者群組中，進行任何亞組分析，這就是我的觀點。我不認為我們的數位支持是基於此的具體結論。

Got it. Okay. That's helpful. And then a quick one for Alberto. Alberto, I wish you all the best in your next endeavors. I just wanted to ask can you maybe give us a little bit more color on the cash burn guidance. I'm curious to know, does it anticipate starting off any follow-on studies with COM701, 902, potential registration enabling studies, et cetera?

知道了。好的。這很有幫助。然後是阿爾貝託的快速發言。阿爾貝托，我祝你在接下來的努力中一切順利。我只是想問你能否給我們更多有關現金消耗指南的資訊。我很想知道，它是否預計會開始對 COM701、902 進行任何後續研究、潛在的註冊支援研究等？

Yeah. Hi, Asthika. Thank you for the wishes. So as we said, we have cash into 2027 and this take into consideration a certain amount of cash that should be used for the next trial. So even if, I mean, we did not -- we don't have plans and we will have plans only once the data will be out. But, yes, we have some reserve for additional trial that we may or may not start going forward.

是的。嗨，阿斯提卡。謝謝你的祝福。正如我們所說，我們到 2027 年都有現金，這考慮到了應該用於下一次試驗的一定數量的現金。所以，我的意思是，即使我們沒有——我們也沒有計劃，只有在數據公佈後我們才會制定計劃。但是，是的，我們有一些額外試驗的儲備，我們可能會或可能不會開始繼續進行。

Great. Thanks for taking my questions, guys.

偉大的。謝謝你們回答我的問題，夥伴們。

Daina Graybosch of Leerink Partners.

Leerink Partners 的 Daina Graybosch。

Hi. Thanks, guys. Another question for me on the platinum-resistant ovarian cancer data. You mentioned that this is a very difficult to treat patient population based on their prior lines and prior therapies. And that because PD-1 has little activity alone, it's a very good place for signal seeking. To me, when I hear that, it feels like you're guiding to a pretty modest overall response rate and duration of response. But I wonder if you could put actual quantification on that. So what kind of range in a 20-patient cohort specifically are you looking for that you think the activity is not only giving you a signal of PVRIG and TIGIT contribution but also is attractive enough to move forward?

你好。謝謝，夥計們。我的另一個問題是關於鉑類抗藥性卵巢癌的數據。您提到，根據先前的治療方案和治療，這是一個非常難以治療的患者群體。由於 PD-1 本身幾乎沒有活性，因此它是尋找訊號的一個非常好的地方。對我來說，當我聽到這個消息時，感覺你正在指導一個相當適度的整體回應率和回應持續時間。但我想知道你是否可以對此進行實際的量化。那麼，您具體在 20 名患者群組中尋找什麼樣的範圍，您認為該活動不僅向您發出了 PVRIG 和 TIGIT 貢獻的信號，而且具有足夠的吸引力以繼續前進？

So I'll start, and then Michelle, if you want to add, please go ahead. It's a very good question. And as I explained, we were seeking to go into areas where we could go show in single-arm studies, more single-arm studies that this is a COM701 PVRIG-driven effect. And we believe that what we show the cross indication for the different studies that we've done that this is a COM701-driven effect. And right now in terms of looking at the guidance, what we did say today that we are looking to repeat the clinical benefit that we have shown in the prior cohort in order to make a decision, okay, with this amount of patients that accumulated data of the two cohorts, we believe this COM701 is active. Then the question is, where do we have the competitive edge in which we should use this combination, where the data that it showed up until now that we had deep durable, in the prior cohorts, deep durable and safe profiles, and where do we give it the best chance to impact the appropriate patient population? But basically, it will be, from our perspective, we're picking the same clinical benefit.

我先開始，然後米歇爾，如果你想補充，請繼續。這是一個非常好的問題。正如我所解釋的，我們正在尋求進入可以在單臂研究中展示的領域，更多的單臂研究表明這是 COM701 PVRIG 驅動的效應。我們相信，我們所做的不同研究的交叉表明這是 COM701 驅動的效應。現在就指導而言，我們今天確實說過，我們希望重複我們在先前隊列中顯示的臨床益處，以便對積累了這麼多數據的患者做出決定在這兩個隊列中，我們認為COM701 是活躍的。那麼問題是，我們在哪裡具有競爭優勢，我們應該在哪裡使用這種組合，到目前為止顯示的數據顯示，我們在先前的隊列中具有深度持久性、深度持久性和安全性，以及我們在哪裡可以使用這種組合。但基本上，從我們的角度來看，我們會選擇相同的臨床益處。

Can you remind us the clinical benefit you observed in the first cohort? I don't think you've given the numbers on the call.

您能提醒我們您在第一組中觀察到的臨床益處嗎？我認為你沒有在電話中提供電話號碼。

Sure. So other than presenting some monotherapy activity, which was in a different study, in the prior triplet study, we were having 20% of our response rate with deep responses. Patients that were responsive, some of them have durability of more than 16 months, and it was, the combination was safe and tolerable. And we have initial biomarker data supporting some association with clinical benefit.

當然。因此，除了在另一項研究中呈現一些單一療法活動之外，在先前的三聯體研究中，我們的反應率達到了 20% 的深度反應。有反應的患者，其中一些患者的持續時間超過 16 個月，而且該組合是安全且可耐受的。我們有初步的生物標記數據支持與臨床益處的某些關聯。

And then in the dataset you're going to have this year, how much follow-up will you have? Will you be able to observe a confirmation of that durability and then how many patients?

然後，在今年您將獲得的資料集中，您將有多少後續行動？您能否觀察到耐久性的確認以及有多少患者？

Let me share, address it. We will not have the 16 months durability time to do monitoring for 16 months but Michelle, do you want to say anything about it?

我來分享一下，解決一下。我們不會有 16 個月的持續時間來進行 16 個月的監控，但米歇爾，你對此有什麼想說的嗎？

Yeah. Sure. So what I can say is we did decide to cut the data a little bit earlier so that we can present data by the end of the year. So it may not be as mature as the prior dataset. However, a number of our patients on the study have already been on the study for a minimum of six months. So it is starting to get to a point where we will be able to observe durability.

是的。當然。所以我可以說的是，我們確實決定提前一點削減數據，以便我們可以在年底前提供數據。所以它可能不像之前的資料集那麼成熟。然而，我們參與研究的許多患者已經參與研究至少六個月。因此，我們已經開始能夠觀察到耐久性了。

Great . Thank you.

偉大的。謝謝。

Tony Butler of Rodman & Renshaw.

羅德曼與倫肖的東尼巴特勒。

Thank you very much for the opportunity. I just wanted to follow on with the last question, and I guess it intersects with the first as well. And that is the -- I'm going to call it hurdle rate that you would like to see at least as it or maybe we would all like to see as it pertains to the Q4 data in ovarian cancer. So if 20% is that hurdle, if that's correct, the question becomes there are two parts, one is, will there be some look at, if they're only six months in duration, for example, per Michelle's comments, then that seems perfectly fine I guess. But there is a question as to whether or not there are late responders. So, for example, if a patient has been on for on triple therapy for x number of months that they respond later. Is there evidence from the previous trial that, that is the case? That's point one.

非常感謝您給我這個機會。我只是想繼續最後一個問題，我想它也與第一個問題相交。這就是——我將稱之為最低門檻率，你至少希望看到它，或者也許我們都希望看到它，因為它與卵巢癌第四季度的數據有關。因此，如果20% 是這個障礙，如果這是正確的，那麼問題就變成了兩個部分，一是是否會進行一些研究，如果它們的持續時間只有六個月，例如，根據米歇爾的評論，那麼這似乎我想完全沒問題。但有一個問題是是否有遲到的響應者。因此，舉例來說，如果患者已經接受三聯療法 x 個月，他們會稍後做出反應。先前的審判有證據顯示情況確實如此嗎？這是第一點。

And number two is, if all the response rates were PRs. Does that matter to, I mean, that's really great for these women for sure. But is there -- are there any PR conversions that you had seen in the previous study which were later than when that particular cutoff occurred? And then I have a follow-up. Thank you.

第二個問題是，如果所有回覆率都是 PR。我的意思是，這對這些女性來說確實很棒。但是，您在先前的研究中是否發現 PR 轉換晚於特定截止時間發生的時間？然後我有一個後續行動。謝謝。

Michelle? Thank you, Tom.

米歇爾？謝謝你，湯姆。

Yeah. So I can speak that there are and is also described in the immunotherapy literature and ovarian cancer that, yes, there are some patients who can develop a later response, so they can be sitting at stable disease for a long period of time and then stable disease over a period of time will become partial response. Again I can't speak to all the details on the current data set and in the prior data set as you're aware, we did have two partial responders that maintain response beyond 16 months. I don't remember off hand what the exact time to respond was in those two patients. But we had a number of stable disease patients as well who were on the study for quite some time. So I feel like I'm not completely answering your question, but I think that's as best as I can get to you right now.

是的。所以我可以說，在免疫治療文獻和卵巢癌中也有描述，是的，有些患者可以產生較晚的反應，因此他們可以在很長一段時間內處於穩定的疾病狀態，然後穩定下來疾病經過一段時間就會變成部分反應。正如您所知，我再次無法透露有關當前數據集和先前數據集的所有詳細信息，我們確實有兩個部分響應者維持響應超過 16 個月。我不記得這兩個病人具體的反應時間是什麼時候。但我們也有一些病情穩定的患者，他們參與研究已經有一段時間了。所以我覺得我沒有完全回答你的問題，但我認為這是我現在能回答你的最好的了。

Yeah. But I guess to some degree did any stable disease patients in the previous trial convert to PR? That was sort of part two.

是的。但我猜想，在先前的試驗中，是否有病情穩定的病人轉為 PR 的？那是第二部分。

So off-hand I don't recall. I just know that there were two partial responders. Like I said, I'm not 100% sure what the time to respond was. I'm not aware of any late conversions from stable disease to partial response. Although, like I said, that has been described in the immuno-oncology literature.

所以我一時不記得了。我只知道有兩個部分響應者。就像我說的，我不能 100% 確定回覆的時間是什麼。我不知道有任何從疾病穩定到部分緩解的後期轉變。儘管，就像我說的，這已經在免疫腫瘤學文獻中進行了描述。

But I think, Tony, I just add and if I understand where you're leading to, I'll just add that the guidance that we shared with repeating the same clinical benefit would be relevant for the time that we will also share our plans based on the data, as I said, we'll always be data-driven. So that maybe gives you some clarity about our guidance.

但我想，托尼，我只是補充一點，如果我明白你的走向，我會補充一點，我們分享的重複相同臨床益處的指導將與我們分享我們的計劃的時間相關。 ，我們將永遠由數據驅動。這樣也許可以讓您對我們的指導有一些清晰的了解。

Thank you, Anat. And maybe the last question, totally different. But in COM503, you make reference to harnessing cytokine biology. And I guess the question is, in your current research efforts, are there other targets that might also harness other cytokines that might be worthwhile as antibodies for which you may bring forth in the future? In other words, something beyond 503? Thank you.

謝謝你，阿納特。也許最後一個問題完全不同。但在 COM503 中，您提到了利用細胞激素生物學。我想問題是，在您目前的研究工作中，是否有其他目標也可能利用其他細胞因子，這些細胞因子可能值得作為您將來可能提出的抗體？換句話說，503 以外的東西？謝謝。

Eran, do you want to take it?

伊蘭，你想接受嗎？

Yes. So overall we use our computational AI-driven platform to identify novel targets. We arrived trials in binding protein as a target, not because we looked for cytokine target, because we looked for resistant mechanisms in the tumor environment computationally. So it's a very different target from PVRIG. TIGIT, for example, and this indeed took us to harness an antibody to unleash natural IL-18 activity in the tumor microenvironment. So we definitely have a variety of other early assets, all coming from our computational discovery platform. And they are across different modalities and different MOAs all coming from, it's kind of MOA agnostic and more patient-centric approach, looking into the tumor microenvironment of patients and unleashing additional resistant mechanism.

是的。因此，總的來說，我們使用計算人工智慧驅動的平台來識別新目標。我們進行了以結合蛋白為標靶的試驗，不是因為我們尋找細胞激素靶點，而是因為我們透過計算尋找腫瘤環境中的抗藥性機制。所以這是一個與 PVRIG 非常不同的目標。例如，TIGIT，這確實讓我們利用抗體在腫瘤微環境中釋放天然的 IL-18 活性。因此，我們肯定擁有各種其他早期資產，全部來自我們的計算發現平台。它們來自不同的模式和不同的 MOA，這是一種與 MOA 無關且更以患者為中心的方法，研究患者的腫瘤微環境並釋放額外的抗藥性機制。

Thank you Eran.

謝謝埃蘭。

This concludes the Q&A session in Compugen's Investor Conference Call. Thank you for your participation. You may go ahead and disconnect.

Compugen 投資人電話會議的問答環節到此結束。感謝您的參與。您可以繼續並斷開連線。