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Operator
Operator
Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's third-quarter 2023 results conference call. (Operator Instructions). As a reminder, today's call is being recorded. An audio webcast of this call will be made available on the Investors section of Compugen's website, www.cgen.com. Please note that if the siren go off during this call, we will need to end the call to take shelter.
女士們、先生們,謝謝你們今天加入我們。歡迎參加 Compugen 2023 年第三季業績電話會議。 (操作員說明)。提醒一下,今天的通話正在錄音。本次電話會議的音訊網路廣播將在 Compugen 網站 www.cgen.com 的投資者部分提供。請注意,如果在通話期間警報器響起,我們將需要結束通話以躲避。
I would now like to introduce Yvonne Naughton, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.
我現在想介紹投資者關係和企業傳播主管 Yvonne Naughton。伊馮,請繼續。
Yvonne Naughton - Head, IR & Corporate Communications
Yvonne Naughton - Head, IR & Corporate Communications
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. Henry Adewoye, Chief Medical Officer, will join us for the Q&A session.
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。首席醫療官 Henry Adewoye 博士將參加我們的問答環節。
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, research and development efforts and their potential outcome, anticipated progress and planned, results and timelines for its programs, financial- and accounting-related matters, including projected financial information as well as statements regarding the company's future cash position and other results, and the company's future initiatives.
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、研發工作及其潛在結果、預期進展和計劃、結果和時間表做出預測或前瞻性陳述。其計劃、財務和會計相關事項,包括預計的財務資訊以及有關公司未來現金狀況和其他業績的報表,以及公司的未來舉措。
We wish to caution you that such statements reflect only the company's current beliefs, expectations, and assumptions and that actual results, performance, or achievements of the company may differ materially. These statements are subject to known and unknown risks and uncertainties, which could cause the company's actual results to differ materially from those projected in such forward-looking statements. 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 filed with the SEC on February 28, 2023, as later amended. The company undertakes no obligation to update projections and forward-looking statements in the future.
我們希望提醒您,此類陳述僅反映公司目前的信念、期望和假設,公司的實際結果、績效或成就可能存在重大差異。這些陳述受到已知和未知的風險和不確定性的影響,這可能導致公司的實際結果與此類前瞻性陳述中的預測有重大差異。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,包括該公司於 2023 年 2 月 28 日向 SEC 提交的最新 20-F 表格年度報告(後來進行了修訂)。該公司不承擔更新未來預測和前瞻性陳述的義務。
And now I turn the call over to Anat.
現在我把電話轉給阿納特。
Anat Cohen-Dayag - President, CEO
Anat Cohen-Dayag - President, CEO
Thank you, Yvonne. Good morning and good afternoon, everyone, and welcome to our third-quarter 2023 update. I will start by saying a few words on the heartbreaking situation in Israel, a humanitarian disaster. We're traumatized and devastated by the human slaughtering and kidnapping of civilians by the terrorist group Hamas. This brutal attack shook us to our core. I'm deeply thankful for all the kind words of support I've received from so many friends, colleagues, partners, investors, analysts, and the medical associations from across the world. Your solidarity means so much to me and provides comfort amidst all the anguish and unbearable pain. Thank you.
謝謝你,伊馮。大家早安、下午好,歡迎來到我們的 2023 年第三季更新。我首先要談談以色列令人心碎的局勢,這是一場人道災難。恐怖組織哈馬斯屠殺和綁架平民,讓我們深受創傷和破壞。這次殘酷的襲擊讓我們內心震撼不已。我非常感謝來自世界各地的許多朋友、同事、合作夥伴、投資者、分析師和醫學協會對我的支持。你們的團結對我來說意義重大,在所有痛苦和難以忍受的痛苦中為我提供了安慰。謝謝。
We recognize the emotional toll this is taking on our employees in Israel, and we're taking care to manage the employee needs with a lot of sensitivity and care. Despite what our team members are going through, this is a time when we see teamwork at its best, everyone supporting each other, and stepping in to ensure we have no guests. The teams are working hard together to ensure we continue to execute and meet our growth. Some are getting 150% when others are not able to. I'm seeing it every day, and it makes me proud.
我們認識到這對我們在以色列的員工造成的情感損失,我們正在以高度的敏感度和關懷小心地管理員工的需求。儘管我們的團隊成員正在經歷什麼,但在這個時候,我們看到了團隊合作的最佳狀態,每個人都互相支持,並介入以確保我們沒有客人。團隊正在共同努力,以確保我們繼續執行並滿足我們的成長。有些人能達到 150%,而有些人卻做不到。我每天都能看到它,這讓我感到自豪。
The infrastructure for remote working was established during the COVID pandemic. And although we allow certain teams to work remotely, we are encouraging our employees to come to the office. As a global company, we're headquartered in Israel and presence in the US, Europe, and Singapore, some management members and teams responsible for some of our key functions, including clinical development, preclinical development, and IT systems, are based outside of Israel. Our clinical trials are running in the US and operating in the ordinary course of business, including with respect to CMC and drug supply.
遠距工作的基礎設施是在新冠疫情期間建立的。儘管我們允許某些團隊遠距工作,但我們鼓勵員工來到辦公室。作為一家全球性公司,我們總部位於以色列,並在美國、歐洲和新加坡設有辦事處,負責我們一些關鍵職能(包括臨床開發、臨床前開發和 IT 系統)的一些管理成員和團隊位於國外以色列。我們的臨床試驗正在美國進行,並在正常業務過程中進行,包括 CMC 和藥物供應方面。
Also, most of our preclinical activities related to COM503 are performed outside of Israel. We continue to work with no material impact on our operations. And if this changes, we will communicate it to the market. At Compugen, our goal is to transform the treatment of cancer patients who have no effective treatment options by using our pioneering computational platform to discover novel drug targets and develop potential first-in-class drugs.
此外,我們與 COM503 相關的大多數臨床前活動都是在以色列境外進行的。我們將繼續工作,不會對我們的營運產生重大影響。如果這種情況發生變化,我們會將其傳達給市場。在 Compugen,我們的目標是透過使用我們開創性的計算平台來發現新的藥物標靶並開發潛在的一流藥物,從而改變沒有有效治療方案的癌症患者的治療方法。
On this front, we're executing on our differentiated clinical approach to evaluate the blockade of the three pathways, PVRIG, TIGIT, and PD-1. We're also advancing IND-enabling studies with our lead preclinical potential first-in-class anti-IL-18BP antibody, COM503, offering novel approach to harness cytokine biology to address resistance to cancer immunotherapy. And we're advancing our earlier-stage pipeline with additional new potential first-in-class programs.
在這方面,我們正在執行差異化的臨床方法來評估 PVRIG、TIGIT 和 PD-1 三種途徑的阻斷。我們也利用我們領先的臨床前潛在一流抗 IL-18BP 抗體 COM503 來推進 IND 研究,提供利用細胞激素生物學解決癌症免疫治療抗藥性的新方法。我們正在透過更多新的潛在一流專案來推進我們的早期研發管線。
At SITC Conference, which just took place, we presented additional data reinforcing a COM701 mediated antitumor activity in tumors, typically not responding to immunotherapy. These data, which we continue to collect and share from our prior signal-seeking studies, edge to the breadth of tumor types typically not responding to anti-PD-1, but responding to COM701 combination.
在剛舉行的 SITC 會議上,我們提供了額外的數據,增強了 COM701 介導的腫瘤抗腫瘤活性,通常對免疫療法沒有反應。我們從先前的訊號尋求研究中繼續收集和分享這些數據,這些數據涉及通常不響應抗 PD-1,但響應 COM701 組合的腫瘤類型的廣度。
Also, the bloods taken from patients treated in this study allows us to advance our biomarker insights as well as further confirm the COM701-mediated mechanism of action. And in parallel, we're conducting our ongoing studies focusing on MSS-CRC and platinum-resistant ovarian cancer.
此外,從本研究中接受治療的患者身上採集的血液使我們能夠推進對生物標記的了解,並進一步確認 COM701 介導的作用機制。同時,我們正在進行針對 MSS-CRC 和鉑抗藥性卵巢癌的研究。
Building on data we presented at ESMO-IO last year, at SITC, we reported clinically meaningful durable partial responses in platinum-resistant ovarian cancer patients treated with COM701 triple combination with no new safety signals. Three patients are continuing steady treatment for more than 16 months. While the numbers are small, typical median duration of response for this population is three to four months with standard chemotherapy, where 6.9 months reported in patients treated with the recently approved antibody drug conjugate.
基於我們去年在 ESMO-IO 和 SITC 上提交的數據,我們報告了接受 COM701 三聯療法治療的鉑耐藥卵巢癌患者俱有臨床意義的持久部分緩解,且沒有新的安全信號。 3名患者持續穩定治療超過16個月。雖然數字很小,但標準化療對該族群的典型反應中位數持續時間為三到四個月,其中使用最近批准的抗體藥物偶聯物治療的患者報告為 6.9 個月。
In addition to these durable responses, our triple combination has the potential added benefit of a favorable safety and tolerability profile, which, as we reported previously, investigators believe is important for patient's quality of life. We also reported that clinical benefit defined as partial response or stable disease of at least 180 days was independent of baseline inflammatory status and was associated with an increase in CD8+ T cell infiltration into the tumor, suggesting again and consistent with what we've previously reported a COM701-mediated mechanism of action.
除了這些持久的反應之外,我們的三重組合還具有良好的安全性和耐受性等潛在的額外好處,正如我們之前報導的那樣,研究人員認為這對患者的生活品質很重要。我們也報告了臨床獲益定義為至少 180 天的部分緩解或疾病穩定,與基線發炎狀態無關,並且與腫瘤中 CD8+ T 細胞浸潤的增加相關,這再次表明並與我們先前報導的一致COM701 介導的作用機制。
Excitingly at 60, we showed, for the first time, in tumor biopsies, an association between the expression of the PVRIG ligand, PVRL2, and clinical benefit, which may suggest the potential of patient's baseline PVRL2 level and the biomarker to help enrich for patients who may gain clinical benefit from COM701 combination. This is consistent with the basic computational-driven hypothesis we shared for this pathway in the past. This initial association findings suggest a COM701-mediated mechanism of action and has the potential for informing our studies, and I will come back to it later.
令人興奮的是,在60 歲時,我們首次在腫瘤活檢中證明了PVRIG 配體PVRL2 的表達與臨床獲益之間的關聯,這可能表明患者基線PVRL2 水平和生物標誌物有助於豐富患者的潛力誰可以從 COM701 組合中獲得臨床益處。這與我們過去為該途徑分享的基本計算驅動假設是一致的。這項初步關聯研究結果表明 COM701 介導的作用機制,並有可能為我們的研究提供信息,我稍後會再討論。
At SITC, we also reported data in heavily pretreated metastatic breast cancer patients. COM701, when combined with nivolumab, resulted in preliminary antitumor activity with an overall response rate of 12%, including one complete response for over 21 months in a patient with HER2-negative metastatic breast cancer, a tumor that is considered immune [com] and a partial response for 10 months in a patient with the triple negative breast cancer, which is the fastest growing and most aggressive kind of breast cancer. The disease control rate was 29%, and the three patients with stable disease were PD-L1 low and with low tumor mutation burden at baseline, suggesting a COM701-mediated mechanism of action. And again, we reported good safety and tolerability with this dual combination.
在 SITC,我們也報告了經過大量治療的轉移性乳癌患者的數據。 COM701 與nivolumab 聯合使用時,產生了初步的抗腫瘤活性,整體緩解率為12%,其中一名HER2 陰性轉移性乳癌患者出現了超過21 個月的完全緩解,HER2 陰性轉移性乳癌是一種被認為具有免疫功能的腫瘤[com] 和三陰性乳癌患者獲得了 10 個月的部分緩解,三陰性乳癌是生長最快、最具侵襲性的乳癌。疾病控制率為29%,三名疾病穩定的患者在基線時PD-L1水平較低且腫瘤突變負荷較低,顯示COM701介導的作用機制。我們再次報告了這種雙重組合具有良好的安全性和耐受性。
These findings are important because this is yet another indication in which patients are deriving durable benefit from COM701 combination despite typically not responding to immunotherapy. Additionally, like the initial biomarker work in platinum-resistant ovarian cancer in these metastatic breast cancer patients, we showed the baseline PVRL2 expression levels are higher in patients with clinical benefit further supporting our biomarker hypothesis.
這些發現很重要,因為這是患者從 COM701 組合中獲得持久益處的另一個跡象,儘管通常對免疫療法沒有反應。此外,與這些轉移性乳癌患者的鉑抗藥性卵巢癌的初始生物標記研究一樣,我們發現,具有臨床獲益的患者的基線PVRL2 表達水平較高,進一步支持了我們的生物標記假設。
And finally, At SITC, part of an oral and poster presentation, we shared new data on our preclinical, potential first-in-class anti-IL18 binding protein antibody, COM503, further supporting our exciting novel approach to harness cytokine biology to tackle resistance to cancer immunotherapy. As a reminder, there is a huge excitement in this space as cytokine has the potential to be powerful therapeutics but has been plugged with challenges of giving them systemically at levels high enough to reach and modulate the tumor microenvironment without causing systemic side effects.
最後,在SITC 上,作為口頭和海報展示的一部分,我們分享了有關我們的臨床前潛在一流抗IL18 結合蛋白抗體COM503 的新數據,進一步支持我們利用細胞因子生物學來解決抗藥性的令人興奮的新方法到癌症免疫治療。提醒一下,這個領域非常令人興奮,因為細胞因子有潛力成為強大的治療方法,但一直面臨著如何全身性地給予它們足夠高的水平以達到和調節腫瘤微環境而不引起全身副作用的挑戰。
We have found a way to address this for the IL-18 pathway. COM503 blocks the interaction between IL-18 binding protein and IL-18, thereby freeing natural IL-18 bit to exhibit cancer growth in the tumor microenvironment.
我們已經找到了解決 IL-18 路徑這個問題的方法。 COM503 阻斷 IL-18 結合蛋白和 IL-18 之間的相互作用,從而釋放天然 IL-18 位點,使其在腫瘤微環境中表現出癌症生長。
The data we presented at SITC addresses two pertinent questions. One, our IL-18 levels in the tumor sufficient to provoke an antitumor response following antibody blockade of IL-18BP? And two, is an IL-18BP antibody safer than an engineered IL-18 cytokine that is given systemically?
我們在 SITC 上提供的數據解決了兩個相關問題。第一,腫瘤中的 IL-18 水平足以在抗體阻斷 IL-18BP 後激發抗腫瘤反應?第二,IL-18BP 抗體比全身給予的工程化 IL-18 細胞激素更安全嗎?
With respect to the first question relating to IL-18 levels in the tumor, we showed that: one, antibody inhibition of IL-18BP, free natural IL-18 prevents tumor growth in multiple mouse tumor models; and two, COM503 has the potential to release local production of IL-18 in human tumors above the minimum range needed to stimulate the immune system.
關於第一個問題與腫瘤中IL-18水平有關,我們顯示:一、IL-18BP的抗體抑制,遊離的天然IL-18在多種小鼠腫瘤模型中阻止腫瘤生長;第二,COM503 有可能將人類腫瘤中局部產生的 IL-18 釋放到刺激免疫系統所需的最低範圍之上。
We also showed that antibody inhibition of IL-18BP induced a significant increase in functional immune cells such as the effector T-cells and induced as T-cell clonal expansion in the tumor, as well as immune memory response. So our data suggests that the answer to the first question is yes. IL-18 levels in the tumor are sufficient to provoke an antitumor immune response following antibody blockade of IL-18 BP.
我們還表明,IL-18BP 的抗體抑制可誘導功能性免疫細胞(如效應 T 細胞)顯著增加,並誘導腫瘤中 T 細胞克隆擴張,以及免疫記憶反應。所以我們的數據顯示第一個問題的答案是肯定的。抗體阻斷 IL-18 BP 後,腫瘤中的 IL-18 水平足以激發抗腫瘤免疫反應。
In addressing the second question relating to whether an IL-18BP antibody safer than an engineered IL-18 cytokine given systemically, we showed that an engineered cytokine generated peripheral inflammatory responses evidenced by increased serum cytokine and lymphocytes. This contrasts with our IL-18BP antibody approach, which modulates the tumor microenvironment without affecting the periphery.
在解決第二個問題(即IL-18BP 抗體是否比全身給予的工程化IL-18 細胞因子更安全)時,我們發現工程化細胞因子會產生週邊發炎反應,這可以透過血清細胞因子和淋巴細胞增加來證明。這與我們的 IL-18BP 抗體方法形成對比,後者調節腫瘤微環境而不影響週邊。
The overall data for our COM503 program suggests that our anti-IL-18BP antibody approach has a leading edge in inhibiting tumor growth while avoiding peripheral toxicity associated with administration of recombinant IL-18 cytokine.
我們的 COM503 計畫的整體數據表明,我們的抗 IL-18BP 抗體方法在抑制腫瘤生長方面具有領先優勢,同時避免與施用重組 IL-18 細胞因子相關的周邊毒性。
Along we get successful ASCO, I would like to refer to additional progress we have made in the quarter. We're delighted to report that we have completed enrollment in the MSS-CRC proof-of-concept study, which is a testament to the substantial unmet medical need in these patients and lack of alternative options. We continue to monitor patients on study treatment, and we believe it will be more prudent to provide an update when we have longer follow-up from this cohort in the first half of 2024. And our preference is to do this at the medical conference.
隨著我們取得 ASCO 的成功,我想談談我們在本季取得的其他進展。我們很高興地報告,我們已經完成了 MSS-CRC 概念驗證研究的招募,這證明了這些患者的大量醫療需求未被滿足,並且缺乏替代選擇。我們將繼續監測接受研究治療的患者,我們相信,當我們在 2024 年上半年對該隊列進行更長時間的隨訪時,提供更新資訊將更加謹慎。我們傾向於在醫學會議上進行此操作。
In the platinum-resistant ovarian cancer study, enrollment is increasing since we last reported with the activation of two additional sites. Nevertheless, completion of enrollment of up to 20 patients were move into 2024.
在鉑金抗藥性卵巢癌研究中,自從我們上次報告啟動另外兩個位點以來,入組人數正在增加。儘管如此,最多 20 名患者的入組工作仍將推遲到 2024 年完成。
The platinum-resistant ovarian cancer landscape is continually evolving and becoming more competitive. Although we did not expect and impact of mirvetuximab on our enrollment, which, as per label, is restricted to about 40% of follow-up as a high patient, ovarian cancer investigators are indicating there is the clinical community gain more confidence in the use of mirvetuximab. This is having an impact on our enrollment. Following comprehensive discussions with our investigators, we are optimistic that we can address it again and working closely with our investigators on patient enrollment. Our investigators remain enthusiastic to further enroll to our study based on the durability of responses with our triple combination reported at SITC, as well as favorable safety profile.
鉑類抗藥性卵巢癌領域正在不斷發展,競爭也變得更加激烈。儘管我們沒有預料到米妥昔單抗會對我們的入組產生影響(根據標籤,作為高患者的隨訪僅限於約40%),但卵巢癌研究人員表明,臨床界對使用米韋妥昔單抗更有信心米維妥昔單抗。這對我們的招生產生了影響。在與我們的研究人員進行全面討論後,我們樂觀地認為我們可以再次解決這個問題,並與我們的研究人員在患者入組方面密切合作。基於 SITC 報告的三聯療法的療效持久性以及良好的安全性,我們的研究人員仍然熱衷於進一步參與我們的研究。
In addition to our progress, I'm delighted to see the progress of our partner AstraZeneca is making with rilvegostomig. Their PD-1/TIGIT bispecific derived from our COM902, which has progressed into Phase 3 as adjuvant therapy for biliary tract cancer after resection in combination with chemotherapy. In addition, AstraZeneca continues to progress their rilvegostomig Phase 1 into a program in additional indications. I believe there's a progress of the rilvegostomig clinical program demonstrates the commitment to explore the potential of TIGIT and our differentiated anti-TIGIT COM902. Like COM902, is to reduce that effector function and to take accountability for in regards to me was engineered to reduce Fc effector functionality with the potential to enhance antitumor activity.
除了我們的進步之外,我很高興看到我們的合作夥伴阿斯特捷利康與 rilvegostomig 的進展。他們的 PD-1/TIGIT 雙特異性藥物源自於我們的 COM902,該藥物已進入 3 期,作為膽道癌切除後聯合化療的輔助治療。此外,阿斯特捷利康繼續將其 rilvegostomig 第一階段進展為其他適應症的計劃。我相信 rilvegostomig 臨床計劃的進展表明了我們致力於探索 TIGIT 和我們差異化抗 TIGIT COM902 潛力的承諾。與 COM902 一樣,它的目的是減少效應器功能,並負責減少 Fc 效應器功能,並有可能增強抗腫瘤活性。
Now moving on to what you should expect to see from us next. First, we plan to report data from our ongoing proof-of-concept study in MSS-CRC in the first half of 2024. Second, we plan to enroll up to 20 patients in our ongoing proof-of-concept study in platinum-resistant ovarian cancer and report data in 2024. More specific guidance will be shared during our end of year conference call. Third, identification of a predictive biomarker to enrich for responders for COM701 combination was always important for us.
現在繼續討論您下一步應該從我們這裡看到的內容。首先,我們計劃在 2024 年上半年報告我們正在進行的 MSS-CRC 概念驗證研究的數據。其次,我們計劃在我們正在進行的鉑耐藥概念驗證研究中招募最多 20 名患者卵巢癌並於2024 年報告數據。我們將在年終電話會議上分享更具體的指導。第三,鑑定預測生物標記以豐富 COM701 組合的反應者對我們來說始終很重要。
To this extent, we're excited about the progress we have made on generating initial biomarker data, which I alluded to earlier, showing for the first time an association between the expression of PVRIG ligand, PVRL2, and clinical benefit that is consistent with our computational prediction. We will continue to build on these preliminary findings as part of our ongoing platinum-resistant ovarian cancer study in which biopsies are mandatory.
從這個意義上說,我們對產生初始生物標記數據所取得的進展感到興奮,我之前提到過,它首次顯示了PVRIG 配體PVRL2 的表達與臨床獲益之間的關聯,這與我們的研究一致。計算預測。我們將繼續以這些初步發現為基礎,作為我們正在進行的鉑金抗藥性卵巢癌研究的一部分,在該研究中,活檢是強制性的。
In parallel, we are also optimizing our PVRL2 assay to feed the potential patient selection study. Having the potential to enrich for responders in the platinum-resistant ovarian cancer patient population together with the durability of response and the safety profile of our triple combination may allow us to build a unique development path for our triplet regimen. We will communicate early next year on how we will use the data to inform future direction. And finally, we're on track for IND filings for COM503 in 2024.
同時,我們也正在優化 PVRL2 檢測,以支持潛在的患者選擇研究。我們的三聯療法具有豐富鉑類抗藥性卵巢癌患者群體應答者的潛力,加上應答的持久性和安全性,可能使我們能夠為我們的三聯療法建立獨特的開發路徑。我們將在明年初就如何使用這些數據來指導未來的方向進行溝通。最後,我們預計在 2024 年提交 COM503 的 IND 申請。
Before handing over to Alberto, I will touch briefly on our finances, and then Alberto will go into the details. We have an expected cash runway through at least the end of 2024, which we believe is sufficient to support all planned operations. This does not include any potential cash inflows, including potential milestone payments, which we may become eligible for through our partnership with AstraZeneca. Also, as we indicated, obtaining non-dilutive cash from partnering is a priority, and we're focusing our efforts on that front.
在交給阿爾貝託之前,我將簡要介紹我們的財務狀況,然後阿爾貝托將詳細介紹。我們預計現金跑道至少持續到 2024 年底,我們相信這足以支持所有計劃的運作。這不包括任何潛在的現金流入,包括潛在的里程碑付款,我們可能有資格透過與阿斯特捷利康的合作獲得這些付款。此外,正如我們所指出的,從合作中獲得非稀釋性現金是一個優先事項,我們正在將努力集中在這方面。
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。
Alberto Sessa - CFO
Alberto Sessa - CFO
Thank you, Anat. I'm happy to summarize our financial results. I will start with our cash balance. As of September 30, 2023, cash, cash equivalents, and cash investments were approximately $57.5 million compared with approximately $83.7 million as of September 31, 2022 (sic - see press release, "December 31, 2022"), affirming our focus on cost management while continuing our execution on our DNAM-1 axis hypothesis and progressing our lead preclinical drug candidate, COM503. As Anat mentioned, we have an expected cash runway through at least the end of 2024, which we believe is sufficient to support all our planned operations. The company has no debt.
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2023 年9 月30 日,現金、現金等價物和現金投資約為5,750 萬美元,而截至2022 年9 月31 日約為8,370 萬美元(原文如此- 請參閱新聞稿“2022 年12 月31 日” ),這證實了我們對成本的關注管理,同時繼續執行 DNAM-1 軸假設並推進我們的主要臨床前候選藥物 COM503。正如阿納特所提到的,我們預計至少到 2024 年底都有現金跑道,我們相信這足以支持我們所有計劃的運營。公司沒有負債。
Now regarding expenses. Expenses for the third quarter of 2023 were in line with our plans. R&D expenses for the third quarter of 2023 were $8.3 million, down from $9.3 million in the third quarter of 2022. The decrease is mainly due to lower expenses associated with our CMC activities, offset by an increase in clinical trial expenses and by the end of the amortization of the deferred participation in R&D expenses, following the termination of the agreement with BMS in the third quarter of 2022.
現在關於費用。 2023 年第三季的費用符合我們的計劃。 2023 年第三季的研發費用為 830 萬美元,低於 2022 年第三季的 930 萬美元。減少的主要原因是與我們的 CMC 活動相關的費用減少,但被臨床試驗費用的增加所抵消。與BMS 的協議於2022 年第三季終止後,遞延參與研發費用的攤銷。
G&A expenses for the third quarter of 2023 were $2.3 million compared to $2.6 million in the third quarter of 2022. Net loss for the third quarter of 2023 was $9.9 million or $0.11 per basic and diluted share compared to a net loss of $11.7 million or $0.14 per basic and diluted share in the third quarter of 2022.
2023 年第三季的一般管理費用為230 萬美元,而2022 年第三季為260 萬美元。2023 年第三季的淨虧損為990 萬美元,即基本股和稀釋股每股0.11 美元,而淨虧損為1,170 萬美元,即每股0.14 美元2022 年第三季的每股基本股和稀釋股。
With that, I will hand back to Anat to summarize.
至此,我將交回給 Anat 進行總結。
Anat Cohen-Dayag - President, CEO
Anat Cohen-Dayag - President, CEO
Thank you, Alberto. To summarize, we continue to execute. with our most recent data presented at SITC, we continue to provide evidence supporting a potential COM701-mediated clinical benefit in hard-to-treat patients who are not responding to standard of care in fair prior I-O therapy. This strengthens our path as we continue to pursue our ongoing proof-of-concept study designed to reinforce the data in our two selected indications and continue to inform our complementary biomarker strategy.
謝謝你,阿爾貝托。總而言之,我們繼續執行。根據我們在 SITC 上公佈的最新數據,我們繼續提供證據支持 COM701 介導的潛在臨床益處,用於對先前 I-O 治療中的標準護理沒有反應的難治性患者。這加強了我們的道路,因為我們繼續進行正在進行的概念驗證研究,旨在加強我們選定的兩個適應症的數據,並繼續為我們的補充生物標記策略提供資訊。
We're looking forward to presenting data from these studies in 2024 and providing more details on our biomarker strategy, informing future direction, and related studies. We've always said that blocking TGIT may not be enough, and the PVRIG may be needed. This belief is consistently being great for us as we roll out our clinical data across multiple indications in most evidently in hard-to-treat patients who are not responding to standard of care in fairs I-O therapy.
我們期待在 2024 年提供這些研究的數據,並提供有關我們的生物標記策略的更多詳細信息,為未來的方向和相關研究提供資訊。我們總是說阻止 TGIT 可能還不夠,可能還需要 PVRIG。這種信念對我們來說始終是偉大的,因為我們在多種適應症中推出了我們的臨床數據,這些數據最明顯是針對那些對 Fair I-O 治療標準護理沒有反應的難治性患者。
With COM701 and COM902, our two wholly owned PVRIG and TIGIT program, we are the leader in the unique chemotherapy-free triple combination approach of blocking three DNAM axis immune checkpoints, PVRIG, TIGIT, and PD-1, with initial clinical data to support our hypothesis. We're also paving the way in harnessing cytokine biology to address cancer immunotherapy resistance, which is a field of high interest to the industry. With COM503 targeting the IL-18 pathway, we're on track to IND filing in 2024.
憑藉我們全資擁有的兩個PVRIG 和TIGIT 項目COM701 和COM902,我們在阻斷三個DNAM 軸免疫檢查點(PVRIG、TIGIT 和PD-1)的獨特無化療三重組合方法方面處於領先地位,並有初步臨床數據支持我們的假設。我們也為利用細胞激素生物學解決癌症免疫治療抗藥性問題鋪平了道路,這是業界高度關注的領域。隨著 COM503 針對 IL-18 途徑,我們預計在 2024 年提交 IND 申請。
I would like to thank all our employees for their dedication, teamwork, and resilience despite the challenges we have been enduring in Israel. With that, I will turn the call back to the operator to initiate the Q&A session.
儘管我們在以色列面臨挑戰,但我要感謝所有員工的奉獻精神、團隊合作和韌性。之後,我會將電話轉回給接線生以啟動問答會話。
Actually, before we go to the operator, I see Pierre Ferre, our Vice President of Preclinical Development, just joined us fresh off the plane from SITC San Diego. Pierre will be glad to answer any questions on COM503, which sparked a lot of interest after his oral presentation at SITC. Welcome, Pierre. Yoni, you can now initiate the Q&A session.
事實上,在我們去找操作員之前,我看到我們的臨床前開發副總裁 Pierre Ferre 剛從 SITC 聖地牙哥剛下飛機就加入了我們。 Pierre 將很樂意回答有關 COM503 的任何問題,他在 SITC 進行口頭演講後引起了人們的極大興趣。歡迎,皮埃爾。 Yoni,您現在可以發起問答環節。
Operator
Operator
(Operator Instructions) Asthika Goonewardene, Truist.
(操作員指示)Asthika Goonewardene,真理論者。
Jing Deng - Analyst
Jing Deng - Analyst
Hey, thanks for taking my questions. I'm Jing, and I'm in the line for Asthika. So I have a question regarding about -- the first question is about, what's your expected milestones or timeline in 2024 and beyond for the program, you co-develop with your partner, AstraZeneca? And then could you tell more details about how you both parties will handle this program? How will you monitor and evaluate the progress and performance of this program, as my first question.
嘿,謝謝你回答我的問題。我是 Jing,我正在排隊等候 Asthika。所以我有一個問題,第一個問題是,您與合作夥伴阿斯特捷利康共同開發的專案在 2024 年及以後的預期里程碑或時間表是什麼?那麼能否詳細介紹一下雙方將如何處理這個專案?我的第一個問題是,您將如何監控和評估該計劃的進度和績效。
Second question is regarding of your COM503. So I would like to know -- I would like to ask how are you going to determine the optimal dose and schedule for this COM503, and then in animal or human studies preclinical? And then how will you account for variability and also stability of these IL-18 and IL-18BP levels in the different individuals or conditions. That's my two questions. Thank you.
第二個問題是關於您的COM503。所以我想知道——我想問一下,你們將如何確定 COM503 的最佳劑量和時間表,然後進行動物或人體研究臨床前?然後,您將如何解釋不同個體或條件下這些 IL-18 和 IL-18BP 水平的變異性和穩定性。這是我的兩個問題。謝謝。
Anat Cohen-Dayag - President, CEO
Anat Cohen-Dayag - President, CEO
Thank you, Jing. I'll start with the first question that relates to AstraZeneca, and then Pierre will take the second question that relates to COM503.
謝謝你,靜。我將從與阿斯特捷利康相關的第一個問題開始,然後皮埃爾將回答與 COM503 相關的第二個問題。
And so first, I would say that with AstraZeneca, the partnership that we have is actually a license agreement, where we licensed to AstraZeneca the rights to develop bispecific antibodies based on our COM902. And from the get-go, this agreement is actually granting the rights for AstraZeneca for the full development and the later commercialization of the program. We're getting updates on this program, but this program is really progressed by AstraZeneca. And obviously, any information about this program will be disclosed only by AstraZeneca.
首先,我想說,我們與阿斯特捷利康的合作夥伴關係實際上是一份許可協議,我們向阿斯特捷利康授予基於我們的 COM902 開發雙特異性抗體的權利。從一開始,該協議實際上授予阿斯特捷利康對該專案進行全面開發和後期商業化的權利。我們正在獲取有關該計劃的更新,但該計劃確實是由阿斯特捷利康推進的。顯然,有關該計劃的任何資訊將僅由阿斯特捷利康披露。
Specifically, for contractual reasons, I cannot provide any insights about the specific milestones and the breakdown and the timing and eligibility. And the only insight that I can give on this front is that the clinical milestones that we were already obtaining were eligible for milestone for the initiation of patient dosing in Phase 1 and Phase 2. It was $6 million for Phase 1 and $7 million for Phase 2. And other than that, at this point in time, I cannot say more. And as I stated, this is really AstraZeneca strategy in how to advance these programs to which indications and it was timing.
具體來說,出於合約原因,我無法提供有關具體里程碑、細分、時間表和資格的任何見解。在這方面我能給的唯一見解是,我們已經獲得的臨床里程碑符合在第一階段和第二階段開始患者給藥的里程碑。第一階段的費用為600 萬美元,第二階段的費用為700 萬美元。2. 除此之外,此時此刻,我不能說更多。正如我所說,這確實是阿斯特捷利康的策略,即如何將這些專案推進到適應症和時機。
And Pierre, will you take the COM503 questions?
皮埃爾,你願意回答 COM503 問題嗎?
Pierre Ferre - VP, Preclinical Development
Pierre Ferre - VP, Preclinical Development
Yes, my pleasure. You were asking how we would conduct the Phase 1 study to go to the active dose. So to do that, we will, of course, run a Phase 1 cancer patients with a standard dose escalation with some accelerating, maybe dose situations. About the dose itself, we have built a large experience at Compugen on the tools and the methods needed to measure all the components required for the pathway.
是的,我很榮幸。您問我們如何進行第一階段研究以達到活性劑量。因此,為了做到這一點,我們當然會以標準劑量遞增的方式對一期癌症患者進行治療,並可能進行一些加速劑量的情況。關於劑量本身,我們在 Compugen 在測量該途徑所需的所有成分所需的工具和方法方面積累了豐富的經驗。
We are still the comprehensive translational package with all our experience in vivo with vivo models, bearing cancers, and also lots of experience on in vitro testing on human samples. So we have made and this will be ongoing for the rest of the time that goes to the clinical trial. We have built a comprehensive PK/PD modeling that we will aim to follow during the course of this study. With the tools that we have, we can monitor the suppression of IL-18BP in the periphery of the patients, and that will be the basis, the main basis of reaching the actual dose.
我們仍然是全面的轉化包,擁有體內模型、攜帶癌症的所有體內經驗,以及人體樣本體外測試的大量經驗。因此,我們已經做出了這項決定,並將在臨床試驗的剩餘時間內繼續進行。我們已經建立了一個全面的 PK/PD 模型,我們的目標是在本研究過程中遵循模型。利用我們現有的工具,我們可以監測患者外周IL-18BP的抑制情況,這將是基礎,達到實際劑量的主要依據。
A very interesting thing with that program is safety so far that we've seen in all the animal models and also the human in vitro models that we have tested. And so with that safety in hand is that a transfer into the expected high tolerance in patients. We really think that we are able to reach active dose level that saturates IL-18BP targets easily in the in the tumor.
該程式的一個非常有趣的事情是迄今為止我們在所有動物模型以及我們測試過的人類體外模型中看到的安全性。因此,有了安全性,患者就可以達到預期的高耐受性。我們確實認為我們能夠達到使腫瘤中 IL-18BP 標靶輕鬆飽和的活性劑量水平。
Jing Deng - Analyst
Jing Deng - Analyst
Thank you again for taking my questions.
再次感謝您回答我的問題。
Operator
Operator
Daina Graybosch, Leerink Partners.
戴娜‧格雷博斯 (Daina Graybosch),Leerink 合夥人。
Jeff La Rosa - Analyst
Jeff La Rosa - Analyst
Hi, good morning. This is Jeff La Rosa for Daina. I have a few questions related to the biomarker data reported to SITC. Can you just recap where you are in the process of developing companion diagnostics in PVRL2 patients prospectively? And how would this past differ for IHC versus the genomic amplification companion diagnostic? And if any, one more practical than the other to implement?
早安.我是戴娜的傑夫·拉羅莎。我有一些與向 SITC 報告的生物標記數據相關的問題。您能否回顧一下您在 PVRL2 患者前瞻性伴隨診斷開發過程中的進展? IHC 與基因組擴增伴隨診斷的過去有何不同?如果有的話,其中一個比另一個更實用?
Second, do you think the data is shared on PVRL2 expression in ovarian cancer and that genomic application data more broadly is something you can leverage to facilitate enrollment in that indication and next year when you reported MSS-CRC data, you plan to show this retrospective PVRL2 expression data in these patients. Thank you.
其次,您是否認為卵巢癌中PVRL2 表達的數據是共享的,並且您可以利用更廣泛的基因組應用數據來促進該適應症的登記,明年當您報告MSS-CRC 數據時,您計劃展示這一回顧性數據這些患者中的 PVRL2 表達數據。謝謝。
Anat Cohen-Dayag - President, CEO
Anat Cohen-Dayag - President, CEO
Thank you, Jeff. I'll start with answering the first portion of the question of where we are and how we move forward. And then Pierre can relate to the ICN genomical duration. I'll just say that at this point in time, first, we're very excited with the data that we got. It's still initial by pointing in the exact right direction. That we were thinking of at this stage that we've been very positive based on computational data, and we are continuing to collect data. And this is from the ongoing study. It is important for us to add more patients and generate more robust data as we go with the ovarian cancer extent.
謝謝你,傑夫。我將首先回答問題的第一部分,即我們所處的位置以及我們如何前進。然後 Pierre 可以將 ICN 基因組持續時間連結起來。我只想說,在這個時候,首先,我們對所獲得的數據感到非常興奮。它仍然是初始的,指向正確的方向。我們現階段認為,基於計算數據,我們非常積極,我們正在繼續收集數據。這是來自正在進行的研究。當我們研究卵巢癌的範圍時,增加更多的患者並產生更可靠的數據對我們來說很重要。
For the meantime, we're also developing an assay, but I want to make sure, maybe Pierre will want to relate with it as well when he answers. And it is not yet final companion diagnostic assay. We're now in part of collecting more data. We're optimizing the assay that will be used eventually for screening patients in this study. And it's not going to be the ultimate companion diagnostic assay, but we're trying to work aggressively on both fronts on collecting the data and optimizing an essay so we are ready to be able to take it forward based on the pending the data will continue to look good.
同時,我們也在開發一種檢測方法,但我想確定一下,也許皮埃爾在回答時也會想與它聯繫起來。這還不是最終的伴隨診斷測定。我們現在正在收集更多數據。我們正在優化最終將用於本研究中篩檢患者的檢測方法。它不會是最終的伴隨診斷測定,但我們正在努力在收集數據和優化論文兩方面積極開展工作,以便我們準備好能夠根據待定的數據繼續推進它為了看上去好點。
Pierre, do you want to relate to the additional questions or to add?
皮埃爾,您想回答其他問題還是想補充?
Pierre Ferre - VP, Preclinical Development
Pierre Ferre - VP, Preclinical Development
Yeah. I would say that the IHC assay is being optimized for use in the [central] laboratory that we already used in the recent past generated data. Based on those data, we are optimizing it further to make it easier on the practical terms in a day-to-day basis if and when we will activate a prospect location selection.
是的。我想說的是,IHC 檢測正在針對我們在最近產生的數據中已經使用過的[中心]實驗室進行最佳化。根據這些數據,我們正在進一步優化它,以便在我們啟動潛在客戶位置選擇時,在日常實踐中變得更容易。
And about the genomic. Indeed, in the poster that we reported in SITC, we have flagged that one of our patients having the highest score on [IHC PVRL2] is also showing a genomic amplification that may be detected, perhaps in the future, from peripheral blood from the periphery. So it will be a noninvasive way of assessing the biomarker and the possibility that the patient may respond. We've used that association between genomic amplification and a high-score PVRL2 are the first confirmation that there is something there of interest. So in public databases on ovarian cancer, it is a low proportion of patients that are having genomic amplification. We don't think that immediately it will be achievable to screen patient on that front. But we are intrigued also by the fact that there are gains, not only amplifications, but also gains, and this is something that we will explore, of course in parallel. But we do think that the IHC that we have in hand will be proximal for any study if we are going to activate that.
關於基因組。事實上,在我們在SITC 中報道的海報中,我們已經標記出,我們的一位在[IHC PVRL2] 上得分最高的患者也顯示出基因組擴增,也許將來可以從外周血中檢測到這種基因組擴增。 。因此,這將是一種評估生物標記和患者反應可能性的非侵入性方法。我們利用基因組擴增和高分 PVRL2 之間的關聯來首次確認其中存在一些令人感興趣的東西。因此,在卵巢癌的公共資料庫中,進行基因組擴增的患者比例很低。我們認為不可能立即在這方面對患者進行篩檢。但我們也對這樣的事實感興趣:增益,不僅是放大,還有增益,這是我們將同時探索的東西。但我們確實認為,如果我們要啟動這項研究,我們手中的 IHC 將最適合任何研究。
Jeff La Rosa - Analyst
Jeff La Rosa - Analyst
Thanks for taking our questions.
感謝您回答我們的問題。
Operator
Operator
Steve Willey, Stifel.
史蒂夫威利,斯蒂菲爾。
Steve Willey - Analyst
Steve Willey - Analyst
Yeah, good morning. Thanks for taking the questions. Can you just speak to, I guess, how many sites are currently active in the ovarian trial? I guess how many have you brought on just with past few months? And I guess over the longer term, do you think you need to bring on more sites in order to expedite patient enrollment?
是的,早安。感謝您提出問題。我想,您能談談目前有多少網站正在積極參與卵巢試驗嗎?我猜你在過去的幾個月裡帶了多少人?我想從長遠來看,您認為您是否需要引入更多網站以加快患者註冊速度?
Anat Cohen-Dayag - President, CEO
Anat Cohen-Dayag - President, CEO
Thank you, Steve. Right now, we have nine sites active. We have few more because based on the plan that we've already rolled, we're thinking about ramping up. And we don't think that we should add additional sites beyond what we've planned and what we're looking to do now. And the reason for this is what I was just alluding to in the prepared remarks. First, we believe that the close monitoring that we're doing now with the investigators and, again, trying to make sure that this study is on the radar. This is something that is going achieve the goal. And this is after we added ovarian cancers specific size. The sizes that are enrolled, specifically ovarian cancer patients. So these two things, adding the size, making sure that we stick with the investigators, and we have -- I have to say that hearing their comments about how they think, about the triplet activity, namely the durability in conjunction with the safety for these patients they really expressed so many lines of treatments, and we don't really need to convince them. So we believe that the ramp-up that we've started to see will continue and that we don't need to add additional sites to the study.
謝謝你,史蒂夫。目前,我們有九個活躍站點。我們還沒有更多,因為根據我們已經推出的計劃,我們正在考慮加強力道。我們認為我們不應該添加超出我們計劃和現在要做的事情之外的其他網站。原因就是我剛才在準備好的發言中提到的。首先,我們相信我們現在正在與研究人員進行密切監測,並再次試圖確保這項研究受到關注。這是要達到目標的事情。這是我們添加卵巢癌具體大小後的結果。招募的規模,特別是卵巢癌患者。因此,這兩件事,增加尺寸,確保我們堅持調查人員的意見,我不得不說,聽到他們對三聯體活性的看法,即耐久性與安全性的評論。這些患者確實表達了很多治療方案,我們真的不需要說服他們。因此,我們相信我們已經開始看到的成長將繼續下去,並且我們不需要在研究中添加額外的站點。
Steve Willey - Analyst
Steve Willey - Analyst
Okay. And then I think you said that, I mean, you're obviously assaying for PVRL2 expression. So I think you said biopsies are mandatory. Is the ask of a patient both an on-treatment and then I guess a baseline and then multiple on-treatment biopsies ore you just looking for one specific biopsy? And I guess is that second on-treatment biopsy requirement. Is that is that in any way rate limiting in terms of your ability to get patients to solicit consent?
好的。然後我想你說過,我的意思是,你顯然是在偵測 PVRL2 表現。所以我認為你說活檢是強制性的。患者的要求是否既是治療中,又是基線,然後是多次治療中活檢,或者您只是在尋找特定的活檢?我想這是第二個治療切片的要求。這是否會以某種方式限制您讓患者徵求同意的能力?
Anat Cohen-Dayag - President, CEO
Anat Cohen-Dayag - President, CEO
It's a very good question. Maybe Henry you want to add anything about it. But to that, in any case, in a study when you ask for biopsies, this is inherited obviously, because patient needs to go through some invasive approach. But we don't anticipate at this point in time. This is a big hurdle. We ask for mandatory biopsies based on a prior to treatment and also on treatment. This is really serving us in order to make sure that eventually we can go with the platinum-resistant ovarian cancer data that we have. And into what eventually will be a biomarker-driven test that will allow us to maximize the potential of COM701 treatment for patients that may respond to these treatments. So at this point in time, this is mandatory. With this mandatory request, we do see a ramp up, and there was a belief that this will not to be the issue for enrollment.
這是一個非常好的問題。也許亨利你想補充一些相關內容。但無論如何,在一項研究中,當你要求進行活檢時,這顯然是遺傳的,因為患者需要經歷一些侵入性的方法。但我們目前還沒有預期。這是一個很大的障礙。我們要求根據治療前和治療後進行強制性活檢。這確實對我們有幫助,以確保我們最終能夠採用現有的鉑金抗藥性卵巢癌數據。最終將進行生物標記驅動的測試,這將使我們能夠最大限度地發揮 COM701 治療可能對這些治療有反應的患者的潛力。所以在這個時候,這是強制性的。透過這項強制性要求,我們確實看到了成長,我們相信這不會成為註冊問題。
Steve Willey - Analyst
Steve Willey - Analyst
Okay. And then just lastly, on the colorectal trial, I know this is open label. Do you have a cents as to what the distribution of patients looks like with respect to the presence or absence of liver metastasis of baseline? Thanks.
好的。最後,在結直腸試驗中,我知道這是開放標籤。您是否知道基線是否有肝轉移的患者分佈如何?謝謝。
Anat Cohen-Dayag - President, CEO
Anat Cohen-Dayag - President, CEO
I'll start, and then Henry maybe you want to add in. Yes, it's open label. We're familiar with it while we're not looking every day on the patient distribution. We're familiar with it. We are -- this kind of study that allows for liver mets, and that's unique. And this is because we believe that there could be some edge there based on the prior data. But as I said, we continue to monitor patients, we continue to collect the data, and we're thinking very hardly on what data we should share. Why the studies continuing, but we've made the decision that it's better for us not to share portion of data. Incomplete picture is better for us to have a longer-term follow-up and share the full picture, as I said, preferably in a medical conference when investors will be able to see the full picture of that data.
我先開始,然後亨利也許你想補充一下。是的,這是開放標籤。我們對此很熟悉,但我們並不是每天都關注患者分佈。我們很熟悉它。我們的這種研究允許進行肝臟代謝物檢測,這是獨一無二的。這是因為我們相信根據先前的數據,那裡可能存在一些優勢。但正如我所說,我們繼續監測患者,繼續收集數據,我們很少考慮應該共享哪些數據。為什麼研究仍在繼續,但我們已經決定最好不要分享部分數據。正如我所說,不完整的情況更好地讓我們進行更長期的追蹤並分享全貌,最好是在醫學會議上,屆時投資者將能夠看到該數據的全貌。
Henry, anything else you'd like to add on the liver mets part of the question?
亨利,關於肝臟代謝問題的部分,您還有什麼要補充的嗎?
Henry Adewoye - SVP, Chief Medical Officer
Henry Adewoye - SVP, Chief Medical Officer
All right. Thank you, Anat. I think you've covered the major parts of the question. But just to give some color, looking back at the data we presented previously, on the 22 subjects patients with microsatellite stable colorectal cancer. At a little above three quarters of those patients had liver mets. That was the initial presentation we had. The number of patients that we anticipate will have liver mets will also probably be around that number based solely on the fact that most of these patients have exhausted all available standard of care therapies. And in addition to that, most common site of metastasis of colorectal cancer, if you just look at the announcement, is the liver. So between half to about two-thirds, about three-quarters of patients will probably have the liver mets on analysis. And I am just making an assumption here and the projection until we do look at that data next year, like Anat has mentioned before, we'll be able to give you more substantive information on that regard.
好的。謝謝你,阿納特。我認為您已經涵蓋了問題的主要部分。但為了提供一些信息,回顧一下我們之前提供的 22 名微衛星穩定結直腸癌患者的數據。其中略高於四分之三的患者患有肝臟代謝異常。這是我們最初的演示。我們預計患有肝臟代謝症候群的患者數量也可能在這個數字左右,這僅僅是因為這些患者中的大多數已經用盡了所有可用的標準護理療法。除此之外,如果你只看公告,大腸直腸癌最常見的轉移部位是肝臟。因此,一半到大約三分之二、大約四分之三的患者可能會進行肝臟代謝物分析。我只是在這裡做出一個假設和預測,直到我們明年真正查看這些數據,就像阿納特之前提到的那樣,我們將能夠為您提供有關這方面的更多實質資訊。
Steve Willey - Analyst
Steve Willey - Analyst
Okay. Thanks for taking the questions.
好的。感謝您提出問題。
Anat Cohen-Dayag - President, CEO
Anat Cohen-Dayag - President, CEO
And maybe, Steve, maybe I'll just add, just to make sure that it is clear, that even in a biomarker-driven study, we will obviously only require for a baseline biopsy, pretreatment biopsy, but not an on-treatment biopsy. So it will be less complicated.
也許,史蒂夫,也許我會補充一點,只是為了確保清楚,即使在生物標誌物驅動的研究中,我們顯然也只需要基線活檢、治療前活檢,而不是治療中活檢。所以它會比較不複雜。
Operator
Operator
This concludes the Q&A session of Compugen's investor relations conference call. Thank you for your participation. You may go ahead and disconnect.
Compugen 投資人關係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。