使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's first quarter 2026 results conference call. (Operator Instructions) An audio webcast of this call is available in the Investors section of Compugen's website at www.cgen.com. As a reminder, today's call is being recorded.
各位女士、先生,感謝各位今天加入我們。歡迎參加 Compugen 2026 年第一季業績電話會議。(接線員指示)本次電話會議的音訊網路直播可於 Compugen 網站 www.cgen.com 的「投資人」專區收看。提醒各位,今天的電話會議將被錄音。
I will now hand the call over to Lindsey Trickett, Head of Investor Relations and Corporate Communications to begin. Lindsey, please go ahead.
現在我將把電話交給投資人關係與企業傳播主管 Lindsey Trickett 來開始。Lindsey,請開始。
Lindsey Trickett - Head of Investor Relations and Corporate Communications
Lindsey Trickett - Head of Investor Relations and Corporate Communications
Thank you, operator. Good morning and good afternoon, everyone, and welcome to Compugen's First Quarter 2026 Financial Results Conference Call. With us today are Dr. Eran Ophir, President and Chief Executive Officer; and David Silberman, Chief Financial Officer. Dr. Michelle Mahler, Chief Medical Officer, will join us for the Q&A portion of the call.
謝謝,接線員。各位早安、午安,歡迎參加 Compugen 2026 年第一季財務業績電話會議。今天與會者包括總裁兼執行長 Eran Ophir 博士,以及財務長 David Silberman。醫務長 Michelle Mahler 博士將在問答環節加入我們。
Before we begin, I'd 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 time lines for our programs, including disclosure of clinical data, financial and accounting-related matters as well as statements regarding our cash position and cash runway.
在開始之前,我想提醒各位,在本次電話會議中,公司可能會就未來事件、業務展望、研發工作及其潛在成果、公司的發現平台、預期進展與計畫、我們各項計畫的結果與時間表(包括臨床數據披露)、財務與會計相關事項,以及關於我們現金部位與現金可支撐期間(cash runway)的陳述,提出預測或前瞻性聲明。
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, and we refer you to our 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.
我們提醒各位注意,此類聲明僅反映公司目前的信念、預期與假設,公司的實際結果、表現或成就可能存在重大差異。這些聲明受到已知與未知風險及不確定性的影響;有關這些風險的更多細節,請參閱我們向 SEC 提交的文件,包括公司最近一期的 Form 20-F 年度報告。公司不承擔未來更新任何預測與前瞻性聲明的義務。
With that, I'll now turn the call over to Dr. Eran Ophir, President and CEO.
接下來,我將把電話交給總裁兼執行長 Eran Ophir 博士。
Eran Ophir - President, Chief Executive Officer, Director
Eran Ophir - President, Chief Executive Officer, Director
Thank you, Lindsey, and good morning and good afternoon, everyone. Before I turn to our business update, I want to take a moment to formally welcome Lindsey, our new Head of Investor Relations and Corporate Communications to Compugen. Lindsey joined us with strong experience in Investor Relations, and we are thrilled to have her leading our communication with the investor community. Welcome, Lindsey, and we are glad to have you on board.
謝謝你,Lindsey,各位早安、午安。在我進入業務更新之前,我想先正式歡迎我們新任投資人關係與企業傳播主管 Lindsey 加入 Compugen。Lindsey 在投資人關係方面具備豐富經驗,我們非常高興由她來領導我們與投資人社群的溝通。歡迎你,Lindsey,很高興你加入我們的團隊。
Now let's start with our business update. 2026 is shaping up to be a significant year for Compugen and I'm pleased to share our progress in the first quarter of 2026 as we continue executing on our strategic priorities, starting with our fully owned clinical program, COM701, a potential first-in-class antibody targeting PVRIG, which is an immune checkpoint with unique biology, much differentiated from other checkpoints, including PD-1 and TIGIT. We believe this unique biology underlies the clinical activity demonstrated for COM701 in less inflamed indications such as ovarian cancer.
現在讓我們開始業務更新。2026 年正逐步成為 Compugen 的重要一年,我很高興分享我們在 2026 年第一季的進展;我們持續執行策略優先事項,首先是我們全資擁有的臨床計畫 COM701——一款具潛在同類首創(first-in-class)的抗體,靶向 PVRIG。PVRIG 是一個具有獨特生物學特性的免疫檢查點,與包括 PD-1 與 TIGIT 在內的其他檢查點有明顯差異。我們相信,這種獨特生物學特性是 COM701 在如卵巢癌等較低發炎(less inflamed)適應症中所展現臨床活性的基礎。
As a reminder, at ESMO last year, we presented a pooled analysis of clinical data showing that COM701 in monotherapy and combinations was well tolerated and showed consistent durable responses in patients with heavily pretreated platinum-resistant ovarian cancer. Based on these results, we decided to progress the development of COM701 and test it in earlier settings of ovarian cancer as a maintenance therapy in patients with relapsed platinum-sensitive ovarian cancer that responded to their most recent line of chemotherapy.
提醒各位,去年在 ESMO 上,我們發表了臨床數據的彙總分析,顯示 COM701 單藥與聯合治療均具有良好耐受性,並在接受多線治療的鉑抗性卵巢癌患者中呈現一致且持久的反應。基於這些結果,我們決定推進 COM701 的開發,並在卵巢癌更早期的治療情境中進行測試:作為維持治療,用於復發性鉑敏感卵巢癌患者,且該等患者對其最近一線化療有反應。
The rationale is to allow COM701 to induce its antitumor activity in earlier line patients with lower tumor burden, less compromised immune system and by that, increase the likelihood of these patients to benefit from COM701 unique mode of action. For this purpose, we initiated the MAIA-ovarian adaptive platform trial. In substudy 1 of this trial, COM701 is randomized as maintenance monotherapy versus placebo in patients with relapsed platinum-sensitive ovarian cancer.
其理據在於,讓 COM701 能在腫瘤負荷較低、免疫系統受損較少的較早線患者中誘發其抗腫瘤活性,從而提高患者受益於 COM701 獨特作用機制的可能性。為此,我們啟動了 MAIA-ovarian 適應性平台試驗。在該試驗的子研究 1 中,COM701 作為維持單藥治療,與安慰劑相比,以隨機分派方式用於復發性鉑敏感卵巢癌患者。
We're actively enrolling patients in clinical sites across the United States, Israel and France. Having all sites open and enrolling, spanning leading academic centers in US and Israel as well as sites from the ARCAGY-GINECO French cooperative group gives us confidence in our ability to complete enrollment on schedule for having the MAIA-ovarian median PFS data at interim analysis by Q1 2027. This patient population comprised of those progressing post PARP inhibitors and/or Bev or who are not candidates for such treatments represent a significant unmet medical need with no current standard of care.
我們正在美國、以色列與法國的臨床中心積極招募患者。所有中心均已啟動並進行招募,涵蓋美國與以色列的頂尖學術中心,以及來自法國 ARCAGY-GINECO 合作研究組的研究中心,這使我們對按計畫完成招募充滿信心,並可望在 2027 年第一季的期中分析時取得 MAIA-ovarian 的中位無惡化存活期(PFS)數據。該患者族群包括 PARP 抑制劑和/或 Bev 治療後仍進展者,或不適合此類治療者,屬於重大未被滿足的醫療需求,目前尚無既定標準治療。
We believe that clear prolongation of PFS in these patients could inform a registration path for COM701 and make it a potential backbone for drug combinations in this population while also enabling a potential broader clinical development plan across earlier and later lines of ovarian cancer treatment as well as in other indications for clinical signals previously seen for COM701.
我們相信,若能在這些患者中明確延長 PFS,將可為 COM701 提供註冊(registration)路徑的依據,並使其有望成為此族群藥物聯合治療的基礎用藥(backbone);同時也可支持在卵巢癌治療的更早線與更晚線,以及在其他適應症中(先前已觀察到 COM701 臨床訊號)制定更廣泛的臨床開發計畫。
In addition, we're happy to see our partner AstraZeneca's progress on their broad rilvegostomig program. We remain confident in Rilve's potential based on a differentiated bispecific antibody format in addition to its clinical and combination strategies.
此外,我們也樂見合作夥伴 AstraZeneca 在其廣泛的 rilvegostomig 計畫上取得進展。基於其差異化的雙特異性抗體形式,以及其臨床與聯合治療策略,我們仍對 Rilve 的潛力充滿信心。
Last month, AstraZeneca presented multiple abstracts featuring Rilve at the AACR Annual Meeting in San Diego, reinforcing our confidence in a differentiated design and growing potential. This includes preclinical data demonstrating potential opportunities for Rilve as an IO backbone for combinations and also late-breaking data from the DESTINY-Gastric03 Phase II trial evaluating Rilve in combination with a blockbuster ADC and HER2 and chemotherapy as first-line treatment for HER2-positive gastric cancers. This data showed promising antitumor activity and also demonstrated combinability of Rilve from safety perspective.
上個月,AstraZeneca 在聖地牙哥舉行的 AACR 年會上發表了多篇以 Rilve 為主題的摘要,進一步強化我們對其差異化設計與日益增長潛力的信心。其中包括臨床前數據,顯示 Rilve 作為免疫腫瘤(IO)聯合治療基礎用藥的潛在機會;以及 DESTINY-Gastric03 第二期試驗的最新突破性數據(late-breaking),該試驗評估 Rilve 與一款重磅 ADC、HER2 及化療聯合,作為 HER2 陽性胃癌的一線治療。數據顯示具前景的抗腫瘤活性,並從安全性角度證明 Rilve 具可聯合用藥性。
Overall, these AACR publications continue to reinforce our confidence in Rilve as AZ continue to advance it along 11 Phase III trials across multiple indications, including the recently opened trial in gastric in combination with the Claudin 18.2 ADC. With that, we are looking forward to the release of additional clinical data on Rilve along the year, including at the next ASCO meeting at the end of the month.
整體而言,這些 AACR 發表內容持續強化我們對 Rilve 的信心;AstraZeneca 也持續推進 Rilve,在多個適應症中展開 11 項第三期試驗,包括近期已啟動的胃癌試驗,並與 Claudin 18.2 ADC 聯合。基於此,我們期待今年內將公布更多 Rilve 的臨床數據,包括在本月底的下一場 ASCO 年會上。
As a reminder, AstraZeneca's previously estimated a non-risk-adjusted peak annual revenue potential of more than $5 billion for Rilve and we are eligible for additional $195 million in future regulatory and commercial milestone payments plus mid-single-digit tiered royalties on sales.
提醒各位,AstraZeneca 先前估計 Rilve 在未進行風險調整(non-risk-adjusted)下的年度峰值營收潛力超過 50 億美元;我們亦有資格獲得未來額外 1.95 億美元的監管與商業里程碑款項,以及按銷售額計算的中個位數(mid-single-digit)分級權利金(tiered royalties)。
Moving to GS-0321, formerly known as COM503, our potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead. GS-0321 represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing Phase I dose escalation trial continued to progress as we planned. As a reminder, we received to date $90 million from Gilead for these assets and are eligible to receive up to $758 million in additional milestone payments plus up to double-digit tiered royalties.
接著談 GS-0321(前稱 COM503),這是我們授權給 Gilead 的、具潛在同類首創的抗 IL-18 結合蛋白(IL-18 binding protein)抗體。GS-0321 代表一種利用細胞激素生物學來治療癌症的新型抗體策略,可能克服直接給予細胞激素所帶來的限制。目前進行中的第一期劑量遞增試驗持續按計畫推進。提醒各位,截至目前我們已自 Gilead 收到 9,000 萬美元,並有資格獲得最高達 7.58 億美元的額外里程碑款項,以及最高達雙位數(double-digit)的分級權利金。
Now to the early-stage pipeline and Unigen discovery engine. Beyond our clinical assets, we continue to invest in our early-stage immuno-oncology pipeline. Unigen, our AI-powered computational target discovery platform has already discovered the targets of COM701, COM902, and GS-0321. We remain committed to identifying and advancing the next wave of innovative programs grounded in novel mechanism of action designed to activate the immune system against cancer.
接下來是早期研發管線與 Unigen 發現引擎。除臨床資產外,我們持續投資於早期免疫腫瘤研發管線。Unigen 是我們以 AI 驅動的計算式靶點發現平台,已發現 COM701、COM902 與 GS-0321 的靶點。我們仍致力於辨識並推進下一波創新計畫,這些計畫建立在新穎作用機制之上,旨在啟動免疫系統對抗癌症。
Importantly, we have a solid financial position with a cash runway expected into 2029 following the December 2025 transaction with AZ through which we received $65 million in nondilutive capital by monetizing only a small portion of our future Rilve royalties. Our financial stability allows us to fully focus on advancing our pipeline and reaching key value-creating milestones with both our internal and partnered programs. And throughout all of this, we continue to benefit from a deeply talented and highly committed team here at Compugen. I'm proud of what we have built and energized by the opportunities ahead.
重要的是,我們擁有穩健的財務狀況;在 2025 年 12 月與 AstraZeneca 的交易完成後,我們透過將未來 Rilve 權利金中僅一小部分變現,取得 6,500 萬美元的非稀釋性資金(nondilutive capital),使我們的現金可支撐期間預期可延伸至 2029 年。我們的財務穩定性使我們能全力專注於推進研發管線,並在自有與合作計畫上達成關鍵的價值創造里程碑。在此過程中,我們也持續受益於 Compugen 內部一支才華洋溢且高度投入的團隊。我為我們所建立的一切感到自豪,也對未來的機會充滿動能。
With that, let me hand over to David for the financial update before we open the floor for Q&A.
接下來,在我們開放問答之前,我先把電話交給 David 進行財務更新。
David Silberman - Chief Financial Officer
David Silberman - Chief Financial Officer
Thank you, Eran, and I would like to add my own warm welcome to Lindsey as well. It is a pleasure to have you join the Compugen team, Lindsey, and we look forward to working together. I am pleased to say that we continue to advance into 2026 with a solid balance sheet and financial flexibility. Cash runway, assuming no further cash inflows is expected to fund our operating plans into 2029. We anticipate using this runway to continue advancing our COM701 platinum-sensitive ovarian cancer trial, MAIA-ovarian and to support the progression of GS-0321 in the clinic together with continued investment in our early-stage pipeline.
謝謝你,Eran,我也要一併熱烈歡迎 Lindsey。Lindsey,很高興你加入 Compugen 團隊,我們期待與你合作。我很高興地表示,我們在邁入 2026 年之際,仍維持穩健的資產負債表與財務彈性。在假設沒有進一步現金流入的情況下,現金可支撐期間預期可支持我們的營運計畫至 2029 年。我們預計運用這段期間持續推進 COM701 的鉑敏感卵巢癌試驗 MAIA-ovarian,並支持 GS-0321 在臨床上的推進,同時持續投資於早期研發管線。
Now going into the details, I will start with our cash balance. As of March 31, 2026, we had approximately $134.9 million in cash, cash equivalents, short-term bank deposits and investments in marketable securities. Revenues for the first quarter of 2026 were approximately $2.2 million compared to approximately $2.3 million of revenue for the comparable period in 2025. The revenues in the third quarters of 2026 and 2025 reflect the recognition of both the upfront payment and the IND milestone payments from the license agreement with Gilead.
現在進入細節部分,我先從我們的現金餘額談起。截至2026年3月31日,我們持有約1.349億美元的現金、現金等價物、短期銀行存款以及可交易證券投資。2026年第一季營收約為220萬美元,相較於2025年同期約230萬美元。2026年與2025年第三季的營收反映了與吉利德(Gilead)的授權協議中,預付款以及IND里程碑款項的認列。
Expenses for the first quarter of 2026 were in line with our plans. R&D expenses for the first quarter of 2026 were approximately $6.9 million compared to approximately $5.8 million in the first quarter of 2025. The increase is mainly due to an increase in clinical expenses related to MAIA-ovarian trial as well as higher drug supply costs supporting our trials. Our G&A expenses for the first quarter of 2026 were approximately $2.3 million compared to approximately $2.4 million for the comparable period in 2025.
2026年第一季的費用符合我們的計畫。2026年第一季研發(R&D)費用約為690萬美元,相較於2025年第一季約580萬美元。增加主要是由於與MAIA-ovarian試驗相關的臨床費用上升,以及支持我們試驗的藥品供應成本較高所致。2026年第一季的一般及行政(G&A)費用約為230萬美元,相較於2025年同期約240萬美元。
For the first quarter of 2026, our net loss was approximately $7.7 million or $0.08 per basic and diluted share compared to a net loss of approximately $7.2 million or $0.08 per basic and diluted share in the first quarter of 2025.
2026年第一季,我們的淨虧損約為770萬美元,或每股基本及稀釋虧損0.08美元;相較之下,2025年第一季淨虧損約為720萬美元,或每股基本及稀釋虧損0.08美元。
With that, I will hand over to the operator to open the call for questions.
接下來,我將把時間交給接線員,開放提問。
Operator
Operator
(Operator Instructions) Daina Graybosch, Leerink Partners.
(接線員指示)Daina Graybosch,Leerink Partners。
Daina Graybosch - Analyst
Daina Graybosch - Analyst
Lindsey, welcome. Nice to see you here. Going into ASCO, I wonder if you could talk about more specifically the data sets Astra is going to present with rilvegostomig and help set the context for what we should expect to see? And are there benchmarks that would -- that we should be keeping in mind when we review the data set?
Lindsey,歡迎。很高興在這裡見到你。隨著ASCO臨近,我想請你更具體談談阿斯特捷利康(Astra)將以rilvegostomig呈現哪些資料集,並協助我們建立對於將看到內容的背景脈絡?另外,在我們檢視該資料集時,有沒有一些基準(benchmarks)是我們應該放在心上的?
Eran Ophir - President, Chief Executive Officer, Director
Eran Ophir - President, Chief Executive Officer, Director
Sure. Thanks, Daina. So we're talking about two data sets, clinical data. Obviously, the actual data is not released yet, and I would be cautious on setting expectations on behalf of AstraZeneca. But overall, we talk about around the I-SPY trial in the -- testing rilvegostomig in adjuvant settings with Enhertu, which is by itself a blockbuster drug, which is very exciting to see these combinations.
好的。謝謝你,Daina。我們談的是兩個臨床資料集。顯然實際數據尚未公布,我也會謹慎,不代表阿斯特捷利康去設定預期。不過整體而言,我們談到的是I-SPY試驗中——在輔助治療(adjuvant)情境下,將rilvegostomig與Enhertu合併測試;Enhertu本身就是一款重磅藥物(blockbuster drug),能看到這些組合非常令人振奮。
Again, I would be cautious about setting expectations, but I think looking again -- and this is a platform trial. So really trying to look across not a randomized study, but trying to look about Rilve versus other data sets. The combinability is again going to be very important to show, again, how the Fc-reduced format of rilvegostomig is easier to combine with such ADCs.
同樣地,我會謹慎不去設定預期,但我認為可以再看——而這是一個平台試驗(platform trial)。因此真正要做的是跨資料集來觀察,不是隨機對照研究,而是嘗試比較Rilve與其他資料集。可合併性(combinability)將再次非常重要,用以展示rilvegostomig的Fc降低(Fc-reduced)形式更容易與此類ADC合併使用。
And then the second set is the GEMINI-Hepatobiliary, which is in combination with chemotherapy. And here again, it will be good to see. I think it's a bit of a longer follow-up from what was reported before. So it'd be interesting to see about the long-term effect, how the PFS, how -- I'm not sure if there will be an OS data, but how the long-term effects are shaping, including the long-term safety in combination with chemo, having in mind that there is -- for this trial, there's an ongoing Phase III study ongoing. So I guess the comparison to historical control should be with caution and still probably is going to be made.
第二個資料集是GEMINI-Hepatobiliary,與化療合併。這裡同樣值得觀察。我認為這會是比先前報告更長的追蹤期,因此看到長期效果會很有意思,例如PFS如何、以及——我不確定是否會有OS數據——但長期效果的走向,包括與化療合併的長期安全性。也要記得,該試驗目前仍有一項第三期(Phase III)研究正在進行。因此我想,與歷史對照(historical control)的比較應該要謹慎,但仍可能會被拿來做比較。
Operator
Operator
Stephen Willey, Stifel.
Stephen Willey,Stifel。
Stephen Willey - Equity Analyst
Stephen Willey - Equity Analyst
Maybe you can just talk a little bit about how you're thinking about disclosing future development candidates that are discovered off the Unigen platform. I think the IL-18 binding protein antibody wasn't announced until it was ready for clinical development. Is that kind of how we should expect incremental assets to emerge out of the pipeline once they're ready for an IND submission?
也許你可以談談你們如何思考揭露(disclosing)未來從Unigen平台發現的開發候選項目。我記得IL-18結合蛋白抗體直到準備進入臨床開發時才公布。這是否就是我們應該預期的方式——也就是管線中的新增資產會在準備提交IND時才逐步浮現?
Eran Ophir - President, Chief Executive Officer, Director
Eran Ophir - President, Chief Executive Officer, Director
Thanks, Steve. So I think it's really dependent. Eventually, definitely, the biggest group in Compugen is the one which continue to work to bring additional innovative assets like COM503, which is called today GS-0321. Specifically for that asset, it was right for this asset and for Compugen at these times to out-license it in preclinical stage. So this also influenced the stage in which we disclosed it.
謝謝你,Steve。我認為這真的取決於情況。最終,Compugen最大的團隊確實會持續努力帶來更多創新資產,例如COM503,也就是現在稱為GS-0321。就該資產而言,在當時對該資產以及對Compugen來說,於臨床前階段將其對外授權(out-license)是合適的。因此這也影響了我們揭露它的時點。
It was relatively early. But it doesn't mean necessarily that we have any specific guidelines that you're quoting on early assets only when it's ready for IND or only on the selection. It really depends on the actual assets on the stage of derisking in which you want to start comment and committing.
那相對較早。但這並不代表我們有任何你所提到的特定準則,例如只在準備好IND時才揭露早期資產,或只在完成篩選(selection)時才揭露。這真的取決於具體資產,以及你希望在去風險(derisking)的哪個階段開始評論並做出承諾。
So again, I wouldn't learn too much from the story of IL-18 binding protein other than the fact that it was another demonstration how our computational platform can bring such innovative approaches, in that case, not only first-in-class asset, but a first-in-class approach to harness cytokine biology for the treatment of cancer. And we are looking into different MOAs, not necessarily similar to that to bring, again, another innovative options that could really make difference to patients.
所以,我不會從IL-18結合蛋白的故事中推論太多,除了它再次證明我們的計算平台能帶來這類創新方法;在那個案例中,不僅是同類首創(first-in-class)的資產,也是同類首創的策略,用以運用細胞激素(cytokine)生物學來治療癌症。我們正在研究不同的作用機制(MOAs),不一定與其相似,以再次帶來真正具創新性的選項,並且能對病患產生實質差異。
Operator
Operator
Leland Gershell, Oppenheimer.
Leland Gershell,Oppenheimer。
Leland Gershell - Analyst
Leland Gershell - Analyst
Wondering if -- could you remind us if the MAIA-ovarian trial, is that stratifying for patients who are PD-L1 or PD-1 expression status? And I also want to ask when we see the interim data in the first quarter, will -- given that this is an adaptive trial, would that mean that the interim data could inform some change to your design? Or would you simply keep going as planned?
我想請教——能否提醒我們MAIA-ovarian試驗是否會依PD-L1或PD-1表達狀態對病患進行分層(stratifying)?另外我也想問,當我們在第一季看到期中數據時——鑑於這是一項適應性試驗(adaptive trial),期中數據是否可能促使你們對設計做出一些改變?還是你們會照原計畫繼續進行?
Eran Ophir - President, Chief Executive Officer, Director
Eran Ophir - President, Chief Executive Officer, Director
Thank you, Leland. I think Michelle can take this one.
謝謝你,Leland。我想Michelle可以回答這題。
Michelle Mahler - Chief Medical Officer
Michelle Mahler - Chief Medical Officer
I'm happy to take this one, yes. So the MAIA-ovarian trial actually is not stratified according to PD-L1 subgroup. We are stratified by second versus third line of treatment. And in 1Q '17 (sic â 1Q '27) , when it reads out, we have multiple options ahead of us in terms of adjustments to the trial. So we would consider adding additional arms and a lot of it is going to depend on the totality of the data and also plans towards engaging with the regulators and steps towards a pivotal trial.
我很樂意回答,是的。MAIA-ovarian試驗其實並未依PD-L1亞組進行分層。我們是依第二線(second line)與第三線(third line)治療進行分層。而在2017年第一季(原文誤植——應為2027年第一季)讀出結果時,就試驗調整而言我們有多種選項。因此我們會考慮新增額外的試驗組別(arms),而其中很大一部分將取決於數據的整體性(totality of the data),以及與監管機關互動的規劃與邁向關鍵性試驗(pivotal trial)的步驟。
Eran Ophir - President, Chief Executive Officer, Director
Eran Ophir - President, Chief Executive Officer, Director
So comment telling about the PD-L1 stratification. I would like to remind you that PVRIG probably because of its unique biology, we saw -- in other indication, it's specifically ovarian cancer, we saw responses across PD-L1 positive and PD-L1 negative patients. So for now, we didn't see that necessarily like for other checkpoints that the PD-L1 subset is the one responding to COM701. And again, I think this is because that's unique biology, very much differentiated from TIGIT, PD-1. So again, not necessarily PD-L1 stratification is a typical certification here.
另外補充關於PD-L1分層。我想提醒你,PVRIG可能因其獨特的生物學特性,我們在——在其他適應症中,特別是卵巢癌,我們看到PD-L1陽性與PD-L1陰性病患都有反應。因此目前我們並未看到像其他檢查點(checkpoints)那樣,PD-L1亞群才是對COM701有反應的族群。再者,我認為這是因為其獨特生物學,與TIGIT、PD-1有明顯差異。因此,PD-L1分層在這裡不一定是典型的做法。
Operator
Operator
RK, HC Wainwright.
RK,HC Wainwright。
Swayampakula Ramakanth - Analyst
Swayampakula Ramakanth - Analyst
So a couple more questions on the ovarian cancer trial. So now that you have all the sites active, what is -- any commentary on the enrollment status itself? And also because this is an event-driven trial, any commentary on the required events that needs to happen for the interim analysis? And the third question is, what are you assuming for the control arm PFS? And what sort of a hazard ratio do you need to see to consider that as a win?
關於卵巢癌試驗我還有幾個問題。既然你們現在所有中心都已啟動,能否評論一下入組(enrollment)狀況?另外因為這是一項事件驅動(event-driven)試驗,能否談談期中分析所需發生的事件數(required events)?第三個問題是,你們對對照組PFS的假設是什麼?以及你們需要看到怎樣的風險比(hazard ratio)才會認為這是一個勝利(win)?
Eran Ophir - President, Chief Executive Officer, Director
Eran Ophir - President, Chief Executive Officer, Director
Thanks, RK. Michelle, do you want to take it?
謝謝,RK。Michelle,你要回答嗎?
Michelle Mahler - Chief Medical Officer
Michelle Mahler - Chief Medical Officer
Yes, sure. So firstly, with respect to enrollment, we're not commenting at this point in time, but I will say to you that we are on track for our interim analysis as planned in the first quarter of 2027. And our participating investigators have a high level of engagement and are working really well with us.
好的,當然。首先,關於入組,我們目前不予評論,但我可以告訴你,我們正按計畫推進,將在2027年第一季進行期中分析。我們的參與研究者投入度很高,並且與我們合作得非常順暢。
Regarding the events and the benchmarking, so the trial is an exploratory trial and -- so at this point in time, we don't know the full magnitude of benefit, but the benchmark for the control arm from prior clinical trials in the second line and third line of maintenance in those trials where patients did not get treatment, the same patient population had a benchmark of approximately 5.5 months, although there was a range. So in some studies, it was as low as 3.8 months and others as high as 5.8 months. So we're hoping to be able to show that there is meaningful single-agent clinical activity of COM701. And we've hypothesized that we would like to see a three months or greater improvement over the benchmark PFS.
關於事件數與基準(benchmarking),這是一項探索性試驗(exploratory trial),因此目前我們尚不清楚效益的完整幅度。不過,對照組的基準來自先前臨床試驗中第二線與第三線維持治療(maintenance)的結果;在那些試驗中,病患未接受治療,而相同病患族群的基準約為5.5個月,雖然存在區間差異。有些研究低至3.8個月,另一些則高至5.8個月。我們希望能顯示COM701作為單藥具有具意義的臨床活性。我們的假設是,希望看到相較於基準PFS改善3個月或以上。
Operator
Operator
This concludes the Q&A session and Compugen's investor conference call. Thank you for your participation. You may go ahead and disconnect.
問答環節以及Compugen投資人電話會議到此結束。感謝各位參與。您現在可以掛線。