Compugen Ltd (CGEN) 2023 Q4 法說會逐字稿

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's fourth quarter and full year 2023 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 第四季和 2023 年全年業績電話會議。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 Communication. 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, operator, 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.

謝謝接線員，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。財務長阿爾貝托·塞薩 (Alberto Sessa)；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 the 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、開發工作和潛在結果、公司的發現平台、預期進展和計劃、結果和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 in 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.

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。

And with that, I'll turn the call over to Anat.

然後，我會將電話轉給阿納特。

Thank you, Yvonne, and thanks to everyone for joining our call today. Before we discuss the full year and fourth quarter highlights, I want to start by welcoming the new addition to our management team, Michelle Mahler, who took over the role of Chief Medical Officer on March 1st, 2024.

謝謝你，伊馮，也謝謝大家今天加入我們的電話會議。在我們討論全年和第四季度的亮點之前，我首先要歡迎我們管理團隊的新成員米歇爾·馬勒 (Michelle Mahler)，她於 2024 年 3 月 1 日接任首席醫療官。

I'm really excited to welcome Michelle, an oncologist by training, with extensive experience in leading clinical development in both biotech and pharma companies in and outside of the US. Michelle is an excellent fit for Compugen and will be a great partner to me and a collaborator to the whole team as we work together on executing our programs to accelerate value creation.

我非常高興地歡迎米歇爾，她是一位經過培訓的腫瘤學家，在美國國內外的生物技術和製藥公司領導臨床開發方面擁有豐富的經驗。米歇爾非常適合 Compugen，並將成為我的出色合作夥伴以及整個團隊的合作者，因為我們將共同執行我們的計劃以加速價值創造。

I would like to take this opportunity to thank Henry for his major contributions and commitment to Compugen and his leadership. Henry has been instrumental for the successful transition of Compugen from a preclinical to clinical stage company and creating the growth opportunities in front of us.

我想藉此機會感謝 Henry 對 Compugen 的重大貢獻和承諾以及他的領導。Henry 為 Compugen 從臨床前公司成功轉​​型為臨床階段公司並為我們創造了成長機會發揮了重要作用。

Moving now to the highlights of 2023. Our successes in 2023 and in the last quarter, in particular, position us well as we advance into 2024 and are expected to play an important role in the exciting future and vision for Compugen.

現在讓我們來看看 2023 年的亮點。我們在 2023 年、特別是上個季度的成功，為我們進入 2024 年奠定了良好的基礎，預計將在 Compugen 令人興奮的未來和願景中發揮重要作用。

Firstly, at the end of the year, we executed a preclinical licensing deal with Gilead for a total deal value of up to $848 million including a $60 million upfront payment and $30 million near-term milestone payment and with additional single-digit to low double-digit royalties on future net sales. Delighted by Gilead of COM503, for which we are expected to lead Phase I development further validates our computational discovery, research and development capabilities.

首先，去年年底，我們與吉利德公司簽署了一項臨床前許可協議，交易總價值高達8.48 億美元，其中包括6000 萬美元的預付款和3000 萬美元的近期里程碑付款，以及額外的個位數到低雙位數的付款。- 未來淨銷售額的特許權使用費。我們對 COM503 的吉利德感到很高興，預計我們將領導產品的第一階段開發，這進一步驗證了我們的計算發現、研究和開發能力。

It is also a testament to the differentiation of our antibody program targeting the IL-18 binding protein. The deal process was competitive, which reflects the significant interest in the IL-18 space and highlights the potential of our COM503's differentiated antibody approach. As a reminder, COM503, a potential first-in-class anti-IL-18 binding protein antibody represents a novel way to harness IL-18 pathway biology for the treatment of cancer by using an antibody against IL-18 binding protein and therefore potentially avoiding the challenges presented by (technical difficulty).

這也證明了我們針對 IL-18 結合蛋白的抗體計畫的差異化。交易過程具有競爭性，這反映了人們對 IL-18 領域的濃厚興趣，並凸顯了我們 COM503 差異化抗體方法的潛力。提醒一下，COM503是一種潛在的一流抗IL-18結合蛋白抗體，代表了一種利用IL-18通路生物學透過使用抗IL-18結合蛋白抗體來治療癌症的新方法，因此有可能避免所帶來的挑戰（技術難度）。

Secondly, focusing on execution and advancing the development of our clinical stage assets, we initiated two proof-of-concept clinical studies with our differentiated COM701 combination in platinum-resistant ovarian cancer and metastatic microsatellite stable colorectal cancer. We completed enrollment in the ongoing MSS-CRC study and we significantly ramped up the enrollment of our ongoing PROC study with enrollment of at least 20 patients expected by the end of the first quarter of 2024. In addition, we presented new data at scientific conferences throughout 2023, including preliminary evidence supporting the association between the biomarker, PVRL2 and clinical benefit intended to guide the next step in our development path for COM701 combination.

其次，專注於執行和推進我們臨床階段資產的開發，我們利用我們差異化的 COM701 組合在鉑耐藥性卵巢癌和轉移性微衛星穩定結直腸癌中啟動了兩項概念驗證臨床研究。我們完成了正在進行的 MSS-CRC 研究的招募，並顯著增加了正在進行的 PROC 研究的招募人數，預計到 2024 年第一季末將招募至少 20 名患者。此外，我們還在 2023 年的科學會議上提供了新數據，包括支持生物標記 PVRL2 與臨床獲益之間關聯的初步證據，旨在指導我們 COM701 組合開發道路的下一步。

Thirdly, in the fourth quarter of 2023, our partner, AstraZeneca advanced rilvegostomig their PD-1/TIGIT bispecific, the TIGIT component of which is derived from Compugen's COM902 into Phase III development in biliary tract cancer. Dosing of the first patient in this Phase III trial entitled us to a milestone payment and brings Compugen one step closer to a potentially marketed drug. AstraZeneca's broad clinical investigation of this asset across multiple indications and across various lines of treatment and combinations increases on probability of realizing future milestone payments and royalties.

第三，在2023年第四季，我們的合作夥伴阿斯特捷利康將其PD-1/TIGIT雙特異性藥物推進rilvegostomig，其中TIGIT成分源自Compugen的COM902，進入膽道癌的III期開發。在這項 III 期試驗中，第一位患者的給藥使我們獲得了里程碑式的付款，並使 Compugen 距離潛在上市藥物又近了一步。阿斯特捷資產進行了跨多種適應症、跨多種治療和組合的廣泛臨床研究，增加了實現未來里程碑付款和特許權使用費的可能性。

Finally, the cash received from our licensing deal with Gilead, a milestone met by AstraZeneca in 2023 allow us to move into 2024 with a solid balance sheet. The additional cash we received and the cash we expect to receive upon IND clearance of COM503 is expected to extend our cash runway from the end of 2024 into 2027 and potentially accelerate value creation by enabling us to invest in enhancing our discovery capabilities and advancing our diversified portfolio, including our differentiated COM701, COM902, IO combination strategy, the Phase I development of COM503 and our early-stage innovative pipeline.

最後，我們從與吉利德的授權協議中獲得的現金，這是阿斯特捷利康在 2023 年實現的里程碑，使我們能夠以穩健的資產負債表進入 2024 年。我們收到的額外現金以及我們預計在COM503 IND 審批後收到的現金預計會將我們的現金跑道從2024 年底延長至2027 年，並有可能通過使我們能夠投資於增強我們的發現能力和推進我們的多元化來加速價值創造產品組合，包括差異化的COM701、COM902、IO組合策略、COM503的一期開發以及我們的早期創新管道。

This is an expecting time for Compugen. This is a good segue for me to move to what to expect from us in 2024. 2024 is planned to be a catalyst-rich year for us with multiple data readouts and update expected from our diversified portfolio. In 2024, we plan to share data from our ongoing proof-of-concept study, NSCLC and platinum-resistant ovarian cancer. These are particularly challenging indications to treat and have historically failed to respond to neurotherapy.

這是 Compugen 的期待時刻。對我來說，這是一個很好的話題，可以讓我們展望 2024 年。2024 年對我們來說將是催化劑豐富的一年，我們的多元化投資組合預計將有多個數據讀數和更新。2024 年，我們計劃分享正在進行的非小細胞肺癌和鉑類抗藥性卵巢癌概念驗證研究的數據。這些是特別具有挑戰性的治療適應症，歷史上對神經療法沒有反應。

While we believe that these indications represent a very high bar, we have previously presented encouraging clinical data, supported by immune activation, suggesting that the unique biology of PVRIG enables anti-PD-1 activity in this challenging indications. The goal of these studies is to further substantiate our clinical findings including our initial biomarker results to potentially enable us to move forward with the biomarker and reach development strategy.

雖然我們認為這些適應症代表了一個非常高的標準，但我們之前已經提供了令人鼓舞的臨床數據，並得到免疫活化的支持，表明PVRIG 的獨特生物學特性能夠在這種具有挑戰性的適應症中發揮抗PD-1 活性。這些研究的目標是進一步證實我們的臨床發現，包括我們最初的生物標記結果，使我們有可能推進生物標記並達成開發策略。

Regarding NSCLC, in the first cohort of 22 patients treated with COM701 in combination with nivolumab, we showed an encouraging overall response rate of 12% and stable diseases in patients with liver metastases, a patient population, which historically has not responded to other drugs. For the ongoing proof-of-concept study, our objective is to understand if there could be an additional benefit of adding an anti-TIGIT to the dual combination and further evaluate the combination in the liver metastasis patient population which represents approximately 70% of the patient population in the evaluated line of treatment.

關於NSCLC，在使用COM701 聯合納武單抗治療的第一批22 名患者中，我們顯示出令人鼓舞的12% 的總體緩解率，並且肝轉移患者（歷史上對其他藥物沒有反應的患者群體）的疾病穩定。對於正在進行的概念驗證研究，我們的目標是了解在雙重組合中添加抗TIGIT 是否會帶來額外的好處，並進一步在肝轉移患者群體（約佔肝轉移患者群體的70%）中評估該組合.接受評估的治療線中的患者群體。

The ongoing study fully recruited in 2023 at a speed which we believe reflects the significant unmet need. Data presentation from this ongoing study is planned for the first half of 2024 with the aim to be presented at a medical conference. You can expect to see baseline characteristics, including safety, overall response rate, disease control rate, duration of response and translational data.

正在進行的研究將於 2023 年全面招募，我們認為這一速度反映了嚴重的未滿足需求。這項正在進行的研究的數據計劃於 2024 年上半年公佈，目的是在醫學會議上公佈。您可以期望看到基線特徵，包括安全性、整體緩解率、疾病控制率、緩解持續時間和轉換資料。

In patients with platinum-resistant ovarian cancer, based on the data from the first cohort of 20 patients treated with triple combination, there was a lot of excitement from investigators reporting durable shrinking or stabilization of tumors in some of their patients who had previously progressed on all available treatment options. We believe the totality of the data reported in these patients is encouraging compared to the current standard of care. We presented a 20% overall response rate with patients responding for over 16 months, which is favorable considering median duration of response for single-agent chemotherapy is around three to four months and in ADC is around 6.9 months.

在鉑類抗藥性卵巢癌患者中，根據第一批20 名接受三聯療法治療的患者的數據，研究人員報告了一些先前接受過聯合治療的患者的腫瘤持續縮小或穩定的情況，這讓研究人員非常興奮。所有可用的治療方案。我們相信，與目前的護理標準相比，這些患者報告的整體數據令人鼓舞。我們提出了20% 的整體緩解率，患者的緩解時間超過16 個月，考慮到單藥化療的中位緩解持續時間約為3 至4 個月，而ADC 的中位緩解持續時間約為6.9 個月，這是有利的。

Responses were also achieved in the hard-to-treat high-grade serous adenocarcinoma patients, along with a favorable safety profile. For the ongoing study in platinum-resistant ovarian cancer, we are delighted to report that our investigators are active on recruitment and we expect to complete recruitment of at least 20 patients this quarter and plan to present in the fourth quarter of 2024. Again, our preference will be to present at a medical conference. For this ongoing study, you can expect to see baseline characteristics and data for at least 20 patients, including safety, overall response rate, disease control rate, duration of responses and preliminary biomarker data.

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。對於正在進行的鉑金抗藥性卵巢癌研究，我們很高興地報告，我們的研究人員正在積極招募患者，我們預計本季度完成至少 20 名患者的招募，併計劃在 2024 年第四季度進行展示。同樣，我們更傾向於在醫學會議上發表演講。對於這項正在進行的研究，您預計會看到至少 20 名患者的基線特徵和數據，包括安全性、整體緩解率、疾病控制率、緩解持續時間和初步生物標記數據。

Moving now to COM503. Rapid execution on both COM503 IND clearance and Phase I development is a priority for us and were intensified by Gilead on this priority. We greatly value the partnership with Gilead. And together, we're well advanced on the Phase I trial design and feel confident that we can initiate Phase I shortly after we gain IND clearance. We are on track for IND submission in the second half of 2024 with subsequent initiation of the Phase I study following IND clearance.

現在轉向 COM503。快速執行 COM503 IND 審批和一期開發是我們的首要任務，吉利德強化了這項優先任務。我們非常重視與吉利德的合作。我們一起在第一階段試驗設計方面取得了很大進展，並且相信我們可以在獲得 IND 許可後不久啟動第一階段。我們預計在 2024 年下半年提交 IND，並在 IND 批准後啟動 I 期研究。

Finally, in the second half of 2024, AstraZeneca expects data from their Phase I/II ARTEMIDE-01 trial in non-small cell lung cancer in frontline setting and their Phase II GEMINI trial in hepatobiliary cancer.

最後，阿斯特捷利康預計將在 2024 年下半年獲得一線非小細胞肺癌 I/II 期 ARTEMIDE-01 試驗和肝膽癌 II 期 GEMINI 試驗的數據。

Before handing over to Alberto to go through our financials, I want to emphasize that we will continue to be financially disciplined, while benefiting from our solid cash position to enhance and advance our company.

在交給阿爾貝托檢查我們的財務狀況之前，我想強調，我們將繼續遵守財務紀律，同時受益於我們堅實的現金狀況，以增強和發展我們的公司。

We're strategic with how we deploy our resources, and this will include two main priorities. One, advancing our clinical stage programs, COM701 and COM902 combinations and COM503 upon initiation of its clinical study; and two, investing in Compugen's core competitive advantage, the integration of our computational discovery platform with innovative research and drug development capabilities.

我們對如何部署資源進行策略規劃，其中包括兩個主要優先事項。一、推進我們的臨床階段方案，COM701和COM902組合以及COM503啟動臨床研究；第二，投資 Compugen 的核心競爭優勢，即我們的計算發現平台與創新研究和藥物開發能力的整合。

In terms of COM701 combination, advancing our ongoing studies will be data and biology driven. In PROC, we believe data showing durable responses and additional biomarker correlations are expected to allow us to move ahead employing a predictive biomarker enrichment strategy.

就 COM701 組合而言，我們正在進行的研究的推進將由數據和生物學驅動。在 PROC 中，我們相信顯示持久反應和其他生物標記相關性的數據預計將使我們能夠繼續採用預測性生物標記富集策略。

As a result of the evolving platinum-resistant ovarian cancer treatment landscape, we see the opportunity for COM701 combination to be used in the treatment option in two patient populations, those progressing on ADCs and those ineligible for ADC.

由於鉑類抗藥性卵巢癌治療模式的不斷發展，我們看到 COM701 組合有機會用於兩個患者群體的治療選擇，即正在接受 ADC 治療的患者群體和那些不適合接受 ADC 治療的患者群體。

In MSS-CRC, the bar is very high due to the many failures and the nonresponsive nature of the liver metastasis patient population. We believe the data showing an overall survival advantage over standard of care would be encouraging.

在 MSS-CRC 中，由於許多失敗以及肝轉移患者群體的無反應性質，門檻非常高。我們相信，顯示整體存活優於標準照護的數據將是令人鼓舞的。

Our study in MSS-CRC is still ongoing as some of the patients enrolled only in September '23. And based on data from the overall and the liver metastasis patient population, we will determine the next steps.

我們對 MSS-CRC 的研究仍在進行中，因為有些患者直到 23 年 9 月才入組。根據總體數據和肝轉移患者群體的數據，我們將確定接下來的步驟。

Based on the encouraging safety and efficacy data generated to date, with our COM701 combination across indications, we believe there is an opportunity to collaborate with potential partners to bring COM701 combination to patients across a broad range of indications, generating a potentially large opportunity.

基於迄今為止產生的令人鼓舞的安全性和有效性數據，透過我們的COM701 組合跨適應症，我們相信有機會與潛在合作夥伴合作，將COM701 組合帶給廣泛適應症的患者，從而產生潛在的巨大機會。

For the second main priority, we will continue to invest in the engine powering our core competitive advantage. We're skilled and highly experienced in integrating cutting-edge computational capabilities with ground-breaking immuno-oncology research and drug development expertise to discover novel drug targets.

第二個重點，我們將繼續投資於驅動我們核心競爭優勢的引擎。我們在將尖端計算能力與突破性的免疫腫瘤學研究和藥物開發專業知識相結合以發現新的藥物標靶方面擁有熟練的技術和豐富的經驗。

Investing to enhance our computational discovery platform from computer prediction to early-stage programs, we believe, will enable us to progress the generation of novel drug candidates, the next COM503.

我們相信，投資增強我們的計算發現平台（從電腦預測到早期程序）將使我們能夠推進新型候選藥物（下一個 COM503）的生成。

And finally, our focus remains on non-diluted funding for which we have demonstrated in 2023, we can successfully execute on.

最後，我們的重點仍然是非稀釋資金，我們已經在 2023 年證明了我們可以成功執行這些資金。

With that, I turn the call over to Alberto.

說完，我把電話轉給了阿爾貝托。

Thank you, Anat. I'm delighted to say that we advanced into 2024 with a solid balance sheet. This is a result of competent accomplishments on the collaboration front in 2023, securing non-dilutive funding, which was always our priority. With cash at end to date and the milestone payment we expect to receive upon IND clearance of COM503, we expect to extend our cash runway to support our operating plans into 2027.

謝謝你，阿納特。我很高興地說，我們以穩健的資產負債表邁入了 2024 年。這是 2023 年合作方面取得的顯著成就的結果，確保非稀釋性資金始終是我們的首要任務。憑藉截至目前的現金以及我們預計在 COM503 的 IND 批准後收到的里程碑付款，我們預計將擴大我們的現金跑道以支持我們到 2027 年的營運計劃。

Going into the details, I will start with our cash balance. As of December 31, 2023, we had approximately $51.1 million in cash, cash equivalents, restricted cash and cash investments compared with approximately $83.7 million as of December 31, 2022.

詳細介紹時，我將從我們的現金餘額開始。截至2023年12月31日，我們擁有約5,110萬美元的現金、現金等價物、限制性現金和現金投資，而截至2022年12月31日約為8,370萬美元。

The cash balance at the end of 2023 does not include the receipt of $60 million upfront payment from Gilead for our COM503 preclinical license and $10 million milestone payments from AstraZeneca on dosing the first patient in the Phase III trial.

2023 年底的現金餘額不包括吉利德為 COM503 臨床前許可支付的 6000 萬美元預付款，以及阿斯特捷利康為 III 期試驗中第一位患者給藥而支付的 1000 萬美元里程碑付款。

In addition, in 2024, we expect to receive from Gilead, an additional $30 million milestone payment upon COM503 IND clearance. I would like to remind you that all payments from Gilead are subject to 15% withholding tax. The company has no debt. As Anat mentioned, we understand the importance of our cash balance and we are financially disciplined.

此外，我們預計在 2024 年 COM503 IND 獲得批准後，我們將收到吉利德額外 3000 萬美元的里程碑付款。我想提醒您，吉利德的所有付款均需繳納 15% 的預扣稅。公司沒有負債。正如阿納特所提到的，我們了解現金餘額的重要性，並且我們遵守財務紀律。

Based on our current plans, we expect that our current cash, together with the milestone payment payable upon COM503 IND clearance will be sufficient to fund our operating plans into 2027. The cash run rate reflects the planned development of our clinical assets and continued investments in our early innovative pipeline.

根據我們目前的計劃，我們預計我們目前的現金以及 COM503 IND 批准後應付的里程碑付款將足以為我們到 2027 年的營運計劃提供資金。現金運行率反映了我們臨床資產的計劃開發以及對早期創新管道的持續投資。

On the revenues front, we reported approximately $33.5 million in revenues for the fourth quarter of 2023 and for the year ended December 31, 2023, compared to $7.5 million in revenues for each of the comparable periods in 2022.

在收入方面，我們報告 2023 年第四季和截至 2023 年 12 月 31 日的年度收入約為 3350 萬美元，而 2022 年每個可比較期間的收入均為 750 萬美元。

The revenues for the year ended December 31st, 2023, include the portion of the upfront payment from the license agreement with Gilead allocated to the license and the clinical milestones from the license agreement with AstraZeneca in the amount of $10 million.

截至2023年12月31日的年度收入包括與吉利德許可協議中分配給許可的預付款部分以及與阿斯特捷利康許可協議中的臨床里程碑部分，金額為1000萬美元。

Now moving to expenses. R&D expenses for the fourth quarter of 2023 and for the year ended December 31st, 2023, were $10.9 million and $34.5 million, respectively, compared with $7.3 million and $30.6 million for the comparable period in 2022.

現在轉向支出。2023年第四季及截至2023年12月31日止年度的研發費用分別為1,090萬美元及3,450萬美元，而2022年同期的研發費用為730萬美元及3,060萬美元。

The increase in 2023 is mainly due to lower amortization of the deferred participation in R&D expenses following the termination of the agreement with BMS, offset by decrease in headcount related expenses. Research and development expenses as of the percentage of the total operating expenses were approximately 78% in 2023 compared to 73% in 2022.

2023 年的成長主要是由於與 BMS 協議終止後遞延參與研發費用的攤銷減少，但被員工人數相關費用的減少所抵銷。2023年研發費用佔總營業費用的比例約為78%，而2022年為73%。

Our G&A expenses for the fourth quarter of 2023 and for the year ended December 31st, 2023, were $2.5 million and $9.7 million, respectively, compared with approximately $2.5 million and approximately $10.3 million for the comparable period in 2022.

我們2023年第四季和截至2023年12月31日的年度的一般管理費用分別為250萬美元和970萬美元，而2022年同期約為250萬美元和約1030萬美元。

Finally, on net loss. For the fourth quarter of 2023, we report a net profit of $9.7 million or $0.11 per basic and diluted share compared to a net loss of $3.1 million or $0.04 per basic and diluted share in the comparable period of 2022.

最後，關於淨虧損。2023 年第四季度，我們報告淨利潤為 970 萬美元，即每股基本股和稀釋股 0.11 美元，而 2022 年同期淨虧損為 310 萬美元，即每股基本股和稀釋股 0.04 美元。

Net loss for the year ended December 31st, 2023, was $18.8 million or $0.21 per basic and diluted share compared with a net loss of $33.7 million or $0.39 per basic and diluted share in the comparable period of 2022.

截至 2023 年 12 月 31 日的年度淨虧損為 1,880 萬美元，即每股基本股和稀釋股 0.21 美元，而 2022 年同期的淨虧損為 3,370 萬美元，即每股基本股和稀釋股 0.39 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。

Thanks, Alberto. To summarize, 2023 was a very successful year for Compugen, both on the execution front and the validation of our computation discovery and development capabilities, including the exciting preclinical license deal with Gilead for our IL-18 BP immunology program, the initiation of two proof-of-concept studies in presentation of preliminary predictive biomarker data with our unique and innovative triple IO combination and progress by our partner at AstraZeneca initiating a Phase III trial with rilvegostomig.

謝謝，阿爾貝托。總而言之，2023 年對於Compugen 來說是非常成功的一年，無論是在執行方面還是在我們的計算發現和開發能力的驗證方面，包括與吉利德公司就我們的IL-18 BP 免疫學項目達成的令人興奮的臨床前許可協議、兩項證據的啟動透過我們獨特和創新的三重IO 組合呈現初步預測生物標誌物數據的概念研究，以及我們在阿斯特捷利康的合作夥伴啟動rilvegostomig 的III 期試驗的進展。

Our accomplishments in 2023 position us well for catalyst to reach 2024 and with an extended cash runway expected into 2027, which we believe will support the development of our clinical assets and novel early-stage pipeline. Partnering remains an important part of our strategy and we'll continue to focus on collaborating to extend the reach of our potentially first-in-class medicines to cancer patients and to accelerate value creation.

我們在 2023 年的成就使我們能夠成為 2024 年目標的催化劑，並預計將現金跑道延長至 2027 年，我們相信這將支持我們臨床資產和新型早期管道的開發。合作仍然是我們策略的重要組成部分，我們將繼續專注於合作，將我們潛在的一流藥物的覆蓋範圍擴大到癌症患者，並加速價值創造。

I would like to thank all our colleagues here as confidence for their passion and commitment to our success in 2023 and their dedication and readiness to drive for success in 2024.

我要感謝我們在座的所有同事，感謝他們對我們 2023 年成功的熱情和承諾，以及他們對推動 2024 年成功的奉獻和準備。

With that, I will turn the call over to questions. Operator?

這樣，我將把電話轉入提問環節。操作員？

(Operator Instructions) Asthika Goonewardene, Truist.

（操作員指示）Asthika Goonewardene，真理論者。

Hey, guys. Good morning and thanks for taking my questions and congrats on all the progress that have been made. Totally agree, looking forward to seeing how the catalyst play out this year, this will be a very interesting year for the company. Anat, I just wanted to check in on the colorectal cancer data, which I'm sure I think everyone on the call is probably assuming that we could see that around ASCO. Perhaps I missed this, will you have biomarker data in that presentation? I know you said you have some translational data, but just want to specifically clarify if there will be biomarker data that you can tie to response?

大家好。早安，感謝您提出我的問題，並祝賀所取得的所有進展。完全同意，期待看到今年的催化劑如何發揮作用，這對公司來說將是非常有趣的一年。Anat，我只是想查看結直腸癌數據，我確信我認為參加電話會議的每個人可能都認為我們可以在 ASCO 周圍看到這一點。也許我錯過了這一點，您在該簡報中會有生物標記數據嗎？我知道您說過您有一些翻譯數據，但只是想具體澄清是否有可以與回應相關的生物標記數據？

So it's a very good question. And we did say that will relate to translational. I want to remind you that with the prior cohort of 22 patients where we disclosed the data already in '23, we did not share biomarker correlations. We did not see biomarker correlations in CRC with the prior cohort. If we'll have anything to report in the -- with the next cohort, we'll do that. But I think that it's fair to say, to mention that up until now, we did not see in the prior cohort biomarker correlations. Eran, is there anything that you want to add on this front?

所以這是一個非常好的問題。我們確實說過這與翻譯有關。我想提醒您，對於我們在 23 年就已披露的 22 名患者的先前隊列，我們沒有分享生物標記相關性。我們沒有看到 CRC 與先前隊列的生物標記相關性。如果我們有什麼要報告的，我們會在下一批中報告。但我認為可以公平地說，到目前為止，我們在先前的隊列生物標記相關性中還沒有看到。Eran，您在這方面還有什麼要補充的嗎？

No. As always, we're doing a lot of efforts in all fronts to analyze both correlation to response and pharmacodynamic markers. And then whatever will be relevant by the time of the presentation will be shared.

不。一如既往，我們在各方面都做了很多努力來分析與反應和藥效標記物的相關性。然後，在演示時相關的任何內容都將被共享。

Thanks.

謝謝。

Got it. And then with the platinum-resistant ovarian cancer data that will be presented later on this year. At the time of the presentation, I know you will have some preliminary biomarker work. But can you talk about what maybe your plans are the next steps then in terms of developing a potential companion diagnostic?

知道了。然後是今年稍後將公佈的鉑金抗藥性卵巢癌數據。在演示時，我知道您將進行一些初步的生物標記工作。但您能否談談在開發潛在的伴隨診斷方面您的下一步計劃是什麼？

I think that it's fair to say that we're now at the stage that we're looking, as we said last time, we're optimizing the assay, while we're testing the samples that we have in place, those that we already tested and new ones. The aim is to be able to set a cut-off and to have an assay that we can use. It does not necessarily need to be a companion diagnostic level in terms of the assay itself, assay in order to be used in clinical trials. So we will -- if the data will repeat itself, and we'll see correlation. We'll make sure that we have an assay that can be used to select patients in a clinical trial. Not necessarily, this will be the assay that will be used eventually, if everything goes well as a companion diagnostics in the market. Just to make sure that this is clear. But if data looks good, we'll make sure that we'll have the assay to select patients ready.

我認為可以公平地說，我們現在正處於我們正在尋找的階段，正如我們上次所說，我們正在優化檢測，同時我們正在測試我們現有的樣本，那些我們已經準備好的樣本。已經測試過的和新的。目的是能夠設定一個截止值並進行我們可以使用的檢測。就測定本身而言，它不一定需要是伴隨診斷水平，以便在臨床試驗中使用。所以我們會——如果數據會重複，我們就會看到相關性。我們將確保我們擁有一種可用於在臨床試驗中選擇患者的檢測方法。不一定，如果市場上一切順利的話，這將是最終使用的檢測方法。只是為了確保這一點清楚。但如果數據看起來不錯，我們將確保準備好檢測方法來選擇患者。

Great. Thanks so much, guys. Thanks for taking my questions. I’ll hop back in queue.

偉大的。非常感謝，夥計們。感謝您回答我的問題。我會重新排隊。

Thank you, Asthika.

謝謝你，阿斯提卡。

Daina Graybosch, Leerink.

戴娜·格雷博斯，萊林克。

Hi. I just kind of have a follow-up to Asthika there. And that to my ear, it sounds like Anat, you're emphasizing the biomarker enrollment strategy much more in this earnings call than you have in many quarters. So what changed, data or strategy-wise, that's leading to that change in emphasis?

你好。我只是對 Asthika 有一個後續行動。在我看來，阿納特（Anat）在這次財報電話會議上比在許多季度中更加強調了生物標誌註冊策略。那麼，數據或策略方面發生了什麼變化，導致了重點的變化呢？

So I think, first, I don't know that we emphasize more, but at least I'll say how we see path forward in light of potential data and in light of the competitive landscape. I think that we all recognize how the competitive landscape -- competitive treatment landscape is changing over time with mirvetuximab and also maybe additional ADCs and we understand that with the biomarker, we may have an edge. And having a biomarker I think plays -- will allow us to go into a study that is well designed, gives us a higher probability of success, maybe a smaller study.

所以我認為，首先，我不知道我們強調更多，但至少我會說我們如何根據潛在數據和競爭格局看待前進的道路。我認為我們都認識到，隨著時間的推移，米維妥昔單抗以及其他 ADC 的競爭格局——競爭性治療格局正在發生變化，我們也知道，有了生物標誌物，我們可能擁有優勢。我認為擁有一個生物標記物可以讓我們進行一項精心設計的研究，讓我們有更高的成功機率，也許是一個規模較小的研究。

We believe that a biomarker will give us an edge. So not implying anything with respect to potential data outcomes. And as you know, we're still enrolling patients, we are only anticipating to complete enrollment by the end of the quarter. I think that it's natural for us looking at the competitive landscape to try to look for places where we can see an edge to ourselves. I will also add, other than the biomarker, we also understand that there are now two populations that we may target. This is those that are progressing on ADCs and those that are not eligible for ADCs. And we're also looking to see where we may have an edge also on these two populations. So maybe that would give some more color on the focus of this call.

我們相信生物標誌物會為我們帶來優勢。因此，並不暗示任何有關潛在數據結果的資訊。如您所知，我們仍在招募患者，我們預計在本季末完成招募。我認為，在競爭格局中，我們自然會嘗試尋找能夠看到自己優勢的地方。我還要補充一點，除了生物標記之外，我們還了解到，現在我們可以針對兩個人群。這是那些在 ADC 上取得進展的專案和那些不符合 ADC 資格的專案。我們也在尋找我們在這兩個群體上可能有優勢的地方。因此，也許這會為這次電話會議的焦點帶來更多色彩。

And then maybe one follow-up. I think I heard you say at the end in your wrap up that you're looking to partner COM701 with other companies, potentially in other novel combinations? Are you thinking any specific novel combinations? Or can you talk more about that strategy?

然後也許還有一個後續行動。我想我聽到你在總結的最後說，你正在尋求與其他公司合作，可能以其他新穎的組合方式與 COM701 合作？您是否正在考慮任何特定的新穎組合？或者你能多談談這個策略嗎？

I think, look, partnering COM701 and COM902 and/or COM902 was always something that we took into consideration, and that's because we're not intending to take the program alone to the market. And I think that today, with the data that we have in place, which is kind of broad across indications, all of these indications that we show data is really hard-to-treat tumor types, where we were able to show durable responses on the patients, with the patients that responded, good tolerability that allows for combinations.

我認為，看，COM701 和 COM902 和/或 COM902 的合作始終是我們考慮的事情，這是因為我們不打算單獨將該程式推向市場。我認為，今天，根據我們現有的數據，這些數據涉及廣泛的適應症，我們顯示數據的所有這些適應症確實是難以治療的腫瘤類型，我們能夠在這些適應症上顯示出持久的反應患者以及有反應的患者俱有良好的耐受性，可以進行聯合治療。

We're thinking not only on what we're doing internally, but we are also thinking about how to broaden the opportunities for our drugs. And we recognize the fact that there is, obviously, as a small biotech company, there is a limit to what we can do and for us, broadening the opportunities through collaborations is a priority. So that's it. I will let Eran relate more to the mechanism of action, potential combination strategy based on this mechanism of action and the tolerable safety profile. Eran, maybe you want to add a few things about it.

我們不僅考慮我們內部正在做的事情，而且還在考慮如何擴大我們藥物的機會。我們認識到，作為一家小型生物技術公司，我們能做的事情顯然是有限的，對我們來說，透過合作擴大機會是我們的首要任務。就是這樣了。我會讓 Eran 更了解其作用機制、基於該作用機制的潛在組合策略以及可容忍的安全性。Eran，也許你想補充一些相關內容。

Yes. So we've shown quite extensive with the PVRIG's unique checkpoint and that blocking PVRIG which can sensitize tumor to TIGIT and PD-1. So and this is what we're testing, right, the triplet combination, which is an IO, pure combination, extremely safe, very good tolerability profile and hope to see the signals mature, and we'll share it later this year. But of course, the potential is out there. It could be combined with chemotherapies, it could be combining earlier lines of therapy. I mean this mechanism of action of PVRIG could be relevant also in many other aspects, providing a relatively safe approach that could drive T cells into the tumor, and we believe this could be combined also in regardless of the triplet combination we are pursuing.

是的。因此，我們已經展示了相當廣泛的 PVRIG 獨特檢查點以及阻斷 PVRIG 的能力，該檢查點可以使腫瘤對 TIGIT 和 PD-1 敏感。這就是我們正在測試的，對吧，三元組組合，這是一個 IO，純粹的組合，極其安全，非常好的耐受性，希望看到信號成熟，我們將在今年晚些時候分享。但當然，潛力是存在的。它可以與化療結合，也可以與早期的療法結合。我的意思是，PVRIG 的這種作用機制也可能與許多其他方面相關，提供一種相對安全的方法，可以驅動T 細胞進入腫瘤，而且我們相信，無論我們正在追求什麼三聯體組合，這也可以結合起來。

Great. Thank you.

偉大的。謝謝。

Stephen Willey, Stifel.

史蒂芬威利，斯蒂菲爾。

Good morning. Thanks for taking the questions. I think you may have mentioned it on the call, but can you just maybe speak to, I guess, the efficacy metrics. I know there's a lot of talk about the biomarker directed strategy. But can you speak a little bit to the efficacy data that you're going to be kind of using out of the colorectal trial to make a new growth decision. And I guess I asked the question because of the historical disconnect here that tends to exist between response rate and event-driven data in this tumor type. And then, I guess, there's obviously a lot of different IO-based regimens that are pursuing the non-liver met population. Is that something that is of interest to you to look at as a potential development opportunity? Or do you think that landscape has kind of become a bit too crowded?

早安.感謝您提出問題。我想你可能在電話會議上提到過這一點，但我想你能談談功效指標嗎？我知道有很多關於生物標誌物導向策略的討論。但是您能談談您將使用結直腸試驗來做出新的生長決策的功效數據嗎？我想我問這個問題是因為這種腫瘤類型的反應率和事件驅動數據之間往往存在歷史脫節。然後，我想，顯然有很多不同的基於 IO 的治療方案正在針對非肝臟疾病族群。您是否有興趣將其視為潛在的發展機會？或者您認為景觀變得有點太擁擠了？

So I think that it's fair to say that when we're looking at what -- how we will judge our data, it's really with respect to the benchmarks and what would be relevant based on the standard -- based on standard of care, but also based on other clinical trials. I think that -- and let me share relate to it, but I think that it's a fair point that you raised the data that we were seeing in the data that we've disclosed already is really data within the liver met population that was intriguing for us because really, this is a very hard to treat patient population. Really, there are no agents there that are really targeting this patient population. And I think that when we will have our data in front of us, we will look at the overall population, but we will also take a close look at the liver met, where we believe there we have an edge. So I'll let Michelle speak about how we may look at our data as compared to benchmarks.

所以我認為可以公平地說，當我們考慮如何判斷我們的數據時，這實際上是關於基準以及基於標準的相關內容——基於護理標準，但也基於其他臨床試驗。我認為——讓我分享與之相關的內容，但我認為你提出了我們在我們已經披露的數據中看到的數據是一個公平的觀點，這些數據實際上是肝臟代謝人群中的數據，這很有趣對我們來說，因為實際上，這是一個非常難以治療的患者群體。事實上，那裡沒有真正針對這群患者的藥物。我認為，當我們將數據擺在我們面前時，我們將關注總體人口，但我們也會仔細研究肝臟，我們相信我們在這方面具有優勢。因此，我將讓米歇爾談談我們如何看待我們的數據與基準的比較。

Great. Thank you. Thanks for the question. I think that you made a very good point, and we think about the data quite similarly. So in early stage clinical trials, as you know, we often look at overall response rates as a way to test whether there's a proof-of-concept. And it's often seen as a target for other end points that are related to progression-free survival and overall survival. But I think also in these hard-to-treat populations, we cannot ignore the sustained, stable disease responders, keeping in mind that once a lot of these drugs go on to Phase III registration studies, the primary endpoints are no longer overall response rate. And many times, they're reporting out a primary endpoint of overall survival.

偉大的。謝謝。謝謝你的提問。我認為你的觀點非常好，我們對數據的看法非常相似。因此，如您所知，在早期臨床試驗中，我們經常將整體回應率視為測試是否存在概念驗證的一種方法。它通常被視為與無惡化存活期和總存活期相關的其他終點的目標。但我認為，在這些難以治療的族群中，我們也不能忽視持續、穩定的疾病反應者，請記住，一旦許多這些藥物進入 III 期註冊研究，主要終點就不再是整體反應率。很多時候，他們會報告整體生存的主要終點。

So when we look at single-arm studies, we have to interpret survival endpoints with the limitations that we have, knowing that our data sets are small, single-arm studies, but we also have to keep in mind the big picture in terms of what are the registration end point. And so I think it's important not to ignore the patients that have sustained responses of stable disease, and that's where the disease control rate becomes relevant in looking at the data. So we will look at the totality of the data to be able to make these go/no-go decisions and we will also look at it with an eye towards what will be the survival benchmarks as the landscape is evolving. And with that I think happy to elaborate if you have additional questions.

因此，當我們研究單臂研究時，我們必須根據我們所擁有的局限性來解釋生存終點，因為我們知道我們的數據集是小型單臂研究，但我們也必須牢記以下方面的大局：註冊終點是什麼？因此，我認為重要的是不要忽視對穩定疾病有持續反應的患者，這就是疾病控制率在查看數據時變得重要的地方。因此，我們將查看全部數據，以便能夠做出這些繼續/不繼續的決定，並且我們還將著眼於隨著情況的發展，生存基準將是什麼。如果您還有其他問題，我想很樂意詳細說明。

And then I just guess, any interest, specifically in maybe looking at the non-liver met population in a bit more granular detail? I know you probably only have a handful of these patients represented in the proof-of-concepts.

然後我只是猜測，是否有興趣，特別是有興趣更詳細地研究非肝病族群？我知道概念驗證中可能只有少數患者。

So I just want to clarify that you're talking about the patients without liver metastases because that data is actually targeted to the most difficult-to-treat patient population. So in the data that was previously presented, 75% of the patient population has liver metastases which is.

所以我想澄清一下，你談論的是沒有肝轉移的患者，因為這些數據其實是針對最難治療的患者族群。因此，在先前提供的數據中，75% 的患者群體存在肝轉移。

Yes.

是的。

Over that, right? But there's obviously a subgroup of non-liver met patients that are now being pursued by a variety of companies with a various number of IO-based regimens.

就這樣吧？但顯然有一個非肝病患者亞組現在正在被多家公司採用​​各種基於 IO 的治療方案進行治療。

Okay. So given what we're seeing and what we've presented in our patients with liver mets, it still remains an area of focus for us. I think just, Steve, I'll just add that we recognize the fact that there is not a lot of data there for liver met at all. I think that there is some data maybe by (inaudible) studies relating to overall survival, median overall survival of 8.7 months, et cetera. We're taking all of this into consideration. I mean overall response rate is not there at all for liver met. And we will look at our overall response rate. We do expect that in our patient population, we have the same representation of the population in terms of the liver met, most of the, more than 70% of the patients in this line of treatment that we are enrolling are having liver met. So we expect that we have the same representation in this. And we will take a careful look at this patient population because we do think that we may have an edge there.

好的。因此，考慮到我們所看到的情況以及我們在肝代謝症候群患者中所呈現的情況，它仍然是我們關注的一個領域。我想，史蒂夫，我只想補充一點，我們認識到這樣一個事實，即根本沒有太多關於肝臟的數據。我認為可能有一些與總存活期、中位總存活期 8.7 個月等相關的（聽不清楚）研究得出的數據。我們正在考慮所有這些。我的意思是肝臟代謝物的整體緩解率根本不存在。我們將查看我們的整體回應率。我們確實預計，在我們的患者群體中，我們在肝臟滿足方面具有相同的人群代表性，我們正在招募的這條治療線中的大多數（超過 70%）患者都患有肝臟滿足。所以我們希望我們在這方面有相同的表現。我們將仔細研究這個患者群體，因為我們確實認為我們可能在這方面具有優勢。

Okay. And then I guess on the partnering optionality front, can you just remind us, are you exclusive with Astra on COM902? Or is that just specific to the use of bispecific antibodies incorporating the TIGIT domain? And I guess I just asked the question because I mean, obviously, Gilead just made a fairly strong vote of confidence in an Fc-silent TIGIT. I know that there's probably some scarcity value around that so.

好的。然後我想在合作選擇方面，您能否提醒我們，您在 COM902 上與 Astra 獨家合作嗎？或者這只是特定於包含 TIGIT 結構域的雙特異性抗體的使用？我想我只是問這個問題，因為我的意思是，很明顯，吉利德剛剛對 Fc 沉默的 TIGIT 投了相當強烈的信任票。我知道這可能有一些稀缺價值。

So totally, the latter, the latter. So AstraZeneca has the right to use the COM902 segment in their bispecifics. So they got the rights to develop bispecific based on our COM902. We own COM902. We also kept to ourselves right for certain bispecifics that we have an interest in. So for example, the TIGIT PVRIG or TIGIT PVRL2 with our COM902 is our -- we do -- we totally relate to COM902 as an asset. It's nice to say that you noted that you mentioned the Fc question, which we were always saying, always that its either do not matter -- does not matter or that if it matters, then it should be a silent one. And we're happy to see that there is data now supporting it.

所以完全是後者，後者。因此阿斯特捷利康有權在其雙特異性藥物中使用 COM902 片段。所以他們獲得了基於我們COM902開發雙特異性的權利。我們擁有COM902。對於我們感興趣的某些雙特異性抗體，我們也保留了自己的權利。例如，帶有 COM902 的 TIGIT PVRIG 或 TIGIT PVRL2 是我們的——我們確實——我們完全將 COM902 作為一項資產。很高興你注意到你提到了 Fc 問題，我們總是說，它要么不重要——不重要，要么如果重要，那麼它應該是一個沉默的問題。我們很高興看到現在有數據來支持它。

We own COM701 and COM902. We believe that these are good partnering opportunities. We have our own plans to move ahead with these assets internally, obviously, in a data-driven manner, in a biology-driven manner. But we do think that these are drug assets that can generate collaboration opportunities for us. And we will intend to proceed because we believe that with partners, we can broadly test them. And as -- I answered today, but I think that one of the key things that should be mentioned. We tested COM701, COM902 combination in the most hard-to-treat patient populations.

我們擁有COM701和COM902。我們相信這些都是很好的合作機會。我們有自己的計劃，以數據驅動的方式、生物學驅動的方式在內部推進這些資產。但我們確實認為這些藥物資產可以為我們創造合作機會。我們打算繼續進行，因為我們相信與合作夥伴一起，我們可以廣泛地測試它們。正如我今天回答的那樣，但我認為這是應該提到的關鍵事情之一。我們在最難治療的患者群體中測試了 COM701、COM902 組合。

It gives us an edge. You can test it in single-arm studies, but one cannot ignore that these assets have a potential in the inflamed tumor type and this is a great opportunity based on the data that we have and the data that we have supporting COM701 driven effect, we believe that it could serve as good partnering opportunities. And hopefully the TIGIT data that is out there and that will be out there by the companies that are leading this field will allow us to clear the air for TIGIT at least to understand that there is a benefit by adding TIGIT to PD-1 and that there is a third component that is needed. And I think that the world starts to say that there is a third component that is needed and we believe that it's PVRIG. So, yes, on partnering front, that's how we think about it.

它給了我們一個優勢。您可以在單組研究中對其進行測試，但不能忽視這些資產在發炎腫瘤類型中具有潛力，根據我們擁有的數據以及支持 COM701 驅動效應的數據，這是一個很好的機會，我們相信這可以成為良好的合作機會。希望現有的以及該領域領先公司將提供的 TIGIT 數據能夠讓我們為 TIGIT 掃清障礙，至少讓我們了解將 TIGIT 添加到 PD-1 中會帶來好處，並且還需要第三個組件。我認為世界開始說需要第三個組件，我們相信它是 PVRIG。所以，是的，在合作方面，這就是我們的想法。

Okay. Thanks for taking the questions.

好的。感謝您提出問題。

Thank you.

謝謝。

This concludes the Q&A session and Compugen's investor conference call. Thank you for your participation. You may go ahead and disconnect.

問答環節和 Compugen 投資者電話會議到此結束。感謝您的參與。您可以繼續並斷開連線。