Agenus Inc (AGEN) 2025 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good morning, and welcome to Agenus Inc.'s first-quarter 2025 earnings conference call. (Operator Instructions)

    早安,歡迎參加 Agenus Inc. 2025 年第一季財報電話會議。(操作員指示)

  • As a reminder, this conference is being recorded.

    提醒一下,本次會議正在錄製中。

  • I will now hand the call over to Zack Armen, Head of Investor Relations. Please go ahead.

    我現在將電話交給投資者關係主管 Zack Armen。請繼續。

  • Zack Armen - Head of Investor Relations, Corporate Development

    Zack Armen - Head of Investor Relations, Corporate Development

  • Thank you, operator. Welcome to Agenus' first-quarter 2025 financial results and corporate update call. Earlier today, we issued a press release detailing our financial results and key corporate developments. A copy of the press release is available on our website at www.investor.agenusbio.com.

    謝謝您,接線生。歡迎參加 Agenus 2025 年第一季財務表現及公司最新動態電話會議。今天早些時候,我們發布了一份新聞稿,詳細介紹了我們的財務表現和公司的主要發展。新聞稿副本可在我們的網站 www.investor.agenusbio.com 上查閱。

  • Before we begin, I'd like to remind everyone that today's discussion will include forward-looking statements. These statements are subject to risks and uncertainties, which may cause actual results to differ materially from expectations. Please refer to our SEC filings for further detail.

    在我們開始之前,我想提醒大家,今天的討論將包括前瞻性陳述。這些聲明受風險和不確定性的影響,可能導致實際結果與預期有重大差異。請參閱我們的美國證券交易委員會 (SEC) 文件以了解更多詳細資訊。

  • Joining me today are Garo Armen, PhD, Chairman and CEO; Dr. Steven O’Day, MD, Chief Medical Officer; Robin Taylor, PhD, Chief Commercial Officer; Richard Goldberg, MD, Chief Development Officer; and Christine Klaskin, VP, Finance and Principal Financial and Accounting Officer.

    今天與我一起出席的還有董事長兼首席執行官 Garo Armen 博士、首席醫療官 Steven O’Day 醫學博士、首席商務官 Robin Taylor 博士、首席開發官 Richard Goldberg 醫學博士以及財務副總裁兼首席財務會計官 Christine Klaskin。

  • Now I'll turn the call over to Dr. Garo Armen.

    現在我將電話轉給 Garo Armen 博士。

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, everybody. Thank you for joining us today. Before we start on today's call, I will cover 6 priorities or I should say we will collectively cover six priorities. First, we are going to present to you the newest BOT/BAL data, validating durable responses in historically untreatable cold tumors. And I might stress that we're talking about new data and more mature data.

    謝謝大家。感謝您今天加入我們。在我們開始今天的電話會議之前,我將討論 6 個優先事項,或者我應該說我們將共同討論 6 個優先事項。首先,我們將向您展示最新的 BOT/BAL 數據,驗證歷史上無法治療的冷腫瘤的持久反應。我想強調的是,我們正在討論新數據和更成熟的數據。

  • We're going to talk about the strategic hire of Dr. Richard Goldberg and his mandate to steer our regulatory path. Next, we'll talk about operational efficiencies that are on track to cut our operational cash burn to below $50 million annualized in the second half of this year.

    我們將討論理查德·戈德堡博士的策略聘用以及他指導我們監管路徑的職責。接下來,我們將討論營運效率,以便在今年下半年將我們的營運現金消耗削減至每年 5,000 萬美元以下。

  • And fourth, four formal near-term transaction proposals that we have received including an Emeryville facility sale, a significant equity investment at a big premium and 2 BOT/BAL licensing deals, each individually or in combination are designed to materially strengthen our balance sheet. And lastly, the changes in the new FDA policies that could favor rapid approval of transformative therapies and our recent request for a Type B meeting and we will provide you with some details as to the rationale of this.

    第四,我們收到了四項正式的近期交易提案,包括埃默里維爾設施出售、高額溢價的大量股權投資和兩項 BOT/BAL 許可交易,每一項單獨或組合都旨在大幅增強我們的資產負債表。最後,FDA 新政策的變化可能有利於快速批准轉化療法,以及我們最近提出的 B 類會議請求,我們將向您提供有關其基本原理的一些詳細資訊。

  • So before I get into the business update, I'd like to acknowledge a critical and growing public health crisis. This underpins everything we do at Agenus. Colorectal cancer is on the rise, particularly among younger people under the age of 50. Colorectal cancer incidences have doubled in the US adults under 55 from 1995 to 2019, less than 25 years.

    因此,在介紹業務更新之前,我想先承認一個嚴重且日益嚴重的公共衛生危機。這是我們在 Agenus 所做的一切的基礎。大腸直腸癌的發生率呈上升趨勢,尤其是在 50 歲以下的年輕人身上。1995年至2019年,不到25年間,美國55歲以下成年人的大腸癌發生率翻了一番。

  • By 2030, colorectal cancer is projected to become the leading cause of cancer-related death in men under 50 in the United States. These younger patients, especially need treatments other than chemotherapy, radiation and life-altering surgeries, particularly in the young. This is important for the young and the old, but particularly in the young, these life-altering treatments can have a lasting devastating effect. And hence, they deserve an alternative, without life-changing side effects. And that's what we think we offer to patients.

    到 2030 年,預計大腸癌將成為美國 50 歲以下男性癌症死亡的主要原因。這些年輕患者尤其需要化療、放療和改變生活的手術以外的治療,尤其是年輕人。這對年輕人和老年人都很重要,但尤其對於年輕人來說,這些改變生活的治療可能會產生持久的毀滅性影響。因此,他們應該得到一種替代方案,而不會產生改變生活的副作用。這就是我們認為我們為患者提供的服務。

  • These younger patients, the new leadership is particularly aware of this. The new leadership at HHS and the FDA recognize this grim reality of today's treatment. One of the President's first actions with Senator -- I'm sorry, Secretary Kennedy was to set up the Make America Healthy Again Commission, which is set to ensure and issue its report any day now. Secretary Kennedy has pledged to root out conflicts of interest.

    這些較年輕的患者,新領導階層尤其意識到了這一點。衛生與公眾服務部和 FDA 的新領導層認識到當今治療的嚴峻現實。總統與參議員——抱歉,是甘迺迪國務卿——採取的首批行動之一就是成立「讓美國再次健康」委員會,該委員會將於近日確保並發布其報告。甘迺迪國務卿承諾要根除利益衝突。

  • And FDA Commissioner, Dr. Marty Makary has repeatedly stressed the need to accelerate approval of meaningful treatments. I underline meaningful treatments. This shift in regulatory environment is deeply encouraging to us. And for the entire research community discovering and developing novel and effective therapies. So it's an exciting time for us and some of our peers.

    FDA 局長 Marty Makary 博士也多次強調加快批准有意義的治療方法的必要性。我強調有意義的治療。監管環境的這種轉變對我們來說是極大的鼓舞。並為整個研究界發現並開發新穎有效的治療方法。因此,對於我們和我們的一些同行來說,這是一個令人興奮的時刻。

  • We have new data, new leadership, new efficiencies and a new environment at the FDA and the government. So we'll talk about these one by one. For botensilimab and balstilimab, which we call BOT/BAL, as you know, we are generating consistent and compelling data across different lines of treatment, both in the neoadjuvant setting and in later line. And across multiple cold tumors that have historically defined standard immuno-oncology therapies. These include MSS colorectal cancer, a huge problem, certain breast cancers, sarcomas, hepatocellular carcinoma and many more.

    我們擁有新的數據、新的領導、新的效率以及 FDA 和政府的新環境。因此我們將逐一討論這些問題。對於我們稱為 BOT/BAL 的 botensilimab 和 balstilimab,如您所知,我們正在新輔助治療和後期治療的不同治療線上產生一致且令人信服的數據。並且跨越了歷史上已定義標準免疫腫瘤療法的多種冷腫瘤。其中包括 MSS 大腸直腸癌(一個巨大的問題)、某些乳癌、肉瘤、肝細胞癌等等。

  • At AACR 2025, two weeks ago, there was a groundbreaking presentation by Dr. Myriam Chalabi, of the Netherlands Cancer Institute. He presented results from the investigator-sponsored study of NEOASIS, in cancer study. Remember, this is many different types of cancers in the neoadjuvant setting. And if you remember, so far, prior to this, we have generated data in the neoadjuvant setting of colon cancer.

    在兩週前的 AACR 2025 上,荷蘭癌症研究所的 Myriam Chalabi 博士做了一次開創性的演講。他介紹了由研究人員發起的 NEOASIS 癌症研究的結果。請記住,新輔助治療中存在多種不同類型的癌症。如果您還記得的話,到目前為止,在此之前,我們已經在結腸癌的新輔助治療中產生了數據。

  • So this takes that concept and broadens it to many other cancers. The study showed pathological complete responses across multiple cancers. No dose-limiting toxicities and all patients proceeded to surgery on schedule.

    因此,我們將這一概念擴展到許多其他癌症。研究顯示多種癌症均獲得了病理完全緩解。沒有劑量限制性毒性並且所有患者均按計劃進行手術。

  • Very important. As Dr. Chalabi stated, these findings substantiate the importance of this immunotherapy in early treatment settings or I should say, earlier treatment settings, because these patients are not really early cancer patients, they are Stage III and highlight the broad potential utility of this combination to what she was speaking of BOT/BAL.

    非常重要。正如 Chalabi 博士所說,這些發現證實了這種免疫療法在早期治療環境中的重要性,或者我應該說,在更早的治療環境中,因為這些患者並不是真正的早期癌症患者,他們是 III 期,並突出了這種組合對她所說的 BOT/BAL 的廣泛潛在效用。

  • In liver cancer, Dr. Anthony El-Khoueiry, Chief of section of developmental therapeutics at the USC Norris Comprehensive Cancer Center presented Phase I data in HCC cohort data of BOT/BAL in patients heavily pretreated with available therapies including PD-L1 blockade plus Avastin, which are the standard of care in last line and still demonstrated deep and durable disease control. Very important for patients.

    在肝癌領域,南加州大學諾里斯綜合癌症中心發展治療科主任 Anthony El-Khoueiry 博士介紹了 BOT/BAL 在肝細胞癌隊列中的 I 期數據,這些患者曾接受過大量現有療法治療,包括 PD-L1 阻斷加 Avastin,這些療法是最後一線治療的標準,並且仍然表現出深度和持久的疾病控制。對於患者來說非常重要。

  • Let me talk about our new leadership. And of course, we have fantastic leadership but this is new leadership to be added on. To support this next phase of development, we welcome Dr. Richard Goldberg, a world renowned GI oncology expert as our Chief Development Officer. His leadership will be pivotal as we advance towards regulatory filings in metastatic CRC and other tumor types.

    讓我來談談我們的新領導階層。當然,我們擁有出色的領導力,但這是需要補充的新領導力。為了支持下一階段的發展,我們歡迎世界知名的胃腸道腫瘤學專家理查德·戈德堡博士擔任我們的首席開發官。在我們推動轉移性大腸直腸癌和其他類型腫瘤的監管備案工作時,他的領導力將發揮關鍵作用。

  • Dr. Goldberg recently authored a guest editorial in the cancer letter, arguing that IO approvals should be customized to spare patients unnecessary, life-changing toxicity, the same theme that we talked about. Rather than speak on his behalf, I'd like to invite him to share his perspectives directly with us today. Dr. Goldberg?

    Goldberg 博士最近在《癌症通訊》上發表了一篇客座評論,認為免疫療法的批准應該進行定制,以避免患者遭受不必要的、改變生活的毒性,這也是我們討論的主題。今天,我並不是想代表他發言,而是想請他直接與我們分享他的觀點。戈德堡博士?

  • Richard Goldberg - Chief Development Officer

    Richard Goldberg - Chief Development Officer

  • Thank you, Garo, for that kind introduction. Five years ago, I stepped away from formal leadership roles in academic oncology and from active clinical practice. That time has allowed me to support companies working on new treatments for GI cancer and to deepen my involvement in patient advocacy.

    謝謝 Garo 的熱情介紹。五年前,我辭去了腫瘤學學術的正式領導職務和積極的臨床實踐。那段時間讓我能夠支持一家致力於胃腸道癌症新療法的公司,並加深我對患者權益的參與。

  • But throughout that time, I keep hearing the same message from patients, from their families and from colleagues, we need better treatments, especially for colorectal cancer. People want more time, better time and ultimately, they want hope for a cure. This need is a especially acute for patients with MSS colorectal cancer, where existing immunotherapies have offered little benefit.

    但在此期間,我不斷從病人、家屬和同事那裡聽到同樣的訊息,我們需要更好的治療方法,特別是針對大腸直腸癌。人們希望有更多的時間、更好的時間,最終他們希望獲得治癒的希望。對於患有 MSS 大腸癌的患者來說,這種需求尤其迫切,因為現有的免疫療法對這些患者幾乎沒有好處。

  • As an adviser, I've had the opportunity to evaluate many programs. What stood out about Agenus and what ultimately brought me back into a full-time leadership role was a potential for BOT and BAL. This combination represents one of the most promising advances I've seen in my career.

    作為顧問,我有機會評估許多項目。Agenus 的突出之處以及最終讓我重返全職領導職位的原因是 BOT 和 BAL 的潛力。這種結合是我職業生涯中見過的最有希望的進步之一。

  • It has the potential to shift outcomes, not just in colorectal cancer, but across a range of difficult-to-treat solid tumors, which represent the biggest challenges in achieving cancer cure. The opportunity to help move these agents forward to gain FDA approval and make them accessible to oncologists and patients across the world is what's compelled me to reenter the field.

    它有可能改變治療結果,不僅是結腸直腸癌,還包括一系列難以治療的實體腫瘤,這些腫瘤是實現癌症治癒的最大挑戰。有機會幫助這些藥物獲得 FDA 批准,並讓世界各地的腫瘤學家和患者都能使用,這促使我重新進入該領域。

  • I'm excited to be here, and I look forward to working with the exceptional team at Agenus to bring forward new hope and meaningful treatments for our patients. These patients especially need treatments other than chemotherapy and radiation and life-altering surgeries. They deserve an alternative without life-changing side effects. The new leadership at HHS and FDA recognize this.

    我很高興來到這裡,並期待與 Agenus 的優秀團隊合作,為我們的患者帶來新的希望和有意義的治療。這些患者尤其需要化療、放療和改變生活的手術以外的治療。他們應該得到一個不會改變生活的副作用的替代方案。HHS 和 FDA 的新領導層認識到了這一點。

  • Thank you, Garo.

    謝謝你,Garo。

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you very much, Richard. It's a real privilege to have you on board, given your career, and given the fact that you know this disease inside out, and you have been gracious enough to invest the time to really understand our data inside out. And so with that kind of endorsement, we're very grateful for your leadership in our next chapter.

    非常感謝,理查德。考慮到您的職業,考慮到您對這種疾病的透徹了解,並且您慷慨地投入時間來徹底了解我們的數據,我們非常榮幸您能加入我們。因此,有了這樣的支持,我們非常感謝您在我們下一章中所扮演的領導角色。

  • As we indicated in our March call, we are on track to cut our annualized operational cash burn below $50 million in the second half of 2025. This is going to free resources to unlock BOT/BAL and its full potential, not just in colorectal cancer, but beyond because as we mentioned, BOT/BAL is a very powerful IO agent that shows activity.

    正如我們在 3 月電話會議上所指出的,我們預計在 2025 年下半年將年度營運現金消耗削減至 5,000 萬美元以下。這將釋放資源來釋放 BOT/BAL 及其全部潛力,不僅在結直腸癌領域,而且在其他領域也是如此,因為正如我們所提到的,BOT/BAL 是一種表現出活性的非常強大的 IO 藥物。

  • And this is corroborated by some of the leading experts across different cancers that are familiar with IO. So before we move on to the financial review by Christine, let me address capital strategy head on. Over the past several weeks, Agenus has received four formal written proposals that would inject or should have the potential to inject substantial new capital.

    一些熟悉IO的不同癌症領域的頂尖專家也證實了這一點。因此,在我們繼續討論克里斯汀的財務審查之前,讓我先來談談資本策略。在過去幾週內,Agenus 收到了四份正式的書面提案,這些提案將注入或有可能注入大量新資本。

  • The proposals would allow us to monetize on our state-of-the-art Emeryville biologics facility. Each of these proposals also have the potential to expand into broader strategic collaborations. A third proposal offers a significant equity investment at a meaningful premium to our current share price. And a fourth contemplates a BOT/BAL licensing agreement with upfront cash, milestones and double-digit royalties.

    這些提議將使我們能夠利用我們最先進的埃默里維爾生物製劑設施賺錢。每項提議也都有可能擴展為更廣泛的策略合作。第三個提議是提供一筆大額股權投資,其價格比我們目前的股價有顯著溢價。第四個方案是考慮簽訂 BOT/BAL 授權協議,其中包括預付現金、里程碑付款和兩位數的版稅。

  • Our Board and our advisers are evaluating these proposals with a high sense of urgency, I might add, and we anticipate announcing at least one of these transactions in the coming days or maybe a few weeks. Any of them would materially strengthen our balance sheet while preserving long-term upside for shareholders and most importantly, accelerating our mission to bring life-saving therapies to patients. With strong scientific momentum, we remain equally focused on operational discipline.

    我想補充的是,我們的董事會和顧問正在高度緊迫地評估這些提議,我們預計將在未來幾天或幾週內宣布至少其中一項交易。其中任何一個都會大大增強我們的資產負債表,同時為股東保留長期的利益,最重要的是,加速我們為病人帶來拯救生命的療法的使命。在強大的科學發展動能下,我們同樣注重操作紀律。

  • With that, I will turn it over to Christine to briefly review the financials. Christine?

    說完這些,我將把任務交給克里斯汀,讓她簡單回顧一下財務狀況。克里斯汀?

  • Christine Klaskin - Vice President - Finance

    Christine Klaskin - Vice President - Finance

  • Thank you, Garo. We ended the first quarter 2025 with a consolidated cash balance of $18.5 million compared to $40.4 million at year-end 2024. Cash used in operations for the first quarter ended March 31, 2025, was $25.6 million which is reduced from $38.2 million for the same period in 2024. For the first quarter ended March 31, 2025, we recognized revenue of $24.1 million and incurred a net loss of $26.4 million or $1.03 per share.

    謝謝你,Garo。截至 2025 年第一季度,我們的綜合現金餘額為 1,850 萬美元,而 2024 年底為 4,040 萬美元。截至 2025 年 3 月 31 日的第一季度,營運現金使用量為 2,560 萬美元,低於 2024 年同期的 3,820 萬美元。截至 2025 年 3 月 31 日的第一季度,我們確認營收 2,410 萬美元,淨虧損 2,640 萬美元或每股 1.03 美元。

  • For the first quarter of 2024, we recognized revenue of $28 million and incurred a net loss of $63.5 million or $3.04 per share. Our revenue primarily includes noncash royalty revenue.

    2024 年第一季度,我們營收 2,800 萬美元,淨虧損 6,350 萬美元,即每股 3.04 美元。我們的收入主要包括非現金特許權使用費收入。

  • I'll turn the call back now to Garo to close out the call.

    我現在將電話轉回給 Garo 以結束通話。

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you very much, Christine. So in closing for all the reasons we've discussed today, which include new data, new leadership, new efficiencies and a new regulatory environment in addition to anticipated near-term corporate transactions. We believe Agenus offers a great deal for patients and all stakeholders. It is for these reasons that on May 5, Agenus formally requested a Type B meeting with the FDA for BOT/BAL. Our dossier built on rigorous data from more than 1,200 patients.

    非常感謝,克里斯汀。因此,最後,我們今天討論的所有原因包括新數據、新領導、新效率和新的監管環境以及預期的近期企業交易。我們相信 Agenus 為病患和所有利害關係人提供了巨大的利益。正是由於這些原因,5 月 5 日,Agenus 正式要求與 FDA 舉行 BOT/BAL 的 B 類會議。我們的檔案建立在 1,200 多名患者的嚴格數據之上。

  • And now that is with a two-year follow-up, showing deep and durable responses and these deep and durable responses, by the way, are the hallmarks of effective IO treatment, as our Chief Medical Officer, has always said. And so we believe our dossier meets every statutory criteria for potential accelerated approval. We're hopeful that the agency will engage promptly and judge our submission and its merits.

    現在經過兩年的跟踪,顯示出深度和持久的反應,順便說一句,這些深度和持久的反應是有效的 IO 治療的標誌,正如我們的首席醫療官一直所說的那樣。因此,我們相信我們的檔案符合所有可能獲得加速批准的法定標準。我們希望該機構能夠及時介入並評判我們的提交及其優點。

  • Our conviction in BOT/BAL's curative potential has never been stronger, and our team is absolutely resolved in delivering this breakthrough to patients who have waited far too long, far too long. Thank you very much for your continued support and attention.

    我們對 BOT/BAL 治療潛力的信念從未如此堅定,我們的團隊決心為等待太久、太久的患者帶來這一突破。非常感謝您一直以來的支持與關注。

  • And operator, we are ready for questions now.

    接線員,我們現在可以回答問題了。

  • Operator

    Operator

  • (Operator Instructions) Emily Bodnar, H.C. Wainwright.

    (操作員指示)Emily Bodnar,H.C. Wainwright。

  • Emily Bodnar - Analyst

    Emily Bodnar - Analyst

  • I guess to start with your commentary about regulatory interactions. How much like longer-term follow-up you have from the Phase II study? And have you hit on the overall survival endpoint yet? And then assuming that you speak to them, if they come back and say that you still need the Phase III study, can you comment on your ability to run a Phase III study and what that might look like?

    我想先從您對監管互動的評論開始。您對第二階段研究的長期追蹤有多深入?您是否已經達到整體存活終點了?然後假設你與他們交談,如果他們回覆說你仍然需要第三階段研究,你能否評論一下你進行第三階段研究的能力以及它可能會是什麼樣子?

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Sure. So I will ask Dr. Steven O'Day to comment on the longer-term efficacy data. And perhaps, I can ask Dr. Buell, who has graced us with her presence today in addition to her responsibilities at MiNK. As you know, she is the Chairman of the Executive Board of Agenus and overseeing all of our regulatory efforts on the Phase II -- on Phase III question. Dr. O'Day .

    當然。因此,我將請 Steven O'Day 博士對長期療效數據進行評論。或許,我可以問問 Buell 博士,她今天不僅在 MiNK 負有職責,還很榮幸來到我們這裡。如您所知,她是 Agenus 執行委員會主席,負責監督我們在第二階段和第三階段問題上的所有監管工作。奧戴博士。

  • Steven Oday - Chief Medical Officer

    Steven Oday - Chief Medical Officer

  • Thank you, Emily. So last year, when we presented to the FDA our data set, both our Phase I and our Phase II was in July based on a March data cut.

    謝謝你,艾米麗。因此,去年,當我們向 FDA 提交我們的數據集時,我們的第一階段和第二階段都是基於三月的數據在七月進行的。

  • So we'll have approximately one more year of data, both in our Phase I and our Phase II. The median follow-up for the Phase I, which now includes 123 patients is 18 months, a substantial increase in duration from last year. The Phase II trial has approximately just over 12 months of median follow-up, also significantly more than it did last year.

    因此,我們將擁有大約一年以上的數據,包括第一階段和第二階段的數據。第一階段的追蹤時間中位數為 18 個月,目前包括 123 名患者,比去年的追蹤時間大幅增加。第二階段試驗的中位追蹤時間約 12 個月多一點,也比去年長很多。

  • So the combination of both our Phase I and Phase II data with the longer follow-up will obviously be a significant factor in the next review with the FDA.

    因此,我們的 I 期和 II 期數據與更長的追蹤相結合顯然將成為 FDA 下次審查的一個重要因素。

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, Steven. And also remember, what's remarkable about these three seemingly separate studies that is Phase I cohort one, Phase I cohort two, and Phase II is the consistency of data across the board, which obviously makes the results much more credible.

    謝謝你,史蒂文。還要記住,這三個看似獨立的研究,即第一階段隊列一、第一階段隊列二和第二階段,其顯著之處在於數據的全面一致性,這顯然使結果更可信。

  • And in terms of our next steps, as you know, last year, when we had the meeting with the FDA, they made, in our opinion, an erroneous judgment based on a paper that was published, which excluded some clinical references and some critical data. And of course, this is not their fault. But because they have a lot on their plate.

    關於我們的下一步行動,如您所知,去年我們與 FDA 會面時,我們認為他們根據發表的一篇論文做出了錯誤的判斷,該論文排除了一些臨床參考文獻和一些關鍵數據。當然,這不是他們的錯。但因為他們有很多事情要做。

  • But this erroneous decision resulted in them telling us that perhaps this study, even with longer-term follow-up may not be adequate for approval. But what is very clear and [starkingly] clear to us is that the longer-term follow-up is very indicative of survival benefit. I mean, these patients, you can follow up for two year, five years, at some point, you need to give in and say, this is indicative of survival. And so, this is what we're basically making a point on. And Dr.

    但這個錯誤的決定導致他們告訴我們,也許這項研究即使經過長期追蹤也可能不足以獲得批准。但對我們來說非常清楚且[非常]清楚的是,長期追蹤非常能顯示出生存益處。我的意思是,這些病人,你可以追蹤兩年、五年,在某個時候,你需要讓步並說,這表明他們還活著。所以,這就是我們基本上要表達的觀點。還有博士。

  • Goldberg, of course, looked at all of this data and concurred with this conclusion. That's one of the reasons he's here, otherwise, this very, very -- accomplishments would have been very difficult to bring in from his so-called retirement at a young age. So I'm going to pass it on to Dr. Buell now to make comments about Phase III because, of course, we're making plans for Phase III, but the question becomes what indication and what types of Phase III trials we're pursuing. Dr.

    當然,戈德堡查看了所有這些數據並同意這一結論。這是他來到這裡的原因之一,否則,他年紀輕輕就退休了,要取得這樣的成就將非常非常困難。所以我現在要把它交給 Buell 博士,讓他對第三階段發表評論,因為當然,我們正在為第三階段製定計劃,但問題是我們正在進行什麼適應症和什麼類型的第三階段試驗。博士

  • Buell?

    布埃爾?

  • Jennifer Buell - Independent Director

    Jennifer Buell - Independent Director

  • So thanks very much, Garo. I'm just going to reiterate a couple of points here, Emily. You're quite aware of the work that we've done, and I think it's an important time. We're grateful for the agency's partnership as we concluded our July meeting last year. And now we're -- as they requested, we're coming back with additional data.

    非常感謝,Garo。艾米麗,我只是想在這裡重申幾點。您非常清楚我們所做的工作,我認為這是一個重要的時刻。在去年 7 月會議結束時,我們非常感謝該機構的合作。現在我們——按照他們的要求,帶回了更多數據。

  • And Steven just mentioned, we have more than 40% additional patients, more patients on the Phase I with very mature follow-up. And then, of course, an additional year of follow-up on the randomized Phase II, which did include a standard of care arm. We expect to present data on these data sets at a major upcoming conference that will be near term.

    史蒂文剛才提到,我們有超過 40% 的額外患者,更多患者處於 I 期研究,後續研究非常成熟。然後,當然,還要對隨機 II 期研究進行額外一年的跟踪,其中包括標準護理組。我們期望在即將召開的一次重要會議上展示這些資料集的資料。

  • So you'll have a sense of the depth and durability of the responses. But as Garo mentioned, previously, the FDA had mentioned to us again, this was a year ago that the advised submission of the results, and this is specifically an outcome of the meeting.

    這樣你就會感受到回應的深度和持久性。但正如 Garo 先前提到的,FDA 曾再次向我們提及,這是一年前建議提交的結果,這是會議的具體成果。

  • Due to the modest overall response rates and the fact of the ability of the response rates to reasonably predict a meaningful benefit for patients. Now the reasons this response is really quite surprising to us was that given the clinical outcomes that we submitted at the time, we've demonstrated more than fourfold -- four to fivefold improvement in tumor shrinkage or response rates and a more than doubling of overall survival in this very hard to treat cancer.

    由於整體反應率適中,且反應率能夠合理地預測患者的有意義的益處。現在,這種反應確實讓我們感到非常驚訝,因為根據我們當時提交的臨床結果,我們已經證明腫瘤縮小或反應率提高了四倍多——四到五倍,並且這種極難治療的癌症的總體生存率提高了一倍多。

  • And since then, now near a year later, our data have further matured, reinforcing and extending the clinical impact in which, in fact, we've got some patients out beyond four years with no progression. So we're really quite excited to bring the data back to the agency. And I think with this new evolving administration we share the urgency to bring new medicines to patients, particularly, in this growing prevalent disease right now that's impacting the young as well.

    從那時起,現在已經過去將近一年了,我們的數據進一步成熟,強化並擴大了臨床影響,事實上,我們已經讓一些患者在四年多的時間裡沒有任何進展。因此,我們非常高興將數據帶回該機構。我認為,在這個不斷發展的新政府中,我們同樣迫切地需要為患者提供新的藥物,特別是針對這種目前日益流行的疾病,這種疾病也影響著年輕人。

  • As far as next steps, we'll also talk with the agency about our randomized design. We're presenting two different approaches to the agency because we have, quite frankly, as Garo mentioned, parties who are really interested in helping us accelerate the development of these for patients with the highest unmet need for which there are currently no available therapies and for patients building on what you observe from the ASCO-TI data and Myriam Chalabi's data in patients in the earliest disease neoadjuvant disease.

    至於下一步,我們也將與該機構討論我們的隨機設計。我們向該機構提出了兩種不同的方法,因為坦率地說,正如 Garo 提到的那樣,我們確實有興趣幫助我們加速這些藥物的開發,這些藥物適用於目前尚無可用療法的未滿足需求最高的患者,以及根據您從 ASCO-TI 數據和 Myriam Chalabi 的早期疾病新輔助疾病患者的數據中觀察到的患者。

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, Jen. So as we all know, besides the important box-checking regulations, rules and regulations. Drugs have to be demonstrated to be efficacious. In other words, they're active and they're safe. I mean safety is, of course, relative to the patient population that we're going after.

    謝謝你,Jen。眾所周知,除了重要的勾選規定、規章制度之外。必須證明藥物是有效的。換句話說,它們很活躍,而且很安全。我的意思是,安全性當然是與我們所追求的患者群體相關的。

  • And one of the most striking features of BOT/BAL is that in the neoadjuvant setting, the efficacy is black and white because we're not aware of very many agents out there, let alone IO agents that within a span of four to eight weeks result in complete resolution of the tumor. And this is what we have seen visually and in terms of pathologic complete responses in the neoadjuvant setting.

    BOT/BAL 最顯著的特徵之一是,在新輔助治療中,其療效是非黑即白的,因為我們不知道有多少種藥物,更不用說在四到八週內導致腫瘤完全消退的 IO 藥物了。這就是我們在新輔助治療中從視覺和病理完全反應所看到的。

  • As to -- as Jen talked about in the late line setting, I think she was being modest by calling the response rate modest. Of course, she also mentioned that it is 3, 4 times better than anything out there because, as you know, in late line setting, response rates of approved products out there range from 1% to a maximum of 7%. And depending on the patient population, we're at least twice that, in most cases 3 times that with a longevity of the durable responses which should translate to survival benefit.

    至於 — — 正如 Jen 在後期設置中談到的那樣,我認為她稱響應率為適中,這是很謙虛的。當然,她也提到,它比現有的任何產品都要好 3 到 4 倍,因為如你所知,在後期設定中,批准產品的回應率範圍從 1% 到最高的 7%。並且根據患者族群的不同,我們至少會將治療時間延長兩倍,在大多數情況下會延長三倍,持久反應的時間會轉化為存活益處。

  • So that's the specific nuance here. Thank you.

    這就是這裡的具體細微差別。謝謝。

  • Operator

    Operator

  • Mayank Mamtani, B. Riley Securities.

    Mayank Mamtani,B. Riley 證券。

  • Mayank Mamtani - Analyst

    Mayank Mamtani - Analyst

  • Pleased to see Dr. Goldberg join the team here. Are you able to discuss any development plan changes or update in light of the recent AACR update thinking your NEOASIS trial did have some non-CRC patients like TNBC and also obviously, you have the late line HCC cohort update.

    很高興看到 Goldberg 博士加入我們的團隊。您是否能夠根據最近的 AACR 更新討論任何開發計劃變更或更新,認為您的 NEOASIS 試驗確實有一些非 CRC 患者,例如 TNBC,而且顯然您有晚期 HCC 隊列更新。

  • So I was just curious how -- as you go into a Type B meeting, some of these non-CRC tumor types kind of play a role in your longer-term development strategy? Or are you just very focused on CRC to get this meeting very focused on CRC? If you could clarify, I have a follow-up.

    所以我很好奇——當您參加 B 型會議時,這些非 CRC 腫瘤類型在您的長期發展策略中發揮著怎樣的作用?或者您只是非常關注 CRC,以使這次會議非常關注 CRC?如果你能澄清一下,我會跟進。

  • Richard Goldberg - Chief Development Officer

    Richard Goldberg - Chief Development Officer

  • So we believe that the shortest distance between presentation and approval is in the colorectal cancer setting. And there are two settings where we believe that this is important, one is in refractory disease, either a third or fourth line therapy. And one of the interesting observations from the emerging data is that the response rate looks the same in third line and in fourth line.

    因此,我們相信,從展示到批准之間的最短距離是在結直腸癌環境中。我們認為在兩種情況下這一點很重要,一種是難治性疾病,要不是三線治療,就是四線治療。從新出現的資料中可以觀察到的一個有趣現像是,第三行和第四行的回應率看起來相同。

  • So that, I think, makes it clear that the mechanism of action of these drugs is divergent from the other drugs that patients have been exposed to. And the other area that we're excited about is in the neoadjuvant setting.

    因此,我認為這清楚地表明這些藥物的作用機制與患者接觸過的其他藥物不同。我們感興趣的另一個領域是新輔助治療。

  • As you may be aware, there was a recent presentation from the team at Memorial Sloan Kettering on their MSI-high patients are showing activity in both MSI-high colon cancer and MSI-high non-colorectal cancers. And we believe that our approach is going to expand that indication to the much larger subset of patients who are microsatellite stable, who are not MSI-high.

    您可能知道,紀念斯隆凱特琳癌症中心的團隊最近做了一個報告,報告顯示他們的 MSI 高患者在 MSI 高結腸癌和 MSI 高非結直腸癌中都表現出活性。我們相信,我們的方法將把這種適應症擴展到微衛星穩定、MSI 非高的更大患者群體。

  • But the path that they have [ablazed] in the MSI-high group is a path that we hope to follow in the neoadjuvant setting. Both in rectal cancer and potentially in colon cancer, where the potential to avoid all of the toxicities of surgery, radiation and chemotherapy would be welcomed by patients.

    但是他們在 MSI-high 組中開闢的道路是我們希望在新輔助治療中遵循的道路。無論是直腸癌還是結腸癌,避免手術、放療和化療的所有毒性的可能性都會受到患者的歡迎。

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Does that address your question, Mayank?

    這回答了你的問題嗎,Mayank?

  • Mayank Mamtani - Analyst

    Mayank Mamtani - Analyst

  • Yes. I guess I'd be meeting focus. I heard that it's going to be primarily CRC-focused. Is that fair? And having those two indications late line and neoadjuvant, yes, that's clear. I guess are you able to comment on when do you expect the Type B meeting to occur? And Garo the strategic discussions that you alluded to, I believe, would need to have those minutes in hand before you're able to move forward in a meaningful way. Is that fair?

    是的。我想我會集中註意力。我聽說它將主要以 CRC 為重點。這樣公平嗎?是的,有晚期治療和新輔助治療這兩個適應症,這很清楚。我想您能否評論一下您預計 B 類會議何時舉行?加羅,我認為,您提到的策略討論需要先有這些會議記錄,然後才能以有意義的方式向前邁進。這樣公平嗎?

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Okay. I'll let Jen answer this very important question.

    好的。我請 Jen 來回答這個非常重要的問題。

  • Jennifer Buell - Independent Director

    Jennifer Buell - Independent Director

  • Mayank, we actually have quite a bit of data and information from the FDA, which has satisfied the discussions that you're referring to the strategic discussion. So the path forward from our perspective is really quite clear. The opportunity is what we want to speak with the agency, which is the fastest path to get these products available to patients. That's independent of the strategic discussions.

    Mayank,我們實際上從 FDA 獲得了相當多的數據和信息,這滿足了您所指的戰略討論。因此,從我們的角度來看,前進的道路確實非常清晰。這個機會是我們想與該機構交談,這是讓這些產品提供給患者的最快途徑。這與戰略討論無關。

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Yes. I think that's an important consideration.

    是的。我認為這是一個重要的考慮因素。

  • Mayank Mamtani - Analyst

    Mayank Mamtani - Analyst

  • And lastly, if you're able to comment on the European counterparts also as that obviously has been a separate engagement. So any update there?

    最後,如果您能夠對歐洲同行發表評論,因為這顯然是一項單獨的活動。有更新嗎?

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Sure. Jen will tell you what our history has been with Europe because right after the unsatisfactory meeting with the FDA last June, we engaged with CHMP and the European authorities. And the outcome of those meetings, I'll let Jen comment on.

    當然。Jen 會告訴你我們與歐洲的歷史,因為在去年 6 月與 FDA 的會談不愉快之後,我們就與 CHMP 和歐洲當局進行了接觸。我會讓 Jen 對這些會議的結果發表評論。

  • Jennifer Buell - Independent Director

    Jennifer Buell - Independent Director

  • Thanks, Garo. Mayank, we have not previously disclosed this. So this is really the first that we're disclosing. The interactions with CHMP and the Scientific Advisory Group last year was incredibly productive. The team was very prepared impressively so.

    謝謝,Garo。Mayank,我們之前沒有透露過這一點。所以這其實是我們披露的第一次。去年與 CHMP 和科學顧問小組的互動非常有成效。令人印象深刻的是,團隊的準備非常充分。

  • They agreed with us on our selected dose. They've agreed that we had achieved contribution of components, and they agreed with a two-arm randomized trial for registration. Now the conditional approval pathway is a possibility for us that we're going to go ahead and pursue. We're talking with the US FDA, and we plan to talk with the European, the EMA and essentially in parallel, the initial interactions with the FDA will incur first, though.

    他們同意我們選擇的劑量。他們同意我們已經實現了組件貢獻,並且他們同意進行雙臂隨機試驗以進行註冊。現在,有條件批准的途徑對我們來說是一種可能性,我們將繼續推行。我們正在與美國 FDA 進行談判,並且我們計劃與歐洲 EMA 進行談判,並且基本上同時進行,不過與 FDA 的初步互動將首先進行。

  • Operator

    Operator

  • Matthew Phipps, William Blair.

    馬修菲普斯、威廉布萊爾。

  • Matthew Phipps - Analyst

    Matthew Phipps - Analyst

  • Garo, I think before you've provided some valuation framework for the Emeryville facility. And I'm wondering if that value has increased given the focus on kind of onshoring pharmaceutical manufacturing over the past few months?

    Garo,我想您之前已經為埃默里維爾工廠提供了一些估值框架。我想知道,考慮到過去幾個月對本土製藥製造業的關注,這一價值是否有所增加?

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • I think this is a very, very good question. And when I say good, I'm not dodging the question, Matt. I believe that the totality of the value we will derive out of the Emeryville facility will reflect that premium. Of course, if we had the luxury to wait another 6 to 12 months, I think that we could get a lot more for it. But right now, it is a relatively inexpensive access to capital. And hence, we are pursuing that route even though we believe the value will continue to go up.

    我認為這是一個非常非常好的問題。當我說好的時候,我並沒有迴避問題,馬特。我相信,我們從埃默里維爾工廠獲得的全部價值將反映出這項溢價。當然,如果我們有能力再等 6 到 12 個月,我想我們可以得到更多。但目前,這是一種相對廉價的資本取得方式。因此,儘管我們相信價值會繼續上升,但我們仍在走這條路線。

  • Matthew Phipps - Analyst

    Matthew Phipps - Analyst

  • Yes. That's fair. And then I'm sure you can't give us too much more details on some of these agreements beyond what you already gave. But the licensing agreement, can you just say if that is geography-specific or if it is broader worldwide?

    是的。這很公平。然後我相信您無法再向我們提供超出您已經提供的資訊的有關這些協議的更多細節。但是對於許可協議,您能否說一下它是針對特定地域的還是全球範圍內的?

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • So the two agreements, which have been submitted to us in writing proposals are global. Two additional agreements that we are potentially looking at as an important option for us are geography-specific. So depending on our cost of capital considerations and immediate needs, of course, the global licensing agreements would contemplate third parties underwriting the entire cost of additional trials and registration for BOT/BAL.

    因此,以書面提案形式提交給我們的這兩項協議是全球性的。我們可能將另外兩項協議視為重要選擇,它們都是針對特定地理位置的。因此,根據我們的資本成本考量和迫切需求,全球授權協議當然會考慮第三方承擔 BOT/BAL 額外試驗和註冊的全部費用。

  • So it has that appeal because it will further drive our operating burn rate down. But let us sort through these because the sequence with which we consummate some of these agreements and bring in cash and create value will be critical in determining our next steps.

    所以它有吸引力,因為它將進一步降低我們的營運消耗率。但讓我們對這些問題進行分類,因為我們完成這些協議、帶來現金和創造價值的順序對於決定我們的下一步至關重要。

  • Operator

    Operator

  • Colleen Kusy, Baird.

    科琳·庫西,貝爾德。

  • Colleen Hanley - Analyst

    Colleen Hanley - Analyst

  • Have you had any interactions yet with the new FDA at this point ahead of the Part B meeting? And can you provide a little more color on the publication that you mentioned that led the FDA to its conclusion last summer? And why you think that might be a different situation this summer?

    在 B 部分會議之前,您是否與新的 FDA 有任何互動?您能否更詳細地介紹一下您提到的促使 FDA 去年夏天得出結論的出版物?為什麼您認為今年夏天的情況可能會有所不同?

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Okay. So I will answer the second question, first. The publication we're talking about, I believe Dr. Buell, correct me if I'm wrong, was a New England Journal of Medicine article by Dr. Richard Pazdur and Julia Beaver.

    好的。因此我先回答第二個問題。我們正在談論的出版物,我相信 Buell 博士,如果我錯了請糾正我,是 Richard Pazdur 博士和 Julia Beaver 在《新英格蘭醫學雜誌》上發表的一篇文章。

  • And this article made a point that IO in combination with other agents, where the response rates are at a certain threshold do not necessarily result in long-term survival. However, there's a big however. Number one, these protocols discussed by and large, were not IO only protocols. There was IO, mainly PD-1 plus something else. And so that doesn't really reflect the power of the lasting durable responses generated by CTLA-4 agents. That's a very important point, very, very important point.

    這篇文章指出,IO 與其他藥物合併使用時,如果反應率達到一定的閾值,並不一定能達到長期存活。然而,有一個很大的但是。首先,總體而言,這些討論的協議並不是僅限於 IO 的協議。有 IO,主要是 PD-1 加上一些其他的東西。因此,這並不能真正反映 CTLA-4 藥物產生的持久反應的威力。這是非常重要的一點,非常非常重要的一點。

  • And secondly, this article excluded a number of cases, we can think about 4, 5 cases where lower response rates, and when I say low responses, I'm talking about single digits. I'm talking about 15%, 20% response rates did indeed translate to longer-term survival. So it was somewhat partial in depicting the facts. And of course, that's one issue.

    其次,本文排除了一些情況,我們可以考慮 4、5 種回應率較低的情況,當我說回應率低時,我指的是個位數。我說的是 15%、20% 的反應率確實意味著長期存活。因此,它在描述事實時有些片面。當然,這是一個問題。

  • Now the second question that you asked, have we engaged with the new FDA? The answer is, no. We have not. Because the new FDA is comprised of leadership, like Dr. Marty Makary and a lot of the senior people at the FDA, and I'm not talking about Cancer division.

    現在您問的第二個問題是,我們是否與新的 FDA 合作過?答案是否定的。我們沒有。因為新的 FDA 由領導層組成,例如 Marty Makary 博士和 FDA 的許多高級人員,我說的不是癌症部門。

  • But a lot of the senior people even in the cancer division, a lot of the senior people have left. And so we're looking at our Type B meeting as an opportunity to reengage the agency. However, the first step for us is to present the totality of the data. And when I talk about totality of the data, remember, Dr. Goldberg made the point that our sharpshooting strategy will be colorectal cancer.

    但即使是癌症科室的許多資深人士也已經離職。因此,我們將 B 類會議視為重新與該機構合作的機會。然而,我們的第一步是呈現全部數據。當我談論整體數據時,請記住,戈德堡博士指出我們的精準攻擊策略是針對大腸癌。

  • However, the totality of data comprising our trials across 9 different cancers. And all those 9 different cancers, about 5 of them both in numbers and in terms of durability of responses have matured to a point where we can proudly demonstrate the consistency of data from one cancer to another to another to another. So that's what we will be presenting as well.

    然而,我們的試驗數據涵蓋了 9 種不同的癌症。所有這 9 種不同的癌症,其中大約有 5 種在數量和反應持久性方面已經成熟到我們可以自豪地展示不同癌症之間數據一致性的程度。這也是我們將要展示的內容。

  • Colleen Hanley - Analyst

    Colleen Hanley - Analyst

  • Great. That's helpful. And Dr. Goldberg, congrats on the new role. Wanted to ask how much of your time do you anticipate being focused on metastatic CRC versus neoadjuvant CRC versus all the other tumor types that BOT/BAL shown activity in?

    偉大的。這很有幫助。戈德堡博士,恭喜您擔任新職務。想問一下,您預計會花多少時間專注於轉移性 CRC、新輔助 CRC 以及 BOT/BAL 顯示出活性的所有其他腫瘤類型?

  • Richard Goldberg - Chief Development Officer

    Richard Goldberg - Chief Development Officer

  • Well, so I think BOT/BAL has demonstrated activity really in virtually every setting that's been tried. The main reason to focus on colorectal cancer is that there's such a strong need expressed by patients and physicians to have an IO intervention that realizes some of the benefits that have been enjoyed by MSI-high patients in the much larger subset of colorectal cancer or patients that are MSS.

    嗯,所以我認為 BOT/BAL 幾乎在每種嘗試過的環境中都表現出了活性。關注大腸直腸癌的主要原因是,患者和醫生強烈需要進行 IO 幹預,以實現更大的結直腸癌亞群或 MSS 患者中 MSI 高患者所享有的一些益處。

  • And the data for activity of the pre approved drugs in late line metastatic colorectal cancer is quite modest. And while the oncology community has embraced those drugs, the patient community is disappointed by what they bring and is looking for something better. So we believe that the comparators in the setting of advanced disease, third and fourth-line disease are favorable comparator arms to the activity that Agenus has observed in the early trials.

    而對於晚期轉移性大腸直腸癌,預先核准的藥物的活性數據相當有限。儘管腫瘤學界已經接受了這些藥物,但患者群體卻對它們的效果感到失望,並正在尋找更好的藥物。因此,我們認為,晚期疾病、三線和四線疾病環境中的比較器是 Agenus 在早期試驗中觀察到的活性的有利比較器。

  • Now from my perspective, the most potential is probably in the neoadjuvant setting. The groundbreaking study by Andrea Cercek and her colleagues at Sloan Kettering and MSI-high tumors where patients avoided chemotherapy, radiation and surgery is really startling. And benefits patients in ways that we couldn't have imagined even five years ago.

    現在從我的角度來看,最有潛力的可能是新輔助治療。安德里亞·塞爾塞克 (Andrea Cercek) 和她在斯隆凱特琳癌症中心的同事對 MSI 高腫瘤患者進行的開創性研究確實令人吃驚,這些患者避免了化療、放療和手術。並且以五年前我們無法想像的方式使患者受益。

  • We believe that, that's translatable to rectal cancer patients with MSS tumors using this intervention and to colon cancer patients, tumors above the rectum, where potentially we could come up with a surgery-free world for managing Stage III colon cancer.

    我們相信,對於使用這種幹預措施的患有 MSS 腫瘤的直腸癌患者和直腸以上腫瘤的結腸癌患者來說,我們有可能實現無需手術即可治療 III 期結腸癌。

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, Richard.

    謝謝你,理查。

  • Colleen Hanley - Analyst

    Colleen Hanley - Analyst

  • That's great. And one last one, if I may. Could you talk about your strategy of sharing the Phase II data with the Street whether that would be in conjunction with the FDA meeting or after?

    那太棒了。如果可以的話,我還有最後一個問題。您能否談談與華爾街分享第二階段數據的策略,是與 FDA 會議同時進行還是在會議之後?

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Sure. I think that's doable. And I just want to draw your attention to the neoadjuvant protocol that was presented at AACR, whereby Myriam Chalabi presented data on patients with a fantastically acceptable safety profile. In fact, there were no real showstoppers in the safety of the drug. And of course, this is in the earlier disease setting with lower doses 25 and 50.

    當然。我認為這是可行的。我只是想提請大家注意在 AACR 上提出的新輔助治療方案,其中 Myriam Chalabi 展示了具有極佳安全性的患者數據。事實上,這種藥物的安全性並沒有什麼真正的問題。當然,這是在早期疾病環境中,劑量較低,為 25 和 50。

  • But nonetheless, there were no real safety signals of any sort, including colitis to really worry about. So we believe that depending on the disease setting, as Richard said, neoadjuvant offers the largest potential. And earlier, the better intervention philosophy, of course, particularly with immunotherapy. And in that setting, we think we're going to be based on all of the studies that have taken place, we're going to be dealing with a safety profile that will be very, very acceptable to patients.

    但儘管如此,並沒有任何真正的安全訊號,包括真正需要擔心的結腸炎。因此,我們認為,根據疾病情況,正如理查所說,新輔助治療具有最大的潛力。當然,更早的干預理念更好,尤其是免疫療法。在這種情況下,我們認為我們將基於所有已進行的研究,處理患者非常容易接受的安全性概況。

  • Operator

    Operator

  • And there are no further questions at this time. I will now turn the call back over to Garo Armen for closing remarks.

    目前沒有其他問題。現在我將把電話轉回給加羅·阿曼 (Garo Armen) 作結束語。

  • Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

    Garo Armen - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you very much, everyone. We are very grateful for your attention and for your persistence with what we're doing for the benefit of patients and all stakeholders, as I mentioned. We're also very grateful to our extended team, Dr. Richard Goldberg, adds a deeper level of expertise in a disease that is the focus of our attention right now and this particular disease is becoming a major problem in the young and the kinds of morbidities generated by existing treatments, chemotherapy, radiation, and surgery could be eliminated, potentially eliminated. And this is a very important issue because, as I said before, both with the young and the old, of course, these are important.

    非常感謝大家。正如我所提到的,我們非常感謝您的關注和堅持,我們所做的一切都是為了病人和所有利害關係人的利益。我們也非常感謝我們的擴展團隊,理查德·戈德堡博士,他對我們現在關注的疾病有了更深層次的專業知識,這種特殊的疾病正在成為年輕人的一個主要問題,現有的治療、化療、放療和手術所產生的各種疾病可以消除,甚至有可能被消除。這是一個非常重要的問題,因為正如我之前所說,無論對年輕人或老年人來說,這些都很重要。

  • But with somebody having to live with these morbidities for the rest of their lives, we're getting patients as young as 8 years old with metastatic colon cancer, which is something remarkable. And so for a young person to live with these difficulties for the rest of their lives is the big issue.

    但是有些人必須在餘生中忍受這些疾病,我們接收的轉移性結腸癌患者年僅 8 歲,這是非常了不起的。因此,對於年輕人來說,在餘生中忍受這些困難是一個大問題。

  • So we're very grateful for all of your attention. And we've been on a path to do what is in the best interest of these patients and as I said, with our stakeholders. And we very much appreciate your support. Thank you.

    因此,我們非常感謝大家的關注。我們一直在努力為這些患者以及我們的利害關係人謀取最大利益。我們非常感謝您的支持。謝謝。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for your participation. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。