Corvus Pharmaceuticals Inc (CRVS) 2024 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good afternoon, everyone, and thank you for standing by.

    大家下午好,謝謝大家的支持。

  • Welcome to the Corvus Pharmaceuticals second quarter 2024 business update and financial results conference call.

    歡迎參加 Corvus Pharmaceuticals 2024 年第二季業務更新與財務業績電話會議。

  • (Operator Instructions)

    (操作員說明)

  • It is now my pleasure to turn the call over to Zack Kubow of Real Chemistry.

    現在我很高興將電話轉給 Real Chemistry 的 Zack Kubow。

  • Please go ahead, sir.

    請繼續,先生。

  • Zack Kubow - IR

    Zack Kubow - IR

  • Thank you, Operator, and good afternoon, everyone.

    謝謝接線員,大家下午好。

  • Thanks for joining us for the Corvus Pharmaceuticals second quarter 2024 business update and financial results conference call.

    感謝您參加 Corvus Pharmaceuticals 2024 年第二季業務更新與財務業績電話會議。

  • On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer; Leiv Lea, Chief Financial Officer; Jeff Arcara, Chief Business Officer; Jim Rosenbaum, Senior Vice President of Research; and Ben Jones, Senior Vice President of Regulatory and Pharmaceutical Sciences.

    執行長理查德·米勒 (Richard Miller) 出席了電話會議,討論業績和業務動態。 Leiv Lea,財務長;傑夫‧阿卡拉,首席商務官; Jim Rosenbaum,研究資深副總裁;以及監管和製藥科學高級副總裁 Ben Jones。

  • The executive team will open the call with some prepared remarks, followed by a question-and-answer period.

    執行團隊將以一些準備好的發言開始電話會議,然後是問答時間。

  • I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements.

    我想提醒大家,管理階層今天發表的評論和問題的回答將包含前瞻性陳述。

  • Forward-looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by those statements, including the risks and uncertainties described in Corvus quarterly report on Form 10-Q for the quarter ended June 30, 2024, that was filed today and other filings the company makes with the SEC from time to time.

    前瞻性陳述是基於截至目前的估計和假設,並受到風險和不確定性的影響,這些風險和不確定性可能導致實際結果與這些陳述明示或暗示的結果有重大差異,包括Corvus 季度報告表10 中描述的風險和不確定性-Q 截至 2024 年 6 月 30 日的季度(今天提交)以及該公司不時向 SEC 提交的其他文件。

  • The company undertakes no obligation to publicly update or revise any forward-looking statements except as required by law.

    除法律要求外,本公司不承擔公開更新或修改任何前瞻性聲明的義務。

  • With that, I’d like to turn the call over to Leiv Lea.

    說到這裡,我想把電話轉給 Leiv Lea。

  • Leiv?

    萊夫?

  • Leiv Lea - Chief Financial Officer

    Leiv Lea - Chief Financial Officer

  • Thank you, Zach.

    謝謝你,扎克。

  • I will begin with a quick overview of our second quarter 2024 financials and then turn the call over to Richard for a business update.

    我將首先快速概述我們 2024 年第二季的財務狀況,然後將電話轉給理查德,以了解業務最新情況。

  • Research and development expenses in the second quarter of 2024 totaled $4.1 million, compared to $4.0 million in the same period in 2023.

    2024 年第二季的研發費用總計 410 萬美元,而 2023 年同期為 400 萬美元。

  • The net loss for the second quarter of 2024 was $4.3 million, including a non-cash loss of $0.6 million related to Angel Pharmaceuticals, our partner in China.

    2024年第二季淨虧損為430萬美元,其中包括與我們在中國的合作夥伴安琪藥業相關的60萬美元非現金虧損。

  • In addition, we recorded a non-cash gain of $1.8 million from the change in fair value of Corvus warrant liability during the second quarter 2024 associated with warrants that we sold as part of our financing completed in early May 2024.

    此外,我們在2024 年第二季度因Corvus 認股權證負債公允價值變化而獲得了180 萬美元的非現金收益,這些收益與我們作為2024 年5 月初完成的融資的一部分出售的認股權證相關。

  • This compares to a net loss of $6.5 million for the same period in 2023, which included a $1.3 million non-cash loss related to Angel Pharmaceuticals.

    相較之下,2023 年同期淨虧損為 650 萬美元,其中包括與 Angel Pharmaceuticals 相關的 130 萬美元非現金虧損。

  • Total stock compensation expense for the second quarter 2024 was $0.8 million, compared to $0.5 million in the same period in 2023.

    2024 年第二季的股票補償費用總額為 80 萬美元,而 2023 年同期為 50 萬美元。

  • As of June 30, 2024, Corvus had cash, cash equivalents and marketable securities totaling $47.3 million, as compared to $27.1 million at December 31, 2023.

    截至2024年6月30日,Corvus擁有現金、現金等價物及有價證券總計4,730萬美元,而截至2023年12月31日為2,710萬美元。

  • This includes $30.3 million raised in our May financing.

    這包括我們在 5 月融資中籌集的 3,030 萬美元。

  • Based upon our current plans, we anticipate our cash provides runway into the fourth quarter of 2025.

    根據我們目前的計劃,我們預計我們的現金供應將持續到 2025 年第四季。

  • Of note, the warrants we sold in May have an exercise price of $3.50 per warrant and expired on June 30, 2025.

    值得注意的是,我們在 5 月出售的認股權證的行使價為每張認股權證 3.50 美元,並於 2025 年 6 月 30 日到期。

  • If all of the warrants are exercised, it will raise approximately $60 million in incremental capital.

    如果所有認股權證均獲行使,將籌集約 6,000 萬美元的增量資本。

  • I will now turn the call over to Richard who will discuss our clinical progress and elaborate on our strategy and plans.

    我現在將把電話轉給理查德,他將討論我們的臨床進展並詳細說明我們的策略和計劃。

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Leiv, and good afternoon, everyone.

    謝謝你,萊夫,大家下午好。

  • Thank you for joining us today for our business update call.

    感謝您今天參加我們的業務更新電話會議。

  • Corvus is pioneering the development of selective ITK inhibition as a new therapeutic modality for a broad range of immune diseases and cancer.

    Corvus 正在率先開發選擇性 ITK 抑製作為廣泛免疫疾病和癌症的新治療方式。

  • Soquelitinib, our next-generation ITK inhibitors, have a unique mechanism of action which works upstream to modulate key T-cell signaling pathways.

    Soquelitinib 是我們的下一代 ITK 抑制劑,具有獨特的作用機制,可在上游調節關鍵 T 細胞訊號傳導路徑。

  • This mechanism is particularly relevant for immune and inflammatory diseases because it results in the modulation of multiple cytokines that are the targets of current approved therapies.

    這種機制與免疫和發炎疾病特別相關,因為它會導致多種細胞因子的調節,而這些細胞因子是目前批准的療法的目標。

  • The emerging clinical evidence from our atopic dermatitis trial and our ongoing preclinical work support the potential for soquelitinib and selective ITK inhibition in several large patient populations, including diseases such as atopic dermatitis, asthma, psoriasis, inflammatory bowel diseases, scleroderma and other fibrotic diseases.

    我們的異位性皮膚炎試驗和正在進行的臨床前工作的新臨床證據支持索奎替尼和選擇性ITK 抑制在幾個大型患者群體中的潛力,包括異位性皮膚炎、氣喘、牛皮癬、發炎性腸病、硬皮症和其他纖維化疾病等疾病。

  • We continue to gain confidence in our ITK inhibitor program, which we believe is now demonstrating activity in a broad range of diseases beyond lymphoma and solid tumors.

    我們繼續對我們的 ITK 抑制劑計劃充滿信心,我們相信該計劃目前正在證明對淋巴瘤和實體瘤以外的廣泛疾病的活性。

  • Our main focus continues to be advancing our lead ITK inhibitor, soquelitinib.

    我們的主要重點仍然是推進我們的領先 ITK 抑制劑 soquelitinib。

  • The opportunity for ITK inhibition in immune diseases is particularly exciting, given its profile as a well-tolerated oral medication, the emerging clinical evidence from our atopic dermatitis trial and our ongoing preclinical work in a wide range of immune diseases.

    鑑於ITK 作為一種耐受性良好的口服藥物的特徵、我們的異位性皮膚炎試驗中出現的新臨床證據以及我們在廣泛的免疫疾病方面正在進行的臨床前工作,ITK 抑制在免疫疾病中的機會特別令人興奮。

  • In cancer, we remain on track to begin enrollment in our planned, registrational Phase 3 clinical trial of soquelitinib for patients with relapsed peripheral T-cell lymphoma in the third quarter.

    在癌症方面,我們仍有望在第三季開始招募針對復發性週邊 T 細胞淋巴瘤患者的 soquelitinib 計畫註冊 3 期臨床試驗。

  • And our confidence in this trial continues to grow as another patient in our Phase 1/1B trial experienced continued tumor regression and recently achieved a complete response after previously having a partial response at first follow-up.

    我們對這項試驗的信心繼續增強,因為我們 1/1B 期試驗中的另一名患者經歷了持續的腫瘤消退,並且在第一次隨訪時獲得部分緩解後最近獲得了完全緩解。

  • Now I will provide more detail on our progress, starting with soquelitinib Phase 1 clinical trial in patients with moderate to severe atopic dermatitis.

    現在我將提供有關我們進展的更多詳細信息,首先是針對中度至重度異位性皮膚炎患者的 soquelitinib 一期臨床試驗。

  • The clinical trial is now open at several sites and we will be adding additional sites based on our early encouraging experience.

    臨床試驗現已在多個地點開放,我們將根據我們早期令人鼓舞的經驗添加更多地點。

  • The trial is designed to enroll 64 patients with moderate to severe atopic dermatitis that have progressed on at least one prior therapy.

    該試驗旨在招募 64 名患有中度至重度異位性皮膚炎的患者,這些患者在接受至少一種既往治療後病情有所進展。

  • The study is randomized, placebo-controlled and blinded to patients and treating physicians.

    該研究是隨機、安慰劑對照的,並且對患者和治療醫生不知情。

  • There will be four sequentially enrolled cohorts of 16 patients, with patients in each cohort being randomized 3:1 to different dosing regimens of soquelitinib or placebo given for 28 days.

    將有四個連續入組的隊列,每組均包含 16 名患者,每個隊列中的患者以 3:1 的比例隨機分配至索奎替尼或安慰劑的不同給藥方案,為期 28 天。

  • The primary endpoint is safety and tolerability and efficacy is measured using the clinically validated measurements of improvement in Eczema Area and Severity Index score, also known as EASI, and the investigator global assessment.

    主要終點是安全性和耐受性,療效是透過臨床驗證的濕疹面積和嚴重程度指數評分(也稱為 EASI)改善測量以及研究者的整體評估來衡量的。

  • The first cohort, which utilizes the lowest soquelitinib dose of 100 milligrams BID, is currently enrolling and we have a few patients that now have completed the 28-day treatment regimen and follow-up.

    第一個隊列使用 100 毫克 BID 的最低索奎替尼劑量,目前正在招募中,我們有一些患者現已完成 28 天的治療方案和追蹤。

  • While the patient and physician are blinded to the treatment assignment, the Corvus team is not blinded to the trial results, and I can report that, although very early, we see signs of clinical activity.

    雖然患者和醫生對治療分配不知情,但 Corvus 團隊對試驗結果並不知情,我可以報告說,儘管很早,我們還是看到了臨床活動的跡象。

  • So far, treated patients have shown substantial improvement in EASI scores at 28 days and corresponding changes in serum cytokine levels that are consistent with soquelitinib’s mechanism of action.

    到目前為止,接受治療的患者在 28 天時 EASI 評分顯著改善,血清細胞激素水平發生相應變化,這與索奎替尼的作用機制一致。

  • This is encouraging, given this is the lowest dose cohort.

    鑑於這是最低劑量的隊列,這是令人鼓舞的。

  • Also, we continue to find that the drug is well-tolerated, with no significant safety issues reported to-date.

    此外,我們繼續發現該藥物具有良好的耐受性,迄今尚未報告重大安全問題。

  • There continues to be high interest in the trial and our novel drug.

    人們對這項試驗和我們的新藥仍然抱有很高的興趣。

  • We anticipate sharing interim data from the initial cohorts in the fourth quarter.

    我們預計在第四季度分享初始隊列的中期數據。

  • The early preliminary data from these initial patients demonstrate important findings in serum cytokine levels that support the potential use of ITK inhibition in other immune diseases.

    這些初始患者的早期初步數據證明了血清細胞因子水平的重要發現,支持 ITK 抑制在其他免疫疾病中的潛在用途。

  • Many of these changes are consistent with those that we have seen in preclinical studies in other inflammatory diseases and suggest that soquelitinib could be effective in these diseases.

    其中許多變化與我們在其他發炎性疾病的臨床前研究中看到的變化一致,表明索奎替尼可能對這些疾病有效。

  • We anticipate reporting on some of this work at the American College of Rheumatology meeting in November.

    我們預計在 11 月的美國風濕病學會會議上報告其中的一些工作。

  • We are gaining more evidence that soquelitinib and selective ITK inhibition may be an important new treatment approach for a range of immune and inflammatory diseases.

    我們正在獲得更多證據表明索奎替尼和選擇性 ITK 抑制可能是一系列免疫和發炎疾病的重要新治療方法。

  • This is further supported by recent work from the lab of Professor Avery August at Cornell University.

    康乃爾大學艾佛瑞奧古斯特教授實驗室最近的工作進一步支持了這一點。

  • Dr. August is a preeminent immunologist and one of the world’s leading authorities on ITK.

    August 博士是一位傑出的免疫學家,也是 ITK 領域的世界領先權威之一。

  • These investigators demonstrated that ITK controls the fate of inflammatory Th17 cells.

    這些研究人員證明 ITK 控制發炎 Th17 細胞的命運。

  • When ITK is inhibited by soquelitinib, the maturing Th17 cells convert or switch to Treg cells that suppress inflammation.

    當 ITK 被 soquelitinib 抑制時,成熟的 Th17 細胞會轉化為抑制發炎的 Treg 細胞。

  • Soquelitinib treatment in an asthma model of mice with allergic airway inflammation significantly reduced the percentage of Th17 cells in the lung, resulting in an increase in the ratio of T regulatory cells to Th17 cells.

    Soquelitinib 治療患有過敏性氣道發炎的小鼠氣喘模型,顯著降低了肺部 Th17 細胞的百分比,導致調節性 T 細胞與 Th17 細胞的比例增加。

  • These studies confirm and extend our understanding of the role of specific ITK inhibition in inflammation and are relevant to many immune diseases.

    這些研究證實並擴展了我們對特異性 ITK 抑制在發炎中的作用的理解,並且與許多免疫疾病有關。

  • We also continue to advance our second- and third-generation ITK inhibitors, which we are further optimizing for use in treating immune and inflammatory diseases.

    我們也繼續開發第二代和第三代 ITK 抑制劑,並進一步優化其用於治療免疫和發炎疾病。

  • We are focusing our preclinical development on asthma, psoriasis, scleroderma, inflammatory bowel diseases and fibrotic diseases, with a host of additional indications identified for future work.

    我們的臨床前開發重點是氣喘、牛皮癬、硬皮症、發炎性腸道疾病和纖維化疾病,並為未來的工作確定了許多其他適應症。

  • Now for an update on soquelitinib for peripheral T-cell lymphoma or PTCL.

    現在介紹索奎替尼治療週邊 T 細胞淋巴瘤或 PTCL 的最新情況。

  • While we are no longer enrolling new patients in our Phase 1 trial, the data continues to evolve as patients on therapy complete their scheduled follow-up assessments.

    雖然我們不再在第一階段試驗中招募新患者,但隨著接受治療的患者完成預定的追蹤評估,數據仍在不斷變化。

  • In the most recent data cutoff from July 15, we had one additional patient who demonstrated continued tumor regression, achieving a complete response after having a partial response at the first follow-up visit.

    在 7 月 15 日截止的最新數據中,我們又有一名患者表現出腫瘤持續消退,在第一次隨訪時獲得部分緩解後實現了完全緩解。

  • With this update, the objective response rate or ORR for the Phase 3 eligible patients remains nine out of 23 or 39%.

    透過此次更新,符合 3 期資格的患者的客觀緩解率或 ORR 仍為 23 例中的 9 例或 39%。

  • But the number of complete responses has increased to six or 26% complete response rate.

    但完整回覆的數量已增加至 6 或 26% 的完整回覆率。

  • Although not studied head-to-head, the complete response rate for soquelitinib at 26% is more than double that seen with belinostat or pralatrexate, the standard chemotherapies for PTCL that will be the comparators in our Phase 3 trial.

    儘管沒有進行頭對頭研究,但索奎替尼的完全緩解率為26%,是貝利司他或普拉曲沙(PTCL 的標準化療藥物,將作為我們3 期試驗的比較藥物)的兩倍多。

  • Similarly, the ORR, disease control rate, progression-free survival, and overall survival for this group compares favorably to the results seen with belinostat or pralatrexate.

    同樣,該組的 ORR、疾病控制率、無惡化存活期和總存活期與貝利司他或普拉曲沙的結果相比也更為有利。

  • The median PFS for our patients, which is the primary endpoint for our Phase 3 trial is 6.2 months.

    我們病患的中位 PFS(我們第 3 期試驗的主要終點)為 6.2 個月。

  • This is substantially better than reported results for the standard agents, which is 1.6 months and 3.5 months for belinostat and pralatrexate, respectively.

    這明顯優於標準藥物的報告結果,貝利司他和普拉曲沙分別為 1.6 個月和 3.5 個月。

  • The durability of our responses is impressive, with some of the earlier enrolled patients now maintaining their responses for more than 24 months.

    我們的反應的持久性令人印象深刻,一些早期入組的患者現在可以維持反應超過 24 個月。

  • We plan to begin patient enrollment in our soquelitinib registrational Phase 3 clinical trial in relapsed PTCL in September of 2024.

    我們計劃於 2024 年 9 月開始招募 Soquelitinib 治療復發性 PTCL 的 3 期註冊臨床試驗。

  • There are currently no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted Orphan Drug designation and Fast Track designation for soquelitinib for the treatment of relapsed T-cell lymphoma.

    目前尚無 FDA 完全批准的治療復發性 PTCL 的藥物,FDA 已授予索奎替尼治療復發性 T 細胞淋巴瘤的孤兒藥資格和快速通道資格。

  • Recently, we received a pediatric waiver from FDA, which means that we will not be required to conduct clinical trials in a pediatric population for this indication.

    最近,我們收到了 FDA 的兒科豁免,這意味著我們將不需要針對該適應症在兒科族群中進行臨床試驗。

  • We are working with or in advanced discussions with a number of leading centers in the United States, Australia, Canada and South Korea.

    我們正在與美國、澳洲、加拿大和韓國的許多領先中心合作或進行深入討論。

  • The study is designed to enroll 150 patients randomized to soquelitinib or standard-of-care, which will be either pralatrexate or belinostat.

    研究旨在招募 150 名患者,隨機接受 soquelitinib 或標準治療(普拉曲沙或貝利司他)。

  • We anticipate about 40 centers will participate in the trial.

    我們預計大約 40 個中心將參與試驗。

  • The vast majority will be in the United States.

    絕大多數將在美國。

  • Some of the study centers include MD Anderson, Memorial Sloan Kettering, City of Hope, Washington University, and other high-profile institutions.

    一些研究中心包括 MD 安德森大學、紀念斯隆凱特琳大學、希望之城大學、華盛頓大學和其他知名機構。

  • We are delighted to have the participation of leading academic centers with extensive experience and expertise in conducting clinical trials in T-cell lymphomas.

    我們很高興擁有在 T 細胞淋巴瘤臨床試驗方面擁有豐富經驗和專業知識的領先學術中心的參與。

  • Outside of our atopic dermatitis and PTCL trials, we’re also planning a soquelitinib solid tumor trial as a single agent in relapsed renal cell cancer, representing a new approach to immunotherapy of this disease.

    除了我們的異位性皮膚炎和 PTCL 試驗之外,我們還計劃進行 soquelitinib 實體瘤試驗,作為復發性腎細胞癌的單一藥物,代表了這種疾病免疫療法的新方法。

  • We also continue to advance our other clinical stage development programs.

    我們也繼續推進其他臨床階段開發計劃。

  • We have been one of the leaders in the development of adenosine A2A receptor antagonism for the treatment of cancer with ciforadenant.

    我們一直是開發腺苷 A2A 受體拮抗劑以治療癌症的領導者之一。

  • This includes our Phase 1b/2 clinical trial that is being conducted in collaboration with the Kidney Cancer Research Consortium.

    這包括我們與腎癌研究聯盟合作進行的 1b/2 期臨床試驗。

  • The trial is evaluating cifo as a potential first-line therapy for metastatic renal cell cancer in combination with ipilimumab and nivolumab.

    該試驗正在評估 cifo 與伊匹單抗和納武單抗聯合治療轉移性腎細胞癌的潛在第一線療法。

  • The study is enrolling at MD Anderson, Vanderbilt, Duke, and the University of Pennsylvania.

    該研究正在 MD 安德森大學、范德比爾特大學、杜克大學和賓夕法尼亞大學招募。

  • The results from the trial and supported published preclinical research demonstrate the potential of the combination of an anti-CTLA-4 antibody with ciforadenant to produce striking antitumor efficacy that is better than what has been observed when combining cifo with anti-PD-1.

    該試驗的結果和支持的已發表的臨床前研究表明,抗 CTLA-4 抗體與 ciforadenant 組合具有顯著的抗腫瘤功效,比 cifo 與抗 PD-1 組合時觀察到的效果更好。

  • In July, a new patent covering our work with ciforadenant was issued in the United States and foreign counterparts are pending.

    7 月,一項涉及我們與 ciforadenant 合作的新專利在美國獲得,外國同行正在申請中。

  • As of the most recent data analysis on May 31, 32 patients were enrolled and the trial continues to meet our pre-specified statistical hurdle for continuation, which is the achievement of at least a 50% improvement in the deep response rate of 32%, which is associated with ipilimumab and nivolumab combination alone.

    截至 5 月 31 日的最新數據分析,已入組 32 名患者,該試驗繼續滿足我們預先指定的繼續進行的統計障礙,即 32% 的深度緩解率至少提高 50%,這與單獨的伊匹單抗和納武單抗組合相關。

  • Deep response rate is the CR rate plus the PR rate, only counting PRs that achieve greater than 50% tumor volume reduction.

    深度緩解率是 CR 率加上 PR 率,僅計算腫瘤體積縮小超過 50% 的 PR。

  • Note, the usual criteria for PRs is 30% tumor reduction.

    請注意,PR 的通常標準是腫瘤減少 30%。

  • The trial continues to enroll patients and we are targeting a potential presentation of the latest data from the trial at a meeting in the fourth quarter.

    該試驗繼續招募患者,我們的目標是在第四季度的一次會議上可能介紹該試驗的最新數據。

  • Outside of RCC, we also expect new preclinical data highlighting the potential of cifo to treat prostate cancer.

    除了 RCC 之外,我們還預期新的臨床前數據會突顯 cifo 治療前列腺癌的潛力。

  • The preclinical and early clinical data will be presented at [CITSI] in November.

    臨床前和早期臨床數據將於 11 月在 [CITSI] 上公佈。

  • This presentation from investigators at UCSF will highlight mechanism and potential biomarkers that are important for prostate cancer.

    加州大學舊金山分校研究人員的演講將重點放在對前列腺癌重要的機制和潛在生物標記。

  • For our anti-CD73 antibody, mupadolimab, our partner, Angel Pharmaceuticals, is continuing to enroll patients in a Phase 1/1b clinical trial in China with mupadolimab alone and together with pembrolizumab in patients with non-small cell lung cancer.

    對於我們的抗 CD73 抗體 mupadolimab,我們的合作夥伴 Angel Pharmaceuticals 正在中國繼續招募患者參加單一 mupadolimab 以及與 pembrolizumab 聯合治療非小細胞肺癌患者的 1/1b 期臨床試驗。

  • Based on observed partial responses with monotherapy, an expansion cohort study examining monotherapy in relapsed non-small cell lung cancer is underway in China.

    基於觀察到的單一療法的部分反應,一項檢驗單一療法治療復發性非小細胞肺癌的擴大隊列研究正在進行中。

  • Summarizing the outlook for the remainder of 2024, we have important clinical milestones for soquelitinib that we expect will increase awareness of the unique mechanism of action with ITK inhibition and its potential to address a wide range of indications.

    總結 2024 年剩餘時間的展望,我們看到了 soquelitinib 的重要臨床里程碑,我們預計這些里程碑將提高人們對 ITK 抑制的獨特作用機制及其解決廣泛適應症的潛力的認識。

  • Upcoming milestones include, for soquelitinib, number one, starting our registrational Phase 3 clinical trial of soquelitinib in PTCL in September; number two, reporting interim results from our soquelitinib Phase 1 atopic dermatitis trial in the fourth quarter, followed by final data in early 2025; number three, present preclinical data in other immune diseases -- other immune disease indications at the ACR meeting in November; number four, initiate a Phase 2 clinical trial with soquelitinib in solid tumors in the fourth quarter, with initial data anticipated in the second half of 2025.

    對於 soquelitinib 而言,即將到來的里程碑包括:第一,將於 9 月啟動 soquelitinib 在 PTCL 的註冊 3 期臨床試驗;第二,報告第四季度 soquelitinib 1 期異位性皮膚炎試驗的中期結果,隨後於 2025 年初報告最終數據;第三,在11月的ACR會議上展示其他免疫疾病的臨床前數據-其他免疫疾病適應症;第四,在第四季度啟動索奎替尼治療實體瘤的 2 期臨床試驗,預計將於 2025 年下半年獲得初步數據。

  • For ciforadenant, reporting additional data from the cifo Phase 1b/2 trial in frontline renal cell cancer in the fourth quarter and reporting data in prostate cancer at the CITSI meeting in November.

    對於ciforadenan,報告了第四季度針對一線腎細胞癌的cifo 1b/2期試驗的更多數據,並在11月的CITSI會議上報告了前列腺癌的數據。

  • Our current cash runway -- our current cash gives us runway into late 2025, allowing us to execute on these important milestones and further demonstrate the value of our programs, and in particular, the significant opportunity for ITK inhibition in immunology and in cancer.

    我們目前的現金跑道——我們目前的現金為我們提供了到2025 年末的跑道,使我們能夠執行這些重要的里程碑,並進一步證明我們計畫的價值,特別是ITK 抑制在免疫學和癌症領域的重大機會。

  • We look forward to providing updates on our programs in the coming quarters.

    我們期待在未來幾季提供我們計劃的最新資訊。

  • I will now turn the call over to the Operator for a Q&A period.

    我現在將把電話轉給接線員進行問答。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Li Watsek, Cantor.

    李·瓦塞克,康托爾。

  • Li Watsek - Analyst

    Li Watsek - Analyst

  • Hey.

    嘿。

  • Great.

    偉大的。

  • Congrats on the progress.

    祝賀取得的進展。

  • Maybe just a one on the Phase 1 data from a topic dermatitis in Q4, which I wonder if we can maybe frame the expectations for us in terms of, what we expect to see and what would be the bar in terms of EASI score.

    也許只是第四季度主題皮膚炎的第一階段數據,我想知道我們是否可以根據我們期望看到的內容以及 EASI 評分的標準來制定我們的期望。

  • And also understand you’re testing maybe multiple doses.

    並且還要了解您可能正在測試多個劑量。

  • So how should we think about the dose response in autoimmune?

    那我們該如何看待自身免疫的劑量反應呢?

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Li, for those questions.

    謝謝李老師提出的問題。

  • I would expect by the fourth quarter, we would be able to report safety and efficacy data on the first two cohorts of our clinical trial.

    我預計到第四季度,我們將能夠報告臨床試驗前兩組的安全性和有效性數據。

  • The first two cohorts are enrolling patients treated at 100 milligrams BID and then 200 milligrams once a day.

    前兩個隊列招募的患者接受 100 毫克 BID 治療,然後每天一次 200 毫克。

  • Of course, we’re trying to move to a once a day dosing.

    當然,我們正在嘗試改為每天一次給藥。

  • In terms of setting the bar for what we would consider success, I would say having a majority of the patients EASI scores above 50% improvement.

    就設定我們認為成功的標準而言,我想說的是,大多數患者 EASI 評分改善超過 50%。

  • Remember, this is a 28-day treatment, so that’s a pretty good score in a short period of time.

    請記住,這是一個為期 28 天的治療,因此在短時間內取得了相當不錯的成績。

  • I would expect that data to be comparable to that was seen with early clinical trials with Dupixent and other competitive products.

    我預計這些數據與 Dupixent 和其他競爭產品的早期臨床試驗中看到的數據相當。

  • So we’re looking to be competitive.

    因此,我們希望保持競爭力。

  • We think we have certain advantage in the long-term with an oral drug, very good safety profile and a novel mechanism that’s going to be applicable to a range of immune and inflammatory diseases.

    我們認為,從長遠來看,我們的口服藥物具有一定的優勢,具有非常好的安全性和適用於一系列免疫和發炎疾病的新穎機制。

  • Li Watsek - Analyst

    Li Watsek - Analyst

  • Okay.

    好的。

  • Great.

    偉大的。

  • So, another question, or if you talk about you’re going to other immune diseases.

    那麼,另一個問題,或者如果你談論你會患上其他免疫疾病。

  • So in terms of the dose that you’re going to be using, do you expect that to be the same or slightly different based on the conditions?

    那麼就您將要使用的劑量而言,您認為根據情況會相同還是略有不同?

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • I would expect them to be the same.

    我希望它們是一樣的。

  • I don’t expect that we’re going to see gross differences in dosing.

    我不認為我們會看到劑量上的巨大差異。

  • Remember, we have a very precise way to measure the pharmacodynamic effects of our drug.

    請記住,我們有一個非常精確的方法來測量我們藥物的藥效作用。

  • We can actually measure how much of the active site of the target is occupied by our drug and we’re also beginning to get a handle on other biological functional assays, such as the production of different cytokines.

    我們實際上可以測量目標的活性位點有多少被我們的藥物佔據,我們也開始掌握其他生物功能測定,例如不同細胞因子的產生。

  • So I don’t expect to have variability from disease-to-disease.

    因此,我預期不同疾病之間不會有差異。

  • Li Watsek - Analyst

    Li Watsek - Analyst

  • Okay.

    好的。

  • Great.

    偉大的。

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Roger Song, Jefferies.

    羅傑·宋,杰弗里斯。

  • Roger Song - Analyst

    Roger Song - Analyst

  • Great.

    偉大的。

  • Thanks for the update and then taking our questions.

    感謝您的更新並回答我們的問題。

  • Maybe the first one is the Phase 1 atopic dermatitis study enrollment.

    也許第一個是第一階段異位性皮膚炎研究的入組。

  • What kind of a patient baseline we should expect given you allow them to have for at least one prior therapy?

    鑑於您允許他們接受至少一種先前的治療,我們應該期望什麼樣的患者基線?

  • Should we expect most of the patients will be having prior biologics or they’re having multiple prior lines?

    我們是否應該預期大多數患者之前都使用過生物製劑,或者他們之前使用過多種藥物?

  • And then given you give us some expectation for the 50 for the majority of the patients, so how should we think about the comparability compared to other trials for the 80?

    然後考慮到您對大多數患者的 50 例試驗給出了一些期望,那麼我們應該如何考慮 80 例試驗與其他試驗的可比性?

  • Thank you.

    謝謝。

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • Well, so far we’ve seen some patients who’ve had biologics and some who have not.

    到目前為止,我們已經看到一些患者服用了生物製劑,而其他患者則沒有。

  • So I don’t -- I’m not sure I’m able to predict what we’ll ultimately get.

    所以我不確定我是否能夠預測我們最終會得到什麼。

  • But the treatment of this disease is changing over the years because there’s other therapies that are effective.

    但多年來,這種疾病的治療方法正在發生變化,因為還有其他有效的療法。

  • And so I’m not sure, Roger, I can predict exactly what the mix is that we’ll get in this Phase 1 trial.

    所以我不確定,羅傑,我可以準確預測我們將在第一階段試驗中得到什麼組合。

  • I would expect that we’ll get a little bit of everything.

    我希望我們能得到一切的一點點。

  • Roger Song - Analyst

    Roger Song - Analyst

  • All right.

    好的。

  • Yeah.

    是的。

  • That makes sense.

    這是有道理的。

  • We’re going to take a closer look at when we report the data.

    當我們報告數據時,我們將仔細研究。

  • And then, so in terms of the solid tumor, can you give us some rationale why it goes into the RCC as the first solid tumor and any preclinical biology rationale to support that?

    那麼,就實體瘤而言,您能否給我們一些解釋為什麼它作為第一個實體瘤進入腎細胞癌,以及任何支持這一點的臨床前生物學原理?

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • Okay.

    好的。

  • Good question.

    好問題。

  • So first of all, remember, soquelitinib or specific ITK inhibition results in what’s called Th1 skewing.

    因此,首先請記住,soquelitinib 或特定的 ITK 抑制會導致所謂的 Th1 傾斜。

  • This, of course, was predicted based on genetic knockout studies done 20 years ago.

    當然,這是根據 20 年前進行的基因敲除研究預測的。

  • And with the motivation for us making a highly selective drug that blocks Th2, Th17, and induces what are called Th1 helper T-cells.

    我們的動機是製造一種高度選擇性的藥物,可以阻斷 Th2、Th17 並誘導所謂的 Th1 輔助 T 細胞。

  • Those lead to the production of an increase in CD8 killer cells.

    這些導致 CD8 殺傷細胞的產生增加。

  • We have shown in animal models, and this has been shown by other investigators, that we induce a host anti-tumor response not just against T-cell lymphomas, but in mice we’ve seen activity against renal cell cancer, against GI tumors, against lung tumors, melanoma and B-cell lymphoma.

    我們已經在動物模型中證明,其他研究人員也證明了這一點,我們不僅誘導了針對T 細胞淋巴瘤的宿主抗腫瘤反應,而且在小鼠中我們發現了針對腎細胞癌和胃腸道腫瘤的活性,對抗肺部腫瘤、黑色素瘤和 B 細胞淋巴瘤。

  • Other investigators have seen other solid tumors.

    其他研究人員也發現了其他實體瘤。

  • Now, the reason we picked renal cell cancer in the clinical trial is, number one, renal cell cancer is a so-called immune responsive disease.

    現在,我們在臨床試驗中選擇腎細胞癌的原因是,第一,腎細胞癌是一種所謂的免疫反應性疾病。

  • We didn’t want to go -- we wanted to go after a disease where we knew that the immune system was important in controlling the tumor.

    我們不想去—我們想要追蹤一種我們知道免疫系統對於控制腫瘤很重要的疾病。

  • We also had mouse data that showed us that soquelitinib worked really well in tumors that were resistant to anti-PD-1 therapy.

    我們也有小鼠數據表明,索奎替尼在對抗 PD-1 療法抗藥性的腫瘤中效果非常好。

  • So renal cell cancer provided a great opportunity for us to treat patients who would have already had failed an anti-PD-1 or a checkpoint inhibitor and had immune-responsive tumors.

    因此,腎細胞癌為我們提供了一個很好的機會來治療那些抗 PD-1 或​​檢查點抑制劑已經失敗且患有免疫反應性腫瘤的患者。

  • And then finally, we have a very good relationship with the Kidney Cancer Research Consortium.

    最後,我們與腎臟癌研究聯盟有著非常好的關係。

  • So we’ve really loved working with these folks.

    所以我們非常喜歡與這些人一起工作。

  • These are the world’s experts in renal cell cancer.

    他們是世界腎細胞癌領域的專家。

  • This provided a very special opportunity for us to move quickly into renal cell cancer.

    這為我們快速進入腎細胞癌領域提供了一個非常特殊的機會。

  • And finally, I might add that if you -- at the last ASCO meeting, even though no question, ipi and nivo are inducing more PRs and CRs and PFSs improved, et cetera, when you really look at some of the original data now that was comparing treatment, checkpoint inhibitor therapy to Sutent, the standard care, it’s not clear that survival has improved.

    最後,我可能會補充一點,如果您在上次 ASCO 會議上,即使毫無疑問,ipi 和 nivo 正在引發更多 PR、CR 和 PFS 改進等,當您真正查看一些原始數據時,現在發現將檢查點抑制劑治療與標準治療索坦治療進行比較,目前尚不清楚存活是否有改善。

  • And so there’s clearly a need for therapies in renal cell that have a different mechanism of action and potentially can improve that PFS even longer and result in an improvement in survival.

    因此,顯然需要一種具有不同作用機制的腎細胞療法,並且有可能延長 PFS 並提高存活率。

  • So renal is a good disease, but it’s a good question.

    所以腎臟病是一種很好的疾病,但也是一個很好的問題。

  • You could also say study melanoma, study lung cancer.

    你也可以說研究黑色素瘤、研究肺癌。

  • There are gastric cancer.

    有胃癌。

  • There are plenty of other immune-responsive tumors.

    還有許多其他免疫反應性腫瘤。

  • But we were in a good position to do renal and we had very strong rationale for that.

    但我們在腎臟方面處於有利位置,並且我們對此有非常充分的理由。

  • Roger Song - Analyst

    Roger Song - Analyst

  • Yeah.

    是的。

  • That makes sense.

    這是有道理的。

  • Multi-factor -- factors to decide the indication selection.

    多因素-決定指示選擇的因素。

  • Maybe just last one, quick one.

    也許只是最後一件事,快一點。

  • Given you’re moving, expanding the application for the soquelitinib, so how should we think about the strategic decision in terms of you moving everything by itself, or maybe at some point you were looking to partner with some other company to be able to be more efficient to expand the program?

    鑑於您正在搬家,擴大索奎替尼的應用範圍,那麼我們應該如何考慮您自行移動所有東西的戰略決策,或者也許在某個時候您希望與其他公司合作以便能夠能夠更有效地擴展程序嗎?

  • Thank you.

    謝謝。

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • Okay.

    好的。

  • Well, we’re really excited about the results, both in lymphoma and in early results in immune disease, not to mention strong preclinical data.

    好吧,我們對淋巴瘤和免疫疾病早期結果的結果感到非常興奮,更不用說強大的臨床前數據了。

  • We’re going to push soquelitinib forward in immune diseases and cancer as fast as we can.

    我們將盡快推動索奎替尼在免疫疾病和癌症領域取得進展。

  • Of course, we have a lot of partnering discussions ongoing, and Mr. Arcara, our Chief Business Officers, busily working away on those.

    當然,我們正在進行大量的合作討論,我們的首席商務官阿卡拉先生正忙著處理這些問題。

  • But we’re pushing both fronts forward as quickly and as fast as we can.

    但我們正在盡可能快地推動這兩條戰線向前發展。

  • We’ll talk to partners and we’ll determine as we get into these discussions based on the economics, the data, et cetera, which -- how to expand these appropriately.

    我們將與合作夥伴交談,當我們根據經濟、數據等進行這些討論時,我們將確定如何適當地擴展這些內容。

  • Roger Song - Analyst

    Roger Song - Analyst

  • Excellent.

    出色的。

  • Thank you, Dr. Miller.

    謝謝你,米勒醫師。

  • Operator

    Operator

  • Aydin Huseynov, Ladenberg.

    艾丁侯賽諾夫,拉登伯格。

  • Aydin Huseynov - Analyst

    Aydin Huseynov - Analyst

  • Hi, Richard and team.

    嗨,理查德和團隊。

  • Congratulations with the progress this quarter and congratulations with converting one PR into a CR.

    恭喜本季度取得的進展,並祝賀將一個 PR 轉換為 CR。

  • So you’ve got six CRs and three PRs now, and usually we get, vice versa, usually we get majority of the patients getting PRs in some of the trials.

    所以現在有 6 個 CR 和 3 個 PR,通常我們會得到,反之亦然,通常我們會讓大多數患者在某些試驗中獲得 PR。

  • So how would you describe these CR patients?

    那麼您會如何描述這些 CR 患者呢?

  • Do you think -- why do you think they are responding so well, the ones that had PRs -- CRs complete responses?

    您認為 - 為什麼您認為他們的反應如此之好,那些擁有 PR - CR 的人完成了反應?

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • So, how would I describe the patient?

    那麼,我該如何描述這個病人呢?

  • Let me take that first.

    讓我先說一下。

  • Well, if you look at our last CR, this was a patient who grew through CHOP.

    好吧,如果你看看我們的上一份 CR,你會發現這是一個透過 CHOP 成長的病人。

  • CHOP chemotherapy is an aggressive chemotherapy.

    CHOP化療是一種侵襲性化療。

  • He grew through that.

    他透過那件事成長了。

  • He did not respond to that.

    他沒有對此做出回應。

  • Then he went on a protocol called, a chemo regimen called ICE, ifosfamide, platinum, etoposide, very aggressive chemotherapy.

    然後他進行了一項名為 ICE 的化療方案,其中包含異環磷酰胺、鉑、依托泊苷,這是非常積極的化療。

  • The patient had a very short partial response and relapsed, and then goes on our drug and has a CR.

    患者出現了非常短暫的部分緩解並復發,然後繼續服用我們的藥物並獲得 CR。

  • So that’s how I would describe that.

    這就是我的描述方式。

  • Now, why does that happen?

    現在,為什麼會發生這種情況?

  • I’m not sure I can answer that question, other than that this is a completely different mechanism.

    我不確定我能否回答這個問題,除非這是一個完全不同的機制。

  • Our drug has a completely different mechanism of action and even though this patient had chemorefractory disease, the immune approach was very effective in him.

    我們的藥物具有完全不同的作用機制,儘管該患者患有化學難治性疾病,但免疫方法對他非常有效。

  • So we do not yet have, I would say, a specific biomarker to predict responsiveness, although in our Phase 3 trial, where we’ll have more patients, we do have biopsies.

    因此,我想說,我們還沒有一種特定的生物標記來預測反應性,儘管在我們的 3 期試驗中,我們將有更多的患者,我們確實進行了活檢。

  • We do also have a research program that is going to be looking, using all kinds of very sophisticated techniques, looking at sequencing of the tumor, sequencing of the host infiltrate in these tumors, and of course, they’re circulating normal blood cells to try to figure out what is predictive.

    我們確實還有一個研究計劃,將使用各種非常複雜的技術來研究腫瘤的測序、這些腫瘤中宿主浸潤的測序,當然,它們正在循環正常血球試圖弄清楚什麼是預測性的。

  • I might also add that almost all of the patients on our trial are so-called GATA3 positive.

    我還想補充一點,我們試驗中幾乎所有患者都是所謂的 GATA3 陽性。

  • GATA3 is a transcription factor that’s called the master regulator of helper T-cell s or Th2 cells.

    GATA3 是一種轉錄因子,被稱為輔助 T 細胞或 Th2 細胞的主調節因子。

  • GATA3 positive tumors are known, it’s in the literature, to be a very poor prognostic very poor.

    根據文獻報告,GATA3 陽性腫瘤的預後非常差。

  • In fact, my colleague Ryan Wilcox at the University of Michigan published a paper a few years ago in PTCL where GATA3 positive patients who went in the hospice did just as well as those that got chemotherapy.

    事實上,我在密西根大學的同事 Ryan Wilcox 幾年前在 PTCL 上發表了一篇論文,其中進入臨終關懷中心的 GATA3 陽性患者的表現與接受化療的患者一樣好。

  • So this is a really bad disease and I think that we’re having a very significant effect on a high -- on basically an unmanageable patient population.

    因此,這是一種非常嚴重的疾病,我認為我們對基本上無法控制的患者群體產生了非常顯著的影響。

  • Aydin Huseynov - Analyst

    Aydin Huseynov - Analyst

  • Thank you.

    謝謝。

  • Very helpful.

    非常有幫助。

  • And another question I have is on second-generation ITK inhibitors.

    我的另一個問題是關於第二代ITK抑制劑。

  • So could you remind us what is going to be different with soquelitinib and when do you think they will enter the clinic?

    那麼您能否提醒我們 soquelitinib 有什麼不同以及您認為它們什麼時候會進入診所?

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • So the second and third generation ITK inhibitors, some have similar chemical structures with just slight changes.

    所以第二代和第三代ITK抑制劑,有的化學結構相似,只是略有變化。

  • Some are very different chemical structures.

    有些是非常不同的化學結構。

  • Some are covalent.

    有些是共價的。

  • Some are non-covalent or reversible.

    有些是非共價的或可逆的。

  • We’ve been examining those -- each of those agents in various biologic assays that we have and we see some differences in their impact on, for example, Th2 versus Th17 versus Th1.

    我們一直在檢查這些藥物——我們進行的各種生物測定中的每一種藥物,我們發現它們對 Th2、Th17 和 Th1 等的影響存在一些差異。

  • So I would say we’re still in the process now of identifying the next-generation for IND-enabling studies.

    因此,我想說,我們現在仍在確定下一代 IND 支持研究的過程。

  • I think we’re 12 months to 15 months away from studies in immune or inflammatory diseases.

    我認為我們距離免疫或發炎疾病的研究還有 12 到 15 個月的時間。

  • In the meantime, we blast forward with soquelitinib in immunology, immune diseases and cancer.

    同時,我們將索奎替尼在免疫學、免疫疾病和癌症方面持續進行。

  • Aydin Huseynov - Analyst

    Aydin Huseynov - Analyst

  • All right.

    好的。

  • Thank you.

    謝謝。

  • Thanks so much and congrats with the progressive score.

    非常感謝並祝賀進步分數。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Jeff Jones, Oppenheimer.

    傑夫瓊斯,奧本海默。

  • Jeff Jones - Analyst

    Jeff Jones - Analyst

  • Good afternoon, guys, and congrats on all the progress.

    下午好,夥計們,祝賀所有的進步。

  • It’s great to see it.

    很高興看到它。

  • I guess, quick question on the AD data.

    我想,關於 AD 數據的快速問題。

  • Any thoughts on how you’ll be presenting this?

    對於如何呈現這個內容有什麼想法嗎?

  • Will this be at a conference or is this something you might do more informally by press release or Investor call?

    這是在會議上還是您可以透過新聞稿或投資者電話會議以更非正式的方式進行?

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • Jeff, probably by some sort of Investor call or R&D update or something like that.

    傑夫,可能是透過某種投資者電話會議或研發更新或類似的方式。

  • I’m not sure there’s any meeting around the end of the year that’s appropriate.

    我不確定年底前後是否有合適的會議。

  • We do have this -- we do have meetings, but they’re not really geared towards immune diseases.

    我們確實有這個——我們確實有會議,但它們並不是真正針對免疫疾病。

  • We’ll be at CITSI.

    我們將參加 CITSI。

  • We’ll be at a GU Oncology meeting in November, but probably be in the form of a press release or investor conference call, something like that.

    我們將參加 11 月的 GU 腫瘤學會議,但可能會採取新聞稿或投資者電話會議等形式。

  • Jeff Jones - Analyst

    Jeff Jones - Analyst

  • Okay.

    好的。

  • Great.

    偉大的。

  • And with respect to the pivotal study, it sounds like you’re right on the cusp of kicking things off, but any gating items that we should be thinking about that need to get knocked down ahead of moving forward or is this ready to go?

    關於關鍵研究,聽起來您正處於啟動階段,但我們應該考慮的任何門控項目都需要在繼續前進之前被擊倒,或者是否已經準備好進行?

  • I think you said in September.

    我想你說的是九月。

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • No gating items.

    沒有門控項目。

  • We’ve got complete clearance from FDA.

    我們已獲得 FDA 的完全許可。

  • We’ve had close communication with them.

    我們與他們進行了密切的溝通。

  • Our sites are ready to go.

    我們的網站已準備就緒。

  • I think we have contracts even in place with some of them and all the approvals there.

    我認為我們甚至與其中一些公司簽訂了合約並獲得了所有批准。

  • Right now, we’re just pressure testing some of our computer systems to make sure there are no glitches.

    目前,我們只是對一些電腦系統進行壓力測試,以確保沒有任何故障。

  • Really, there’s nothing in our way now that I can see.

    真的,現在我可以看到,沒有任何東西能擋住我們的路了。

  • Jeff Jones - Analyst

    Jeff Jones - Analyst

  • Okay.

    好的。

  • And then, I guess, last question, just a little further clarity on the next-generation of ITK inhibitors that you spoke to earlier.

    然後,我想,最後一個問題,只是進一步澄清您之前談到的下一代 ITK 抑制劑。

  • Sounds like they’re a little over a year away, if I understood correctly, from the clinic, but maybe some clarity there.

    如果我沒理解錯的話,聽起來他們距離診所還有一年多的時間,但也許那裡有些清晰了。

  • And is -- are these things you would think of moving ahead into the clinic yourself or would that await a partner on some of these INI indications, as you’ve spoken to before?

    您是否會考慮自己將這些事情帶入診所,還是等待合作夥伴根據其中一些 INI 適應症進行?

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • Both of those things are being considered.

    這兩件事都在考慮之中。

  • Jeff Jones - Analyst

    Jeff Jones - Analyst

  • Okay.

    好的。

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • With our backup, the second and third generation compounds, first of all, we have to do more testing in animals.

    有了我們的後盾,第二代和第三代化合物,首先,我們必須在動物身上做更多的測試。

  • We think certain ones would be better for particular diseases and so we just need to get more information on that.

    我們認為某些藥物對特定疾病效果更好,因此我們只需要獲得更多相關資訊。

  • But right now, we love sulcolitinib for immune diseases.

    但現在,我們喜歡用舒可替尼來治療免疫疾病。

  • Jeff Jones - Analyst

    Jeff Jones - Analyst

  • All right.

    好的。

  • Great.

    偉大的。

  • Thank you very much, guys.

    非常感謝你們,夥伴們。

  • Operator

    Operator

  • Graig Suvannavejh, Mizuho.

    Graig Suvannavejh,瑞穗。

  • Graig Suvannavejh - Analyst

    Graig Suvannavejh - Analyst

  • Good afternoon.

    午安.

  • Thanks for taking my questions.

    感謝您回答我的問題。

  • It’s nice to see the progress.

    很高興看到進展。

  • First question, if I could, is just around the current budget or operating plan vis-a-vis the cash runway.

    如果可以的話,第一個問題是關於當前預算或營運計劃與現金跑道的關係。

  • Can you just remind us what the current budget actually allows for in terms of the programs that are funded, and to what stage are those programs funded, again, given the current cash situation?

    您能否提醒我們,目前的預算實際上允許資助的項目是多少,以及考慮到當前的現金狀況,這些項目的資金資助到了什麼階段?

  • Leiv Lea - Chief Financial Officer

    Leiv Lea - Chief Financial Officer

  • Sure.

    當然。

  • The programs that we’ve described in terms of the Phase -- beginning of the Phase 3 trial are the completion of our Phase 1/1b trial, the solid tumor trial and the cifo trial are all in the budget with our cash forecast into the end of 2025.

    我們在階段 - 3 期試驗開始時描述的計劃是我們 1/1b 期試驗的完成,實體瘤試驗和 cifo 試驗都在預算中,我們的現金預測為2025年底。

  • Graig Suvannavejh - Analyst

    Graig Suvannavejh - Analyst

  • Okay.

    好的。

  • Thanks so much for that clarification.

    非常感謝您的澄清。

  • And then just on the pivotal Phase 3 study that you’re planning to start by September, I might have missed this previously, but can you provide just kind of a sketch of kind of the timelines of when you might expect to get to a data readout for that study?

    然後,就您計劃在 9 月開始的關鍵第三階段研究而言,我以前可能錯過了這一點,但是您能否提供一個大概的時間表,說明您可能期望何時達到預期目標?數據讀出?

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • So, first of all, the Phase 3 registration trial, I said it will start in September, not by September.

    所以,首先,第三階段的註冊試驗,我說的是九月開始,不是九月開始。

  • And so, that trial enrolls 150 patients.

    因此,該試驗招募了 150 名患者。

  • There’s an interim analysis at 65 events, PFS events.

    對 65 個事件(PFS 事件)進行了中期分析。

  • That’s probably a year away after we start the trial, 18 months to complete enrollment, two years to get the data, less than two years to get the data, topline data.

    這可能是我們開始試驗後一年的時間,18 個月才能完成註冊,兩年才能獲得數據,不到兩年就能獲得數據,最重要的數據。

  • Graig Suvannavejh - Analyst

    Graig Suvannavejh - Analyst

  • Okay.

    好的。

  • Thank you very much.

    非常感謝。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • There are no further questions at this time.

    目前沒有其他問題。

  • Richard Miller - Chairman of the Board, President, Chief Executive Officer

    Richard Miller - Chairman of the Board, President, Chief Executive Officer

  • Okay.

    好的。

  • Operator, thank you.

    接線員,謝謝。

  • Thank you, everyone, for participating in our call.

    謝謝大家參與我們的電話會議。

  • We look forward to updating you at future conference calls.

    我們期待在未來的電話會議上向您通報最新情況。

  • Thank you very much.

    非常感謝。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • That does conclude our conference for today.

    我們今天的會議到此結束。

  • Thank you all for participating.

    感謝大家的參與。

  • You may all disconnect.

    你們都可以斷開連線。