Corvus Pharmaceuticals Inc (CRVS) 2025 Q2 法說會逐字稿

Good afternoon, everyone. Thank you for standing by, and welcome to the Corvus Pharmaceuticals second quarter 2025 business update and financial results conference call. (Operator Instructions) It is now my pleasure to turn the call over to Zack Kubow of Real Chemistry. Please go ahead, sir.

大家下午好。感謝您的支持，歡迎參加 Corvus Pharmaceuticals 2025 年第二季業務更新與財務業績電話會議。（操作員指示）現在我很高興將電話轉給 Real Chemistry 的 Zack Kubow。先生，請繼續。

Thank you, operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals second quarter 2025 business update and financial results conference call. On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer; Leiv Lea, Chief Financial Officer; Jeffrey Arcara, Chief Business Officer; and Ben Jones, Senior Vice President of Regulatory and Pharmaceutical Sciences.

謝謝接線員，大家下午好。感謝您參加 Corvus Pharmaceuticals 2025 年第二季業務更新與財務業績電話會議。參加電話會議討論業績和業務更新的有首席執行官理查德·米勒 (Richard Miller)、首席財務官萊夫·利亞 (Leiv Lea)、首席商務官杰弗裡·阿卡拉 (Jeffrey Arcara) 和監管與製藥科學高級副總裁本·瓊斯 (Ben Jones)。

The executive team will open the call with some prepared remarks, followed by a question-and-answer period. I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements.

執行團隊將以一些準備好的發言開始電話會議，然後是問答環節。我想提醒大家，管理階層今天發表的評論和對問題的回答將包括前瞻性陳述。

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, 2025, and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. With that, I'd like to turn the call over to Leiv Lea. Leiv?

前瞻性陳述是基於截至今天的估計和假設，並受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表達或暗示的結果存在重大差異，包括 Corvus 截至 2025 年 6 月 30 日季度的 10-Q 表季度報告中描述的風險和不確定性，以及公司不時向美國證券交易委員會提交的其他文件中描述的風險和不確定性，以及公司不時向美國證券交易委員會提交的不確定性。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。說完這些，我想把電話轉給 Leiv Lea。雷夫？

Thank you, Zack. I will begin with a brief overview of our second quarter 2025 financials and then turn the call over to Richard for a business update. Research and development expenses in the second quarter of 2025 totaled $7.9 million compared to $4.1 million for the same period in 2024.

謝謝你，扎克。我將首先簡要概述我們 2025 年第二季的財務狀況，然後將電話轉給理查德，讓他介紹業務最新情況。2025 年第二季的研發費用總計 790 萬美元，而 2024 年同期為 410 萬美元。

The $3.8 million increase was primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel-related costs. The net loss for the second quarter of 2025 was $8 million, including a non-cash loss of $400,000 related to Angel Pharmaceuticals, our partner in China.

380 萬美元的成長主要是由於與索奎替尼開發相關的臨床試驗和製造成本增加以及人員相關成本增加。2025 年第二季淨虧損為 800 萬美元，其中包括與我們在中國的合作夥伴 Angel Pharmaceuticals 相關的 40 萬美元非現金損失。

In addition, we recorded a non-cash gain of $2 million from the change in the fair value of Corvus' warrant liability during the second quarter of 2025. This compares to a net loss of $4.3 million for the same period in 2024, which included a $1.8 million non-cash gain related to the change in fair value of Corvus' warrant liability and a $600,000 non-cash loss related to Angel Pharmaceuticals.

此外，我們在 2025 年第二季度因 Corvus 認股權證負債公允價值變動而獲得了 200 萬美元的非現金收益。相較之下，2024 年同期的淨虧損為 430 萬美元，其中包括與 Corvus 認股權證負債公允價值變動相關的 180 萬美元非現金收益，以及與 Angel Pharmaceuticals 相關的 60 萬美元非現金損失。

Total stock compensation expense for the second quarter 2025 was $1.3 million compared to $800,000 in the same period in 2024. As of June 30, 2025, Corvus had cash, cash equivalents and marketable securities totaling $74.4 million as compared to $52 million at December 31, 2024. During the second quarter, all of the remaining common stock warrants were exercised, resulting in cash proceeds of approximately $35.7 million which included $2 million from warrants exercised by our CEO, Dr. Miller.

2025 年第二季股票薪酬總費用為 130 萬美元，而 2024 年同期為 80 萬美元。截至 2025 年 6 月 30 日，Corvus 的現金、現金等價物和有價證券總額為 7,440 萬美元，而 2024 年 12 月 31 日為 5,200 萬美元。在第二季度，所有剩餘的普通股認股權證均已行使，產生約 3,570 萬美元的現金收益，其中包括我們執行長米勒博士行使的 200 萬美元認股權證。

Based on our current plans, we expect our current cash to fund operations into the fourth quarter of 2026. I now turn the call over to Richard, who will discuss our clinical progress and elaborate on our strategy and plans.

根據我們目前的計劃，我們預計目前的現金將為 2026 年第四季的營運提供資金。現在我將電話轉給理查德，他將討論我們的臨床進展並詳細闡述我們的策略和計劃。

Thank you, Leiv, and good afternoon, everyone. Thank you for joining us today for our update call. Our main focus continues to be the development of soquelitinib for atopic dermatitis, where we believe we are uniquely positioned with an oral medication featuring a novel mechanism of action that so far has shown favorable safety and efficacy profile.

謝謝你，Leiv，大家下午好。感謝您今天參加我們的更新電話會議。我們的主要重點仍然是開髮用於治療異位性皮膚炎的索奎替尼，我們相信，我們在這一領域具有獨特的優勢，因為這種口服藥物具有新穎的作用機制，迄今為止已顯示出良好的安全性和有效性。

We are making significant progress on multiple fronts, including new data from our Phase 1 trial reported in June that increases our confidence in the long-term potential for soquelitinib in this indication and beyond. On today's call, I will provide a high-level recap of this data, review our go-forward clinical plans, including our planned Phase 2 trial design, and briefly discuss our progress with our other clinical programs.

我們在多個方面取得了重大進展，包括 6 月報告的第 1 階段試驗的新數據，這增強了我們對索奎替尼在該適應症及其他方面的長期潛力的信心。在今天的電話會議上，我將對這些數據進行高層次的回顧，回顧我們的未來臨床計劃，包括我們計劃的第二階段試驗設計，並簡要討論我們在其他臨床項目中的進展。

We view the data through Cohort 3 of the Phase 1 trial as very encouraging. All of the treatment cohorts demonstrated a favorable safety and efficacy profile compared to placebo and Cohort 3 data is especially exciting, demonstrating earlier and deeper and more durable responses compared to Cohorts 1 and 2.

我們認為第一階段試驗第 3 組的數據非常令人鼓舞。與安慰劑相比，所有治療組均表現出良好的安全性和有效性，而第 3 組的數據尤其令人興奮，與第 1 組和第 2 組相比，顯示出更早、更深層和更持久的反應。

Specifically, at just four weeks of treatment, Cohort 3 showed a mean percent reduction of EASI score of 64.8% compared to 54.6% for the combined Cohorts 1 and 2 and 34.4% for placebo. No placebo patients achieved the clinically meaningful endpoints of EASI-75, EASI-90 or IGA 0 or 1. We compare this to the results seen for the soquelitinib patients where many achieved these endpoints.

具體來說，僅經過四周的治療，第 3 組患者的 EASI 評分平均降低了 64.8%，而第 1 組和第 2 組患者的 EASI 評分平均降低了 54.6%，安慰劑組患者的 EASI 評分平均降低了 34.4%。沒有安慰劑患者達到EASI-75、EASI-90或IGA 0或1的臨床意義終點。我們將其與索奎替尼患者的結果進行了比較，其中許多患者達到了這些終點。

In Cohort 3, 50% of patients achieved EASI 75, 8% achieved EASI 90, and 25% achieved IGA 0 or 1. This compares to 29%, 4% and 21% in the combined Cohorts 1 and 2 that were treated, respectively. In terms of the kinetics of response, Cohort 3 showed earlier and deeper separation from placebo beginning at day eight with the EASI score improvement continuing through day 15 and 28 and far beyond.

在隊列 3 中，50% 的患者達到 EASI 75，8% 的患者達到 EASI 90，25% 的患者達到 IGA 0 或 1。相較之下，接受治療的第 1 組和第 2 組的合併治療比例分別為 29%、4% 和 21%。就反應動力學而言，第 3 組從第 8 天開始就顯示出與安慰劑更早、更深的分離，EASI 評分改善持續到第 15 天和第 28 天甚至更久。

For Cohorts 1 and 2, the separation from placebo began at day 15 and showed continued separation at day 28. For all 3 cohorts, this separation was maintained during the 30-day post-treatment follow-up period.

對於隊列 1 和 2，與安慰劑的分離從第 15 天開始，並在第 28 天持續分離。對於所有 3 個隊列，這種分離在治療後 30 天的追蹤期間得以維持。

In addition, for all 3 cohorts, the downward slope of the curves at day 15 to day 28 suggests that longer treatment duration could potentially deepen responses further. We also have found a remarkable impact on PP-NRS, a patient self-reported assessment of itch.

此外，對於所有 3 個隊列，第 15 天至第 28 天的曲線向下傾斜表明更長的治療時間可能會進一步加深反應。我們也發現 PP-NRS（患者自我報告的搔癢評估）有顯著影響。

A number of Cohort 3 patients reported steep drops in the score beginning at day eight, which aligned with the reductions we see in serum cytokine levels of IL-31 and IL-33. Both of these cytokines are known to be involved in the itch response. In addition, other biomarker data from the trial continues to support the ITK inhibition mechanism of action, including the potential induction of anti-inflammatory T regulatory cells.

許多第 3 組患者報告稱，從第八天開始評分急劇下降，這與我們看到的血清細胞因子 IL-31 和 IL-33 水平的下降一致。已知這兩種細胞激素都與搔癢反應有關。此外，試驗中的其他生物標記數據繼續支持 ITK 抑製作用機制，包括抗發炎 T 調節細胞的潛在誘導。

Regarding safety, there were no safety issues observed with soquelitinib with no significant differences between treatment and placebo groups and no clinically significant laboratory abnormalities were seen. The total current treatment experience with soquelitinib now involves over 150 patients with T-cell lymphoma or atopic dermatitis, representing more than 9,000 patient treatment days. In our lymphoma trial, some patients have been on continuous daily therapy up to two years.

關於安全性，索奎替尼沒有觀察到安全性問題，治療組和安慰劑組之間沒有顯著差異，也沒有發現臨床上顯著的實驗室異常。目前，索奎替尼的治療經驗已涉及超過 150 名 T 細胞淋巴瘤或異位性皮膚炎患者，相當於超過 9,000 個患者治療日。在我們的淋巴瘤試驗中，有些患者已經連續接受每日治療長達兩年。

Based on the results obtained to date, we are advancing the clinical development of soquelitinib in two ways. First, we amended the Phase 1 trial protocol to replace the previously planned Cohort 4 with an extension Cohort 4 that will evaluate an additional 24 patients at the Cohort 3 dose of 200 milligrams twice per day given for eight weeks with an additional 30-day follow-up without therapy.

根據目前所獲得的結果，我們正在透過兩種方式推進索奎替尼的臨床開發。首先，我們修改了第 1 階段試驗方案，以擴展隊列 4 取代先前計劃的隊列 4，該隊列將對另外 24 名患者進行評估，這些患者服用第 3 隊列的劑量為每天兩次，每次 200 毫克，持續八週，並進行額外的 30 天隨訪，無需治療。

The 24 patients will be randomized in a blinded fashion one-to-one with placebo, 12 active and 12 placebo. The extension Cohort 4 will give us data on a longer treatment duration of eight weeks versus four weeks seen with Cohorts 1 and 3.

這 24 名患者將以盲法一對一隨機分配接受安慰劑治療，其中 12 名接受活性藥物治療，12 名接受安慰劑治療。擴展隊列 4 將為我們提供長達八週的治療持續時間的數據，而隊列 1 和 3 的治療持續時間為四週。

We have now enrolled more than half the patients and continue to anticipate that data from the extension cohort will be available in the fourth quarter. Second, we are finalizing the design of our planned Phase 2 clinical trial of soquelitinib for atopic dermatitis, and I am happy to share those plans with you now. The trial will be an international randomized, placebo-controlled and double-blinded.

我們現在已經招募了超過一半的患者，並繼續預計擴展隊列的數據將在第四季度提供。其次，我們正在最終確定索奎替尼治療異位性皮膚炎的 2 期臨床試驗計劃，我很高興現在與大家分享這些計劃。該試驗將是一項國際隨機、安慰劑對照和雙盲試驗。

The company will also be blinded. It will enroll approximately 200 patients with moderate to severe atopic dermatitis that have failed at least one prior topical or systemic therapy. Patients will be required to have a baseline EASI score that is greater than or equal to 16, IGA of 3 or 4 and body surface involvement that is greater than or equal to 10%.

公司也會蒙蔽。它將招募大約 200 名患有中度至重度異位性皮膚炎且至少接受過一次局部或全身治療的患者。患者的基線 EASI 分數必須大於或等於 16，IGA 必須為 3 或 4，且體表受累程度必須大於或等於 10%。

The patients will be randomized equally into four cohorts, 50 patients in each cohort receiving either 200-milligram soquelitinib once per day, 200 milligrams twice per day, 400 milligrams once per day or placebo. Let me repeat those groups, 200 milligrams once per day, 200 milligrams twice per day, 400 milligrams once per day or placebo.

這些患者將隨機分成四組，每組 50 名患者分別接受索奎替尼治療，每次 200 毫克，每日一次；索奎替尼治療，每次 200 毫克，每日兩次；索奎替尼治療，每次 400 毫克，或接受安慰劑治療。讓我重複這些組別，每天一次 200 毫克，每天兩次 200 毫克，每天一次 400 毫克或安慰劑。

The treatment period will be 12 weeks, and patients will be followed for an additional 30 days without therapy. The primary endpoint will be the percent change in EASI score from baseline to week 12. Secondary endpoints will include the percent of patients achieving EASI 75 or IGA 0 or 1 at week 12.

治療期為 12 週，患者也將接受額外 30 天的無治療追蹤。主要終點是從基線到第 12 週 EASI 評分的百分比變化。次要終點包括第 12 週達到 EASI 75 或 IGA 0 或 1 的患者百分比。

The impact on itch will be measured by percent of patients achieving greater than or equal to 4 point decrease in the PP-NRS scale at week 12 and of course, safety as well. We anticipate including 30 to 40 clinical trial sites globally.

對搔癢的影響將透過第 12 週 PP-NRS 量表上達到或等於 4 分下降的患者百分比來衡量，當然還有安全性。我們預計將在全球設立 30 至 40 個臨床試驗地點。

We are currently finalizing the trial design with the investigators with strong interest from many leading centers, and we are on track to initiate the trial before the end of the year. Outside of our clinical trials, our partner in China, Angel Pharmaceuticals, plans to initiate a Phase 1b/2 trial of soquelitinib for atopic dermatitis in China.

我們目前正在與許多領先中心的研究人員一起敲定試驗設計，並預計在今年年底前啟動試驗。除了我們的臨床試驗之外，我們在中國的合作夥伴安吉製藥計劃在中國啟動索奎替尼治療異位性皮膚炎的 1b/2 期試驗。

This study will enroll 48 patients and is anticipated to build on the data from our Phase 1 trial by studying a longer treatment period of 12 weeks and an additional dosing option of 400 milligrams once daily, in line with the direction we are headed with our Phase 2 trial.

這項研究將招募 48 名患者，預計將以我們第 1 階段試驗的數據為基礎，研究 12 週的更長治療期和每天一次 400 毫克的額外給藥選擇，這與我們第 2 階段試驗的方向一致。

Briefly on our other clinical programs, we have submitted an abstract to present the final results from our Phase 1 clinical trial of soquelitinib for the treatment of relapsed/refractory T-cell lymphomas at the American Society of Hematology meeting in December. We continue to enroll patients in our registrational Phase 3 trial of soquelitinib in patients with relapsed PTCL, driving towards interim data in late 2026.

簡要介紹我們的其他臨床項目，我們已提交了一份摘要，在 12 月的美國血液學會會議上介紹索奎替尼治療復發/難治性 T 細胞淋巴瘤的 1 期臨床試驗的最終結果。我們將繼續招募患者參與索奎替尼治療復發性 PTCL 患者的註冊性 3 期試驗，爭取在 2026 年底獲得中期數據。

In addition, patient enrollment is ongoing in our Phase 2 trial of soquelitinib in patients with ALPS, autoimmune lymphoproliferative syndrome. Depending on enrollment trends, it is possible we could see initial data from the Phase 2 ALPS study in late 2025 or early 2026.

此外，我們正在對患有 ALPS（自體免疫性淋巴增生症候群）的患者進行索奎替尼 2 期試驗，招募患者。根據入學趨勢，我們可能會在 2025 年末或 2026 年初看到第二階段 ALPS 研究的初步數據。

We have completed enrollment in our Phase 2 trial with Ciforadenant in renal cell cancer. These data will be presented in an oral presentation in October at the ESMO meeting, European Society for Medical Oncology. In closing, the soquelitinib results in atopic dermatitis and T-cell lymphoma underscore the importance of ITK as a critical target for a range of diseases involving inflammation and cancer and the broad potential for soquelitinib in many areas of medicine, such as dermatology, oncology, rheumatology, pulmonary medicine and other areas.

我們已經完成了 Ciforadenant 治療腎細胞癌的 2 期試驗的招募。這些數據將於 10 月在歐洲腫瘤內科學會 (ESMO) 會議的口頭報告中公佈。最後，索奎替尼在異位性皮膚炎和 T 細胞淋巴瘤中的結果強調了 ITK 作為一系列涉及發炎和癌症的疾病的關鍵靶點的重要性，以及索奎替尼在皮膚病學、腫瘤學、風濕病學、肺病學和其他許多醫學領域的廣泛潛力。

We feel we may be entering a new era of immunotherapy for autoimmune inflammatory diseases that is based on drugs with novel mechanisms of action that modulate or rebalance immunity by keeping pro-inflammatory or aberrant T-cells in check.

我們感覺我們可能正在進入自體免疫性發炎疾病免疫療法的新時代，該時代基於具有新作用機制的藥物，透過控制促炎或異常的 T 細胞來調節或重新平衡免疫力。

This potential has motivated us to complement the development of soquelitinib with the discovery and development of next-generation ITK inhibitors with unique properties. In the near term, we look forward to continuing the clinical development of soquelitinib in atopic dermatitis and PTCL and look forward to providing updates on our programs in the coming quarters. I will now turn the call over to the operator for a questions-and-answer period. Operator?

這種潛力促使我們透過發現和開發具有獨特特性的下一代 ITK 抑制劑來補充索奎替尼的開發。短期內，我們期待繼續進行索奎替尼在異位性皮膚炎和 PTCL 方面的臨床開發，並期待在未來幾季提供有關我們計劃的最新資訊。現在我將把電話轉給接線員進行問答。操作員？

(Operator Instructions)

（操作員指示）

Jeff Jones.

傑夫瓊斯。

Congrats on a hugely productive quarter. I guess you've got a plethora of opportunities in front of you. As you think about Cifo in autoimmune disease, in addition to accelerating as you are in the Phase 2, how are you thinking about next indications and financially being able to support the many opportunities that Cifo represents?

恭喜本季取得了豐碩成果。我想你面前有很多機會。當您考慮 Cifo 在自體免疫疾病領域的應用時，除了在第 2 階段加速發展之外，您如何考慮下一步的適應症，以及如何在財務上支持 Cifo 所代表的眾多機會？

Okay. So Jeff, let me first correct. Yes, Cifo is renal cell cancer. But soquelitinib obviously, we're pursuing aggressively atopic dermatitis, but we've already begun to think about follow-up indications. And the two indications that we're thinking about, we're thinking about two of them.

好的。那麼傑夫，讓我先糾正一下。是的，Cifo 是腎細胞癌。但索奎替尼顯然正在積極治療異位性皮膚炎，但我們已經開始考慮後續適應症。我們正在考慮的兩個跡像是，我們正在考慮其中的兩個。

One, of course, we sort of want to maintain our presence in dermatology. We have experience there now. We have a lot of information on, we think, the behavior of the drug in these cutaneous diseases. So I think a likely target for us might be something like hidradenitis suppurativa. There is totally unmet need there, I would say.

首先，當然，我們希望保持在皮膚病學領域的地位。我們現在在那裡有經驗。我們認為，我們掌握了大量有關藥物在這些皮膚疾病中的作用的資訊。所以我認為我們可能的目標可能是像化膿性汗腺炎之類的疾病。我想說，那裡完全存在著未滿足的需求。

And then the other disease moving away from dermatology in the inflammation area would be pulmonary disease. Asthma is probably scientifically the most justification for a disease is probably asthma. We have three or four different animal models where we see excellent activity of our drug in asthma, both acute and chronic.

然後，發炎領域中與皮膚病無關的另一種疾病是肺部疾病。氣喘可能是科學上最合理的疾病，可能是氣喘。我們有三到四種不同的動物模型，在這些模型中，我們看到我們的藥物對急性和慢性氣喘都有出色的療效。

Also the mechanism of action, specifically the inhibition of what are called innate lymphoid cells really leads us to believe that we might have a very important novel approach to asthma and perhaps other pulmonary diseases. But you're quite right. It is difficult for us to pursue all these indications. But we've shown that we're very adept and agile in terms of efficiently maximizing the value of, I'd say, each of our products.

而且其作用機制，特別是對所謂的先天淋巴細胞的抑制，確實讓我們相信，我們可能對氣喘和其他肺部疾病有一種非常重要的新方法。但你說得很對。對我們來說，追尋所有這些跡像是困難的。但我們已經證明，在有效最大化我們每款產品的價值方面，我們非常熟練和靈活。

I appreciate that. And then the follow-up question is actually on Cifo. In terms of the renal update coming at ESMO, how are you thinking about next steps for the program, assuming with an oral that there's going to be a positive update here on the program?

我很感激。後續問題其實是關於 Cifo 的。就 ESMO 即將發布的腎臟更新而言，您如何考慮該計劃的下一步行動，假設口服藥物會帶來積極的更新？

Okay. So just to remind everyone, ciforadenant is an A2A antagonist, the oral medication. We did a Phase 2 study in first-line renal cell cancer, patients who are receiving ipi and nivo. So we added the A2A antagonist. And the idea there, of course, is to look at response rate, but also very importantly, to look at since they stay on the A2A antagonist every day for a long time, they get the ipi and nivo for a short time.

好的。所以提醒大家，ciforadenant 是一種 A2A 拮抗劑，是一種口服藥物。我們對接受 ipi 和 nivo 治療的第一線腎細胞癌患者進行了 2 期研究。因此我們添加了 A2A 拮抗劑。當然，這裡的想法是觀察反應率，但同樣非常重要的是，觀察由於他們每天長時間使用 A2A 拮抗劑，因此他們只能短暫使用 ipi 和 nivo。

I think one of the things that we'll be looking for in addition to, of course, objective responses is the durability of responses and PFS in other words. So let's see what that data is. This is a study that was conducted by the Kidney Cancer Consortium, several centers, MD Anderson, Vanderbilt, and several others. They ran that study. We, of course, provided the drug and some financial support.

我認為，除了客觀反應之外，我們還要尋找的一件事就是反應的持久性，換句話說就是 PFS。那麼讓我們看看這些數據是什麼。這是一項由腎癌聯盟、多個中心、MD 安德森癌症中心、范德堡大學和其他幾家機構共同進行的研究。他們進行了那項研究。當然，我們提供了藥物和一些經濟支持。

So let's see what's presented in an oral presentation at ESMO, and then we'll go from there. Based on the data that comes out of that, we'll make our decisions about how to follow-up on that.

那麼，讓我們看看 ESMO 的口頭報告會呈現什麼內容，然後我們從那裡開始。根據得出的數據，我們將決定如何跟進。

Okay. But it is quite a unique study. I mean, it's first-line disease. It's renal cell cancer. We know that's immune-responsive.

好的。但這是一項相當獨特的研究。我的意思是，這是一線疾病。這是腎細胞癌。我們知道這是免疫反應。

I'm emphasizing this because I know today some other company came out with some A2A stuff, and I think it was metastatic colon cancer, and they had chemotherapy and a number of various treatments there and one of the things that we've always done well is to carefully study our agents initially as a monotherapy and then move into combinations where we have a good understanding of the efficacy and safety and mechanism. So that's helped us a lot. Does that answer your question?

我強調這一點是因為我知道今天其他一些公司推出了一些 A2A 產品，我認為是用於治療轉移性結腸癌，他們有化療和多種不同的治療方法，而我們一直做得很好的一件事就是仔細研究我們的藥物，最初作為單一療法，然後轉向組合療法，這樣我們對療效、安全性和機制都有了很好的了解。這對我們幫助很大。這回答了你的問題嗎？

It does.

確實如此。

Graig Suvannavejh.

格雷格·蘇萬納維。

This is Sam on for Graig. Congrats on the progress. Maybe just a quick one on soquelitinib and PTCL. Just curious how the enrollment is going and if the previous guidance for data in late 2026 is still there.

這是 Sam 代替 Graig 上場。恭喜你取得進展。也許只是對索奎替尼和 PTCL 進行簡要介紹。只是好奇入學情況如何，以及先前對 2026 年底數據的指導是否仍然有效。

Our guidance is still intact. We're enrolling according to plan. We have probably about 20 centers open now. These are the best of the best centers in the United States and Canada. So everything there is going according to plan. And we're hoping that our presentation on the Phase 1 will really start to focus attention on this drug.

我們的指導仍然有效。我們正在按計劃招生。我們現在大概有 20 個中心開放。這些是美國和加拿大最好的中心。所以一切都按計劃進行。我們希望我們關於第一階段的介紹能真正引起人們對這種藥物的關注。

Aydin Huseynov.

艾登·胡賽諾夫。

Congrats with the quarter. A couple of questions from us. So could you walk us through the decision process, thinking process regarding the Phase 2 trial design for atopic dermatitis. So I appreciate giving us color about four different cohorts, 200 QD, 200 BID, 400 QD, and placebo.

恭喜本季。我們有幾個問題。那麼，您能否向我們介紹一下針對異位性皮膚炎的 2 期試驗設計的決策過程和思考過程？因此，我很高興能向我們提供有關四種不同群體的詳細信息，即 200 QD、200 BID、400 QD 和安慰劑。

Just so far, we see in atopic dermatitis, the most productive cohort is Cohort 3. So I was curious to better understand, was it more like an FDA suggestion to give a little bit weaker dose, a little bit harder -- a little bit stronger dose? Just walk us through the process if you could.

到目前為止，我們發現，在異位性皮膚炎中，最有成效的群體是群體 3。所以我很好奇，想更能理解，這是否更像是 FDA 的建議，給予稍微弱一點的劑量，稍微強一點的劑量？如果可以的話，請向我們介紹整個過程。

Okay. Thank you for that question. So first of all, there's a lot of precedents now for Phase 2 trials in atopic dermatitis. We're not the first company to do that. And a 200-patient trial with roughly 50 per arm is, I would say, pretty standard.

好的。謝謝你的提問。首先，現在有許多針對異位性皮膚炎的 2 期試驗的先例。我們不是第一家這樣做的公司。我認為，每組約 50 名患者參與的 200 次試驗是相當標準的。

And you are correct, Aydin. Usually, there is -- the FDA wants to see some dosing -- different doses studied so that you can determine what's the lowest dose that's possibly effective and what's a higher dose that becomes maybe not more effective than another dose. So we selected these doses because the 200 once a day, we think is active. We don't think it's going to be -- and we've already tested it. You've seen that data in Cohort 2.

你說得對，艾登。通常，FDA 希望看到一些劑量——對不同劑量進行研究，以便確定可能有效的最低劑量，以及可能不會比其他劑量更有效的較高劑量。因此，我們選擇這些劑量是因為我們認為每天一次 200 毫克是有效的。我們認為這不會發生——而且我們已經對其進行了測試。您已在第 2 組看到了該資料。

I think that will be an active dose. It's a single -- it's a daily dose. Some people, of course, prefer a single dose, once-a-day dosing for atopic dermatitis. But the 200 BID, we saw a better response. That's a doubling of the dose in our Cohort 3, and that's what we're studying in our extension now.

我認為這將是有效劑量。這是單次劑量－每日劑量。當然，有些人喜歡每天服用一次單一劑量來治療異位性皮膚炎。但對於 200 BID，我們看到了更好的反應。這是我們第 3 組劑量的兩倍，這也是我們現在在擴展中研究的內容。

So that's the second cohort, 200 once a day, 200 twice a day. And then, of course, we want to do 400 once a day, same total dose as the 200 BID, but given once a day. I think we can do once-a-day dosing. So this will give us an opportunity to confirm that. And then, of course, placebo.

這是第二批，每天一次，200 人，每天兩次，200 人。然後，當然，我們希望每天服用 400 毫克，總劑量與 200 毫克 BID 相同，但每天服用一次。我認為我們可以每天服用一次。因此這將給我們一個機會來確認這一點。當然，還有安慰劑。

I can't emphasize enough how important it is to have placebos in Phase 1 and Phase 2 trials. I am seeing companies now do these studies with no placebos, and it's absolutely astounding to me. But in any event, so 50 patients in each arm, 200 total, placebo-controlled, totally blinded, company is blinded. The endpoints are pretty standard. The mean percent change in EASI is the usual primary endpoint for a Phase 2 study, secondary endpoints being EASI 75s and IGA 0 and 1s.

我再怎麼強調在第一階段和第二階段試驗中使用安慰劑的重要性也不為過。我看到現在有些公司在進行這些研究時不使用安慰劑，這對我來說絕對令人震驚。但無論如何，每組有 50 名患者，總共 200 名，安慰劑對照，完全盲測，公司也是盲測。端點非常標準。EASI 的平均百分比變化是第 2 階段研究的通常主要終點，次要終點是 EASI 75 秒和 IGA 0 秒和 1 秒。

So that's all really pretty standard. Yes, and we're moving to 12 weeks of therapy. We'll have experience with eight weeks of therapy, which we already have right now. And we think that, that should give us a pretty good result. In terms of the statistics, if we have even a 20% improvement in any of the groups, you can just -- we can just look at any one group versus the placebo.

所以這一切都非常標準。是的，我們將進行為期 12 週的治療。我們將擁有八週治療的經驗，目前我們已經擁有了。我們認為，這應該會為我們帶來相當不錯的結果。從統計數據來看，如果任何一組有 20% 的改善，我們可以 — — 我們可以比較任何一組與安慰劑組。

If we're 20%, 22% better, we want to -- we expect to be better than that. But even if that's at the lower end of our -- of our information. We have an 80% power to see that a p-value of 0.05 on that. And in the Phase 2 trial, that will be fine. So the sizes statistically make sense.

如果我們提高了 20%、22%，我們希望——我們期望比這更好。但即使這只是我們所掌握資訊的最低限度。我們有 80% 的功效來證明 p 值為 0.05。在第二階段試驗中，情況會很好。因此從統計上來說，這些尺寸是有意義的。

The dosing makes sense based on what we know and what we also know about occupancy and the receptor. And we think this is a very manageable trial for us. There's a lot of experience in doing these international Phase 2s, 200 patients would be very manageable for a company like Corvus. I hope that answered your question.

根據我們所知道的以及我們對佔有率和受體的了解，劑量是合理的。我們認為這對我們來說是一個非常容易管理的試驗。在進行這些國際第 2 階段研究方面擁有豐富的經驗，對於像 Corvus 這樣的公司來說，200 名患者是非常容易管理的。我希望這回答了你的問題。

Absolutely. Yeah, it does. Just wanted to -- a couple of follow-up questions on this trial. So I know this could be a little bit early, but would you be able to provide the time line, when do you think we can see the results? I mean, I understand this is randomized blinded trial, but if you could give us some hints in terms of when it could be ready.

絕對地。是的，確實如此。只是想問幾個有關這次審判的後續問題。所以我知道這可能有點早，但您能否提供時間表，您認為我們什麼時候可以看到結果？我的意思是，我知道這是隨機盲法試驗，但你能不能給我們一些關於何時可以準備好的提示。

Okay. No, happy to give that. We've, of course, been thinking about that. I think you're looking at enrollment in 12 to 15 months, maybe you have results in 18 months, and we'll start the trial in December. And we have a couple of things, I think, going for us.

好的。不，我很樂意給予。當然，我們一直在考慮這個問題。我認為你預計會在 12 到 15 個月內完成招生，也許在 18 個月內得到結果，我們會在 12 月開始試驗。我認為，我們有幾件事對我們有利。

Obviously, it's oral. That should help enrollment. I think the second thing, novel mechanism of action, I think that will also facilitate enrollment. We're not requiring biopsies, although we're going to have some centers where we're going to try to motivate people to do some biopsies. But of course, that should also improve enrollment.

顯然，這是口頭的。這應該有助於入學。我認為第二件事，新穎的作用機制，我認為這也會促進入學。我們並沒有要求進行活檢，儘管我們會在一些中心嘗試鼓勵人們進行活檢。但當然，這也應該會提高入學率。

But the biggest thing that's going to facilitate enrollment is that we are allowing patients who have failed systemic therapies. So that really opens up the potential patient population. So many of these studies, they won't take you if you've already failed a systemic therapy, a JAK inhibitor, let's say, or a dupi or something like that or an anti-IL-13, but we're allowing those patients.

但最有利於患者入組的事情是我們允許系統治療失敗的患者入組。這確實開拓了潛在的患者群。在許多這類研究中，如果您已經對全身療法、JAK 抑制劑、dupi 或類似藥物或抗 IL-13 療法失敗，他們就不會接受您，但我們允許這些患者接受。

And the reason we're allowing those patients is because our mechanism of action is completely distinct from those, number one. And number two, we've had patients like that on our study so far, and it hasn't mattered, they've done just as well.

我們允許這些患者使用藥物的原因首先是因為我們的作用機制與這些患者完全不同。第二，到目前為止，我們的研究中已經遇到過這樣的患者，但這沒關係，他們的表現也一樣好。

So my assumption is that you'll probably be stratifying based on which exactly therapy they failed topical or systemic but yes.

所以我的假設是，你可能會根據他們失敗的特定治療方法（局部治療或全身性治療）進行分層，但確實如此。

Absolutely. I mean there are a few things you might stratify on. Obviously, I mean if you're baseline EASI score, that will be a stratification factor and whether or not you failed the systemic therapy. We haven't gotten into that degree of detail yet, but there'll probably be two or three different stratification factors. You can't get too many in a study with only 200 patients.

絕對地。我的意思是，您可能會根據一些事情進行分層。顯然，我的意思是，如果您的基線 EASI 評分是這樣的，這將是一個分層因素，以及您是否未能完成全身性治療。我們還沒有深入到這種程度的細節，但可能會有兩到三個不同的分層因素。在一項只有 200 名患者的研究中，你不可能得到太多的數據。

Right, right. Yes. And my question I have was about the next-generation ITK inhibitor. As we move forward with that, could you give us some thoughts on how it will be different from soquelitinib and which indications you'd be planning to target if it's not too early?

對，對。是的。我的問題是關於下一代 ITK 抑制劑。隨著我們繼續推進這項工作，您能否告訴我們它與索奎替尼有何不同，以及如果時間還不算太早，您計劃針對哪些適應症？

Okay. So first of all, for certain intellectual property reasons, I'd rather not go into the details of how they're different because there are a lot of people who are now working on ITK inhibitors. And I'd rather not go into the details. But suffice it to say, let me answer your question this way. ITK plays many roles in a cell, T-cell receptor signaling, everything from T-cell receptor signaling to control of Th2 cytokine production to apoptosis.

好的。因此首先，出於某些智慧財產權的原因，我寧願不詳細討論它們的不同之處，因為現在有很多人正在研究 ITK 抑制劑。我不想談論細節。但我只想說，讓我這樣回答你的問題。ITK 在細胞、T 細胞受體訊號傳導中發揮多種作用，從 T 細胞受體訊號傳導到控制 Th2 細胞因子的產生再到細胞凋亡。

And we think we have compounds that might work better for some of those indications than others or some of those mechanisms. So let me answer it that way.

我們認為，我們的化合物可能對某些適應症比其他化合物或某些機制更有效。那麼就讓我這樣回答吧。

There are no further questions at this time. I will now turn the call over to Richard Miller. Please continue.

目前沒有其他問題。現在我將把電話轉給理查德·米勒。請繼續。

Thank you, operator. First of all, let me thank everyone for participating in today's call. Look forward to updating you again in the next quarter and updating you on the progress with all our clinical trials. Thank you very much.

謝謝您，接線生。首先，感謝大家參加今天的電話會議。期待在下個季度再次向您通報我們所有臨床試驗的進展。非常感謝。

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.

女士們、先生們，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。