Corvus Pharmaceuticals (CRVS) 2026年第三季度业绩电话会: 2027年临床试验催化剂

核心要点

• Corvus Pharmaceuticals (NASDAQ: CRVS) 公布2026年第三季度净亏损为2030万美元，而2025年第三季度净亏损为1020万美元；主要因研发支出从850万美元增至1780万美元。
• 截至2026年9月30日，现金、现金等价物及有价证券总额为2.029亿美元。管理层预计该资金可支持公司运营至2028年第二季度。
• soquelitinib用于治疗复发/难治性外周T细胞淋巴瘤的注册性3期试验入组进展顺利。预计将于2027年第一季度进行事件驱动的无效性分析，顶线数据预计在2027年年底前公布。
• 约200名患者参与的SIERRA-1特应性皮炎2期试验的顶线数据预计将于2027年第三季度公布。若取得积极结果，有望支持在2028年启动3期临床项目。
• 安济药业预计将于2027年3月公布首个24名特应性皮炎队列患者的初步数据。此外，Corvus预计将于2027年上半年公布化脓性汗腺炎1b期试验结果。
• Corvus计划于2027年第一季度启动一项哮喘试验；同时，在3名患者取得积极初步结果后，ALPS项目预计将从美国国家过敏和传染病研究所（NIAID）移交给Corvus。

核心财务数据

业务及临床进展

外周T细胞淋巴瘤

Corvus表示，soquelitinib治疗复发/难治性外周T细胞淋巴瘤的注册性3期试验入组工作进展符合预期。

独立数据监察委员会将在达到预设的无进展生存事件数量后开展无效性分析。管理层预计该审查将在2027年第一季度进行，不过具体时间由事件驱动而非日历驱动。若试验继续进行，Corvus将披露委员会的决定，但不会公布中期安全性或疗效数据。顶线结果预计在2027年年底前公布。

特应性皮炎

SIERRA-1 2期试验设计入组约200名患者，涵盖三个soquelitinib剂量组和一个安慰剂组。治疗持续12周，随后进行为期90天的停药期。顶线数据预计将于2027年第三季度公布。

管理层表示，若SIERRA-1试验取得成功，Corvus有望于2028年启动3期项目。这项潜在的关键性试验将以第12周或第16周相对于安慰剂的EASI和IGA评分作为评估指标。

在中国，安济药业已完成其双盲、安慰剂对照试验队列1的入组工作。该队列包含24名患者，被平均随机分配至soquelitinib每日两次（每次100毫克）、每日一次（每次200毫克）或安慰剂组。在所有患者完成12周治疗及至少30天随访后，初步数据预计将于2027年3月公布。

安济药业计划在队列2中再入组24名患者，分为soquelitinib每日两次（每次200毫克）、每日一次（每次400毫克）及安慰剂组。队列2数据有望于2027年下半年公布。根据前48名患者的试验结果，安济药业预计将在2期阶段进一步入组60至90名患者。

化脓性汗腺炎

Corvus于2026年9月启动了一项1b期试验。该研究计划入组最多25名患者，所有患者均接受每日两次、每次200毫克的soquelitinib治疗，为期12周，随后进入90天的停药观察期。

主要终点为安全性和耐受性。疗效指标包括第12周的HiSCR 50和HiSCR 75，以及对结节、脓肿、引流窦道和与Th17、Th2及调节性T细胞相关生物标志物的评估。

管理层表示，入组约一个月后进度已超预期，有望支持在2027年上半年公布数据。

哮喘与ALPS

Corvus计划于2027年第一季度启动一项涵盖T2型和非T2型疾病的哮喘试验。试验方案将嗜酸性粒细胞截断值设为150，高于该水平的患者归为T2型，低于该水平的归为非T2型；同时还将把FeNO水平高于25作为T2型疾病的评估指标。中期分析将允许公司在发现无效时终止任一疾病组的研究。

在自身免疫性淋巴增生综合征（ALPS）方面，首批3名成年患者均完成了为期一年、每日两次（每次200毫克）的soquelitinib治疗。未报告治疗中断或3级/4级不良事件。3名患者均停用了包括皮质类固醇和免疫抑制剂在内的基础药物。其中2名患者的外周循环增殖性双阴性T细胞减少，2名患者脾肿大缓解。

Corvus计划从NIAID接管ALPS的新药临床试验申请（IND），扩增治疗中心数量，并就纳入儿科患者与FDA展开沟通。

管理层指引

• 管理层预计，按照公司当前规划，截至2026年9月30日的现金储备可支持运营至2028年第二季度。
• 3期PTCL试验的无效性分析结果预计于2027年第一季度出炉，顶线数据预计在2027年年底前公布。
• 安济药业队列1的特应性皮炎数据预计将于2027年3月公布。
• 化脓性汗腺炎1b期试验结果预计可在2027年上半年公布。
• SIERRA-1特应性皮炎2期试验的顶线数据预计将于2027年第三季度公布。
• 安济药业队列2数据有望在2027年下半年出炉。
• Corvus与安济药业均计划在2027年启动哮喘研究。

风险与关注重点

• PTCL中期审查的时间取决于是否达到预设的无进展生存事件数量。独立委员会可能建议继续试验，或因无效而建议终止试验。
• 若PTCL试验继续进行，Corvus将不会公布中期安全性或疗效结果，这将限制在顶线数据出炉前外界所能获取的信息。
• 特应性皮炎项目推进至3期临床以SIERRA-1试验取得积极结果为前提。
• 安济药业拟额外入组60至90名特应性皮炎患者的计划取决于队列1和队列2的结果。
• 哮喘方案包含无效性分析，这可能导致Corvus终止T2型或非T2型任一亚组的研发。

分析师问答亮点

• 安济药业数据读出时间：管理层表示，2027年3月的时间安排可确保队列1中的每位患者均完成12周治疗以及至少30天的随访，且期间公司、研究者和患者均保持设盲状态。
• 特应性皮炎入组标准：SIERRA-1允许局部外用皮质类固醇或系统治疗（包括Dupixent、JAK抑制剂和全身性皮质类固醇）失败的患者入组。管理层认为，soquelitinib未来既有望用作一线系统治疗，也可用于后线治疗。
• 化脓性汗腺炎评估基准：管理层指出，对于一款安全性良好的口服药物而言，50%至60%的HiSCR 50应答率以及约30%的HiSCR 75应答率将是令人鼓舞的结果。
• 哮喘试验时间调整：管理层认为从2026年12月下旬调整至2027年1月并无实质性影响，并表示新药临床试验申请（IND）已通过FDA审查。
• ALPS给药剂量：成年受试者接受每日两次、每次200毫克的剂量，与淋巴瘤和特应性皮炎试验中使用的剂量一致。儿科剂量可能根据患儿体型调整，管理层表示目前探讨定价或商业化尚为时过早。

业绩电话会完整实录

完整财报电话会议逐字稿

管理层陈述

Operator

Good afternoon, everyone, and thank you for standing by. Welcome to the Corvus Pharmaceuticals Third Quarter 2026 Business Update and Financial Results Conference Call. [Operator Instructions] It is now my pleasure to turn the call over to Zack Kubow, Vice President, Investor Relations and Corporate Communications. Please go ahead, sir.

Zack Kubow

Thank you, Operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals third quarter 2026 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, Jeff Arcara, Chief Business Officer, Ben Jones, Senior Vice President of Pharmaceutical Development, and Suresh Mahabhashyam, Vice President of Clinical Development.

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. 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's quarterly report on Form 10-Q for the quarter ended September 30, 2026, 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?

Leiv Lea

Thank you, Zack. I will begin with a brief overview of our third quarter 2026 financials and then turn the call over to Richard for a business update.

Research and development expenses in the third quarter of 2026 totaled $17.8 million, compared to $8.5 million for the same period in 2025. The increase in R&D expenses was primarily due to higher clinical trial costs associated with the development of soquelitinib, as well as an increase in personnel costs.

Net loss for the third quarter of 2026 was $20.3 million, compared to a net loss of $10.2 million for the same period in 2025. Included in the net loss for the third quarter of 2026 and 2025 were non-cash losses of $0.9 million and $0.3 million, respectively, from Corvus's equity method investment in Angel Pharmaceuticals.

Total stock compensation expense for the three months ended September 30, 2026, was $2.8 million, compared to $1.2 million for the same period in 2025. As of September 30, 2026, Corvus had cash, cash equivalents, and marketable securities totaling $202.9 million, as compared to $56.8 million at December 31, 2025.

Cash as of September 30, 2026, included approximately $189.4 million in net proceeds received in a follow-on offering completed in Q1. Also, as announced on June 9, 2026, Corvus invested $5 million in a $13.5 million financing completed by Angel Pharmaceuticals in the second quarter of 2026.

Based on our cash position at September 30, 2026, and our current plans, we expect our cash to fund operations into the second quarter of 2028. I'll now turn the call over to Richard, who will discuss our clinical progress and elaborate on our strategy and plans.

Richard Miller

Thank you, Leiv, and good afternoon, everyone. Thank you for joining us today for our update call. We are highly focused on soquelitinib, our first-in-class selective ITK inhibitor, and maximizing its potential across a broad range of diseases. We now have soquelitinib in several clinical trials covering a number of areas of medicine.

Our priority is advancing our two lead opportunities, the registrational Phase 3 trial in relapsed/refractory peripheral T-cell lymphoma and our SIERRA-1 Phase 2 trial in moderate-to-severe atopic dermatitis. Both programs are on track and represent significant opportunities to bring needed new treatment options to patients.

Based on soquelitinib's immunologic properties, we are leveraging its novel mechanism of action and broad immunomodulatory profile by strategically expanding its development to include new indications that are currently not well addressed by existing agents. This includes our trial in hidradenitis suppurativa, our planned asthma trial across T2 and non-T2 patients, and the ongoing trial in ALPS.

Combined with the clinical activities in China conducted by our partner, Angel Pharmaceuticals, we anticipate a number of key data readouts and milestones associated with our pipeline over the next year. We are positioned to generate significant value with our pipeline in 2027.

I will start with a brief update on our Phase 3 trial in relapsed/refractory PTCL. Enrollment is on track with our expectations, with the next milestone being a futility analysis anticipated in the first quarter of 2027. As a reminder, the futility analysis will be conducted by an independent data monitoring committee after a predefined number of progression-free survival, or PFS, events have occurred. This is event-driven, not time-driven. Based on the data at that point, the committee will determine whether the study should be continued or terminated for futility based on available safety and efficacy data.

Corvus will not announce any safety or efficacy data in conjunction with the interim analysis, but will disclose the committee's decision to continue or discontinue the trial. We remain excited about the potential of soquelitinib to provide a new treatment option for patients with relapsed/refractory PTCL, particularly given the challenges with current therapies, none of which are fully FDA approved for this indication.

On a related note, there will be an abstract published in the American Society of Hematology, or ASH, annual meeting abstract supplement of research done by a team from Memorial Sloan Kettering Cancer Center that further supports soquelitinib's mechanism of action. The MSK team studied pre- and post-treatment biopsy material from three patients from our Phase 1 trial with cutaneous T-cell lymphomas, a Th2-derived malignancy involving the skin. Using very sophisticated spatial transcriptomics, they showed that response to soquelitinib was associated with blocking GATA3 signaling, the master regulator of Th2 cells, leading to reduced Th2 cells in the skin.

I mention this work because it is relevant to the treatment of both PTCL and atopic dermatitis and adds to the growing body of knowledge supporting the fascinating immunologic properties of soquelitinib. Now for an update on soquelitinib for atopic dermatitis.

We remain very excited about the data to date, and we are working to advance development and enrollment in the Phase 2 SIERRA-1 trial as quickly as possible. The trial was planned to enroll approximately 200 patients, including patients who received prior systemic therapies across three soquelitinib doses and a placebo group. The treatment period is 12 weeks with a 90-day drug-free follow-up period. Enrollment is on track with our plans with top-line data anticipated in the third quarter of 2027.

Assuming a successful result from SIERRA-1, our strategy is to advance soquelitinib into a Phase 3 program similar to the other approved systemic therapies for atopic dermatitis. This includes a primary endpoint based on EASI score and IGA score at 12 or 16 weeks of therapy compared to a placebo. If our current timelines for SIERRA-1 hold, we could be in a position to start a Phase 3 trial in 2028. Our goal is to make soquelitinib available as soon as possible for patients and then expand the clinical evidence and label with post-marketing studies exploring some of its more unique attributes, such as post-treatment response duration.

In addition to our efforts, our partner in China, Angel Pharmaceuticals, is conducting a Phase 1b/2 clinical trial that may provide further evidence in support of soquelitinib safety and efficacy in atopic dermatitis, while also advancing its development in China. The ANGEL trial has a similar design to our Phase 2 trial and is open at several leading dermatology centers in China who have been involved in many global registration trials. It is a double-blind, placebo-controlled trial.

ANGEL has completed enrollment in Cohort 1, which includes 24 patients randomized evenly to soquelitinib doses of 100 milligrams twice per day, 200 milligrams once per day, or placebo. This is the same as the lower dose level studied in our Phase 1 trial, but the treatment period is longer at 12 weeks compared to 4 weeks. Recall, we found evidence of efficacy at these lower doses in our Phase 1 trial with 4 weeks of therapy.

We have been working closely with the ANGEL team on the trial, including the review of photographic images of disease from every single patient. Based on current timelines, we anticipate Angel and Corvus will announce preliminary data in March 2027. This timing accounts for all patients to complete 12 weeks of therapy and at least a 30-day post-treatment follow-up period, allowing us to remain blinded up until this point. The physicians and patients will continue to be blinded for the complete 90 days post-treatment, which will allow us to evaluate the durability of response.

We are pleased with the progress of the ANGEL trial, and we are monitoring blinded baseline patient characteristics. I can report that the ANGEL patients have similar baseline clinical characteristics to those patients enrolled in our Phase 1 atopic dermatitis trial. Of particular interest, and we are pretty excited about this, is that Asian American patients who were enrolled in Corvus's Phase 1 trial have very similar characteristics to the patients enrolled in the ANGEL trial conducted in Chinese patients.

In our Phase 1 trial, Asian Americans accounted for 11% or 8 of the total of 72 patients. Our testing shows that our Asian American patients had significantly elevated levels of serum IL-17 at baseline compared to the rest of our non-Asian population and a group of healthy volunteers. This aligns with the literature, which shows that Asian patients and certain other populations with atopic dermatitis have a greater component of Th17 disease, making them more difficult to treat with existing therapies that only target Th2 pathways. A recent report indicates that some patients have the coexistence of atopic dermatitis and psoriasis, either concurrently or as a result of treatment-induced phenotype switching between the two.

We anticipate ANGEL will begin enrolling patients in Cohort 2 this month, November, with data from Cohort 2 potentially available in the second half of 2027. Cohort 2 will include 24 patients randomized evenly to soquelitinib doses of 200 milligrams twice per day, 400 milligrams once per day, or placebo. Depending on the results from these 48 patients in Cohorts 1 and 2, an additional 60 to 90 patients are anticipated to be enrolled in the Phase 2 portion of the study.

Turning back to Corvus, in September, we initiated a Phase 1 trial of soquelitinib in patients with moderate to severe hidradenitis suppurativa. While there are approved biologic therapies for HS, many patients are in need of new treatment options due to lack of efficacy or results that wane over time. The approved therapies mainly target IL-17, a key downstream cytokine of Th17 cells, which are the primary drivers of this disease.

We believe soquelitinib is well positioned in HS because, number 1, we have shown it reduces both Th17 and Th2 in our atopic dermatitis trial and other work; 2, we have shown in preclinical studies that it reduces fibrosis, another hallmark of HS; and 3, it is an oral therapy in a category where the majority of approved products and development candidates are injectable biologics.

The Phase 1b HS trial is designed to enroll up to 25 patients. All patients will receive a soquelitinib dose of 200 milligrams twice per day for 12 weeks, followed by a 90-day follow-up period with no treatment. The primary endpoint of this trial is safety and tolerability. The key efficacy endpoint is the proportion of patients achieving hidradenitis suppurativa clinical response, or HiSCR 50 or 75, at week 12. We plan to intensively evaluate skin and blood biomarkers looking for Th17, Th2, Tregs, and related effects.

There has been very strong interest in our HS trial. While we have only been open about 1 month, we are ahead of our enrollment plan, positioning us to potentially report data in the first half of 2027.

We are also making progress on the asthma front. This includes our plan to enroll both the allergic or eosinophilic and non-allergic type of asthma, also referred to as T2 and non-T2. Most asthma drugs and most clinical trials address only the allergic T2 patients. We intend to enroll both types based on our mechanism of action, which we believe will address both T2 and non-T2 disease. A substantial proportion of asthma patients, up to 40%, have the non-T2 type and are in need of new and better therapies. The trial design will include an interim analysis, which will allow us to discontinue a disease type such as T2 or non-T2 if there is futility. We are on track to initiate the asthma trial in the first quarter of 2027.

I would like to report on our work in ALPS, or autoimmune lymphoproliferative syndrome, a study led by NIAID. Initial data covering three patients enrolled in the trial and treated for 1 year was selected for a poster presentation at the ASH meeting in December, and the related abstract was published yesterday. The data is consistent with the safety profile we have seen across our lymphoma and atopic dermatitis trials. All three patients had a positive response to therapy.

Key highlights include, first, safety. All three patients completed 1 year of treatment at the 200-milligram twice per day dose. The treatment was well tolerated with no interruptions in therapy and no Grade 3 or 4 adverse events reported. Next, clinical activity was observed in the three ALPS patients as follows: All three patients were able to discontinue their background medications, including corticosteroids and immunosuppressive drugs. Two of three patients had a drop in circulating, proliferating double-negative T cells in the blood, which are the pathologic cells in ALPS. One of the patients had very low circulating numbers to start with, making quantitation difficult. Splenomegaly was reduced in two of the three patients. Other disease-related markers were also improved.

Based on these results, we plan to transfer the IND for soquelitinib treatment of ALPS to Corvus. Our plan is to meet with the FDA to expand the number of treatment centers and to reduce the age eligibility to include pediatric patients.

Overall, we believe we are executing on a strategy to confirm the broad potential of soquelitinib and ITK inhibition across a range of Th2 and Th17-driven diseases. In 2027, we have significant milestones across our pipeline with clinical trials covering four significant market opportunities: PTCL, atopic dermatitis, hidradenitis suppurativa, and asthma. This will be complemented by ANGEL, which is expected to have trials in atopic dermatitis and asthma, and the NIAID study in ALPS that is transitioning to Corvus.

To briefly review our upcoming and 2027 anticipated milestones: initial ALPS data at ASH in December; interim futility analysis from the Phase 3 PTCL trial in the first quarter; Angel Pharmaceuticals atopic dermatitis Cohort 1 data in March; hidradenitis suppurativa Phase 1b results in the first half of 2027; Corvus SIERRA-1 Phase 2 data in the third quarter; Angel Pharma Cohort 2 data in the second half of the year; and the Phase 3 PTCL top-line data before the end of the year 2027.

In addition, both Corvus and Angel plan to launch asthma trials in 2027. The key through line across our development pipeline is the unique mechanism of action of ITK inhibition, resetting the immune system by modulating several key cellular functions with an oral tablet that so far has shown a very favorable safety profile.

We look forward to updating you on our progress in future calls. I will now turn the call over to the operator for the question-and-answer period. Operator?

Operator

Thank you. Ladies and gentlemen, [Operator Instructions] One moment, please, for your first question. Your first question comes from Li Wang Watsek from Cantor. Please go ahead.

分析师问答

Li Wang Watsek

So just, in terms of the [ ANGEL readout data ], looks like it's been pushed out by a quarter. Maybe help us understand the reason for the timeline shift. And you noted that the baseline characteristics in the trial are very similar to the U.S. trial. Just wondering which cohort that you're referring to, given there is some variability between cohorts.

Richard Miller

So, Li, thanks for the question. I assume you're referring to the atopic dermatitis trial by ANGEL. So, in the ANGEL patients enrolled so far, that's their first cohort, their baseline characteristics, blinded baseline characteristics we can look at, things like age, gender, et cetera, other mean EASI scores, et cetera. So when we look at that and compare that to the patients that we enrolled in our entire Phase 1 trial, 72 patients, we find that the characteristics are very, very similar regarding age, EASI scores, IGA scores, et cetera. This motivated us, obviously we're tracking ANGEL very carefully, this motivated us to go back and look at cytokines in Asian patients enrolled in the Corvus Phase 1 study. Obviously, there are Asians that are sometimes enrolled in American studies. And when we look at those patients, the baseline characteristics are very, very similar to the Chinese patients.

And most interesting to us is Chinese papers show that Asian patients with atopic dermatitis have a very strong IL-17, Th17 component. We confirm that in our U.S. Asian patients. Now, the ANGEL trial is going as planned. We've been very careful about patient selection, documentation of disease by photographic images, working at the very best centers in China. And so we are just enrolling that according to plan. In addition, before we disclose any data, we wanted to have the full 12 weeks of therapy with 30 days of follow-up, and we remain blinded during that period of time, the company, the patients, the doctor, everybody. So that's the reason why we've extended that out a little bit. Does that answer your question?

Li Wang Watsek

Yes, thank you very much.

Operator

Your next question comes from Graig Suvannavejh from Mizuho. Please go ahead.

Graig Suvannavejh

I had two questions, please. One, on your futility analysis that you will be announcing first quarter of next year. I think you said in your prepared comments that you are just going to announce pretty much like a yes or no answer and not disclose any safety or efficacy. Is that true in either case? In other words, if there was a futility that went negative, you still wouldn't want to share the safety/tolerability data? So just wanted to clarify that and perhaps the reasoning.

And then just second, as it relates to your hidradenitis suppurativa readout, I think the HiSCR 50 or 75 are the main efficacy endpoints. I was just curious if you were going to also share or if there are any lesion-based clinical endpoints that you have incorporated into the study and will you be sharing any?

Richard Miller

Okay, thanks, Greg. Regarding the futility analysis, if the study continues, we would just let people know that. I mean, it would be inappropriate to disclose data publicly at that time, because one could argue it could bias the remainder of the study. So that's fairly typical. Now, if the study is negative and you stop it, yes, of course, you can disclose data at some point.

Now, the second question on the HS, there are other parameters that we're measuring in HS. We're very interested in not just the nodules, but we're also scoring abscesses, tunnels, draining tunnels, all that sort of stuff. We're excited about HS because we're pretty convinced now we're having an effect on Th17. Th17 is a major player in asthma and in HS. A lot of neutrophils in these lesions. Neutrophils come from Th17 effects. So all of these things are sort of coming together. There's a reason behind the diseases that we chose based on the mechanism of action of soquelitinib. So the HS endpoints will look at all this, everything you mentioned, nodule count, which is just the HiSCR, but we are very interested in the other aspects, abscesses and tunnels, because we've previously reported, and this is a Th2-mediated effect, that soquelitinib has an effect on fibrosis. That was published last year and presented at the ACR meeting. It was in a mouse model of systemic sclerosis. I hope that answers the question.

Graig Suvannavejh

It does, thanks. And then just a quick follow-up on your ALPS program.

Richard Miller

I hope that answers your question.

Graig Suvannavejh

It's interesting that you're going to have the IND transferred over to Corvus. And I'm wondering, if you can confirm, those are the same doses that you previously have tested, and given just the patient population, which tends to be, I believe, a more rare type of a situation versus something more broad like asthma or atopic dermatitis, how are you thinking about dosing or pricing, I guess, ultimately, if you were to have success in all of these indications?

Richard Miller

Okay, so first of all, so far the ALPS patients have been adults. They've been 30 to 40 years old. And the dose has been 200 milligrams BID, same thing we're doing in lymphoma and in AD. Now, ALPS is mostly a disease in children, and we're going to meet with the FDA and move to a pediatric population, expand the number of sites. We want to have more control over this study. That's why we're taking over the IND. Obviously, when we go to a pediatric population, the doses may change based on just the size of the individuals involved.

The value of ALPS is what it is teaching us about our drug, about ITK, and about the immune system. So right now we work in T-cell lymphoma and autoimmune diseases. ALPS sits at the adjacency between these two areas. We have learned so much from the ALPS patients. Not only did it confirm the safety that we've been seeing in a pretty successful way, but really it's been giving us a lot of information on other diseases that we may want to go after in the future. Now, regarding pricing and commercialization, I think it's a little early to talk about that.

Graig Suvannavejh

Okay. Thank you very much.

Operator

Your next question comes from Roger Song from Jefferies. Please go ahead.

Cha Cha Yang

This is Chacha on for Roger. Just two questions for me. I just want to confirm on your Phase 2 AD patients, you said they failed at least one systemic or topical therapy, but does that mean that they've not necessarily failed Dupixent or JAK, is that correct? And then my second question is about your HS study. Can you just give us some expectations for the data benchmarks in order for soquelitinib to be competitive in this space?

Richard Miller

Okay, thanks for that question. Let's be clear. On our Phase 2 study, you must have failed a topical, either a topical corticosteroid or a systemic therapy, but you can have failed more than that. And so we accept patients who have failed Dupixent, a JAK inhibitor, or other therapies or systemic corticosteroids. So that's in distinction to, I think, most other trials. You can have failed Dupixent. And in fact, in our Phase 1, if you go back and look at the data that we presented at SID, there were several patients who had failed JAK inhibitors or Dupixent. Okay? And the reason we're excited about that is because our mechanism of action does not overlap with those mechanisms. And so we would not expect, nor did we ever see, any evidence of cross-resistance.

Now, the second question on HS, what do we expect to see? What we expect, I think that's what you were asking, we expect, so that's a trial that we're doing where we have now very good biomarkers to look at. We know what to look for: IL-17, Th17s, and the correlated transcription factors. Myeloid cells are going to be really interesting in that setting as well. As well, and this is surprising, there are a lot of B cells in the HS lesions. Let me also point out there are a lot of B cells in ALPS patients, even though it's a T-cell disease, there are a lot of B cells in their lesions. And if you look at our poster at ASH, you'll see some work on that in that area. T cells drive B cells. So anyway, we'll be looking at all of that. And I think we'll be able to get a good feel for whether or not we're seeing efficacy. And as soon as we see that, we don't have to wait for all 25 patients to be treated. We can start planning on a more definitive, randomized, placebo-controlled Phase 2. We don't have to wait till the end. Does that answer your question?

Cha Cha Yang

Yes, thanks.

Operator

Your next question comes from Jeffrey Jones from Oppenheimer. Please go ahead.

Jeffrey Jones

Maybe just to build on the AD and HS questions, as you look at the other studies in the field, any feel for benchmarks or hurdles that you would want to see, the degree of efficacy or signal that you want to see to support moving ahead? And then one follow-up.

Richard Miller

Yes, so I think that, you know, their benchmarks for HiSCR 75 and 50, you'd want for HiSCR 50, you'd want to see 50% to 60% of the patients achieve that. For the HiSCR 75, maybe around 30%. So I think if we hit that or better, we would be happy with that result with an oral agent with a good safety profile. And of course, I didn't talk much about it on this call, but as you know, we're very interested in durability of response.

Jeffrey Jones

Great. Appreciate that. And then in follow-up, I guess, then on the AD side, obviously really interesting, as you were just talking about, in some of the patient recruitment and allowing some of these patients who have failed more advanced therapy. Given what you've seen to date, how are you thinking about where soquelitinib would fit in sort of the treatment milieu given the various biologics and approvals out there and some of the bispecifics advancing? Any particular patient subsets where you think soquelitinib would fit particularly well?

Richard Miller

Based on what we've seen so far from our Phase 1 study, based on our safety and based on our mechanism, we think soquelitinib can be an upfront treatment for patients with moderate to severe AD or can be used in the relapse setting for patients who have already had other therapies. Now keep in mind, there are many other therapies out there now, and the pool of patients that are prior systemic therapy experienced is increasing, which we actually predicted a couple of years ago when we started working in this area. So, Jeff, I think the answer is we have every reason to think that you could use this as a first-line systemic therapy or later line.

Jeffrey Jones

Greatly appreciate it. Thanks, guys.

Richard Miller

Thank you, Jeff.

Operator

Your next question comes from Sean Lee from HC Wainwright. Please go ahead.

Xun Lee

I just have one on the asthma study. So we noticed that the start is slightly delayed to early next year. So what caused the delay? And have you finalized on what kind of patients you are going to recruit for this study in terms of thresholds for T2 or non-T2 groups?

Richard Miller

So, first of all, we had been talking about late December to start asthma. Given that it's Christmas and New Year's, we figured we would, it would be safer to talk about January. There's no material change in that timeline. As a matter of fact, our IND is already through FDA and everything's fine. What was the second part of the question?

Xun Lee

The patient types and predefined groups for T2 and non-T2 patients.

Richard Miller

What are the what? I'm sorry.

Xun Lee

The thresholds.

Richard Miller

Oh, yes. Okay, I understand your question. Sorry, I didn't understand the question. Eosinophil is 150. If you're above 150, you're T2, and if you're below 150, you're non-T2.

Xun Lee

And do you have any predefined thresholds for FeNO?

Richard Miller

And then we're also looking at the forced expiratory nitric oxide, which is above 25 for the T2. These are very typical. So 150 is our cutoff. Any other questions?

Xun Lee

Got it. Thank you for that.

Richard Miller

Okay. Well, thank you. I think, operator, there are no other questions. And I want to thank everyone for participating in our conference call. We look forward to updating you in the future. Thank you, everyone.

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