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DATE
Thursday, Aug. 6, 2026 at 4:30 p.m. ET
CALL PARTICIPANTS
- Chief Executive Officer-Richard A. Miller
- Chief Financial Officer-Leiv Lea
- Chief Business Officer-Jeffrey Arcara
- Senior Vice President of Pharmaceutical Development-Ben Jones
TAKEAWAYS
- Cash and Marketable Securities -- $215.2 million as of June 30, 2026, which included $189.4 million in net proceeds from a January follow-on offering.
- Net Loss -- $18.0 million for the quarter ended June 30, 2026, compared to a net loss of $8.0 million in the same period last year.
- Research and Development Expenses -- $16.0 million for the second quarter, an increase of $8.1 million due to higher clinical trial costs for soquelitinib and higher personnel expenses.
- Cash Runway -- expected to fund operations into the second quarter of 2028 based on current cash reserves and operating plans.
- Phase III PTCL Trial Enrollment -- 150 patients targeted for the registrational study of soquelitinib versus standard of care chemotherapy.
- Interim Futility Analysis Timing -- projected for the first quarter of 2027 for the Phase III peripheral T-cell lymphoma program based on current event rates.
- Phase II Atopic Dermatitis Enrollment -- approximately 200 patients planned for the SIERRA-1 trial, which evaluates three different dose levels of soquelitinib.
- Top-Line Data Forecast (AD) -- expected in the third quarter of 2027 for the Phase II SIERRA-1 trial following the completion of enrollment in early 2027.
- Phase 1 Atopic Dermatitis Efficacy -- 75% of patients in the highest dose cohort achieved EASI-70 compared to 20% in the placebo group.
- Highest Dose Cohort Detail (AD) -- 56 days of 200 milligram twice-daily dosing resulted in 25% of patients achieving EASI-90 and 33% achieving an IGA of 0 or 1.
- Angel Pharmaceuticals Investment -- $5.0 million invested in a $13.5 million financing round to support ongoing clinical trials in China.
- Angel Pharmaceuticals AD Timeline -- Cohort 1 data anticipated by the end of 2026 and Cohort 2 data expected in the second quarter of 2027.
- Hidradenitis Suppurativa Trial Initiation -- planned for Sept. 2026, targeting up to 25 patients with moderate to severe disease to monitor Th17 biomarkers.
- Asthma Trial Strategy -- management plans to enroll both T2 and non-T2 subtypes, noting that the non-T2 type represents 40% to 50% of the patient population.
- Peripheral T-Cell Lymphoma PFS -- 3 months median progression-free survival for current treatment options, serving as the benchmark for the registrational trial.
- Stock-Based Compensation -- $2.6 million for the three months ended June 30, 2026, compared to $1.3 million for the prior year period.
- Angel Pharma Equity Stake -- 49% excluding 6% of equity reserved for the employee stock ownership plan.
- Noncash Financial Adjustments -- $700,000 in losses from the Angel Pharmaceuticals investment and the absence of a $2.0 million gain from warrant liability fair value changes reported in 2025.
- ALPS Phase II Trial -- 30 patients aged 16 or older are being enrolled under a research agreement with the NIAID.
- Phase II AD Follow-up Period -- 90 days of follow-up with no treatment to evaluate the potential for drug-free remissions.
- Phase 1b/2 Angel Trial Size -- 48 patients in the initial cohorts with a potential expansion of 60 to 90 additional patients.
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RISKS
- Miller stated, "The futility analysis will be conducted by an independent data monitoring committee that will determine whether the study should be continued or terminated for futility based on available safety and efficacy data at the time," highlighting a critical milestone for the Phase III PTCL trial.
SUMMARY
Management at Corvus Pharmaceuticals, Inc. (CRVS -1.88%) focused on the clinical development of soquelitinib, a selective ITK inhibitor being evaluated across multiple indications. The company is advancing a registrational Phase III trial in peripheral T-cell lymphoma and a Phase II trial in atopic dermatitis while preparing to initiate new studies in asthma and hidradenitis suppurativa later in 2026. Financial updates confirmed that a Q1 follow-on offering extended the cash runway into 2028. Strategic initiatives through the partnership with Angel Pharmaceuticals are designed to expand the soquelitinib data set in the Chinese market, specifically targeting inflammatory drivers such as Th17 cells.
- CEO Miller stated that "a single dose of 200 milligrams will completely saturate the ITK target," which supports the dosing strategy across current and upcoming clinical trials.
- Management noted the observation of prolonged treatment benefit in atopic dermatitis extending beyond the period of dosing without evidence of disease rebound.
- The results of the Phase 1 trial for soquelitinib are currently in press in Blood, the medical journal of the American Society of Hematology.
- Management intends to use an interim analysis in the asthma trial to allow for the discontinuation of either the T2 or non-T2 disease type cohorts if futility is met.
- CEO Miller attributed sales growth in glasses to being "some of the fastest-growing consumer electronics in history," with wearables investment prioritized in Reality Labs.
- The company is evaluating both once-daily and twice-daily dosing regimens, with management anticipating that once-daily dosing may provide suitable efficacy for longer-term treatment.
INDUSTRY GLOSSARY
- ITK inhibitor: A drug designed to selectively inhibit interleukin-2-inducible T-cell kinase, an enzyme primarily expressed in T-cells.
- PTCL: Peripheral T-cell lymphoma, a group of mature T-cell malignancies.
- EASI-70: A 70% reduction from baseline in the Eczema Area and Severity Index score.
- IGA: Investigator Global Assessment, a scale used to measure the severity of skin diseases like atopic dermatitis.
- ALPS: Autoimmune Lymphoproliferative Syndrome, a rare genetic disorder of the immune system.
- Th2 and Th17: Subsets of helper T-cells that produce different cytokines and drive various inflammatory responses.
- T2 and non-T2 asthma: Asthma classifications based on the presence or absence of Type 2 inflammation.
- FeNO: Fractional exhaled nitric oxide, a biomarker used to measure airway inflammation.
Full Conference Call Transcript
Operator: Good afternoon, everyone, and thank you for standing by. Welcome to the Corvus Pharmaceuticals second quarter 2020 Business Update and Financial Results Conference Call. At this time, all participants are in listen only mode. Peter, we will conduct a question and answer session. And instructions will follow at that time. It is now my pleasure to turn the call over to Zack Kubow, of Real Chemistry. Please go ahead, sir.
Zack Kubow: Thank you, operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals second quarter 2026 Business Update and Financial Results Conference Call. On the call to discuss the results and business updates are Richard A. Miller, chief executive officer Leiv Lea, chief financial officer, Jeffrey Arcara, chief business officer, and Ben Jones, senior vice president of pharmaceutical 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 Corbus' annual report quarterly report on Form 10-Q for the quarter ended 06/30/2026 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 would like to turn the call over to Leiv Lea. Leiv?
Leiv Lea: Thank you, Zack. I will begin with a brief overview of our second quarter 2026 financials and then turn the call over to Richard for a business update. Research and development expenses in the second quarter of 2026 totaled $16 million compared to $7.9 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 second quarter 2026 was $18 million compared to a net loss of $8 million for the same period in 2025.
Included in the net loss for the second quarter of 2026 and 2025 were noncash losses of $700 thousand and $400 thousand respectively, from Corvus' equity method investment in Angel Pharmaceuticals, and a noncash gain of $2 million in the second quarter of 2025 associated with a change in fair value of the company's warrant liability. Total stock compensation expense for the 3 months ended June 30, 2026 was $2.6 million compared to $1.3 million for the same period in 2025. As of 06/30/2026, Corvus had cash equivalents and marketable securities totaling $215 million as compared to $56.8 million at 12/31/2025.
Cash as of 06/30/2026 included approximately $189 million in net proceeds received in a follow on offering completed in Q1. Also, announced on 06/09/2026, 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 June 30, 2026, and our current plans, we expect our cash to fund operations into the second quarter of 2028. I will now turn the call over to Richard, who will discuss our clinical progress and elaborate on our strategy and plans.
Richard A. Miller: Thank you, Leiv Lea, 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. Our efforts are primarily directed to driving patient enrollment and executing on our clinical trials to reach the next milestones for Soquelitinib's 2 lead opportunities. Our Phase III peripheral T cell lymphoma program, or PTCL, and our Phase II atopic dermatitis program. In parallel, we continue to advance Soquelitinib's development across broad areas of medicine. Including near term plans to initiate trials in hidradenitis suppurativa, and asthma. As well as the ongoing trial at the NIAID in ALPS.
The growing body of clinical and preclinical evidence supports the broad potential of Soquelitinib based on its novel mechanism of action and ability to reset or rebalance immunity. Our ongoing development efforts with Soquelitinib position Corvus to deliver key data readouts and milestones associated with our pipeline over the next year. I will start with a brief update on our Phase III trial in relapsed/refractory PTCL. Which is planned to enroll 150 patients randomized 1-to-1 between Soquelitinib and standard of care chemotherapy with belinostat or pralotrexate. The primary endpoint is progression free survival or PFS, which, with current treatment options has a median of about 3 months.
Enrollment is on track with our expectations with the next milestone being a futility analysis that will be conducted after a predefined number of PFS events have occurred. Based on current trends, we believe this interim futility analysis will occur in the first quarter of 2027. The futility analysis will be conducted by an independent data monitoring committee that will determine whether the study should be continued or terminated for futility based on available safety and efficacy data at the time. No safety or efficacy data will be publicly released at that time.
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 approved for this indication. I should also mention that the results of our Phase 1 trial are now in press in blood. The peer reviewed medical journal of the American Society of Hematology. We expect the results will be published later this year, providing an important overview of Soquelitinib's mechanism of action rationale, data obtained from the Phase 1 trial, Some of this data was presented at the ASH meeting last year. Turning to our other high indications for Soquelitinib, atopic dermatitis.
We remain very excited about the data to date and our path forward in this indication. During the second quarter, we presented the final data from the randomized blinded placebo controlled phase 1 trial evaluating Soquelitinib in patients with moderate to severe atopic dermatitis at the Society for Investigative Dermatology or SID Annual Meeting. The data demonstrated safety and positive efficacy results including 75% of Soquelitinib patients achieving EASI-70 in cohort 4 compared to 20 percent of placebo patients. Cohort 4 studied was the highest dose and longest dosing period tested in the trial. Covering 24 patients randomized in a 1-to-1 ratio to receive 56-day (8 weeks) 200 milligram twice-daily regimen of Soquelitinib or equivalent placebo.
In addition to the compelling EASI-75 result, 25 percent of Soquelitinib patients in cohort 4 achieved EASI-90 and 33 percent achieved an IGA 0 or 1. No patients receiving placebo achieved EASI-90 or IGA 0 or 1. Importantly, Soquelitinib's efficacy results were observed in patients who received prior systemic therapy some of whom were confirmed to be treatment resistant to these systemic therapies. The data also showed a dose dependent efficacy trend and additional clinical benefit with longer treatment. Of significant interest was the observation of prolonged treatment benefit extending beyond the period of dosing without evidence of disease rebound. Disease rebound has been observed with other agents including dupilumab JAK inhibitors, and STAT6 degraders and inhibitors.
The finding of Soquelitinib's durable activity was not surprising given research done by Corvus and others demonstrating that ITK blockade results in enhancement of T regulatory function. In the SID presentations, we presented compelling data correlating the induction of Tregs with prolonged clinical responses. If confirmed in future studies, these findings may usher in a new treatment paradigm for autoimmunity. Resetting or rebalancing of immunity, On the safety front, no significant safety issues were observed. No severe or serious adverse events were reported. And no significant lab abnormalities were seen. There was no conjunctivitis and of course no site problems since it is an oral drug. There was no difference in adverse events seen comparing placebo to the active groups.
All of this is in line with our experience with Soquelitinib in lymphoma patients. Some of whom are on continuous drug for over 2 years. Based on its novel mechanism of action, oral dosing, and the safety and efficacy data to date, we believe Soquelitinib could become a leading therapy for dermatitis that may find a valuable role in frontline therapy or treatment of relapsed refractory disease. Our strategy is to progress Soquelitinib as quickly as possible through the typical development pathway similar to the other approved systemic therapies for atopic dermatitis. This includes our Phase II trial, the SEERA-1 trial, which is currently enrolling patients followed by the usual phase 3 trials.
These trials will have a primary endpoint based on EASI score and IGA score at 12 or 16 weeks of therapy compared to placebo. 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. The phase 2 SEERA-1 trial is planned to enroll approximately 200 patients with moderate to severe atopic dermatitis that have failed at least 1 prior topical or systemic therapy.
It is a double-blind, randomized trial that includes 4 cohorts of 50 patients each with Soquelitinib doses of 200 milligrams once per day 200 milligrams twice per day, and 400 milligrams once per day along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment. And the primary endpoint is reduction in mean EASI score at 12 weeks compared to the placebo. There is no open label extension. There is no OLE because we believe there will be durability of remissions that we do not want to obscure with additional treatment. Our OLE is no treatment Enrollment and site activations are on track with our plans.
With anticipated enrollment completion in early 2027 and top line data in the third quarter of 2027. In parallel, we are working in close collaboration with our partner in China, Angel Pharmaceuticals, on their Phase 1b/2 clinical trial of Soquelitinib in moderate to severe atopic dermatitis. The ANGEL trial has similar design to our Phase II trial. It is blinded, placebo controlled, and is evaluating a 12-week treatment regimen and 90-day follow-up period across a similar range of Soquelitinib doses. Cohort 1 includes 24 patients randomized evenly to Soquelitinib doses of 100 milligrams twice per day, 200 milligrams once per day, or placebo.
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. The trial is open at several leading dermatology centers in China who have been involved in many global registration trials. We anticipate that ANGEL will complete patient enrollment from the first cohort in September and data from the first cohort of the trial will be available before year end 2026.
The Soquelitinib doses studied in this cohort are the same as the lower dose levels studied in our Phase 1 trial, 200 milligram total per day, taken as either 100 milligram tablet twice per day or 200 milligrams once per day. The treatment period, however, is significantly longer at 12 weeks compared to the 4-week period studied for these doses in our Phase 1 trial. Recall we found evidence of efficacy at these lower doses in our Phase 1 trial with 4 weeks of therapy. Angel is evaluating these doses at a 12-week dosing regimen. We anticipate that data from the Cohort 2 will be available in the second quarter of 2027.
So just to reiterate the timelines for Angel, we expect they will complete enrollment of the first cohort in September, data from this cohort by the end of this year data from the second cohort in Q2 2027. With the ANGEL data, together with our own data that will be generated during the year of 2027, we could be in a position to start a phase 3 trial by the end of the year in 2027. In addition, to providing clinical data supporting the value of Soquelitinib in atopic dermatitis, there is another important strategic feature to the ANGEL trial.
It is widely reported in the literature that Asian patients with atopic dermatitis have a greater component of Th17 disease and do not respond as well to IL4 and IL13 targeted treatments like dupilumab, which is designed to treat Th2 disease. And does not affect Th17. Based on mechanism of action with ITK inhibition, which decreases both Th2 and Th17 cell function, and their downstream cytokines, we think this positions Soquelitinib well for this population. Finding results in these types of patients may serve to broaden and confirm the potential utility in Th17 diseases. An example of the importance of Angel to Corvus is our participation in ANGEL's recent $13.5 million financing.
Corvus is a founder of Angel and continues to be its largest shareholder with $5 million invested in this new financing. The funding is anticipated to support Angel's ongoing Phase 1b/2 trial of Soquelitinib for atopic dermatitis and a new phase 2 trial of Soquelitinib for asthma that is expected to start in early 2027. We believe Corvus is positioned to benefit from both of these trials which will contribute to the overall data set for Soquelitinib in these indications and enhance the opportunity for ITK inhibition in the large Chinese inflammation and immunology market.
I am the CEO and Chairman of Angel, and I must add, that it has been a privilege and delight to work with the very talented team in China. In the US, Corvus remains on track to initiate our own Phase II asthma trial later this year along with a Phase 1b proof of concept trial in patients with HS, hidradenitis suppurativa. Our plan to expand the Soquelitinib pipeline into these indications is aligned with the biology of ITK inhibition. We started with T-cells in T-cell lymphoma and then moved to atopic dermatitis. Which is primarily driven by Th2 cells. Next, we are moving to hidradenitis suppurativa, which is primarily driven by Th17 cells.
And then into asthma, which is primarily driven by Th2 cells but in certain types dominated by Th17 cells. There is an important strategy to our clinical programs. With each program designed to not only address an important clinical indication, but also to provide data supporting Soquelitinib's mechanism of action and potential utility across a spectrum of underlying drivers of disease. For the Phase 1b hidradenitis suppurativa trial, we currently anticipate the trial will enroll up to 25 patients with moderate to severe disease. There will be no placebo group All patients will receive the same dose of Soquelitinib for 12 weeks, 200 milligrams BID.
In addition to measuring safety and the standard hidradenitis suppurativa clinical response score, we are also planning to include intensive monitoring of skin and blood biomarkers looking for Th17 effects. We plan to start this study in September. The potential broad utility of Soquelitinib is an important factor in the design of our planned asthma study. We intend to enroll both the allergic or eosinophilic and non allergic types of asthma. You may also hear these 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.
Approximately 40% to 50% of asthma patients have the non T2 type It is a very substantial proportion of asthma patients. This doubles the potential population of patients. 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 remain excited about soclidine's potential to modulate several key cellular functions that are not currently targeted by approved and in development stage biologic therapies with an oral tablet. At the SID meeting, Stanford Professors Chiou and Sarin from Stanford presented new immunologic and biomarker data that showed the potential of ITK inhibition with Soquelitinib to increase persistent Treg cells and influence multiple inflammatory pathways.
These data support the potential for Soquelitinib to reset or rebalance the immune system and treat a range of autoimmune and inflammatory diseases. Longer term, it also raises the very intriguing potential to produce drug free remissions. A long sought goal. In closing, our confidence in Soquelitinib continues to grow. And we are making good progress with our key priorities to unlock the opportunity to help a broad range of patients with the ITK inhibition. Over the remainder of the year, we are focused on, first, driving enrollment in our Soquelitinib Phase 3 registration PTCL trial and our phase 2 atopic dermatitis trial.
Second, coordinating closely with our partner in China, Angel Pharmaceuticals, on their Phase 1b/2 atopic dermatitis trial with data from the first cohort before year end and data from the second cohort in the second quarter of 2027. Third, advancing the broader Soquelitinib opportunity with the planned initiation of trials for asthma, and hidradenitis suppurativa before year end. As we achieve these milestones, we believe there will be increased appreciation for the potential of ITK inhibition and immunomodulation. Which could lead to new and better therapies for inflammatory autoimmune fibrotic diseases and cancers.
Operator: I will now turn the call over to the operator for questions and answer period. Operator? Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Star followed by the number 1 on your touch-tone phone, and you will hear a prompt that your hand has been raised. If you wish to decline from the polling process, please press the star followed by the number 2. 1 moment, please, for your first question. And your first question comes from the line of Jeffrey Jones of Oppenheimer. Your line is now open.
Jeff Jones: Hi, guys. Can you hear me? Yes. Hear you fine. Great. Hi, Richard, and congrats on all the progress and continued progress for this program. You know, on the topic of drug free remissions, have you had any discussions with the agency about the potential for drug free remissions and how you would generate a claim on the label and what that study design could look like?
Richard A. Miller: So, Jeffrey, everything we are doing now, the design is straightforward. We compare Soquelitinib to placebo EASI scores, EASI 75, IgA's at 12 or 16 weeks. Same as everybody else. that is what is required. Those are our protocols. Now what we do in the remission periods or drug free periods just like everybody else, dupilumab, JAK inhibitors, they continue to treat some patients or some they were allocated to placebos. Determine whether or not there was disease rebound, and there almost always is, And therefore they determined that the maintenance therapies were required for those disease But those were not part of the original approvals. So that is not necessary to do that.
Now we think it is very important if we have sustained remissions that do not require drug that represents, I think, an amazing opportunity and unique advantage for Soquelitinib. But that is not part of the regulatory strategy Now later, should you want to be able to retreat patients Then, of course, additional trials. You would do additional trials to confirm that. Does that make sense?
Jeff Jones: Yep. Makes perfect sense. And then just 1 follow-up. Obviously, top dose appears to be 200 mg BID right now. Are you guys doing any work to look at extended release formulations?
Richard A. Miller: So we do have work going on in the company looking at other formulations. We also have work at the company looking at a lot of work going on in terms of other ITK inhibitors, other chemical structures, etcetera. But I think that we are going to end up here probably with a regimen that is once a day dosing. Because I think as we treat patients longer than 4 weeks, there will be very suitable efficacy with a once a day dosing regimen. Now we are looking at various regimens As you know, our cancer study, we went up to 600 milligrams BID. But we know that a single dose of 200 milligrams will completely saturate the ITK target.
Great. Thank you very much, Richard. And congrats again on all the progress.
Operator: Thank you. And your next question comes from the line of Graig Suvannavejh of Mizuho. Please go ahead.
Sam: Hi. This is Sam on for Greg. Thanks for taking our question. Congrats on the progress. Team. Maybe just on the PTCL. It seems that there was a delay in the potential interim read readout by a quarter. I am just curious what the considerations were there and do you guys still anticipate the phase 3 data by the end of next year, or is that more of a 2020 story now? Thanks.
Richard A. Miller: We anticipate the final data late 2027, as originally stated. The interim analysis, of course, is projected based on events. So it is hard to say exactly when they occur. Plus it is based on number of events according to our statistical plan. And agreement with the FDA. Based on event rates, we are now projecting early in 2027. That could change a little bit depending on the number of events that occur. Very helpful. Thanks so much, Richard.
Operator: And your next question comes from the line of Paul Choi of Goldman Sachs. Please go ahead.
Eric: Hi. This is Eric on for Paul. Thanks for taking the question. I have a quick question. Are you able to use the angel partner data as part of the safety database for further FDA filing? And are you assuming incrementally better efficacy in the Chinese population? For AD or what are your thoughts there? Can you provide us some color on what your thoughts are on how you expect efficacy to change in the Chinese population?
Richard A. Miller: Yes. We can use the Chinese safety and efficacy data in our regulatory filings and vice versa. They can use our data in their filings. that is 1 of the reasons we initiated this collaboration several years ago. The idea behind it was accelerated and extend and leverage the Chinese population and regulatory authorities and clinical trial infrastructure, all that. So, yes, the data can be shared. The second part of your question is do I expect it to be? I expect comparable data from Angel It is a different study. it is an entirely different clinical trial done at a different point in time at different institutions. Hard to predict exactly.
Theoretically, I think that we will be we could beat the placebo by more because we have this combined effect on the Th17 and Th2. So 1 might expect let's say compared to other treatments, a better effect. But it is going to be hard to compare across clinical trials and across the Pacific Ocean. But the Chinese trials are being done at oh, I think there is around 10 centers now. They are very good well known academic, large hospital and dermatology clinics. They are commonly sites for large pharma and many other agents in dermatology and atopic dermatitis. So, we feel very good about the quality and, the information we are going to get out of there. Right.
Really helpful. Thanks.
Operator: Your next question comes from the line of Cha Yang of Jefferies. Please go ahead.
Cha Yang: Hi. This is Cha on for Roger. Thanks for taking my question here. I have 2. So 1 is, can you just tell us more about the thought process behind doing a 12-week versus the 4 the 16 week trial for AD. For your phase 2. And then my second question is, you may have touched on this. I may have missed it, but can you just tell us more about the trial design and some of the baseline characteristics for your HS and asthma trial? Thanks.
Richard A. Miller: So we have looked at 4 weeks of on the on the length of time, 4 we looked initially at 4 weeks of dosing, then went to 8, and now we are doing 12 weeks of dosing. We saw very good efficacy at 4 weeks with the with 2 hundred milligrams BID. We saw very good efficacy at 8 weeks with curves continuing to go down. So we will look at the 12-week data that we get both from Angel and from what we are, what we are doing in our phase 2, and we will make a decision beyond that. I know that there is a lot of questions like 16 weeks is magic. It is not.
The in our view, if you can get excellent efficacy with a shorter dosing regimen, why would not you do that? So now eventually, if we see the curves continuing to go down, we will go to 16 weeks. But I do not see any reason to do that now. We have had some of our dermatology experts tell us that, gee, your results at 4 weeks are as good as what you are seeing at 16 weeks. And by the way, would go back and look at the publications on dupilumab and JAK inhibitors and you will see 12 and 16 weeks of treatment. And guess what? Those curves plateau at around 6 or 8 weeks.
So most of the efficacy in these 12- and 16-week regimens go back and look at the easy curves. Most of the efficacy is seen in the first couple of months. And after that, the changes are really pretty small. Okay. I was there another part of your question?
Cha Yang: Can you Yeah. Just about trial design and baseline characteristics for your HS and asthma trial.
Richard A. Miller: Moderate to severe HS moderate to severe asthma. The only the asthma trial in particular, that is worth talking about So as you know, most studies are allergic or T2. And they will frequently use an eosinophil count of 300 or a 150, above 300 or above 150. that is changing these days. To as an eligibility requirement. We are allowing both T2 and non T2. That is we will take patients above 150 and below 150 eosinophils. Now we have looked at our AD data with respect to eosinophil count. We have patients who are above 150 and patients who are below And in terms of the efficacy, we see basically equal efficacy in both groups. So Okay.
Aydin, I think that I think we are starting to now talk about what are the potential advantages of our novel mechanism of action. Well, the non-T2 asthma if you look at their lungs, you do not see Th2 cells. You see a lot of neutrophils. You see other inflammatory cells that are induced by Th17 cells. Th17 cells make neutrophil attractant things like GM CSF and things like that. And so we have seen in our animal models that we can affect that. And, of course, mechanistically, we know we are blocking the differentiation of the Th17 cell. So that is the major eligibility there is the eosinophil count.
Now of course we look at FeNO and other things but that is the major thing. Alright? Thank you. Thanks.
Operator: And your next question comes from the line of Li Watsek of Cantor. Please go ahead.
Rubina: Hi. This is Rubina on for Watsek. 1 question about your asthma program. So you said that you are targeting both T2 and the non-T2 as well. Can you explain, mechanically, why you think Soquelitinib would be able to work in both T2 and non-T2 as well?
Richard A. Miller: Yes. Well, Well, T2, of course, the reason it is called T2 is because it is Th2-mediated. And, of course, as we have you know, mentioned previously, we will block the differentiation of TH cells and the resulting cytokines. So the Th2 is sort of obvious. The non T2 is Th17. Mostly you see Th17 cells and other inflammatory cells. But the other inflammatory cells are induced by these TH17 cells. So since we block the differentiation of activated Th17 and Th17 cells, we would expect to see activity in both T2 and non T2.
Now there is another important cell involved in both of these T2 and non-T2, is called the innate lymphoid cell type 2, highest expression of ITK. Of any lymphocyte. And we know we inhibit that very well also. So there are many reasons to think that we would affect the non T2 and this represents a great opportunity for us to test this in the clinic. And of course, provides a unique advantage over other asthma treatments. Thank you. that is helpful.
Operator: And your next question comes from the line of Aydin Huseynov of Ladenburg. Please go ahead.
Kevin Peter: Great. Thanks for taking our questions. I also have a question on the asthma program, specifically, the planned Angel Pharma Phase II program. Can you just comment a little bit more about potential study design there and how the learning from that study will be incorporated into the global program. Thank you.
Richard A. Miller: Sorry. Was that the you are asking about the Angel AD study or-- oh.
Kevin Peter: Correct. Yes.
Richard A. Miller: Well, I am not sure I am I know. The angel asthma study. The Angel Asthma study. Yeah. The current plan. Is for the Angel trial to basically be identical to ours. Our current plan is to run 2 identical phase 2 trials. So it will be essentially the same protocols in both places. But run independently.
Kevin Peter: Great. And on those protocols, can you just help us better understand the decision tree with regard to the ability to drop either T2 or non-T2? Is there a certain number of patients that will go into that assessment and yeah, just a little bit more on that part of the study design. Thank you.
Richard A. Miller: So yes, we will look at actually, we are going to base it on the percentage of the trial patients treated. And at that time, we will look at the data. And we have written that part of it sort of with broad criteria. Because the success in non-T2 is different than T2. The bar for efficacy is lower. it is harder to treat. So we have a general guidelines now after a certain number of patients are treated if we do not meet a certain threshold in the T2 or the non T2, we can drop either 1 of those or we can drop them all.
But and the reason we are doing that is because let's just say it is not working in the non-T2, we would not want to continue and dilute out the effect, let's say, a positive effect on the T2. Makes sense? It does. Thank you very much.
Operator: And there are no further questions at this time. I would like to turn the call back to Zack for the closing remarks.
Richard A. Miller: All right. Thank you, operator. First of all, thank you, everyone, for joining us today. We are very busy here at Corvus. The team, which I might add, has a lot of experience in conducting randomized trials. Is working very hard now meeting the goals I have outlined. We look forward to keeping you updated as we move through the rest of this year and next year. Thank you very much.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you, everyone, for participation. You may now disconnect.
