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Investor releaseQuarter not tagged2026-08-14Corvus Pharmaceuticals (CRVS) Q2 2026 Earnings Call Transcript
Motley Fool
Corvus Pharmaceuticals (CRVS) Q2 2026 Earnings Call Transcript
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Chief Executive Officer-Richard A. Miller Chief Financial Officer-Leiv Lea Chief Business Officer-Jeffrey Arcara Senior Vice President of Pharmaceutical Development-Ben Jones 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 Soquelitin…Read full documentShow less
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Chief Executive Officer-Richard A. Miller Chief Financial Officer-Leiv Lea Chief Business Officer-Jeffrey Arcara Senior Vice President of Pharmaceutical Development-Ben Jones 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. Before you buy stock in Corvus Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Corvus Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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Investor releaseQuarter not tagged2026-08-07Corvus Pharmaceuticals Q2 Earnings Call Highlights
MarketBeat
Corvus Pharmaceuticals Q2 Earnings Call Highlights
Interested in Corvus Pharmaceuticals, Inc.? Here are five stocks we like better. Corvus reported a wider Q2 loss as research and development spending rose to $16 million for soquelitinib trials, while its $215.2 million cash position is expected to fund operations into Q2 2028. The company said enrollment is progressing in its Phase III PTCL trial, with an interim futility analysis expected in Q1 2027 and final data still targeted for late 2027. Corvus is advancing soquelitinib across inflammatory diseases: Phase II atopic dermatitis enrollment is expected to finish in early 2027 with data due in Q3 2027, while hidradenitis suppurativa and asthma studies are planned to begin in 2026. Momentum Is Just Starting for These 3 Rapid-Growth Stocks in 2026 Corvus Pharmaceuticals (NASDAQ:CRVS) reported a wider second-quarter loss as it increased spending on clinical development of soquelitinib, its selective ITK inhibitor, while outlining expected milestones across programs in peripheral T-cell lymphoma, atopic dermatitis, hidradenitis suppurativa and asthma. Research and development expense totaled $16 million for the second quarter of 2026, compared with $7.9 million in the prior-year period. Chief Financial Officer Leiv Lea attributed the increase primarily to higher clinical-trial costs for soquelitinib and increased personnel expenses. Net loss was $18 million, compared with $8 million a year earlier. → 3 Drone Stocks That Should Soar After the Summer Slump As of June 30, Corvus held $215.2 million in cash equivalents and marketable securities, up from $56.8 million at the end of 2025. The balance included approximately $189.4 million of net proceeds from a first-quarter follow-on offering. Lea said the company expects its cash position, based on current operating plans, to fund operations into the second quarter of 2028. Corvus also invested $5 million during the quarter in a $13.5 million financing completed by Angel Pharmaceuticals, its China-based partner. The company is Angel's largest shareholder, according to management. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Chief Executive Officer Richard Miller said Corvus is focused on enrolling patients and executing studies for its two lead opportunities: a Phase III trial in relapsed or refractory peripheral T-cell lymphoma, or PTCL, and a Phase II trial in moderate-to-severe atopic derm…Read full documentShow less
Interested in Corvus Pharmaceuticals, Inc.? Here are five stocks we like better. Corvus reported a wider Q2 loss as research and development spending rose to $16 million for soquelitinib trials, while its $215.2 million cash position is expected to fund operations into Q2 2028. The company said enrollment is progressing in its Phase III PTCL trial, with an interim futility analysis expected in Q1 2027 and final data still targeted for late 2027. Corvus is advancing soquelitinib across inflammatory diseases: Phase II atopic dermatitis enrollment is expected to finish in early 2027 with data due in Q3 2027, while hidradenitis suppurativa and asthma studies are planned to begin in 2026. Momentum Is Just Starting for These 3 Rapid-Growth Stocks in 2026 Corvus Pharmaceuticals (NASDAQ:CRVS) reported a wider second-quarter loss as it increased spending on clinical development of soquelitinib, its selective ITK inhibitor, while outlining expected milestones across programs in peripheral T-cell lymphoma, atopic dermatitis, hidradenitis suppurativa and asthma. Research and development expense totaled $16 million for the second quarter of 2026, compared with $7.9 million in the prior-year period. Chief Financial Officer Leiv Lea attributed the increase primarily to higher clinical-trial costs for soquelitinib and increased personnel expenses. Net loss was $18 million, compared with $8 million a year earlier. → 3 Drone Stocks That Should Soar After the Summer Slump As of June 30, Corvus held $215.2 million in cash equivalents and marketable securities, up from $56.8 million at the end of 2025. The balance included approximately $189.4 million of net proceeds from a first-quarter follow-on offering. Lea said the company expects its cash position, based on current operating plans, to fund operations into the second quarter of 2028. Corvus also invested $5 million during the quarter in a $13.5 million financing completed by Angel Pharmaceuticals, its China-based partner. The company is Angel's largest shareholder, according to management. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Chief Executive Officer Richard Miller said Corvus is focused on enrolling patients and executing studies for its two lead opportunities: a Phase III trial in relapsed or refractory peripheral T-cell lymphoma, or PTCL, and a Phase II trial in moderate-to-severe atopic dermatitis. The Phase III PTCL study is designed to enroll 150 patients randomized evenly between soquelitinib and standard-of-care chemotherapy using belinostat or pralatrexate. The primary endpoint is progression-free survival. Miller said enrollment is tracking with the company's expectations. → Jersey Mike's Serves Fresh Gains After IPO Stumble Corvus now expects an interim futility analysis to occur in the first quarter of 2027, based on the timing of predefined progression-free-survival events. An independent data-monitoring committee will determine whether the trial should continue or stop for futility, and no safety or efficacy data will be publicly released at that point, Miller said. In response to an analyst question, Miller said Corvus continues to anticipate final Phase III PTCL data in late 2027. He noted that the timing of the interim analysis could move depending on event rates. The company also said results from its Phase I PTCL trial are in press at the journal Blood and are expected to be published later in 2026. Corvus highlighted final results from a randomized, blinded, placebo-controlled Phase I study of soquelitinib in moderate-to-severe atopic dermatitis that were presented during the second quarter at the Society for Investigative Dermatology annual meeting. In the highest-dose, longest-duration cohort, 75% of soquelitinib-treated patients achieved EASI-75, compared with 20% of placebo recipients, according to Miller. The cohort included 24 patients randomized evenly to receive 200 milligrams of soquelitinib twice daily or placebo for 56 days. Corvus said 25% of treated patients achieved EASI-90 and 33% achieved an Investigator's Global Assessment score of 0 or 1, while no placebo patients reached either outcome. Miller said the study did not report severe or serious adverse events, significant laboratory abnormalities, conjunctivitis or a difference in adverse events between placebo and active-treatment groups. He also said the company observed clinical benefit continuing beyond the dosing period without evidence of disease rebound, though he emphasized that potential drug-free remissions are not part of Corvus's current regulatory strategy. The company is enrolling its Phase II SIERRA-1 trial, which is planned to include approximately 200 patients with moderate-to-severe atopic dermatitis who have failed at least one prior topical or systemic therapy. The study includes three soquelitinib dosing groups—200 mg once daily, 200 mg twice daily and 400 mg once daily—and a placebo group. Treatment lasts 12 weeks, followed by a 90-day period without treatment. Corvus expects SIERRA-1 enrollment to finish in early 2027 and anticipates top-line data in the third quarter of 2027. Miller said the company will use the 12-week data from the trial and Angel's study to determine whether longer treatment periods are needed in subsequent studies. Angel expects to complete enrollment in the first cohort of its Chinese Phase Ib/II atopic dermatitis study in September 2026. Corvus expects first-cohort data from Angel before the end of 2026. Second-cohort data from Angel are anticipated in the second quarter of 2027. Management said the combined data from Angel and Corvus could support starting a Phase III atopic dermatitis study by the end of 2027. Miller said the companies can use each other's Chinese and U.S. safety and efficacy data in regulatory filings. Angel's study is evaluating 12 weeks of treatment and a 90-day follow-up period across several dose levels. Corvus plans to begin a Phase Ib proof-of-concept trial in moderate-to-severe hidradenitis suppurativa in September. The study is expected to enroll up to 25 patients, with no placebo arm. All participants will receive soquelitinib at 200 mg twice daily for 12 weeks, while the company evaluates safety, clinical response and skin and blood biomarkers. The company also remains on track to initiate a U.S. Phase II asthma trial later in 2026. Miller said the study is intended to enroll both allergic or eosinophilic T2 asthma patients and non-T2 patients, who together represent a substantial portion of the asthma population. The design includes an interim analysis that could allow Corvus to discontinue either disease subtype for futility. Angel is expected to begin a separate Phase II asthma study in early 2027. Miller said the current plan is for Angel's asthma protocol to be essentially identical to Corvus's Phase II study, with the two trials conducted independently. Management said the company will prioritize PTCL and atopic dermatitis enrollment through the remainder of 2026, coordinate with Angel on its atopic dermatitis study, and advance planned asthma and hidradenitis suppurativa trials before year-end. Corvus Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation immuno-oncology therapies. The company's research efforts are centered on harnessing both the innate and adaptive immune systems to counteract tumor-driven immunosuppression. By targeting key pathways that regulate immune cell function, Corvus aims to create novel agents that can be combined with existing cancer treatments to improve patient outcomes. Corvus's lead pipeline candidates include small-molecule and antibody therapies designed to inhibit the adenosine pathway, a known mediator of tumor immune escape. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Corvus Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-08-07Corvus Pharmaceuticals Inc (CRVS) (Q2 2026) Earnings Call Highlights: Advancing Soquelitinib ...
GuruFocus.com
Corvus Pharmaceuticals Inc (CRVS) (Q2 2026) Earnings Call Highlights: Advancing Soquelitinib ...
This article first appeared on GuruFocus. R&D Expenses: $16 million in Q2 2026, up from $7.9 million in Q2 2025, driven by higher clinical trial costs for soquelitinib and increased personnel costs. Net Loss: $18 million in Q2 2026, compared to a net loss of $8 million in Q2 2025. Non-Cash Losses: $0.7 million in Q2 2026 and $0.4 million in Q2 2025 from equity method investment in Angel Pharmaceuticals. Non-Cash Gain: $2 million in Q2 2025 from change in fair value of warrant liability. Stock Compensation Expense: $2.6 million for the three months ended June 30, 2026, versus $1.3 million for the same period in 2025. Cash Position: $215.2 million in cash equivalents and marketable securities as of June 30, 2026, compared to $56.8 million at December 31, 2025. Follow-On Offering Proceeds: Approximately $189.4 million in net proceeds received in Q1 2026. Investment in Angel Pharmaceuticals: $5 million invested in a $13.5 million financing completed by Angel in Q2 2026. Cash Runway: Expected to fund operations into the second quarter of 2028. Warning! GuruFocus has detected 1 Warning Sign with CRVS. Is CRVS fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Phase 3 PTCL trial enrollment is on track, with a futility analysis expected in early 2027 and final data anticipated by late 2027. Phase 1 trial results for soquelitinib in PTCL have been accepted for publication in the peer-reviewed journal Blood. Phase 1 atopic dermatitis data showed strong efficacy, with 75% of patients achieving EASI-75 in cohort 4 versus 20% for placebo, and no significant safety issues. Soquelitinib demonstrated durable responses beyond the dosing period without disease rebound, potentially offering drug-free remissions. Expansion into hidradenitis suppurativa and asthma trials is planned, with asthma targeting both T2 and non-T2 patients, potentially doubling the addressable population. Angel Pharmaceuticals' phase 1b/2 atopic dermatitis trial in China is progressing, with first cohort data expected by year-end 2026, and data can be shared for regulatory filings. Cash position of $215.2 million is expected to fund operations into Q2 2028. R&D expenses increased significantly to $16 million in Q2 2026 from $7.9 million in Q2 2025, and net loss wi…Read full documentShow less
This article first appeared on GuruFocus. R&D Expenses: $16 million in Q2 2026, up from $7.9 million in Q2 2025, driven by higher clinical trial costs for soquelitinib and increased personnel costs. Net Loss: $18 million in Q2 2026, compared to a net loss of $8 million in Q2 2025. Non-Cash Losses: $0.7 million in Q2 2026 and $0.4 million in Q2 2025 from equity method investment in Angel Pharmaceuticals. Non-Cash Gain: $2 million in Q2 2025 from change in fair value of warrant liability. Stock Compensation Expense: $2.6 million for the three months ended June 30, 2026, versus $1.3 million for the same period in 2025. Cash Position: $215.2 million in cash equivalents and marketable securities as of June 30, 2026, compared to $56.8 million at December 31, 2025. Follow-On Offering Proceeds: Approximately $189.4 million in net proceeds received in Q1 2026. Investment in Angel Pharmaceuticals: $5 million invested in a $13.5 million financing completed by Angel in Q2 2026. Cash Runway: Expected to fund operations into the second quarter of 2028. Warning! GuruFocus has detected 1 Warning Sign with CRVS. Is CRVS fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Phase 3 PTCL trial enrollment is on track, with a futility analysis expected in early 2027 and final data anticipated by late 2027. Phase 1 trial results for soquelitinib in PTCL have been accepted for publication in the peer-reviewed journal Blood. Phase 1 atopic dermatitis data showed strong efficacy, with 75% of patients achieving EASI-75 in cohort 4 versus 20% for placebo, and no significant safety issues. Soquelitinib demonstrated durable responses beyond the dosing period without disease rebound, potentially offering drug-free remissions. Expansion into hidradenitis suppurativa and asthma trials is planned, with asthma targeting both T2 and non-T2 patients, potentially doubling the addressable population. Angel Pharmaceuticals' phase 1b/2 atopic dermatitis trial in China is progressing, with first cohort data expected by year-end 2026, and data can be shared for regulatory filings. Cash position of $215.2 million is expected to fund operations into Q2 2028. R&D expenses increased significantly to $16 million in Q2 2026 from $7.9 million in Q2 2025, and net loss widened to $18 million from $8 million. The futility analysis for the PTCL trial has been delayed to early 2027, and no efficacy data will be released at that time, creating uncertainty. The phase 2 atopic dermatitis trial (Sierra-1) is not expected to complete enrollment until early 2027, with topline data only in Q3 2027, delaying potential registration. The company is investing additional $5 million in Angel Pharmaceuticals, increasing financial exposure to a partner with uncertain trial outcomes. The phase 1b hidradenitis suppurativa trial has no placebo group, which may limit the strength of efficacy conclusions. The asthma trial design allows for discontinuation of either T2 or non-T2 patient groups based on futility, indicating potential for failure in one or both populations. Q: 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? A: Richard Miller, CEO: Our current regulatory strategy is straightforward, comparing soquelitinib to placebo with standard endpoints like EASI-75 and IGA at 12 or 16 weeks, similar to other approved therapies. The potential for drug-free remissions is not part of the initial regulatory strategy. However, we believe sustained remissions without a drug represent a unique advantage for soquelitinib. Later, if we want to pursue a retreatment claim, we would conduct additional trials to confirm that. Q: On the PTCL program, it seems there was a delay in the potential interim readout by a quarter. Do you still anticipate the phase 3 data by the end of next year, or is that more of a 2028 story now? A: Richard Miller, CEO: We anticipate the final data in late 2027, as originally stated. The interim futility analysis is projected based on the number of PFS events, so the exact timing is hard to predict. Based on current event rates, we are now projecting the interim analysis to occur early in 2027, but that could change slightly depending on the number of events that occur. Q: Are you able to use the Angel partner data as part of the safety database for further FDA filings, and are you assuming incrementally better efficacy in the Chinese population for AD? A: Richard Miller, CEO: 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. This was a key reason for initiating the collaboration. Regarding efficacy, I expect comparable data from Angel. Theoretically, we could beat placebo by more because of our combined effect on TH2 and TH17, but it's hard to compare across clinical trials. The Chinese trial sites are well-known academic centers that are commonly used for large pharma dermatology trials, so we feel very good about the quality of the data. Q: Can you tell us more about the thought process behind doing a 12-week versus a 16-week trial for AD in your phase 2, and can you provide more details on the trial design and baseline characteristics for your HS and asthma trials? A: Richard Miller, CEO: We initially looked at 4 weeks of dosing, then 8 weeks, and now 12 weeks. We saw very good efficacy at 4 weeks with 200 mg BID, and the curves continued to go down at 8 weeks. We will evaluate the 12-week data from both Angel and our phase 2 trial to make a decision. If we can get excellent efficacy with a shorter regimen, we will do that. For HS, we are enrolling moderate to severe patients with no placebo group, all receiving 200 mg BID for 12 weeks. For asthma, we are enrolling both T2 and non-T2 patients, allowing eosinophil counts above and below 150. Our AD data shows equal efficacy in both groups, and mechanistically, we block TH17 cell differentiation, which is relevant for non-T2 asthma. Q: Can you explain why you think soquelitinib would be able to work in both T2 and non-T2 asthma? A: Richard Miller, CEO: T2 asthma is mediated by TH2 cells, and we block their differentiation and resulting cytokines. Non-T2 asthma is mostly driven by TH17 cells, which induce other inflammatory cells like neutrophils. Since we block the differentiation of activated TH2 and TH17 cells, we expect activity in both types. Additionally, there is an important cell called the innate lymphoid cell type 2, which has the highest expression of ITK of any lymphocyte, and we know we inhibit that very well. This provides a unique advantage over other asthma treatments. Q: Can you comment on the planned Angel Pharma phase 2 program for asthma and how the learning from that study will be incorporated into the global program? A: Richard Miller, CEO: The current plan is for the Angel trial to be basically identical to ours. We plan to run two identical phase 2 trials, essentially the same protocols in both places, but run independently. Q: On those protocols, can you help us better understand the decision tree with regard to the ability to drop either T2 or non-T2 patients at a certain number of patients? A: Richard Miller, CEO: We will look at the percentage of patients treated and evaluate the data. We have written broad criteria because the bar for efficacy is lower in non-T2, as it is harder to treat. After a certain number of patients are treated, if we don't meet a certain threshold in either the T2 or non-T2 group, we can drop that group. This prevents diluting out a positive effect in one group with a negative effect in the other. Q: Are you doing any work to look at extended-release formulations for soquelitinib? A: Richard Miller, CEO: We do have work going on in the company looking at other formulations and other ITK inhibitors and chemical structures. However, I think we will likely end up with a once-a-day dosing regimen. As we treat patients longer than 4 weeks, we expect suitable efficacy with a once-daily regimen. In our cancer study, we went up to 600 mg BID, but we know a single dose of 200 mg will completely saturate the ITK target. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-08-07Corvus Pharmaceuticals, Inc. Q2 2026 Earnings Call Summary
Moby
Corvus Pharmaceuticals, Inc. Q2 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is positioning Soquelitinib as a first-in-class selective ITK inhibitor capable of 'resetting' immunity by rebalancing Th2 and Th17 cell functions. The Phase III PTCL program is prioritized as a lead oncology opportunity, targeting a high-unmet-need population where current standard-of-care PFS is approximately 3 months. Strategic expansion into atopic dermatitis (AD) is driven by Phase I data showing durable, drug-free remissions, which management attributes to the enhancement of T-regulatory (Treg) function. The partnership with Angel Pharmaceuticals in China is a core strategic pillar, designed to leverage the Chinese clinical infrastructure and explore Soquelitinib's efficacy in Asian AD patients who typically exhibit higher Th17 disease components. Operational focus is shifting toward multi-indication development, with upcoming trials in asthma and hidradenitis suppurativa (HS) intended to validate the drug's mechanism across different inflammatory drivers. Financial stability is supported by a cash runway extending into Q2 2028, following a significant follow-on offering that raised approximately $189 million in net proceeds. An interim futility analysis for the Phase III PTCL trial is projected for Q1 2027, contingent upon reaching a predefined number of progression-free survival events. Top-line data from the Phase II SEERA-1 trial in atopic dermatitis is anticipated in Q3 2027, following the completion of enrollment in early 2027. Management expects to initiate a Phase III trial in atopic dermatitis by the end of 2027, utilizing combined data from both US and Angel Pharmaceuticals' Chinese trials. Near-term data catalysts include results from Angel Pharmaceuticals' first AD cohort by year-end 2026 and their second cohort in Q2 2027. The asthma trial design includes an interim analysis to allow for the potential discontinuation of either T2 or non-T2 patient groups based on specific efficacy thresholds. Corvus invested $5 million in Angel Pharmaceuticals' recent $13.5 million financing to maintain its position as the largest shareholder and support collaborative global development. R&D expenses doubled year-over-year to $16 million, primarily reflecting the scaling of Soquelitinib clinical…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is positioning Soquelitinib as a first-in-class selective ITK inhibitor capable of 'resetting' immunity by rebalancing Th2 and Th17 cell functions. The Phase III PTCL program is prioritized as a lead oncology opportunity, targeting a high-unmet-need population where current standard-of-care PFS is approximately 3 months. Strategic expansion into atopic dermatitis (AD) is driven by Phase I data showing durable, drug-free remissions, which management attributes to the enhancement of T-regulatory (Treg) function. The partnership with Angel Pharmaceuticals in China is a core strategic pillar, designed to leverage the Chinese clinical infrastructure and explore Soquelitinib's efficacy in Asian AD patients who typically exhibit higher Th17 disease components. Operational focus is shifting toward multi-indication development, with upcoming trials in asthma and hidradenitis suppurativa (HS) intended to validate the drug's mechanism across different inflammatory drivers. Financial stability is supported by a cash runway extending into Q2 2028, following a significant follow-on offering that raised approximately $189 million in net proceeds. An interim futility analysis for the Phase III PTCL trial is projected for Q1 2027, contingent upon reaching a predefined number of progression-free survival events. Top-line data from the Phase II SEERA-1 trial in atopic dermatitis is anticipated in Q3 2027, following the completion of enrollment in early 2027. Management expects to initiate a Phase III trial in atopic dermatitis by the end of 2027, utilizing combined data from both US and Angel Pharmaceuticals' Chinese trials. Near-term data catalysts include results from Angel Pharmaceuticals' first AD cohort by year-end 2026 and their second cohort in Q2 2027. The asthma trial design includes an interim analysis to allow for the potential discontinuation of either T2 or non-T2 patient groups based on specific efficacy thresholds. Corvus invested $5 million in Angel Pharmaceuticals' recent $13.5 million financing to maintain its position as the largest shareholder and support collaborative global development. R&D expenses doubled year-over-year to $16 million, primarily reflecting the scaling of Soquelitinib clinical trials and increased personnel costs. Management highlighted the risk that interim futility analysis timing for the PTCL trial is event-driven and subject to change based on real-world patient outcomes. The company is intentionally avoiding open-label extensions in AD trials to prevent obscuring the potential for durable, drug-free remissions. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that while drug-free remission is a unique strategic advantage, the initial regulatory path follows standard 12-to-16-week EASI score comparisons. Claims for sustained remission without maintenance therapy would likely require additional post-marketing or separate clinical trials. Management argued that most efficacy for systemic AD therapies is captured within the first 8 weeks, with curves often plateauing thereafter. They believe 12 weeks is sufficient to demonstrate competitive efficacy, though they remain open to 16-week designs for Phase III if data suggests continued improvement. Soquelitinib is being tested in both T2 (allergic) and non-T2 (non-allergic) asthma, the latter of which represents 40% to 50% of the patient population. Management believes ITK inhibition uniquely addresses non-T2 asthma by blocking Th17-mediated neutrophil attraction, a mechanism not addressed by current biologics. Management confirmed that safety and efficacy data from Angel Pharmaceuticals' trials in China can be used in US regulatory filings and vice versa. They anticipate comparable data but noted that the Chinese population might show a higher relative benefit due to the prevalence of Th17-driven disease.
Investor releaseQuarter not tagged2026-08-06Corvus: Q2 Earnings Snapshot
Associated Press
Corvus: Q2 Earnings Snapshot
SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Corvus Pharmaceuticals Inc. (CRVS) on Thursday reported a loss of $18 million in its second quarter. On a per-share basis, the South San Francisco, California-based company said it had a loss of 19 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRVS at https://www.zacks.com/ap/CRVS
Investor releaseQuarter not tagged2026-08-06Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2026 Financial Results
GlobeNewswire
Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2026 Financial Results
Enrollment in soquelitinib registrational Phase 3 relapsed/refractory peripheral T-cell lymphoma (PTCL) and Phase 2 atopic dermatitis trials on track Soquelitinib’s potential in atopic dermatitis and broader immunology and inflammation indications supported by Phase 1 clinical, immunologic and biomarker data presented at the Society for Investigative Dermatology (SID) annual meeting Cash, cash equivalents and marketable securities of $215.2 million at June 30, 2026, providing runway into 2Q28 Conference call and webcast today at 4:30 pm ET / 1:30 pm PT SOUTH SAN FRANCISCO, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the second quarter ended June 30, 2026. “We believe soquelitinib, our oral, selective ITK inhibitor, is well positioned as a potential new treatment paradigm for patients across a broad range of diseases, based on a novel mechanism that rebalances the immune system,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We are focused on driving enrollment in our registrational Phase 3 relapsed/refractory PTCL and Phase 2 atopic dermatitis trials, and we are working closely with our partner in China, Angel Pharmaceuticals, on their Phase 1b/2 atopic dermatitis trial. With planned studies in hidradenitis suppurativa and asthma anticipated to be initiated later this year, we are steadily building a body of clinical evidence that we believe demonstrates the breadth of soquelitinib’s potential across the large immunology and inflammation market.” Business Update and Strategy Soquelitinib for Immune Diseases Final data from the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis were presented in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting. The data demonstrated safety and positive efficacy results, including in patients who received prior systemic therapy and were treatment resistant. In addition, there was a dose dependent efficacy trend in cohorts 1-3, and additional clinical benefit was observed with longer treatment in cohort 4. Immunologic and biomarker data from the study supports the potential of ITK inhibition with soquelitinib to incr…Read full documentShow less
Enrollment in soquelitinib registrational Phase 3 relapsed/refractory peripheral T-cell lymphoma (PTCL) and Phase 2 atopic dermatitis trials on track Soquelitinib’s potential in atopic dermatitis and broader immunology and inflammation indications supported by Phase 1 clinical, immunologic and biomarker data presented at the Society for Investigative Dermatology (SID) annual meeting Cash, cash equivalents and marketable securities of $215.2 million at June 30, 2026, providing runway into 2Q28 Conference call and webcast today at 4:30 pm ET / 1:30 pm PT SOUTH SAN FRANCISCO, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the second quarter ended June 30, 2026. “We believe soquelitinib, our oral, selective ITK inhibitor, is well positioned as a potential new treatment paradigm for patients across a broad range of diseases, based on a novel mechanism that rebalances the immune system,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We are focused on driving enrollment in our registrational Phase 3 relapsed/refractory PTCL and Phase 2 atopic dermatitis trials, and we are working closely with our partner in China, Angel Pharmaceuticals, on their Phase 1b/2 atopic dermatitis trial. With planned studies in hidradenitis suppurativa and asthma anticipated to be initiated later this year, we are steadily building a body of clinical evidence that we believe demonstrates the breadth of soquelitinib’s potential across the large immunology and inflammation market.” Business Update and Strategy Soquelitinib for Immune Diseases Final data from the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis were presented in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting. The data demonstrated safety and positive efficacy results, including in patients who received prior systemic therapy and were treatment resistant. In addition, there was a dose dependent efficacy trend in cohorts 1-3, and additional clinical benefit was observed with longer treatment in cohort 4. Immunologic and biomarker data from the study supports the potential of ITK inhibition with soquelitinib to increase persistent Treg cells and influence multiple inflammatory pathways. Corvus is enrolling patients in the SIERRA1 Phase 2 randomized, blinded, placebo-controlled atopic dermatitis clinical trial. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. This includes four cohorts of 50 patients each, with soquelitinib doses of 200 mg once per day, 200 mg twice per day and 400 mg once per day, along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment. The primary endpoint of the trial is the percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12. Angel Pharmaceuticals (Angel Pharma), Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitinib doses of 100 mg twice per day, 200 mg once per day, 200 mg twice per day and 400 mg once per day. The patient eligibility and endpoints are similar to those used previously by Corvus. Depending on the results from the Phase 1b portion of the study, an additional 60-90 patients will 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 global registration trials. The study is conducted in close collaboration with Corvus. Results from cohort 1 (100 mg twice per day, 200 mg once per day and placebo) are anticipated late this year. Corvus invested $5.0 million in a $13.5 million equity financing for Angel Pharma. The funding is anticipated to support Angel Pharma’s ongoing Phase 1b/2 trial of soquelitinib for atopic dermatitis and a new Phase 2 trial of soquelitinib for asthma. Angel Pharma anticipates that it will initiate the Phase 2 asthma trial in early 2027. Corvus plans to initiate a Phase 1b clinical trial evaluating soquelitinib in patients with hidradenitis suppurativa and a Phase 2 trial evaluating soquelitinib in patients with asthma, later this year. Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation for specific immunology and oncology indications. Collaboration with National Institute of Allergy and Infectious Diseases (NIAID) The Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial continues to advance. This trial is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing. Soquelitinib for T Cell Lymphoma Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate chemotherapies. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy. Financial ResultsAs of June 30, 2026, Corvus had cash, cash equivalents and marketable securities of $215.2 million compared to $56.8 million as of December 31, 2025. Cash, cash equivalents and marketable securities as of June 30, 2026 included approximately $189.4 million in net proceeds received in a financing completed on January 23, 2026. As announced on June 9, 2026, Corvus invested $5.0 million in a $13.5 million financing completed by Angel Pharma in the second quarter of 2026. Based on its current plans, Corvus expects its cash, cash equivalents and marketable securities to fund operations into the second quarter of 2028. Research and development expenses for the three months ended June 30, 2026 totaled $16.0 million compared to $7.9 million for the same period in 2025. The increase in research and development expenses of $8.1 million was primarily due to higher clinical trial costs associated with the development of soquelitinib as well as an increase in personnel related costs. Net loss for the three months ended June 30, 2026 was $18.0 million compared to $8.0 million for the same period in 2025. Included in net loss for the three months ended June 30, 2026 and 2025 were non-cash losses of $0.7 million and $0.4 million, respectively, from Corvus’ investment in Angel Pharma and a non-cash gain of $2.0 million in the second quarter of 2025 associated with a change in the fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended June 30, 2026 was $2.6 million compared to $1.3 million for the same period in 2025. About Corvus PharmaceuticalsCorvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of immune diseases and cancer. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Soquelitinib is being evaluated in a registration Phase 3 clinical trial for relapsed/refractory PTCL and in a Phase 2 clinical trial for the treatment of atopic dermatitis. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn. About SoquelitinibSoquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation, which has the potential to suppress autoimmune and inflammatory reactions. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with autoimmune and allergic diseases and in cancers, including solid tumors. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company is enrolling a registration Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed/refractory PTCL. Soquelitinib is also now being investigated in a randomized placebo-controlled Phase 2 clinical trial in patients with atopic dermatitis. A publication describing the chemistry, enzymology and biology of soquelitinib appeared in npj Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website. About Peripheral T Cell LymphomaPeripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. First line treatment for these diseases is typically combination chemotherapy; however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the three to four month range and overall median survival of six to 12 months. There are no approved drugs in relapsed/refractory PTCL based on randomized trials. PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. About Atopic DermatitisAtopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical and clinical studies to inhibit cytokine production from Th2 lymphocytes. About Autoimmune Lymphoproliferative Syndrome (ALPS)ALPS is a rare genetic disease affecting children that manifests with lymphadenopathy, splenomegaly, cytopenias (low blood counts), proteinuria and autoimmunity. The disease is caused by a mutation in the Fas gene, which provides instructions for making a signaling protein involved in the induction of apoptosis. The mutation results in immune dysregulation due to abnormally high levels of “double negative” T cells (CD4 and CD8 double negative), which infiltrate the blood, spleen and lymphoid tissues. Fas signaling is regulated by ITK and T cell receptor signaling and patients with ALPS have an imbalance in this regulation resulting in a failure of T cells to undergo apoptosis and an accumulation of abnormal T cells. About Angel PharmaceuticalsAngel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – soquelitinib, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49% equity stake in Angel Pharmaceuticals excluding 6% of Angel’s equity reserved for issuance under the Angel employee stock ownership plan. For more information, visit www.angelpharma.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to the potential safety, tolerability, clinical benefit and efficacy of the Company’s product candidates; the potential use of soquelitinib to improve therapy for a broad range of patients with atopic dermatitis, other immune diseases and cancers; clinical strategy and the design of clinical trials, including the Company’s collaborations and the timeline for initiation, target or expected number of patients to be enrolled, dose levels, number of sites and other product development milestones; market size; and the amount of cash to fund operations into the second quarter of 2028. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the cash on hand providing funding into the second quarter of 2028 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The Company’s results for the second quarter ended June 30, 2026 are not necessarily indicative of its operating results for any future periods. INVESTOR CONTACT:Leiv LeaChief Financial OfficerCorvus Pharmaceuticals, [email protected] MEDIA CONTACT:Julia SternReal [email protected]
TranscriptFY2026 Q22026-08-06FY2026 Q2 earnings call transcript
Earnings source - 71 paragraphs
FY2026 Q2 earnings call transcript
Good afternoon, everyone. Thank you for standing by. Welcome to the Corvus Pharmaceuticals Second Quarter 2026 Business Update and Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. 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.
Thank you, operator. 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 Miller, Chief Executive Officer, Leiv Lea, Chief Financial Officer, Jeff 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 Corvus's annual report, quarterly report on Form 10-Q for the quarter ended June 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?
Thank you, Zack. I will begin with a brief overview of our second quarter 2026 financials. Then turn the call over to Richard for a business update. Research and Development expenses in the second quarter of 2026 total $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 non-cash losses of $0.7 million and $0.4 million, respectively, from Corvus's equity method investment in Angel Pharmaceuticals, and a non-cash 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 three months ended June 30th 2026 was $2.6 million, compared to $1.3 million for the same period in 2025. As of June 30th 2026, Corvus had cash equivalents, and marketable securities totaling $215.2 million as compared to $56.8 million at December 31st 2025. Cash as of June 30th 2026 included approximately $189.4 million in net proceeds received in a follow-on offering completed in Q1.
As announced on June 9th 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 30th 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.
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. Our efforts are primarily directed to driving patient enrollment and executing on our clinical trials to reach the next milestones for soquelitinib's two 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 pre-clinical 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 one-to-one between soquelitinib and standard of care chemotherapy with belinostat or pralatrexate. The primary endpoint is progression-free survival, or PFS, which with current treatment options, has a median of about three 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 I 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, and data obtained from the phase I trial.
Some of this data was presented at the ASH meeting last year. Turning to our other high-priority 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 I 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-75 in Cohort 4, compared to 20% of placebo patients. Cohort 4 studied is the highest dose and longest dosing period tested in the trial, covering 24 patients randomized in a one-to-one ratio to receive 56-day, eight weeks, 200 mg twice a day daily regimen of soquelitinib or equivalent placebo.
In addition to the compelling EASI-75 result, 25% of soquelitinib patients in Cohort 4 achieved EASI-90, and 33% achieved an IGA 0 or 1. No patients receiving placebo achieved EASI-90 or IGA 0/1. 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 injection 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 two 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 atopic 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 SIERRA-1 trial, which is currently enrolling patients, followed by the usual phase III 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 II SIERRA trial is planned to enroll approximately 200 patients with moderate to severe atopic dermatitis that have failed at least one prior topical or systemic therapy. It is double-blind, randomized, that includes four cohorts of 50 patients each with soquelitinib doses of 200 mg once per day, 200 mg twice per day, and 400 mg once per day, along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment. The primary endpoint is reduction in mean EASI score at 12 weeks compared to the placebo. There is no OLE, or open-label extension, 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 2027. In parallel, we are working in close collaboration with our partner in China, Angel Pharmaceuticals, on their phase Ib/II 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 mg twice per day, 200 mg once per day, or placebo. Cohort 2 will include 24 patients randomized evenly to soquelitinib doses of 200 mg twice per day, 400 mg once per day, or placebo.
Depending on the results from these 48 patients in Cohorts 1 and 2, an additional 60-90 patients are anticipated to be enrolled in the phase II 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 level studied in our phase I trial, 200 mg total per day, taken as either 100 mg tablet twice per day or 200 mg once per day. The treatment period, however, is significantly longer at 12 weeks compared to the four-week period studied for these doses in our phase I trial.
Recall, we found evidence of efficacy at these lower doses in our phase I trial with four weeks of therapy. Angel is evaluating these doses in a 12-week dosing regimen. We anticipate that data from the Cohort 2 will be available in the second quarter of 2027. Just to reiterate the timelines for Angel, we expect they'll 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 III 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 don't respond as well to IL-4 and IL-13-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 Ib/II trial of soquelitinib for atopic dermatitis and a new phase II 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 U.S., Corvus remains on track to initiate our own phase II asthma trial later this year, along with a phase Ib 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 TH2 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 Ib 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 mg BID. In addition to measuring safety and the standard hidradenitis suppurativa clinical response score, we're 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%-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 soquelitinib'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 Chu and Saran 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. We are making good progress with our key priorities to unlock the opportunity to help a broad range of patients with ITK inhibition. Over the remainder of the year, we are focused on, first, driving enrollment in our soquelitinib phase III registration PTCL trial and our phase II atopic dermatitis trial. Second, coordinating closely with our partner in China, Angel Pharmaceuticals, on their phase Ib/II 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. I will now turn the call over to the operator for the question-and-answer period. Operator?
Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. If you have a question, please press star followed by the number one 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 two. One moment please for your first question. Your first question comes from the line of Jeff Jones of Oppenheimer. Your line is now open.
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. 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 study design could look like?
Jeff, everything we're doing now, the design is straightforward. We compare soquelitinib to placebo, EASI scores, EASI-75s, IGAs at 12 or 16 weeks. Same as everybody else. That's what's required. Those are our protocols. 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 allocated to placebos, to determine whether or not there was disease rebound, and there almost always is. Therefore, they determined that the maintenance therapies were required for those diseases. Those were not part of the original approvals. That is not necessary to do that. We think it's very important if we have sustained remissions that don't require a drug.
That represents an amazing opportunity and unique advantage for soquelitinib. That is not part of the regulatory strategy. Later, should you want to be able to re-treat patients, of course, you would do additional trials to confirm that. Does that make sense?
Great. Yep, makes perfect sense. Then just one 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?
We do have work going on in the company looking at other formulations. We also have a lot of work going on in terms of other ITK inhibitors, other chemical structures, et cetera. I think that we're going to end up here probably with a regimen that's once-a-day dosing, because I think as we treat patients longer than four weeks, there will be very suitable efficacy with a once-a-day dosing regimen. We're looking at various regimens. As you know, in our cancer study, we went up to 600 mg BID. We know that a single dose of 200 mg will completely saturate the ITK target.
Great. Thank you very much, Richard. Congrats again on all the progress.
Thank you.
Your next question comes from the line of Graig Suvannavejh of Mizuho. Please go ahead.
Hi, this is Salim on for Graig. Thanks for taking our question, and congrats on the progress, team. Maybe just on the PTCL. It seems that there was a delay in the potential interim readout by a quarter. I'm just curious what the considerations were there and do you guys still anticipate the phase III data by the end of next year or is that more of a 2028 story now? Thanks.
We anticipate the final data late 2027, as originally stated. The interim analysis, of course, is projected based on events. It's hard to say exactly when they occur, because it's based on number of events, according to our statistical plan and agreement with FDA. Based on event rates, we're 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.
Your next question comes from the line of Paul Choi of Goldman Sachs. Please go ahead.
Hi, this is Erik 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 filings? Are you assuming incrementally better efficacy in the Chinese population for AD? What are your thoughts, or can you provide us some color on what your thoughts are on how you expect efficacy to change in the Chinese population?
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's one of the reasons we initiated this collaboration several years ago. The idea behind it was accelerated and extend our capabilities and leverage the Chinese population and regulatory authorities and clinical trial infrastructure, all that. Yes, the data can be shared. The second part of your question is, do I expect comparable data from Angel? It is a different study. It's an entirely different clinical trial done at a different point in time at different institutions. Hard to predict exactly. Theoretically, I think that we could beat the placebo by more because we have this combined effect on the TH17/TH2.
One might expect, let's say, compared to other treatments, a better effect. It's going to be hard to compare across clinical trials and across the Pacific Ocean. The Chinese trials are being done at, I think there's around 10 centers now. They're very good, well-known, academic, large hospital and dermatology clinics. They're commonly sites for large pharma and many other agents in dermatology and atopic dermatitis in particular. We feel very good about the quality and the information we're going to get out of there.
All right. Really helpful. Thanks.
Your next question comes from the line of Cha Cha Yang of Jefferies. Please go ahead.
Hi, this is Cha Cha on for Roger. Thanks for taking my question here. I have two. One is, can you just tell us more about the thought process behind doing a 12-week versus the 16-week trial for AD for your phase II? 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 trials? Thanks.
We have looked at four weeks of we looked initially at four weeks of dosing, then went to eight, and now we're doing 12 weeks of dosing. We saw very good efficacy at four weeks with 200 mg BID. We saw very good efficacy at eight weeks with curves continuing to go down. We'll look at the 12-week data that we get both from Angel and from what we're doing in our phase II, and we'll make a decision beyond that. I know that there's a lot of questions like 16 weeks is magic. It isn't. In our view, if you can get excellent efficacy with a shorter dosing regimen, why wouldn't you do that? Now eventually, if we see the curves continuing to go down, we will go to 16 weeks. I don't see any reason to do that now.
We've had some of our dermatology experts tell us that, "Gee, your results at four weeks are as good as what you're seeing at 16 weeks." By the way, I would go back and look at the publications on dupilumab and JAK inhibitors, and you'll see 12 and 16 weeks of treatment. Guess what? Those curves plateau at around six or eight weeks. Most of the efficacy in these 12 and 16-week regimens, go back and look at the EASI curves. Most of the efficacy is seen in the first couple of months. After that, the changes are really pretty small. Okay. Was there another part of your question? Can you-
Yeah. Just about trial design and baseline characteristics for your HS and asthma trials.
Moderate to severe HS, moderate to severe asthma. The asthma trial in particular, that's worth talking about. As you know, most studies are allergic or T2, and they'll frequently use an eosinophil count of 300 or 150 above 300 or above 150, that's changing these days, as an eligibility requirement. We're allowing both T2 and non-T2. That is, we'll 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.
Okay. Thank you
I think we're 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 don't 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. We've seen in our animal models that we can affect that. Of course, mechanistically, we know we're blocking the differentiation of the TH17 cell. The major eligibility there is the eosinophil count. Now, of course, we look at pheno and other things, but that's the major thing. All right.
Thank you.
Thanks.
Your next question comes from the line of Li Watsek of Cantor Fitzgerald. Please go ahead.
Hi, this is Mubina on for Li. One question about your asthma program. You said that you're targeting both the T2 and the non-T2 as well. Can you explain mechanistically why you think soquelitinib would be able to work in both T2 and non-T2 as well? Thank you.
Well, the reason it's called T2, because it's TH2 mediated, and of course, as we've mentioned previously, we'll block the differentiation of TH2 cells and the resulting cytokines. The TH2 is sort of obvious. The non-T2 is TH17. Mostly you see TH17 cells and other inflammatory cells. The other inflammatory cells are induced by these TH17 cells. Since we blocked the differentiation of activated TH2 and TH17 cells, we would expect to see activity in both T2 and non-T2. There's another important cell involved in both of these, T2 and non-T, which is called the innate lymphoid cell type 2. Highest expression of ITK of any lymphocyte, and we know we inhibit that very well also. 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.
Of course, provides a unique advantage over other asthma treatments.
Thank you. That's helpful.
Your next question comes from the line of Kevin DeGeeter of Ladenburg. Please go ahead.
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.
Sorry, you're asking about the Angel AD study or?
Oh, correct. Yes.
Well, I'm not sure I'm.
I know. The Angel asthma study. The Angel asthma study.
Okay. Yeah. The current plan is for the Angel trial to basically be identical to ours. Our current plan is to run two identical phase II trials. It'll be essentially the same protocols in both places, but run independently.
Great. 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 it a certain number of patients that will go into that assessment? Yeah, just a little bit more on that part of the study design. Thank you.
Yes. Actually, we're going to base it on the percentage of the trial patients treated. At that time, we'll look at the data. We've written that part of it sort of with broad criteria. The success in non-T2 is different than T2. The bar for efficacy is lower. It's harder to treat. We have general guidelines now. After a certain number of patients are treated, if we don't meet a certain threshold in the T2 or the non-T2, we can drop either one of those, or we can drop them all. The reason we're doing that is because let's just say it's not working in the non-T2, we wouldn't want to continue and dilute out the effect, let's say, positive effect on the T2. Make sense?
It does. Thank you very much.
There are no further questions at this time. I would like to turn the call back to Zack for the closing remarks.
All right. Thank you, operator. First of all, thank you everyone for joining us today. We're 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've outlined. We look forward to keeping you updated as we move through the rest of this year and next year. Thank you very much.
Ladies and gentlemen, this concludes today's conference call. Thank you everyone for your participation. You may now disconnect.
Investor releaseQuarter not tagged2026-07-30Corvus Pharmaceuticals to Provide Business Update and Second Quarter 2026 Financial Results on August 6, 2026
GlobeNewswire
Corvus Pharmaceuticals to Provide Business Update and Second Quarter 2026 Financial Results on August 6, 2026
Company to host conference call and webcast at 4:30 pm ET / 1:30 pm PT SOUTH SAN FRANCISCO, Calif., July 30, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the company will host a conference call and webcast on August 6, 2026 at 4:30 pm ET (1:30 pm PT) to provide a business update and report second quarter 2026 financial results. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days. About Corvus PharmaceuticalsCorvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of immune diseases and cancer. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Soquelitinib is being evaluated in a registration Phase 3 clinical trial for relapsed/refractory PTCL and in a Phase 2 clinical trial for the treatment of atopic dermatitis. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn. INVESTOR CONTACT:Leiv LeaChief Financial OfficerCorvus Pharmaceuticals, [email protected] MEDIA CONTACT:Julia SternReal [email protected]
Investor releaseQuarter not tagged2026-05-08Corvus: Q1 Earnings Snapshot
Associated Press
Corvus: Q1 Earnings Snapshot
SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Corvus Pharmaceuticals Inc. (CRVS) on Thursday reported a loss of $13.7 million in its first quarter. The South San Francisco, California-based company said it had a loss of 15 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CRVS at https://www.zacks.com/ap/CRVS
Investor releaseQuarter not tagged2026-05-08Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2026 Financial Results
GlobeNewswire
Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2026 Financial Results
Soquelitinib clinical development for atopic dermatitis advancing with Phase 1 cohort 4 positive data and initiation of Phase 2 trial during the quarter New immunologic and biomarker data supporting the potential for drug-free remissions with soquelitinib to be presented at Society for Investigative Dermatology (SID) annual meeting Company hosting investor and analyst meeting to review SID data on May 14, 2026 at 1:30 pm ET (12:30 pm CT) SOUTH SAN FRANCISCO, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the first quarter ended March 31, 2026. “We started the year with strong momentum for soquelitinib, our selective ITK inhibitor that we believe is well positioned to improve therapy for a broad range of patients with atopic dermatitis, other immune diseases and cancers,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The data generated from our clinical and preclinical work support soquelitinib’s potential to provide a new treatment paradigm for these diseases based on a rebalancing of the immune system. We will share additional data supporting this mechanism at the upcoming annual meeting of the Society for Investigative Dermatology, where we are reviewing data from our Phase 1 atopic dermatitis trial in two oral presentations. Looking forward, we are focused on our ongoing and planned soquelitinib clinical trials, including the initiation of new Phase 2 studies in hidradenitis suppurativa and asthma anticipated later this year.” Business Update and Strategy Soquelitinib for Immune Diseases In January 2026, Corvus reported data from cohort 4 of the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis (data as of January 15, 2026). Cohort 4 data demonstrated positive safety and efficacy results, including additional clinical benefit observed following longer 8-week treatment. Final data from the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis will be presented in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting, which is taking place May 13-16, 2026 in Chicago. The Compan…Read full documentShow less
Soquelitinib clinical development for atopic dermatitis advancing with Phase 1 cohort 4 positive data and initiation of Phase 2 trial during the quarter New immunologic and biomarker data supporting the potential for drug-free remissions with soquelitinib to be presented at Society for Investigative Dermatology (SID) annual meeting Company hosting investor and analyst meeting to review SID data on May 14, 2026 at 1:30 pm ET (12:30 pm CT) SOUTH SAN FRANCISCO, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the first quarter ended March 31, 2026. “We started the year with strong momentum for soquelitinib, our selective ITK inhibitor that we believe is well positioned to improve therapy for a broad range of patients with atopic dermatitis, other immune diseases and cancers,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The data generated from our clinical and preclinical work support soquelitinib’s potential to provide a new treatment paradigm for these diseases based on a rebalancing of the immune system. We will share additional data supporting this mechanism at the upcoming annual meeting of the Society for Investigative Dermatology, where we are reviewing data from our Phase 1 atopic dermatitis trial in two oral presentations. Looking forward, we are focused on our ongoing and planned soquelitinib clinical trials, including the initiation of new Phase 2 studies in hidradenitis suppurativa and asthma anticipated later this year.” Business Update and Strategy Soquelitinib for Immune Diseases In January 2026, Corvus reported data from cohort 4 of the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis (data as of January 15, 2026). Cohort 4 data demonstrated positive safety and efficacy results, including additional clinical benefit observed following longer 8-week treatment. Final data from the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis will be presented in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting, which is taking place May 13-16, 2026 in Chicago. The Company will host an in-person and virtual investor and analyst meeting on May 14, 2026 to review soquelitinib data being presented at SID, including new immunologic and biomarker data that focus on the drug’s mechanism of action and potential for drug-free remissions. Corvus initiated its Phase 2 randomized placebo-controlled atopic dermatitis clinical trial during the first quarter 2026. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. This includes four cohorts of 50 patients each, with soquelitinib doses of 200 mg once per day, 200 mg twice per day and 400 mg once per day, along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment. Angel Pharmaceuticals, Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitinib doses of 100 mg twice per day, 200 mg once per day, 200 mg twice per day and 400 mg once per day. The patient eligibility and endpoints are similar to those used previously by Corvus. Depending on the results from the Phase 1b portion of the study, an additional 60-90 patients will 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 global registration trials. The study is conducted in close collaboration with Corvus. Results from the initial cohorts are anticipated late this year. Corvus plans to initiate two additional Phase 2 clinical trials evaluating soquelitinib in patients with hidradenitis suppurativa and asthma. Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation for specific immunology and oncology indications. Collaboration with National Institute of Allergy and Infectious Diseases (NIAID) The Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial continues to advance. This trial is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing. Soquelitinib for T Cell Lymphoma Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate chemotherapies. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy. Financial Results As of March 31, 2026, Corvus had cash, cash equivalents and marketable securities of $236.7 million compared to $56.8 million as of December 31, 2025. Cash, cash equivalents and marketable securities as of March 31, 2026 included approximately $189.4 million in net proceeds received in a financing completed on January 23, 2026. Based on its current plans, Corvus expects its cash, cash equivalents and marketable securities to fund operations into the second quarter of 2028. Research and development expenses for the three months ended March 31, 2026 totaled $11.2 million compared to $7.5 million for the same period in 2025. The increase in research and development expenses of $3.7 million was primarily due to higher clinical trial costs associated with the development of soquelitinib as well as an increase in personnel related costs. Net loss for the three months ended March 31, 2026 was $13.7 million compared to net income of $15.2 million for the same period in 2025. Included in net loss for the three months ended March 31, 2026 and net income for the three months ended March 31, 2025 were non-cash losses of $0.6 million and $0.5 million, respectively, from Corvus’ investment in Angel Pharmaceuticals and non-cash income of $25.1 million in the three months ended March 31, 2025 associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended March 31, 2026 was $2.7 million compared to $1.3 million for the same period in 2025. About Corvus Pharmaceuticals Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of immune diseases and cancer. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Soquelitinib is being evaluated in a registration Phase 3 clinical trial for relapsed/refractory PTCL and in a Phase 2 clinical trial for the treatment of atopic dermatitis. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn. About Soquelitinib Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Recent third-party studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation, which has the potential to suppress autoimmune and inflammatory reactions. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company has initiated a registration Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed/refractory PTCL. Soquelitinib is also now being investigated in a randomized placebo-controlled Phase 2 clinical trial in patients with atopic dermatitis. A publication describing the chemistry, enzymology and biology of soquelitinib appeared in npj Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website. About Peripheral T Cell Lymphoma Peripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. First line treatment for these diseases is typically combination chemotherapy; however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the three to four month range and overall median survival of six to 12 months. There are no approved drugs in relapsed/refractory PTCL based on randomized trials. PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. About Atopic Dermatitis Atopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes. About Autoimmune Lymphoproliferative Syndrome (ALPS) ALPS is a rare genetic disease affecting children that manifests with lymphadenopathy, splenomegaly, cytopenias (low blood counts), proteinuria and autoimmunity. The disease is caused by a mutation in the Fas gene, which provides instructions for making a signaling protein involved in the induction of apoptosis. The mutation results in immune dysregulation due to abnormally high levels of “double negative” T cells (CD4 and CD8 double negative), which infiltrate the blood, spleen and lymphoid tissues. Fas signaling is regulated by ITK and T cell receptor signaling and patients with ALPS have an imbalance in this regulation resulting in a failure of T cells to undergo apoptosis and an accumulation of abnormal T cells. About Angel Pharmaceuticals Angel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – soquelitinib, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49.7% equity stake in Angel Pharmaceuticals excluding 7% of Angel’s equity reserved for issuance under the Angel employee stock ownership plan, and Corvus has designated three individuals on Angel’s five-person Board of Directors. For more information, visit www.angelpharma.com. Forward-Looking Statements This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates; the potential use of soquelitinib to improve therapy for a broad range of patients with atopic dermatitis, other immune diseases and cancers; clinical strategy and the design of clinical trials, including the Company’s collaborations and the timeline for initiation, target or expected number of patients to be enrolled, dose levels, number of sites and other product development milestones; and the amount of cash to fund operations into the second quarter of 2028. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the cash on hand providing funding into the second quarter of 2028 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The Company’s results for the first quarter ended March 31, 2026 are not necessarily indicative of its operating results for any future periods. INVESTOR CONTACT: Leiv Lea Chief Financial Officer Corvus Pharmaceuticals, Inc. +1-650-900-4522 [email protected] MEDIA CONTACT: Julia Stern Real Chemistry +1-949-903-4750 [email protected]
Investor releaseQuarter not tagged2026-03-13Corvus (CRVS) Q4 2025 Earnings Call Transcript
Motley Fool
Corvus (CRVS) Q4 2025 Earnings Call Transcript
Image source: The Motley Fool. Thursday, March 12, 2026 at 4:30 p.m. ET Chief Financial Officer — Leiv Lea President and Chief Executive Officer — Richard A. Miller Need a quote from a Motley Fool analyst? Email [email protected] Leiv Lea: Thank you, Zack. I will begin with a brief overview of our fourth quarter and full year 2025 financials and then turn the call over to Richard for a business update. Research and development expenses in the fourth quarter of 2025 totaled $9.9 million compared to $6 million for the same period in 2024. R&D expenses for the full year 2025 totaled $33.7 million compared to $19.4 million for the full year 2024. For both the fourth quarter and full year 2025, the increases in R&D expenses were primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel costs. Net loss for the fourth quarter 2025 was $12.3 million compared to a net loss of $12.1 million for the same period in 2024. Included in the net loss for the fourth quarter of 2025 and 2024 were noncash losses of $0.7 million and $2.2 million, respectively, from Corvus' equity method investment in Angel Pharmaceuticals and a noncash loss of $2.3 million in the fourth quarter of 2024 associated with the change in fair value of the company's warrant liability. Total stock compensation expense for the 3 months ended December 31, 2025, was $1.6 million compared to $0.8 million for the same period in 2024. As of December 31, 2025, Corvus had cash, cash equivalents and marketable securities totaling $56.8 million compared to $52 million at December 31, 2024. In January, we closed an upsized underwritten public offering that included a premier group of biotech investors and generated net proceeds of $189 million including the net proceeds from this financing, pro forma cash at December 31, '25, was approximately $246 million, extending our cash runway 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 Miller: Thank you, Leiv, and good afternoon, everyone. Thank you for joining us today for our update call. In 2025, we made significant progress advancing the development of soquelitinib, our first-in-class selective ITK inhibitor that is designed to rebalance or reset the immune system. This w…Read full documentShow less
Image source: The Motley Fool. Thursday, March 12, 2026 at 4:30 p.m. ET Chief Financial Officer — Leiv Lea President and Chief Executive Officer — Richard A. Miller Need a quote from a Motley Fool analyst? Email [email protected] Leiv Lea: Thank you, Zack. I will begin with a brief overview of our fourth quarter and full year 2025 financials and then turn the call over to Richard for a business update. Research and development expenses in the fourth quarter of 2025 totaled $9.9 million compared to $6 million for the same period in 2024. R&D expenses for the full year 2025 totaled $33.7 million compared to $19.4 million for the full year 2024. For both the fourth quarter and full year 2025, the increases in R&D expenses were primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel costs. Net loss for the fourth quarter 2025 was $12.3 million compared to a net loss of $12.1 million for the same period in 2024. Included in the net loss for the fourth quarter of 2025 and 2024 were noncash losses of $0.7 million and $2.2 million, respectively, from Corvus' equity method investment in Angel Pharmaceuticals and a noncash loss of $2.3 million in the fourth quarter of 2024 associated with the change in fair value of the company's warrant liability. Total stock compensation expense for the 3 months ended December 31, 2025, was $1.6 million compared to $0.8 million for the same period in 2024. As of December 31, 2025, Corvus had cash, cash equivalents and marketable securities totaling $56.8 million compared to $52 million at December 31, 2024. In January, we closed an upsized underwritten public offering that included a premier group of biotech investors and generated net proceeds of $189 million including the net proceeds from this financing, pro forma cash at December 31, '25, was approximately $246 million, extending our cash runway 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 Miller: Thank you, Leiv, and good afternoon, everyone. Thank you for joining us today for our update call. In 2025, we made significant progress advancing the development of soquelitinib, our first-in-class selective ITK inhibitor that is designed to rebalance or reset the immune system. This was highlighted by the presentation of final results from our Phase I/Ib trial in peripheral T-cell lymphoma in an oral session at the ASH Annual Meeting and the recent announcement of data from cohort 4 of our Phase I atopic dermatitis trial, which showed that soquelitinib could become a leading therapy for atopic dermatitis and potentially other inflammatory diseases. Shortly after the data announcement, we completed a $200 million financing, reflecting high investor interest in the opportunity for soquelitinib and ITK inhibition given our strong data to date, its unique mechanism of action and its broad potential to help patients across multiple areas of medicine. As a result, we are entering 2026 in a position of strength with ongoing enrollment in our Phase III PTCL trial, our recently initiated Phase II atopic dermatitis trial and the opportunity to expand into mid-stage trials for other important inflammatory diseases such as hidradenitis suppurativa and asthma later this year. Based on our current plans and anticipated time lines, our cash runway extends beyond key data readouts for all of these programs. On today's call, I will recap the highlights from our cohort 4 data announcement, share the latest on our plans to present additional data from the trial at an upcoming medical meeting and provide an update on our Phase II trial. I will also review our pipeline expansion plans and key upcoming milestones. The results from cohort 4 and the full Phase I trial show that soquelitinib's emerging clinical profile appears to provide substantial advantages in the treatment landscape for atopic dermatitis. One, it is an oral medication. Two, it has a novel mechanism of action that combines tissue selective and target-specific precision with ability to affect multiple inflammatory signaling pathways. Three, it appears safe and effective in a broad range of patients, including those who have received prior systemic therapies; and four, it produces durable responses with no disease rebound. Based on our market research, this profile would be considered a significant advancement for patients with atopic dermatitis. So we are excited that soquelitinib data further elevates its profile and potential. It shows one of the strongest EASI 75 results at only 8 weeks of therapy and the durability of responses with no disease rebound may provide the opportunity for new approaches to therapy of immune diseases, including the potential for soquelitinib to be an intermittent therapy. Overall, if the current profile continues to be supported by larger clinical trials, we believe soquelitinib will be very well positioned to be among the leading options for the treatment of patients with moderate-to-severe atopic dermatitis. I will now review key highlights from our recent data announcement. First highlight, efficacy. For cohort 4, which was designed as a randomized placebo-controlled trial with drug given over an 8-week treatment period, the mean percent reduction in EASI was 72% versus 40% for placebo that was statistically significant at 0.035. 75% of patients, 9 of 12 achieved EASI 75 and 1 additional patient was in EASI 74. 25% of patients achieved EASI 90 and 33% achieved IGA 0/1. 11 of 12 patients achieved EASI 50. The only nonresponder was a patient who was refractory to previous therapy with both Dupixent and Rinvoq. Two of the EASI 90 patients were resistant or nonresponsive to prior systemic therapies. 20% of placebo patients achieved EASI 75 or 17% if you include 2 patients that missed the day 56 evaluation and on later evaluation, never reached EASI 75. In addition, 2 placebos required rescue medication due to disease flares versus none in the active group. The 2 placebo patients who were EASI 75 were both patients who had not received prior systemic therapies. None of 7 placebo patients who received prior systemic therapy achieved EASI 75, whereas 3 of 5 active patients who received prior systemic therapies achieved EASI 75. The cohort 4 results confirm our hypothesis from cohorts 1 through 3, which is that extending the treatment duration would deepen responses. The data also show that soquelitinib is superior to placebo in every efficacy endpoint evaluated. And when compared to other agents, we believe the results obtained so far for soquelitinib place it among the most active agents, oral or injectable approved or under development for atopic dermatitis. Second highlight, durability. Starting with cohort 3, we took a more systematic approach to measuring the remission duration with a longer blinded post-treatment follow-up period of 90 days compared to 30 days tracked for cohorts 1 and 2. The cohort 3 data show that responses observed at day 28, the last day of treatment were maintained or slightly improved out to 118 days or 90 days without therapy. This compares to other systemic therapies for atopic dermatitis, which all show a rapid rebound in disease that starts as soon as 1-week after stopping therapy. We see no rebound phenomenon with soquelitinib, both in cohorts 3 and 4. We believe that the induction of T regulatory cells by soquelitinib could be responsible for this durable suppression of inflammation and sustained disease remission. We have seen this in preclinical experiments and biomarker data shows an increase in circulating Tregs in Cohort 3 patients. The demonstration of circulating Tregs is quite remarkable as usually, these cells are very rarely found in the blood. It is likely that these cells are migrating to and concentrating in sites of disease as we have found in our animal models. Third highlight, broad applicability. 35% of all patients enrolled in the Phase I trial had received prior systemic therapies, including 50% of patients in cohort 4. Dupilumab was the most commonly used prior therapy followed by JAK inhibitors and some patients received multiple prior therapies. This includes patients who were resistant to their last systemic therapy. In other words, they were nonresponsive to their prior treatment. Typically, patients that are treatment-resistant or who have gone through multiple prior therapies are more challenging, and this was confirmed when looking at the placebo patients in the trial. The response curve data showed that placebo patients who received prior systemic therapies do worse than those who did not receive prior therapies, indicating that prior systemic therapy is an unfavorable characteristic. However, the response curves for patients receiving soquelitinib are very similar across these groups, indicating that soquelitinib is not affected by prior systemic therapy experience. Together with our baseline patient characteristics, this also indicates that the patient population treated on our protocol was more unfavorable than those reported in most atopic dermatitis clinical trials. As noted above, in patients who received prior systemic therapies, the EASI 75 was 0% for placebo 0 out of 7 versus 60%, 3 of 5 seen in patients who received soquelitinib. So in terms of patient indications, our conclusions are that soquelitinib is active in patients who have received prior systemic therapies with outcomes no different than naive patients despite these patients having more unfavorable disease. Responses were observed in patients who are refractory to their prior systemic therapy. This supports our hypothesis regarding the novel mechanism of action for soquelitinib and the lack of resistance due to prior therapy experience. Fourth highlight, safety. No new safety signals were seen in cohort 4 with a longer 8-week treatment duration. In cohort 4 and the full Phase I trial, reported adverse events are similar in both placebo and active groups. No significant lab abnormalities were observed. There were no hepatic abnormalities, no changes in liver function tests. Infections were similar in treated and placebos and were minor. I'd like to make some additional comments on infection. We have received questions from investors regarding the potential for EBV viral reactivation. These questions are based on very rare reports in the literature of EBV infection in babies born with germline mutations in ITK. In a neonate, the immune system is primitive as T and B cells have not yet formed. Immune system maturation occurs during development and exposure to antigens. A germline mutation in ITK in the primitive developing immune system is completely different than transiently blocking the kinase domain of ITK with a small molecule drug in an individual with a mature immune system. We have seen no serious infections of any kind in more than 150 patients treated with soquelitinib across our lymphoma, atopic dermatitis and ALPS trials to date. This involves over 14,000 patient days of treatment with some patients on therapy for more than 2 years. In PTCL, most patients harbor EBV and other viruses such as CMV. In our Phase I lymphoma study, we identified over 30 patients with EBV virus detectable at baseline, that is before therapy in their blood measured using a PCR technique that is they are viremic. None of these patients or any other patient had any evidence of EBV reactivation or related illness during the treatment, which, in some cases, lasted over 2 years. And recall, these patients are extremely immunocompromised. One other thing to note, ITK inhibition spares Th1 cells, also known as Th1 skewing. Th1 cells are the cells responsible for eliminating viruses. Now beyond clinical results, biomarkers have been identified that support the novel mechanism of action with ITK inhibition that leads to immune rebalancing. Some of these biomarkers represent new discoveries. Briefly, the data show a decrease in IL-4, IL-5 and IL-17 cytokines, a small reduction in TARC, a reduction in Th2 cells and an increase in Tregs. In ongoing work, we are also finding very significant and interesting changes in the JAK/STAT signaling pathways that will be reported on later. With the additional information that is emerging both from the clinic and our biomarker analysis such as induction of Tregs, we believe that soquelitinib's novel mechanism of action and safety will allow for its utility in diverse indications in immune inflammatory diseases and in cancers. Our soquelitinib abstract was accepted for oral presentation at the Society for Investigative Dermatology, or SID Annual Meeting, which takes place in mid-May. We plan to present the Phase I clinical data, expanding our safety and durability data. We will also focus on our biomarker results in this presentation, which we believe will provide novel ideas regarding control of immune diseases. Our late-breaker abstract was not selected for presentation at AAD, which typically favors later-stage trials. Angel Pharmaceuticals, our partner in China, is enrolling their Phase Ib/II trial in atopic dermatitis. This is a blinded placebo-controlled trial that is evaluating a 12-week treatment regimen in 48 patients with soquelitinib doses of 100 milligrams BID, 200 milligrams QD, 200 milligrams BID and 400 milligrams QD. The patient eligibility and endpoints are the same as was used by Corvus. Depending on the results from the Phase I portion, an additional 60 to 90 patients will be enrolled in the Phase II portion of the study. This trial is open at leading centers in China that are very experienced in performing these types of trials. The study is conducted in close collaboration with the Corvus team. Results from the initial cohorts are expected late this year. Now I would like to discuss our Phase II randomized placebo-controlled trial in atopic dermatitis. We announced today that the trial has been initiated. This trial is planned to enroll 200 patients with moderate to severe disease randomized into 1 of 4 cohorts with 50 patients in each cohort. We will allow patients who have received prior systemic therapies. Doses of 200 milligrams QD, 200 milligrams BID and 400 milligrams QD will be examined along with placebo. The treatment duration is 12 weeks with an off-treatment follow-up period of 90 days. The primary end point is median percent reduction in EASI at 12 weeks, a typical endpoint for Phase II studies in atopic dermatitis. Other endpoints include EASI 75, EASI 90, IGA, PP-NRS and others. This will be an international study. We anticipate the data from this trial will be available in mid-2027. Outside of atopic dermatitis, we continue to enroll patients in our Phase III registration PTCL trial with an interim analysis expected later this year. We recently conducted a planned meeting of our outside independent Data Safety Monitoring Board. No safety signals were observed, and the study continues as planned. In December, at the American Society of Hematology or ASH Annual Meeting, we presented the final data from our Phase I/Ib clinical trial evaluating soquelitinib in patients with T-cell lymphoma. The data are supportive of the ongoing Phase III program showing that patients in the 200-milligram BID cohort, the same dose being studied in Phase III had a median progression-free survival of 6.2 months and a median overall survival of 28 months comparing favorably -- very favorably to results with other therapies. For example, median survivals with chemotherapy are less than 1 year and PFSs are less than 3.5 months. The data presented at ASH also shows soquelitinib's immunobiological effects and its mechanism of action of affecting T cell differentiation via ITK inhibition. These data support its potential in atopic dermatitis and a much broader range of immune and inflammatory diseases. We also continue to collect very exciting data from our ALPS or autoimmune lymphoproliferative syndrome clinical trial with 3 patients now on therapy for close to a year. We continue to collaborate with the team at NIAID and our current plan is to submit data for a potential presentation on the study at the ASH meeting in December. In terms of upcoming clinical trials, we plan to initiate a Phase II trial of soquelitinib for hidradenitis suppurativa and asthma later this year. There is strong scientific rationale for evaluating soquelitinib in HS, which is it is an IL-17-driven disease. In both in vitro and in vivo animal models, soquelitinib is a potent inhibitor of Th17 cells and reduces IL-17 production. Our trial design for HS is further along. At a high level, we are planning to enroll about 60 total patients with moderate to severe HS into 3 arms: 200-milligram BID, 400-milligram QD and placebo. The treatment period will be 12 weeks and the primary endpoints are safety and efficacy measured by HiSCR 50, HiSCR 75. The asthma study design is emerging and will likely involve about 150 patients treated for 3 months. In closing, our confidence continues to grow in the long-term potential for soquelitinib in atopic dermatitis, peripheral T-cell lymphoma and a broad range of additional inflammatory diseases. We are only beginning to unlock the full potential of ITK inhibition and immunomodulation, which could lead to new and better therapies for inflammatory, autoimmune and fibrotic diseases and cancers. We are building strong momentum with soquelitinib and our ITK platform, and we look forward to updating you on our progress throughout the year. I will now turn the call over to the operator for questions-and-answer period. Operator? Operator: [Operator Instructions] And your first question comes from Roger Song from Jefferies. Jiale Song: Congrats for all the progress you have made. Richard, maybe just one question related to the read-through from the data readout you will have before the Phase II, the global atopic dermatitis data mid next year. So you will have a PTCL potentially data and then also the China 12-week study data. So how should we think about the read-through from those data readouts to the Phase II AD maybe from the efficacy and then the safety perspective, particularly on the high-dose 400-milligram QD? Richard Miller: Okay. So we are anticipating that Angel Pharmaceuticals, who is conducting a placebo randomized trial and looking at different doses, will have some data from their initial couple of cohorts later this year. That would be the first data readout. That's going to be looking at 100 milligrams BID and 200 milligrams QD. But recall, they're going for 12 weeks. They're treating for 12 weeks. We've only gone up to 8 weeks. So that will be very important information for us. Then that data is unblinded. They look at that. We can report that. And then the next part of the study will look at 200 milligrams BID and 400 QD. That will be probably middle of 2027. Okay? So we'll get some data on more patients and things. Now in total, after that, the Angel goes on and does 40 -- what, 50, 60 or 60 to 90 patients in a Phase II study rolls right into that. In total, you're looking at around 140 patients or so. And that -- yes, 130, 140 patients, and that's totally completed by mid-2027 or early '27. So we'll have some data from them late this year, more data in first half of 2027. The PTCL trial will have an interim formal review in later this year. That has a futility analysis as part of it, so -- and safety analysis. And -- but the complete trial results are expected in late '27. Okay. Now what I talked about on the call was we do have also periodic safety -- outside independent safety reviews on the Phase III PTCL trial. We had one of those very recently and everything looked good, as I mentioned. Operator: And your next question comes from Li Watsek from Cantor. Li Wang Watsek: Two from us. Maybe just first on the data that you're going to present at the SID meeting in May. Rich, you talked about biomarker and durability data before. Can you just maybe set expectations for us? Richard Miller: Yes. Well, I can set expectations. The durability continues to look great. And in terms of biomarkers, the things I've mentioned previously, but we have discovered some new biomarkers, which is going to be probably the main part of the SID presentation, fascinating work around the T regulatory cells and some of the JAK-STAT signaling. And the key message there is that you're affecting different multiple cytokine pathways. Even though you're targeting a very specific enzyme restricted to T cells that can affect several different cytokines, all of which are important in inflammatory diseases like IL-5 and 4 and 17, et cetera. So plus we'll update the clinical data with the durability and a few other things. Li Wang Watsek: And then sorry, my second question is on the Phase II trial in HS. Just wondering what the benchmark that you're looking at, especially relative to the approved agents like IL-17 in the space, do you think in terms of efficacy, you have to match the biologics? Richard Miller: Well, first of all, we have to find the optimum dose, which we're going to look at a couple of different doses. But of course, the AD study informs us as well as the T-cell lymphoma study informs us on the HS trial. I would expect efficacy as good or better than what's out there, which is what the corrected HiSCR scores are, what, 25% or so. Operator: And your next question comes from Graig Suvannavejh from Mizuho. Graig Suvannavejh: Richard, congrats on the great progress we're seeing with soquelitinib across multiple indications. I just wanted to maybe touch upon a couple of things. First, just on your next data presentations, you did mention that maybe you did apply for late-breaker abstract to AAD. I think you gave us a reason why perhaps your abstract was not accepted, although I do think that Kymera does have a late breaker. I don't know their data set very well as I don't cover it, and so it's not at the top of -- or the tip of my tongue. But any thoughts on whether it is perhaps they had a bigger database because I do think that the just curious to get any thoughts there. Richard Miller: Well, Graig, what gets accepted abstracts that get accepted or even publications that get accepted. This is a capricious process, and there are a lot of factors. I don't know why they accept some and not others. I personally am shocked that Kymera with no placebo and an interesting study for sure. But I don't have an explanation for it. Graig Suvannavejh: There may not be a good one. I just thought I'd speculate... Richard Miller: I wouldn't get too worried about that. I mean I've had some really, really good papers get accepted at journals and be rejected at others. At the end of the day, it's -- 1 or 2 guys read some abstracts. I used to do it myself. You get a few hundred to review and you decide what looks good, whatever. So I don't know if I focus too much on any reasons on that. We're not very active in AAD. We've never done anything there. We don't have booths. We don't subscribe to their journals. I think that's another factor -- could be another factor, not sure. Anyway, SID is a good meeting. If anything, scientifically more rigorous, it is the meeting for early stage and translational biology and research. So we ended up, I think, in a very good place. Graig Suvannavejh: Okay. Great. If I could ask just on the Phase II trial in AD that you did start and congratulations there. I think you mentioned that data would be available in middle of 2027 and just trying to get a sense of in between now and mid-2027, will there be an opportunity for the company to provide some kind of update? Just trying to get a sense of news flow from that trial from now until mid-2027? Richard Miller: So that Phase II trial is placebo-controlled, randomized and blinded. No, we will not see that data until it's completed. And as I mentioned, the Angel trial is underway. That's also blinded and placebo controlled, but they can look at the data after each cohort, similar to what we did in our Phase I. So there will be a news flow from that in terms of the AD stuff. Graig Suvannavejh: Okay. And last question, if I could, just on hidradenitis suppurativa, just given coverage of some other companies that I have, I'm under the view that there are not very good preclinical models of HS and just wondering then how do you handicap success in HS when perhaps there are not very well established or good predictive models in HS? Richard Miller: You are correct, there are not good animal models for HS, but it's pretty clear in human studies that IL-17 is very important. Th17 and IL-17 are very important. And in fact, IL-17s are approved to treat it. So I think there's proof of principle already that if you can block IL-17, it should work. And we block IL-17 among the many other cytokines that we block. Hidradenitis suppurativa has a lot of different inflammatory cells, T cells, neutrophils, B cells, for example. And again, I think the advantage of soquelitinib is that since you're blocking multiple cytokine pathways, you actually affect many different lineages. And I think that's going to be important because when you look at the sites of disease, even in atopic dermatitis, you just don't see Th2 cells, you see a lot of different cells. So I think that, that's one -- I mean, I would say the best explanation for that is, hey, anti-IL-17 works in that disease. And we block it even better. Operator: And your next question comes from Jeff Jones from Oppenheimer. Jeffrey Jones: Since I think we've beaten HS to death, maybe talk about AD and how you guys are -- this is a different disease and indication than the dermatological ones. How are you thinking about dosing and your strategy there? Richard Miller: I think you mean asthma probably. Jeffrey Jones: Asthma, I'm sorry. Richard Miller: Yes, you mentioned AD. So well, as you know, atopic dermatitis and asthma frequently go together and drugs that work in one often work in the other. They seem to be part of the atopic syndromes. We have several -- now that's one where we do have several animal models and our drug works really well in those asthma models, 4 or 5 different models work. Soquelitinib works beautifully. In terms of dosing, I think it's the same dosing that we've talked about. The AD and PTCL studies inform the asthma. The asthma study is pretty much the same dosing regimens. There'll be no reason to change that. Jeffrey Jones: Okay. And then one... Richard Miller: Sorry, just to elaborate, remember, we have the best biomarker in the world, which is that -- and we've been doing this for years. You can give the drug, you take out the T cells from the patient, either in the blood or the sites of disease and you can measure quite accurately the drug sitting in the target. It is a clean quantitative assay. It blocks the function of that enzyme. That's a biomarker. And we know that when you give a 200-milligram dose, you pretty much completely block that. Sorry, Jeff. Jeffrey Jones: I appreciate that, Richard. And then on the ALPS trial, which you're doing with the NIH, can you maybe comment on how that -- the outcome of that might impact how you think about other indications or inform what you guys are doing? Richard Miller: So ALPS is a disease where you have such an overreactive autoimmune response to so many different things. They have antibodies to red cells and white cells and platelets and other things. And [indiscernible] and lymphocyte proliferation, abnormal lymphocytes. And we have seen really interesting results in our patients. So I think the -- that what we're learning there is similar to what we learned in lymphoma is that the drug is very active, it's safe and it's interfering with the signaling pathways that we would predict. Now I'm not sure I can say, okay, if it works in ALPS, it's going to work in lupus, even though the ALPS mouse equivalent is a model for SLE. But I don't think we're thinking of it that way. We're thinking of it as an indicator that we're affecting aberrant auto-inflammatory responses in a disease where there's no good treatments really. So it's kind of a model, if you will, but it's a human model. It is an orphan disease. There's no good therapies. Could you get approval for ALPS? Yes, you could. It's more of a childhood disease. We've been treating adults. We do intend to increase the number of sites, and we do intend to move down in age into children over the next year or so. We've been talking about that with NIH. So it's another indication, and it happens to be in autoimmune disease. Operator: And your next question comes from Aydin Huseynov from Ladenburg. Aydin Huseynov: Richard, congratulations for the tremendous progress so far this quarter in your pipeline in the drug soquelitinib. I got a couple of questions. So first, I wanted to ask about the near-term focus near-term Phase III readout interim analysis from the trial in PTCL. I was curious to hear any comments you may provide regarding the enrollment process so far? What types of PTCL you're actually enrolling? Is it NIS? Is it ALCL, follicular cutaneous? And what the physicians are using a standard of care prefer belinostat and pralatrexate? Just curious to hear overall dynamic of the trial. Richard Miller: Okay. So let's take that question first. So the trial is enrolling and it's going perfectly according to plan. The patients get randomized into either soquelitinib monotherapy 200 milligrams BID versus the investigator's choice of either belinostat or pralatrexate. Now recall, belinostat and pralatrexate are received conditional approval, accelerated approval maybe 15 years ago or so based on response rate in patients with relapsed PTCL. So in our discussions with FDA, that was the logical control arm. So soquelitinib versus those agents. Now it's not a blinded trial because you can't -- well, first of all, we don't usually do that in cancer, but you can't blind -- soquelitinib is oral, right, as we know. Belinostat and pralatrexate are given intravenously and have associated usual toxicities of chemotherapy, mucositis, blood count problems, things like that. So, so far, the trial is enrolling. We had our first safety monitoring board, and there were no new safety or different safety signals with regard to soquelitinib. Obviously, it's much safer than chemotherapy. So we win on every count on that. Now later -- now the types of patients that are enrolled are as stated in the protocol, are PTCL NOS, that's the most common one. We do allow anaplastic lymphomas that are ALK positive. The other big category would be what's called T follicular helper, which used to be what's called angioimmunoblastic lymphoma. So not CTCL. CTCL really is a little bit more of a chronic disease and is treated differently. So that's the reason not to include that in this trial. But it's pretty typical. These are the most common peripheral T-cell lymphomas. Now peripheral T-cell lymphoma, again, just to remind people, there is no fully approved treatment for relapsed disease. It has a median PFS and belinostat median PFS is 1.7 months. Pralatrexate is 3 months. And OSs are under a year. So those are really bad -- these are really bad disease. These are sick patients. I can tell you that we are very, very happy with the way the trial is going. And I think it could represent a very important breakthrough in hematology if we finish the trial and get the results that we're expecting. Does that answer your question? Aydin Huseynov: Appreciate that. I got another one for asthma, if you don't mind. Richard Miller: Sure. Aydin Huseynov: So yes, so regarding the upcoming trial design in asthma, do you plan to have a cohort with patients who may have both asthma and atopic dermatitis? And in your opinion, is there any accelerated path with small pivotal trial with patients with 2 diseases simultaneously. So essentially, that would allow soquelitinib to cure 2 diseases at the same time. And as we know, Dupixent is the only drug that treats both diseases, but maybe you can have it in one shot. Richard Miller: Well, that would be great. But I don't know -- so first of all, trying to get 2 indications on -- that's really very difficult. And you can get anecdotal information. I know some people report that. And we've had some anecdotal information about that. But the problem is you don't know how many patients are going to have both diseases concomitantly, how severe it is, what measurements you're going to use and how you power the study statistically for each disease. So it's really hard to do that. Anecdotally, it's something you would look at. You have to do a separate trial. And even Dupixent was separate trials for asthma and eosinophilic esophagitis and COPD and all those things. So it requires a separate trial. Now one thing we are considering is we're really very interested in, I would say, 2 things. One is this durability of response is quite interesting. And we think we have explanation for it. I think we have a very good immunologic explanation for it. It's very elegant and compatible with what's known about the immune responses and so forth. We also are very struck by the activity we see in patients who failed previous therapies. And I talked about that in my discussion here. So we are allowing and I don't know if I mentioned it, we are allowing patients who have failed prior therapies in our Phase II atopic dermatitis study. Now some people, many investors have been asking me, why don't you do a separate study in the resistant patients with atopic dermatitis. And that is something we are thinking about. That could be a smaller trial because the efficacy and the placebo do so -- the efficacy and placebo -- sorry, placebos do so poorly, you would presumably show a bigger difference with a fewer number of patients. But we are including both naive and experienced patients in our Phase II. I would do that in Phase III as well, which would enable you to get the total population of patients. But there's no doubt that with more and more therapies coming out in atopic dermatitis, the proportion of patients that are not treatment naive, that is that have failed the prior therapies, that pool of patients is increasing. And the pool of patients that is naive is going to decrease proportionately. Okay? So that the resistant patient becomes, I think, very attractive. So I would say the 2 exciting -- I mean, we have a lot of things that we're excited about with soquelitinib. It's oral and it's safe and all that other stuff. But the durability is, I think, a game changer, changes how you approach the disease. And I think the fact that you can think about frontline therapy or relapsed disease or multiple therapies, intermittent therapy. That's our -- it's the way we think about it. Aydin Huseynov: Congrats for the results. Operator: And your last question comes from Sean Lee from H.C. Wainwright. Xun Lee: To touch upon the durability a bit more. I think in the previous Phase I study, you guys followed the patients for up to 3 months. How long are you following these patients in Phase II? And is the study powering any way to really make a differentiation on the durability of this response? Richard Miller: So the Phase II trial has built in continued blinding of the trial out to 90 days beyond the therapy. So it's 12 weeks of therapy plus the 90 follow-up. That's baked into the protocol. However, the endpoint is the EASI score compared to placebo at 12 weeks, and that's the typical endpoint. To do something different would be sort of atypical. Now I think that in the future, this issue of how durable the responses are is something that you might study separately. But I think it stands to reason. I mean, we'll talk more about this, but we have over 90% of our patients don't relapse and follow-up now out to 3 months beyond the last dose. Over 90% of patients, disease just doesn't come back. Now you look at other agents, dupi, STAT6, whatever the IL-13s, IL-2s, whatever, these diseases come back pretty quickly. In my view, that's not a very good therapy. Best therapy is a shorter treatment duration. Disease goes away, you don't need to take your drug again for a long time, if at all, hopefully, but that's asking a lot. So the durability is important because it's important to understand why it's happening, does it pertain to other inflammatory diseases? In other words, how broad is that going to be? Is that unique to atopic dermatitis? Or is that something that you could think about for other autoimmune diseases? And that's why we're excited about that. But anyway, the answer to your question is in the Phase II, it is part of the formal follow-up is blinded, but it's not part of the statistical endpoint. The statistical endpoint is the typical one, which is EASI score at 12 weeks. Xun Lee: Okay. Got it. For the -- touching on the asthma study for our second question. As the upcoming study, will you be focusing on eosinophilic asthma with the Th2 high? Or are you targeting the more difficult to treat Th17 driven population as well? Richard Miller: We're probably going to -- so those are some of the things we're discussing now. We're leaning to taking everybody. Xun Lee: I see. Richard Miller: I'm actually -- Sean, I'm glad you brought that up because there's something -- some people say, well, we only treat Th2 disease. I don't know where that comes from. Some people said, "Oh, you're only selecting patients with atopic dermatitis that are Th2. First of all, I don't even know how to do that. But we're not doing that. Our atopic dermatitis patients are run-of-the-mill patients from U.S. centers. They have to have the necessary eligibility criteria, but we didn't enrich for any patient population. Most of our -- by the way, AD patients do not have eosinophilia. Their eosinophil counts are normal or little. So I don't think we're going to restrict it to the high EO asthma. Although I have to say the asthma study protocol has not yet been finalized, and that's still under discussion. Alright. Okay. Well, first of all, thank you, everyone, for participating in our call. We look forward to updating you throughout the rest of the year and beyond. Appreciate everybody's interest. Thank you. Operator: Ladies and gentlemen, this does conclude your conference call for today. We thank you very much for your participation, and you may now disconnect. Have a great day. Before you buy stock in Corvus Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Corvus Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $511,735!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,140,464!* Now, it’s worth noting Stock Advisor’s total average return is 946% — a market-crushing outperformance compared to 191% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. 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Investor releaseQuarter not tagged2026-03-13Corvus Pharmaceuticals Q4 Earnings Call Highlights
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Corvus Pharmaceuticals Q4 Earnings Call Highlights
Balance sheet and spending: After an upsized January offering that raised net $189 million, Corvus reports pro forma cash of ~$246 million, which management says extends the company's cash runway into Q2 2028, even as R&D spending rose to $33.7 million in 2025 driven by soquelitinib clinical and manufacturing costs. Atopic dermatitis progress: Phase 1 cohort 4 showed a mean EASI reduction of 72% vs 40% (p=0.035) with EASI-75 in 75% of treated patients, durable responses out to day 118 and no new safety signals reported; a blinded phase 2 randomized AD trial of 200 patients has been initiated with data expected mid-2027 and an SID presentation planned. Oncology and pipeline expansion: Enrollment continues in the phase 3 PTCL registration trial with an interim analysis expected later this year and no DSMB safety signals so far, while the company also plans mid-stage trials in hidradenitis suppurativa and asthma and maintains a China partner trial via Angel Pharmaceuticals. Interested in Corvus Pharmaceuticals, Inc.? Here are five stocks we like better. Momentum Is Just Starting for These 3 Rapid-Growth Stocks in 2026 Corvus Pharmaceuticals (NASDAQ:CRVS) outlined expanding clinical plans for its selective ITK inhibitor soquelitinib while reporting higher research and development spending for 2025, reflecting a broader and more advanced pipeline. Management emphasized recent atopic dermatitis data, ongoing enrollment in a phase 3 peripheral T-cell lymphoma (PTCL) study, and new mid-stage trials planned for additional inflammatory diseases. Chief Financial Officer Leif Li said research and development expenses were $9.9 million for the fourth quarter of 2025, up from $6.0 million in the year-ago quarter. For the full year, R&D expenses totaled $33.7 million versus $19.4 million in 2024. Li attributed the increases primarily to higher clinical trial and manufacturing costs related to soquelitinib as well as increased personnel costs. → Alphabet’s Pullback May Be Opening a New Entry Point Net loss for the fourth quarter of 2025 was $12.3 million compared to $12.1 million in the fourth quarter of 2024. Li noted the results included non-cash losses from Corvus’s equity method investment in Angel Pharmaceuticals of $0.7 million in 4Q 2025 and $2.2 million in 4Q 2024. The 4Q 2024 net loss also included a $2.3 million non-cash loss tied to a change in the fair value of…Read full documentShow less
Balance sheet and spending: After an upsized January offering that raised net $189 million, Corvus reports pro forma cash of ~$246 million, which management says extends the company's cash runway into Q2 2028, even as R&D spending rose to $33.7 million in 2025 driven by soquelitinib clinical and manufacturing costs. Atopic dermatitis progress: Phase 1 cohort 4 showed a mean EASI reduction of 72% vs 40% (p=0.035) with EASI-75 in 75% of treated patients, durable responses out to day 118 and no new safety signals reported; a blinded phase 2 randomized AD trial of 200 patients has been initiated with data expected mid-2027 and an SID presentation planned. Oncology and pipeline expansion: Enrollment continues in the phase 3 PTCL registration trial with an interim analysis expected later this year and no DSMB safety signals so far, while the company also plans mid-stage trials in hidradenitis suppurativa and asthma and maintains a China partner trial via Angel Pharmaceuticals. Interested in Corvus Pharmaceuticals, Inc.? Here are five stocks we like better. Momentum Is Just Starting for These 3 Rapid-Growth Stocks in 2026 Corvus Pharmaceuticals (NASDAQ:CRVS) outlined expanding clinical plans for its selective ITK inhibitor soquelitinib while reporting higher research and development spending for 2025, reflecting a broader and more advanced pipeline. Management emphasized recent atopic dermatitis data, ongoing enrollment in a phase 3 peripheral T-cell lymphoma (PTCL) study, and new mid-stage trials planned for additional inflammatory diseases. Chief Financial Officer Leif Li said research and development expenses were $9.9 million for the fourth quarter of 2025, up from $6.0 million in the year-ago quarter. For the full year, R&D expenses totaled $33.7 million versus $19.4 million in 2024. Li attributed the increases primarily to higher clinical trial and manufacturing costs related to soquelitinib as well as increased personnel costs. → Alphabet’s Pullback May Be Opening a New Entry Point Net loss for the fourth quarter of 2025 was $12.3 million compared to $12.1 million in the fourth quarter of 2024. Li noted the results included non-cash losses from Corvus’s equity method investment in Angel Pharmaceuticals of $0.7 million in 4Q 2025 and $2.2 million in 4Q 2024. The 4Q 2024 net loss also included a $2.3 million non-cash loss tied to a change in the fair value of the company’s warrant liability. Stock-based compensation for the quarter was $1.6 million, up from $0.8 million a year earlier. As of December 31, 2025, Corvus reported cash, cash equivalents, and marketable securities of $56.8 million, compared with $52.0 million at year-end 2024. Li also said the company completed an upsized underwritten public offering in January that generated net proceeds of $189 million. Including that financing, pro forma cash at December 31, 2025 was approximately $246 million, which management said extends the company’s cash runway into the second quarter of 2028. → D-Wave Keeps Delivering Good News—So Why Is It Falling? Chief Executive Officer Richard Miller highlighted progress in soquelitinib across both oncology and inflammatory disease programs, pointing to recently announced cohort 4 results from the company’s phase 1 atopic dermatitis trial. Miller described soquelitinib as a first-in-class selective ITK inhibitor intended to “rebalance or reset the immune system.” Miller said cohort 4 was designed as a randomized, placebo-controlled trial with an eight-week treatment period. Key efficacy figures he cited included: Mean percent reduction in EASI of 72% for soquelitinib versus 40% for placebo (p=0.035). EASI 75 achieved by 75% of treated patients (9 of 12), with one additional patient reaching EASI 74. EASI 90 achieved by 25% of treated patients; IGA 0/1 achieved by 33%. Two placebo patients required rescue medication due to disease flares versus none in the active-treatment group. → Tesla’s Big China Sales Spike Didn’t Excite Investors—Here’s Why He added that the only non-responder in the active group was described as refractory to prior therapy with both Dupixent and Rinvoq, while two of the EASI 90 responders had been resistant or non-responsive to prior systemic therapies. Miller also discussed outcomes by prior treatment history, stating that none of seven placebo patients with prior systemic therapy achieved EASI 75, while three of five treated patients with prior systemic therapy achieved EASI 75. Miller emphasized durability as a differentiating feature, stating that in cohort 3, responses observed at day 28 were maintained or slightly improved out to day 118 (90 days off therapy). He said the company observed no rebound phenomenon in cohorts 3 and 4. He linked this to a hypothesized induction of T-regulatory cells (Tregs), noting biomarker data showing increased circulating Tregs in cohort 3 patients. On safety, Miller said no new safety signals were seen with the longer eight-week treatment in cohort 4, and he reported similar adverse events in placebo and active groups, no significant lab abnormalities, and no hepatic abnormalities. He also addressed investor questions about EBV reactivation risk, citing experience in more than 150 treated patients across lymphoma, atopic dermatitis, and ALPS trials, representing more than 14,000 patient-days of exposure, with some patients treated for more than two years. In the phase 1 lymphoma study, he said more than 30 patients had detectable EBV at baseline and none had evidence of EBV reactivation or related illness during treatment. Miller said Corvus’s soquelitinib abstract was accepted for oral presentation at the Society for Investigative Dermatology (SID) annual meeting in mid-May, where the company plans to present phase 1 clinical data with expanded safety and durability results and a focus on biomarker findings, including work involving Tregs and JAK-STAT signaling. He also discussed progress at Angel Pharmaceuticals, Corvus’s partner in China, which is enrolling a blinded, placebo-controlled phase 1b/2 atopic dermatitis trial evaluating 12-week treatment in 48 patients across multiple dose regimens (including 100 mg BID, 200 mg QD, 200 mg BID, and 400 mg QD). Miller said results from the initial cohorts are expected late this year, with additional dose cohorts expected to read out later as the study progresses. Corvus announced on the call that it has initiated a phase 2 randomized, placebo-controlled atopic dermatitis trial expected to enroll 200 patients with moderate to severe disease. Patients will be randomized into four cohorts (50 patients each) to receive 200 mg QD, 200 mg BID, 400 mg QD, or placebo for 12 weeks, followed by a 90-day off-treatment follow-up period. The primary endpoint is median percent reduction in EASI at 12 weeks, with additional endpoints including EASI-75, EASI-90, IGA, and PP-NRS. Management said it expects data from this study in mid-2027 and noted the trial is blinded, limiting interim visibility into results. In oncology, Miller said Corvus continues to enroll patients in its phase 3 registration trial in PTCL, with an interim analysis expected later this year. He also noted a recent independent data safety monitoring board meeting with no safety signals observed. Discussing the trial design during Q&A, Miller said patients are randomized to soquelitinib 200 mg BID monotherapy versus investigator’s choice of belinostat or pralatrexate, and that the study is not blinded given differences in administration and typical toxicities between treatments. Miller also referenced final data presented at the American Society of Hematology (ASH) meeting from the phase 1/1b trial in T-cell lymphoma, stating that in the 200 mg BID cohort, median progression-free survival was 6.2 months and median overall survival was 28 months. Beyond these programs, Miller said the company plans to initiate phase 2 trials in hidradenitis suppurativa and asthma later in the year. For hidradenitis suppurativa, he outlined a preliminary design of about 60 patients across 200 mg BID, 400 mg QD, and placebo arms over 12 weeks, with safety and efficacy endpoints including HiSCR50 and HiSCR75. For asthma, he said the study design is still being finalized and is expected to involve roughly 150 patients treated for three months, with dosing guided by experience in atopic dermatitis and PTCL. Corvus Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation immuno-oncology therapies. The company's research efforts are centered on harnessing both the innate and adaptive immune systems to counteract tumor-driven immunosuppression. By targeting key pathways that regulate immune cell function, Corvus aims to create novel agents that can be combined with existing cancer treatments to improve patient outcomes. Corvus's lead pipeline candidates include small-molecule and antibody therapies designed to inhibit the adenosine pathway, a known mediator of tumor immune escape. The article "Corvus Pharmaceuticals Q4 Earnings Call Highlights" was originally published by MarketBeat.

