Earnings Call Transcript - CRVS Q2 2025

Operator, Operator

Good afternoon, everyone. Thank you for being here, and welcome to the Corvus Pharmaceuticals Second Quarter 2025 Business Update and Financial Results Conference Call. It is now my pleasure to hand the call over to Zack Kubow of Real Chemistry. Please proceed.

Zack Kubow, Corporate Communications

Thank you, operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals Second Quarter 2025 Business Update and Financial Results Conference Call. On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer; Leiv Lea, Chief Financial Officer; Jeffrey Arcara, Chief Business Officer; and Ben Jones, Senior Vice President of Regulatory and Pharmaceutical Sciences. 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' quarterly report on Form 10-Q for the quarter ended June 30, 2025, and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. With that, I'd like to turn the call over to Leiv Lea. Leiv?

Leiv Lea, CFO

Thank you, Zack. I will begin with a brief overview of our second quarter 2025 financials and then turn the call over to Richard for a business update. Research and development expenses in the second quarter of 2025 totaled $7.9 million compared to $4.1 million for the same period in 2024. The $3.8 million increase was primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel-related costs. The net loss for the second quarter of 2025 was $8 million, including a noncash loss of $400,000 related to Angel Pharmaceuticals, our partner in China. In addition, we recorded a noncash gain of $2 million from the change in the fair value of Corvus' warrant liability during the second quarter of 2025. This compares to a net loss of $4.3 million for the same period in 2024, which included a $1.8 million noncash gain related to the change in fair value of Corvus' warrant liability and a $600,000 noncash loss related to Angel Pharmaceuticals. Total stock compensation expense for the second quarter 2025 was $1.3 million compared to $800,000 in the same period in 2024. As of June 30, 2025, Corvus had cash, cash equivalents, and marketable securities totaling $74.4 million as compared to $52 million at December 31, 2024. During the second quarter, all of the remaining common stock warrants were exercised, resulting in cash proceeds of approximately $35.7 million, which included $2 million from warrants exercised by our CEO, Dr. Miller. Based on our current plans, we expect our current cash to fund operations into the fourth quarter of 2026. I now turn the call over to Richard, who will discuss our clinical progress and elaborate on our strategy and plans.

Richard A. Miller, CEO

Thank you, Leiv, and good afternoon, everyone. Thank you for joining us today for our update call. Our main focus continues to be the development of soquelitinib for atopic dermatitis, where we believe we are uniquely positioned with an oral medication featuring a novel mechanism of action that so far has shown a favorable safety and efficacy profile. We are making significant progress on multiple fronts, including new data from our Phase I trial reported in June that increases our confidence in the long-term potential for soquelitinib in this indication and beyond. On today's call, I will provide a high-level recap of this data, review our go-forward clinical plans, including our planned Phase II trial design and briefly discuss our progress with our other clinical programs. We view the data through Cohort 3 of the Phase I trial as very encouraging. All of the treatment cohorts demonstrated a favorable safety and efficacy profile compared to placebo, and Cohort 3 data is especially exciting, demonstrating earlier, deeper, and more durable responses compared to Cohorts 1 and 2. Specifically, at just four weeks of treatment, Cohort 3 showed a mean percent reduction of EASI score of 64.8% compared to 54.6% for the combined Cohorts 1 and 2 and 34.4% for placebo. No placebo patients achieved the clinically meaningful endpoints of EASI-75, EASI-90, or IGA 0 or 1. We compare this to the results seen for the soquelitinib patients where many achieved these endpoints. In Cohort 3, 50% of patients achieved EASI-75, 8% achieved EASI-90, and 25% achieved IGA 0 or 1. This compares to 29%, 4%, and 21% in the combined cohorts 1 and 2 that were treated, respectively. In terms of the kinetics of response, Cohort 3 showed earlier and deeper separation from placebo beginning at day 8, with the EASI score improvement continuing through day 15 and 28 and far beyond. For Cohorts 1 and 2, the separation from placebo began at day 15 and showed continued separation at day 28. For all three cohorts, this separation was maintained during the 30-day post-treatment follow-up period. In addition, for all three cohorts, the downward slope of the curves from day 15 to day 28 suggests that longer treatment duration could potentially deepen responses further. We also have found a remarkable impact on PP-NRS, a patient self-reported assessment of itch. A number of Cohort 3 patients reported steep drops in the score beginning at day 8, which aligned with the reductions we see in serum cytokine levels of IL-31 and IL-33. Both of these cytokines are known to be involved in the itch response. In addition, other biomarker data from the trial continues to support the ITK inhibition mechanism of action, including the potential induction of anti-inflammatory T regulatory cells. Regarding safety, there were no safety issues observed with soquelitinib with no significant differences between treatment and placebo groups, and no clinically significant laboratory abnormalities were seen. The total current treatment experience with soquelitinib now involves over 150 patients with T-cell lymphoma or atopic dermatitis, representing more than 9,000 patient treatment days. In our lymphoma trial, some patients have been on continuous daily therapy for up to two years. Based on the results obtained to date, we are advancing the clinical development of soquelitinib in two ways. First, we amended the Phase I trial protocol to replace the previously planned Cohort 4 with an extension Cohort 4 that will evaluate an additional 24 patients at the Cohort 3 dose of 200 milligrams twice per day given for 8 weeks with an additional 30-day follow-up without therapy. The 24 patients will be randomized in a blinded fashion 1:1 with placebo, 12 active and 12 placebo. The extension Cohort 4 will give us data on a longer treatment duration of 8 weeks versus 4 weeks seen with Cohorts 1 and 3. We have now enrolled more than half the patients and continue to anticipate that data from the extension cohort will be available in the fourth quarter. Second, we are finalizing the design of our planned Phase II clinical trial of soquelitinib for atopic dermatitis, and I am happy to share those plans with you now. The trial will be an international randomized, placebo-controlled, and double-blinded. The company will also be blinded. It will enroll approximately 200 patients with moderate to severe atopic dermatitis who have failed at least one prior topical or systemic therapy. Patients will be required to have a baseline EASI score that is greater than or equal to 16, IGA of 3 or 4, and body surface involvement that is greater than or equal to 10%. The patients will be randomized equally into four cohorts, 50 patients in each cohort receiving either 200 milligrams soquelitinib once per day, 200 milligrams twice per day, 400 milligrams once per day, or placebo. Let me repeat those groups: 200 milligrams once per day, 200 milligrams twice per day, 400 milligrams once per day, or placebo. The treatment period will be 12 weeks, and patients will be followed for an additional 30 days without therapy. The primary endpoint will be the percent change in EASI score from baseline to week 12. Secondary endpoints will include the percent of patients achieving EASI-75 or IGA 0 or 1 at week 12. The impact on itch will be measured by the percent of patients achieving greater than or equal to 4-point decrease in the PP-NRS scale at week 12 and, of course, safety as well. We anticipate including 30 to 40 clinical trial sites globally. We are currently finalizing the trial design with the investigators with strong interest from many leading centers, and we are on track to initiate the trial before the end of the year. Outside of our clinical trials, our partner in China, Angel Pharmaceuticals, plans to initiate a Phase Ib/II trial of soquelitinib for atopic dermatitis in China. This study will enroll 48 patients and is anticipated to build on the data from our Phase I trial by studying a longer treatment period of 12 weeks and an additional dosing option of 400 milligrams once daily, in line with the direction we are headed with our Phase II trial. Briefly about our other clinical programs, we have submitted an abstract to present the final results from our Phase I clinical trial of soquelitinib for the treatment of relapsed/refractory T-cell lymphomas at the American Society of Hematology meeting in December. We continue to enroll patients in our registrational Phase III trial of soquelitinib in patients with relapsed PTCL, driving towards interim data in late 2026. In addition, patient enrollment is ongoing in our Phase II trial of soquelitinib in patients with ALPS, autoimmune lymphoproliferative syndrome. Depending on enrollment trends, it is possible we could see initial data from the Phase II ALPS study in late 2025 or early 2026. We have completed enrollment in our Phase II trial with ciforadenant in renal cell cancer. These data will be presented in an oral presentation in October at the ESMO meeting, European Society for Medical Oncology. In closing, the soquelitinib results in atopic dermatitis and T-cell lymphoma underscore the importance of ITK as a critical target for a range of diseases involving inflammation and cancer and the broad potential for soquelitinib in many areas of medicine, such as dermatology, oncology, rheumatology, pulmonary medicine, and other areas. We feel we may be entering a new era of immunotherapy for autoimmune inflammatory diseases that is based on drugs with novel mechanisms of action that modulate or rebalance immunity by keeping pro-inflammatory or aberrant T cells in check. This potential has motivated us to complement the development of soquelitinib with the discovery and development of next-generation ITK inhibitors with unique properties. In the near term, we look forward to continuing the clinical development of soquelitinib in atopic dermatitis and PTCL, and we look forward to providing updates on our programs in the coming quarters. I will now turn the call over to the operator for a questions-and-answer period.

Operator, Operator

Your first question comes from Jeff Jones.

Jeffrey Michael Jones, Analyst

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

Richard A. Miller, CEO

Okay, so let me first clarify. Yes, Cifo is for renal cell cancer. However, we are actively pursuing soquelitinib for atopic dermatitis and have already started considering follow-up indications. We are focusing on two possibilities. First, we want to maintain our presence in dermatology, where we have gained experience and valuable information, and we believe the drug behaves well for cutaneous diseases. A likely target could be hidradenitis suppurativa, as there is a significant unmet need there. The second indication, moving away from dermatology, would be in the inflammation area, specifically pulmonary disease. Asthma may be the most scientifically justified focus. We have observed excellent activity of the drug in multiple animal models for both acute and chronic asthma. The mechanism of action, particularly the inhibition of innate lymphoid cells, suggests we may have a novel approach to asthma and possibly other pulmonary diseases. It is challenging for us to pursue all these indications, but we have demonstrated our ability to efficiently maximize the value of each product.

Jeffrey Michael Jones, Analyst

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

Leiv Lea, CFO

Okay. So just to remind everyone, ciforadenant is an A2A antagonist, the oral medication. We did a Phase II study in first-line renal cell cancer patients who are receiving ipi + nivo. So we added the A2A antagonist. And the idea there, of course, is to look at the response rate, but also very importantly, to look at, since they stay on the A2A antagonist every day for a long time, they get the ipi + nivo for a short time. I think one of the things that we'll be looking for in addition to, of course, objective responses is the durability of responses and PFS in other words. So let's see what that data is. This is a study that was conducted by the Kidney Cancer Consortium, several centers, MD Anderson, Vanderbilt, and several others. They ran that study. We, of course, provided the drug and some financial support. So let's see what's presented in an oral presentation at ESMO, and then we'll go from there. Based on the data that comes out of that, we'll make our decisions about how to follow up on that.

Richard A. Miller, CEO

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

Jeffrey Michael Jones, Analyst

It does.

Operator, Operator

The next question comes from Graig Suvannavejh.

Unidentified Analyst, Analyst

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

Richard A. Miller, CEO

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

Operator, Operator

Your next call comes from Aydin Huseynov.

Aydin Huseynov, Analyst

Congratulations on the quarter. I have a couple of questions. Could you explain the decision-making process regarding the Phase II trial design for atopic dermatitis? I appreciate the details about the four different cohorts: 200 Q.D., 200 B.I.D., 400 Q.D., and placebo. So far, it seems like Cohort 3 is the most productive for atopic dermatitis. I’m curious if the decision to use a weaker or stronger dose was influenced by FDA suggestions. Could you walk us through that process?

Richard A. Miller, CEO

Thank you for your question. Firstly, there are many precedents for Phase II trials in atopic dermatitis, and we're not the first company to conduct one. A 200-patient trial with about 50 participants per group is quite standard. You're correct, Aydin, that the FDA typically wants to see varying doses studied to identify the lowest effective dose and how it compares to higher doses that may not yield increased effectiveness. We chose these doses because we believe that the 200 mg once a day will be effective. We've already tested it, and the data from Cohort 2 supports its efficacy. This is a single daily dose, and some patients do prefer this method for atopic dermatitis. However, we observed a better response with the 200 mg twice a day, which is what we are investigating in our current extension study. Therefore, we have the second cohort of 200 mg once a day and 200 mg twice a day, along with an additional plan to evaluate 400 mg once a day, which totals the same dose as the 200 mg twice a day but administered once daily. We believe that once-a-day dosing is feasible. This will help us confirm that. It’s essential to include placebos in Phase I and Phase II trials, and I've noticed some companies conducting studies without placebos, which is quite surprising. Our trial design includes 50 patients in each group, totaling 200, and it will be placebo-controlled and completely blinded, even for the company. The endpoints are fairly straightforward: the mean percent change in the EASI score is the typical primary endpoint for a Phase II study, while secondary endpoints include EASI-75 and IGA scores of 0 and 1, which are also standard metrics. We are moving towards a 12-week treatment duration, having already gathered data from 8 weeks of therapy, which we expect will yield satisfactory results. Statistically, if we observe at least a 20% improvement in any of the groups, we could compare any group's performance against the placebo. We expect to achieve better results than that, but even if we only achieve the lower end of our expectations, we can demonstrate significance with an 80% chance at a p-value of 0.05. The sizes and doses in this trial adhere to statistical norms based on our knowledge and experience with occupancy and receptor interactions. We are confident this trial will be manageable for us, given our experience with international Phase IIs—200 patients is quite feasible for Corvus. I hope this clarifies things.

Aydin Huseynov, Analyst

Absolutely. Yes, it does. I have a couple of follow-up questions about this trial. I know it might be a bit early, but could you provide a timeline for when we might see the results? I understand this is a randomized blinded trial, but any hints about when it could be ready would be appreciated.

Richard A. Miller, CEO

We've been considering the timeline for enrollment, which is expected to take about 12 to 15 months, with potential results coming in 18 months. We plan to start the trial in December. There are several factors that should facilitate enrollment. First, the oral administration of the treatment should help attract participants. Additionally, the novel mechanism of action is likely to aid in enrollment as well. We aren't requiring biopsies, although we will have some centers encouraging them, which may also enhance participation. The most significant factor is that we are allowing patients who have previously failed systemic therapies to join the trial. This expands our potential patient pool significantly. Many studies exclude individuals who have failed treatments like JAK inhibitors or dupilumab, but we are open to including those patients, as our treatment mechanism is entirely different from theirs. Moreover, we have previously included such patients in our studies and they have performed just as well.

Aydin Huseynov, Analyst

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

Richard A. Miller, CEO

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

Aydin Huseynov, Analyst

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

Richard A. Miller, CEO

Okay. So first of all, for certain intellectual property reasons, I'd rather not go into the details of how they're different because there are a lot of people who are now working on ITK inhibitors. And I'd rather not go into the specifics. But suffice it to say, let me answer your question this way. ITK plays many roles in a cell, T cell receptor signaling, everything from T cell receptor signaling to control of Th2 cytokine production to apoptosis. And we think we have compounds that might work better for some of those indications than others or some of those mechanisms. So let me answer it that way.

Operator, Operator

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

Richard A. Miller, CEO

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

Operator, Operator

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