Corvus (CRVS) Q2 FY26 earnings call: guidance and Q&A

Has the company discussed drug-free remissions with the FDA for label claims, and what would the study design look like?

Management stated that current trial designs are standard (socalitinib vs. placebo, measuring EZ/IGA scores). Drug-free remissions, while a unique advantage if achieved, are not part of the initial regulatory strategy for approval, which focuses on maintenance therapy. Additional trials would be needed later to confirm retreatment potential.

“Now, we think it's very important if we have sustained remissions that don't require a drug that represents a I think an amazing opportunity in unique advantage for so-called in it, but that is not part of the regulatory strategy.”

asked by Jeffrey Jones · answered by Richard Miller

Is the company exploring extended-release formulations for socalitinib, given the current top dose of 200 mg BID?

The company is working on other formulations and exploring other ITK inhibitors. They anticipate a once-a-day dosing regimen will be suitable for longer treatments, noting that a single 200 mg dose already saturates the ITK target.

“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, et cetera.”

asked by Jeffrey Jones · answered by Richard Miller

Why was the PTCL interim readout delayed by a quarter, and does the company still expect Phase 3 data by end of next year (2027) or is it now a 2028 story?

The final data for PTCL Phase 3 is still anticipated in late 2027 as originally stated. The interim futility analysis projection for Q1 2027 is based on event rates and statistical plan, which can fluctuate.

“We anticipate the final data late 27 as originally stated. Interim analysis of course is projected based on events. So it's hard to say exactly when they occur, plus 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.”

asked by Sam on for Greg Suvanave · answered by Richard Miller

Can Angel Partner data be used for FDA filings, and does the company expect incrementally better efficacy in the Chinese population for AD due to TH17 component?

Yes, Chinese safety and efficacy data can be used for FDA filings and vice versa, as part of the collaboration strategy. While theoretically, better efficacy might be expected in Chinese patients due to socalitinib's TH17 effect, it's hard to predict exact comparability across different trials and populations. The Chinese trials are conducted at high-quality centers.

“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 initially initiated this collaboration several years ago.”

asked by Eric on for Paul Choi · answered by Richard Miller

Why choose a 12-week trial for AD Phase 2 instead of 16 weeks? Also, details on trial design and baseline characteristics for HS and asthma trials.

For AD, 12 weeks was chosen because good efficacy was seen at 4 and 8 weeks, and most efficacy in other drugs plateaus by 6-8 weeks. If curves continue to improve, they might extend. For HS, it's moderate to severe disease, 25 patients, no placebo, 200mg BID for 12 weeks, with intensive biomarker monitoring. For asthma, it's moderate to severe, allowing both T2 (allergic/eosinophilic) and non-T2 types, including patients with eosinophil counts above and below 150/300, as socalitinib is expected to address both.

“We saw very good efficacy at four weeks with 200 milligrams BID. We saw very good efficacy at eight weeks with curves continuing to go down. So we'll look at the twelve week data that we get both from angel and from what we're, you know, what we're doing in our phase two, and we'll make a decision beyond that.”

asked by Chacha Yang · answered by Richard Miller

Mechanistically, why does socalitinib work for both T2 and non-T2 asthma?

Socalitinib blocks differentiation of TH2 cells (for T2 asthma) and TH17 cells (for non-T2 asthma, which drives other inflammatory cells like neutrophils). It also inhibits innate lymphoid cell type 2 (ILC2), which has high ITK expression. This broad mechanism supports activity in both types.

“Since we block the differentiation of activated Th2 and Th17 cells, we would expect to see activity in both T2 and non-T2. Now, 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 iodine. of any of any lymphocyte and we know we inhibit that very well also.”

asked by Rubin on for Lee Watzik · answered by Richard Miller

More details on the Angel Pharma Phase 2 asthma study design and the decision tree for dropping T2 or non-T2 arms.

The Angel Pharma asthma trial is planned to be identical to Corvus's own Phase 2 trial, running independently with essentially the same protocols. For the T2/non-T2 decision tree, they will assess data after a certain percentage of patients are treated. The criteria are broad because the bar for efficacy is lower in non-T2. They can drop either arm or both if a certain threshold isn't met, to avoid diluting positive effects.

“The current plan is for the ANGEL trial to basically be identical to ours. Our current plan is to run two identical phase two trials. So it'd be essentially the same protocols in both places, but run independently.”

asked by Kevin Peter · answered by Richard Miller