Corvus Pharmaceuticals' Q3 2025: Contradictions Emerge on Indication Expansion, Soquelitinib Timing, and Dosing Strategies

Guidance:

• Cash, cash equivalents and marketable securities of $65.7M as of Sep 30, 2025; cash expected to fund operations into Q4 2026.
• Extension Cohort 4 (24 patients, 8‑week dosing) 8‑week data to be reported in January 2026.
• Phase II atopic dermatitis trial initiation expected early Q1 2026 (~200 pts, 4 arms, 12‑week treatment).
• ASH oral presentation in December on Phase I/Ib PTCL data (PFS/OS, durability).
• Phase III PTCL registrational trial: futility interim late 2026; full data by end‑2027.
• Plan to expand into other immune indications (e.g., asthma, additional dermatology) and evaluate partnerships/funding.

Business Commentary:

* Financial Performance: - Corvus Pharmaceuticals reported a net loss of $10.2 million for Q3 2025, compared to a net loss of $40.2 million in the same period in 2024. - This improvement was primarily due to a reduction in noncash losses related to warrant liabilities and a decrease in research and development expenses from $8.5 million to $5.2 million.

• Research and Development Expenses:
• Research and development expenses increased from $5.2 million in Q3 2024 to $8.5 million in Q3 2025.

• The increase was largely driven by higher clinical trial and manufacturing costs for soquelitinib and an increase in personnel-related costs.

• Clinical Program Progress:

• Corvus completed enrollment in Cohort 4 of the Phase I trial for soquelitinib in atopic dermatitis, with full data expected to be reported in January 2026.

• The Cohort 4 trial aims to confirm the results of earlier cohorts and evaluate if a longer treatment duration of 8 weeks leads to better efficacy compared to the previous 28-day treatment period.

• Phase II Trial Initiation:

• Corvus plans to initiate a Phase II clinical trial for atopic dermatitis in early Q1 2026, which will enroll approximately 200 patients.
• The trial is designed to include patients who have failed previous systemic therapies, potentially expanding the potential use of soquelitinib in a relapsed setting.

  Sentiment Analysis:

  Overall Tone: Positive

  • Management repeatedly expressed optimism: “we remain very optimistic about the potential of soquelitinib,” cited “significant signals of activity,” emphasized “building significant momentum” across ASH, Cohort 4, Phase II AD initiation and ongoing Phase III PTCL enrollment, and highlighted plans to expand indications and pursue partnerships.

Q&A:

• Question from Graig Suvannavejh (Mizuho Securities USA LLC): I'm wondering, we saw very impressive OS data, and with that in mind, with other information that was in that abstract, could you perhaps put in context the comparability that obviously leads to your enthusiasm for the prospects of soquelitinib in peripheral T cell lymphoma?
  Response: ASH Phase I PFS/OS are markedly better than historical relapsed PTCL medians (~6 months); the data plus mechanistic insights (GATA3/Th2 biology) support activity in PTCL and provide rationale for immune‑disease programs.

• Question from Graig Suvannavejh (Mizuho Securities USA LLC): As you have expanded the treatment duration and as you've expanded the number of patients, is it fair for us to assume that what you saw previously will have an improvement on the efficacy that you saw? And if you don't see an improvement versus what you saw previously, does that change in any way your enthusiasm for the prospects of soquelitinib in atopic dermatitis?
  Response: Extension Cohort 4 aims to (1) confirm Cohort 3 results in a larger, randomized set and (2) test whether 8 weeks deepens responses versus 28 days; lack of further improvement would be informative but primary aims remain consistency and safety confirmation.

• Question from Jeffrey Jones (Oppenheimer & Co. Inc.): What are your plans to take soquelitinib forward in other indications at this point, sort of indications and timing?
  Response: Priorities are PTCL Phase III and AD Phase II now; preclinical data support expansion into asthma and another dermatologic indication, with more detail to be provided early next year.

• Question from Jeffrey Jones (Oppenheimer & Co. Inc.): The Kidney Cancer Research Consortium reported an update on the cifo trial at ESMO. Just curious as to the next steps there. The trial is still ongoing, there are still patients on follow‑up. How are you thinking about ciforadenant in the context of renal cell and beyond?
  Response: The cifo trial is run/paid largely by the Kidney Cancer Consortium; ~19 of 50 patients remain on treatment/follow‑up and Corvus will continue to monitor results before determining next steps.

• Question from Li Wang Watsek (Cantor Fitzgerald & Co.): First, maybe just in terms of baseline characteristics of the Cohort 4 versus prior 3 cohorts. Is it reasonable for us to assume they're pretty similar to Cohort 3? Or is there any difference that we should keep in mind?
  Response: Cohort 4 demographics and eligibility are essentially the same as Cohort 3 — same 17 U.S. centers and unchanged inclusion criteria.

• Question from Li Wang Watsek (Cantor Fitzgerald & Co.): For the Phase II trial, just given the patient population that you'll be enrolling, it sounds like the patients can be exposed to JAK inhibitors and Dupi. So just given this demographic, what should be the bar for the EASI score?
  Response: Too early to set a definitive efficacy 'bar'; Phase II deliberately allows prior Dupixent/JAK failures to assess activity in that subgroup and the team will evaluate after Phase I data.

• Question from Aydin Huseynov (Ladenburg Thalmann & Co. Inc.): Curious to hear any thoughts on potential other dermatologic indications such as hidradenitis suppurativa, vitiligo, psoriasis or anything else. And can you run several trials simultaneously?
  Response: Preclinical and translational data prioritize asthma and HS; other targets (prurigo nodularis, alopecia areata) are under consideration — the company intends to run multiple immune‑disease trials but will likely need additional capital to scale.

• Question from Aydin Huseynov (Ladenburg Thalmann & Co. Inc.): I just wanted to better understand the timelines, the potential readout, and hopefully, the potential launch of the drug for PTCL and AD.
  Response: PTCL registrational trial has a futility interim late‑2026 and full data by end‑2027; because it’s a single randomized registration trial with short endpoints, approval and rapid clinical uptake are feasible if endpoints are met.

• Question from Jordan Becker (Barclays Bank PLC): Do you plan to do any post hoc analysis following the Cohort 4 completion to look at efficacy in Dupi and JAK‑naive and refractory populations? And then two, can we expect a similar analysis in terms of biomarker correlates of clinical efficacy with the updated data?
  Response: Yes — post‑hoc subgroup analyses (prior therapy effects) and biomarker studies will be performed; extensive blood single‑cell RNA‑seq is planned while biopsies are minimized, and findings will be exploratory due to small N.

• Question from Xun Lee (H.C. Wainwright & Co, LLC): What's the reasoning behind settling on a 12‑week duration treatment rather than the 8 weeks that you're testing in Cohort 4? And are there any notable differences between the enrollment criteria of the Phase II compared to the patients that you're enrolling in Phase I?
  Response: Eligibility is largely identical; 12 weeks chosen because most efficacy separation in AD studies occurs by 12 weeks, so Phase II uses 12‑week primary evaluation to balance speed and efficacy.

• Question from Cha Cha Yang (Jefferies LLC): Can you give color on any plans for potential partnerships or licensing deals for soquelitinib, or if you plan to raise money and take this forward yourselves in either AD and oncology?
  Response: Management is in discussions with major companies and will evaluate partnering opportunities, but is currently advancing programs internally and expects to raise additional capital or pursue deals as needed.

• Question from Graig Suvannavejh (Mizuho Securities USA LLC): As you think about your ITK portfolio and comments around potentially advancing next‑generation ITK, could you share the vision or strategy around adding another indication for soquelitinib versus moving forward with a next‑generation ITK inhibitor?
  Response: Priority is advancing soquelitinib because existing human safety/efficacy data enable faster progress; next‑gen/backups require IND‑enabling work and more time, though they and degraders/formulations are being explored.

• Question from Jeffrey Jones (Oppenheimer & Co. Inc.): Would you be powering the Phase II study to do a subgroup analysis that could be statistically significant to separate systemically exposed patients versus systemic therapy naive patients?
  Response: They will stratify randomization by prior systemic therapy but will not power the Phase II to detect statistically significant subgroup differences at this stage; powering would be premature without clearer signals.

Contradiction Point 1

Expansion of Indications and Strategic Focus

It involves the company's strategic direction regarding the expansion of indications for their drug candidates, which could impact research and development priorities, timing, and resource allocation.

Are there plans to expand into other dermatologic indications beyond atopic dermatitis, and can multiple trials be conducted concurrently? - Aydin Huseynov (Ladenburg Thalmann & Co. Inc.)

2025Q3: We are considering diseases like hidradenitis suppurativa and prurigo nodularis. Preclinical data suggests a potential for various dermatologic and immune-related indications. We intend to pursue multiple immune diseases and expand trials beyond atopic dermatitis, pending funding that we anticipate will be available based on the upcoming data. - Richard Miller(CEO)

How are you planning to advance Cifo's Phase II autoimmune disease trials and financially support its future indications? - Jeffrey Michael Jones (Oppenheimer & Co. Inc., Research Division)

2025Q2: We're thinking about expanding indications in dermatology and inflammation areas. Likely targets include hidradenitis suppurativa and pulmonary diseases, such as asthma. Our focus on maximizing the value of each product aligns with our prudent financial management. - Richard A. Miller(CEO)

Contradiction Point 2

Timing of Interim Data for Soquelitinib in PTCL

It involves the company's timeline for reporting interim data on the soquelitinib trial in Peripheral T-Cell Lymphoma (PTCL), which could impact investor expectations and clinical development milestones.

How comparable is the data from the ASH presentation, and what are its implications for peripheral T cell lymphoma and immune-inflammatory diseases? - Graig Suvannavejh (Mizuho Securities USA LLC)

2025Q3: We are on track for interim data in late 2026. - Richard Miller(CEO)

What is the status of patient enrollment for soquelitinib in PTCL, and is the current guidance for data availability in late 2026 still valid? - Unidentified Analyst (Ladenburg Thalmann & Co. Inc., Research Division)

2025Q2: Enrollment is proceeding as planned with about 20 centers open in the U.S. and Canada. We are on track for interim data in late 2026. - Richard A. Miller(CEO)

Contradiction Point 3

Dose Optimization for Soquelitinib

It involves the optimal dosing strategy for soquelitinib, which could impact the drug's efficacy and patient outcomes.

Is the Phase 2 trial considering a QD dose? What is the rationale for the dosing strategy? - Roger Song (Jefferies)

2025Q3: Currently, 200 BID seems to be the optimal dose. Final Phase 2 trial design is not yet confirmed. - Richard Miller(CEO)

Is the Phase 2 trial considering a QD dose? What is the rationale for the dosing strategy? - Roger Song (Jefferies)

2025Q1: The Phase 2 trial will have at least two active doses, including 200 BID, with additional doses like 200 QD or 400 QD being considered. The rationale is to confirm efficacy and choose the optimal dose. - Richard Miller(CEO)

Contradiction Point 4

Expansion of Soquelitinib Indications

It involves the timeline and prioritization for expanding the indications of soquelitinib, which could impact research and development focus as well as market opportunities.

What are your plans to advance soquelitinib in other I&I indications beyond atopic dermatitis and PTCL? - Jeffrey Jones (Oppenheimer & Co. Inc.)

2025Q3: We see potential in conditions like asthma and another dermatologic condition, yet to be defined. We're making definite plans to explore these areas early next year, based on preclinical models and the drug's mechanism of action. - Richard Miller(CEO)

Does the company plan to explore other dermatologic indications beyond atopic dermatitis and run multiple trials simultaneously? - Aydin Huseynov (Ladenburg Thalmann & Co. Inc.)

2025Q1: We are considering diseases like hidradenitis suppurativa and prurigo nodularis. Preclinical data suggests a potential for various dermatologic and immune-related indications. We intend to pursue multiple immune diseases and expand trials beyond atopic dermatitis, pending funding that we anticipate will be available based on the upcoming data. - Richard Miller(CEO)

Contradiction Point 5

Dose Selection for Soquelitinib

It involves the decision on the optimal dose for soquelitinib in different indications, which can impact the drug's efficacy and safety profile.

What are your plans to advance soquelitinib in other I&I indications beyond atopic dermatitis and PTCL? - Jeffrey Jones (Oppenheimer & Co. Inc.)

2025Q3: We are making definite plans to explore these areas early next year, based on preclinical models and the drug's mechanism of action. - Richard Miller(CEO)

What are the plans for Cohort 4, and why was 400mg chosen instead of the 200mg optimal dose from the oncology trial? - Aydin Huseynov (Ladenburg Thalmann & Co. Inc.)

2024Q4: Currently planning Cohort 4 at 400 milligrams, but will decide based on Cohort 3 data. - Richard Miller(CEO)