Corvus Pharmaceuticals, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001104659-26-091975
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001104659-26-123317
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 121 previous paragraphs and 126 current paragraphs.
75 unchanged; 39 reworded; 9 added; 1 removed; 6 previous and 3 current paragraphs rearranged.
Tables are not compared: 40 previous and 41 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
up to 600 mg twice-daily, including no myelosuppression or immunosuppression;
Current report
Soquelitinib for treatment of hidradenitis suppurativa.
Current report
In September 2026, we initiated a Phase 1b clinical trial with soquelitinib in patients with moderate to severe hidradenitis suppurativa. The trial is designed to enroll up to 25 patients 18 years and older who will receive a soquelitinib dose of 200 mg twice per day for 12 weeks, followed by a 90-day follow-up period with no treatment. The primary endpoint of the trial is safety and tolerability. The key efficacy endpoint is the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50/75 at week 12, and the trial will also evaluate skin and blood biomarkers. Initial results from this trial are expected in the first half of 2027.
Current report
Soquelitinib for treatment of autoimmune lymphoproliferative syndrome.
Current report
In March 2025, under a Cooperative Research and Development Agreement, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, initiated a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease. The trial is designed to enroll up to 30 patients aged 16 or older with confirmed mutations of ALPS-FAS based on genetic testing. Two dosing cohorts will be studied. The patients will receive soquelitinib doses of 200 mg or 400 mg twice per day for a period of up to 360 days. The primary endpoint of the trial is efficacy determined by reductions in splenomegaly and lymph node volumes as measured by computed tomography (CT) or positron emission tomography/computed tomography (PET/CT). Improvements in cytopenias will be assessed by complete blood count. Secondary endpoints include safety and tolerability.
Current report
In November 2026, initial data from the Phase 2 ALPS trial was published in an abstract for the 68th American
Current report
Society of Hematology (ASH) Annual Meeting & Exposition. The data as of August 30, 2026 showed positive one-year safety and efficacy data from three patients enrolled in the trial, including a safety profile consistent with results from our soquelitinib T cell lymphoma and atopic dermatitis clinical trials. These patients completed one year of treatment with a 200 mg twice per day dose of soquelitinib. The treatment was well tolerated, with no grade 3 or 4 adverse events and no interruptions in therapy. All three patients were able to discontinue background medications including steroids and reported improvement in ALPS related systemic symptoms.
Current report
We believe the data supports continued enrollment in the trial and based on the results to-date, we plan to explore longer treatment durations and enroll younger pediatric patients. We are in the process of transferring the investigational new drug (IND) application supporting the Phase 2 trial from the NIAID to Corvus. Upon competition of the transfer, we intend to work with the U.S. Food and Drug Administration (FDA) to expand the trial to additional sites and to include patients ages 12 to 15.
Current report
For the nine months ended September 30, 2026, the increases in other programs of costs of $0.3 million as compared to the nine months ended September 30, 2025, primarily consisted of an increase in outside service costs.
Removed paragraphs (1)
Previous report
In this patient population:
Reworded paragraphs (39)
Previous wording
Since the immune cells targeted by our product candidates play a role in many diseases, our strategy is to leverage our research and development capabilities by evaluating our product candidates in clinical trials where there is an understanding of the role of specific T cells in the target indication and where we believe such product candidates have the broadest potential. We believe this strategy has enabled us to move rapidly from preclinical to clinical trials in diverse disease areas, each with large unmet needs. We are enrolling patients in a potentially registrational Phase 3 clinical trial of soquelitinib for relapsed peripheral T cell lymphomas. Soquelitinib is also being evaluated in a randomized, placebo-controlled Phase 2 trial in patients with atopic dermatitis. We have two additional product candidates which are in clinical development for the treatment of various solid tumors, also based on modulation of immune function.
Current wording
Since the immune cells targeted by our product candidates play a role in many diseases, our strategy is to leverage our research and development capabilities by evaluating our product candidates in clinical trials where there is an understanding of the role of specific T cells in the target indication and where we believe such product candidates have the broadest potential. We believe this strategy has enabled us to move rapidly from preclinical to clinical trials in diverse disease areas, each with large unmet needs. We are enrolling patients in a potentially registrational Phase 3 clinical trial of soquelitinib for relapsed peripheral T cell lymphomas. Soquelitinib is also being evaluated in a randomized, placebo-controlled Phase 2 trial in patients with atopic dermatitis and a Phase 1b trial in patients with hidradenitis suppurativa.
Previous wording
In ITK genetic knockout mice, which completely lack expression of ITK, T cells exhibit defects in T helper cell differentiation and cytokine secretion but retain the ability to differentiate into cytotoxic T cells that secrete IL-2 and interferon gamma (“IFNg”), which are the cells responsible for tumor rejection. We believe that skewing T helper cell differentiation to favor cytotoxic T cells, known as Th1 skewing, may be beneficial in treating T cell lymphomas and many other types of cancer. Mice with genetic knock-out of ITK also demonstrate a reduction in Th2 and Th17 cells, which produce the cytokines that are often responsible for autoimmunity and allergy such as interleukin (Il) Il-4, Il-5, Il-13, Il-17 and many others.
Current wording
In ITK genetic knockout mice, which completely lack expression of ITK, T cells exhibit defects in T helper cell differentiation and cytokine secretion but retain the ability to differentiate into cytotoxic T cells that secrete IL-2 and interferon gamma (“IFNg”), which are the cells responsible for tumor rejection. We believe that skewing T helper cell differentiation to favor cytotoxic T cells, known as Th1 skewing, may be beneficial in treating T cell lymphomas and many other types of cancer. Mice with genetic knock-out of ITK also demonstrate a reduction in Th2 and Th17 cells, which produce the cytokines that are often responsible for autoimmunity and allergy such as interleukin (Il) Il-4, Il-5, Il-13, Il-17 and many others. Recent research by others has shown that ITK also regulates a switch between proinflammatory Th17 cells and suppressive T regulatory cells. Blockade of ITK with soquelitinib has been observed to result in the generation of T regulatory cells that suppress inflammatory responses, which may be important in the treatment of autoimmune and inflammatory diseases.
Previous wording
We have designed and developed soquelitinib to covalently target the cysteine amino acid residue at position 442 in the ITK protein. We believe this irreversible targeting of ITK has the potential to provide a potent, selective and prolonged duration of activity without the need for high systemic exposures and thereby improve the therapeutic window. This approach was previously used by our cofounders to generate ibrutinib. Selective inhibition of ITK can block the production and function of Th2 and Th17 helper T cells, potentially leading to a biasing toward the differentiation of naïve T cells into Th1 helper T cells. Th1 cells lead to the generation of killer T cells that can eliminate tumor cells or viral infected cells. Th1 cells produce interferon gamma and tumor necrosis factor that are cytokines known to destroy cancer cells. We believe, based on our preclinical and Phase 1/1b data from our T cell lymphoma
Current wording
prolonged duration of activity without the need for high systemic exposures and thereby improve the therapeutic window. This approach was previously used by our cofounders to generate ibrutinib. Selective inhibition of ITK can block the production and function of Th2 and Th17 helper T cells, potentially leading to a biasing toward the differentiation of naïve T cells into Th1 helper T cells. Th1 cells lead to the generation of killer T cells that can eliminate tumor cells or viral infected cells. Th1 cells produce interferon gamma and tumor necrosis factor that are cytokines known to destroy cancer cells. We believe, based on our preclinical and Phase 1/1b data from our T cell lymphoma clinical trial, that soquelitinib has the potential to rebalance normal immune responses that also could be beneficial for the treatment of certain autoimmune, inflammatory and allergic diseases. Overactive Th2 and Th17 cells are known to play a role in autoimmune, inflammatory and allergic diseases, which can potentially be ameliorated by selective ITK inhibition by blocking Th2 and Th17 function and their production of inflammatory cytokines such as IL4, IL5, IL13, IL17 and others.
Previous wording
Final data from the Phase 1/1b clinical trial were presented at the American Society of Hematology Annual Meeting (“ASH”) in December 2025. Key highlights from the data supporting the ongoing registration Phase 3 trial in relapsed/refractory PTCL include:
Current wording
Final data from the Phase 1/1b clinical trial were presented at the American Society of Hematology Annual Meeting (“ASH”) in December 2025 and published online inBlood, the journal of the American Society of Hematology, in August 2026. Key highlights from the data supporting the ongoing registration Phase 3 trial in relapsed/refractory PTCL include:
Previous wording
In November 2023, we announced the posting of preclinical data on soquelitinib in bioRxiv that demonstrated that ITK’s selective inhibition produced therapeutic benefits in several autoimmune and allergy preclinical models, including psoriasis, asthma, pulmonary fibrosis, scleroderma and graft versus host disease. The mechanism of action involves the inhibition of Th2 and Th17 cells and their subsequent production of cytokines such as IL-4, IL-5, IL-17 and other cytokines involved in these diseases. The novel mechanism is a result of ITK inhibition and blockade of formation of Th2 and Th17 cells.
Current wording
In November 2023, we announced the posting of preclinical data on soquelitinib in bioRxiv that demonstrated that ITK’s selective inhibition produced therapeutic benefits in several autoimmune and allergy preclinical models, including psoriasis, asthma, pulmonary fibrosis, scleroderma and graft versus host disease. The mechanism of action involves the inhibition of Th2 and Th17 cells and their subsequent production of cytokines such as IL-4, IL-5, IL-17 and
Previous wording
mg oral twice per day, 200 mg oral once per day, 200 mg oral twice per day and 400 mg oral once per day. Patients would be treated for 28 days and are then followed for an additional 30 days with no therapy. The primary endpoints included safety and tolerability, and efficacy, measured by improvement in Eczema Area and Severity Index (“EASI”) score, Investigator Global Assessment (“IGA”), reduction in itch and various cytokine biomarkers. EASI scores are also evaluated by the percent of patients that achieve a specified percent reduction in EASI score – EASI 50 for patients that achieved a 50% reduction; EASI 75 for a 75% reduction; and EASI 90 for a 90% reduction.
Current wording
In April 2024, we initiated a randomized, double-blind, placebo-controlled Phase 1 clinical trial with soquelitinib in patients with moderate to severe atopic dermatitis that previously failed one prior topical or systemic therapy. The clinical trial was planned to enroll 64 patients into one of four dosing cohorts in a 3:1 ratio (12 active and 4 placebo) to receive either soquelitinib or placebo. The cohorts were designed to sequentially enroll and to examine 100 mg oral twice per day, 200 mg oral once per day, 200 mg oral twice per day and 400 mg oral once per day. Patients would be treated for 28 days and are then followed for an additional 30 days with no therapy. The primary endpoints included safety and tolerability, and efficacy, measured by improvement in Eczema Area and Severity Index (“EASI”) score, Investigator Global Assessment (“IGA”), reduction in itch and various cytokine biomarkers. EASI scores are also evaluated by the percent of patients that achieve a specified percent reduction in EASI score – EASI 50 for patients that achieved a 50% reduction; EASI 75 for a 75% reduction; and EASI 90 for a 90% reduction.
Previous wording
Angel Pharmaceuticals, our 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 in our Phase 1 clinical trial. 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 being conducted in close collaboration with Corvus. Results from the cohort 1 (100mg twice per day, 200 mg once per day and placebo) are anticipated late this year.
Current wording
Angel Pharmaceuticals, our 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 in our Phase 1 clinical trial. 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 being conducted in close collaboration with Corvus. Enrollment has been completed in cohort 1 (100mg twice per day, 200 mg once per day and placebo) and results are anticipated in the first quarter 2027.
Previous wording
Based on results from our on-going and completed studies, we are planning to conduct additional clinical trials to evaluate soquelitinib for the treatment of other immune diseases, including a Phase 1b clinical trial in hidradenitis suppurativa and a Phase 2 clinical trial in asthma. Start-up activities for these clinical trials have begun and we anticipate both will be initiated later this year.
Current wording
Based on results from our on-going and completed studies, we are planning to conduct additional clinical trials to evaluate soquelitinib for the treatment of other immune diseases, including a Phase 2 clinical trial in asthma. Start-up activities for this clinical trial has begun and we anticipate it will be initiated in the first quarter of 2027.
Previous wording
Mupadolimab, B Cell Activating Anti-CD73 Antibody. Our third product candidate is mupadolimab, a humanized monoclonal antibody that is designed to react with a specific site on CD73. In both preclinical and in vivo studies, mupadolimab has demonstrated binding to various immune cells and the enhancement of immune responses by activating B cells. While we believe mupadolimab has the potential to be an important new therapeutic agent with a novel proposed mechanism of action to support its development for the treatment of a broad range of cancers and
Current wording
Mupadolimab, B Cell Activating Anti-CD73 Antibody. Our third product candidate is mupadolimab, a humanized monoclonal antibody that is designed to react with a specific site on CD73. In both preclinical and in vivo studies, mupadolimab has demonstrated binding to various immune cells and the enhancement of immune responses by activating B cells. While we believe mupadolimab has the potential to be an important new therapeutic agent with a novel proposed mechanism of action to support its development for the treatment of a broad range of cancers and infectious diseases, we are waiting to initiate a potential Phase 2 randomized clinical trial in order to prioritize the development of our lead product candidate.
Previous wording
To date, the majority of our efforts have been focused on the research, development and advancement of soquelitinib, ciforadenant, and mupadolimab, and we have not generated any revenue from product sales and, as a result, we have incurred significant losses. We expect to continue to incur significant research and development and general and administrative expenses related to our operations. Our net loss for the three and six months ended June 30, 2026 and 2025 was $18.0 million and $31.7 million, respectively. Our net loss for the three months ended June 30, 2025 was $8.0 million and our net income for the six months ended June 30, 2025 was $7.2 million, which includes non-operating income of $27.1 million associated with a change in fair value of warrant liability. As of June 30, 2026, we had an accumulated deficit of $443.9 million. We expect our losses will increase as we continue our development of, seek regulatory approval for and, if approved, begin to commercialize soquelitinib, ciforadenant and mupadolimab, and as we develop other product candidates. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.
Current wording
To date, the majority of our efforts have been focused on the research, development and advancement of soquelitinib, ciforadenant, and mupadolimab, and we have not generated any revenue from product sales and, as a result, we have incurred significant losses. We expect to continue to incur significant research and development and general and administrative expenses related to our operations. Our net loss for the three and nine months ended September 30, 2026 and 2025 was $20.3 million and $52.0 million, respectively. Our net loss for the three and nine months ended September 30, 2025 was $10.2 million and $3.0 million, respectively. Net loss for the nine months ended September 30, 2025 includes non-operating income of $27.1 million associated with a change in fair value of warrant liability. As of September 30, 2026, we had an accumulated deficit of $464.3 million. We expect our losses will increase as we continue our development of, seek regulatory approval for and, if approved, begin to commercialize soquelitinib, ciforadenant and mupadolimab, and as we develop other product candidates. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.
Previous wording
During the six months ended June 30, 2026, we did not sell any shares of common stock under our at-the-market offering program. As of June 30, 2026, $200.0 million remained available for sale under the Amended Sales Agreement.
Current wording
During the nine months ended September 30, 2026, we did not sell any shares of common stock under our at-the-market offering program. As of September 30, 2026, $200.0 million remained available for sale under the Amended Sales Agreement.
Previous wording
As a result of our ongoing development efforts, we anticipate needing to spend substantial resources for the foreseeable future. Consequently, we will need additional financing to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity or debt financings or other sources, which may include collaborations with third parties. Such financing could result in dilution to stockholders and may include the imposition of debt covenants and repayment obligations or other restrictions that may affect our business. If we raise additional capital through strategic collaboration agreements, we may have to relinquish valuable rights to our product candidates, including potential future revenue streams. Adequate additional financing may not be available to us on acceptable terms, or at all. For example, the trading prices for our and other biopharmaceutical companies’ stock have been highly volatile as a result of factors such as the impacts of pandemics and increases in inflation rates or interest rates or the broad imposition of tariffs and other trade controls. As a result, we may face difficulties raising capital through sales of our common stock and any such sales may be on unfavorable terms. Our inability to raise capital as and when needed would have a negative impact on
Current wording
As a result of our ongoing development efforts, we anticipate needing to spend substantial resources for the foreseeable future. Consequently, we will need additional financing to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity or debt financings or other sources, which may include collaborations with third parties. Such financing could result in dilution to stockholders and may include the imposition of debt covenants and repayment obligations or other restrictions that may affect our business. If we raise additional capital through strategic collaboration agreements, we may have to relinquish valuable rights to our product candidates, including potential future revenue streams. Adequate additional financing may not be available to us on acceptable terms, or at all. For example, the trading prices for our and other biopharmaceutical companies’ stock have been highly volatile as a result of factors such as the impacts of pandemics and increases in inflation rates or interest rates or the broad imposition of tariffs and other trade controls. As a result, we may face difficulties raising capital through sales of our common stock and any such sales may be on unfavorable terms. Our inability to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.
Previous wording
As of June 30, 2026, we had capital resources consisting of cash, cash equivalents and marketable securities of approximately $215.2 million. Based on our currently available cash resources and our currently planned level of operations and cash flows, we expect that our cash resources will be sufficient to enable us to advance our programs into the second quarter of 2028. In accordance with applicable accounting standards, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern for at least the next 12 months from the date of the issuance of the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q and concluded that our existing cash, cash equivalents and marketable securities are sufficient to fund our operations for at least the next 12 months from issuance of the condensed consolidated financial statements. However, the Company will need to continue to raise additional capital to fund its operations. See “Risk Factors—Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital.”
Current wording
As of September 30, 2026, we had capital resources consisting of cash, cash equivalents and marketable securities of approximately $202.9 million. Based on our currently available cash resources and our currently planned level of operations and cash flows, we expect that our cash resources will be sufficient to enable us to advance our programs into the second quarter of 2028. In accordance with applicable accounting standards, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern for at least the next 12 months from the date of the issuance of the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q and concluded that our existing cash, cash equivalents and marketable securities are sufficient to fund our operations for at least the next 12 months from issuance of the condensed consolidated financial statements. However, the Company will need to continue to raise additional capital to fund its operations. See “Risk Factors—Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital.”
Previous wording
Our significant accounting policies are described in Note 2 to our consolidated financial statements for the year ended December 31, 2025 included in our Annual Report on Form 10-K filed with the SEC on March 12, 2026. There have been no material changes to our significant accounting policies during the six months ended June 30, 2026 from those discussed in our Annual Report on Form 10-K.
Current wording
Our significant accounting policies are described in Note 2 to our consolidated financial statements for the year ended December 31, 2025 included in our Annual Report on Form 10-K filed with the SEC on March 12, 2026. There have been no material changes to our significant accounting policies during the nine months ended September 30, 2026 from those discussed in our Annual Report on Form 10-K.
Previous wording
Research and development expenses for the three and six months ended June 30, 2026 and 2025 consisted of the following costs by program as well as unallocated employee costs and overhead costs (specific program costs consist solely of external costs) (in thousands):
Current wording
Research and development expenses for the three and nine months ended September 30, 2026 and 2025 consisted of the following costs by program as well as unallocated employee costs and overhead costs (specific program costs consist solely of external costs) (in thousands):
Previous wording
For the three months ended June 30, 2026, the increase in soquelitinib costs of $6.3 million as compared to the three months ended June 30, 2025, primarily consisted of an increase of $3.2 million in clinical trial expenses, an increase of $2.4 million in other outside service costs and in increase of $0.7 million in drug manufacturing costs.
Current wording
For the three months ended September 30, 2026, the increase in soquelitinib costs of $6.9 million as compared to the three months ended September 30, 2025, primarily consisted of an increase of $3.8 million in clinical trial expenses, an increase of $2.8 million in other outside service costs and an increase of $0.3 million in drug manufacturing costs.
Previous wording
For the six months ended June 30, 2026, the increase in soquelitinib costs of $8.7 million as compared to the six months ended June 30, 2025, primarily consisted of an increase of $6.3 million in clinical trial expenses and an increase of $3.0 million in other outside service costs, which were partially offset by a decrease of $0.6 million in drug manufacturing costs.
Current wording
For the nine months ended September 30, 2026, the increase in soquelitinib costs of $15.6 million as compared to the nine months ended September 30, 2025, primarily consisted of an increase of $10.1 million in clinical trial expenses and an increase of $5.9 million in other outside service costs, which were partially offset by a decrease of $0.4 million in drug manufacturing costs.
Previous wording
For the three and six months ended June 30, 2026, the increases in other programs costs were negligible.
Current wording
For the three months ended September 30, 2026, the increases in other programs of costs of $0.3 million as compared to the three months ended September 30, 2025, primarily consisted of an increase in outside service costs.
Previous wording
For the six months ended June 30, 2026, the increase in unallocated costs of $3.1 million as compared to the six months ended June 30, 2025, primarily consisted of an increase of $3.2 million in personnel and related costs, which were partially offset by a decrease of $0.1 million in facilities related cost.
Current wording
For the three months ended September 30, 2026, the increase in unallocated costs of $2.1 million as compared to the three months ended September 30, 2025, primarily consisted of an increase of $1.6 million in personnel and related costs, an increase of $0.3 million in outside service costs and an increase of $0.2 million in facilities related costs.
Previous wording
For the three months ended June 30, 2026, the increase in unallocated costs of $1.9 million as compared to the three months ended June 30, 2025, primarily consisted of an increase in personnel and related costs.
Current wording
For the nine months ended September 30, 2026, the increase in unallocated costs of $5.2 million as compared to the nine months ended September 30, 2025, primarily consisted of an increase of $4.6 million in personnel and related costs and an increase of $0.6 million in outside service costs.
Previous wording
For the six months ended June 30, 2026, the increase in general and administrative expenses of $2.2 million as compared to the six months ended June 30, 2025, primarily consisted of an increase of $1.9 million in personnel and related costs and an increase of $0.3 million in outside service costs.
Current wording
For the three months ended September 30, 2026, the increase in general and administrative expenses of $1.5 million as compared to the three months ended September 30, 2025, primarily consisted of an increase of $1.1 million in personnel and related costs and an increase of $0.4 million in outside service costs.
Previous wording
For the three months ended June 30, 2026, the increase in general and administrative expenses of $0.9 million as compared to the three months ended June 30, 2025, primarily consisted of an increase in personnel and related costs.
Current wording
For the nine months ended September 30, 2026, the increase in general and administrative expenses of $3.6 million as compared to the nine months ended September 30, 2025, primarily consisted of an increase of $3.0 million in personnel and related costs and an increase of $0.6 million in outside service costs.
Previous wording
For the three months ended June 30, 2026, the increase in interest income and other expense, net of $1.4 million as compared to the three months ended June 30, 2025, primarily consisted of an increase in interest income earned due to an increase in cash equivalents and marketable securities.
Current wording
For the three months ended September 30, 2026, the increase in interest income and other expense, net of $1.2 million as compared to the three months ended September 30, 2025, primarily consisted of an increase in interest income earned due to an increase in cash equivalents and marketable securities.
Previous wording
For the six months ended June 30, 2026, the increase in interest income and other expense, net of $2.7 million as compared to the six months ended June 30, 2025, primarily consisted of an increase in interest income earned due to an increase in cash equivalents and marketable securities.
Current wording
For the nine months ended September 30, 2026, the increase in interest income and other expense, net of $3.8 million as compared to the nine months ended September 30, 2025, primarily consisted of an increase in interest income earned due to an increase in cash equivalents and marketable securities.
Previous wording
For the three and six months ended June 30, 2026, the change in fair value of warrant liability was zero as all common warrants had been exercised as of June 30, 2025.
Current wording
For the three and nine months ended September 30, 2026, the change in fair value of warrant liability was zero as all common warrants had been exercised as of June 30, 2025.
Previous wording
For the three months ended June 30, 2026, the increase in loss from equity method investment of $0.3 million as compared to the three months ended June 30, 2025, primarily consisted of an increase in Angel Pharmaceuticals’ loss for the three months ended June 30, 2026.
Current wording
For the three months ended September 30, 2026, the increase in loss from equity method investment of $0.6 million as compared to the three months ended September 30, 2025, primarily consisted of an increase in Angel Pharmaceuticals’ loss for the three months ended September 30, 2026.
Previous wording
For the six months ended June 30, 2026, the increase in loss from equity method investment of $0.4 million as compared to the six months ended June 30, 2025, primarily consisted of an increase in Angel Pharmaceuticals’ loss for the six months ended June 30, 2026.
Current wording
For the nine months ended September 30, 2026, the increase in loss from equity method investment of $0.9 million as compared to the nine months ended September 30, 2025, primarily consisted of an increase in Angel Pharmaceuticals’ loss for the nine months ended September 30, 2026.
Previous wording
As of June 30, 2026, we had cash, cash equivalents and marketable securities of $215.2 million, and an accumulated deficit of $443.9 million.
Current wording
As of September 30, 2026, we had cash, cash equivalents and marketable securities of $202.9 million, and an accumulated deficit of $464.3 million.
Previous wording
During the six months ended June 30, 2026, we did not sell any shares of common stock under our at-the-market offering program. As of June 30, 2026, $200.0 million remained available for sale under the Amended Sales Agreement.
Current wording
During the nine months ended September 30, 2026, we did not sell any shares of common stock under our at-the-market offering program. As of September 30, 2026, $200.0 million remained available for sale under the Amended Sales Agreement.
Previous wording
Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $443.9 million through June 30, 2026. We do not expect positive cash flows from operations in the foreseeable future, if ever. Historically, we have incurred operating losses as a result of ongoing efforts to develop our product candidates, including conducting ongoing research and development, clinical and preclinical studies and providing general and administrative support for these operations. We do not have any products approved for sale, and we do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our current and future product candidates and/or enter into additional significant collaboration agreements with third parties, and we do not know when, or if, either will occur. We expect to continue to incur net operating losses for at least the next several years and we expect the losses to increase as we advance soquelitinib, as well as any other product candidates, through clinical development, seek regulatory approval, prepare for and, if approved, proceed to commercialization and continue our research and development efforts. We are subject to all the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We do not yet have a sales organization or commercial infrastructure and, accordingly, we will need to incur significant expenses to develop a sales organization and commercial infrastructure in advance of generating any commercial product sales. Moreover, we incur substantial costs associated with operating as a public company. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Current wording
Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $464.3 million through September 30, 2026. We do not expect positive cash flows from operations in the foreseeable future, if ever. Historically, we have incurred operating losses as a result of ongoing efforts to develop our product candidates, including conducting ongoing research and development, clinical and preclinical studies and providing general and administrative support for these operations. We do not have any products approved for sale, and we do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our current and future product candidates and/or enter into additional significant collaboration agreements with third parties, and we do not know when, or if, either will occur. We expect to continue to incur net operating losses for at least the next several years and we expect the losses to increase as we advance soquelitinib, as
Previous wording
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to
Current wording
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount of our operating capital requirements. Our future capital requirements depend on many factors, including:
Previous wording
Cash used in operating activities during the six months ended June 30, 2026 was $25.8 million, which primarily consisted of net loss of $31.7 million, adjusted by net non-cash transactions of $6.8 million, that primarily consisted of $5.3 million of stock-based compensation expense and $1.3 million of loss from equity method investment; an increase of $4.3 million in prepaid and other current assets; an increase of $0.9 million in other assets; an increase of $1.6 million in accounts payable; and an increase of $2.7 million in accrued and other current liabilities.
Current wording
Cash used in operating activities during the nine months ended September 30, 2026 was $38.0 million, which primarily consisted of net loss of $52.0 million, adjusted by net non-cash transactions of $10.3 million, that primarily consisted of $8.1 million of stock-based compensation expense and $2.2 million of loss from equity method investment; a decrease of $2.0 million in prepaid and other current assets; a decrease of $0.8 million in other assets; an increase of $3.2 million in accounts payable; and an increase of $2.8 million in accrued and other current liabilities.
Previous wording
Cash used in operating activities during the six months ended June 30, 2025 was $14.0 million, which primarily consisted of net income of $7.2 million, adjusted by net non-cash transactions of $24.3 million, that primarily consisted of $2.5 million of stock-based compensation expense, $0.9 million of loss from equity method investment and a decrease of $27.1 million in the fair value of warrant liability; a decrease of $1.1 million in prepaid and other current assets; an increase of $0.6 million in accounts payable; an increase of $1.3 million in accrued and other current liabilities; and a decrease of $0.1 million in operating lease right-of-use asset.
Current wording
Cash used in operating activities during the nine months ended September 30, 2025 was $23.6 million, which primarily consisted of a net loss of $3.0 million, adjusted by net non-cash transactions of $23.5 million, that primarily consisted of $3.8 million of stock-based compensation expense, $1.3 million of loss from equity method investment and a decrease of $27.1 million in the fair value of warrant liability; a decrease of $1.1 million in prepaid and other current assets; a decrease of $0.6 million in accounts payable; an increase of $2.0 million in accrued and other current liabilities; an increase in other assets of $0.2 million; and a decrease of $0.1 million in operating lease right-of-use asset.
Previous wording
During the six months ended June 30, 2026, net cash flows used in investing activities was $150.8 million, which primarily consisted of purchases of marketable securities of $209.5 million, purchases of property and equipment
Current wording
During the nine months ended September 30, 2026, net cash flows used in investing activities was $143.3 million, which primarily consisted of purchases of marketable securities of $239.9 million, purchases of property and equipment of $0.7 million and an investment in Angel Pharmaceuticals of $5.0 million, which were partially offset by maturities of marketable securities of $102.3 million.
Previous wording
During the six months ended June 30, 2025, net cash flows used in investing activities was $16.1 million, which primarily consisted of purchases of marketable securities of $47.2 million and purchases of property and equipment of $0.2 million, which were partially offset by maturities of marketable securities of $31.3 million.
Current wording
During the nine months ended September 30, 2025. net cash flows used in investing activities was $18.7 million, which primarily consisted of purchases of marketable securities of $78.3 million and purchases of property and equipment of $0.2 million, which were partially offset by maturities of marketable securities of $59.8 million.
Previous wording
During the six months ended June 30, 2026, cash provided by financing activities was $190.9 million, which primarily consisted of net proceeds of $189.4 million from the January 2026 follow-on public offering and proceeds of $1.5 million from the exercise of stock options.
Current wording
During the nine months ended September 30, 2026, cash provided by financing activities was $191.7 million, which primarily consisted of net proceeds of $189.4 million from the January 2026 follow-on public offering and proceeds of $2.3 million from the exercise of stock options.
Previous wording
During the six months ended June 30, 2025, cash provided by financing activities was $36.0 million, which primarily consisted of proceeds of $35.7 million from the exercise of common warrants and proceeds of $0.3 million from the exercise of stock options.
Current wording
During the nine months ended September 30, 2025, cash provided by financing activities was $36.4 million, which primarily consisted of proceeds of $35.7 million from the exercise of common warrants and proceeds of $0.7 million from the exercise of stock options.
Previous wording
There have been no material changes outside the ordinary course of our business to our contractual obligations during the six months ended June 30, 2026, as compared to those disclosed in our Annual Report on Form 10-K filed with the SEC on March 12, 2026.
Current wording
There have been no material changes outside the ordinary course of our business to our contractual obligations during the nine months ended September 30, 2026, as compared to those disclosed in our Annual Report on Form 10-K filed with the SEC on March 12, 2026.
Previous wording
There have been no changes to our critical accounting estimates during the six months ended June 30, 2026, as compared to those disclosed in our Annual Report on Form 10-K filed with the SEC on March 12, 2026.
Current wording
There have been no changes to our critical accounting estimates during the nine months ended September 30, 2026, as compared to those disclosed in our Annual Report on Form 10-K filed with the SEC on March 12, 2026.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
We have designed and developed soquelitinib to covalently target the cysteine amino acid residue at position 442 in the ITK protein. We believe this irreversible targeting of ITK has the potential to provide a potent, selective and
Current report — wording carried from elsewhere
other cytokines involved in these diseases. The novel mechanism is a result of ITK inhibition and blockade of formation of Th2 and Th17 cells.
Current report — wording carried from elsewhere
well as any other product candidates, through clinical development, seek regulatory approval, prepare for and, if approved, proceed to commercialization and continue our research and development efforts. We are subject to all the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We do not yet have a sales organization or commercial infrastructure and, accordingly, we will need to incur significant expenses to develop a sales organization and commercial infrastructure in advance of generating any commercial product sales. Moreover, we incur substantial costs associated with operating as a public company. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
clinical trial, that soquelitinib has the potential to rebalance normal immune responses that also could be beneficial for the treatment of certain autoimmune, inflammatory and allergic diseases. Overactive Th2 and Th17 cells are known to play a role in autoimmune, inflammatory and allergic diseases, which can potentially be ameliorated by selective ITK inhibition by blocking Th2 and Th17 function and their production of inflammatory cytokines such as IL4, IL5, IL13, IL17 and others.
Previous report — wording carried elsewhere
In April 2024, we initiated a randomized, double-blind, placebo-controlled Phase 1 clinical trial with soquelitinib in patients with moderate to severe atopic dermatitis that previously failed one prior topical or systemic therapy. The clinical trial was planned to enroll 64 patients into one of four dosing cohorts in a 3:1 ratio (12 active and 4 placebo) to receive either soquelitinib or placebo. The cohorts were designed to sequentially enroll and to examine 100
Previous report — wording carried elsewhere
infectious diseases, we are waiting to initiate a potential Phase 2 randomized clinical trial in order to prioritize the development of our other two lead product candidates.
Previous report — wording carried elsewhere
our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.
Previous report — wording carried elsewhere
estimate the exact amount of our operating capital requirements. Our future capital requirements depend on many factors, including:
Previous report — wording carried elsewhere
of $0.7 million and an investment in Angel Pharmaceuticals of $5.0 million, which were partially offset by maturities of marketable securities of $64.3 million.