UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 8, 2025
_______________________________
Corvus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
_______________________________
Delaware | 001-37719 | 46-4670809 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
901 Gateway Boulevard, Third Floor | 94080 |
South San Francisco, California | |
(Address of principal executive offices) | (Zip Code) |
(Registrant's telephone number, including area code): (650) 900-4520
Former name or former address, if changed since last report: Not applicable
_______________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, Par Value $0.0001 per share | CRVS | Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On May 8, 2025, Corvus Pharmaceuticals, Inc. (the “Company” or “Corvus”) issued a press release regarding, among other matters, its financial results for the three months ended March 31, 2025 and its financial position as of March 31, 2025 and provided a business update. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
The information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
On May 8, 2025, the Company issued the press release furnished as Exhibit 99.2 hereto.
The information in this Item 7.01 of this Form 8-K and the Exhibit 99.2 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
On May 8, 2025, the Company announced interim new data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data demonstrated a favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 mg) compared to cohorts 1 and 2 (100 mg twice per day and 200 mg once per day, total daily dose 200 mg). Overall, all three cohorts showed significant responses in the soquelitinib treatment groups compared to placebo for clinically significant endpoints of EASI (Eczema Area and Severity Index) 75 and IGA (Investigator Global Assessment) 0 or 1.
Soquelitinib Interim Data from the Atopic Dermatitis Phase 1 Clinical Trial
As of May 6, 2025, enrollment into cohorts 1, 2 and 3 has been completed for a total of 48 patients. The data covers 32 patients receiving soquelitinib and 12 placebos with 28-day follow-up, and four additional patients receiving soquelitinib with 15-day follow-up from cohort 3. These four patients have not yet completed the 28-day treatment course.
Baseline patient characteristics are shown below in Table 1. Patients enrolled in cohort 3 had more severe disease with higher mean baseline EASI scores compared to cohorts 1 and 2. A higher proportion also failed prior systemic therapies. Across all cohorts, the mean EASI scores are 22.3 and 21.2 for active and placebo, respectively. Placebo (n=12) and active (n=36) treatment groups were well-balanced with regard to baseline characteristics.
Table 1: Patient Characteristics
The percent reduction in mean EASI scores at 28 days for the combined cohort 1 and 2 group was 54.6% for patients receiving soquelitinib and 30.6% for patients receiving placebo. In cohort 3, the percent reduction in mean EASI score at 28 days was 71.1% for patients receiving soquelitinib and 42.1% for patients receiving placebo.
Figure 1 below shows the percent of patients that achieved IGA 0 or 1 or EASI 75 at day 28 of treatment. The placebo patients from cohort 1 (n=4), cohort 2 (n=4) and cohort 3 (n=4) are combined, with no placebo patients achieving IGA 0 or 1 or EASI 75. IGA 0 or 1 and EASI 75 have been determined by the U.S. Food and Drug Administration (FDA) to be clinically meaningful and approvable endpoints and have been the endpoints used in clinical trials for other FDA approved treatments for atopic dermatitis.
Figure 1: Percent Patients Achieving Endpoints IGA 0 or 1, EASI 75 at Day 28 of Treatment
The graphs below (Figures 2 and 3) show the kinetics of response for each of the cohorts and for the combined cohorts 1, 2 and 3. The placebo patients (n=12) are combined in both graphs. Separation of the curves for patients receiving active drug began at day 15 and increased by day 28 for cohorts 1 and 2. Cohort 3 patients experienced earlier and deeper separation from placebo starting by day 8. The combined soquelitinib treatment group is significantly superior to placebo at day 28, p=0.03.
Figure 2: Percent Reduction in Mean EASI Score for Cohorts 1, 2 and 3. Mean percent change in EASI score over time is shown. Treatment beginning is designated “Baseline” and days post-baseline are shown. Screening to baseline data is shown and demonstrates relative disease stability. The study blinding remains in effect for the entire 58-day period. Numbers at the top of the graphs indicate numbers of patients evaluated at the various time points.
Figure 3: Percent Reduction in Mean EASI Score for Combined Cohorts 1, 2 and 3. The data is displayed below with cohorts combined. Four active patients in cohort 3 have not yet reached day 28 of treatment.
Safety Data
Soquelitinib was well tolerated, with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts. No interruption of drug dosing was seen in any of the cohorts. Grade 1/2 adverse events (treatment related and unrelated) were seen in 33.3% of patients receiving soquelitinib and 25% receiving placebo. Only one treatment related adverse event of grade 1 nausea was reported with soquelitinib treatment.
Serum Cytokine and Other Biomarker Studies
As reported previously, relationships between reductions in certain cytokines with improvement in EASI scores were observed. Reductions in serum cytokine levels were seen for IL-5, IL-9, IL-17, IL-31, IL-33, TSLP and TARC. Differences between responding and non-responding patients were found, while no such relationships were seen in the placebo group. Increasing trends were seen in numbers of circulating T regulatory cells, consistent with the presumed mechanism of action of soquelitinib.
Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Design and Protocol Update
The randomized, double-blind, placebo-controlled Phase 1 clinical trial was designed
to enroll 64 patients with moderate to severe atopic dermatitis that previously failed one prior topical or systemic therapy. Patients
were planned to be enrolled into one of four dosing cohorts in a 3:1 ratio (12 active and four placebo) to receive either soquelitinib
or placebo. The cohorts are sequentially enrolled and will examine 100 mg orally twice per day, 200 mg orally once per day, 200 mg orally
twice per day and 400 mg orally once per day. Patients are treated for 28 days and are then followed for an additional 30 days with no
therapy. The Company amended the clinical trial protocol to replace cohort 4 (400 mg once per day) with 24 patients randomized 1:1 between
active and placebo. Treatment for this group will be extended to 8 weeks with additional 30-day follow-up with no treatment. The dose
level for this group is planned to be the same as cohort 3 – 200 mg orally twice per day.
These doses were selected based on the Company’s prior experience evaluating soquelitinib in T cell lymphoma patients. The doses in the atopic dermatitis trial studied in cohorts 1 and 2 are lower than the 200 mg orally twice a day dosing regimen (same dose as cohort 3 of the atopic dermatitis trial), which is the level that has been shown to provide complete ITK occupancy and that is being evaluated in the Company’s ongoing registrational Phase 3 clinical trial of soquelitinib in peripheral T cell lymphoma.
The primary endpoints include safety and tolerability. Efficacy, measured by improvement in EASI score and IGA, are secondary endpoints. Reduction in itch and various cytokine biomarkers are exploratory endpoints. 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. Corvus and a data monitoring committee monitor the data from the trial as the trial progresses.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including statements
related to the potential safety and efficacy of soquelitinib and the Company’s conduct of and monitoring of data from clinical trials.
All statements other than statements of historical fact contained in this Current Report on Form 8-K 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 first quarter ended
March 31, 2025, 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; 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.
Exhibit No. | Description | |||
99.1 | Press release of Corvus Pharmaceuticals, Inc. regarding first quarter financial results dated May 8, 2025. | |||
99.2 | Press release of Corvus Pharmaceuticals, Inc. regarding data from Phase 1 clinical trial of soquelitinib for atopic dermatitis dated May 8, 2025. | |||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Corvus Pharmaceuticals, Inc. | ||
Date: May 8, 2025 | By: | /s/ Leiv Lea |
Leiv Lea | ||
Chief Financial Officer | ||
EXHIBIT 99.1
Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2025 Financial Results
Soquelitinib data from cohorts 1-3 of atopic dermatitis Phase 1 clinical trial demonstrate favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 compared to cohorts 1-2
Phase 3 registrational clinical trial of soquelitinib in peripheral T cell lymphoma (PTCL) enrolling with multiple clinical sites open
Early exercise of common stock warrants by stockholders providing cash proceeds of approximately $31.3 million
Soquelitinib data to be highlighted on conference call and webcast today at 4:30 p.m. ET / 1:30 p.m. PT
SOUTH SAN FRANCISCO, Calif., May 08, 2025 (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, 2025.
“The new soquelitinib data being presented at the Society for Investigative Dermatology annual meeting supports its potential to be a meaningful new treatment for atopic dermatitis, along with the broader opportunity for ITK inhibition to provide a new mechanism of action to treat a range of immune diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “Looking forward, we remain on track with our key potential value-driving initiatives for soquelitinib in atopic dermatitis, including data from our new extension cohort in the fourth quarter and initiating a Phase 2 clinical trial before year-end. We also remain excited about our other soquelitinib clinical programs – patient enrollment in the Phase 3 registration clinical trial in peripheral T cell lymphoma (PTCL) and the Phase 2 trial in autoimmune lymphoproliferative syndrome (ALPS) is ongoing, and we plan to initiate a solid tumor clinical trial later in 2025.”
Business Update and Strategy
Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
Soquelitinib for T Cell Lymphoma
Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor)
Partner Led Program: Mupadolimab (anti-CD73)
Financial Results
As of March 31, 2025, Corvus had cash, cash equivalents and marketable securities of $44.2 million as compared to $52.0 million as of December 31, 2024. In May 2025, holders of 8,945,175 common stock warrants to purchase 8,945,175 shares of common stock, exercised all of their warrants at $3.50 per share in advance of the June 30, 2025 expiration date which resulted in cash proceeds to Corvus of approximately $31.3 million. Included in the 8,945,175 shares were 559,073 shares purchased for $1,956,756 by Richard Miller, Corvus’ CEO, related to his early exercise of common stock warrants. Based on its current plans, Corvus expects its cash to fund operations into the fourth quarter of 2026.
Research and development expenses for the three months ended March 31, 2025 totaled $7.5 million compared to $4.1 million for the same period in 2024. The increase of approximately $3.4 million 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.
Net income for the three months ended March 31, 2025 was $15.2 million, which included a gain of $25.1 million associated with the change in fair value of the Company’s warrant liability. Net loss for the same period in 2024 was $5.7 million. Total stock compensation expense for the three months ended March 31, 2025 was $1.3 million compared to $0.7 million for the same period in 2024 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.5 million for the three months ended March 31, 2025 compared to non-cash income of $0.2 million for the same period in 2024.
Conference Call Details
Corvus will host a conference call and webcast today, Thursday, May 8, 2025, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the first quarter 2025 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 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 cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. 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 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 registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also now being investigated in a randomized placebo-controlled phase 1 clinical trial in patients with atopic dermatitis. A recent 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 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 Ciforadenant
Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2a receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies.
About Mupadolimab
Mupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. Unlike certain other anti-CD73 antibodies and small molecules in development for treatment of cancer, which react with a different region of CD73, mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. It is postulated that the activation of B cells will enhance immunity within the tumors, leading to improved clinical outcomes.
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 interim results from the Phase 1 trial of soquelitinib in patients with atopic dermatitis; the potential use of soquelitinib to treat a variety of hematological cancers and autoimmune diseases; clinical strategy and the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, dose levels, number of sites and other product development milestones; the availability and timing of clinical and preclinical data announcements and clinical readouts, including data from the extension cohort of the Phase 1 clinical trial for atopic dermatitis with soquelitinib; and the amount of cash to fund operations into the first quarter of 2026. 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 first quarter ended March 31, 2025, 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 first quarter of 2026 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, 2025 are not necessarily indicative of its operating results for any future periods.
CORVUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) | |||||||
Three Months Ended March 31, |
|||||||
(unaudited) | |||||||
Operating expenses: | |||||||
Research and development | $ | 7,453 | $ | 4,075 | |||
General and administrative | 2,469 | 2,178 | |||||
Total operating expenses | 9,922 | 6,253 | |||||
Loss from operations | (9,922 | ) | (6,253 | ) | |||
Interest income and other expense, net | 525 | 316 | |||||
Change in fair value of warrant liability | 25,129 | - | |||||
Income (loss) before equity method investment | 15,732 | (5,937 | ) | ||||
Income (loss) from equity method investment | (539 | ) | 236 | ||||
Net income (loss) | $ | 15,193 | $ | (5,701 | ) | ||
Net income (loss) per share, basic | $ | 0.21 | $ | (0.12 | ) | ||
Net loss per share, diluted | $ | (0.13 | ) | $ | (0.12 | ) | |
Shares used to compute net income (loss) per share, basic | 72,126,496 | 49,038,582 | |||||
Shares used to compute net loss per share, diluted | 75,152,514 | 49,038,582 | |||||
CORVUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | |||||||
March 31, | December 31, | ||||||
2025 | 2024 | ||||||
(unaudited) | |||||||
Assets | |||||||
Cash, cash equivalents and marketable securities | $ | 44,212 | $ | 51,964 | |||
Operating lease right-of-use asset | 1,095 | 1,177 | |||||
Other assets | 2,073 | 3,226 | |||||
Investment in Angel Pharmaceuticals | 12,058 | 12,540 | |||||
Total assets | $ | 59,438 | $ | 68,907 | |||
Liabilities and stockholders' equity | |||||||
Accounts payable and accrued liabilities and other liabilities | $ | 5,179 | $ | 6,307 | |||
Operating lease liability | 1,153 | 1,122 | |||||
Warrant liability | 3,781 | 28,910 | |||||
Stockholders' equity | 49,325 | 32,568 | |||||
Total liabilities and stockholders' equity | $ | 59,438 | $ | 68,907 | |||
INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com
MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com
EXHIBIT 99.2
Corvus Pharmaceuticals Announces Data from Cohorts 1-3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis
Data continue to demonstrate favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 compared to cohorts 1-2
Data to be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual Meeting
Company to discuss data today on its first quarter 2025 business update conference call and webcast at 4:30 pm ET / 1:30 pm PT
SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data demonstrated a favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 mg) compared to cohorts 1 and 2 (100 mg twice per day and 200 mg once per day, total daily dose 200 mg). Overall, all three cohorts showed significant responses in the soquelitinib treatment groups compared to placebo for clinically significant endpoints of EASI (Eczema Area and Severity Index) 75 and IGA (Investigator Global Assessment) 0 or 1.
“We continue to be encouraged by the results from our Phase 1 trial of soquelitinib in patients with atopic dermatitis, which show a favorable safety and efficacy profile with a convenient oral tablet,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We believe the results are particularly exciting given the relatively short treatment duration of 28 days and durable post-treatment results, both of which we associate with the novel mechanism of action provided by ITK inhibition. This is supported by biomarker studies from the trial, which show evidence of multiple effects derived from the selective blockade of ITK including the reduction of various inflammatory cytokines and the potential induction of T regulatory cells, further amplifying the disease modifying effects of soquelitinib. Based on these results, we have amended the trial protocol to evaluate an additional 24 patients at the 200 mg twice per day dose, randomized one-to-one with placebo for an extended treatment period of 8 weeks. This amendment gives us the opportunity to evaluate the potential for even stronger efficacy with longer treatment duration. This additional experience is intended to help optimize the design of a Phase 2 trial, which we are on track to initiate before the end of the year.”
Soquelitinib Interim Data from the Atopic Dermatitis Phase 1 Clinical Trial
As of May 6, 2025, enrollment into
cohorts 1, 2 and 3 has been completed for a total of 48 patients. The data covers 32 patients receiving soquelitinib and 12 placebos with
28-day follow-up, and four additional patients receiving soquelitinib with 15-day follow-up from cohort 3. These four patients have not
yet completed the 28-day treatment course.
Baseline patient characteristics are shown below in Table 1. Patients enrolled in cohort 3 had more severe disease with higher mean baseline EASI scores compared to cohorts 1 and 2. A higher proportion also failed prior systemic therapies. Across all cohorts, the mean EASI scores are 22.3 and 21.2 for active and placebo, respectively. Placebo (n=12) and active (n=36) treatment groups were well-balanced with regard to baseline characteristics.
Table 1: Patient Characteristics
The percent reduction in mean EASI scores at 28 days for the combined cohort 1 and 2 group was 54.6% for patients receiving soquelitinib and 30.6% for patients receiving placebo. In cohort 3, the percent reduction in mean EASI score at 28 days was 71.1% for patients receiving soquelitinib and 42.1% for patients receiving placebo.
Figure 1 below shows the percent of patients that achieved IGA 0 or 1 or EASI 75 at day 28 of treatment. The placebo patients from cohort 1 (n=4), cohort 2 (n=4) and cohort 3 (n=4) are combined, with no placebo patients achieving IGA 0 or 1 or EASI 75. IGA 0 or 1 and EASI 75 have been determined by the U.S. Food and Drug Administration (FDA) to be clinically meaningful and approvable endpoints and have been the endpoints used in clinical trials for other FDA approved treatments for atopic dermatitis.
Figure 1: Percent Patients Achieving Endpoints IGA 0 or 1, EASI 75 at Day 28 of Treatment
The graphs below (Figures 2 and 3) show the kinetics of response for each of the cohorts and for the combined cohorts 1, 2 and 3. The placebo patients (n=12) are combined in both graphs. Separation of the curves for patients receiving active drug began at day 15 and increased by day 28 for cohorts 1 and 2. Cohort 3 patients experienced earlier and deeper separation from placebo starting by day 8. The combined soquelitinib treatment group is significantly superior to placebo at day 28, p=0.03.
Figure 2: Percent Reduction in Mean EASI Score for Cohorts 1, 2 and 3. Mean percent change in EASI score over time is shown. Treatment beginning is designated “Baseline” and days post-baseline are shown. Screening to baseline data is shown and demonstrates relative disease stability. The study blinding remains in effect for the entire 58-day period. Numbers at the top of the graphs indicate numbers of patients evaluated at the various time points.
Figure 3: Percent Reduction in Mean EASI Score for Combined Cohorts 1, 2 and 3. The data is displayed below with cohorts combined. Four active patients in cohort 3 have not yet reached day 28 of treatment.
Safety Data
Soquelitinib was well tolerated, with no dose limiting toxicities (DLTs) and no clinically significant
laboratory abnormalities observed in any of the cohorts. No interruption of drug dosing was seen in any of the cohorts. Grade 1/2 adverse
events (treatment related and unrelated) were seen in 33.3% of patients receiving soquelitinib and 25% receiving placebo. Only one treatment
related adverse event of grade 1 nausea was reported with soquelitinib treatment.
Serum Cytokine and Other Biomarker Studies
As reported previously, relationships between reductions in certain
cytokines with improvement in EASI scores were observed. Reductions in serum cytokine levels were seen for IL-5, IL-9, IL-17, IL-31, IL-33,
TSLP and TARC. Differences between responding and non-responding patients were found, while no such relationships were seen in the placebo
group. Increasing trends were seen in numbers of circulating T regulatory cells, consistent with the presumed mechanism of action of soquelitinib.
Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Design and Protocol Update
The randomized, double-blind,
placebo-controlled Phase 1 clinical trial was designed to enroll 64 patients with moderate to severe atopic dermatitis that previously
failed one prior topical or systemic therapy. Patients were planned to be enrolled into one of four dosing cohorts in a 3:1 ratio (12
active and four placebo) to receive either soquelitinib or placebo. The cohorts are sequentially enrolled and will examine 100 mg orally
twice per day, 200 mg orally once per day, 200 mg orally twice per day and 400 mg orally once per day. Patients are treated for 28 days
and are then followed for an additional 30 days with no therapy. The Company amended the clinical trial protocol to replace cohort 4 (400
mg once per day) with 24 patients randomized 1:1 between active and placebo. Treatment for this group will be extended to 8 weeks with
additional 30-day follow-up with no treatment. The dose level for this group is planned to be the same as cohort 3 – 200 mg orally
twice per day.
These doses were selected based on the Company’s prior experience evaluating soquelitinib in T cell lymphoma patients. The doses in the atopic dermatitis trial studied in cohorts 1 and 2 are lower than the 200 mg orally twice a day dosing regimen (same dose as cohort 3 of the atopic dermatitis trial), which is the level that has been shown to provide complete ITK occupancy and that is being evaluated in the Company’s ongoing registrational Phase 3 clinical trial of soquelitinib in peripheral T cell lymphoma.
The primary endpoints include safety and tolerability. Efficacy, measured by improvement in EASI score and IGA, are secondary endpoints. Reduction in itch and various cytokine biomarkers are exploratory endpoints. 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. Corvus and a data monitoring committee monitor the data from the trial as the trial progresses.
Presentation at Society for Investigative Dermatology 2025 Annual Meeting
The data from the Phase 1 clinical trial
of soquelitinib for atopic dermatitis will be presented by Albert S. Chiou, M.D., MBA, Clinical Associate Professor, Dermatology
and Director of Clinical Research in the Department of Dermatology at Stanford University Medical Center. Dr. Chiou’s clinical
focus is in medical dermatology and he conducts clinical trials investigating new therapies for inflammatory and genetic skin disease,
including atopic dermatitis. The details of Dr. Chiou’s presentations are as follows:
Upcoming Presentation and Webcast
Dr. Miller will present details on the new data from the soquelitinib Phase
1 clinical trial during the Company’s first quarter 2025 business update conference call and webcast today, Thursday, May 8, 2025 at 4:30
pm ET / 1:30 pm PT. 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, which will include presentation slides,
may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’
website for 60 days.
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 cancer and immune diseases. The Company’s
lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. 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.
Forward-Looking Statements
This press release contains forward-looking statements related to the potential of
the Company’s product candidates including soquelitinib and the interim results from the Phase 1 trial of soquelitinib in patients
with atopic dermatitis, the design and timing of initiation of a Phase 2 trial, the advancement of ITK inhibition and the opportunities
it provides, and continued advancement of the Company’s clinical pipeline. 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 Quarterly Report
on Form 10-Q for the first quarter ended March 31, 2025, 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; 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.
INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com
MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com
Photos accompanying this announcement are available at:
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