CRVS Corvus Pharmaceuticals Inc.

7.56
-0.97  -11%
Previous Close 8.53
Open 8.4
52 Week Low 1.86
52 Week High 9.54
Market Cap $320,703,962
Shares 42,421,159
Float 29,500,551
Enterprise Value $197,062,551
Volume 25,219,563
Av. Daily Volume 8,558,581
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Upcoming Catalysts

Drug Stage Catalyst Date
Mupadolimab (CPI-006)
HPV+ Oropharyngeal Cancer
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Mupadolimab (CPI-006)
COVID-19 (Mild to Moderate)
Phase 3
Phase 3
Phase 3 trial results, which cover 40 patients that were enrolled in the trial prior to its voluntary discontinuation, suggest improvement in the primary and key secondary endpoints in patients treated with single doses of mupadolimab at 2mg/kg and 1mg/kg compared to placebo. No drug related adverse events were reported in the trial. September 22, 2021.
Ciforadenant (CPI-444)
Renal cell cancer
Phase 2
Phase 2
Phase 2 trial planned.
CPI-818
Peripheral T-cell lymphoma (PTCL)
Phase 2
Phase 2
Phase 2 trial to be initiated late-2021.
Mupadolimab (CPI-006)
Solid tumors
Phase 1b
Phase 1b
Phase 1/1b trial ongoing.

Latest News

  1. Announces results published online in medRxiv in 40 patients from COVID-19 randomized controlled study, which showed primary and secondary endpoints trend toward more favorable outcome for mupadolimab treated patients vs. placebo

    COVID-19 study immune response data found to be consistent with proposed mechanism

    Oncology Phase 1b/2 clinical trial enrolling patients with head and neck cancers and patients with lung cancer; data anticipated at SITC meeting in November

    BURLINGAME, Calif., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today provided an update on its development programs in oncology and infectious disease for mupadolimab (formerly CPI-006), a humanized…

    Announces results published online in medRxiv in 40 patients from COVID-19 randomized controlled study, which showed primary and secondary endpoints trend toward more favorable outcome for mupadolimab treated patients vs. placebo

    COVID-19 study immune response data found to be consistent with proposed mechanism

    Oncology Phase 1b/2 clinical trial enrolling patients with head and neck cancers and patients with lung cancer; data anticipated at SITC meeting in November

    BURLINGAME, Calif., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today provided an update on its development programs in oncology and infectious disease for mupadolimab (formerly CPI-006), a humanized monoclonal antibody directed against CD73 with a proposed dual mechanism of activating B cells to generate immune responses to viruses and tumor antigens, and inhibiting the production of immunosuppressive adenosine in the tumor micro environment.

    Corvus is developing mupadolimab as a therapeutic for oncology indications and for infectious disease, starting with COVID-19. Today the Company announced results from its Phase 3 clinical trial of mupadolimab for COVID-19, which have been published online at medRxiv.org. The results, which cover 40 patients that were enrolled in the trial prior to its voluntary discontinuation, suggest improvement in the primary and key secondary endpoints in patients treated with single doses of mupadolimab at 2mg/kg and 1mg/kg compared to placebo. No drug related adverse events were reported in the trial.

    "We believe the results from our Phase 3 Covid trial show the potential for a dose response effect on the primary endpoint of time to respiratory failure or death for the 2mg/kg and 1mg/kg mupadolimab cohorts compared to placebo. Secondary endpoints also favored the cohorts receiving mupadolimab. Most interestingly, antiviral responses in the 2mg/kg cohort trended higher across all variants tested, including delta. Cross reactivity to the delta variant is of interest as patients were enrolled prior to its emergence as the dominant variant in the United States," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "As expected when we discontinued the trial, statistical significance was not reached due to the sample size. However, we are very encouraged by the consistent trends and immune response data, which we believe support mupadolimab's proposed mechanism of action and its potential value for the treatment of viral infections. Combined with the findings in our previous Phase 1 trial in 29 patients, we believe there is mounting evidence that mupadolimab could become a universal treatment for viral diseases, with the ability to address immune escape from variants. We plan to evaluate our next steps with mupadolimab for COVID-19 as we continue to analyze the trial data and explore partnership opportunities to continue its development as a therapeutic."

    Mupadolimab also is currently being studied in a Phase 1b/2 clinical study in patients with HPV+ oropharyngeal cancers and non small cell lung cancers (NSCLC) that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Data from the Phase 1b/2 clinical study has been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) annual meeting in November.

    "Mupadolimab is one of the most studied anti-CD73 antibodies and is uniquely positioned with a potential dual mechanism, B cell activation and inhibition of immunosuppressive adenosine production," said Dr. Miller. "The complementary mechanisms could result in enhanced immune responses to viral antigens and to tumor antigens. We believe this will enable a unique approach to treating cancers, that can benefit both from removing the adenosine-mediated blockade of the immune system and enhancing immune responses through B cell activation. We look forward to presenting new data from our Phase 1b/2 oncology study at the SITC meeting in November."

    Mupadolimab for COVID-19 Trial Results

    This was a randomized, double blind placebo-controlled trial design. In July, Corvus discontinued the clinical trial, which had planned to enroll approximately 1,000 patients, due to positive trends exhibited by COVID-19 vaccines in lowering serious infection and hospitalizations at that time. The discontinuation was not related to any safety or efficacy issues observed in study patients and occurred prior to the recent surge in COVID-19 cases and before the dominant emergence of the delta variant. Of the 40 patients enrolled prior to the discontinuation, 15 received the mupadolimab 2mg/kg dose, 14 received the mupadolimab 1mg/kg dose, and 11 received placebo. Treatment arms were well balanced, except for the 2mg/kg cohort, which had patients with more severe disease on admission with 60% on non-invasive ventilation or high flow oxygen devices, compared to 7% in the 1mg/kg cohort and 27% in the placebo cohort. Data from the three cohorts remained blinded until the final analysis.

    The primary endpoint of the clinical trial was the proportion of patients progressing to respiratory failure or death during the 28 days after dosing. In the 2mg/kg cohort, 93.3% of patients were alive and free from respiratory failure, compared to 85.7% in the 1mg/kg cohort and 81.1% in the placebo. The results in the placebo control group were in line with results reported in other randomized trials. In addition, positive trends favoring mupadolimab treatment compared to placebo were seen for all the key secondary endpoints, including time to clinical improvement, time to sustained clinical improvement and time to hospital discharge.

    Mupadolimab 2mg/kg and 1mg/kg vs. placebo

    (all received standard of care treatment)
     



    2 mg/kg + SOC

    (N=15)
    1 mg/kg + SOC

    (N=14)
    Placebo + SOC

    (N=11)
    Primary Endpoint:   
    Free from Respiratory Failure or Death (%)93.385.781.1
    Secondary Endpoints:   
    Median Days to Improvement (95% CI)7.0 (4-9)5.5 (3-14)11.0 (2-14)
    Median Days Sustained Improve (95% CI)8.0 (4-12)6.0 (3-14)11.0 (2-21)
    Median Days to Discharge (95% CI)6.0 (4-12)4.0 (2-5)7.0 (2-12)

    The results also included anti-viral antibody responses for 26 patients for which pre-treatment and day 28 blood serum are available (8 from the 1mg/kg cohort, 11 from the 2mg/kg cohort and 7 from the placebo cohort). Serum titers in the 2mg/kg cohort appeared to trend higher against the original COVID-19 strain and variants (alpha (B.1.1.7), beta (B.1.351), gamma (P.1) and delta (B.1.617.2), with several patients exhibiting very high titers. Patients in the 2mg/kg cohort demonstrated higher cross-reactivity with the beta, gamma and delta variants compared to 1mg/kg and placebo.

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidate is mupadolimab (CPI-006), a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. The Company's second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. For more information, visit www.corvuspharma.com.

    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. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents 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. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1/1b study in patients with advanced HPV+ (human papilloma virus) head and neck cancers. It is postulated that the activation of B cells will enhance immunity to viral antigens within the tumors of these patients, leading to improved clinical outcomes.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the potential safety and efficacy of mupadolimab, CPI-818 and ciforadenant, the Company's ability and our Chinese partner, Angel Pharmaceuticals' ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, whether mupadolimab could become a universal treatment for viral diseases with the ability to address immune escape from variants, whether mupadolimab's mechanisms could result in enhanced immune responses to viral antigens and to tumor antigens and the timing of reporting data in the Company's oncology trials. 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 quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 2, 2021, 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 mupadolimab, CPI-818 and ciforadenant; the accuracy of the Company's estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the results of preclinical studies may not be predictive of future results; the results of clinical trials that did not achieve statistical significance may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the impact of the COVID-19 pandemic on the Company's operations and clinical development plans, as well as the operations of its partners and suppliers; 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



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  2. BURLINGAME, Calif., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that the Company's management will participate in two upcoming investor conferences in September:

    • The first conference is the H.C. Wainwright Annual Global Investment Conference, which is taking place September 13-15, 2021. The Company will conduct one-on-one meetings with investors at this conference and a pre-recorded corporate overview presentation by Richard A. Miller, M.D., president and chief executive officer of Corvus, will be available to play on-demand starting at 7:00 am ET on September 13. Attendees can register to view the webcast here.

    • The second conference is the Cantor…

    BURLINGAME, Calif., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that the Company's management will participate in two upcoming investor conferences in September:

    • The first conference is the H.C. Wainwright Annual Global Investment Conference, which is taking place September 13-15, 2021. The Company will conduct one-on-one meetings with investors at this conference and a pre-recorded corporate overview presentation by Richard A. Miller, M.D., president and chief executive officer of Corvus, will be available to play on-demand starting at 7:00 am ET on September 13. Attendees can register to view the webcast here.



    • The second conference is the Cantor Virtual Global Healthcare Conference, which is taking place September 27-30, 2021. The Company will conduct one-on-one meetings with investors at this conference and a virtual corporate overview presentation will be conducted by Dr. Miller at 3:20-3:50 pm ET on September 29. Attendees can register for the virtual presentation here.

    Attendees can also access the webcast of the presentations noted above via the investor relations section of the Corvus website and replays will be available for 90 days following the events.

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidate is mupadolimab (CPI-006), a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and is currently being evaluated in Phase 1b/2 clinical trials in patients with either head and neck cancers or lung cancers. The Company's second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. For more information, visit www.corvuspharma.com.

    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 



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  3. JIAXING, China and BURLINGAME, Calif., Aug. 16, 2021 /PRNewswire/ -- Angel Pharmaceuticals Ltd. ("Angel Pharma") today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its IND application for the initiation of a Phase 1/1b clinical trial of its small molecule ITK inhibitor CPI-818 for treatment of relapsed/refractory T-cell lymphomas. Angel Pharma plans to initiate the trial before the end of 2021.

    CPI-818, the first-and-only ITK inhibitor in clinical development in China, has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase) without effect on related kinases such as RLK (resting lymphocyte kinase) and BTK (Bruton's tyrosine kinase). ITK…

    JIAXING, China and BURLINGAME, Calif., Aug. 16, 2021 /PRNewswire/ -- Angel Pharmaceuticals Ltd. ("Angel Pharma") today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its IND application for the initiation of a Phase 1/1b clinical trial of its small molecule ITK inhibitor CPI-818 for treatment of relapsed/refractory T-cell lymphomas. Angel Pharma plans to initiate the trial before the end of 2021.

    CPI-818, the first-and-only ITK inhibitor in clinical development in China, has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase) without effect on related kinases such as RLK (resting lymphocyte kinase) and BTK (Bruton's tyrosine kinase). ITK is a 72 kDa protein kinase that plays an essential role in the activation, differentiation and proliferation of T-cells. There is evidence that ITK may play a role in the development and growth of T-cell lymphomas. Based on these properties, ITK is a promising treatment target for autoimmune diseases and for lymphoproliferative diseases such as T-cell lymphomas (TCL), which comprise an aggressive and heterogeneous subtype of non-Hodgkin lymphoma.

    Angel Pharma licensed the rights to CPI-818 from Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) for development, manufacturing and commercialization in China.   Corvus is studying CPI-818 in a multi-center Phase 1/1b clinical trial in patients with several types of TCL in the U.S. and Asia. As of February 17, 2021, 25 patients (16 in dose escalation and 9 in expansion) have received CPI-818 treatment. Overall, CPI-818 has been shown to be well-tolerated, and has shown anti-tumor activity in peripheral T-cell lymphomas (PTCL) and in cutaneous T-cell lymphomas. As reported at the annual meeting of the American Society of Hematology in December 2020, 2 of 7 patients with refractory PTCL experienced responses to treatment with CPI-818; one complete response and one partial response.

    "The NMPA's acceptance of the IND for CPI-818 is an important step towards bringing this innovative product candidate to patients in China," said Richard A. Miller, M.D., co-founder and chairman of Angel Pharmaceuticals. There is a need for novel effective therapies for patients with T-cell lymphoma since current treatment options are limited and outcomes are often poor. Angel Pharma has a robust pipeline and the advancement of CPI-818 is only the first step in developing several potential first-in-class therapeutic opportunities. T-cell lymphomas are more common in China than in the U.S., highlighting the potential synergies of the collaboration between Angel Pharma and Corvus, which could accelerate development of our drugs for global markets."

    Dr. Ted Wang, co-founder and general manager of Angel Pharmaceuticals, commented, "The aspiration of Angel Pharma is to gather world-class resources to bring innovative therapies to benefit Chinese people. With CPI-818, we will be able to potentially provide a safer, highly differentiated therapy for patients suffering from T-cell lymphoma and potentially other indications such as autoimmune diseases."

    Separately, Angel Pharma announced the launch of its research centers in China and the U.S in July 2021. The new research center in China, based in Jiaxing, Zhejiang Province, occupies over 3,000 square meters of state-of-the-art research and development facilities including chemistry, molecular biology and pharmaceutical development laboratories. The U.S. research center, located in Burlingame, CA, occupies more than 1,000 square meters dedicated to research and development. Since its launch in October 2020, Angel Pharma has built an experienced R&D team, including expertise in clinical sciences, clinical operations, pharmacovigilance, CMC, regulatory, early discovery and pharmacology.

    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. Angel Pharmaceuticals was launched with strategic collaboration with U.S. biopharmaceutical company Corvus Pharmaceuticals, Inc., with investments from Zhejiang Puissance Capital, Hisun Pharmaceuticals, Tigermed and fund associated with Betta Pharmaceuticals. Angel Pharmaceuticals' initial pipeline includes licensed rights to develop and commercialize three clinical-stage candidates, mupadolimab, CPI-818 and ciforadenant, in greater China, and global commercial and IP rights for a pre-clinical stage new generation of BTK inhibitor. For more information, visit www.angelpharma.com

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidate is mupadolimab (CPI-006), a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. The Company's second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. For more information, visit  www.corvuspharma.com.

    About CPI-818

    CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. Corvus is conducting a Phase 1/1b trial in patients with refractory T-cell lymphomas in the U.S. and Angel Pharmaceuticals, which has rights to CPI-818 in China, is leading a global trial in patients with relapsed/refractory (R/R) T-cell lymphomas.

    Cision View original content:https://www.prnewswire.com/news-releases/angel-pharmaceuticals-announces-ind-acceptance-for-clinical-trial-of-itk-inhibitor-cpi-818-in-china-301355659.html

    SOURCE Angel Pharmaceuticals

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  4. BURLINGAME, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that an IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), for the initiation of a Phase 1/1b clinical trial of Corvus' small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T cell lymphomas has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). Angel Pharma plans to initiate the trial before the end of 2021 and will be responsible for all expenses related to executing the trial in China.

    "The pending initiation of a Phase 1/1b clinical trial of CPI-818…

    BURLINGAME, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that an IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), for the initiation of a Phase 1/1b clinical trial of Corvus' small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T cell lymphomas has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). Angel Pharma plans to initiate the trial before the end of 2021 and will be responsible for all expenses related to executing the trial in China.

    "The pending initiation of a Phase 1/1b clinical trial of CPI-818 in China through our partner Angel Pharma is an important milestone for our pipeline and our global growth strategy," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "In China, there is a higher prevalence of T cell lymphomas, which have limited treatment options, leaving a significant opportunity to improve clinical outcomes. Based on its proposed mechanism, CPI-818 also has the potential to expand into the treatment of autoimmune diseases over time. CPI-818 is the first-and-only clinical stage ITK-inhibitor in China and we believe that Angel Pharma is well-positioned to accelerate its development for this market and globally."

    CPI-818 is an investigational, orally bioavailable, covalent inhibitor of ITK designed to have low nanomolar affinity. In vitro studies have shown that it potently inhibited T cell receptor signal transduction. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize CPI-818 in greater China.

    Corvus is studying CPI-818 in a Phase 1/1b clinical trial that was designed to select the optimal dose of CPI-818 and evaluate its safety, pharmacokinetics (PK), target occupancy, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies. As of March 4, 2021, of seven patients with PTCL, there has been one complete response lasting over 15 months and one partial response lasting for over five months; both responses are ongoing. The interim data was presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2020.

    Separately, Corvus announced that in July 2021 Angel Pharma launched new research centers in Jiaxing, Zhejiang Province, in China and in Burlingame, CA in the United States. The new research center in China occupies over 30,000 square feet of state-of-the-art research and development facilities including chemistry, molecular biology and pharmaceutical development laboratories. The new research center in the United States occupies more than 1,000 square feet dedicated to research and development. Since its launch in October 2020, Angel Pharma has built an experienced R&D team with expertise in clinical sciences, clinical operations, pharmacovigilance, CMC, regulatory, early discovery and pharmacology.

    About Angel Pharmaceuticals

    Angel Pharma 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 Pharma was launched through a collaboration with U.S.-based Corvus Pharmaceuticals and investments from investors in China. Angel Pharma licensed the rights to develop and commercialize Corvus' three clinical-stage candidates – mupadolimab, CPI-818 and ciforadenant – in greater China and obtained global rights to Corvus' BTK inhibitor preclinical programs. Under the collaboration, Corvus initially retained a 49.7% equity stake in Angel Pharma and designated three individuals on Angel's five-person Board of Directors. For more information, visit www.angelpharma.com

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidate is mupadolimab (CPI-006), a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. The Company's second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. For more information, visit www.corvuspharma.com.

    About CPI-818

    CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. Corvus is conducting a Phase 1/1b trial in patients with refractory T-cell lymphomas in the United States and Angel Pharma, which has rights to CPI-818 in China, is leading a global Phase 1/1b trial in patients with relapsed/refractory (R/R) T-cell lymphomas.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the potential safety and efficacy of mupadolimab, CPI-818 and ciforadenant, the Company's ability and Angel Pharma's ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including Angel Pharma's plans to initiate a clinical trial of CPI-818 before the end of 2021 and whether CPI-818 has the potential to expand into the treatment of autoimmune diseases over time. 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 quarter ended June 30, 2021, filed with the Securities and Exchange Commission on or about August 2, 2021, 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 mupadolimab, CPI-818 and ciforadenant; the accuracy of the Company's estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the impact of the COVID-19 pandemic on the Company's operations and clinical development plans, as well as the operations of its partners and suppliers; 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



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  5. BURLINGAME, Calif., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the second quarter ended June 30, 2021.

    "We continue to advance mupadolimab, our anti-CD73 antibody, with a focus on HPV positive (human papilloma virus) head and neck cancer and other viral associated cancers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We believe mupadolimab is well positioned to improve patient outcomes based on its dual mechanism of inhibiting immunosuppressive adenosine and enhancing antibody responses to viruses, which have been shown to cause certain cancers. This…

    BURLINGAME, Calif., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the second quarter ended June 30, 2021.

    "We continue to advance mupadolimab, our anti-CD73 antibody, with a focus on HPV positive (human papilloma virus) head and neck cancer and other viral associated cancers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We believe mupadolimab is well positioned to improve patient outcomes based on its dual mechanism of inhibiting immunosuppressive adenosine and enhancing antibody responses to viruses, which have been shown to cause certain cancers. This is based on the known B cell stimulating properties of mupadolimab and data we have generated in cancer and viral diseases such as COVID-19. We also continue to advance our other oncology programs, including with our Chinese partner, Angel Pharmaceuticals, who recently filed an IND in China to initiate Phase 1/2 clinical development of CPI-818 for the treatment of T cell lymphomas."  

    2021 Key Areas of Focus

    The Company is efficiently advancing its clinical programs – mupadolimab, CPI-818 and ciforadenant – along with pre-clinical programs in its pipeline. The highlights from the Company's clinical pipeline include:

    Mupadolimab Expansion Clinical Trial for HPV+ Oropharyngeal Cancer

    • The Company began enrollment of a Phase1b/2 clinical trial in patients with HPV+ oropharyngeal cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the clinical trial is response rate and results are anticipated by year end 2021. HPV is a transmissible DNA virus that causes approximately 75% of head and neck cancers. The incidence of this disease has been increasing in the United States and elsewhere.

    Mupadolimab Focus on Viral Associated Cancers

    • The Company plans to evaluate mupadolimab in other viral associated tumors such as cancer of the cervix and head and neck cancers caused by Epstein Barr virus (EBV), which is a member of the herpes virus family and one of the most common human viruses.
    • In July 2021, the Company discontinued its Phase 3 clinical trial of mupadolimab in COVID-19 due to positive trends exhibited by COVID-19 vaccines in lowering serious infection and hospitalizations. The discontinuation was not related to any safety or efficacy issues observed in trial patients. As a result, the Company's projected 2021 net cash used in operating activities decreased by an estimated $11 million.

    CPI-818 Phase 2 Clinical Trial for T cell Lymphoma in Partnership with Angel Pharmaceuticals

    • Angel Pharmaceuticals has filed an investigational new drug application (IND) for CPI-818 with the Center for Drug Evaluation (CDE) in China. If approved, Angel plans to initiate a Phase 2 clinical trial of CPI-818 for the treatment of refractory T cell lymphomas in late 2021, with the potential to expand into autoimmune diseases over time.

    Ciforadenant Phase 2 Clinical Trial for Front Line RCC

    • Corvus is a leader in the development of precisely targeted therapies targeting the adenosine pathway. Ciforadenant is small molecule antagonist of the adenosine A2A receptor. It is designed to disable a tumor's ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. The Company also discovered the Adenosine Gene Signature, which has demonstrated the potential to serve as a biomarker to identify patients most likely to respond to treatment with ciforadenant.
    • The Company plans to collaborate with the Kidney Cancer Consortium to initiate a Phase 2 clinical trial of ciforadenant in first-line therapy for metastatic renal cell cancer (RCC) in combination with pembrolizumab and a tyrosine kinase inhibitor. The clinical trial is expected to enroll up to 60 patients and is intended to increase complete responses and deep responses in the front-line setting. Preclinical studies and data from earlier clinical trials with ciforadenant indicate adenosine may be a cause of resistance to current therapies with anti-PD(L)-1 and tyrosine kinase inhibitors. Tumor biopsies will be evaluated for expression of the Adenosine Gene Signature.

    Financial Results

    As of June 30, 2021, Corvus had cash, cash equivalents and marketable securities totaling $66.5 million. This compared to cash, cash equivalents and marketable securities of $44.3 million as of December 31, 2020. The increase in cash of $22.2 million resulted from the receipt of approximately $43.8 million in net proceeds from the sale of common stock through an underwritten offering and the Company's at the market equity offering program, and was reduced by $21.4 million of cash used in operating activities in the six months ended June 30, 2021. With the discontinuation of the mupadolimab Phase 3 clinical trial in COVID-19, Corvus now expects full year 2021 net cash used in operating activities to be between $35 million and $37 million, a decrease of an estimated $11 million compared to the previously expected range of $46 million and $48 million and resulting in a projected balance of cash, cash equivalents and marketable securities of between $51.1 million to $53.1 million at December 31, 2021.

    Research and development expenses for the three months ended June 30, 2021 totaled $9.1 million compared to $7.9 million for the same period in 2020. The increase of $1.2 million was primarily due to an increase in clinical trial costs for the Company's mupadolimab Phase 3 COVID-19 clinical trial, which was partially offset by lower clinical trial costs for CPI-818 and ciforadenant.   

    The net loss for the three months ended June 30, 2021 was $11.8 million compared to a net loss of $10.6 million for the same period in 2020. Total stock compensation expense for the three months ended June 30, 2021 was $1.2 million compared to $1.4 million for the same period in 2020.

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidate is mupadolimab (CPI-006), a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. The Company's second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. For more information, visit www.corvuspharma.com.

    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. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents 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. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1/1b study in patients with advanced HPV+ (human papilloma virus) head and neck cancers. It is postulated that the activation of B cells will enhance immunity to viral antigens within the tumors of these patients, leading to improved clinical outcomes.

    About CPI-818

    CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. The Company is conducting a Phase 1/1b trial in patients with refractory T-cell lymphomas.

    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 in the tumor microenvironment to the A2A receptor. 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.

    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 U.S.-based Corvus Pharmaceuticals and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus' three clinical-stage candidates – mupadolimab, CPI-818 and ciforadenant – in greater China and obtained global rights to Corvus' BTK inhibitor preclinical programs. Under the collaboration, Corvus initially retained a 49.7% equity stake in Angel Pharmaceuticals and designated three individuals on Angel's five-person Board of Directors.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the potential safety and efficacy of mupadolimab, CPI-818 and ciforadenant, the Company's ability and Angel Pharmaceutical's ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company's Phase 1b/2 clinical trial of mupadolimab , Angel's plans to initiate a Phase 2 clinical trial of CPI-818, the timing of the availability and announcement of clinical data and certain other product development milestones, the estimated amount of net cash used in operating activities for 2021 and the projected balance of cash, cash equivalents and marketable securities at December 31, 2021. 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 quarter ended June 30, 2021, filed with the Securities and Exchange Commission on or about August 2, 2021, 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 mupadolimab, CPI-818 and ciforadenant; the accuracy of the Company's estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company's ability to accurately estimate the amount of net used in operating activities for the remainder of the fiscal year; 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.





    CORVUS PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except share and per share data)

      Three Months Ended

    June 30,
     Six Months Ended

    June 30,
       2021   2020   2021   2020 
         
      (unaudited) (unaudited)
    Operating expenses:        
    Research and development $9,106  $7,857  $17,336  $18,020 
    General and administrative  2,184   2,910   5,437   6,016 
    Total operating expenses  11,290   10,767   22,773   24,036 
    Loss from operations  (11,290)  (10,767)  (22,773)  (24,036)
    Interest income and other expense, net  1   156   4   490 
    Loss from equity method investment  (463)  -   (563)  - 
    Net income (loss) $(11,752) $(10,611) $(23,332) $(23,546)
    Net income (loss) per share, basic and diluted $(0.28) $(0.36) $(0.61) $(0.80)
    Shares used to compute net loss per share, basic and diluted  42,247,094   29,428,249   38,402,464   29,419,741 



    CORVUS PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

      June 30, December 31,
       2021   2020 
      (unaudited)  
    Assets    
    Cash, cash equivalents and marketable securities $66,460  $44,259 
    Operating lease right-of-use asset  1,264   1,648 
    Other assets  3,623   2,397 
    Investment in Angel Pharmaceuticals  38,047   37,225 
    Total assets $109,394  $85,529 
    Liabilities and stockholders' equity    
    Accounts payable and accrued liabilities and other liabilities $11,207  $11,071 
    Operating lease liability  1,784   2,310 
    Stockholders' equity  96,403   72,148 
    Total liabilities and stockholders' equity $109,394  $85,529 



    INVESTOR CONTACT:

    Leiv Lea

    Chief Financial Officer

    Corvus Pharmaceuticals, Inc.

    +1-650-900-4522

    llea@corvuspharma.com

    MEDIA CONTACT:

    Sheryl Seapy

    W2O pure

    +1-949-903-4750

    sseapy@realchemistry.com



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