Corvus Pharmaceuticals(US:CRVS)2020-10-29 20:15Financial Performance - The net loss for the nine months ended September 30, 2020, was $33.3 million, with an accumulated deficit of $250.5 million as of the same date [97]. - The company has not generated any revenues to date and does not expect to until regulatory approval and commercialization of its products [138]. - The net loss for the nine months ended September 30, 2020, was $33.342 million, an improvement of $2.283 million compared to a net loss of $35.625 million for the same period in 2019 [147]. - Cash used in operating activities during the nine months ended September 30, 2020, was $26.571 million, primarily due to a net loss of $33.3 million [171]. - Cash used in operating activities for the nine months ended September 30, 2019, was $28.8 million, primarily due to a net loss of $35.6 million, adjusted by non-cash charges of $5.6 million [172]. - The company reported a net increase in cash and cash equivalents of $17.822 million for the nine months ended September 30, 2020, compared to a decrease of $30.129 million for the same period in 2019 [170]. Clinical Trials and Product Development - Ciforadenant, the company's lead product candidate, has shown evidence of anti-tumor activity as a monotherapy and in combination with atezolizumab [110]. - The company has enrolled over 300 patients in the Phase 1/1b clinical trial for ciforadenant, which includes various solid tumor types [109]. - The company is developing CPI-006, an anti-CD73 monoclonal antibody, currently in a Phase 1/1b clinical trial [95]. - CPI-818, a selective inhibitor of ITK, is in a multi-center Phase 1/1b clinical trial for patients with various malignant T-cell lymphomas [95]. - The objective response rate (ORR) for ciforadenant in adenosine signature positive patients was 17% based on data from 51 patients, while the ORR was 0% in the negative group [112]. - In a clinical trial of CPI-006, 90 cancer patients were treated, with a maximum dose of 24 mg/kg every three weeks, showing evidence of B-cell activation [115]. - CPI-006 demonstrated a dose-response relationship, with IgG and IgM titers significantly higher in the 1.0 mg/kg cohort compared to the 0.3 mg/kg cohort, with day 56 IgG titers at 204,800 vs. 49,519 [127]. - 14 out of 15 patients treated with CPI-006 were discharged from the hospital with clinical improvement after a median of 4.5 days [124]. - CPI-818 has shown substantial ITK target occupancy and was well-tolerated in a Phase 1/1b clinical trial, with a confirmed complete response in one patient with peripheral T-cell lymphoma [133]. - A Phase 1 clinical trial for CPI-006 in COVID-19 patients is expected to enroll up to 30 patients, with primary efficacy endpoints focused on changes in serum immunoglobulin levels [118]. - The company is currently conducting multiple clinical trials, including Phase 1/1b trials for ciforadenant and CPI-006, and plans to initiate pivotal trials for CPI-006 in hospitalized COVID-19 patients [141]. - The company plans to present updated clinical data from the CPI-818 trial at the ASH annual meeting in December 2020 [134]. Financial Resources and Funding - As of September 30, 2020, the company had capital resources of approximately $51.4 million, which are insufficient to fund ongoing or planned clinical trials [101]. - The company expects to increase spending related to the development and commercialization of product candidates, with funding primarily through equity and/or debt financings [167]. - The company has not sold any shares under the Sales Agreement with Jefferies LLC as of September 30, 2020 [99]. - The company has paused work on CPI-182 due to the COVID-19 pandemic, despite having begun IND-enabling studies and scale-up manufacturing [105]. - Research and development expenses primarily consist of employee-related costs, external research expenses, and costs to acquire technologies, with no material changes reported during the nine months ended September 30, 2020 [140]. - Research and development expenses for the three months ended September 30, 2020, were $6.619 million, a decrease of $2.377 million compared to $8.996 million for the same period in 2019 [147]. - General and administrative expenses for the three months ended September 30, 2020, increased by $0.709 million to $3.226 million compared to $2.517 million for the same period in 2019 [147]. - As of September 30, 2020, the company had cash, cash equivalents, and marketable securities of $51.4 million, down from $78.0 million as of December 31, 2019 [163]. - Cash provided in investing activities for the nine months ended September 30, 2020, was $44.3 million, consisting of proceeds from maturities of marketable securities of $78.8 million [173]. - Cash provided by financing activities for the nine months ended September 30, 2020, was $0.1 million, from proceeds of stock options exercised [175]. Company Status and Market Conditions - The company formed Angel Pharmaceuticals, a wholly-owned subsidiary, with a post-money valuation of approximately $106.0 million, based on a $41.0 million cash investment from a Chinese investor group [100]. - The company remains an emerging growth company until certain revenue or market value thresholds are met, with a total annual gross revenue threshold of $1.07 billion [179]. - The company has not entered into any off-balance sheet arrangements and does not hold any variable interest entities [176]. - There have been no material changes to the company's contractual obligations during the nine months ended September 30, 2020 [178]. - The company has opted not to take advantage of exemptions under the JOBS Act regarding new or revised accounting standards [179]. - An immediate 10% increase in interest rates would not materially affect the fair market value of the company's investment portfolio due to its short-term duration and low risk profile [180]. - The company acknowledges numerous uncertainties related to the timing and costs of clinical trials, which may impact the successful development of product candidates [143].