Corvus Pharmaceuticals(CRVS)
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Corvus Pharmaceuticals(CRVS) - 2020 Q2 - Earnings Call Transcript
2020-08-02 06:48
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) Q2 2020 Earnings Conference Call July 30, 2020 4:30 PM ET Company Participants Zack Kubow - Investor Relations, Pure Communications Leiv Lea - Chief Financial Officer Richard Miller - Chief Executive Officer Mehrdad Mobasher - Chief Medical Officer Conference Call Participants Mara Goldstein - Mizuho Tony Butler - ROTH Capital Partners Arthur He - H.C. Wainwright Operator Thank you for standing by. This is the conference operator. Welcome to the Corvus Pharmaceutic ...
Corvus Pharmaceuticals(CRVS) - 2020 Q2 - Quarterly Report
2020-07-30 22:46
PART I — FINANCIAL INFORMATION [Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Corvus Pharmaceuticals presents unaudited condensed consolidated financial statements, reporting a **$10.6 million net loss** for Q2 2020, an **accumulated deficit of $240.7 million**, and a decrease in total assets to **$64.2 million** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $20,705 | $5,154 | | Marketable securities | $38,553 | $72,828 | | **Total current assets** | **$60,561** | **$79,344** | | **Total assets** | **$64,177** | **$83,646** | | Total current liabilities | $11,553 | $10,225 | | **Total liabilities** | **$13,337** | **$12,535** | | Accumulated deficit | ($240,691) | ($217,145) | | **Total stockholders' equity** | **$50,840** | **$71,111** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,857 | $10,640 | $18,020 | $20,059 | | General and administrative | $2,910 | $2,956 | $6,016 | $5,842 | | **Total operating expenses** | **$10,767** | **$13,596** | **$24,036** | **$25,901** | | **Net loss** | **($10,611)** | **($12,978)** | **($23,546)** | **($24,621)** | | Net loss per share | ($0.36) | ($0.44) | ($0.80) | ($0.84) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) - Total stockholders' equity decreased from **$71.1 million** at December 31, 2019, to **$50.8 million** at June 30, 2020, primarily due to a **$23.5 million net loss** for the six-month period, partially offset by **$3.2 million** in stock-based compensation expense[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($18,839) | ($18,204) | | Net cash provided by investing activities | $34,367 | $9,185 | | Net cash provided by financing activities | $23 | $6 | | **Net increase (decrease) in cash** | **$15,551** | **($9,013)** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company, a clinical-stage biopharmaceutical firm, has incurred significant losses since its 2014 inception, with an **accumulated deficit of $240.7 million** as of June 30, 2020[22](index=22&type=chunk)[26](index=26&type=chunk) - As of June 30, 2020, the company held **$59.3 million** in cash, cash equivalents, and short-term marketable securities, which management believes are sufficient to support planned operations for at least the next 12 months[29](index=29&type=chunk)[34](index=34&type=chunk) - Key license and collaboration agreements with Vernalis, Scripps, Genentech, and Monash University involve potential future milestone and royalty payments[52](index=52&type=chunk)[56](index=56&type=chunk)[59](index=59&type=chunk) - In March 2020, an at-the-market (ATM) equity offering program was established with Jefferies to sell up to **$50 million** of common stock, though no shares had been sold as of June 30, 2020[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reviews the company's clinical-stage biopharmaceutical pipeline, reporting a **$23.5 million net loss** for H1 2020 and an **accumulated deficit of $240.7 million**, with **$59.3 million** in cash deemed sufficient for the next 12 months despite COVID-19 risks [Overview and Product Pipeline](index=26&type=section&id=Overview%20and%20Product%20Pipeline) - Corvus is a clinical-stage biopharmaceutical company with three main product candidates in clinical trials[89](index=89&type=chunk)[90](index=90&type=chunk) - **Ciforadenant (A2A receptor antagonist):** In a Phase 2 expansion protocol for advanced renal cell cancer (RCC) and metastatic castration-resistant prostate cancer (mCRPC)[91](index=91&type=chunk)[103](index=103&type=chunk) - **CPI-006 (anti-CD73 antibody):** In a Phase 1/1b trial for various cancers and a separate Phase 1 trial for patients with COVID-19[91](index=91&type=chunk)[109](index=109&type=chunk)[113](index=113&type=chunk) - **CPI-818 (ITK inhibitor):** In a Phase 1/1b trial for patients with T-cell lymphomas[91](index=91&type=chunk)[120](index=120&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Comparison of Operating Results (in thousands) | Period | Research & Development | General & Administrative | Net Loss | | :--- | :--- | :--- | :--- | | **Q2 2020** | $7,857 | $2,910 | ($10,611) | | **Q2 2019** | $10,640 | $2,956 | ($12,978) | | **Change** | **($2,783)** | **($46)** | **$2,367** | | **H1 2020** | $18,020 | $6,016 | ($23,546) | | **H1 2019** | $20,059 | $5,842 | ($24,621) | | **Change** | **($2,039)** | **$174** | **$1,075** | - The decrease in R&D expenses for Q2 2020 compared to Q2 2019 was primarily driven by reduced costs for the ciforadenant program (**$0.8 million decrease**) and the CPI-818 program (**$0.7 million decrease**)[137](index=137&type=chunk)[138](index=138&type=chunk)[143](index=143&type=chunk) - Interest income decreased by **$0.5 million** in Q2 2020 compared to Q2 2019, due to lower cash and marketable securities balances and a decline in interest rates[150](index=150&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2020, the company had **$59.3 million** in cash, cash equivalents, and marketable securities, with an **accumulated deficit of $240.7 million**[153](index=153&type=chunk) - Management believes current capital resources are sufficient to fund planned operations for at least the next twelve months[157](index=157&type=chunk) - In March 2020, an at-the-market (ATM) sales agreement was established to sell up to **$50 million** of common stock, but no proceeds had been received as of June 30, 2020[156](index=156&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate exposure on its **$59.3 million** cash and investment portfolio, which management deems low-risk and not materially impacted by a hypothetical 10% interest rate increase - The company's main market risk is interest rate risk on its cash and investment portfolio[171](index=171&type=chunk) - The investment portfolio, consisting of bank deposits, money market funds, U.S. Treasury and government agency securities, and corporate debt, is considered low-risk with a short-term duration[171](index=171&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2020, with no material changes in internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective as of the end of the period covered by the report[175](index=175&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[176](index=176&type=chunk) PART II — OTHER INFORMATION [Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) Corvus Pharmaceuticals is not currently involved in any material litigation or legal proceedings - As of the filing date, Corvus Pharmaceuticals is not involved in any material legal proceedings[179](index=179&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including limited operating history, substantial financing needs, COVID-19 impact, early-stage product development failures, reliance on third parties, commercialization challenges, intellectual property issues, and stock price volatility [Risks Related to Financial Condition and Capital Requirements](index=48&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Condition%20and%20Capital%20Requirements) - The company has a limited operating history, has incurred significant losses since its 2014 inception (**accumulated deficit of $240.7 million** as of June 30, 2020), and expects losses to continue[181](index=181&type=chunk)[182](index=182&type=chunk) - Substantial additional financing is required to achieve goals, and failure to obtain it could force delays or termination of development programs[183](index=183&type=chunk)[184](index=184&type=chunk) - The COVID-19 pandemic poses significant risks that could adversely impact business, clinical trials, and financial condition, including enrollment delays and supply chain interruptions[191](index=191&type=chunk)[192](index=192&type=chunk) [Risks Related to Discovery and Development](index=52&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Product%20Candidates) - Product candidates are in early stages of development and may fail or suffer delays, which would materially harm the business[197](index=197&type=chunk)[198](index=198&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process; results from early trials are not necessarily predictive of future results[205](index=205&type=chunk)[206](index=206&type=chunk) - Interim and preliminary data from clinical trials may change as more patient data becomes available, potentially resulting in material changes in final data[221](index=221&type=chunk)[222](index=222&type=chunk) [Risks Related to Reliance on Third Parties](index=70&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) - The company relies on third parties, such as CROs and medical institutions, to conduct its clinical trials, and their poor performance could delay or derail development programs[257](index=257&type=chunk)[258](index=258&type=chunk) - The company lacks internal manufacturing capabilities and is dependent on contract manufacturers, who are subject to significant cGMP regulations and potential supply disruptions[266](index=266&type=chunk)[267](index=267&type=chunk) - Reliance on third parties requires sharing trade secrets, which increases the risk of misappropriation or disclosure[275](index=275&type=chunk)[276](index=276&type=chunk) [Risks Related to Commercialization](index=75&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Product%20Candidates) - Successful commercialization depends on many factors, including regulatory approval, manufacturing scale-up, market acceptance, and competition[279](index=279&type=chunk)[280](index=280&type=chunk) - Failure to obtain or maintain adequate coverage and reimbursement from government and private payors could limit the ability to market products and generate revenue[300](index=300&type=chunk)[301](index=301&type=chunk) - The company faces intense competition from larger, better-funded pharmaceutical and biotech companies with more resources and established products[330](index=330&type=chunk)[331](index=331&type=chunk)[333](index=333&type=chunk) [Risks Related to Intellectual Property](index=103&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company relies on license agreements for key product candidates like ciforadenant and CPI-006, and failure to comply could result in the loss of rights[392](index=392&type=chunk)[393](index=393&type=chunk) - The company's success depends on its ability to obtain and maintain patent protection and protect trade secrets, which is an uncertain, expensive, and time-consuming process[398](index=398&type=chunk)[403](index=403&type=chunk) - The company may be involved in costly and unsuccessful lawsuits to protect its patents or defend against claims of infringement on others' proprietary rights[406](index=406&type=chunk)[413](index=413&type=chunk) [Risks Related to Common Stock](index=118&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) - The trading price of the company's common stock has been and could continue to be highly volatile[448](index=448&type=chunk) - As of June 30, 2020, executive officers, directors, and stockholders with over 5% ownership collectively held approximately **63%** of the voting stock, giving them significant control over corporate matters[453](index=453&type=chunk)[454](index=454&type=chunk) - The company is an 'emerging growth company' and its use of reduced reporting requirements may make its common stock less attractive to some investors[461](index=461&type=chunk)[462](index=462&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=128&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the reporting period - There were no unregistered sales of equity securities in the quarter[478](index=478&type=chunk) [Defaults Upon Senior Securities](index=130&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon its senior securities - None[480](index=480&type=chunk) [Mine Safety Disclosures](index=130&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[480](index=480&type=chunk) [Other Information](index=130&type=section&id=Item%205.%20Other%20Information) No other information required for disclosure in this section was reported - None[480](index=480&type=chunk) [Exhibits](index=131&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and required CEO/CFO certifications - The report includes a list of all exhibits filed, including corporate governance documents and required CEO/CFO certifications[483](index=483&type=chunk)
Corvus Pharmaceuticals(CRVS) - 2020 Q1 - Earnings Call Transcript
2020-05-02 13:58
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) Q1 2020 Earnings Conference Call April 30, 2020 4:30 PM ET Company Participants Zack Kubow - Investor Relations, Pure Communications Richard Miller - President & Chief Executive Officer Leiv Lea - Chief Financial Officer Mehrdad Mobasher - Chief Medical Officer Conference Call Participants Mara Goldstein - Mizuho Tony Butler - Roth Capital Swayampakula Ramakanth - H.C. Wainwright Gabriel Fung - Mizuho Securities Operator Good afternoon, ladies and gentlemen. Thank ...
Corvus Pharmaceuticals(CRVS) - 2020 Q1 - Quarterly Report
2020-04-30 20:16
Table of Contents- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Corvus Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37719 46-4670809 (State or other jurisdiction of incorporation) (Commissi ...
Corvus Pharmaceuticals(CRVS) - 2019 Q4 - Annual Report
2020-03-09 20:08
Part I [Business](index=5&type=section&id=Item%201.%20Business) Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company developing targeted oncology therapies, with a pipeline of clinical and preclinical programs and a strategy focused on biomarker-driven patient selection and collaborations - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing precisely targeted oncology therapies, with **five programs** in its pipeline, **three** of which are in international multicenter trials[17](index=17&type=chunk) Product Pipeline Overview | Product Candidate | Target/Mechanism | Key Indication(s) | Development Stage | | :--- | :--- | :--- | :--- | | **Ciforadenant** | Adenosine A2A Receptor Antagonist | Renal Cell Cancer (RCC), Prostate Cancer (mCRPC) | Phase 1b/2 | | **CPI-006** | Anti-CD73 Antibody | Multiple Cancers | Phase 1/1b | | **CPI-818** | ITK Inhibitor | T-Cell Lymphoma | Phase 1/1b | | **CPI-182** | Anti-CXCR2 Antibody | Multiple Cancers | IND-Enabling | | **CPI-935** | Adenosine A2B Receptor Antagonist | Fibrosis, Cancer | Development Candidate Selected | - The company's strategy emphasizes leveraging immunology and oncology expertise, efficient adaptive clinical trial designs, developing standalone and combination therapies, biomarker-driven patient selection, and collaborative relationships[30](index=30&type=chunk)[31](index=31&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - Corvus relies on third-party contract manufacturers for clinical and potential commercial supply of its product candidates, enabling an efficient infrastructure and focus on development[97](index=97&type=chunk) [Ciforadenant (A2A Receptor Antagonist)](index=5&type=section&id=Ciforadenant%20(A2A%20Receptor%20Antagonist)) Ciforadenant, an oral A2A receptor antagonist, is in Phase 2 trials for RCC and mCRPC, showing anti-tumor activity and well-tolerated profile, with an identified predictive biomarker and patent expiry in July 2029 - Ciforadenant, an oral A2A receptor antagonist, is being studied in combination with Genentech's Tecentriq (atezolizumab) for advanced, refractory renal cell cancer (RCC) and metastatic castration-resistant prostate cancer (mCRPC)[17](index=17&type=chunk)[19](index=19&type=chunk) - Clinical trials indicate ciforadenant is **well-tolerated**, demonstrates **anti-tumor activity** as monotherapy and in combination, with RCC, mCRPC, and NSCLC appearing most responsive[19](index=19&type=chunk)[21](index=21&type=chunk)[61](index=61&type=chunk) - An adenosine gene expression signature has been identified, correlating with tumor response and progression-free survival in RCC patients, potentially serving as a **predictive biomarker**[21](index=21&type=chunk)[34](index=34&type=chunk)[67](index=67&type=chunk) Interim RCC Trial Results (Published Jan 2020) | Metric | Combination Therapy (ciforadenant + atezolizumab) | Monotherapy (ciforadenant) | | :--- | :--- | :--- | | **Overall Survival (OS)** | 90% at 25 months follow-up | 69% at 16 months follow-up | | **Progression-Free Survival (PFS)** | 5.8 months | 4.1 months | | **Disease Control (>6 months)** | 39% of patients | 17% of patients | | **Confirmed Partial Response (PR)** | 11% of patients | 1 patient | [CPI-006 (Anti-CD73 Antibody)](index=7&type=section&id=CPI-006%20(Anti-CD73%20Antibody)) CPI-006, an immunomodulatory anti-CD73 monoclonal antibody, is in Phase 1/1b trials as monotherapy and in combination, showing novel immunomodulatory activities and tumor regression in RCC and mCRPC patients - CPI-006, an anti-CD73 monoclonal antibody, is in a Phase 1/1b trial as a single agent and in combination with ciforadenant and pembrolizumab, designed to inhibit adenosine production and stimulate immune cells[23](index=23&type=chunk)[79](index=79&type=chunk) - Interim data indicates CPI-006 exhibits novel immunomodulatory activities, including B-cell differentiation and activation, with a recommended dose of **18 mg/kg** for further study[81](index=81&type=chunk)[82](index=82&type=chunk) - Tumor regression has been observed in predefined cohorts of patients with Renal Cell Carcinoma (RCC) and metastatic Castration-Resistant Prostate Cancer (mCRPC)[84](index=84&type=chunk) [CPI-818 (ITK Inhibitor)](index=7&type=section&id=CPI-818%20(ITK%20Inhibitor)) CPI-818, a selective ITK inhibitor for T-cell lymphomas, initiated Phase 1/1b study in March 2019, showing good tolerability, target occupancy, and early clinical activity including lymphadenopathy reduction - CPI-818 is a selective, covalent inhibitor of ITK, an enzyme in T-cells, being developed for T-cell lymphomas, with a Phase 1/1b study initiated in **March 2019**[25](index=25&type=chunk)[88](index=88&type=chunk) - As of **February 2020**, **16 patients** enrolled in the dose-escalation phase showed no dose-limiting toxicities, with the drug well tolerated and achieving increasing target occupancy[91](index=91&type=chunk)[93](index=93&type=chunk) - Early clinical activity includes lymphadenopathy reduction in one Cutaneous T-cell Lymphoma (CTCL) patient and improved cutaneous disease in another CTCL patient[92](index=92&type=chunk) [Licenses and Collaborations](index=21&type=section&id=Licenses%20and%20Collaborations) Corvus maintains key licensing agreements for ciforadenant (Vernalis), CPI-006 (Scripps), and an anti-CXCR2 antibody (Monash University), alongside clinical trial collaborations with Genentech for ciforadenant and Tecentriq Key Licensing and Collaboration Agreements | Partner | Asset/Program | Key Financial Terms | | :--- | :--- | :--- | | **Vernalis** | Ciforadenant | $1.0M upfront, $3M milestone paid, up to ~$220M total milestones, mid-single to low-double digit royalties | | **Scripps** | CPI-006 | $10k upfront, $25k annual fee, up to $2.6M milestones, low-single digit royalties | | **Genentech** | Ciforadenant + Tecentriq | Two clinical trial collaborations. Corvus is responsible for its Phase 1/1b trial costs; costs are shared for the Phase 1b/2 Morpheus trial. Genentech supplies Tecentriq | | **Monash University** | Anti-CXCR2 Antibody (CPI-182) | $275k upfront, $25k annual fee, up to $45.1M milestones, low-single digit royalties | [Regulation](index=23&type=section&id=Regulation) The company's products are subject to extensive FDA and international regulation, requiring multi-phase clinical trials and compliance with manufacturing, marketing, and safety reporting, alongside broader healthcare laws and reform measures - The FDA drug development process mandates preclinical studies, IND submission, and adequate human clinical trials (Phase 1, 2, and 3) prior to NDA or BLA submission[126](index=126&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk) - The FDA offers expedited development and review programs, including Fast Track, priority review, accelerated approval, and Breakthrough Therapy Designation, for drugs addressing serious conditions and unmet medical needs[149](index=149&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk) - The company is subject to various healthcare laws, including the federal Anti-Kickback Statute, False Claims Act, HIPAA, and the Physician Payments Sunshine Act, which restrict pharmaceutical business practices[186](index=186&type=chunk)[188](index=188&type=chunk) - Healthcare reform, including the Affordable Care Act (ACA), and other cost-containment measures by government and third-party payors may impact product coverage, reimbursement, and pricing if approved[196](index=196&type=chunk)[198](index=198&type=chunk)[200](index=200&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including limited operating history, substantial losses, need for future financing, high development uncertainty, reliance on third parties, commercialization challenges, intellectual property protection, competition, product liability, cybersecurity, and stock price volatility - The company has a limited operating history, incurring **$217.1 million** in accumulated deficit as of **December 31, 2019**, and anticipates significant losses for the foreseeable future[215](index=215&type=chunk)[216](index=216&type=chunk) - Substantial additional financing is required, and failure to obtain necessary capital could delay, reduce, or terminate product development and commercialization efforts[218](index=218&type=chunk)[221](index=221&type=chunk) - Product candidates are in early development stages, and clinical drug development is a lengthy, expensive process with uncertain outcomes, where early trial results are not necessarily predictive of future results[226](index=226&type=chunk)[237](index=237&type=chunk) - The company relies on third parties for clinical trials and manufacturing, and their unsatisfactory performance could delay or prevent product candidate development and commercialization[280](index=280&type=chunk)[287](index=287&type=chunk)[289](index=289&type=chunk) - Protecting intellectual property is crucial, as the company faces risks of patent invalidation, third-party infringement claims, and potential loss of trade secrets[408](index=408&type=chunk)[412](index=412&type=chunk)[421](index=421&type=chunk) [Unresolved Staff Comments](index=81&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) None [Properties](index=81&type=section&id=Item%202.%20Properties) The company leases approximately 27,280 square feet of office and research and development facilities in Burlingame, California, with the lease expiring in 2023 - The company leases approximately **27,280 square feet** of office and R&D space in Burlingame, CA, with the lease expiring in **2023**[492](index=492&type=chunk) [Legal Proceedings](index=81&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings [Mine Safety Disclosures](index=81&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable Part II [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=82&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Corvus Pharmaceuticals' common stock trades on The Nasdaq Global Market under "CRVS", with approximately **25 stockholders** of record as of **March 9, 2020**, and the company has never paid cash dividends nor anticipates doing so, retaining earnings for business operations - The company's common stock is listed on The Nasdaq Global Market under the symbol **"CRVS"**[497](index=497&type=chunk) Quarterly Stock Price Range (2018-2019) | Period | High ($) | Low ($) | | :--- | :--- | :--- | | **2019 Q4** | 5.10 | 2.53 | | **2019 Q3** | 8.10 | 2.91 | | **2019 Q2** | 4.75 | 3.23 | | **2019 Q1** | 5.44 | 3.55 | | **2018 Q4** | 9.19 | 3.22 | | **2018 Q3** | 11.53 | 8.50 | | **2018 Q2** | 13.91 | 9.05 | | **2018 Q1** | 11.64 | 7.42 | - The company has never declared or paid cash dividends and does not anticipate paying any in the foreseeable future[500](index=500&type=chunk) [Selected Financial Data](index=84&type=section&id=Item%206.%20Selected%20Financial%20Data) This section summarizes the company's financial data from **2015** to **2019**, highlighting consistent operating losses, a **$46.7 million** net loss in **2019**, **$38.0 million** in R&D expenses, and **$78.0 million** in cash, cash equivalents, and marketable securities as of **December 31, 2019** Selected Financial Data (in thousands, except per share data) | | 2019 | 2018 | 2017 | 2016 | 2015 | | :--- | :--- | :--- | :--- | :--- | :--- | | **Statements of Operations Data** | | | | | | | Research and development | $37,975 | $38,586 | $46,305 | $29,356 | $11,352 | | General and administrative | $10,879 | $10,636 | $10,219 | $7,620 | $2,418 | | Loss from operations | $(48,854) | $(49,222) | $(56,524) | $(36,976) | $(13,770) | | Net loss | $(46,672) | $(46,939) | $(55,663) | $(36,375) | $(31,335) | | Net loss per share, basic and diluted | $(1.59) | $(1.71) | $(2.72) | $(2.36) | $(83.86) | | **Balance Sheet Data (End of Period)** | | | | | | | Cash, cash equivalents and marketable securities | $77,982 | $114,597 | $90,055 | $134,896 | $94,386 | | Total assets | $83,646 | $118,232 | $94,775 | $140,150 | $98,459 | | Total stockholders' equity (deficit) | $71,111 | $110,336 | $84,835 | $132,801 | $(31,101) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=85&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In **2019**, Corvus Pharmaceuticals reported a net loss of **$46.7 million**, with R&D expenses decreasing to **$38.0 million** due to reduced ciforadenant costs offset by increased spending on CPI-006 and CPI-818 trials, ending the year with **$78.0 million** in cash, sufficient for the next **12 months** Comparison of Operating Results (in thousands) | | Year Ended Dec 31, 2019 | Year Ended Dec 31, 2018 | Change | | :--- | :--- | :--- | :--- | | Research and development | $37,975 | $38,586 | $(611) | | General and administrative | $10,879 | $10,636 | $243 | | **Total operating expenses** | **$48,854** | **$49,222** | **$(368)** | | Loss from operations | $(48,854) | $(49,222) | $368 | | Net loss | $(46,672) | $(46,939) | $267 | Research & Development Expense by Program (in thousands) | Program | 2019 | 2018 | Change | | :--- | :--- | :--- | :--- | | Ciforadenant | $5,750 | $10,378 | $(4,628) | | CPI-006 | $6,774 | $6,108 | $666 | | CPI-818 | $6,577 | $4,707 | $1,870 | | Other programs | $981 | $877 | $104 | | Unallocated employee and overhead | $17,893 | $16,516 | $1,377 | | **Total R&D Expense** | **$37,975** | **$38,586** | **$(611)** | - The **$4.628 million** decrease in ciforadenant costs in **2019** was primarily due to lower drug manufacturing costs (**$2.8 million**) and reduced clinical trial expenses (**$1.3 million**) as enrollment focused on RCC and mCRPC patients[529](index=529&type=chunk) - As of **December 31, 2019**, the company held **$78.0 million** in cash, cash equivalents, and marketable securities, which management believes are sufficient to support planned operations for at least the next **12 months**[543](index=543&type=chunk)[546](index=546&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=94&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk stems from interest rate changes affecting its **$78.0 million** portfolio of cash, cash equivalents, and marketable securities as of **December 31, 2019**, though management believes a **10%** interest rate increase would not materially impact its fair value due to the portfolio's short-term, low-risk nature - The company's primary market risk relates to interest rate changes on its **$78.0 million** portfolio of cash, cash equivalents, and marketable securities[570](index=570&type=chunk) - Due to the short-term and low-risk nature of the investment portfolio, the company does not believe interest rate fluctuations would materially affect its fair market value[570](index=570&type=chunk) [Financial Statements and Supplementary Data](index=95&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited financial statements for fiscal years ended **December 31, 2019, 2018, and 2017**, including Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Changes in Stockholders' Equity, and Statements of Cash Flows, along with accompanying notes Key Financial Statement Data (Year Ended Dec 31, 2019) | Metric | Amount (in thousands) | | :--- | :--- | | **Balance Sheet** | | | Total Assets | $83,646 | | Total Liabilities | $12,535 | | Total Stockholders' Equity | $71,111 | | **Statement of Operations** | | | Total Operating Expenses | $48,854 | | Net Loss | $(46,672) | | Net Loss Per Share | $(1.59) | | **Statement of Cash Flows** | | | Net Cash Used in Operating Activities | $(37,321) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=119&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) None [Controls and Procedures](index=119&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and internal control over financial reporting were effective as of **December 31, 2019**, with no material changes during the fiscal year, and no auditor attestation report is required as an emerging growth company - Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2019**[699](index=699&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of **December 31, 2019**, based on the **COSO 2013 framework**[701](index=701&type=chunk) - As an emerging growth company, the company is exempt from the requirement to include an auditor's attestation report on internal controls[704](index=704&type=chunk) [Other Information](index=120&type=section&id=Item%209B.%20Other%20Information) Not applicable Part III [Directors, Executive Officers and Corporate Governance](index=121&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details the company's board of directors and executive officers as of **January 31, 2020**, highlighting the classified board structure, Dr. Richard A. Miller's leadership, the three standing committees (Audit, Compensation, Nominating and Corporate Governance), and the company's risk oversight framework and code of conduct - The Board of Directors is classified into **three classes** with staggered **three-year terms**[711](index=711&type=chunk) - The board has three standing committees: an Audit Committee, a Compensation Committee, and a Nominating and Corporate Governance Committee[730](index=730&type=chunk) - Risk oversight is administered by the board as a whole, with specific responsibilities delegated to the Audit Committee (financial risk), Nominating and Governance Committee (governance guidelines), and Compensation Committee (compensation-related risk)[729](index=729&type=chunk) [Executive Compensation](index=129&type=section&id=Item%2011.%20Executive%20Compensation) This section details **2019** compensation for non-employee directors and named executive officers (NEOs), including CEO Richard A. Miller (**$1.1 million**), CFO Leiv Lea (**$0.75 million**), and CMO Mehrdad Mobasher (**$1.36 million**), comprising base salary, bonuses, and stock options, alongside change in control and severance benefits 2019 Director Compensation | Name | Fees Earned in Cash ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | | Ian T. Clark | 45,000 | 38,552 | 83,552 | | Elisha P. (Terry) Gould III | 43,000 | 38,552 | 81,552 | | Linda S. Grais, M.D. J.D. | 32,667 | 123,622 | 156,289 | | Steve E. Krognes | 51,000 | 38,552 | 89,552 | | Scott W. Morrison | 61,000 | 38,552 | 99,552 | | Peter Thompson, M.D. | 47,000 | 38,552 | 85,552 | 2019 Summary Compensation Table (NEOs) | Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | Richard A. Miller, M.D. (CEO) | 2019 | 300,000 | — | 795,039 | 1,098,039 | | Leiv Lea (CFO) | 2019 | 349,308 | — | 397,520 | 749,828 | | Mehrdad Mobasher, M.D. (CMO) | 2019 | 406,731 | 245,000 | 702,425 | 1,357,156 | - The company has employment agreements with its NEOs providing for severance payments and accelerated vesting of equity awards upon certain termination events, including change in control[789](index=789&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=134&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of **January 31, 2020**, executive officers and directors as a group beneficially owned approximately **13.8%** of outstanding common stock, with major shareholders including OrbiMed Private Investments V, L.P. (**24.21%**), Adams Street Partners (**11.72%**), Novo Holdings A/S (**10.47%**), and BVF, Inc. (**9.99%**), based on **27,953,233 shares** outstanding Security Ownership of 5% and Greater Stockholders (as of Jan 31, 2020) | Name of Beneficial Owner | Number of Shares Beneficially Owned | Percent of Total | | :--- | :--- | :--- | | OrbiMed Private Investments V, L.P. | 6,767,584 | 24.21% | | Entities affiliated with Adams Street Partners | 3,275,616 | 11.72% | | Novo Holdings A/S | 2,927,560 | 10.47% | | BVF, Inc. | 2,921,177 | 9.99% | - All executive officers and directors as a group beneficially owned **13,814,000 shares**, representing a significant ownership stake[802](index=802&type=chunk)[816](index=816&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=137&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has a written policy for reviewing and approving related party transactions, overseen by the audit committee, and the board has determined all directors, except CEO Dr. Richard A. Miller, are independent under Nasdaq listing requirements - The company has adopted a written policy for the review and approval of related party transactions, overseen by the audit committee[823](index=823&type=chunk) - The Board of Directors has determined that all directors are independent under Nasdaq listing requirements, with the exception of Dr. Miller, who is an employee of the company[829](index=829&type=chunk) [Principal Accounting Fees and Services](index=139&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) This section details fees billed by PricewaterhouseCoopers LLP, the company's independent registered public accounting firm, for fiscal years **2019** and **2018**, with all services pre-approved by the audit committee Accountant Fees (in thousands) | Fee Category | Fiscal Year 2019 | Fiscal Year 2018 | | :--- | :--- | :--- | | Audit Fees | $551,000 | $625,226 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | All Other Fees | $900 | $900 | | **Total** | **$551,900** | **$626,126** | Part IV [Exhibits and Financial Statement Schedules](index=140&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements, schedules, and exhibits filed as part of the Annual Report on Form 10-K, with financial statements under Item 8 and schedules omitted if not applicable or provided elsewhere, alongside a detailed index of exhibits - The financial statements required by this item are filed under **Item 8** of this report[841](index=841&type=chunk) - All financial statement schedules have been omitted because they are not applicable or the necessary information is included in the financial statements or notes[841](index=841&type=chunk) [Form 10-K Summary](index=143&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has elected not to include a summary of the information required by Form 10-K under this optional item
Corvus Pharmaceuticals(CRVS) - 2019 Q4 - Earnings Call Transcript
2020-03-06 01:41
Financial Data and Key Metrics Changes - As of December 31, 2019, the company had cash, cash equivalents, and marketable securities totaling $78 million, down from $114.6 million at the end of 2018 [5] - Research and development expenses for Q4 2019 were $8.9 million, compared to $8.4 million in Q4 2018, primarily due to increased costs for CPI-006 and CPI-818 programs [5] - The net loss for Q4 2019 was $11 million, compared to a net loss of $10.5 million for the same period in 2018 [7] - For the full year 2019, the net loss was $46.7 million, slightly improved from a net loss of $46.9 million in 2018 [7] Business Line Data and Key Metrics Changes - The company reported encouraging data from the Phase Ib/2 clinical trial of ciforadenant in combination with atezolizumab for advanced refractory renal cell cancer, with over 300 patients treated [9] - CPI-006, a novel anti-CD73 antibody, showed potential as both a monotherapy and in combination therapies across various tumor types [10] - CPI-818, an ITK inhibitor, is in the early stages of clinical trials, with initial data presented at recent conferences [20] Market Data and Key Metrics Changes - The Adenosine Gene Signature has been identified as a potential predictive biomarker for ciforadenant, indicating a subgroup of renal cell cancer patients who may benefit from treatment [15] - The company is focusing on late-line treatment for patients who have failed prior therapies, which is becoming a significant patient population due to advancements in earlier lines of treatment [38] Company Strategy and Development Direction - The company aims to advance its clinical studies for ciforadenant, CPI-006, and CPI-818, with a focus on the adenosine pathway and its implications in oncology [11][21] - There is a strategic emphasis on identifying patients most likely to benefit from therapies, particularly through the use of the Adenosine Gene Signature [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in 2019 and the potential for their product candidates to address significant unmet needs in oncology [8] - The company plans to provide updates on clinical and biomarker data at the ASCO annual meeting in June, which is expected to enhance their positioning in the market [16][21] Other Important Information - The company is exploring the combination of ciforadenant with daratumumab in multiple myeloma patients, leveraging the role of CD38 in adenosine production [35][36] - Management highlighted the importance of D-cells in predicting responses to immunotherapy, which aligns with their ongoing research efforts [19] Q&A Session Summary Question: Antibodies produced in patients treated with CPI-006 - Management observed low target antibody responses in some patients, with one identified antigen being a known lung tumor antigen [24] Question: Updates on CPI-006 data - Updates on CPI-006 are expected to be presented at the ASCO meeting, with a focus on the biomarker data [24] Question: Incorporation of the adenosine signature into clinical trials - The company is enrolling additional patients to confirm findings related to the adenosine signature and plans to incorporate it into clinical trial designs [26] Question: Confirmation of the dose for CPI-818 - The confirmed dose for CPI-818 is 600 milligrams TID, with no observed toxicity during the DLT period [28] Question: Details on additional RCC patients - The additional 25 RCC patients are similar to previous patients but with a restriction on prior therapies, focusing on those who have failed both IO and TKI treatments [30] Question: Expected patient data for ciforadenant and prostate cancer - Approximately 33 to 35 patients are being followed for prostate cancer, with more biological data expected at the ASCO meeting [32] Question: Opening of combination dosing with pembrolizumab - The combination dosing with pembrolizumab is already open for enrollment [34]
Corvus Pharmaceuticals(CRVS) - 2019 Q3 - Quarterly Report
2019-10-30 00:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Corvus Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37719 46-4670809 (State or other jurisdiction of incorporation) (Commi ...
Corvus Pharmaceuticals(CRVS) - 2019 Q3 - Earnings Call Transcript
2019-10-30 00:22
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) Q3 2019 Results Conference Call October 29, 2019 4:30 PM ET Company Participants Zack Kubow - IR, Pure Communications Richard Miller - CEO Leiv Lea - CFO Dr. Stephen Willingham - Senior Scientist Conference Call Participants Biren Amin - Jefferies Tony Butler - ROTH Capital Partners Operator Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Corvus Pharmaceuticals Third Quarter 2019 Update and Financial Results Webcast. Today's conf ...
Corvus Pharmaceuticals (CRVS) Presents At Wedbush PacGrow Healthcare Conference - Slideshow
2019-08-16 20:30
Corvus Corporate Presentation Wedbush Healthcare Conference Aug 14, 2019 Forward-Looking Statements / Safe Harbor 2 This presentation and the accompanying oral presentation contain "forward‐looking" statements, including statements related to the potential safety and efficacy of CPI-006, ciforadenant and CPI-818, the potential similarities of BTK inhibition and ITK inhibition, the Company's ability to develop and advance product candidates into and successfully complete preclinical studies and clinical tria ...
Corvus Pharmaceuticals(CRVS) - 2019 Q2 - Earnings Call Transcript
2019-08-04 19:31
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) Q2 2019 Earnings Conference Call August 1, 2019 4:30 PM ET Company Participants Zack Kubow - IR, Pure Communications Leiv Lea - CFO Richard Miller - President & CEO Conference Call Participants Michael Morabito - Crédit Suisse Operator Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Corvus Pharmaceuticals Second Quarter 2019 Business Update and Financial Results Conference Call. As a reminder, today's conference is being recorded ...