Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Aug. 01, 2019 | |
Document And Entity Information | ||
Entity Registrant Name | Corvus Pharmaceuticals, Inc. | |
Entity Central Index Key | 0001626971 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 29,390,400 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 30,183 | $ 39,196 |
Marketable securities | 66,657 | 75,401 |
Prepaid and other current assets | 1,305 | 992 |
Total current assets | 98,145 | 115,589 |
Property and equipment, net | 1,824 | 2,180 |
Operating lease right-of-use asset | 2,634 | |
Other assets | 513 | 463 |
Total assets | 103,116 | 118,232 |
Current liabilities: | ||
Accounts payable | 2,638 | 1,998 |
Operating lease liability current | 820 | |
Accrued and other liabilities | 7,244 | 5,029 |
Total current liabilities | 10,702 | 7,027 |
Operating lease liability noncurrent | 2,760 | |
Other liabilities | 869 | |
Total liabilities | 13,462 | 7,896 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Preferred stock: $0.0001 par value; 10,000,000 shares authorized at June 30, 2019 and December 31, 2018; 0 shares issued and outstanding at June 30, 2019 and December 31, 2018 | ||
Common stock: $0.0001 par value; 290,000,000 shares authorized at June 30, 2019 and December 31, 2018; 29,348,400 and 29,323,930 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 3 | 3 |
Additional paid-in capital | 284,706 | 280,840 |
Accumulated other comprehensive income (loss) | 39 | (34) |
Accumulated deficit | (195,094) | (170,473) |
Total stockholders' equity | 89,654 | 110,336 |
Total liabilities and stockholders' equity | $ 103,116 | $ 118,232 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 290,000,000 | 290,000,000 |
Common stock, shares issued | 29,348,400 | 29,323,930 |
Common stock, shares outstanding | 29,348,400 | 29,323,930 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating expenses: | ||||
Research and development | $ 10,640 | $ 9,715 | $ 20,059 | $ 21,818 |
General and administrative | 2,956 | 2,543 | 5,842 | 5,084 |
Total operating expenses | 13,596 | 12,258 | 25,901 | 26,902 |
Loss from operations | (13,596) | (12,258) | (25,901) | (26,902) |
Interest income and other expense, net | 618 | 627 | 1,280 | 970 |
Net loss | $ (12,978) | $ (11,631) | $ (24,621) | $ (25,932) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.44) | $ (0.40) | $ (0.84) | $ (1.01) |
Shares used to compute net loss per share, basic and diluted (in shares) | 29,309,150 | 28,979,514 | 29,301,505 | 25,785,543 |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on marketable securities | $ 28 | $ 19 | $ 73 | $ 21 |
Comprehensive loss | $ (12,950) | $ (11,612) | $ (24,548) | $ (25,911) |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | Common Stock. | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total |
Balance at Dec. 31, 2017 | $ 2,000 | $ 208,408,000 | $ (41,000) | $ (123,534,000) | $ 84,835,000 |
Balance (in shares) at Dec. 31, 2017 | 21,041,250 | ||||
Increase (Decrease) in Stockholders' Deficit | |||||
Issuance of common stock | $ 1,000 | 64,876,000 | 64,877,000 | ||
Issuance of stock (in shares) | 8,117,647 | ||||
Common stock issued on exercise of stock options | 7,000 | 7,000 | |||
Common stock issued on exercise of stock options (in shares) | 24,584 | ||||
Vesting of restricted stocks issued upon early exercise of stock options | 7,000 | 7,000 | |||
Stock-based compensation expense | 1,801,000 | 1,801,000 | |||
Unrealized loss on marketable securities | 2,000 | 2,000 | |||
Net loss | (14,301,000) | (14,301,000) | |||
Balance at Mar. 31, 2018 | $ 3,000 | 275,099,000 | (39,000) | (137,835,000) | 137,228,000 |
Balance (in shares) at Mar. 31, 2018 | 29,183,481 | ||||
Balance at Dec. 31, 2017 | $ 2,000 | 208,408,000 | (41,000) | (123,534,000) | 84,835,000 |
Balance (in shares) at Dec. 31, 2017 | 21,041,250 | ||||
Increase (Decrease) in Stockholders' Deficit | |||||
Net loss | (25,932,000) | ||||
Balance at Jun. 30, 2018 | $ 3,000 | 276,882,000 | (20,000) | (149,466,000) | 127,399,000 |
Balance (in shares) at Jun. 30, 2018 | 29,197,857 | ||||
Balance at Mar. 31, 2018 | $ 3,000 | 275,099,000 | (39,000) | (137,835,000) | 137,228,000 |
Balance (in shares) at Mar. 31, 2018 | 29,183,481 | ||||
Increase (Decrease) in Stockholders' Deficit | |||||
Common stock issued on exercise of stock options | 41,000 | 41,000 | |||
Common stock issued on exercise of stock options (in shares) | 14,376 | ||||
Vesting of restricted stocks issued upon early exercise of stock options | 6,000 | 6,000 | |||
Stock-based compensation expense | 1,736,000 | 1,736,000 | |||
Unrealized loss on marketable securities | 19,000 | 19,000 | |||
Net loss | (11,631,000) | (11,631,000) | |||
Balance at Jun. 30, 2018 | $ 3,000 | 276,882,000 | (20,000) | (149,466,000) | 127,399,000 |
Balance (in shares) at Jun. 30, 2018 | 29,197,857 | ||||
Balance at Dec. 31, 2018 | $ 3,000 | 280,840,000 | (34,000) | (170,473,000) | 110,336,000 |
Balance (in shares) at Dec. 31, 2018 | 29,323,930 | ||||
Increase (Decrease) in Stockholders' Deficit | |||||
Common stock issued on exercise of stock options | $ 2,970 | 1,000 | 1,000 | ||
Vesting of restricted stocks issued upon early exercise of stock options | 5,000 | 5,000 | |||
Stock-based compensation expense | 1,953,000 | 1,953,000 | |||
Unrealized loss on marketable securities | 45,000 | 45,000 | |||
Net loss | (11,643,000) | (11,643,000) | |||
Balance at Mar. 31, 2019 | $ 3,000 | 282,799,000 | 11,000 | (182,116,000) | 100,697,000 |
Balance (in shares) at Mar. 31, 2019 | 29,326,900 | ||||
Balance at Dec. 31, 2018 | $ 3,000 | 280,840,000 | (34,000) | (170,473,000) | 110,336,000 |
Balance (in shares) at Dec. 31, 2018 | 29,323,930 | ||||
Increase (Decrease) in Stockholders' Deficit | |||||
Net loss | (24,621,000) | ||||
Balance at Jun. 30, 2019 | $ 3,000 | 284,706,000 | 39,000 | (195,094,000) | 89,654,000 |
Balance (in shares) at Jun. 30, 2019 | 29,348,400 | ||||
Balance at Mar. 31, 2019 | $ 3,000 | 282,799,000 | 11,000 | (182,116,000) | 100,697,000 |
Balance (in shares) at Mar. 31, 2019 | 29,326,900 | ||||
Increase (Decrease) in Stockholders' Deficit | |||||
Common stock issued on exercise of stock options | 5,000 | 5,000 | |||
Common stock issued on exercise of stock options (in shares) | 21,500 | ||||
Vesting of restricted stocks issued upon early exercise of stock options | 4,000 | 4,000 | |||
Stock-based compensation expense | 1,898,000 | 1,898,000 | |||
Unrealized loss on marketable securities | 28,000 | 28,000 | |||
Net loss | (12,978,000) | (12,978,000) | |||
Balance at Jun. 30, 2019 | $ 3,000 | $ 284,706,000 | $ 39,000 | $ (195,094,000) | $ 89,654,000 |
Balance (in shares) at Jun. 30, 2019 | 29,348,400 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (24,621) | $ (25,932) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 372 | 439 |
Accretion related to marketable securities | (384) | (232) |
Stock-based compensation | 3,851 | 3,536 |
Other | 86 | (229) |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | (313) | (9) |
Other assets | (50) | (323) |
Accounts payable | 640 | (1,199) |
Accrued and other liabilities | 2,215 | 2,015 |
Net cash used in operating activities | (18,204) | (21,934) |
Cash flows from investing activities | ||
Purchases of marketable securities | (64,502) | (99,455) |
Maturities of marketable securities | 73,703 | 39,479 |
Purchase of property and equipment | (16) | (60) |
Net cash provided by (used in) investing activities | 9,185 | (60,036) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net (includes $30,850 in aggregate gross proceeds from related parties for the six months ended June 30, 2018 | 64,877 | |
Proceeds from exercise of common stock options | 6 | 55 |
Net cash provided by financing activities | 6 | 64,932 |
Net decrease in cash and cash equivalents | (9,013) | (17,038) |
Cash and cash equivalents at beginning of the period | 39,196 | 45,106 |
Cash and cash equivalents at end of the period | $ 30,183 | $ 28,068 |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASH FLOW (Parenthetical) $ in Thousands | 6 Months Ended |
Jun. 30, 2018USD ($) | |
CONSOLIDATED STATEMENTS OF CASH FLOWS | |
Proceeds from issuance of common stock, net, from related parties | $ 30,850 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2019 | |
Organization | |
Organization | 1. Organization Corvus Pharmaceuticals, Inc. (“Corvus” or the “Company”) was incorporated in Delaware on January 27, 2014 and commenced operations in November 2014. Corvus is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies. The Company’s operations are located in Burlingame, California. Initial Public Offering On March 22, 2016, the Company’s registration statement on Form S-1 (File No. 333-208850) relating to its initial public offering (“IPO”) of its common stock was declared effective by the Securities and Exchange Commission (“SEC”) and the shares of its common stock began trading on the Nasdaq Global Market on March 23, 2016. The public offering price of the shares sold in the IPO was $15.00 per share. The IPO closed on March 29, 2016, pursuant to which the Company sold 4,700,000 shares of its common stock. On April 26, 2016, the Company sold an additional 502,618 shares of its common stock to the underwriters upon partial exercise of their over-allotment option, at the initial offering price of $15.00 per share. The Company received aggregate net proceeds of approximately $70.6 million, net of underwriting discounts, commissions and offering expenses payable by the Company. Immediately prior to the consummation of the IPO, all outstanding shares of convertible preferred stock were converted into common stock. Follow-on Public Offering In March 2018, the Company completed a follow-on public offering in which the Company sold 8,117,647 shares of common stock at a price of $8.50 per share, which included 1,058,823 shares issued pursuant to the underwriters’ exercise of their option to purchase additional shares of common stock. The aggregate net proceeds received by the Company from the offering were approximately $64.9 million, net of underwriting discounts and commissions and offering expenses payable by the Company. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s functional and reporting currency is the U.S. dollar. The accompanying condensed financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and discharge of liabilities in the normal course of business. Since its inception, the Company has incurred significant losses and negative cash flows from operations. As of June 30, 2019, the Company had an accumulated deficit of $195.1 million and cash, cash equivalents and marketable securities of $96.8 million. The Company has financed its operations primarily with the proceeds from the sale of stock. The Company will need to raise additional capital to meet its business objectives. The Company believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its planned expenditures and meet its obligations through at least the next twelve months from the issuance of these financial statements. Unaudited Interim Financial Information The accompanying interim condensed financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the results of operations for the periods presented. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. The condensed results of operations for the six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. The accompanying condensed financial statements should be read in conjunction with the audited financial statements and the related notes for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 7, 2019. Use of Estimates The preparation of the Company’s condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Actual results could differ from such estimates. Concentrations of Credit Risk and Other Risks and Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited in accounts with two financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company maintains its cash with an accredited financial institution and accordingly, such funds are subject to minimal credit risk. The Company’s marketable securities consist of investments in U.S. government agency securities and corporate debt obligations, which can be subject to certain credit risks. However, the Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer, and monitoring the ongoing creditworthiness of the financial institutions and issuers. The Company has not experienced any losses on its deposits of cash, cash equivalents or marketable securities. The Company is subject to a number of risks similar to other early stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, and protection of proprietary technology. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision‑maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment, that of the development of and commercialization of precisely targeted oncology therapies. Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 to its financial statements for the year ended December 31, 2018, included in its Annual Report on Form 10-K. Other than the adoption of ASU No. 2016-02, Leases (Topic 842) described below, there have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2019. Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize an ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019 and has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company. See also Note 11. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2019 | |
Net Loss per Share | |
Net Loss per Share | 3. Net Loss per Share The following table shows the calculation of net loss per share (in thousands, except share and per share data): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Numerator: Net loss - basic and diluted $ (12,978) $ (11,631) $ (24,621) $ (25,932) Denominator: Weighted average common shares outstanding 29,329,229 29,194,462 29,328,075 26,048,630 Less: weighted average common shares subject to repurchase (20,079) (214,948) (26,570) (263,087) Weighted average common shares outstanding used to compute basic and diluted net loss per share 29,309,150 28,979,514 29,301,505 25,785,543 Net loss per share, basic and diluted $ (0.44) $ (0.40) $ (0.84) $ (1.01) The amounts in the table below were excluded from the calculation of diluted net loss per share, due to their anti‑dilutive effect: Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Common stock subject to repurchase 12,384 172,955 12,384 172,955 Outstanding options 4,157,154 3,019,438 4,157,154 3,019,438 Total shares of common stock equivalents 4,169,538 3,192,393 4,169,538 3,192,393 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements Financial assets and liabilities are measured and recorded at fair value. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs: · Level 1—Quoted prices in active markets for identical assets or liabilities · Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly · Level 3—Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability There have been no transfers of assets and liabilities between levels of hierarchy. The Company’s Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs. The following tables present information as of June 30, 2019 and December 31, 2018 about the Company’s assets that are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy the Company utilized to determine such fair values (in thousands): June 30, 2019 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 29,679 $ — $ — $ 29,679 Marketable securities — 66,657 — 66,657 $ 29,679 $ 66,657 $ — $ 96,336 December 31, 2018 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 38,698 $ — $ — $ 38,698 Marketable securities — 75,401 — 75,401 $ 38,698 $ 75,401 $ — $ 114,099 As of June 30, 2019, marketable securities had a maximum remaining maturity of eleven months. As of June 30, 2019 and December 31, 2018, the fair value of available for sale marketable securities by type of security were as follows (in thousands): June 30, 2019 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Government agency securities $ 32,837 $ 18 $ — $ 32,855 Corporate debt obligations 33,781 26 (5) 33,802 $ 66,618 $ 44 $ (5) $ 66,657 December 31, 2018 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Government agency securities $ 49,124 $ — $ (27) $ 49,097 Corporate debt obligations 26,311 — (7) 26,304 $ 75,435 $ — $ (34) $ 75,401 |
License and Collaboration Agree
License and Collaboration Agreements | 6 Months Ended |
Jun. 30, 2019 | |
License And Collaboration Agreements [Abstract] | |
License and Collaboration Agreements | 5. License and Collaboration Agreements Scripps Licensing Agreement In December 2014, the Company entered into a license agreement with The Scripps Research Institute (“Scripps”), pursuant to which it was granted a non‑exclusive, world‑wide license for all fields of use under Scripps’ rights in certain know‑how and technology related to a mouse hybridoma clone expressing an anti‑human CD73 antibody, and to progeny, mutants or unmodified derivatives of such hybridoma and any antibodies expressed by such hybridoma, from which we developed CPI-006. Scripps also granted the Company the right to grant sublicenses in conjunction with other proprietary rights the Company holds, or to others collaborating with or performing services for the Company. Under this license agreement, Scripps has agreed not to grant any additional commercial licenses with respect to such materials, other than march‑in rights granted to the U.S. government. Upon execution of the agreement, the Company made a one‑time cash payment to Scripps of $10,000 in 2015 and is also obligated to pay a minimum annual fee to Scripps of $25,000. The one‑time cash payment was recorded as research and development expense as technological feasibility of the asset had not been established and there was no alternative future use. A minimum annual fee payment is due on each anniversary of the effective date of the agreement for the term of the agreement. The Company is also required to make performance‑based cash payments upon successful completion of clinical and sales milestones. The aggregate potential milestone payments are $2.6 million. The Company is also required to pay royalties on net sales of licensed products (including CPI-006) sold by it, its affiliates and its sublicensees at a rate in the low‑single digits. In addition, should the Company sublicense the rights licensed under the agreement, it has agreed to pay a percentage of sublicense revenue received at specified rates that start at double digit percentages and decrease to single digit percentages based on the elapsed time from the effective date of the agreement and the time of entry into such sublicense. To date, no milestone payments have been made. The Company’s license agreement with Scripps will terminate upon expiration of its obligation to pay royalties to Scripps under the license agreement. The Company’s license agreement with Scripps is terminable by the consent of the parties, at will by the Company upon providing 90 days written notice to Scripps, or by Scripps for certain material breaches, or if the Company undergoes a bankruptcy event. In addition, Scripps may terminate the license on a product‑by‑product basis, or the entire agreement, if the Company fails to meet specified diligence obligations related to the development and commercialization of licensed products. Scripps may also terminate the agreement after the third anniversary of the effective date of the agreement if it reasonably believes, based on reports the Company provides to Scripps, that the Company has not used commercially reasonable efforts as required under the agreement, subject to a specified notice and cure period. Vernalis Licensing Agreement In February 2015, the Company entered into a license agreement with Vernalis (R&D) Limited (“Vernalis”), which was subsequently amended as of November 5, 2015, and, pursuant to which the Company was granted an exclusive, worldwide license under certain patent rights and know-how, including a limited right to grant sublicenses, for all fields of use to develop, manufacture and commercialize products containing certain adenosine receptor antagonists, including ciforadenant (formerly CPI-444). Pursuant to this agreement, the Company made a one-time cash payment to Vernalis in the amount of $1.0 million, which was recorded as research and development expense as technological feasibility of the asset had not been established and there was no alternative future use. The Company is also required to make cash milestone payments to Vernalis upon the successful completion of clinical and regulatory milestones for licensed products depending on the indications for which such licensed products are developed and upon achievement of certain sales milestones. In February 2017, the Company made a milestone payment of $3.0 million to Vernalis following the expansion of a cohort of patients with renal cell cancer treated with single agent ciforadenant in the Company’s Phase 1/1b clinical trial. The aggregate potential milestone payments are approximately $220 million for all indications. The Company has also agreed to pay Vernalis tiered incremental royalties based on the annual net sales of licensed products containing ciforadenant on a product‑by‑product and country‑by‑country basis, subject to certain offsets and reductions. The tiered royalty rates for products containing ciforadenant range from the mid‑single digits up to the low‑double digits on a country‑by‑country net sales basis. The royalties on other licensed products that do not include ciforadenant also increase with the amount of net sales on a product-by-product and country‑by‑country basis and range from the low‑single digits up to the mid‑single digits on a country‑by‑country net sales basis. The Company is also obligated to pay to Vernalis certain sales milestones as indicated above when worldwide net sales reach specified levels over an agreed upon time period. The agreement will expire on a product‑by‑product and country‑by‑country basis upon the expiration of the Company’s payment obligations to Vernalis in respect of a particular product and country. Both parties have the right to terminate the agreement for an uncured material breach by the other party. The Company may also terminate the agreement at its convenience by providing 90 days written notice, provided that the Company has not received notice of its own default under the agreement at the time the Company exercises such termination right. Vernalis may also terminate the agreement if the Company challenges a licensed patent or undergoes a bankruptcy event. Genentech Collaboration Agreements In October 2015, the Company entered into a clinical trial collaboration agreement with Genentech to evaluate the safety, tolerability and preliminary efficacy of ciforadenant combined with Genentech’s investigational cancer immunotherapy, Tecentriq (atezolizumab), a fully humanized monoclonal antibody targeting protein programmed cell death ligand 1(“PD-L1”), in a variety of solid tumors in a Phase 1/1b clinical trial. Pursuant to this agreement, the Company will be responsible for the conduct and cost of the relevant studies, under the supervision of a joint development committee made up of representatives of the Company and representatives of Genentech. Genentech will supply Tecentriq. As part of the agreement, the Company granted Genentech certain rights of first negotiation to participate in future clinical trials that the Company may conduct evaluating the administration of ciforadenant in combination with an anti-PD-1 or anti-PD-L1 antibody. If the Company and Genentech do not reach agreement on the terms of any such participation by Genentech within a specified time period, the Company retains the right to collaborate with third parties in such activities. The Company also granted Genentech certain rights of first negotiation should it decide to license development and commercialization rights to ciforadenant. Should the Company and Genentech not reach agreement on the terms of such a license within a specified time period, it retains the right to enter into a license with another third party. The Company and Genentech each have the right to terminate the agreement for material breach by the other party. In addition, the agreement may be terminated by either party due to safety considerations, if directed by a regulatory authority or if development of ciforadenant or Tecentriq is discontinued. Further, the agreement will expire after a set period of time following the provision by the Company of the final clinical study report to Genentech. In May, 2017, the Company signed a second clinical trial collaboration agreement with Genentech. Under the second agreement, ciforadenant administered in combination with Tecentriq is being evaluated in a Phase 1b/2 randomized, controlled clinical study, known as Morpheus, as second-line therapy in patients with non-small cell lung cancer who are resistant and/or refractory to prior therapy with an anti-PD-(L)1 antibody. The patients in the Morpheus trial are currently in the follow-up phase of the trial. Genentech is responsible for the conduct of the study and the parties share the cost of the Morpheus trial, which began enrolling patients in the fourth quarter of 2017. The Company is responsible for supplying ciforadenant and retains global development and commercialization rights to ciforadenant. The Company and Genentech each have the right to terminate the agreement for material breach by the other party. In addition, the agreement may be terminated by either party due to safety considerations, if directed by a regulatory authority or if development of ciforadenant or Tecentriq is discontinued. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2019 | |
Balance Sheet Components | |
Balance Sheet Components | 6. Balance Sheet Components (in thousands) June 30, December 31, 2019 2018 Prepaid and Other Current Assets Interest receivable $ 253 $ 337 Prepaid research and development manufacturing expenses — 75 Prepaid facility expenses 152 149 Prepaid insurance 398 166 Other 502 265 $ 1,305 $ 992 Property and Equipment Laboratory equipment $ 2,388 $ 2,371 Computer equipment and purchased software 142 142 Leasehold improvements 2,084 2,084 4,614 4,597 Less: accumulated depreciation and amortization (2,790) (2,417) $ 1,824 $ 2,180 Accrued and Other Liabilities Accrued clinical trial related $ 2,923 $ 2,718 Accrued manufacturing expense 2,518 1,077 Personnel related 1,345 649 Deferred rent — 160 Accrued legal and accounting 175 77 Other accrued expenses 283 348 $ 7,244 $ 5,029 Other Liabilities Deferred rent $ — $ 869 $ — $ 869 |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2019 | |
Common Stock | |
Common Stock | 7. Common Stock As of June 30, 2019, the amended and restated certificate of incorporation authorizes the Company to issue 290 million shares of common stock and 10 million shares of preferred stock. Each share of common stock is entitled to one vote. Common stockholders are entitled to dividends if and when declared by the board of directors. As of June 30, 2019, no dividends on common stock had been declared. In September 2017, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”) to sell shares of the Company’s common stock, from time to time, with aggregate gross sales proceeds of up to $125,000,000, through an at-the-market equity offering program under which Cowen will act as its sales agent. The issuance and sale of shares of common stock by the Company pursuant to the Sales Agreement are deemed an “at-the-market” offering under the Securities Act of 1933, as amended. Cowen is entitled to compensation for its services equal to up to 3.0% of the gross proceeds of any shares of common stock sold through Cowen under the Sales Agreement. During the six months ended June 30, 2019, the Company received no proceeds from the sale of shares of common stock pursuant to the Sales Agreement. The Company has reserved shares of common stock for issuance as follows: June 30, December 31, 2019 2018 Shares available for future option grants 3,253,272 2,486,637 Outstanding options 4,157,154 3,778,259 Unvested restricted common stock (founders and early exercise of stock options) 12,384 43,076 Shares reserved for employee stock purchase plan 400,000 400,000 Total 7,822,810 6,707,972 |
Stock Option Plans
Stock Option Plans | 6 Months Ended |
Jun. 30, 2019 | |
Stock Option Plans | |
Stock Option Plans | 8. Stock Option Plans In February 2014, the Company adopted the 2014 Equity Incentive Plan (the “2014 Plan”), which was subsequently amended in November 2014, July 2015 and September 2015, under which it granted incentive stock options (“ISOs”) or non-qualified stock options (“NSOs”). Terms of stock agreements, including vesting requirements, are determined by the board of directors or a committee authorized by the board of directors, subject to the provisions of the 2014 Plan. In general, awards granted by the Company vest over four years and have a maximum exercise term of 10 years. The 2014 Plan provides that grants must be at an exercise price of 100% of fair market value of the Company’s common stock as determined by the board of directors on the date of the grant. In connection with the consummation of the IPO in March 2016, the 2016 Equity Incentive Award Plan (the “2016 Plan”), became effective. Under the 2016 Plan, incentive stock options, non-statutory stock options, stock purchase rights and other stock-based awards may be granted. Terms of stock agreements, including vesting requirements, are determined by the board of directors or a committee authorized by the board of directors, subject to the provisions of the 2016 Plan. In general, awards granted by the Company vest over four years and have a maximum exercise term of 10 years. The 2016 Plan provides that grants must be at an exercise price of 100% of fair market value of the Company’s common stock as determined by the board of directors on the date of the grant. In conjunction with adopting the 2016 Plan, the 2014 Plan was terminated and no further awards will be granted under the 2014 Plan. Options outstanding under the 2014 Plan as of the effective date of the 2016 Plan that are forfeited or lapse unexercised may be re-issued under the 2016 Plan, up to a maximum of 1,136,229 shares. Activity under the Company’s stock option plans is set forth below: Options Outstanding Weighted ‑ Shares Average Available Number of Exercise for Grant Options Price Balance at December 31, 2018 2,486,637 3,778,259 $ 10.32 Additional shares authorized 1,170,000 — — Options granted (417,000) 417,000 3.87 Options exercised — (24,470) 0.28 Options forfeited 13,635 (13,635) 11.86 Balance at June 30, 2019 3,253,272 4,157,154 $ 9.73 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Stock-Based Compensation | |
Stock-Based Compensation | 9. Stock‑Based Compensation The Company’s results of operations include expenses relating to employee and non‑employee stock‑based awards as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 800 $ 785 $ 1,598 $ 1,545 General and administrative 1,098 951 2,253 1,991 Total $ 1,898 $ 1,736 $ 3,851 $ 3,536 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2019 | |
Income Taxes | |
Income Taxes | 10. Income Taxes During the three and six months ended June 30, 2019 and 2018, the Company recorded no income tax benefits for the net operating losses (NOLs) incurred due to the uncertainty of realizing a benefit from those items. On December 22, 2017, the 2017 Tax Cuts and Jobs Act (the "Tax Act") was enacted into law and the new legislation contains several key tax provisions that affected the Company, including a reduction of the corporate income tax rate to 21% effective January 1, 2018, among others. The Company was required to recognize the effect of the tax law changes in the period of enactment, such as remeasuring its U.S. deferred tax assets and liabilities as well as reassessing the net realizability of its deferred tax assets and liabilities. As of December 31, 2017, the Company re-measured all deferred taxes at 21% and recorded a decrease related to the net deferred tax asset balance with a corresponding net adjustment to the Company's valuation allowance. As of December 31, 2018, the Company had completed its accounting under the Tax Act and no additional adjustments to its financial statements were recorded. |
Facility Lease
Facility Lease | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Facility lease | 11. Facility Lease In January 2015, the Company signed an initial operating lease, effective February 1, 2015 for 8,138 square feet of office and laboratory space with a one year term. Between January 2015 and October 2018, the Company entered into a series of lease amendments to increase the amount of leased space to 27,280 square feet and extend the expiration of the lease to February 2023. The lease agreement includes annual rent escalations. Under the lease and subsequent amendments, the landlord provided approximately $1.9 million in free rent and lease incentives. The Company records rent expense on a straight-line basis over the effective term of the lease, including any free rent periods and incentives. In calculating the present value of the lease payments, the Company has utilized its incremental borrowing rate. The Company’s facility lease is a net lease, as the non-lease components (i.e. common area maintenance) are paid separately from rent based on actual costs incurred. Therefore, the non-lease components were not included in the right-of-use asset and liability and are reflected as an expense in the period incurred. As of June 30, 2019 and December 31, 2018, the right-of-use asset under operating lease was $2.6 million and $0, respectively. The elements of lease expense were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Operating lease cost Rent expense $ 233 $ 167 $ 481 $ 344 Common area maintenance 81 73 162 149 Total operating lease cost $ 314 $ 240 $ 643 $ 493 Other Information Operating cash flows used for operating lease $ 370 $ 343 $ 729 $ 699 Operating lease liabilities arising from obtaining right-of-use asset — — 3,580 — Remaining lease term 3.6 years 2.6 years 3.6 years 2.6 years Discount rate — — As of June 30, 2019, minimum rental commitments under this lease were as follows (in thousands): Year Ended December 31 (in thousands) 2019* $ 563 2020 1,159 2021 1,260 2022 1,299 Total lease payments $ 4,281 Less: imputed interest (701) Total $ 3,580 * Remainder of the year As of December 31, 2018, minimum rental commitments under this lease were as follows (in thousands): Year Ended December 31 (in thousands) 2019 $ 1,110 2020 1,142 2021 1,251 2022 1,296 2023 109 Total $ 4,908 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies In August 2015, the Company entered into an agreement for a line of credit of $0.1 million for the purpose of issuing its landlord a letter of credit of $0.1 million as a security deposit under its facility lease. The Company pledged money market funds and marketable securities as collateral for the line of credit. For further discussion of the Company’s facility lease agreement, see Note 11. Pursuant to the Company’s license agreements with each of Vernalis and Scripps, it has obligations to make future milestone and royalty payments to these parties, respectively. However, because these amounts are contingent, they have not been included on the Company’s balance sheet. For further discussion of the Vernalis and Scripps licensing agreements, see Note 5. Indemnifications In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third‑party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. There have been no claims to date and the Company has a directors and officers insurance policy that may enable it to recover a portion of any amounts paid for future claims. Legal Proceedings The Company is not a party to any material legal proceedings. |
Related Party Transaction
Related Party Transaction | 6 Months Ended |
Jun. 30, 2019 | |
Related Party Transaction | |
Related Party Transaction | 13. Related Party Transactions In March 2018, the Company completed a follow-on public offering in which the Company sold 8,117,647 shares of common stock at a price of $8.50 per share, which included 1,058,823 shares issued pursuant to the underwriters’ exercise of their option to purchase additional shares of common stock. The aggregate net proceeds received by the Company from the offering were approximately $64.9 million, net of underwriting discounts and commissions and offering expenses payable by the Company. The following aggregate number of shares of common stock were sold to our owners of more than 5% of our common stock, directors, or executive officers during the March 2018 underwritten public offering: March 2018 Public Offering Number of Aggregate Shares of Purchase Common Stock Price Owners of More Than 5% of Our Common Stock FMR LLC 1,176,470 $ 9,999,995 Orbimed Advisors LLC (1) 588,235 4,999,998 Novo Holdings A/S (2) 1,176,470 9,999,995 Adams Street Partners (3) 588,235 4,999,998 Board of Directors Richard A. Miller, M.D. 100,000 850,000 (1) Peter Thompson, M.D., a member of our Board of Directors since November 2014, is a Private Equity Partner for OrbiMed Advisors, LLC. (2) Peter Moldt, Ph.D., a Partner at Novo Ventures (US) Inc., which provide certain consultancy services to Novo Holdings A/S, served as a member of our Board of Directors from January 2015 to January 2019. (3) Elisha P. (Terry) Gould III, a member of our Board of Directors since November 2014, is a Partner at Adams Street Partners, LLC. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s functional and reporting currency is the U.S. dollar. The accompanying condensed financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and discharge of liabilities in the normal course of business. Since its inception, the Company has incurred significant losses and negative cash flows from operations. As of June 30, 2019, the Company had an accumulated deficit of $195.1 million and cash, cash equivalents and marketable securities of $96.8 million. The Company has financed its operations primarily with the proceeds from the sale of stock. The Company will need to raise additional capital to meet its business objectives. The Company believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its planned expenditures and meet its obligations through at least the next twelve months from the issuance of these financial statements. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim condensed financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the results of operations for the periods presented. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. The condensed results of operations for the six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. The accompanying condensed financial statements should be read in conjunction with the audited financial statements and the related notes for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 7, 2019. |
Use of Estimates | Use of Estimates The preparation of the Company’s condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Actual results could differ from such estimates. |
Concentrations of Credit Risk and Other Risks and Uncertainties | Concentrations of Credit Risk and Other Risks and Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited in accounts with two financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company maintains its cash with an accredited financial institution and accordingly, such funds are subject to minimal credit risk. The Company’s marketable securities consist of investments in U.S. government agency securities and corporate debt obligations, which can be subject to certain credit risks. However, the Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer, and monitoring the ongoing creditworthiness of the financial institutions and issuers. The Company has not experienced any losses on its deposits of cash, cash equivalents or marketable securities. The Company is subject to a number of risks similar to other early stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, and protection of proprietary technology. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. |
Segments | Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision‑maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment, that of the development of and commercialization of precisely targeted oncology therapies. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 to its financial statements for the year ended December 31, 2018, included in its Annual Report on Form 10-K. Other than the adoption of ASU No. 2016-02, Leases (Topic 842) described below, there have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2019. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize an ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019 and has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company. See also Note 11. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Net Loss per Share | |
Schedule of net loss per share, basic and diluted | Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Numerator: Net loss - basic and diluted $ (12,978) $ (11,631) $ (24,621) $ (25,932) Denominator: Weighted average common shares outstanding 29,329,229 29,194,462 29,328,075 26,048,630 Less: weighted average common shares subject to repurchase (20,079) (214,948) (26,570) (263,087) Weighted average common shares outstanding used to compute basic and diluted net loss per share 29,309,150 28,979,514 29,301,505 25,785,543 Net loss per share, basic and diluted $ (0.44) $ (0.40) $ (0.84) $ (1.01) |
Schedule of antidilutive securities excluded from calculation of diluted net loss per share | Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Common stock subject to repurchase 12,384 172,955 12,384 172,955 Outstanding options 4,157,154 3,019,438 4,157,154 3,019,438 Total shares of common stock equivalents 4,169,538 3,192,393 4,169,538 3,192,393 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Measurements | |
Schedule of fair value of assets measured at fair value on a recurring basis, by level of fair value hierarchy | June 30, 2019 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 29,679 $ — $ — $ 29,679 Marketable securities — 66,657 — 66,657 $ 29,679 $ 66,657 $ — $ 96,336 December 31, 2018 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 38,698 $ — $ — $ 38,698 Marketable securities — 75,401 — 75,401 $ 38,698 $ 75,401 $ — $ 114,099 |
Schedule of fair value of available for sale marketable securities | June 30, 2019 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Government agency securities $ 32,837 $ 18 $ — $ 32,855 Corporate debt obligations 33,781 26 (5) 33,802 $ 66,618 $ 44 $ (5) $ 66,657 December 31, 2018 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Government agency securities $ 49,124 $ — $ (27) $ 49,097 Corporate debt obligations 26,311 — (7) 26,304 $ 75,435 $ — $ (34) $ 75,401 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Balance Sheet Components | |
Schedule of balance sheet components | June 30, December 31, 2019 2018 Prepaid and Other Current Assets Interest receivable $ 253 $ 337 Prepaid research and development manufacturing expenses — 75 Prepaid facility expenses 152 149 Prepaid insurance 398 166 Other 502 265 $ 1,305 $ 992 Property and Equipment Laboratory equipment $ 2,388 $ 2,371 Computer equipment and purchased software 142 142 Leasehold improvements 2,084 2,084 4,614 4,597 Less: accumulated depreciation and amortization (2,790) (2,417) $ 1,824 $ 2,180 Accrued and Other Liabilities Accrued clinical trial related $ 2,923 $ 2,718 Accrued manufacturing expense 2,518 1,077 Personnel related 1,345 649 Deferred rent — 160 Accrued legal and accounting 175 77 Other accrued expenses 283 348 $ 7,244 $ 5,029 Other Liabilities Deferred rent $ — $ 869 $ — $ 869 |
Common Stock (Tables)
Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Common Stock | |
Schedule of shares of common stock reserved for issuance | June 30, December 31, 2019 2018 Shares available for future option grants 3,253,272 2,486,637 Outstanding options 4,157,154 3,778,259 Unvested restricted common stock (founders and early exercise of stock options) 12,384 43,076 Shares reserved for employee stock purchase plan 400,000 400,000 Total 7,822,810 6,707,972 |
Stock Option Plans (Tables)
Stock Option Plans (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Stock Option Plans | |
Summary of stock option activity | Options Outstanding Weighted ‑ Shares Average Available Number of Exercise for Grant Options Price Balance at December 31, 2018 2,486,637 3,778,259 $ 10.32 Additional shares authorized 1,170,000 — — Options granted (417,000) 417,000 3.87 Options exercised — (24,470) 0.28 Options forfeited 13,635 (13,635) 11.86 Balance at June 30, 2019 3,253,272 4,157,154 $ 9.73 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Stock-Based Compensation | |
Schedule of expenses relating to employee and non-employee stock-based awards | Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 800 $ 785 $ 1,598 $ 1,545 General and administrative 1,098 951 2,253 1,991 Total $ 1,898 $ 1,736 $ 3,851 $ 3,536 |
Facility Lease (Tables)
Facility Lease (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Elements of lease expense | Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Operating lease cost Rent expense $ 233 $ 167 $ 481 $ 344 Common area maintenance 81 73 162 149 Total operating lease cost $ 314 $ 240 $ 643 $ 493 Other Information Operating cash flows used for operating lease $ 370 $ 343 $ 729 $ 699 Operating lease liabilities arising from obtaining right-of-use asset — — 3,580 — Remaining lease term 3.6 years 2.6 years 3.6 years 2.6 years Discount rate — — |
Minimum rental commitments | As of June 30, 2019, minimum rental commitments under this lease were as follows (in thousands): Year Ended December 31 (in thousands) 2019* $ 563 2020 1,159 2021 1,260 2022 1,299 Total lease payments $ 4,281 Less: imputed interest (701) Total $ 3,580 * Remainder of the year |
Schedule of future minimum lease payments under Topic 840 | As of December 31, 2018, minimum rental commitments under this lease were as follows (in thousands): Year Ended December 31 (in thousands) 2019 $ 1,110 2020 1,142 2021 1,251 2022 1,296 2023 109 Total $ 4,908 |
Related Party Transaction (Tabl
Related Party Transaction (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Related Party Transaction | |
Schedule of common stock sold to related parties | March 2018 Public Offering Number of Aggregate Shares of Purchase Common Stock Price Owners of More Than 5% of Our Common Stock FMR LLC 1,176,470 $ 9,999,995 Orbimed Advisors LLC (1) 588,235 4,999,998 Novo Holdings A/S (2) 1,176,470 9,999,995 Adams Street Partners (3) 588,235 4,999,998 Board of Directors Richard A. Miller, M.D. 100,000 850,000 (1) Peter Thompson, M.D., a member of our Board of Directors since November 2014, is a Private Equity Partner for OrbiMed Advisors, LLC. (2) Peter Moldt, Ph.D., a Partner at Novo Ventures (US) Inc., which provide certain consultancy services to Novo Holdings A/S, served as a member of our Board of Directors from January 2015 to January 2019. (3) Elisha P. (Terry) Gould III, a member of our Board of Directors since November 2014, is a Partner at Adams Street Partners, LLC. |
Organization - Public Offerings
Organization - Public Offerings (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 26, 2016 | Mar. 29, 2016 | Mar. 31, 2018 | Jun. 30, 2018 |
Public Offerings | ||||
Proceeds from sale of stock | $ 64,877 | |||
IPO | ||||
Public Offerings | ||||
Shares Issued, Price Per Share | $ 15 | |||
Issuance of stock (in shares) | 4,700,000 | |||
Net proceeds from IPO | $ 70,600 | |||
Over-Allotment Option | ||||
Public Offerings | ||||
Shares Issued, Price Per Share | $ 15 | |||
Issuance of stock (in shares) | 502,618 | 1,058,823 | ||
FPO | ||||
Public Offerings | ||||
Shares Issued, Price Per Share | $ 8.50 | |||
Issuance of stock (in shares) | 8,117,647 | |||
Proceeds from sale of stock | $ 64,900 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Basis of Presentation, Credit Risk and Income Taxes (Details) $ in Thousands | Jan. 01, 2019 | Jun. 30, 2019USD ($)segmentitem | Dec. 31, 2018USD ($) |
Summary of Significant Accounting Policies | |||
Accumulated deficit | $ (195,094) | $ (170,473) | |
Cash, cash equivalents and marketable securities | $ 96,800 | ||
Concentrations of Credit Risk and Other Risks and Uncertainties | |||
Number of financial institutions used for cash and cash equivalent deposits | item | 2 | ||
Segments | |||
Number of operating segments | segment | 1 | ||
Recent accounting pronouncements | |||
Package of practical expedients adopted | true | ||
Use of hindsight adopted | false |
Net Loss per Share - Net Loss p
Net Loss per Share - Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Numerator: | ||||||
Net loss - basic and diluted | $ (12,978) | $ (11,643) | $ (11,631) | $ (14,301) | $ (24,621) | $ (25,932) |
Denominator: | ||||||
Weighted average common shares outstanding | 29,329,229 | 29,194,462 | 29,328,075 | 26,048,630 | ||
Less: weighted average common shares subject to repurchase | (20,079) | (214,948) | (26,570) | (263,087) | ||
Weighted average common shares outstanding used to compute basic and diluted net loss per share | 29,309,150 | 28,979,514 | 29,301,505 | 25,785,543 | ||
Net loss per share, basic and diluted (in dollars per share) | $ (0.44) | $ (0.40) | $ (0.84) | $ (1.01) |
Net Loss per Share - Anti-Dilut
Net Loss per Share - Anti-Dilutive Securities (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Excluded from the calculation of diluted net loss per share, due to anti-dilutive effect | ||||
Shares of common stock equivalents | 4,169,538 | 3,192,393 | 4,169,538 | 3,192,393 |
Common stock subject to repurchase | ||||
Excluded from the calculation of diluted net loss per share, due to anti-dilutive effect | ||||
Shares of common stock equivalents | 12,384 | 172,955 | 12,384 | 172,955 |
Outstanding options | ||||
Excluded from the calculation of diluted net loss per share, due to anti-dilutive effect | ||||
Shares of common stock equivalents | 4,157,154 | 3,019,438 | 4,157,154 | 3,019,438 |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2018 | |
Transfer between levels | ||
Transfer of assets from level 1 to 2 | $ 0 | |
Transfer of assets from level 2 to 1 | 0 | |
Transfer of liabilities from level 1 to 2 | 0 | |
Transfer of liabilities from level 2 to 1 | 0 | |
Transfer of assets into level 3 | 0 | |
Transfer of assets out of level 3 | 0 | |
Transfer of liabilities into level 3 | 0 | |
Transfer of liabilities out of level 3 | $ 0 | |
Assets | ||
Maximum remaining maturity of marketable securities | 11 months | |
Recurring | ||
Assets | ||
Cash equivalents | $ 29,679 | $ 38,698 |
Marketable securities | 66,657 | 75,401 |
Total Assets | 96,336 | 114,099 |
Recurring | Level 1 | ||
Assets | ||
Cash equivalents | 29,679 | 38,698 |
Total Assets | 29,679 | 38,698 |
Recurring | Level 2 | ||
Assets | ||
Marketable securities | 66,657 | 75,401 |
Total Assets | $ 66,657 | $ 75,401 |
Fair Value Measurements - Avail
Fair Value Measurements - Available For Sale (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Fair value of available for sale marketable securities | ||
Amortized Cost | $ 66,618 | $ 75,435 |
Gross Unrealized Gains | 44 | |
Gross Unrealized Losses | (5) | (34) |
Fair Value | 66,657 | 75,401 |
U.S. Government agency securities | ||
Fair value of available for sale marketable securities | ||
Amortized Cost | 32,837 | 49,124 |
Gross Unrealized Gains | 18 | |
Gross Unrealized Losses | (27) | |
Fair Value | 32,855 | 49,097 |
Corporate debt obligations | ||
Fair value of available for sale marketable securities | ||
Amortized Cost | 33,781 | 26,311 |
Gross Unrealized Gains | 26 | |
Gross Unrealized Losses | (5) | (7) |
Fair Value | $ 33,802 | $ 26,304 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - Licensing Agreement - USD ($) | 6 Months Ended | |||
Jun. 30, 2019 | Feb. 28, 2017 | Dec. 31, 2015 | Feb. 28, 2015 | |
Scripps Research Institute | ||||
License and Collaboration Agreements | ||||
Minimum annual fee | $ 25,000 | |||
Aggregate potential milestone payments | $ 2,600,000 | |||
Milestone payments made | $ 0 | |||
Period of written notice to terminate | 90 days | |||
Scripps Research Institute | Research and development | ||||
License and Collaboration Agreements | ||||
One-time cash payment | $ 10,000 | |||
Vernalis (R&D) Limited | ||||
License and Collaboration Agreements | ||||
Milestone payments made | $ 3,000,000 | |||
Period of written notice to terminate | 90 days | |||
Vernalis (R&D) Limited | Minimum | ||||
License and Collaboration Agreements | ||||
Aggregate potential milestone payments | $ 220,000,000 | |||
Vernalis (R&D) Limited | Research and development | ||||
License and Collaboration Agreements | ||||
One-time cash payment | $ 1,000,000 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Prepaid and Other Current Assets | ||
Interest receivable | $ 253 | $ 337 |
Prepaid research and development manufacturing expenses | 75 | |
Prepaid facility expenses | 152 | 149 |
Prepaid insurance | 398 | 166 |
Other | 502 | 265 |
Total of prepaid and other current assets | $ 1,305 | $ 992 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Property and Equipment | ||
Property and equipment, gross | $ 4,614 | $ 4,597 |
Less: accumulated depreciation and amortization | (2,790) | (2,417) |
Property and equipment, net | 1,824 | 2,180 |
Laboratory equipment | ||
Property and Equipment | ||
Property and equipment, gross | 2,388 | 2,371 |
Computer equipment and purchased software | ||
Property and Equipment | ||
Property and equipment, gross | 142 | 142 |
Leasehold improvements | ||
Property and Equipment | ||
Property and equipment, gross | $ 2,084 | $ 2,084 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued and Other Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Accrued and Other Liabilities | ||
Accrued clinical trial related | $ 2,923 | $ 2,718 |
Accrued manufacturing expense | 2,518 | 1,077 |
Personnel related | 1,345 | 649 |
Deferred rent | 160 | |
Accrued legal and accounting | 175 | 77 |
Other accrued expenses | 283 | 348 |
Total of accrued and other liabilities | $ 7,244 | $ 5,029 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Liabilities (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Other Liabilities | |
Deferred rent | $ 869 |
Total of other liabilities | $ 869 |
Common Stock (Details)
Common Stock (Details) | 1 Months Ended | 6 Months Ended | ||
Sep. 30, 2017USD ($) | Jun. 30, 2019USD ($)Voteshares | Jun. 30, 2018USD ($) | Dec. 31, 2018shares | |
Common Stock | ||||
Common stock, shares authorized for issuance | 290,000,000 | 290,000,000 | ||
Preferred stock, shares authorized for issuance | 10,000,000 | 10,000,000 | ||
Number of votes per share of common stock | Vote | 1 | |||
Dividends on common stock | $ | $ 0 | |||
Proceeds from sale of stock | $ | $ 64,877,000 | |||
Shares of common stock reserved for issuance, on an as-converted basis | ||||
Shares available for future option grants | 3,253,272 | 2,486,637 | ||
Outstanding options | 4,157,154 | 3,778,259 | ||
Unvested restricted common stock (founders and early exercise of stock options) | 12,384 | 43,076 | ||
Shares reserved for employee stock purchase plan | 400,000 | 400,000 | ||
Total | 7,822,810 | 6,707,972 | ||
At-the-market offering | Cowen | ||||
Common Stock | ||||
Proceeds from sale of stock | $ | $ 0 | |||
At-the-market offering | Cowen | Maximum | ||||
Common Stock | ||||
Potential gross proceeds | $ | $ 125,000,000 | |||
Stock issuance costs, as a percent of gross proceeds | 3.00% |
Stock Option Plans - Stock Opti
Stock Option Plans - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Mar. 31, 2016 | Feb. 28, 2014 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | |
Shares Available for Grant | |||||||
Beginning balance | 2,486,637 | 2,486,637 | |||||
Exercised | $ 5 | $ 1 | $ 41 | $ 7 | |||
Ending balance | 3,253,272 | 3,253,272 | |||||
Number of Options | |||||||
Beginning balance | 3,778,259 | 3,778,259 | |||||
Ending balance | 4,157,154 | 4,157,154 | |||||
2014 Plan | |||||||
Stock Option Plans | |||||||
Vesting period | 4 years | ||||||
Maximum exercise term | 10 years | ||||||
Exercise price of common stock of its fair value (as a percent) | 100.00% | ||||||
Maximum number of options that may be re-issued under the 2016 plan | 1,136,229 | ||||||
Shares Available for Grant | |||||||
Ending balance | 0 | ||||||
2016 Plan | |||||||
Stock Option Plans | |||||||
Vesting period | 4 years | ||||||
Maximum exercise term | 10 years | ||||||
Exercise price of common stock of its fair value (as a percent) | 100.00% | ||||||
Shares Available for Grant | |||||||
Beginning balance | 2,486,637 | 2,486,637 | |||||
Additional shares authorized | 1,170,000 | ||||||
Granted | (417,000) | ||||||
Forfeited | 13,635 | ||||||
Ending balance | 3,253,272 | 3,253,272 | |||||
Number of Options | |||||||
Beginning balance | 3,778,259 | 3,778,259 | |||||
Granted | 417,000 | ||||||
Exercised | (24,470) | ||||||
Forfeited | (13,635) | ||||||
Ending balance | 4,157,154 | 4,157,154 | |||||
Weighted-Average Exercise Price | |||||||
Beginning balance (in dollars per share) | $ 10.32 | $ 10.32 | |||||
Granted (in dollars per share) | 3.87 | ||||||
Exercised (in dollars per share) | 0.28 | ||||||
Forfeited (in dollars per share) | 11.86 | ||||||
Ending balance (in dollars per share) | $ 9.73 | $ 9.73 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense Allocation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Stock-based compensation | ||||
Stock-based compensation expense | $ 1,898 | $ 1,736 | $ 3,851 | $ 3,536 |
Research and development | ||||
Stock-based compensation | ||||
Stock-based compensation expense | 800 | 785 | 1,598 | 1,545 |
General and administrative | ||||
Stock-based compensation | ||||
Stock-based compensation expense | $ 1,098 | $ 951 | $ 2,253 | $ 1,991 |
Income Taxes - Tax Cut and Jobs
Income Taxes - Tax Cut and Jobs Act (Details) - USD ($) $ in Thousands | Jan. 01, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 |
Income Taxes | |||||
Income tax benefits | $ 0 | $ 0 | $ 0 | $ 0 | |
Effect of Tax Cuts and Jobs Act [Abstract] | |||||
Corporate income tax rate (as a percent) | 21.00% |
Facility Lease - Lessee informa
Facility Lease - Lessee information (Details) $ in Thousands | 46 Months Ended | ||
Oct. 31, 2018USD ($)ft² | Jun. 30, 2019USD ($) | Jan. 31, 2015ft² | |
Lessee Disclosure [Abstract] | |||
Area of leased facility | ft² | 27,280 | 8,138 | |
Lease term | 1 year | ||
Landlord Provided Free Rent And Lease Incentives | $ 1,900 | ||
Operating lease right-of-use asset | $ 2,634 |
Facility Lease - Lease cost (De
Facility Lease - Lease cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating lease cost | ||||
Base rent expense | $ 233 | $ 167 | $ 481 | $ 344 |
Common area maintenance | 81 | 73 | 162 | 149 |
Total operating lease cost | 314 | 240 | 643 | 493 |
Other Information | ||||
Operating cash flows used for operating lease | 370 | $ 343 | 729 | $ 699 |
Operating lease liabilities arising from obtaining right-of-use asset | $ 3,580 | $ 3,580 | ||
Remaining lease term | 3 years 7 months 6 days | 2 years 7 months 6 days | 3 years 7 months 6 days | 2 years 7 months 6 days |
Discount rate | 10.00% | 10.00% |
Facility Lease - Minimum rental
Facility Lease - Minimum rental commitments (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Minimum rental commitments under Topic 842 | ||
2019* | $ 563 | |
2020 | 1,159 | |
2021 | 1,260 | |
2022 | 1,299 | |
Total lease payments | 4,281 | |
Less: imputed interest | (701) | |
Total | $ 3,580 | |
Minimum rental commitments under Topic 840 | ||
2019 | $ 1,110 | |
2020 | 1,142 | |
2021 | 1,251 | |
2022 | 1,296 | |
2023 | 109 | |
Total | $ 4,908 |
Commitments and Contingencies -
Commitments and Contingencies - Line of Credit (Details) $ in Millions | Aug. 31, 2015USD ($) |
Line of credit | |
Security deposit | $ 0.1 |
Secured debt | |
Line of credit | |
Line of credit | $ 0.1 |
Related Party Transaction (Deta
Related Party Transaction (Details) - USD ($) | Apr. 26, 2016 | Mar. 29, 2016 | Mar. 31, 2018 | Jun. 30, 2018 |
Public Offerings | ||||
Proceeds from sale of stock | $ 64,877,000 | |||
FMR LLC | ||||
Public Offerings | ||||
Number of Share of Common Stock issued | 1,176,470 | |||
Owners of More Than 5% of Our Common Stock or Board of Directors | ||||
Aggregate Purchase Price | $ 9,999,995 | |||
Orbimed Advisors LLC | ||||
Public Offerings | ||||
Number of Share of Common Stock issued | 588,235 | |||
Owners of More Than 5% of Our Common Stock or Board of Directors | ||||
Aggregate Purchase Price | $ 4,999,998 | |||
Novo Holdings A/S | ||||
Public Offerings | ||||
Number of Share of Common Stock issued | 1,176,470 | |||
Owners of More Than 5% of Our Common Stock or Board of Directors | ||||
Aggregate Purchase Price | $ 9,999,995 | |||
Adams Street Partners | ||||
Public Offerings | ||||
Number of Share of Common Stock issued | 588,235 | |||
Owners of More Than 5% of Our Common Stock or Board of Directors | ||||
Aggregate Purchase Price | $ 4,999,998 | |||
Director | ||||
Public Offerings | ||||
Number of Share of Common Stock issued | 100,000 | |||
Owners of More Than 5% of Our Common Stock or Board of Directors | ||||
Aggregate Purchase Price | $ 850,000 | |||
IPO | ||||
Public Offerings | ||||
Share offering price | $ 15 | |||
Number of Share of Common Stock issued | 4,700,000 | |||
Net proceeds from IPO | $ 70,600,000 | |||
Over-Allotment Option | ||||
Public Offerings | ||||
Share offering price | $ 15 | |||
Number of Share of Common Stock issued | 502,618 | 1,058,823 |