Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | Apr. 30, 2020 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2020 | |
Entity Registrant Name | Corvus Pharmaceuticals, Inc. | |
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 | 27,953,233 | |
Entity Central Index Key | 0001626971 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 23,498 | $ 5,154 |
Marketable securities | 45,209 | 72,828 |
Prepaid and other current assets | 1,136 | 1,362 |
Total current assets | 69,843 | 79,344 |
Property and equipment, net | 1,278 | 1,462 |
Operating lease right-of-use asset | 2,163 | 2,327 |
Other assets | 513 | 513 |
Total assets | 73,797 | 83,646 |
Current liabilities: | ||
Accounts payable | 3,356 | 2,448 |
Operating lease liability | 927 | 878 |
Accrued and other liabilities | 7,429 | 6,899 |
Total current liabilities | 11,712 | 10,225 |
Operating lease liability | 2,050 | 2,310 |
Total liabilities | 13,762 | 12,535 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Preferred stock: $0.0001 par value; 10,000,000 shares authorized at March 31, 2020 and December 31, 2019; 0 shares issued and outstanding at March 31, 2020 and December 31, 2019 | ||
Common stock: $0.0001 par value; 290,000,000 shares authorized at March 31, 2020 and December 31, 2019; 27,953,233 and 27,953,233 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 3 | 3 |
Additional paid-in capital | 290,069 | 288,224 |
Accumulated other comprehensive income | 43 | 29 |
Accumulated deficit | (230,080) | (217,145) |
Total stockholders' equity | 60,035 | 71,111 |
Total liabilities and stockholders' equity | $ 73,797 | $ 83,646 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
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 | 27,953,233 | 27,953,233 |
Common stock, shares outstanding | 27,953,233 | 27,953,233 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating expenses: | ||
Research and development | $ 10,163 | $ 9,419 |
General and administrative | 3,106 | 2,886 |
Total operating expenses | 13,269 | 12,305 |
Loss from operations | (13,269) | (12,305) |
Interest income and other expense, net | 334 | 662 |
Net loss | $ (12,935) | $ (11,643) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.44) | $ (0.40) |
Shares used to compute net loss per share, basic and diluted (in shares) | 29,411,233 | 29,292,135 |
Other comprehensive loss: | ||
Unrealized gain on marketable securities | $ 14 | $ 45 |
Comprehensive loss | $ (12,921) | $ (11,598) |
STATEMENTS OF CHANGES IN STOCKH
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock. | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total |
Balance at Dec. 31, 2018 | $ 3 | $ 280,840 | $ (34) | $ (170,473) | $ 110,336 |
Balance (in shares) at Dec. 31, 2018 | 29,323,930 | ||||
Increase (Decrease) in Stockholders' Deficit | |||||
Common stock issued on exercise of stock options | 1 | 1 | |||
Common stock issued on exercise of stock options (in shares) | 2,970 | ||||
Vesting of restricted stocks issued upon early exercise of stock options | 5 | 5 | |||
Stock-based compensation expense | 1,953 | 1,953 | |||
Unrealized gain (loss) on marketable securities | 45 | 45 | |||
Net loss | (11,643) | (11,643) | |||
Balance at Mar. 31, 2019 | $ 3 | 282,799 | 11 | (182,116) | 100,697 |
Balance (in shares) at Mar. 31, 2019 | 29,326,900 | ||||
Balance at Dec. 31, 2019 | $ 3 | 288,224 | 29 | (217,145) | 71,111 |
Balance (in shares) at Dec. 31, 2019 | 27,953,233 | ||||
Increase (Decrease) in Stockholders' Deficit | |||||
Stock-based compensation expense | 1,845 | 1,845 | |||
Unrealized gain (loss) on marketable securities | 14 | 14 | |||
Net loss | (12,935) | (12,935) | |||
Balance at Mar. 31, 2020 | $ 3 | $ 290,069 | $ 43 | $ (230,080) | $ 60,035 |
Balance (in shares) at Mar. 31, 2020 | 27,953,233 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (12,935) | $ (11,643) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 184 | 186 |
Accretion related to marketable securities | (64) | (170) |
Stock-based compensation | 1,845 | 1,953 |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | 226 | (205) |
Operating lease right-of-use asset | 164 | 146 |
Other assets | (51) | |
Accounts payable | 908 | 266 |
Accrued and other liabilities | 530 | 714 |
Operating lease liability | (211) | (186) |
Net cash used in operating activities | (9,353) | (8,990) |
Cash flows from investing activities | ||
Purchases of marketable securities | (11,411) | (29,903) |
Sales of marketable securities | 1,009 | |
Maturities of marketable securities | 38,099 | 38,688 |
Purchases of property and equipment | (16) | |
Net cash provided by investing activities | 27,697 | 8,769 |
Cash flows from financing activities | ||
Proceeds from exercise of common stock options | 1 | |
Net cash provided by financing activities | 1 | |
Net increase (decrease) in cash and cash equivalents | 18,344 | (220) |
Cash and cash equivalents at beginning of the period | 5,154 | 39,196 |
Cash and cash equivalents at end of the period | $ 23,498 | 38,976 |
Supplemental disclosures of cash flow information | ||
Purchases of property and equipment incurred but not paid | $ 16 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2020 | |
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, after underwriting discounts, commissions and offering expenses. 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. Liquidity The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, contract manufacturer and contract research organizations, compliance with government regulations and the need to obtain additional financing to fund operations. Since commencing operations in 2014, the majority of the Company’s efforts have been focused on the research and development of ciforadenant, CPI-006 and CPI-818. The Company believes that it will continue to expend substantial resources for the foreseeable future as it continues clinical development of, seek regulatory approval for and, if approved, prepare for the commercialization of ciforadenant, CPI-006, and CPI-818, as well as product candidates under the Company’s other development programs. These expenditures will include costs associated with research and development, conducting preclinical studies and clinical trials, obtaining regulatory approvals, manufacturing and supply, sales and marketing and general operations. In addition, other unanticipated costs may arise. Because the outcome of any clinical trial and/or regulatory approval process is highly uncertain, the Company may not be able to accurately estimate the actual amounts necessary to successfully complete the development, regulatory approval process and commercialization of ciforadenant, CPI-006, CPI-818 or any other product candidates. The Company does not expect its existing capital resources to be sufficient to enable it to fund the completion of its clinical trials and remaining development program of ciforadenant, CPI-006 or CPI-818 through commercialization. In addition, its operating plan may change as a result of many factors, including those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed on March 9, 2020. The Company has incurred significant losses and negative cash flows from operations in all periods since inception and had an accumulated deficit of $230.1 million as of March 31, 2020. The Company has historically financed its operations primarily through the sale of redeemable convertible preferred stock and common stock. While the Company has been able to raise multiple rounds of financing, there can be no assurance that in the event the Company requires additional financing, such financing will be available on terms which are favorable or at all. Failure to generate sufficient cash flows from operations, raise additional capital or reduce certain discretionary spending would have a material adverse effect on the Company’s ability to achieve its intended business objectives. As of March 31, 2020, the Company had cash, cash equivalents and short-term marketable securities of $68.7 million. Management believes that the Company’s current cash, cash equivalents and short-term marketable securities will be sufficient to fund its planned operations for at least 12 months from the date of the issuance of these financial statements. Exchange Warrants On November 8, 2019, the Company entered into an exchange agreement (the “Exchange Agreement”) with an Investor and its affiliates (the “Exchanging Stockholders”), pursuant to which the Company exchanged an aggregate of 1,458,000 shares of the Company’s common stock, par value $0.0001 per share, owned by the Exchanging Stockholders for pre-funded warrants (the “Exchange Warrants”) to purchase an aggregate of 1,458,000 shares of common stock (subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Exchange Warrants), with an exercise price of $0.0001 per share. The Exchange Warrants will expire ten years from the date of issuance. The Exchange Warrants are exercisable at any time prior to expiration except that the Exchange Warrants cannot be exercised by the Exchanging Stockholders if, after giving effect thereto, the Exchanging Stockholders would beneficially own more than 9.99% of the Company’s common stock, subject to certain exceptions. In accordance with Accounting Standards Codification Topic 505, Equity, and Accounting Research Bulletin 43, the Company recorded the retirement of the common stock exchanged as a reduction of common shares outstanding and elected to record the excess over par value as a debit to additional paid-in-capital at the fair value of the Exchange Warrants on the issuance date. The Exchange Warrants are classified as equity in accordance with Accounting Standards Codification Topic 480, Distinguishing Liabilities from Equity, and Accounting Standards Codification Topic 815, Derivatives and Hedging, and the fair value of the Exchange Warrants was recorded as a credit to additional paid-in capital and is not subject to remeasurement. The Company determined that the fair value of the Exchange Warrants is substantially similar to the fair value of the retired shares on the issuance date due to the negligible exercise price for the Exchange Warrants. As of March 31, 2020, none of the Exchange Warrants have been exercised. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
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 March 31, 2020, the Company had an accumulated deficit of $230.1 million and cash, cash equivalents and marketable securities of $68.7 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 three months ended March 31, 2020 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, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 9, 2020. 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. Treasury securities, 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, 2019, included in its Annual Report on Form 10-K. There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2020. Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board 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. Upon adoption of ASU 2016-02, the Company recognized an operating lease, right-of-use asset of $2.8 million and a corresponding liability of $3.8 million and eliminated $1.0 million of deferred rent in the Company’s condensed balance sheet. The adoption of ASU 2016-02 did not have any impact on the Company’s condensed statements of operations and comprehensive loss. See also Note 11. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2020 | |
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 March 31, 2020 2019 Numerator: Net loss - basic and diluted $ (12,935) $ (11,643) Denominator: Weighted average common shares outstanding 29,411,233 29,326,075 Less: weighted average common shares subject to repurchase — (33,940) Weighted average common shares outstanding used to compute basic and diluted net loss per share 29,411,233 29,292,135 Net loss per share, basic and diluted $ (0.44) $ (0.40) Weighted average common shares outstanding for the three months ended March 31, 2020 include 1,458,000 shares of common stock issuable on the conversion of pre-funded warrants described in Note 1. 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 March 31, 2020 2019 Common stock subject to repurchase — 27,073 Outstanding options 5,719,820 4,040,925 Total shares of common stock equivalents 5,719,820 4,067,998 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
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 March 31, 2020 and December 31, 2019 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): March 31, 2020 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 22,366 $ — $ — $ 22,366 Marketable securities 2,016 43,193 — 45,209 $ 24,382 $ 43,193 $ — $ 67,575 December 31, 2019 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 4,252 $ — $ — $ 4,252 Marketable securities 7,023 65,805 — 72,828 $ 11,275 $ 65,805 $ — $ 77,080 As of March 31, 2020, marketable securities had a maximum remaining maturity of nine months. As of March 31, 2020 and December 31, 2019, the fair value of available for sale marketable securities by type of security were as follows (in thousands): March 31, 2020 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Treasury securities $ 2,005 $ 11 $ — $ 2,016 U.S. Government agency securities 9,851 50 — 9,901 Corporate debt obligations 33,310 12 (30) 33,292 $ 45,166 $ 73 $ (30) $ 45,209 December 31, 2019 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Treasury securities $ 7,019 $ 4 $ — $ 7,023 U.S. Government agency securities 17,701 16 — 17,717 Corporate debt obligations 48,079 17 (8) 48,088 $ 72,799 $ 37 $ (8) $ 72,828 |
License and Collaboration Agree
License and Collaboration Agreements | 3 Months Ended |
Mar. 31, 2020 | |
License and Collaboration Agreements | |
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. Monash License Agreement In April 2017, the Company entered into a license agreement with Monash University (Monash), pursuant to which the Company was granted an exclusive, sublicensable worldwide license under certain know‑how, patent rights and other intellectual property rights controlled by Monash to research, develop, and commercialize certain antibodies directed to CXCR2 for the treatment of human diseases. Upon execution of the agreement, the Company made a one‑time cash payment to Monash of $275,000 and reimbursed Monash for certain patent prosecution costs incurred prior to execution of the agreement. The Company us also obligated to pay an annual license maintenance fee to Monash of $25,000 until a certain development milestone is met with respect to the licensed product, after which no further maintenance fee will be due. The Company is also required to make development and sales milestone payments to Monash with respect to the licensed products in the aggregate of up to $45.1 million. The Company is also required to pay to Monash tiered royalties on net sales of licensed products sold by it, its affiliates and its sublicensees at a rate ranging in the low‑single digits. In addition, should the Company sublicense its rights under the agreement, the Company has agreed to pay a percentage of sublicense revenue received at specified rates that are currently at low double digit percentages and decrease to single digit percentages based on the achievement of development milestones. The term of the Company’s agreement with Monash continues until the expiration of its obligation to pay royalties to Monash thereunder. The license agreement is terminable at will by the Company upon providing 30 days written notice to Monash, or by either party for material breaches by the other party. In addition, Monash may terminate the entire agreement or convert the license to a non-exclusive license if the Company has materially breached our obligation to use commercially reasonable efforts to develop and commercialize a licensed product, subject to a specified notice and cure mechanism. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2020 | |
Balance Sheet Components | |
Balance Sheet Components | 6. Balance Sheet Components (in thousands) March 31, December 31, 2020 2019 Prepaid and Other Current Assets Interest receivable $ 174 $ 329 Prepaid research and development manufacturing expenses 205 240 Prepaid facility expenses 160 157 Prepaid insurance 85 150 Other 512 486 $ 1,136 $ 1,362 Property and Equipment Laboratory equipment $ 2,396 $ 2,396 Computer equipment and purchased software 142 142 Leasehold improvements 2,084 2,084 4,622 4,622 Less: accumulated depreciation and amortization (3,344) (3,160) $ 1,278 $ 1,462 Accrued and Other Liabilities Accrued clinical trial related $ 4,131 $ 4,300 Accrued manufacturing expense 1,102 696 Personnel related 1,535 1,624 Other 661 279 $ 7,429 $ 6,899 |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2020 | |
Common Stock | |
Common Stock | 7. Common Stock As of March 31, 2020, 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 March 31, 2020, no dividends on common stock had been declared. In March 2020, the Company entered into an open market sale agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) to sell shares of the Company’s common stock, from time to time, with aggregate gross sales proceeds of up to $50,000,000, through an at-the-market equity offering program under which Jefferies 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. Jefferies 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 Jefferies under the Sales Agreement. As of March 31, 2020, the Company had 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: March 31, December 31, 2020 2019 Exchange warrants 1,458,000 1,458,000 Shares available for future option grants 2,745,773 1,704,183 Outstanding options 5,719,820 5,643,410 Shares reserved for employee stock purchase plan 400,000 400,000 Total 10,323,593 9,205,593 |
Stock Option Plans
Stock Option Plans | 3 Months Ended |
Mar. 31, 2020 | |
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, 2019 1,704,183 5,643,410 $ 8.05 Additional shares authorized 1,118,000 — — Options granted (100,000) 100,000 2.14 Options forfeited 23,590 (23,590) 7.24 Balance at March 31, 2020 2,745,773 5,719,820 $ 7.95 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
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 March 31, 2020 2019 Research and development $ 869 $ 798 General and administrative 976 1,155 Total $ 1,845 $ 1,953 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2020 | |
Income Taxes | |
Income Taxes | 10. Income Taxes During the three months ended March 31, 2020 and 2019, 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. The Company continues to maintain a full valuation allowance against its net deferred tax assets. |
Facility Lease
Facility Lease | 3 Months Ended |
Mar. 31, 2020 | |
Facility Lease | |
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. As the interest rate implicit in lease arrangements is typically not readily available, in calculating the present value of the lease payments, the Company has utilized its incremental borrowing rate, which is determined based on the prevailing market rates for collateralized debt with maturity dates commensurate with the term of its lease . 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 March 31, 2020 and December 31, 2019, the right-of-use asset under operating lease was $2.2 million and $2.3 million, respectively. The elements of lease expense were as follows (in thousands): Three Months Ended Statements of operations and March 31, comprehensive loss location 2020 2019 Costs of operating lease Operating lease costs Research and development, $ 239 $ 249 Costs of non-lease components (previously common area maintenance) Research and development, 88 81 Total operating lease cost $ 327 $ 330 Other Information Operating cash flows used for operating lease $ 377 $ 359 Remaining lease term 2.8 years 3.8 years Discount rate As of March 31, 2020, minimum rental commitments under this lease were as follows (in thousands): Year Ended December 31 (in thousands) 2020* $ 870 2021 1,260 2022 1,299 Total lease payments 3,429 Less: imputed interest (452) Total $ 2,977 * Remainder of the year As of December 31, 2019, minimum rental commitments under this lease were as follows (in thousands): Year Ended December 31 (in thousands) 2020 $ 1,159 2021 1,260 2022 1,299 Total lease payments 3,718 Less: imputed interest (530) Total $ 3,188 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
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, Scripps and Monash, 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, Scripps and Monash 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
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 March 31, 2020, the Company had an accumulated deficit of $230.1 million and cash, cash equivalents and marketable securities of $68.7 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 three months ended March 31, 2020 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, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 9, 2020. |
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. Treasury securities, 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, 2019, included in its Annual Report on Form 10-K. There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2020. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board 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. Upon adoption of ASU 2016-02, the Company recognized an operating lease, right-of-use asset of $2.8 million and a corresponding liability of $3.8 million and eliminated $1.0 million of deferred rent in the Company’s condensed balance sheet. The adoption of ASU 2016-02 did not have any impact on the Company’s condensed statements of operations and comprehensive loss. See also Note 11. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Net Loss per Share | |
Schedule of net loss per share, basic and diluted | Three Months Ended March 31, 2020 2019 Numerator: Net loss - basic and diluted $ (12,935) $ (11,643) Denominator: Weighted average common shares outstanding 29,411,233 29,326,075 Less: weighted average common shares subject to repurchase — (33,940) Weighted average common shares outstanding used to compute basic and diluted net loss per share 29,411,233 29,292,135 Net loss per share, basic and diluted $ (0.44) $ (0.40) |
Schedule of antidilutive securities excluded from calculation of diluted net loss per share | Three Months Ended March 31, 2020 2019 Common stock subject to repurchase — 27,073 Outstanding options 5,719,820 4,040,925 Total shares of common stock equivalents 5,719,820 4,067,998 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Measurements | |
Schedule of fair value of assets measured at fair value on a recurring basis, by level of fair value hierarchy | March 31, 2020 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 22,366 $ — $ — $ 22,366 Marketable securities 2,016 43,193 — 45,209 $ 24,382 $ 43,193 $ — $ 67,575 December 31, 2019 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 4,252 $ — $ — $ 4,252 Marketable securities 7,023 65,805 — 72,828 $ 11,275 $ 65,805 $ — $ 77,080 |
Schedule of fair value of available for sale marketable securities | March 31, 2020 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Treasury securities $ 2,005 $ 11 $ — $ 2,016 U.S. Government agency securities 9,851 50 — 9,901 Corporate debt obligations 33,310 12 (30) 33,292 $ 45,166 $ 73 $ (30) $ 45,209 December 31, 2019 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Treasury securities $ 7,019 $ 4 $ — $ 7,023 U.S. Government agency securities 17,701 16 — 17,717 Corporate debt obligations 48,079 17 (8) 48,088 $ 72,799 $ 37 $ (8) $ 72,828 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Balance Sheet Components | |
Schedule of balance sheet components | March 31, December 31, 2020 2019 Prepaid and Other Current Assets Interest receivable $ 174 $ 329 Prepaid research and development manufacturing expenses 205 240 Prepaid facility expenses 160 157 Prepaid insurance 85 150 Other 512 486 $ 1,136 $ 1,362 Property and Equipment Laboratory equipment $ 2,396 $ 2,396 Computer equipment and purchased software 142 142 Leasehold improvements 2,084 2,084 4,622 4,622 Less: accumulated depreciation and amortization (3,344) (3,160) $ 1,278 $ 1,462 Accrued and Other Liabilities Accrued clinical trial related $ 4,131 $ 4,300 Accrued manufacturing expense 1,102 696 Personnel related 1,535 1,624 Other 661 279 $ 7,429 $ 6,899 |
Common Stock (Tables)
Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Common Stock | |
Schedule of shares of common stock reserved for issuance | March 31, December 31, 2020 2019 Exchange warrants 1,458,000 1,458,000 Shares available for future option grants 2,745,773 1,704,183 Outstanding options 5,719,820 5,643,410 Shares reserved for employee stock purchase plan 400,000 400,000 Total 10,323,593 9,205,593 |
Stock Option Plans (Tables)
Stock Option Plans (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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, 2019 1,704,183 5,643,410 $ 8.05 Additional shares authorized 1,118,000 — — Options granted (100,000) 100,000 2.14 Options forfeited 23,590 (23,590) 7.24 Balance at March 31, 2020 2,745,773 5,719,820 $ 7.95 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Stock-Based Compensation | |
Schedule of expenses relating to employee and non-employee stock-based awards | Three Months Ended March 31, 2020 2019 Research and development $ 869 $ 798 General and administrative 976 1,155 Total $ 1,845 $ 1,953 |
Facility Lease (Tables)
Facility Lease (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Facility Lease | |
Elements of lease expense | Three Months Ended Statements of operations and March 31, comprehensive loss location 2020 2019 Costs of operating lease Operating lease costs Research and development, $ 239 $ 249 Costs of non-lease components (previously common area maintenance) Research and development, 88 81 Total operating lease cost $ 327 $ 330 Other Information Operating cash flows used for operating lease $ 377 $ 359 Remaining lease term 2.8 years 3.8 years Discount rate |
Minimum rental commitments | As of March 31, 2020, minimum rental commitments under this lease were as follows (in thousands): Year Ended December 31 (in thousands) 2020* $ 870 2021 1,260 2022 1,299 Total lease payments 3,429 Less: imputed interest (452) Total $ 2,977 * Remainder of the year As of December 31, 2019, minimum rental commitments under this lease were as follows (in thousands): Year Ended December 31 (in thousands) 2020 $ 1,159 2021 1,260 2022 1,299 Total lease payments 3,718 Less: imputed interest (530) Total $ 3,188 |
Organization - Public Offerings
Organization - Public Offerings (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 08, 2019 | Apr. 26, 2016 | Mar. 29, 2016 | Mar. 31, 2018 | Mar. 31, 2020 | Dec. 31, 2019 |
Public Offerings | ||||||
Accumulated deficit | $ (230,080) | $ (217,145) | ||||
Cash, cash equivalents and short-term marketable securities | $ 68,700 | |||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||
Exchange warrants issued | 1,458,000 | |||||
Exchange Warrants | ||||||
Public Offerings | ||||||
Issuance of stock (in shares) | 1,458,000 | 1,458,000 | ||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||
Exchange warrants issued | 1,458,000 | |||||
Warrant exercise price | $ 0.0001 | |||||
Exchange warrant expiry term | 10 years | |||||
Percentage of shares owned by exchanging shareholders | 9.99% | |||||
Warrants Exercised | 0 | |||||
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 | |||||
Proceeds from sale of stock | $ 64,900 | |||||
Issuance of stock (in shares) | 8,117,647 | |||||
IPO | ||||||
Public Offerings | ||||||
Shares Issued, Price Per Share | $ 15 | |||||
Net proceeds from IPO | $ 70,600 | |||||
Issuance of stock (in shares) | 4,700,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Basis of Presentation, Credit Risk and Income Taxes (Details) $ in Thousands | Jan. 01, 2019USD ($) | Mar. 31, 2020USD ($)segmentitem | Dec. 31, 2019USD ($) |
Accumulated deficit | $ (230,080) | $ (217,145) | |
Cash, cash equivalents and marketable securities | $ 68,700 | ||
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 | ||
Operating lease right-of-use asset | $ 2,163 | 2,327 | |
Operating lease liabilities | $ 2,977 | $ 3,188 | |
ASU 2016-02 | |||
Recent accounting pronouncements | |||
Operating lease right-of-use asset | $ 2,800 | ||
Operating lease liabilities | 3,800 | ||
Deferred rent | $ 1,000 |
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 | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Numerator: | ||
Net loss - basic and diluted | $ (12,935) | $ (11,643) |
Denominator: | ||
Weighted average common shares outstanding | 29,411,233 | 29,326,075 |
Less: weighted average common shares subject to repurchase | (33,940) | |
Weighted average common shares outstanding used to compute basic and diluted net loss per share | 29,411,233 | 29,292,135 |
Net loss per share, basic and diluted (in dollars per share) | $ (0.44) | $ (0.40) |
Shares of common stock issuable on the conversion of pre-funded warrants | 1,458,000 |
Net Loss per Share - Anti-Dilut
Net Loss per Share - Anti-Dilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Excluded from the calculation of diluted net loss per share, due to anti-dilutive effect | ||
Shares of common stock equivalents | 5,719,820 | 4,067,998 |
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 | 27,073 | |
Outstanding options | ||
Excluded from the calculation of diluted net loss per share, due to anti-dilutive effect | ||
Shares of common stock equivalents | 5,719,820 | 4,040,925 |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
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 | 9 months | |
Recurring | ||
Assets | ||
Cash equivalents | $ 22,366 | $ 4,252 |
Marketable securities | 45,209 | 72,828 |
Total Assets | 67,575 | 77,080 |
Recurring | Level 1 | ||
Assets | ||
Cash equivalents | 22,366 | 4,252 |
Marketable securities | 2,016 | 7,023 |
Total Assets | 24,382 | 11,275 |
Recurring | Level 2 | ||
Assets | ||
Marketable securities | 43,193 | 65,805 |
Total Assets | $ 43,193 | $ 65,805 |
Fair Value Measurements - Avail
Fair Value Measurements - Available For Sale (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Fair value of available for sale marketable securities | ||
Amortized Cost | $ 45,166 | $ 72,799 |
Gross Unrealized Gains | 73 | 37 |
Gross Unrealized Losses | (30) | (8) |
Fair Value | 45,209 | 72,828 |
U.S. Treasury securities | ||
Fair value of available for sale marketable securities | ||
Amortized Cost | 2,005 | 7,019 |
Gross Unrealized Gains | 11 | 4 |
Fair Value | 2,016 | 7,023 |
U.S. Government agency securities | ||
Fair value of available for sale marketable securities | ||
Amortized Cost | 9,851 | 17,701 |
Gross Unrealized Gains | 50 | 16 |
Fair Value | 9,901 | 17,717 |
Corporate debt obligations | ||
Fair value of available for sale marketable securities | ||
Amortized Cost | 33,310 | 48,079 |
Gross Unrealized Gains | 12 | 17 |
Gross Unrealized Losses | (30) | (8) |
Fair Value | $ 33,292 | $ 48,088 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2020 | Feb. 28, 2017 | Dec. 31, 2015 | Feb. 28, 2015 | |
Monash License | ||||
License and Collaboration Agreements | ||||
Minimum annual fee | $ 25,000 | |||
Aggregate potential milestone payments | $ 45,100,000 | |||
Period of written notice to terminate | 30 days | |||
Monash License | Research and development | ||||
License and Collaboration Agreements | ||||
One-time cash payment | $ 275,000 | |||
Licensing Agreement | 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 | |||
Licensing Agreement | Scripps Research Institute | Research and development | ||||
License and Collaboration Agreements | ||||
One-time cash payment | $ 10,000 | |||
Licensing Agreement | Vernalis (R&D) Limited | ||||
License and Collaboration Agreements | ||||
Milestone payments made | $ 3,000,000 | |||
Period of written notice to terminate | 90 days | |||
Licensing Agreement | Vernalis (R&D) Limited | Minimum | ||||
License and Collaboration Agreements | ||||
Aggregate potential milestone payments | $ 220,000,000 | |||
Licensing Agreement | 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 | Mar. 31, 2020 | Dec. 31, 2019 |
Prepaid and Other Current Assets | ||
Interest receivable | $ 174 | $ 329 |
Prepaid research and development manufacturing expenses | 205 | 240 |
Prepaid facility expenses | 160 | 157 |
Prepaid insurance | 85 | 150 |
Other | 512 | 486 |
Total of prepaid and other current assets | $ 1,136 | $ 1,362 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Property and Equipment | ||
Property and equipment, gross | $ 4,622 | $ 4,622 |
Less: accumulated depreciation and amortization | (3,344) | (3,160) |
Property and equipment, net | 1,278 | 1,462 |
Laboratory equipment | ||
Property and Equipment | ||
Property and equipment, gross | 2,396 | 2,396 |
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 | Mar. 31, 2020 | Dec. 31, 2019 |
Accrued and Other Liabilities | ||
Accrued clinical trial related | $ 4,131 | $ 4,300 |
Accrued manufacturing expense | 1,102 | 696 |
Personnel related | 1,535 | 1,624 |
Other accrued expenses | 661 | 279 |
Total of accrued and other liabilities | $ 7,429 | $ 6,899 |
Common Stock (Details)
Common Stock (Details) | Nov. 08, 2019shares | Sep. 30, 2017USD ($) | Mar. 31, 2020USD ($)Voteshares | Dec. 31, 2019shares |
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 | |||
Shares of common stock reserved for issuance, on an as-converted basis | ||||
Shares reserved for exchange warrants | 1,458,000 | 1,458,000 | ||
Shares available for future option grants | 2,745,773 | 1,704,183 | ||
Outstanding options | 5,719,820 | 5,643,410 | ||
Shares reserved for employee stock purchase plan | 400,000 | 400,000 | ||
Total | 10,323,593 | 9,205,593 | ||
Exchange Warrants | ||||
Shares of common stock reserved for issuance, on an as-converted basis | ||||
Exchange warrants | 1,458,000 | 1,458,000 | ||
At-the-market offering | Cowen | ||||
Common Stock | ||||
Proceeds from sale of stock | $ | $ 0 | |||
At-the-market offering | Cowen | Maximum | ||||
Common Stock | ||||
Potential gross proceeds | $ | $ 50,000,000 | |||
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 | ||
Mar. 31, 2016 | Feb. 28, 2014 | Mar. 31, 2020 | Mar. 31, 2019 | |
Shares Available for Grant | ||||
Beginning balance | 1,704,183 | |||
Exercised | $ 1 | |||
Ending balance | 2,745,773 | |||
Number of Options | ||||
Beginning balance | 5,643,410 | |||
Ending balance | 5,719,820 | |||
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 | 1,704,183 | |||
Additional shares authorized | 1,118,000 | |||
Granted | (100,000) | |||
Forfeited | 23,590 | |||
Ending balance | 2,745,773 | |||
Number of Options | ||||
Beginning balance | 5,643,410 | |||
Granted | 100,000 | |||
Forfeited | (23,590) | |||
Ending balance | 5,719,820 | |||
Weighted-Average Exercise Price | ||||
Beginning balance (in dollars per share) | $ 8.05 | |||
Granted (in dollars per share) | 2.14 | |||
Forfeited (in dollars per share) | 7.24 | |||
Ending balance (in dollars per share) | $ 7.95 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense Allocation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Stock-based compensation | ||
Stock-based compensation expense | $ 1,845 | $ 1,953 |
Research and development | ||
Stock-based compensation | ||
Stock-based compensation expense | 869 | 798 |
General and administrative | ||
Stock-based compensation | ||
Stock-based compensation expense | $ 976 | $ 1,155 |
Income Taxes - Tax Cut and Jobs
Income Taxes - Tax Cut and Jobs Act (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Income Taxes | ||
Income tax benefits | $ 0 | $ 0 |
Facility Lease - Lessee informa
Facility Lease - Lessee information (Details) $ in Thousands | 1 Months Ended | |||
Oct. 31, 2018USD ($)ft² | Mar. 31, 2020USD ($) | Dec. 31, 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 | $ 2,163 | $ 2,327 |
Facility Lease - Lease cost (De
Facility Lease - Lease cost (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating lease cost | ||
Operating lease costs | $ 239 | $ 249 |
Costs of non-lease components (previously common area maintenance) | 88 | 81 |
Total operating lease cost | 327 | 330 |
Other Information | ||
Operating cash flows used for operating lease | $ 377 | $ 359 |
Remaining lease term | 2 years 9 months 18 days | 3 years 9 months 18 days |
Discount rate | 10.00% | 10.00% |
Facility Lease - Minimum rental
Facility Lease - Minimum rental commitments (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Minimum rental commitments under Topic 842 | ||
2020* | $ 870 | |
2020 | $ 1,159 | |
2021 | 1,260 | 1,260 |
2022 | 1,299 | 1,299 |
Total lease payments | 3,429 | 3,718 |
Less: imputed interest | (452) | (530) |
Total | $ 2,977 | $ 3,188 |
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 |