Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 31, 2019 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | PROTAGONIST THERAPEUTICS, INC. | |
Entity Central Index Key | 0001377121 | |
Current Fiscal Year End Date | --12-31 | |
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 | 26,280,086 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 71,143 | $ 82,233 |
Restricted cash - current | 10 | 10 |
Available-for-sale securities | 54,958 | 46,620 |
Receivable from collaboration partner and contract asset - related party | 4,889 | 4,587 |
Research and development tax incentive receivable | 1,421 | 1,429 |
Prepaid expenses and other current assets | 4,899 | 2,624 |
Total current assets | 137,320 | 137,503 |
Property and equipment, net | 1,692 | 861 |
Restricted cash - noncurrent | 450 | 450 |
Operating lease right-of-use asset | 6,539 | |
Deferred tax asset | 2,104 | 658 |
Total assets | 148,105 | 139,472 |
Current liabilities: | ||
Accounts payable | 2,787 | 5,711 |
Payable to collaboration partner - related party | 810 | 1,061 |
Accrued expenses and other payables | 10,845 | 11,163 |
Operating lease liability - current | 1,164 | |
Deferred revenue - related party | 17,717 | 8,223 |
Total current liabilities | 33,323 | 26,158 |
Deferred revenue - related party - noncurrent | 23,850 | |
Operating lease liability - noncurrent | 6,616 | |
Deferred rent | 799 | |
Total liabilities | 63,789 | 26,957 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.00001 par value, 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock, $0.00001 par value, 90,000,000 shares authorized; 24,967,603 and 23,187,219 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | ||
Additional paid-in capital | 268,234 | 253,222 |
Accumulated other comprehensive loss | (167) | (233) |
Accumulated deficit | (183,751) | (140,474) |
Total stockholders’ equity | 84,316 | 112,515 |
Total liabilities and stockholders’ equity | $ 148,105 | $ 139,472 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Condensed Consolidated Balance Sheets | ||
Preferred stock, par value | $ 0.00001 | $ 0.00001 |
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 | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 90,000,000 | 90,000,000 |
Common stock, shares issued | 24,967,603 | 23,187,219 |
Common stock, shares outstanding | 24,967,603 | 23,187,219 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Condensed Consolidated Statements of Operations | ||||
License and collaboration revenue - related party | $ (8,189) | $ 11,674 | $ (6,629) | $ 22,455 |
Operating expenses: | ||||
Research and development | 19,355 | 17,735 | 31,799 | 33,103 |
General and administrative | 3,863 | 3,178 | 7,627 | 6,820 |
Total operating expenses | 23,218 | 20,913 | 39,426 | 39,923 |
Loss from operations | (31,407) | (9,239) | (46,055) | (17,468) |
Interest income | 604 | 576 | 1,333 | 1,144 |
Loss before income tax benefit | (30,803) | (8,663) | (44,722) | (16,324) |
Income tax benefit | 1,629 | 0 | 1,445 | 0 |
Net loss | $ (29,174) | $ (8,663) | $ (43,277) | $ (16,324) |
Net loss per share, basic and diluted | $ (1.18) | $ (0.41) | $ (1.77) | $ (0.77) |
Weighted-average shares used to compute net loss per share, basic and diluted | 24,662,779 | 21,207,234 | 24,481,186 | 21,160,076 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (29,174) | $ (8,663) | $ (43,277) | $ (16,324) |
Other comprehensive loss: | ||||
Loss on translation of foreign operations | (19) | (68) | (4) | (86) |
Unrealized gain on available-for-sale securities | 41 | 54 | 70 | 6 |
Comprehensive loss | $ (29,152) | $ (8,677) | $ (43,211) | $ (16,404) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Balance, Beginning at Dec. 31, 2017 | $ 222,188 | $ (6) | $ (101,550) | $ 120,632 | |
Balance, Beginning (in shares) at Dec. 31, 2017 | 21,088,306 | ||||
Balance, Ending at Mar. 31, 2018 | 223,904 | (72) | (109,211) | 114,621 | |
Balance, Ending (in shares) at Mar. 31, 2018 | 21,163,590 | ||||
Balance, Beginning at Dec. 31, 2017 | 222,188 | (6) | (101,550) | 120,632 | |
Balance, Beginning (in shares) at Dec. 31, 2017 | 21,088,306 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Stock-based compensation expense | 2,830 | 2,830 | |||
Common stock issued under equity incentive and employee stock purchase plans | 604 | 604 | |||
Common stock issued under equity incentive and employee stock purchase plans (in shares) | 129,188 | ||||
Other comprehensive gain | (80) | (80) | |||
Net loss | (16,324) | (16,324) | |||
Balance, Ending at Jun. 30, 2018 | 225,622 | (86) | (117,874) | 107,662 | |
Balance, Ending (in shares) at Jun. 30, 2018 | 21,217,494 | ||||
Balance, Beginning at Mar. 31, 2018 | 223,904 | (72) | (109,211) | 114,621 | |
Balance, Beginning (in shares) at Mar. 31, 2018 | 21,163,590 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Stock-based compensation expense | 1,645 | 1,645 | |||
Common stock issued under equity incentive and employee stock purchase plans | 73 | 73 | |||
Common stock issued under equity incentive and employee stock purchase plans (in shares) | 53,904 | ||||
Other comprehensive gain | (14) | (14) | |||
Net loss | (8,663) | (8,663) | |||
Balance, Ending at Jun. 30, 2018 | 225,622 | (86) | (117,874) | 107,662 | |
Balance, Ending (in shares) at Jun. 30, 2018 | 21,217,494 | ||||
Balance, Beginning at Dec. 31, 2018 | 253,222 | (233) | (140,474) | $ 112,515 | |
Balance, Beginning (in shares) at Dec. 31, 2018 | 23,187,219 | 23,187,219 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Stock-based compensation expense | 3,992 | $ 3,992 | |||
Common stock issued pursuant to at-the-market offering, net of issuance costs | 10,543 | 10,543 | |||
Common stock issued pursuant to at-the-market offering, net of issuance costs (in shares) | 921,684 | ||||
Common stock issued pursuant to exercise of Exchange Warrants (in shares) | 599,997 | ||||
Common stock issued under equity incentive and employee stock purchase plans | 477 | 477 | |||
Common stock issued under equity incentive and employee stock purchase plans (in shares) | 258,703 | ||||
Other comprehensive gain | 66 | 66 | |||
Net loss | (43,277) | (43,277) | |||
Balance, Ending at Jun. 30, 2019 | 268,234 | (167) | (183,751) | $ 84,316 | |
Balance, Ending (in shares) at Jun. 30, 2019 | 24,967,603 | 24,967,603 | |||
Balance, Beginning at Mar. 31, 2019 | 255,591 | (189) | (154,577) | $ 100,825 | |
Balance, Beginning (in shares) at Mar. 31, 2019 | 23,392,534 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | |||||
Stock-based compensation expense | 2,013 | 2,013 | |||
Common stock issued pursuant to at-the-market offering, net of issuance costs | 10,543 | 10,543 | |||
Common stock issued pursuant to at-the-market offering, net of issuance costs (in shares) | 921,684 | ||||
Common stock issued pursuant to exercise of Exchange Warrants (in shares) | 599,997 | ||||
Common stock issued under equity incentive and employee stock purchase plans | 87 | 87 | |||
Common stock issued under equity incentive and employee stock purchase plans (in shares) | 53,388 | ||||
Other comprehensive gain | 22 | 22 | |||
Net loss | (29,174) | (29,174) | |||
Balance, Ending at Jun. 30, 2019 | $ 268,234 | $ (167) | $ (183,751) | $ 84,316 | |
Balance, Ending (in shares) at Jun. 30, 2019 | 24,967,603 | 24,967,603 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (43,277) | $ (16,324) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 3,992 | 2,830 |
Operating lease right-of-use asset amortization | 903 | |
Change in deferred tax asset | (1,446) | |
Depreciation and amortization | 306 | 248 |
Net (accretion of discount) amortization of premium on available-for-sale securities | (209) | 110 |
Changes in operating assets and liabilities: | ||
Research and development tax incentive receivable | (963) | |
Receivable from collaboration partner - related party | (302) | (3,968) |
Prepaid expenses and other assets | (1,804) | 807 |
Accounts payable | (2,998) | 1,014 |
Payable to collaboration partner - related party | (251) | 276 |
Accrued expenses and other payables | (319) | 3,984 |
Operating lease liability | (931) | |
Deferred revenue - related party | 33,344 | (18,550) |
Net cash used in operating activities | (12,992) | (30,536) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of available-for-sale securities | (52,459) | (39,012) |
Proceeds from maturities of available-for-sale securities | 44,400 | 27,035 |
Purchases of property and equipment, net | (1,058) | (276) |
Net cash used in investing activities | (9,117) | (12,253) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from at-the-market offering, net of issuance costs | 10,543 | |
Proceeds from issuance of common stock upon exercise of stock options and purchases under employee stock purchase plan | 477 | 604 |
Net cash provided by financing activities | 11,020 | 604 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (1) | 20 |
Net decrease in cash, cash equivalents and restricted cash | (11,090) | (42,165) |
Cash, cash equivalents and restricted cash, beginning of period | 82,693 | 106,489 |
Cash, cash equivalents and restricted cash, end of period | 71,603 | 64,324 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH FINANCING AND INVESTING INFORMATION: | ||
Purchases of property and equipment in accounts payable and accrued liabilities | 82 | $ 8 |
Tenant improvement allowance reimbursement | $ 469 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Jun. 30, 2019 | |
Summary of Significant Accounting Policies. | |
Organization and Description of Business | Note 1. Organization and Description of Business Protagonist Therapeutics, Inc. (the “Company”) was incorporated in the state of Delaware on August 22, 2006 and is headquartered in Newark, California. The Company is a clinical-stage biopharmaceutical company with a proprietary technology platform that enables the discovery and development of novel constrained peptide-based drug candidates that address significant unmet medical needs. Protagonist Pty Limited (“Protagonist Australia”) is a wholly-owned subsidiary of the Company and is located in Brisbane, Queensland, Australia. Protagonist Australia was incorporated in Australia in September 2001. The Company manages its operations as a single operating segment. Liquidity The Company has incurred net losses from operations since inception and has an accumulated deficit of $183.8 million as of June 30, 2019. The Company’s ultimate success depends on the outcome of its research and development and collaboration activities. The Company expects to incur additional losses in the future and anticipates the need to raise additional capital to continue to execute its long-range business plan. Through June 30, 2019, the Company has financed its operations primarily through private placements of redeemable convertible preferred stock, offerings of common stock and payments received under license and collaboration agreements. |
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 | Note 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted, and accordingly the consolidated balance sheet as of December 31, 2018 has been derived from the Company’s audited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the Company’s consolidated financial information. The results of operations for the three and six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other interim period or for any other future year. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10‑K, filed with the SEC on March 12, 2019. Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, accruals for research and development activities, stock-based compensation, income taxes, research and development tax incentives, available-for-sale securities and leases. Estimates related to revenue recognition include actual costs incurred versus total estimated budgeted costs of the Company’s deliverables to determine percentage of completion, and application and estimates of constraints in the determination of the transaction price under its license and collaboration agreements. Management bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to forecasted amounts and future events. Actual results may differ significantly from those estimates. Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and available-for-sale securities. Substantially all of the Company’s cash is held by two financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits. The primary focus of the Company’s investment strategy is to preserve capital and to meet liquidity requirements. The Company’s cash equivalents and available-for-sale securities are managed by external managers within the guidelines of the Company’s investment policy. The Company’s investment policy addresses the level of credit exposure by limiting concentration in any one corporate issuer and establishing a minimum allowable credit rating. To manage its credit risk exposure, the Company maintains its portfolio of cash equivalents and available-for-sale securities in fixed income securities denominated and payable in U.S. dollars. Permissible investments of fixed income securities include obligations of the U.S. government and its agencies, money market instruments including commercial paper and negotiable certificates of deposit, and highly rated corporate debt obligations and money market funds. Cash Equivalents Cash equivalents that are readily convertible to cash are stated at cost, which approximates fair value. The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Restricted Cash Restricted cash consists of cash balances primarily held as security in connection with a letter of credit related to the Company’s facility lease entered into in March 2017 and the Company’s corporate credit card. Cash as Reported in Condensed Consolidated Statements of Cash Flows Cash as reported in the condensed consolidated statements of cash flows includes the aggregate amounts of cash and cash equivalents and the restricted cash as presented on the condensed consolidated balance sheets. Cash as reported in the condensed consolidated statements of cash flows consists of (in thousands): June 30, 2019 2018 Cash and cash equivalents $ 71,143 $ 63,864 Restricted cash - current 10 10 Restricted cash - noncurrent 450 450 Cash balance in condensed consolidated statements of cash flows $ 71,603 $ 64,324 Available-for-Sale Securities All marketable securities have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation as of each balance sheet date. Short-term marketable securities have maturities greater than three months but no longer than 365 days as of the balance sheet date. Long-term marketable securities have maturities of 365 days or longer as of the balance sheet date. Unrealized gains and losses are excluded from earnings and are reported as a component of comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest income. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest income. Leases The Company adopted Accounting Standards Topic 842, Leases, (“ASC 842”) effective January 1, 2019. The Company determines if an arrangement is a lease at inception. Pursuant to ASC 842, operating leases are included in operating lease right-of-use (“ROU”) assets, operating lease liabilities, and noncurrent operating lease liabilities on the consolidated balance sheets. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. If the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Lease terms include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company records tenant improvement allowances as a reduction to the ROU asset with the impact of the decrease recognized prospectively over the remaining lease term. The leasehold improvements will be amortized over the shorter of their useful life or the remaining term of the lease. Revenue Recognition The Company follows Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligations when (or as) the performance obligations are satisfied. The Company constrains its estimate of the transaction price up to the amount (the “variable consideration constraint”) that a significant reversal of recognized revenue is not probable. Licenses of intellectual property: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in an arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring proportional performance for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of proportional performance each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone payments: At the inception of each arrangement or amendment that includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. ASC 606 suggests two alternatives to use when estimating the amount of variable consideration: the expected value method and the most likely amount method. Under the expected value method, an entity considers the sum of probability-weighted amounts in a range of possible consideration amounts. Under the most likely amount method, an entity considers the single most likely amount in a range of possible consideration amounts. Whichever method is used, it should be consistently applied throughout the life of the contract; however, it is not necessary for the Company to use the same approach for all contracts. The Company expects to use the most likely amount method for development and regulatory milestone payments. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis. The Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability or achievement of each such milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Upfront payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. Amounts payable to the Company and not yet billed to the collaboration partner are recorded as contract assets. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Contractual cost sharing payments made to a customer are accounted for as a reduction to the transaction price if such payments are not related to distinct goods or services received from the customer. Contracts may be amended to account for changes in contract specifications and requirements. The period between when the Company transfers control of promised goods or services and when the Company receives payment is expected to be one year or less, and that expectation is consistent with the Company’s historical experience. Upfront payment contract liabilities resulting from the Company’s license and collaboration agreements do not represent a financing component as the payment is not financing the transfer of goods and services, and the technology underlying the licenses granted reflects research and development expenses already incurred by the Company. As such, the Company does not adjust its revenues for the effects of a significant financing component. Research and Development Costs Research and development costs are expensed as incurred, unless there is an alternate future use in other research and development projects or otherwise. Research and development costs include salaries and benefits, stock-based compensation expense, laboratory supplies and facility-related overhead, outside contracted services including clinical trial costs, manufacturing and process development costs for both clinical and pre-clinical materials, research costs, development milestone payments under license and collaboration agreements, and other consulting services. The Company accrues for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of pre-clinical studies and clinical trials, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated services provided but not yet invoiced and includes these costs in accrued expenses and other payables in the condensed consolidated balance sheets and within research and development expense in the condensed consolidated statements of operations. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued liabilities and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollment may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. Research and Development Tax Incentive The Company is eligible under the AusIndustry research and development tax incentive program to obtain a cash refund from the Australian Taxation Office. The refundable cash tax incentive is available to the Company on the basis of specific criteria with which the Company must comply. Specifically, the Company must have annual turnover of less than AUD 20.0 million and cannot be controlled by income tax exempt entities. The refundable cash research and development tax incentive is recognized as a reduction to research and development expense when the right to receive has been attained and funds are considered to be collectible. The tax incentive is denominated in Australian dollars and, therefore, the related receivable is remeasured into U.S. dollars as of each reporting date. The Company may alternatively be eligible for a taxable credit in the form of a non-cash tax incentive. The Company evaluates its eligibility under tax incentive programs as of each balance sheet date and makes accrual and related adjustments based on the most current and relevant data available. Net Loss per Share Basic net loss per share is calculated by dividing the Company’s net loss by the weighted average number of shares of common stock and Exchange Warrants outstanding during the period, without consideration of potentially dilutive securities. In accordance with Accounting Standards Codification Topic 260, Earnings Per Share , the Exchange Warrants are included in the computation of basic net loss per share because the exercise price is negligible, and they are fully vested and exercisable after the original issuance date. Diluted net loss per share is the same as basic net loss per share for all periods presented since the effect of potentially dilutive securities is anti-dilutive given the net loss of the Company. See Note 9. Stockholder’s Equity for additional information regarding the Exchange Warrants. Recently Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016‑02, Leases (Topic 842). In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases , which provides clarification to ASU 2016-02. These ASUs (collectively, the new lease standard) require an entity to recognize a lease liability and a ROU asset on the balance sheet for leases with lease terms of more than twelve months. Lessor accounting is largely unchanged, while lessees are no longer provided with a source of off-balance sheet financing. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842) - Targeted Improvements, which allows entities to elect an optional transition method where entities may continue to apply the existing lease guidance during the comparative periods and apply the new lease requirements through a cumulative effect adjustment in the period of adoption rather than in the earliest period presented. The Company adopted the new lease standard using the modified retrospective approach effective January 1, 2019 and elected the package of transitional practical expedients, such that, for leases existing prior to the adoption of ASC 842, the Company did not need to reassess whether contracts are leases, retained historical lease classification and historical initial direct costs classification. The Company did not elect the hindsight practical expedient to determine the lease term for existing leases. At January 1, 2019, the Company derecognized its deferred rent liability in the amount of $0.8 million, and recognized a ROU asset and related lease liability in the amount of $7.5 million and $8.3 million, respectively. In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting , which is intended to simplify the accounting for nonemployee share-based payment transactions by expanding the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The Company adopted this guidance prospectively as of January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial position, results of operations or liquidity. Recently Issued Accounting Pronouncements Not Yet Adopted as of June 30, 2019 In June 2016, the FASB issued ASU No. 2016‑13, Financial Instruments - Credit Losses (Topic 326) , which is intended to provide financial statement users with more useful information about expected credit losses on financial assets held by a reporting entity at each reporting date. In May 2019, the FASB issued ASU No. 2019-05, which amended the new standard by providing targeted transition relief. The new guidance replaces the existing incurred loss impairment methodology with a methodology that requires consideration of a broader range of reasonable and supportable forward-looking information to estimate all expected credit losses. This guidance is effective for the fiscal years and interim periods within those years beginning after December 15, 2019 and early adoption is permitted for fiscal years and interim periods within those years beginning after December 15, 2018. The Company is currently evaluating the impact of this new guidance on its consolidated financial statements and disclosures. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) – Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement , which modifies the disclosure requirements on fair value measurements and is intended to improve the effectiveness of disclosures, including the consideration of costs and benefits. The guidance is effective for the fiscal years and interim periods within those years beginning after January 1, 2020. Early adoption is permitted, and an entity is permitted to early adopt any removed or modified disclosures and delay adoption of additional disclosures until their effective date. The Company does not expect this new guidance to impact its consolidated financial statements and is currently evaluating the impact on its disclosures. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606 , which is intended to clarify the circumstances under which certain transactions in collaborative arrangements should be accounted for under the revenue recognition standard. Certain transactions between collaboration arrangement participants should be accounted for as revenue under ASC Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. This guidance is effective for fiscal years and interim periods within those years beginning after December 15, 2020. Early adoption is permitted. The Company is in the process of assessing the impact of this new guidance on its consolidated financial statements and disclosures. |
License and Collaboration Agree
License and Collaboration Agreement | 6 Months Ended |
Jun. 30, 2019 | |
License and Collaboration Agreement | |
License and Collaboration Agreement | |
License and Collaboration Agreement | Note 3. License and Collaboration Agreement Agreement Terms On May 26, 2017, the Company and Janssen Biotech, Inc., (“Janssen”), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, entered into an exclusive license and collaboration agreement (the “Janssen License and Collaboration Agreement”) for the development, manufacture and commercialization of PTG‑200 worldwide for the treatment of Crohn’s disease ("CD") and ulcerative colitis ("UC"). Janssen is a related party to the Company as Johnson & Johnson Innovation - JJDC, Inc., a significant stockholder of the Company, and Janssen are both subsidiaries of Johnson & Johnson. PTG‑200 is the Company’s oral gut-restricted Interleukin 23 receptor (“IL‑23R”) antagonist drug candidate currently in development. The Janssen License and Collaboration Agreement became effective on July 13, 2017. Upon the effectiveness of the agreement, the Company received a non-refundable, upfront cash payment of $50.0 million from Janssen. Under the Janssen License and Collaboration Agreement, the Company granted to Janssen an exclusive worldwide license to develop, manufacture and commercialize PTG‑200 and related IL‑23R compounds for all indications, including CD and UC. The Company was responsible, at its own expense, for the conduct of the Phase 1 clinical trial for PTG-200, and Janssen is responsible for the conduct of the first Phase 2 clinical trial for PTG-200 in CD, including filing the U.S. Investigational New Drug application (“IND”). Development costs for the Phase 2 clinical trial are shared between the parties on an 80/20 basis, with Janssen assuming the larger share. The Company entered into an amendment (the “First Amendment”) to the Janssen License and Collaboration Agreement effective May 7, 2019. The First Amendment builds upon the Company’s ongoing development collaboration with Janssen for PTG-200 and, upon the effectiveness of the First Amendment, the Company became eligible to receive a $25.0 million payment from Janssen, which was received during the second quarter of 2019. The First Amendment expands the scope of the Janssen License and Collaboration Agreement by supporting research efforts towards identifying and developing second-generation IL-23 receptor antagonists (“second-generation compounds”). As part of the services added in the First Amendment, Janssen will pay certain costs and milestones related to advancing pre-clinical candidates from the second-generation research program into Phase 1 studies, including funding of a certain number of full-time equivalent employees (“FTEs”) at the Company for a set period of time and funding of the research activities of such FTEs. The Company will pay 100% of the costs for the Phase 1 studies for the first second-generation compound, and 50% of the costs of the Phase 1 studies for the second and third second-generation compounds; thereafter Janssen will pay 100% of the Phase 1 costs. Development costs for the Phase 2 clinical trials for second-generation compounds are shared between the parties on an 80/20 basis, with Janssen assuming the larger share. The Company’s Phase 1 and Phase 2 development costs are also limited by overall spending caps. The Company was eligible to receive a $25.0 million milestone payment upon Janssen’s filing of the IND. This amount was considered constrained up until the First Amendment became effective, at which time the Company became eligible to receive the $25.0 million payment from Janssen. Payments to the Company for research and development services are generally billed and collected as services are performed, including research activities and Phase 1 and Phase 2 development activities. Janssen bills the Company for its 20% share of the Phase 2 development costs as expenses are incurred by Janssen. Milestone payments are paid when achieved. Pursuant to the First Amendment, the Company will continue to receive clinical development, regulatory and commercial milestones if Janssen elects to retain its license following completion of Phase 2a and/or Phase 2b studies with PTG-200 and/or second-generation compounds. Following the conclusion of the planned Phase 2a portion of a Phase 2 clinical trial with respect to PTG-200, if Janssen elects to maintain its license rights and continue the development of PTG-200 in the Phase 2b portion of such clinical trials (the “Amended First Opt-in”) prior to dosing of the third patient in the first Phase 2 clinical trial of second-generation compound, the Company would be eligible to receive a $50.0 million payment. Following the conclusion of the planned Phase 2b portion of a Phase 2 clinical trial with respect to PTG-200 or the first Phase 2 clinical trial of second-generation compounds, if Janssen elects to maintain its license rights (the “Amended Second Opt-in”), among other things, the Company would be eligible to receive a $50.0 million payment. Formerly, the first and second opt-in payments were $125.0 million and $215.0 million, respectively. If Janssen does not make the Amended Second Opt-in election, with respect to either PTG-200 or a second-generation compound, the Janssen License and Collaboration Agreement would terminate. Upon making the Amended Second Opt-in election, Janssen will receive exclusive, worldwide rights to develop and commercialize PTG-200 and any second-generation compounds derived from the research collaboration contemplated by the Janssen License and Collaboration Agreement and the First Amendment. Pursuant to the First Amendment, the Company will be eligible to receive tiered royalties on net product sales at percentages ranging from mid-single digits to ten. As set forth in the First Amendment, the Company will also be eligible for certain additional milestone payments including a potential payment of either $100.0 million upon a Phase 3 CD clinical trial reaching a primary clinical endpoint with respect to PTG-200 or $115.0 million upon a Phase 3 CD clinical trial reaching a primary clinical endpoint with respect to a second-generation compound. Under the terms of the First Amendment, the Company will be eligible to receive up to $1.0 billion in research, development, regulatory and sales milestones. The Janssen License and Collaboration Agreement remains in effect until the royalty obligations cease following patent and regulatory expiry, unless terminated earlier. Upon a termination of the Janssen License and Collaboration Agreement, all rights revert back to the Company, and in certain circumstances, if such termination occurs during ongoing clinical trials, Janssen would, if requested, provide certain financial and operational support to the Company for the completion of such trials. Revenue Recognition The Company has concluded that the amended Janssen License and Collaboration Agreement continues to contain a single performance obligation including the development license; second-generation compound research services; Phase 1 development services for PTG-200 and two potential second-generation compounds; the Company’s services associated with Phase 2 development for PTG-200 until Phase 2a; the Company’s services associated with Phase 2 development for a second-generation product until the dosing of the third patient in Phase 2b; and The Company determined that the license was not distinct from the added research and development services within the context of the agreement because the added research and development services significantly increase the utility of the intellectual property. The Company also determined that the remaining research and development services are not distinct from the partially delivered combined promise comprised under the agreement prior to the First Amendment of the development license and PTG-200 services, including compound supply and other services. Therefore, the First Amendment is treated as if it were part of the original Janssen License and Collaboration Agreement. The First Amendment will be accounted for as if it were an extension of services under the initial Janssen License and Collaboration Agreement by applying a cumulative catch-up adjustment to revenue. As of the effective date of the First Amendment, the Company calculated the adjusted cumulative revenue under the amended Janssen License and Collaboration Agreement by updating the transaction price for the incremental consideration to be received, net of the incremental development cost reimbursement to be paid to Janssen, and an updated percentage complete, which resulted in a cumulative adjustment that reduced revenue by $9.4 million. The contract duration is defined as the period in which parties to the contract have present enforceable rights and obligations. For revenue recognition purposes, the Company determined that the duration of the Janssen License and Collaboration Agreement, as amended, began on the effective date of July 13, 2017 and ends upon the later of end of Phase 2a for PTG-200 or upon dosing of the third patient in Phase 2b for a second-generation compound. The Company uses the most likely amount method to estimate variable consideration included in the transaction price. Variable consideration after the First Amendment consists of future milestone payments and cost sharing payments from Janssen for agreed upon services offset by Phase 2 development costs reimbursement payable to Janssen. Cost sharing payments from Janssen relate to the agreed upon services for Phase 2 activities that the Company performs within the duration of the contract are included in the transaction price at an amount equal to 80% of the estimated budgeted costs for these activities, including primarily internal full-time equivalent effort and third party contract costs. Cost sharing payments to Janssen relate to agreed upon services for Phase 2 activities that Janssen performs within the duration of the contract are not a distinct service that Janssen transfers to the Company. Therefore, the consideration payable to Janssen is accounted for as a reduction in the transaction price. The Company determined that the new transaction price of the Janssen License and Collaboration Agreement was $109.2 million as of June 30, 2019, an increase of $48.6 million from the transaction price of $60.6 million at March 31, 2019. In order to determine the transaction price, the Company evaluated all payments to be received during the duration of the contract, net of Phase 2 development costs reimbursement expected to be payable to Janssen. The Company determined that the transaction price includes the $50.0 million upfront payment, the $25.0 million payment payable upon the effectiveness of the First Amendment, $17.3 million of reimbursement from Janssen for services performed for PTG-200 Phase 2 and for second-generation compound research costs and other services, and $16.9 million of estimated variable consideration. The Company evaluated whether the variable component of the transaction price should be constrained to ensure that a significant reversal of revenue recognized on a cumulative basis as of June 30, 2019 is not probable. The Company concluded that that the variable consideration constraint does not further decrease the estimated transaction price as of June 30, 2019. The additional potential development, regulatory and sales milestone payments after the completion of Phase 2b activities that the Company is eligible to receive are outside the contract term and as such have been excluded from the transaction price. The increase in transaction price following the First Amendment was due primarily to the collection of the $25 million payment and increases in reimbursable costs related to new and extended research and development services, offset by Phase 2 development costs reimbursement payable to Janssen. The Company re-evaluates the transaction price, including variable consideration, at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur. The Company and Janssen make quarterly cost sharing payments to one another in amounts necessary to ensure that each party bears its contractual share of the overall shared costs incurred. The Company utilizes a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. In applying the cost-based input methods of revenue recognition, the Company uses actual costs incurred relative to expected costs to fulfill the combined performance obligation. These costs consist primarily of internal full-time equivalent effort and third-party contract costs. Revenue will be recognized based on actual costs incurred as a percentage of total estimated costs as the Company completes its performance obligations. A cost-based input method of revenue recognition requires management to make estimates of costs to complete the Company’s performance obligations. The Company believes this is the best measure of progress because other measures do not reflect how the Company transfers its performance obligation to Janssen. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete the Company’s performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. A significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods. For the three months ended June 30, 2019, the Company recorded a $9.4 million cumulative catchup adjustment reducing license and collaboration revenue, partially offset by $1.2 million of license and collaboration revenue following the contract modification for the First Amendment. For the three months ended June 30, 2018, the Company recognized $11.7 million of license and collaboration revenue. For the six months ended June 30, 2019, the Company recorded a $9.4 million cumulative catchup adjustment reducing license and collaboration revenue, partially offset by $1.2 million of license and collaboration revenue following the contract modification for the First Amendment and $1.6 million of revenue recognized during the first quarter of 2019 under the original Janssen License and Collaboration agreement. For the six months ended June 30, 2018, the Company recognized $22.5 million of license and collaboration revenue. The following tables present changes in the Company’s contract assets and liabilities during the periods presented (in thousands): Balance at Balance at Beginning of End of Six Months Ended June 30, 2019 Period Additions Deductions Period Contract assets: Receivable from collaboration partner - related party $ 2,042 $ 29,881 $ (27,034) $ 4,889 Contract asset - related party $ 2,545 $ — $ (2,545) $ — Contract liabilities: Deferred revenue - related party $ 8,223 $ 34,526 $ (1,182) $ 41,567 Payable to collaboration partner - related party $ 1,061 $ 625 $ (876) $ 810 Balance at Balance at Beginning of End of Six Months Ended June 30, 2018 Period Additions Deductions Period Contract assets: Receivable from collaboration partner - related party $ 1,816 $ 4,627 $ (658) $ 5,785 Contract liabilities: Deferred revenue - related party $ 31,752 $ 3,451 $ (22,001) $ 13,202 Payable to collaboration partner - related party $ — $ 580 $ (304) $ 276 During the three and six months ended June 30 2019, the Company recognized revenue of $1.6 million from amounts included in the deferred revenue contract liability balance at the beginning of the period. During the three and six months ended June 30, 2018, the Company recognized revenue of $11.5 million and $22.0 million, respectively, from amounts included in the contract liability balance at the beginning of the period. None of the costs to obtain or fulfill the contract were capitalized. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Measurements | |
Fair Value Measurements | Note 4. Fair Value Measurements Financial assets and liabilities are recorded at fair value. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1 —Inputs are unadjusted quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2— Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. Level 3 —Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. In determining fair value, the Company utilizes quoted market prices, broker or dealer quotations, or valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The following table presents the fair value of the Company’s financial assets determined using the inputs defined above (in thousands). June 30, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 38,877 $ — $ — $ 38,877 Corporate bonds — 12,578 — 12,578 Commercial paper — 36,563 — 36,563 Government bonds — 33,150 — 33,150 Total financial assets $ 38,877 $ 82,291 $ — $ December 31, 2018 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 25,390 $ — $ — $ 25,390 Corporate bonds — 8,989 — 8,989 Commercial paper — 59,730 — 59,730 Government bonds — 33,394 — 33,394 Total financial assets $ 25,390 $ 102,113 $ — $ 127,503 The Company’s corporate bonds, commercial paper and government bonds are classified as Level 2 as they were valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2019 | |
Balance Sheet Components | |
Balance Sheet Components | Note 5. Balance Sheet Components Cash Equivalents and Available-for-sale Securities Cash equivalents and available-for-sale securities consisted of the following (in thousands): June 30, 2019 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 38,876 $ — $ — $ 38,876 Corporate bonds 12,567 12 (1) 12,578 Commercial paper 36,565 3 (4) 36,564 Government bonds 33,126 24 — 33,150 Total cash equivalents and available-for-sale securities $ $ 39 $ (5) $ Classified as: Cash equivalents $ 66,210 Available-for-sale securities 54,958 Total cash equivalents and available-for-sale securities $ December 31, 2018 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 25,390 $ — $ — $ 25,390 Corporate bonds 8,997 — (8) 8,989 Commercial paper 59,730 — — 59,730 Government bonds 33,423 — (29) 33,394 Total cash equivalents and available-for-sale securities $ 127,540 $ — $ (37) $ 127,503 Classified as: Cash equivalents $ 80,883 Available-for-sale securities 46,620 Total cash equivalents and available-for-sale securities $ 127,503 Available-for-sale securities - current held as of June 30, 2019 and December 31, 2018 had contractual maturities of less than one year. There were no material realized gains or realized losses on available-for-sale securities for the periods presented. The Company has not experienced any material credit losses on its investments. Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): June 30, December 31, 2019 2018 Laboratory equipment $ 2,869 $ 2,533 Furniture and computer equipment 467 338 Leasehold improvements 739 67 Total property and equipment 4,075 2,938 Less: accumulated depreciation and amortization (2,383) (2,077) Property and equipment, net $ 1,692 $ 861 Accrued Expenses and Other Payables Accrued expenses and other payables consisted of the following (in thousands): June 30, December 31, 2019 2018 Accrued clinical and research related expenses $ 6,593 $ 7,781 Accrued employee related expenses 2,460 2,726 Accrued research and development tax incentive payable 1,241 — Accrued professional service fees 529 61 Other 22 595 Total accrued expenses and other payables $ 10,845 $ 11,163 |
Research Collaboration and Lice
Research Collaboration and License Agreement | 6 Months Ended |
Jun. 30, 2019 | |
Research Collaboration and License Agreement | |
Collaboration and License Agreement | |
License and Collaboration Agreement | Note 6. Research Collaboration and License Agreement In October 2013, the Company’s former collaboration partner decided to abandon a collaboration program with the Company and, pursuant to the terms of the agreement between the Company and the former collaboration partner, the Company elected to assume the responsibility for the development and commercialization of the product. Upon the former collaboration partner’s abandonment, it assigned to the Company certain intellectual property that relates to the products arising from the collaboration. Milestone payments to collaboration partners are recorded as research and development expenses in the period that the expense is incurred. The Company did not accrue any payments due to former collaboration partners for research and development expenses during the three and six months ended June 30, 2019 and 2018. |
Government Programs
Government Programs | 6 Months Ended |
Jun. 30, 2019 | |
Government Programs | |
Government Programs | Note 7. Government Programs Research and Development Tax Incentive The Company recognized AUD 2.4 million ($1.7 million) and AUD 1.8 million ($1.2 million) of research and development expenses for the three and six months ended June 30, 2019, respectively, in connection with a reversal of previously recorded reductions to research and development expenses in connection with the tax incentive from Australia. The Company determined that it had exceeded the annual turnover limit to claim such amounts following the receipt of certain payments under the Janssen License and Collaboration Agreement. The Company recognized AUD 463,000 ($359,000) and AUD 1.2 million ($964,000) as a reduction of research and development expenses for the three and six months ended June 30, 2018, respectively, in connection with the research and development tax incentive from Australia. As of June 30, 2019 and December 31, 2018, the research and development tax incentive receivable was AUD 2.0 million ($1.4 million). Small Business Innovation Research (“SBIR”) Grants The Company has received SBIR grants from the National Institutes of Health (“NIH”) in support of research aimed at its product candidates. The Company recognizes a reduction to research and development expenses when expenses related to the grants have been incurred and the grant funds become contractually due from NIH. The Company recorded $358,000 and $546,000 as a reduction of research and development expenses for the three and six months ended June 30, 2019, respectively. The Company recorded $64,000 and $125,000 as a reduction of research and development expenses for the three and six months ended June 30, 2018, respectively. The Company recorded a receivable for $358,000 and $309,000 as of June 30, 2019 and December 31, 2018, respectively, to reflect the eligible costs incurred under the grants that are contractually due to the Company, and such amounts are included in prepaid expenses and other current assets on the condensed consolidated balance sheets. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2019 | |
Leases | |
Leases | Note 8. Leases On January 1, 2019, the Company adopted ASC 842, which requires entities to recognize assets and liabilities for leases with lease terms of more than 12 months on the balance sheet. Adoption of ASC 842 resulted in the recording of operating lease assets of $7.5 million and operating lease liabilities of $8.3 million. The impact of the changes made to the consolidated balance sheet as of January 1, 2019 as a result of adopting the new guidance was as follows (in thousands): Balance at Adjustments Balance at December 31, Due to January 1, 2018 ASC 842 2019 Balance Sheet: Operating lease right-of-use asset - noncurrent $ — 7,499 $ Operating lease liability - current $ — $ 1,080 Operating lease liability - noncurrent $ — 7,219 $ 7,219 Deferred rent - noncurrent $ 799 (799) $ — The Company has one operating lease agreement entered into in March 2017 for laboratory and office space located in Newark, California. The Company provided the landlord with a $450,000 letter of credit collateralized by restricted cash as security deposit for the lease, which expires in May 2024. In March 2019, the Company recorded a receivable from the landlord of $469,000 related to eligible leasehold improvements made to the leased property, which the Company received in July 2019. Leases with terms of 12 months or less are not recorded on the balance sheet, as the related lease expenses are recognized on a straight-line basis over the lease term. During the three and six months ended June 30, 2019, the Company recognized $21,000 of sublease income. The weighted average lease term and discount rate are as follows: June 30, 2019 Operating Lease Term and Discount Rate: Weighted-average remaining lease term 4.9 years Weighted-average discount rate 11.0% The following table summarizes the Company’s minimum lease payments and lease liability as of June 30, 2019 (in thousands): Year Ending December 31: Amount 2019 (remaining six months) $ 954 2020 1,941 2021 2,000 2022 2,059 2023 2,121 Thereafter 895 Total future minimum lease payments Less: imputed interest (2,190) Present value of future minimum lease payments 7,780 Less: current portion of operating lease liability (1,164) Operating lease liability - noncurrent $ 6,616 As previously disclosed in the Company’s 2018 Annual Report on Form 10-K and under the previous lease accounting standard, future minimum lease payments for operating leases having initial or remaining noncancellable lease terms in excess of one year would have been as follows (in thousands): Year Ending December 31: Amount 2019 $ 1,941 2020 2,000 2021 2,059 2022 2,121 2023 2,185 Thereafter 922 Total $ 11,228 Supplemental lease cost information is as follows (in thousands): Three Months Ended Six Months Ended June 30, 2019 June 30, 2019 Operating lease cost $ 444 $ 903 Supplemental balance sheet information is as follows (in thousands): June 30, 2019 Operating Leases: Operating lease right-of-use asset - non-current $ 6,539 Operating lease liability - current $ 1,164 Operating lease liability - noncurrent 6,616 Total operating lease liabilities $ 7,780 Supplemental cash flow information is as follows (in thousands): Six Months Ended June 30, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow from operating leases $ |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders’ Equity | |
Stockholders’ Equity | Note 9. Stockholders’ Equity In September 2017, the Company filed a registration statement on Form S-3 with the Securities and Exchange Commission (“SEC”) (File No. 333-220314), effective as of October 5, 2017, as amended, which permits the offering, issuance, and sale by the Company of up to a maximum aggregate offering price of $200.0 million of its common stock. Up to a maximum of $50.0 million of the maximum aggregate offering price of $200.0 million may be issued and sold pursuant to an at-the-market (“ATM”) financing facility under a sales agreement (the “Sales Agreement”). The Company sold 921,684 shares of its common stock pursuant to the Sales Agreement during the three and six months ended June 30, 2019 for net proceeds of $10.5 million, after deducting issuance costs. There were no sales of the Company’s common stock pursuant to the Sales Agreement during the three and six months ended June 30, 2018. As of June 30, 2019, a total of $96.5 million of common stock remained available for sale under the registration statement on Form S-3, $37.5 million of which remained available for sale under the ATM financing facility. On August 6, 2018, the Company entered into a Securities Purchase Agreement with certain accredited investors (each, an “Investor” and, collectively, the “Investors”), pursuant to which the Company sold an aggregate of 2,750,000 shares of its common stock at a price of $8.00 per share, for aggregate net proceeds of $21.7 million, after deducting offering expenses payable by the Company. In a concurrent private placement, the Company issued the Investors warrants to purchase an aggregate of 2,750,000 shares of its common stock (each, a “Warrant,” and collectively, the “Warrants”). Each Warrant is exercisable from August 8, 2018 through August 8, 2023. Warrants to purchase 1,375,000 shares of the Company’s common stock have an exercise price of $10.00 per share and Warrants to purchase 1,375,000 shares of the Company’s common stock have an exercise price of $15.00 per share. The exercise price and number of shares of common stock issuable upon the exercise of the Warrants (the “Warrant Shares”) are subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Warrants. Under certain circumstances, the warrants may be exercisable on a “cashless” basis. In connection with the issuance and sale of the common stock and Warrants, the Company granted the Investors certain registration rights with respect to the Warrants and the Warrant Shares. The common stock and warrants are classified as equity in accordance with Accounting Standards Codification Topic 480 , Distinguishing Liabilities from Equity, and the net proceeds from the transaction were recorded as a credit to additional paid-in capital. As of June 30, 2019, none of the warrants have been exercised. On December 21, 2018, 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 1,000,000 shares of the Company’s common stock, par value $0.00001 per share, owned by the Exchanging Stockholders for pre-funded warrants (the “Exchange Warrants”) to purchase an aggregate of 1,000,000 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 $0.00001 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 , the Company recorded the retirement of the common stock exchanged as a reduction of common shares outstanding and a corresponding 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 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 June 30, 2019, Exchange Warrants to purchase 600,000 shares of common stock were net exercised, resulting in the issuance of 599,997 shares of common stock. |
Equity Plans
Equity Plans | 6 Months Ended |
Jun. 30, 2019 | |
Equity Plans | |
Equity Plans | Note 10. Equity Plans Equity Incentive Plans In July 2016, the Company’s board of directors and stockholders approved the Company’s 2016 Equity Incentive Plan (the “2016 Plan”) to replace the 2007 Stock Option Plan. The 2016 Plan is administered by the board of directors or a committee appointed by the board of directors, which determines the types of awards to be granted, including the number of shares subject to the awards, the exercise price and the vesting schedule. Awards granted under the 2016 Plan expire no later than ten years from the date of grant. As of June 30, 2019, approximately 522,856 shares were available for issuance under the 2016 Plan. Inducement Plan In May 2018, the Company’s board of directors approved the 2018 Inducement Plan, a non-stockholder approved stock plan, under which it reserved and authorized up to 750,000 shares of the Company’s common stock in order to award options and restricted stock unit awards to persons that were not previously employees or directors of the Company, or following a bona fide period of non-employment, as an inducement material to such persons entering into employment with the Company, within the meaning of Rule 5635(c)(4) of the NASDAQ Listing Rules. The 2018 Inducement Plan is administered by the board of directors or the Compensation Committee of the board, which determines the types of awards to be granted, including the number of shares subject to the awards, the exercise price and the vesting schedule. Awards granted under the 2018 Inducement Plan expire no later than ten years from the date of grant. As of June 30, 2019, approximately 460,000 shares were available for issuance under the 2018 Inducement Plan. Stock Options Stock options generally have an exercise price equal to the fair market value of the Company’s common stock on the grant date. Employee stock options generally vest over a period of four years. Employee stock option incentive awards granted in 2018 vest in three equal installments at six-month intervals over a period of 18 months. Non-employee director initial stock options generally vest over a period of three years, and non-employee director annual refresher stock options generally vest over a period of approximately one year. Non-employee consultant options generally vest over a period of one to four years. Stock option activity under the Company’s equity incentive and inducement plans is set forth below: Weighted- Weighted- Average Average Exercise Remaining Aggregate Options Price Per Contractual Intrinsic Outstanding Share Life (years) Value (1) (in millions) Balances at December 31, 2018 3,178,441 $ 12.23 7.52 Options granted 1,067,300 8.75 Options exercised (95,627) 1.59 Options forfeited (369,669) 12.27 Balances at June 30, 2019 3,780,445 $ 11.51 7.54 $ 12.3 Options exercisable – June 30, 2019 1,802,359 $ 11.57 6.16 $ 7.4 Options vested and expected to vest – June 30, 2019 3,780,445 $ 11.51 7.54 $ 12.3 (1) The aggregate intrinsic values were calculated as the difference between the exercise price of the options and the closing price of the Company’s common stock on June 30, 2019. The calculation excludes options with an exercise price higher than the closing price of the Company’s common stock on June 30, 2019. During the six months ended June 30, 2019, the estimated weighted-average grant-date fair value of common stock underlying options granted to employees was $5.13 per share. Stock Options Valuation The fair value of employee stock option awards was estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions: Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Expected term (in years) 5.50 - 6.08 5.50 - 6.08 5.50 - 6.08 5.50 - 6.08 Expected volatility 62.0 - 62.7% 64.0 - 66.4% 62.0 - 62.7% 64.0 - 66.4% Risk-free interest rate 1.88 - 2.20% 2.65 - 2.98% 1.88 - 2.58% 2.42 - 2.98% Dividend yield — — — — Restricted Stock Units A restricted stock unit is an agreement to issue shares of the Company’s common stock at the time of vesting. Restricted stock unit annual refresher awards vest in four equal installments on approximately the first, second, third and fourth anniversaries of the grant date. Restricted stock unit incentive awards granted in 2018 vest in three equal installments at six-month intervals over a period of 18 months. Restricted stock unit activity under the Company’s equity incentive plans is set forth below: Un Weighted- Average Number of Grant Date Shares Fair Value Unvested at December 31, 2018 418,450 $ 10.45 Restricted stock units granted 160,650 8.02 Restricted stock units vested Restricted stock units forfeited (91,176) Unvested at June 30, 2019 368,571 $ Employee Stock Purchase Plan The 2016 Employee Stock Purchase Plan (“2016 ESPP”) allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation. At the end of each offering period, eligible employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock at the beginning of the offering period or at the end of each applicable purchase period. As of June 30, 2019, a total of 146,673 shares of common stock have been issued under the 2016 ESPP, and 613,304 shares were available for issuance. Stock-Based Compensation Total stock-based compensation expense was as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 977 $ 837 $ 2,100 $ 1,378 General and administrative 1,036 808 1,892 1,452 Total stock-based compensation expense $ 2,013 $ 1,645 $ 3,992 $ 2,830 As of June 30, 2019, total unrecognized stock-based compensation expense was approximately $16.2 million, which the Company expects to recognize over a weighted-average period of approximately 2.6 years. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2019 | |
Income Taxes | |
Income Taxes | Note 11. Income Taxes The Company recorded income tax benefit of $1.6 million and $1.4 million for the three and six months ended June 30, 2019, respectively, representing an effective income tax rate of 5.3% and 3.2%, respectively. Income tax benefit for the three and six months ended June 30, 2019 included a discrete tax benefit of approximately $1.1 million for the 2017 Australia refundable R&D tax offset The Company’s effective income tax rate for the three and six months ended June 30, 2019 differs from the Company’s federal statutory rate of 21%, primarily because its U.S. loss cannot be benefited due to the full valuation allowance position and reduced by foreign taxes. No income tax expense or benefit was recorded for the three and six months ended June 30, 2018. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2019 | |
Net Loss per Share | |
Net Loss per Share | Note 12. Net Loss per Share As the Company had net losses for the three and six months ended June 30, 2019 and 2018, all potential common shares were determined to be anti-dilutive. The following table sets forth the computation of basic and diluted 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 $ (29,174) $ (8,663) $ (43,277) $ (16,324) Denominator: Weighted-average shares used to compute net loss per common share, basic and diluted 24,662,779 21,207,234 24,481,186 21,160,076 Net loss per shares, basic and diluted $ (1.18) $ (0.41) $ (1.77) $ (0.77) The following outstanding shares of potentially dilutive securities have been excluded from diluted net loss per share computations for the periods presented because their inclusion would be anti-dilutive: June 30, 2019 2018 Options to purchase common stock 3,780,445 3,071,618 Common stock warrants 2,750,000 — Restricted stock units 368,571 113,625 ESPP shares 36,999 19,417 Total 6,936,015 3,204,660 |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2019 | |
Subsequent Event. | |
Subsequent Event | Note 13. Subsequent Event The Company sold 1.2 million shares of its common stock pursuant to the Sales Agreement during the period from July 1, 2019 through July 31, 2019 for net proceeds of $15.0 million, after deducting issuance costs. As of July 31, 2019, a total of $81.1 million of common stock remained available for sale under the registration statement on Form S-3, $22.1 million of which remained available for sale under the ATM financing facility. |
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 unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted, and accordingly the consolidated balance sheet as of December 31, 2018 has been derived from the Company’s audited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the Company’s consolidated financial information. The results of operations for the three and six months ended June 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other interim period or for any other future year. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10‑K, filed with the SEC on March 12, 2019. |
Principles of Consolidation | Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation. |
Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, accruals for research and development activities, stock-based compensation, income taxes, research and development tax incentives, available-for-sale securities and leases. Estimates related to revenue recognition include actual costs incurred versus total estimated budgeted costs of the Company’s deliverables to determine percentage of completion, and application and estimates of constraints in the determination of the transaction price under its license and collaboration agreements. Management bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to forecasted amounts and future events. Actual results may differ significantly from those estimates. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and available-for-sale securities. Substantially all of the Company’s cash is held by two financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits. The primary focus of the Company’s investment strategy is to preserve capital and to meet liquidity requirements. The Company’s cash equivalents and available-for-sale securities are managed by external managers within the guidelines of the Company’s investment policy. The Company’s investment policy addresses the level of credit exposure by limiting concentration in any one corporate issuer and establishing a minimum allowable credit rating. To manage its credit risk exposure, the Company maintains its portfolio of cash equivalents and available-for-sale securities in fixed income securities denominated and payable in U.S. dollars. Permissible investments of fixed income securities include obligations of the U.S. government and its agencies, money market instruments including commercial paper and negotiable certificates of deposit, and highly rated corporate debt obligations and money market funds. |
Cash Equivalents | Cash Equivalents Cash equivalents that are readily convertible to cash are stated at cost, which approximates fair value. The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. |
Restricted Cash | Restricted Cash Restricted cash consists of cash balances primarily held as security in connection with a letter of credit related to the Company’s facility lease entered into in March 2017 and the Company’s corporate credit card. |
Cash as Reported in Condensed Consolidated Statements of Cash Flows | Cash as Reported in Condensed Consolidated Statements of Cash Flows Cash as reported in the condensed consolidated statements of cash flows includes the aggregate amounts of cash and cash equivalents and the restricted cash as presented on the condensed consolidated balance sheets. Cash as reported in the condensed consolidated statements of cash flows consists of (in thousands): June 30, 2019 2018 Cash and cash equivalents $ 71,143 $ 63,864 Restricted cash - current 10 10 Restricted cash - noncurrent 450 450 Cash balance in condensed consolidated statements of cash flows $ 71,603 $ 64,324 |
Available-for-Sale Securities | Available-for-Sale Securities All marketable securities have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation as of each balance sheet date. Short-term marketable securities have maturities greater than three months but no longer than 365 days as of the balance sheet date. Long-term marketable securities have maturities of 365 days or longer as of the balance sheet date. Unrealized gains and losses are excluded from earnings and are reported as a component of comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest income. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest income. |
Leases | Leases The Company adopted Accounting Standards Topic 842, Leases, (“ASC 842”) effective January 1, 2019. The Company determines if an arrangement is a lease at inception. Pursuant to ASC 842, operating leases are included in operating lease right-of-use (“ROU”) assets, operating lease liabilities, and noncurrent operating lease liabilities on the consolidated balance sheets. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. If the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. Lease terms include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company records tenant improvement allowances as a reduction to the ROU asset with the impact of the decrease recognized prospectively over the remaining lease term. The leasehold improvements will be amortized over the shorter of their useful life or the remaining term of the lease. |
Revenue Recognition | Revenue Recognition The Company follows Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligations when (or as) the performance obligations are satisfied. The Company constrains its estimate of the transaction price up to the amount (the “variable consideration constraint”) that a significant reversal of recognized revenue is not probable. Licenses of intellectual property: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in an arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring proportional performance for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of proportional performance each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone payments: At the inception of each arrangement or amendment that includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. ASC 606 suggests two alternatives to use when estimating the amount of variable consideration: the expected value method and the most likely amount method. Under the expected value method, an entity considers the sum of probability-weighted amounts in a range of possible consideration amounts. Under the most likely amount method, an entity considers the single most likely amount in a range of possible consideration amounts. Whichever method is used, it should be consistently applied throughout the life of the contract; however, it is not necessary for the Company to use the same approach for all contracts. The Company expects to use the most likely amount method for development and regulatory milestone payments. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis. The Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability or achievement of each such milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Upfront payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. Amounts payable to the Company and not yet billed to the collaboration partner are recorded as contract assets. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Contractual cost sharing payments made to a customer are accounted for as a reduction to the transaction price if such payments are not related to distinct goods or services received from the customer. Contracts may be amended to account for changes in contract specifications and requirements. The period between when the Company transfers control of promised goods or services and when the Company receives payment is expected to be one year or less, and that expectation is consistent with the Company’s historical experience. Upfront payment contract liabilities resulting from the Company’s license and collaboration agreements do not represent a financing component as the payment is not financing the transfer of goods and services, and the technology underlying the licenses granted reflects research and development expenses already incurred by the Company. As such, the Company does not adjust its revenues for the effects of a significant financing component. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred, unless there is an alternate future use in other research and development projects or otherwise. Research and development costs include salaries and benefits, stock-based compensation expense, laboratory supplies and facility-related overhead, outside contracted services including clinical trial costs, manufacturing and process development costs for both clinical and pre-clinical materials, research costs, development milestone payments under license and collaboration agreements, and other consulting services. The Company accrues for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of pre-clinical studies and clinical trials, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated services provided but not yet invoiced and includes these costs in accrued expenses and other payables in the condensed consolidated balance sheets and within research and development expense in the condensed consolidated statements of operations. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued liabilities and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollment may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. |
Research and Development Tax Incentive | Research and Development Tax Incentive The Company is eligible under the AusIndustry research and development tax incentive program to obtain a cash refund from the Australian Taxation Office. The refundable cash tax incentive is available to the Company on the basis of specific criteria with which the Company must comply. Specifically, the Company must have annual turnover of less than AUD 20.0 million and cannot be controlled by income tax exempt entities. The refundable cash research and development tax incentive is recognized as a reduction to research and development expense when the right to receive has been attained and funds are considered to be collectible. The tax incentive is denominated in Australian dollars and, therefore, the related receivable is remeasured into U.S. dollars as of each reporting date. The Company may alternatively be eligible for a taxable credit in the form of a non-cash tax incentive. The Company evaluates its eligibility under tax incentive programs as of each balance sheet date and makes accrual and related adjustments based on the most current and relevant data available. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the Company’s net loss by the weighted average number of shares of common stock and Exchange Warrants outstanding during the period, without consideration of potentially dilutive securities. In accordance with Accounting Standards Codification Topic 260, Earnings Per Share , the Exchange Warrants are included in the computation of basic net loss per share because the exercise price is negligible, and they are fully vested and exercisable after the original issuance date. Diluted net loss per share is the same as basic net loss per share for all periods presented since the effect of potentially dilutive securities is anti-dilutive given the net loss of the Company. See Note 9. Stockholder’s Equity for additional information regarding the Exchange Warrants. |
Recently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements Not Adopted | Recently Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016‑02, Leases (Topic 842). In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases , which provides clarification to ASU 2016-02. These ASUs (collectively, the new lease standard) require an entity to recognize a lease liability and a ROU asset on the balance sheet for leases with lease terms of more than twelve months. Lessor accounting is largely unchanged, while lessees are no longer provided with a source of off-balance sheet financing. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842) - Targeted Improvements, which allows entities to elect an optional transition method where entities may continue to apply the existing lease guidance during the comparative periods and apply the new lease requirements through a cumulative effect adjustment in the period of adoption rather than in the earliest period presented. The Company adopted the new lease standard using the modified retrospective approach effective January 1, 2019 and elected the package of transitional practical expedients, such that, for leases existing prior to the adoption of ASC 842, the Company did not need to reassess whether contracts are leases, retained historical lease classification and historical initial direct costs classification. The Company did not elect the hindsight practical expedient to determine the lease term for existing leases. At January 1, 2019, the Company derecognized its deferred rent liability in the amount of $0.8 million, and recognized a ROU asset and related lease liability in the amount of $7.5 million and $8.3 million, respectively. In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting , which is intended to simplify the accounting for nonemployee share-based payment transactions by expanding the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The Company adopted this guidance prospectively as of January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial position, results of operations or liquidity. Recently Issued Accounting Pronouncements Not Yet Adopted as of June 30, 2019 In June 2016, the FASB issued ASU No. 2016‑13, Financial Instruments - Credit Losses (Topic 326) , which is intended to provide financial statement users with more useful information about expected credit losses on financial assets held by a reporting entity at each reporting date. In May 2019, the FASB issued ASU No. 2019-05, which amended the new standard by providing targeted transition relief. The new guidance replaces the existing incurred loss impairment methodology with a methodology that requires consideration of a broader range of reasonable and supportable forward-looking information to estimate all expected credit losses. This guidance is effective for the fiscal years and interim periods within those years beginning after December 15, 2019 and early adoption is permitted for fiscal years and interim periods within those years beginning after December 15, 2018. The Company is currently evaluating the impact of this new guidance on its consolidated financial statements and disclosures. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) – Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement , which modifies the disclosure requirements on fair value measurements and is intended to improve the effectiveness of disclosures, including the consideration of costs and benefits. The guidance is effective for the fiscal years and interim periods within those years beginning after January 1, 2020. Early adoption is permitted, and an entity is permitted to early adopt any removed or modified disclosures and delay adoption of additional disclosures until their effective date. The Company does not expect this new guidance to impact its consolidated financial statements and is currently evaluating the impact on its disclosures. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606 , which is intended to clarify the circumstances under which certain transactions in collaborative arrangements should be accounted for under the revenue recognition standard. Certain transactions between collaboration arrangement participants should be accounted for as revenue under ASC Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. This guidance is effective for fiscal years and interim periods within those years beginning after December 15, 2020. Early adoption is permitted. The Company is in the process of assessing the impact of this new guidance on its consolidated financial statements and disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Summary of Significant Accounting Policies | |
Schedule of cash as reported in the consolidated statements of cash flows | Cash as reported in the condensed consolidated statements of cash flows consists of (in thousands): June 30, 2019 2018 Cash and cash equivalents $ 71,143 $ 63,864 Restricted cash - current 10 10 Restricted cash - noncurrent 450 450 Cash balance in condensed consolidated statements of cash flows $ 71,603 $ 64,324 |
License and Collaboration Agr_2
License and Collaboration Agreement (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
License and Collaboration Agreement. | |
Schedule of changes in contract assets and liabilities | Balance at Balance at Beginning of End of Six Months Ended June 30, 2019 Period Additions Deductions Period Contract assets: Receivable from collaboration partner - related party $ 2,042 $ 29,881 $ (27,034) $ 4,889 Contract asset - related party $ 2,545 $ — $ (2,545) $ — Contract liabilities: Deferred revenue - related party $ 8,223 $ 34,526 $ (1,182) $ 41,567 Payable to collaboration partner - related party $ 1,061 $ 625 $ (876) $ 810 Balance at Balance at Beginning of End of Six Months Ended June 30, 2018 Period Additions Deductions Period Contract assets: Receivable from collaboration partner - related party $ 1,816 $ 4,627 $ (658) $ 5,785 Contract liabilities: Deferred revenue - related party $ 31,752 $ 3,451 $ (22,001) $ 13,202 Payable to collaboration partner - related party $ — $ 580 $ (304) $ 276 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Measurements | |
Schedule of fair value of financial assets | The following table presents the fair value of the Company’s financial assets determined using the inputs defined above (in thousands). June 30, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 38,877 $ — $ — $ 38,877 Corporate bonds — 12,578 — 12,578 Commercial paper — 36,563 — 36,563 Government bonds — 33,150 — 33,150 Total financial assets $ 38,877 $ 82,291 $ — $ December 31, 2018 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 25,390 $ — $ — $ 25,390 Corporate bonds — 8,989 — 8,989 Commercial paper — 59,730 — 59,730 Government bonds — 33,394 — 33,394 Total financial assets $ 25,390 $ 102,113 $ — $ 127,503 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Balance Sheet Components | |
Schedule of cash equivalents and available-for-sale securities | Cash equivalents and available-for-sale securities consisted of the following (in thousands): June 30, 2019 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 38,876 $ — $ — $ 38,876 Corporate bonds 12,567 12 (1) 12,578 Commercial paper 36,565 3 (4) 36,564 Government bonds 33,126 24 — 33,150 Total cash equivalents and available-for-sale securities $ $ 39 $ (5) $ Classified as: Cash equivalents $ 66,210 Available-for-sale securities 54,958 Total cash equivalents and available-for-sale securities $ December 31, 2018 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 25,390 $ — $ — $ 25,390 Corporate bonds 8,997 — (8) 8,989 Commercial paper 59,730 — — 59,730 Government bonds 33,423 — (29) 33,394 Total cash equivalents and available-for-sale securities $ 127,540 $ — $ (37) $ 127,503 Classified as: Cash equivalents $ 80,883 Available-for-sale securities 46,620 Total cash equivalents and available-for-sale securities $ 127,503 |
Summary of Property and Equipment Net | Property and equipment, net consisted of the following (in thousands): June 30, December 31, 2019 2018 Laboratory equipment $ 2,869 $ 2,533 Furniture and computer equipment 467 338 Leasehold improvements 739 67 Total property and equipment 4,075 2,938 Less: accumulated depreciation and amortization (2,383) (2,077) Property and equipment, net $ 1,692 $ 861 |
Summary of Accrued Expenses and Other Payables | Accrued expenses and other payables consisted of the following (in thousands): June 30, December 31, 2019 2018 Accrued clinical and research related expenses $ 6,593 $ 7,781 Accrued employee related expenses 2,460 2,726 Accrued research and development tax incentive payable 1,241 — Accrued professional service fees 529 61 Other 22 595 Total accrued expenses and other payables $ 10,845 $ 11,163 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases | |
Schedule of weighted average lease term and discounts rate | June 30, 2019 Operating Lease Term and Discount Rate: Weighted-average remaining lease term 4.9 years Weighted-average discount rate 11.0% |
Schedule of minimum lease payments and lease liabilities | The following table summarizes the Company’s minimum lease payments and lease liability as of June 30, 2019 (in thousands): Year Ending December 31: Amount 2019 (remaining six months) $ 954 2020 1,941 2021 2,000 2022 2,059 2023 2,121 Thereafter 895 Total future minimum lease payments Less: imputed interest (2,190) Present value of future minimum lease payments 7,780 Less: current portion of operating lease liability (1,164) Operating lease liability - noncurrent $ 6,616 |
Schedule of future minimum lease payments for operating leases | As previously disclosed in the Company’s 2018 Annual Report on Form 10-K and under the previous lease accounting standard, future minimum lease payments for operating leases having initial or remaining noncancellable lease terms in excess of one year would have been as follows (in thousands): Year Ending December 31: Amount 2019 $ 1,941 2020 2,000 2021 2,059 2022 2,121 2023 2,185 Thereafter 922 Total $ 11,228 |
Schedule of least cost information | Supplemental lease cost information is as follows (in thousands): Three Months Ended Six Months Ended June 30, 2019 June 30, 2019 Operating lease cost $ 444 $ 903 |
Schedule of balance sheet information | Supplemental balance sheet information is as follows (in thousands): June 30, 2019 Operating Leases: Operating lease right-of-use asset - non-current $ 6,539 Operating lease liability - current $ 1,164 Operating lease liability - noncurrent 6,616 Total operating lease liabilities $ 7,780 |
Schedule of cash flow information | Supplemental cash flow information is as follows (in thousands): Six Months Ended June 30, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow from operating leases $ |
ASU 2016-02 | |
Leases | |
Schedule of adopting new guidance | The impact of the changes made to the consolidated balance sheet as of January 1, 2019 as a result of adopting the new guidance was as follows (in thousands): Balance at Adjustments Balance at December 31, Due to January 1, 2018 ASC 842 2019 Balance Sheet: Operating lease right-of-use asset - noncurrent $ — 7,499 $ Operating lease liability - current $ — $ 1,080 Operating lease liability - noncurrent $ — 7,219 $ 7,219 Deferred rent - noncurrent $ 799 (799) $ — |
Equity Plans (Tables)
Equity Plans (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Schedule of activity under equity incentive plans | Weighted- Weighted- Average Average Exercise Remaining Aggregate Options Price Per Contractual Intrinsic Outstanding Share Life (years) Value (1) (in millions) Balances at December 31, 2018 3,178,441 $ 12.23 7.52 Options granted 1,067,300 8.75 Options exercised (95,627) 1.59 Options forfeited (369,669) 12.27 Balances at June 30, 2019 3,780,445 $ 11.51 7.54 $ 12.3 Options exercisable – June 30, 2019 1,802,359 $ 11.57 6.16 $ 7.4 Options vested and expected to vest – June 30, 2019 3,780,445 $ 11.51 7.54 $ 12.3 (1) The aggregate intrinsic values were calculated as the difference between the exercise price of the options and the closing price of the Company’s common stock on June 30, 2019. The calculation excludes options with an exercise price higher than the closing price of the Company’s common stock on June 30, 2019. |
Schedule of stock-based compensation expense | Total stock-based compensation expense was as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 977 $ 837 $ 2,100 $ 1,378 General and administrative 1,036 808 1,892 1,452 Total stock-based compensation expense $ 2,013 $ 1,645 $ 3,992 $ 2,830 |
Employee stock options | |
Black-Scholes option-pricing model assumptions | Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Expected term (in years) 5.50 - 6.08 5.50 - 6.08 5.50 - 6.08 5.50 - 6.08 Expected volatility 62.0 - 62.7% 64.0 - 66.4% 62.0 - 62.7% 64.0 - 66.4% Risk-free interest rate 1.88 - 2.20% 2.65 - 2.98% 1.88 - 2.58% 2.42 - 2.98% Dividend yield — — — — |
Restricted stock units | |
Schedule of activity under equity incentive plans | Un Weighted- Average Number of Grant Date Shares Fair Value Unvested at December 31, 2018 418,450 $ 10.45 Restricted stock units granted 160,650 8.02 Restricted stock units vested Restricted stock units forfeited (91,176) Unvested at June 30, 2019 368,571 $ |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Net Loss per Share | |
Schedule of computation of the basic and diluted net loss per share attributable to common stockholders | The following table sets forth the computation of basic and diluted 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 $ (29,174) $ (8,663) $ (43,277) $ (16,324) Denominator: Weighted-average shares used to compute net loss per common share, basic and diluted 24,662,779 21,207,234 24,481,186 21,160,076 Net loss per shares, basic and diluted $ (1.18) $ (0.41) $ (1.77) $ (0.77) |
Schedule of potentially dilutive securities excluded from diluted net loss per share calculations | June 30, 2019 2018 Options to purchase common stock 3,780,445 3,071,618 Common stock warrants 2,750,000 — Restricted stock units 368,571 113,625 ESPP shares 36,999 19,417 Total 6,936,015 3,204,660 |
Organization and Description _2
Organization and Description of Business - Liquidity (Details) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019USD ($)segment | Dec. 31, 2018USD ($) | |
Summary of Significant Accounting Policies. | ||
Number of operating segments | segment | 1 | |
Net losses from operations since inception | ||
Accumulated deficit | $ | $ (183,751) | $ (140,474) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details) | Jun. 30, 2019Institution |
Summary of Significant Accounting Policies | |
Number of financial institutions at which cash is held | 2 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Cash and Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2017 |
Aggregate amounts of cash and cash equivalents and the restricted cash | ||||
Cash and cash equivalents | $ 71,143 | $ 82,233 | $ 63,864 | |
Restricted cash - current | 10 | 10 | 10 | |
Restricted cash - noncurrent | 450 | 450 | 450 | |
Cash balance in condensed consolidated statements of cash flows | $ 71,603 | $ 82,693 | $ 64,324 | $ 106,489 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Research and Development Tax Incentive (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2019AUD ($) | |
Revenue, Practical Expedient [Abstract] | |
Financing component | true |
Maximum | Australian | |
Revenue, Practical Expedient [Abstract] | |
Revenue for availability of research and development tax incentive | $ 20 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Recently Adopted Accounting Pronouncements (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | |
Recent Accounting Pronouncements | |||
Practical expedients - package | true | ||
Practical expedients - hindsight | false | ||
Deferred rent liability | $ 799 | ||
Operating lease right-of-use asset | $ 6,539 | $ 7,500 | |
Lease liability | $ 7,780 | 8,300 | |
ASU 2016-02 | |||
Recent Accounting Pronouncements | |||
Operating lease right-of-use asset | 7,499 | ||
Adjustment | ASU 2016-02 | |||
Recent Accounting Pronouncements | |||
Deferred rent liability | (799) | ||
Operating lease right-of-use asset | 7,499 | ||
Lease liability | $ 8,300 |
License and Collaboration Agr_3
License and Collaboration Agreement (Details) - USD ($) $ in Thousands | May 07, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 13, 2017 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront payments and fees | $ 23,850 | $ 23,850 | |||||||
Revenue recognized | 1,600 | $ 11,500 | 1,600 | $ 22,000 | |||||
Deferred revenue - related party | 17,717 | 17,717 | $ 8,223 | ||||||
Receivable from collaboration partner and contract asset - related party | 4,889 | 4,889 | 4,587 | ||||||
Payable to collaboration partner - related party | 810 | $ 810 | 1,061 | ||||||
License and Collaborative Revenue | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Development cost | 20.00% | ||||||||
Second-Generation Analog, Phase 3 CD Clinical Trial Primary Clinical Endpoint [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Development cost | 80.00% | ||||||||
License and Collaboration Agreement | License and Collaborative Revenue | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | $ (1,600) | ||||||||
First Amendment | License and Collaborative Revenue | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | 1,200 | $ 1,200 | |||||||
First Amendment | Development, regulatory and sales milestone payments | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Amount to be received | $ 1,000,000 | ||||||||
Janssen Biotech, Inc. | Second-Generation Analog, Phase 3 CD Clinical Trial Primary Clinical Endpoint [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Development cost | 20.00% | ||||||||
Janssen Biotech, Inc. | License and Collaboration Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenue | $ 16,900 | ||||||||
Revenue recognized | 11,700 | 22,500 | |||||||
Deferred revenue - related party | 41,567 | 13,202 | 41,567 | 13,202 | 8,223 | $ 31,752 | |||
Payable to collaboration partner - related party | 810 | $ 276 | 810 | 276 | $ 1,061 | ||||
Transaction price recognized based on proportional performance | $ 60,600 | 1,182 | $ 22,001 | ||||||
Transaction price | 109,200 | $ 109,200 | |||||||
Development cost | 80.00% | ||||||||
Increase (decrease) in transaction price | 48,600 | ||||||||
Janssen Biotech, Inc. | License and Collaboration Agreement | Upfront cash payment | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront payments and fees | $ 50,000 | ||||||||
Janssen Biotech, Inc. | First, second-generation compound | Second-Generation Analog, Phase 3 CD Clinical Trial Primary Clinical Endpoint [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Research program cost | 100.00% | ||||||||
Janssen Biotech, Inc. | Second and third, second-generation compounds | Second-Generation Analog, Phase 3 CD Clinical Trial Primary Clinical Endpoint [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Research program cost | 50.00% | ||||||||
Janssen Biotech, Inc. | Thereafter | Second-Generation Analog, Phase 3 CD Clinical Trial Primary Clinical Endpoint [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Research program cost | 100.00% | ||||||||
Janssen Biotech, Inc. | Phase 2 clinical trial | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenue | $ 17,300 | ||||||||
Janssen Biotech, Inc. | Phase 2 clinical trial | PTG-200, Phase 3 CD Clinical Trial Primary Clinical Endpoint | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Tiered royalties on net product sales, lower range, percent | 1.50% | ||||||||
Tiered royalties on net product sales, upper range, percent | 10.00% | ||||||||
Janssen Biotech, Inc. | First Amendment | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Amount payable upon the effectiveness of the First Amendment | 25,000 | ||||||||
Increase (decrease) in transaction price | $ (9,400) | $ (9,400) | |||||||
Janssen Biotech, Inc. | First Amendment | Milestone payment | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Amount to be received | $ 25,000 | ||||||||
Janssen Biotech, Inc. | First Amendment | PTG-200, Phase 3 CD Clinical Trial Primary Clinical Endpoint | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Amount to be received | 100,000 | ||||||||
Janssen Biotech, Inc. | First Amendment | Second-Generation Analog, Phase 3 CD Clinical Trial Primary Clinical Endpoint [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Amount to be received | 115,000 | ||||||||
Janssen Biotech, Inc. | Amended First Opt-in | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Former opt-in payments | 125,000 | ||||||||
Janssen Biotech, Inc. | Amended First Opt-in | Upfront cash payment | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Amount to be received | 50,000 | ||||||||
Janssen Biotech, Inc. | Amended Second Opt-in | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Former opt-in payments | 215,000 | ||||||||
Janssen Biotech, Inc. | Amended Second Opt-in | Upfront cash payment | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Amount to be received | $ 50,000 |
License and Collaboration Agr_4
License and Collaboration Agreement - Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Deferred revenue - related party | |||||
Balance at beginning of period | $ 8,223 | $ 8,223 | |||
Balance at End of Period | $ 17,717 | 17,717 | |||
Payable to collaboration partner - related party | |||||
Balance at Beginning of Period | 1,061 | 1,061 | |||
Balance at End of Period | 810 | 810 | |||
Revenue recognized from contract liability balance at beginning of period | 1,600 | $ 11,500 | 1,600 | $ 22,000 | |
Costs to obtain or fulfill the contract that were capitalized | 0 | 0 | 0 | 0 | |
Janssen Biotech, Inc. | License and Collaboration Agreement | |||||
Receivable from collaboration partner - related party | |||||
Balance at beginning of period | 2,042 | 2,042 | 1,816 | ||
Additions | 29,881 | 4,627 | |||
Deductions | (27,034) | (658) | |||
Balance at end of period | 4,889 | 5,785 | 4,889 | 5,785 | |
Contract asset - related party | |||||
Contract asset - related party, Balance at Beginning of Period | 2,545 | 2,545 | |||
Contract asset - related party, Deductions | (2,545) | ||||
Deferred revenue - related party | |||||
Balance at beginning of period | 8,223 | 8,223 | 31,752 | ||
Additions | 34,526 | 3,451 | |||
Deductions | (60,600) | (1,182) | (22,001) | ||
Balance at End of Period | 41,567 | 13,202 | 41,567 | 13,202 | |
Payable to collaboration partner - related party | |||||
Balance at Beginning of Period | $ 1,061 | 1,061 | |||
Additions | 625 | 580 | |||
Deductions | (876) | (304) | |||
Balance at End of Period | $ 810 | 276 | $ 810 | 276 | |
Revenue recognized from contract liability balance at beginning of period | $ 11,700 | $ 22,500 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 121,168 | $ 127,503 |
Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 38,877 | 25,390 |
Corporate Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 12,578 | 8,989 |
Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 36,563 | 59,730 |
Government Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 33,150 | 33,394 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 38,877 | 25,390 |
Level 1 | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 38,877 | 25,390 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 82,291 | 102,113 |
Level 2 | Corporate Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 12,578 | 8,989 |
Level 2 | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 36,563 | 59,730 |
Level 2 | Government Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 33,150 | $ 33,394 |
Balance Sheet Components - Cash
Balance Sheet Components - Cash Equivalents and Available-for-sale Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Cash Equivalents and Available-for-sale Securities | ||
Total cash equivalents and available-for-sale securities, Amortized Cost | $ 121,134 | $ 127,540 |
Total cash equivalents and available-for-sale securities, Gross Unrealized Gains | 39 | |
Total cash equivalents and available-for-sale securities, Gross Unrealized Losses | (5) | (37) |
Total cash equivalents and available-for-sale securities, Fair Value | 121,168 | 127,503 |
Corporate Bonds | ||
Cash Equivalents and Available-for-sale Securities | ||
Total cash equivalents and available-for-sale securities, Amortized Cost | 12,567 | 8,997 |
Total cash equivalents and available-for-sale securities, Gross Unrealized Gains | 12 | |
Total cash equivalents and available-for-sale securities, Gross Unrealized Losses | (1) | (8) |
Total cash equivalents and available-for-sale securities, Fair Value | 12,578 | 8,989 |
Government Bonds | ||
Cash Equivalents and Available-for-sale Securities | ||
Total cash equivalents and available-for-sale securities, Amortized Cost | 33,126 | 33,423 |
Total cash equivalents and available-for-sale securities, Gross Unrealized Gains | 24 | |
Total cash equivalents and available-for-sale securities, Gross Unrealized Losses | (29) | |
Total cash equivalents and available-for-sale securities, Fair Value | 33,150 | 33,394 |
Money Market Funds | ||
Cash Equivalents and Available-for-sale Securities | ||
Total cash equivalents and available-for-sale securities, Amortized Cost | 38,876 | 25,390 |
Total cash equivalents and available-for-sale securities, Fair Value | 38,876 | 25,390 |
Commercial Paper | ||
Cash Equivalents and Available-for-sale Securities | ||
Total cash equivalents and available-for-sale securities, Amortized Cost | 36,565 | 59,730 |
Total cash equivalents and available-for-sale securities, Gross Unrealized Gains | 3 | |
Total cash equivalents and available-for-sale securities, Gross Unrealized Losses | (4) | |
Total cash equivalents and available-for-sale securities, Fair Value | $ 36,564 | $ 59,730 |
Balance Sheet Components - Clas
Balance Sheet Components - Classification of Cash Equivalents and Available-for-sale Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Classified as: | ||
Cash equivalents | $ 66,210 | $ 80,883 |
Available-for-sale securities | 54,958 | 46,620 |
Total cash equivalents and available-for-sale securities | $ 121,168 | $ 127,503 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Property and Equipment | ||
Total property and equipment | $ 4,075 | $ 2,938 |
Less: accumulated depreciation and amortization | (2,383) | (2,077) |
Property and equipment, net | 1,692 | 861 |
Laboratory equipment | ||
Property and Equipment | ||
Total property and equipment | 2,869 | 2,533 |
Furniture and computer equipment | ||
Property and Equipment | ||
Total property and equipment | 467 | 338 |
Leasehold improvements | ||
Property and Equipment | ||
Total property and equipment | $ 739 | $ 67 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Expenses and Other Payables (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Balance Sheet Components | ||
Accrued clinical and research related expenses | $ 6,593 | $ 7,781 |
Accrued employee related expenses | 2,460 | 2,726 |
Accrued research and development tax incentive payable | 1,241 | |
Accrued professional service fees | 529 | 61 |
Other | 22 | 595 |
Total accrued expenses and other payables | $ 10,845 | $ 11,163 |
Government Programs (Details)
Government Programs (Details) | 3 Months Ended | 6 Months Ended | |||||||||
Jun. 30, 2019AUD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018AUD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019AUD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018AUD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2018AUD ($) | Dec. 31, 2018USD ($) | |
Government Programs | |||||||||||
Reduction of research and development expenses related to tax | $ 2,400,000 | $ 463,000 | $ 359,000 | $ 1,200,000 | $ 964,000 | ||||||
Research and development tax incentive receivable | $ 1,421,000 | $ 1,429,000 | |||||||||
SBIR Grant | |||||||||||
Government Programs | |||||||||||
Reduction of research and development expenses related to tax | $ 358,000 | $ 64,000 | $ 546,000 | $ 125,000 | |||||||
Grants receivable | 358,000 | 309,000 | |||||||||
Australian | |||||||||||
Government Programs | |||||||||||
Reduction of research and development expenses related to tax | $ 1,700,000 | $ 1,800,000 | $ 1,200,000 | ||||||||
Overseas Findings | Australian | |||||||||||
Government Programs | |||||||||||
Research and development tax incentive receivable | $ 2,000,000 | $ 2,000,000 | $ 1,400,000 | $ 2,000,000 | $ 1,400,000 |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Leases | |||
Operating lease right-of-use asset | $ 6,539 | $ 7,500 | |
Lease liability | 7,780 | 8,300 | |
Operating lease liability - current | 1,164 | ||
Operating lease liability - noncurrent | $ 6,616 | ||
Deferred rent - noncurrent | $ 799 | ||
ASU 2016-02 | |||
Leases | |||
Operating lease right-of-use asset | 7,499 | ||
Operating lease liability - current | 1,080 | ||
ASU 2016-02 | Adjustment | |||
Leases | |||
Operating lease right-of-use asset | 7,499 | ||
Lease liability | 8,300 | ||
Operating lease liability - current | 1,080 | ||
Deferred rent - noncurrent | (799) | ||
Noncurrent | ASU 2016-02 | |||
Leases | |||
Operating lease liability - noncurrent | 7,219 | ||
Noncurrent | ASU 2016-02 | Adjustment | |||
Leases | |||
Operating lease liability - noncurrent | $ 7,219 |
Leases - Agreement (Details)
Leases - Agreement (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
Jul. 31, 2019USD ($) | Mar. 31, 2017USD ($)lease | Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) | |
Leases | ||||
Security deposit | $ 450,000 | |||
Sublease Income | $ 21,000 | $ 21,000 | ||
Forecast | ||||
Leases | ||||
Tenant improvement allowances | $ 469,000 | |||
Newark, California | ||||
Leases | ||||
Number of operating lease agreement | lease | 1 |
Leases - Weighted average lease
Leases - Weighted average lease term and discount rate (Details) | Jun. 30, 2019 |
Leases | |
Weighted-average remaining lease term | 4 years 10 months 24 days |
Weighted-average discount rate | 11.00% |
Leases - Minimum lease payments
Leases - Minimum lease payments (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 |
Minimum lease payments: | ||
2019 (remaining six months) | $ 954 | |
2020 | 1,941 | |
2021 | 2,000 | |
2022 | 2,059 | |
2023 | 2,121 | |
Thereafter | 895 | |
Total future minimum lease payments | 9,970 | |
Less: imputed interest | (2,190) | |
Present value of future minimum lease payments | 7,780 | $ 8,300 |
Less: current portion of operating lease liability | (1,164) | |
Operating lease liability - noncurrent | $ 6,616 |
Leases - Future minimum lease p
Leases - Future minimum lease payments - ASC 840 (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Future minimum lease payments - ASC 840 | |
2019 | $ 1,941 |
2020 | 2,000 |
2021 | 2,059 |
2022 | 2,121 |
2023 | 2,185 |
Thereafter | 922 |
Total | $ 11,228 |
Leases - Lease cost information
Leases - Lease cost information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Leases | ||
Operating lease cost | $ 444 | $ 903 |
Leases - Supplemental balance s
Leases - Supplemental balance sheet information (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 |
Operating Leases: | ||
Operating lease right-of-use asset | $ 6,539 | $ 7,500 |
Financial position | us-gaap:OperatingLeaseRightOfUseAsset | |
Operating lease liability - current | $ 1,164 | |
Financial position | us-gaap:OperatingLeaseLiabilityCurrent | |
Operating lease liability - noncurrent | $ 6,616 | |
Financial position | us-gaap:OperatingLeaseLiabilityNoncurrent | |
Total operating lease liabilities | $ 7,780 | $ 8,300 |
Financial position | us-gaap:OperatingLeaseLiabilityCurrent us-gaap:OperatingLeaseLiabilityNoncurrent |
Leases - Cash flow information
Leases - Cash flow information (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Leases | |
Operating cash flow from operating leases | $ 931 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 21, 2018 | Aug. 06, 2018 | Sep. 30, 2017 | Jun. 30, 2019 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 |
Stock transactions | ||||||||
Common stock sold | 24,967,603 | 24,967,603 | 23,187,219 | |||||
Net proceeds from sale of stock | $ 10,543 | |||||||
Par value (per share) | $ 0.00001 | $ 0.00001 | $ 0.00001 | |||||
Common Stock | ||||||||
Stock transactions | ||||||||
Stock issued (in shares) | 921,684 | 921,684 | ||||||
Common stock issued pursuant to exercise of Exchange Warrants (in shares) | 599,997 | 599,997 | ||||||
Common Stock | Shelf offering | ||||||||
Stock transactions | ||||||||
Maximum aggregate offering price | $ 200,000 | |||||||
Common Stock | Private Placement | ||||||||
Stock transactions | ||||||||
Number of warrants exercised | 0 | 0 | ||||||
Cantor Fitzgerald & Co. Sales Agreement | ||||||||
Stock transactions | ||||||||
Common stock available for sale | $ 96,500 | $ 96,500 | ||||||
Cantor Fitzgerald & Co. Sales Agreement | At-the-market offering | ||||||||
Stock transactions | ||||||||
Stock issued (in shares) | 0 | 0 | ||||||
Maximum aggregate offering price | $ 50,000 | |||||||
Common stock available for sale | $ 37,500 | $ 37,500 | ||||||
Cantor Fitzgerald & Co. Sales Agreement | Common Stock | At-the-market offering | ||||||||
Stock transactions | ||||||||
Common stock sold | 921,684 | 921,684 | ||||||
Net proceeds from sale of stock | $ 10,500 | $ 10,500 | ||||||
Investors | Common Stock | ||||||||
Stock transactions | ||||||||
Stock issued (in shares) | 2,750,000 | |||||||
Price (in dollars per share) | $ 8 | |||||||
Aggregate gross proceeds | $ 21,700 | |||||||
Investors | Common Stock | Private Placement | ||||||||
Stock transactions | ||||||||
Warrants to purchase common stock, number of shares | 2,750,000 | |||||||
Purchase of common stock | 2,750,000 | |||||||
Exchange Agreement | Exchanging Stockholders | ||||||||
Stock transactions | ||||||||
Warrants to purchase common stock, number of shares | 1,000,000 | |||||||
Warrants exercise price | $ 0.00001 | |||||||
Common stock exchanged for pre-funded warrants | 1,000,000 | |||||||
Par value (per share) | $ 0.00001 | |||||||
Purchase of common stock | 1,000,000 | |||||||
Exercise Price (per share) | $ 0.00001 | |||||||
Duration of warrants from date of issuance (in years) | 10 years | |||||||
Equity Method Investment, Ownership Percentage | 9.99% | |||||||
Exchange Agreement | Exchanging Stockholders | Common Stock | ||||||||
Stock transactions | ||||||||
Number of warrants exercised | 600,000 | 600,000 | ||||||
Common stock issued pursuant to exercise of Exchange Warrants (in shares) | 599,997 | |||||||
Group one | Common Stock | Private Placement | ||||||||
Stock transactions | ||||||||
Number of shares to be converted for each warrant | 1,375,000 | |||||||
Warrants exercise price | $ 10 | |||||||
Exercise Price (per share) | $ 10 | |||||||
Group two | Common Stock | Private Placement | ||||||||
Stock transactions | ||||||||
Number of shares to be converted for each warrant | 1,375,000 | |||||||
Warrants exercise price | $ 15 | |||||||
Exercise Price (per share) | $ 15 |
Equity Plans - Description (Det
Equity Plans - Description (Details) - shares | 6 Months Ended | |
Jun. 30, 2019 | May 31, 2018 | |
2016 Equity Incentive Plan | ||
Equity Plans | ||
Number of shares available for issuance | 522,856 | |
2018 Inducement Plan | ||
Equity Plans | ||
Expiration period | 10 years | |
Number of shares authorized | 750,000 | |
Number of shares available for issuance | 460,000 | |
Stock options - employees, consultants, directors | 2016 Equity Incentive Plan | ||
Equity Plans | ||
Expiration period | 10 years | |
Employee stock options | 2016 Equity Incentive Plan | ||
Equity Plans | ||
Vesting period | 4 years | |
Non Employee Director Initial Stock Options | 2016 Equity Incentive Plan | ||
Equity Plans | ||
Vesting period | 3 years | |
Nonemployee Director Annual Refresher Stock Options | 2016 Equity Incentive Plan | ||
Equity Plans | ||
Vesting period | 1 year | |
Nonemployee Consultant Options | 2016 Equity Incentive Plan | Minimum | ||
Equity Plans | ||
Vesting period | 1 year | |
Nonemployee Consultant Options | 2016 Equity Incentive Plan | Maximum | ||
Equity Plans | ||
Vesting period | 4 years |
Equity Plans - Activity (Detail
Equity Plans - Activity (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Dec. 31, 2018 | |
Options Outstanding | ||
Options Outstanding, Beginning balance | 3,178,441 | |
Options Outstanding, Options granted | 1,067,300 | |
Options Outstanding, Options exercised | (95,627) | |
Options Outstanding, Options forfeited | (369,669) | |
Options Outstanding, Ending balance | 3,780,445 | 3,178,441 |
Options Outstanding, Options exercisable | 1,802,359 | |
Options Outstanding, Options vested and expected to vest | 3,780,445 | |
Weighted-Average Exercise Price Per Share | ||
Weighted-Average Exercise Price Per Share, Beginning balance | $ 12.23 | |
Weighted-Average Exercise Price Per Share, Options granted | 8.75 | |
Weighted-Average Exercise Price Per Share, Options exercised | 1.59 | |
Weighted-Average Exercise Price Per Share, Options forfeited | 12.27 | |
Weighted-Average Exercise Price Per Share, Ending balance | 11.51 | $ 12.23 |
Weighted-Average Exercise Price Per Share, Options exercisable | 11.57 | |
Weighted-Average Exercise Price Per Share, Options vested and expected to vest | $ 11.51 | |
Weighted-Average Remaining Contractual Life (years) | ||
Weighted-Average Remaining Contractual Life (years) | 7 years 6 months 15 days | |
Weighted-Average Remaining Contractual Life (years), Options exercisable | 6 years 1 month 28 days | |
Weighted-Average Remaining Contractual Life (years), Options vested and expected to vest | 7 years 6 months 15 days | 7 years 6 months 7 days |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Options Outstanding | $ 12.3 | |
Aggregate Intrinsic Value, Options exercisable | 7.4 | |
Aggregate Intrinsic Value, Options vested and expected to vest | $ 12.3 | |
Options, weighted-average grant-date fair value | $ 5.13 |
Equity Plans - Employee Stock O
Equity Plans - Employee Stock Options Valuation Assumptions (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Equity Plans | ||||
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Employee stock options | ||||
Equity Plans | ||||
Expected volatility, Minimum | 62.00% | 64.00% | 62.00% | 64.00% |
Expected volatility, Maximum | 62.70% | 66.40% | 62.70% | 66.40% |
Risk-free interest rate, Minimum | 1.88% | 2.65% | 1.88% | 2.42% |
Risk-free interest rate, Maximum | 2.20% | 2.98% | 2.58% | 2.98% |
Employee stock options | Minimum | ||||
Equity Plans | ||||
Expected term | 5 years 6 months | 5 years 6 months | 5 years 6 months | 5 years 6 months |
Employee stock options | Maximum | ||||
Equity Plans | ||||
Expected term | 6 years 29 days | 6 years 29 days | 6 years 29 days | 6 years 29 days |
Equity Plans - Restricted Stock
Equity Plans - Restricted Stock Units - (Details) | 6 Months Ended |
Jun. 30, 2019installment$ / sharesshares | |
Equity Plans | |
Restricted stock units vesting, number of equal installments | installment | 4 |
Number of Shares | |
Number of shares, Unvested, Beginning balance | shares | 418,450 |
Number of shares, Granted | shares | 160,650 |
Number of shares, Vested | shares | (119,353) |
Number of Shares, Forfeited | shares | (91,176) |
Number of shares, Unvested, Ending balance | shares | 368,571 |
Weighted-Average Grant Date Fair Value | |
Weighted-Average Grant Date Fair Value, Unvested, Beginning balance | $ / shares | $ 10.45 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | 8.02 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 10.04 |
Weighted-Average Grant Date Fair Value, Forfeited | $ / shares | 9.79 |
Weighted-Average Grant Date Fair Value, Unvested, Ending balance | $ / shares | $ 9.68 |
Equity Plans - ESPP Description
Equity Plans - ESPP Description and Rights Valuation Assumptions (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Equity Plans | ||||
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
2016 Employee Stock Purchase Plan | ||||
Equity Plans | ||||
Shares issued in period | 146,673 | |||
Number of shares available for issuance | 613,304 | 613,304 | ||
Maximum payroll deduction for share purchases (as a percent) | 15.00% | 15.00% | ||
Purchase price of stock (as a percent) | 85.00% |
Equity Plans - Compensation Exp
Equity Plans - Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 2,013 | $ 1,645 | $ 3,992 | $ 2,830 |
Total unrecognized stock-based compensation costs related to stock options | 16,200 | $ 16,200 | ||
Period of unrecognized stock-based compensation costs to be recognized | 2 years 7 months 6 days | |||
Research and Development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 977 | 837 | $ 2,100 | 1,378 |
General and Administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 1,036 | $ 808 | $ 1,892 | $ 1,452 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Effective tax rate of provision for income taxes difference from federal statutory rate | ||||
Income tax benefit | $ (1,629) | $ 0 | $ (1,445) | $ 0 |
Effective income tax rate (as a percent) | 5.30% | 3.20% | ||
Discrete tax benefit for 2017 Australia refundable R&D tax offset | $ 1,100 | $ 1,100 | ||
Federal statutory income tax rate (as a percent) | 21.00% | 21.00% |
Net Loss per Share - Computatio
Net Loss per Share - Computation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Numerator: | ||||
Net loss | $ (29,174) | $ (8,663) | $ (43,277) | $ (16,324) |
Denominator: | ||||
Weighted-average shares used to compute net loss per common share, basic and diluted | 24,662,779 | 21,207,234 | 24,481,186 | 21,160,076 |
Net loss per shares, basic and diluted | $ (1.18) | $ (0.41) | $ (1.77) | $ (0.77) |
Net Loss per Share - Antidiluti
Net Loss per Share - Antidilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 6,936,015 | 3,204,660 |
Employee stock options | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 3,780,445 | 3,071,618 |
Common stock warrants | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 2,750,000 | |
Restricted stock units | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 368,571 | 113,625 |
ESPP rights | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 36,999 | 19,417 |
Subsequent Event - First Amendm
Subsequent Event - First Amendment (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
Jul. 31, 2019 | Jun. 30, 2019 | Jun. 30, 2019 | Dec. 31, 2018 | |
Subsequent Event | ||||
Common stock sold | 24,967,603 | 24,967,603 | 23,187,219 | |
Net proceeds from sale of stock | $ 10,543 | |||
Cantor Fitzgerald & Co. Sales Agreement | ||||
Subsequent Event | ||||
Common stock available for sale | $ 96,500 | 96,500 | ||
Cantor Fitzgerald & Co. Sales Agreement | Subsequent Event | ||||
Subsequent Event | ||||
Common stock available for sale | $ 81,100 | |||
Cantor Fitzgerald & Co. Sales Agreement | At-the-market offering | ||||
Subsequent Event | ||||
Common stock available for sale | $ 37,500 | $ 37,500 | ||
Cantor Fitzgerald & Co. Sales Agreement | At-the-market offering | Common Stock | ||||
Subsequent Event | ||||
Common stock sold | 921,684 | 921,684 | ||
Net proceeds from sale of stock | $ 10,500 | $ 10,500 | ||
Cantor Fitzgerald & Co. Sales Agreement | At-the-market offering | Subsequent Event | ||||
Subsequent Event | ||||
Common stock available for sale | $ 22,100 | |||
Cantor Fitzgerald & Co. Sales Agreement | At-the-market offering | Subsequent Event | Common Stock | ||||
Subsequent Event | ||||
Common stock sold | 1,200,000 | |||
Net proceeds from sale of stock | $ 15,000 |