Cover Page
Cover Page - $ / shares | 6 Months Ended | |||
Jun. 30, 2019 | Aug. 05, 2019 | Dec. 31, 2018 | Jul. 02, 2018 | |
Cover page. | ||||
Document Type | 10-Q | |||
Document Quarterly Report | true | |||
Document Period End Date | Jun. 30, 2019 | |||
Document Transition Report | false | |||
Entity File Number | 001-38558 | |||
Entity Registrant Name | TRICIDA, INC. | |||
Entity Incorporation, State or Country Code | DE | |||
Entity Tax Identification Number | 46-3372526 | |||
Entity Address, Address Line One | 7000 Shoreline Court | |||
Entity Address, Address Line Two | Suite 201 | |||
Entity Address, City or Town | South San Francisco | |||
Entity Address, State or Province | CA | |||
Entity Address, Postal Zip Code | 94080 | |||
City Area Code | 415 | |||
Local Phone Number | 429-7800 | |||
Title of 12(b) Security | Common stock, par value $0.001 per share | |||
Trading Symbol | TCDA | |||
Security Exchange Name | NASDAQ | |||
Entity Current Reporting Status | Yes | |||
Entity Interactive Data Current | Yes | |||
Entity Filer Category | Non-accelerated Filer | |||
Entity Small Business | false | |||
Entity Emerging Growth Company | true | |||
Entity Ex Transition Period | true | |||
Entity Shell Company | false | |||
Entity Common Stock, Shares Outstanding | 49,390,364 | |||
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Amendment Flag | false | |||
Document Fiscal Year Focus | 2019 | |||
Document Fiscal Period Focus | Q2 | |||
Entity Central Index Key | 0001595585 | |||
Current Fiscal Year End Date | --12-31 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 24,797 | $ 37,172 |
Short-term investments | 369,037 | 203,906 |
Prepaid expenses and other current assets | 4,666 | 3,269 |
Total current assets | 398,500 | 244,347 |
Long-term investments | 11,497 | 2,287 |
Property and equipment, net | 1,892 | 1,215 |
Operating lease right-of-use assets | 1,843 | |
Total assets | 413,732 | 247,849 |
Current liabilities: | ||
Accounts payable | 4,673 | 8,460 |
Current operating lease liabilities | 1,046 | |
Accrued expenses and other current liabilities | 22,296 | 6,344 |
Total current liabilities | 28,015 | 14,804 |
Long-term liabilities | ||
Term Loan | 37,463 | 38,071 |
Non-current operating lease liabilities | 994 | |
Other long-term liabilities | 416 | 449 |
Total liabilities | 66,888 | 53,324 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 40,000,000 shares authorized, no shares issued or outstanding as of June 30, 2019 and December 31, 2018 | 0 | 0 |
Common stock, $0.001 par value; 400,000,000 shares authorized as of June 30, 2019 and December 31, 2018; 49,276,445 and 42,148,247 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | 49 | 42 |
Additional paid-in capital | 612,883 | 386,830 |
Accumulated other comprehensive income (loss) | 629 | (153) |
Accumulated deficit | (266,717) | (192,194) |
Total stockholders’ equity | 346,844 | 194,525 |
Total liabilities and stockholders’ equity | $ 413,732 | $ 247,849 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 1 | $ 1 |
Preferred stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 400,000,000 | 400,000,000 |
Common stock, shares outstanding (in shares) | 49,276,445 | 42,148,247 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating expenses: | ||||
Research and development | $ 28,976 | $ 21,034 | $ 60,399 | $ 37,667 |
General and administrative | 8,861 | 4,245 | 15,213 | 7,710 |
Total operating expenses | 37,837 | 25,279 | 75,612 | 45,377 |
Loss from operations | (37,837) | (25,279) | (75,612) | (45,377) |
Other income (expense), net | 2,602 | 827 | 3,869 | 740 |
Interest expense | (1,391) | (910) | (2,780) | (1,229) |
Net loss | (36,626) | (25,362) | (74,523) | (45,866) |
Other comprehensive income (loss): | ||||
Net unrealized gain (loss) on available-for-sale investments | 480 | 41 | 782 | (13) |
Total comprehensive loss | $ (36,146) | $ (25,321) | $ (73,741) | $ (45,879) |
Net loss per share, basic and diluted (in USD per share) | $ (0.75) | $ (10.89) | $ (1.64) | $ (19.91) |
Weighted-average number of shares outstanding, basic and diluted (in shares) | 48,674,238 | 2,329,085 | 45,489,861 | 2,304,087 |
CONDENSED STATEMENTS OF CONVERT
CONDENSED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2017 | 104,129,702 | ||||
Beginning balance at Dec. 31, 2017 | $ 147,070 | ||||
Beginning balance (in shares) at Dec. 31, 2017 | 2,272,609 | ||||
Beginning balance at Dec. 31, 2017 | (88,041) | $ 2 | $ 1,356 | $ (13) | $ (89,386) |
Total Stockholders’ Equity (Deficit) | |||||
Issuance of warrants in connection with Term Loan | 24 | ||||
Issuance of common stock under equity incentive plans (in shares) | 29,519 | ||||
Issuance of common stock under equity incentive plans | 24 | ||||
Issuance of common stock in connection with public equity offering, net of underwriter discounts, commissions and issuance costs | 353 | 353 | |||
Net unrealized gain (loss) on available-for-sale investments | (54) | (54) | |||
Net loss | $ (20,504) | (20,504) | |||
Ending balance (in shares) at Mar. 31, 2018 | 104,129,702 | ||||
Ending balance at Mar. 31, 2018 | $ 147,070 | ||||
Ending balance (in shares) at Mar. 31, 2018 | 2,302,128 | ||||
Ending balance at Mar. 31, 2018 | $ (108,222) | $ 2 | 1,733 | (67) | (109,890) |
Beginning balance (in shares) at Dec. 31, 2017 | 104,129,702 | ||||
Beginning balance at Dec. 31, 2017 | $ 147,070 | ||||
Beginning balance (in shares) at Dec. 31, 2017 | 2,272,609 | ||||
Beginning balance at Dec. 31, 2017 | (88,041) | $ 2 | 1,356 | (13) | (89,386) |
Total Stockholders’ Equity (Deficit) | |||||
Stock-based compensation | 970 | ||||
Net unrealized gain (loss) on available-for-sale investments | (13) | ||||
Net loss | $ (45,866) | ||||
Ending balance (in shares) at Jun. 30, 2018 | 104,225,638 | ||||
Ending balance at Jun. 30, 2018 | $ 147,528 | ||||
Ending balance (in shares) at Jun. 30, 2018 | 2,453,606 | ||||
Ending balance at Jun. 30, 2018 | $ (132,271) | $ 2 | 3,005 | (26) | (135,252) |
Beginning balance (in shares) at Mar. 31, 2018 | 104,129,702 | ||||
Beginning balance at Mar. 31, 2018 | $ 147,070 | ||||
Beginning balance (in shares) at Mar. 31, 2018 | 2,302,128 | ||||
Beginning balance at Mar. 31, 2018 | (108,222) | $ 2 | 1,733 | (67) | (109,890) |
Total Stockholders’ Equity (Deficit) | |||||
Issuance of warrants in connection with Term Loan | $ 194 | 194 | |||
Series A warrant exercise (in shares) | 95,936 | ||||
Issuance of common stock in connection with public equity offering, net of underwriter discounts, commissions and issuance costs (in shares) | 151,478 | ||||
Issuance of common stock in connection with public equity offering, net of underwriter discounts, commissions and issuance costs | $ 108 | $ 0 | 108 | ||
Stock-based compensation | 970 | ||||
Net unrealized gain (loss) on available-for-sale investments | 41 | 41 | |||
Net loss | $ (25,362) | (25,362) | |||
Ending balance (in shares) at Jun. 30, 2018 | 104,225,638 | ||||
Ending balance at Jun. 30, 2018 | $ 147,528 | ||||
Ending balance (in shares) at Jun. 30, 2018 | 2,453,606 | ||||
Ending balance at Jun. 30, 2018 | $ (132,271) | $ 2 | 3,005 | (26) | (135,252) |
Beginning balance (in shares) at Dec. 31, 2018 | 0 | ||||
Beginning balance at Dec. 31, 2018 | $ 0 | ||||
Beginning balance (in shares) at Dec. 31, 2018 | 42,148,247 | ||||
Beginning balance at Dec. 31, 2018 | 194,525 | $ 42 | 386,830 | (153) | (192,194) |
Total Stockholders’ Equity (Deficit) | |||||
Issuance of warrants in connection with Term Loan | 284 | 284 | |||
Issuance of common stock under equity incentive plans (in shares) | 527,859 | ||||
Issuance of common stock under equity incentive plans | 737 | $ 1 | 736 | ||
Stock-based compensation | 2,658 | 2,658 | |||
Net unrealized gain (loss) on available-for-sale investments | 302 | 302 | |||
Net loss | $ (37,897) | (37,897) | |||
Ending balance (in shares) at Mar. 31, 2019 | 0 | ||||
Ending balance at Mar. 31, 2019 | $ 0 | ||||
Ending balance (in shares) at Mar. 31, 2019 | 42,676,106 | ||||
Ending balance at Mar. 31, 2019 | $ 160,609 | $ 43 | 390,508 | 149 | (230,091) |
Beginning balance (in shares) at Dec. 31, 2018 | 0 | ||||
Beginning balance at Dec. 31, 2018 | $ 0 | ||||
Beginning balance (in shares) at Dec. 31, 2018 | 42,148,247 | ||||
Beginning balance at Dec. 31, 2018 | 194,525 | $ 42 | 386,830 | (153) | (192,194) |
Total Stockholders’ Equity (Deficit) | |||||
Series A warrant exercise | 458 | ||||
Net unrealized gain (loss) on available-for-sale investments | 782 | ||||
Net loss | $ (74,523) | ||||
Ending balance (in shares) at Jun. 30, 2019 | 0 | ||||
Ending balance at Jun. 30, 2019 | $ 0 | ||||
Ending balance (in shares) at Jun. 30, 2019 | 49,276,445 | ||||
Ending balance at Jun. 30, 2019 | $ 346,844 | $ 49 | 612,883 | 629 | (266,717) |
Beginning balance (in shares) at Mar. 31, 2019 | 0 | ||||
Beginning balance at Mar. 31, 2019 | $ 0 | ||||
Beginning balance (in shares) at Mar. 31, 2019 | 42,676,106 | ||||
Beginning balance at Mar. 31, 2019 | 160,609 | $ 43 | 390,508 | 149 | (230,091) |
Total Stockholders’ Equity (Deficit) | |||||
Issuance of common stock under equity incentive plans (in shares) | 160,339 | ||||
Issuance of common stock under equity incentive plans | 959 | 959 | |||
Issuance of common stock in connection with public equity offering, net of underwriter discounts, commissions and issuance costs (in shares) | 6,440,000 | ||||
Issuance of common stock in connection with public equity offering, net of underwriter discounts, commissions and issuance costs | 217,009 | $ 6 | 217,003 | ||
Stock-based compensation | 4,413 | 4,413 | |||
Net unrealized gain (loss) on available-for-sale investments | 480 | 480 | |||
Net loss | $ (36,626) | (36,626) | |||
Ending balance (in shares) at Jun. 30, 2019 | 0 | ||||
Ending balance at Jun. 30, 2019 | $ 0 | ||||
Ending balance (in shares) at Jun. 30, 2019 | 49,276,445 | ||||
Ending balance at Jun. 30, 2019 | $ 346,844 | $ 49 | $ 612,883 | $ 629 | $ (266,717) |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Operating activities: | ||
Net loss | $ (74,523) | $ (45,866) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 341 | 280 |
Amortization of operating lease right-of-use assets | 413 | |
Amortization of Term Loan discount and issuance costs | 1,011 | 504 |
Accretion (amortization) of premiums and discounts on investments | (2,031) | (264) |
Stock-based compensation | 7,071 | 1,323 |
Changes in fair value of compound derivative liability and warrants | 165 | (236) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (1,393) | 229 |
Accounts payable | (3,785) | 4,652 |
Accrued expenses and other liabilities | 16,240 | 5,303 |
Operating lease liabilities | (438) | |
Net cash used in operating activities | (56,929) | (34,075) |
Investing activities: | ||
Purchase of investments | (299,085) | (20,002) |
Maturities of investments | 127,557 | 28,475 |
Purchase of property and equipment | (1,021) | (542) |
Net cash provided by (used in) investing activities | (172,549) | 7,931 |
Financing activities: | ||
Proceeds from equity offerings, net | 217,930 | 0 |
Payments of equity offering costs | (921) | (2,017) |
Proceeds from exercise of common stock under equity incentive plans | 1,608 | 236 |
Proceeds from issuance of convertible preferred stock, net | 0 | 85 |
Proceeds from leasehold improvement loan | 0 | 220 |
Repayment of leasehold improvement loan | (65) | 0 |
Proceeds (payments) under Term Loan, net | (1,449) | 23,634 |
Net cash provided by financing activities | 217,103 | 22,158 |
Net decrease in cash and cash equivalents | (12,375) | (3,986) |
Cash and cash equivalents at beginning of period | 37,172 | 9,774 |
Cash and cash equivalents at end of period | 24,797 | 5,788 |
Supplemental disclosures | ||
Cash paid for interest | 1,650 | 539 |
Supplemental disclosures of non-cash financing activities | ||
Deferred offering costs incurred but not paid | 0 | 4,320 |
Warrants and compound derivative liability related to Term Loan | 284 | 810 |
Purchase of property and equipment in accounts payable and accrued expenses | $ 24 | $ 90 |
ORGANIZATION AND BASIS OF PRESE
ORGANIZATION AND BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND BASIS OF PRESENTATION | ORGANIZATION AND BASIS OF PRESENTATION Organization —Tricida, Inc. (the Company) was incorporated in the state of Delaware on May 22, 2013 and was granted its certification of qualification in the state of California on August 5, 2013, or inception. The Company is focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis by binding and removing acid from the gastrointestinal, or GI, tract. In May 2018, the Company completed its pivotal Phase 3 clinical trial, TRCA-301, that met both its primary and secondary endpoints in a highly statistically significant manner. In March 2019, the Company completed its 40-week extension trial, TRCA-301E. T he TRCA-301E trial met all of its primary and secondary endpoints. The Company plans to submit a New Drug Application, or NDA, for veverimer in the third quarter of 2019 under the U.S. Food and Drug Administration’s, or FDA’s, Accelerated Approval Program. As part of the Accelerated Approval Program, a confirmatory postmarketing trial is required. The Company is currently conducting its confirmatory postmarketing trial, VALOR-CKD (also known as TRCA-303), to evaluate the efficacy and safety of veverimer in delaying CKD progression in subjects with metabolic acidosis. The Company has sustained operating losses and expects such annual losses to continue over the next several years. The Company’s ultimate success depends on the outcome of its research and development and commercialization activities for veverimer, for which it expects to incur additional losses in the future. Through June 30, 2019 , the Company has relied primarily on the proceeds from equity offerings and debt financing to finance its operations. The Company recognizes that it may need to raise additional capital to fully implement its business plan, and if market conditions are favorable or if the Company identifies specific strategic opportunities or needs, intends to do so through the issuance of equity, borrowings, or strategic alliances with partner companies. However, if such financing is not available at adequate levels or on reasonable terms, the Company will need to reevaluate its operating plans. Basis of Presentation —The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The condensed balance sheet as of June 30, 2019 , the condensed statements of operations and comprehensive loss for the three and six months ended June 30, 2019 and 2018 , the condensed statements of convertible preferred stock and stockholders' equity (deficit) for the three and six months ended June 30, 2019 and 2018 and the condensed statements of cash flows for the six months ended June 30, 2019 and 2018 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The condensed balance sheet at December 31, 2018 has been derived from audited financial statements. Although the Company believes that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission. Results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018 |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES With the exception of the change for the accounting of leases as a result of the adoption of Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842), or Topic 842, there have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, that are of significance, or potential significance, to the Company. Leases —The Company determines if an arrangement contains a lease at inception. For arrangements where the Company is the lessee, operating leases are included in operating lease right-of-use (ROU) assets; current operating lease liabilities; and non-current operating lease liabilities on its condensed balance sheets. The Company currently does not have any finance leases. 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 the commencement date. ROU assets also include any initial direct costs incurred and any lease payments made on or before the lease commencement date, less lease incentives received. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company’s leases generally do not provide an implicit rate. The Company considered information available at the adoption date of Topic 842 to determine the incremental borrowing rate for leases in existence as of this date. Lease terms may include options to extend or terminate the lease when the Company is reasonably certain that the option will be exercised. Lease expense is recognized on a straight-line basis over the lease term. The Company elected to apply each of the practical expedients described in Accounting Standards Codification (ASC) Topic 842-10-65-1(f) which allow companies not to reassess: (i) whether any expired or existing agreements contain leases, (ii) the classification of any expired or existing leases, and (iii) the capitalization of initial direct costs for any existing leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for short-term operating leases. A short-term is a lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. Recent Accounting Pronouncements Adopted Standards In February 2016, the Financial Accounting Standards Board (FASB) issued Topic 842, which amended prior accounting standards for leases. The Company adopted Topic 842 on January 1, 2019, using the alternative modified transition method, which applies the standard as of the effective date and therefore, the Company has not applied the standard to the comparative periods presented on the Company's condensed financial statements . The Company elected the following practical expedients when assessing the transition impact available to lessees: (i) not to reassess whether any expired or existing contracts as of January 1, 2019, are or contain leases; (ii) not to reassess the lease classification for any expired or existing leases as of January 1, 2019; and (iii) not to reassess initial direct costs for any existing leases as of January 1, 2019. As a lessee, the primary impact for the Company was the recognition of operating lease ROU assets of $2.3 million and operating lease liabilities of $2.5 million on its condensed balance sheet as of January 1, 2019. See Note 4 " Leases " for additional details. Standards Not Yet Effective In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326) : Measurement of Credit Losses on Financial Instruments (ASU 2016-13). ASU 2016-13 implements an impairment model, known as the current expected credit loss model, based on expected losses rather than incurred losses. Under the new guidance, an entity will recognize, as an allowance, its estimate of expected credit losses. The ASU is effective for interim and annual periods beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption of ASU 2016-13 to have a material impact on its financial statements. In September 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 amends ASC Topic 820, Fair Value Measurement . The FASB issued final guidance that eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. Under the ASU, entities will no longer be required to disclose the amount of transfers between Level 1 and Level 2 of the fair value hierarchy. Public companies will be required to disclose changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. ASU No. 2018-13 is effective for public business entities for annual reporting periods, and interim periods within those annual periods, beginning after December 15, 2019. Early adoption will be permitted in any interim or annual period. The Company plans to adopt this guidance on January 1, 2020. The new guidance only affects disclosures in the notes to the financial statements and will not affect the Company's financial statements. |
FAIR VALUE MEASUREMENTS AND FAI
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS | FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS The fair value of the Company’s financial assets and liabilities are determined in accordance with the fair value hierarchy established in the FASB's ASC Topic 820, Fair Value Measurements and Disclosures . ASC Topic 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy of ASC Topic 820 requires an entity to maximize the use of observable inputs when measuring fair value and classifies those inputs into three levels: Level 1 —Observable inputs, such as quoted prices in active markets; Level 2 —Inputs, other than the quoted prices in active markets, which are observable either directly or indirectly such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the instrument’s anticipated life; and Level 3 —Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. The Company's policy is to recognize transfers in and out of Level 1, 2 and 3 as of the end of the reporting period. There were no transfers of assets or liabilities between the fair value measurement levels during the six months ended June 30, 2019 . The Company's financial instruments consist primarily of cash, cash equivalents, short-term and long-term investments, accounts payable and the Term Loan with Hercules. Cash, cash equivalents and investments are reported at their respective fair values on the Company's condensed balance sheets. Where quoted prices are available in an active market, securities are classified as Level 1. The Company classifies money market funds as Level 1. When quoted market prices are not available for the specific security, then the Company estimates fair value by using 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. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third-party data providers, including but not limited to benchmark yields, reported trades and broker/dealer quotes. Where applicable the market approach utilizes prices and information from market transactions for similar or identical assets. The Company classifies U.S. government agency securities, commercial paper, corporate debt securities and asset-backed securities as Level 2. The Company's short-term and long-term investments are classified as available-for-sale. The following tables set forth the fair value of the Company's cash and financial assets remeasured on a recurring basis based on the three-tier fair value hierarchy by significant investment category as of June 30, 2019 and December 31, 2018 . June 30, 2019 Reported as: (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Short-Term Investments Long-Term Investments Cash $ 1,592 $ — $ — $ 1,592 $ 1,592 $ — $ — Level 1: Money market fund 17,958 — — 17,958 17,958 — — Level 2: U.S. government agency securities 1,000 — (1 ) 999 — — 999 Commercial paper 168,214 280 — 168,494 — 168,494 — Corporate debt securities 164,255 294 (6 ) 164,543 5,247 148,798 10,498 Asset-backed securities 51,683 62 — 51,745 — 51,745 — Subtotal 385,152 636 (7 ) 385,781 5,247 369,037 11,497 Total assets measured at fair value $ 404,702 $ 636 $ (7 ) $ 405,331 $ 24,797 $ 369,037 $ 11,497 December 31, 2018 Reported as: (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Short-Term Investments Long-Term Investments Cash $ 3,021 $ — $ — $ 3,021 $ 3,021 $ — $ — Level 1: Money market fund 33,154 — — 33,154 33,154 — — Level 2: Commercial paper 68,467 — (63 ) 68,404 997 67,407 — Corporate debt securities 89,038 4 (63 ) 88,979 — 86,692 2,287 Asset-backed securities 49,838 3 (34 ) 49,807 — 49,807 — Subtotal 207,343 7 (160 ) 207,190 997 203,906 2,287 Total assets measured at fair value $ 243,518 $ 7 $ (160 ) $ 243,365 $ 37,172 $ 203,906 $ 2,287 Interest income related to the Company's cash, cash equivalents and available-for-sale investments included in other income (expense), net was approximately $2.7 million and $0.4 million for the three months ended June 30, 2019 and 2018 , respectively, and $4.2 million and $0.6 million for the six months ended June 30, 2019 and 2018 , respectively. There were no gross realized gains and gross realized losses for the three and six months ended June 30, 2019 and 2018 . The following table summarizes the Company's available-for-sale investments that were in a continuous unrealized loss position but were not deemed to be other-than-temporarily impaired, as of June 30, 2019 and December 31, 2018 . June 30, 2019 December 31, 2018 (in thousands) Fair Value Unrealized Losses Fair Value Unrealized Losses U.S. government agency securities $ 999 $ (1 ) $ — $ — Commercial paper — — 67,407 (63 ) Corporate debt securities 9,251 (6 ) 85,699 (63 ) Asset-backed securities — — 36,730 (34 ) Total $ 10,250 $ (7 ) $ 189,836 $ (160 ) The Company held a total of 4 and 48 positions which were in an unrealized loss position as of June 30, 2019 and December 31, 2018 , respectively. All available-for-sale investments in an unrealized loss position were in a continuous loss position for less than 12 months. As of June 30, 2019 , unrealized losses on available-for-sale investments were not attributable to credit risk. The Company determined that there were no other-than-temporary impairments as of June 30, 2019 because the Company does not intend to sell these securities nor does the Company believe that it will be required to sell these securities before the recovery of their amortized cost basis. The following table summarizes the maturities of the Company’s cash equivalents (excluding money market funds) and available-for-sale investments, as of June 30, 2019 . (in thousands) Amortized Cost Fair Value Mature in less than one year $ 373,673 $ 374,284 Mature in one to five years 11,479 11,497 Total $ 385,152 $ 385,781 The following table presents a reconciliation of financial liabilities measured at fair value on a recurring basis using Level 3 unobservable inputs for the six months ended June 30, 2019 and 2018 . Six Months Ended June 30, 2019 2018 (in thousands) Compound Derivative Liability Compound Derivative Liability Warrant Liability Fair value at beginning of period $ 161 $ — $ 106 Additions — 654 156 Change in fair value 165 (541 ) 305 Reclassification to equity — — (194 ) Issuance of convertible preferred stock on exercise of warrant — — (373 ) Fair value at end of period $ 326 $ 113 $ — The following table presents information about significant unobservable inputs related to the Company's Level 3 financial liabilities as of June 30, 2019 . June 30, 2019 (in thousands) Fair Value Valuation Technique Significant Unobservable Input Range of Inputs Compound derivative liability $ 326 Discounted cash flow Discount rate 10.5 % - 11.5 % Probability of the occurrence of certain events 10.0 % Term Loan The estimated fair value of the Term Loan was $40.6 million as of June 30, 2019 which approximates the carrying value and is classified as Level 3. The Company utilized a market yield analysis and income approach to estimate a range of values for the Term Loan. The discount rate ranged between 10.5% and 11.5% |
LEASES
LEASES | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
LEASES | LEASES The Company has an operating lease for its office and laboratory space in South San Francisco, California. Operating lease expense was $0.3 million for the three months ended June 30, 2019 and $0.5 million for the six months ended June 30, 2019 . Cash paid within operating cash flows for operating leases was $0.5 million for the six months ended June 30, 2019 . Expense related to short-term leases was not significant for the three and six months ended June 30, 2019 . The following table presents supplemental balance sheet information related to operating leases as of June 30, 2019 . (in thousands, except lease term and discount rate) June 30, 2019 Operating lease right-of-use assets $ 1,843 Operating lease liabilities: Current operating lease liabilities 1,046 Non-current operating lease liabilities 994 Total operating lease liabilities $ 2,040 Weighted average remaining lease term 2.0 years Weighted average discount rate 8.0 % The following table presents the maturities of the Company's operating lease liabilities as of June 30, 2019 . (in thousands) June 30, 2019 2019 (remaining six months) $ 546 2020 1,108 2021 562 Total lease payments 2,216 Less: imputed interest (176 ) Total operating lease liabilities $ 2,040 ASC Topic 840 Disclosures The Company elected the alternative modified transition method and is required to present previously disclosed information under the prior accounting standard for leases. The following table presents the future minimum lease commitments under the Company’s operating leases as of December 31, 2018, as previously disclosed. (in thousands) December 31, 2018 2019 $ 1,076 2020 1,108 2021 562 2022 and thereafter — Total future minimum lease payments $ 2,746 |
OTHER BALANCE SHEET COMPONENTS
OTHER BALANCE SHEET COMPONENTS | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
OTHER BALANCE SHEET COMPONENTS | OTHER BALANCE SHEET COMPONENTS Property and Equipment, Net The following table presents the components of property and equipment, net as of June 30, 2019 and December 31, 2018 . (in thousands) June 30, December 31, Furniture and fixtures $ 193 $ 193 Computer and lab equipment 2,898 1,888 Leasehold improvements 1,063 1,055 4,154 3,136 Less: accumulated depreciation and amortization (2,262 ) (1,921 ) Total property and equipment, net $ 1,892 $ 1,215 Depreciation and amortization expense was approximately $0.2 million and $0.1 million for the three months ended June 30, 2019 and 2018 , respectively, and $0.3 million for the six months ended June 30, 2019 and 2018 . Accrued Expenses and Other Current Liabilities The following table presents the components of accrued expenses and other current liabilities as of June 30, 2019 and December 31, 2018 . (in thousands) June 30, December 31, Accrued clinical and nonclinical study costs $ 6,674 $ 2,168 Accrued contract manufacturing 11,077 1,676 Accrued compensation 2,368 1,565 Accrued professional fees and other 2,177 935 Total accrued expenses and other current liabilities $ 22,296 $ 6,344 |
BORROWINGS
BORROWINGS | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
BORROWINGS | BORROWINGS Term Loan On February 28, 2018 , the Company entered into the Term Loan with Hercules. The Term Loan provided for a loan in an aggregate principal amount of up to $100.0 million to be funded in five tranches subject to certain performance‑based milestones. The first tranche, in the amount of $25.0 million , was funded on the closing date of the Term Loan. On October 15, 2018, the Company entered into the second amendment to the Term Loan with Hercules, which amended certain terms of the Term Loan. After giving effect to the second amendment, the Term Loan continued to provide for a loan in an aggregate principal amount of up to $100.0 million to be funded in five tranches subject to certain performance‑based milestones. The second tranche was reduced from $25.0 million to $15.0 million and was funded on December 28, 2018 . The Company accounted for the second amendment as a modification to the existing Term Loan. On March 27, 2019 , the Company modified the Term Loan with Hercules by entering into the third amendment to the Term Loan. After giving effect to the third amendment, the amount available under the Term Loan is increased from up to $100.0 million to up to $200.0 million to be funded in tranches, subject to certain performance-based milestones, and the maturity of the Term Loan is extended. Under the terms of the Term Loan, as amended by the third amendment, the $40.0 million principal outstanding remains outstanding, and additional tranches of $20.0 million and $15.0 million will be available for draw down prior to December 15, 2019 and December 15, 2020, respectively. An additional tranche of $75.0 million will be available for draw down between January 1, 2020 and December 15, 2020, on the condition that the Company obtains final approval from the FDA for the NDA for veverimer. A final tranche of $50.0 million will be available for draw down on or prior to December 15, 2021, upon request by the Company and the approval of Hercules' investment committee. The Company accounted for the third amendment as a modification to the existing Term Loan. The Term Loan bears interest at a floating per annum interest rate equal to the greater of either (i) 8.35% or (ii) the lesser of (x) 8.35% plus the prime rate as reported in The Wall Street Journal minus 6.00% and (y) 9.85% . The maturity date is extended to April 1, 2023 and may be extended to April 1, 2024 if the tranche of $75.0 million described above is drawn. The Company will initially be making interest-only payments until April 1, 2021. If the Company achieves certain performance milestones and financial covenants, the interest-only period could be extended for up to an additional 24 months. Upon expiration of the interest-only period, the Company will repay the Term Loan in equal monthly installments comprised of principal and interest, based on a 30 -month amortization schedule, through maturity. The Company will pay an additional amount of (a) $2.6 million due on March 1, 2022 and (b) the product of 7.55% and the aggregate loans funded under the Term Loan due at maturity or on any earlier date on which the loans become due. If the Company prepays the Term Loan, the Company will be required to pay a prepayment charge equal to (i) 2.00% of the amount being prepaid at any time during the first 12 months following the effective date of the third amendment (ii) 1.50% of the amount being prepaid after 12 months but prior to 24 months following the effective date of the third amendment (iii) 1.00% of the amount being prepaid after 24 months but prior to 36 months following the effective date of the third amendment and (iv) zero if prepaid any time after 36 months following the effective date of the third amendment but prior to the maturity. The Term Loan is secured by substantially all of the Company's assets, except its intellectual property, which is the subject of a negative pledge; however, the collateral does consist of rights to payments and proceeds from the sale, licensing or disposition of all or any part of, or rights in, its intellectual property. Under the Term Loan, the Company is subject to certain covenants, including but not limited to requirements to deliver financial reports at designated times of the year and maintain a minimum level of cash. These covenants also limit or restrict the Company's ability to incur additional indebtedness or liens, acquire, own or make any investments, pay cash dividends, repurchase stock or enter into certain corporate transactions, including mergers and changes of control. Warrants In conjunction with the Term Loan entered into on February 28, 2018 , the Company issued warrants to Hercules to purchase 53,458 shares of its common stock with an exercise price of $9.35 per share. The estimated fair value of the warrants at the date of issuance was approximately $0.2 million . The fair value of the common stock warrant liability was determined using the probability‑weighted expected return method. It was recorded at its fair value at inception and was remeasured at each financial reporting period with any changes in fair value being recognized as a component of other income (expense), net in the accompanying condensed statements of operations and comprehensive loss. On April 10, 2018, the Company entered into amendments with Hercules that resulted in the reclassification of the warrant liability to stockholders' equity (deficit) as the amended terms of the warrants qualified for them to be accounted for as equity instruments and, as such, were no longer subject to remeasurement. The fair value of the common stock warrants of approximately $0.2 million was reclassified to stockholders' equity upon execution of the amendment. In connection with the funding of the second tranche on December 28, 2018 , the Company issued to Hercules a warrant to purchase 53,458 shares of its common stock with an exercise price of $9.35 per share. The common stock warrant was recorded in stockholders' equity (deficit) at its fair value of approximately $0.9 million on December 28, 2018 . In conjunction with the third amendment, the Company issued warrants to Hercules to purchase 16,721 shares of its common stock with an exercise price of $23.92 per share. The common stock warrants were recorded in stockholders' equity (deficit) at its fair value of approximately $0.3 million on March 27, 2019. The fair value of the common stock warrants were determined using an option-pricing model with the following assumptions: time to liquidity of 7.0 years, volatility of 75.0% , risk-free rate of 2.3% and stock price based on the March 27, 2019 closing price of the Company's common stock reported by The Nasdaq Global Select Market. In connection with each subsequent draw down under the tranches described above, the Company is obligated to issue additional warrants to purchase a number of shares of the Company's common stock determined by dividing (x) an amount equal to 1.0% of the principal amount of the applicable tranche by (y) $23.92 subject to adjustments following certain corporate events. Embedded Derivatives and Other Debt Issuance Costs The Company determined that certain loan features were embedded derivatives requiring bifurcation and separate accounting. Those embedded derivatives were bundled together as a single, compound embedded derivative and then bifurcated and accounted for separately from the host contract. The Company initially recorded a compound derivative liability of $0.7 million , which is required to be marked to market in future periods. As of June 30, 2019 , the Company calculated the fair values of the compound derivative by computing the difference between the fair value of the Term Loan with the compound derivative using the “with and without” method under the income approach, and the fair value of the Term Loan without the compound derivative. The Company calculated the fair values using a probability‑weighted discounted cash flow analysis. The key valuation assumptions used consist of the discount rate of 11.0% and the probability of the occurrence of certain events of 10.0% . The compound derivative liability is being remeasured at each financial reporting period with any changes in fair value being recognized as a component of other income (expense), net in the condensed statements of operations and comprehensive loss. The fair value of the compound derivative liability was approximately $0.3 million as of June 30, 2019 and was classified as other long-term liabilities on the condensed balance sheet. The facility fee, fair value of warrants at issuance, fair value of embedded derivatives which were bifurcated, and other debt issuance costs have been treated as debt discounts on the Company’s condensed balance sheets and together with the additional payment are being amortized to interest expense throughout the life of the Term Loan using the effective interest rate method. As of June 30, 2019 and December 31, 2018 , there were unamortized issuance costs and debt discounts of $3.8 million and $2.7 million , respectively, which were recorded as a direct deduction from the Term Loan on the condensed balance sheets. The following table presents future payments of principal and interest on the Term Loan as of June 30, 2019 . (in thousands) June 30, 2019 2019 (remaining six months) $ 1,698 2020 3,396 2021 14,173 2022 20,403 2023 16,282 55,952 Less: amount representing interest (15,952 ) Present value of Term Loan 40,000 Less: current portion — Long-term portion of Term Loan $ 40,000 Convertible Preferred Stock Warrant Liability The Company entered into a Note and Warrant Purchase Agreement with Sibling Co—Investment LLC, or Sibling, in 2013, the principal and interest of which was subsequently converted into the Company’s Series A convertible preferred stock in the same year. In accordance with the agreement a warrant to purchase 95,936 shares of Series A convertible preferred stock was established in conjunction with the Series A financing round. The warrant had a contractual life of 7 years and an exercise price of $0.886 . The fair value of the warrant liability was determined using a Black-Scholes option pricing model and was recorded at its fair value at inception and remeasured at each financial reporting period with any changes in fair value being recognized as a component of other income (expense), net in the accompanying statement of operations and comprehensive loss. On June 16, 2018, Sibling provided the Notice of Exercise and purchased 95,936 shares of Series A convertible preferred stock. The fair value adjustment recognized upon exercise was determined using the intrinsic value which was calculated as the initial public offering, or IPO, price of $19.00 less the warrant exercise price, with the change in fair value being recognized as a component of other income (expense), net in the condensed statements of operations and comprehensive loss. The resultant fair value was reclassified to Series A convertible preferred stock on June 16, 2018. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Facilities In July 2014, the Company entered into a five -year noncancelable operating lease that was scheduled to expire in June 2019, with an option for the Company to extend the lease for an additional three years . In August 2017, the Company entered into an amendment which extended the existing operating lease to June 2021 and added 13,258 square feet of additional lease space resulting in a total of 26,987 square feet being leased in the aggregate under the amended lease. In November 2017, the Company entered into a second amendment which reduced the common areas resulting in a total of 26,897 square feet being leased in aggregate under the second amendment. See Note 4 " Leases " for details of related commitments. In addition, associated with the operating lease, the Company has a tenant improvement loan with remaining payments totaling approximately $0.2 million as of June 30, 2019 . Other Commitments On May 8, 2018, the Company and Patheon Austria GmbH & Co KG, or Patheon, entered into a master development/validation services and clinical/launch supply agreement, or MDS, pursuant to which Patheon will manufacture and supply the Company drug substances. Statements of work under the MDS commit the Company to certain purchase obligations of approximately $134.2 million , of which $16.5 million was paid through June 30, 2019 and $117.7 million will be paid over the next 36 months, with approximately one-third of this amount occurring in each of the three successive 12 -month periods. The Company also enters into other contracts in the normal course of business with CROs, contract development and manufacturing organizations and other service providers and vendors. These contracts generally provide for termination on short notice and are cancelable contracts and accordingly, are not included in the contractual obligations and disclosures summarized above. Contingencies While there are no legal proceedings the Company is aware of, the Company may become party to various claims and complaints arising in the ordinary course of business. The Company does not believe that any ultimate liability resulting from any of these claims will have a material adverse effect on its results of operations, financial position, or liquidity. However, the Company cannot give any assurance regarding the ultimate outcome of these claims, and their resolution could be material to operating results for any particular period, depending upon the level of income for the period. Guarantees and Indemnifications The Company indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits, while the director is or was serving at the Company’s request in such capacity, as permitted under Delaware law and in accordance with its certificate of incorporation and bylaws. The term of the indemnification period lasts as long as a director may be subject to any proceeding arising out of acts or omissions of such director in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director and officer liability insurance. This insurance allows the transfer of risk associated with the Company’s exposure and may enable it to recover a portion of any future amounts paid. The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, it has not recognized any liabilities relating to these obligations for any period presented. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
STOCKHOLDERS' EQUITY | STOCKHOLDERS' EQUITY On July 2, 2018, the Company’s amended and restated certificate of incorporation became effective, authorizing the Company to issue a total of 440,000,000 shares of all classes of capital stock, consisting of 400,000,000 shares of common stock, par value $0.001 per share, and 40,000,000 shares of preferred stock, par value $0.001 per share. As of June 30, 2019 and December 31, 2018 , the Company had 49,276,445 and 42,148,247 shares of common stock outstanding, respectively. As of June 30, 2019 and December 31, 2018 , the Company had no shares of preferred stock outstanding. Common Stock On July 2, 2018 , the Company completed its IPO and issued 13,455,000 shares of common stock at an offering price of $19.00 per share for net proceeds of approximately $237.7 million , after deducting underwriting discounts and commissions of $17.9 million . Upon the closing of the IPO, all of the 104,225,638 shares of convertible preferred stock outstanding were automatically converted on a 1:3.98 basis into 26,187,321 shares of common stock. On April 8, 2019 , the Company consummated an underwritten public offering and issued 6,440,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 840,000 additional shares of common stock at an offering price of $36.00 per share for net proceeds of approximately $217.9 million , after deducting underwriting discounts and commissions of $13.9 million . Common stock reserved for future issuance as of June 30, 2019 and December 31, 2018 , consisted of the following. June 30, December 31, Stock options and RSUs issued and outstanding 6,723,332 4,599,307 Stock options, RSUs and ESPP shares authorized for future issuance 3,829,972 4,534,784 Total 10,553,304 9,134,091 |
NET LOSS PER SHARE
NET LOSS PER SHARE | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | NET LOSS PER SHARE The following table sets forth the computation of the basic and diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2019 and 2018 . Three Months Ended Six Months Ended (In thousands, except share and per share amounts) 2019 2018 2019 2018 Numerator: Net loss $ (36,626 ) $ (25,362 ) $ (74,523 ) $ (45,866 ) Denominator: Weighted average common shares outstanding 48,684,744 2,354,946 45,501,818 2,322,947 Less: weighted average shares subject to repurchase (10,506 ) (25,861 ) (11,957 ) (18,860 ) Weighted average number of shares used in basic and diluted net loss per share 48,674,238 2,329,085 45,489,861 2,304,087 Net loss per share, basic and diluted $ (0.75 ) $ (10.89 ) $ (1.64 ) $ (19.91 ) Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. The following weighted-average outstanding common stock equivalents were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive. June 30, 2019 2018 Series A convertible preferred stock — 2,863,990 Series B convertible preferred stock — 8,172,579 Series C convertible preferred stock — 8,996,586 Series D convertible preferred stock — 6,154,166 Warrants to purchase common stock 123,637 53,458 Common stock subject to repurchase 8,707 38,976 Options and RSUs issued and outstanding 6,723,332 4,470,054 Total potential common shares excluded from the computation of diluted net loss per share 6,855,676 30,749,809 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation —The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The condensed balance sheet as of June 30, 2019 , the condensed statements of operations and comprehensive loss for the three and six months ended June 30, 2019 and 2018 , the condensed statements of convertible preferred stock and stockholders' equity (deficit) for the three and six months ended June 30, 2019 and 2018 and the condensed statements of cash flows for the six months ended June 30, 2019 and 2018 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The condensed balance sheet at December 31, 2018 has been derived from audited financial statements. |
Leases | Leases —The Company determines if an arrangement contains a lease at inception. For arrangements where the Company is the lessee, operating leases are included in operating lease right-of-use (ROU) assets; current operating lease liabilities; and non-current operating lease liabilities on its condensed balance sheets. The Company currently does not have any finance leases. 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 the commencement date. ROU assets also include any initial direct costs incurred and any lease payments made on or before the lease commencement date, less lease incentives received. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company’s leases generally do not provide an implicit rate. The Company considered information available at the adoption date of Topic 842 to determine the incremental borrowing rate for leases in existence as of this date. Lease terms may include options to extend or terminate the lease when the Company is reasonably certain that the option will be exercised. Lease expense is recognized on a straight-line basis over the lease term. The Company elected to apply each of the practical expedients described in Accounting Standards Codification (ASC) Topic 842-10-65-1(f) which allow companies not to reassess: (i) whether any expired or existing agreements contain leases, (ii) the classification of any expired or existing leases, and (iii) the capitalization of initial direct costs for any existing leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for short-term operating leases. A short-term is a lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Adopted Standards In February 2016, the Financial Accounting Standards Board (FASB) issued Topic 842, which amended prior accounting standards for leases. The Company adopted Topic 842 on January 1, 2019, using the alternative modified transition method, which applies the standard as of the effective date and therefore, the Company has not applied the standard to the comparative periods presented on the Company's condensed financial statements . The Company elected the following practical expedients when assessing the transition impact available to lessees: (i) not to reassess whether any expired or existing contracts as of January 1, 2019, are or contain leases; (ii) not to reassess the lease classification for any expired or existing leases as of January 1, 2019; and (iii) not to reassess initial direct costs for any existing leases as of January 1, 2019. As a lessee, the primary impact for the Company was the recognition of operating lease ROU assets of $2.3 million and operating lease liabilities of $2.5 million on its condensed balance sheet as of January 1, 2019. See Note 4 " Leases " for additional details. Standards Not Yet Effective In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326) : Measurement of Credit Losses on Financial Instruments (ASU 2016-13). ASU 2016-13 implements an impairment model, known as the current expected credit loss model, based on expected losses rather than incurred losses. Under the new guidance, an entity will recognize, as an allowance, its estimate of expected credit losses. The ASU is effective for interim and annual periods beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption of ASU 2016-13 to have a material impact on its financial statements. In September 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 amends ASC Topic 820, Fair Value Measurement . The FASB issued final guidance that eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. Under the ASU, entities will no longer be required to disclose the amount of transfers between Level 1 and Level 2 of the fair value hierarchy. Public companies will be required to disclose changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. ASU No. 2018-13 is effective for public business entities for annual reporting periods, and interim periods within those annual periods, beginning after December 15, 2019. Early adoption will be permitted in any interim or annual period. The Company plans to adopt this guidance on January 1, 2020. The new guidance only affects disclosures in the notes to the financial statements and will not affect the Company's financial statements. |
FAIR VALUE MEASUREMENTS AND F_2
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIALINSTRUMENTS (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Cash and financial assets remeasured on a recurring basis by hierarchy | The following tables set forth the fair value of the Company's cash and financial assets remeasured on a recurring basis based on the three-tier fair value hierarchy by significant investment category as of June 30, 2019 and December 31, 2018 . June 30, 2019 Reported as: (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Short-Term Investments Long-Term Investments Cash $ 1,592 $ — $ — $ 1,592 $ 1,592 $ — $ — Level 1: Money market fund 17,958 — — 17,958 17,958 — — Level 2: U.S. government agency securities 1,000 — (1 ) 999 — — 999 Commercial paper 168,214 280 — 168,494 — 168,494 — Corporate debt securities 164,255 294 (6 ) 164,543 5,247 148,798 10,498 Asset-backed securities 51,683 62 — 51,745 — 51,745 — Subtotal 385,152 636 (7 ) 385,781 5,247 369,037 11,497 Total assets measured at fair value $ 404,702 $ 636 $ (7 ) $ 405,331 $ 24,797 $ 369,037 $ 11,497 December 31, 2018 Reported as: (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Short-Term Investments Long-Term Investments Cash $ 3,021 $ — $ — $ 3,021 $ 3,021 $ — $ — Level 1: Money market fund 33,154 — — 33,154 33,154 — — Level 2: Commercial paper 68,467 — (63 ) 68,404 997 67,407 — Corporate debt securities 89,038 4 (63 ) 88,979 — 86,692 2,287 Asset-backed securities 49,838 3 (34 ) 49,807 — 49,807 — Subtotal 207,343 7 (160 ) 207,190 997 203,906 2,287 Total assets measured at fair value $ 243,518 $ 7 $ (160 ) $ 243,365 $ 37,172 $ 203,906 $ 2,287 |
Available-for-sale investment in a continuous unrealized loss position but not deemed OTTI | The following table summarizes the Company's available-for-sale investments that were in a continuous unrealized loss position but were not deemed to be other-than-temporarily impaired, as of June 30, 2019 and December 31, 2018 . June 30, 2019 December 31, 2018 (in thousands) Fair Value Unrealized Losses Fair Value Unrealized Losses U.S. government agency securities $ 999 $ (1 ) $ — $ — Commercial paper — — 67,407 (63 ) Corporate debt securities 9,251 (6 ) 85,699 (63 ) Asset-backed securities — — 36,730 (34 ) Total $ 10,250 $ (7 ) $ 189,836 $ (160 ) |
Maturities of cash equivalents and available-for-sale investments | The following table summarizes the maturities of the Company’s cash equivalents (excluding money market funds) and available-for-sale investments, as of June 30, 2019 . (in thousands) Amortized Cost Fair Value Mature in less than one year $ 373,673 $ 374,284 Mature in one to five years 11,479 11,497 Total $ 385,152 $ 385,781 |
Reconciliation of liabilities using Level 3 unobservable inputs | The following table presents a reconciliation of financial liabilities measured at fair value on a recurring basis using Level 3 unobservable inputs for the six months ended June 30, 2019 and 2018 . Six Months Ended June 30, 2019 2018 (in thousands) Compound Derivative Liability Compound Derivative Liability Warrant Liability Fair value at beginning of period $ 161 $ — $ 106 Additions — 654 156 Change in fair value 165 (541 ) 305 Reclassification to equity — — (194 ) Issuance of convertible preferred stock on exercise of warrant — — (373 ) Fair value at end of period $ 326 $ 113 $ — |
Significant fair value unobservable inputs | The following table presents information about significant unobservable inputs related to the Company's Level 3 financial liabilities as of June 30, 2019 . June 30, 2019 (in thousands) Fair Value Valuation Technique Significant Unobservable Input Range of Inputs Compound derivative liability $ 326 Discounted cash flow Discount rate 10.5 % - 11.5 % Probability of the occurrence of certain events 10.0 % |
LEASES (Tables)
LEASES (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Supplemental balance sheet information related to leases | The following table presents supplemental balance sheet information related to operating leases as of June 30, 2019 . (in thousands, except lease term and discount rate) June 30, 2019 Operating lease right-of-use assets $ 1,843 Operating lease liabilities: Current operating lease liabilities 1,046 Non-current operating lease liabilities 994 Total operating lease liabilities $ 2,040 Weighted average remaining lease term 2.0 years Weighted average discount rate 8.0 % |
Operating lease maturity schedule | The following table presents the maturities of the Company's operating lease liabilities as of June 30, 2019 . (in thousands) June 30, 2019 2019 (remaining six months) $ 546 2020 1,108 2021 562 Total lease payments 2,216 Less: imputed interest (176 ) Total operating lease liabilities $ 2,040 |
Operating lease maturity schedule under prior guidance | The following table presents the future minimum lease commitments under the Company’s operating leases as of December 31, 2018, as previously disclosed. (in thousands) December 31, 2018 2019 $ 1,076 2020 1,108 2021 562 2022 and thereafter — Total future minimum lease payments $ 2,746 |
OTHER BALANCE SHEET COMPONENTS
OTHER BALANCE SHEET COMPONENTS (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Property and Equipment, Net | The following table presents the components of property and equipment, net as of June 30, 2019 and December 31, 2018 . (in thousands) June 30, December 31, Furniture and fixtures $ 193 $ 193 Computer and lab equipment 2,898 1,888 Leasehold improvements 1,063 1,055 4,154 3,136 Less: accumulated depreciation and amortization (2,262 ) (1,921 ) Total property and equipment, net $ 1,892 $ 1,215 |
Schedule of Accrued Expenses and Other Current Liabilities | The following table presents the components of accrued expenses and other current liabilities as of June 30, 2019 and December 31, 2018 . (in thousands) June 30, December 31, Accrued clinical and nonclinical study costs $ 6,674 $ 2,168 Accrued contract manufacturing 11,077 1,676 Accrued compensation 2,368 1,565 Accrued professional fees and other 2,177 935 Total accrued expenses and other current liabilities $ 22,296 $ 6,344 |
BORROWINGS (Tables)
BORROWINGS (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Future Payments of Principal and Interest | The following table presents future payments of principal and interest on the Term Loan as of June 30, 2019 . (in thousands) June 30, 2019 2019 (remaining six months) $ 1,698 2020 3,396 2021 14,173 2022 20,403 2023 16,282 55,952 Less: amount representing interest (15,952 ) Present value of Term Loan 40,000 Less: current portion — Long-term portion of Term Loan $ 40,000 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | Common stock reserved for future issuance as of June 30, 2019 and December 31, 2018 , consisted of the following. June 30, December 31, Stock options and RSUs issued and outstanding 6,723,332 4,599,307 Stock options, RSUs and ESPP shares authorized for future issuance 3,829,972 4,534,784 Total 10,553,304 9,134,091 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Basic and diluted net loss per share | The following table sets forth the computation of the basic and diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2019 and 2018 . Three Months Ended Six Months Ended (In thousands, except share and per share amounts) 2019 2018 2019 2018 Numerator: Net loss $ (36,626 ) $ (25,362 ) $ (74,523 ) $ (45,866 ) Denominator: Weighted average common shares outstanding 48,684,744 2,354,946 45,501,818 2,322,947 Less: weighted average shares subject to repurchase (10,506 ) (25,861 ) (11,957 ) (18,860 ) Weighted average number of shares used in basic and diluted net loss per share 48,674,238 2,329,085 45,489,861 2,304,087 Net loss per share, basic and diluted $ (0.75 ) $ (10.89 ) $ (1.64 ) $ (19.91 ) |
Antidilutive securities excluded from computation | The following weighted-average outstanding common stock equivalents were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive. June 30, 2019 2018 Series A convertible preferred stock — 2,863,990 Series B convertible preferred stock — 8,172,579 Series C convertible preferred stock — 8,996,586 Series D convertible preferred stock — 6,154,166 Warrants to purchase common stock 123,637 53,458 Common stock subject to repurchase 8,707 38,976 Options and RSUs issued and outstanding 6,723,332 4,470,054 Total potential common shares excluded from the computation of diluted net loss per share 6,855,676 30,749,809 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Recent accounting pronouncements (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 |
Accounting Policies [Abstract] | ||
Operating lease right-of-use assets | $ 1,843 | $ 2,300 |
Total operating lease liabilities | $ 2,040 | $ 2,500 |
FAIR VALUE MEASUREMENTS AND F_3
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS - Additional information (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019USD ($)Position | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($)Position | Jun. 30, 2018USD ($) | Dec. 31, 2018Position | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Investment interest income | $ 2,700,000 | $ 400,000 | $ 4,200,000 | $ 600,000 | |
Gross realized gains and gross realized losses on Available-for-sale securities | $ 0 | $ 0 | $ 0 | ||
Debt instruments held in continuous unrealized loss position | Position | 4 | 4 | 48 | ||
Discount Rate | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Derivative liability, measurement input | 0.110 | 0.110 | |||
Term Loan | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Debt instrument, fair value | $ 40,600,000 | $ 40,600,000 | |||
Minimum | Discount Rate | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Derivative liability, measurement input | 0.105 | 0.105 | |||
Maximum | Discount Rate | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Derivative liability, measurement input | 0.115 | 0.115 |
FAIR VALUE MEASUREMENTS AND F_4
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS - Marketable securities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Debt Securities, Available-for-sale [Line Items] | ||
Cash | $ 24,797 | $ 37,172 |
Level 2: | ||
Short-term investments | 369,037 | 203,906 |
Long-term investments | 11,497 | 2,287 |
Fair Value, Measurements, Recurring | ||
Total assets measured at fair value | ||
Amortized Cost | 404,702 | 243,518 |
Gross Unrealized Gains | 636 | 7 |
Gross Unrealized Losses | (7) | (160) |
Total assets measured at fair value | 405,331 | 243,365 |
Cash | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash | 1,592 | 3,021 |
Cash and Cash Equivalents | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash | 24,797 | 37,172 |
Cash and Cash Equivalents | Cash | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash | 1,592 | 3,021 |
Level 1: | ||
Money market fund | 1,592 | 3,021 |
Short-term Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Short-term investments | 369,037 | 203,906 |
Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Long-term investments | 11,497 | 2,287 |
Level 1 | Money market fund | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash | 17,958 | 33,154 |
Level 1: | ||
Money market fund | 17,958 | 33,154 |
Level 1 | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash | 17,958 | 33,154 |
Level 2 | ||
Level 2: | ||
Gross Unrealized Losses | (7) | (160) |
Level 2 | U.S. government agency securities | ||
Level 2: | ||
Gross Unrealized Losses | (1) | 0 |
Level 2 | Commercial paper | ||
Level 2: | ||
Gross Unrealized Losses | 0 | (63) |
Level 2 | Corporate debt securities | ||
Level 2: | ||
Gross Unrealized Losses | (6) | (63) |
Level 2 | Asset-backed securities | ||
Level 2: | ||
Gross Unrealized Losses | 0 | (34) |
Level 2 | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Amortized Cost | 385,152 | 207,343 |
Gross Unrealized Gains | 636 | 7 |
Gross Unrealized Losses | (7) | (160) |
Estimated Fair Value | 385,781 | 207,190 |
Level 2 | Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Level 2: | ||
Amortized Cost | 1,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (1) | |
Estimated Fair Value | 999 | |
Level 2 | Fair Value, Measurements, Recurring | Commercial paper | ||
Level 2: | ||
Amortized Cost | 168,214 | 68,467 |
Gross Unrealized Gains | 280 | 0 |
Gross Unrealized Losses | 0 | (63) |
Estimated Fair Value | 168,494 | 68,404 |
Level 2 | Fair Value, Measurements, Recurring | Corporate debt securities | ||
Level 2: | ||
Amortized Cost | 164,255 | 89,038 |
Gross Unrealized Gains | 294 | 4 |
Gross Unrealized Losses | (6) | (63) |
Estimated Fair Value | 164,543 | 88,979 |
Level 2 | Fair Value, Measurements, Recurring | Asset-backed securities | ||
Level 2: | ||
Amortized Cost | 51,683 | 49,838 |
Gross Unrealized Gains | 62 | 3 |
Gross Unrealized Losses | 0 | (34) |
Estimated Fair Value | 51,745 | 49,807 |
Level 2 | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Estimated Fair Value | 5,247 | 997 |
Level 2 | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Level 2: | ||
Estimated Fair Value | 0 | |
Level 2 | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | Commercial paper | ||
Level 2: | ||
Estimated Fair Value | 0 | 997 |
Level 2 | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | Corporate debt securities | ||
Level 2: | ||
Estimated Fair Value | 5,247 | 0 |
Level 2 | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | Asset-backed securities | ||
Level 2: | ||
Estimated Fair Value | 0 | 0 |
Level 2 | Short-term Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Short-term investments | 369,037 | 203,906 |
Level 2 | Short-term Investments | Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Level 2: | ||
Short-term investments | 0 | |
Level 2 | Short-term Investments | Fair Value, Measurements, Recurring | Commercial paper | ||
Level 2: | ||
Short-term investments | 168,494 | 67,407 |
Level 2 | Short-term Investments | Fair Value, Measurements, Recurring | Corporate debt securities | ||
Level 2: | ||
Short-term investments | 148,798 | 86,692 |
Level 2 | Short-term Investments | Fair Value, Measurements, Recurring | Asset-backed securities | ||
Level 2: | ||
Short-term investments | 51,745 | 49,807 |
Level 2 | Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Long-term investments | 11,497 | 2,287 |
Level 2 | Investments | Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Level 2: | ||
Long-term investments | 999 | |
Level 2 | Investments | Fair Value, Measurements, Recurring | Commercial paper | ||
Level 2: | ||
Long-term investments | 0 | 0 |
Level 2 | Investments | Fair Value, Measurements, Recurring | Corporate debt securities | ||
Level 2: | ||
Long-term investments | 10,498 | 2,287 |
Level 2 | Investments | Fair Value, Measurements, Recurring | Asset-backed securities | ||
Level 2: | ||
Long-term investments | $ 0 | $ 0 |
FAIR VALUE MEASUREMENTS AND F_5
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS - Available-for-sale investments in continuous unrealized loss position not deemed to be OTTI (Details) - Level 2 - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair Value | $ 10,250 | $ 189,836 |
Unrealized Losses | (7) | (160) |
U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair Value | 999 | 0 |
Unrealized Losses | (1) | 0 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 67,407 |
Unrealized Losses | 0 | (63) |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair Value | 9,251 | 85,699 |
Unrealized Losses | (6) | (63) |
Asset-backed securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair Value | 0 | 36,730 |
Unrealized Losses | $ 0 | $ (34) |
FAIR VALUE MEASUREMENTS AND F_6
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS - Maturities of cash equivalents and available-for-sale investments (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Amortized Cost | |
Mature in less than one year | $ 373,673 |
Mature in one to five years | 11,479 |
Total | 385,152 |
Fair Value | |
Mature in less than one year | 374,284 |
Mature in one to five years | 11,497 |
Total | $ 385,781 |
FAIR VALUE MEASUREMENTS AND F_7
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS - Reconciliation of liabilities measured using Level 3 (Details) - Level 3 - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Compound Derivative | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value at beginning of period | $ 161 | $ 0 |
Addition | 0 | 654 |
Change in fair value | 165 | (541) |
Reclassification to equity | 0 | 0 |
Issuance of convertible preferred stock on exercise of warrant | 0 | 0 |
Fair value at end of period | $ 326 | 113 |
Warrant Liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value at beginning of period | 106 | |
Addition | 156 | |
Change in fair value | 305 | |
Reclassification to equity | (194) | |
Issuance of convertible preferred stock on exercise of warrant | (373) | |
Fair value at end of period | $ 0 |
FAIR VALUE MEASUREMENTS AND F_8
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS - Significant unobservable inputs related to level 3 assets and liabilities (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Discount Rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Derivative liability, measurement input | 0.110 |
Measurement Input, Probability Of Occurrence Of Certain Events | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Derivative liability, measurement input | 0.100 |
Level 3 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Compound derivative liability | $ 326 |
Level 3 | Measurement Input, Probability Of Occurrence Of Certain Events | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Derivative liability, measurement input | 0.100 |
Minimum | Level 3 | Discount Rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Derivative liability, measurement input | 0.105 |
Maximum | Level 3 | Discount Rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Derivative liability, measurement input | 0.115 |
LEASES - Information related to
LEASES - Information related to operating lease cost (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Leases [Abstract] | ||
Operating lease expense | $ 0.3 | $ 0.5 |
Cash paid within operating cash flows for the three months ended March 31, 2019 | $ 0.5 |
LEASES - Supplemental balance s
LEASES - Supplemental balance sheet information regarding operating leases (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 |
Assets | ||
Operating lease right-of-use assets | $ 1,843 | $ 2,300 |
Operating lease liabilities: | ||
Current operating lease liabilities | 1,046 | |
Non-current operating lease liabilities | 994 | |
Total operating lease liabilities | $ 2,040 | $ 2,500 |
Weighted average remaining lease term | 2 years | |
Weighted average discount rate | 8.00% |
LEASES - Operating lease schedu
LEASES - Operating lease schedule of maturity (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 |
Leases [Abstract] | ||
2019 (remaining six months) | $ 546 | |
2020 | 1,108 | |
2021 | 562 | |
Total lease payments | 2,216 | |
Less: imputed interest | (176) | |
Total operating lease liabilities | $ 2,040 | $ 2,500 |
LEASES - Operating lease sche_2
LEASES - Operating lease schedule of maturity under previous guidance (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 1,076 |
2020 | 1,108 |
2021 | 562 |
2022 and thereafter | 0 |
Total future minimum lease payments | $ 2,746 |
OTHER BALANCE SHEET COMPONENT_2
OTHER BALANCE SHEET COMPONENTS - Property and equipment, net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 4,154 | $ 4,154 | $ 3,136 | ||
Less: accumulated depreciation and amortization | (2,262) | (2,262) | (1,921) | ||
Total property and equipment, net | 1,892 | 1,892 | 1,215 | ||
Depreciation and amortization expense | 200 | $ 100 | 341 | $ 280 | |
Furniture and fixtures | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 193 | 193 | 193 | ||
Computer and lab equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 2,898 | 2,898 | 1,888 | ||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 1,063 | $ 1,063 | $ 1,055 |
OTHER BALANCE SHEET COMPONENT_3
OTHER BALANCE SHEET COMPONENTS - Accrued expense and other current liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued clinical and nonclinical study costs | $ 6,674 | $ 2,168 |
Accrued contract manufacturing | 11,077 | 1,676 |
Accrued compensation | 2,368 | 1,565 |
Accrued professional fees and other | 2,177 | 935 |
Total accrued expenses and other current liabilities | $ 22,296 | $ 6,344 |
BORROWINGS - Additional informa
BORROWINGS - Additional information (Details) | Mar. 27, 2019USD ($)$ / sharesshares | Jun. 30, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 28, 2018USD ($)$ / sharesshares | Oct. 15, 2018USD ($)tranche | Jul. 02, 2018$ / shares | Jun. 16, 2018shares | Apr. 10, 2018USD ($) | Feb. 28, 2018USD ($)tranche$ / sharesshares | Dec. 31, 2013$ / shares |
Debt Instrument [Line Items] | ||||||||||
Long-term portion of Term Loan | $ 37,463,000 | $ 38,071,000 | ||||||||
Number of shares called by warrant (in shares) | shares | 95,936 | |||||||||
Exercise price of warrant (in USD per share) | $ / shares | $ 0.886 | |||||||||
Percentage of principal | 1.00% | |||||||||
Contractual life of warrant | 7 years | |||||||||
Term Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt aggregate principal amount | $ 100,000,000 | $ 100,000,000 | ||||||||
Debt, number of tranches | tranche | 5 | 5 | ||||||||
Long-term portion of Term Loan | $ 40,000,000 | |||||||||
Debt payment terms, multiplier | 7.55% | |||||||||
Number of shares called by warrant (in shares) | shares | 53,458 | |||||||||
Exercise price of warrant (in USD per share) | $ / shares | $ 9.35 | |||||||||
Estimated fair value of warrants | $ 200,000 | |||||||||
Increase (decrease) in equity due to warrants | $ 900,000 | $ 200,000 | ||||||||
Fair value of embedded derivative liability | $ 300,000 | $ 700,000 | ||||||||
Unamortized issuance costs and debt discounts | $ 3,800,000 | $ 2,700,000 | ||||||||
Term Loan | Minimum | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt prepayment fee, percentage | 2.00% | |||||||||
Term Loan | Tranche one | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt aggregate principal amount | 25,000,000 | |||||||||
Term Loan | Tranche two | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt aggregate principal amount | $ 15,000,000 | $ 25,000,000 | ||||||||
Number of shares called by warrant (in shares) | shares | 53,458 | |||||||||
Exercise price of warrant (in USD per share) | $ / shares | $ 9.35 | |||||||||
New Term Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Maximum borrowing capacity of term loan | $ 200,000,000 | |||||||||
Term of principal and interest payments | 30 months | |||||||||
One time payment of principal | $ 2,600,000 | |||||||||
Debt prepayment fee, percentage year two | 1.50% | |||||||||
Debt prepayment fee, percentage year three | 1.00% | |||||||||
Debt prepayment fee, percentage after year three | 0.00% | |||||||||
New Term Loan | Maximum | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Extended period for payment of interest only | 24 months | |||||||||
New Term Loan | Tranche one | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt aggregate principal amount | $ 20,000,000 | |||||||||
New Term Loan | Tranche two | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt aggregate principal amount | 15,000,000 | |||||||||
New Term Loan | Tranche three | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt aggregate principal amount | 75,000,000 | |||||||||
New Term Loan | Tranche four | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt aggregate principal amount | $ 50,000,000 | |||||||||
Third Amendment to Term Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Number of shares called by warrant (in shares) | shares | 16,721 | |||||||||
Exercise price of warrant (in USD per share) | $ / shares | $ 23.92 | |||||||||
Increase (decrease) in equity due to warrants | $ 300,000 | |||||||||
Floating variable rate 1 | Term Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt interest rate | 8.35% | |||||||||
Floating variable rate 2 | Term Loan | Prime rate | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt, basis spread on variable rate | 8.35% | |||||||||
Floating variable rate 2 | New Term Loan | Prime rate | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt, basis spread on adjusted variable rate | 6.00% | |||||||||
Floating variable rate 3 | Term Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt interest rate | 9.85% | |||||||||
Time To Liquidity | Third Amendment to Term Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Measurement input, time to liquidity | 7 years | |||||||||
Volatility | Third Amendment to Term Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants measurement input | 0.750 | |||||||||
Risk-free interest rate | Third Amendment to Term Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants measurement input | 0.023 | |||||||||
Discount Rate | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Derivative liability, measurement input | 0.110 | |||||||||
Measurement Input, Probability Of Occurrence Of Certain Events | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Derivative liability, measurement input | 0.100 | |||||||||
IPO | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Share price (in USD per share) | $ / shares | $ 19 |
BORROWINGS - Debt maturity sche
BORROWINGS - Debt maturity schedule (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Debt Disclosure [Abstract] | |
2019 (remaining six months) | $ 1,698 |
2020 | 3,396 |
2021 | 14,173 |
2022 | 20,403 |
2023 | 16,282 |
Long-term debt including interest payable | 55,952 |
Less: amount representing interest | (15,952) |
Present value of Term Loan | 40,000 |
Less: current portion | 0 |
Long-term portion of Term Loan | $ 40,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) $ in Millions | May 08, 2018USD ($) | Jun. 30, 2019USD ($) | Aug. 31, 2017ft² | Jul. 31, 2014 |
Debt Instrument [Line Items] | ||||
Operating lease, term | 5 years | |||
Operating lease renewal term | 3 years | |||
Purchase obligation | $ | $ 134.2 | $ 117.7 | ||
Payment of long-term purchase commitment | $ | 16.5 | |||
Purchase obligation term | 36 months | |||
Tenant Improvement Loan | ||||
Debt Instrument [Line Items] | ||||
Tenant improvement loan, remaining payments | $ | $ 0.2 | |||
Subject to Operating Lease | ||||
Debt Instrument [Line Items] | ||||
Lease rentable area (in square feet) | ft² | 13,258 | |||
Amended Lease | Subject to Operating Lease | ||||
Debt Instrument [Line Items] | ||||
Lease rentable area (in square feet) | ft² | 26,987 | |||
Second Amendment To Lease | Subject to Operating Lease | ||||
Debt Instrument [Line Items] | ||||
Lease rentable area (in square feet) | ft² | 26,897 |
STOCKHOLDERS' EQUITY - Addition
STOCKHOLDERS' EQUITY - Additional information (Details) $ / shares in Units, $ in Millions | Apr. 08, 2019USD ($)$ / sharesshares | Jul. 02, 2018USD ($)$ / sharesshares | Jun. 14, 2018 | Jun. 30, 2019$ / sharesshares | Dec. 31, 2018$ / sharesshares |
Class of Stock [Line Items] | |||||
Total number of shares authorized for issue (in shares) | 440,000,000 | ||||
Common stock, shares authorized (in shares) | 400,000,000 | 400,000,000 | 400,000,000 | ||
Common stock, par value (in USD per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||
Preferred stock, shares authorized (in shares) | 40,000,000 | 40,000,000 | 40,000,000 | ||
Preferred stock, par value (in USD per share) | $ / shares | $ 0.001 | $ 1 | $ 1 | ||
Common stock, shares outstanding (in shares) | 49,276,445 | 42,148,247 | |||
Preferred stock, outstanding (in shares) | 0 | 0 | |||
Number of common stock issued upon conversion (in shares) | 26,187,321 | ||||
Reserve stock split ratio | 0.2513 | ||||
IPO | |||||
Class of Stock [Line Items] | |||||
Number of common stock issued (in shares) | 13,455,000 | ||||
Share price (in USD per share) | $ / shares | $ 19 | ||||
Proceeds from initial public offering, net of issuance costs | $ | $ 237.7 | ||||
Underwriting discounts and commissions | $ | $ 17.9 | ||||
Underwritten Public Offering | |||||
Class of Stock [Line Items] | |||||
Number of common stock issued (in shares) | 6,440,000 | ||||
Share price (in USD per share) | $ / shares | $ 36 | ||||
Proceeds from initial public offering, net of issuance costs | $ | $ 217.9 | ||||
Underwriting discounts and commissions | $ | $ 13.9 | ||||
Over-Allotment Option | |||||
Class of Stock [Line Items] | |||||
Number of common stock issued (in shares) | 840,000 | ||||
Convertible Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Convertible preferred stock, shares outstanding (in shares) | 104,225,638 |
STOCKHOLDERS' EQUITY - Common s
STOCKHOLDERS' EQUITY - Common stock (Details) - shares | Jun. 30, 2019 | Dec. 31, 2018 |
Equity [Abstract] | ||
Stock options and RSUs issued and outstanding (in shares) | 6,723,332 | 4,599,307 |
Stock options, RSUs and ESPP shares authorized for future issuance (in shares) | 3,829,972 | 4,534,784 |
Total (in shares) | 10,553,304 | 9,134,091 |
NET LOSS PER SHARE - Basic and
NET LOSS PER SHARE - Basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Numerator: | ||||||
Net loss | $ (36,626) | $ (37,897) | $ (25,362) | $ (20,504) | $ (74,523) | $ (45,866) |
Denominator: | ||||||
Weighted average common shares outstanding (in shares) | 48,684,744 | 2,354,946 | 45,501,818 | 2,322,947 | ||
Less: weighted average shares subject to repurchase (in shares) | (10,506) | (25,861) | (11,957) | (18,860) | ||
Weighted-average number of shares used in basic and diluted net loss per share (in shares) | 48,674,238 | 2,329,085 | 45,489,861 | 2,304,087 | ||
Net loss per share, basic and diluted (in USD per share) | $ (0.75) | $ (10.89) | $ (1.64) | $ (19.91) |
NET LOSS PER SHARE - Antidiluti
NET LOSS PER SHARE - Antidilutive securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 6,855,676 | 30,749,809 |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 123,637 | 53,458 |
Common stock subject to repurchase | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 8,707 | 38,976 |
Options and RSUs issued and outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 6,723,332 | 4,470,054 |
Series A convertible preferred stock | Convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 0 | 2,863,990 |
Series B convertible preferred stock | Convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 0 | 8,172,579 |
Series C convertible preferred stock | Convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 0 | 8,996,586 |
Series D convertible preferred stock | Convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 0 | 6,154,166 |