Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 06, 2020 | Jun. 28, 2019 | |
Cover page. | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | REGULUS THERAPEUTICS INC. | ||
Entity Central Index Key | 0001505512 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Voluntary Filer | No | ||
Entity Well-known seasoned issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 24.3 | ||
Entity Common Stock, Shares Outstanding | 21,040,118 | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Interactive Data Current | Yes |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 34,121 | $ 13,935 |
Contract and other receivables | 1,141 | 26 |
Prepaid materials, net | 3,924 | 4,194 |
Prepaid expenses and other current assets | 1,221 | 1,140 |
Total current assets | 40,407 | 19,295 |
Property and equipment, net | 921 | 7,806 |
Intangibles, net | 266 | 500 |
Other assets | 487 | 326 |
Total assets | 42,081 | 27,927 |
Current liabilities: | ||
Accounts payable | 1,321 | 1,714 |
Accrued liabilities | 917 | 1,625 |
Accrued compensation | 1,676 | 1,601 |
Current portion of term loan, less debt issuance costs | 14,631 | 16,575 |
Current portion of contract liabilities | 6 | 2,572 |
Other current liabilities | 3,047 | 2,559 |
Total current liabilities | 21,598 | 26,646 |
Contract liabilities, less current portion | 0 | 6 |
Deferred rent, less current portion | 0 | 6,820 |
Other long-term liabilities | 468 | 309 |
Total liabilities | 22,066 | 33,781 |
Stockholders’ equity (deficit): | ||
Common stock, $0.001 par value; 200,000,000 shares authorized, 21,018,663 and 8,818,019 shares issued and outstanding at December 31, 2019 and 2018, respectively | 21 | 9 |
Additional paid-in capital | 431,305 | 386,860 |
Accumulated deficit | (411,315) | (392,723) |
Total stockholders’ equity (deficit) | 20,015 | (5,854) |
Total liabilities and stockholders’ equity (deficit) | 42,081 | 27,927 |
Class A-1 Convertible Preferred Stock | ||
Stockholders’ equity (deficit): | ||
Convertible preferred stock | 1 | 0 |
Class A-2 Convertible Preferred Stock | ||
Stockholders’ equity (deficit): | ||
Convertible preferred stock | $ 3 | $ 0 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 21,018,663 | 8,818,019 |
Common stock, shares outstanding | 21,018,663 | 8,818,019 |
Class A-1 Convertible Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 415,898 | 0 |
Preferred stock, shares issued | 415,898 | 0 |
Preferred stock, shares outstanding | 415,898 | 0 |
Class A-2 Convertible Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 3,288,390 | 0 |
Preferred stock, shares issued | 3,288,390 | 0 |
Preferred stock, shares outstanding | 3,288,390 | 0 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | ||
Total revenues | $ 6,832 | $ 72 |
Operating expenses: | ||
Research and development | 12,349 | 33,975 |
General and administrative | 11,317 | 12,860 |
Total operating expenses | 23,666 | 46,835 |
Loss from operations | (16,834) | (46,763) |
Other income (expense): | ||
Interest and other income | 374 | 459 |
Interest and other expense | (2,131) | (2,343) |
Loss before income taxes | (18,591) | (48,647) |
Income tax expense | (1) | (62) |
Net loss and comprehensive net loss | $ (18,592) | $ (48,709) |
Net loss per share - basic and diluted (in dollars per share) | $ (1.08) | $ (5.59) |
Weighted average shares used to compute basic and diluted net loss per share (in shares) | 17,260,176 | 8,718,563 |
Revenue under collaborations | ||
Revenues: | ||
Total revenues | $ 6,832 | $ 72 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive income (loss) | Accumulated deficit | Convertible Preferred Stock |
Beginning balance (in shares) at Dec. 31, 2017 | 8,662,435 | |||||
Beginning balance at Dec. 31, 2017 | $ 35,216 | $ 9 | $ 381,199 | $ (134) | $ (345,858) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options (in shares) | 328 | |||||
Issuance of common stock upon exercise of options | 1 | 1 | ||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 128,840 | |||||
Stock-based compensation expense | 5,441 | 5,441 | ||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 26,416 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 219 | 219 | ||||
Unrealized gain on short-term investments | 134 | 134 | ||||
Net loss | (48,709) | (48,709) | ||||
Ending balance (in shares) at Dec. 31, 2018 | 8,818,019 | |||||
Ending balance at Dec. 31, 2018 | (5,854) | $ 9 | 386,860 | 0 | (392,723) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon exercise of options (in shares) | 2,750 | |||||
Issuance of common stock upon exercise of options | 3 | 3 | ||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 559,445 | |||||
Stock-based compensation expense | 2,288 | 2,288 | ||||
Issuance of common stock, preferred stock and warrants from private placement, net of offering costs (in shares) | 9,730,534 | 3,704,288 | ||||
Issuance of common stock, preferred stock and warrants from private placement, net of offering costs | 40,084 | $ 10 | 40,070 | $ 4 | ||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 4,035 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 3 | 3 | ||||
Issuance of common stock, net of $292 of offering costs (in shares) | 1,903,880 | |||||
Issuance of common stock through ATM | 2,083 | $ 2 | 2,081 | |||
Net loss | (18,592) | (18,592) | ||||
Ending balance (in shares) at Dec. 31, 2019 | 21,018,663 | 3,704,288 | ||||
Ending balance at Dec. 31, 2019 | $ 20,015 | $ 21 | $ 431,305 | $ 0 | $ (411,315) | $ 4 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities | ||
Net loss | $ (18,592) | $ (48,709) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization expense | 931 | 2,262 |
Stock-based compensation | 2,288 | 5,441 |
Amortization of premium on investments, net | 0 | 148 |
Gain on reduction of lease liability | 1,839 | 0 |
Other | 293 | 756 |
Change in operating assets and liabilities: | ||
Contracts and other receivables | (1,115) | 347 |
Prepaid materials | 270 | 134 |
Prepaid expenses and other assets | (242) | 630 |
Accounts payable | (393) | (4,029) |
Accrued liabilities | (708) | (1,370) |
Accrued compensation | 75 | (384) |
Contract liabilities | (2,572) | 2,428 |
Deferred rent | 0 | (1,252) |
Other liabilities | (1,895) | 325 |
Net cash used in operating activities | (19,821) | (43,273) |
Investing activities | ||
Purchases of short-term investments | 0 | 0 |
Sales and maturities of short-term investments | 0 | 46,541 |
Purchases of property and equipment | (221) | (22) |
Sales of property and equipment | 318 | 0 |
Acquisition of intangibles | (23) | 0 |
Net cash provided by investing activities | 74 | 46,519 |
Financing activities | ||
Proceeds from issuance of securities through private placement, net of issuance costs | 40,084 | 0 |
Proceeds from issuance of common stock, net | 2,086 | 219 |
Proceeds from exercise of common stock options | 3 | 1 |
Proceeds from financing leases | 0 | 492 |
Payments on financing leases | (263) | (200) |
Principal payments on term loan | (1,977) | (3,342) |
Net cash provided by (used in) financing activities | 39,933 | (2,830) |
Net increase in cash and cash equivalents | 20,186 | 416 |
Cash and cash equivalents at beginning of period | 13,935 | 13,519 |
Cash and cash equivalents at end of period | 34,121 | 13,935 |
Supplemental disclosure of cash flow information | ||
Interest paid | (1,655) | (2,073) |
Income taxes paid | (1) | (1) |
Supplemental disclosure of non-cash investing and financing activities | ||
Non-cash acquisition of property and equipment | $ 3 | $ 0 |
The Business, Basis of Presenta
The Business, Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
The Business, Basis of Presentation and Summary of Significant Accounting Policies | The Business, Basis of Presentation and Summary of Significant Accounting Policies We are a biopharmaceutical company focused on discovering and developing first-in-class drugs that target microRNAs to treat a broad range of diseases. We were formed in 2007 when Alnylam and Ionis contributed significant intellectual property, know-how and financial and human capital to pursue the development of drugs targeting micro RNAs pursuant to a license and collaboration agreement. Regulus Therapeutics Inc. was converted to a Delaware corporation on January 2, 2009. As used in this report, unless the context suggests otherwise, “the Company,” “our,” “us” and “we” means Regulus Therapeutics Inc. Liquidity The accompanying financial statements have been prepared on a basis which assumes we are a going concern, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from any uncertainty related to our ability to continue as a going concern. Through the date of the issuance of these financial statements, we have principally been financed through proceeds received from the sale of our common stock and other equity securities, debt financings, up-front payments and milestones received from collaboration agreements, totaling $454.1 million . As of December 31, 2019, we had approximately $34.1 million of cash and cash equivalents. Based on our operating plans, we believe our cash and cash equivalents may not be sufficient to fund our operations for the period one year following the issuance of these financial statements. As a result, there is substantial doubt about our ability to continue as a going concern. All amounts due under the Term Loan (see note 9) have been classified as a current liability as of December 31, 2019 and 2018 due to the considerations discussed above and the assessment that the material adverse change clause under the Term Loan is not within the Company's control. We have not been notified, by the Lender, of an event of default as of the date of the filing of this Form 10-K. We intend to seek additional capital through equity and/or debt financings, collaborative or other funding arrangements with partners or through other sources of financing. Should we seek additional financing from outside sources, we may not be able to raise such financing on terms acceptable to us or at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to scale back or discontinue the advancement of product candidates, reduce headcount, file for bankruptcy, reorganize, merge with another entity, or cease operations. If we become unable to continue as a going concern, we may have to liquidate our assets, and might realize significantly less than the values at which they are carried on our financial statements, and stockholders may lose all or part of their investment in our common stock. Use of Estimates Our financial statements are prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), which requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes. An estimated loss contingency is accrued in our financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Although these estimates are based on our knowledge of current events and actions we may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Revenue Recognition Our revenues generally consist of upfront payments for licenses or options to obtain licenses in the future, milestone payments and payments for other research services under license and collaboration agreements. Effective January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) (“Topic 606”) using the modified retrospective method which consisted of applying and recognizing the cumulative effect of Topic 606 at the date of initial application. Topic 606 supersedes the revenue recognition requirements in Accounting Standards Codification (“ASC”) Topic 605, Revenue Recognition (“Topic 605”). The following paragraphs in this section describe our revenue recognition accounting polices under Topic 606 upon adoption on January 1, 2018. Refer to Note 1 to the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2017 for revenue recognition accounting policies under Topic 605. We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligation(s). At contract inception, we assess the goods or services promised within each contract, assess whether each promised good or service is distinct and identify those that are performance obligations. We recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Collaborative Arrangements We enter into collaborative arrangements with partners that typically include payment to us of one of more of the following: (i) license fees; (ii) payments related to the achievement of developmental, regulatory, or commercial milestones; and (iii) royalties on net sales of licensed products. Where a portion of non-refundable up-front fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as contract liabilities and recognized as revenue when (or as) the underlying performance obligation is satisfied. As part of the accounting for these arrangements, we must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligation(s). The stand-alone selling price may include items such as forecasted revenues, development timelines, discount rates, and probabilities of technical and regulatory success. We evaluate each performance obligation to determine if it can be satisfied at a point in time, or over time. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. License Fees If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other performance obligations, we use judgment to assess the nature of the combined performance obligation to determine whether it is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes milestone payments (variable consideration), we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price. If it is probable that a milestone event would occur at the inception of an arrangement, the associated milestone value is included in the transaction price. Milestone payments that are contingent upon the achievement of events that are uncertain or not controllable, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received, and therefore not included in the transaction price. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, we evaluate the probability of achievement of such milestones and any related constraint(s), and if necessary, may adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which could affect license, collaboration or other revenues and earnings in the period of adjustment. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, we have not recognized any royalty revenue resulting from any of our collaborative arrangements. Stock-Based Compensation We account for stock-based compensation expense related to stock options granted to employees and members of our board of directors by estimating the fair value of each stock option on the date of grant using the Black-Scholes option pricing model. We recognize stock-based compensation expense using the accelerated multiple-option approach. Under the accelerated multiple-option approach (also known as the graded-vesting method), we recognize compensation expense over the requisite service period for each separately vesting tranche of the award as though the award was in substance multiple awards, resulting in accelerated expense recognition over the vesting period. For performance-based awards granted to employees (i) the fair value of the award is determined on the grant date, (ii) we assess the probability of the individual milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. We account for restricted stock units by determining the fair value of each restricted stock unit based on the closing market price of our common stock on the date of grant. We recognize stock-based compensation expense using the accelerated multiple-option approach over the requisite service periods of the awards. Clinical Trial and Preclinical Study Accruals We make estimates of our accrued expenses for clinical trial and preclinical study activities as of each balance sheet date in our financial statements based on the facts and circumstances known to us at that time. These accruals are based upon estimates of costs incurred and fees that may be associated with services provided by clinical trial investigational sites, CROs and for other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of clinical trial milestones. In accruing for these services, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from these service providers. However, we may be required to estimate these services based on other information available to us. If we underestimate or overestimate the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in our accruals. Prepaid Materials We capitalize the purchase of certain raw materials and related supplies for use in the manufacturing of drug product in our preclinical and clinical development programs, as we have determined that these materials have alternative future use. We can use these raw materials and related supplies in multiple clinical drug products, and therefore have future use independent of the development status of any particular drug program until it is utilized in the manufacturing process. We expense the cost of materials when used. We periodically review these capitalized materials for continued alternative future use and write down the asset to its net realizable value in the period in which an impairment is identified. Research and Development Research and development costs are expensed as incurred and consist of costs associated with research activities supporting our drug discovery efforts, compensation and related benefits, non-cash stock-based compensation, license fees, laboratory supplies and associated overhead and facility costs. Income Taxes Income taxes are accounted for under the asset and liability method. This approach requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of the differences between the tax basis of assets or liabilities and their carrying amounts in the financial statements using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. We provide a valuation allowance against net deferred tax assets if it is more likely than not that these items will either expire before we are able to realize their benefit or if future deductibility is uncertain. In accordance with the accounting standards for uncertain tax positions, we evaluate the recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. Cash and Cash Equivalents We classify time deposits and other investments that are highly liquid and have maturities of 90 days or less at the date of purchase as cash equivalents. The carrying amounts approximate fair value due to the short maturities of these instruments. Concentrations of Credit Risk Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash equivalents and short-term investments. We maintain deposits in federally insured financial institutions in excess of federally insured limits. We have not experienced any material losses in such accounts and believe we are not exposed to significant risk. We maintain our cash equivalents with two highly accredited financial institutions. We have historically invested our excess cash primarily in certificates of deposit and debt instruments of financial institutions and corporations, United States Treasury securities and United States government-sponsored enterprise securities. Additionally, we adhere to established guidelines regarding approved investments and maturities of investments, which are designed to preserve their principal value and maintain liquidity. Property and Equipment We carry our property and equipment at cost, which consists of lab equipment, computer equipment and software, furniture and fixtures and leasehold improvements. Property and equipment is depreciated using the straight-line method over the estimated useful lives (generally three to five years). Leasehold improvements are amortized over the lesser of their useful life or the remaining lease term, including any renewal periods that are deemed to be reasonably assured. Repair and maintenance costs that do not improve service potential or extend economic life are expensed as incurred. Intangibles We capitalize costs which consist principally of outside legal costs and filing fees related to obtaining patents. We review our capitalized patent costs periodically to determine that they include costs for patent applications that have future value and an alternative future use. We evaluate costs related to patents that we are not actively pursuing and write off these costs. We amortize patent costs over their patent lives, beginning with the date the patents are issued. The weighted average remaining life of the issued patents was approximately 7 years at December 31, 2019 . We obtain licenses from third parties and capitalize the costs related to exclusive licenses that have alternative future use within multiple potential programs. We amortize capitalized licenses over their estimated useful life or term of the agreement. We did not have any licenses capitalized on our balance sheet at December 31, 2019 and 2018. Impairment of Long-Lived Assets We regularly review the carrying amount of our property, equipment and intangible assets to determine whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. If indications of impairment exist, projected future undiscounted cash flows associated with the asset are compared to the carrying amount to determine whether the asset’s value is recoverable. If the carrying value of the asset exceeds such projected undiscounted cash flows, the asset will be written down to its estimated fair value. No impairment charges were recorded during the years ended December 31, 2019 or 2018 . Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, we have viewed our operations and managed our business as one segment operating primarily within the United States. Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. Our only component of other comprehensive loss is unrealized losses on available-for-sale securities. Comprehensive losses have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements of stockholders’ equity for all periods presented. Corporate Restructuring In July 2018, we implemented corporate restructurings to streamline our operations, reduce our operating expenses, extend our cash runway and focus our resources on our most promising programs. In connection with our July 2018 restructuring, we reduced our workforce by approximately 60% . We recorded net charges of approximately $0.8 million for employee severance and other related termination benefits and less than $0.1 million in net one-time, non-cash stock-based compensation charges due to the acceleration of outstanding stock options, in accordance with executive employment agreements, partially offset by the reversal of expense previously recognized for stock options that were cancelled upon termination. All payments associated with the corporate restructuring were paid in full by the end of the third quarter of 2018. Recent Accounting Pronouncements As disclosed above, effective January 1, 2018, we adopted Topic 606. Since ASU 2014-09 was issued, several additional ASUs have been issued and incorporated within Topic 606 to clarify various elements of the guidance. As part of our adoption efforts, we have completed the assessment of our collaboration and license agreements under Topic 606. We adopted Topic 606 in the first quarter of 2018 using the modified retrospective method which consists of applying and recognizing the cumulative effect of Topic 606 at the date of initial application and providing certain additional disclosures as defined per Topic 606. On January 1, 2018, we recorded a cumulative adjustment to decrease deferred revenue and accumulated deficit by approximately $1.8 million to reflect the impact of the adoption of Topic 606. The cumulative adjustment relates primarily to our agreement with Sanofi which is described further in Note 5. Below is a summary of the affected line items of the balance sheets upon adoption of Topic 606 (in thousands): Balance at December 31, 2017 Adjustments due to Topic 606 Balance at January 1, 2018 Balance Sheet Deferred revenue (contract liabilities), non-current 1,921 (1,844 ) 77 Accumulated deficit (345,858 ) 1,844 (344,014 ) There was no impact on revenue recognized in 2019 or 2018 as a result of the adoption of Topic 606. In February 2016, the FASB issued ASU No. 2016-02, Leases, which increases transparency and comparability among organizations by requiring recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements. Since ASU 2016-02 was issued, several additional ASUs have been issued to clarify various elements of the guidance. The standard is effective for annual reporting periods beginning after December 15, 2018, including interim periods within those annual reporting periods. We adopted the new lease standard on January 1, 2019, using the alternative modified transition method provided by the standard and did not retrospectively apply to prior periods. We elected the “package of practical expedients” (excluding the hindsight practical expedient) permitted under the transition guidance which allows us to not reassess our historical assessment of whether existing contracts are or contain a lease and the classification of existing lease arrangements. As a result of the adoption of the new standard, we recognized operating lease right-of-use assets ("ROU assets") of $3.3 million and operating lease liabilities of $11.3 million on our balance sheet as of January 1, 2019. Operating lease ROU assets are recorded within our balance sheets as other assets and operating lease liabilities are recorded within our balance sheets as other current liabilities and other long-term liabilities. There was no change upon adoption to our capital leases, referred to as finance leases under the new lease standard. Our finance lease ROU asset and liability balances were each $0.6 million as of January 1, 2019. Finance lease ROU assets are recorded in property and equipment, net and current and non-current finance lease liabilities are recorded in other current liabilities and other long-term liabilities, respectively, in our balance sheets. The adoption of the new lease standard had no impact on our accumulated deficit and also had no impact on our results of operations and cash flows. See Note 13, Leases, for further detail. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . The amendments in this update replace the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Entities will apply the new guidance as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is adopted. This update is effective for annual periods beginning after December 15, 2019, and interim periods within those periods. Early adoption is permitted. The adoption of this guidance is not anticipated to have an impact on our financial statements. In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting , which aligns the measurement and classification guidance for share-based payment to non-employees with the guidance for share-based payments to employees. Under the new guidance, the measurement period for equity-classified non-employee awards will be fixed at the grant date. This update is effective for annual periods beginning after December 15, 2018, and interim periods within those periods. The adoption of this guidance had no impact on our financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement: Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement , which updates and modifies the disclosure requirements on fair value measurements in Topic 820, primarily in relation to Level 3 fair value measurements. This update is effective for annual periods beginning after December 15, 2019, and interim periods within those periods. Early adoption is permitted. The adoption of this guidance is not anticipated to have an impact on our financial statements. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements , which clarifies the interaction between Topic 808 , Collaborative Arrangements and Topic 606, including clarification around certain transactions between collaborative arrangement participants and adding unit-of-account guidance to Topic 808. This update is effective for annual periods beginning after December 15, 2019, and interim periods within those periods. Early adoption is permitted. The adoption of this guidance is not anticipated to have an impact on our financial statements. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes - Simplifying the Accounting for Income Taxes (“ASU 2019-12”). The guidance removes exceptions to the general principles in Income Taxes (Topic 740) for allocating tax expense between financial statement components, accounting basis differences stemming from an ownership change in foreign investments and interim period income tax accounting for year-to-date losses that exceed projected losses. The guidance becomes effective for annual reporting periods beginning after December 15, 2020 and interim periods within those fiscal years with early adoption permitted. The Company plans to adopt ASU 2019-12 effective January 1, 2020 and does not expect this adoption to have a material impact on our financial statements. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury stock method for stock options outstanding under our stock options plans and the if-converted method for convertible preferred stock. Dilutive common stock equivalents are comprised of stock options outstanding under our stock option plans, restricted stock units and convertible preferred stock. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted net loss per share. Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive consisted of 3,342,533 shares attributable to convertible preferred stock for the year ended December 31, 2019 and zero shares attributable to common stock options and restricted stock units for the year ended December 31, 2018. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments Historically, we have invested our excess cash primarily in debt instruments of financial institutions, corporations, U.S. government-sponsored agencies and the U.S. treasury. We generally hold our investments until to maturity and do not sell our investments before we have recovered our amortized cost basis. As of December 31, 2019 and 2018, our cash balance was comprised entirely of cash and cash equivalents (money market funds) and there was no unrealized gain or loss in either period. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements We have certain financial assets recorded at fair value which have been classified as Level 1, 2, or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. Accounting standards define 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 as of the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The accounting standards provide an established hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in valuing the asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are inputs that reflect our assumptions about the factors that market participants would use in valuing the asset or liability. The accounting standards prioritize the inputs used in measuring the fair value into the following hierarchy: • Level 1 includes financial instruments for which quoted market prices for identical instruments are available in active markets. • Level 2 includes financial instruments for which there are inputs other than quoted prices included within Level 1 that are observable for the instrument such as quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets with insufficient volume or infrequent transactions (less active markets) or model-driven valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data. • Level 3 includes financial instruments for which fair value is derived from valuation techniques in which one or more significant inputs are unobservable, including management’s own assumptions. Financial Assets Measured at Fair Value The following table presents our fair value hierarchy for assets measured at fair value on a recurring basis as of December 31, 2019 and 2018 (in thousands): Fair value as of December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Cash equivalents $ 8,909 $ 8,909 $ — $ — $ 8,909 $ 8,909 $ — $ — Fair value as of December 31, 2018 Total Level 1 Level 2 Level 3 Assets: Cash equivalents $ 11,173 $ 11,173 $ — $ — $ 11,173 $ 11,173 $ — $ — We obtain pricing information from quoted market prices or quotes from brokers/dealers. We have historically determined the fair value of our investment securities using standard observable inputs, including reported trades, broker/dealer quotes, bids and/or offers. |
Collaborations
Collaborations | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations | Collaborations Revenue recognized from our strategic collaborations was $6.8 million for the year ended December 31, 2019 and less than $0.1 million for the year ended December 31, 2018. Sanofi In July 2012, we amended and restated our collaboration and license agreement with Sanofi to expand the potential therapeutic applications of the micro RNA collaboration targets to be developed under such agreement. We determined that the elements within the strategic collaboration agreement with Sanofi should be treated as a single unit of accounting because the delivered elements did not have stand-alone value to Sanofi. The following elements were delivered as part of the strategic collaboration with Sanofi: (1) a license for up to four micro RNA targets; and (2) a research license under our technology collaborations. In June 2013, the original research term expired, upon which we and Sanofi entered into an option agreement pursuant to which Sanofi was granted an exclusive right to negotiate the co-development and commercialization of certain of our unencumbered micro RNA programs and we were granted the exclusive right to negotiate with Sanofi for co-development and commercialization of certain miR-21 anti-miRs in oncology and Alport syndrome. In July 2013, we received an upfront payment of $2.5 million , of which $1.25 million is creditable against future amounts payable by Sanofi to us under any future co-development and commercialization agreement we enter pursuant to the option agreement. Revenue associated with the creditable portion of this option payment was deferred as of December 31, 2017, and recorded as an adjustment to accumulated deficit upon our adoption of Topic 606 on January 1, 2018. The non-creditable portion of this payment, $1.25 million , was recognized as revenue over the option period from the effective date of the option agreement in June 2013 through the expiration of the option period in January 2014. In February 2014, we and Sanofi entered into a second amended and restated collaboration and license agreement (the “2014 Sanofi Amendment”) to renew our strategic collaboration to discover, develop and commercialize micro RNA therapeutics to focus on specific orphan disease and oncology targets. Under the terms of the 2014 Sanofi Amendment, Sanofi had opt-in rights to our clinical fibrosis program targeting miR-21 for the treatment of Alport syndrome, our preclinical program targeting miR-21 for oncology indications, and our preclinical program targeting miR-221/222 for HCC. We were responsible for developing each of these programs to proof-of-concept, at which time Sanofi had an exclusive option on each program. If Sanofi chose to exercise its option on any of these programs, Sanofi would reimburse us for a significant portion of our preclinical and clinical development costs and would also pay us an option exercise fee for any such program, provided that $1.25 million of the $2.5 million upfront option fee paid to us by Sanofi in connection with the June 2013 option agreement would be creditable against such option exercise fee. We are eligible to receive royalties on micro RNA therapeutic products commercialized by Sanofi and will have the right to co-promote these products relating to our preclinical program targeting miR-221/222. As indicated below, we entered into an additional amendment with Sanofi in November 2018, under which Sanofi's opt-in rights to our miR-21 programs under the 2014 Sanofi Amendment were relinquished. Sanofi's opt-in rights with regard to our miR-221/222 preclinical program under the 2014 Sanofi Amendment remained unchanged. In connection with the 2014 Sanofi Amendment, we entered into a Common Stock Purchase Agreement (the “ Sanofi Purchase Agreement”), pursuant to which we sold 108,648 shares of our common stock to Aventisub LLC (“Aventis”), an entity affiliated with Sanofi, in a private placement at a price per share of $92.04 (as adjusted for the reverse stock split effected in October 2018) for an aggregate purchase price of $10.0 million . Under the terms of the Sanofi Purchase Agreement, Aventis was not permitted to sell, transfer, make any short sale of, or grant any option for the sale of any common stock for the 12 -month period following its effective date. The Sanofi Purchase Agreement and the 2014 Sanofi Amendment were negotiated concurrently and were therefore evaluated as a single agreement. Based upon restricted stock studies of similar duration and a Black-Scholes valuation to measure the discount for lack of marketability, approximately $0.4 million of the proceeds from the Sanofi Purchase Agreement was attributed to the 2014 Sanofi Amendment, and represents consideration for the value of the program targeting miR-221/222 for HCC. We are recognizing the $0.4 million allocated consideration into revenue ratably over the estimated period of performance of the miR-221/222 program. As of December 31, 2019 , contract liability associated with the Purchase Agreement and the 2014 Sanofi Amendment was less than $0.1 million , which we are expecting to recognize over the remaining estimated period of performance of less than one year. We are eligible to receive milestone payments of up to $38.8 million for proof-of-concept option exercise fees (net of $1.25 million creditable, as noted above), $40.0 million for clinical milestones and up to $130.0 million for regulatory and commercial milestones. In addition, we are entitled to receive royalties based on a percentage of net sales of any products from the miR-221/222 program which, in the case of sales in the United States, will be in the middle of the 10 to 20% range, and, in the case of sales outside of the United States, will range from the low end to the middle of the 10 to 20% range, depending upon the volume of sales. If we exercise our option to co-promote a miR-221/222 product, we will continue to be eligible to receive royalties on net sales of each product in the United States at the same rate, unless we elect to share a portion of Sanofi’s profits from sales of such product in the United States in lieu of royalties. In November 2018, we entered into an amendment to the 2014 Sanofi Amendment with Sanofi to modify the parties’ rights and obligations with respect to our miR-21 programs, including our RG-012 program (the “2018 Sanofi Amendment”). Under the terms of the 2018 Sanofi Amendment, we have granted Sanofi a worldwide, royalty-free, fee-bearing, exclusive license, with the right to grant sublicenses, under our know-how and patents to develop and commercialize miR-21 compounds and products for all indications, including Alport Syndrome. Sanofi will control and will assume all responsibilities and obligations for developing and commercializing each of our miR-21 programs, including our obligations regarding the administration and expense of clinical trials and all other costs, including in-license royalties and other in-license payments, related to our miR-21 programs. Under the terms of the 2018 Sanofi Amendment, we have assigned to Sanofi certain agreements, product-specific patents and all materials directed to miR-21 or to any miR-21 compound or product and are required to provide reasonable technical assistance to Sanofi for a period of 24 months after the date of the 2018 Sanofi Amendment. Under the terms of the 2018 Sanofi Amendment, we are eligible to receive approximately $6.8 million in upfront payments for the license and for miR-21 program-related materials (collectively, the “Upfront Amendment Payments”). We are also eligible to receive up to $40.0 million in development milestone payments. In addition, Sanofi has agreed to reimburse us for certain out-of-pocket transition activities and assume our upstream license royalty obligations. We and Sanofi also agreed to a general release of claims against each other for any claims that arose at any time prior to the date of the 2018 Sanofi Amendment, or that thereafter could arise based on anything that occurred prior to the date of the 2018 Sanofi Amendment. As of December 31, 2018, we had received $2.5 million of the approximately $6.8 million in Upfront Amendment Payments under the 2018 Sanofi Amendment. We determined the amount constituted a contract liability as of December 31, 2018 under Topic 606, as the performance obligation conditions had not been satisfied as of that date. We completed the performance obligations under the 2018 Sanofi Amendment, received the remaining cash proceeds and recognized the $6.8 million of Upfront Amendment Payments in 2019. As of December 31, 2019, the $40.0 million in development milestone payments (variable consideration) are fully constrained and therefore, do not meet the criteria for revenue recognition. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net The following table summarizes our major classes of property and equipment (in thousands): December 31, 2019 2018 Laboratory equipment $ 4,967 $ 8,163 Computer equipment and software 281 281 Furniture and fixtures — 706 Leasehold improvements 83 8,550 5,331 17,700 Less accumulated depreciation and amortization (4,410 ) (9,894 ) Property and equipment, net $ 921 $ 7,806 Depreciation and amortization of property and equipment of $0.9 million and $2.3 million was recorded for the years ended December 31, 2019 and 2018 , respectively. |
Intangible Assets, net
Intangible Assets, net | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets, net | Intangible Assets, net The following table summarizes our major classes of intangible assets (in thousands): December 31, 2019 2018 Patents $ 465 $ 721 Accumulated amortization - Patents (199 ) (221 ) Intangibles, net $ 266 $ 500 Intangible asset amortization of less than $0.1 million was recorded for the year ended December 31, 2019 , compared to $0.1 million for the year ended December 31, 2018 . Amortization of intangible assets over the next five years is expected to be less than $0.1 million per year. The weighted-average period over which the amortization remaining at December 31, 2019 is expected to be recognized is approximately 14.9 years . |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Federal Securities Litigation On January 31, 2017, a putative class action complaint was filed by Baran Polat in the United States District Court for the Southern District of California (“District Court”) against the Company, its then-Chief Executive Officer Paul C. Grint, and its then-Chief Operating Officer Joseph P. Hagan (currently the Company’s Chief Executive Officer). The complaint includes claims asserted, on behalf of certain purchasers of the Company’s securities, under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended. In general, the complaint alleges that, between January 21, 2016, and June 27, 2016, the defendants violated the federal securities laws by making materially false and misleading statements regarding the Company’s business and the prospects for RG-101, thereby artificially inflating the price of the Company’s securities. The plaintiff seeks unspecified monetary damages and other relief. On February 10, 2017, a second putative class action complaint was filed by Li Jin in the District Court against the Company, Mr. Hagan, Dr. Grint, and Timothy Wright, the Company’s Chief Research and Development Officer. The Complaint alleges claims similar to those asserted by Mr. Polat. The actions have been related. On February 17, 2017, the District Court entered an order stating that defendants need not answer, or otherwise respond, until the District Court enters an order appointing, pursuant to the Private Securities Litigation Reform Act of 1995, lead plaintiff and lead counsel, and the parties then submit a schedule to the District Court for the filing of an amended or consolidated complaint and the timing of defendants’ answer or response. On April 3, 2017, two motions for consolidation of the two actions, appointment of lead plaintiff, and approval of counsel were filed in the action (“Motions to Consolidate”). On October 26, 2017, the District Court entered an order consolidating the cases, appointing Mark Appel and Michael Spitters to serve as co-lead plaintiffs, and appointing Levi & Korsinsky LLP to serve as lead counsel. On December 22, 2017, lead plaintiffs filed a consolidated complaint against the Company, Dr. Grint, Mr. Hagan, and Michael Huang (the Company’s former Vice President of Clinical Development). The consolidated complaint alleges that between February 17, 2016 and June 12, 2017, the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, by making materially false and misleading statements regarding RG-101. The consolidated complaint seeks unspecified monetary damages and an award of attorneys’ fees and costs. On February 6, 2018, the defendants filed a motion to dismiss the consolidated complaint. On March 23, 2018, lead plaintiffs filed their opposition to the motion to dismiss. On April 24, 2018, the defendants filed their reply in support of the motion to dismiss. On September 5, 2019, the court granted defendants’ motion to dismiss with leave to amend. Plaintiffs filed their amended complaint on October 1, 2019. Subsequent to the filing of the amended complaint, counsel for the parties engaged in negotiations to resolve the case. On November 4, 2019, the parties agreed in principle to settle the case for $0.9 million , with approximately $0.3 million to be paid by us and the balance to be paid by our D&O insurance carrier. On December 11, 2019, the parties entered into a stipulation and agreement of settlement, which was amended on February 6, 2020. On February 7, 2020, plaintiffs filed a motion for preliminary approval of the settlement. The settlement is contingent upon court approval. In connection with the proposed settlement and in accordance with authoritative guidance, we recorded the $0.9 million loss contingency as a current liability on our balance sheet at December 31, 2019, and recorded the $0.6 million of expected insurance proceeds from our D&O insurance carrier as a current receivable on our balance sheet at December 31, 2019. The $0.3 million settlement amount payable by the Company was recorded to the statement of operations and comprehensive loss for the year ended December 31, 2019. The settlement is contingent upon both the parties’ entry into a definitive settlement agreement and court approval. License Agreements We have license agreements with third parties that require us to make annual license maintenance payments and future payments upon the success of licensed products that include milestones and/or royalties. Minimum future payments over the next five years are not material. |
Term Loan
Term Loan | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Term Loan | Term Loan On June 17, 2016, we entered into a loan and security agreement ("Loan Agreement") with Oxford Finance, LLC, ("Oxford" or sometimes referred to as the “ Lender ” ), pursuant to which Oxford agreed to lend us up to $30.0 million , issuable in two separate term loans of $20.0 million (the "Term A Loan") and $10.0 million (the "Term B Loan"). On June 22, 2016, we received $20.0 million in proceeds from the Term A Loan, net of debt issuance costs. The ability to borrow on the Term B Loan expired on March 31, 2017, and no amounts were borrowed under the Term B Loan. We refer to all amounts outstanding under the Loan Agreement as the Term Loan. The outstanding Term Loan will mature on May 1, 2022 (the “Maturity Date”) and bears interest at a floating per annum rate equal to (i) 8.51% plus (ii) the greater of (a) the 30 day U.S. Dollar LIBOR rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue and (b) 0.44% . Under the original Loan Agreement, we were required to make interest-only payments through June 1, 2018, followed by 24 equal monthly payments of principal and unpaid accrued interest. In August 2018, we and Oxford entered into an amendment to our Loan Agreement, providing for a modification of the loan amortization period. Under the terms of the amendment, principal amortization and repayment was deferred between August 2018 through October 2018, and during this period, we were required to make payments of interest-only. Amortization payments recommenced in November 2018. Pursuant to the amendment, we granted the Lender a security interest in our intellectual property as additional collateral for the repayment of the Term Loan. In November 2018, and in connection with the 2018 Sanofi Amendment, we entered into a fourth amendment to the Loan Agreement with the Lender (the "Fourth Amendment"). Under the terms of the Fourth Amendment, the Lender consented to the 2018 Sanofi Amendment and our license, assignment and transfer to Sanofi of certain of our intellectual property, as required to be delivered to Sanofi under the 2018 Sanofi Amendment (the “Assigned Assets”), which previously served as collateral under the Loan Agreement, and released its liens in the Assigned Assets, provided that the Lender will continue to have liens on all proceeds received by us pursuant to our collaboration and license agreement with Sanofi dated February 4, 2014 (the “Sanofi License Agreement”). Under the terms of the Fourth Amendment, we have the option to prepay part of the Term Loan at any time and in any amount after 10 days’ prior written notice. We are also required to prepay a portion of the Term Loan with 25% of certain payments we receive under the 2018 Sanofi Amendment, which payments consist of the Upfront Amendment Payments and the first development milestone payment in the amount of $10.0 million . In accordance with this term, we prepaid $0.6 million pursuant to our receipt of $2.5 million in Upfront Amendment Payments in November 2018. Additionally, we prepaid $0.4 million pursuant to our receipt of $1.8 million in Upfront Amendment Payments in March 2019. We are required to pay the applicable 5.5% final payment fee related to each such 2018 Sanofi Amendment prepayment. On January 31, 2019, we entered into a fifth amendment to the Loan Agreement with the Lender (the "Fifth Amendment"). Under the terms of the Fifth Amendment, our required monthly payment to the Lender for the month of February 2019 was comprised of interest only. On March 7, 2019, we entered into a sixth amendment to the Loan Agreement with the Lender (the "Sixth Amendment"). Under the terms of the Sixth Amendment, our required monthly payment to the Lender for the month of March 2019 was comprised of interest only. On April 9, 2019 we entered into a seventh amendment to the Loan Agreement with the Lender (the "Seventh Amendment"). Under the terms of the Seventh Amendment, our required monthly payments to the Lender were to be comprised of interest only through and including the payment date immediately preceding the following date (the “Second Amortization Date”): (i) April 1, 2019, if we did not receive unrestricted gross cash proceeds of not less than $10 million on or before April 30, 2019 from (a) the issuance and sale of our unsecured subordinated convertible debt and/or equity securities and/or (b) “up front” or milestone payments in connection with a joint venture, collaboration or other partnering transaction other than pursuant to the Sanofi License Agreement (the receipt of such net proceeds, the “ Seventh Amendment Capital Event”), and (ii) May 1, 2019, if the Seventh Amendment Capital Event occurs. The Seventh Amendment Capital event did not occur on or before April 30, 2019. Commencing on the Second Amortization Date, and continuing on each successive payment date thereafter, we were to be required to make consecutive equal monthly payments of principal, together with applicable interest, in arrears, to the Lender; provided, however, that we were required to make the monthly principal payment due April 1, 2019 on May 1, 2019 (in addition to all other payments due on May 1, 2019) if the Seventh Amendment Capital Event did not occur. The Seventh Amendment also provided that we can irrevocably elect to increase the prepayment percentage for the funds that we are required to prepay under the Term Loan in the event we receive $10.0 million from the first development milestone under the 2018 Sanofi Amendment (the "Milestone Payment") from 25% to 75% (the “Applicable Sanofi Percentage”). Under the Seventh Amendment, we are required to maintain cash in a collateral account controlled by the Lender of (i) $10.0 million if the Applicable Sanofi Percentage is 25% and if we had not prepaid an aggregate of $5 million under the Term Loan (which amount shall not include any Sanofi License Agreement prepayments) on or before April 30, 2019 (such prepayment, the “Principal Paydown Event”), (ii) $5.0 million if the Applicable Sanofi Percentage is 75% and the Principal Paydown Event had not occurred and (iii) zero if the Principal Paydown Event had occurred. On May 3, 2019, concurrently with our Securities Purchase Agreement dated May 2019 (the "Purchase Agreement") (as described in further detail in Note 10), we entered into an eighth amendment to the Loan Agreement with the Lender (the "Eighth Amendment"). Pursuant to the terms of the Eighth Amendment and as a result of the completion of the initial closing under the Purchase Agreement, our required monthly payments to the Lender were comprised of interest only from May 2019 through and including the payment to be made in April 2020, in exchange for an interest-only period extension fee of $0.1 million . Additionally, under the Eighth Amendment, the Term Loan maturity date was extended from June 2020 to May 2022, in exchange for a maturity date extension fee of $0.7 million . Pursuant to the Eighth Amendment, as a result of our receipt of over $20.0 million in capital in December 2019 under the second and final closing (the "Milestone Closing") under the Purchase Agreement (the “Eighth Amendment Capital Event”), our required monthly payments to the Lender are comprised of interest only through and including the payment to be made in April 2021. Commencing in May 2021, and continuing on each successive payment date thereafter, we are required to make consecutive equal monthly payments of principal, together with applicable interest, in arrears, to the Lender. The Eighth Amendment also provides for an increase in the prepayment percentage for the funds that we are required to prepay under the Term Loan, in the event that we receive the $10.0 million Milestone Payment, from 75% to 100% of the Milestone Payment. Upon payment of the Milestone Payment to the Lender, we will no longer be required to maintain cash in a collateral account controlled by Lender and the positive lien on our intellectual property will be released. We used the proceeds from the Term Loan solely for working capital and to fund our general business requirements. Our obligations under the Loan Agreement are secured by a first priority security interest in substantially all of our current and future assets, other than our intellectual property, for which Oxford currently has a positive lien, and certain assets under capital lease obligations. We have also agreed not to encumber our intellectual property assets, except as permitted by the Loan Agreement. The Loan Agreement includes customary events of default, including instances of a material adverse change in our operations, that may require prepayment of the outstanding Term Loan. As of December 31, 2019 we were in compliance with all covenants under the Loan Agreement. As of December 31, 2019, $14.7 million was outstanding under the Term Loan, with an additional $1.9 million payable at the conclusion of the Term Loan. We had approximately $0.1 million of debt issuance costs outstanding as of December 31, 2019, which are being accreted to interest expense over the life of the Term Loan. In connection with the Term Loan, the debt issuance costs have been recorded as a debt discount in our balance sheets, which are being accreted to interest expense over the life of the Term Loan using an effective interest rate of 8.98% . The exit fees are being accrued over the life of the Term Loan through interest expense. Future principal payments for the Term Loan due under the Loan Agreement are as follows (in thousands): 2020 $ — 2021 9,035 2022 5,646 $ 14,681 |
Common Stock and Stockholders'
Common Stock and Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Common Stock and Stockholders’ Equity | Common Stock and Stockholders’ Equity Common Stock As of December 31, 2019 , there were 21,018,663 shares of common stock outstanding. Each share of common stock is entitled to one vote. The holders of the common stock are also entitled to receive dividends whenever funds are legally available and when declared by our Board of Directors. 2019 Equity Incentive Plan On June 15, 2019 the Company's board of directors approved, and on August 1, 2019 the Company's stockholders approved, the Company's 2019 Equity Incentive Plan (the "2019 Plan"). The 2019 Plan is intended as the successor to and continuation of the Company's 2012 Equity Incentive Plan. As of December 31, 2019, 403,939 shares of common stock were available for new equity award grants under the 2019 Plan and 3,226,804 shares of common stock are reserved for issuance pursuant to equity awards outstanding as of December 31, 2019. The number of shares authorized for issuance under the 2019 Plan may be increased by (a) the shares subject to outstanding stock awards granted under the Company’s 2009 Equity Incentive Plan (the “2009 Plan”) and the Company’s 2012 Equity Incentive Plan (together the with 2009 Plan, the “Prior Plans”) that on or after the effective date of the 2019 Plan (i) expire or terminate for any reason prior to exercise or settlement; (ii) are forfeited because of the failure to meet a contingency or condition required to vest such shares or otherwise return to the Company, or (iii) are reacquired, withheld (or not issued) to satisfy a tax withholding obligation in connection with an award or to satisfy the purchase price or exercise price of a stock award. No further grants will be made under the Prior Plans. In addition, on January 22, 2020, an additional 4,166,860 shares of common stock became available for issuance under the 2019 Plan pursuant to the Milestone Closing of the May 2019 SPA. Further, on January 1 st of each year, for a period of not more than ten years, beginning on January 1, 2021 and continuing through January 1, 2029, the number of shares authorized for issuance under the 2019 Plan will increase by 5.0% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by our Board of Directors. Private Placement of Common Stock, Non-Voting Preferred Stock and Warrants On May 3, 2019, we entered into the May 2019 SPA with certain institutional and other accredited investors, including certain directors, executive officers and employees of the Company (the “Purchasers”), pursuant to which we agreed to sell and issue shares of our common stock, shares of our newly designated non-voting convertible preferred stock, and warrants to purchase common stock, in up to two closings, in a private placement transaction (the “Private Placement”). At an initial closing under the May 2019 SPA that occurred on May 7, 2019 (the “Initial Closing”), we sold and issued to the Purchasers (i) 9,730,534 shares of common stock and accompanying warrants to purchase up to an aggregate of 9,730,534 shares of common stock at a combined purchase price of $1.205 per share, and (ii) 415,898 shares of non-voting Class A-1 convertible preferred stock, in lieu of shares of common stock, at a price of $10.80 per share, and accompanying warrants to purchase an aggregate of 4,158,980 shares of common stock at a price of $0.125 for each share of common stock underlying such warrants. Total gross proceeds from the Initial Closing were approximately $16.7 million , which does not include any proceeds that may be received upon exercise of the warrants. Each share of non-voting Class A-1 convertible preferred stock is convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The warrants are exercisable for a period of five years following the date of issuance and have an exercise price of $1.08 per share, subject to proportional adjustments in the event of stock splits or combinations or similar events. The warrants are exercisable on a net exercise "cashless" basis. An aggregate of 526,083 shares of common stock and warrants to purchase up to 526,083 shares of common stock were purchased for $0.6 million by certain directors and executive officers of the Company under the Initial Closing. Pursuant to the May 2019 SPA, in the event our Board of Directors unanimously resolves to recommence our Phase 1 multiple ascending dose clinical trial of our RGLS4326 product candidate for the treatment of ADPKD") (the “Phase 1 Trial”) based on correspondence from the U.S. Food and Drug Administration’s Division of Cardiovascular and Renal Products, and thereafter but on or before December 31, 2019 we make a public announcement of our plan to recommence the Phase 1 Trial (the “Public Announcement”), we may sell and the Purchasers may purchase, at a second closing under the May 2019 SPA (“Milestone Closing”), shares of our non-voting convertible preferred stock and accompanying warrants to purchase shares of Common Stock (collectively, “Milestone Securities”). On December 15, 2019, the Company’s Board of Directors unanimously resolved to recommence the Phase 1 Trial based on correspondence from the U.S. Food & Drug Administration’s Division of Cardiovascular and Renal Products and on December 16, 2019, we made the related Public Announcement, triggering the Milestone Closing, which occurred on December 24, 2019. At the Milestone Closing, we sold and issued to the Purchasers 3,288,390 shares of non-voting Class A-2 convertible preferred stock and accompanying warrants to purchase an aggregate of 32,883,900 shares of common stock for an aggregate purchase price of approximately $26.0 million . Net proceeds to the Company from the Milestone Closing were approximately $24.6 million . Each share of non-voting Class A-2 convertible preferred stock is convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The warrants will be exercisable for a period of five years following the date of issuance and have an exercise price of $0.666 per share, subject to proportional adjustments in the event of stock splits or combinations or similar events. The warrants are exercisable on a net exercise “cashless” basis. An aggregate of 121,581 shares of Class A-2 convertible preferred stock and warrants to purchase up to 1,215,810 shares of common stock were purchased for approximately $1.0 million by certain directors and executive officers of the Company under the Milestone Closing. We evaluated the non-voting Class A-1 convertible preferred stock and common stock warrants sold in the Initial Closing and the Class A-2 convertible preferred stock and common stock warrants sold in the Milestone Closing under ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging, and determined permanent equity treatment was appropriate for these freestanding financial instruments. The Initial Closing and Milestone Closing did not include any embedded features that required bifurcation. The non-voting Class A-2 convertible preferred stock and warrants issuable under the Milestone Closing were not subject to accounting recognition until the Milestone Closing occurred, as the terms of the Milestone Closing did not provide a right or an obligation on either the Company nor the Purchasers. Exchange Offer On October 15, 2018, we filed a tender offer statement on Schedule TO with the Securities and Exchange Commission related to an offer by us to certain eligible optionholders, subject to specified conditions, to exchange some or all of their outstanding options to purchase shares of our common stock for new RSUs (the "Exchange Offer"). The exchange ratio for each option eligible for exchange was determined using the Black-Scholes option pricing model and was based on, among other things, the fair market value of a share of our common stock, the volatility of our common stock, U.S. treasury rates, the exercise prices of such options, the remaining terms of such options and the term of the new RSUs. There were a total of 915,009 options eligible for exchange in the Exchange Offer by 31 eligible optionholders, all of which were exchanged for 603,058 RSUs. Of the 603,058 RSUs issued in the Exchange Offer, 514,955 contain certain performance conditions requisite for vesting commencement. Incremental stock-based compensation cost associated with the Exchange Offer was $0.4 million . ATM Offering On December 12, 2018, we entered into a Common Stock Sales Agreement (the “Stock Sales Agreement”) with H.C. Wainwright & Co., LLC (“HCW”), pursuant to which we may sell and issue shares of our common stock from time to time through HCW, as our sales agent (the “ATM Offering”). We have no obligation to sell any shares of common stock in the ATM Offering, and may at any time suspend offers under the Stock Sales Agreement or terminate the Stock Sales Agreement. Subject to the terms and conditions of the Stock Sales Agreement, HCW will use its commercially reasonable efforts to sell shares of our common stock from time to time based upon our instructions (including any price, time or size limits or other parameters or conditions the we may impose, subject to certain restrictions). We pay HCW a commission of 3.0% of the gross sales price of any shares sold under the Stock Sales Agreement. A total of 1,903,880 shares were sold for proceeds of $2.1 million (net of approximately $0.1 million in commissions) under the ATM Offering during the year ended December 31, 2019. No shares were sold during the year ended December 31, 2018. Shares Reserved for Future Issuance The following shares of common stock were reserved for future issuance as of December 31, 2019 (in thousands): Class A-1 convertible preferred stock outstanding (as-converted) 4,159 Class A-2 convertible preferred stock outstanding (as-converted) 32,884 Initial Closing warrants 13,890 Milestone Closing warrants 32,884 Common stock options outstanding 3,098 RSUs outstanding 129 Common stock available for future grant under the 2019 Equity Incentive Plan 404 Employee Stock Purchase Plan 192 Total common shares reserved for future issuance 87,640 The following table summarizes our stock option activity under all equity incentive plans for the year ended December 31, 2019 (shares and aggregate intrinsic value in thousands): Number of Weighted Weighted average remaining contractual term Aggregate intrinsic value Options outstanding at December 31, 2018 59 $ 45.60 Granted 3,224 $ 0.68 Exercised (3 ) $ 0.95 Canceled/forfeited/expired (182 ) $ 6.81 Options outstanding at December 31, 2019 3,098 $ 1.17 9.6 $ 703 Exercisable at December 31, 2019 237 $ 6.78 8.5 $ 35 The weighted average grant date fair value per share of employee stock options granted during the years ended December 31, 2019 and 2018 was $0.52 and $8.63 , respectively. The total intrinsic value of stock options exercised was less than $0.1 million for the years ended December 31, 2019, and 2018. Cash received from the exercise of stock options was less than $0.1 million for the years ended December 31, 2019 and 2018. The total compensation cost related to stock options not yet recognized was $1.2 million as of December 31, 2019 . The weighted-average period over which this expense is expected to be recognized is approximately 1.7 years . The following table summarizes our RSU activity under all equity incentive plans for the year ended December 31, 2019 (shares and aggregate intrinsic value in thousands): Number of options Weighted average grant date fair value Weighted average remaining contractual term Aggregate intrinsic value RSUs outstanding at December 31, 2018 601 $ 1.50 Granted 287 $ 0.95 Vested (559 ) $ 1.27 Canceled/forfeited/expired (200 ) $ 1.34 RSUs outstanding at December 31, 2019 129 $ 1.50 0.8 $ 115 The total compensation cost related to non-vested RSUs not yet recognized was $0.4 million as of December 31, 2019 . The weighted-average period over which this expense is expected to be recognized is approximately 0.8 years . Stock-Based Compensation The following table summarizes the weighted average assumptions used to estimate the fair value of stock options and performance stock awards granted to employees under our 2012 Equity Incentive Plan, 2015 Inducement Plan, 2019 Equity Incentive Plan and the shares purchasable under our Employee Stock Purchase Plan during the periods presented: Year ended December 31, 2019 2018 Stock options Risk-free interest rate 1.7 % 2.7 % Volatility 94.6 % 87.8 % Dividend yield — — Expected term (years) 6.1 6.1 Performance stock options Risk-free interest rate 2.6 % 2.7 % Volatility 93.8 % 87.4 % Dividend yield — — Expected term (years) 6.1 5.7 Employee stock purchase plan shares Risk-free interest rate 2.3 % 1.9 % Volatility 110.5 % 100.6 % Dividend yield — — Expected term (years) 0.5 0.5 Risk-free interest rate - The risk-free interest rate assumption was based on observed interest rates appropriate for the expected term of the stock option grants. Expected dividend yield - The expected dividend yield assumption was based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends. Expected volatility - The expected volatility assumption was based on the historical volatility of the trading price of our common stock. Expected term - The expected term represents the period of time that options are expected to be outstanding. Because we do not have sufficient historical exercise behavior data, we determine the expected life using the simplified method, which was an average of the contractual term of the option and its ordinary vesting period. Forfeitures - We account for forfeitures as they occur. The following table summarizes the allocation of our stock-based compensation expense for all stock awards during the periods presented (in thousands): Year ended December 31, 2019 2018 Research and development $ 309 $ 2,256 General and administrative 1,979 3,184 Total $ 2,288 $ 5,440 Employee Stock Purchase Plan In October 2012, we adopted the 2012 Employee Stock Purchase Plan (“2012 Purchase Plan”), which enables participants to contribute up to 15% of such participant’s eligible compensation during a defined six-month period to purchase our common stock. The purchase price of common stock under the 2012 Purchase Plan will be the lesser of: (i) 85% of the fair market value of our common stock at the inception of the enrollment period or (ii) 85% of the fair market value of our common stock at the applicable purchase date. As of December 31, 2019 , 91,948 shares of our common stock had been issued under the 2012 Purchase Plan, with 4,035 shares of common stock issued for the year ended December 31, 2019. Under the 2012 Purchase Plan, 192,687 shares of our common stock were reserved for future issuance and have been authorized for purchase as of December 31, 2019 . |
Defined Contribution Plan
Defined Contribution Plan | 12 Months Ended |
Dec. 31, 2019 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | Defined Contribution Plan In 2009, we established an employee 401(k) salary deferral plan (“401(k) Plan”) covering all eligible employees. Active employees who are at least 18 years old and are not otherwise disqualified under the terms of the 401(k) Plan are eligible to participate. Employees may contribute up to 50% of their compensation per year (subject to a maximum limit prescribed by federal tax law). Under the 401(k) Plan, we may elect to match a discretionary percentage of employee contributions. We elected to match 50% of employees’ contributions up to 6% of the employees’ eligible salary for the periods presented. We made matching contributions of $0.1 million for the years ended December 31, 2019 and 2018 . |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The following table summarizes the components of our income tax (benefit) expense (in thousands): Year ended December 31, 2019 2018 Current: Federal $ (13 ) $ (26 ) State 1 1 (12 ) (25 ) Deferred: Federal 13 87 State — — 13 87 Income tax expense $ 1 $ 62 The following is a reconciliation of the expected statutory federal income tax provision to our actual income tax provision (in thousands): Year ended December 31, 2019 2018 Expected income tax benefit at federal statutory tax rate $ (3,904 ) $ (10,216 ) State income taxes, net of federal benefit (1,390 ) (3,005 ) Tax credits (374 ) (3,666 ) Change in valuation allowance 603 12,706 Return to provision adjustments (358 ) 441 Stock compensation 3,934 251 Reserve for uncertain tax positions 1,444 3,596 Other 46 (45 ) Income tax expense $ 1 $ 62 The following table summarizes the significant components of our deferred tax assets and liabilities (in thousands): December 31, 2019 2018 Deferred tax assets: Net operating loss carryovers $ 79,675 $ 74,965 Research and development and other tax credits 33,429 33,121 Deferred revenue 1 16 Intangibles and property and equipment basis difference 782 — Stock compensation expense 1,389 5,033 Lease liability 164 — Other 461 2,027 Total deferred tax assets 115,901 115,162 Total deferred tax liabilities (325 ) (176 ) Net deferred tax asset 115,576 114,986 Valuation allowance (115,564 ) (114,960 ) Net deferred tax asset $ 12 $ 26 For all periods presented, we have determined that it is more likely than not that our deferred tax asset will not be realized, with the exception of the refundable AMT tax credit. Accordingly, we have recorded a valuation allowance to offset the net deferred tax asset of $115.6 million . As of December 31, 2019, we had NOL carryforwards for U.S. federal and California state tax purposes of $328.0 million and $276.0 million , respectively, which begin to expire in 2030 and 2031, respectively. The federal NOL generated after 2017 of $64.6 million will carry forward indefinitely and be available to offset up to 80% of future taxable income each year. As of December 31, 2019, we also had federal and California research and development tax credit carryforwards of $31.1 million and $9.1 million , respectively. The federal research and development tax credit carryforwards will begin to expire in 2029. The California research and development tax credit carryforwards are available indefinitely. Pursuant to Sections 382 and 383, use of the Company’s net operating loss and credit carryforwards may be limited if a cumulative change in ownership of more than 50% (by value) occurs within a three-year period. The Company has not performed an analysis through December 31, 2019 to determine whether its net operating loss and research and development credit carryforwards are subject to annual limitation under Sections 382 or 383 of the Code, and these financial statements do not contain any adjustment relating to such potential limitations. However, if the Company experienced an ownership change that resulted in an annual limitation on the Company’s net operating loss carryforwards under Section 382 of the Code there would be no material impact to the Company’s financial statements. The following table summarizes the changes in the amount of our unrecognized tax benefits (in thousands): Year Ended December 31, 2019 2018 Beginning balance of unrecognized tax benefits $ 14,700 $ 4,421 (Decrease) increase for prior year tax positions (7 ) 5,961 Increase for current year tax positions 1,880 4,318 Total $ 16,573 $ 14,700 Included in unrecognized tax benefits of $16.6 million at December 31, 2019 was $13.3 million of tax benefits that, if recognized, would reduce our annual effective tax rate, subject to valuation allowance. We do not expect that there will be a significant change in the unrecognized tax benefits over the next 12 months. We are subject to taxation in the United States and state jurisdictions where applicable. Our tax years for 2009 and forward are subject to examination by the U.S. tax authorities and our tax years for 2010 and forward are subject to examination by the California tax authorities due to carryforward of unutilized net operating losses and research and development credits. It is our practice to recognize interest and/or penalties related to income tax matters in income tax expense. For the years ended December 31, 2019 and 2018 , we have not recognized any interest or penalties related to income taxes. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | Leases At the inception of a contractual arrangement, we determine whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. For operating leases with an initial term greater than 12 months, we recognize operating lease ROU assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease ROU assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when we are reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For our operating leases, we generally cannot determine the interest rate implicit in the lease, in which case we use our incremental borrowing rate as the discount rate for the lease. We estimate our incremental borrowing rate for our operating leases based on what we would normally pay to borrow on a collateralized basis over a similar term for an amount equal to the lease payments. Operating lease expense is recognized on a straight-line basis over the lease term. Leases with a lease term of 12 months or less are not recorded on the balance sheet. Instead, we recognize lease expense for these leases on a straight-line basis over the lease term. Our lease agreements do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Certain leases require us to pay taxes, insurance, utilities, and maintenance costs for the building, which do not represent lease components. We elected to not separate lease and non-lease components. In July 2015, we entered into an operating lease agreement (the "Prior Lease") for approximately 59,248 square feet of office and laboratory facility space located at 10614 Science Center Drive, San Diego, California 92121. The lease term was 96 months from the lease commencement date, and we moved our headquarters into this facility in May 2016. In conjunction with the lease, we received $1.4 million of lease incentives and $8.2 million of tenant improvement allowance, which was to be used for non-structural leasehold improvements. The lease incentives and tenant improvement allowance were included within deferred rent. Our deferred rent balance as of December 31, 2018 was $8.0 million . The Prior Lease agreement was with ARE SD Region No. 44 LLC (“Landlord”). On February 19, 2019, we entered into an agreement, the (“Space Swap Agreement"), with Nitto Biopharma, Inc. ("Nitto"), pursuant to which we agreed, contingent upon the execution of a new lease agreement (the "February Lease") for Nitto's space with Landlord and the termination of the Prior Lease, to, among other things, (i) swap buildings with Nitto, and (ii) sell, convey and transfer all right, title and interest in certain furniture, fixtures and equipment to Nitto, as set forth in the Space Swap Agreement. Under the Space Swap Agreement, we paid Nitto (a) a relocation assistance payment in the amount of $0.1 million ; (b) $0.2 million representing the difference between the security deposits under the Prior Lease and Nitto’s prior lease, and (c) $1.3 million as reimbursement for the six monthly installments of base monthly rent due pursuant to the new lease between Nitto and Landlord, subject to certain adjustments, which reimbursements are to be paid as rent comes due for Nitto under its new lease. On February 25, 2019, we and Landlord entered into a second amendment (the “Prior Lease Amendment”) to the Prior Lease. Under the terms of the Prior Lease Amendment, the expiration date of the Prior Lease was accelerated from April 30, 2024 to March 31, 2019 and the Prior Lease terminated on April 1, 2019. The Prior Lease Amendment eliminated all further cash payments due under the Prior Lease, including aggregate base rent over its remaining term of approximately $14.4 million . On February 25, 2019, we entered into the February Lease with Landlord, for the lease of approximately 24,562 square feet of rentable area of the building located at 10628 Science Center Drive, San Diego, California, 92121 (the "Premises"), which Premises were previously occupied by Nitto. The commencement date of the February Lease was April 1, 2019 (the “Commencement Date”). The Premises served as our new principal executive offices and as a laboratory for research and development, manufacturing and other related uses. The term of the February Lease (“Initial Term”) was 51 months , ending June 30, 2023. The aggregate base rent due over the Initial Term was approximately $4.8 million . We were also responsible for the payment of additional rent to cover our share of the annual operating expenses, the annual tax expenses and the annual utilities costs related to the February Lease. The base rent payments due were: $0.6 million in 2019, $1.2 million in 2020, $1.2 million in 2021, $1.2 million in 2022, and $0.6 million in 2023. The execution of the February Lease and Prior Lease Amendment resulted in a modification which was not accounted for as a separate contract. Rather, we accounted for the two contracts with Landlord in combination as they were entered into at the same time and negotiated as a package to achieve the same commercial objective. The leasehold improvements under the Prior Lease were accounted for as non-cash consideration of $5.6 million paid by us upon termination of the Prior Lease to the Landlord. We accounted for a $1.3 million portion of the reduction in the lease liability for the Prior Lease as a non-cash gain in the statement of operations due to the reduction in lease term and leased space with Landlord and a $0.9 million portion of the reduction of the lease liability as a deferred credit that is amortized as a reduction to rent expense over the term of the Lease. The $1.6 million obligation to reimburse Nitto for six monthly installments of base rent of the Prior Lease and certain other costs were accounted for as cost of terminating the Prior Lease in the statement of operations. The net impact of the modification was a $0.4 million charge in the statement of operations. Our payment obligations to Nitto under the Space Swap Agreement were fully satisfied as of September 2019 and no assets or liabilities remained with respect to the Prior Lease as of December 31, 2019. The commencement date of the February Lease did not occur until April 1, 2019 and therefore, as of March 31, 2019, the lease liability for the February Lease was zero. On April 1, 2019, we recorded a $3.8 million lease liability for the February Lease, which was calculated as the present value of future lease payments to be made under the February Lease. A $2.9 million ROU asset was also recorded on April 1, 2019, which represents the difference between the lease liability and the $0.9 million deferred credit for the reduction of the lease liability under the Prior Lease. On June 19, 2019, we entered into a lease agreement (the “New Lease”) with Landlord for the lease of approximately 8,727 square feet of rentable area of the building located at 10628 Science Center Drive, Suite 225, San Diego, California 92121 (the “New Premises”). The commencement date of the New Lease was July 1, 2019 (the “New Commencement Date”). We are using the New Premises as our new principal executive offices and as a laboratory for research and development and other related uses. The term of the New Lease (the “New Initial Term”) is two years, six months , ending December 31, 2021. The base rent payments due for the New Premises are: $0.1 million in 2019, $0.4 million in 2020 and $0.4 million in 2021, net of certain rent abatement terms. We will also be responsible for the payment of additional rent to cover our share of the annual operating expenses of the building, the annual tax expenses of the building and the annual utilities cost of the building. On June 19, 2019, we entered into a first amendment to the February Lease with Landlord (the “February Lease Amendment”). Under the terms of the February Lease Amendment, the expiration date of the February Lease was accelerated from June 30, 2023 to June 30, 2019 and the February Lease terminated upon the Commencement Date of the New Lease. The February Lease Amendment eliminated all further rents due under the February Lease, including aggregate base rent over its remaining term of approximately $4.8 million . The execution of the New Lease and February Lease Amendment resulted in a modification which was not accounted for as a separate contract. Rather, we accounted for the two contracts with Landlord in combination as they were entered into at the same time and negotiated as a package to achieve the same commercial objective. We accounted for a $0.5 million portion of the reduction in the lease liability for the February Lease as a non-cash gain in the statement of operations due to the reduction in lease term and leased space with Landlord and a $0.2 million portion of the reduction of the lease liability as a deferred credit that is amortized as a reduction to rent expense over the term of the New Lease. No other assets or liabilities remained with respect to the February Lease as of December 31, 2019. The commencement date of the New Lease did not occur until July 1, 2019 and therefore, as of June 30, 2019, the lease liability for the New Lease was zero . On July 1, 2019, we recorded a $0.8 million lease liability for the New Lease, which was calculated as the present value of future lease payments to be made under the New Lease. A $0.6 million ROU asset was also recorded on July 1, 2019, which represents the difference between the lease liability and the remaining $0.2 million deferred credit for the reduction of the lease liability under the February Lease. The table below summarizes our lease liabilities and corresponding ROU assets as of December 31, 2019 (in thousands): Assets Operating $ 464 Financing 466 Total ROU assets $ 930 Liabilities Current: Operating $ 361 Financing 277 Long-term: Operating 417 Financing 56 Total lease liabilities $ 1,111 Rent expense for the years ended December 31, 2019 and 2018 was $0.7 million and $1.3 million , respectively. The table below summarizes our lease costs from our statement of operations and cash payments from our statement of cash flows during the year ended December 31, 2019 (in thousands): Year ended Lease cost: Operating lease cost $ 715 Finance lease cost: Amortization of right-of-use assets 182 Interest expense on lease liabilities 5 Total lease cost $ 902 Cash payment information: Operating cash used for operating leases $ 756 Operating cash used for finance leases 24 Financing cash used for finance leases 263 Total cash paid for amounts included in the measurement of lease liabilities $ 1,043 The table below summarizes other non-cash information under our operating and financing lease obligations as of December 31, 2019 (in thousands, except years and rates): Supplemental non-cash information: Operating lease liabilities arising from obtaining right-of-use assets $ 778 Weighted-average remaining lease term (years) - operating leases 2.0 Weighted-average remaining lease term (years) - finance leases 1.2 Weighted-average discount rate - operating leases 10.9 % Weighted-average discount rate - finance leases 4.9 % Our future lease payments under operating and finance leases at December 31, 2019 are as follows (in thousands): Operating Leases Finance Leases 2020 429 287 2021 442 57 Total lease payments $ 871 $ 344 Less: amount representing interest (93 ) (11 ) Present value of obligations under leases 778 333 Less: current portion (361 ) (277 ) Long-term lease obligations $ 417 $ 56 As of December 31, 2018, prior to the adoption of the new leases standard, aggregate future annual minimum lease payments for the Company’s operating lease were as follows: $2.7 million in 2019 and 2020, $2.8 million in 2021, $2.9 million in 2022, $3.0 million in 2023 and $1.0 million thereafter. |
Leases | Leases At the inception of a contractual arrangement, we determine whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. For operating leases with an initial term greater than 12 months, we recognize operating lease ROU assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease ROU assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when we are reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For our operating leases, we generally cannot determine the interest rate implicit in the lease, in which case we use our incremental borrowing rate as the discount rate for the lease. We estimate our incremental borrowing rate for our operating leases based on what we would normally pay to borrow on a collateralized basis over a similar term for an amount equal to the lease payments. Operating lease expense is recognized on a straight-line basis over the lease term. Leases with a lease term of 12 months or less are not recorded on the balance sheet. Instead, we recognize lease expense for these leases on a straight-line basis over the lease term. Our lease agreements do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Certain leases require us to pay taxes, insurance, utilities, and maintenance costs for the building, which do not represent lease components. We elected to not separate lease and non-lease components. In July 2015, we entered into an operating lease agreement (the "Prior Lease") for approximately 59,248 square feet of office and laboratory facility space located at 10614 Science Center Drive, San Diego, California 92121. The lease term was 96 months from the lease commencement date, and we moved our headquarters into this facility in May 2016. In conjunction with the lease, we received $1.4 million of lease incentives and $8.2 million of tenant improvement allowance, which was to be used for non-structural leasehold improvements. The lease incentives and tenant improvement allowance were included within deferred rent. Our deferred rent balance as of December 31, 2018 was $8.0 million . The Prior Lease agreement was with ARE SD Region No. 44 LLC (“Landlord”). On February 19, 2019, we entered into an agreement, the (“Space Swap Agreement"), with Nitto Biopharma, Inc. ("Nitto"), pursuant to which we agreed, contingent upon the execution of a new lease agreement (the "February Lease") for Nitto's space with Landlord and the termination of the Prior Lease, to, among other things, (i) swap buildings with Nitto, and (ii) sell, convey and transfer all right, title and interest in certain furniture, fixtures and equipment to Nitto, as set forth in the Space Swap Agreement. Under the Space Swap Agreement, we paid Nitto (a) a relocation assistance payment in the amount of $0.1 million ; (b) $0.2 million representing the difference between the security deposits under the Prior Lease and Nitto’s prior lease, and (c) $1.3 million as reimbursement for the six monthly installments of base monthly rent due pursuant to the new lease between Nitto and Landlord, subject to certain adjustments, which reimbursements are to be paid as rent comes due for Nitto under its new lease. On February 25, 2019, we and Landlord entered into a second amendment (the “Prior Lease Amendment”) to the Prior Lease. Under the terms of the Prior Lease Amendment, the expiration date of the Prior Lease was accelerated from April 30, 2024 to March 31, 2019 and the Prior Lease terminated on April 1, 2019. The Prior Lease Amendment eliminated all further cash payments due under the Prior Lease, including aggregate base rent over its remaining term of approximately $14.4 million . On February 25, 2019, we entered into the February Lease with Landlord, for the lease of approximately 24,562 square feet of rentable area of the building located at 10628 Science Center Drive, San Diego, California, 92121 (the "Premises"), which Premises were previously occupied by Nitto. The commencement date of the February Lease was April 1, 2019 (the “Commencement Date”). The Premises served as our new principal executive offices and as a laboratory for research and development, manufacturing and other related uses. The term of the February Lease (“Initial Term”) was 51 months , ending June 30, 2023. The aggregate base rent due over the Initial Term was approximately $4.8 million . We were also responsible for the payment of additional rent to cover our share of the annual operating expenses, the annual tax expenses and the annual utilities costs related to the February Lease. The base rent payments due were: $0.6 million in 2019, $1.2 million in 2020, $1.2 million in 2021, $1.2 million in 2022, and $0.6 million in 2023. The execution of the February Lease and Prior Lease Amendment resulted in a modification which was not accounted for as a separate contract. Rather, we accounted for the two contracts with Landlord in combination as they were entered into at the same time and negotiated as a package to achieve the same commercial objective. The leasehold improvements under the Prior Lease were accounted for as non-cash consideration of $5.6 million paid by us upon termination of the Prior Lease to the Landlord. We accounted for a $1.3 million portion of the reduction in the lease liability for the Prior Lease as a non-cash gain in the statement of operations due to the reduction in lease term and leased space with Landlord and a $0.9 million portion of the reduction of the lease liability as a deferred credit that is amortized as a reduction to rent expense over the term of the Lease. The $1.6 million obligation to reimburse Nitto for six monthly installments of base rent of the Prior Lease and certain other costs were accounted for as cost of terminating the Prior Lease in the statement of operations. The net impact of the modification was a $0.4 million charge in the statement of operations. Our payment obligations to Nitto under the Space Swap Agreement were fully satisfied as of September 2019 and no assets or liabilities remained with respect to the Prior Lease as of December 31, 2019. The commencement date of the February Lease did not occur until April 1, 2019 and therefore, as of March 31, 2019, the lease liability for the February Lease was zero. On April 1, 2019, we recorded a $3.8 million lease liability for the February Lease, which was calculated as the present value of future lease payments to be made under the February Lease. A $2.9 million ROU asset was also recorded on April 1, 2019, which represents the difference between the lease liability and the $0.9 million deferred credit for the reduction of the lease liability under the Prior Lease. On June 19, 2019, we entered into a lease agreement (the “New Lease”) with Landlord for the lease of approximately 8,727 square feet of rentable area of the building located at 10628 Science Center Drive, Suite 225, San Diego, California 92121 (the “New Premises”). The commencement date of the New Lease was July 1, 2019 (the “New Commencement Date”). We are using the New Premises as our new principal executive offices and as a laboratory for research and development and other related uses. The term of the New Lease (the “New Initial Term”) is two years, six months , ending December 31, 2021. The base rent payments due for the New Premises are: $0.1 million in 2019, $0.4 million in 2020 and $0.4 million in 2021, net of certain rent abatement terms. We will also be responsible for the payment of additional rent to cover our share of the annual operating expenses of the building, the annual tax expenses of the building and the annual utilities cost of the building. On June 19, 2019, we entered into a first amendment to the February Lease with Landlord (the “February Lease Amendment”). Under the terms of the February Lease Amendment, the expiration date of the February Lease was accelerated from June 30, 2023 to June 30, 2019 and the February Lease terminated upon the Commencement Date of the New Lease. The February Lease Amendment eliminated all further rents due under the February Lease, including aggregate base rent over its remaining term of approximately $4.8 million . The execution of the New Lease and February Lease Amendment resulted in a modification which was not accounted for as a separate contract. Rather, we accounted for the two contracts with Landlord in combination as they were entered into at the same time and negotiated as a package to achieve the same commercial objective. We accounted for a $0.5 million portion of the reduction in the lease liability for the February Lease as a non-cash gain in the statement of operations due to the reduction in lease term and leased space with Landlord and a $0.2 million portion of the reduction of the lease liability as a deferred credit that is amortized as a reduction to rent expense over the term of the New Lease. No other assets or liabilities remained with respect to the February Lease as of December 31, 2019. The commencement date of the New Lease did not occur until July 1, 2019 and therefore, as of June 30, 2019, the lease liability for the New Lease was zero . On July 1, 2019, we recorded a $0.8 million lease liability for the New Lease, which was calculated as the present value of future lease payments to be made under the New Lease. A $0.6 million ROU asset was also recorded on July 1, 2019, which represents the difference between the lease liability and the remaining $0.2 million deferred credit for the reduction of the lease liability under the February Lease. The table below summarizes our lease liabilities and corresponding ROU assets as of December 31, 2019 (in thousands): Assets Operating $ 464 Financing 466 Total ROU assets $ 930 Liabilities Current: Operating $ 361 Financing 277 Long-term: Operating 417 Financing 56 Total lease liabilities $ 1,111 Rent expense for the years ended December 31, 2019 and 2018 was $0.7 million and $1.3 million , respectively. The table below summarizes our lease costs from our statement of operations and cash payments from our statement of cash flows during the year ended December 31, 2019 (in thousands): Year ended Lease cost: Operating lease cost $ 715 Finance lease cost: Amortization of right-of-use assets 182 Interest expense on lease liabilities 5 Total lease cost $ 902 Cash payment information: Operating cash used for operating leases $ 756 Operating cash used for finance leases 24 Financing cash used for finance leases 263 Total cash paid for amounts included in the measurement of lease liabilities $ 1,043 The table below summarizes other non-cash information under our operating and financing lease obligations as of December 31, 2019 (in thousands, except years and rates): Supplemental non-cash information: Operating lease liabilities arising from obtaining right-of-use assets $ 778 Weighted-average remaining lease term (years) - operating leases 2.0 Weighted-average remaining lease term (years) - finance leases 1.2 Weighted-average discount rate - operating leases 10.9 % Weighted-average discount rate - finance leases 4.9 % Our future lease payments under operating and finance leases at December 31, 2019 are as follows (in thousands): Operating Leases Finance Leases 2020 429 287 2021 442 57 Total lease payments $ 871 $ 344 Less: amount representing interest (93 ) (11 ) Present value of obligations under leases 778 333 Less: current portion (361 ) (277 ) Long-term lease obligations $ 417 $ 56 As of December 31, 2018, prior to the adoption of the new leases standard, aggregate future annual minimum lease payments for the Company’s operating lease were as follows: $2.7 million in 2019 and 2020, $2.8 million in 2021, $2.9 million in 2022, $3.0 million in 2023 and $1.0 million thereafter. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | Selected Quarterly Financial Data (Unaudited) The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for 2019 and 2018 are as follows (in thousands, except per share data): For the quarters ending March 31 June 30 September 30 December 31 2019 Total revenues $ 6,778 $ 18 $ 18 $ 18 Total operating expenses (9,516 ) (4,686 ) (5,011 ) (4,453 ) Net loss (3,260 ) (5,016 ) (5,423 ) (4,893 ) Net loss per share, basic and diluted (1) $ (0.31 ) $ (0.30 ) $ (0.26 ) $ (0.23 ) 2018 Total revenues $ 18 $ 18 $ 18 $ 18 Total operating expenses (15,601 ) (13,362 ) (9,872 ) (8,000 ) Net loss (16,025 ) (13,847 ) (10,273 ) (8,563 ) Net loss per share, basic and diluted (1) $ (1.85 ) $ (1.59 ) $ (1.18 ) $ (0.98 ) (1) Net loss per share is computed independently for each of the quarters presented. Therefore, the sum of the quarterly per-share calculations will not necessarily equal the annual per share calculation. |
The Business, Basis of Presen_2
The Business, Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates Our financial statements are prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), which requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes. An estimated loss contingency is accrued in our financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Although these estimates are based on our knowledge of current events and actions we may undertake in the future, actual results may ultimately differ from these estimates and assumptions. |
Revenue Recognition | Revenue Recognition Our revenues generally consist of upfront payments for licenses or options to obtain licenses in the future, milestone payments and payments for other research services under license and collaboration agreements. Effective January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) (“Topic 606”) using the modified retrospective method which consisted of applying and recognizing the cumulative effect of Topic 606 at the date of initial application. Topic 606 supersedes the revenue recognition requirements in Accounting Standards Codification (“ASC”) Topic 605, Revenue Recognition (“Topic 605”). The following paragraphs in this section describe our revenue recognition accounting polices under Topic 606 upon adoption on January 1, 2018. Refer to Note 1 to the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2017 for revenue recognition accounting policies under Topic 605. We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligation(s). At contract inception, we assess the goods or services promised within each contract, assess whether each promised good or service is distinct and identify those that are performance obligations. We recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Collaborative Arrangements We enter into collaborative arrangements with partners that typically include payment to us of one of more of the following: (i) license fees; (ii) payments related to the achievement of developmental, regulatory, or commercial milestones; and (iii) royalties on net sales of licensed products. Where a portion of non-refundable up-front fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as contract liabilities and recognized as revenue when (or as) the underlying performance obligation is satisfied. As part of the accounting for these arrangements, we must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligation(s). The stand-alone selling price may include items such as forecasted revenues, development timelines, discount rates, and probabilities of technical and regulatory success. We evaluate each performance obligation to determine if it can be satisfied at a point in time, or over time. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. License Fees If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other performance obligations, we use judgment to assess the nature of the combined performance obligation to determine whether it is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes milestone payments (variable consideration), we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price. If it is probable that a milestone event would occur at the inception of an arrangement, the associated milestone value is included in the transaction price. Milestone payments that are contingent upon the achievement of events that are uncertain or not controllable, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received, and therefore not included in the transaction price. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, we evaluate the probability of achievement of such milestones and any related constraint(s), and if necessary, may adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which could affect license, collaboration or other revenues and earnings in the period of adjustment. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, we have not recognized any royalty revenue resulting from any of our collaborative arrangements. |
Stock-Based Compensation | Stock-Based Compensation We account for stock-based compensation expense related to stock options granted to employees and members of our board of directors by estimating the fair value of each stock option on the date of grant using the Black-Scholes option pricing model. We recognize stock-based compensation expense using the accelerated multiple-option approach. Under the accelerated multiple-option approach (also known as the graded-vesting method), we recognize compensation expense over the requisite service period for each separately vesting tranche of the award as though the award was in substance multiple awards, resulting in accelerated expense recognition over the vesting period. For performance-based awards granted to employees (i) the fair value of the award is determined on the grant date, (ii) we assess the probability of the individual milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. We account for restricted stock units by determining the fair value of each restricted stock unit based on the closing market price of our common stock on the date of grant. We recognize stock-based compensation expense using the accelerated multiple-option approach over the requisite service periods of the awards. |
Clinical Trial and Preclinical Study Accruals | Clinical Trial and Preclinical Study Accruals We make estimates of our accrued expenses for clinical trial and preclinical study activities as of each balance sheet date in our financial statements based on the facts and circumstances known to us at that time. These accruals are based upon estimates of costs incurred and fees that may be associated with services provided by clinical trial investigational sites, CROs and for other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of clinical trial milestones. In accruing for these services, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from these service providers. However, we may be required to estimate these services based on other information available to us. If we underestimate or overestimate the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in our accruals. |
Prepaid Materials | Prepaid Materials We capitalize the purchase of certain raw materials and related supplies for use in the manufacturing of drug product in our preclinical and clinical development programs, as we have determined that these materials have alternative future use. We can use these raw materials and related supplies in multiple clinical drug products, and therefore have future use independent of the development status of any particular drug program until it is utilized in the manufacturing process. We expense the cost of materials when used. We periodically review these capitalized materials for continued alternative future use and write down the asset to its net realizable value in the period in which an impairment is identified. |
Research and Development | Research and Development Research and development costs are expensed as incurred and consist of costs associated with research activities supporting our drug discovery efforts, compensation and related benefits, non-cash stock-based compensation, license fees, laboratory supplies and associated overhead and facility costs. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. This approach requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of the differences between the tax basis of assets or liabilities and their carrying amounts in the financial statements using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. We provide a valuation allowance against net deferred tax assets if it is more likely than not that these items will either expire before we are able to realize their benefit or if future deductibility is uncertain. In accordance with the accounting standards for uncertain tax positions, we evaluate the recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. |
Cash and Cash Equivalents | Cash and Cash Equivalents We classify time deposits and other investments that are highly liquid and have maturities of 90 days or less at the date of purchase as cash equivalents. The carrying amounts approximate fair value due to the short maturities of these instruments. |
Concentration of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash equivalents and short-term investments. We maintain deposits in federally insured financial institutions in excess of federally insured limits. We have not experienced any material losses in such accounts and believe we are not exposed to significant risk. We maintain our cash equivalents with two highly accredited financial institutions. We have historically invested our excess cash primarily in certificates of deposit and debt instruments of financial institutions and corporations, United States Treasury securities and United States government-sponsored enterprise securities. Additionally, we adhere to established guidelines regarding approved investments and maturities of investments, which are designed to preserve their principal value and maintain liquidity. |
Property and Equipment | Property and Equipment We carry our property and equipment at cost, which consists of lab equipment, computer equipment and software, furniture and fixtures and leasehold improvements. Property and equipment is depreciated using the straight-line method over the estimated useful lives (generally three to five years). Leasehold improvements are amortized over the lesser of their useful life or the remaining lease term, including any renewal periods that are deemed to be reasonably assured. Repair and maintenance costs that do not improve service potential or extend economic life are expensed as incurred. |
Intangibles | Intangibles We capitalize costs which consist principally of outside legal costs and filing fees related to obtaining patents. We review our capitalized patent costs periodically to determine that they include costs for patent applications that have future value and an alternative future use. We evaluate costs related to patents that we are not actively pursuing and write off these costs. We amortize patent costs over their patent lives, beginning with the date the patents are issued. The weighted average remaining life of the issued patents was approximately 7 years at December 31, 2019 . We obtain licenses from third parties and capitalize the costs related to exclusive licenses that have alternative future use within multiple potential programs. We amortize capitalized licenses over their estimated useful life or term of the agreement. We did not have any licenses capitalized on our balance sheet at December 31, 2019 and 2018. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets We regularly review the carrying amount of our property, equipment and intangible assets to determine whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. If indications of impairment exist, projected future undiscounted cash flows associated with the asset are compared to the carrying amount to determine whether the asset’s value is recoverable. If the carrying value of the asset exceeds such projected undiscounted cash flows, the asset will be written down to its estimated fair value. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, we have viewed our operations and managed our business as one segment operating primarily within the United States. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. Our only component of other comprehensive loss is unrealized losses on available-for-sale securities. Comprehensive losses have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements of stockholders’ equity for all periods presented. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements As disclosed above, effective January 1, 2018, we adopted Topic 606. Since ASU 2014-09 was issued, several additional ASUs have been issued and incorporated within Topic 606 to clarify various elements of the guidance. As part of our adoption efforts, we have completed the assessment of our collaboration and license agreements under Topic 606. We adopted Topic 606 in the first quarter of 2018 using the modified retrospective method which consists of applying and recognizing the cumulative effect of Topic 606 at the date of initial application and providing certain additional disclosures as defined per Topic 606. On January 1, 2018, we recorded a cumulative adjustment to decrease deferred revenue and accumulated deficit by approximately $1.8 million to reflect the impact of the adoption of Topic 606. The cumulative adjustment relates primarily to our agreement with Sanofi which is described further in Note 5. Below is a summary of the affected line items of the balance sheets upon adoption of Topic 606 (in thousands): Balance at December 31, 2017 Adjustments due to Topic 606 Balance at January 1, 2018 Balance Sheet Deferred revenue (contract liabilities), non-current 1,921 (1,844 ) 77 Accumulated deficit (345,858 ) 1,844 (344,014 ) There was no impact on revenue recognized in 2019 or 2018 as a result of the adoption of Topic 606. In February 2016, the FASB issued ASU No. 2016-02, Leases, which increases transparency and comparability among organizations by requiring recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements. Since ASU 2016-02 was issued, several additional ASUs have been issued to clarify various elements of the guidance. The standard is effective for annual reporting periods beginning after December 15, 2018, including interim periods within those annual reporting periods. We adopted the new lease standard on January 1, 2019, using the alternative modified transition method provided by the standard and did not retrospectively apply to prior periods. We elected the “package of practical expedients” (excluding the hindsight practical expedient) permitted under the transition guidance which allows us to not reassess our historical assessment of whether existing contracts are or contain a lease and the classification of existing lease arrangements. As a result of the adoption of the new standard, we recognized operating lease right-of-use assets ("ROU assets") of $3.3 million and operating lease liabilities of $11.3 million on our balance sheet as of January 1, 2019. Operating lease ROU assets are recorded within our balance sheets as other assets and operating lease liabilities are recorded within our balance sheets as other current liabilities and other long-term liabilities. There was no change upon adoption to our capital leases, referred to as finance leases under the new lease standard. Our finance lease ROU asset and liability balances were each $0.6 million as of January 1, 2019. Finance lease ROU assets are recorded in property and equipment, net and current and non-current finance lease liabilities are recorded in other current liabilities and other long-term liabilities, respectively, in our balance sheets. The adoption of the new lease standard had no impact on our accumulated deficit and also had no impact on our results of operations and cash flows. See Note 13, Leases, for further detail. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . The amendments in this update replace the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Entities will apply the new guidance as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is adopted. This update is effective for annual periods beginning after December 15, 2019, and interim periods within those periods. Early adoption is permitted. The adoption of this guidance is not anticipated to have an impact on our financial statements. In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting , which aligns the measurement and classification guidance for share-based payment to non-employees with the guidance for share-based payments to employees. Under the new guidance, the measurement period for equity-classified non-employee awards will be fixed at the grant date. This update is effective for annual periods beginning after December 15, 2018, and interim periods within those periods. The adoption of this guidance had no impact on our financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement: Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement , which updates and modifies the disclosure requirements on fair value measurements in Topic 820, primarily in relation to Level 3 fair value measurements. This update is effective for annual periods beginning after December 15, 2019, and interim periods within those periods. Early adoption is permitted. The adoption of this guidance is not anticipated to have an impact on our financial statements. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements , which clarifies the interaction between Topic 808 , Collaborative Arrangements and Topic 606, including clarification around certain transactions between collaborative arrangement participants and adding unit-of-account guidance to Topic 808. This update is effective for annual periods beginning after December 15, 2019, and interim periods within those periods. Early adoption is permitted. The adoption of this guidance is not anticipated to have an impact on our financial statements. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes - Simplifying the Accounting for Income Taxes (“ASU 2019-12”). The guidance removes exceptions to the general principles in Income Taxes (Topic 740) for allocating tax expense between financial statement components, accounting basis differences stemming from an ownership change in foreign investments and interim period income tax accounting for year-to-date losses that exceed projected losses. The guidance becomes effective for annual reporting periods beginning after December 15, 2020 and interim periods within those fiscal years with early adoption permitted. The Company plans to adopt ASU 2019-12 effective January 1, 2020 and does not expect this adoption to have a material impact on our financial statements. |
Fair Value Measurements | Fair Value Measurements We have certain financial assets recorded at fair value which have been classified as Level 1, 2, or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. Accounting standards define 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 as of the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The accounting standards provide an established hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in valuing the asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are inputs that reflect our assumptions about the factors that market participants would use in valuing the asset or liability. The accounting standards prioritize the inputs used in measuring the fair value into the following hierarchy: • Level 1 includes financial instruments for which quoted market prices for identical instruments are available in active markets. • Level 2 includes financial instruments for which there are inputs other than quoted prices included within Level 1 that are observable for the instrument such as quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets with insufficient volume or infrequent transactions (less active markets) or model-driven valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data. • Level 3 includes financial instruments for which fair value is derived from valuation techniques in which one or more significant inputs are unobservable, including management’s own assumptions. |
The Business, Basis of Presen_3
The Business, Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | Below is a summary of the affected line items of the balance sheets upon adoption of Topic 606 (in thousands): Balance at December 31, 2017 Adjustments due to Topic 606 Balance at January 1, 2018 Balance Sheet Deferred revenue (contract liabilities), non-current 1,921 (1,844 ) 77 Accumulated deficit (345,858 ) 1,844 (344,014 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Hierarchy for Assets | The following table presents our fair value hierarchy for assets measured at fair value on a recurring basis as of December 31, 2019 and 2018 (in thousands): Fair value as of December 31, 2019 Total Level 1 Level 2 Level 3 Assets: Cash equivalents $ 8,909 $ 8,909 $ — $ — $ 8,909 $ 8,909 $ — $ — Fair value as of December 31, 2018 Total Level 1 Level 2 Level 3 Assets: Cash equivalents $ 11,173 $ 11,173 $ — $ — $ 11,173 $ 11,173 $ — $ — |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | The following table summarizes our major classes of property and equipment (in thousands): December 31, 2019 2018 Laboratory equipment $ 4,967 $ 8,163 Computer equipment and software 281 281 Furniture and fixtures — 706 Leasehold improvements 83 8,550 5,331 17,700 Less accumulated depreciation and amortization (4,410 ) (9,894 ) Property and equipment, net $ 921 $ 7,806 |
Intangible Assets, net (Tables)
Intangible Assets, net (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets | The following table summarizes our major classes of intangible assets (in thousands): December 31, 2019 2018 Patents $ 465 $ 721 Accumulated amortization - Patents (199 ) (221 ) Intangibles, net $ 266 $ 500 |
Term Loan (Tables)
Term Loan (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Future Principal Payments | Future principal payments for the Term Loan due under the Loan Agreement are as follows (in thousands): 2020 $ — 2021 9,035 2022 5,646 $ 14,681 |
Common Stock and Stockholders_2
Common Stock and Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Common Stock Reserved for Future Issuance | The following shares of common stock were reserved for future issuance as of December 31, 2019 (in thousands): Class A-1 convertible preferred stock outstanding (as-converted) 4,159 Class A-2 convertible preferred stock outstanding (as-converted) 32,884 Initial Closing warrants 13,890 Milestone Closing warrants 32,884 Common stock options outstanding 3,098 RSUs outstanding 129 Common stock available for future grant under the 2019 Equity Incentive Plan 404 Employee Stock Purchase Plan 192 Total common shares reserved for future issuance 87,640 |
Stock Option Activity | The following table summarizes our stock option activity under all equity incentive plans for the year ended December 31, 2019 (shares and aggregate intrinsic value in thousands): Number of Weighted Weighted average remaining contractual term Aggregate intrinsic value Options outstanding at December 31, 2018 59 $ 45.60 Granted 3,224 $ 0.68 Exercised (3 ) $ 0.95 Canceled/forfeited/expired (182 ) $ 6.81 Options outstanding at December 31, 2019 3,098 $ 1.17 9.6 $ 703 Exercisable at December 31, 2019 237 $ 6.78 8.5 $ 35 |
Schedule of Restricted Stock Units Activity | The following table summarizes our RSU activity under all equity incentive plans for the year ended December 31, 2019 (shares and aggregate intrinsic value in thousands): Number of options Weighted average grant date fair value Weighted average remaining contractual term Aggregate intrinsic value RSUs outstanding at December 31, 2018 601 $ 1.50 Granted 287 $ 0.95 Vested (559 ) $ 1.27 Canceled/forfeited/expired (200 ) $ 1.34 RSUs outstanding at December 31, 2019 129 $ 1.50 0.8 $ 115 |
Assumptions Used to Estimate Fair Value of Stock Options and Performance Stock and Employee Stock Purchase Plan | The following table summarizes the weighted average assumptions used to estimate the fair value of stock options and performance stock awards granted to employees under our 2012 Equity Incentive Plan, 2015 Inducement Plan, 2019 Equity Incentive Plan and the shares purchasable under our Employee Stock Purchase Plan during the periods presented: Year ended December 31, 2019 2018 Stock options Risk-free interest rate 1.7 % 2.7 % Volatility 94.6 % 87.8 % Dividend yield — — Expected term (years) 6.1 6.1 Performance stock options Risk-free interest rate 2.6 % 2.7 % Volatility 93.8 % 87.4 % Dividend yield — — Expected term (years) 6.1 5.7 Employee stock purchase plan shares Risk-free interest rate 2.3 % 1.9 % Volatility 110.5 % 100.6 % Dividend yield — — Expected term (years) 0.5 0.5 |
Stock-Based Compensation | The following table summarizes the allocation of our stock-based compensation expense for all stock awards during the periods presented (in thousands): Year ended December 31, 2019 2018 Research and development $ 309 $ 2,256 General and administrative 1,979 3,184 Total $ 2,288 $ 5,440 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The following table summarizes the components of our income tax (benefit) expense (in thousands): Year ended December 31, 2019 2018 Current: Federal $ (13 ) $ (26 ) State 1 1 (12 ) (25 ) Deferred: Federal 13 87 State — — 13 87 Income tax expense $ 1 $ 62 |
Schedule of Effective Income Tax Rate Reconciliation | The following is a reconciliation of the expected statutory federal income tax provision to our actual income tax provision (in thousands): Year ended December 31, 2019 2018 Expected income tax benefit at federal statutory tax rate $ (3,904 ) $ (10,216 ) State income taxes, net of federal benefit (1,390 ) (3,005 ) Tax credits (374 ) (3,666 ) Change in valuation allowance 603 12,706 Return to provision adjustments (358 ) 441 Stock compensation 3,934 251 Reserve for uncertain tax positions 1,444 3,596 Other 46 (45 ) Income tax expense $ 1 $ 62 |
Schedule of Deferred Tax Assets and Liabilities | The following table summarizes the significant components of our deferred tax assets and liabilities (in thousands): December 31, 2019 2018 Deferred tax assets: Net operating loss carryovers $ 79,675 $ 74,965 Research and development and other tax credits 33,429 33,121 Deferred revenue 1 16 Intangibles and property and equipment basis difference 782 — Stock compensation expense 1,389 5,033 Lease liability 164 — Other 461 2,027 Total deferred tax assets 115,901 115,162 Total deferred tax liabilities (325 ) (176 ) Net deferred tax asset 115,576 114,986 Valuation allowance (115,564 ) (114,960 ) Net deferred tax asset $ 12 $ 26 |
Summary of Income Tax Contingencies | The following table summarizes the changes in the amount of our unrecognized tax benefits (in thousands): Year Ended December 31, 2019 2018 Beginning balance of unrecognized tax benefits $ 14,700 $ 4,421 (Decrease) increase for prior year tax positions (7 ) 5,961 Increase for current year tax positions 1,880 4,318 Total $ 16,573 $ 14,700 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Schedule of Lease Liabilities and ROU Assets | The table below summarizes our lease liabilities and corresponding ROU assets as of December 31, 2019 (in thousands): Assets Operating $ 464 Financing 466 Total ROU assets $ 930 Liabilities Current: Operating $ 361 Financing 277 Long-term: Operating 417 Financing 56 Total lease liabilities $ 1,111 |
Schedule of Lease Cost | The table below summarizes our lease costs from our statement of operations and cash payments from our statement of cash flows during the year ended December 31, 2019 (in thousands): Year ended Lease cost: Operating lease cost $ 715 Finance lease cost: Amortization of right-of-use assets 182 Interest expense on lease liabilities 5 Total lease cost $ 902 Cash payment information: Operating cash used for operating leases $ 756 Operating cash used for finance leases 24 Financing cash used for finance leases 263 Total cash paid for amounts included in the measurement of lease liabilities $ 1,043 The table below summarizes other non-cash information under our operating and financing lease obligations as of December 31, 2019 (in thousands, except years and rates): Supplemental non-cash information: Operating lease liabilities arising from obtaining right-of-use assets $ 778 Weighted-average remaining lease term (years) - operating leases 2.0 Weighted-average remaining lease term (years) - finance leases 1.2 Weighted-average discount rate - operating leases 10.9 % Weighted-average discount rate - finance leases 4.9 % |
Schedule of Operating Lease, Liability, Maturity | Our future lease payments under operating and finance leases at December 31, 2019 are as follows (in thousands): Operating Leases Finance Leases 2020 429 287 2021 442 57 Total lease payments $ 871 $ 344 Less: amount representing interest (93 ) (11 ) Present value of obligations under leases 778 333 Less: current portion (361 ) (277 ) Long-term lease obligations $ 417 $ 56 |
Schedule of Finance Lease, Liability, Maturity | Our future lease payments under operating and finance leases at December 31, 2019 are as follows (in thousands): Operating Leases Finance Leases 2020 429 287 2021 442 57 Total lease payments $ 871 $ 344 Less: amount representing interest (93 ) (11 ) Present value of obligations under leases 778 333 Less: current portion (361 ) (277 ) Long-term lease obligations $ 417 $ 56 |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | Summarized quarterly data for 2019 and 2018 are as follows (in thousands, except per share data): For the quarters ending March 31 June 30 September 30 December 31 2019 Total revenues $ 6,778 $ 18 $ 18 $ 18 Total operating expenses (9,516 ) (4,686 ) (5,011 ) (4,453 ) Net loss (3,260 ) (5,016 ) (5,423 ) (4,893 ) Net loss per share, basic and diluted (1) $ (0.31 ) $ (0.30 ) $ (0.26 ) $ (0.23 ) 2018 Total revenues $ 18 $ 18 $ 18 $ 18 Total operating expenses (15,601 ) (13,362 ) (9,872 ) (8,000 ) Net loss (16,025 ) (13,847 ) (10,273 ) (8,563 ) Net loss per share, basic and diluted (1) $ (1.85 ) $ (1.59 ) $ (1.18 ) $ (0.98 ) (1) Net loss per share is computed independently for each of the quarters presented. Therefore, the sum of the quarterly per-share calculations will not necessarily equal the annual per share calculation. |
The Business, Basis of Presen_4
The Business, Basis of Presentation and Summary of Significant Accounting Policies - Liquidity (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Financing from sale proceeds, debt, and agreement revenues | $ 454,100 | |
Cash and cash equivalents | $ 34,121 | $ 13,935 |
The Business, Basis of Presen_5
The Business, Basis of Presentation and Summary of Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Minimum | |
Property, Plant and Equipment [Line Items] | |
Useful life, in years | 3 years |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Useful life, in years | 5 years |
The Business, Basis of Presen_6
The Business, Basis of Presentation and Summary of Significant Accounting Policies - Intangibles (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Weighted Average | Patents | |
Finite-Lived Intangible Assets [Line Items] | |
Finite-lived intangible asset, useful life | 7 years |
The Business, Basis of Presen_7
The Business, Basis of Presentation and Summary of Significant Accounting Policies - Impairment of Long-Lived Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Asset impairment charges | $ 0 | $ 0 |
The Business, Basis of Presen_8
The Business, Basis of Presentation and Summary of Significant Accounting Policies - Segment Reporting (Details) | 12 Months Ended |
Dec. 31, 2019segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
The Business, Basis of Presen_9
The Business, Basis of Presentation and Summary of Significant Accounting Policies - Corporate Restructuring (Details) $ in Millions | 1 Months Ended |
Jul. 31, 2018USD ($) | |
Accounting Policies [Abstract] | |
Reduction of workforce | 60.00% |
Severance costs | $ 0.8 |
Non-cash stock-based compensation charges | $ 0.1 |
The Business, Basis of Prese_10
The Business, Basis of Presentation and Summary of Significant Accounting Policies - Balance Sheet, Topic 606 Adoption (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Deferred revenue (contract liabilities), non-current | $ 77 | |||
Accumulated deficit | $ (411,315) | $ (392,723) | (344,014) | |
Calculated under Revenue Guidance in Effect before Topic 606 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Deferred revenue (contract liabilities), non-current | $ 1,921 | |||
Accumulated deficit | $ (345,858) | |||
Accounting Standards Update 2014-09 | Difference between Revenue Guidance in Effect before and after Topic 606 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Deferred revenue (contract liabilities), non-current | (1,844) | |||
Accumulated deficit | $ 1,844 |
The Business, Basis of Prese_11
The Business, Basis of Presentation and Summary of Significant Accounting Policies - Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease, right-of-use asset | $ 464 | |
Operating lease, liability | 778 | |
Finance lease, liability | $ 333 | |
Accounting Standards Update 2016-02 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease, right-of-use asset | $ 3,300 | |
Operating lease, liability | 11,300 | |
Finance lease, liability | $ 600 |
Net Loss Per Share - Potentiall
Net Loss Per Share - Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Earnings Per Share [Abstract] | ||
Potentially dilutive securities not included in calculation of diluted net loss per share (in shares) | 3,342,533 | 0 |
Investments - Narrative (Detail
Investments - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | ||
Unrealized gain (loss) | $ 0 | $ 0 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Hierarchy for Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | $ 8,909 | $ 11,173 |
Cash equivalents | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | 8,909 | 11,173 |
Fair Value, Inputs, Level 1 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | 8,909 | 11,173 |
Fair Value, Inputs, Level 1 | Cash equivalents | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | 8,909 | 11,173 |
Fair Value, Inputs, Level 2 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | 0 | 0 |
Fair Value, Inputs, Level 2 | Cash equivalents | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | 0 | 0 |
Fair Value, Inputs, Level 3 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | 0 | 0 |
Fair Value, Inputs, Level 3 | Cash equivalents | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | $ 0 | $ 0 |
Collaborations (Details)
Collaborations (Details) | 1 Months Ended | 3 Months Ended | 8 Months Ended | 12 Months Ended | |||||||||||||||
Apr. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Nov. 30, 2018USD ($) | Jul. 31, 2017USD ($) | Feb. 28, 2014USD ($)$ / sharesshares | Jul. 31, 2013USD ($) | Jul. 31, 2010target | Dec. 31, 2019USD ($)shares | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($)shares | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Jan. 31, 2014USD ($) | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Jan. 01, 2018USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 18,000 | $ 18,000 | $ 18,000 | $ 6,778,000 | $ 18,000 | $ 18,000 | $ 18,000 | $ 18,000 | $ 6,832,000 | $ 72,000 | |||||||||
Common stock, shares issued (shares) | shares | 21,018,663 | 8,818,019 | 21,018,663 | 8,818,019 | |||||||||||||||
Common stock value | $ 21,000 | $ 9,000 | $ 21,000 | $ 9,000 | |||||||||||||||
Upfront payment received | $ 1,800,000 | $ 2,500,000 | |||||||||||||||||
Deferred revenue | $ 77,000 | ||||||||||||||||||
Strategic Alliances and Collaborations | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Revenue from Contract with Customer, Excluding Assessed Tax | 6,800,000 | 100,000 | |||||||||||||||||
Sanofi | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Number of collaborative areas granted | target | 4 | ||||||||||||||||||
Upfront payment received | $ 6,800,000 | $ 6,800,000 | $ 400,000 | $ 2,500,000 | |||||||||||||||
Expected revenue through milestone payments | $ 6,800,000 | ||||||||||||||||||
Agreement period | 24 months | ||||||||||||||||||
Development Milestone Not Achievable | 40,000,000 | 40,000,000 | |||||||||||||||||
Sanofi | Private Placement | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Common stock, shares issued (shares) | shares | 108,648 | ||||||||||||||||||
Price per share (in dollars per share) | $ / shares | $ 92.04 | ||||||||||||||||||
Common stock value | $ 10,000,000 | ||||||||||||||||||
Restriction period in which Alliances could not sell, transfer, make any short sale of, or grant any option for the sale of any common stock | 12 months | ||||||||||||||||||
Sanofi | Development Commercialization And License Agreement | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Initial upfront option payment | $ 2,500,000 | $ 2,500,000 | |||||||||||||||||
Deferred revenue creditable against future milestones | $ 1,250,000 | $ 1,250,000 | $ 1,250,000 | ||||||||||||||||
Milestone payments, earned | $ 1,250,000 | ||||||||||||||||||
Sanofi | Minimum | United States | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Royalties based on percentage of net sales | 1000.00% | ||||||||||||||||||
Sanofi | Minimum | Outside of the US | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Royalties based on percentage of net sales | 1000.00% | ||||||||||||||||||
Sanofi | Maximum | United States | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Royalties based on percentage of net sales | 20.00% | ||||||||||||||||||
Sanofi | Maximum | Outside of the US | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Royalties based on percentage of net sales | 20.00% | ||||||||||||||||||
Sanofi | Common Stock Purchase Agreement | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Deferred revenue | 100,000 | $ 100,000 | |||||||||||||||||
Deferred revenue recognition period | 1 year | ||||||||||||||||||
Sanofi | Development Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Expected revenue through milestone payments | $ 40,000,000 | ||||||||||||||||||
Sanofi | Proof-of-Concept Trial | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Expected revenue through milestone payments | 38,800,000 | $ 38,800,000 | |||||||||||||||||
Sanofi | Clinical | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Expected revenue through milestone payments | 40,000,000 | 40,000,000 | |||||||||||||||||
Sanofi | Regulatory and Commercialization Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Expected revenue through milestone payments | $ 130,000,000 | $ 130,000,000 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 5,331 | $ 17,700 |
Less accumulated depreciation and amortization | (4,410) | (9,894) |
Property and equipment, net | 921 | 7,806 |
Depreciation and amortization expense | 931 | 2,262 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 4,967 | 8,163 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 281 | 281 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 0 | 706 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 83 | $ 8,550 |
Intangible Assets, net (Details
Intangible Assets, net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible asset amortization (2019, less than) | $ 100 | $ 100 |
Finite-lived intangible assets, amortization expense, next 12 months (less than $1 million) | 100 | |
Finite-lived intangible assets, amortization expense, year two (less than $1 million) | 100 | |
Finite-lived intangible assets, amortization expense, year three (less than $1 million) | 100 | |
Finite-lived intangible assets, amortization expense, year four (less than $1 million) | 100 | |
Finite-lived intangible assets, amortization expense, year five (less than $1 million) | $ 100 | |
Remaining amortization period | 14 years 10 months 25 days | |
Patents | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-lived intangible assets, gross | $ 465 | 721 |
Accumulated amortization - Patents | (199) | (221) |
Intangibles, net | $ 266 | $ 500 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - Settled Litigation - USD ($) $ in Millions | Nov. 04, 2019 | Dec. 31, 2019 |
Loss Contingencies [Line Items] | ||
Amount awarded to other party | $ 0.3 | |
Damages paid | $ 0.9 | |
Estimate of possible loss | 0.9 | |
Estimated recovery from third party for settlement | $ 0.6 | |
Regulus | ||
Loss Contingencies [Line Items] | ||
Damages paid | $ 0.3 |
Term Loan (Details)
Term Loan (Details) | May 03, 2019USD ($) | Apr. 09, 2019USD ($) | Jun. 22, 2016USD ($) | Jun. 17, 2016USD ($)loannumber_of_payment | Mar. 31, 2019USD ($) | Nov. 30, 2018USD ($) | Dec. 31, 2019USD ($) | May 07, 2019USD ($) | Nov. 05, 2018USD ($) | Mar. 31, 2017USD ($) |
Debt Instrument [Line Items] | ||||||||||
Upfront payment received | $ 1,800,000 | $ 2,500,000 | ||||||||
Debt Financing Agreement Tranche A | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Maximum borrowing capacity | $ 20,000,000 | |||||||||
Proceeds from borrowing under term loan | $ 20,000,000 | |||||||||
Long-term debt | $ 14,681,000 | |||||||||
Debt Financing Agreement Tranche B | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Maximum borrowing capacity | 10,000,000 | |||||||||
Long-term line of credit | $ 0 | |||||||||
Fourth Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment requirement of loan from license fees | 25.00% | |||||||||
Expected revenue through milestone payments | $ 10,000,000 | |||||||||
Prepayment required for loan | $ 400,000 | $ 600,000 | ||||||||
Payment fee | 5.50% | |||||||||
Seventh Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Minimum cash, debt covenant | $ 10,000,000 | |||||||||
Debt covenant, cash amount, condition one | 10,000,000 | |||||||||
Debt covenant, cash amount, condition two | 5,000,000 | |||||||||
Eight Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Minimum cash, debt covenant | $ 20,000,000 | |||||||||
Interest only payment fee | $ 100,000 | |||||||||
Maturity extension fee | $ 700,000 | |||||||||
Eight Amendment - Milestone Payment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Minimum cash, debt covenant | $ 10,000,000 | |||||||||
Debt Financing Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Maximum borrowing capacity | $ 30,000,000 | |||||||||
Number of term loans | loan | 2 | |||||||||
Stated interest rate, percentage | 8.51% | |||||||||
Number of monthly payments | number_of_payment | 24 | |||||||||
Long-term debt | 14,700,000 | |||||||||
Fee amount | 1,900,000 | |||||||||
Deferred finance costs | $ 100,000 | |||||||||
Debt instrument effective rate | 8.98% | |||||||||
Debt Financing Agreement | London Interbank Offered Rate (LIBOR) | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Basis spread on variable rate, percentage | 0.44% | |||||||||
Minimum | Seventh Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment requirement of loan from license fees | 25.00% | |||||||||
Prepayment required for loan | $ 5,000,000 | |||||||||
Minimum | Eight Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment requirement of loan from license fees | 75.00% | |||||||||
Maximum | Seventh Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment requirement of loan from license fees | 75.00% | |||||||||
Maximum | Eight Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment requirement of loan from license fees | 100.00% |
Term Loan - Future Principal Pa
Term Loan - Future Principal Payments (Details) - Debt Financing Agreement Tranche A $ in Thousands | Dec. 31, 2019USD ($) |
Debt Instrument [Line Items] | |
Future Repayments of Principal, 2020 | $ 0 |
Future Repayments of Principal, 2021 | 9,035 |
Future Repayments of Principal, 2022 | 5,646 |
Long-term debt | $ 14,681 |
Common Stock and Stockholders_3
Common Stock and Stockholders' Equity - Narrative 1 (Details) $ / shares in Units, $ in Thousands | Jan. 22, 2020shares | Dec. 24, 2019USD ($)$ / sharesshares | May 07, 2019USD ($)$ / sharesshares | May 03, 2019USD ($)shares | Dec. 12, 2018USD ($)shares | Oct. 15, 2018USD ($)optionholdershares | Dec. 31, 2019USD ($)voteshares | Dec. 31, 2018USD ($)shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock, shares issued (shares) | 21,018,663 | 8,818,019 | ||||||
Common stock voting rights per share | vote | 1 | |||||||
Common shares reserved for future issuance (in shares) | 87,640,000 | |||||||
Conversion ratio | 0.08333 | |||||||
Exchange Offer shares available for exchange (in shares) | 915,009 | |||||||
Number of optionholders | optionholder | 31 | |||||||
Restricted shares issued (in shares) | 603,058 | |||||||
Stock-based compensation expenses | $ | $ 400 | $ 2,288 | $ 5,440 | |||||
Performance Shares | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Restricted shares issued (in shares) | 514,955 | |||||||
Private Placement | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares issued (in shares) | 9,730,534 | |||||||
Number of securities called by warrants (in shares) | 9,730,534 | |||||||
Sale of stock (usd per share) | $ / shares | $ 1.205 | |||||||
Consideration received on transaction | $ | $ 16,700 | |||||||
Convertible preferred stock, shares issued upon conversion (in shares) | 10 | |||||||
Warrant exercise period | 5 years | |||||||
Warrant exercise price (usd per share) | $ / shares | $ 1.08 | |||||||
Milestone Closing | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Consideration received on transaction | $ | $ 24,600 | |||||||
At The Moment | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares issued (in shares) | 1,903,880 | |||||||
Consideration received on transaction | $ | $ 2,100 | |||||||
Commission fee rate | 3.00% | |||||||
Payments for commissions | $ | $ 100 | |||||||
Shares issued (in shares) | 0 | |||||||
Preferred Class A | Private Placement | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of securities called by warrants (in shares) | 4,158,980 | |||||||
Sale of stock (usd per share) | $ / shares | $ 10.80 | |||||||
Nonvoting convertible preferred stock issued (in shares) | 415,898 | |||||||
Preferred Class A | Private Placement | Warrant | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Sale of stock (usd per share) | $ / shares | $ 0.125 | |||||||
Class A-2 Convertible Preferred Stock | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Conversion ratio | 10 | |||||||
Class A-2 Convertible Preferred Stock | Milestone Closing | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares issued (in shares) | 3,288,390 | |||||||
Number of securities called by warrants (in shares) | 32,883,900 | |||||||
Consideration received on transaction | $ | $ 26,000 | |||||||
Warrants, term | 5 years | |||||||
Warrant exercise price (usd per share) | $ / shares | $ 0.666 | |||||||
Directors, Executive Officers and Employees | Private Placement | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares issued (in shares) | 526,083 | |||||||
Directors, Executive Officers and Employees | Preferred Class A | Private Placement | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of securities called by warrants (in shares) | 526,083 | |||||||
Proceeds from issuance of preferred warrants | $ | $ 600 | |||||||
Certain Directors and Executive Officers | Class A-2 Convertible Preferred Stock | Milestone Closing | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares issued (in shares) | 121,581 | |||||||
Number of securities called by warrants (in shares) | 1,215,810 | |||||||
Consideration received on transaction | $ | $ 1,000 | |||||||
2019 Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares available for future grant (in shares) | 403,939 | |||||||
Common shares reserved for future issuance (in shares) | 3,226,804 | |||||||
Subsequent Event | 2019 Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Additional shares available (in shares) | 4,166,860 | |||||||
Yearly authorized increase | 5.00% |
Common Stock and Stockholders_4
Common Stock and Stockholders' Equity - Shares Reserved for Future Issuance (Details) shares in Thousands | Dec. 31, 2019shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock options outstanding | 3,098 |
Total common shares reserved for future issuance | 87,640 |
Common stock available for future grant under the 2019 Equity Incentive Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares available for future grant | 404 |
Employee Stock Purchase Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares available for future grant | 192 |
RSUs outstanding | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
RSUs outstanding | 129 |
Class A-1 convertible preferred stock outstanding (as-converted) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Preferred stock, shares outstanding | 4,159 |
Class A-2 convertible preferred stock outstanding (as-converted) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Preferred stock, shares outstanding | 32,884 |
Initial Closing warrants | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants outstanding | 13,890 |
Milestone Closing warrants | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants outstanding | 32,884 |
Common Stock and Stockholders_5
Common Stock and Stockholders' Equity - Stock Option Activity (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($)$ / sharesshares | |
Number of options | |
End number of options (in shares), outstanding | 3,098 |
Stock options | |
Number of options | |
Beginning number of options (in shares), outstanding | 59 |
Number of options, Granted (in shares) | 3,224 |
Number of options, Exercised (in shares) | (3) |
Number of options, Canceled/forfeited/expired (in shares) | (182) |
End number of options (in shares), outstanding | 3,098 |
Number of options, Exercisable (in shares) | 237 |
Weighted average exercise price | |
Beginning, Weighted average exercise price, Options outstanding (in dollars per share) | $ / shares | $ 45.60 |
Weighted average exercise price, Granted (in dollars per share) | $ / shares | 0.68 |
Weighted average exercise price, Exercised (in dollars per share) | $ / shares | 0.95 |
Weighted average exercise price, Canceled/forfeited/expired (in dollars per share) | $ / shares | 6.81 |
Ending, Weighted average exercise price, Options outstanding (in dollars per share) | $ / shares | 1.17 |
Weighted average exercise price, Exercisable (in dollars per share) | $ / shares | $ 6.78 |
Weighted average remaining contractual term | |
Weighted average remaining contractual term, Options outstanding | 9 years 6 months 29 days |
Weighted average remaining contractual term, Exercisable | 8 years 6 months 7 days |
Aggregate intrinsic value | |
Aggregate intrinsic value, Options outstanding | $ | $ 703 |
Aggregate intrinsic value, Exercisable | $ | $ 35 |
Common Stock and Stockholders_6
Common Stock and Stockholders' Equity - Narrative 2 (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | 87 Months Ended | |
Oct. 31, 2012 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2019 | |
Class of Stock [Line Items] | ||||
Proceeds from stock options exercised (less than in 2018 and 2017) | $ 3 | $ 1 | ||
Stock options | ||||
Class of Stock [Line Items] | ||||
Weighted average grant date fair value of employee stock options (in dollars per share) | $ 0.52 | $ 8.63 | ||
Total intrinsic value of stock options exercised (less than in 2018 and 2017) | $ 100 | |||
Proceeds from stock options exercised (less than in 2018 and 2017) | 100 | $ 100 | ||
Compensation cost related to non-vested awards not yet recognized | $ 1,200 | $ 1,200 | ||
Weighted-average recognition period of compensation cost related to non-vested awards not yet recognized | 1 year 8 months 24 days | |||
RSUs outstanding | ||||
Class of Stock [Line Items] | ||||
Compensation cost related to non-vested awards not yet recognized | $ 400 | $ 400 | ||
Weighted-average recognition period of compensation cost related to non-vested awards not yet recognized | 9 months | |||
Employee Stock Purchase Plan 2012 | ||||
Class of Stock [Line Items] | ||||
Percentage of participants eligible compensation | 15.00% | |||
Shares issued (in shares) | 4,035 | 91,948 | ||
Common stock shares reserved for future issuance and authorized for purchase (in shares) | 192,687 | 192,687 | ||
Option One - at inception of enrollment period | ||||
Class of Stock [Line Items] | ||||
Percentage of fair market value of common stock | 85.00% | |||
Option Two - at applicable purchase date | ||||
Class of Stock [Line Items] | ||||
Percentage of fair market value of common stock | 85.00% |
Common Stock and Stockholders_7
Common Stock and Stockholders' Equity - RSU Activity (Details) - RSUs outstanding - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding [Roll Forward] | ||
RSUs outstanding, beginning balance (in shares) | 601 | |
Granted (in shares) | 287 | |
Vested (in shares) | (559) | |
Canceled/forfeited/expired (in shares) | (200) | |
RSUs outstanding, ending balance (in shares) | 129 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
RSUs outstanding, beginning balance (usd per share) | $ 1.50 | |
Granted (usd per share) | 0.95 | |
Vested (usd per share) | 1.27 | |
Forfeited (usd per share) | 1.34 | |
RSUs outstanding, ending balance (usd per share) | $ 1.50 | $ 1.50 |
Weighted average remaining contractual term | 9 months | |
Aggregate intrinsic value | $ 115 |
Common Stock and Stockholders_8
Common Stock and Stockholders' Equity - Assumptions Used to Estimate Fair Value of Stock Options and Performance Stock and Employee Stock Purchase Plan (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Stock options | ||
Weighted average assumptions | ||
Risk-free interest rate | 1.70% | 2.70% |
Volatility | 94.60% | 87.80% |
Dividend yield | 0.00% | 0.00% |
Expected term (years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Performance stock options | ||
Weighted average assumptions | ||
Risk-free interest rate | 2.60% | 2.70% |
Volatility | 93.80% | 87.40% |
Dividend yield | 0.00% | 0.00% |
Expected term (years) | 6 years 1 month 6 days | 5 years 7 months 28 days |
Employee Stock Purchase Plan | ||
Weighted average assumptions | ||
Risk-free interest rate | 2.30% | 1.90% |
Volatility | 110.50% | 100.60% |
Dividend yield | 0.00% | 0.00% |
Expected term (years) | 6 months | 6 months |
Common Stock and Stockholders_9
Common Stock and Stockholders' Equity - Schedule of Compensation Expense (Details) - USD ($) $ in Thousands | Oct. 15, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expenses | $ 400 | $ 2,288 | $ 5,440 |
Research and development | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expenses | 309 | 2,256 | |
General and administrative | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expenses | $ 1,979 | $ 3,184 |
Defined Contribution Plan (Deta
Defined Contribution Plan (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Retirement Benefits [Abstract] | |
Defined contribution minimum age requirement of eligible employees | 18 years |
Maximum 401 (K) plan contribution rates as percentage of employees compensation | 50.00% |
Rate of contribution to 401(K) plan as a percentage of employees contribution | 50.00% |
Percentage of employee's earnings the company may contribute to the 401(k) plan | 6.00% |
Employer contribution to 401(k) plan | $ 0.1 |
Income Taxes - Components of In
Income Taxes - Components of Income Tax (Benefit) Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Current: | ||
Federal | $ (13) | $ (26) |
State | 1 | 1 |
Current Income Tax Expense (Benefit), total | (12) | (25) |
Deferred: | ||
Federal | 13 | 87 |
State | 0 | 0 |
Deferred Income Tax Expense (Benefit), total | 13 | 87 |
Income tax expense | $ 1 | $ 62 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Expected Statutory Federal Income Tax Provision to Actual Income Tax Provision (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | ||
Expected income tax benefit at federal statutory tax rate | $ (3,904) | $ (10,216) |
State income taxes, net of federal benefit | (1,390) | (3,005) |
Tax credits | (374) | (3,666) |
Change in valuation allowance | 603 | 12,706 |
Return to provision adjustments | (358) | 441 |
Stock compensation | 3,934 | 251 |
Reserve for uncertain tax positions | 1,444 | 3,596 |
Other | 46 | (45) |
Income tax expense | $ 1 | $ 62 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Net operating loss carryovers | $ 79,675 | $ 74,965 |
Research and development and other tax credits | 33,429 | 33,121 |
Deferred revenue | 1 | 16 |
Intangibles and property and equipment basis difference | 782 | 0 |
Stock compensation expense | 1,389 | 5,033 |
Lease liability | 164 | |
Other | 461 | 2,027 |
Total deferred tax assets | 115,901 | 115,162 |
Total deferred tax liabilities | (325) | (176) |
Net deferred tax asset | 115,576 | 114,986 |
Valuation allowance | (115,564) | (114,960) |
Net deferred tax asset | $ 12 | $ 26 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Operating Loss Carryforwards [Line Items] | |||
Valuation allowance | $ 115,564,000 | $ 114,960,000 | |
Net operating loss carryovers | 79,675,000 | 74,965,000 | |
Unrecognized tax benefits | 16,573,000 | 14,700,000 | $ 4,421,000 |
Unrecognized tax benefits that would impact effective tax rate | 13,300,000 | ||
Income tax penalties and interest accrued | 0 | $ 0 | $ 0 |
Internal Revenue Service (IRS) | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryovers | 328,000,000 | ||
Internal Revenue Service (IRS) | Research Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Research and development tax credits carryforward | 31,100,000 | ||
California | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryovers | 276,000,000 | ||
California | Research Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Research and development tax credits carryforward | 9,100,000 | ||
After 2017, No Expiration | Internal Revenue Service (IRS) | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryovers | $ 64,600,000 |
Income Taxes - Changes in Amoun
Income Taxes - Changes in Amount of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Beginning balance of unrecognized tax benefits | $ 14,700 | $ 4,421 |
(Decrease) increase for prior year tax positions | (7) | 5,961 |
Increase for current year tax positions | 1,880 | 4,318 |
Total | $ 16,573 | $ 14,700 |
Leases (Details)
Leases (Details) | Feb. 19, 2019USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Jul. 01, 2019USD ($) | Jun. 19, 2019USD ($)ft² | Apr. 01, 2019USD ($) | Feb. 25, 2019USD ($)ft² | Dec. 31, 2016USD ($) | Aug. 31, 2015USD ($) | Jul. 31, 2015ft² |
Lessee, Lease, Description [Line Items] | ||||||||||
Net rentable area | ft² | 59,248 | |||||||||
Term of lease | 96 months | |||||||||
Tenant incentive | $ 1,400,000 | |||||||||
Tenant improvement allowance used | $ 8,200,000 | |||||||||
Lease expense extinguished from prior lease | $ 14,400,000 | |||||||||
Total lease payments | $ 871,000 | |||||||||
Lessee, operating lease, liability, payments | 429,000 | |||||||||
Operating lease, liability, payments, due year two | 442,000 | |||||||||
Noncash leasehold improvements | 5,600,000 | |||||||||
Deferred costs accumulated amortization | 900,000 | |||||||||
Operating lease, liability | 778,000 | |||||||||
Termination of lease | (1,600,000) | |||||||||
Reduction of lease liability | 1,300,000 | |||||||||
Operating lease, right-of-use asset | 464,000 | |||||||||
Rent expense | 700,000 | $ 1,300,000 | ||||||||
February Lease | ||||||||||
Lessee, Lease, Description [Line Items] | ||||||||||
Net rentable area | ft² | 24,562 | |||||||||
Term of lease | 51 months | |||||||||
Total lease payments | 4,800,000 | $ 4,800,000 | ||||||||
Lessee, operating lease, liability, payments | 600,000 | |||||||||
Operating lease, liability, payments, due year two | 1,200,000 | |||||||||
Operating lease, liability, payments, due year three | 1,200,000 | |||||||||
Operating lease, liability, payments, due year four | 1,200,000 | |||||||||
Operating lease, liability, payments, due year five | 600,000 | |||||||||
New Premises | ||||||||||
Lessee, Lease, Description [Line Items] | ||||||||||
Net rentable area | ft² | 8,727 | |||||||||
Term of lease | 2 years 6 months | |||||||||
Lessee, operating lease, liability, payments | 100,000 | |||||||||
Operating lease, liability, payments, due year two | 400,000 | |||||||||
Operating lease, liability, payments, due year three | 400,000 | |||||||||
Deferred costs accumulated amortization | 200,000 | |||||||||
Operating lease, liability | 0 | |||||||||
Initial direct cost liability | $ 800,000 | |||||||||
Lease payments eliminated | $ 4,800,000 | |||||||||
Reduction of lease liability | 500,000 | |||||||||
Operating lease, right-of-use asset | 600,000 | |||||||||
Deferred credit, operating lease liability | $ 200,000 | |||||||||
Nitto | ||||||||||
Lessee, Lease, Description [Line Items] | ||||||||||
Relocation assistance payment | $ 100,000 | |||||||||
Difference between the security deposits under the Prior Lease and Nitto’s prior lease | 200,000 | |||||||||
Rent reimbursement | $ 1,300,000 | |||||||||
Lease modification impact | $ 400,000 | |||||||||
Initial direct cost liability | $ 3,800,000 | |||||||||
Operating lease, right-of-use asset | 2,900,000 | |||||||||
Deferred credit, operating lease liability | $ 900,000 | |||||||||
Other Noncurrent Liabilities | ||||||||||
Lessee, Lease, Description [Line Items] | ||||||||||
Deferred rent balance | $ 8,000,000 |
Leases Leases (Lease Asset and
Leases Leases (Lease Asset and Liabilities) (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Assets | |
Operating | $ 464 |
Financing | 466 |
Total ROU assets | 930 |
Current: | |
Operating | 361 |
Financing | 277 |
Long-term: | |
Operating | 417 |
Financing | 56 |
Total lease liabilities | $ 1,111 |
Leases Leases (Lease Cost) (Det
Leases Leases (Lease Cost) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 715 |
Finance lease cost: | |
Amortization of right-of-use assets | 182 |
Interest expense on lease liabilities | 5 |
Total lease cost | 902 |
Cash payment information: | |
Cash payment information: | 756 |
Operating cash used for finance leases | 24 |
Financing cash used for finance leases | 263 |
Total cash paid for amounts included in the measurement of lease liabilities | 1,043 |
Operating lease liabilities arising from obtaining right-of-use assets | $ 778 |
Weighted-average remaining lease term (years) - operating leases | 2 years |
Weighted-average remaining lease term (years) - finance leases | 1 year 2 months |
Weighted-average discount rate - operating leases | 10.90% |
Weighted-average discount rate - finance leases | 4.90% |
Leases (Future Lease Payments U
Leases (Future Lease Payments Under Operating and Finance Leases) (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Operating Leases | |
2020 | $ 429 |
2021 | 442 |
Total lease payments | 871 |
Less: amount representing interest | (93) |
Present value of obligations under leases | 778 |
Less: current portion | (361) |
Long-term lease obligations | 417 |
Finance Leases | |
2020 | 287 |
2021 | 57 |
Total lease payments | 344 |
Less: amount representing interest | (11) |
Present value of obligations under leases | 333 |
Less: current portion | (277) |
Long-term lease obligations | $ 56 |
Leases (Lease Liabilities Prior
Leases (Lease Liabilities Prior to ASC 842 Adoption) (Details) $ in Millions | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
Future minimum lease payments, 2019 | $ 2.7 |
Future minimum lease payments, 2020 | 2.7 |
Future minimum lease payments, 2021 | 2.8 |
Future minimum lease payments, 2022 | 2.9 |
Future minimum lease payments, 2023 | 3 |
Future minimum lease payments, thereafter | $ 1 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||
Total revenues | $ 18 | $ 18 | $ 18 | $ 6,778 | $ 18 | $ 18 | $ 18 | $ 18 | $ 6,832 | $ 72 |
Total operating expenses | (4,453) | (5,011) | (4,686) | (9,516) | (8,000) | (9,872) | (13,362) | (15,601) | (23,666) | (46,835) |
Net loss | $ (4,893) | $ (5,423) | $ (5,016) | $ (3,260) | $ (8,563) | $ (10,273) | $ (13,847) | $ (16,025) | $ (18,592) | $ (48,709) |
Basic and diluted net loss per share (dollars per share) | $ (0.23) | $ (0.26) | $ (0.30) | $ (0.31) | $ (0.98) | $ (1.18) | $ (1.59) | $ (1.85) | $ (1.08) | $ (5.59) |
Uncategorized Items - rgls-2019
Label | Element | Value |
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 1,844,000 |
Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 1,844,000 |