Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 10, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q/A | |
Amendment Flag | true | |
Amendment Description | This amendment No. 1 to the Quarterly Report on Form 10-Q/A (the “Amendment”) of GI Dynamics, Inc. (“the Company”) is being filed to amend the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2019, which was originally filed with the Securities and Exchange Commission on May 16, 2019 (the “Original Filing”). The Amendment corrects a numerical error that resulted from a publishing software tabulation error in the Statement of Cash Flows on the Debt issuance costs line item and a subsequent rounding effect in a table within the Original Filing. No other changes have been made to the Amendment. | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | GIDYL | |
Entity Registrant Name | GI DYNAMICS, INC. | |
Entity Central Index Key | 0001245791 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 19,277,545 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 1,286 | $ 3,806 |
Restricted cash | 30 | 30 |
Prepaid expenses and other current assets | 556 | 530 |
Total current assets | 1,872 | 4,366 |
Property and equipment, net | 60 | 63 |
Total assets | 1,932 | 4,429 |
Current liabilities: | ||
Accounts payable | 467 | 1,050 |
Accrued expenses | 987 | 1,645 |
Short term debt to related party, net of debt discount | 4,986 | 4,960 |
Derivative liabilities | 883 | 51 |
Total current liabilities | 7,323 | 7,706 |
Long term debt to related party, net of discount | 326 | 168 |
Total liabilities | 7,649 | 7,874 |
Commitments (Note 11) | ||
Stockholders’ deficit: | ||
Preferred stock, $0.01 par value – 500,000 shares authorized; no shares issued and outstanding at March 31, 2019 and December 31, 2018 | ||
Common stock, $0.01 par value – 50,000,000 shares authorized at March 31, 2019 and December 31, 2018; and 19,277,545 shares issued and outstanding at March 31, 2019 and December 31, 2018 | 193 | 193 |
Additional paid-in capital | 263,580 | 263,521 |
Accumulated deficit | (269,490) | (267,159) |
Total stockholders’ deficit | (5,717) | (3,445) |
Total liabilities and stockholders’ deficit | $ 1,932 | $ 4,429 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 500,000 | 500,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 19,277,545 | 19,277,545 |
Common stock, shares outstanding | 19,277,545 | 19,277,545 |
Consolidated Statements of Oper
Consolidated Statements of Operations (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating expenses: | ||
Research and development | $ 810 | $ 373 |
Sales and marketing | 16 | 204 |
General and administrative | 1,344 | 1,185 |
Total operating expenses | 2,170 | 1,762 |
Loss from operations | (2,170) | (1,762) |
Other income (expense): | ||
Interest income | 3 | 7 |
Interest expense | (177) | (81) |
Foreign exchange gain (loss) | (9) | 9 |
Gain on write-off of accounts payable | 29 | |
Re-measurement of derivative liabilities | (1) | 1 |
Other income (expense), net | (155) | (64) |
Loss before income tax expense | (2,325) | (1,826) |
(Benefit from) Provision for income taxes | 6 | (18) |
Net loss | $ (2,331) | $ (1,808) |
Basic and diluted net loss per common share | $ (0.12) | $ (0.15) |
Weighted-average number of common shares used in basic and diluted net loss per common share | 19,277,545 | 11,803,221 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Deficit (unaudited) - USD ($) $ in Thousands | Total | Common stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning Balance at Dec. 31, 2017 | $ (3,715) | $ 112 | $ 255,294 | $ (259,121) |
Beginning Balance (in shares) at Dec. 31, 2017 | 11,157,489 | |||
Issuance of shares upon private placement, net of issuance costs | 1,503 | $ 12 | 1,491 | |
Issuance of shares upon private placement, net of issuance costs (in shares) | 1,175,612 | |||
Stock-based compensation expense | 29 | 29 | ||
Net loss | (1,808) | (1,808) | ||
Ending Balance at Mar. 31, 2018 | (3,991) | $ 124 | 256,814 | (260,929) |
Ending Balance (in shares at Mar. 31, 2018 | 12,333,101 | |||
Beginning Balance at Dec. 31, 2018 | (3,445) | $ 193 | 263,521 | (267,159) |
Beginning Balance (in shares) at Dec. 31, 2018 | 19,277,545 | |||
Stock-based compensation expense | 59 | 59 | ||
Net loss | (2,331) | (2,331) | ||
Ending Balance at Mar. 31, 2019 | $ (5,717) | $ 193 | $ 263,580 | $ (269,490) |
Ending Balance (in shares at Mar. 31, 2019 | 19,277,545 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities: | ||
Net loss | $ (2,331) | $ (1,808) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 8 | 11 |
Amortization of debt issuance costs non-cash interest expense | 18 | |
Non-cash interest expense | 110 | 198 |
Accretion of debt discount | 65 | |
Stock-based compensation expense | 59 | 29 |
Re-measurement of derivative liabilities | 1 | (1) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 40 | |
Prepaid expenses and other current assets | (26) | (29) |
Accounts payable | (583) | (353) |
Accrued expenses | (768) | (79) |
Net cash used in operating activities | (3,465) | (1,974) |
Investing activities | ||
Purchases of property and equipment | (5) | |
Net cash used in investing activities | (5) | |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 1,503 | |
Debt issuance costs | (50) | |
Proceeds from long term debt, related party | 1,000 | |
Net cash provided by financing activities | 950 | 1,503 |
Net decrease in cash and cash equivalents | (2,520) | (471) |
Cash, cash equivalents and restricted cash at beginning of period | 3,836 | 3,064 |
Cash, cash equivalents and restricted cash at end of period | 1,316 | 2,593 |
Supplemental cash flow disclosures | ||
Income taxes paid | 6 | $ 11 |
Interest paid | $ 394 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Nature of Business | 1. Nature of Business GI Dynamics ® Diabetes mellitus type 2 (also known as type 2 diabetes) is a long-term progressive metabolic disorder characterized by high blood sugar, insulin resistance, and reduced insulin production. According to the Centers for Disease Control and Prevention (CDC), people with type 2 diabetes represent 90% of the worldwide diabetes population, whereas 10% of this population is diagnosed with type 1 diabetes (a form of diabetes mellitus in which not enough insulin is produced). Being overweight is a condition where the patient’s body mass index (BMI) is greater than 25 (kg/m 2 When considering treatment for type 2 diabetes, it is optimal to address obesity concurrently with diabetes. EndoBarrier ® The current treatment paradigm for type 2 diabetes is lifestyle therapy combined with pharmacological treatment, whereby treating clinicians prescribe a treatment regimen of one to four concurrent medications that could include insulin for patients with higher levels of blood sugar. Insulin carries a significant risk of increased mortality and may contribute to weight gain, which in turn may lead to higher levels of insulin resistance and increased levels of blood sugar. Fewer than 50% of patients treated pharmacologically for type 2 diabetes are adequately managed, meaning that medication does not lower blood sugar adequately and does not halt the progressive nature of diabetes of these patients. The current pharmacological treatment algorithms for type 2 diabetes fall short of ideal, creating a large and unfilled treatment gap. Our vision is to make EndoBarrier EndoBarrier ® Since incorporation, the Company has devoted substantially all of its efforts to product commercialization, research and development, business planning, recruiting management and technical staff, acquiring operating assets, and raising capital. The Company currently operates in one reportable business segment. EndoBarrier History In 2011, the Company began commercial sales of its product, EndoBarrier, which was approved and commercially available in multiple countries outside the U.S. at the time. In 2013, the Company received approval from the U.S. Food and Drug Administration (“FDA”) to commence its initial pivotal trial of EndoBarrier (the “ENDO Trial”). The Company announced its decision to stop the ENDO Trial in the second half of fiscal year 2015 and thereafter announced that it was reducing headcount by approximately 46% as part of its efforts to restructure its business and expenses and to ensure sufficient cash remained available for it to establish new priorities, continue limited market development and research, and to evaluate strategic options. In the second and third quarters of fiscal year 2016, the Company took additional actions that it thought necessary to allow the opportunity to evolve its strategic options. These actions resulted in non-recurring charges totaling approximately $1.1 million, including $0.4 million related to restructuring charges in our second quarter, $0.6 million related to employee departures in both our second and third quarters and $0.1 million related to abandonment of our former headquarters in Lexington, MA. In October 2016, the Company received final cancellation notification from the Therapeutic Goods Administration (“TGA”) for the listing of EndoBarrier on the Australian Register of Therapeutic Goods (“ARTG”). In May 2017, the Company received notification from its notified body, SGS United Kingdom Limited (“SGS”), that the CE Mark for EndoBarrier had been suspended pending closure of non-conformances related to its quality management system required under International Organization for Standardization (“ISO”) regulations. On November 10, 2017, the Company received notification from SGS that SGS was withdrawing the Certificate of Conformance for EndoBarrier, ending the CE Marking of EndoBarrier in Europe and select Middle East countries. In December 2017, the Company received notification from the Medicines and Healthcare Products Regulatory Agency (“MHRA”) that all EndoBarrier delivery systems (liners) in inventory needed to be returned to the Company. In August 2018, the Company received approval of an investigational device exemption (“IDE”) from the FDA to begin enrollment in a pivotal trial evaluating the safety and efficacy of EndoBarrier in the United States pending Institutional Review Board (“IRB”) approval, which was received in February 2019. Financing History From its inception in 2003 to its initial public offering (“IPO”) in 2011, the Company was financed by a series of preferred stock financings. In September 2011, the Company completed its IPO of common stock in the form of CHESS Depositary Interests (“CDIs”) in Australia. As a result of the IPO and simultaneous private placement in the U.S., the Company raised a total of approximately $72.5 million in proceeds, net of expenses and repayment of $6.0 million of the Company’s convertible term promissory notes. Additionally, in July and August 2013, the Company issued CDIs on the Australian Securities Exchange (“ASX”) through a private placement and share purchase plan, which raised a total of approximately $52.5 million, net of expenses. In May 2014, the Company raised an additional total of approximately $30.8 million, net of expenses, when it issued CDIs on the ASX through a private placement. On December 20, 2016, the Company completed a private placement issue of 69,865,000 CDIs (1,397,300 shares) at an issue price of A$0.022 per CDI raising approximately $1.0 million, net of issuance costs. In January 2017, the Company completed the issue of 12,481,600 CDIs (249,632 shares) to eligible investors under a Security Purchase Plan for approximately $0.83 per share of common stock (A$0.022 per CDI) resulting in net proceeds after issuance costs of approximately $0.2 million. In June 2017, the Company completed a Convertible Term Promissory Note (the “2017 Note”) secured financing with its largest shareholder Crystal Amber Fund Limited (“Crystal Amber”) for a gross amount of $5.0 million. The 2017 Note accrues interest at 5% per annum compounded annually. Crystal Amber is deemed a Related Party of the Company for ASX purposes due to the size of its ownership position. The 2017 Note was originally due on December 31, 2018 and contains provisions for conversion during its term and is also subject to security arrangements in favor Crystal Amber (See Note 10 of the Consolidated Financial Statements for a more complete description of the terms and conditions of the financing). In January and March 2018, the Company raised approximately $1.6 million in an offering of its CDIs to sophisticated and professional investors, including certain existing investors in Australia, the United States and the United Kingdom. In May 2018, the Company completed a Convertible Term Promissory Note (the “2018 Note”) and Warrant (the “2018 Warrant”) financing with its largest shareholder Crystal Amber for a gross amount of $1.75 million. The 2018 Note accrues interest at 10% per annum compounded annually. The 2018 Note matures and the 2018 Warrant expires on May 30, 2023. Crystal Amber is deemed a Related Party of the Company for ASX purposes due to the size of its ownership position. (See Note 10 of the Consolidated Financial Statements for a more complete description of the terms and conditions of the financing). In September 2018, the Company received commitments for a private placement of approximately $5 million in an offering of its CDIs to sophisticated and professional investors, including certain existing investors in Australia, the United States and the United Kingdom. The first tranche of $2.2 million closed and cash was received in September 2018. The second and final tranche of $2.8 million was contingent upon shareholder approval, which was obtained in October 2018. Cash proceeds were received in November 2018. In December 2018, the maturity date of the 2017 Note was extended from December 31, 2018 to March 31, 2019 in exchange for payment of $394 thousand, the total accrued interest on the 2017 Note at December 31, 2018. In March 2019, the Company completed a Convertible Term Promissory Note (the “March 2019 Note”) and Warrant (the “March 2019 Warrant”) financing with its largest shareholder, Crystal Amber, for a gross amount of $1.0 million. The March 2019 Note accrues interest at 10% per annum compounded annually. Certain specific terms associated with the conversion of the March 2019 Note and issuance of the March 2019 Warrant require shareholder approval, which will be sought in a vote of the stockholders of the Company during the Annual Meeting of Stockholders anticipated to be held in May or June 2019. The March 2019 Note matures on March 15, 2024 and the March 2019 Warrant, if issued, will expire on the fifth anniversary of the date of issuance. Crystal Amber is deemed a Related Party of the Company for ASX purposes due to the size of its ownership position. (See Note 10 of the Consolidated Financial Statements for a more complete description of the terms and conditions of the financing). In March 2019, the maturity date of the 2017 Note was extended to May 1, 2019. In April 2019, the maturity date of the 2017 Note was extended to July 1, 2019. In May 2019, the Company completed a Convertible Term Promissory Note (the “May 2019 Note”) and Warrant (the “May 2019 Warrant”) financing with its largest shareholder, Crystal Amber, for a gross amount of up to $3.0 million. The May 2019 Note accrues interest at 10% per annum, computed daily until the date upon which full funding under the May 2019 Note is anticipated to be received, regardless of whether full funding is made on such date (the “Full Funding Date”) and compounded annually beginning on the Full Funding Date. The $3.0 million payment will be made in several tranches. Certain specific terms associated with the conversion of the May 2019 Note and issuance of the May 2019 Warrant require shareholder approval, which will be sought in a vote of the stockholders of the Company during the Annual Meeting of Stockholders anticipated to be held in May or June 2019. The May 2019 Note matures and the May 2019 Warrant, if issued, will expire on the fifth anniversary of the Full Funding Date. Crystal Amber is deemed a Related Party of the Company for ASX purposes due to the size of its ownership position. (See Note 10 of the Consolidated Financial Statements for a more complete description of the terms and conditions of the financing). Going Concern As of March 31, 2019, the Company’s primary source of liquidity is its cash and cash equivalents balances. The Company continues to evaluate which markets are appropriate to pursue regulatory approvals, continue pursuing reimbursement, market awareness and general market development and selling efforts. The Company continues to restructure its business and costs, establish new priorities, and evaluate strategic options. As a result, if the Company remains in business, it expects to incur significant operating losses for the next several years. The Company has incurred operating losses since inception and at March 31, 2019 had an accumulated deficit of approximately $270 million, a working capital deficit of approximately $5.5 million, cash used in operating activities of approximately $3.5 million and cash and cash equivalents of approximately $1.3 million. Cash provided by these activities will be used predominantly to prepare for the Company’s clinical trial, which will result in increased expenses. The Company does not expect its current cash balances will be sufficient to operate beyond July 1, 2019 if cash is required to settle the 2017 Note on that date. Both parties to the 2017 Note are aware that if the Company is required to make this payment on the due date of July 1, 2019, the Company will be required either to renegotiate the due date of the loan or potentially cease operations. Crystal Amber and the Company are in discussions to extend of the due date of the 2017 Note, but there can be no assurance that any extension will occur. If the Company is able to amend the terms of the 2017 Note, it believes its cash and cash equivalents will be sufficient to fund operations to the end of August 2019, or until the modified due date of the note. The Company will need to raise additional funds through any combination of collaborative arrangements, strategic alliances, and additional equity and debt financings or from other sources. The Company has no guaranteed source of capital that will sustain operations beyond August 2019. There can be no assurance that other potential financing opportunities will be available on acceptable terms, if at all. As such, if access to capital is not achieved to satisfy cash needs in the near term, the Company’s business, financial condition and results of operations will be materially harmed or the Company may be required to cease operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business. The consolidated financial statements as of March 31, 2019 and December 31, 2018 and the three months ended March 31, 2019 and 2018 do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Basis of Presentation | 2. Summary of Significant Accounting Policies and Basis of Presentation The accompanying interim consolidated financial statements and related disclosures as of March 31, 2019, and for the three months ended March 31, 2019 and 2018, are unaudited and have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. These interim consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K (“Form 10-K”), filed with the SEC on March 13, 2019. The December 31, 2018 consolidated balance sheet included herein was derived from the audited financial statements as of that date but does not include all disclosures including notes required by GAAP for complete financial statements. Principles of Consolidation The accompanying consolidated financial statements include the accounts of GI Dynamics, Inc. and its wholly owned subsidiaries. All intercompany transactions and balances are eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in accordance with GAAP requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. On an ongoing basis, the Company’s management evaluates its estimates, including those related to impairment of long-lived assets, income taxes including the valuation allowance for deferred tax assets, research and development, contingencies, valuation of derivative liabilities, estimates used to assess its ability to continue as a going concern and stock-based compensation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. Cash and Cash Equivalents The Company considers all highly liquid investment instruments with an original maturity when purchased of three months or less to be cash equivalents. Investments qualifying as cash equivalents primarily consist of money market funds and have a carrying amount that approximates fair value. The amount of cash equivalents included in cash and cash equivalents was approximately $4 thousand The Company has $30 thousand in restricted cash used to secure a corporate credit card account. Inventory When the Company resumes commercial activity, the Company will state inventory at the lower of first-in, first-out cost or net realizable value. When capitalizing inventory, the Company will consider factors such as status of regulatory approval, alternative use of inventory, and anticipated commercial use of the product. At March 31, 2019 and December 31, 2018, there was no inventory or reserves against inventory on the balance sheet. Property and Equipment Property and equipment, including leasehold improvements, are recorded at cost and are depreciated when placed in service using the straight-line method based on their estimated useful lives. Included in property and equipment are certain costs of software obtained for internal use. Costs incurred during the preliminary project stage are expensed as incurred, while costs incurred during the application development stage are capitalized and amortized over the estimated useful life of the software. The Company also capitalizes costs related to specific upgrades and enhancements when it is probable the expenditures will result in additional functionality. Maintenance and training costs related to software obtained for internal use are expensed as incurred. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the remaining lease term. Costs for capital assets not yet placed into service have been capitalized as construction in progress and will be depreciated in accordance with the above guidelines once placed into service. Maintenance and repair costs are expensed as incurred. Research and Development Costs Research and development costs are expensed when incurred. Research and development costs include costs of all basic research activities as well as other research, engineering, and technical effort required to develop a new product or service or make significant improvement to an existing product or manufacturing process. Research and development costs also include preapproval regulatory and clinical trial expenses. Patent Costs The Company expenses as incurred all costs, including legal expenses, associated with obtaining patents until the patented technology becomes feasible. All costs incurred after the patented technology is feasible will be capitalized as an intangible asset. As of March 31, 2019, and December 31, 2018, no such costs had been capitalized. The Company expensed no patent costs within general and administrative expenses in the consolidated statements of operations for each quarter ended March 31, 2019 and 2018, respectively. Stock-Based Compensation We account for stock-based compensation in accordance with the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 718, Stock Compensation For awards that vest based on service conditions, we use the straight-line method to allocate compensation expense to reporting periods. The grant date fair value of options granted is calculated using the Black-Scholes option pricing model, which requires the use of subjective assumptions including volatility, expected term and the fair value of the underlying Common Stock, among others. The assumptions used in determining the fair value of stock-based awards represent management’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change, and we use different assumptions, our stock-based compensation could be materially different in the future. The risk-free interest rate used for each grant is based on a zero-coupon U.S. Treasury instrument with a remaining term similar to the expected term of the stock-based award. Because we do not have a sufficient history to estimate the expected term, we use the simplified method for estimating the expected term. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. We estimate our expected stock volatility based on our to-date historical price volatility. We have not paid and do not anticipate paying cash dividends on our shares of Common Stock; therefore, the expected dividend yield is assumed to be zero. In 2017, the Company elected to use an actual occurrence method of recording award forfeitures rather than the prior standard of estimating forfeitures as of the grant date. We periodically issue performance-based awards. For these awards, vesting will occur upon the achievement of certain milestones. When achievement of the milestone is deemed probable, we expense the compensation of the stock award over the implicit service period. Stock awards to non-employees are accounted for in accordance with ASC 505-50, Equity-Based Payments to Non-Employees Impairment of Long-Lived Assets The Company regularly reviews the carrying amount of its long-lived assets to determine whether indicators of impairment may exist that 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. Loss Contingencies In accordance with ASC 450, Contingencies Income Taxes The Company provides for income taxes under the liability method. The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial reporting and the tax bases of assets and liabilities measured using the enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to reflect the uncertainty associated with their ultimate realization. The Company accounts for uncertain tax positions recognized in the consolidated financial statements by applying a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Guarantees The Company has identified the guarantees described below as disclosable, in accordance with ASC 460, Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that should limit its exposure and enable it to recover a portion of any future amounts paid. The Company is a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate the Company to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from the date of execution of the applicable agreement for a period equal to the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. For the three months ended March 31, 2019 and 2018, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible. As a result, no related reserves have been established. Issuance Costs Related to Equity and Debt The Company allocates issuance costs between the individual freestanding instruments identified on the same basis as proceeds were allocated. Issuance costs associated with the issuance of stock or equity contracts (i.e., equity-classified warrants and convertible preferred stock) are recorded as a charge against the gross proceeds of the offering. Any issuance costs associated with the issuance of liability-classified warrants are expensed as incurred. Issuance costs associated with the issuance of debt (i.e., convertible debt) is recorded as a direct reduction of the carrying amount of the debt liability but limited to the notional value of the debt. The Company accounts for debt as liabilities measured at amortized cost and amortizes the resulting debt discount to interest expense using the effective interest method over the expected term of the notes pursuant to ASC 835, Interest Embedded Conversion Features The Company evaluates embedded conversion features within convertible debt under ASC 815 “Derivatives and Hedging” to determine whether the embedded conversion feature(s) should be bifurcated from the host instrument and accounted for as a derivative at fair value with changes in fair value recorded in earnings. If the conversion feature does not require derivative treatment under ASC 815, the instrument is evaluated under ASC 470-20 “Debt with Conversion and Other Options.” Under the ASC 470-20, an entity must separately account for the liability and equity components of the convertible debt instruments that may be settled entirely or partially in cash upon conversion in a manner that reflects the issuer’s economic interest cost. The effect of ASC 470-20 on the accounting for our convertible debt instruments is that the equity component is required to be included in the additional paid-in capital section of stockholders’ equity on the consolidated balance sheets and the value of the equity component is treated as original issue discount for purposes of accounting for the debt component of the notes. As a result, we are required to record non-cash interest expense as a result of the amortization of the discounted carrying value of the convertible debt to their face amount over the term of the convertible debt. We report higher interest expense in our financial results because ASC 470-20 requires interest to include both the current period’s amortization of the debt discount and the instrument’s coupon interest. For conventional convertible debt where the rate of conversion is below market value, the Company records a "beneficial conversion feature" ("BCF") and related debt discount. When the Company records a BCF, the relative fair value of the BCF is recorded as a debt discount against the face amount of the respective debt instrument (offset to additional paid in capital) and amortized to interest expense over the life of the debt. Subsequent Events The Company evaluates events occurring after the date of its consolidated balance sheet for potential recognition or disclosure in its consolidated financial statements. Other than the following, there have been no material subsequent events that occurred through the date the Company issued its consolidated financial statements that require disclosure in or adjustment to its consolidated financial statements. On April 22, 2019, the Company entered into a right of use lease (see Note 11). On April 30, 2019, the Company entered into an amendment to its 2017 Note and Warrant Purchase Agreement and its 2017 Senior Secured Convertible Promissory Note (see Note 10). On May 8, 2019, the Company entered into a Note and Warrant Purchase Agreement and issued a Senior Unsecured Convertible Promissory Note (see Notes 4 and 10). New Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), or ASU 2016-02. ASU 2016-02 requires that lessees recognize in the statement of financial position for all leases (with the exception of short-term leases) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis, and a right-of-use asset, which is an asset representing the lessee’s right to use the underlying asset for the lease term. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. Lessees must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Lessees may not apply a full retrospective transition approach. We have elected not to apply the guidance to short-term leases and the adoption of ASU 2016-02 has no impact on our consolidated financial statements as of December 31, 2018 and March 31, 2019 and for the three months ended March 31, 2019 and 2018. In September 2017, the FASB issued ASU No. 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments. Leases In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718) In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements affects a wide variety of topics, including the following: Amendments to Subtopic 220-10, Income Statement— Reporting Comprehensive Income—Overall relates to income taxes not payable in cash; Amendments to Subtopic 470-50, Debt—Modifications and Extinguishments relates to debt extinguishment and requires that the net carrying amount of extinguished fair value elected debt equals its fair value at reacquisition and related gains or losses in other comprehensive income must be included in net income upon extinguishment of the debt; Amendments to Subtopic 480-10, Distinguishing Liabilities from Equity—Overall relates to combinations of freestanding financial instruments with non-controlling interests; Amendments to Subtopic 718-740, Compensation—Stock Compensation—Income Taxes relate to recognition timing clarification for excess tax benefits or deficiencies for compensation expense; Amendments to Subtopic 805-740, Business Combinations— Income Taxes relate to allocating tax provisions to an acquired entity; Amendments to Subtopic 815-10, Derivatives and Hedging— Overall relate to accounting for offsetting derivatives; Amendments to Subtopic 820-10, Fair Value Measurement— Overall relate to the wording with respect to how transfer restrictions effect the fair value of an asset and adds explicit wording to allow entities to measure fair value on a net basis for those portfolios in which financial assets and financial liabilities and nonfinancial instruments are managed and valued together; Amendments to Subtopic 940-405, Financial Services—Brokers and Dealers—Liabilities relate to guidance about offsetting on the balance sheet; and Amendments to Subtopic 962-325, Plan Accounting—Defined Contribution Pension Plans—Investments—Other relate to plan evaluation of whether a readily determinable fair value exists to determine whether those investments may qualify for the practical expedient to measure at net asset value in accordance with Topic 820. The transition and selection of an effective date is based on the facts and circumstances of each amendment, but many of the amendments have transition guidance with effective dates for annual periods beginning after December 15, 2018, for public business entities. The Company is currently evaluating the relevance of each component and potential impact of ASU 2018-09 components on its consolidated financial statements. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842), Targeted Improvements In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement , or ASU 2018-13, which provides guidance focused on the disclosure requirements for disclosing fair value estimates, assumptions, and methodology. Removed requirements to disclose details around amount and reasoning for level 1 to level 2 transfers, timing policies for transfer between levels, and the valuation processes for level 3 fair value measurements. Modified requirements include details regarding net asset redemption restrictions and timing related to uncertainty disclosures. Added requirements to include disclosures of changes in unrealized gains and losses for recurring level 3 measurements held as of the reporting date and disclosures around the range and weighted average of significant inputs used to develop level 3 fair value measurements. These amendments are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of this Update. An entity is permitted to early adopt any removed or modified disclosures upon issuance of this Update and delay adoption of the additional disclosures until their effective date. The Company is currently evaluating the individual components and as these are disclosure refinements, expects no impact to its consolidated financial statements on adoption. In March 2019, the FASB issued ASU No. 2019-01, Leases (Topic 842), Codification Improvements |
Net Loss per Common Share
Net Loss per Common Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | 3. Net Loss per Common Share Basic net loss per common share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Potential common stock equivalents are determined using the treasury stock method. For diluted net loss per share purposes, the Company excludes stock options and other stock-based awards, including shares issued as a result of option exercises but which are subject to repurchase by the Company, whose effect would be anti-dilutive from the calculation. During the three months ended March 31, 2019 and 2018, common stock equivalents were excluded from the calculation of diluted net loss per common share, as their effect was anti-dilutive due to the net loss incurred. Therefore, basic and diluted net loss per share was the same in all periods presented. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of March 31, 2019 and 2018, as they would be anti-dilutive: Three Months Ended March 31, 2019 2018 Warrants to purchase common stock 3,552,672 28,532 Options to purchase common stock and other stock-based awards 1,545,719 1,668,219 Total 5,098,391 1,696,751 |
Warrants to Purchase Common Sto
Warrants to Purchase Common Stock and CDIs | 3 Months Ended |
Mar. 31, 2019 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | |
Warrants to Purchase Common Stock and CDIs | 4. Warrants to Purchase Common Stock and CDIs On May 4, 2016, the Company entered into a consulting agreement pursuant to which a consulting firm provides strategic advisory, finance, accounting, human resources and administrative functions, including chief financial officer services, to the Company. In connection with the consulting agreement, the Company granted the consulting firm a warrant (“Consultant Warrant”) to purchase up to 28,532 shares of the Company’s common stock at an exercise price per share equal to $0.64. The Consultant Warrant is fully vested and expires on May 4, 2021. The Company has reserved 28,532 shares of common stock related to the Consultant Warrant. As of March 31, 2019, the Consultant Warrants had not been exercised. On May 30, 2018, the Company entered into a Note and Warrant Purchase agreement that included a warrant to purchase 97,222,200 CDIs (representing 1,944,444 shares of common stock). The exercise price is US$0.018 per CDI and the warrant can be exercised with cash or as a net exercise. The warrant is immediately exercisable on issuance and expires on May 30, 2023. On March 15, 2019, the Company entered into a Note and Warrant Purchase agreement that included a form of warrant to purchase 78,984,823 CDIs (representing 1,579,696 shares of common stock). The issuance of the warrant requires shareholder approval, which will be sought in a vote of the stockholders of the Company during the Annual Meeting of Stockholders anticipated to be held in May or June 2019. If issued, the warrant’s exercise price is US$0.0127 per CDI, and the warrant can be exercised with cash or as a net exercise. The warrant is immediately exercisable on issuance and will expire (if issued) on the fifth anniversary of the date of issuance. On May 8, 2019, the Company entered into a Note and Warrant Purchase agreement that included a form of warrant to purchase 236,220,472 CDIs (representing 4,724,409 shares of common stock), or a lesser number of CDIs proportion to the amount finally funded under the simultaneously issued $3 million note. The issuance of the warrant requires shareholder approval, which will be sought in a vote of the stockholders of the Company during the Annual Meeting of Stockholders anticipated to be held in May or June 2019. If issued, the warrant’s exercise price is US$0.0127 per CDI, and the warrant can be exercised with cash or as a net exercise. The warrant is immediately exercisable on issuance and will expire on the fifth anniversary of the Full Funding Date (as defined in Note 1 to these Consolidated Financial Statements). |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 5. Fair Value of Financial Instruments The tables below present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis as of March 31, 2019 and December 31, 2018 and indicates the fair value hierarchy of the valuation techniques the Company used to determine such fair value. In general, fair values determined by Level 1 inputs utilize observable inputs such as quoted prices in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are either directly or indirectly observable, such as quoted prices, interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points in which there is little or no market data, requiring the Company to develop its own assumptions for the asset or liability. The following tables present the assets and liabilities the Company has measured at fair value on a recurring basis (in thousands): Fair Value Measurements at Reporting Date Using Quoted Prices Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Description March 31, 2019 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 4 $ 4 $ — $ — Total assets $ 4 $ 4 $ — $ — Liabilities Derivative liability $ 883 $ — $ — $ 883 Total liabilities $ 883 $ — $ — $ 883 Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Description December 31, 2018 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 1,097 $ 1,097 $ — $ — Total assets $ 1,097 $ 1,097 $ — $ — Liabilities Derivative liability $ 51 $ — $ — $ 51 Total liabilities $ 51 $ — $ — $ 51 The assumptions used in the Black-Scholes option pricing model to determine the fair value of the common stock warrants as of March 31, 2019, and December 31, 2018 were as follows: March 31, December 31, 2019 2018 Exercise price (A$55.00 at the then current exchange rate) $ 0.64 $ 0.64 Fair value of common stock $ 0.67 $ 0.57 Expected volatility 179.0 % 134.0 % Expected term (in years) 2.11 2.35 Risk-free interest rate 2.3 % 2.5 % Expected dividend yield — % — % The following table rolls forward the fair value of the Derivative Liabilities, where fair value is determined by Level 3 inputs (in thousands): Balance at December 31, 2018 $ 51 Increase in fair value of warrants upon re-measurement 1 Amortization of conversion rights (40 ) Fair value of warrants issued with 2019 Note 871 Balance at March 31, 2019 $ 883 Cash, cash equivalents, restricted cash, prepaid expenses and other current assets, accounts payable, accrued expenses and short-term debt to Crystal Amber Fund Limited, a related party, at March 31, 2019 and December 31, 2018 are carried at amounts that approximate fair value due to their short-term maturities and highly liquid nature of these instruments. The carrying value of the Company’s long-term debt to Crystal Amber Fund Limited, a related party, at March 31, 2019 and December 31, 2018 approximates fair value based on commonly applied estimation methodologies and industry studies obtained by the Company. |
Concentrations of Credit Risk a
Concentrations of Credit Risk and Related Valuation Accounts | 3 Months Ended |
Mar. 31, 2019 | |
Valuation And Qualifying Accounts [Abstract] | |
Concentrations of Credit Risk and Related Valuation Accounts | 6. Concentrations of Credit Risk and Related Valuation Accounts Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents and restricted cash. The Company maintains its cash and cash equivalent balances with high quality financial institutions, and consequently, the Company believes that such funds are subject to minimal credit risk. The Company’s short-term investments potentially subject the Company to concentrations of credit risk. The Company has adopted an investment policy that limits the amounts the Company may invest in any one type of investment and requires all investments held by the Company to hold at least an A rating from a recognized credit rating agency, thereby reducing credit risk concentration. The Company grants credit to customers in the normal course of business but generally does not require collateral or any other security to support its receivables. The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for receivables when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices not individually reviewed. In certain circumstances, the Company allows customers to return defective or nonconforming products for credit or replacement products. Defective or nonconforming products typically include those products that resulted in an unsuccessful implant procedure. The Company records an estimate for product returns based upon historical trends. The associated reserve for product returns is recorded as a reduction of the Company’s accounts receivable. Amounts determined to be uncollectible are written off against the total reserve. The Company recorded write-offs of uncollectible accounts receivable of $38 thousand in the three months ended March 31, 2018. As of March 31, 2019 and December 31, 2018, the Company had no accounts receivable and no reserves for uncollectible accounts receivable. The following is a rollforward of the Company’s allowance for doubtful accounts (in thousands): Three Months Ended March 31, 2019 2018 Beginning balance $ — $ 42 Net charges to expenses — 38 Utilization of allowances — (2 ) Ending balance $ — $ 78 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | 7. Inventory The Company states inventory at the lower of first-in, first-out cost or net realizable value. The Company records a provision for excess, expired, and obsolete inventory based primarily on estimates of forecasted revenues. When capitalizing inventory, the Company considers factors such as status of regulatory approval, alternative use of inventory, and anticipated commercial use of the product. A significant change in the timing or level of demand for products as compared to forecasted amounts may result in recording additional provisions for excess, expired, and obsolete inventory in the future. Currently, the determination of obsolete or excess inventory requires the Company to estimate regulatory approval probability and timing and subsequent demand for its products within approved markets. The estimated future demand is compared to inventory levels to determine the amount, if any, of obsolete and excess inventory. Given the probability and timing of regulatory approval and appropriate inventory life span, we fully reserved our inventory as of December 31, 2017 and subsequently wrote off all inventory and reserves in 2018 as the materials on hand were not expected to be usable for future sales. There is no inventory or reserves against inventory on the balance sheet at March 31, 2019 and December 31, 2018, respectively. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 8. Property and Equipment Property and equipment consisted of the following (in thousands): March 31, December 31, 2019 2018 Laboratory and manufacturing equipment $ 591 $ 591 Computer equipment and software 1,187 1,182 Office furniture and equipment 183 183 1,961 1,956 Less accumulated depreciation and amortization (1,901 ) (1,893 ) Total $ 60 $ 63 Depreciation and amortization expense of property and equipment totaled approximately $8 and $11 thousand for the three months ended March 31, 2019 and 2018, respectively. At March 31, 2019 and December 31, 2018, the Company had no assets under capital lease. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 9. Accrued Expenses Accrued expenses consisted of the following (in thousands): March 31, December 31, 2019 2018 Payroll and related liabilities $ 167 $ 386 Professional fees 434 573 Credit refunds 167 186 Interest 211 494 Other 8 6 Total $ 987 $ 1,645 |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Notes Payable | 10. Notes Payable 2017 Convertible Note Financing On June 15, 2017, the Company entered into a Note Purchase Agreement by and between the Company, as borrower, and Crystal Amber Fund Limited, as purchaser (the “Purchaser”). Pursuant to the Note Purchase Agreement, the Company issued and sold to the Purchaser a Senior Secured Convertible Promissory Note in an aggregate original principal amount of $5.0 million (the “2017 Note”). The Purchaser is a related party for ASX purposes and is the Company’s largest shareholder. The 2017 Note accrues interest at a rate equal to 5% per annum, compounded annually, other than during the continuance of an event of default, when the 2017 Note accrues interest at a rate of 8% per annum. The entire outstanding principal balance and all unpaid accrued interest thereon was initially due on the original maturity date, December 31, 2018 but was extended to March 31, 2019 in December 2018 and further extended to May 1, 2019 in March 2019 and July 1, 2019 in April 2019. The 2017 Note is secured by a first priority security interest in substantially all tangible and intangible assets of the Company, including intellectual property (the “Collateral”). In the event of an uncured default, the Purchaser is authorized to sell, transfer, assign or otherwise deal in or with the Collateral or the proceeds thereof or any related goods securing the Collateral, as fully and effectually as if the Purchaser were the absolute owner thereof. The ASX provided the Company with a waiver to allow all asset liens (the “Security”) to be granted to the Purchaser without the normal requirement of having to obtain shareholder approval for the grant of a security to a related party of the Company (which the Purchaser is for ASX purposes). As a result of the waiver, the Security contains a provision that provides that if an event of default occurs and the Purchaser exercises its rights under the Security, neither the Purchaser nor any of its associates can acquire any legal or beneficial interest in an asset of the Company or its subsidiaries in full or partial satisfaction of the Company’s obligations under the Security, or otherwise deal with the assets of the Company or its subsidiaries, without the Company first having complied with any applicable ASX Listing Rules, including ASX Listing Rule 10.1, other than as required by law or through a receiver, or receiver or manager (or analogous person) appointed by the Purchaser exercising its power of sale under the Security and selling the assets to an unrelated third party on arm’s length commercial terms and conditions and distributing the cash proceeds to the Purchaser or any of its associates in accordance with their legal entitlements. The entire outstanding principal balance under the 2017 Note and all unpaid accrued interest thereon is convertible into CHESS Depositary Interests (“CDIs”), each representing 1/50th of a share of the Company’s common stock, (i) prior to the maturity date, at the option of the Purchaser at a conversion price calculated based on the five-day volume weighted average price of the Company’s CDIs on the ASX (“Optional Conversion Price”), or (ii) automatically upon the occurrence of an equity financing in which the Company raises at least $10 million (a “Qualified Financing”) at the price per CDI of the CDIs issued and sold in such financing. In the event that the Borrower issues additional CDIs in a subsequent equity financing at a price per CDI that is less than the then-effective optional conversion price (based on the five-day volume weighted average price on the ASX), the Purchaser has a 30-day option to convert at an adjusted conversion price reflecting, on a weighted average basis, the lower price per CDI. The number of CDIs that the Purchaser may acquire upon conversion of the 2017 Note at this adjusted conversion price is limited to the number that maintains the Purchaser’s fully-diluted ownership percentage of the Company at the same level as existed immediately preceding the applicable subsequent equity financing. In addition, upon a change of control of the Company (other than a change of control resulting from a Qualified Financing) in which the Company’s stockholders receive cash consideration, the Company is obligated to prepay all accrued and unpaid interest plus 110% of the remaining outstanding unconverted principal balance. If the consideration received for such change of control is a non-cash consideration, the Purchaser may convert the entire outstanding principal balance under the 2017 Note and all unpaid accrued interest thereon into CDIs at the abovementioned Optional Conversion Price. Other than as described above, the Company may not prepay the 2017 Note without the consent of the Purchaser. The 2017 Note Purchase Agreement contains customary events of default including a failure to perform obligations under the 2017 Note Purchase Agreement, bankruptcy, a decision by the board of directors of the Company to wind up the Company, or if the Company otherwise ceases to carry on its ongoing business operations. If a default occurs and is not cured within the applicable cure period or is not waived, any outstanding obligations under the 2017 Note may be accelerated. The 2017 Note Purchase Agreement and related 2017 Note documents also contain additional representations and warranties, covenants and conditions, in each case customary for transactions of this type. The Company recorded the $5 million 2017 Note, net of debt issuance costs of $115 thousand and amortized the debt issuance costs over the life of the 2017 Note. For the year ended December 31, 2017, the Company accrued $136 thousand of interest expense and $44 thousand in amortization of debt issuance costs related to the 2017 Note. For comparative purposes, an adjustment was made to separate the short-term debt balance and the 2017 Note derivative liability related to the value of certain conversion rights. Additionally, for comparative purposes, the 2017 interest accrual was shown separately from the change in accrued expenses in the Statement of Cash Flows in order to conform to 2018 presentation. Due to the timing of the finalization of the 2017 Note financing in 2017, the 2017 Note was issued without stockholder approval. As a consequence, while the 2017 Note contains conversion provisions, the Purchaser had, for a period of time, no right to exercise those rights until such rights of exercise were approved by the stockholders of the Company. Stockholder approval of the Purchaser’s right to convert the 2017 Note was obtained at the Company’s Annual Meeting on May 24, 2018. In December 2018, the maturity date of the 2017 Note was extended to March 31, 2019 in exchange for payment of $394 thousand which was the total accrued interest on the 2017 Note at December 31, 2018. Payment of this amount was made in January 2019. The modification extended the conversion rights and resulted in an additional $40 thousand of debt discount liability being recorded. For the three months ended March 31, 2019, the Company accrued $62 thousand of interest expense and recorded an additional $40 thousand of interest expense related to the amortized derivative liability recorded for the 2017 Note. For the three months ended March 31, 2018, the Company accrued interest expense of $62 thousand and amortization of debt issuance costs of $18 thousand related to the 2017 Note. In March 2019, the maturity date of the 2017 Note was extended to May 1, 2019. The modification extended the beneficial conversion rights and resulted in an additional $14 thousand of debt discount liability being recorded. In April 2019, the maturity date of the 2017 Note was further extended to July 1, 2019. 2018 Convertible Note and Warrant Financing On May 30, 2018, the Company entered into a Note Purchase Agreement by and between the Company, as borrower, and Crystal Amber Fund Limited, as purchaser (the “Purchaser”). Pursuant to the Note Purchase Agreement, the Company issued and sold to the Purchaser a Senior Unsecured Convertible Promissory Note in an aggregate original principal amount of $1.75 million (the “2018 Note”). The Purchaser is a related party and is the Company’s largest shareholder. The 2018 Note accrues interest at a rate equal to 10% per annum, compounded annually, other than during the continuance of an event of default, when the 2018 Note accrues interest at a rate of 16% per annum. The entire outstanding principal balance and all unpaid accrued interest thereon is due on the maturity date, May 30, 2023. The entire outstanding principal balance under the 2018 Note and all unpaid accrued interest thereon is convertible into CHESS Depositary Interests (“CDIs”), each representing 1/50th of a share of the Company’s common stock, at the option of the Purchaser at a conversion price of US$0.018 per CDI. In the event that the Borrower issues additional CDIs in a subsequent equity financing at a price per CDI that is less than US$0.018, the conversion price of the 2018 Note will adjust to the lower CDI conversion price. In addition, upon a change of control of the Company, the Purchaser may demand prepayment of accrued and unpaid interest plus 110% of the remaining outstanding unconverted principal balance of the 2018 Note. The 2018 Note contains customary events of default including a failure to perform obligations under the 2018 Note Purchase Agreement, bankruptcy, a decision by the board of directors of the Company to wind up the Company, or if the Company otherwise ceases to carry on its ongoing business operations. If a default occurs and is not cured within the applicable cure period or is not waived, any outstanding obligations under the 2018 Note may be accelerated. The 2018 Note Purchase Agreement and related 2018 Note documents also contain additional representations and warranties, covenants and conditions, in each case customary for transactions of this type. In connection with the issuance of the 2018 Note, the Company also issued to the Purchaser a warrant to purchase 97,222,200 CDIs at an initial exercise price of US$0.018 per CDI, subject to adjustment as described in the warrant, which warrant expires on May 30, 2023 (the “2018 Warrant”). The 2018 Warrant may be exercised at any time on a cash or cashless basis. The 2018 Warrant includes a price protection clause. If the Company issues securities in a subsequent financing at a per CDI price of less than US$0.018, the exercise price of the 2018 Warrant will be reduced to the lowest such price per CDI (or the equivalent for shares of common stock) at which the newly issued securities were sold. The Company has evaluated the guidance ASC 480-10 Distinguishing Liabilities from Equity, A Contracts in an Entity's Own Equity Debt with Conversion and Other Options The Company recorded the 2018 Note, net of the total debt discount of $1.75 million and will amortize the debt discount over the life of the 2018 Note. For the three months ended March 31, 2019, the Company recognized interest expense of $44 thousand and debt discount amortization of $72 thousand. March 2019 Convertible Note and Warrant Financing On March 15, 2019, the Company entered into a Note Purchase Agreement by and between the Company, as borrower, and Crystal Amber Fund Limited, as purchaser (the “Purchaser”). Pursuant to the Note Purchase Agreement, the Company issued and sold to the Purchaser a Senior Unsecured Convertible Promissory Note in an aggregate original principal amount of $1 million (the “March 2019 Note”). The Purchaser is a related party and is the Company’s largest shareholder. The March 2019 Note accrues interest at a rate equal to 10% per annum, compounded annually, other than during the continuance of an event of default, when the March 2019 Note accrues interest at a rate of 16% per annum. The entire outstanding principal balance and all unpaid accrued interest thereon is due on the maturity date, March 15, 2024. The entire outstanding principal balance under the March 2019 Note and all unpaid accrued interest thereon is convertible into CHESS Depositary Interests (“CDIs”), each representing 1/50th of a share of the Company’s common stock, at the option of the Purchaser at a conversion price of US$0.0127 per CDI. In the event that the Borrower issues additional CDIs in a subsequent equity financing at a price per CDI that is less than US$0.0127, the conversion price of the March 2019 Note will adjust to the lower CDI conversion price. In addition, upon a change of control of the Company, the Purchaser may demand prepayment of accrued and unpaid interest plus 110% of the remaining outstanding unconverted principal balance of the March 2019 Note. The March 2019 Note contains customary events of default including a failure to perform obligations under the March 2019 Note Purchase Agreement, bankruptcy, a decision by the board of directors of the Company to wind up the Company, or if the Company otherwise ceases to carry on its ongoing business operations. If a default occurs and is not cured within the applicable cure period or is not waived, any outstanding obligations under the March 2019 Note may be accelerated. The March 2019 Note Purchase Agreement and related March 2019 Note documents also contain additional representations and warranties, covenants and conditions, in each case customary for transactions of this type. In connection with the issuance of the March 2019 Note, the Company has, subject to obtaining shareholder approval, agreed to issue to the Purchaser a warrant to purchase 78,984,823 CDIs at an initial exercise price of US$0.0127 per CDI, subject to adjustment as described in the warrant, which warrant expires on the fifth anniversary of the date of issuance (the “March 2019 Warrant”). Upon issuance, the March 2019 Warrant may be exercised at any time on a cash or cashless basis. The March 2019 Warrant includes a price protection clause. If the Company issues securities in a subsequent financing at a per CDI price of less than US$0.0127, the exercise price of the March 2019 Warrant will be reduced to the lowest such price per CDI (or the equivalent for shares of common stock) at which the newly issued securities were sold. The Company has evaluated the guidance ASC 480-10 Distinguishing Liabilities from Equity, A Contracts in an Entity's Own Equity Debt with Conversion and Other Options May 2019 Convertible Note and Warrant Financing In May 2019, the Company completed a Convertible Term Promissory Note (the “May 2019 Note”) and Warrant (the “May 2019 Warrant”) financing with its largest shareholder, Crystal Amber, for a gross amount of up to $3.0 million. The May 2019 Note accrues interest at 10% per annum, computed daily until the date upon which full funding under the May 2019 Note is anticipated to be received, regardless of whether full funding is made on such date (the “Full Funding Date”) and compounded annually beginning on the Full Funding Date. The $3.0 million payment will be made in several tranches. Certain specific terms associated with the conversion of the May 2019 Note and issuance of the May 2019 Warrant require shareholder approval, which will be sought in a vote of the stockholders of the Company during the Annual Meeting of Stockholders anticipated to be held in May or June 2019. The May 2019 Note matures and the May 2019 Warrant, if issued, will expire on the fifth anniversary of the Full Funding Date. Crystal Amber is deemed a Related Party of the Company for ASX purposes due to the size of its ownership position. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. Commitments and Contingencies Lease Commitments In June 2016, the Company entered into a non-cancelable agreement to lease approximately 4,200 square feet of office space in Boston, Massachusetts. The lease commenced in June 2016 and expired in April 2018. Rent during the term was $12 thousand per month. In December 2018, the Company entered into a membership agreement with WeWork for 985 square feet of office space located in Boston, Massachusetts. The committed lease term expires in May 2019 and contains a two-month cancellation provision. Future minimum lease payments under all short-term lease arrangements at March 31, 2019 are $36 thousand. Rent expense on non-cancelable operating leases was approximately $56 and $37 thousand for the three months ended March 31, 2019 and 2018, respectively. On May 1, 2019, the Company entered into a right of use lease commencing May 1, 2019 for 3,520 square feet of office space in Boston, Massachusetts. The lease expires May 31, 2022 and the Company will record a fair value right to use asset and a related operating lease liability of $643 thousand, the asset to be depreciated and the liability to be amortized over the term of the lease. Additional pro-rata building operating expenses, property taxes and utilities will all be expensed in the period incurred |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity (Deficit) | 12. Stockholders’ Equity (Deficit) On May 22, 2017, the Stockholders of the Company approved an increase of its authorized shares of Common Stock from 13,000,000 to 50,000,000 and to eliminate Class B shares of Common Stock of the Company. As of March 31, 2019, the authorized capital stock of the Company consists of 50,500,000 shares, of which 50,000,000 shares are designated as Common Stock and 500,000 shares are designated as Preferred Stock. In 2018, the Company received commitments for two private placements to sophisticated and professional investors in Australia, the United States and the United Kingdom, consisting of U.S. and non-U.S. persons (as defined in Regulation S (“Regulation S”) of the Securities Act of 1933 (the “Securities Act”)) to raise up to approximately $6.61 million (the “2018 Placements”). The first placement (“First Quarter 2018 Placement”) consisted of a total of 406,002,869 fully paid CDIs of the Company (representing 8,120,057 shares of common stock) at an issue price of A$0.035 per CDI. The issue of CDIs under the First Quarter 2018 Placement occurred in two tranches. The first tranche closed on January 22, 2018 (US Eastern time), pursuant to which the Company issued 28,467,063 CDIs (representing 569,341 shares of common stock) resulting in gross proceeds of approximately $781 thousand and related issuance costs of $63 thousand. The closing of the second tranche of the First Quarter 2018 Placement resulted in the raising of $824 thousand and related issuance costs of $39 thousand by the issue of 30,313,556 CDIs (606,271 shares) following stockholder approval granted on February 27, 2018. There were two participants in the First Quarter 2018 Placement second tranche; Crystal Amber Fund, a related party, purchased 27,391,756 CDIs. A Board member of the Company purchased 2,921,800 CDIs. The second placement (“Autumn 2018 Placement”) consisted of a total of 347,222,250 fully paid CDIs of the Company (representing 6,944,445 shares of common stock) at an issue price of A$0.020 per CDI. The investors in the Autumn 2018 Placement included certain existing investors. The issue of these CDIs occurred in two tranches. The first tranche closed on September 20, 2018 (US Eastern time), pursuant to which the Company issued 150,000,000 CDIs (representing 3,000,000 shares of common stock) resulting in gross proceeds of approximately $2.2 million and related issuance costs of $56 thousand. The closing of the second tranche resulted in the raising of $2.8 million by the issue of 197,222,250 CDIs (representing 3,944,445 shares of common stock) following stockholder approval at the adjourned Special Meeting of stockholders on October 29, 2018. There were three participants in the second tranche; Crystal Amber Fund, a related party, purchased 168,194,450 CDIs. Existing investors in the United States and Australia also purchased 23,819,450 and 5,208,350 CDIs, respectively. All second tranche CDIs were allotted to investors in November 2018. |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | 13. Share-Based Compensation The Company has two stock-based compensation plans. In May 2003, the Board of Directors adopted the 2003 Omnibus Stock Plan (the “2003 Plan”), which provides for the grant of qualified incentive stock options and nonqualified stock options or other awards to the Company’s employees, officers, directors, advisors, and outside consultants to purchase up to an aggregate of 922,086 shares of the Company’s common stock. In August 2011, the Board of Directors adopted the 2011 Employee, Director and Consultant Equity Incentive Plan (the “2011 Plan”, together with the 2003 Plan, the “Plans”) as the successor to the 2003 Plan. Under the 2011 Plan, the Company may grant incentive stock options, nonqualified stock options, restricted and unrestricted stock awards and other stock-based awards. The Company had initially reserved 450,000 shares of its common stock for issue under the 2011 Plan. Awards that are returned to the Company’s 2003 Plan as a result of their forfeiture, expiration or cancellation without delivery of common stock shares or that result in the forfeiture of shares back to the Company on or after August 1, 2011, the date the 2011 Plan became effective, are automatically made available for issuance under the 2011 Plan. At August 1, 2011, 80,235 shares available for grant under the 2003 Plan were transferred to the 2011 Plan. At March 31, 2019, there were 1,748,812 shares available for future grant under the 2011 Plan. In addition, the 2011 Plan allows for an annual increase in the number of shares available for issue under the 2011 Plan commencing on the first day of each fiscal year during the period beginning in fiscal year 2012 and ending in fiscal year 2020. The annual increase in the number of shares shall be equal to the lowest of: a. 500,000 shares; b. 4% of the number of common shares outstanding as of such date; and c. an amount determined by the Board of Directors or the Company’s compensation committee. Accordingly, in the first quarter of fiscal 2019, 500,000 options available for future grant were added to the 2011 Plan. Stock-Based Compensation Stock-based compensation is reflected in the consolidated statements of operations as follows for the three months ended March 31, 2019 and 2018 (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 16 $ 5 Sales and marketing — 6 General and administrative 43 18 $ 59 $ 29 The stock options granted under the Plans generally vest over a four-year period and expire ten years from the date of grant. From time to time, the Company grants stock options to purchase common stock subject to performance-based milestones. The vesting of these stock options will occur upon the achievement of certain milestones. When achievement of the milestone is deemed probable, the Company expenses the compensation of the respective stock option over the implicit service period. In calculating stock-based compensation costs, the Company estimates the fair value of stock options using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model was developed for use in estimating the fair value of short-lived, exchange-traded options that have no vesting restrictions and are fully transferable. Such costs are then recognized over the requisite service period of the awards on a straight-line basis. Determining the fair value of stock-based awards using the Black-Scholes option-pricing model requires the use of highly subjective assumptions, including the expected term of the award and expected stock price volatility. The weighted-average assumptions used to estimate the fair value of employee stock options using the Black-Scholes option-pricing model were as follows for the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Expected volatility 122.0 % 114.9 % Expected term (in years) 6.05 6.05 Risk-free interest rate 2.3 % 2.6 % Expected dividend yield 0 % 0 % Stock Options The following table summarizes share-based activity under the Company’s stock option plans for the three months ended March 31, 2019: Shares of Common Stock Attributable to Options Weighted- Average Exercise Price Weighted- Average Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at December 31, 2018 985,224 $ 2.24 8.48 $ — Granted 160,000 $ — Exercised — $ — Cancelled — $ — Outstanding at March 31, 2019 1,145,224 $ 2.24 8.24 $ 1 Vested or expected to vest at March 31, 2019 1,145,224 $ 2.24 8.24 $ 1 Exercisable at March 31, 2019 451,805 $ 4.87 6.87 $ — As of March 31, 2019, there was approximately $637 thousand of unrecognized stock-based compensation related to unvested stock option grants having service-based vesting under the Plans which is expected to be recognized over a weighted-average period of 2.3 years. The intrinsic value in the table above represents the difference between the fair value of the Company’s common stock on the measurement date and the exercise price of the stock option. The stock-based compensation plans provide that grantees may have the right to exercise an option prior to vesting. Shares purchased upon the exercise of unvested options will be subject to the same vesting schedule as the underlying options and are subject to repurchase at the original exercise price by the Company should the grantee discontinue providing services to the Company for any reason, prior to becoming fully vested in such shares. Restricted Stock Units & Performance Stock Units Each restricted stock unit and performance stock unit (“RSU & PSU”) issued under the Company Plans represents a contingent right to receive one share of the Company’s common stock. The RSUs & PSUs outstanding at March 31, 2019 vest upon the achievement of certain product revenue, regulatory and reimbursement milestones. There is no consideration payable on the vesting of RSUs & PSUs issued. Upon vesting, RSUs and PSUs are exercised automatically and settled in shares of the Company’s common stock. The following table summarizes information related to RSU & PSU activity for the three months ended March 31, 2019: Number of Units Weighted- Average Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at December 31, 2018 250,000 7.23 $ 141 Granted — Exercised — Cancelled — Outstanding at March 31, 2019 250,000 6.98 $ 186 The aggregate intrinsic value at March 31, 2019 and December 31, 2018 noted in the table above represents the closing price of the Company’s common stock multiplied by the number of RSUs and PSUs outstanding. The fair value of each RSU and PSU award equals the closing price of the Company’s common stock on the date of grant At March 31, 2019, all RSUs and PSUs outstanding are subject to performance-based vesting criteria as described in the applicable award agreement. For these awards, vesting will occur upon the achievement of certain product revenue, regulatory and reimbursement milestones. When achievement of the milestone is deemed probable, the Company expenses the compensation of the respective stock award over the implicit service period. At March 31, 2019 and 2018, no RSUs and PSUs that have performance-based vesting criteria are considered probable of achievement. For the three months ended March 31, 2019 and 2018, the Company did not recognize any stock-based compensation for RSUs and PSUs subject to performance-based vesting criteria. As of March 31, 2019, there remains approximately $140 thousand of unrecognized stock-based compensation. |
Segment Reporting
Segment Reporting | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Segment Reporting | 14. Segment Reporting Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision-maker in deciding how to allocate resources and in assessing performance. The Company has one reportable segment which designs, develops, manufactures and markets medical devices for non-surgical approaches to treating type 2 diabetes and obesity. Geographic Reporting The Company has historically reported various geographic segments, but at March 31, 2019, long-lived assets, comprised of property and equipment, of approximately $60 thousand are all held in the U.S. and the Company did not have revenue for the three months ended March 31, 2019 and 2018, respectively. Major Customers The Company did not recognize any revenue for the three months ended March 31, 2019 and 2018, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of GI Dynamics, Inc. and its wholly owned subsidiaries. All intercompany transactions and balances are eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in accordance with GAAP requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. On an ongoing basis, the Company’s management evaluates its estimates, including those related to impairment of long-lived assets, income taxes including the valuation allowance for deferred tax assets, research and development, contingencies, valuation of derivative liabilities, estimates used to assess its ability to continue as a going concern and stock-based compensation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investment instruments with an original maturity when purchased of three months or less to be cash equivalents. Investments qualifying as cash equivalents primarily consist of money market funds and have a carrying amount that approximates fair value. The amount of cash equivalents included in cash and cash equivalents was approximately $4 thousand The Company has $30 thousand in restricted cash used to secure a corporate credit card account. |
Inventory | Inventory When the Company resumes commercial activity, the Company will state inventory at the lower of first-in, first-out cost or net realizable value. When capitalizing inventory, the Company will consider factors such as status of regulatory approval, alternative use of inventory, and anticipated commercial use of the product. At March 31, 2019 and December 31, 2018, there was no inventory or reserves against inventory on the balance sheet. |
Property and Equipment | Property and Equipment Property and equipment, including leasehold improvements, are recorded at cost and are depreciated when placed in service using the straight-line method based on their estimated useful lives. Included in property and equipment are certain costs of software obtained for internal use. Costs incurred during the preliminary project stage are expensed as incurred, while costs incurred during the application development stage are capitalized and amortized over the estimated useful life of the software. The Company also capitalizes costs related to specific upgrades and enhancements when it is probable the expenditures will result in additional functionality. Maintenance and training costs related to software obtained for internal use are expensed as incurred. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the remaining lease term. Costs for capital assets not yet placed into service have been capitalized as construction in progress and will be depreciated in accordance with the above guidelines once placed into service. Maintenance and repair costs are expensed as incurred. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed when incurred. Research and development costs include costs of all basic research activities as well as other research, engineering, and technical effort required to develop a new product or service or make significant improvement to an existing product or manufacturing process. Research and development costs also include preapproval regulatory and clinical trial expenses. |
Patent Costs | Patent Costs The Company expenses as incurred all costs, including legal expenses, associated with obtaining patents until the patented technology becomes feasible. All costs incurred after the patented technology is feasible will be capitalized as an intangible asset. As of March 31, 2019, and December 31, 2018, no such costs had been capitalized. The Company expensed no patent costs within general and administrative expenses in the consolidated statements of operations for each quarter ended March 31, 2019 and 2018, respectively. |
Stock-Based Compensation | Stock-Based Compensation We account for stock-based compensation in accordance with the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 718, Stock Compensation For awards that vest based on service conditions, we use the straight-line method to allocate compensation expense to reporting periods. The grant date fair value of options granted is calculated using the Black-Scholes option pricing model, which requires the use of subjective assumptions including volatility, expected term and the fair value of the underlying Common Stock, among others. The assumptions used in determining the fair value of stock-based awards represent management’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change, and we use different assumptions, our stock-based compensation could be materially different in the future. The risk-free interest rate used for each grant is based on a zero-coupon U.S. Treasury instrument with a remaining term similar to the expected term of the stock-based award. Because we do not have a sufficient history to estimate the expected term, we use the simplified method for estimating the expected term. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. We estimate our expected stock volatility based on our to-date historical price volatility. We have not paid and do not anticipate paying cash dividends on our shares of Common Stock; therefore, the expected dividend yield is assumed to be zero. In 2017, the Company elected to use an actual occurrence method of recording award forfeitures rather than the prior standard of estimating forfeitures as of the grant date. We periodically issue performance-based awards. For these awards, vesting will occur upon the achievement of certain milestones. When achievement of the milestone is deemed probable, we expense the compensation of the stock award over the implicit service period. Stock awards to non-employees are accounted for in accordance with ASC 505-50, Equity-Based Payments to Non-Employees |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company regularly reviews the carrying amount of its long-lived assets to determine whether indicators of impairment may exist that 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. |
Loss Contingencies | Loss Contingencies In accordance with ASC 450, Contingencies |
Income Taxes | Income Taxes The Company provides for income taxes under the liability method. The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial reporting and the tax bases of assets and liabilities measured using the enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to reflect the uncertainty associated with their ultimate realization. The Company accounts for uncertain tax positions recognized in the consolidated financial statements by applying a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. |
Guarantees | Guarantees The Company has identified the guarantees described below as disclosable, in accordance with ASC 460, Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that should limit its exposure and enable it to recover a portion of any future amounts paid. The Company is a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate the Company to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from the date of execution of the applicable agreement for a period equal to the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. For the three months ended March 31, 2019 and 2018, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible. As a result, no related reserves have been established. |
Issuance Costs Related to Equity and Debt | Issuance Costs Related to Equity and Debt The Company allocates issuance costs between the individual freestanding instruments identified on the same basis as proceeds were allocated. Issuance costs associated with the issuance of stock or equity contracts (i.e., equity-classified warrants and convertible preferred stock) are recorded as a charge against the gross proceeds of the offering. Any issuance costs associated with the issuance of liability-classified warrants are expensed as incurred. Issuance costs associated with the issuance of debt (i.e., convertible debt) is recorded as a direct reduction of the carrying amount of the debt liability but limited to the notional value of the debt. The Company accounts for debt as liabilities measured at amortized cost and amortizes the resulting debt discount to interest expense using the effective interest method over the expected term of the notes pursuant to ASC 835, Interest |
Embedded Conversion Features | Embedded Conversion Features The Company evaluates embedded conversion features within convertible debt under ASC 815 “Derivatives and Hedging” to determine whether the embedded conversion feature(s) should be bifurcated from the host instrument and accounted for as a derivative at fair value with changes in fair value recorded in earnings. If the conversion feature does not require derivative treatment under ASC 815, the instrument is evaluated under ASC 470-20 “Debt with Conversion and Other Options.” Under the ASC 470-20, an entity must separately account for the liability and equity components of the convertible debt instruments that may be settled entirely or partially in cash upon conversion in a manner that reflects the issuer’s economic interest cost. The effect of ASC 470-20 on the accounting for our convertible debt instruments is that the equity component is required to be included in the additional paid-in capital section of stockholders’ equity on the consolidated balance sheets and the value of the equity component is treated as original issue discount for purposes of accounting for the debt component of the notes. As a result, we are required to record non-cash interest expense as a result of the amortization of the discounted carrying value of the convertible debt to their face amount over the term of the convertible debt. We report higher interest expense in our financial results because ASC 470-20 requires interest to include both the current period’s amortization of the debt discount and the instrument’s coupon interest. For conventional convertible debt where the rate of conversion is below market value, the Company records a "beneficial conversion feature" ("BCF") and related debt discount. When the Company records a BCF, the relative fair value of the BCF is recorded as a debt discount against the face amount of the respective debt instrument (offset to additional paid in capital) and amortized to interest expense over the life of the debt. |
Subsequent Events | Subsequent Events The Company evaluates events occurring after the date of its consolidated balance sheet for potential recognition or disclosure in its consolidated financial statements. Other than the following, there have been no material subsequent events that occurred through the date the Company issued its consolidated financial statements that require disclosure in or adjustment to its consolidated financial statements. On April 22, 2019, the Company entered into a right of use lease (see Note 11). On April 30, 2019, the Company entered into an amendment to its 2017 Note and Warrant Purchase Agreement and its 2017 Senior Secured Convertible Promissory Note (see Note 10). On May 8, 2019, the Company entered into a Note and Warrant Purchase Agreement and issued a Senior Unsecured Convertible Promissory Note (see Notes 4 and 10). |
New Accounting Pronouncements | New Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), or ASU 2016-02. ASU 2016-02 requires that lessees recognize in the statement of financial position for all leases (with the exception of short-term leases) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis, and a right-of-use asset, which is an asset representing the lessee’s right to use the underlying asset for the lease term. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. Lessees must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Lessees may not apply a full retrospective transition approach. We have elected not to apply the guidance to short-term leases and the adoption of ASU 2016-02 has no impact on our consolidated financial statements as of December 31, 2018 and March 31, 2019 and for the three months ended March 31, 2019 and 2018. In September 2017, the FASB issued ASU No. 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments. Leases In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718) In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements affects a wide variety of topics, including the following: Amendments to Subtopic 220-10, Income Statement— Reporting Comprehensive Income—Overall relates to income taxes not payable in cash; Amendments to Subtopic 470-50, Debt—Modifications and Extinguishments relates to debt extinguishment and requires that the net carrying amount of extinguished fair value elected debt equals its fair value at reacquisition and related gains or losses in other comprehensive income must be included in net income upon extinguishment of the debt; Amendments to Subtopic 480-10, Distinguishing Liabilities from Equity—Overall relates to combinations of freestanding financial instruments with non-controlling interests; Amendments to Subtopic 718-740, Compensation—Stock Compensation—Income Taxes relate to recognition timing clarification for excess tax benefits or deficiencies for compensation expense; Amendments to Subtopic 805-740, Business Combinations— Income Taxes relate to allocating tax provisions to an acquired entity; Amendments to Subtopic 815-10, Derivatives and Hedging— Overall relate to accounting for offsetting derivatives; Amendments to Subtopic 820-10, Fair Value Measurement— Overall relate to the wording with respect to how transfer restrictions effect the fair value of an asset and adds explicit wording to allow entities to measure fair value on a net basis for those portfolios in which financial assets and financial liabilities and nonfinancial instruments are managed and valued together; Amendments to Subtopic 940-405, Financial Services—Brokers and Dealers—Liabilities relate to guidance about offsetting on the balance sheet; and Amendments to Subtopic 962-325, Plan Accounting—Defined Contribution Pension Plans—Investments—Other relate to plan evaluation of whether a readily determinable fair value exists to determine whether those investments may qualify for the practical expedient to measure at net asset value in accordance with Topic 820. The transition and selection of an effective date is based on the facts and circumstances of each amendment, but many of the amendments have transition guidance with effective dates for annual periods beginning after December 15, 2018, for public business entities. The Company is currently evaluating the relevance of each component and potential impact of ASU 2018-09 components on its consolidated financial statements. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842), Targeted Improvements In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement , or ASU 2018-13, which provides guidance focused on the disclosure requirements for disclosing fair value estimates, assumptions, and methodology. Removed requirements to disclose details around amount and reasoning for level 1 to level 2 transfers, timing policies for transfer between levels, and the valuation processes for level 3 fair value measurements. Modified requirements include details regarding net asset redemption restrictions and timing related to uncertainty disclosures. Added requirements to include disclosures of changes in unrealized gains and losses for recurring level 3 measurements held as of the reporting date and disclosures around the range and weighted average of significant inputs used to develop level 3 fair value measurements. These amendments are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of this Update. An entity is permitted to early adopt any removed or modified disclosures upon issuance of this Update and delay adoption of the additional disclosures until their effective date. The Company is currently evaluating the individual components and as these are disclosure refinements, expects no impact to its consolidated financial statements on adoption. In March 2019, the FASB issued ASU No. 2019-01, Leases (Topic 842), Codification Improvements |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Potentially Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of March 31, 2019 and 2018, as they would be anti-dilutive: Three Months Ended March 31, 2019 2018 Warrants to purchase common stock 3,552,672 28,532 Options to purchase common stock and other stock-based awards 1,545,719 1,668,219 Total 5,098,391 1,696,751 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Assets and Liabilities Measured on Recurring Basis | The following tables present the assets and liabilities the Company has measured at fair value on a recurring basis (in thousands): Fair Value Measurements at Reporting Date Using Quoted Prices Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Description March 31, 2019 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 4 $ 4 $ — $ — Total assets $ 4 $ 4 $ — $ — Liabilities Derivative liability $ 883 $ — $ — $ 883 Total liabilities $ 883 $ — $ — $ 883 Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Description December 31, 2018 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 1,097 $ 1,097 $ — $ — Total assets $ 1,097 $ 1,097 $ — $ — Liabilities Derivative liability $ 51 $ — $ — $ 51 Total liabilities $ 51 $ — $ — $ 51 |
Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Common Stock Warrants | The assumptions used in the Black-Scholes option pricing model to determine the fair value of the common stock warrants as of March 31, 2019, and December 31, 2018 were as follows: March 31, December 31, 2019 2018 Exercise price (A$55.00 at the then current exchange rate) $ 0.64 $ 0.64 Fair value of common stock $ 0.67 $ 0.57 Expected volatility 179.0 % 134.0 % Expected term (in years) 2.11 2.35 Risk-free interest rate 2.3 % 2.5 % Expected dividend yield — % — % |
Rollforward of Fair Value of Derivative Liabilities | The following table rolls forward the fair value of the Derivative Liabilities, where fair value is determined by Level 3 inputs (in thousands): Balance at December 31, 2018 $ 51 Increase in fair value of warrants upon re-measurement 1 Amortization of conversion rights (40 ) Fair value of warrants issued with 2019 Note 871 Balance at March 31, 2019 $ 883 |
Concentrations of Credit Risk_2
Concentrations of Credit Risk and Related Valuation Accounts (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Valuation And Qualifying Accounts [Abstract] | |
Rollforward of Allowance for Doubtful Accounts | The following is a rollforward of the Company’s allowance for doubtful accounts (in thousands): Three Months Ended March 31, 2019 2018 Beginning balance $ — $ 42 Net charges to expenses — 38 Utilization of allowances — (2 ) Ending balance $ — $ 78 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | Property and equipment consisted of the following (in thousands): March 31, December 31, 2019 2018 Laboratory and manufacturing equipment $ 591 $ 591 Computer equipment and software 1,187 1,182 Office furniture and equipment 183 183 1,961 1,956 Less accumulated depreciation and amortization (1,901 ) (1,893 ) Total $ 60 $ 63 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following (in thousands): March 31, December 31, 2019 2018 Payroll and related liabilities $ 167 $ 386 Professional fees 434 573 Credit refunds 167 186 Interest 211 494 Other 8 6 Total $ 987 $ 1,645 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | Stock-based compensation is reflected in the consolidated statements of operations as follows for the three months ended March 31, 2019 and 2018 (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 16 $ 5 Sales and marketing — 6 General and administrative 43 18 $ 59 $ 29 |
Weighted-average Assumptions used to Estimate Fair Value of Stock Options | The weighted-average assumptions used to estimate the fair value of employee stock options using the Black-Scholes option-pricing model were as follows for the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Expected volatility 122.0 % 114.9 % Expected term (in years) 6.05 6.05 Risk-free interest rate 2.3 % 2.6 % Expected dividend yield 0 % 0 % |
Share-Based Activity | The following table summarizes share-based activity under the Company’s stock option plans for the three months ended March 31, 2019: Shares of Common Stock Attributable to Options Weighted- Average Exercise Price Weighted- Average Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at December 31, 2018 985,224 $ 2.24 8.48 $ — Granted 160,000 $ — Exercised — $ — Cancelled — $ — Outstanding at March 31, 2019 1,145,224 $ 2.24 8.24 $ 1 Vested or expected to vest at March 31, 2019 1,145,224 $ 2.24 8.24 $ 1 Exercisable at March 31, 2019 451,805 $ 4.87 6.87 $ — |
Restricted Stock Units and Performance Stock Units Activity | The following table summarizes information related to RSU & PSU activity for the three months ended March 31, 2019: Number of Units Weighted- Average Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Outstanding at December 31, 2018 250,000 7.23 $ 141 Granted — Exercised — Cancelled — Outstanding at March 31, 2019 250,000 6.98 $ 186 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) $ / shares in Units, $ in Thousands | May 15, 2019USD ($) | Apr. 30, 2019 | Nov. 30, 2018 | Dec. 20, 2016USD ($)$ / sharesshares | Aug. 21, 2015 | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Nov. 30, 2018USD ($) | Sep. 30, 2018USD ($) | May 30, 2018USD ($) | Mar. 31, 2018USD ($) | Jan. 31, 2018USD ($) | Jun. 30, 2017USD ($) | Jan. 31, 2017USD ($)$ / sharesshares | May 31, 2014USD ($) | Sep. 30, 2011USD ($) | Aug. 31, 2013USD ($) | Mar. 31, 2019USD ($)Segment | Mar. 31, 2018USD ($)shares | Jun. 30, 2016USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2018USD ($) | Jan. 31, 2017$ / shares |
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Number of reportable segments | Segment | 1 | ||||||||||||||||||||||
Percentage of reducing headcount | 46.00% | ||||||||||||||||||||||
Non-recurring charges | $ 1,100 | ||||||||||||||||||||||
Issuance of shares, value | $ 1,600 | $ 1,600 | $ 30,800 | $ 72,500 | $ 52,500 | $ 1,503 | |||||||||||||||||
Repayment of convertible term promissory notes | $ 6,000 | ||||||||||||||||||||||
Common stock issued, price per share | (per share) | $ 0.83 | $ 0.022 | |||||||||||||||||||||
Private placement amount received | $ 1,000 | ||||||||||||||||||||||
Proceeds from issuance of common stock | $ 200 | 1,503 | |||||||||||||||||||||
Accumulated deficit | $ (269,490) | $ (267,159) | $ (269,490) | $ (267,159) | |||||||||||||||||||
Working capital deficit | (5,500) | (5,500) | |||||||||||||||||||||
Cash used in operating activities | (3,465) | (1,974) | |||||||||||||||||||||
Cash and cash equivalents | $ 1,286 | $ 3,806 | 1,286 | 3,806 | |||||||||||||||||||
2019 Warrant | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Maturity description | will expire on the fifth anniversary of the date of issuance. | ||||||||||||||||||||||
Tranche One | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Private placement amount received | $ 2,200 | ||||||||||||||||||||||
Tranche Two | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Private placement amount received | $ 2,800 | ||||||||||||||||||||||
Private Placement | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Issuance of shares, value | $ 5,000 | ||||||||||||||||||||||
Private placement amount received | 6,610 | ||||||||||||||||||||||
2017 Senior Secured Convertible Promissory Note | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Debt principal amount | $ 5,000 | ||||||||||||||||||||||
Interest rate during period | 5.00% | ||||||||||||||||||||||
Maturity Date | Dec. 31, 2018 | May 1, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | |||||||||||||||||||
Accrued interest | $ 394 | $ 394 | |||||||||||||||||||||
2017 Senior Secured Convertible Promissory Note | Subsequent Event | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Maturity Date | Apr. 30, 2019 | ||||||||||||||||||||||
2018 Senior Secured Convertible Promissory Note and Warrant | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Debt principal amount | $ 1,750 | ||||||||||||||||||||||
Maturity Date | May 30, 2023 | ||||||||||||||||||||||
2018 Senior Secured Convertible Promissory Note | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Interest rate during period | 10.00% | ||||||||||||||||||||||
2019 Senior Secured Convertible Promissory Note and Warrant | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Debt principal amount | $ 1,000 | $ 1,000 | |||||||||||||||||||||
2019 Senior Secured Convertible Promissory Note and Warrant | Subsequent Event | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Debt principal amount | $ 3,000 | ||||||||||||||||||||||
Maturity description | will expire on the fifth anniversary of the Full Funding Date. | ||||||||||||||||||||||
Debt payment terms | The $3.0 million payment will be made in several tranches. | ||||||||||||||||||||||
2019 Senior Secured Convertible Promissory Note | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Interest rate during period | 10.00% | ||||||||||||||||||||||
Maturity Date | Mar. 15, 2024 | ||||||||||||||||||||||
2019 Senior Secured Convertible Promissory Note | Subsequent Event | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Interest rate during period | 10.00% | ||||||||||||||||||||||
Common stock | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Issuance of shares, value | $ 12 | ||||||||||||||||||||||
Stock issued, shares | shares | 1,397,300 | 249,632 | 1,175,612 | ||||||||||||||||||||
CHESS Depositary Interests | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Stock issued, shares | shares | 69,865,000 | 12,481,600 | |||||||||||||||||||||
Common stock issued, price per share | $ / shares | $ 0.022 | ||||||||||||||||||||||
Restructuring Charges | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Non-recurring charges | $ 400 | ||||||||||||||||||||||
Employee Severance | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Non-recurring charges | 600 | ||||||||||||||||||||||
Facility Closing | |||||||||||||||||||||||
Nature Of Operations [Line Items] | |||||||||||||||||||||||
Non-recurring charges | $ 100 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Basis of Presentations - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Restricted cash | $ 30,000 | $ 30,000 | |
Inventory, net | 0 | 0 | |
General and administrative | 1,344,000 | $ 1,185,000 | |
Patents | |||
Summary Of Significant Accounting Policies [Line Items] | |||
General and administrative | 0 | $ 0 | |
Cash and Cash Equivalents | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Cash equivalents | $ 4,000 | $ 1,100,000 |
Potentially Dilutive Securities
Potentially Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares (Detail) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 5,098,391 | 1,696,751 |
Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 3,552,672 | 28,532 |
Options to purchase common stock and other stock-based awards | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,545,719 | 1,668,219 |
Warrants to Purchase Common S_2
Warrants to Purchase Common Stock and CDIs - Additional Information (Detail) - $ / shares | May 08, 2019 | Mar. 15, 2019 | May 04, 2016 | Mar. 31, 2019 | May 30, 2018 |
2018 Senior Secured Convertible Promissory Note and Warrant | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant expiration date | May 30, 2023 | ||||
2018 Senior Secured Convertible Promissory Note and Warrant | CHESS Depositary Interests | |||||
Class of Warrant or Right [Line Items] | |||||
Common stock warrants, shares issued | 97,222,200 | ||||
Common stock warrant, exercise price | $ 0.018 | ||||
2019 Senior Unsecured Convertible Promissory Note and Warrant | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant expiration description | will expire (if issued) on the fifth anniversary of the date of issuance | ||||
2019 Senior Unsecured Convertible Promissory Note and Warrant | CHESS Depositary Interests | |||||
Class of Warrant or Right [Line Items] | |||||
Common stock warrants, shares issued | 78,984,823 | ||||
Common stock warrant, exercise price | $ 0.0127 | ||||
2019 Convertible Promissory Note and Warrant | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant expiration description | will expire on the fifth anniversary of the Full Funding Date | ||||
2019 Convertible Promissory Note and Warrant | CHESS Depositary Interests | |||||
Class of Warrant or Right [Line Items] | |||||
Common stock warrants, shares issued | 236,220,472 | ||||
Common stock warrant, exercise price | $ 0.0127 | ||||
Common stock | 2018 Senior Secured Convertible Promissory Note and Warrant | |||||
Class of Warrant or Right [Line Items] | |||||
Common stock warrants, shares issued | 1,944,444 | ||||
Common stock | 2019 Senior Unsecured Convertible Promissory Note and Warrant | |||||
Class of Warrant or Right [Line Items] | |||||
Common stock warrants, shares issued | 1,579,696 | ||||
Common stock | 2019 Convertible Promissory Note and Warrant | |||||
Class of Warrant or Right [Line Items] | |||||
Common stock warrants, shares issued | 4,724,409 | ||||
Consulting Agreement | Consultant Warrant | |||||
Class of Warrant or Right [Line Items] | |||||
Common stock warrants, shares issued | 28,532 | ||||
Common stock warrant, exercise price | $ 0.64 | ||||
Warrant vested, expiration date | May 4, 2021 | ||||
Common stock warrant, share reserved | 28,532 | ||||
Common stock warrant, shares exercised | 0 |
Fair Value of Assets and Liabil
Fair Value of Assets and Liabilities Measured on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | $ 4 | $ 1,097 |
Derivative liability | 883 | 51 |
Total liabilities | 883 | 51 |
Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 4 | 1,097 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 4 | 1,097 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 4 | 1,097 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability | 883 | 51 |
Total liabilities | $ 883 | $ 51 |
Assumptions Used in the Black-S
Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Common Stock Warrants (Detail) | Mar. 31, 2019$ / shares$ / shares | Dec. 31, 2018$ / shares$ / shares |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Fair value of common stock | $ 0.67 | $ 0.57 |
Exercise Price | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Valuation assumptions measurement input | 55 | 55 |
Expected Volatility | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Valuation assumptions measurement input | 179 | 134 |
Expected Term | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Valuation assumptions expected term | 2 years 1 month 9 days | 2 years 4 months 6 days |
Risk-free Interest Rate | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Valuation assumptions measurement input | 2.3 | 2.5 |
Expected Dividend Yield | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Valuation assumptions measurement input | 0 | 0 |
Assumptions Used in the Black_2
Assumptions Used in the Black-Scholes Option Pricing Model to Determine the Fair Value of the Common Stock Warrants (Parenthetical) (Detail) | Mar. 31, 2019$ / shares | Mar. 31, 2019$ / shares | Dec. 31, 2018$ / shares | Dec. 31, 2018$ / shares |
Exercise Price | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Valuation assumptions measurement input | 0.64 | 55 | 0.64 | 55 |
Rollforward of Fair Value of De
Rollforward of Fair Value of Derivative Liabilities (Detail) - Derivative Liabilities $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Beginning balance | $ 51 |
Increase in fair value of warrants upon re-measurement | 1 |
Amortization of conversion rights | (40) |
Fair value of warrants issued with 2019 Note | 871 |
Ending balance | $ 883 |
Concentrations of Credit Risk_3
Concentrations of Credit Risk and Related Valuation Accounts - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2019 | Dec. 31, 2018 | |
Valuation And Qualifying Accounts [Abstract] | |||
Write-offs of uncollectible accounts receivable | $ 38,000 | ||
Accounts receivable | $ 0 | $ 0 | |
Reserves for uncollectible accounts receivable | $ 0 | $ 0 |
Rollforward of Allowance for Do
Rollforward of Allowance for Doubtful Accounts (Detail) - Allowance for Doubtful Accounts $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Valuation and Qualifying Accounts Disclosure [Line Items] | |
Beginning balance | $ 42 |
Net charges to expenses | 38 |
Utilization of allowances | (2) |
Ending balance | $ 78 |
Inventory - Additional Informat
Inventory - Additional Information (Detail) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Inventory, net | $ 0 | $ 0 |
Inventory reserve | $ 0 | $ 0 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Property Plant and equipment gross | $ 1,961 | $ 1,956 |
Less accumulated depreciation and amortization | (1,901) | (1,893) |
Total | 60 | 63 |
Laboratory and manufacturing equipment | ||
Property Plant And Equipment [Line Items] | ||
Property Plant and equipment gross | 591 | 591 |
Computer equipment and software | ||
Property Plant And Equipment [Line Items] | ||
Property Plant and equipment gross | 1,187 | 1,182 |
Office furniture and equipment | ||
Property Plant And Equipment [Line Items] | ||
Property Plant and equipment gross | $ 183 | $ 183 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |||
Depreciation and amortization expense | $ 8,000 | $ 11,000 | |
Assets under capital leases | $ 0 | $ 0 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Payroll and related liabilities | $ 167 | $ 386 |
Professional fees | 434 | 573 |
Credit refunds | 167 | 186 |
Interest | 211 | 494 |
Other | 8 | 6 |
Total | $ 987 | $ 1,645 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | May 15, 2019 | Apr. 30, 2019 | Mar. 15, 2019 | Dec. 31, 2018 | Jun. 15, 2017 | Mar. 31, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2017 | May 30, 2018 |
Debt Instrument [Line Items] | ||||||||||
Accrued interest expense | $ 494 | $ 211 | $ 211 | |||||||
Amortization of the issuance costs | $ 18 | |||||||||
2018 Warrant | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Estimated fair value of warrant | 743 | 743 | ||||||||
March 2019 Warrant | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Estimated fair value of warrant | $ 871 | $ 871 | ||||||||
2018 Senior Unsecured Convertible Promissory Note | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 1,750 | |||||||||
Interest rate during period | 10.00% | |||||||||
Interest rate during default | 16.00% | 16.00% | ||||||||
Maturity Date | May 30, 2023 | |||||||||
Debt instrument, convertible, beneficial conversion feature | $ 1,200 | |||||||||
Debt instrument, effective interest rate | 26.40% | 26.40% | ||||||||
Interest expense | $ 44 | |||||||||
Amortization of debt discount | 72 | |||||||||
2018 Senior Unsecured Convertible Promissory Note and Warrant | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument, convertible, beneficial conversion feature | $ 1,000 | |||||||||
March 2019 Senior Unsecured Convertible Promissory Note | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 1,000 | |||||||||
Interest rate during period | 10.00% | |||||||||
Interest rate during default | 16.00% | 16.00% | ||||||||
Maturity Date | Mar. 15, 2024 | |||||||||
Debt issuance costs | $ 50 | $ 50 | ||||||||
Debt instrument, effective interest rate | 29.40% | 29.40% | ||||||||
Subsequent Event | May 2019 Senior Secured Convertible Promissory Note and Warrant | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 3,000 | |||||||||
Maturity description | will expire on the fifth anniversary of the Full Funding Date. | |||||||||
Debt payment terms | The $3.0 million payment will be made in several tranches. | |||||||||
Subsequent Event | May 2019 Senior Secured Convertible Promissory Note | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate during period | 10.00% | |||||||||
Chess Deposit Interest | 2018 Warrant | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrant to purchase CDIs | 97,222,200 | |||||||||
Warrant initial exercise price per CDI | $ 0.018 | |||||||||
Warrant expiration date | May 30, 2023 | |||||||||
Chess Deposit Interest | March 2019 Warrant | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrant to purchase CDIs | 78,984,823 | |||||||||
Warrant initial exercise price per CDI | $ 0.0127 | |||||||||
Warrant expiration description | warrant expires on the fifth anniversary of the date of issuance | |||||||||
Chess Deposit Interest | 2018 Senior Unsecured Convertible Promissory Note | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument conversion ratio | 0.02 | |||||||||
Debt instrument conversion description | The entire outstanding principal balance under the 2018 Note and all unpaid accrued interest thereon is convertible into CHESS Depositary Interests (“CDIs”), each representing 1/50th of a share of the Company’s common stock, at the option of the Purchaser at a conversion price of US$0.018 per CDI. In the event that the Borrower issues additional CDIs in a subsequent equity financing at a price per CDI that is less than US$0.018, the conversion price of the 2018 Note will adjust to the lower CDI conversion price. In addition, upon a change of control of the Company, the Purchaser may demand prepayment of accrued and unpaid interest plus 110% of the remaining outstanding unconverted principal balance of the 2018 Note. | |||||||||
Percentage of remaining outstanding unconverted principal payment obligation upon change of control | 110.00% | 110.00% | ||||||||
Debt instrument conversion price per CDI | $ 0.018 | $ 0.018 | ||||||||
Chess Deposit Interest | March 2019 Senior Unsecured Convertible Promissory Note | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument conversion ratio | 0.02 | |||||||||
Debt instrument conversion description | The entire outstanding principal balance under the March 2019 Note and all unpaid accrued interest thereon is convertible into CHESS Depositary Interests (“CDIs”), each representing 1/50th of a share of the Company’s common stock, at the option of the Purchaser at a conversion price of US$0.0127 per CDI. In the event that the Borrower issues additional CDIs in a subsequent equity financing at a price per CDI that is less than US$0.0127, the conversion price of the March 2019 Note will adjust to the lower CDI conversion price. In addition, upon a change of control of the Company, the Purchaser may demand prepayment of accrued and unpaid interest plus 110% of the remaining outstanding unconverted principal balance of the March 2019 Note. | |||||||||
Percentage of remaining outstanding unconverted principal payment obligation upon change of control | 110.00% | 110.00% | ||||||||
Debt instrument conversion price per CDI | $ 0.0127 | $ 0.0127 | ||||||||
2017 Senior Secured Convertible Promissory Note | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt principal amount | $ 5,000 | |||||||||
Interest rate during period | 5.00% | |||||||||
Interest rate during default | 8.00% | 8.00% | ||||||||
Maturity Date | Mar. 31, 2019 | Dec. 31, 2018 | May 1, 2019 | |||||||
Debt issuance costs | $ 115 | |||||||||
Accrued interest expense | $ 62 | $ 62 | 62 | $ 136 | ||||||
Amortization of the issuance costs | $ 18 | $ 44 | ||||||||
Accrued interest | $ 394 | |||||||||
Increase in debt discount liability | $ 40 | $ 14 | ||||||||
Interest expense related to change in derivative liabilities | $ 40 | |||||||||
2017 Senior Secured Convertible Promissory Note | Subsequent Event | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Maturity Date | Jul. 1, 2019 | |||||||||
2017 Senior Secured Convertible Promissory Note | Chess Deposit Interest | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument conversion ratio | 0.02 | |||||||||
Qualified financing least amount raised | $ 10,000 | |||||||||
Debt instrument conversion description | The entire outstanding principal balance under the 2017 Note and all unpaid accrued interest thereon is convertible into CHESS Depositary Interests (“CDIs”), each representing 1/50th of a share of the Company’s common stock, (i) prior to the maturity date, at the option of the Purchaser at a conversion price calculated based on the five-day volume weighted average price of the Company’s CDIs on the ASX (“Optional Conversion Price”), or (ii) automatically upon the occurrence of an equity financing in which the Company raises at least $10 million (a “Qualified Financing”) at the price per CDI of the CDIs issued and sold in such financing. | |||||||||
Percentage of remaining outstanding unconverted principal payment obligation upon change of control | 110.00% | 110.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | May 01, 2019USD ($)ft² | Dec. 31, 2018ft² | Jun. 30, 2016USD ($)ft² | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) |
Loss Contingencies [Line Items] | |||||
Rentable area of leased premises | ft² | 4,200 | ||||
Lease commencement month and year | 2016-06 | ||||
Lease expiration month and year | 2018-04 | ||||
Rent expense | $ | $ 12 | $ 56 | $ 37 | ||
Future minimum lease payments | $ | $ 36 | ||||
Subsequent Event | |||||
Loss Contingencies [Line Items] | |||||
Rentable area of leased premises | ft² | 3,520 | ||||
Lease commencement date | May 1, 2019 | ||||
Lease expiration date | May 31, 2022 | ||||
Operating lease liability | $ | $ 643 | ||||
WeWork | |||||
Loss Contingencies [Line Items] | |||||
Rentable area of leased premises | ft² | 985 | ||||
Lease expiration month and year | 2019-05 | ||||
Lease cancellation provision term | 2 months |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) - Additional Information (Detail) $ / shares in Units, $ in Thousands | Oct. 29, 2018USD ($)shares | Sep. 20, 2018USD ($)shares | Feb. 27, 2018USD ($)shares | Jan. 22, 2018USD ($)shares | Dec. 20, 2016USD ($)$ / sharesshares | Nov. 30, 2018USD ($)$ / shares | Sep. 30, 2018USD ($) | Jan. 31, 2017$ / sharesshares | Nov. 30, 2018$ / sharesshares | Mar. 31, 2018$ / sharesshares | Dec. 31, 2018USD ($)PrivatePlacementshares | Mar. 31, 2019shares | May 22, 2017shares | Jan. 31, 2017$ / shares | Dec. 31, 2016shares |
Class of Stock [Line Items] | |||||||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | 13,000,000 | |||||||||||
Capital stock, shares authorized | 50,500,000 | ||||||||||||||
Preferred stock, shares authorized | 500,000 | 500,000 | |||||||||||||
Common stock issued, price per share | (per share) | $ 0.83 | $ 0.022 | |||||||||||||
Private placement amount received | $ | $ 1,000 | ||||||||||||||
Common stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 1,397,300 | 249,632 | 1,175,612 | ||||||||||||
CHESS Depositary Interests | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 69,865,000 | 12,481,600 | |||||||||||||
Common stock issued, price per share | $ / shares | $ 0.022 | ||||||||||||||
Tranche One | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Private placement amount received | $ | $ 2,200 | ||||||||||||||
Tranche Two | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Private placement amount received | $ | $ 2,800 | ||||||||||||||
First Quarter 2018 Placement | Common stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 8,120,057 | ||||||||||||||
First Quarter 2018 Placement | CHESS Depositary Interests | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 406,002,869 | ||||||||||||||
Common stock issued, price per share | $ / shares | $ 0.035 | ||||||||||||||
First Quarter 2018 Placement | Tranche One | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Private placement amount received | $ | $ 781 | ||||||||||||||
Stock issuance costs | $ | $ 63 | ||||||||||||||
First Quarter 2018 Placement | Tranche One | Common stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 569,341 | ||||||||||||||
First Quarter 2018 Placement | Tranche One | CHESS Depositary Interests | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 28,467,063 | ||||||||||||||
First Quarter 2018 Placement | Tranche Two | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Private placement amount received | $ | $ 824 | ||||||||||||||
Stock issuance costs | $ | $ 39 | ||||||||||||||
First Quarter 2018 Placement | Tranche Two | Common stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 606,271 | ||||||||||||||
First Quarter 2018 Placement | Tranche Two | CHESS Depositary Interests | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 30,313,556 | ||||||||||||||
First Quarter 2018 Placement | Tranche Two | CHESS Depositary Interests | Board Member | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 2,921,800 | ||||||||||||||
First Quarter 2018 Placement | Tranche Two | CHESS Depositary Interests | Crystal Amber Fund | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 27,391,756 | ||||||||||||||
Private Placement | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Private placement amount received | $ | $ 6,610 | ||||||||||||||
Number of private placements | PrivatePlacement | 2 | ||||||||||||||
Autumn 2018 Placement | Common stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 6,944,445 | ||||||||||||||
Autumn 2018 Placement | CHESS Depositary Interests | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 347,222,250 | ||||||||||||||
Autumn 2018 Placement | CHESS Depositary Interests | Existing Investors | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Common stock issued, price per share | $ / shares | $ 0.020 | $ 0.020 | |||||||||||||
Autumn 2018 Placement | Tranche One | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Private placement amount received | $ | $ 2,200 | ||||||||||||||
Stock issuance costs | $ | $ 56 | ||||||||||||||
Autumn 2018 Placement | Tranche One | Common stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 3,000,000 | ||||||||||||||
Autumn 2018 Placement | Tranche One | CHESS Depositary Interests | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 150,000,000 | ||||||||||||||
Autumn 2018 Placement | Tranche Two | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Private placement amount received | $ | $ 2,800 | ||||||||||||||
Autumn 2018 Placement | Tranche Two | Common stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 3,944,445 | ||||||||||||||
Autumn 2018 Placement | Tranche Two | CHESS Depositary Interests | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 197,222,250 | ||||||||||||||
Autumn 2018 Placement | Tranche Two | CHESS Depositary Interests | Existing Investors | United States | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 23,819,450 | ||||||||||||||
Autumn 2018 Placement | Tranche Two | CHESS Depositary Interests | Existing Investors | Australia | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 5,208,350 | ||||||||||||||
Autumn 2018 Placement | Tranche Two | CHESS Depositary Interests | Crystal Amber Fund | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Stock issued, shares | 168,194,450 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) | 3 Months Ended | |||||
Mar. 31, 2019USD ($)CompensationPlanshares | Mar. 31, 2018USD ($)shares | Dec. 31, 2018shares | Aug. 31, 2011shares | Aug. 01, 2011shares | May 31, 2003shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of stock-based compensation plans | CompensationPlan | 2 | |||||
Annual increase in number of shares available for grant | 500,000 | |||||
Percentage of common shares outstanding | 4.00% | |||||
Number of shares available for issue, additional shares | 500,000 | |||||
Stock options, vesting period | 4 years | |||||
Stock options, expire period | 10 years | |||||
Unrecognized stock-based compensation | $ | $ 637,000 | |||||
Recognized weighted-average period years | 2 years 3 months 18 days | |||||
Stock-based compensation expense | $ | $ 59,000 | $ 29,000 | ||||
Restricted Stock Units (RSUs) and Performance Stock Units (PSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares of common stock to be received, per restricted stock unit and performance stock unit | 1 | |||||
Restricted stock units outstanding | 250,000 | 250,000 | ||||
Restricted Stock Units (RSUs) and Performance Stock Units (PSUs) Subject to Performance-based Vesting | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Restricted stock units outstanding | 0 | 0 | ||||
Stock-based compensation expense | $ | $ 0 | $ 0 | ||||
Performance Shares | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized stock based compensation | $ | $ 140,000 | |||||
Stock Incentive Plan 2003 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for future grants | 922,086 | |||||
Stock Incentive Plan 2011 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for future grants | 1,748,812 | 80,235 | ||||
Share reserved for incentive plan | 450,000 |
Stock-Based compensation Reflec
Stock-Based compensation Reflected in Consolidated Statements of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 59 | $ 29 |
Research and Development | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 16 | 5 |
Sales and Marketing | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 6 | |
General and Administrative | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 43 | $ 18 |
Weighted-average Assumptions us
Weighted-average Assumptions used to Estimate Fair Value of Stock Options (Detail) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Expected volatility | 122.00% | 114.90% |
Expected term (in years) | 6 years 18 days | 6 years 18 days |
Risk-free interest rate | 2.30% | 2.60% |
Expected dividend yield | 0.00% | 0.00% |
Share-Based Activity (Detail)
Share-Based Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Options | ||
Outstanding, beginning balance | 985,224 | |
Granted | 160,000 | |
Exercised | 0 | |
Cancelled | 0 | |
Outstanding, ending balance | 1,145,224 | 985,224 |
Vested or expected to vest at March 31, 2019 | 1,145,224 | |
Exercisable at March 31, 2019 | 451,805 | |
Weighted Average Exercise Price | ||
Outstanding, beginning balance | $ 2.24 | |
Granted | 0 | |
Exercised | 0 | |
Cancelled | 0 | |
Outstanding, ending balance | 2.24 | $ 2.24 |
Vested or expected to vest at March 31, 2019 | 2.24 | |
Exercisable at March 31, 2019 | $ 4.87 | |
Weighted Average Contractual Life (in Years) | ||
Outstanding at end of period | 8 years 2 months 26 days | 8 years 5 months 23 days |
Vested or expected to vest at March 31, 2019 | 8 years 2 months 26 days | |
Exercisable at March 31, 2019 | 6 years 10 months 13 days | |
Aggregate Intrinsic Value | ||
Outstanding at end of period | $ 1 | $ 0 |
Vested or expected to vest at March 31, 2019 | 1 | |
Exercisable at March 31, 2019 | $ 0 |
Restricted Stock Units and Perf
Restricted Stock Units and Performance Stock Units Activity (Detail) - Restricted Stock Units (RSUs) and Performance Stock Units (PSUs) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Number of Units | ||
Outstanding, beginning balance | 250,000 | |
Granted | 0 | |
Exercised | 0 | |
Cancelled | 0 | |
Outstanding, ending balance | 250,000 | 250,000 |
Weighted Average Contractual Life (in years) | ||
Outstanding at end of period | 6 years 11 months 23 days | 7 years 2 months 23 days |
Aggregate Intrinsic Value | ||
Outstanding Aggregate Intrinsic Value | $ 186 | $ 141 |
Segment Reporting - Additional
Segment Reporting - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2019USD ($)Segment | Mar. 31, 2018USD ($) | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Number of reportable segments | Segment | 1 | |
Long-lived assets | $ 60,000 | |
Revenues | 0 | $ 0 |
Major Customers | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 0 | $ 0 |